Ijcp november 2017

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Volume 28, Number 6

November 2017, Pages 501–600

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yy American Family Physician yy Community Medicine yy Dermatology yy Diabetology yy Neurology yy Obstetrics and Gynecology yy Oncology yy Surgery

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yy Conference Proceedings

Phly Physic y l mi ami

yy Expert View yy Medilaw

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yy Around the Globe

er merican m A eA

yy Inspirational story

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yy Lighter Reading

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IJCP Group of Publications

Volume 28, Number 6, November 2017

Dr Sanjiv Chopra Group Consultant Editor Dr Deepak Chopra Chief Editorial Advisor

Dr KK Aggarwal Padma Shri Awardee Group Editor-in-Chief Dr Veena Aggarwal Group Executive Editor

IJCP Editorial Board Obstetrics and Gynaecology Dr Alka Kriplani, Dr Thankam Verma, Dr Kamala Selvaraj Cardiology Dr Praveen Chandra, Dr SK Parashar Paediatrics Dr Swati Y Bhave Diabetology Dr CR Anand Moses, Dr Sidhartha Das, Dr A Ramachandran, Dr Samith A Shetty, Dr Vijay Viswanathan, Dr V Mohan, Dr V Seshiah, Dr Vijayakumar ENT Dr Jasveer Singh, Dr Chanchal Pal Dentistry Dr KMK Masthan, Dr Rajesh Chandna Gastroenterology Dr Ajay Kumar, Dr Rajiv Khosla, Dr JS Rajkumar Dermatology Dr Hasmukh J Shroff, Dr Pasricha, Dr Koushik Lahiri, Dr Jayakar Thomas Nephrology Dr Georgi Abraham Neurology Dr V Nagarajan, Dr Vineet Suri, Dr AV Srinivasan Oncology Dr V Shanta Orthopedics Dr J Maheshwari

Anand Gopal Bhatnagar Editorial Anchor Advisory Bodies Heart Care Foundation of India Non-Resident Indians Chamber of Commerce & Industry World Fellowship of Religions

This journal is indexed in IndMED (http://indmed.nic.in) and full-text of articles are included in medIND databases (http://mednic.in) hosted by National Informatics Centre, New Delhi.

from the desk of THE group editor-in-chief

505 IMA Led Two Major Revision Policies on TB and HIV-AIDS Passed by World Medical Association Annual General Assembly

KK Aggarwal

American Family Physician

512 Exercise Stress Testing: Indications and Common Questions

Kathryn K. Garner, William Pomeroy, James J. Arnold

518 Practice Guidelines 520 Photo Quiz COMMUNITY MEDICINE

522 Effectiveness of Teaching Standardized Protocol on Safe Medication Administration Process Upon the Level of Knowledge Among Nurses at a Tertiary Care Hospital, Chennai

Kasthuri P, N Chidambaranathan, Latha Venkatesan

DERMATOLOGY

529 Clinical Survey on Alopecia: A Dermatologist’s Perspective on Choice of Medical Therapy and Patient’s Expectations

SN Charugulla

DIABETOLOGY

539 Fasting Serum Magnesium Levels in Patients with Uncontrolled and Controlled T2DM in Relation to Its Complications

Shashidhar G, Suraj R Bhutada, Manjunath U, Prashanth Gk, Vinodh

NEUROLOGY

544 Guillain-Barré Syndrome - Sensory Ataxic Variant: A Rare Case Report

Deepika Sagar

546 A Study of Clinical Profile of Hyperglycemic Seizures

P Balamurugan, Cj Selvakumar, Anoop Paulose

OBSTETRICS and GYNECOLOGY

550 Wilson’s Disease in Pregnancy: A Case Report

Shreyasi Bid, Sambhunath Bandyopadhyay, Anik Das, Srijani Chowdhury

556 Prevalence of Reproductive Tract Infections/ Sexually Transmitted Infections Among Women in a Tertiary Care Hospital: An Observational Study

Published, Printed and Edited by Dr KK Aggarwal, on behalf of IJCP Publications Ltd. and Published at E - 219, Greater Kailash Part - 1 New Delhi - 110 048 E-mail: editorial@ijcp.com

Ruby Bhatia, Parmjit Kaur, Santosh Kumari, Aman Dev

ONCOLOGY

560 Repeatedly Recurrent Supernumerary Bilateral Fibroadenoma Breast with Family History of Breast Cancer in a Young Girl: A Surgeon’s Dilemma

Printed at New Edge Communications Pvt. Ltd., New Delhi E-mail: edgecommunication@gmail.com Copyright 2017 IJCP Publications Ltd. All rights reserved.

The copyright for all the editorial material contained in this journal, in the form of layout, content including images and design, is held by IJCP Publications Ltd. No part of this publication may be published in any form whatsoever without the prior written permission of the publisher.

Somendra M Sharma, Disha Sharma, B Ananda

SURGERY

565 Comparison of Pulmonary Functions Following Elective Laparoscopic Cholecystectomy and Other Upper Abdominal Surgeries

Editorial Policies The purpose of IJCP Academy of CME is to serve the medical profession and provide print continuing medical education as a part of their social commitment. The information and opinions presented in IJCP group publications reflect the views of the authors, not those of the journal, unless so stated. Advertising is accepted only if judged to be in harmony with the purpose of the journal; however, IJCP group reserves the right to reject any advertising at its sole discretion. Neither acceptance nor rejection constitutes an endorsement by IJCP group of a particular policy, product or procedure. We believe that readers need to be aware of any affiliation or financial relationship (employment, consultancies, stock ownership, honoraria, etc.) between an author and any organization or entity that has a direct financial interest in the subject matter or materials the author is writing about. We inform the reader of any pertinent relationships disclosed. A disclosure statement, where appropriate, is published at the end of the relevant article.

Gaurav Gupta, Ashish Garg, Ranjeet Singh Virk, Kamal Bagdi

CONFERENCE Proceedings

573 45th Annual Meeting of the Research Society for the Study of Diabetes in India (RSSDI 2017) Expert View

582 What is the Role of Biomarker Assay in Evaluation of Heart Failure Patients?

HK Chopra

Medilaw

584 What are the Principles of Natural Justice?

AROUND THE GLOBE

585 News and Views Inspirational story

Note: Indian Journal of Clinical Practice does not guarantee, directly or indirectly, the quality or efficacy of any product or service described in the advertisements or other material which is commercial in nature in this issue.

594 Depend on Miracles Lighter reading

595 Lighter Side of Medicine

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from the desk of THE group editor-in-chief

Dr KK Aggarwal

Padma Shri Awardee National President, IMA Group Editor-in-Chief, IJCP Group

IMA Led Two Major Revision Policies on TB and HIV-AIDS Passed by World Medical Association Annual General Assembly

T

he World Medical Association (WMA) periodically develops policies and resolutions covering a wide range of diverse subjects, of significance to human health and also of importance to physicians world over. These documents give ethical guidance to physicians and also serve as a guide to National Medical Associations (NMAs) in their policy making.

The policies and resolutions are revised based on new evidence or knowledge gained on a particular subject.

There are two types of Revisions: Minor revision (done any time) and major revision (done after every 10 years).

The WMA sends the document under consideration for revision to all its member national medical associations as a standard practice. One NMA volunteers to become the revision coordinating body for that document.

The WMA currently has 112 NMAs as its members.

All member countries/NMAs can raise their national issues even including work conditions of their Resident Doctors e.g., duty hours, etc. through the International bodies. When these International bodies raise an issue even if it relates to individual countries or segments, all member countries follow-up such matters with the relevant related authorities in those country(ies)/ Segment(s), creating a huge impact on the early resolution of the issue.

The Indian Medical Association (IMA) led two major revisions policies on behalf of WMA on human

immunodeficiency virus and acquired immune deficiency syndrome (HIV-AIDS) and tuberculosis (TB).

As the coordinating NMA for both these resolutions, suggestions from all member NMAs were sent to IMA, who compiled and finalized the resolutions. The WMA passed and adopted the two resolutions on TB and HIV-AIDS, after undergoing major revisions in the Annual General Assembly in Chicago held from October 11-14, 2017.

Both these Resolutions on TB and HIV-AIDS were first adopted in October 2006 by the WMA Annual General Assembly in South Africa.

WMA Resolution on TB Adopted by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006 and revised by the 68th WMA General Assembly, Chicago, United States, October 2017

Preamble 1. According to the World Health Organization (WHO), TB is a significant global public health problem. South-East Asian and African countries are most affected.

2. In developing countries, the incidence of TB has risen dramatically because of high prevalence of HIV/AIDS, increasing migration of populations,

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from the desk of THE group editor-in-chief urbanization and over-crowding. The incidence and severity of the disease is closely associated with the social and economic living conditions within a population.

3. The emergence of strains of TB bacteriaresistant to first-line drugs have become a major public health threat in the forms of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDRTB). MDR-TB and XDR-TB are indicators of the growing antimicrobial resistance whose drivers are multifactorial and complex and require a multisectoral approach. MDR-TB and XDR-TB is a significant threat to development and the safety of global health.

4. Community awareness and public health education and promotion are essential elements of tuberculosis prevention.

5. Screening of high risk groups including PLHIV (people living with HIV) and vulnerable populations including migrants, prisoners and the homeless should be considered within each national epidemiological context as a component of TB prevention. Systematic screening of contacts of infected persons is also recommended.

10. The WMA supports the WHO “End TB Strategy” and its visions, goals and milestones.

11. The WMA supports calls for adequate financial, material and human resources for TB and HIV/AIDS research and prevention, including adequately trained healthcare providers and adequate public health infrastructure, and will participate with health professionals in providing information on TB and its treatment.

12. Healthcare professionals should have access to all required medical and protective equipment to guard against the risk of infection and spread of the disease.

13. The WMA encourages continuing efforts to build-up the capacity of healthcare professionals in the use of rapid diagnostics methods, their availability in the public and private sector and in the management of all forms of TB, including MDR and XDR. 14. The WMA calls on NMAs to support their National TB Programs by generating awareness among healthcare professionals about TB management and early reporting of cases in the community.

6. Rapid diagnosis with molecular tests and supervised daily treatment started early should help arrest the spread of disease.

15. The WMA calls on NMAs to promote methods of TB prevention including respiratory hygiene, cough etiquettes, and safe sputum disposal.

7. BCG (Bacille Calmette-Guérin) vaccination as early as possible after birth should continue, in line with International Union against Tuberculosis and Lung Disease (IUATLD) criteria, until a new more effective vaccine is available.

16. NMAs should encourage their members to notify in a timely manner to relevant authorities, about all patients diagnosed with TB or put on TB treatment for initiation of contact screening and adequate follow-up till the completion of treatment.

8. Intensified research and innovation is also considered imperative if attempts to address the epidemic and emerging resistance are to be successful.

17. In addition, NMAs should encourage the development of strong pharmacovigilance and active TB drug-safety monitoring and management, to detect, manage and report suspected or confirmed drug toxicities, and encourage all their members to contribute actively to these systems.

Recommendations 9. The WMA, in consultation with WHO and national and international health authorities and organizations, will continue its work to generate community awareness about symptoms of TB and increase capacity building of healthcare providers in early identification and diagnosis of TB cases and to ensure complete treatment utilizing Directly Observed Treatment Short course or other appropriate therapy.

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18. NMAs should co-ordinate with their TB National Program and promote the adopted guidelines to all members.

19. The WMA supports WHO’s efforts and calls upon all governments, communities, civil society and the private sector to act together to end TB worldwide.

from the desk of THE group editor-in-chief

Adopted by the 57th WMA General Assembly, Pilanesberg, South Africa, October 2006 and amended by the 68th WMA General Assembly, Chicago, United States, October 2017

2.4 Women and men having sex with same sex partners are at a higher risk of discrimination at all levels. National Medical Organizations shall work with Government, Non-Governmental Organizations (NGOs) and Community-based organizations to remove the discrimination for these under-privileged disadvantaged groups.

Introduction

Appropriate/Competent Medical Care

WMA Resolution on HIV-AIDS and the Medical Profession

1. HIV/AIDS, a chronic manageable disease, is a global pandemic that has created unprecedented challenges for physicians and health infrastructures.

In addition to representing a staggering public health crisis, HIV/AIDS is also fundamentally a human rights issue.

Many factors drive the spread of the disease, such as poverty, homelessness, illiteracy, prostitution, human trafficking, drug (substance) abuse, stigma, discrimination and gender-based inequality.

These social, economic, legal and human rights factors affect not only the public health dimension of HIV/AIDS but also individual physicians/health workers and patients, their decisions and relationships. Efforts to tackle the disease are also constrained by the lack of human and financial resources available in healthcare systems.

2. Discrimination against HIV/AIDS patients by physicians is unacceptable and must be eliminated completely from the practice of medicine.

2.1 All persons with HIV/AIDS are entitled to adequate and timely support, treatment and care with compassion and respect for human dignity.

2.2 It is unethical for a physician to refuse to treat a patient whose condition is within his/her current realm of competence, solely because the patient is seropositive.

2.3 NMAs should work with respective governments, patient groups and relevant national and international organizations to ensure that national health policies clearly and explicitly prohibit discrimination against people infected with or affected by HIV/AIDS, including vulnerable groups such as males having sex with males and transgender persons.

3. Patients with HIV/AIDS must be provided with competent and appropriate medical care at all stages of the disease.

4. A physician who is not able to provide the care and services required by patients with HIV/AIDS must make an appropriate timely referral to those physicians or facilities that are equipped to provide such services. Unless or until the referral can be accomplished, the physician must take care for the patient.

5. All physicians should be able to timely suspect and identify common opportunistic infections such as TB, fungal infections in HIVAIDS patients and also suspect HIV-AIDS in presence of these infections especially in high risk individuals like IV drug users. They must timely counsel these patient about the nexus of these infections with HIV infection.

6. Physicians and other appropriate professional bodies must ensure that patients have accurate information regarding transmission of HIV/ AIDS and strategies to protect themselves against infection. Proactive measures should be taken to ensure that all members of the population, particularly at-risk groups, are educated to this effect.

Public information and related strategies should recognize that everyone is at risk, and attempt to spell out methods of risk reduction.

7. Physicians must effectively counsel all seropositive patients regarding responsible behavior to prevent the spread of the infection to their partners and prevention of opportunistic infections.

8. Physicians must recognize that many people still believe HIV/AIDS to be an automatic and immediate death sentence and therefore will not seek testing. Physicians must ensure that patients have accurate information regarding

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from the desk of THE group editor-in-chief

the treatment options available to them. Patients should understand the potential and need of starting early antiretroviral treatment (ART) to improve not only their medical condition but also the quality of their lives. The new strategy is test and treat strategy.

Effective ART can greatly extend the period that patients are able to lead healthy productive lives, functioning socially and in the workplace and maintaining their independence.

HIV/AIDS is now a manageable chronic condition.

For ART country - specific WHO evidence based practice guidelines should be followed and promoted by all NMAs. 9. Physicians should be aware that misinformation regarding the negative aspects of ART has created resistance toward treatment by patients in some areas. Where misinformation is being spread about ART, physicians and medical associations must make it an immediate priority to publicly challenge the source of the misinformation and to work with the HIV/AIDS community to counteract the negative effects of the misinformation.

10. Physicians should encourage the involvement of support networks to assist patients in adhering to ART regimens. With the patient’s consent, counseling and training should be available to family members to assist them in providing care.

11. Physicians must be aware of the discriminatory attitudes toward HIV/AIDS that are prevalent in society and local culture. Because physicians are the first, and sometimes the only, people who are informed of their patients’ HIV status, physicians should be able to counsel them about their basic social and legal rights and responsibilities or should refer them to counselors who specialize in the rights of persons living with HIV/AIDS. 12. Physicians should be aware of the current availability and prescribing guidelines for preexposure and post-exposure prophylaxis for any patient and healthcare providers who may have been exposed to HIV.

Testing 13. Mandatory testing for HIV must be required of donated blood and blood fractions collected

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for donation or to be used in the manufacture of blood products; organs and other tissues intended for transplantation; and semen or ova collected for assisted reproduction procedures.

Newer technologies which are more sensitive, specific and reduce the window period of HIV detection, such as nuclear acid testing (NAT), should be encouraged for such screening.

14. Mandatory HIV testing of an individual against his/her will is a violation of medical ethics and human rights.

15. Physicians must clearly explain the purpose of an HIV test, the reasons it is recommended and the implications of a positive test result. Before a test is administered, the physician should have an action plan in place in case of a positive test result. Informed consent must be obtained from the patient prior to testing.

16. While certain groups are labeled “high risk”, anyone who has had unprotected sex should be considered at risk. Physicians must become increasingly proactive about recommending testing to patients, based on a mutual understanding of the level of risk and the potential to benefit from testing. Pregnant women and her partner should routinely be offered testing for HIV, and those pregnant women found to be HIV positive should be offered immediate counseling and offered timely ART (at diagnosis) in order to prevent transmission of the virus to the fetus and treatment of the fetus if seropositive.

17. Counseling and voluntary anonymous testing for HIV should be available to all persons who request it, along with adequate post-testing support mechanisms.

Protection from HIV in the Healthcare Environment 18. Physicians and all healthcare workers have the right to a safe work environment. Especially in developing countries, the problem of occupational exposure to HIV has contributed to high attrition rates of the health labor force.

In some cases, employees become infected with HIV, and in other cases fear of infection causes healthcare workers to leave their jobs voluntarily. Fear of infection among health workers can also lead to refusal to treat HIV/ AIDS patients. Likewise, patients have the

from the desk of THE group editor-in-chief right to be protected to the greatest degree possible from transmission of HIV from health professionals and in healthcare institutions.

18.1 Proper infection control procedures and universal precautions consistent with the most current national or international standards, as appropriate, should be implemented in all health care facilities. This includes procedures for the use of preventive and timely bART for health professionals who have been exposed to HIV. 18.2 If the appropriate safeguards for protecting physicians or patients against infection are not in place, physicians and NMAs should take action to correct the situation.

18.3 Physicians who are infected with HIV should not engage in any activity that creates a risk of transmission of the disease to others. In the context of possible exposure to HIV, the activity in which the physician wishes to engage will be the determining factor. There may be nationally agreed standards but if not a determination should be made by a suitable expert panel or committee of health workers.

18.4 In the provision of medical care, if a risk of transmission of an infectious disease from a physician to a patient exists, disclosure of that risk to patients is not enough; patients are entitled to expect that their physicians will not increase their exposure to the risk of contracting an infectious disease.

18.5 If no risk exists, disclosure of the physician’s medical condition to his/her patients will serve no rational purpose.

18.6 Physicians should be aware of current professional guidelines for post-exposure prophylaxis of healthcare workers in case of any accidental exposure to HIV.

Protecting Patient Privacy and Issues Related to Notification 19. Fear of stigma and discrimination is a driving force behind the spread of HIV/AIDS. The social and economic repercussions of being identified as infected can be devastating and can include violence, rejection by family and community members, loss of housing and loss of employment. Normalizing the presence of HIV/AIDS in society through public education

is the only way to reduce discriminatory attitudes and practices. Until that can be universally achieved, or a cure is developed, potentially infected individuals may refuse testing to avoid these consequences. The result of individuals not knowing their HIV status is not only disastrous on a personal level in terms of not receiving treatment, but may also lead to high rates of avoidable transmission of the disease. Fear of unauthorized disclosure of information also provides a disincentive to participate in HIV/AIDS research and generally thwarts the efficacy of prevention programs.

Lack of confidence in protection of personal medical information regarding HIV status is a threat to public health globally and a core factor in the continued spread of HIV/AIDS. At the same time, in certain circumstances, the right to privacy must be balanced with the right of partners (sexual and injection drug) of persons with HIV/AIDS to be informed of their potential infection. Failure to inform partners not only violates their rights but also leads to the health problems of avoidable transmission and delay in treatment.

20. All standard ethical principles and duties related to confidentiality and protection of patients’ health information, as articulated in the WMA Declaration of Lisbon on the Rights of the Patient, apply equally in the context of HIV/AIDS. In addition, NMAs and physicians should take note of the special circumstances and obligations (outlined below) associated with the treatment of HIV/AIDS patients.

20.1 NMAs and physicians must, as a matter of priority, ensure that HIV/AIDS public education, prevention and counseling programs contain explicit information related to protection of patient information as a matter not only of medical ethics but of their human right to privacy.

20.2 Special safeguards are required when HIV/AIDS care involves a physically dispersed care team that includes home-based service providers, family members, counselors, case workers or others who require medical information to provide comprehensive care and assist in adherence to treatment regimens. In addition to implementing protection mechanisms regarding transfer of information, ethics training

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from the desk of THE group editor-in-chief regarding patient privacy should be given to all team members. Many countries have specific legislation to protect the privacy of those who are HIV positive. Others may consider the same.

20.3 Physicians must make all efforts to convince HIV/AIDS patients to take action to notify all partners (sexual and/or injection drug) about their exposure and potential infection. Physicians must be competent to counsel patients about the options for notifying partners. These options should include: 20.3.1 Notification of the partner(s) by the patient. In this case, the patient should receive counseling regarding the information that must be provided to the partner and strategies for delivering it with sensitivity and in a manner that is easily understood. A timetable for notification should be established and the physician should followup with the patient to ensure that notification has occurred.

20.3.2 Notification of the partner(s) by a third party.

In this case, the third party must make every effort to protect the identity of the patient.

20.4 When all strategies to convince the patient to take such action have been exhausted, and if the physician knows the identity of the patient’s partner(s), the physician is compelled, either by law or by moral obligation, to take action to notify the partner(s) of their potential infection.

Depending on the system in place, the physician will either notify directly the person at risk or report the information to a designated authority responsible for notification. Physicians must be aware of the laws and regulations in the jurisdiction in which they are practicing. In cases where a physician must disclose the information regarding exposure, the physician must: 20.4.1 inform the patient of his or her intentions, 20.4.2 to the extent possible, ensure that the identity of the patient is protected, 20.4.3 take the appropriate measures to protect the safety of the patient, especially in the case of a female patient vulnerable to domestic violence.

20.5 Regardless of whether it is the patient, the physician or a third party who undertakes notification, the person learning of his/her potential infection should be offered support and assistance in order to access testing and treatment.

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20.6 NMAs should develop guidelines to assist physicians in decision-making related to notification. These guidelines should help physicians understand the legal requirements and consequences of notification decisions as well as the medical, psychological, social and ethical considerations.

20.7 As per local and national laws and guidelines requiring the reporting of new HIV infections, sexually transmitted diseases (STD) and opportunistic infections, physicians must protect the privacy and confidentiality of all patients and maintain the highest ethical standards.

20.8 NMAs should work with governments to ensure that physicians who carry out their ethical obligation to notify individuals at risk, and who take precautions to protect the identity of their patient, are afforded adequate legal protection.

Medical Education 21. Nmas should assist in ensuring that there is training and education of physicians in the most current prevention strategies and medical treatments available for all stages of HIV/AIDS and associated infections, including prevention and support.

22. Nmas should, when appropriate, collaborate with NGOs and community-based organizations, insist upon, and when possible assist with, the education of physicians in the relevant psychological, legal, cultural and social dimensions of HIV/AIDS. 23. NMAs should fully support the efforts of physicians wishing to concentrate their expertise in HIV/AIDS care, even where HIV/AIDS is not recognized as an official specialty or subspecialty within the medical education system.

24. The WMA encourages its NMAs to promote the inclusion of designated, comprehensive courses on HIV/AIDS in undergraduate and postgraduate medical education programs, as well as continuing medical education.

Integration of HIV/AIDS Services with other STDs Management Activities 25. The NMAs should support governments to integrate HIV/AIDS preventive and curative services with other STD management activities in a comprehensive manner.

from the desk of THE group editor-in-chief The WMA Assembly also passed a Revised Declaration of Geneva, which was adopted by the Association in 1948, incorporating various changes and additions over a 2-year revision process, including a period for public consultation.

IMA was also a part of the workgroup that worked on the amendments to ‘The revised Declaration, to be called ‘The Physicians Pledge’, focuses on the changing doctor-patient relationship, doctor-doctor relationship and includes issues such as patient autonomy.

Adopted by the 2nd General Assembly of the World Medical Association, Geneva, Switzerland, September 1948 and amended by the 22nd World Medical Assembly, Sydney, Australia, August 1968 and the 35th World Medical Assembly, Venice, Italy, October 1983 and the 46th WMA General Assembly, Stockholm, Sweden, September 1994 and editorially revised by the 170th WMA Council Session, Divonne-les-Bains, France, May 2005 and the 173rd WMA Council Session, Divonneles-Bains, France, May 2006 and amended by the 68th WMA General Assembly, Chicago, United States, October 2017 AS A MEMBER OF THE MEDICAL PROFESSION: ÂÂ

I SOLEMNLY PLEDGE to dedicate my life to the service of humanity;

ÂÂ

THE HEALTH AND WELL-BEING OF MY PATIENT will be my first consideration;

ÂÂ

I WILL RESPECT the autonomy and dignity of my patient;

ÂÂ

I WILL MAINTAIN the utmost respect for human life;

ÂÂ

I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin, gender, nationality, political affiliation, race, sexual orientation, social standing or any other factor to intervene between my duty and my patient;

ÂÂ

I WILL RESPECT the secrets that are confided in me, even after the patient has died;

ÂÂ

I WILL PRACTICE my profession with conscience and dignity and in accordance with good medical practice;

ÂÂ

I WILL FOSTER the honor and noble traditions of the medical profession;

ÂÂ

I WILL GIVE to my teachers, colleagues, and students the respect and gratitude that is their due;

ÂÂ

I WILL SHARE my medical knowledge for the benefit of the patient and the advancement of healthcare;

ÂÂ

I WILL ATTEND TO my own health, well-being, and abilities in order to provide care of the highest standard;

ÂÂ

I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat;

ÂÂ

I MAKE THESE PROMISES solemnly, freely and upon my honor.

IMA is also leading the revisions to "WMA Statement on Assisted Reproductive Technologies", which is likely to be passed by the Annual General Assembly in 2018.

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American Family Physician

Exercise Stress Testing: Indications and Common Questions KATHRYN K. GARNER, WILLIAM POMEROY, JAMES J. ARNOLD

Abstract Exercise stress testing is a validated diagnostic test for coronary artery disease in symptomatic patients, and is used in the evaluation of patients with known cardiac disease. Testing of asymptomatic patients is generally not indicated. It may be performed in select deconditioned adults before starting a vigorous exercise program, but no studies have compared outcomes from preexercise testing vs. encouraging light exercise with gradual increases in exertion. Preoperative exercise stress testing is helpful for risk stratification in patients undergoing vascular surgery or who have active cardiac symptoms before undergoing nonemergent noncardiac surgery. Exercise stress testing without imaging is the preferred initial choice for risk stratification in most women. Sensitivity and specificity increase with the use of adjunctive imaging such as echocardiography or myocardial perfusion imaging with single-photon emission computed tomography. Exercise stress testing is rarely an appropriate option to evaluate persons with known coronary artery disease who have no new symptoms less than two years after percutaneous intervention or less than five years after coronary artery bypass grafting. The Duke treadmill score has excellent prognostic value for exercise stress testing. Imaging is not necessary if patients are able to achieve more than 10 metabolic equivalents on exercise stress testing. Exercise stress testing is not indicated before noncardiac surgeries in patients who can achieve 4Â metabolic equivalents without symptoms.

Keywords: Exercise stress testing, coronary artery disease, symptomatic patients, risk stratification, Duke treadmill score

E

xercise stress testing is used to detect inducible cardiac ischemia in symptomatic intermediate-risk patients who can exercise and who have interpretable electrocardiography results.1 Risk is determined by American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines for stable ischemic heart disease or the Diamond and Forrester score to assess pretest probability of coronary artery disease (CAD; Table 1).1,2

The standard Bruce protocol is preferred for exercise stress testing3 (eTable A). Its outcomes are well validated, and exercise capacity measured in metabolic equivalents (METs) has good prognostic value. The Bruce protocol can be modified for patients

KATHRYN K. GARNER, MD, is a faculty member at the National Capital Consortium Family Medicine Residency in Fort Belvoir, Va., and an assistant professor of family medicine at the Uniformed Services University of the Health Sciences, Bethesda, Md. WILLIAM POMEROY, MD, is a staff cardiologist at Keesler Medical Center, Biloxi, Miss.

JAMES J. ARNOLD, DO, FACOFP, FAAFP, is the senior associate program director at the National Capital Consortium Family Medicine Residency and an assistant professor of family medicine at the Uniformed Services University of the Health Sciences.

Source: Adapted from Am Fam Physician. 2017;96(5):293-299.

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with predicted poor exercise capacity by adding two warm-up stages before the first stage. The Naughton protocol allows for a more gradual increase in exertion and uses shorter stages, increasing the likelihood of diagnostic results in older and deconditioned patients.3 This article reviews indications for and answers common questions about exercise stress testing.

What Are the Indications for Exercise Stress Testing?

Exercise stress testing is commonly used for the detection of CAD in patients with chest pain or dyspnea on exertion who are at intermediate risk of acute coronary syndrome.

Exercise stress testing reduces costs of hospitalization without worsening outcomes in patients presenting to the emergency department with chest pain and negative cardiac enzymes. Additional indications for exercise stress testing include prediction of cardiovascular events, assessment of chronotropic competence, evaluation of exercise-induced symptoms, evaluation of unexplained syncope in patients at intermediate to high risk of CAD, and assessment of response after medical or surgical interventions in patients with valve disease, arrhythmias, or other heart diseases. Consensus opinion from the ACCF/AHA is that exercise stress testing

American Family Physician eTable A. Common Treadmill Protocols for Exercise Stress Testing Protocol

Miles per hour

Grade (%)

Metabolic equivalents

Standard Bruce protocol (3 minutes per stage) Stage 1

1.7

10

4

Stage 2

2.5

12

7

Stage 3

3.4

14

10

Stage 4

4.2

16

13

Stage 5

5.0

18

16

Stage 6

5.5

20

NA

Stage 7

6.0

22

NA

Modified Bruce protocol (3 minutes per stage) Stage 1

1.7

0

2

Stage 2

1.7

5

3

Stage 3

1.7

10

4

Stage 4

2.5

12

7

Stage 5

3.4

14

10

Stage 6

4.2

16

13

Stage 7

5.0

18

16

Stage 8

5.5

20

NA

Stage 9

6.0

22

NA

Naughton protocol (2 minutes per stage) Stage 1

1.0

0

1

Stage 2

2.0

0

2

Stage 3

2.0

3.5

3

Stage 4

2.0

7

4

Stage 5

2.0

10.5

5

Stage 6

2.0

14

6

Stage 7

2.0

17.5

7

NA = Not available.

Information from Fletcher GF, Ades PA, Kligfield P, et al.; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013;128(8):873-934.

can be used for exercise prescriptions, but data on patientoriented outcomes are lacking.

Evidence Summary The AHA states that early exercise stress testing in emergency departments and chest pain units is safe,

accurate, and cost-effective because of fewer hospital admissions.3 In a prospective cohort study of 3,552 patients in chest pain units who had low Diamond and Forrester scores, none had a positive stress test.4 Another study evaluated intermediate-risk patients presenting to the emergency department who had no known CAD and in whom acute coronary syndrome was excluded with two negative cardiac enzyme tests performed six hours apart.2 Exercise stress testing stratified intermediate-risk patients to a near zero short-term risk of acute coronary syndrome. A retrospective analysis of 3,987 patients younger than 40 years who were at intermediate risk of CAD and in whom myocardial infarction (MI) had been excluded found that exercise stress testing was of minimal value given the 0.4% incidence of positive findings.5 Preoperative exercise stress testing is not indicated for risk stratification before noncardiac surgery in patients who are able to achieve a minimum of 4 METs (e.g., walking up one flight of stairs) without cardiac symptoms, even if they have a history of CAD.1,5 Exercise stress testing is helpful for risk stratification in patients undergoing vascular surgery and in those who have active cardiac symptoms before undergoing nonemergent noncardiac surgery.1,5 Patients with poor functional capacity (unable to achieve 4 METs) should undergo stress echocardiography or exercise singlephoton emission computed tomography (SPECT) before undergoing vascular surgery or a kidney or liver transplant.1 Activities greater than 6 METs are associated with an increased risk of acute coronary syndrome. Experts recommend that deconditioned patients with diabetes mellitus, men older than 45 years or women older than 55 years, and those with two or more risk factors for CADÂ undergo exercise stress testing before starting a vigorous exercise program. However, no studies have compared outcomes from preexercise stress testing vs. encouraging light exercise with gradual increases in exertion.3 When Should Exercise Stress Testing Not Be Used?

Exercise stress testing is generally inappropriate for detection of ischemia in asymptomatic patients with no history of revascularization. Absolute contraindications include MI in the previous two days, ongoing unstable angina, uncontrolled cardiac arrhythmia with hemodynamic compromise, and symptomatic severe aortic stenosis (Table 2).1,3 One in 10,000 exercise stress tests results in sudden cardiac death or hospitalization.

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American Family Physician Evidence Summary Testing asymptomatic patients without a history of revascularization is not recommended.1,3 The U.S. Preventive Services Task Force recommends against testing low-risk patients and found insufficient evidence for those at intermediate and high risk.6 The American Academy of Family Physicians supports this recommendation.7 A randomized controlled trial of asymptomatic patients 50 to 75 years of age who had type 2 diabetes and no known CAD found that screening with adenosine-stress radionuclide myocardial perfusion imaging did not reduce nonfatal MIs or cardiac deaths over five years compared with no screening.8 Testing patients with no new symptoms less than two years after percutaneous coronary intervention or less than five years after coronary artery bypass grafting is rarely appropriate.1 What Is the Diagnostic Value of Exercise Stress Testing with and Without Imaging for CAD? Exercise stress testing is often better at excluding CAD than confirming it. Testing without imaging is the primary initial choice for risk stratification for most women and men.

Imaging is best used when there is a baseline abnormality in resting electrocardiography that would make interpretation of results difficult, if the patient has symptoms at rest, if anatomic cardiac features require evaluation, or if it is likely that the test results would be nondiagnostic (e.g., in patients

with poor exercise tolerance due to severe osteoarthritis) and that further testing would be required. Adjunctive imaging is required in patients taking digitalis because of the high false-positive rate of exercise stress testing alone in these patients.

Evidence Summary Stress echocardiography and exercise SPECT are appropriate in symptomatic patients at intermediate or high risk of CAD and in those with difficult-to-interpret electrocardiography results.1 Symptomatic patients with a history of percutaneous coronary intervention or coronary artery bypass grafting should undergo exercise SPECT, stress echocardiography, or coronary angiography as clinically indicated.1 A 2012 systematic review of 34 prospective studies found that exercise stress testing and stress echocardiography were better at excluding CAD than confirming it (likelihood ratio [LR] of ruling out CAD via exercise stress testing = –0.34; 95% confidence interval [CI], 0.28 to 0.41; LR for stress echocardiography = –0.24; 95% CI, 0.17 to 0.32).9 Of the two testing modalities, stress echocardiography was better at ruling in CAD (LR = 7.94 vs. 3.57 for exercise stress testing).9 Sensitivity and specificity for CAD detection increase when imaging is performed with exercise stress testing (Table 3).10-14 The prevalence of severe CAD is higher in older patients; exercise stress testing has a sensitivity of 84% in this population but

Table 3. Summary of Tests for Detection of Coronary Artery Disease Test

Sensitivity (%)

Specificity Limitations (%)

Advantages

Cardiac catheterization

98

82

Invasive, requires radiation

Preferred test, allows for detection and intervention

Exercise single-photon emission computed tomography

85

85

Cannot assess myocardium or valves, heart rhythm irregularities may affect results, soft tissue attenuation artifacts, requires radiation

Assesses myocardial perfusion and regional/global function at rest and during stress, good prognostic data and negative predictive value

Exercise stress testing

68

77

Requires normal baseline electrocardio- Less expensive, limited equipment graphy, not recommended for patients required, good prognostic data and with history of percutaneous coronary negative predictive value intervention or coronary artery bypass grafting

Stress echocardiography 79

87

Image quality affected by body habitus Assesses cardiac structure, global and and dependent on operator, limited time segment function at rest and during for imaging postexercise stress, relatively inexpensive, does not require radiation, good prognostic data and negative predictive value

Information from references 10 through 14.

