Indian journal of clinical practice march 2015 by IJCP

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Volume 25, Number 10

March 2015, Pages 901â&#x20AC;&#x201C;1000

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IJCP Group of Publications Dr Sanjiv Chopra Prof. of Medicine & Faculty Dean Harvard Medical School Group Consultant Editor Dr Deepak Chopra Chief Editorial Advisor Padma Shri, Dr BC Roy & National Science Communication Awardee

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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 ENT Dr Jasveer Singh Dr Chanchal Pal Dentistry Dr KMK Masthan Dr Rajesh Chandna Gastroenterology Dr Ajay Kumar Dr Rajiv Khosla Dermatology Dr Hasmukh J Shroff Dr Pasricha Dr Koushik Lahiri Nephrology Dr Georgi Abraham Neurology Dr V Nagarajan Dr Vineet Suri Journal of Applied Medicine & Surgery Dr SM Rajendran, Dr Jayakar Thomas Orthopedics Dr J Maheshwari

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Volume 25, Number 10, March 2015 FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

906 Are you Being Blamed of Commercialization?

AMERICAN FAMILY PHYSICIAN

907 Thyroiditis: An Integrated Approach

Lori B. Sweeney, Christopher Stewart, David Y. Gaitonde

914 Practice Guidelines 916 Photo Quiz ANESTHESIOLOGY

918 Bleeding Complication During Emergency LSCS: HELLP Syndrome

Preeti Ganpat More, Tejasi Santosh Waigankar, Janhavi J Pol

921 Diagnosed and Suspected Extrapulmonary Tuberculosis: A Study on Response to Anesthesia

Jayashree Sen, Bitan Sen

CARDIOLOGY

927 Affect and Coping Mechanisms Among Coronary Heart Disease Patients

Pooja Bhatnagar Varma, Waheeda Khan

934 Impact of Vitamin D Supplementation on Lipid Profile and Clinical Status in Coronary Artery Disease Patients

Jigna Shah, Ashvini Soni, Drasty Vora, Ninad Badrakia, Kamal Sharma

COMMUNITY MEDICINE

947 Validation of Postnatal Care Health Data Reported Under Health Management Information System by the Primary Health Centers of Rural Vadodara, Gujarat

Sangita V Patel, Harsh Bakshi, Dhara Zalavadiya, Prakash Kotecha

CRITICAL MEDICINE

958 Incidence, Susceptibility Profiles and Risk Factors of Multidrug-resistant Nonfermenting Gram-negative Bacilli Causing Ventilator-associated Pneumonia in a Tertiary Care Hospital

Kalidas Rit, Bipasa Chakraborty, Udayan Majumder, Parthasarathi Chakrabarty, Saswati Chattopadhyay, Hirak Jyoti Raj

GASTROENTEROLOGY

962 Mutton Bone Ingestion Complicated by Terminal Î&#x2122;leum Perforation

Non-Resident Indians Chamber of Commerce & Industry World Fellowship of Religions

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KK Aggarwal

D Gopal Rao, K Suryanarayana, T Srinivas, K Raghu, Satish, R Naga S Ashok, Yamuna, Nyna Sindhu

OBSTETRICS AND GYNECOLOGY

965 A Laparoscopic Surprise

Shweta Suryaraj, MG Dhanalakshmi

968 Rapidly Progressing Tuboovarian Abscess in a Young Woman

Seetha Mohan, Jaya Vijayaraghavan

OBSTETRICS AND GYNECOLOGY 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

970 Effects of Intrathecal Midazolam with Bupivacaine on Postoperative Analgesia Following Cesarean Delivery and Neonatal Outcome

Amitava Pal, Debasis Saha, Sarbari Swaika, Sumanta Ghosh Maulik, Sibram Chatterjee, Rupali Modak

974 A Study of Antepartum Cardiotocography in Mothers with

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Reduced Fetal Movement at Term and its Correlation with Fetal Outcome

Monalisa Neogi, Tapan Kumar Lahiri, Bandana Biswas, Tarasankar Bag, Pallab Kumar Mistri, Avishek Bhadra

OPHTHALMOLOGY

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.

979 External Ophthalmomyiasis Due to Oestrus ovis: A Case Report

Sumangala B, Tejashree

PEDIATRICS

Editorial Policies

981 Freeman-Sheldon Syndrome with Pulmonary Hypoplasia: A Rare Case Report

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.

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IMAGE AND INVESTIGATION

984 Porencephalic Cyst

Monika Maheshwari

AROUND THE GLOBE

985 News and Views MEDILAW

989 Ethical Advertising and Doctor Pharma Relationship

KK Aggarwal

INSPIRATIONAL STORY

993 Be Content About Your Life LIGHTER READING

994 Lighter Side of Medicine

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FROM THE DESK OF THE GROUP EDITOR-IN-CHIEF

Prof. Dr KK Aggarwal

Padma Shri, Dr BC Roy & National Science Communication Awardee Sr. Physician and Cardiologist, Moolchand Medcity President, Heart Care Foundation of India Group Editor-in-Chief, IJCP Group and eMedinewS

Are you Being Blamed of Commercialization? Most doctors are honest. It’s only a minority who bring a bad name to the entire profession. In one of its judgments, the Supreme Court of India has observed: 27. “On the other hand, we have the Doctors, hospitals, nursing homes and clinics in the private commercial sector. There is a general perception among the middle class public that these private hospitals and doctors prescribe avoidable costly diagnostic procedures and medicines, and subject them to unwanted surgical procedures, for financial gain. The public feel that many doctors who have spent a crore or more for becoming a specialist, or nursing homes which have invested several crores on diagnostic and infrastructure facilities, would necessarily operate with a purely commercial and not service motive; that such doctors and hospitals would advise extensive costly treatment procedures and surgeries, where conservative or simple treatment may meet the need and that what used to be a noble service oriented profession is slowly, but steadily converting into a purely business.” 28. “But unfortunately not all doctors in government hospitals are paragons of service, nor fortunately, all private hospitals/doctors are commercial minded. There are many a doctor in government hospitals who do not care about patients and unscrupulously insist upon ‘unofficial’ payment for free treatment or insist upon private consultations. On the other hand, many private hospitals and Doctors give the best of treatment without exploitation, at a reasonable cost, charging a fee, which is reasonable recompense for the service rendered. Of course, some doctors, both in private practice or in government service, look at patients not as persons who should be relieved from pain and suffering by prompt and proper treatment at an affordable cost, but as potential income-providers/customers who can be exploited by prolonged or radical diagnostic and treatment procedures. It is this minority who bring a bad name to the entire profession.” REFERENCE 1. SCI Appeal (Civil) No. 1949 of 2004, 16.01.2008, Samira Kohli vs Dr. Prabha Manchanda and Anr. Bench: B.N. Agrawal, P.P. Naolekar and R.V. Raveendran. ■■■■

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AMERICAN FAMILY PHYSICIAN

Thyroiditis: An Integrated Approach LORI B. SWEENEY, CHRISTOPHER STEWART, DAVID Y. GAITONDE