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American Family Physician a decreased specificity of 70%.3 SPECT is no better at detecting severe CAD than exercise stress testing, but it stratifies more intermediate-risk patients as low risk.15 SPECT is superior to echocardiography for attaining images diagnostic for CAD in obese patients and in those with chronic obstructive pulmonary disease.16 A randomized controlled trial of symptomatic women at intermediate risk of CAD showed no difference in eventfree survival over two years of follow-up between those undergoing exercise stress testing vs. exercise SPECT.17 However, exercise stress testing costs less. Systematic reviews show that because the median prevalence of CAD in women is less than that in men, a positive result on exercise stress testing indicates a lower probability of CAD (69% vs. 89%); however, negative results in women have better negative predictive value.9 Exercise stress testing without imaging is the preferred initial choice for risk stratification in women.

In a 2014 randomized controlled trial comparing exercise stress testing alone and exercise stress testing with myocardial perfusion imaging, 965 patients younger than 65 years who had no known CAD, normal resting electrocardiography, and symptoms of CAD underwent exercise stress testing for risk stratification. Per the provisional exercise stress testing protocol, if they achieved maximal predicted heart rate or greater than 10 METs of exercise with a clinically and electrically negative exercise stress test result, no imaging was performed.18 All-cause mortality was similar between those who underwent imaging and those who did not.

No cardiac deaths occurred in those who underwent exercise stress testing alone.

Which Patients May Be Safely Risk Stratified with Exercise Stress Testing Alone?

Persons who achieve greater than 10 METs on exercise stress testing have an excellent prognosis, with a low prevalence of significant ischemia or CAD mortality. Further imaging in these patients increases cost without increasing prognostic benefit.

Evidence Summary Patients with Duke exercise treadmill scores greater than 7 have a five-year survival rate of 93% compared with 67% for those with scores less than –11.19 METs are the only treadmill-associated variable significantly related to all-cause mortality.20 Decreased exercise capacity is associated with increased risk of MI, unstable angina, and coronary revascularization.21 A 1-MET increase in peak period treadmill workload was associated with an

18% reduction in cardiac events in patients older than 65 years and a 14% reduction in younger patients.22 Achievement of more than 10 METs on exercise stress testing equates to a low risk of death, regardless of imaging results.22 A prospective study of 7,236 patients without known dilated cardiomyopathy or moderate valvular disease who achieved more than 10 METs on stress echocardiography found less than 1% CAD mortality per person-year of follow-up, regardless of the presence of wall motion abnormalities on exertion.23 Similarly, patients who achieved less than 10 METs on exercise SPECT had an annualized cardiac mortality rate of 0.1% and combined cardiac death and nonfatal MI rate of 0.4%.20 This suggests that when less than 10 METs are achieved, further imaging increases cost without increasing prognostic benefit.20,23 What Findings on Exercise Stress Testing Warrant Termination and Further Evaluation?

ST-segment elevation of more than 1 mm without preexisting Q waves is an absolute indication for termination of exercise stress testing, whereas a horizontal or downsloping depression of more than 2 mm measured 60 to 80 milliseconds after the J-point is a relative indication (Table 4).3 Evidence of chronotropic incompetence by the inability of a patient’s systolic blood pressure (BP) to rise above or drop below the resting systolic BP increases the risk of cardiovascular events.24 A decrease in systolic BP of more than 10 mm Hg with other evidence of ischemia is an absolute indication to terminate testing. An isolated decrease in systolic BP is a relative indication.

Evidence Summary ST-segment elevation of more than 1 mm during stress identifies areas of ischemia in proximal coronary vasculature.25 ST-segment depression of more than 2 mm does not localize anatomic ischemia, but when combined with clinical symptoms of ischemia suggests CAD (Figure 1).3 The sooner ST-segment depression develops during testing and the longer it persists into recovery, the more severe the CAD.26 As exercise increases cardiac output, systolic BP should increase.

Inability to increase systolic BP suggests left ventricular systolic dysfunction or CAD. A prospective study (n = 44,000) of men and women, including blacks, with a mean age of 53 years showed a strong association between decreasing exercise systolic BP response, allcause death, and MI.27 The lower the patient’s rise in systolic BP in response to exercise, the higher the incidence rate of MI per 1,000 person-years (increase of more than 20 mm Hg above baseline = 3.9 incidence rate

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American Family Physician [95% CI, 3.6 to 4.1], 1 to 20 mm Hg above baseline = 8.0 [95% CI, 7.0 to 9.1], and decrease from baseline = 12.5 [95% CI, 10.2 to 15.4]).27 Therefore, it is recommended that exercise stress testing be discontinued if systolic BP decreases by more than 10 mm Hg. Conversely, a hypertensive response to moderateintensity exercise (systolic BP greater than 210 mm Hg in men or greater than 190 mm Hg in women) indicates a 1.36-fold greater rate of cardiovascular events and mortality (95% CI, 1.02 to 1.83; P = .039).28 The AHA recommends termination of testing when systolic BP exceeds 250 mm Hg or when diastolic BP exceeds 115 mm Hg.3 Reaching 85% of the maximal predicted heart rate (220 minus age) is a measure of adequate diagnostic exercise stress testing, but the AHA recommends that it not be used in isolation to terminate testing.3 During exercise, the heart rate should increase by 10 beats per minute per 1 MET. Failure of the heart rate to increase and prolonged delay in returning to resting levels may affect prognosis and indicate CAD. Note: For complete article visit: www.aafp.org/afp.

REFERENCES 1. Wolk MJ, Bailey SR, Doherty JU, et al.; American College of Cardiology Foundation Appropriate Use Criteria Task Force. ACCF/AHA/ASE/ASNC/HFSA/HRS/SCAI/ SCCT/SCMR/STS 2013 multimodality appropriate use criteria for the detection and risk assessment of stable ischemic heart disease: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2014;63(4):380-406.

2. Greenslade JH, Parsonage W, Ho A, et al. Utility of routine exercise stress testing among intermediate risk chest pain patients attending an emergency department. Heart Lung Circ. 2015;24(9):879-884.

3. Fletcher GF, Ades PA, Kligfield P, et al.; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention.

Exercise standards for testing and training: a scientific statement from the American Heart Association.

Circulation. 2013;128(8):873-934.

4. Napoli AM. The association between pretest probability of coronary artery disease and stress test utilization and

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outcomes in a chest pain observation unit. Acad Emerg Med. 2014;21(4):401-407.

5. Scott AC, Bilesky J, Lamanna A, et al. Limited utility of exercise stress testing in the evaluation of suspected acute coronary syndrome in patients aged less than 40 years with intermediate risk features. Emerg Med Australas.

2014;26(2):170-176.

6. U.S. Preventive Services Task Force.

Final recommendation statement: coronary heart disease: screening with electrocardiography. https: //www. uspreventiveservicestaskforce.org/Page/Document/Recom mendationStatementFinal/coronary-heart-disease-scree ning-with-electrocardiography. Accessed October 9, 2016.

7. American Academy of Family Physicians. Clinical preventive service recommendation: coronary heart disease. http://www.aafp.org/patientcare/clinical-reco mmendations/all/coronary-heart-disease.html. Accessed October 9, 2016.

8. Young LH, Wackers FJ, Chyun DA, et al.; DIAD Investigators. Cardiac outcomes after screening for asymptomatic coronary artery disease in patients with type 2 diabetes: the DIAD study: a randomized controlled trial. JAMA. 2009;301(15):1547-1555.

9. Banerjee A, Newman DR, Van den Bruel A, Heneghan C. Diagnostic accuracy of exercise stress testing for coronary artery disease: a systematic review and meta-analysis of prospective studies. Int J Clin Pract. 2012;66(5): 477-492.

10. Mc Ardle BA, Dowsley TF, deKemp RA, Wells GA, Beanlands RS. Does rubidium-82 PET have superior accuracy to SPECT perfusion imaging for the diagnosis of obstructive coronary disease? A systematic review and meta-analysis. J Am Coll Cardiol. 2012;60(18):1828-1837.

11. Heijenbrok-Kal MH, Fleischmann KE, Hunink MG. Stress echocardiography, stress single-photon-emission computed tomography and electron beam computed tomography for the assessment of coronary artery disease: a meta-analysis of diagnostic performance. Am Heart J. 2007;154(3):415-423.

12. Gianrossi R, Detrano R, Mulvihill D, et al. Exerciseinduced ST depression in the diagnosis of coronary artery disease. A meta-analysis. Circulation. 1989;80(1):87-98.

13. Tweet MS, Arruda-Olson AM, Anavekar NS, Pellikka PA. Stress echocardiography: what is new and how does it compare with myocardial perfusion imaging and other modalities? Curr Cardiol Rep. 2015;17(6):43.

14. Dowsley T, Al-Mallah M, Ananthasubramaniam K, Dwivedi G, McArdle B, Chow BJ. The role of noninvasive imaging in coronary artery disease detection, prognosis, and clinical decision making. Can J Cardiol. 2013;29(3): 285-296.

15. Christian TF, Miller TD, Bailey KR, Gibbons RJ. Exercise tomographic thallium-201 imaging in patients with severe coronary artery disease and normal electrocardiograms.

Ann Intern Med. 1994;121(11):825-832.

American Family Physician 16. Miller TD, Askew JW, Anavekar NS. Noninvasive stress testing for coronary artery disease. Cardiol Clin. 2014; 32(3):387-404.

17. Shaw LJ, Mieres JH, Hendel RH, et al.; WOMEN Trial Investigators. Comparative effectiveness of exercise electrocardiography with or without myocardial perfusion single photon emission computed tomography in women with suspected coronary artery disease: results from the What Is the Optimal Method for Ischemia Evaluation in Women (WOMEN) trial. Circulation. 2011;124(11): 1239-1249.

18. Duvall WL, Savino JA, Levine EJ, Hermann LK, Croft LB, Henzlova MJ. Prospective evaluation of a new protocol for the provisional use of perfusion imaging with exercise stress testing. Eur J Nucl Med Mol Imaging. 2015;42(2): 305-316.

19. Mark DB, Hlatky MA, Harrell FE Jr, Lee KL, Califf RM, Pryor DB. Exercise treadmill score for predicting prognosis in coronary artery disease. Ann Intern Med. 1987;106(6):793-800.

20. Bourque JM, Charlton GT, Holland BH, Belyea CM, Watson DD, Beller GA. Prognosis in patients achieving ≥10 METS on exercise stress testing: was SPECT imaging useful? J Nucl Cardiol. 2011;18(2):230-237.

21. Peterson PN, Magid DJ, Ross C, et al. Association of exercise capacity on treadmill with future cardiac events in patients referred for exercise testing. Arch Intern Med. 2008;168(2):174-179.

22. Myers J, Prakash M, Froelicher V, Do D, Partington S, Atwood JE. Exercise capacity and mortality among

men referred for exercise testing. N Engl J Med. 2002; 346(11):793-801.

23. Fine NM, Pellikka PA, Scott CG, Gharacholou SM, McCully RB. Characteristics and outcomes of patients who achieve high workload (≥ 10 metabolic equivalents) during treadmill exercise echocardiography. Mayo Clin Proc.

2013;88(12):1408-1419.

24. de Liefde II, Hoeks SE, van Gestel YR, et al. Prognostic value of hypotensive blood pressure response during single-stage exercise test on longterm outcome in patients with known or suspected peripheral arterial disease.

Coron Artery Dis. 2008;19(8):603-607.

25. Beinart R, Matetzky S, Shechter M, et al. Stress-induced ST-segment elevation in patients without prior Q-wave myocardial infarction. J Electrocardiol. 2008;41(4):312-317.

26. Goldschlager N, Selzer A, Cohn K. Treadmill stress tests as indicators of presence and severity of coronary artery disease. Ann Intern Med. 1976;85(3):277-286.

27. O’Neal WT, Qureshi WT, Blaha MJ, Keteyian SJ, Brawner CA, Al-Mallah MH. Systolic blood pressure response during exercise stress testing: the Henry Ford ExercIse Testing (FIT) Project. J Am Heart Assoc. 2015;4(5):1-8.

28. Schultz MG, Otahal P, Cleland VJ, Blizzard L, Marwick TH, Sharman JE. Exercise-induced hypertension, cardiovascular events, and mortality in patients undergoing exercise stress testing: a systematic review and meta-analysis. Am J Hypertens. 2013;26(3):357-366.

29. Fletcher GF, Mills WC, Taylor WC. Update on exercise stress testing. Am Fam Physician. 2006;74(10):1749-1756.

30. Darrow MD. Ordering and understanding the exercise stress test. Am Fam Physician. 1999;59(2):401-410.

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Practice Guidelines Newly Detected Atrial Fibrillation: AAFP Updat e s G u i d e l i n e o n P harma c o lo g i c Management Atrial fibrillation, which can be paroxysmal or persistent, is a common arrhythmia, occurring in up to approximately 6 million adults in the United States.

It is responsible for more than 750,000 hospitalizations, 130,000 deaths, and $6 billion in health care costs annually. Patients can present without symptoms or with any number of symptoms, including irregular heart rate, palpitations, and fatigue. Rate and rhythm control and thromboembolic episode prevention via medication, electrical cardioversion ablation, and surgery are possible management options.

The American Academy of Family Physicians (AAFP) has updated its 2003 guideline to provide guidance on atrial fibrillation treatment via medication in the primary care setting. The guideline focuses on adults with nonvalvular atrial fibrillation as diagnosed by electrocardiography; atrial fibrillation with a valvular or reversible etiology is not addressed in this update.

there are no differences in mortality, hospitalization, heart failure symptoms, quality of life, thromboembolic episodes, or bleeding between the two. In addition, because strict control is more difficult to attain and more medication may be needed, it is associated with greater risk of harm from adverse effects.

The risk of stroke and bleeding should be discussed with patients when anticoagulation is prescribed. Stroke risk can be determined using the continuous CHADS2 or CHA2DS2-VASc, with low-quality data indicating that both scores have a modest ability to determine the risk of stroke in persons with atrial fibrillation. Although the CHA2DS2-VASc includes additional risk factors for age, vascular disease, and female sex, it is not better than CHADS2 in predicting stroke risk. HAS-BLED can be used to determine bleeding risk and is slightly better for identifying the risk in patients taking warfarin vs. some other scales (i.e., HEMORRHAGES, BRI, ATRIA).

It can be difficult to evaluate the potential benefits and harms of anticoagulation, because risk factors for major bleeding and stroke often overlap.

Rate control is strongly preferred to rhythm control in most patients, using nondihydropyridine calcium channel blockers and beta blockers, which are superior to digoxin. Rhythm control with amiodarone, dronedarone, propafenone, or sotalol can be considered for persons in whom rate control is ineffective and based on symptoms, exercise tolerance, and patient preference. High-quality data indicate that there are fewer hospitalizations with rate control than with rhythm control. In addition, there are significant risks and adverse effects with medications to control rhythm.

Long-term anticoagulation should be prescribed for all patients with atrial fibrillation, with the exception of those who have contraindications or a low stroke risk defined as a CHADS2 score less than 2. When selecting the anticoagulant (e.g., warfarin, apixaban, dabigatran, edoxaban, rivaroxaban), the history and patient preferences should be taken into account.

Vitamin K agonists are the first-line option, with highquality data indicating that they have a lower stroke risk and all-cause mortality vs. placebo. They do, however, have an increased risk of major bleeding and a narrow therapeutic window, as well as monitoring requirements and changes in diet.

Rate control to less than 110 beats per minute (bpm) at rest (lenient control) is recommended over rate control to less than 80 bpm (strict control). However, if there is no change in symptoms, physicians should consider stricter rate control. Low-quality data indicate that lenient control is associated with a lower incidence of stroke vs. strict control, and limited data indicate that

High-quality data indicate that the direct thrombin inhibitor dabigatran, 150 mg, decreases stroke, embolism, and intracranial hemorrhage compared with warfarin, but it is also associated with a greater risk of gastrointestinal bleeding. In addition, moderate-quality data indicate that it is also associated with a greater risk of myocardial infarction.

Source: Adapted from Am Fam Physician. 2017;96(5):332-333.

Factor Xa inhibitors include apixaban, rivaroxaban, and edoxaban. High-quality data indicate that apixaban decreases stroke, intracranial hemorrhage, and major bleeding compared with warfarin, with moderate

Recommendations

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American Family Physician quality data also indicating a decrease in all-cause mortality. In addition, there is a decrease in stroke compared with aspirin. Moderate-quality data indicate that rivaroxaban is similar to warfarin regarding stroke prevention and major bleeding, with high-quality data indicating similarity in all-cause mortality. Moderatequality data indicate that edoxaban is similar to warfarin regarding stroke and systemic embolism prevention, with high-quality data indicating that it is associated with decreased risk of bleeding and cardiovascular mortality.

Direct oral anticoagulants, warfarin, and aspirin plus clopidogrel are better than aspirin alone for stroke prevention, but all are associated with a greater risk of bleeding, except apixaban, which is associated with a risk of bleeding similar to that of aspirin. Dabigatran is the only anticoagulant that has a reversal agent for

major bleeding approved by the U.S. Food and Drug Administration. Vitamin K or prothrombin complex concentrates, however, can be used as a reversal agent for vitamin K antagonists.

Available data do not indicate if one anticoagulant is superior to another. For this reason, medication should be chosen using shared decision making, taking into account cost, harms, benefits, availability of a reversal agent, and contraindications.

Combination treatment with an anticoagulant and an antiplatelet agent is not recommended for most patients.

Moderate-quality data indicate that combining warfarin with clopidogrel or aspirin is associated with greater risk of major bleeding vs. warfarin monotherapy; that combining warfarin with aspirin is associated with a greater risk of ischemic stroke; and combining warfarin with clopidogrel has the same risk of ischemic stroke.

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Photo Quiz White Spot on the Wrist A 50-year-old woman presented with an asymptomatic white patch on her wrist that appeared two months earlier. There was no itching, pain, or swelling in the area. Her medical history included ulcerative colitis, asthma, carpal tunnel syndrome, and osteoarthritis.

Her family history included a maternal aunt with extensive vitiligo.

Physical examination revealed a single, irregularly shaped, well-defined, hypopigmented patch involving the lateral, dorsal, and ventral surfaces of the right wrist with an area of proximal linear extension along the ventral forearm (Figure 1). The area was smooth and not raised. The remainder of the physical examination was unremarkable.

Question Based on the patient’s history and physical examination findings, which one of the following is the most likely diagnosis?

A. Idiopathic guttate hypomelanosis.

B. Pityriasis alba.

Figure 1.

C. Steroid-induced hypopigmentation.

D. Vitiligo.

Source: Adapted from Am Fam Physician. 2017;96(5):329-330.

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See the following page for discussion.

American Family Physician Discussion The answer is C: steroid-induced hypopigmentation. A single patch of hypopigmented skin over a joint space leads to high suspicion for an exogenous condition.

Hypopigmentation caused by corticosteroids presents as an irregularly shaped but well-defined hypopigmented patch. Further questioning of the patient revealed that she received a triamcinolone acetonide injection in the right carpometacarpal joint to treat osteoarthritis four months before presentation.

Triamcinolone acetonide is commonly used for intraarticular injections. It is a macromolecule with reduced solubility, which leads to more prolonged duration of action but a higher risk of hypopigmentation.1 Possible adverse effects of steroid injections include local irritation, infections, telangiectasia, cutaneous and subcutaneous atrophy, and epidermal dyspigmentation.1 Steroid-induced hypopigmentation is a common adverse effect of topical corticosteroids; however, it is less common following intra-articular steroid injections.2 Hypopigmentation usually occurs at the site of injection but may occur as linear rays, thought to be from lymphatic spread of suspended triamcinolone crystals.3 Most published cases of steroid-induced hypopigmentation occurred in black patients, although cutaneous hypopigmentation is less noticeable in patients with lighter skin tones and may be underreported.4 The reaction may be more cosmetically problematic in patients with darker skin types. Because hypopigmentation may occur months after an injection, the patient may not relate it to the steroid injection.4,5 Cutaneous hypopigmentation tends to resolve without treatment, although it may take several months to one year.4,5 Idiopathic guttate hypomelanosis is a common acquired benign skin condition in patients older than 50 years with dark skin tones. It typically presents as many small, scattered, well-demarcated, hypopigmented macules on sun-exposed areas of the extremities.6 Pityriasis alba is a common condition in children with a history of atopy. It presents as hypopigmented patches with fine scaling and ill-defined borders that typically affect the cheeks.7 Vitiligo is an acquired condition characterized by depigmented macules and patches due to loss of

Summary Table Condition

Characteristics

Idiopathic guttate hypomelanosis

Many small, scattered, well-demarcated, hypopigmented macules on sun-exposed areas of the extremities; occurs in persons older than 50 years with dark skin tones

Pityriasis alba

Hypopigmented patches with fine scaling and ill-defined borders; occurs in children with a history of atopy; typically involves the cheeks

Steroid-induced hypopigmentation

Irregularly shaped, well-defined hypopigmented patch; history of corticosteroid injection in the local area

Vitiligo

Depigmented macules and patches; often symmetric; usually affects the face, neck, and scalp, or areas of repeated trauma

melanocytes. The lesions are usually symmetric and most often affect the face, neck, and scalp, or areas of repeated trauma.6 REFERENCES 1. Cardone DA, Tallia AF. Joint and soft tissue injection. Am Fam Physician. 2002;66(2):283-288.

2. Gray RG, Gottlieb NL. Intra-articular corticosteroids: an updated assessment. Clin Orthop Relat Res. 1983;177: 235-263.

3. Schwartz C, Javvaji S, Feinberg JS. Linear rays of hypopigmentation following intra-articular corticosteroid injection for post-traumatic degenerative joint disease.

Dermatol Online J. 2012;18(5):11.

4. Friedman SJ, Butler DF, Pittelkow MR. Perilesional linear atrophy and hypopigmentation after intralesional corticosteroid therapy. Report of two cases and a review of the literature. J Am Acad Dermatol. 1988;19(3): 537-541.

5. Stapczynski JS. Localized depigmentation after steroid injection of a ganglion cyst on the hand. Ann Emerg Med. 1991;20(7):807-809.

6. Ortonne JP, Passeron T. Vitiligo and other disorders of hypopigmentation. In: Bolognia J, Jorizzo JL, Schaffer JV, eds. Dermatology. 3rd ed. London, United Kingdom: Elsevier Saunders; 2012:1023-1030.

7. Lapeere H, Boone B, Schepper SD, et al. Hypomelanoses and hypermelanoses. In: Fitzpatrick TB, Goldsmith LA, eds. Fitzpatrick’s Dermatology in General Medicine.

8th ed. New York, NY: McGraw-Hill; 2012:804-826.

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COMMUNITY MEDICINE

Effectiveness of Teaching Standardized Protocol on Safe Medication Administration Process Upon the Level of Knowledge Among Nurses at a Tertiary Care Hospital, Chennai KASTHURI P*, N CHIDAMBARANATHAN†, LATHA VENKATESAN‡

Abstract Strategies to improve medication safety focused on acute care settings. Twenty-six studies and descriptions of quality improvement projects were identified. Strategies used to focus on recommendations to prevent medication errors at various stages, from a nationwide voluntary organization to improve safety of patients and empower education system of nurses and other healthcare providers in safe practices in healthcare system and vast growing technology.

Keywords: Medication errors, healthcare delivery, lack of communication, monitoring side effects of drugs, adverse drug reactions, sentinel events, high risk and alert medications, strategies to reduce medication errors and legal implications

“Success is not final, failure is not fatal: it is the courage to continue that counts.” —Winston Churchill

M

edication errors produce a variety of problems for patients, ranging from minor discomfort to substantial morbidity that may prolong hospitalization or lead to death. The 1999 IOM (Institute of Medicine) report implicates medication errors, at least in part, as a direct cause of up to 98,000 patients death annually. Drug errors associated with morbidity and mortality increase inpatient healthcare costs by an estimated $4700 per hospital admission, or approximately $2.8 million annually for a 700-bed teaching hospital. In addition, time spent by the healthcare team tracking errors, such as missed doses, can have an effect on time available for direct patient care.

*Nursing Scholar Apollo College of Nursing, Chennai, Tamil Nadu †Head Dept. of Radiology and Imaging Sciences Radio Diagnosis, Apollo Hospitals, Chennai, Tamil Nadu ‡Principal Apollo College of Nursing, Chennai, Tamil Nadu Address for correspondence Kasthuri P Nursing Scholar Apollo College of Nursing, The Tamil Nadu Dr MGR Medical University Chennai, Tamil Nadu E-mail: kasthurisenthil77@gmail.com

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Medication safety is a significant issue in hospitals and throughout healthcare. Great improvements are needed, and hospitals are making great efforts to reduce errors and increase this aspect of patient safety. Effective leadership and appropriateness of intervention are associated with successful change implementation.

Healthcare professionals play a vital role in improving the quality of care and also in monitoring the quality assurance of patients in health-care settings. Examining the root cause analysis of events, to promote personnel training and communication barriers for corrective action of healthcare professionals to deliver quality of care to clients. Therefore adding new technology, revising policies and procedures, and providing more education have often been the approaches taken to reduce medication errors.

Need and Relevance of Study In the Harvard Medical Practice Study, Leape and colleagues examined more than 30,000 hospital discharges selected at random from 51 hospitals in the State of New York in 1984. The researchers found that 3.7% of hospitalizations involved adverse events that prolonged hospital stay or were manifested as a new disability at the time of discharge. About one in four

COMMUNITY MEDICINE of these adverse events were judged to be attributable to negligence, and 58% were judged to be preventable.

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Literature related to rates and types of medication administration errors

James Reason (1995), a leading author in error management believed people generally do not act in isolation, but that their behavior is influenced by circumstances. He maintained that the likelihood of an unsafe act being committed is heavily influenced by the nature of the task and by the local workplace conditions.

Examples include, increasing staffing and decreasing workload, software enhancement or modification, eliminating or reducing distractions, checklists and clinical or critical pathways, eliminate look-alike and sound-alike’s, read back and enhanced documentation and communication. Moreover, there are medication errors that require necessary interventions to sustain life.

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Literature related to knowledge on medication administration process among nurses

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Literature related to technology and medication errors among nurses

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Literature related to medication prevention strategies for nurses.

Optimization of the medication process can be obtained by adopting various strategies such as medication standardization, clinical pathway/critical pathway, electronic physician order entry system or computerized physician order entry (CPOE) system, barcode technology, electronic medication administration record (EMAR), medication reconciliation (updating current medications prescribed for the patients from admission till discharge).

Objectives ÂÂ

To assess the pre- and post-test level of knowledge regarding safe medication administration process in experimental and control group of nurses to enhance quality monitor to improve patient care among nurses.

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To evaluate the effectiveness of teaching standardized protocol by comparing the pre- and post-test level of knowledge regarding safe medication process in experimental and control group of nurses to enhance quality monitor to improve patient care among nurses.

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To find out the difference between pre- and posttest level of knowledge regarding safe medication process in experimental and control group of nurses to enhance quality monitor to improve patient care among nurses.

Review of Literature A literature review is an organized written presentation of what has been published on a topic by scholars.

Burns and Groove (2004). The review of literature for this study is presented under the following headings: ÂÂ

Literature related to medication administration errors among nurses

errors

and

Literature Related to Medication Administration Errors among Nurses Oliveira et al (2016) systematically conducted a literature review by utilizing the databases: MEDLINE, CINAHL, LILACS, SciELO, BDENF and Cochrane from studies in English, Portuguese or Spanish, published by 2015. Of 594 potential studies, 8 comprised the final sample of the review. The Nursing Activities Score (NAS; 37.5%) and the Therapeutic Intervention Scoring System (TISS; 37.5%) were the instruments most frequently used for assessing nursing workload.

Six studies (75.0%) identified the influence of work overload in events of infection, PU (pressure ulcer) and medication errors. This study identifies evidences of the influence of nursing workload on the occurrence of adverse events (AE) in adult patients admitted to the intensive care unit (ICU). Thus, it concludes that the nursing workload of patients in the ICU influenced the occurrence of AE, and nurses must monitor this variable daily to ensure proper sizing of staff and safety of care by prevention of medication errors.

Literature Related to Rates and Types of Medication Administration Errors A randomized controlled trials (RCTs) and controlled trials (CTs) reporting rates of medication administration errors (MAEs) or related adverse drug events between an intervention group and a comparator group was conducted by Keers et al (2014). Risk ratios (RRs, with 95% confidence intervals [CIs]) were used to examine the effect of an intervention. Ten electronic databases were searched between 1985 and November 2013. Six RCTs and 7 CTs were included. Types of interventions clustered around four main themes: medication use technology (n = 4); nurse education and training (n = 3); changing practice in anesthesia (n = 2) and ward system changes (n = 4). Reductions in MAE rates were reported by 5 studies; these included automated drug dispensing (RR 0.72, 95% CI 0.53-1.00), CPOE (RR 0.51, 95% 0.40-0.66), barcode-assisted medication administration with electronic administration records (RR 0.71, 95% CI 0.53-0.95), nursing education/training

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COMMUNITY MEDICINE using simulation (RR 0.17, 95% CI 0.08-0.38) and clinical pharmacist-led training (RR 0.76, 95% CI 0.670.87). Increased or equivocal outcome rates were found for the remaining studies. Weaknesses in the internal or external validity were apparent for most included studies. There is a need to identify effective interventions to minimize the threat posed by MAEs. The study concludes with review and critically appraise interventions designed to reduce MAEs in the hospital setting. There is emerging evidence of the impact of specific interventions to reduce MAEs in hospitals, which warrant further investigation using rigorous and standardized study designs. Theory-driven efforts to understand the underlying causes of MAEs may lead to more effective interventions in the future.

Literature Related to Knowledge on Medication Administration Process among Nurses Pirinen et al (2015), conducted a study to describe the different stages of Medication Administration Process (MAP) from the registered nurses (RNs’) perspective.

A qualitative descriptive research design, with a purposive sample involving thematic interviews of 20 RNs and questions to them in a paper form, was conducted in two medical units. Data were analyzed by using deductive content analysis. The results revealed that RNs confront numerous problems such as equivocal prescriptions, problems with information technology (IT), unavailability or incompatibility of the medicines, a substantial amount of generic substitutions and changing medicine brands. Disruptions and distraction run through each stage of the MAP, excluding prescribing. The RNs desire support in all stages of the MAP. There are areas to improve in each stage of the MAP from the RNs perspective.

Real-time and ubiquitous documentation, along with software including the data and knowledge required in medication management, is needed.

Literature Related to Technology and Medication Errors Among Nurses A total of 2,603 articles were initially identified

by Hutton et al (2017) and 10 studies, which used prospective before-and-after study design, were fully reviewed in this article. A systematic search of databases was performed from 1998 to December 2016. Studies measuring the effect of bar-coding technology on medication errors were included in a full-text review.

Studies with the outcomes other than medication errors such as efficiency or workarounds were excluded.

The results of this review show that bar-coding

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technology may reduce medication errors in hospital settings, particularly on preventing targeted wrong dose, wrong drug, wrong patient, unauthorized drug and wrong route errors. However, few studies have addressed the impact of bar-coding technology with strong prospective methodologies and the research, which has been conducted from both in-pharmacy and bedside implementations.

Literature Related to Medication Errors and Prevention Strategies for Nurses An cross-sectional descriptive study was conducted

by Gorgich et al (2016), to investigate the causes of medication errors and strategies to prevention of them from nurses and nursing student viewpoint. This cross-sectional descriptive study was conducted on 327 nursing staff of Khatam-al-Anbia Hospital and 62 intern nursing students in nursing and midwifery school of Zahedan, Iran, enrolled through the availability sampling in 2015. The data were collected by the valid and reliable questionnaire. To analyze the data, descriptive statistics, t-test and analysis of variance (ANOVA) were applied by use of SPSS software version 16. The results showed that the most common causes of medication errors in nursing were tiredness due to increased workload (97.8%), and in nursing students it was drug calculation (77.4%).

The most important way for prevention in nurses and nursing student’s opinion, was reducing the work pressure by increasing the personnel, proportional to the number and condition of patients and also creating a unit for medication calculation. Also there was a significant relationship between the type of ward and the mean of medication errors in two groups. Based on the results, it was recommended that nurse-managers resolve the human resources problem, provide workshops and in-service education about preparing medications, side effects of drugs and pharmacological knowledge. Using electronic medications cards is a measure, which would reduce medications errors.

Methodology and Procedures

Research Design ÂÂ

Research design: Experimental research designQuasi (pre- and post-test design).

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Research setting: Tertiary care hospital, Chennai.

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Sampling technique: Probability systematic random sampling technique.

COMMUNITY MEDICINE ÂÂ

Target population: The target population comprised of all nurses who satisfied the inclusion criteria.

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Accessible population: Comprised of nurses who satisfied the inclusion criteria at a tertiary care hospital, Chennai.

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Sample size: Fifty (25 in experimental and 25 in control) registered nurses/midwives at tertiary care hospital, Chennai.

moderately adequate (40%, 20%) in pre-test (Fig. 1), whereas after teaching standardized protocol on SMAP 100% in experimental and 96% in control group had adequate knowledge; 4% in moderately adequate in post-test and none of them had inadequate knowledge (Fig. 2).

With regard to the mean (M) and standard deviation (SD) for the pre-test scores of level knowledge on teaching standardized protocol on SMAP (M = 11.16, SD = 2.528), (M = 10.48, SD = 2.023) showed no significant difference at p > 0.05. On the other hand, after receiving knowledge the mean and SD (M = 23.60, SD = 0.866), (M = 22.84, SD = 1.028) of post-test scores were adequate knowledge when compared with pre-test scores (Fig. 3). The difference was found to be statistically significant at p < 0.01 in experimental and control group of nurses, respectively.

ÂÂ

Description of the Research Tool Tool consisted of 3 sections ÂÂ

Section I - Demographic data: It included the baseline information about the nurses.

ÂÂ

Section II - Structured questionnaire to assess the level of knowledge regarding safe medication administration process (SMAP)*. The score was interpreted as follows: Scoring key zz

Adequate - ≥75%

zz

Moderately adequate - 50-75%

zz

Inadequate - <50% Percentage (%)

Section III - Practice observation checklist to assess the enteral route on SMAP*, by using standardized protocol.

Prior permission was obtained from concerned management of hospital. Confidentiality of the information was maintained.

60

60

40

40 20

20 0

Ethical Considerations

Inadequate

Control group

Plan for data analysis: Descriptive and inferential statistics method.

100

Analysis and Findings

Major Findings ÂÂ

With regard to knowledge, a significant percentage of nurses had inadequate knowledge (60%, 80%),

Moderately adequate

Figure 1. Percentage distribution of level of knowledge pre-test scores on SMAP in experimental and control group during medication process.

Method of data collection: Observation method.

Experimental group 96

100

80 Percentage (%)

As per the data most of the nurses were aged between 20 to 29 years (84%, 100%) group, has female (84%, 100%), graduate nurses (64%, 60%) working in general wards (32%, 36%), with years of experience (56%, 36%), employed permanently (56%, 44%) belongs to nuclear family (76%, 72%) in experimental and control group, respectively.

Experimental group

80

80

The scoring key was graded into adequate knowledge, moderately adequate knowledge and inadequate knowledge on percentage basis. ÂÂ

Control group

100

60 40 20 0

0

0

Inadequate

4

0

Moderately adequate

Adequate

Figure 2. Percentage distribution of level of knowledge post-test scores on SMAP in experimental and control group during medication process.

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COMMUNITY MEDICINE Pre-test

30

Mean ± SD

25

23.60 ± 0.866

Post-test

22.84 ± 1.028

20 15

11.16 ± 2.528

10.48 ± 2.023

10

Implications

5 0

Enhanced communication skills and better interactions among members of the healthcare team and the patients’ are essential. Reducing medication compliance is an ongoing process of quality improvement. Thus, faculty systems must be redesigned and seamless, computerized integrated medication delivery must be inculcated by healthcare professionals for adequate training to use such technological advances.

Control group

Experimental group

Nursing Practice

With regard to the mean and SD for the enteral route of medication administration in first post-test observation scores on SMAP (M = 33.7, SD = 0.723), (M = 18.84, SD = 0.374) among nurses was significant at p < 0.01. On the other hand, the enteral route of medication administration in second post-test observation scores (M = 35.56, SD = 0.712), (M = 18.84, SD = 0.374) was statistically significant at p < 0.001 in experimental and control group of nurses; the difference was found statistically significant at p < 0.001, respectively.

Therefore, it is suggested to train nurses and hospital administrators on facilitators and barriers of error reporting in order to enhance patient safety. Effective prevention of these type of errors depends on the presence of a well-organized reporting system which is able to set targets for costs, quality of information, responsiveness, employee satisfaction and degree of innovation to establish drug distribution system, in respect of quality and cost-effectiveness and represents the best and most cost-effective way of preventing medication errors. Thus, the researchers intend to develop a protocol as prevention strategy for reduction of medication compliance in order to define the differences in quality and cost-effectiveness to enhance the quality improvement among nurses.

Association Findings

Nursing Education

Figure 3. Comparison of mean and SD on pre- and post-test level of knowledge scores on SMAP in experimental and control group of nurses during medication process.

These findings reveal that age, gender, educational qualification, area of clinical experience, occupation and type of family were influencing the level of knowledge on SMAP among nurses, which led them to face challenges in healthcare delivery system (HCDS).

Many researchers have recommended by increasing pharmacological knowledge of nurses as a strategy to reduce serious of medication compliance and adverse reaction of drugs. Therefore, nurses are required to update their knowledge about medicines, especially newer drugs. Obviously, it is absolutely impossible to eliminate all medication compliance. However, the role of nursing administrators in reducing and preventing these errors is vital. Reporting medication errors is an ethical duty to maximize the benefits of patient care. It can thus improve patient safety and health.

Therefore, managers should have a positive attitude toward the reporting of medication compliance by nurses. Intervention and prevention programs should primarily focus on this type of medication error. More than 75% of nurses strongly agree that continuous education and up-to-date information of pharmacology are necessary to avoid medication errors.

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Nursing students can be altruistic and optimistic if they are molded from the beginning. Almost all the nurses follow written guidelines for administering medication.

Potential problems were identified in documenting side effects/adverse reactions of medications, storage of medications, student self-administration practices and appropriate authorization of nonprescription drug use. Faculty might consider curriculum revisions that incorporate safety medication use throughout nursing courses. Educational programs to raise awareness and reduce hospital MAEs in children have been delivered to doctors, nurses and graduating students.

Nursing Administration The role of nursing administrators in reducing and preventing these errors is vital. Although most medication compliance issues can be minor and may not harm the patients, they need more supervision and planning. Nurses involved in a hospital administration should conduct regular skill training programs to empower the novice nurses with three domains (cognitive, conative and affect).

COMMUNITY MEDICINE Nursing Research Many researchers have recommended increasing pharmacological knowledge of nurses as a strategy to reduce serious medication errors. Preparing future generations of nursing professionals with a positive career will be a unique challenge. The Joint Commission International (JCI) advocates the pursuit of continuous improvement in decreasing medication errors so as to enhance patient safety.

Recommendations ÂÂ

A similar study can be conducted on a large sample to generalize the findings.

ÂÂ

The study can be replicated in different settings.

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A different (exploratory/prospective) study design can be conducted to evaluate awareness about medication errors amongst healthcare personnel in various hospital settings.

Conclusion Nurses are most involved in safe medication administration process, although they provide a vital function in detecting and preventing errors that occurred in the prescribing, transcribing, dispensing and administration stages. Research addressing the complex process of medication use in hospitals is urgently needed and requires a new approach to produce valid knowledge from studies done in this field to equip nurses with updated knowledge and skills so as enhance continuous quality improvement to deliver optimum standardized healthcare services to patients.

5. Pirinen H, Kauhanen L, Danielsson-Ojala R, Lilius J, Tuominen I, Díaz Rodríguez N, et al. Registered nurses’ experiences with the medication administration process. Advances in Nursing. 2015;2015:941589.

6. Stolic S. Educational strategies aimed at improving student nurse’s medication calculation skills: a review of the research literature. Nurse Educ Pract. 2014;14(5):491-503.

7. Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, et al. Guidelines for perioperative care in bariatric surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations. World J Surg. 2016;40(9):2065-83.

8. Ehsani SR, Cheraghi MA, Nejati A, Salari A, Esmaeilpoor AH, Nejad EM. Medication errors of nurses in the emergency department. J Med Ethics Hist Med. 2013;6:11.

9. Bayazidi S, Zarezadeh Y, Zamanzadeh V, Parvan K. Medication error reporting rate and its barriers and facilitators among nurses. J Caring Sci. 2012;1(4):231-6.

10. Cheragi MA, Manoocheri H, Mohammadnejad E, Ehsani SR. Types and causes of medication errors from nurse’s viewpoint. Iran J Nurs Midwifery Res. 2013; 18(3):228-31.

11. Carlton G, Blegen MA. Medication-related errors: a literature review of incidence and antecedents. Annu Rev Nurs Res. 2006;24:19-38.

12. Brown MM. Managing medication errors by design.

Crit Care Nurs Q. 2001;24(3):77-97.

13. Hartly GM, Dillon S. An observational study of the prescribing and administration of intravenous during in a general hospital. Int J Pharm Pract. 1998;8:18-45.

14. Koohestani HR, Baghcheghi N. Barriers to the reporting of medication administration errors among nursing students. Aust J Adv Nurs. 2010;27(1):66-74.

Suggested Reading

15. O’Shea E. Factors contributing to medication errors: a literature review. J Clin Nurs. 1999;8(5):496-504.

1. Oliveira AC, Garcia PC, Nogueira LS. Nursing workload and occurrence of adverse events in intensive care: a systematic review. Rev Esc Enferm USP. 2016;50(4): 683-94.

16. van Doormaal JE, van den Bemt PM, Mol PG, Zaal RJ, Egberts AC, Haaijer-Ruskamp FM, et al. Medication errors: the impact of prescribing and transcribing errors on preventable harm in hospitalised patients. Qual Saf Health Care. 2009;18(1):22-7.

2. Hutton K, Ding Q, Wellman G. The effects of bar-coding technology on medication errors: a systematic literature review. J Patient Saf. 2017 Feb 24. [Epub ahead of print]

17. Latter S, Yerrell P, Rycroft-Malone J, Shaw D. Nursing, medication education and the new policy agenda: the evidence base. Int J Nurs Stud. 2000;37(6):469-79.

3. Keers RN, Williams SD, Cooke J, Walsh T, Ashcroft DM. Impact of interventions designed to reduce medication administration errors in hospitals: a systematic review.

Drug Saf. 2014;37(5):317-32.

18. Benjamin DM. Reducing medication errors and increasing patient safety: case studies in clinical pharmacology.

J Clin Pharmacol. 2003;43(7):768-83.

4. Gorgich EA, Barfroshan S, Ghoreishi G, Yaghoobi M. Investigating the causes of medication errors and strategies to prevention of them from nurses and nursing student viewpoint. Glob J Health Sci. 2016; 8(8):54448.

19. Chedoe I, Molendijk H, Hospes W, Van den Heuvel ER, Taxis K. The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. Arch Dis Child Fetal Neonatal Ed. 2012;97(6):F449-55.

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DERMATOLOGY

Clinical Survey on Alopecia: A Dermatologist’s Perspective on Choice of Medical Therapy and Patient’s Expectations SN CHARUGULLA

Abstract Androgenetic alopecia (AGA) is an exceedingly common condition that affects both men and women. It represents one of the commonest reasons that patients consult dermatologists. Ideally, early diagnosis and intervention are essential in management of AGA. The management of AGA is challenging and the choice of treatment depends on factors such as efficacy, risks and costs. Treatment modalities include medical or surgical management. Early intervention with topical and oral medications is important. Validating minOxIdil by dermatologists ConsEnsus (VOICE) II is a survey conducted amongst Indian dermatologists to understand the various treatment modalities chosen for their patients suffering from hair loss with respect to different clinical grades and to determine their perceived patients’ expectations regarding treatment in terms of time taken to observe results.

In this article, we evaluate such data including the different strengths of topical minoxidil recommended as monotherapy, on the following parameters: clinical diagnosis of the patient; grade of alopecia (MPHL/FPHL) and the treatment expectation of patients in terms of time taken to observe visible results.

Keywords: Minoxidil, alopecia, androgenetic alopecia

A

ndrogenetic alopecia (AGA) is an exceedingly common condition that affects both men and women.1 It represents one of the commonest reasons that patients consult dermatologists.2 Male AGA is a very common form of hair loss seen in men, and is estimated to affect nearly 30-50% of men by the age of 50 years.3 About 13% of premenopausal women have been reported to have some evidence of AGA. The incidence increases following menopause, and nearly 75% of women >65 years of age may develop AGA.1 Dihydrotestosterone (DHT) has a significant role to play in the pathophysiology of alopecia.1 DHT is a tissue metabolite of testosterone. DHT can stimulate the growth of the hair follicles on the face, chest and genital area, while inhibiting the growth of hair in the skin of the scalp.4 High levels of the potent androgen DHT and increased expression of the androgen receptor gene have been noted in balding scalps.5

Medical Affairs Dr Reddy's Laboratories Ltd., Hyderabad, India E-mail: sujeetnc@drreddys.com

Male AGA, or male-pattern hair loss (MPHL), is marked by gradual thinning of hair in the temporal areas (bitemporal recession), thus reshaping the anterior part of the hairline. Women present with diffuse hair thinning on the crown. Bitemporal recession occurs to a lesser extent in women than in men. The frontal hairline is usually maintained in women. Female AGA or female-pattern hair loss (FPHL) begins as widening of the center part and then diffuse hair loss over the crown, resulting in gradual thinning of the hair rather than an area of marked baldness.

In both males and females with AGA, the transition from large, thick, pigmented terminal hair to thinner, shorter, indeterminate hair and then to short, wispy, nonpigmented vellus hairs in the involved areas occurs gradually.1,6 AGA may be a sign of hyperandrogenism in premenopausal women, when associated with hirsutism and acne.7 AGA tends to affect the patients psychologically. Hair loss can cause significant distress, low self-esteem, low self-confidence and increased level of anxiety and depression.8 Ideally, early patient presentation (early diagnosis) and adequate therapeutic intervention are essential in AGA management as demands from patients are very high. History and physical examination are significant components of the diagnosis. Examination includes

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DERMATOLOGY evaluation of hair loss on the scalp in order to identify if the hair loss is patterned or not, and looking for factors that may aggravate AGA, such as seborrheic dermatitis.

A thorough medical and drug history and family history are important. Assessment for any hormonal dysfunction among females, patientâ&#x20AC;&#x2122;s diet and nutritional status and obtaining history of lifestyle-related factors, such as smoking, are needed. Hair pull test helps determine the severity of hair loss. Trichoscopy is also helpful in establishing the diagnosis of AGA.2

Clinical Diagnosis

The management of AGA is challenging and the choice of treatment depends on factors such as efficacy, risks and costs. Treatment modalities include medical or surgical management.2 Early intervention with topical and/or oral medications is important. Most of the approved drug therapies are aimed at arresting the progression of hair loss and stimulating partial regrowth of hair.3

MPHL was classified into Stages I-VII according to the Norwood-Hamilton scale 2. The number of patients in each stage is summarized in Table 3. Figure 2 shows the percentage of patients with different stages of alopecia.

Validating minOxIdil by dermatologists ConsEnsus (VOICE) II is a survey conducted amongst Indian dermatologists (n = 340) to collect their responses for their patients with hair loss (n = 13,356) on aspects of various medical treatment modalities chosen for this condition with respect to different grades of hair loss and to determine the patientsâ&#x20AC;&#x2122; expectations regarding treatment in terms of time to observe results.

Male patients were found to be diagnosed mainly with four types of hair loss - MPHL, acute telogen effluvium, chronic telogen effluvium and alopecia areata. The number of patients with each diagnosis is shown in Figure 1. MPHL was the most common diagnosis. There were several patients who were diagnosed with more than one type of hair loss (Table 2).

Grade of Alopecia

Table 1. Age-wise Distribution of Male Patients Age group 18-20

293

21-30

3238

31-40

2925

41-50

879

51-60

90

61-70

18

>70

5

In this article, we have evaluated data for patients prescribed different strengths of minoxidil administered as monotherapy.

Methodology

Number of patients

820 617 446

Acute telogen effluvium

In all, 340 dermatologists across various regions in India were part of this survey. Their clinical experience related to minoxidil 2%, 5% and 10% was documented with the help of a simple questionnaire.

The survey was based on the following key parameters: clinical diagnosis of the patient; grade of alopecia (MPHL/ FPHL) and the treatment expectation of patients in terms of time taken to observe visible results.

MPHL Chronic telogen effluvium Alopecia areata 6955

Figure 1. Number of male patients with different types of hair loss.

Results

Table 2. Patients Diagnosed with More Than One Type of Hair Loss

Males

Cause of hair loss

In this survey, 7448 males were found to be diagnosed with hair loss, and were prescribed topical minoxidil, oral finasteride, topical peptides, oral nutraceuticals, shampoo and other therapies. The age-wise distribution of male patients in the survey population is shown in Table 1. Majority of patients were in the age group 21-40 years.

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Number of patients

MPHL+ ATE

350

MPHL+ CTE

549

MPHL + AA

491

ATE + AA

3

CTE + AA

3

MPHL = Male-pattern hair loss; ATE = Acute telogen effluvium; CTE = Chronic telogen effluvium; AA = Alopecia areata.

DERMATOLOGY

Minoxidil Monotherapy In all, 2795 male patients were found to have been prescribed minoxidil monotherapy (with or without oral nutraceuticals and shampoo). Out of these, 212 were found to be treated with minoxidil 2%, 1876 with minoxidil 5% and 707 patients with minoxidil 10%. The percentage of patients treated with each of the minoxidil monotherapies is shown in Figure 3.

Of the 3 strengths of minoxidil solutions used as monotherapy in male patients in the survey, minoxidil 5% appeared to be the choice of monotherapy. Figure 4 shows that minoxidil 5% was used more than 2% and 10% strengths.* It was observed that minoxidil 5% was choice of monotherapy in all stages of MPHL. Figure 5 shows that use of minoxidil 10% increased with advanced stages of

MPHL, and reached close to use of minoxidil 5% for Stages IV, V and VI. The use of minoxidil 2% showed an opposite trend to that observed with 10% strength.

Treatment Expectation of Patients in Terms of Time Taken to Observe Visible Results Table 4 summarizes the number of male patients expecting to observe visible results within 1-2 months, 2-4 months, 4-6 months and 6-10 months with the 3 different strengths of minoxidil as monotherapy 80 Percentage of patients minoxidil monotherapy

Across age groups, majority of MPHL patients belonged to Stages II and III. In terms of age, the majority of patients between 18 and 40 years were diagnosed with Stage I and Stage II. The number of patients decreased as the disease stage increased. In patients aged between 41 and 70 years, most patients were diagnosed with Stages III vertex, IV and V.

67.12

70 60 50 40 30

25.30

20 7.58

10 0

Minoxidil 2%

Figure 3. Patients treated with minoxidil monotherapy.

80

Minoxidil 2%

Percentage of patients in each category

Number of patients

Stage I

801

Stage II

2050

Stage III

1751

Stage III vertex

660

10

Stage IV

806

0

Stage V

614

Stage VI

264

Stage VII

9

40 30 20

MPHL

Percentage of patients in each stage

I

St

ag

e

VI

VI

V

ag e St

ag e St

St

e ag I VI

VI

ag e St

V

ag e St

ag e St

ag ve e I rte II St x ag e IV

St

e

III

II e ag

ag St

I St

ag e St

Figure 2. MPHL patients in each stage.

III ag ve e I rte II x St ag e IV

0 II

0.13

0

10

ag e

3.80

5

Minoxidil 10%

20

e

8.83

Minoxidil 5%

30

St

9.49

AA

40

I

10

CTE

50

ag

20

St

25.18

Minoxidil 2%

80 70 60

St

Percentage of patients with MPHL

29.48

11.59

ATE

Figure 4. Choice of minoxidil strengths as monotherapy in each type of hair loss.*

35

11.52

Minoxidil 10%

50

*According to Norwood-Hamilton Scale 2.

15

Minoxidil 5%

60

Stage

25

Minoxidil 10%

70

Table 3. Number of Male Patients in Each Stage*

30

Minoxidil 5%

Figure 5. Selection of minoxidil strengths as monotherapy in each stage.

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DERMATOLOGY that were elicited from the dermatologist’s responses.

Figure 6 shows the percentage of male patients expecting to observe treatment results within the aforementioned durations. It was noted that majority of male patients expected to observe results within the first 4 months (Table 4).

Females In this survey, a total of 5908 females were diagnosed with hair loss, and were found to be treated with minoxidil, topical peptides, oral nutraceuticals, shampoo and other therapies. Table 5 shows the agewise distribution of female patients in the survey population. Majority of female patients were found to be between 21 and 40 years.

Clinical Diagnosis Female patients were found to be diagnosed with seven types of hair loss - FPHL, acute telogen effluvium, chronic telogen effluvium, alopecia areata, hair loss due to polycystic ovarian disease (PCOD), postpartum hair shedding and hair shedding due to menopause.

The number of patients with each diagnosis is shown Table 4. Treatment Expectation in Terms of Time Taken to Observe Visible Results Minoxidil concentration

No. of patients expecting visible results

in Figure 7. FPHL was the most common diagnosis.

There were several patients who were diagnosed with more than one type of hair loss (Table 6).

Grade of Alopecia FPHL was classified into three stages on the basis of the Ludwig scale 2. Table 7 represents the number of female patients in each stage while the percentage of patients in each stage is depicted in Figure 8. In terms of age group, the majority of patients between 18 and 40 years of age were diagnosed with Stage I. The number of patients was found to decrease as the disease stage increased. However, in patients aged between 41 and 70 years, the highest number of patients were found to have Stage II alopecia.

Minoxidil Monotherapy In all, 3447 female patients were found to be prescribed minoxidil monotherapy (with or without oral nutraceuticals and shampoo). Out of these, 1760 were found to be treated with minoxidil 2% while 1687 were found to be treated with minoxidil 5%. The percentage of patients treated with each minoxidil monotherapy is shown in Figure 9. Figure 10 shows the choice of minoxidil strength as monotherapy in each type of hair loss.* Minoxidil 2% was noted to be preferred in patients with Stage I, while minoxidil 5% was found to be the choice of monotherapy in Stages II and III (Fig. 11).

within 1-2 months

within 2-4 months

within 4-6 months

within 6-10 months

Minoxidil 2%

81

79

48

4

18-20

476

Minoxidil 5%

329

824

642

81

21-30

2786

Table 5. Age-wise Distribution of Female Patients Age group

Number of patients

Minoxidil 10%

66

226

341

74

31-40

1730

Total

476

1129

1031

159

41-50

646

51-60

233

61-70

32

>70

5

Minoxidil 2%

Minoxidil 5%

Minoxidil 10%

80 Percentage of patients on minoxidil monotherapy

70 60 50

645 529

40

483

30 20

4500

1190

10 0 within 1-2 months

within 2-4 months

within within 4-6 months 6-10 months

Figure 6. Expectation in terms of time taken to observe visible results with minoxidil monotherapy.

532

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1091

FPHL Acute telogen effluvium Chronic telogen effluvium Alopecia areata Hair loss due to PCOD Postpartum hair shedding Hair shedding due to menopause

Figure 7. Number of female patients with found to be diagnosed different types of hair loss.

DERMATOLOGY

Cause of hair loss

Number of patients

FPHL+ ATE

708

FPHL+ CTE

824

FPHL + AA

227

FPHL + Hair loss due to PCOD

404

FPHL + Postpartum hair shedding

420

FPHL + Hair shedding due to menopause

265

CTE + Hair shedding due to menopause

6

ATE + AA

8

ATE + Hair loss due to PCOD

6

ATE + Postpartum hair shedding

10

CTE + AA

1

CTE + Hair loss due to PCOD

24

CTE + Postpartum hair shedding

3

AA + Hair loss due to PCOD

2

AA + Postpartum hair shedding

4

Hair loss due to PCOD + Postpartum hair shedding

2

Hair loss due to PCOD + Hair shedding due to menopause

14

Number of patients

Stage I

2495

Stage II

1801

Stage III

204

Percentage of patients with FPHL

30 20 10 0 Minoxidil 2%

Minoxidil 5%

Minoxidil 2%

Minoxidil 5%

Percentage of patients in each category

60 50 40 30 20 10 0

FPHL

ATE

CTE

AA

PCOD PPHS

MHS

Figure 10. Choice of minoxidil strength as monotherapy in each type of hair loss.* Minoxidil 2%

80 Percentage of patients in each stage

Stage

Minoxidil 5%

70 60 50 40 30 20 10 0 Stage I

Stage II

Stage III

Figure 11. Selection of minoxidil strengths as monotherapy in each stage.

Treatment Expectation of Patients in Terms of Time Taken to Observe Visible Results

55.44

50 40.02

30 20 10

4.53

0 Stage I

48.98

40

70

Table 7. Number of Female Patients in Each of the 3 Stages

40

51.06

50

Figure 9. Patients treated with minoxidil monotherapy.

FPHL = Female-pattern hair loss; ATE = Acute telogen effluvium; CTE = Chronic telogen effluvium; AA = Alopecia areata.

60

60 Percentage of patients on minoxidil monotherapy

Table 6. Patients Diagnosed with More Than One Type of Hair Loss

Stage II

Figure 8. FPHL patients in each stage.

Stage III

Table 8 summarizes the number of female patients expecting to observe visible results within 1-2 months, 2-4 months, 4-6 months and 6-10 months with the 2 different strengths of minoxidil as monotherapy that were elicited from the dermatologist’s responses.

Figure 12 shows the percentage of female patients expecting to observe treatment results within the aforementioned durations. It was noted that majority of female patients expected to observe results within the first 4 months.

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DERMATOLOGY Table 8. Treatment Expectation in Terms of Time Taken to Observe Visible Results Minoxidil concentration

No. of patients expecting visible results within 1-2 months

within 2-4 months

within 4-6 months

within 6-10 months

Minoxidil 2%

460

748

487

65

Minoxidil 5%

245

689

649

104

Total

705

1437

1136

169

Percentage of patients on minoxidil monotherapy

70 60 50 40 30 20 10 0

within 1-2 months

within 2-4 months

within 4-6 months

within 6-10 months

Figure 12. Expectation in terms of time taken to observe visible results with minoxidil monotherapy.

Discussion

in 22.12% and Grade III in 21.78% subjects. The grade of alopecia increased with increase in age. Pattern alopecia was noted in about 47.5% subjects in the 30-35 years age group, 58.7% in the 36-40 years age group and 73.2% in the 41-45 years age group. In the 30-35 years age group, Grade I alopecia was seen in 51.18%, Grade II in 42.77% and Grade VI in 18.52%.

In the 41-45 years age group, Grade I was evident in 13.38%, Grade III in 33.85% and Grade VI in 66.67%.12 Sehgal et al13 noted in their study that among Indian males, there was a significant gradual shift in the type of AGA from the earlier types (II and III) to more severe types (VI) with increasing age. AGA types II and III were the most common types in this population.

In women too, the incidence of AGA increases with increasing age. There is a lack of conclusive published data on the epidemiology of female AGA from the Indian subcontinent.14 Sehgal et al15 assessed 35 consecutive women presenting with AGA and attempted classification across Ludwig and Norwood guidelines. Sixteen women were classified as having Grade I alopecia, 10 had Grade II and 1 had Grade III as per Ludwig classification. In addition, 6 other women had Christmas tree baldness: 1 each of frontoparietal and male pattern baldness.

Hair transplantation is one of the best and at times may be the only therapeutic option in advanced AGA. Topical biopeptides are one of the recent advancements in the management of hair loss, and are available globally. Other emerging therapeutic options for hair loss include hair stimulating complex (HSC), stem cell-based therapies, prostaglandin-based therapies, tetrapeptides, other anti-androgens and platelet-rich plasma.11

In this clinician survey, it was noted that alopecia was most common in the age group 21-30 years, both in males and females. Among males, 29.48% had Stage II alopecia while 25.18% had Stage III. Among females, 55.44% had Stage I alopecia, 40.02% had Stage II, while 4.53% had Stage III. Among males, the majority of patients between 18 and 40 years were diagnosed with Stage I and Stage II AGA. As the stage of alopecia advanced, the number of patients were found to be decreased. In patients aged between 41 and 70 years, most patients were diagnosed with Stages III vertex, IV and V. Among females, the majority of patients between 18 and 40 years of age were diagnosed with Stage I. In females also; as the stage of alopecia advanced, the number of patients were found to be decreased. However, in patients aged between 41 and 70 years, the highest number of patients were found to have Stage II AGA.

AGA affects all races; however, the prevalence rates may differ. Caucasians are estimated to have the highest prevalence of AGA. The prevalence rates in Caucasians are estimated to be around 30% for men in their 30s, 40% in their 40s and 50% in their 50s.2 In the Indian context, a population-based study of 1005 males, aged 30-50 years, revealed that 58% of the subjects had AGA. Grade II alopecia was seen in 27.27% subjects, Grade I

Hair loss is associated with psychological distress. Bade and colleagues8 evaluated the psychological impact of AGA in male patients and the quality-of-life (QoL) of these patients. About 66.5% of the subjects had a history of stress. The QoL subscale results demonstrated that subjects below 30 years of age were less affected on symptoms subscale. The younger age group appeared more self-assured. The mean Dermatology Life Quality

Guidelines recommend different strengths of topical minoxidil as the first-line treatment option for hair loss in males and females.9 Topical minoxidil and oral finasteride are the only approved drugs for the management of AGA in highly regulated countries, like the US.10

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DERMATOLOGY Index (DLQI) of younger subjects was significantly higher than older subjects. It was concluded that younger patients were more stigmatized, had poor functioning and emotions stability, but were more self-assured. Younger patients retained better QoL despite AGA. In another study, Sawant et al16 noted that younger patients had a significantly better psychological health.

On assessing the QoL, self-assurance appeared to be better in younger patients. Emotions seemed to be more affected in the younger patients, while older patients reported with worse functioning, more symptoms and more sense of stigmatization. Older patients had more psychological symptoms on almost all scales and scored high on obsessive-compulsive, interpersonal sensitivity and depression subscales.

It is thus known that alopecia has a significant impact of QoL in affected patients, and should therefore be treated appropriately.

Topical minoxidil was the first drug to be approved for the treatment of AGA in both men and women.17 Regular topical application of minoxidil is known to result in hair regrowth, but continuous use is needed to maintain the effect.3 A study evaluated whether topical minoxidil solution treatment could improve the QoL of patients with FPHL. A statistically significant difference between the visual analog scale (VAS) and DLQI scores was evident before and after treatment with 2% minoxidil. The QoL of the patients was severely impaired by FPHL. Topical minoxidil enhanced the QoL of the patients.18 Thomas F Cash19 conducted an online survey in 6 countries that aimed to specify the concerns and selftreating efforts of men seeking medical treatment for MPHL. The survey also intended at describing their expectations and actual experiences of a physician consultation. The survey involved 604 men aged 25-49 years. About 75% of the treatment seeking men were concerned, very concerned or extremely concerned about their hair loss; 96% were at least somewhat concerned. This high level of concern gave way to multiple information-seeking actions - 53.9% reported two or three actions; 24.6% reported four or five actions - and several self-treatments before physician consultation. Only 16% of the subjects did not try any treatment. About 21% of the treatment-motivated men with MPHL were uncomfortable while 37% were only moderately comfortable consulting a physician and delayed this consultation. Factors motivating men with MPHL to consult a physician included a concern about

worsening hair loss (82%), a desire to benefit from physicians’ treatment expertise (85%) or physicianprescribed products (75%), and dissatisfaction with nonprescription products (73%). Expectations for the physician’s treatment actions were met less often than was desired, resulting in dissatisfaction among onefourth of the men. Dissatisfaction occurred as a result of lack of specific treatment recommendations (66%), unanswered questions (54%) and a perception that the doctor was uncomfortable or uninterested in discussing their hair loss (52%). The survey, thus suggested that men seeking treatment for MPHL have significant concerns about the condition and make considerable efforts to obtain information and to self-treat.

The present clinician survey included a large number of patients and thus gives insight into reasonable perceptions amongst prescribers and their thoughts on patients. Of the 7448 males included in the survey results, 2795 male patients were found to be treated with minoxidil monotherapy. Out of these, 212 were found to be treated with minoxidil 2%, 1876 with minoxidil 5% and 707 patients with minoxidil 10%. Of the 3 strengths of minoxidil solutions used as monotherapy in male patients in the survey, minoxidil 5% appeared to be the choice of monotherapy. Use of minoxidil 10% increased with increase in stage of MPHL. In terms of patients’ expectations regarding time to observe visible results with the treatment, maximum number of male patients expected to see visible results within the first 4 months.

Of the 5908 females included in the survey results, 3447 female patients were found to be treated with minoxidil monotherapy. Out of these, 1760 were found to be treated with minoxidil 2%, while 1687 were found to be treated with minoxidil 5%. Minoxidil 2% was preferred in patients with Stage I, while minoxidil 5% was choice of monotherapy in Stages II and III. Again, maximum number of female patients expected to see visible results within the first 4 months.

Some limitations of this survey include objective based responses as eliciting subjective responses may have been difficult and patient expectations during and after the follow-up period after treatment initiation were not included, which might have better captured the change in expectations and satisfaction to therapy.

Conclusion This is a large survey conducted across several centers in India and gives deeper insights into the trends of choosing the minoxidil concentration as monotherapy

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DERMATOLOGY in India and the patient’s expectations on results.

Additionally, it provides the age-wise distribution of patients with alopecia seen in dermatology clinics across India and the stage of alopecia diagnosed in these patients. *Minoxidil is approved for AGA and that this document may have contained clinical usage beyond the approved indication. Dr Reddy’s and IJCP Publications Ltd. do not promote off label usage.

Disclaimer: Although great care has been taken in compiling and checking the information given herein to ensure that it is accurate, the publisher shall not be in no way directly or indirectly responsible for any error, omissions or inaccuracy in this publication whether arising from negligence or otherwise.

IJCP Publications Ltd. does not guarantee, directly or indirectly, the quality or efficacy of the product or service described in the advertisements or other material which is commercial in nature in this publication.

References 1. Thomas J. Androgenetic alopecia - Current status. Indian J Dermatol. 2005;50(4):179-90.

2. Kaliyadan F, Nambiar A, Vijayaraghavan S. Androgenetic alopecia: an update. Indian J Dermatol Venereol Leprol.

2013;79(5):613-25.

3. Cranwell W, Sinclair R. Male androgenetic alopecia.

In: Endotext [Internet]. Available from: https://www. ncbi.nlm.nih.gov/books/NBK278957/.

Accessed on July 26, 2017.

9. Tsuboi R, Itami S, Inui S, Ueki R, Katsuoka K, Kurata S, et al; Guidelines Planning Committee for the Management of Androgenetic Alopecia. Guidelines for the management of androgenetic alopecia (2010).

J Dermatol. 2012;39(2):113-20.

10. Chandrashekar BS, Nandhini T, Vasanth V, Sriram R, Navale S. Topical minoxidil fortified with finasteride: an account of maintenance of hair density after replacing oral finasteride. Indian Dermatol Online J. 2015;6(1):17-20.

11. Sonthalia S, Daulatabad D, Tosti A. Hair restoration in androgenetic alopecia: looking beyond minoxidil, finasteride and hair transplantation. J Cosmo Trichol.

2016;2:105.

12. Krupa Shankar D, Chakravarthi M, Shilpakar R. Male androgenetic alopecia: population-based study in 1,005 subjects. Int J Trichology. 2009;1(2):131-3.

13. Sehgal VN, Kak R, Aggarwal A, Srivastava G, Rajput P. Male pattern androgenetic alopecia in an Indian context: a perspective study. J Eur Acad Dermatol Venereol.

2007;21(4):473-9.

14. Singal A, Sonthalia S, Verma P. Female pattern hair loss.

Indian J Dermatol Venereol Leprol. 2013;79(5):626-40.

15. Sehgal VN, Srivastava G, Aggarwal AK, Midha R. Androgenic alopecia in women: an Indian perspective.

Skinmed. 2013;11(6):332-40.

4. Urysiak-Czubatka I, Kmieć ML, Broniarczyk-Dyła G. Assessment of the usefulness of dihydrotestosterone in the diagnostics of patients with androgenetic alopecia.

Postepy Dermatol Alergol. 2014;31(4):207-15.

16. Sawant N, Chikhalkar S, Mehta V, Ravi M, Madke B, Khopkar U. Androgenetic alopecia: quality-of-life and associated lifestyle patterns. Int J Trichology.

2010;2(2):81-5.

5. Lee WS, Lee HJ. Characteristics of androgenetic alopecia in Asian. Ann Dermatol. 2012;24(3):243-52.

17. Santos Z, Avci P, Hamblin MR. Drug discovery for alopecia: gone today, hair tomorrow. Expert Opin Drug Discov. 2015;10(3):269-92.

6. Herskovitz I, Tosti A. Female pattern hair loss. Int J Endocrinol Metab. 2013;11(4): e9860.

7. França K, Rodrigues TS, Ledon J, Savas J, Chacon A. Comprehensive overview and treatment update on hair loss. J Cosmet Dermatol Sci Appl. 2013;3(3A1):35881.

18. Zhuang XS, Zheng YY, Xu JJ, Fan WX. Quality of life in women with female pattern hair loss and the impact of topical minoxidil treatment on quality of life in these patients. Exp Ther Med. 2013;6(2):542-6.

8. Bade R, Bhosle D, Bhagat A, Shaikh H, Sayyed A, Shaikh A. Impact of androgenic alopecia on the quality of life in male subjects: results of an observational study from tertiary care hospital. 2016;4(10):12900-7.

19. Cash TF. Attitudes, behaviors, and expectations of men seeking medical treatment for male pattern hair loss: results of a multinational survey. Curr Med Res Opin.

2009;25(7):1811-20.

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DIABETOLOGY

Fasting Serum Magnesium Levels in Patients with Uncontrolled and Controlled T2DM in Relation to Its Complications SHASHIDHAR G*, SURAJ R BHUTADA†, MANJUNATH U†, PRASHANTH GK†, VINODH†

Abstract Background: Magnesium deficiency is proposed factor in pathogenesis of diabetic complications. Hypomagnesemia can be both a cause and consequence of diabetic complications. Objective: The aim of our study was to know the relationships between magnesium levels and diabetes its association with level of control of diabetes. Study design: This study was done in MVJ Medical College and Research Hospital, Hoskote, Bangalore. A total of 75 cases of type 2 diabetes mellitus (T2DM) were taken for study after satisfying the inclusion and exclusion criteria and also 35 nondiabetic patients admitted during this period were also included in this study under control group. All the patients were evaluated in detail including fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c) and fasting serum magnesium levels were estimated by using Calmagite method. Results: The serum magnesium among cases and controls are 1.88 ± 0.28 mg/dL and 2.10 ± 0.29 mg/dL, respectively. The mean serum magnesium levels in patients with controlled diabetes were 2.04 mg/dL, while they were 1.73 mg/dL in uncontrolled T2DM. Significant association was found between hypomagnesemia and diabetic retinopathy and nephropathy. Conclusions: There was significant reduction in serum magnesium levels in diabetics compared to controls.

There was significant correlation between magnesium levels and levels of control in diabetics. Uncontrolled diabetics had low levels of serum magnesium. Duration of diabetes and high levels FBS also had an association with low magnesium levels. Low magnesium levels were mainly associated with diabetic retinopathy and nephropathy.

Keywords: Type 2 diabetes mellitus, magnesium, diabetic nephropathy, diabetic retinopathy

D

iabetes mellitus (DM) refers to a group of common metabolic disorders that share the phenotype of hyperglycemia. Several distinct type of DM are caused by a complex interaction of genetics and environmental factors. Depending upon etiology of DM, factors contributing to hyperglycemia include reduced insulin secretion, decreased glucose utilization and increased glucose production. The metabolic dysregulation associated with DM causes secondary pathophysiologic changes in multiple organ systems such as microvascular (retinopathy, nephropathy, neuropathy) and macrovascular (coronary

*Associate Professor †Postgraduates Dept. of General Medicine MVJ Medical College and Research Hospital, Bangalore, Karnataka Address for correspondence Dr Suraj R Bhutada C/o: Dr RB Bhutada Lokmanya Colony, Irwin Chowk, Amravati - 444 601, Maharashtra E-mail: bhutadasurajmbbs@gmail.com

heart disease, peripheral arterial disease, cerebrovascular disease).1 Low magnesium status has repeatedly been demonstrated in patients with type 2 diabetes.

Magnesium deficiency appears to have a negative impact on glucose homeostasis and insulin sensitivity in patients with type 2 diabetes.2 Magnesium deficiency has been found to be associated with microvascular disease in diabetes.

Hypomagnesemia has been demonstrated in patients with diabetic retinopathy, lower levels of magnesium more is the risk for diabetic retinopathy.