ABSTRACT Thyroiditis is a general term that encompasses several clinical disorders characterized by inflammation of the thyroid gland. The most common is Hashimoto thyroiditis; patients typically present with a nontender goiter, hypothyroidism, and an elevated thyroid peroxidase antibody level. Treatment with levothyroxine ameliorates the hypothyroidism and may reduce goiter size. Postpartum thyroiditis is transient or persistent thyroid dysfunction that occurs within one year of childbirth, miscarriage, or medical abortion. Release of preformed thyroid hormone into the bloodstream may result in hyperthyroidism. This may be followed by transient or permanent hypothyroidism as a result of depletion of thyroid hormone stores and destruction of thyroid hormoneâ&#x20AC;&#x201C;producing cells. Patients should be monitored for changes in thyroid function. Beta blockers can treat symptoms in the initial hyperthyroid phase; in the subsequent hypothyroid phase, levothyroxine should be considered in women with a serum thyroid-stimulating hormone level greater than 10 mIU per L, or in women with a thyroid-stimulating hormone level of 4 to 10 mIU per L who are symptomatic or desire fertility. Subacute thyroiditis is a transient thyrotoxic state characterized by anterior neck pain, suppressed thyroid-stimulating hormone, and low radioactive iodine uptake on thyroid scanning. Many cases of subacute thyroiditis follow an upper respiratory viral illness, which is thought to trigger an inflammatory destruction of thyroid follicles. In most cases, the thyroid gland spontaneously resumes normal thyroid hormone production after several months. Treatment with high-dose acetylsalicylic acid or nonsteroidal anti-inflammatory drugs is directed toward relief of thyroid pain.

Keywords: Thyroiditis, Hashimoto thyroiditis, hypothyroidism, levothyroxine, nonsteroidal anti-inflammatory drugs

hyroiditis is a general term that refers to inflammation of the thyroid gland and encompasses several clinical disorders. The family physician will most commonly diagnose thyroiditis because of abnormal results on thyroid function testing in a patient with symptoms of thyroid dysfunction or anterior neck pain. The diagnosis of chronic autoimmune thyroiditis (Hashimoto thyroiditis) is usually straightforward. Patients typically present with a nontender goiter, symptoms of hypothyroidism, and elevated thyroid peroxidase (TPO) antibody level. However, a diagnostic dilemma occurs when the patient presents with thyroid-stimulating hormone (TSH) suppression. The natural history of postpartum, silent, or subacute thyroiditis may include a hyperthyroid or

LORI B. SWEENEY, MD, is an associate professor of medicine at Virginia Commonwealth University Health System in Richmond. At the time this article was written, she was a staff endocrinologist at the Dwight D. Eisenhower Army Medical Center in Fort Gordon, Ga. CHRISTOPHER STEWART, MD, is a staff internist at Bayne-Jones Army Community Hospital in Fort Polk, La. At the time this article was written, he was a resident in the internal medicine program at the Dwight D. Eisenhower Army Medical Center. DAVID Y. GAITONDE, MD, is chief of endocrinology and metabolism at the Dwight D. Eisenhower Army Medical Center. Source: Adapted from Am Fam Physician. 2014;90(6):389-396.

toxic phase of short duration, followed by transient or permanent hypothyroidism. When hyperthyroidism does not match the clinical picture, several steps should be taken. First, the laboratory test result should be confirmed, and free thyroxine (T4) and free triiodothyronine (T3) levels should be measured. Second, the laboratory test result should be interpreted within the context of the medical status of the patient. Patients recovering from recent illness or those taking drugs such as glucocorticoids or opiates may have suppressed TSH, but free thyroid hormone levels will be normal or low. Third, the degree of hyperthyroidism and the severity of symptoms should be considered. Patients with overt hyperthyroidism (suppressed TSH and elevated free thyroid hormone levels) and significant symptoms can be treated with beta blockers, regardless of the etiology. Fourth, the physician should attempt to differentiate between Graves disease and other forms of thyroiditis, because patients with Graves disease are candidates for thionamide therapy. This differentiation is best made by measuring radioactive iodine uptake on a thyroid scan. In the case of postpartum, silent, or subacute thyroiditis, the radioactive iodine uptake during the hyperthyroid phase will be low. Most of these patients will have recovery of euthyroidism, but some may

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AMERICAN FAMILY PHYSICIAN benefit from treatment aimed at relieving symptoms of hyperthyroidism or hypothyroidism, provided they are monitored for anticipated changes in thyroid function. Surveillance and clinical follow-up are necessary in all forms of thyroiditis because of the potential for change in thyroid status. Treatment with levothyroxine may result in iatrogenic hyperthyroidism. Table 1 summarizes key aspects of thyroiditis, including less

common forms. Table 2 summarizes drugs associated with thyroiditis.1-8 Figure 1 is an algorithm for the diagnosis of thyroiditis.9 CHRONIC AUTOIMMUNE THYROIDITIS Chronic autoimmune thyroiditis (Hashimoto thyroiditis) is the most common form. It is characterized by

Table 1. Thyroiditis Subtypes Type

Presentation

Etiology

Chronic autoimmune thyroiditis (Hashimoto thyroiditis, chronic lymphocytic thyroiditis)

Hypothyroidism; rarely thyrotoxicosis secondary to alternating stimulating and inhibiting thyroid autoantibodies

Autoimmune

Infectious thyroiditis (suppurative thyroiditis)

Thyroid pain, high fever, leukocytosis, and cervical lymphadenopathy; focal inflammation may result in compressive symptoms such as dysphonia or dysphagia; patients may assume a posture to limit neck extension; palpation may reveal focal or diffuse swelling of the thyroid gland and the overlying skin will be warm and erythematous; presence of fluctuance suggests abscess formation

Multiple infectious organisms, most commonly bacterial Streptococcus pyogenes; Staphylococcus aureus and Pneumococcus are among the most common isolates

Postpartum thyroiditis

Hyperthyroidism alone; hyperthyroidism followed by hypothyroidism; or hypothyroidism alone within one year of parturition

Autoimmune

Radiation-induced thyroiditis†

Patients may present with thyroid pain and transient thyrotoxicosis

Radiation

Riedel thyroiditis (fibrous thyroiditis)‡

Very firm goiter or compressive symptoms (dyspnea, stridor, dysphagia), which appear disproportionate to the size of the thyroid; hypocalcemia may occur as a result of fibrotic transformation of the parathyroid glands

Autoimmunity may contribute to the pathogenesis

Silent thyroiditis (silent sporadic thyroiditis, painless sporadic thyroiditis, subacute lymphocytic thyroiditis)

Hyperthyroidism alone; hyperthyroidism followed by hypothyroidism; or hypothyroidism alone

Autoimmune

Thyroid pain; hyperthyroidism followed by transient Subacute thyroiditis (subacute granulomatous hypothyroidism most commonly thyroiditis, giant cell thyroiditis, de Quervain thyroiditis)

Postviral

TPO = Thyroid peroxidase. *A thyroid scan with radioactive iodine uptake is contraindicated during pregnancy or breastfeeding. †Typically occurs within one week of iodine 131 therapy. ‡Destructive thyroiditis characterized by dense fibrosis, which can extend beyond the thyroid gland into adjacent tissues.

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AMERICAN FAMILY PHYSICIAN varying degrees of lymphocytic infiltration and fibrotic transformation of the thyroid gland. Patients typically present with a nontender goiter, hypothyroidism, and an elevated TPO antibody level. It can, however, present without a goiter (atrophic form). The atrophic form represents extensive thyroid fibrosis and is more likely to result in overt hypothyroidism. A family or personal history of autoimmune thyroid disease

confers increased risk, and there is a strong female predominance in this disorder. Higher rates of chronic autoimmune thyroiditis have been observed in patients with type 1 diabetes mellitus, Turner syndrome, Addison disease, and untreated hepatitis C.10-12 The annual incidence of chronic autoimmune thyroiditis is estimated to be 0.3 to 1.5 cases per 1,000 persons.13 Presenting symptoms depend on the degree

Diagnosis

Complications

Therapy

Presence of nontender goiter; thyroid function tests; elevated TPO antibody levels

Hypothyroidism is usually permanent

Levothyroxine

Thyroid fine-needle aspiration with Gram stain and culture; blood cultures; neck magnetic resonance imaging or computed tomography with contrast media; plain radiography of the lateral neck may reveal gas in the soft tissues; thyroid autoantibodies are generally absent; serum thyroxine and triiodothyronine levels are usually normal

Acute complications may include septicemia and acute airway obstruction; later sequelae of the acute infection may include transient hypothyroidism or vocal cord paralysis

Hospitalization and treatment with intravenous antibiotics (nafcillin plus gentamicin or a third-generation cephalosporin); abscess formation may necessitate surgical drainage; euthyroidism is generally restored after treatment of infection

Thyroid function tests; elevated TPO antibody levels; low radioactive iodine uptake in the hyperthyroid phase*

Euthyroidism is generally achieved by 18 months, but up to 25% of women become permanently hypothyroid; high rate of recurrence with subsequent pregnancies

Beta blockers can be considered for significant hyperthyroid symptoms (in the hyperthyroid phase); levothyroxine for symptomatic hypothyroidism (in the hypothyroid phase) and for permanent hypothyroidism

Clinical diagnosis made in the setting of recent previous radiation

Hyperthyroidism generally resolves within one month

Self-limited, but symptoms may be treated with beta blockers and nonsteroidal antiinflammatory drugs

Thyroid biopsy

Most patients are euthyroid, approximately 30% are hypothyroid

Glucocorticoids and mycophenolate (Cellcept); tamoxifen may work by inhibiting fibroblast proliferation

Thyroid function tests; elevated TPO antibody levels; low radioactive iodine uptake in the hyperthyroid phase

Euthyroidism is generally achieved by 18 months, but up to 11% of patients become permanently hypothyroid; rarely recurs

Beta blockers can be considered for significant hyperthyroid symptoms (in the hyperthyroid phase); levothyroxine for symptomatic hypothyroidism (in the hypothyroid phase) and permanent hypothyroidism

Thyroid function tests; elevated TPO antibody levels; low radioactive iodine uptake in the hyperthyroid phase

Euthyroidism is generally achieved by 18 months, but up to 15% of patients become permanently hypothyroid; rarely recurs

Beta blockers can be considered for significant hyperthyroid symptoms (in the hyperthyroid phase); levothyroxine for symptomatic hypothyroidism (in the hypothyroid phase) and permanent hypothyroidism

Presence of an elevated TPO antibody level confers risk for many types of thyroid dysfunction and is a general marker of thyroid autoimmunity; a frankly elevated TPO antibody level is more specific for Hashimoto thyroiditis

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AMERICAN FAMILY PHYSICIAN Table 2. Drugs Associated with Thyroiditis Drug

Use

Thyroid function

Mechanism

Amiodarone

Atrial fibrillation, ventricular arrhythmia

Hypo- or hyperthyroidism

In type 1 amiodarone-induced thyrotoxicosis there is increased synthesis of thyroid hormone (usually in patients with preexisting goiter) In type 2 amiodarone-induced thyrotoxicosis there is excess release of thyroxine and triiodothyronine into the circulation caused by destructive thyroiditis Type 1 is treated with antithyroid medications (thioureas) and type 2 is treated with glucocorticoids; in both cases, beta blockers can be used for symptoms of hyperthyroidism1,2

Denileukin

Persistent or recurrent cutaneous T cell lymphoma, psoriasis, graft-versus-host disease, chronic lymphocytic leukemia

Hyperthyroidism

Unknown3

Interferon alfa

Hairy cell leukemia, follicular lymphoma, malignant melanoma, AIDS-related Kaposi sarcoma, chronic hepatitis B and C

Hypo- or hyperthyroidism

Autoimmune4

Interleukin-2

Renal cell carcinoma, melanoma

Hypothyroidism more often than hyperthyroidism

Autoimmune5

Kinase inhibitors

Gastrointestinal stromal tumors, renal cell carcinoma

Hypothyroidism

Inhibition of uptake by the thyroid6

Lithium

Depression, bipolar disorders

Hypothyroidism more often than hyperthyroidism

Autoimmune7,8

Information from references 1 through 8.

of associated thyroid dysfunction, but most commonly include a feeling of fullness in the neck, generalized fatigue, weight gain, cold intolerance, and diffuse muscle pain. When chronic autoimmune thyroiditis is suspected, the family physician should perform a careful thyroid examination and measure serum TSH and TPO antibody levels. An elevated TPO antibody level may influence the decision to treat patients with subclinical hypothyroidism. The thyroid examination will commonly reveal a firm, bumpy gland with symmetric enlargement. TPO antibodies will be present in 90% of affected persons. The mere presence of detectable TPO antibodies does not, however, necessitate empiric treatment with thyroid hormone. Patients with overt hypothyroidism (elevated TSH and low free T4 levels) should be treated with levothyroxine to a goal TSH level of 1 to 3 mIU per L. A starting dosage of 1.6 mcg per kg

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per day can be initiated, with subsequent incremental changes made every 10 to 12 weeks to achieve this goal. Thyroid hormone therapy should resolve hypothyroid symptoms and may result in a reduction in goiter size. This generally occurs within six months after achievement of euthyroidism. Treatment with thyroid hormone in patients with elevated TPO antibody levels and subclinical hypothyroidism (TSH level greater than the upper limit of the reference range, but less than 10 mIU per L) is reasonable, especially if symptoms of hypothyroidism are present. Dosages of 25 to 50 mcg per day of levothyroxine can be initiated in these patients and titrated to the same TSH goals as in overt hypothyroidism. If no thyroid hormone is administered, patients should be monitored annually for the development of overt hypothyroidism.12 Guidelines exist to direct the family physician in the