Magnesium depletion has also been associated with arrhythmogenesis, vasospasm, platelet activity and hypertension.3 The reason why magnesium deficiency occurs in diabetes are not clear but may include increased urinary loss, lower dietary intake or impaired absorption of magnesium compared to nondiabetic individuals.4 Low dietary intake can also contribute to hypomagnesemia in diabetics. Patients with type 2 diabetes

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DIABETOLOGY are often overweight and may consume a diet higher in fat and lower in magnesium than nondiabetics.5,6 The present study was undertaken to know the relationships between magnesium levels and diabetes and association with level of control of diabetes.

Material and Methods Patients with type 2 diabetes admitted in MVJ Medical College and Research Hospital, Hoskote, Bangalore for a period of 1 year were included in the study. A total of 75 cases of T2DM were taken for study and also 35 nondiabetic patients admitted during this period were also included in this study under control group. All the patients were evaluated in detail including fasting blood sugar (FBS), postprandial blood sugar (PPBS), glycated hemoglobin (HbA1c) and fasting serum magnesium levels were estimated by using Calmagite method.

Inclusion Criteria All cases of T2DM and age- and sex-matched nondiabetic patients admitted to MVJ Medical College and Research Hospital, Hoskote, Bangalore.

Exclusion Criteria Patients with ÂÂ

Chronic renal failure

ÂÂ

Acute myocardial infarction in last 6 months

ÂÂ

Malabsorption or chronic diarrhea

ÂÂ

History of alcohol abuse

ÂÂ

Hypertension, proteinuria, eclampsia

ÂÂ

History of epilepsy

ÂÂ

Patients on diuretics and receiving magnesium supplements or magnesium containing antacids.

Statistical Method T-test was used to find the significance of mean pattern of serum magnesium between cases/controls, controlled/uncontrolled.

Analysis of variance (ANOVA) was used to find the mean pattern of serum magnesium in different complications in different range of FBS. Results A comparative study consisting of 75 diabetics and 35 controls was conducted to find serum magnesium in DM cases when compared to controls and magnesium levels in relation to complications.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

The mean age of diabetics was 59.56 ± 9.70 and 58.66 ±1 0.26 was that of controls (Table 1). The mean serum magnesium levels in cases and controls was 1.88 mg/dL and 2.1 mg/dL, respectively with p value of <0.003, which was statistically significant (Table 1).

Hypomagnesemia was seen in 38.6% of the cases, whereas only 2.9% of controls had hypomagnesemia (Table 1).

Mean serum magnesium levels among uncontrolled DM were lower as compared to patients with controlled DM (Table 2).

Mean serum magnesium levels in patients with and without diabetic retinopathy was 1.77 mg/dL and 2.01 mg/dL, respectively, showing that patient with diabetic retinopathy had significantly lower levels of serum magnesium compared to those without retinopathy (p < 0.0006) (Table 3). The mean serum magnesium levels in patients with and without diabetic neuropathy were 1.80 mg/dL and 2.09 mg/dL, respectively, which were statistically significant (p < 0.0002) (Table 3).

The mean serum magnesium levels in patients with and without diabetic neuropathy were 1.92 mg/dL and 1.83 mg/dL, respectively, which were not statistically significant (p < 0.2120) (Table 3). The mean serum magnesium levels in patients with and without ischemic heart disease (IHD) were 1.81 mg/dL and 1.92 mg/dL, respectively, which were not statistically significant (p < 0.139) (Table 3).

Table 1. Age, Sex, Mean FBS, Mean Serum Magnesium Among Cases and Controls Cases (n = 75)

Controls (n = 35)

59.56 ± 9.70

58.66 ± 10.26

Male

57.33%

57.14%

Female

42.67%

42.86%

Mean FBS (mg/dL)

206.33 ± 14.89

94.86 ± 11.78

0.0001

Mean serum magnesium (mg/dL)

1.88 ± 0.28

2.1 ± 0.29

<0.003

<1.8

29 (38.6%)

1 (2.9%)

1.8-2.5

45 (60.0%)

32 (91.4%)

1 (1.4%)

2 (5.7%)

Mean age

P value

Sex

Serum magnesium

>2.5

DIABETOLOGY Table 2. Effect of Level of Control of DM on Serum Magnesium Controlled diabetes (n = 37)

Uncontrolled diabetes (n = 38)

1.5-2.7

1.1-2.1

2.04 ± 0.29

1.73 ± 0.23

Range (min-max) Mean ± SD P < 0.001

Mean Mg levels (mg/dL)

Serum magnesium (mg/dL)

2.5 2.2 2

Serum magnesium (mg/dL)

Mean ± SD

P value

Retinopathy

1.77 ± 0.22

<0.0006

NPDR (n = 23)

1.86 ± 0.25

PDR (n = 16)

1.63 ± 0.20

No retinopathy

2.01 ± 0.31

Proteinuria (n = 53)

1.80 ± 0.28

Microalbuminuria (n = 35)

1.86 ± 0.29

Macroalbuminuria (n = 18)

1.67 ± 0.20

No proteinuria (n = 22)

2.09 ± 0.27

Neuropathy

1.92 ± 0.32

No neuropathy

1.83 ± 0.27

IHD (n = 51)

1.81 ± 0.28

No IHD (n = 24)

1.92 ± 0.32

<0.0002

1.80

181-230

231-280

1.73

1.5 1 0.5 0

Table 3. Serum Magnesium Levels in Patients With and Without Retinopathy, Nephropathy, Neuropathy and IHD

1.76

130-180

281-330

Figure 1. Comparison of serum magnesium levels according to different ranges of FBS.

Table 4. Comparison of Serum Magnesium Levels According to the Number of Complications Serum magnesium (mg/dL)

One complication

Two complications

(n = 25)

(n = 35)

Mean ± SD

2.07 ± 0.30

1.79 ± 0.25

All three (n = 13)

1.74 ± 0.29

Table 5. Comparison of Serum Magnesium Levels in Relation to HBA1c Levels <0.212

<0.139

NPDR = Nonproliferative diabetic retinopathy; PDR = Proliferative diabetic retinopathy; IHD = Ischemic heart disease.

Mean serum magnesium levels in patients with one complication, two complications and three complications was 2.07 mg/dL, 1.79 mg/dL and 1.74 mg/dL, respectively, which means that as the number of complications increase mean serum magnesium levels decrease (Table 4).

Mean serum magnesium levels in higher FBS range was low as compared to low FBS range i.e.: in range 130-180 mg/dL, 181-230 mg/dL, 231-280 mg/dL, 281-330 mg/dL, they were 2.2 mg/dL, 1.76 mg/dL, 1.80 mg/dL, 1.73 mg/dL, respectively (Fig. 1).

Serum magnesium levels were low when HbA1c was on higher side i.e.: When HbA1c was >9.80 then serum magnesium level was <1.7 mg/dL and when HbA1c was <7.20 then serum magnesium level was >1.7 mg/dL (Table 5).

Serum magnesium (mg/dL) HbA1c

<1.7

≥1.7

9.80 ± 1.75

7.20 ± 0.70

P <0.001

Table 6. Comparison of Serum Magnesium Levels in Relation to Duration of Diabetes Serum magnesium (mg/dL)

0-5 years (n = 17)

6-10 years (n = 39)

11-15 years (n = 12)

16-20 years (n = 7)

Mean ± SD

2.00 ± 0.36

1.90 ± 0.27

1.71 ± 0.29

1.78 ± 0.20

Mean serum magnesium levels according to the duration of diabetes i.e.: 0-5, 6-10, 11-15 and 16-20 years were 2.00, 1.90, 1.52 and 1.78 mg/dL, respectively (Table 6).

Discussion The present study included 75 diabetics and 35 nondiabetics. Serum magnesium levels were determined in all the subjects.

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DIABETOLOGY The present study had diabetic patients whose ages ranged for 41-80 years, which was consistent with study done by Biradar et al.7 Mean age

Cases

Controls

Biradar et al

55.42 ± 12.65

55.58 ± 12.84

Present study

59.56 ± 9.70

58.66 ± 10.26

Male patients in cases and controls were 57.3% and 57.14%, respectively and females were 42.6% and 42.8%, respectively.

Mean serum magnesium Mean ± SD

Cases

Controls

P value

1.88 ± 0.28

2.10 ± 0.29

<0.003

In this study, serum magnesium levels were more in controlled group as compared to uncontrolled group, which was consistent with the study done by Jain et al.8

Mean serum magnesium (mg/dL)

Microalbuminuria Macroalbuminuria

Rao et al

2.0 ± 0.24

1.80 ± 0.20

Present study

1.86 ± 0.29

1.67 ± 0.20

Above Box shows that patients with macroalbuminuria had a lower serum magnesium level as compared to patients with microalbuminuria.12 There was no association seen with magnesium levels in patients with neuropathy. There was a correlation between serum magnesium levels and number of complications.

Patients with only one complication had mean serum magnesium level of 2.07 ± 0.03 mg/dL and patient with two complications had a mean of 1.79 ± 0.25 mg/dL and those with three complications had a mean of 1.74 ± 0.29 mg/dL.

Mean serum magnesium levels (Mean ± SD)

Controlled diabetes

Uncontrolled diabetes

Patient with more than one complication had much lower serum magnesium levels, indicating more the complications, lesser the magnesium levels.

Jain et al

1.85 ± 0.08

1.68 ± 0.12

Conclusion

Present study

2.04 ± 0.29

1.73 ± 0.23

In present study, there was no any significant association between age and sex but duration of diabetes had a relation with serum magnesium levels; patients with duration of diabetes more than 5 years had a lower serum magnesium levels as compared to those with a duration less than 5 years.

In our study also significantly lower levels of serum magnesium were observed in diabetics with microvascular complications.

Hypomagnesemia has been reported in patients with diabetic retinopathy. Lower the level of serum magnesium greater is the risk of severe diabetic retinopathy, which was consistent with study done by Kauser et al and Mirza Shariff et al.9,10 Mean serum magnesium levels (mg/dL)

Retinopathy

No retinopathy

Kauser et al

1.79 ± 0.15

2.25 ± 0.16

Mirza Shariff et al

1.28 ± 0.30

1.60 ± 0.40

Present study

1.76 ± 0.23

2.01 ± 0.31

The mechanism by which hypomagnesemia predisposes to retinopathy is unclear. Grfton et al11 have proposed the inositol transport theory to explain this association.

But exact reason remains obscure.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

ÂÂ

Serum magnesium levels were low in type 2 diabetics when compared to controls.

ÂÂ

Levels of serum magnesium were further lowered in uncontrolled type 2 diabetics than those in whom diabetes was controlled.

ÂÂ

Hypomagnesemia was associated with diabetic retinopathy and diabetic nephropathy.

ÂÂ

No correlation was found in respect to neuropathy and IHD.

ÂÂ

More the duration of diabetes and the levels of FBS, lower was the serum magnesium levels.

ÂÂ

Hypomagnesemia is a factor in type 2 diabetes and associated with various complications and duration of diabetes leading to various complications. Hence, it is worth measuring serum magnesium levels in patients with T2DM and probably correlate their relationship with various complications.

References 1. Alvin CP. Harrison’s Principle of Internal Medicine. 19th Edition, McGraw-Hill; 2012.

2. Nadler JL, Buchanan T, Natarajan R, Antonipillai I, Bergman R, Rude R. Magnesium deficiency produces insulin resistance and increased thromboxane synthesis.

Hypertension. 1993;21(6 Pt 2):1024-9.

3. Sasaki S, Oshima T, Matsuura H, Ozono R, Higashi Y, Sasaki N, et al. Abnormal magnesium status in patients with

DIABETOLOGY cardiovascular diseases. Clin Sci (Lond). 2000;98(2): 175-81.

4. Wälti MK, Zimmermann MB, Spinas GA, Hurrell RF. Low plasma magnesium in type 2 diabetes. Swiss Med Wkly. 2003;133(19-20):289-92.

5. Ma J, Folsom AR, Melnick SL, Eckfeldt JH, Sharrett AR, Nabulsi AA, et al. Associations of serum and dietary magnesium with cardiovascular disease, hypertension, diabetes, insulin, and carotid arterial wall thickness: the ARIC study. Atherosclerosis Risk in Communities Study.

J Clin Epidemiol. 1995;48(7):927-40.

8. Jain AP, Gupta NN, Kumar A. Some metabolic facets of magnesium in diabetes mellitus. J Assoc Physicians India. 1976;24(12):827-31.

9. Kauser MM, Afreen A, Kasi J. Study of serum magnesium levels in diabetic retinopathy. J Res Med Den Sci. 2014;2(3):19-22.

10. Mirza Sharif Ahmed Baig, Mohd Siyadat Ali, Tejovathi B. Study of serum magnesium in diabetic retinopathy. Int J Biol Med Res. 2012;3(4):2480-2.

6. Schmidt LE, Arfken CL, Heins JM. Evaluation of nutrient intake in subjects with non-insulin-dependent diabetes mellitus. J Am Diet Assoc. 1994;94(7):773-4.

11. Grafton G, Baxter MA. The role of magnesium in diabetes mellitus. A possible mechanism for the development of diabetic complications. J Diabetes Complications. 1992;6(2):143-9.

7. Biradar S, Patil S, Kadeli D. Study of serum magnesium levels in type 2 diabetes mellitus. Int J Cur Res Rev. 2017;9(4):26-8.

12. Rao PP, Ghouse M. Serum magnesium levels in type 2 DM with microalbuminuria and macroalbuminuria.

IJSS. 2014.

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Global Nutrition Report 2017 Finds Overweight and Obesity to be Global Health Problems “The world faces a grave nutrition situation” says the Global Nutrition Report 2017 released recently. It shows that malnutrition, whether due to undernutrition or obesity, is prevalent in almost all countries around the world, which is hampering the broader global development efforts. The report, which studied 140 countries including India, further highlights the need for an urgent, integrated response to meet any of the 2030 Sustainable Development Goals (SDGs).

The Report found ‘significant burdens’ of three important forms of malnutrition used as a indicator of broader trends: Childhood stunting; anemia in women of reproductive age and overweight adult women.

Most countries (88%) face the burden of two or three of these forms of malnutrition. Some key observations of the Report are: ÂÂ

Overweight and obesity are on the rise in almost every country; 2 billion adults are now overweight or obese.

There is less than 1% chance of meeting the global target of halting the rise in obesity and diabetes by 2025.

ÂÂ

At least 41 million children under five are overweight, with the problem affecting high and lower income countries alike.

ÂÂ

At least 10 million children in Africa are now classified as overweight. One-third of North American men (33%) and women (34%) are obese.

ÂÂ

Although undernutrition rates are declining, it is not enough to meet the internationally agreed nutrition goals, including the SDGs target 2.2 to end all forms of malnutrition by 2030.

ÂÂ

One hundred fifty-five million children under five are stunted; Africa is the only region where absolute numbers are rising, due to population growth.

ÂÂ

Fifty-two million children worldwide are defined as wasted, meaning they do not weigh enough for their height.

ÂÂ

Two billion people lack key micronutrients like iron and vitamin A.

ÂÂ

Anemia rates are rising globally in women of reproductive age. More than half of all women of reproductive age in India have anemia with India.

(Source: Global Nutrition Report, November 3, 2017)

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

543

Neurology

Guillain-Barré Syndrome - Sensory Ataxic Variant: A Rare Case Report DEEPIKA SAGAR

Abstract Guillain-Barré syndrome (GBS) is a type of acute inflammatory neuropathy which is characterized by progressive symmetrical limb weakness, in which deep tendon reflexes disappear. It has an acute onset and the clinical symptoms often reach their peak at the 4th week. GBS is manifested as multiple nerve root and peripheral nerve injury, often with protein cell separation in the cerebrospinal fluid. There are many subtypes of the condition, which include acute inflammatory demyelinating polyneuropathy, acute motor axonal neuropathy, acute motor-sensory axonal neuropathy, Miller Fisher syndrome, acute autonomic neuropathy and acute sensory neuropathy. We report a rare case of sensory GBS in a 19-year-old, unmarried Hindu female patient who presented to us with 6 days history of tingling sensations in all the four limbs, tremulousness in both upper limb and imbalance while walking with swaying to either directions. She was investigated and a diagnosis of sensory ataxic variant of GBS was made. She was managed with intravenous immunoglobulins in a dose of 2 mg/kg body weight after which the disease progression stopped from third day and patient started improving after 5 days of treatment and recovered completely by 2 weeks.

Keywords: Guillain-Barré syndrome, acute inflammatory neuropathy, sensory ataxic variant, intravenous immunoglobulins

C

lassical Guillain-Barré syndrome (GBS) is a progressive symmetrical limb weakness, in which deep tendon reflexes disappear. The disease is characterized by an acute onset and the clinical symptoms often reach their peak at the 4th week. GBS is manifested as multiple nerve root and peripheral nerve injury, often with protein-cell separation in the cerebrospinal fluid (CSF). It often presents a single-phase self-limiting course; intravenous immunoglobulin and plasma exchange therapy are effective for the treatment of GBS. Demyelination is the main electrophysiological and pathological feature of this disease.1,2 In the past 20 years, it has been recognized that there are extensive subtypes of the condition, which include acute inflammatory demyelinating polyneuropathy, acute motor axonal neuropathy, acute motor-sensory axonal neuropathy, Miller Fisher syndrome, acute autonomic neuropathy and acute sensory neuropathy. Certain patients with sensory neuropathy may actually exhibit sensory GBS. However, case reports are rare.3,4 A case of sensory GBS treatment is described in the present study.

Senior Resident Dept. of Neurology Sms Medical College, Jaipur, Rajasthan E-mail: deepikakgmu@gmail.com

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Case Report A 19-year-old, unmarried Hindu female patient presented to us with 6 days history of tingling sensations in all the four limbs, tremulousness in both upper limb and imbalance, while walking with swaying to either directions. Patient had history of loose stools 10 days before the onset of above symptoms for which she had taken some local treatment. There is no history of neck pain, neck trauma, bowel bladder involvement, limb weakness, visual disturbance, slurring of speech, nausea and vomiting.

The patient had no history of habitation in an epidemic or rural environment and no history of smoking or alcohol abuse. She was unaware of any familial hereditary disease history or similar cases in her family.

On examination, patient was conscious, oriented with normal general gestures. Higher mental function, speech, cranial nerves, motor system and cerebellum examination was normal. Deep tendon reflexes were absent in all four limbs with bilateral flexor response.

Sensory examination revealed impaired fine touch, vibration and joint position up to bilateral wrist and knee joint with normal pain and temperature sensations. Gait was sensory ataxic type with positive Romberg test. Routine blood investigations including vitamin B12 and retroviral test was normal. Magnetic resonance imaging (MRI) brain with cervical screening

Neurology was normal. CSF examination showed normal cell count, glucose level with mildly raised protein level (93 mg/dL). Nerve conduction study showed sensory motor axonal affection of left peroneal nerve with sensory axonal affection of right median, right ulnar and both sural nerves.

Based on above findings, diagnosis of sensory ataxic variant of GBS was made. Intravenous immunoglobulins was started at 2 mg/kg body weight after which the disease progression stopped from third day and patient started improving after 5 days treatment. Patient was discharged after 8 days and she improved completely after 2 weeks of follow-up.

Discussion In the present case, the clinical manifestations in the patient were sensory disturbance and imbalance.

The objective examination did not reveal loss of muscle strength; however, the electrophysiological examination suggested evidence of sensorimotor fiber demyelination; this was considered to be a type of acute sensory fiber polyneuropathy. Oh et al5 proposed nine criteria for the diagnosis of sensory GBS in 2001: i) Acute symmetrical sensory loss, ii) a peak in symptoms at 4 weeks, iii) abating or disappearing tendon reflexes, iv) normal muscle strength, v) at least two pieces of evidence for nerve demyelination in the electrophysiological examination, vi) single-phase course, vii) the exclusion of other neurological diseases, viii) no family history and ix) increases in protein levels in the CSF in the acute phase.

As described, the patient met all the above-mentioned diagnostic criteria. However, clinical case reports about sensory GBS remain rare, and the understanding of this type of sensory GBS remains superficial. Firstly, clinical and electrophysiological characteristics of sensory GBS show heterogeneity. Seneviratne and Gunasekera6 reported 6 cases of sensory GBS with clinical manifestations of sensory impairment to the extremities but no deep sensory abnormalities or

ataxia. The electrophysiological examinations were normal, and CSF examination showed isolated protein cells. The 6 patients had a good prognosis, considering the effects of the small fiber damage. Dawson et al7 described a case of sensory GBS in which the patient exhibited abnormal sensation and joint position sense, vibratory sensory abnormalities and ataxia.

Certain patients may exhibit subjective weak limb muscle strength, and electrophysiology tests can show demyelination of the involved motor fiber, which is also considered as a lesion in the large sensory fiber. Lee and Lee8 believed that those patients who showed only clinical sensory neuropathy, and who were indicated to have motor and sensory fiber demyelination by electrophysiological examination, or demyelination only involving the sensory fibers, could be diagnosed with sensory type GBS. References 1. Asbury AK. Diagnostic considerations in Guillain-Barré syndrome. Ann Neurol. 1981;9 Suppl:1-5.

2. Asbury AK, Cornblath DR. Assessment of current diagnostic criteria for Guillain-Barré syndrome. Ann Neurol. 1990;27 Suppl:S21-4.

3. Guillain-Barré syndrome variants in Emilia-Romagna, Italy, 1992-3: incidence, clinical features, and prognosis.

Emilia-Romagna Study Group on Clinical and Epidemiological Problems in Neurology. J Neurol Neurosurg Psychiatry. 1998;65(2):218-24.

4. Ropper AH. Unusual clinical variants and signs in Guillain-Barré syndrome. Arch Neurol. 1986;43(11):1150-2.

5. Oh SJ, LaGanke C, Claussen GC. Sensory Guillain-Barré syndrome. Neurology. 2001;56(1):82-6.

6. Seneviratne U, Gunasekera S. Acute small fibre sensory neuropathy: another variant of Guillain-Barré syndrome?

J Neurol Neurosurg Psychiatry. 2002;72(4):540-2.

7. Dawson DM, Samuels MA, Morris J. Sensory form of acute polyneuritis. Neurology. 1988;38(11):1728-31.

8. Lee SS, Lee SH. Does sensory Guillain-Barré syndrome exist without any abnormalities in motor nerve conduction? Neurology. 2006;66(6):947-8.

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MRI Brain can Detect Children at High Risk of Multiple Sclerosis A study published in the November 2017 issue of the journal Neurology: Neuroimmunology & Neuroinflammation has shown that MRI brain can reveal changes in the brain associated with multiple sclerosis (MS) before the clinical symptoms of the disease appear in children. The study further reports that about 42% of children with MRI findings of MS developed the first clinical symptoms of the disease 2 years after the abnormal MRI.

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545

NEUROLOGY

A Study of Clinical Profile of Hyperglycemic Seizures P BALAMURUGAN*, CJ SELVAKUMAR†, ANOOP PAULOSE‡

Abstract Introduction: Seizures associated with nonketotic hyperglycemia (NKH) is an uncommon recognized entity in adults. Seizures may be initial presentation in diabetes mellitus. Possible mechanisms are hyperglycemia or hyperosmolarity, a low level of gamma-aminobutyric acid (GABA) and focal ischemia. Another mechanism is Krebs cycle in NKH is inhibited, GABA metabolism is increased and thus level decreases lowering threshold activity for seizure. Seizures can be also due to metabolic disturbances. Aim: The purpose of the study was to find a relationship between clinical profile of the patient and seizure type. Material and methods: The study was conducted in Coimbatore Medical College Hospital, Coimbatore in 50 patients admitted with hyperglycemic seizures. Patients who satisfied inclusion criteria were subjected to basic blood investigations with measuring of serum osmolarity, CT brain and electroencephalography being done in all these patients. Results: Hyperglycemia is associated with seizures; they can occur in ketotic and NKH but are common in patients with NKH. Hyperglycemic seizures are rarely associated with diabetic ketoacidosis. Conclusion: Thus, it is evident from this study that in all patients with newonset seizures above the age of 50 years, diabetes mellitus should be thought off and evaluated for it.

Keywords: Seizures, nonketotic hyperglycemia, diabetes mellitus, focal ischemia, Kerbs cycle, GABA metabolism

S

eizures associated with nonketotic hyperglycemia (NKH) are now more commonly recognized as a new entity among adults in our area. Hyperglycemic seizure, a special neuroendocrine syndrome due to NKH, has got its unique way of presentation; clinical recognition of this entity was first made by Maccairo in 1965. The seizures may be the initial manifestation of diabetes mellitus. Diabetes is one of the most common diseases with a rising trend and its association with seizures is to be studied in detail as early diagnosis and institution of appropriate therapy is required to control seizures.

The neurologic symptoms generally resolve with correction of hyperglycemia. The severity of NKH can vary widely, from no symptoms to severe symptoms, such as coma and even death. It can presents with neurological manifestations including delirium, partial

*Senior Assistant Professor Dept. of Medicine †Senior Assistant Professor Dept. of Neurology ‡Junior Resident Dept. of Medicine Coimbatore Medical College, Coimbatore, Karnataka Address for correspondence Dr Anoop Paulose ‡Junior Resident Dept. of Medicine Coimbatore Medical College, Coimbatore, Karnataka E-mail: invisible.pavlo3@gmail.com

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

or generalized seizures, hemichorea-hemiballism, epilepsia partialis continua and as any neurological presentation.

Recognition of the association of these neurological abnormalities and NKH is important because correction of the underlying hyperglycemia will lead to rapid improvement of the patient’s condition.

Aim The purpose of the study was to find a relationship between clinical profile of the patient and seizure type.

Material and Methods This study included 50 patients who were diagnosed to have hyperglycemic seizures on the basis of clinical evaluation, biochemical investigations, CT scan brain and electroencephalographic (EEG) studies, who were admitted in Coimbatore Medical College during 1st July 2016 to 31st September 2016.

Inclusion Criteria ÂÂ

Patients admitted with first time convulsions who were later found to be diabetic, whose blood sugar on admission was in the hyperglycemic range.

ÂÂ

Known diabetic patients who had focal neurologic symptoms/convulsions whose blood sugar during convulsions showed hyperglycemia.

NEUROLOGY ÂÂ

Patients with other systemic disorders who had convulsions during their hospital stay and showed hyperglycemic level of blood glucose and were later diagnosed as diabetic patients.

Exclusion Criteria ÂÂ All patients with seizure disorder of varying etiology without hyperglycemia. ÂÂ Patients with diabetes and cerebrovascular accidents without convulsions. ÂÂ Patients with previously known structural brain disorder with seizures or patients with convulsions following IV glucose.

Out of 50 patients, 35 patients had focal seizures and 11 patients had generalized tonic-clonic seizures (GTCS), 4 patients had epilepsia partialis continua (Fig. 3).

Forty-four percent of the patients came under glucose of 250-299 mg/dL, with second maximum fraction in the range 300-349 mg/dL (Fig. 4).

Ninety percent patients had hyperosmolality (Fig. 5).

Among 50 patients, 1 had plasma both plasma and urine acetone positive.

30

27

25

Results

20

The total number of patients included in the study was 50. Out of which 1 patient belonged to age group less than 20 years. The youngest of them was 18 years old.

Two patients belonged to age group of 30-39 years.

Ten patients belonged to age group of 40-49 years.

Thirteen patients belonged to age group of 50-59 years.

Twenty patients belonged to age group of above 60 years.

Thirteen patients were below the age of 50 years. Thirtyseven patients were above the age of 50 years (Fig. 1).

Out of the 50 study patients, 28 patients had first time seizures without known diabetes, 22 patients had diabetes with seizures. Of the 50 patients admitted, 32 were males and 18 were females (Fig. 2).

15 10 6

5 0

6 3

2 A

B

C

D

4

2

E

F

G

Figure 3. Analysis of symptoms and signs of hyperglycemia.

AFocal seizure, BFocal seizure with altered sensorium, CFocal seizure with speech

abnormality, DGTCS, EGTCS with altered sensorium, FGTCS with speech defect, partialis continua.

GEpilepsia

25 22 20

0% 2% 4%

Years: Age <19 20%

20-29 30-39

48%

40-49 26%

50-59

11

10 5

>60 0

Figure 1. Percentage of age-wise distribution of patients.

15

15

1 <200

200-249

250-299 300-349

1

0

350-399

>400

Figure 4. Blood glucose analysis.

10%

44%

56%

First time admission with seizures

Normal (275-295)

Diabetes mellitus with seizures

Abnormal (above 295)

90%

Figure 2. Admission status of patients in percentage.

Figure 5. Osmolality analysis.

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

547

NEUROLOGY Out of 50 patients, 36 patients had a normal CT scan and 14 had abnormal CT scan. Among 14 patients, 13 patients had infarct in the CT scan and 1 patient had cortical atrophy. When EEG was taken 42 patients had normal EEG and 8 had abnormal EEG. In among 8 patients, 2 had intermittent spike and sharp waves discharge on left parietal leads, and 4 patients had bilateral epileptiform waves on right side and 2 had epileptiform waves on left side.

Discussion From the study and analysis of results of 50 patients, it has been evident that seizure can be a presenting feature of hyperglycemia with NKH. GTCS as the first manifestation of NKH is found rare. Most common type of seizure that occurred in our study was focal seizure. Another observation from the study was that ketotic hyperglycemia is less associated with seizure possibility because of the antiepileptic effect of ketosis.

Also, it was evident from the study that hyperosmolality was present in 90% of the patients with seizures.

Hyperglycemic seizure occurred commonly above the age of 50 years and the incidence is more in males.

CT scan of 72% patients involved in the study showed normal without any structural brain lesion and EEG was normal in majority of patients with NKH seizures.

There is a direct correlation between blood glucose and serum osmolality with the frequency and duration of seizures.

The correction of NKH with insulin and IV fluids showed early and complete recovery, and mostly these seizures are refractory to antiepileptic medications.

Conclusion Nonketotic hyperglycemic seizures is one of the entity that should be suspected in a person with no previous history of seizures and so patient with new-onset seizures above age of 50, diabetes mellitus should be thought of and evaluated for it.

Suggested Reading 1. Joslin’s Diabetes Mellitus by C. Ronald Kahn, Gordon C Weir.

2. Neurology in Clinical Practice by Walter G Bradley et al.

3. Harrison’s Principles of Internal Medicine. 19th Edition.

in epileptic EL mice by reducing blood glucose.

Epilepsia. 2001;42(11):1371-8.

6. Stafstrom CE. Effects of fatty acids and ketones on neuronal excitability: implications for epilepsy and its treatment. In: Mostofsky DI, Yehuda S, Salem N Jr (Eds.).

Fatty Acids: Physiological and Behavioral Functions.

Totowa, NJ: Humana Press; 2001. pp. 273-90.

7. Gispen WH, Biessels GJ. Cognition and synaptic plasticity in diabetes mellitus. Trends Neurosci.

2000;23(11):542-9.

8. Maccario M, Messis CP, Vastola EF. Focal seizures as a manifestation of hyperglycemia without ketoacidosis.

A report of seven cases with review of the literature.

Neurology. 1965;15:195-206.

9. Scherer C. Seizures and non-ketotic hyperglycemia.

Presse Med. 2005;34(15):1084-6.

10. Lammouchi T, Zoghlami F, Ben Slamia L, Grira M, Harzallah MS, Benammou S. Epileptic seizures in nonketotic hyperglycemia. Neurophysiol Clin. 2004;34 (3-4):183-7.

11. Postuma RB, Lang AE. Hemiballism: revisiting a classic disorder. Lancet Neurol. 2003;2(11):661-8.

12. El Otmani H, Moutaouakil F, Fadel H, El Ouafi N, Abdoh Rafai M, El Moutaouakil B, et al. Choreaballismus in acute non-ketotic hyperglycaemia. Funct Neurol. 2009;24(3):129-32.

13. Chang MH, Li JY, Lee SR, Men CY. Non-ketotic hyperglycaemic chorea: a SPECT study. J Neurol Neurosurg Psychiatry. 1996;60(4):428-30.

14. Singh BM, Gupta DR, Strobos RJ. Nonketotic hyperglycemia and epilepsia partialis continua. Arch Neurol. 1973;29(3):187-90.

15. Hennis A, Corbin D, Fraser H. Focal seizures and non-ketotic hyperglycaemia. J Neurol Neurosurg Psychiatry. 1992;55(3):195-7.

16. Donat A, Guilloton L, Bonnet C, Depreux G, Lamboley JL, Drouet A. Partial visual seizures induced by non-ketosic hyperglycemia: magnetic resonance imaging and visual evoked potential descriptions. A study of two cases reports with radiologic and electrophysiologic abnormalities. Rev Neurol (Paris). 2013;169(2):154-61.

17. Ohara S, Nakagawa S, Tabata K, Hashimoto T. Hemiballism with hyperglycemia and striatal T1-MRI hyperintensity: an autopsy report. Mov Disord. 2001;16(3):521-5.

18. Boughammoura-Bouatay A, Chebel S, YounesMhenni S, Frih-Ayed M. Biballism due to non-ketotic hyperglycaemia. Diabetes Metab. 2008;34(6 Pt 1):617-9.

4. Schwartzkroin PA. Characteristics of CA1 neurons recorded intracellularly in the hippocampal in vitro slice preparation. Brain Res. 1975;85(3):423-36.

19. Gupta A, Rao VA, Pandian DG, Das AK. Cortical blindness with absent visually evoked potential in non-ketotic hyperglycemia. Indian J Ophthalmol. 2008; 56(1):88-9.

5. Greene AE, Todorova MT, McGowan R, Seyfried TN. Caloric restriction inhibits seizure susceptibility

20. Taieb-Dogui T, Harzallah MS, Khlifa K, Dogui M, Ben Ammou S, Jallon P. Acute repetitive gyratory seizures

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NEUROLOGY as a manifestation of nonketotic hyperglycemia.

Neurophysiol Clin. 2002;32(4):254-7.

21. Kaseda Y, Yamawaki T, Ikeda J, Hayata M, Dohi E, Ohshita T, et al. Amelioration of persistent, nonketotic hyperglycemia-induced hemichorea by repetitive transcranial magnetic stimulation. Case Rep Neurol. 2013 ;5(1):68-73.

22. Qi X, Yan YY, Gao Y, Zheng ZS, Chang Y. Hemichorea associated with non-ketotic hyperglycaemia: a case report. Diabetes Res Clin Pract. 2012;95(1):e1-3.

23. Cheema H, Federman D, Kam A. Hemichoreahemiballismus in non-ketotic hyperglycaemia. J Clin Neurosci. 2011;18(2):293-4.

24. Lin JJ, Chang MK. Hemiballism-hemichorea and non-ketotic hyperglycaemia. J Neurol Neurosurg Psychiatry. 1994;57(6):748-50.

25. Lai PH, Tien RD, Chang MH, Teng MM, Yang CF, Pan HB, et al. Chorea-ballismus with nonketotic hyperglycemia in primary diabetes mellitus. AJNR Am J Neuroradiol. 1996;17(6):1057-64.

26. Bathla G, Policeni B, Agarwal A. Neuroimaging in patients with abnormal blood glucose levels. AJNR Am J Neuroradiol. 2014;35(5):833-40.

27. Kim HJ, Moon WJ, Oh J, Lee IK, Kim HY, Han SH. Subthalamic lesion on MR imaging in a patient with nonketotic hyperglycemia-induced hemiballism. AJNR Am J Neuroradiol. 2008;29(3):526-7.

28. Ahlskog JE, Nishino H, Evidente VG, Tulloch JW, Forbes GS, Caviness JN, et al. Persistent chorea triggered by hyperglycemic crisis in diabetics. Mov Disord. 2001;16(5):890-8.

29. Shan DE, Ho DM, Chang C, Pan HC, Teng MM. Hemichorea-hemiballism: an explanation for MR signal changes. AJNR Am J Neuroradiol. 1998;19(5):863-70.

30. Wintermark M, Fischbein NJ, Mukherjee P, Yuh EL, Dillon WP. Unilateral putaminal CT, MR, and diffusion abnormalities secondary to nonketotic hyperglycemia in the setting of acute neurologic symptoms mimicking stroke. AJNR Am J Neuroradiol. 2004;25(6):975-6.

31. Guez A, Obadia M, Lafitte F, Tin SN, Héran F, Gout O. Magnetic resonance spectroscopy findings in a case of hyperglycaemic hemianopia. Rev Neurol (Paris). 2010;166(8-9):737-40.

32. Abe Y, Yamamoto T, Soeda T, Kumagai T, Tanno Y, Kubo J, et al. Diabetic striatal disease: clinical presentation, neuroimaging, and pathology. Intern Med. 2009;48(13):1135-41.