AMERICAN FAMILY PHYSICIAN treatment of women with detectable TPO antibodies who are pregnant or who desire fertility.14,15 POSTPARTUM THYROIDITIS Postpartum thyroiditis is transient or persistent thyroid dysfunction that occurs within one year of parturition, miscarriage, or medical abortion. The timing likely reflects a rebound in immune function after a period of relative immune tolerance during pregnancy. In the United States, the prevalence ranges from 1.1% to 9%.16 Postpartum thyroiditis is now considered an unmasking or acute presentation of underlying chronic thyroid autoimmune disease. Like Hashimoto thyroiditis, postpartum thyroiditis is characterized by an elevated TPO antibody level, but the clinical presentation is more variable. In the case of postpartum thyroiditis, immune-mediated thyroid destruction may result in the release of preformed thyroid hormone into the bloodstream, causing hyperthyroidism. This may be followed by transient or permanent hypothyroidism as a result of depletion of thyroid hormone stores and destruction of thyroid hormoneâ&#x20AC;&#x201C;producing cells. Typically, the hyperthyroid phase occurs one to six months postpartum and persists for one to two months.17 The symptoms of hyperthyroidism overlap with those of Graves disease, but tend to be milder. Women typically present with palpitations, irritability, and heat intolerance. Graves disease may be differentiated from postpartum thyroiditis by the presence of exophthalmos, thyroid bruit, and positive TSH receptor antibody. Radioactive iodine uptake during the hyperthyroid phase of postpartum thyroiditis will be low (1% to 2% at 24 hours), as opposed to Graves disease, in which uptake is high. Postpartum hyperthyroidism and Graves disease are characterized by elevated free thyroid hormones and suppressed TSH; however, postpartum thyroiditis has a lower free T3 to free T4 ratio, because free T4 is the predominant form of thyroid hormone produced by the thyroid gland, and thereby is released into the bloodstream secondary to glandular inflammation and destruction. As such, antithyroid medications (thioureas) are ineffective for postpartum thyroiditis. Treatment with beta blockers (propranolol, 10 to 20 mg four times per day) may be initiated in symptomatic women and is acceptable in those who are breastfeeding.18 Therapy is usually required for only one to three months, and patients can be tapered off medication fairly quickly. In postpartum thyroiditis, the hypothyroid phase generally presents at four to eight months postpartum and lasts four

to six months, although permanent hypothyroidism occurs in 25% of women.17 The presenting symptoms typically include fatigue, cognitive dysfunction (or depression), and cold intolerance. Although most women with postpartum thyroiditis will become euthyroid, treatment with levothyroxine should be considered in women with a serum TSH level greater than 10 mIU per L, or in women with a TSH level of 4 to 10 mIU per L who are symptomatic or desire fertility. Treatment with levothyroxine is generally initiated at 50 mcg per day and titrated to achieve a TSH level between 1 and 2.5 mIU per L. Given the natural course of postpartum thyroiditis, tapering of levothyroxine may be considered after 12 months of therapy.17 This may be accomplished by reducing the dose by 50% and repeating thyroid function testing at four- to eightweek intervals.17 Alternatively, it is reasonable to continue levothyroxine therapy during a womanâ&#x20AC;&#x2122;s reproductive years, given the potential adverse effects of maternal hypothyroidism and the high likelihood of recurrence of postpartum thyroiditis, which approaches 70% with subsequent pregnancies.17 Hypothyroidism that occurs beyond one year postpartum should not be classified as postpartum thyroiditis. Women with postpartum thyroiditis and subclinical hypothyroidism should be treated with levothyroxine to achieve a TSH level of less than 2.5 mIU per L if they are pregnant or desire fertility.15 SILENT THYROIDITIS Silent thyroiditis is similar to postpartum thyroiditis, but its presentation is not limited to the postpartum state. Patients may present in the hypothyroid or hyperthyroid phase. In contrast with postpartum thyroiditis, silent thyroiditis is less likely to result in permanent hypothyroidism (up to 11% of patients), and recurrence is less common.19 The considerations for initiation of therapy and the treatment approach are the same as for postpartum thyroiditis. SUBACUTE THYROIDITIS Subacute thyroiditis is a transient thyrotoxic state characterized by anterior neck pain, suppressed TSH, and low uptake of iodine 123 on thyroid scanning. Patients may also have typical symptoms of hyperthyroidism.20,21 Many cases of subacute thyroiditis follow an upper respiratory viral illness, which is thought to trigger an inflammatory destruction of thyroid follicles. As in other forms of destructive thyroiditis, preformed thyroid hormone is released

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AMERICAN FAMILY PHYSICIAN into the blood, leading to increased levels of thyroid hormone and suppressed TSH.

five to seven days of high-dose prednisone, the dose is then tapered over the next 30 days.

There are few large epidemiologic studies on subacute thyroiditis; however, one large community-based study performed in Olmstead County, Minn., between 1960 and 1997 reported an incidence of 4.9 cases per 100,000 persons per year.20 Women are significantly more likely to be affected than men, and the peak incidence in both sexes occurs at 40 to 50 years of age.20,21 Cases of subacute thyroiditis generally cluster in the late summer and fall.20,21 An increased association of subacute thyroiditis in persons with HLA-B35 is well established.22-24 Anterior neck pain in the area of the thyroid bed is the cardinal feature of subacute thyroiditis and is most often what prompts patients to seek medical attention. The neck pain may be bilateral or unilateral, and may radiate to the jaw.20,21,25 Dysphagia is also reported by patients, with increased sweating, tremor, and weight loss. Up to one-fourth of patients report symptoms of an upper respiratory infection in the 30 days before initial presentation.20,21 The thyroid may also be diffusely enlarged. Other signs of thyrotoxicosis such as fever, tachycardia, tremor, and increased skin warmth may be present.

Thyroid hormone supplementation is generally not necessary for the transient hypothyroid phase of subacute thyroiditis unless patients are symptomatic or have clear signs of hypothyroidism. Permanent hypothyroidism is uncommon but is reported to develop in up to 15% of patients with subacute thyroiditis, and can develop more than one year following presentation.20 It should be noted that the use of corticosteroids is not associated with a lower incidence of permanent hypothyroidism.20 Rarely, patients may experience recurrent episodes of subacute thyroiditis. There is no role for antibiotics in the treatment of subacute thyroiditis, and referral for thyroidectomy is not warranted.25 The differential diagnosis for thyroid bed pain includes hemorrhage into a thyroid cyst and acute infectious or suppurative thyroiditis. Thyroid ultrasonography in subacute thyroiditis shows a nonuniform echotexture, hypoechoic areas, and decreased vascularity throughout the gland. In contrast, acute thyroid hemorrhage and acute infectious thyroiditis will show a focal cystic and/or solid mass in the region of the thyroid bed pain. Patients with severe thyroid pain and systemic symptoms (e.g., high fever, leukocytosis, cervical lymphadenopathy) should undergo fine-needle aspiration to rule out infectious thyroiditis.26

In the thyrotoxic phase, thyroid function tests show suppressed TSH and free T4 and free T3 levels that are within the normal range or frankly elevated. If the patient presents beyond the thyrotoxic phase, which typically lasts four to eight weeks, TSH and free T4 levels may be low. Supporting laboratory data include an elevated erythrocyte sedimentation rate, C-reactive protein level, and thyroglobulin level. A thyroid scan with radioactive iodine uptake is the preferred imaging test to determine the cause of low TSH levels. During the thyrotoxic phase of subacute thyroiditis, this test shows a low uptake of iodine (less than 1% to 2%). Subacute thyroiditis is self-limited, and in most cases the thyroid gland spontaneously resumes normal thyroid hormone production after several months. Treatment, therefore, is directed toward relief of thyroid pain. High-dose acetylsalicylic acid or nonsteroidal antiinflammatory drugs are usually the first-line treatment.25 There are no randomized controlled trials comparing doses or agents. Aspirin (2,600 mg per day in divided doses) or ibuprofen (3,200 mg per day in divided doses) is appropriate. If the neck pain is not improved after four days, or if the patient presents with severe neck pain, then corticosteroids can be considered.25 In one study, the mean starting dosage was 40 mg of prednisone per day.20 Pain should rapidly improve within two days with use of prednisone. After

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Note: For complete article visit: www.aafp.org/afp. REFERENCES 1. Pearce EN, Farwell AP, Braverman LE. Thyroiditis [published correction appears in N Engl J Med. 2003;349(6):620]. N Engl J Med. 2003;348(26):2646-2655. 2. Harjai KJ, Licata AA. Effects of amiodarone on thyroid function. Ann Intern Med. 1997;126(1):63-73. 3. Ghori F, Polder KD, Pinter-Brown LC, et al. Thyrotoxicosis after denileukin diftitox therapy in patients with mycosis fungoides. J Clin Endocrinol Metab. 2006;91(6):2205-2208. 4. Deutsch M, Dourakis S, Manesis EK, et al. Thyroid abnormalities in chronic viral hepatitis and their relationship to interferon alfa therapy. Hepatology. 1997;26(1):206-210. 5. Schwartzentruber DJ, White DE, Zweig MH, Weintraub BD, Rosenberg SA. Thyroid dysfunction associated with immunotherapy for patients with cancer. Cancer. 1991;68(11):2384-2390. 6. Mannavola D, Coco P, Vannucchi G, et al. A novel tyrosine-kinase selective inhibitor, sunitinib, induces transient hypothyroidism by blocking iodine uptake. J Clin Endocrinol Metab. 2007;92(9): 3531-3534.

AMERICAN FAMILY PHYSICIAN 7. Myers DH, Carter RA, Burns BH, Armond A, Hussain SB, Chengapa VK. A prospective study of the effects of lithium on thyroid function and on the prevalence of antithyroid antibodies. Psychol Med. 1985;15(1):55-61.

16. Roti E, Uberti Ed. Post-partum thyroiditis—a clinical update. Eur J Endocrinol. 2002;146(3):275-279.

8. Perrild H, Hegedüs L, Baastrup PC, Kayser L, Kastberg S. Thyroid function and ultrasonically determined thyroid size in patients receiving long-term lithium treatment. Am J Psychiatry. 1990;147(11):1518-1521.

18. Azizi F, Amouzegar A. Management of hyperthyroidism during pregnancy and lactation. Eur J Endocrinol. 2011;164(6):871-876.

9. Bindra A, Braunstein GD. Thyroiditis. Am Fam Physician. 2006;73(10):1769-1776. 10. Menconi F, Hasham A, Tomer Y. Environmental triggers of thyroiditis: hepatitis C and interferon-α. J Endocrinol Invest. 2011;34(1):78-84. 11. Badenhoop K, Boehm BO. Genetic susceptibility and immunological synapse in type 1 diabetes and thyroid autoimmune disease. Exp Clin Endocrinol Diabetes. 2004;112(8):407-415. 12. Fink H, Hintze G. Autoimmune thyroiditis (Hashimoto’s thyroiditis): current diagnostics and therapy [in German]. Med Klin (Munich). 2010;105(7):485-493. 13. Vanderpump MP, Tunbridge WM, French JM, et al. The incidence of thyroid disorders in the community: a twenty-year follow-up of the Whickham Survey. Clin Endocrinol (Oxf). 1995;43(1):55-68.

17. Stagnaro-Green A. Clinical review 152: postpartum thyroiditis. J Clin Endocrinol Metab. 2002;87(9):4042-4047.

19. Singer PA. Thyroiditis. Acute, subacute, and chronic. Med Clin North Am. 1991;75(1):61-77. 20. Fatourechi V, Aniszewski JP, Fatourechi GZ, Atkinson EJ, Jacobsen SJ. Clinical features and outcome of subacute thyroiditis in an incidence cohort: Olmsted County, Minnesota, study. J Clin Endocrinol Metab. 2003;88(5):2100-2105. 21. Nishihara E, Ohye H, Amino N, et al. Clinical characteristics of 852 patients with subacute thyroiditis before treatment. Intern Med. 2008;47(8):725-729. 22. Hamaguchi E, Nishimura Y, Kaneko S, Takamura T. Subacute thyroiditis developed in identical twins two years apart. Endocr J. 2005;52(5):559-562. 23. Kramer AB, Roozendaal C, Dullaart RP. Familial occurrence of subacute thyroiditis associated with human leukocyte antigen-B35. Thyroid. 2004;14(7):544-547.

14. Garber JR, Cobin RH, Gharib H, et al. Clinical practice guidelines for hypothyroidism in adults: cosponsored by the American Association of Clinical Endocrinologists and the American Thyroid Association [published correction appears in Endocr Pract. 2013;19(1):175]. Endocr Pract. 2012;18(6):988-1028.

24. Nyulassy S, Hnilica P, Buc M, Guman M, Hirschová V, Stefanovic J. Subacute (de Quervain’s) thyroiditis: association with HLA-Bw35 antigen and abnormalities of the complement system, immunoglobulins and other serum proteins. J Clin Endocrinol Metab. 1977;45(2): 270-274.

15. Daniels GH. The American Thyroid Association and American Association of Clinical Endocrinologists guidelines for hyperthyroidism and other causes of thyrotoxicosis: an appraisal. Endocr Pract. 2011;17(3): 325-333.

26. Miyauchi A. Thyroid gland: a new management algorithm for acute supprative thyroiditis? Nat Rev Endocrinol. 2010;6(8):424-426.