33. Pisani A, Diomedi M, Rum A, Cianciulli P, Floris R, Orlacchio A, et al. Acanthocytosis as a predisposing factor for non-ketotic hyperglycaemia induced chorea-ballism.

J Neurol Neurosurg Psychiatry. 2005;76(12):1717-9.

34. Singh BM, Strobos RJ. Epilepsia partialis continua associated with nonketotic hyperglycemia: clinical and biochemical profile of 21 patients. Ann Neurol. 1980;8(2):155-60.

35. Brick JF, Gutrecht JA, Ringel RA. Reflex epilepsy and nonketotic hyperglycemia in the elderly: a specific neuroendocrine syndrome. Neurology. 1989;39(3):394-9.

36. Duckrow RB, Beard DC, Brennan RW. Regional cerebral blood flow decreases during hyperglycemia. Ann Neurol. 1985;17(3):267-72.

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Study Shows Association Between Sports Concussion and Common Mental Disorders A history of concussions is associated with symptoms of common mental disorders and of later development of neurodegenerative disease, in particular chronic traumatic encephalopathy (CTE) in former male professional athletes across a range of contact sports, says a new study reported September 13, 2017 in the Physician and Sportsmedicine.

Gene Therapy Successful in Early-stage Adrenoleukodystrophy Results of the STARBEAM trial published October 4, 2017 in the New England Journal of Medicine and also presented at the 2017 Child Neurology Society Annual Meeting in Kansas City, USA demonstrate the success of hematopoietic stem-cell gene therapy (Lenti-D) in children with early-stage adrenoleukodystrophy, fatal neurologic degenerative condition suggesting it as a safe and effective alternative to allogeneic stem-cell transplantation.

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

549

OBSTETRICS AND GYNECOLOGY

Wilson’s Disease in Pregnancy: A Case Report SHREYASI BID*, SAMBHUNATH BANDYOPADHYAY†, ANIK DAS‡, SRIJANI CHOWDHURY‡

Abstract Wilson’s disease has a deleterious effect on fertility as it causes hepatic, pancreatic and cerebral dysfunction and menstrual irregularities. Here, we present a known case of Wilson’s disease who conceived spontaneously after 3 miscarriages. With regular antenatal check-up and neurological consultation she had a good pregnancy outcome.

Keywords: Wilson’s disease, pregnancy and zinc

S

uccessful pregnancy in a case of Wilson’s disease has rarely been reported. Both Wilson’s disease and pregnancy are associated with alteration in copper metabolism, in particular, that of ceruloplasmin. While this protein is markedly reduced in most of the cases of Wilson’s disease, it is usually increased in pregnancy due to increased estrogen levels. So, it appears that there had been significant clinical improvement in the severity of the disease during and months following pregnancy. Here, we present a case report of successful pregnancy following three abortions in a patient with long-standing Wilson’s disease and who has been under continuous therapy with zinc for 4 years.

Case Report A 28-year-old woman G4P0+3 nondiabetic, nonhypertensive, euthyroid admitted on 09.11.13 with dribbling and pain abdomen at 38 weeks of gestation.

She is a known case of Wilson’s disease. She is suffering from gradually progressive tremor all over the body for last 4 years. It is associated with thinning of proximal aspect of all limbs followed by distal parts. She was diagnosed as a case of Wilson’s disease in 2009. She conceived spontaneously after 3 consecutive abortions.

The laboratory work-up revealed an elevated urinary copper level and low serum ceruloplasmin. Her brother

was also suffering from Wilson’s disease. She has been using zinc sulfate 60 mg thrice-daily, trihexyphenidyl 2 mg thrice-daily, since the time of diagnosis and continued it throughout her pregnancy.

All the antenatal laboratory tests were within normal limits. Her urinary copper level was obtained in first trimester which was normal. Anomaly scan performed at 19 weeks revealed no gross congenital anomalies.

Oral glucose tolerance test done at 24 weeks of gestation, which ruled out gestational diabetes. Ultrasonography (USG) of whole abdomen at 32 weeks revealed coarse liver disease suggestive of chronic liver disease (CLD), chronic calculous cholecystitis and normal growth pattern of the fetus. Maternal echocardiogram was performed which was within normal limits. Magnetic resonance imaging (MRI) of brain showed bilateral basal ganglia, thalamic and midbrain hyperintensity with sparing of red nuclei and tegmentum. There was minimal cerebral and cerebellar atrophy. Complete blood count, thyroid profile test, liver function test, coagulation profile were performed 7 days prior to admission, all are within normal limits.

The patient underwent emergency LUCS on 09.11.13 due to oligohydramnios. Intraoperative course of events was unremarkable and a healthy boy baby weighing 2.5 kg with a good Apgar score was born. The postoperative period was unremarkable with proper wound healing.

Discussion

*RMO cum Clinical Tutor †Associate Professor ‡Postgraduate Trainee Dept. of Obstetrics and Gynecology Institute of Post Graduate Medical Education and Research, Kolkata, West Bengal Address for correspondence Dr Shreyasi Bid Dakshi Apartment, 75 James Long Sarani, Joka, Kolkata, West Bengal E-mail: drshreyasibid@gmail.com

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Wilson’s disease is a rare autosomal recessive disorder with prevalence of 1:50,000-1:1,00,000 live birth.

Although copper is a trace mineral and accounts for only 0.01% of total body weight, it plays an important role in electron transport, neurotransmitter synthesis, collagen cross - linkage, melatonin production and

OBSTETRICS AND GYNECOLOGY important factor in coagulation cascade. Copper is absorbed by the proximal small intestine and transported to the liver. In the liver copper is incorporated into apoceruloplasmin. Ceruloplasmin represent 90% of circulating copper and excess are excreted into bile.

The protein responsible for copper transport from liver to bile is ATP7B on chromosome 13q14. Absence or diminished function of ATP7B results in decreased copper excretion, the excess copper accumulates in the liver, brain, heart and pancreas. This results in liver cirrhosis, neurological abnormalities, cardiac dysfunction, pancreatic dysfunction.1

Trientine is an oral chelating drug used as an alternate when patients develop a reaction to penicillamine.

Its effectiveness has been proven and case reports regarding its use in pregnancy do not show any adverse fetomaternal outcomes.11,12

Moreover, it can lead to menstrual irregularities due to hepatotoxicity and recurrent miscarriages due to copper deposition in the uterus in women in reproductive age group.2,3 Women with Wilson’s disease may require infertility treatment but many patients conceive spontaneously. In our case, the patient conceived spontaneously after 3 miscarriages. The serum copper and ceruloplasmin levels have been observed to change as the pregnancy progresses. The levels may increase till 24 weeks followed by a modest decline probably due to fetal intake of copper. There is approximately 12 mg copper in a neonate and the fetus is thought to remove an average of 0.044 mg of copper per day from the maternal serum, due to which improvement in symptoms of Wilson’s disease have also been reported.4,5

In our case, the patient was treated with zinc sulfate without occurrence of any congenital anomaly in neonate. It is evident that the outcome of pregnancy in women with Wilson’s disease is determined by compliance with the prescribed regimen or deviation from it, rather than the choice of medication. The available data do not support the claim that zinc is “optimal” or that the patient should be advised to change a well-tolerated, effective regimen. Additionally, counseling and timely delivery, can greatly improve neonatal and maternal outcome.

Recent studies have shown that during pregnancy, ATP7B plays a role in transporting copper from placenta to maternal circulation, thus preventing fetal overload. If dysfunctional, excess copper remain in the fetus, placenta and endometrium resulting in fetal loss or damage. Wilson’s disease can be associated with preeclampsia, the fetus can be growth restricted and have neurological sequel due to oxidative damage caused by copper accumulation in the placenta and fetal tissue.6,7 However, such complications were not encountered in our patient. Wilson’s disease, if not treated promptly, can lead to significant morbidity and can be potentially fatal.

Penicillamine is the category D drug in pregnancy.

Fetal connective tissue anomaly can occur as a result of inhibition of collagen synthesis - neonatal inguinal hernia, reversible cutis laxa, hyperflexible joints, vascular fragility and poor wound healing have all been reported.

Although the evidence is incomplete, maintaining the daily dose at 500 mg or less may reduce the incidence of penicillamine-induced toxicity to newborn. If cesarean section is planned reduce the dose to 250 mg/day for 6 weeks before delivery and postoperatively in order to prevent delayed wound healing.8-10

More recently, zinc is increasingly being used as a therapeutic option in managing Wilson’s disease.

Zinc interferes with absorption of copper from the gastrointestinal tract. Zinc performs its function by induction of intestinal cells metallothioneine, which has a high affinity for copper and prevents serosal transfer of copper into blood.13

References 1. Roberts EA, Schilsky ML; American Association for Study of Liver Diseases (AASLD). Diagnosis and treatment of Wilson disease: an update. Hepatology. 2008;47(6):2089-111.

2. Mustafa MS, Shamina AH. Five successful deliveries following 9 consecutive spontaneous abortions in a patient with Wilson disease. Aust N Z J Obstet Gynaecol. 1998;38(3):312-4.

3. Morimoto I, Ninomiya H, Komatsu K, Satho M. Pregnancy and penicillamine treatment in a patient with Wilson’s disease. Jpn J Med. 1986;25(1):59-62.

4. Sherwin AL, Beck IT, McKenna RD. The course of Wilson’s disease (hepatolenticular degeneration) during pregnancy and after delivery. Can Med Assoc J. 1960;83:160-3.

5. Brewer GJ, Johnson VD, Dick RD, Hedera P, Fink JK, Kluin KJ. Treatment of Wilson’s disease with zinc. XVII: treatment during pregnancy.

Hepatology. 2000;31(2):364-70.

6. Young T, Downey G, Maheshwari MB, Nicholl DJ. A cupric pregnancy - thirteenth time lucky. JRSM Short Rep. 2010;1(6):51.

7. Kaplan JH, Lutsenko S. Copper transport in mammalian cells: special care for a metal with special needs. J Biol Chem. 2009;284(38):25461-5.

8. Geever EF, Youssef S, Seifter E, Levenson SM. Penicillamine and wound healing in young guinea pigs.

J Surg Res. 1967;7(4):160-6.

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OBSTETRICS AND GYNECOLOGY 9. Walshe JM. Pregnancy in Wilson’s disease. Q J Med. 1977;46(181):73-83.

10. Nimni ME, Bavetta LA. Collagen defect induced by penicillamine. Science. 1965;150(3698):905-7.

11. Walshe JM. The management of pregnancy in Wilson’s disease treated with trientine. Q J Med. 1986;58 (225):81-7.

12. Dupont P, Irion O, Béguin F. Pregnancy in a patient with treated Wilson’s disease: a case report. Am J Obstet Gynecol. 1990;163(5 Pt 1):1527-8.

13. Yuzbasiyan-Gurkan V, Grider A, Nostrant T, Cousins RJ, Brewer GJ. Treatment of Wilson’s disease with zinc: X. Intestinal metallothionein induction. J Lab Clin Med. 1992;120(3):380-6.

■■■■

Is Longer Operative Time Associated with Postoperative complications in Patients Undergoing Minimally-invasive Surgery for Endometrial Cancer?

According to a study printed in the Gynecologic Oncology Journal, increased operative time is independently associated with high risk of developing complications after laparoscopic surgery for endometrial cancer.

This study was performed with an aim of determining the impact of operative time on the development of postoperative medical and surgical complications in patients undergoing minimally-invasive surgery for endometrial cancer. The findings showed that as operative time increased, rates of complications also increased. Operative time ≥240 minutes was associated with increased overall complication rate (11.7% vs.

6%), medical complication rate (9.3% vs. 4.2%), and surgical complication rate (3.9% vs. 2.4%). On performing multi-variate logistic regression of factors associated with increased complication rates, it was found that increased operative time, chronic obstructive pulmonary disease, hypertension, diabetes, American Society of Anesthesiology (ASA) class ≥3, dependent functional status and chronic steroid use were independently linked with increased complications. On the other hand, lymphadenectomy was not related to increased operative time or increase in complications.

Determining the influence of Surgical Staging on the Prognosis of Mucinous Borderline Tumors of the Ovaries A recent multicenter study published in the Anticancer Research Journal that was conducted to determine the effect of complete surgical staging of patients with mucinous borderline ovarian tumors (mBOTs) especially appendectomy on progression-free survival (PFS) and overall survival (OS) revealed that patients with conservative surgery do not have higher recurrence rates. In addition, it was suggested that fertility-sparing surgery should be considered in the reproductive age group. It was also found that detailed surgical staging including lymphadenectomy, appendectomy and omentectomy has no impact on survival rates.

For this study, the database of 14 gynecological oncology departments from Turkey and Germany were comprehensively searched for women who underwent primary surgery for an ovarian tumor between January 1, 1998, and December 31, 2015, and whose final diagnosis was mBOT. A total of 364 patients with mBOT (median age: 43.1 years) were included in this study. The median OS of all patients was 53.1 months. Around 78.6% patients had stage IA. Univariate and multivariate analyses showed that radical surgery, omentectomy, appendectomy, lymphadenectomy and adding adjuvant chemotherapy were not independent prognostic factors for PFS and OS. Moreover, FIGO stage (≥ IC vs. &lt; IC), radical surgery and staging surgery were not considered as independent risk factors for recurrence of mBOTs. On the other hand, abnormal macroscopic appendix and FIGO stage (≥ IC vs. &lt; IC) were independent risk factors for appendiceal involvement.

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Every citizen of India should have the right to accessible, affordable, quality and safe heart care irrespective of his/her economical background

Sameer Malik Heart Care Foundation Fund An Initiative of Heart Care Foundation of India

E-219, Greater Kailash, Part I, New Delhi - 110048 E-mail: heartcarefoundationfund@gmail.com Helpline Number: +91 - 9958771177

“No one should die of heart disease just because he/she cannot afford it” About Sameer Malik Heart Care Foundation Fund

Who is Eligible?

“Sameer Malik Heart Care Foundation Fund” it is an initiative of the Heart Care Foundation of India created with an objective to cater to the heart care needs of people.

Objectives Assist heart patients belonging to economically weaker sections of the society in getting affordable and quality treatment.

Raise awareness about the fundamental right of individuals to medical treatment irrespective of their religion or economical background.

Sensitize the central and state government about the need for a National Cardiovascular Disease Control Program.

Encourage and involve key stakeholders such as other NGOs, private institutions and individual to help reduce the number of deaths due to heart disease in the country.

To promote heart care research in India.

All heart patients who need pacemakers, valve replacement, bypass surgery, surgery for congenital heart diseases, etc. are eligible to apply for assistance from the Fund. The Application form can be downloaded from the website of the Fund. http://heartcarefoundationfund.heartcarefoundation. org and submitted in the HCFI Fund office.

Important Notes The patient must be a citizen of India with valid Voter ID Card/ Aadhaar Card/Driving License.

The patient must be needy and underprivileged, to be assessed

by Fund Committee.

The HCFI Fund reserves the right to accept/reject any application for financial assistance without assigning any reasons thereof.

The review of applications may take 4-6 weeks.

All applications are judged on merit by a Medical Advisory Board who meet every Tuesday and decide on the acceptance/rejection of applications.

The HCFI Fund is not responsible for failure of treatment/death of patient during or after the treatment has been rendered to the patient at designated hospitals.

To promote and train hands-only CPR.

Activities of the Fund Financial Assistance

The HCFI Fund reserves the right to advise/direct the beneficiary to the designated hospital for the treatment.

Financial assistance is given to eligible non emergent heart patients.

Apart from its own resources, the fund raises money through donations, aid from individuals, organizations, professional bodies, associations and other philanthropic organizations, etc.

The financial assistance granted will be given directly to the treating hospital/medical center.

After the sanction of grant, the fund members facilitate the patient in getting his/her heart intervention done at state of art heart hospitals in Delhi NCR like Medanta – The Medicity, National Heart Institute, All India Institute of Medical Sciences (AIIMS), RML Hospital, GB Pant Hospital, Jaipur Golden Hospital, etc. The money is transferred directly to the concerned hospital where surgery is to be done.

Drug Subsidy

The HCFI Fund has the right to print/publish/webcast/web post details of the patient including photos, and other details. (Under taking needs to be given to the HCFI Fund to publish the medical details so that more people can be benefitted).

The HCFI Fund does not provide assistance for any emergent heart interventions.

Check List of Documents to be Submitted with Application Form Passport size photo of the patient and the family A copy of medical records Identity proof with proof of residence Income proof (preferably given by SDM)

The HCFI Fund has tied up with Helpline Pharmacy in Delhi to facilitate

BPL Card (If Card holder)

patients with medicines at highly discounted rates (up to 50%) post surgery.

Details of financial assistance taken/applied from other sources (Prime Minister’s Relief Fund, National Illness Assistance Fund Ministry of Health Govt of India, Rotary Relief Fund, Delhi Arogya Kosh, Delhi Arogya Nidhi), etc., if anyone.

The HCFI Fund has also tied up for providing up to 50% discount on imaging (CT, MR, CT angiography, etc.)

Free Diagnostic Facility

Free Education and Employment Facility

The Fund has installed the latest State-of-the-Art 3 D Color Doppler EPIQ 7C Philips at E – 219, Greater Kailash, Part 1, New Delhi.

HCFI has tied up with a leading educational institution and an export house in Delhi NCR to adopt and to provide free education and employment opportunities to needy heart patients post surgery. Girls and women will be preferred.

This machine is used to screen children and adult patients for any heart disease.

Laboratory Subsidy HCFI has also tied up with leading laboratories in Delhi to give up to 50% discounts on all pathological lab tests.

About Heart Care Foundation of India

Help Us to Save Lives The Foundation seeks support, donations and contributions from individuals, organizations and establishments both private and governmental in its endeavor to reduce the number of deaths due to heart disease in the country. All donations made towards the Heart Care Foundation Fund are exempted from tax under Section 80 G of the IT Act (1961) within India. The Fund is also eligible for overseas donations under FCRA Registration (Reg. No 231650979). The objectives and activities of the trust are charitable within the meaning of 2 (15) of the IT Act 1961.

Heart Care Foundation of India was founded in 1986 as a National Charitable Trust with the basic objective of creating awareness about all aspects of health for people from all walks of life incorporating all pathies using low-cost infotainment modules under one roof.

HCFI is the only NGO in the country on whose community-based health awareness events, the Government of India has released two commemorative national stamps (Rs 1 in 1991 on Run For The Heart and Rs 6.50 in 1993 on Heart Care Festival- First Perfect Health Mela). In February 2012, Government of Rajasthan also released one Cancellation stamp for organizing the first mega health camp at Ajmer.

Objectives Preventive Health Care Education Perfect Health Mela Providing Financial Support for Heart Care Interventions Reversal of Sudden Cardiac Death Through CPR-10 Training Workshops Research in Heart Care

Donate Now...

Heart Care Foundation Blood Donation Camps The Heart Care Foundation organizes regular blood donation camps. The blood collected is used for patients undergoing heart surgeries in various institutions across Delhi.

Committee Members

Chief Patron

President

Raghu Kataria

Dr KK Aggarwal

Entrepreneur

Padma Shri, Dr BC Roy National & DST National Science Communication Awardee

Governing Council Members Sumi Malik Vivek Kumar Karna Chopra Dr Veena Aggarwal Veena Jaju Naina Aggarwal Nilesh Aggarwal H M Bangur

Advisors Mukul Rohtagi Ashok Chakradhar

Executive Council Members Deep Malik Geeta Anand Dr Uday Kakroo Harish Malik Aarti Upadhyay Raj Kumar Daga Shalin Kataria Anisha Kataria Vishnu Sureka

This Fund is dedicated to the memory of Sameer Malik who was an unfortunate victim of sudden cardiac death at a young age.

Rishab Soni

HCFI has associated with Shree Cement Ltd. for newspaper and outdoor publicity campaign HCFI also provides Free ambulance services for adopted heart patients HCFI has also tied up with Manav Ashray to provide free/highly subsidized accommodation to heart patients & their families visiting Delhi for treatment.

http://heartcarefoundationfund.heartcarefoundation.org

OBSTETRICS AND and GYNECOLOGY

Prevalence of Reproductive Tract Infections/Sexually Transmitted Infections Among Women in a Tertiary Care Hospital: An Observational Study RUBY BHATIA*, PARMJIT KAUR†, SANTOSH KUMARI‡, AMAN DEV#

Abstract Background: Reproductive tract infections/sexually transmitted infections (RTIs/STIs) are an important public health problem; 6% of adult population in India has one or more RTI/STI. Approximately 30-35 million new episodes of RTI/STI occur every year in our country. RTI/STI are an important cause of infertility. Roughly 21% pregnancies result in stillbirth and 9% in neonatal death due to untreated syphilis. Aims and objectives: To study the prevalence of RTI/STI in women, to find out commonest RTI/STI and its correlation with human immunodeficiency virus/Venereal Disease Research Laboratory (HIV/VDRL) and Pap smear abnormality, if any. Material and methods: This is a cross-sectional observational study undertaken for 1 year in 2,294 consecutive women with RTI/STI in the age group of 15-49 years, attending the Gynecology Outpatient Department of a tertiary care hospital in North India. Result: The prevalence of RTI/STI in our study was 13.19%. Majority of patients were married (94.86%), Para 1 and above (93.4%) from low socioeconomic group (90.6%), illiterate (72.5%) between 26-35 years of age (67.47%). Vaginal discharge (62.51%) and lower abdominal pain/backache (43.42%) were most common presenting complaints. Vaginitis (62.51%), cervicitis (27.81%) and chronic pelvic inflammatory disease (PID) (15.63%) were most frequently encountered RTI/STI. Bacterial vaginosis (49.79%), candidiasis (35.84%) and trichomoniasis (21.33%) were important causes of vaginal discharge either alone or in combination. HIV and VDRL were reactive in only 15 (0.68%) and 11 (0.56%) RTI/STI females, respectively. Inflammatory Pap smear was observed in 36.4% cases while 9 cases (0.9%) had dysplasia of varying degree. Conclusion: Vaginal discharge and lower abdominal pain are the commonest presenting complaints. Mixed vaginitis, cervicitis and chronic PID are the frequently encountered RTI/STI in Gyne OPD practice. Bacterial vaginosis, candidiasis and trichomoniasis remain important causes of vaginal discharge. Counseling, testing for HIV/VDRL and Pap smear analysis along with syndromic management helps in prevention of RTI/STI.

Keywords: Reproductive tract infections, sexually transmitted infections, vaginal discharge, condom

S

exually transmitted infections/reproductive tract infections (STIs/RTIs) are an important public health problem in developing world and rank in the top five disease categories for which adults seek healthcare.

They are a silent epidemic for women of reproductive age group in developing countries.1 RTIs are defined as any infection of the reproductive system. They include STIs and also other infections of the reproductive

system that are not caused by sexual contact. STIs are infections transmitted from person to person by sexual contact.2 Globally, 499 million new episodes of STIs (trichomoniasis, chlamydia, gonorrhea, syphilis) occur yearly in the age group 15-49 years of which a significant proportion (80%) of these infections occur in developing countries and 79 million in India alone.3 Women are more susceptible to STIs for socioeconomic and biological reasons. The vaginal surface is larger and more vulnerable to sexual secretions than primarily skin covered penis.

*Associate Professor †Professor ‡Postgraduate Student #Civil Surgeon Dept. of Obstetrics and Gynecology Govt. Medical College and Rajindra Hospital, Patiala, Punjab Address for correspondence Dr Ruby Bhatia D-8, Medical College Campus, Patiala - 147 001, Punjab E-mail: drrubybhatia@yahoo.com

Around 11% women and 5% men in 15-49 years age group have RTI/STI related symptoms.4 STI/RTI are known to cause infertility and reproductive morbidity affecting not only mother but also newborn adversely.

STIs have been associated with number of adverse pregnancy outcomes: spontaneous abortion, stillbirths, prematurity, low birth weight, postpartum endometritis

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OBSTETRICS and GYNECOLOGY and sequlae in surviving neonates. With the recognition of human immunodeficiency virus (HIV) infection in 1980s and subsequent behavior, social and psychological changes, the pattern of genital ulcer disease has shifted from bacterial to viral STIs.5 There is significant decline of bacterial STIs (syphilis and gonorrhea). Chancroid is on verge of disappearance while viral STIs are showing an increasing trend. STIs are markers for high risk behavior for HIV infection. STIs are biological cofactors for acquisition and transmission of HIV infection.6 Material and Methods It was an observational study conducted in Outpatient Department of Obstetrics and Gynecology (STI Clinic), Govt. Medical College, Patiala for a period of 1 year (1-9-2009 to 31-8-2010) on a total of 2,294 RTI/STI female patients in the age group of 15-49 years, with an aim to study the prevalence of RTI/STI, to find out commonest RTI/STI and its correlation with HIV, Venereal Disease Research Laboratory (VDRL) and Pap smear abnormality, if any. A detailed history with special reference to any abnormal vaginal discharge amount, color, odor, rash or pruritus over genitalia, frequency/burning micturition, pain lower abdomen/backache, dysmenorrhea, post coital bleeding, menorrhagia, infertility was taken.

History of high risk sexual behavior (oral/anal sex), and number of sexual partners was sought. Gynecological examination including per speculum and per vaginum examination undertaken with complete audio visual privacy was undertaken. Women with carcinoma cervix were excluded from the study. All patients with RTI/STI were referred to Integrated Counseling and Testing Centers (ICTC) for voluntary counseling and testing for HIV antibody test and VDRL/RPR (rapid plasma reagin) for syphilis. Wet mount, 10% potassium hydroxide (KOH), Whiff test and Gram stain of the vaginal discharge and Pap smear with Ayre’s spatula was made in all the cases. All RTI/STI patients were treated as per user friendly syndromic approach to management with color-coded kits, partner management and provision of condoms, counseling for safe sex with correct and consistent use of condoms done in all cases.

from low and low middle socioeconomic group (90.68%) and 72.5% were illiterate (Table 2). It was seen that 62.51% RTI/STI women presented with vaginal discharge followed by 43.42% with lower abdominal pain and backache. Pruritus vulvi, dyspareunia, dysmenorrhea, polymenorrhagia, dysuria, post coital bleeding and anorectal discharge were other presenting complaints (Table 3). Majority of patients had more than Table 1. Distribution of Gynecology OPD Patients (1.9.2009 to 31.8.2010) Number Percentage (%) Total OPD patients

17,392

100

Total RTI/STI females

2,294

13.19

RTI/STI patients with positive HIV test

15

0.68

RTI/STI patients with reactive VDRL/RPR

11

0.56

Table 2. Socio-demographic Characteristics (Total = 2,294/100%) Age in years

Number

Percentage (%)

<20

123

5.36

21-25

238

10.37

26-30

912

39.75

36-40

636

27.72

>41-49

233

10.16

Married

2,176

94.86

Unmarried

9,118

5.14

151

6.64

2,143

93.36

1,663

72.5

Marital status

Parity Nulliparous >Para 1 Literacy Illiterate

Results

Up to Class V

353

15.4

With a total outpatient attendance of 17,392 for 1 year study period, 2294 females were diagnosed suffering from various RTIs/STIs. Overall prevalence of RTI/STI was 13.91%. Fifteen (0.68%) patients were positive for HIV antibody test, while VDRL/RPR was reactive in 11 (0.56%) RTI/STI cases (Table 1). Majority of RTI/STI females were married (94.86%), > Para 1 and above (93.36%), belonged to 26-35 years of age (67.47%),

Class VI-X

163

7.1

>Class X

115

5.0

1,600

69.75

Low middle

480

20.93

Upper middle

214

9.30

Socioeconomic group Low

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OBSTETRICS and GYNECOLOGY Table 3. Distribution as per Presenting Complaints (Total = 2,294/100%)

Table 5. Causative Organism in Vaginal Discharge (Total = 1,434/100%)

Presenting complaints

Types of vaginal discharge

Causative organism

Bacterial vaginosis

Gardnerella vaginalis

713

49.79

Candidiasis

Candida albicans

514

35.84

Trichomoniasis

Trichomonas vaginalis

306

21.33

Bacterial

N. gonorrhoea

84

13.27

Number

Percentage (%)

1,434

62.51

Lower abdominal pain and backache

996

43.42

Pruritus (local)

402

17.52

Dyspareunia

358

15.63

Dysmenorrhea

358

15.63

Polymenorrhagia

321

13.99

Dysuria/Burning micturition

102

4.44

Post coital bleeding

26

1.13

Anorectal discharge

11

0.44

Vaginal discharge

Table 4. Distribution According to Diagnosis (Total = 2,294/100%) Diagnosis Vaginitis Chronic cervicitis

Number

Percentage (%)

1,434

62.51

638

27.81

Number Percentage (%)

Table 6. Pap Smear Analysis (Total = 996/100%) Number

Percentage (%)

Normal

618

62.04

Inflammatory

363

36.4

Dysplasia

09

0.9

Mild

3

0.3

Moderate

4

0.4

Severe

2

0.2

6

0.6

Chronic pelvic inflammatory disease

358

15.63

Urethritis

96

4.18

Anorectal discharge

10

0.44

Discussion

Syphilis

11

0.48

Herpes simplex

4

0.17

Condyloma accuminata

4

0.17

The prevalence of RTI/STI in our study group was 13.19%, the National Family Health Survey III 2005 reports that 11% women and 5% men in 15-49 years age group have STI/RTI related symptoms4 almost similar to our results. The prevalence of RTI was 36.3% among women in reproductive age group in Shimla town.7 Bohra et al in their study observed 30% of women had symptoms related to RTI and 19% had STIs.8 Prevalence of RTI was estimated to be 27% among women by Hedge et al.9 In our study group, 0.68% and 0.56% of females in an RTI/STI were seropositive for HIV and syphilis, respectively. Ray et al10 reported low prevalence of HIV (0.1%) among women with RTI/STI. Khokhar et al reported 0.49% positive for syphilis and 0.39% for HIV.11 Majority of patients were married; (94.86%) were Para 1 and above (93.36%) were illiterate and 72.5% were from low socioeconomic status. Similar results were reported

by Ray et al.10 Majority of our patients (67.47%) were in the age group of 26-35 years as observed by Jindal et al and Gupta.12,13 Vaginal discharge (62.51%) was the most common presenting complaint in the present

Koilocytosis

one complaint. A diagnosis of vaginitis mostly mixed vaginitis was made in 62.51% RTI/STI women.

Chronic cervicitis was seen in 27.8 and chronic pelvic inflammatory disease in 15.63% followed by urethritis in 4.18% and syphilis in 0.48% of cases (Table 4). Many patients had vaginitis with cervicitis along with pelvic inflammatory disease. Bacterial vaginosis (49.79%) was the most important cause of vaginal discharge followed by candidiasis in 35.84%, trichomoniasis in 21.33% and bacterial (Neisseria gonorrhoeae) in 13.27% only (Table 5). Mixed vaginitis due to more than one microorganisms was observed in many cases.

Pap smear cytology report of 996 RTI/STI patients was analyzed; 36.4% patients had inflammatory Pap smear, 6 cases showed koilocytosis, while 9 women (0.9%) had cervical dysplasia of varying degree (Table 6).

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OBSTETRICS and GYNECOLOGY study. We reported vaginal discharge in 80% HIV negative and 66% in HIV positive. RTI/STI females in our previous study.14 Vaginal discharge (62.51%) and lower abdominal pain/backache were the most common symptoms in our study in accordance with other authors.9,12,13 Majority of patients in our study had vaginitis (62.51%), followed by cervicitis in 27.81% and pelvic inflammatory disease in 15.63%. Thus, kit-1, kit-2 and kit-6 were utilized to the maximum. The most common cause of vaginitis was observed to be bacterial vaginosis (49.79%) followed by candidiasis in 35.84% and trichomonal in 21.33%, while bacterial (gonorrhea) only in 13.27% RTI/STI females. Many of the patients had mixed vaginitis. There is significant burden of lower RTI (trichomoniasis, bacterial vaginosis and candidiasis) among women with no evidence to suggest a decline in prevalence, thus affecting quality of their reproductive life.3 In our previous study also, we observed that in case of HIV negative women, the most common cause of vaginal discharge was bacterial vaginosis (28%) followed by candidiasis (22%), trichomoniasis 18% and gonorrhea in 2%.14 In our study, 36.4% RTI/STI females had inflammatory Pap smear, while 9 (0.9%) had cervical dysplasia of varying degree. Pap smear were inflammatory in 56% and 22% in HIV positive and HIV negative STI/ RTI women, respectively as reported in our previous study.14 Seethalakshmi et al reported abnormal Pap smear in 58.8% and 43.75%. HIV positive and HIV negative women, respectively.15 In a study conducted

by Sharma et al, inflammatory smears were seen in 55% and 28%, while cervical dysplasia was reported in 5% and 3% HIV positive and HIV negative STI/RTI patients, respectively.16 Conclusion Prevalence of RTI/STI in our Gynecology OPD, a tertiary care hospital was reported to be 13.19% in women of reproductive group. Vaginitis, cervicitis and pelvic inflammatory disease are commonly encountered RTI/STI. There is significant burden of lower RTI (bacterial vaginosis, candidiasis and trichomoniasis) among women with no evidence to suggest a decline in prevalence. Counseling and testing for HIV/VDRL and Pap smear along with user friendly syndromic approach may go a long way in management of RTI/STI. References 1. Elahee SMA, Muhmud S, Tanvir S, Rahman MZ. Breaking the silence: reproductive tract infections (RTIs) among women in slums of Khulna City, Bangladesh, Bangladesh, e-Journal of Sociology. 2013;10(2):119-34.

2. Sharma VK, Khandpur S. Epidemiology of sexually transmitted diseases. In: Sharma VK (Ed.). Sexually Transmitted Diseases and AIDS. New Delhi: Viva Books Private Limited; 2003. pp. 1-41.

3. National Guidelines on Prevention Management and Control of Reproduction Tract Infections and Sexually Transmitted Infections. July 2014.

4. National Family Health Survey III 2005-2006. Ministry of Health & Family Welfare, Government of India.

5. Sharma VK, Khandpur S. Changing patterns of sexually transmitted infections in India. Natl Med J India. 2004;17(6):310-9.

6. Fact Sheet: Sexually transmitted infections (Internet).

World Health Organization, 2011 Aug. Available at: http:// www.who.int/mediacentre/factsheets/FS/10/en/ 7. Prashar A, Gupta BP, Bhardwaj AK, Sarin R. Prevalence of RTIs among women of reproductive age group in Shimla town. Indian J Community Med. 2006;31:15-7.

8. Bohra MS, Joshi AB, Lekhak B, Gurung G. Reproductive tract infections among women attending gynaecology outpatient department. Int J Infect Microbiol. 2012;1(1):29-33.

9. Hedge SKB, Aggarwal T, Ramesh N, Sugara M, Joseph PM, Singh S, et al. Reproductive tract infections among women in a peri-urban under privileged area in Bangalore, India: Knowledge, prevalence and treatment seeking behaviour.

Ann Trop Med Public Health. 2013;6(2):215-20.

10. Ray K, Muralidhar S, Bala M, Kumari M, Salhan S, Gupta SM, et al. Comparative study of syndromic and etiological diagnosis of reproductive tract infections/ sexually transmitted infections in women in Delhi. Int J Infect Dis. 2009;13(6):e352-9.

11. Khokhar N, Jethwa D, Lunagaria R, Panchal N, Badrakiya S, Badrakiya G. Seroprevlaence of hepatitis B, hepatitis C, syphilis and HIV in pregnant women in a tertiary care hospital, Gujarat, India. Int J Curr Microbiol App Sci. 2015;4(9):188-94.

12. Jindal N, Aggarwal A, Gill P, Sabharwal B, Sheevani BB. community-based study of reproductive tract infections, including sexually transmitted infections, among the rural population of Punjab, India. Indian J Community Med. 2009;34(4):359-61.

13. Gupta A. Prevalence of STI/STDs among women of reproductive age group in Tribal district of North India.

Sex Transm Infect. 2013;89:A172.

14. Chopra D, Sandhu I, Bahl RK, Bhatia R, Goyal A. Prevalence of sexually transmitted infections in HIV positive and HIV negative females, in a tertiary care hospital - An observational study. Indian J Sex Transm Dis. 2015;36(1):59-63.

15. Seethalakshmi GV, Shoba D, Mohan KR, Sourabh C, Manoharan G, Chandrashekhar C. A comparative study of Pap smear findings among HIV positive and negative women at Government Hospital of Thoracic Medicine (GHTM) Tambaram. BMJ Infect Dis. 2012;12(Suppl 1):p35.