25. Volpé R. The management of subacute (DeQuervain’s) thyroiditis. Thyroid. 1993;3(3):253-255.

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Practice Guidelines IDSA RELEASES RECOMMENDATIONS ON VACCINATIONS IN IMMUNOCOMPROMISED PATIENTS Vaccination of immunocompromised patients is important because impaired host defenses predispose patients to an increased risk of vaccine-preventable infections. These patients also have a greater risk of exposure to pathogens because of their frequent contact with medical environments. Primary care physicians who provide care for immunocompromised persons share responsibility with subspecialists for ensuring that appropriate vaccines are administered to these patients and for recommending appropriate vaccinations for other members of the household. Recommended vaccination schedules for immunocompetent children and adults are published annually by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention. However, these schedules do not address vaccinations for immunocompromised persons who are at greater risk of morbidity and mortality from vaccine-preventable infections. To address this gap, the Infectious Diseases Society of America (IDSA) recently published evidence-based recommendations for vaccinations in immunocompromised persons and their household members. The guideline covers children and adults with primary (congenital) immunodeficiency; those with secondary immunodeficiency caused by human immunodeficiency virus (HIV) infection, cancer chemotherapy, stem cell or solid organ transplant, sickle cell disease, and surgical asplenia; and patients with chronic inflammatory diseases who are receiving systemic corticosteroids, immunomodulators, or biologic agents. The guideline includes several tables, one for each condition, that list specific vaccines that are recommended and contraindicated, with the level of evidence associated with each recommendation. Some of the recommendations distinguish between high- and low-level immunosuppression. High-level immunosuppression includes patients who have a primary immunodeficiency; who are receiving

Source: Adapted from Am Fam Physician. 2014;90(9):664-665.

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chemotherapy; who have received a solid organ transplant within the previous two months; who have HIV infection and a CD4 cell count less than 200 per mm3 (0.20 Ă&#x2014; 109 per L; for adults and older children) or less than 15% (for infants and young children); who are receiving daily corticosteroid therapy equivalent to 20 mg of prednisone or greater for at least 14 days; or who are receiving biologic immunomodulators. After hematopoietic stem cell transplant, the duration of high-level immunosuppression depends on the type of transplant (longer for allogenic than for autologous); type of donor and stem cell source; and posttransplant complications, such as graft vs. host disease.

Planned Immunosuppression When feasible, vaccines should be administered before planned immunosuppression. Live vaccines should be given at least four weeks in advance and should be avoided in the two weeks before immunosuppression is started. Inactivated vaccines should be administered at least two weeks in advance.

Vaccination in Household Members Immunocompetent persons who live in the same household as the immunocompromised patient can safely receive inactivated vaccines according to the recommended schedule from ACIP. If the immunocompromised patient is six months or older, household members may receive the inactivated influenza vaccine, or the live attenuated influenza vaccine if they are healthy, not pregnant, and two to 49 years of age. Exceptions include those who live with an immunocompromised person who received a hematopoietic stem cell transplant in the previous two months, who has graft vs. host disease, or who has severe combined immunodeficiency. Live vaccine should not be administered to these persons or, if administered, contact between the immunocompromised patient and household member should be avoided for seven days. Healthy immunocompetent persons who live with an immunocompromised patient should receive the following live vaccines based on ACIPâ&#x20AC;&#x2122;s recommended schedule: combined measles, mumps, and rubella (MMR); rotavirus for infants two to seven months of age; varicella; and zoster (Table 1). These persons can safely receive the yellow fever and oral typhoid vaccines for

AMERICAN FAMILY PHYSICIAN travel. Oral polio vaccine should not be administered to persons who live with an immunocompromised patient. Highly immunocompromised patients should avoid handling diapers of infants who have received rotavirus vaccine for four weeks after vaccination. Immunocompromised patients should avoid contact with persons who develop skin lesions after receiving varicella or zoster vaccines until the lesions resolve.

Varicella and Zoster Vaccination Varicella vaccine should not be administered to highly immunocompromised patients. However, select patients (e.g., those with HIV infection who are not highly immunocompromised, those with a primary immunodeficiency without defective T cell–mediated immunity) should receive two doses of vaccine three months apart. Varicella vaccination can be considered in patients who do not have evidence of immunity (i.e., age-appropriate varicella vaccination, serologic evidence of immunity, clinician-diagnosed or -verified history of varicella or zoster, or laboratory-proven

varicella or zoster) and who are receiving long-term, low-dose immunosuppressant drugs. When indicated, varicella vaccine should be administered as a singleantigen product and not combined with the MMR vaccine. Zoster vaccine should be administered to patients 60 years and older who are receiving therapy to induce low-level immunosuppression. The vaccine should not be administered to highly immunocompromised patients.

Influenza Vaccination Annual administration of inactivated influenza vaccine is recommended for immunocompromised patients six months and older, except those who are unlikely to respond (e.g., those receiving intensive chemotherapy, those who have received anti–B-cell antibodies within the previous six months). Live attenuated influenza vaccine should not be administered to immunocompromised persons. Note: For complete article visit: www.aafp.org/afp.

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Photo Quiz MOUTH PAIN WITH RED GUMS A 74-year-old man presented with pain in his mouth. The pain had been present for a few months but had recently increased in intensity. He had not had recent dental work and did not see a dentist regularly. He did not have a history of oral, head, or neck surgery. He did not have fever, chills, swelling of the face or neck, or discharge or drainage from the area. On physical examination there was diffuse erythema of the gums with mild edema and tenderness. The patient had thick deposits at the gum line that could not be wiped off. There were areas of erythema, gum recession, and increased movement of the teeth. There was pain when moving the teeth. There was no purulence, facial edema, or lymphadenopathy.

Figure.

A. Dental abscess. B. Dental caries. C. Periodontal disease.

Question

D. Plaque gingivitis.

Based on the patientâ&#x20AC;&#x2122;s history and physical examination findings, which one of the following is the most likely diagnosis?

SEE THE FOLLOWING PAGE FOR DISCUSSION.

Source: Adapted from Am Fam Physician. 2014;90(9):653-654.

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AMERICAN FAMILY PHYSICIAN DISCUSSION

Summary Table

The answer is C: periodontal disease. Periodontal disease is the loss of gum attachment at the base of the tooth, creating at least one pocket.1 Periodontal disease leads to a calculus comprised of bacteria, acid, food, and saliva located above and below the gum line that cannot be wiped off. This calculus creates pockets along the dentition, providing space for infection, inflammation, and breakdown of the bone and tissues that support the teeth. This causes loose teeth, erythema, edema, bleeding, and pain. Nearly 50% of adults in the United States have periodontitis, usually with pocket formation around multiple teeth. Men, Mexican Americans, and smokers are at highest risk. The incidence of periodontal disease is inversely proportional to income and education level.2 Adolescents are prone to Actinobacillus actinomycetemcomitans infection that can rapidly and aggressively cause periodontitis.3 Pregnancy-related gingivitis can progress to more severe disease. Some diseases are associated with higher rates of periodontal disease, including diabetes mellitus, human immunodeficiency virus infection, and autoimmune disease. Medications such as bisphosphonates, phenytoin, cyclosporine, and nifedipine have been linked with gingival and jaw changes that contribute to periodontal disease.4 Early treatment of periodontal disease helps prevent tooth loss and includes removal of calculi above and below the gum line. There is no indication for antibiotics. Education and prevention include encouraging patients to brush after meals and floss daily. Later treatment includes more invasive and surgical approaches. Dental abscesses are localized infections resulting from the introduction of bacteria into a gingival pocket or as a progression of decay into the pulp. They cause pain, inflammation, purulent drainage, lymphadenopathy, and facial edema. Systemic symptoms, including fever, chills, and malaise, may also occur. Dental caries or cavities are the result of decay in the enamel that subsequently causes tooth decay. It