16. Sharma A, Marfatia YS, Modi M. Reproductive tract infections in HIV positive women: A case control study.

Indian J Sex Transm Dis. 2009;30(1):16-8.

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ONCOLOGY

Repeatedly Recurrent Supernumerar y Bilateral Fibroadenoma Breast with Family History of Breast Cancer in a Young Girl: A Surgeon’s Dilemma SOMENDRA M SHARMA*, DISHA SHARMA†, B ANANDA‡

Abstract More than 4 fibroadenomas in a single breast are uncommon. Repeated recurrences of supernumerary fibroadenomas, in multiple numbers, after excision, are extremely rare. The malignant potential of breast fibroadenoma increases significantly in women with complex fibroadenomas, proliferative disease or a family history of breast cancer. Such a condition poses a management dilemma to the surgeon. Prophylactic bilateral mastectomy is controversial, and requires a rigorous assessment of risk benefit ratio and a better assessment of psychosocial impact and ethical issues. More often than not, the patient prefers repeat excision and close surveillance as the most agreeable course of action; the relatively higher risk of malignancy notwithstanding.

Repeated excision as new fibroadenomas appear seems to be a feasible option.

Keywords: Fibroadenoma breast, multiple fibroadenoma, recurrent fibroadenoma, supernumerary fibroadenoma

B

reast fibroadenoma is a fairly common condition, accounting for nearly 50% of all breast biopsies, and about 75% biopsies in women under 20 years of age.1,2 The malignant potential of breast fibroadenoma is low at 0.125-0.02%.3 But, the same risk increases significantly in women with complex fibroadenomas, proliferative disease or a family history of breast cancer.4

Although up to four fibroadenoma in a single breast are not very uncommon,5,6 Haagensen (1986) and Foster et al (1988) in their two different studies found the incidence to be nearly 16% of all fibroadenomas. But, more than that in a single breast is rare.7 It is possible that many such cases remain unreported. Nevertheless, recurrence of supernumerary fibroadenoma seems to be extremely rare.

Both conservative and surgical management of isolated fibroadenoma have their advocates, generally allowing

*Consultant Surgeon JW Global Hospital and Research Centre, Mount Abu, Rajasthan †Final MBBS Student Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra ‡Consultant Radiologist JW Global Hospital and Research Centre, Mount Abu, Rajasthan Address for correspondence Dr Disha Sharma 603, UGPG Girls Hostel, KEM Hospital Campus, Mumbai - 400 012, Maharashtra E-mail: dishasharma1994@gmail.com

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expectant treatment in younger females up to 30 years of age, and more aggressive surgical treatment for patients who are more than 30 years of age.8,9 The question becomes tricky when there are recurrences, or when there is a family history of breast cancer.

We present such a case. The uniqueness of this case lies in the fact that, besides being young and having supernumerary fibroadenomas (6 in 1 breast and 3 in the other), she had repeated recurrences, in multiple numbers after excision, and had a family history of breast cancer.

Case Report A 21-year-old young girl presented to our surgical clinic with history of multiple lumps in both breasts for the past 3 years. She had similar lumps about 5 years ago, which were removed from her left breast and were reported to be benign. She noticed that the lumps reappeared within 2 years after surgery, but she postponed consulting a doctor presuming them to be benign as earlier. When some of the lumps attained large size, she came in for treatment.

On clinical examination, 6 lumps in the left breast and 3 in the right breast were palpable. Ultrasound and radio mammograms, and fine needle aspiration cytology confirmed the benign nature of these lesions.

The patient’s mother had died of breast cancer at less than 50 years of age, and her maternal grandfather

ONCOLOGY fibroadenomas of undetectable size present in both breasts at the time of first and second surgeries, and, may be there would be some present during the subsequent surgeries till this growth period stops at a certain age.

Figure 1. Surgically removed fibroadenomas, 3 from the right breast and 6 from the left breast.

Rt Craniocaudal

Lt Craniocaudal

Lt Mediolateral

Rt Mediolateral

Figure 2. Radio mammography report, at the time of the second recurrence, showing multiple fibroadenomas, 10 in the right breast and 5 in the left breast.

had carcinoma cheek, although he had died of some other cause. Six lumps from the left breast and 3 from the right breast were removed (Fig. 1) and sent for histopathological examination. All were reported to be benign fibroadenomas. The girl refused for BRCA gene mutation assessment, but agreed for a follow-up in case of recurrence.

On her last clinical visit on 7th September, 2016, the radio mammography and sonography reports revealed 10 fibroadenomas in the right breast and 5 in the left breast (Fig. 2).

Discussion and Review of Literature Although breast fibroadenoma is a fairly common disease with a number of 2-4 being seen in nearly 16% of all fibroadenomas; finding more than 6 fibroadenomas in a single breast is rare. In 1993, Williamson et al mentioned that they could find only 6 such cases in the literature.7 Fibroadenomas are formed as a result of minor aberrations in the normal process of development and maturation of the breast tissue, and are identical to hyperplastic lobules as shown by various histological studies.10-12 In our case, it was perhaps an ongoing process as evident by such a rapid recurrence in such large numbers. We presume that there were budding

A Mayo Clinic Study (2015) concluded that, although complex, fibroadenomas were more likely to have concomitant high risk histological features like incomplete involution and proliferative disease without atypia, they alone were not high risk markers for breast cancer.13 As such, the malignant potential of fibroadenoma breast is extremely low. Zheng et al (2015) could find less than 130 such cases in literature.14 Yu Ting et al (2014) in a detailed analysis of literature mentioned the incidence as 0.125-0.02%. Pick et al (1984),15 went on to assert that the only importance of fibroadenoma, as far as breast malignancy is concerned, is to contribute to its early detection; and as such they are the parameter independent of the development of cancer in either ipsilateral or contralateral breast.

But, the scenario changes when there is a family history of breast cancer. DuPont et al (1994) in a very wellstructured study found that patients having complex fibroadenoma breast and a family history of breast cancer had a relative risk of 3.72 as compared to controls without a family history, of developing cancer.4 Based on the rich data on the natural history of fibroadenoma, (be it single or multiple) and also based on their own experience, Greenberg et al (1998)8 recommended that expectant management for single as well as multiple fibroadenomas is preferable if they are diagnosed before the age of 35 years, and are not increasing in size on a 6-monthly follow-up.

In case no regression occurs after the age of 35 years, or if they are increasing in size, they must be excised.

Fibroadenoma(s) detected after the age of 35 years can still be observed for 6-12 months, but must be excised if they persist beyond that or are increasing in size. In patients with family history of breast cancer, or known changes of complex fibroadenoma, excision biopsy is recommended without delay.

Although the role of BRCA 1/2 gene mutation assessment as a cancer risk predictor is well-established, role of prophylactic mastectomy in high risk women is still seen with scepticism. Lostumbo et al (2004) in their Cochrane review article, and Rhiem and Schmutzler (2014) in their well-researched article have stressed that a more rigorous assessment of risk benefit ratio and a better assessment of psychosocial impact and ethical issues is required before issuing an undisputable verdict.16,17

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ONCOLOGY Our patient was counseled at length about her increased chances of contracting a malignancy in her breast because her mother had died of breast cancer at an early age of below 50. The girl understood her risk, but absolutely refused to consider a radical surgery like bilateral mastectomy, and, for that matter, even to check her BRCA gene status. We agreed upon a close follow-up and removal of lumps as they appear.

Post the second excision, and on her last clinical visit on 7 September, 2016, she had 10 fibroadenomas in the right breast and 5 in the left breast. She was advised excision of the recurrent fibroadenomas once again.

Conclusion More than 4 fibroadenomas in a single breast is an extremely rare condition, and repeated recurrence in multiple numbers in such a case is extremely rare.

Early excision irrespective of age must be done, where there is a family history of breast cancer. Prophylactic bilateral mastectomy is a difficult and controversial decision even when there are repeated recurrences in large numbers. It requires a more rigorous assessment of risk benefit ratio and a better assessment of psychosocial impact and ethical issues. More often than not, the patient prefers repeat excision and close surveillance as the most agreeable course of action, the relatively higher risk of malignancy notwithstanding.

References 1. Schuerch C 3rd, Rosen PP, Hirota T, Itabashi M, Yamamoto H, Kinne DW, et al. A pathologic study of benign breast diseases in Tokyo and New York. Cancer. 1982;50(9): 1899-903.

2. Onuigbo WI. Adolescent breast masses in Nigerian Igbos.

Am J Surg. 1979;137(3):367-8.

3. Wu YT, Chen ST, Chen CJ, Kuo YL, Tseng LM, Chen DR, et al.

Breast cancer arising within fibroadenoma: collective analysis of case reports in the literature and hints on treatment policy. World J Surg Oncol. 2014;12:335.

4. Dupont WD, Page DL, Parl FF, Vnencak-Jones CL, Plummer WD Jr, Rados MS, et al. Long-term risk of breast cancer in women with fibroadenoma. N Engl J Med. 1994;331(1):10-5.

5. Haagensen CD. Diseases of the Breast. 3rd Edition, Philadelphia: WB Saunders; 1986.

6. Foster ME, Garrahan N, Williams S. Fibroadenoma of the breast: a clinical and pathological study. J R Coll Surg Edinb. 1988;33(1):16-9.

7. Williamson ME, Lyons K, Hughes LE. Multiple fibroadenomas of the breast: a problem of uncertain incidence and management. Ann R Coll Surg Engl. 1993;75(3):161-3.

8. Greenberg R, Skornick Y, Kaplan O. Management of breast fibroadenomas. J Gen Intern Med. 1998;13(9):640-5.

9. Dixon JM, Dobie V, Lamb J, Walsh JS, Chetty U. Assessment of the acceptability of conservative management of fibroadenoma of the breast. Br J Surg. 1996;83(2):264-5.

10. Parks AG. The micro-anatomy of the breast. Ann R Coll Surg Engl. 1959;25:235-51.

11. Canny PF, Berkowitz GS, Kelsey JL, LiVolsi VA. Fibroadenoma and the use of exogenous hormones. A case-control study. Am J Epidemiol. 1988;127(3):454-61.

12. Noguchi S, Motomura K, Inaji H, Imaoka S, Koyama H. Clonal analysis of fibroadenoma and phyllodes tumor of the breast. Cancer Res. 1993;53(17):4071-4.

13. Nassar A, Visscher DW, Degnim AC, Frank RD, Vierkant RA, Frost M, et al. Complex fibroadenoma and breast cancer risk: a Mayo Clinic Benign Breast Disease Cohort Study. Breast Cancer Res Treat. 2015;153(2):397-405.

14. Zheng H, Chen J, Wu X, Jin L, Qi C. Bilateral breast cancer with a unilateral carcinoma within a fibroadenoma: A case report. Oncol Lett. 2015;10(3):1513-6.

15. Pick PW, Iossifides IA. Occurrence of breast carcinoma within a fibroadenoma. A review. Arch Pathol Lab Med. 1984;108(7):590-4.

16. Lostumbo L, Carbine N, Wallace J, Ezzo J. Prophylactic mastectomy for the prevention of breast cancer. Cochrane Database Syst Rev. 2004;(4):CD002748.

17. Rhiem K, Schmutzler R. Impact of prophylactic mastectomy in BRCA1/2 mutation carriers. Breast Care (Basel). 2014;9(6):385-9.

■■■■

ASCO Identifies Alcohol as a Potentially Modifiable Risk Factor for Cancer In a statement published online before print November 7, 2017 in the Journal of Clinical Oncology, the American Society of Clinical Oncology (ASCO) has identified alcohol as a definite risk factor for many cancers and says that it is a potentially modifiable risk factor for cancer. Evidence shows that alcohol use—whether light, moderate, or heavy—is linked with increasing the risk of several leading cancers, including those of the breast, colon, esophagus and head and neck. Between 5-6% of new cancers and cancer deaths globally are directly attributable to alcohol.

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SURGERY

Comparison of Pulmonary Functions Following Elective Laparoscopic Cholecystectomy and Other Upper Abdominal Surgeries GAURAV GUPTA*, ASHISH GARG†, RANJEET SINGH VIRK‡, KAMAL BAGDI‡

Abstract Objective: To compare the pulmonary functions between the patients operated for laparoscopic cholecystectomy and patients operated for conventional cholecystectomy and other upper abdominal surgeries. Methods: This study was a prospective randomized study conducted on 100 patients of ASA Grade I or II of either sex or age group 18-60 years, undergoing various upper abdominal surgeries in the Dept. of Anesthesiology at Grecian Super Speciality Hospital, Mohali. All the patients were divided into two groups of 50 each. Group A patients underwent upper abdominal surgeries by conventional methods, while Group B patients underwent laparoscopic cholecystectomy. All patients were asked to perform the following pulmonary function tests (PFT’s) - Breath holding test (BHT), match stick blowing test, tidal volume (Vt), minute volume (MV) and vital capacity (VC) were measured using Wright’s respirometer and peak expiratory flow rate (PEFR) measured using mini-Wright peak flow meter. Results: Comparing PFT of patients of Group A with Group B, it was observed that values in preoperative period are almost similar indicating that there is not much difference in age, sex and BMI in between two groups. There is 77% decrease in BHT, 71% decrease in TV, 59% in MV, 69% in VC, 73% in PEFR and 83% in MSBT in the immediate postoperative period as compared to preoperative period in Group A. Similar values in Group B were 75%, 66%, 50%, 61%, 63% and 68%, respectively. The ‘P’ value is significant for all parameters and in both the groups. Conclusion: There is a definite decrease in pulmonary functions postoperatively in patients undergoing upper abdominal surgeries in both groups but the decrease is more following conventional surgery patients than following laparoscopic surgery. So cholecystectomy, if possible should be performed by laparoscopic method, particularly in patients with compromised lung function and in economically and socially productive age group.

Keywords: Pulmonary function tests, laparoscopic cholecystectomy, upper abdominal surgery

P

ulmonary complications after abdominal surgery play an important role in causing postoperative morbidity and mortality. Upper abdominal surgery, long incisions and tight abdominal binders which cause either intense pain or decrease the respiratory excursion further add to the occurrence of postoperative pulmonary complications.

higher in patients with existing pulmonary disease.

Postoperative deaths were as likely to be due to pulmonary complications as to cardiac complications and patients who sustained a pulmonary complication stayed in the hospital on an average of 12 days longer than those who had either cardiac complication or an uncomplicated course.

Cough, sputum production, dyspnea, chest pain, fever and radiographic changes occur in half of such patients, with respiratory failure necessitating mechanical ventilation occurring in 0-21%. The incidence is much

Major pulmonary complications mainly include pneumonia, bronchitis, atelectasis, bronchospasm and exacerbation of underlying chronic lung disease.

Pulmonary function tests (PFT’s) are helpful in defining the type, severity and reversibility of pulmonary pathology. Simple spirometry (volume recorded as a function of time) can provide a very good indication of a patient’s respiratory reserves, but requires significant patient cooperation. PFT’s are helpful in confirming that a patient with asthma or chronic obstructive pulmonary disease (COPD) is at his/her best baseline. In addition, PFT may be useful in the rare situations where dyspnea

*Senior Consultant Anesthesiologist †Consultant Intensivist ‡Consultant Anesthesiologist Grecian Hospital, Mohali, Punjab Address for correspondence Dr Gaurav Gupta 1076, Sector 91, Mohali, Punjab - 140 307

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565

SURGERY or exercise intolerance remain unexplained after preoperative clinical evaluation.

Since, the laparoscopic cholecystectomy is progressively becoming more and more popular, it is mandatory to have a conclusive data on the effects of CO2 pneumoperitoneum on hemodynamic and pulmonary status of these patients during general anesthesia.

This encouraged us to take up this research work on changes in pulmonary functions following laparoscopic cholecystectomy in comparison to other upper abdominal surgeries by conventional methods on the patients under general anesthesia.

Material and Methods A prospective randomized study was conducted in 100 adults, ASA Grade I or II patients undergoing upper abdominal surgeries either by conventional (A) methods or by laparoscopic (B) methods under general anesthesia.

The aim was to compare the decrease in pulmonary functions in postoperative period between the two groups and set guidelines for the modification of the anesthetic technique and the ideal monitoring needed to prevent and detect the complications associated with upper abdominal surgeries.

The materials used for this study were as follows: ÂÂ

Wright’s respirometer

ÂÂ

Mini-Wright peak flow meter

ÂÂ

Candle and match box

ÂÂ

Wrist/stop watch

ÂÂ

Noninvasive blood pressure monitor

ÂÂ

Pulse oximeter

ÂÂ

End-tidal CO2 monitor.

Detailed preoperative evaluation and systemic examination was done as for major surgery. The body weight and height of each patient was recorded.

Additional investigations were asked for according to the individual need of the patients. All patients were asked to perform PFT’s as follows: ÂÂ

566

Breath holding test (BHT): In this, patients were asked to take full breath and hold it as long as possible. Patients were instructed to raise his/her hand at the time beyond which it was not possible to hold the breath further. This BHT was noted and recorded in seconds with the help of a wrist watch. Movements of chest were observed to avoid any false reading. Readings >25 seconds were taken as normal while between 15 and 25 seconds as marginal and below 15 seconds were taken as subnormal.

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

ÂÂ

Match stick blowing test: In this test, patients were asked to blow a candle keeping at 15 cm in front of his/her mouth. While blowing, patient should keep his/her mouth open and should not take help of facial muscles and other accessory muscles of respiration. Each patient was given three chances to blow off the candle.

ÂÂ

How to use peak flow meter: Mini-Wright peak flow meter is an accurate scientific instrument. It measures peak expiratory flow (PEF), which is the biggest fastest huff one can achieve after taking a deep breath. Patient was asked to take a deep breath and place the mouthpiece end into his/her mouth and make an air-tight seal with his/her lips around the mouthpiece. The patient blowed into the peak flow meter as fast as he/she could. The pointer shot up the slot and remained in a position opposite the scale, which corresponds to PEF. This test was repeated twice more so as to end up with a series of three readings. Only the highest reading of these three was recorded.

How to Use Wright’s Respirometer Tidal volume (Vt), minute volume (MV) and vital capacity (VC) were measured using Wright’s respirometer, which is having a clock-shaped meter and a mouthpiece. The patient was asked to breathe in respirometer. After allowing the instrument to record for 1 minute, the MV was read directly and the Vt then calculated from this reading and the respiratory rate. For VC, patient was asked to have full inspiration and then expire fully as long as possible into the respirometer and reading was recorded.

All these above tests were performed in this study at following time: Preoperatively, immediate postoperatively, 6-hour postoperatively, 24-hour postoperatively and 48-hour postoperatively. All the readings were tabulated and then compared. Data were expressed as measuring + SD. Results were analyzed by student’s t-test with p < 0.05 considered significant.

All patients received balanced general anesthesia with controlled ventilation.

Observation and Results Hemodynamic parameters were in normal range during entire surgery as well as in the postoperative period indicating balanced general anesthetic technique, adequate pain relief and vigilant care of patients at all times. Moreover, respiratory rate was in normal range at all time periods in both groups indicating no respiratory

SURGERY distress, adequate pain relief and good ventilation of patients. Oxygen saturation remained within normal limits at almost every level in both the groups that’s why there was no increase in morbidity and mortality (Tables 1 and 2).

PFT In Group A, the mean BHT (in sec) preoperatively was 26.26 ± 9.62, immediate postoperatively was 6.0 ± 2.52, 6-hour postoperatively was 10.25 ± 4.97, 24-hour postoperatively was 14.67 ± 6.65 and 48-hour postoperatively was 24.20 ± 6.12.

In Group B, the mean BHT (in sec) preoperatively was 26.57 ± 5.36, immediate postoperatively was 6.40 ± 1.82, 6-hour postoperatively was 13.55 ± 4.41, 24-hour postoperatively was 19.77 ± 7.17 and 48-hour postoperatively was 23.00 ± 4.47. ‘t’ and ‘p’ value was calculated for BHT by comparing their preoperative values with other time periods by paired sample ‘t’ test in both the groups (Table 3).

The mean Vt (in mL) in Group A preoperatively was 411.08 ± 86.03, immediate postoperatively was 118.57 ± 53.67, 6-hour postoperatively was 182.50 ± 87.19, 24-hour postoperatively was 257.50 ± 78.99 and 48-hour postoperatively was 364 ± 45.06. The mean Vt (in mL) in Group B preoperatively was 400.01 ± 80.68, immediate postoperatively was 136.00 ± 43.36, 60-hour postoperatively was 237.73 ± 69.62, 24-hour postoperatively was 316.15 ± 88.37 and 48-hour postoperatively was 353.33 ± 91.36. ‘t’ and ‘p’ value was calculated for Vt by comparing their preoperative values with other time periods by paired sample ‘t’ test in both the groups (Table 4).

The mean VC in Group A (in mL) preoperatively was 2206.67 ± 624.96, immediate postoperatively was 678.57 ± 182.70, 6-hour postoperatively was 935.00 ± 480.56, 24-hour postoperatively was 1434.16 ± 478.72 and 48-hour postoperatively was 1774.00 ± 462.47, whereas in Group B, mean VC (in mL) preoperatively was 2038.57 ± 489.25,

Table 1. Mean Values of Clinical Parameters in Group A Time/ Parameters

Preoperative

Immediate postoperatively

6-hour postoperatively

24-hour postoperatively

48-hour postoperatively

Pulse (/mt)

82.33

97.04

90.74

86.18

84.64

Range

72-104

82-120

80-108

76-106

74-104

BP (in mmHg)

132.74

136.08

128.56

126.50

128.33

(83.81)

(86.44)

(79.24)

(76.80)

(77.14)

RR (/mt)

15.16

20.33

17.83

16.66

14.00

Range

12-20

14-24

13-22

12-20

12-17

SaO2 (%)

96.50

94.76

--

--

--

Range

94-99

93-97

Table 2. Mean Values of Clinical Parameters in Group B Time/Test

Preoperative

Immediate postoperatively

6-hour postoperatively

24-hour postoperatively

48-hour postoperatively

Pulse (/mt)

84.60

96.06

87.54

83.60

82.34

Range

70-106

78-116

74-98

72-94

70-94

BP (in mmHg)

124.77

130.06

126.92

122.84

122.16 7

(82.64)

(84.14)

(80.94)

(78.50)

(6.44)

RR (/mt)

14.66

18.74

16.64

15.91

14.04

Range

12-22

14-24

12-20

12-18

12-16

SaO2 (%)

97.50

96.04

--

--

--

Range

95-99

94-98

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

567

SURGERY Table 3. Comparison of BHT (in Sec) Between Two Groups Group A

Variable

Group B

T0

T1

T2

T3

T4

T0

T1

T2

T3

T4

Mean

26.25

6.0

10.25

14.67

24.20

24.57

6.40

13.55

19.77

23.00

SD

9.62

2.52

4.97

6.65

6.12

5.36

1.82

4.41

7.17

4.47

SE

2.78

0.95

1.44

1.94

2.87

1.43

0.81

1.33

1.99

0.81

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

<0.021

HS

HS

HS

HS

HS

HS

S

S

-5.692

-7.867

-6.630

-6.086

-7.625

-11.431

-4.54

-6.08

P value

‘t’ value

Table 4. Comparison of Vt (in mL) Between Two Groups Variable

Group A

Group B

T0

T1

T2

T3

T4

T0

T1

T2

T3

T4

Mean

411.0

118.57

182.50

257.50

364.00

400.0

136.00

237.73

316.1

353.3

SD

86.03

53.67

87.19

78.99

45.06

80.68

43.36

69.62

88.37

91.36

SE

24.84

20.29

25.17

22.80

20.15

21.56

19.39

20.99

24.51

37.30

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

0.036

0.289

HS

HS

HS

HS

HS

HS

S

NS

-23.229

-11.954

-7.885

-7.188

-9.467

-10.008

-5.45

-1.18

P value

‘t’ value

immediate postoperatively was 776.00 ± 109.45, 6-hour postoperatively was 1140.00 ± 424.50, 24-hour postoperatively was 1507.69 ± 436.52 and 48-hour postoperatively was 1783.33 ± 476.79. The ‘p’ and ‘t’ value was calculated for VC by comparing their preoperative value with other time periods by paired sample 't' test in both the groups (Table 5).

In Group A, the mean peak expiratory flow rate (PEFR, in Lit/mt) preoperatively was 342.92 ± 102.75, immediate postoperatively was 91.42 ± 25.45, 6-hour postoperatively was 132.08 ± 54.83, 24-hour postoperatively was 208.33 ± 76.73 and 48-hour postoperatively was 278.00 ± 73.96, whereas in Group B, the mean PEFR (in Lit/min) preoperatively was 319.29 ± 72.05, immediate postoperatively was 243.08 ± 66.00 and 48-hour postoperatively was 286.67 ± 30.11. ‘P’ and ‘t’ value calculated similarly as for other parameters of pulmonary functions (Table 6).

practice. Therefore, when laparoscopic surgeries arrived on the scene, as an alternative to conventional surgery, it was hailed as the panacea for the patients undergoing upper abdominal surgeries.

Long incisions in conventional upper abdominal surgery and tight abdominal binders may result in intense pain or decreased excursion of chest leading to reduction in lung volumes. This reduction in lung volumes in restrictive pattern contributes to the development of atelectasis, which further leads to other postoperative pulmonary complications.

Discussion

The parameters used to compare pulmonary functions were simple basic measures indicating both static and dynamic tests of ventilation and can be performed easily by the bedside of the patient. These simple, primitive measures were studied taking into account the progressively increasing trend of laparoscopic surgeries and reaching far off areas where other sophisticated measures for pulmonary functions were not available.

Upper abdominal surgeries account for significant proportion of surgical load in our routine surgical

There was significant decrease in the pulmonary functions in immediate postoperative period in both

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

SURGERY Table 5. Comparison of VC (in mL) Between Two Groups Variable

Group A

Group B

T0

T1

T2

T3

T4

T0

T1

T2

T3

T4

Mean

2206

678.5

935.0

1434

1774

2038

776.0

1140

1507

1783

SD

624

182.7

480.5

478.7

462.4

489

109.4

424.5

436.5

476.7

SE

180

69.06

138.7

137.1

206.8

130

48.95

127.9

127.9

194.6

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

0.002

0.035

HS

HS

HS

HS

HS

HS

S

S

-11.42

-13.26

-7.236

-4.739

-5.116

-6.196

-4.97

-7.58

P value

‘t’ value

Table 6. Comparison of PEFR (in Lit/mt) Between Two Groups Variable

Group A

Group B

T0

T1

T2

T3

T4

T0

T1

T2

T3

T4

Mean

342

91.42

132.08

208.33

278.0

319

116.0

176.82

243.1

286.7

SD

102

25.45

54.83

76.73

73.96

72.1

64.27

71.56

66.00

30.11

SE

29.6

9.62

15.83

22.15

33.08

19.2

28.74

21.58

18.31

12.23

<0.001

<0.001

<0.001

<0.001

<0.001

<0.001

0.024

0.043

HS

HS

HS

HS

HS

HS

S

S

-7.452

-11.04

-6.536

-4.07

-6.550

-5.754

-5.35

-2.69

P value

‘t’ value

groups. There was 77% decrease in BHT, 71% decrease in Vt, 59% decrease in MV, 69% decrease in VC, 73% decrease in PEER in Group A patients in the immediate postoperative period when compared with preoperative values. Similar values in Group B were 75%, 66%, 50%, 61%, 63%, respectively. This decrease may be due to long upper abdominal incision and hence more pain, tight abdominal strapping, impairment of diaphragmatic contractility leading to decreased excursion of chest, thereby decreasing lung volumes.

On comparing preoperative values of PFTs with the postoperative ones by paired sample 't' test, it was found that all values were significant in Group A, while in Group B, Vt and MV values at 48-hour interval were not significant indicating earlier recovery of lung functions in Group B. So, the decrease in pulmonary functions is more in patients of Group A as compared to patients of Group B. Pain following laparoscopic surgery consists of an early transient vague abdominal and shoulder discomfort due to peritoneal irritation caused by the residual CO2. Pain from puncture

wounds is generally mild because the wounds are small. Although, the creation of pneumoperitoneum during laparoscopic surgery leads to diminished excursion of diaphragm, increased pressure on lower lobes results in hypoventilation of lower lobes but probably these factors hamper lung functions less than in patients operated conventionally. Further factors like pneumoperitoneum leading to elevation of diaphragm were deleted in the postoperative period.

Conclusion Hence, it is concluded that the mechanical and pain factors involved in conventional surgery have more depressant effects on pulmonary functions than pneumoperitonium during laparoscopic surgery.

Patients with restricted lung function should be brought to optimum level by controlling infection with antibiotics, relieving spasm with bronchodilators and by chest physiotherapy. Postoperative pain relief should be adequate, but it should not interfere with respiration. So cholecystectomy, if possible should

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

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SURGERY be performed by laparoscopic method, particularly in patients with compromised lung function and in economically and socially productive age group.

9. Chui PT, Gin T, Oh TE. Anaesthesia for laparoscopic general surgery. Anaesth Intensive Care. 1993;21(2): 163-71.

Suggested Reading

10. Churchill-Davidson HC. A Practice of Anaesthesia, 5th Edition, London: Lloyd Luke Ltd.; 1984. p. 51, 61, 104, 132.

1. Alexander GD, Noe FE, Brown EM. Anesthesia for pelvic laparoscopy. Anesth Analg. 1969;48(1):14-8.

2. Ali J, Weisel RD, Layug AB, Kripke BJ, Hechtman HB. Consequences of postoperative alterations in respiratory mechanics. Am J Surg. 1974;128(3):376-82.

3. Ayoub J, Cohendy R, Prioux J, Ahmaidi S, Bourgeois JM, Dauzat M, et al. Diaphragm movement before and after cholecystectomy: a sonographic study. Anesth Analg. 2001;92(3):755-61.

4. Baraka A, Jabbour S, Hammoud R, Aouad M, Najjar F, Khoury G, et al. End-tidal carbon dioxide tension during laparoscopic cholecystectomy. Correlation with the baseline value prior to carbon dioxide insufflation.

Anaesthesia. 1994;49(4):304-6.

5. Baratz RA, Karis JH. Blood gas studies during laparoscopy under general anesthesia. Anesthesiology. 1969; 30(4):463-4.

6. Bardoczky GI, Engelman E, Levarlet M, Simon P. Ventilatory effects of pneumoperitoneum monitored Anaesthesia. with continuous spirometry.

1993;48(4):309-11.

7. Beebe DS, Belani KG. Anaesthetic management for laparoscopic surgery. J Anaesth Clin Pharmacol.

1992;8:275-9.

8. Benhamou D, Simonneau G, Poynard T, Goldman M, Chaput JC, Duroux P. Diaphragm function is not impaired by pneumoperitoneum after laparoscopy. Arch Surg. 1993;128(4):430-2.

11. Churchill-Davidson HC. A Practice of Anaesthesia, 6th Edition, London: Lloyd Luke Ltd.; 1995. p. 1130.

12. Chuter TA, Weissman C, Starker PM, Gump FE. Effect of incentive spirometry on diaphragmatic function after surgery. Surgery. 1989;105(4):488-93.

13. Crea MA, Sallozze L, Perillo V. Respiratory effects of laparoscopic cholecystectomy. Br J Anaesth.

1993;70(Suppl):A63.

14. Cunningham AJ, Brull SJ. Laparoscopic cholecystectomy: anesthetic implications. Anesth Analg. 1993;76(5):1120-33.

15. Delaunay L, Bonnet D, Rimaniol. Cardio-respiratory and muscular capacity after laparoscopic cholecystectomy. Br J Anaesth. 1994;72(Suppl):A35.

16. Desmond J, Gordon RA. Ventilation in patients anaesthetized for laparoscopy. Can Anaesth Soc J. 1970;17(4):378-87.

17. Dhoste K, Karayan J, Lecoste L. Haemodynamic changes during laparoscopic cholecystectomy in the elderly. Br J Anaesth. 1994;72(Suppl):A32.

18. Erice F, Fox GS, Salib YM, Romano E, Meakins JL, Magder SA. Diaphragmatic function before and after laparoscopic cholecystectomy. Anesthesiology. 1993;79(5):966-75; discussion 27A-28A.

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Coronary Artery Bypass Grafting versus Percutaneous Coronary Intervention in NITDM The goal of a new study published in Diabetes/Metabolism Research and Reviews was to establish outcomes and prognosis of revascularization by either coronary artery bypass grafting (CABG) surgery or percutaneous coronary intervention (PCI) in patients with non-insulin treated type 2 diabetes mellitus (NITDM). This study involved the identification of randomized controlled trials (RCTs) from Pubmed, EMBASE and Cochrane library through May 2016. A total of four RCTs involving five studies, consisting of 2,270 patients with NITDM were identified. When compared to CABG-treated patients, PCI-treated patients were found to have notably higher all-cause mortality, myocardial infarction, repeated revascularization and major adverse cardiovascular and cerebrovascular events. On the other hand, PCI was associated with lower incidence of stroke. Thus, it was concluded that in NITDM patients, CABG surgery is associated with reduced risk of mortality and morbidity, whereas PCI is associated with a reduced incidence of stroke in comparison. It was recommended that the decision to have PCI or CABG surgery take into account the risk for stroke of the patients when considering CABG over PCI. It was stated that adequately-powered RCTs are needed to confirm the results of this meta-analysis.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

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CONFERENCE Proceedings

45th Annual Meeting of the Research Society for the Study of Diabetes in India (RSSDI 2017) NAFLD and Diabetes: Indian Perspective and Management

CV Safety Role of SUs in the Era of CV Safety Concern in T2DM Dr Vijay Viswanathan, Chennai

Dr Anoop Misra, New Delhi ÂÂ

Nonalcoholic fatty liver disease (NAFLD) is as prevalent as metabolic syndrome; occurs in about 1/3rd of urban individuals.

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Indians are highly predisposed to develop NAFLD associated with insulin resistance. It is not an innocuous condition; closely associated with diabetes, CVD, cirrhosis of liver and even liver cancers.

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Presence of NAFLD poses difficulty in managing diabetes.

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Best treatment remains weight loss; achieved by any means: diet, exercise, drugs.

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CV deaths are increased up to 4-fold in diabetics compared with their nondiabetic counterparts.

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Guidance for industry - A therapy should demonstrate that it will not result in an unacceptable increase in: CV mortality; myocardial infarction (MI) and stroke; hospitalization for acute coronary syndrome, urgent revascularization procedures; other endpoints. CV safety of modern vs. older SUs: Modern SUs like glimepiride do not inhibit mitochondrial K(ATP) channels in the heart; hence, the protective mechanism of ischemic preconditioning (IPC) is preserved with glimepiride; older SUs inhibit mitochondrial K(ATP), which further inhibits IPC. The use of 2nd and 3rd generation SUs in patients with type 2 diabetes is not associated with increased CV risk irrespective of comparator or background medication.

ÂÂ

SUs as an add-on to metformin have been considered safe in terms of overall and CV mortality. In a recent pragmatic trial, incidence of CV events was similar with SUs and pioglitazone as add-on treatments to metformin. New SUs (glimepiride/gliclazide) may be associated with a lower risk of MI than old SUs (glibenclamide).

Modern SUs have fewer early complications and lower mortality than older SUs. Newer SUs, especially glimepiride, may be preferred in patients with underlying CAD.

Some drugs ameliorate NAFLD: Vitamin E, pioglitazone and GLP-1 receptor agonists, etc.

Indian Perspective of Atherogenic Dyslipidemia and Role of Saroglitazar Dr Shashank Joshi, Mumbai ÂÂ

Statins are first-line therapy: Residual CVD risk remains in patients with diabetes treated with statins.

ÂÂ

Therapy with statin and TG-lowering combination may be considered for men with both TG level ≥204 mg/dl and HDL-C level ≤34 mg/dl.

ÂÂ

For high TG, treatment should be initiated: For CV risk reduction - when TG >200 mg/ dL; for pancreatitis risk reduction - when TG >500 mg/dL.

My Journey in Diabetology

Saroglitazar is the first approved dual PPAR-a/g agonist. It is approved for the treatment of diabetic dyslipidemia and hypertriglyceridemia in T2DM uncontrolled with statin therapy.

Saroglitazar has 11 years of research data and 4 years of post-marketing data.

Saroglitazar should be used in type 2 diabetes patients with uncontrolled TG >200 mg/dl.

We have worked for last 4 decades in the field of diabetes research and education with numerous papers published in reputed journals. With my team, I have covered various aspects of diabetes including epidemiology, regional disparities in care, public education, diet (maize, starch), metabolic syndrome, prevalence of type 2 diabetes and hypertension, fatty liver, HIV, fasts and feasts in diabetes, psychosocial

ÂÂ

ÂÂ ÂÂ

Dr Sarita Bajaj, President

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

573

CONFERENCE Proceedings aspects, insulin, complications, H. pylori with type 2 diabetes, oral manifestations, vitamin D, diabetic kidney disease, thyroid disorder. In 2013, the South Asian Federation of Endocrine Societies (SAFES) was established. We worked on a noninvasive method of mass screening for patients using easy scan to look into peripheral neuropathy. and are working on the RSSDI digital diabetes collaboration. We have also worked in the field of women’s health and diabetes with emphasis on GDM. In the SAFES Dhaka Declaration 2015, GDM was identified as the focus of attention for the term 2015-17. GDM: SAFES Recommendations and Action Plan will be released in Lahore this month.

In the study - Prevalence of GDM and associated risk factors in UP, we determined the prevalence of GDM and risk factors associated with it in 2417 women attending an antenatal care clinic in UP. About 11.37% women had GDM. Gestational glucose intolerance was observed in 23.4% women. Average BMI in GDM patients was 23.58 kg/m2. Risk factors found to be associated with GDM were: age; socioeconomic status; educational level; pre-pregnancy weight and BMI; weight gain; family history of diabetes or hypertension, past history of GDM. I feel that the healthcare system should consider customdesigned prevention and control programs tailored for women based on local and regional attitudes on healthcare, cultural beliefs, and available social support systems.

Apart from health issues of universal concern in relation to Ramadan fasting, issues pertaining exclusively to women which need to be addressed include: Menstruation; sexual obligations of married life; pregnancy; lactation/ breastfeeding. Insulin, glibenclamide and metformin are safe and effective therapies for GDM during 2nd and 3rd trimesters, and may be initiated as first-line treatment after failing to achieve glucose control with lifestyle medication. Among OADs, metformin may be a better choice than glibenclamide.

Harnessing Glycation for Clinical Care: HbA1c and Beyond Dr AG Unnikrishnan, Pune Twin studies of HbA1c suggest that HbA1c is genetically determined. Presence of CKD leads to underestimation of diabetes when HbA1c is used. Presence of iron deficiency anemia overestimates HbA1c. Hemolytic anemias underestimate HbA1c. Age increases HbA1c by a factor of 0.4.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

For the moment, limitations of HbA1c may be kept in mind. Can understanding protein binding lead to modification in glycation patterns, and help in designing new therapies? - Time will tell.

Reversal of Type 2 Diabetes with Lifestyle Measures Dr Sunil Mishra, Gurugram Type 2 diabetes is on the rise; lifestyle is mainly responsible for the rise. There is younger age of onset and fewer people reach targets. Prevention is the only answer. Candidates for aggressive diet plan: Recently diagnosed diabetics; obese or overweight; candidates for bariatric surgery but unwilling; motivated; without any apparent macro- or microvascular complications.

Reversal of diabetes is possible. There is a need to relook into the pathogenesis of the disease.

Assessment of 1,5 AG Levels in Subjects with Prediabetes: A Pilot Study Dr D Devi Pratyush, Pune This study aimed to observe 1,5-anhydroglucitol (AG) values and its corelation with HbA1c and oral OGTT values in subjects with normoglycemia, prediabetes and diabetes. The findings highlighted that 1,5 AG (tested

by ELISA) negatively correlates with HbA1c and plasma glucose. Approximately 20% individuals with diabetes and prediabetes (bases on HbA1c) had 1,5 AG levels above 10 μg/mL. The results suggested that 1,5 AG may detect subjects with glycemic variation over previous 1-2 weeks or those with very recent onset hyperglycemia, with more ease than HbA1c.

Profile of Normoalbuminuric CKD Patients with Type 2 Diabetes Dr K Satyawani, Chennai This study aimed to determine the clinical biochemical characteristics of angiotensin II type 1 receptor (AT1R) genetic variant associated with normoalbuminiric (NA) and albuminuric CKD in South Indian population with type 2 diabetes. The findings of this study revealed that apart from the relatively low eGFR levels in the current study, NA-CKD patients were older, with high prevalence of HTN and dyslipidemia than NA and CKD groups. The results showed that ESR was significantly higher in NA-CKD group.

It was speculated that this may be due to cholesterol

CONFERENCE Proceedings microemboli resulting in inflammation, which in turn elevates the ESR. It was stated that the present study is the first of its kind to determine polymorphism of AT1R in NA-CKD subjects in South Indian population.

Short- and Long-term View of Diabetes and Complications: Whatâ&#x20AC;&#x2122;s New with Saxagliptin?

Dr Rakesh Sahay, Hyderabad Saxagliptin has shown good efficacy among elderly patients. The safety with saxagliptin amongst elderly patients is as good as young patients; in fact hazard ratio is favorable. Saxagliptin provides significant reversal of microalbuminuria in all stages of renal failure and is effective even in normoalbuminuric diabetics, which is a big plus point when being used in elderly patients.

The HOMA-B improvement and possible preservation of b cells will further improve outcome amongst elderly patients.

Immunomodulatory Role of Eosinophils and Insulin Resistance Dr Prince Johnson Samuel, Chennai The present study investigated the relationship between eosinophils and insulin resistance. Since, eosinophil and monocyte derivatives have already been established, a combined absolute count representing innate immunity was considered in this study.

The results of this study suggested a significant increase in the innate immunity response in subjects with higher insulin resistance. It was stated that the odds of having higher insulin resistance is twice, with higher absolute counts of eosinophils or monocytes or higher counts of combined eosinophils-monocytes.

Glycemic Status, Insulin Resistance and Hypogonadism in HIV-infected Males Dr Alok Singh, UP This study aimed to evaluate glycemic status, dysglycemia, insulin resistance and predisposition to hypogonadism of HIV-infected males.

Dysglycemia, insulin resistance and hypogonadism were found to be highly prevalent in HIV population.

Patients with lower CD4 counts had significantly higher dysglycemia and insulin resistance. Patients with higher percentage of android fat (a marker of central obesity) had significantly higher insulin resistance.

Secondary hypogonadism was more common than primary hypogonadism among the HIV affected population. Serum testosterone levels were progressively lower (insignificant) with decreasing CD4 counts.

Vitamin B12 and Vitamin D Deficiency in South Indians with Different Degrees of Glucose Intolerance Dr R Guha Pradeepa, Chennai This study aimed to establish the incidence of vitamin B12 and vitamin D deficiency in urban South Indian population, and to evaluate the association of various cardiometabolic risk factors with vitamin B12 and vitamin D deficiencies. The overall prevalence of vitamin B12 and vitamin D deficiency were found to be 14.9% and 84%, respectively. The highest prevalence of vitamin B12, vitamin D, and folic acid deficiencies were observed among diabetic individuals, followed by those with prediabetes and normal glucose tolerance.

Additionally, vitamin B12 deficiency was associated with a higher prevalence of hypertriglyceridemia.

Vitamin D deficiency was associated with a higher prevalence of abdominal and general obesity, as well as metabolic syndrome.

Epidemiology of Diabetes in India - latest updates from ICMR-INDIAB Study Dr RM Anjana, Chennai The prevalence of diabetes in India varies widely in different states from 4.3% in Bihar to 13.6% in Chandigarh. There is evidence of an epidemiological transition, with a higher prevalence of diabetes in lower socioeconomic status groups in urban areas of the more economically developed states. There is shift of diabetes epidemic from urban to rural areas and older to younger people. There are a large number of undiagnosed diabetics in India.

ICMR-INDIAB Study - other metabolic NCDs Dr V Mohan, Chennai Prevalence rates of both generalized obesity and abdominal obesity are high in India. The prevalence of hypertension and dyslipidemia are also high. There is a huge variation in prevalence rates of all these metabolic NCDs between different states of India. In general, rates are higher in urban areas, but rural areas are fast catching up. There is an urgent need to increase awareness about NCDs in India and institute preventive measures.

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

575

CONFERENCE Proceedings Indigenous Medicines and Diabetes: Indian Experience

Sulfonylurea Combinations: An International Consensus

Dr Arvind Gupta, Jaipur

Dr Sarita Bajaj, President

Complementary and alternative medicine (CAM) therapy has been traditionally used to define medical practices and approaches that did not conform to the standard beliefs of medical practitioners. These therapies have been primarily used as adjuncts to conventional medicines in the past. Indigenous means native to a particular region or environment.

Jamun is a very rich source of vitamin C, calcium, phosphorus and iron. This has been traditionally used by Unani, Ayurvedic and other Asian medicine systems for controlling diabetes. The main ingredient with antidiabetic function in jamun is jamboline. Many researchers have established that amla is effective in lowering FBS or HbA1c levels in diabetic patients (in just half an hour). The chemical hydroxychalcone has been identified as a potential active ingredient in cinnamon, which is believed to modify the sensitivity of cells to insulin, enhancing their uptake.

A research conducted on people with type 2 diabetes established that 1-6 g of cinnamon per day lowers serum glucose.

Curry leaves are potent antidiabetic agents. The type and amount of fiber, and the bio-active compounds, murrayacinine, isomahanimbine/mahanimbicine, mahanimboline, contained within the leaves also play a significant role in lowering blood sugar levels.

Bitter gourd fruits and the whole plant is rich in plant insulin – polypeptide-P. This is a biochemical which is effective in reducing blood sugar. Garlic helps in controlling abnormally high blood sugar levels in diabetics. Indigenous foods have antidiabetic properties but still they can be used only as supportive therapy. However, they may play a role in delaying the onset of the disease.

Association of Cystatin-C with ICAM-1 Values in Early T2DM Dr Nisha Jha, Mangalore ÂÂ

Cystatin-C is a marker of pre-clinical renal dysfunction.

ÂÂ

ICAM-1 (intercellular adhesion molecule-1) is a marker of pre-clinical coronary artery disease (CAD).

ÂÂ

Cystatin-C cannot be used as a marker for preclinical CAD in early T2DM.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

ÂÂ

Weight gain is least with modern sulfonylurea (SU), glimepiride, when compared with other SUs. As compared to older SUs, glimepiride: Has lower risk of hypoglycemic events; exhibits a higher exchange rate and lower binding affinity to b cells.

ÂÂ

Potent efficacy confirmed with modern SU: Patients treated with glimepiride, have: 12% greater reduction in HbA1c; 4 mg/dl greater reduction in FPG; significantly fewer dropouts; 20% less risk of needing rescue treatments.

ÂÂ

A combination of metformin and SUs helps in addressing multiple etiologies of hyperglycemia.

The use of 2nd and 3rd generation SUs in patients with type 2 diabetes is not associated with increased CV risk irrespective of comparator or background medication. SUs as an add-on to metformin have been considered safe in terms of overall and CV mortality. SUs have durable action and b-cell exhaustion with SU is a myth.

ÂÂ

SUs are not associated with increased risk for allcause mortality, CV mortality, MI or stroke. SUs cause maximum reduction of HbA1c.

ÂÂ

Safe and Smart Plus: An International Task Force with experts from Africa, Asia and Middle East. This is a guidance on usage of SUs in combination with other OADs, as well as insulin, to help physicians across the country and beyond.

Barriers and Challenges in SMBG Dr Rajeev Chawla, New Delhi ÂÂ

Patient factors: Suboptimal health literacy; lack of access to healthcare facilities: Poor socioeconomic status, culture and language capabilities, less awareness and practice of self-care.

ÂÂ

The clinician factors that may influence the management of diabetes include the following: Beliefs and attitude of clinicians; knowledge about self-management of diabetes for their patients; effective communication skills may impact the perception of patients; well-integrated healthcare system; perception on regulatory aspects of devices. Identifying barriers to diabetes management is essential to improve the quality of diabetes care, metabolic control and diabetes self-management.

CONFERENCE Proceedings ÂÂ

Benefits of SMBG: It helps formulate antidiabetic drug regimens and optimize existing regimens; if performed with adequate frequency, it indicates the magnitude of glycemic variability; it facilitates improved HbA1c levels; it helps alert patients and physicians to the risk of diabetes complications, even in patients with controlled HbA1c levels; it helps recognize hypoglycemic and hyperglycemic episodes; it helps improve QoL of patients; it helps patients to adhere to lifestyle and drug prescriptions.

Dietary Protein and Diabetes: Food as Medicine - Socioeconomic Challenges Dr Bina Naik, Bengaluru There are three nutritional issues related to protein nutrition and diabetes - Glycemic control, diabetes complications and energy balance. Protein stimulates insulin just as carbohydrates, but does not increase blood glucose levels. For people with type 2 diabetes, 20-30% of total energy intake should be from protein.

This amount of protein will help improve glycemic control, aid in satiety and preserve lean body mass during weight loss in both diabetes and prediabetes. It will also provide for increased protein requirements of the older adult. The best mix of protein, carbohydrate and fat varies depending on individual circumstances: Dietary reference intakes recommend that healthy adults should consume 45-65% of energy from carbohydrate, 20-35% from fat and 10-35% from protein. Total caloric intake must be appropriate for weight management.

Tricyclic antidepressants and nortriptyline may be beneficial in depression. Psychotherapy may have an important role.

Optimizing Insulin Therapy with Injection Technique: FITTER Recommendations Hony. Brigadier Prof. GS Sainani, Mumbai Forum for Injection Technique and Therapy Expert Recommendations (FITTER), India 2017: All injectable agents rely on the correct injection technique, hence appropriate injection technique is crucial for the success of insulin therapy. Forum for Injection Technique (FIT), India revised the existing recommendations to achieve the best possible health outcomes by ensuring that the correct dose of medication is delivered to the correct injection site, using the correct technique.

FITTER India 2017 TOP Recommendations are: 4mm pen needles and 6 mm insulin syringes (shortest needle length) are recommended as the first-line of choice in all patient categories; Systematic site rotation should be practiced; Screening and prevention of lipohypertrophy is necessary; Prevention of re-use of insulin syringes and pen needles must be emphasized.

Timely Insulinization the Basal Way Dr Shashank Joshi, Mumbai ÂÂ

Potential barriers to effective dose titration: Hypoglycemia or fear of hypoglycemia, psychological insulin resistance, perceived complexity of insulin dose titration, demanding self-care regimens. Basal insulins continue to be the most convenient insulin to initiate, reported the ADA/EASD 2017 guideline.

ÂÂ

INSIGHT study: Basal insulin led to greater and safe A1c-lowering than OAD optimization. Basal insulin led to twice the number of patients reaching goal; greater treatment satisfaction.

ÂÂ

Starting basal insulin once-daily is safe and effective. Appropriate use of basal insulin therapy can help restore b-cell function. Ensuring effective titration can be a challenge due to hypoglycemia concerns and may cause patients to fall short of their individualized glycemic goals. Next generation basal insulins hold promise in improving the initiation experience on insulin, with stable and prolonged glycemic control beyond 24 hours and safer titration.

Psychosocial Effects of Diabetes Dr Dheeraj Kapoor, Gurugram Many studies have investigated the association of comorbidities of mental illness with diabetes. The prevalence of depression in diabetics is about 3-4 times more than in nondiabetics. The symptomatology also, is of a higher grade in a diabetic. However, severity of symptoms does not correlate with disease severity or with glycemic control. Diabetic complications alone may not cause depression, unless there are functional limitations. Adverse events, personality and genetic factors may also contribute. Anxiety disorders are also commoner in diabetics. Incidence of anorexia and bulimia is not precisely known in diabetes but both disorders can worsen glycemic control. Also, the threshold for reporting of symptoms may be lowered by psychological factors. Interestingly, stress in a diabetic may cause both hyperglycemia and hypoglycemia.

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CONFERENCE Proceedings HIV and Diabetes Dr Salam Ranabir, Imphal Screening for diabetes mellitus is strongly recommended among patients on antiretroviral therapy (ART). Both fasting and postprandial glucose values should be used to diagnose diabetes among HIV-infected cases. HbA1c may underestimate the degree of hyperglycemia and is not a good tool. Lipid abnormalities can be seen as early as 6 months of ART, so lipid profile should be done after 6 months of ART and then yearly.

Diabetes Mellitus and Sleep Disordered Breathing Prof (Dr) Nibedita Pani, Cuttack Sleep disordered breathing (SDB) is a spectrum of disorders consisting of snoring, upper airway resistance syndrome, sleep apnea. Sleep apnea can be obstructive, central or mix. OSA is the most common SDB with a prevalence of 2-4% in the general population. About 40% of people with OSA have T2DM and prevalence of OSA in diabetic patients is 23%. OSA increases the severity of T2DM independent of age and obesity. Treatment with CPAP reduces IR and improves glycemic control, thereby indicating a close relationship between diabetes and OSA. We should also consider the use of various exercises, behavioral modifications, yoga and other advanced modalities like adaptive servo-ventilation, oral appliances, etc., available in our armamentarium today and various minimally invasive in-office procedures to alleviate the complications of SDB as well as diabetes mellitus in the long run.

is important, and supports the philosophy of chronic disease model; periodic follow-up is required.

Diabetes and Oral Cavity Dr Jugal Kishor Sharma, New Delhi T2DM has been described as a new epidemic.

Approximately 2 million people worldwide suffer from diabetes, and the number is predicted to increase by about 50% by the year 2050. Oral health awareness is lacking among health professionals and patients with diabetes, although there is a strong body of evidence that supports the relationship between oral health and T2DM. There is a need for education of the treating physician about the various oral manifestations of diabetes so that they can be diagnosed early and referrals to oral health specialists can be made early.

The established link between periodontitis and diabetes calls for an increased need to study ways to control both diseases, particularly among populations with health disparities and limited access to oral healthcare. The various diseases affecting the oral cavity are periodontal diseases, dental caries, oral mucosal diseases, salivary dysfunction and neuropathy consequences.

Emerging Diabetes in the Young Indians Dr MV Jali, Belagavi ÂÂ

The overall global prevalence of type 2 diabetes is rising steadily. Previously, type 2 diabetes was predominantly a disease of middle-aged and older people. In recent decades, the age of onset has decreased, and type 2 diabetes is being reported in young people and children worldwide,1 particularly in high prevalence populations. The average age of onset of diabetes in Indians is a decade earlier than other races. Many are in the late 20s.2 Risks of emerging rise in prevalence of diabetes mellitus in young Indians are gaining fast momentum. Additional CV risk factors are often associated with type 2 diabetes in the young. It has profound societal cost implications that are high and escalating. The data on the pathophysiology in the young are sparse, but there is no evidence to suggest differences from adults with diabetes.

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The incidence of type 2 diabetes in the young is rising in parallel with the prevalence with overweight and obesity, suggesting a possible causal relationship, mainly when the obesity is central and in relation to decreased physical activity. Other factors include family history, gestational diabetes in the mother and low birthweight.1

Teaching, Learning and Positive Behavior Change Towards Best Health Science and Human Spirit Dr Nagamani Srinivas, Bengaluru Teaching and learning leads to positive behavior change and better health outcome. Diabetes is a gigantic public health problem in India and the world. Compassion and empathy towards patients help in fostering positive health behavior, and enriching the lives of the patient as well as the educators. Indian philosophy of yoga and associated concepts give one of the most scientific basic of human behavior, health and happiness. Holistic, compassionate scientific and team approach is the key for diabetes care. Spiritual foundation as yoga, meditation, prayers and other religious practices help in better understanding of the meaning and purpose of life. For successful diabetes care, diabetes education

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CONFERENCE Proceedings ÂÂ

It is further observed that young, ambitious Asians and especially Indians, are getting diabetes sooner, and dying younger. Several lines of evidence show that genetic mechanisms are robust in Indian diabetic population,‘the Asian-Diabetes Phenotypes’. It remains controversial whether the decrease in β-cell function is due to an inevitable consequence of “early biological aging” or environmental and lifestyle variables apart from the Asian Diabetes Phenotype. Prevention must be the primary strategy for the future. Strategies for the prevention of type 2 diabetes in children need to involve government and societal, as well as individual change. Programs should focus on the prevention of obesity through increased physical activity and promotion of healthy living (eating),1 and to save young Indians from getting diabetes.

References: 1http://care.diabetesjournals.org/content/27/7/1798.short?27/7/1799&citedby=... 2Gupta R, Misra A et al.2009.

NAFLD and NASH links DR Pramila Kalra, Bengaluru Nonalcoholic fatty liver disease (NAFLD) is defined as macrovesicular steatosis in >5% of hepatocytes according to histological analysis or by proton density fat fraction, or >5.6% as assessed by proton magnetic resonance spectroscopy or quantitative fat/water selective MRI with no secondary cause for steatosis.

Conditions like alcohol abuse and hepatitis C infection need to be excluded. NAFL is a benign condition in which the fatty infiltration is simple and there is no inflammation. The liver function tests show slight increase in serum glutamic-pyruvic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) in some cases and liver USG or fibroscan reveals fatty liver. NASH is a condition in which there is fatty infiltration along with liver inflammation (steatohepatitis). The confirmation is done by liver biopsy. NASH occurs mostly in people who have features of metabolic syndrome, and liver enzyme elevation may be seen more than that seen in NAFL. NASH can progress to cirrhosis.

Exploring New Horizons in SMBG: Translating to Better Clinical Outcomes Dr Jothydev Kesavadev, Kerala Structured SMBG is an integral part of diabetes care to ensure continuing success. Use of glucose meters has a role at every stage of diabetes, including prediabetes, to motivate subjects adopt healthier lifestyles. Glucose

meters wirelessly connected to mobile apps enhance drug adherence, enable to create reports, analysis, etc., and mail it to physician’s office. New generation meters and strips adhere to updated ISO standards with better accuracy and no wastage of strips.

Telemedicine and Telecounseling in Diabetes Care Ms Uma Dayashankar, Bengaluru Application of telemedicine in diabetes care is telediabetology. Telemedicine is the use of telecommunication to support healthcare from one side to another via electronic communication.

Barriers reimbursement, EHR integration, multidiscipline physiology, privacy and security, consumer trust and acceptance. Future trends - greater adoption of telemedicine from 2017 and beyond, medical tourism, licensing and legal issues (telemedicine cannot substitute face-to-face consultation), to save money and time of the patient. Telemedicine is a part of new digital age in transforming the diabetes world by precision medicine treatment. It is well-suited for treating diabetes which is both clinically and economically useful for patients with diabetes and other comorbid conditions.

It will play a greater role in future.

Digital Health Education Ms S Geetha Rao, Bengaluru Everyone in the healthcare industry knows what challenges we face - an aging population, more lifestyle-related ill health and growing constraints on budgets. The use of digital communication tools has also allowed for greater patient engagement, which means more individuals are focused on improving their health and wellness, such as sticking to a healthy recommended diet, continuing exercise routines and adhering to their medication schedule along with follow-up appointments. The challenges of mHealth solutions include the practicalities of data storage and management, availability and maintenance of the network, as well as compatibility and interoperability.

One of the greatest opportunities of the 21st century is our ambition towards health and care system that enables people to make healthier choices, to be more resilient, to deal more effectively with illness and disability when it arises, and to have happier, longer lives in old age; a health and care system where technology can help tackle inequalities and improve access to services for the vulnerable.

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CONFERENCE Proceedings for long and complex procedures (e.g., CABG, renal transplant or prolonged neurosurgical operations) or any patient with poor glycemic control. Patients with type 2 diabetes on OADs or noninsulin injectables - hold these agents on the morning of surgery: Correction insulin (usually 6 hourly) until the patient is eating and either can resume oral agents/noninsulin injectables or a basal-bolus insulin regimen is initiated.

Basal Intensification: Evidence-based Recommendation Dr Banshi Saboo, Ahmedabad The insulin initiation of the T2DM patients can be done with basal insulin, premix insulin, basal plus. Most of the international standard guidelines recommend initiation of basal insulin once and further titration according to the sugars. But, as you know that the Indian diet is a carbohydrate rich diet, a twice-daily premix regime is more preferred by the diabetologists while initiating the insulin regime, at the cost of more frequency of hypoglycemia. This is also one of the reasons for uncontrolled glycemia despite insulin therapy.

SMBG and total diet recall from the patient are required for further titration of insulin. Diet counseling plays an important role in patients with postprandial hyperglycemia. If there is persistent postprandial hyperglycemia, then a premeal short-acting bolus insulin can be added. This is known as “basal plus” regime. This regime has lesser hypos and the titration is easier in comparison to the premix regime. There is flexibility for the patients to take the insulin with the largest meal of the day. This also empowers the patients to titrate their own insulin by a few units on their own using SMBG. Perioperative Hyperglycemia Management Dr Shalini Jaggi, New Delhi ÂÂ

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Patients with diabetes have higher incidence of morbidity and mortality. Poor perioperative glycemic control: ↑ risk of adverse outcomes.

There is a strong correlation between perioperative hyperglycemia and increased complications, especially nosocomial infection. Pre-existing metabolic disturbances are exacerbated by surgery.

Metabolic impact of surgery may worsen glycemic control. Metabolic worsening can result in increased mortality, morbidity and length of hospital stay.

Management strategy: Baseline assessment: History and examination, type of diabetes, glycemic status, current medications, associated complications (ECG, renal and cardiac functions); Goals: Maintaining euglycemia with avoidance of hypoglycemia, prevention of ketoacidosis, maintenance of fluid and electrolyte balance; Target: aim to keep the glucose readings between 140 and 180 mg/dL; Ideally, all patients with diabetes mellitus should have their surgery prior to 9 AM to minimize the disruption of their management routine while being NPO; IV insulin infusion is usually required Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

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Patients who are on insulin can continue with SC insulin perioperatively at a reduced dose (rather than an insulin infusion) for procedures that are not long and complex (e.g., no more than one or two missed meals).

Diabesity = Diabetes + Obesity Dr Ved V Gossain, USA Both diseases are common (frequently coexist like conjoined twins) and their prevalence is increasing worldwide. Both have some genetic component as their etiology, but lifestyle is also an important contributing factor. Both are associated with CV complications. Both can be managed by lifestyle modification. In selected cases, pharmacotherapy can be used for the treatment of obesity. When using drugs for the management of diabetes, attention should be paid to their side effects, since some of them can cause weight gain. Bariatric surgery is an effective treatment for both. Bariatric surgery can reduce CV complications and reduce total mortality.

Many Faces of Interaction between Diabetes Mellitus and Microbes Dr Nancy Khardori, USA The complex interaction between microbes and diabetes mellitus involves role of microbes in causation/initiation of disease, and once initiated-making the patients susceptible to even more serious infection caused by microbes (viruses, bacteria and fungi). A number of viruses have been implicated by epidemiological, and more recently by molecular evidence in being causative agents of diabetes mellitus. The abnormal metabolic state induced subsequently leads to immunological dysfunction at multiple levels starting with defects with the first-line of defense provided by phagocytic cells. Skin, soft tissue and bone infections are a major cause of morbidity and mortality in patients with diabetes mellitus. Resistance to antibiotics renders them ineffective even in patients without diabetes or immunocompromise. The expectation of newer antibiotics to combat resistance is logical but not realistic.

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Expert View

What is the Role of Biomarker Assay in Evaluation of Heart Failure Patients?

HK Chopra

H

eart failure (HF) biomarkers have dramatically impacted the way HF patients are evaluated and managed. B-type natriuretic peptide (BNP) and N-terminal pro-BNP (NT-proBNP) are the gold standard biomarkers in determining the diagnosis and prognosis of HF. An array of additional biomarkers has emerged, each reflecting different pathophysiological processes in the development and progression of HF: myocardial insult, inflammation and remodeling. Patient-specific biomarker profiles are useful not only for the purpose of monitoring disease severity and progression, to guide therapy, but also for characterizing the pathophysiology of HF. Broadly biomarkers can be arranged into the following categories: 1) Myocardial stress/injury, 2) neurohormonal activation, 3) remodeling and 4) comorbidities. The list is long but only the most clinically relevant biomarkers are described.

Myocardial stress/injury BNP and NT-proBNP are considered the benchmarks against which other biomarkers are compared.

Biomarkers of myocardial necrosis and oxidative stress are also included in this category.

BNP and NT-proBNP The most potent inducer of BNP gene transcription is left ventricular (LV) wall stretch from increased pressure or volume. A prohormone (proBNP) is cleaved to BNP and NT-proBNP, resulting in a serologic evidence of BNP, NT-proBNP and proBNP. Normally, circulating BNP and NT-proBNP levels are quite low, but in the setting of HF, their concentrations rise dramatically.

The Breathing Not Properly Multinational Study demonstrated that BNP values >100 pg/mL diagnosed acute HF with high accuracy at 85% and strongly

Editor, Indian Heart Journal President, CSI Delhi Branch, New Delhi

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predicted HF. Both BNP and NT-proBNP are also useful in excluding the diagnosis when their values are very low. Some conditions are associated with lower than expected natriuretic peptide levels: HF with preserved ejection fraction (HFpEF) compared with HF with reduced ejection fraction (HFrEF) and obesity.

BNP and NT-proBNP strongly predictor clinical outcomes in all stages of HF. In the Acute Decompensated Heart Failure National Registry (ADHERE), admission BNP values for acute HF decompensation in the highest quartile (BNP ≥1,730 pg/mL) was associated with 2.23-fold increase in in-hospital mortality compared with BNP in the lowest quartile (<430 pg/mL), even after adjustment for potential confounders and regardless of EF. Likewise, NT-proBNP concentrations are strongly predictive of short-and long-term clinical outcomes; admission NT-proBNP >986 pg/mL was associated with almost three-fold increase in 1 year mortality (adjusted hazard ratio [HR] 2.88).

HF therapies that improve mortality and morbidity in HF reduce these natriuretic peptide values. Meta-analyses suggest a 20-30% mortality reduction with biomarkerguided HF care over standard HF care and prospective studies have demonstrated that serial outpatient assessment of natriuretic peptides leads to more uptitration of HF medications and decrease in natriuretic peptides.

Troponins Troponin T (TnT) and I (TnI), are frequently detectable in HF. In the ADHERE, 6.2% of patients with acute decompensated HF had an elevated troponin (as defined by conventional troponin assays as ≥1.0 µg/L for TnI or ≥0.1 µg/L for TnT, which was associated with worse inhospital mortality (adjusted odds ratio = 2.55).

Neurohormonal activation Cardiac injury leads to the activation of a number of biologically active proteins that attempt to compensate for reduced myocardial function. However, prolonged activation often leads to maladaptive effects and further progression of HF.

Expert View MR-proADM and copeptin Mid-regional proadrenomedullin (MR-proADM) is a precursor to a potent vasodilator with inotropic properties, adrenomedullin, originally isolated from pheochromocytoma cells. MR-proADM is elevated in patients with acute and chronic HF and is a strong predictor of clinical outcomes such as mortality and HF hospitalization, when added to BNP or NT-proBNP. Copeptin is a stable C-terminal propeptide fragment of arginine vasopressin (AVP); AVP is centrally involved in the regulation of free water clearance and plasma osmolality by regulating absorption of water from the kidneys. In the Biomarkers in Acute Heart Failure (BACH) trial, elevated copeptin level strongly predicted mortality and in those with hyponatremia, elevated copeptin level was more predictive, even after adjusting for NT-proBNP and traditional variables.

Myocardial remodeling Myocardial remodeling is the pivotal process leading to progressive myocardial dysfunction and risk in HF. While BNP, NT-proBNP and high sensitive troponin (hsTn) are all also linked to remodeling risk, other biomarkers are worth mentioning.

ST2 ST2 gene is strongly induced in the setting of cardiomyocyte or cardiac fibroblasts stretch. ST2 is closely involved in LV hypertrophy, fibrosis and remodeling via its interaction with interleukin (IL)-33, a protein with antifibrotic and antiremodeling properties.

Increasing ST2 concentrations (e.g., >35 ng/mL) are

powerfully associated with adverse clinical outcomes in HF, and compared with BNP or NT-proBNP, ST2 is not as affected by age, renal function or BMI. Galectin-3 Galectin-3 is involved in the inflammatory pathway following injury and ventricular remodeling via tissue repair, myofibroblast proliferation and fibrogenesis.

Galectin-3 is elevated in patients with acute or chronic HF. Comorbidities Cystatin C and b trace protein (BTP) are better than traditional renal markers for determining prognosis in HF, presumably due to enhanced ability to gauge renal function at milder levels of abnormality. Several novel serum or urine biomarkers have been evaluated to date with regards to their ability to detect acute kidney injury (AKI) earlier: neutrophil-gelatinase associated lipocalin (NGAL), kidney injury molecule (KIM)-1, N-acetyl b-(D)-glucosaminidase (NAG), liver-type fatty acid-binding protein and IL-18. While elevated levels of NGAL are associated with poor clinical outcomes, this relationship was less impressive after adjusting for extensive variables including NT-proBNP. In addition, its ability to predict imminent AKI was fair (68% sensitivity and 70% specificity).

Suggested reading 1. Available at: http://www.acc.org/latest-in-cardiology/ articles/.../cardiac-biomarkers-and-heart-failure 2. Stokes NR, Dietz BW, Liang JJ. Cardiopulmonary laboratory biomarkers in the evaluation of acute dyspnea. Open Access Emerg Med. 2016;8:35-45.

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Medilaw

What are the Principles of Natural Justice?

The two essential elements of Natural Justice are: ÂÂ

No man shall be Judge in his own cause (the judge should not have any interest or bias in any party)

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must give reasonable notice to the parties to the dispute and afford each party adequate opportunity of presenting his case.

The Court/Tribunal must act honestly and impartially and not under the dictation of other persons to whom authority is not given by Law.

Audi Alteram Partem (Both sides shall be heard)

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A judgment will not be conclusive, however, if the proceeding in which it was obtained is opposed to natural justice.

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A judgment which is the result of bias or want of impartiality on the part of a Judge will be regarded as a nullity and the trial coram non judice.

That no one should be condemned unheard.

Party to an action is prima facie entitled to be heard in his presence.

Canara Bank and others vs. Sri Debasis Das: AIR 2003, 2041:

He is entitled to dispute his opponent’s case, cross examine his opponent’s witnesses and entitled to call his own witnesses and give his own evidence before Court.

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Natural Justice is same as administration of justice in a common sense liberal way.

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Rules of Natural Justice are principles ingrained into the conscience of man and are based on natural ideals and human values.

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The administration of Justice is to be freed from the narrow and restricted considerations which are usually associated with a formulated law involving linguistic technicalities and grammatical niceties.

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Whenever legal justice fails to achieve this solemn purpose, natural justice is called in aid of legal justice. Natural justice relieves legal justice from unnecessary technicality, grammatical pedantry or logical prevarication.

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The adherence to principles of Natural Justice as recognized by all civilized States is of Supreme importance when a quasi-judicial body embarks on determining disputes between the parties, or any administrative action involving civil consequences is in issue.

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Notice it is the first limb of the principle of Audi Alteram Partem. Adequate time should be given to make his representation.

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What particular rule of natural justice to be applied depends upon the facts of that case, the statute governing the issue, etc.

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The old distinction between an Administrative Act and Judicial Act does not survive any longer.

Every Administrative order which involves civil consequences must follow the rules of natural justice.

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In the absence of a notice and reasonable opportunity to a person to meet the case against him, the order passed becomes wholly vitiated.

He is entitled to know the reasons for the decision rendered by a Court/Tribunal.

Supreme Court references (Tulsiram Patel case): ÂÂ

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Principles of natural justice are applicable to quasijudicial and administrative process.

Justice should not only be done but should manifestly be seem to be done: “He who shall decide anything without the other side having been heard, although he may have said what is right, will not have done what is right, in other words has it is now expressed, Justice should not only be done but should manifestly be seem to be done.” (Tulsiram Patel Case).

While considering the Audi Alteram Partem rule a person against whom an order to his prejudice may be passed should be informed of the charges against him.

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Such person should be given an opportunity of submitting his explanation which also include the right to know the oral and documentary evidence which are to be used against him.

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Witnesses who are to give evidence against him be examined in his presence with right to cross examine them.

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To lead his own evidence both oral and documentary, in his defence.

AIR 1963 SC page 1, Viswanathan vs. Abdul Wajid: ÂÂ

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The court must be composed of impartial persons, acting fairly, without bias and in good faith; it

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(Source: Excerpts from: Justice T.S. Sivagnanam: at Tamil Nadu State Judicial Academy on 01.06.2009)

AROUND THE GLOBE

News and Views Emergency Funding Needed to Combat Climate Change, Says WMA A call for national governments to provide designated funds for the strengthening of health systems to combat climate change has come from the World Medical Association (WMA). In a policy statement adopted at its annual Assembly in Chicago, the WMA emphasises the urgency for taking action and for emergency planning on local, national and international levels.