Condition

Characteristics

Dental abscess

Localized infection; pain, inflammation, purulent drainage, lymphadenopathy, and facial edema; possible systemic symptoms, such as fever, chills, and malaise

Dental caries

Destruction of enamel and subsequently tooth structure; dark spots, localized pain, hot or cold sensitivity, and pain with eating

Periodontal disease

Chronic gingival disease; pocket formation and gingival recession; characterized by the presence of calculus and tooth destruction

Plaque gingivitis

Reversible gingival erythema and inflammation; soft plaque formation that is easily wiped off; no calculus and pocket formation or tooth destruction

is identifiable as dark spots of tooth destruction that occur at any location on the tooth. This causes localized pain, hot or cold sensitivity, and pain with eating. Plaque gingivitis is a reversible condition defined by gingival erythema and soft plaque deposits that are easily wiped off. It is distinguishable from periodontal disease because there is no calculus and pocket formation or tooth destruction. Gingival irritation may be related to poor dental hygiene and is common in pregnancy and in persons with diabetes. REFERENCES 1. National Institute of Dental and Craniofacial Research. Periodontal disease in adults (age 20 to 64). http://www. nidcr.nih.gov/datastatistics/finddatabytopic/gumdisease/ periodontaldiseaseadults20to64.htm.Accessed March 11, 2013. 2. Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ; CDC Periodontal Disease Surveillance Workgroup. Prevalence of periodontitis in adults in the United States: 2009-2010. J Dent Res. 2012;91(10):914-920. 3. American Academy of Periodontology; Research, Science, and Therapy Committee. Periodontal Diseases of Children and Adolescents. Chicago, Ill.: The Academy; 1992. 4. Gum disease in-depth report. The New York Times. http: / / health.nytimes.com/health/guides /disease/periodontitis/ print.html. Accessed March 11, 2013.

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Bleeding Complication During Emergency LSCS: HELLP Syndrome PREETI GANPAT MORE*, TEJASI SANTOSH WAIGANKAR†, JANHAVI J POL‡

ABSTRACT The syndrome of hemolysis, elevated liver enzymes, low platelet count (HELLP syndrome) is a consequence of severe pre-eclampsia/eclampsia. It is characterized by essential criteria of thrombocytopenia (platelet count <100 × 109 L-1), elevated SGOT, SGPT, abnormal blood smear: Hemolysis and associated with abdominal pain, nausea, vomiting and headache, disseminated intravascular coagulation and postpartum hemorrhage. Its early diagnosis, prompt treatment, a multidisciplinary team approach and challenging anesthetic managements helps in preventing the complications and perinatal mortality. Conventional management includes resuscitation with fluids, blood, surgical maneuvers and embolization of feeding blood vessels. We report the perioperative anesthetic management of a similar case of obstetric bleeding who developed HELLP syndrome and its successful postoperative ICU management.

Keywords: Obstetric bleeding, pre-eclampsia, HELLP syndrome, disseminated intravascular coagulation

emolysis, elevated liver enzymes and low platelets (HELLP) syndrome although rare is a known complication of pregnancy-induced hypertension (PIH) associated with maternal and fetal mortality. We report here a case of a primigravida posted for emergency lower-segment cesarean section (LSCS) for probable abruptio placentae, who developed unexpected bleeding complications intraoperatively and was subsequently diagnosed with HELLP syndrome and disseminated intravascular coagulation (DIC) and was promptly successfully managed.

CASE REPORT A 30-year-old primigravida with 36 weeks pregnancy was admitted in labor. On admission, her blood pressure (BP) was 170/100 mmHg. Antenatal reports showed BP fluctuations, but no proper treatment. No history of bleeding or leaking per vaginum (PV), headache, visual disturbances, pedal edema or epigastric pain.

*Associate Professor †Senior Resident ‡2nd Year Junior Resident ESI-PGIMSR, MGM Hospital, Parel, Mumbai Address for correspondence Dr Preeti Ganpat More Saisakshi CHS, Flat No-001, B-Wing Sector-3, Plot No-17, Ghansoli, Navi Mumbai - 400 701 E-mail: preetipreety@hotmail.com

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Her hemogram, platelets, renal, liver, thyroid function tests and urine examination were within normal limits. Her vitals were strictly monitored: BP ranged from 170/100 mmHg to 140/90 mmHg. Urine showed trace albumin. She was administered nifedipine 5 mg and labor was augmented with tablet misoprostol and later pitocin infusion. Her BP; however, continued to remain high; she was therefore given tablet methyldopa 250 mg and magnesium sulfate, prophylactically. She then started passing clots PV. Abruptio placentae was ruled out by artificial rupture of membranes. The patient; however, continued to pass clots, therefore, was taken up for emergency LSCS in view of pre-eclampsia with bleeding PV in labor. High-risk consent was taken and intravenous (IV) line was secured. All monitors were attached (electrocardiography [ECG], noninvasive BP [NIBP], pulse oximetry). Urinary catheterization was done. Her BP in the OT was 140/90 mmHg. Spinal anesthesia was given with 2 mL of 0.5% bupivacaine heavy in a sitting position by midline approach with 23 g spinal. Baby delivered; pitocin 20 U infusion was started and placenta was delivered. Thereafter, continuous ooze was noted from the surgical site. Injection tranexamic acid 500 mg IV given. Despite this, the uterus was flabby and the urine was blood-stained. The oozing continued and another 30 U of pitocin was administered as an infusion, and injection prostodin 0.25 mg intramuscular (IM) was given. IV injection furosemide 10 mg was