WMA President Dr Yoshitake Yokokura said: ‘With the next United Nations conference on climate change less than a month away, it is important that the voice of the world’s physicians is heard about the risks posed to health by climate change’.

The WMA says that human influence on the climate system is clear, with recent emissions of green-house gases the highest in history. Recent climate changes have had widespread impact on human and natural systems. Compelling evidence proves numerous health risks which threaten all countries. These include more frequent and potentially more severe heatwaves, droughts, floods, storms and bushfires.

Climate change, especially warming, is already leading to changes in the environment in which disease paths flourish. There is reduced availability and quality of potable water, and worsening food insecurity leading to malnutrition and population displacement.

And although climate change is universal, its effects are uneven, with many of the areas most affected the least able to manage the challenges it poses. Those with generally the poorest health and lowest life and health expectancy will be least able to adapt to the adverse effects of climate.

Dr Yokokura said: ‘We are also urging national governments to provide for the health and well-being of people displaced by environmental causes, including those becoming refugees because of the consequences of climate change’ (WMA News Release, October 20, 2017).

CDC Guidelines for Management of infants with Congenital Zika Virus Infection The Centers for Disease Control and Prevention (CDC) has published updated clinical guidance on caring for infants with congenitally acquired Zika infection.

According to the guidelines, infants with clinical

findings consistent with congenital Zika syndrome regardless of maternal testing results and infants without clinical findings consistent with congenital Zika syndrome who were born to mothers with laboratory evidence of possible Zika virus infection should be further tested and clinically evaluated for Zika.

Regular Walking Lowers All-cause Mortality According to a new study published online October 19, 2017 in the American Journal of Preventive Medicine, regular walking, even below minimum recommended levels, is associated with lower all-cause mortality compared with inactivity. Walking at or above physical activity recommendations is associated with even greater decreased risk.

New IOF Compendium Documents Osteoporosis, its Management and Global Burden The International Osteoporosis Foundation (IOF) issued the first edition of a comprehensive and scientifically referenced report on osteoporosis “IOF Compendium of Osteoporosis” on the occasion of World Osteoporosis Day. This compendium will be available in five languages, is to be periodically updated, and is intended as an authoritative reference document for all key stakeholders in the field of musculoskeletal health.

First Guidelines on Chronic Pain in People Living with HIV According to guidelines released by the HIV Medicine Association (HIVMA) of the Infectious Diseases Society of America (IDSA), people living with HIV should be assessed for chronic pain. Those who screen positive should be offered a variety of options for managing pain, starting with nondrug treatment such as cognitive behavioral therapy, yoga and physical therapy. These recommendations are published online September 14, 2017 in the journal Clinical Infectious Diseases.

Study Suggests Four in One Tablet as Switch Option for Treatment of HIV-1 Infection in Adults Findings of the EMERALD phase 3 noninferiority trial published online October 6, 2017 in The Lancet HIV

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AROUND THE GLOBE have demonstrated that a new single-tablet regimen (STR) containing darunavir, cobicistat, emtricitabine and tenofovir alafenamide maintained viral suppression at 48 weeks of the study in most study participants with HIV-1.

AAP Updates Guidance to Prevent Spread of Germs in Doctors’ Offices The American Academy of Pediatrics (AAP) has released updated recommendations on the best ways to prevent the spread of germs during doctor visits in a policy statement published online October 23, 2017 in the journal Pediatrics. The AAP recommends mandatory annual influenza immunization for staff, and documentation of immunity or immunization against other vaccine-preventable infections including pertussis, measles, mumps, rubella, varicella and hepatitis B.

Ornithine Phenylacetate Rapidly Lowers Ammonia Levels in Hepatic Encephalopathy Findings of a study presented at Liver Meeting, the annual conference of the American Association for the Study of Liver Diseases in Washington show that compared to standard care, ornithine phenylacetate (OCR-002), a new treatment for hepatic encephalopathy, rapidly lowered ammonia levels and also led to faster clinical improvement compared with placebo, with a 21-hour median reduction in time to improvement.

Depression Increases Risk of Early Death Results from the 60-year Stirling County Study published in Canadian Medical Association Journal online October 23, 2017 suggest that depression continues to be a strong risk factor for early death. This risk has increased for women in recent years. The study authors recommend monitoring of patients for mood disturbances, especially recurrent episodes of depression, so that they timely treatment and support can be given.

Length of Incision may Affect Pain After Cesarean Delivery As per a study presented October 21, 2017 at Anesthesiology 2017 annual meeting in Boston, both short and long surgical incisions for cesarean births are associated with increased pain after delivery. The study advises that neither shorter nor longer incisions be performed when possible and further recommend an optimal range for cesarean incision length to be between 12 and 17 cm.

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Drug Holidays should be Avoided in Women with Osteoporosis Drug holidays from denosumab should be avoided as they potentially increase the risk of atypical fractures such as of femur, even for women taking bisphosphonates who are at low-risk for fracture. These views were presented October 11, 2017 at the North American Menopause Society 2017 Annual Meeting in Philadelphia, USA.

7,000 Newborns Die Every Day, Despite Steady Decrease in Under-five Mortality: UN At current trends, 30 million newborns will die within first 28 days of life between 2017 and 2030.

Every day in 2016, 15,000 children died before their fifth birthday, 46% of them – or 7,000 babies – died in the first 28 days of life, according to a new report “Levels and Trends in Child Mortality 2017” by UNICEF, the World Health Organization (WHO), the World Bank and the Population Division of UNDESA which make up the Inter-agency Group for Child Mortality Estimation (IGME). Although the number of children dying before the age of five is at a new low– 5.6 million in 2016, compared with nearly 9.9 million in 2000, the proportion of under-five deaths in the newborn period has increased from 41% to 46% during the same period.

At current trends, 60 million children will die before their fifth birthday between 2017 and 2030, half of them newborns… (WHO, October 19, 2017)

Early Liver Transplant and Alcohol Abstinence in Severe Alcoholic Hepatitis Improves Survival A multicenter retrospective analysis of data from the ACCELERATE-AH study presented at the annual conference of the American Association for the Study of Liver Diseases (AASLD) shows that some patients with severe alcoholic hepatitis with a failing liver can still undergo liver transplant, however, continued use of alcohol reduced survival rate from 94% at 1 year to 84% after 3 years post-transplant.

US FDA Approves Herpes Zoster Vaccine for Adults Aged 50 Years and Older The US Food and Drug Administration (FDA) has approved recombinant zoster vaccine (adjuvanted) to prevent herpes zoster in adults aged 50 years and older. The vaccine, Shingrix, includes glycoprotein E, an antigen and AS01B, an adjuvant system. It is to be administered in two doses, at a gap of 2-6 months.

AROUND THE GLOBE Patients Prefer Doctors not Use Computers in Exam Room

ACOG New Practice Bulletin on Vaginal Birth After Cesarean Delivery

A new study to be presented at the 2017 Palliative and Supportive Care in Oncology Symposium to be held in San Diego, California from October 27-28 suggests that people with advanced cancer prefer doctors communicate with them face-to-face with just a notepad in hand rather than repeatedly using a computer. Patients perceived such physicians as more compassionate, professional and with better communication skills.

Updated guidelines on vaginal birth after cesarean delivery (VBAC) from the American College of Obstetricians and Gynecologists (ACOG) say that VBAC should be attempted at maternal care facilities that typically manage uncomplicated births if they are capable of performing emergency deliveries. The new Practice Bulletin will be published in the November 2017 issue of Obstetrics & Gynecology.

AAP Guidelines on Addressing Sexual and Reproductive Health Topics with Teenagers A new report from the AAP offers guidance to pediatricians on providing appropriate healthcare services and education to teens and young adults to prevent sexually transmitted infections and unintended pregnancies. The report published online October 23, 2017 in Pediatrics says that conversations on sexual and reproductive health may be initiated during a single office visit or over the course of several visits.

WhatsApp Use by Ambulances Reduces Delay Between First Medical Contact and Primary Angioplasty Use of WhatsApp by ambulance doctors in Argentina was associated with faster treatment of heart attack and lower mortality, according to an observational study presented October 19, 2017 at the Argentine Congress of Cardiology (SAC 2017). WhatsApp was used to send diagnostic ECGs directly to hospital catheterization labs, enabling patients to bypass the emergency department and reduced the time between symptom onset and treatment to 150 minutes compared to those who were taken to ERs first.

India to Host World Congress on Adolescent Health New Delhi, Oct 24 (PTI) Home to around 253 million adolescents, India hosted the World Congress on Adolescent Health this year from October 27-29.

Billed as the biggest global event in adolescent health, it is held once every 4 years and the International Association for Adolescent Health’s 11th World Congress was organized on the theme “Investing in Adolescent Health the Future is Now”.

India was chosen as the venue for the conference as it has the largest number of adolescents in the world.

Study Identifies Brain Patterns Underlying Mothers’ Responses to Infant Cries According to a new study of mothers in 11 countries, infant cries activate specific brain regions related to movement and speech. Behaviors and brain activity on functional magnetic resonance imaging (fMRI) were found to be consistent between mothers from different countries.

The study was published online October 23, 2017 in Proceedings of the National Academy of Sciences.

New Guidelines Issued for Patients with Mitochondrial Disease The Mitochondrial Medicine Society published online July 27, 2017 consensus-based recommendations for optimal managing and care for patients with primary mitochondrial disease in the journal Genetics in Medicine.

Among other issues, the guidelines also included a list of medications, such as statins and acetaminophen that must be used with caution or avoided in patients with mitochondrial disease.

Leukemia Patients and Their Oncologists have Vastly Different Perceptions of Prognosis A study of 100 people with acute myeloid leukemia (AML) receiving chemotherapy to be presented at the upcoming 2017 Palliative and Supportive Care in Oncology Symposium in San Diego, California suggests that overall, patients tended to overestimate both the risk of dying due to treatment and the likelihood of a cure than their oncologists. Prognostic misperceptions are especially striking in patients receiving nonintensive chemotherapy.

US FDA Expands Indications for Golimumab The US FDA has approved use of golimumab, tumor necrosis factor (TNF)-α inhibitor, for two new indications: adults with active psoriatic arthritis or active ankylosing spondylitis (AS). Golimumab is already approved for treatment of moderately to severely active rheumatoid arthritis (RA).

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AROUND THE GLOBE FSSAI Notifies Revised Standards for Milk and Milk Products

ACC Guidelines on Management of Mitral Regurgitation

The Food Safety and Standards Authority of India (FSSAI) has notified the FSS (Prohibition and Restriction on Sales Amendment Regulations, 2017 regarding certain restrictions on sale of cream and FSS (Food Products Standards and Food Additives) Amendment Regulations, 2017 regarding revised standards for milk and milk products. Along with other recommendations, the new standards redefine milk and milk products to cover all conventional and nonconventional milk products as per the global standards. FSSAI has also introduced new standards for camel milk, dairy whitener, edible lactose, flavored dahi, fermented milk drinks such as lassi along with revised standards for cow milk, uniform all through the country… (FSSAI, October 24, 2017).

A consensus decision pathway document on the management of mitral regurgitation (MR) has been published by the American College of Cardiology (ACC) online October 18, 2017 in the Journal of the American College of Cardiology. According to the statement, recognition of MR should prompt an evaluation of its etiology, mechanism, severity including indications for treatment.

ADA/EASD Scientific Statement on Improving Clinical Value and Use of CGM Systems The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have jointly published a scientific statement on the clinical value and use of continuous glucose monitoring (CGM) systems in patients with diabetes in the November 2017 issue of Diabetes Care. The statement will be simultaneously published in Diabetologia by the European Association for the Study of Diabetes.

Brains are Still Recovering from Concussion Even After Return to Play, Says Study Hockey players in their early teens who have had a concussion may still have brain changes 3 months later, long after other symptoms have cleared and they are allowed to return to play, according to a study published in the October 25, 2017 issue of Neurology.

Brain scans of the concussed players 3 months postconcussion showed signs of widespread damage to the white matter and 10% reduction in molecules associated with metabolism.

ACOG Recommends Against Vaginal Seeding for Infants The American College of Obstetricians and Gynecologists (ACOG) does not encourage or recommend vaginal seeding for infants outside of the context of institutional review board-approved research due to lack of data regarding the safety and efficacy of vaginal seeding.

ACOG Committee Opinion #725, “Vaginal Seeding” will be published in the November 2017 issue of the journal Obstetrics & Gynecology.

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Cloth Caps Prevent Contamination in OTs More Effectively Than Disposable Caps Results of a study presented October 25, 2017 at the ACS Clinical Congress 2017 suggest that surgeon’s caps that expose small amounts of the ears and hair are not inferior to the bouffant-style, disposable scrub hats that cover those features. Cloth skull caps, which do not have a porous crown like their disposable counterparts, showed lower particle counts and significantly lower microbial shedding at the sterile field compared with bouffant hats.

WMA Reiterates Strong Opposition to Physician Assisted Suicide and to Australian Bill The World Medical Association (WMA) and its national member medical associations, which include the Australian Medical Association, have strongly reiterated their long-standing opposition to physician assisted suicide and euthanasia on the basis that they constitute the unethical practice of medicine. The WMA calls on Australia’s Victorian Upper House to reject the Victorian Voluntary Assisted Dying Bill.

The association cites its declaration on euthanasia which states: ‘Euthanasia, that is the act of deliberately ending the life of a patient, even at the patient’s own request or at the request of close relatives, is unethical’.

It also refers to its Statement on Physician Assisted Suicide which declares: ‘Physician assisted suicide, like euthanasia, is unethical and must be condemned by the medical profession. Where the assistance of the physician is intentionally and deliberately directed at enabling an individual to end his or her own life, the physician acts unethically’. And further it quotes its resolution on euthanasia, which notes that the practice of euthanasia with physician assistance has been adopted into law in some countries and that ‘The WMA reaffirms its strong belief that euthanasia is in conflict with basic ethical principles of medical practice, and strongly encourages all national medical associations and physicians to refrain

AROUND THE GLOBE from participating in euthanasia, even if national law allows it or decriminalizes it under certain conditions’.

ÂÂ

Do not order RBC folate values; consider folate supplementation instead of testing in adults with macrocytic anemia.

Finally, the WMA has expressed its concern that should the Victorian Bill be passed into law, it will create a situation of direct conflict with physicians’ ethical obligations to patients and will harm the “ethical tone” of the profession. It also warns that vulnerable people will be placed at risk of abuse and that a precedent will be set whereby physician assisted suicide and euthanasia are ethically acceptable (WMA, October 27, 2017).

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Do not use sputum cytology to evaluate patients with peripheral lung lesions.

Study Identifies Biomarker to Measure Benefits of Folic Acid on Stroke Prevention A posthoc analysis of the China Stroke Primary Prevention Trial (CSPPT) presented October 27, 2017 at the 28th Great Wall International Congress of Cardiology (GW-ICC) in Beijing, China and published in Neurology has suggested decrease in homocysteine level as a biomarker to measure the benefits of folic acid supplementation in reducing the risk of stroke in patients with hypertension.

ACOG Practice Bulletin on LARC and Reproductive Choice A new practice bulletin from the ACOG has described data on the safety of long-acting reversible contraception (LARC), the most effective, reversible contraceptive methods available. Safety and efficacy of each of the five different intrauterine devices (IUDs), how they function to prevent pregnancy and their duration of effectiveness was also discussed.

ASCP Adds Five New Tests Added to Choosing Wisely Campaign The American Society for has added five tests to its which were unveiled at Clinical Pathology (ASCP) in September in Chicago. ÂÂ

Clinical Pathology (ASCP) choosing wisely campaign, the American Society for 2017 Annual Meeting held

Do not order a frozen section if the result will not affect intraoperative or perioperative patient management.

ÂÂ

Do not repeat hemoglobin electrophoresis or its equivalent in patients who have a prior result and do not require intervention or monitoring.

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Do not test protein C, protein S, antithrombin III during an active clotting event; these tests are not accurate to diagnose a hereditary deficiency,

Resilience Intervention Improves Psychosocial Health in Young Patients with Cancer Findings of a new pilot randomized clinical trial show that a brief in-person intervention, PRISM or promoting resilience in stress management improved resilience and cancer-related quality-of-life, increased hope, and lowered distress in most adolescents and young adults living with cancer compared with those who received usual psychosocial care.

These findings will be presented at the upcoming 2017 Palliative and Supportive Care in Oncology Symposium in San Diego, California.

Good Long-term Improvement After ‘Reverse’ Shoulder Replacement in Patients Under 60 According to a study published October 26, 2017 in The Journal of Bone & Joint Surgery, a reverse total shoulder arthroplasty (RTSA) results in significant long-term improvement in shoulder function in patients younger than 60 years with severe damage to the rotator cuff muscles without clinical deterioration beyond 10 years. But, it has a substantial complication rate.

ECTRIMS/EAN Treatment Guidelines for Multiple Sclerosis Guidelines on the use of disease-modifying therapies in multiple sclerosis have been released jointly by the European Committee for Research and Treatment of Multiple Sclerosis (ECTRIMS) and the European Academy of Neurology (EAN) October 27, 2017 at the 7th Joint ECTRIMS-Americas Committee for Research and Treatment of Multiple Sclerosis (ACTRIMS) 2017 meeting in Paris.

AHA Scientific Statement on Management of Cardiogenic Shock The American Heart Association (AHA) has published a scientific statement on the contemporary management of cardiogenic shock October 17, 2017 in the journal Circulation describing the epidemiology, pathophysiology, and in-hospital management of cardiogenic shock.

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AROUND THE GLOBE IBS Patients may Benefit from Individualized Diets According to a new study reported online September 20, 2016 in BMJ Open Gastroenterology, People with IBS who went on customized diets that avoided foods with the potential to trigger symptoms felt better than patients whose diets included foods that were problematic for them

Study Shows Association of Atrial Fibrillation with High Free Thyroxine Levels Higher levels of free thyroxine (FT4) at baseline but within the normal range significantly increase the risk of new-onset atrial fibrillation, says a study reported online October 23, 2017 in Circulation. TSH at baseline was not significantly associated with incident AF in euthyroid participants or those with subclinical hypothyroidism.

Chances of Early Menopause More Likely in Underweight Women According to a new study published in the journal Human Reproduction, women who were underweight in early or mid-adulthood, especially those who reported severe weight cycling, had higher risk for early menopause compared to lean-normal weight women.

AAP Guidelines on Using the Medical Home to Care for Children with Congenital Heart Disease The AAP has published guidelines on care of children with congenital heart disease in their primary medical home online October 30, 2017 in the journal Pediatrics.

Some of the recommendations are: Promoting care coordination and communication between the family, primary care provider and subspecialists - especially during transition from hospital to home or from pediatric to adult care, encouraging caregivers to undergo CPR training for patients at increased risk of sudden death and promoting a lifestyle of good nutrition and physical activity in children and adolescents with congenital heart disease.

Study Recommends 45 Years as Cut-off Age to Start Screening for Colorectal Cancer A new study presented October 30, 2017 at the 25th UEG Week Barcelona recommends that screening for colorectal cancer (CRC) should begin at 45 years of age to match rising mortality rates in young adults. Analysis of more than 6,000 colonoscopies found a 400% increase in the detection of neoplasia in patients aged between 45-49 vs. those aged 40-44.

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Sickle Cell Anemia Treatment Does Not Increase Malaria Risk in Africa Hydroxyurea does not increase the risk of malaria infection in patients with sickle cell anemia who live in malaria-endemic regions, according to findings of the year-long Novel use of Hydroxyurea in an African Region with Malaria (NOHARM) trial published online October 19, 2017 in the journal Blood. No between-group differences in terms of incidence or severity of malaria infection or other adverse events were observed.

Children who received hydroxyurea also had lower rates of pain crises and hospitalizations.

Body Composition Influences QOL and Function in OA Patients As per results from the knee and hip osteoarthritis longterm assessment (KHOALA) cohort reported October 18, 2017 in the journal Seminars in Arthritis and Rheumatism, patients with osteoarthritis (OA) and normal body mass index (BMI) and low body lean mass had worse qualityof-life (QOL) and function than their counterparts with normal body mass. Conserving muscle mass may preserve function and gait in people with knee or hip OA, especially those with normal BMI.

Statins may Reduce Risk of S. aureus Bacteremia Use of statins was associated with a 27% lower risk of community-acquired Staphylococcus aureus bacteremia, especially in those patients who were using statins for long-term. These findings were published in the October 2017 issue of Mayo Clinic Proceedings. Higher doses were found to be associated with even greater protection.

AAP Encourages Use of Public Cord Blood Banks In a policy statement published online October 30, 2017, the AAP has called for renewed emphasis and education about the advantages and need for public cord blood banking. It recommends that physicians talk with families about donating cord blood during an early prenatal visit. The statement also discusses the differences between public cord blood banks vs. private, for profit cord blood banks. Public cord blood banks serve patients worldwide by matching individuals in need, while private banks store the cord blood for the donor family’s potential self use

US FDA Approves Rivaroxaban for Extended VTE Prevention The US FDA has approved the factor Xa oral anticoagulant rivaroxaban (Xarelto, Janssen) 10 mg once

AROUND THE GLOBE daily for reducing the ongoing risk for recurrent venous thromboembolism (VTE) following at least 6 months of initial anticoagulation therapy.

Long-term Weight Loss Intervention Increases Blood Flow in Brain Long-term weight loss intervention in overweight and obese adults with type 2 diabetes mellitus is associated with 6% greater overall cerebral blood flow, but in obese individuals with poor cognitive function, weight loss may impair neurovascular responses to increases in cerebral blood flow, according to analysis of data from the 10-year-long Action for Health in Diabetes (Look AHEAD) trial. The study was published online October 30, 2017 in the Journal of the American Geriatrics Society. Minimal or no association between cognitive performance and cerebral blood flow was found in these patients.

DK Crush Technique Reduces Target Lesion Failure in Complex Bifurcation Stenting Findings of the DKCRUSH-V trial presented at the Transcatheter Cardiovascular Therapeutics meeting in Denver show that a double kissing (DK) crush technique leads to better outcomes when stenting unprotected left main bifurcation lesions compared to provisional stenting. The primary endpoint of 1-year target lesion failure - cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization reduced by 58% with the DK crush technique.

Study Shows Fatty Liver Common in Hepatitis C Patients Following Treatment According to a study presented October 23, 2017 at the Liver Meeting 2017: American Association for the Study of Liver Diseases (AASLD) in Washington DC, 48% of hepatitis C patients showed evidence of steatosis posttreatment even after achieving a sustained virologic response with direct-acting antivirals. Of these, 6% had advanced fibrosis. The study authors recommend evaluation of such patients to detect nonalcoholic fatty liver disease (NAFLD) and progression of fibrosis.

Sugar-sweetened Drinks Increase Risk of Diabetes and Metabolic Syndrome A review of epidemiological studies published online November 2, 2017 in the Journal of the Endocrine Society has added to the growing evidence of the association of sugar-sweetened beverages with chronic lifestyle disorders such as type 2 diabetes, hypertension and heart disease.

The review, which examined the association of sugarsweetened beverages with type 2 diabetes, metabolic syndrome and hypertension, found that regularly drinking sugar-sweetened beverages such as soda and juice contributes to the development of type 2 diabetes and high blood pressure (BP). Most of the studies included in the review found that consumption of sugar-sweetened beverages also increased the risk of metabolic syndrome, which in turn increased the risk of developing heart disease, stroke and diabetes.

The review included 36 studies on the cardiometabolic effects of sugar-sweetened beverage consumption from the last 10 years.

Most of the analyzed studies for metabolic syndrome included individuals who drank more than five sugarsweetened beverages a week, while consuming as few as two servings of sugar-sweetened beverages a week increased the risk of developing type 2 diabetes.

Drinking at least one sugar-sweetened beverage a day was associated with high BP. These findings yet again highlight the need to educate the general public, the young in particular, about the adverse health effects of sugar-sweetened beverages, who frequently consume foods and drinks high in added sugars. It is very important therefore to raise awareness among the public about the lifestyle diseases prevalent in our country, which are now occurring at a younger age and the lifestyle measure by which these disease can be prevented.

(Source: Endocrine Society News Release, November 2, 2017)

WHO Publishes its Draft 13th General Program of Work: “Promote health, Keep the World Safe, Serve the Vulnerable” WHO has published its draft 13th General Program of Work (GPW13), which will be discussed at a special session of WHO’s Executive Board on 22 and 23 November, 2017. To continue the inclusive process of developing GPW13, these draft documents are now open for comment before November 15th. Feedback from Non-State Actors will be provided to WHO’s Executive Board to inform their deliberations. The Executive Board will further consider the GPW13 at its 142nd session to be held from 22-27 January 2018 and submit GPW13 to the World Health Assembly in May 2018. The Mission is to “Promote health, keep the world safe, serve the vulnerable”. The strategic priorities outlined in the draft include: Health coverage

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AROUND THE GLOBE (1 billion more people with health coverage), Health emergencies (1 billion more people made safer) and Health priorities (1 billion lives improved)… (WHO, November 1, 2017)

Greater BP Drops in Hypertensive Patients may Harm the Kidneys

rate in cholesterol as those with no history of coronary heart disease.

‘Morning larks’ have Weaker Nocturnal Sleep Spindles Activity During Night Than ‘Night Owls’

In individuals undergoing intensive BP treatment, greater reductions in mean BP were linked with an increased risk of kidney function decline, according to findings of a study published online November 3, 2017 in the Clinical Journal of the American Society of Nephrology (CJASN).

A new study published in Scientific Reports has shown that significantly weaker spindle activity among the morning preference group compared to other groups.

Sleep spindles are bursts of oscillatory brain activity visible on an EEG that occur mainly during stage 2 sleep. Sleep spindles are associated with sleep maintenance and strengthening of the memory traces during sleep.

10-year Fall in Blood Cholesterol of Heart Attack Patients Suggests Statin Impact

Lower Urinary Symptoms Common in Systemic Sclerosis Patients

A 10-year decline in the blood cholesterol of heart attack patients in Malaysia suggests that statins are having a positive impact, according to an observational study in nearly 49,000 patients presented November 3, 2017 at the ASEAN Federation of Cardiology Congress 2017 (AFCC 2017) in Brunei.

Acute coronary syndrome patients with a history of coronary heart disease had almost twice the declining

Self-reported lower urinary tract symptoms (LUTS) are amongst the most frequent symptoms in patients with systemic sclerosis and are associated with lower quality-of-life (QoL). The storage category of LUTS was the most prevalent (91.9%) followed by voiding (72.2%) and postmicturition symptoms (49.8%). The study was published online October 26, 2017 in the journal Arthritis Care and Research.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

Ind e ISS xed N 0 with 971 -08 IndME 76 D

Volume 1, Number 1

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Asian Journal of Diabetology

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Emerging role of Cardiac MRI in Ischemic and Non-ischemic Cardiomyopathy

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Acute Renal Failure and Silent Myocardial Infarction Following Multiple Honey Bee Stings

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Superficial Brachial Artery: Its Embryological and Clinical Significance

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Glucose Tolerance in Nondiabetic Patients after First Attack of Acute Myocardial Infarction and its Outcome

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A Case of Left Atrial Myxoma Presenting as Severe Pulmonary Hypertension

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Double-Chambered Right Ventricle with Transient 2:1 Atrioventricular Block: A Rare Presentation

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Cornary Artery Air Embolism

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Inspirational story

Depend on Miracles “You are never given a wish without also having been given the power to make it come true.”

O

ne Sunday morning I heard my minister say if you want result from prayer, pray for 30 days without ceasing. I didn’t know why it was 30 days, but I was willing to give it a try. The following became my daily prayer: I am available, Lord, to be used by You each day. Guide me, precious Lord, and lead me in what I say and do. May my words and actions be a witness that You are living in me. To the one that is lonely, may I be a friend. To those with heavy burdens, help me to meet their needs. Lord, I do not want fame or fortune. My prayer is that You will use me to glorify your name. I know I don’t have much to offer, but I will give You my all. Guide me to be what You want me to be. Amen

On the 21st day of this prayer, CPR took on a new meaning for me. I was working an extremely busy 12-hour night shift in Labor and Delivery. I had just sat down for my first break when a phone call came from my friend working in the Emergency Room (ER).

I barely recognized her urgent voice. An 18-year-old boy had been brought to the ER for alcohol and drug overdose. The young man was very close to death and they had done all they could do to help him. The father of this boy was requesting a priest or minister and they were having difficulty locating one that could come to the ER quickly. My friend stated, “We know you’re a Christian and we need you to come and try to comfort this father. Please help.”

Reluctantly, I said I would come down. As I waited for the elevator my thoughts became very judgmental and frustration welled up inside me. Then I remembered the prayer I’d been praying. I walked into the ER and approached the father. Taking his hand, I silently led him to the chapel. Before I could even say, “I am not a minister,” this six-foot, 220-pound man sank into the chair and became a broken hearted child.

Through his nonstop sobbing he spoke, “Christian, pray for Raymond. I remember the first time I held my boy. I felt so proud and I just kept saying, ‘I have a son.’ As the years passed those tiny feet became bigger and walked away from his family’s love and entered a strange, hardened, and destructive world. Tonight, too much alcohol and an overdose of drugs are taking his life. It’s as though he wants to rebel against everything his family stood for. He knew what he was doing was wrong. Sometimes, he seemed so afraid, but he wouldn’t stop. Now it is too late. Christian, you have to pray for Raymond.” Those large hands trembled in mine and as I looked into his eyes, I mourned with him.

Silence fell between us, as I searched for the words that would comfort this crumbling tower of a man. I felt so inadequate. I wanted to scream, “Lord it has only been 21 days since I began that prayer! I am not ready for this!”

Time was running out and I knew I couldn’t stall any longer. I clutched his hands, now wet with tears, and began to pray. The words came easy, much to my surprise. I finished praying with him and went to Raymond’s bedside. I took his cold, lifeless hand and once again began to pray. “Lord I am asking for a miracle and I know you can do it.”

I stayed with them both until Raymond was taken to Intensive Care. I visited Raymond on a daily basis and continued to pray for him. Eight days passed with little improvement. On the ninth day I entered the ICU and a miracle had taken place. Raymond was awake and talking with his father. CPR had taken on a new meaning for me: “Christian Pray for Raymond”. As I left the ICU with tears falling down my face, I realized, today is the 30th day of my prayer.

Now I not only believe in miracles, I depend on them.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

—Richard Bach

lighter reading

A Following Person

Laundry

A teacher was sitting at her desk grading papers when her first-grade class came back from lunch.

Alice informed the teacher, “Paul has to go to the principal’s office.”

One day, a housework-challenged husband decided to wash his sweatshirt. Seconds after he stepped into the laundry room, he shouted to his wife, “What setting do I use on the washing machine?”

“I wonder why,” the teacher mused.

“Because he’s a following person,” Alice replied.

“A what?” the teacher asked.

“It came over the loudspeaker: ‘The following persons are to go to the office’.”

“It depends,” she replied. “What does it say on your shirt?”

He yelled back, “Texas A & M.” Funny Questions and Answers

Saturday and Sunday are holidays

What is the opposite of ‘Dominos’?

Teacher: This is the fifth time this week that I have had to punish you. What do you have to say?

Think...

Student: “Thank God, Saturday and Sunday are holidays, Sir!” The Lecture A man is stopped by the police at midnight and asked where he’s going.

“I’m on the way to listen to a lecture about the effects of alcohol and drug abuse on the human body.”

The policeman asks, “Really? And who’s going to give a lecture at this time of night?”

“My wife”, he replied.

Tired?

“Domi doesn’t know”

Dr. Good and Dr. Bad Situation: A type 2 diabetic patient was asked to take

probiotics.

Probiotics are not useful in diabetic patients

They may help in improving diabetes

Threatening Letters The fellow stormed into the postmaster’s office in a fury. “I’ve been getting threatening letters in the mail for months and I want them stopped.”

“Of course,” said the postmaster. “Sending threatening letters through the mail is a federal offence. Do you know who’s sending them?”

“Yes,” shouted the man. “It’s those idiots down at the Internal Revenue Service.”

© IJCP Academy

HUMOR

Lighter Side of Medicine

Lesson: Probiotics have emerged as a beneficial

option for T2DM patients as they help in lowering glucose and HbA1c levels and also exert a positive impact on insulin levels.

J Pediatr Endocrinol Metab. 2017;30(6):611-22.

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–

Title page Should contain the title, short title, names of all the authors (without degrees or diplomas), names and full location of the departments and institutions where the work was performed,

– These should be concise and include only the tables and figures necessary to enhance the understanding of the text.

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Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

Confidence intervals for the measurements should be provided wherever appropriate.

Results

Discussion –

This should consist of a review of the literature and relate the major findings of the article to other publications on the subject. The particular relevance of the results to healthcare in India should be stressed, e.g., practicality and cost.

References These should conform to the Vancouver style. References should be numbered in the order in which they appear in the texts and these numbers should be inserted above the lines on each occasion the author is cited (Sinha12 confirmed other reports13,14...). References cited only in tables or in legends to figures should be numbered in the text of the particular table or illustration. Include among the references papers accepted but not yet published; designate the journal and add ‘in press’ (in parentheses). Information from manuscripts submitted but not yet accepted should be cited in the text as ‘unpublished observations’ (in parentheses).

At the end of the article the full list of references should include the names of all authors if there are fewer than seven or if there are more, the first six followed by et al., the full title of the journal article or book chapters; the title of journals abbreviated according to the style of the Index Medicus and the first and final page numbers of the article or chapter. The authors should check that the references are accurate. If they are not this may result in the rejection of an otherwise adequate contribution.

Examples of common forms of references are: Articles Paintal AS. Impulses in vagal afferent fibres from specific pulmonary deflation receptors. The response of those receptors to phenylguanide, potato S-hydroxytryptamine and their role in respiratory and cardiovascular reflexes.

Q. J. Expt. Physiol. 1955;40:89-111.

Figures – Two complete sets of glossy prints of high quality should be submitted. The labelling must be clear and neat.

– All photomicrographs should indicate the magnification of the print.

– Special features should be indicated by arrows or letters which contrast with the background.

– The back of each illustration should bear the first author’s last name, figure number and an arrow indicating the top. This should be written lightly in pencil only. Please do not use a hard pencil, ball point or felt pen.

– Color illustrations will be accepted if they make a contribution to the understanding of the article.

–

Do not use clips/staples on photographs and artwork.

–

Illustrations must be drawn neatly by an artist and photographs must be sent on glossy paper. No captions should be written directly on the photographs or illustration. Legends to all photographs and illustrations should be typed on a separate sheet of paper. All illustrations and figures must be referred to in the text and abbreviated as “Fig.”.

Please complete the following checklist and attach to the manuscript: 1. Classification (e.g. original article, review, selected summary, etc.)_______________________________ 2. Total number of pages ________________________ 3. Number of tables ____________________________ 4. Number of figures ___________________________

Books

5. Special requests _____________________________

Stansfield AG. Lymph Node Biopsy Interpretation Churchill Livingstone, New York 1985.

6. Suggestions for reviewers (name and postal address)

Articles in Books

2.____________ 2.________________

Strong MS. Recurrent respiratory papillomatosis. In: Scott Brown’s Otolaryngology. Paediatric Otolaryngology Evans JNG (Ed.), Butterworths, London 1987;6:466-470.

3.____________ 3.________________

4.____________ 4.________________

Tables –

These should be typed double spaced on separate sheets with the table number (in Roman Arabic numerals) and title above the table and explanatory notes below the table.

Legends – These should be typed double spaces on a separate sheet and figure numbers (in Arabic numerals) corresponding with the order in which the figures are presented in the text.

–

The legend must include enough information to permit interpretation of the figure without reference to the text.

Indian 1.____________Foreign 1.________________

7. All authors’ signatures________________________ 8.

Corresponding author’s name, current postal and e-mail address and telephone and fax numbers __________________________________________

Online Submission Also e-Issue @ www.ijcpgroup.com For Editorial Correspondence

Dr KK Aggarwal

Group Editor-in-Chief Indian Journal of Clinical Practice E-219, Greater Kailash Part-1 New Delhi - 110 048. Tel: 40587513 E-mail: editorial@ijcp.com Website: www.ijcpgroup.com

Indian Journal of Clinical Practice, Vol. 28, No. 6, November 2017

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R.N.I. No. 50798/1990 Date of Publication 13th of Same Month Date of Posting 13-14 Same Month

POSTAL REGISTRATION NO. DL (S)-01/3200/2015-2017 Posted in N.D. PSO New Delhi