ANESTHESIOLOGY given. The uterus was well-contracted, but still a steady ooze from the raw areas around the uterine incision and muscle continued. The total blood loss was approximately 1,500 mL. A provisional diagnosis of HELLP syndrome/DIC was made. A central-line was secured. The central venous pressure (CVP) was about 2 cm of water despite 3 liters of crystalloids. Physicianâ&#x20AC;&#x2122;s opinion was taken and infusion of packed red cells, platelet concentrates and fresh frozen plasma was advised. Patient was shifted to intensive care unit (ICU) for further postoperative management. In the ICU, the patient received 2 units packed red cells, 2 units fresh frozen plasma and 4 units platelets. Fresh investigations showed a hemoglobin of 7.8 g/dL, platelet count of 71,000/mm3, peripheral blood smear showed the presence of schistocytes and spherocytes. Liver function tests were also deranged: Total bilirubin - 3.10 mg/dL, direct blirubin - 1.25 mg/dL, serum glutamic oxaloacetic transaminase (SGOT) - 170.4 U/L, serum glutamic pyruvic transaminase (SGPT) - 111 U/L and haptoglobulin was <7.56 mg/dL. D-dimer was 1.4 mg/L (normal range: 0-0.3 mg/L); and plasma fibrin degradation products (FDP) was highly raised (2.91 Âľg/L). Renal function tests, prothrombin time, international normalized ratio (INR) and activated partial thromboplastin time (aPTT) were within normal limits. Her vitals were stable and BP was 130/90 mmHg. A diagnosis of HELLP syndrome with DIC was made with strict monitoring in the ICU. On the second postoperative day, platelet count reduced further to 46,000/mm3 and serum lactate dehydrogenase (LDH) was raised 1701.5 U/L. She was transfused 2 more units of fresh frozen plasma and 4 platelets. On the third postoperative day, the platelet counts increased to 68,000/mm3 and serum LDH decreased to 1,240 U/L. She was on magnesium sulfate postoperatively, and her BP was gradually controlled. On the fourth postoperative day, the platelet count was 2,00,000/ mm3. She was shifted to the ward on the seventh postoperative day and later discharged on iron and calcium supplements. DISCUSSION Obstetric bleeding may be caused by combined uteroplacental pathology, surgical and/or acquired coagulopathic insult (DIC, defective thrombin generation), which is common in abruptio placentae.1 Pre-eclampsia and eclampsia are hypertensive

disorders associated with pregnancy. HELLP syndrome characterized by hemolysis, elevated liver enzymes and low platelet counts is a serious, life-threatening obstetrics complication. It is a multisystemic disorder usually associated with PIH, but may occur in its absence as well.2 The syndrome was first described by Pritchard in 1954, and the term HELLP syndrome was first used by Weinstein.3 The classic symptoms include abdominal pain, nausea, vomiting, headache and visual disturbances. Though our patient did not have any of these symptoms, it is important to maintain a highdegree of suspicion for HELLP syndrome in a patient with PIH as there is a high incidence of delayed or missed diagnosis.3 Our patient was taken for emergency LSCS for bleeding PV with a clinical diagnosis of preeclampsia with probable abruptio placentae. HELLP syndrome can be classified in two ways:2 The Mississippi classification and the Tennessee classification. The Mississippi classification is based on the platelet counts and accordingly patients can be classified into three classes: Class I (<50,000/mm3), Class II (50,000-1,00,000/mm3) and Class III (1,00,0001,50,000/mm3). The Tennessee classification is based on aspartate aminotransferase (AST) and LDH levels, in addition to platelet counts (AST >70 IU/L, LDH >600 IU/L, platelet count <100,000/mm3). Patients can thus be classified as complete (all three parameters are present) or partial HELLP syndrome (one or two parameters are present). Our patient had Class I and complete HELLP syndrome. Patients with complete HELLP syndrome are usually at a higher risk for complications like DIC, renal failure, abruptio placentae, stroke, cardiac arrest, etc.4 HELLP syndrome associated with DIC usually carries a worse prognosis. HELLP syndrome is usually diagnosed antepartum (70% of the cases)1 and delivery is the only definitive treatment. Conventional treatment for massive intraoperative bleeding includes replacement of the fluids, blood and blood products, surgical interventions and embolization of feeding blood vessels.4 In our patient, it was suspected intraoperatively and managed with fluid replacement and the diagnosis confirmed postoperatively. Our patient had PIH, and her postoperative investigations revealed schistocytes and spherocytes in the peripheral smear with decreased serum haptoglobin, raised liver enzymes and bilirubin, and low platelet counts, all pointing to a diagnosis of HELLP syndrome. Raised D-dimers and FDP suggest DIC.

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ANESTHESIOLOGY Postoperative management of HELLP syndrome is largely supportive. ICU management with strict hemodynamic monitoring and vigilance to bleeding manifestations is needed. CVP monitoring serves as a guide to fluid management. Liver function tests, hemoglobin and platelet counts must be monitored closely and immediate treatment instituted whenever indicated with fresh frozen plasma, packed red cells and platelet concentrates. Our patient was also managed in a similar manner. Serum electrolytes often get deranged in a critical illness. Blood glucose levels should be monitored regularly as patients with HELLP syndrome may develop hypoglycemia.5 Corticosteroids, although, hasten fetal lung maturity, may improve platelet counts and liver function tests, however, there is insufficient evidence to support their use in terms of maternal and perinatal mortality and major maternal and perinatal morbidity.6,7 Replacement therapy and large volumes of fluid resuscitation can pose problems of dilutional and acquired coagulopathy and massive transfusion related problems. rFVIIa, a pro-hemostatic agent plays a vital role in hemostasis.8,9 CONCLUSION Hence, we managed to diagnose, control and treat an unanticipated HELLP syndrome occurring in a patient with PIH with suspected abruptio placentae (bleeding PV in labor) with replacement therapy under physician and ICU management without any serious complication of DIC.

REFERENCES 1. Spahn DR, Rossaint R. Coagulopathy and blood component transfusion in trauma. Br J Anaesth 2005;95(2):130-9. 2. Mihu D, Costin N, Mihu CM, Seicean A, Ciortea R. HELLP syndrome - a multisystemic disorder. J Gastrointestin Liver Dis 2007;16(4):419-24. 3. Crosby ET. Obstetrical anaesthesia for patients with the syndrome of haemolysis, elevated liver enzymes and low platelets. Can J Anaesth 1991;38(2):227-33. 4. Braveman FR. Pregnancy associated diseases (Chapter 23). Stoeltings anesthesia and coexisting disease. 5th edition, Hines RL, Marshall KE (Eds.), Churchill Livingstone, 2002. 5. Mushambi MC, Halligan AW, Williamson K. Recent developments in the pathophysiology and management of pre-eclampsia. Br J Anaesth 1996;76(1):133-48. 6. A morim M, Katz L. Corticosteroids for HELLP (haemolysis, elevated liver enzymes, low platelets) syndrome in pregnancy: RHL commentary (last revised: 1 May 2011). The WHO Reproductive Health Library; Geneva: World Health Organization. Available from: http://apps.who.int/rhl/pregnancy_childbirth/medical/ hypertension/cd008148_amorimm_com/en/. 7. Matchaba P, Moodley J. Corticosteroids for HELLP syndrome in pregnancy. Cochrane Database Syst Rev 2004;(1):CD002076. 8. Price G, Kaplan J, Skowronski G. Use of recombinant factor VIIa to treat life-threatening non-surgical bleeding in a post-partum patient. Br J Anaesth 2004;93(2):298-300. 9. Burad J, Bhakta P, Sharma J. Timely ‘off-label’ use of recombinant activated factor VII (NovoSeven) can help in avoiding hysterectomy in intractable obstetric bleeding complicated with disseminated intravascular coagulation: A case report and review of the literature. Indian J Anaesth 2012;56(1):69-71.

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Preanesthetic Analgesics before Elective Surgery Unnecessary Compared with no premedication or a placebo, lorazepam premedication failed to improve patients' overall satisfaction with the perioperative experience, and prolonged recovery, reported the randomized multicenter PremedX trial published in the March 3 issue of JAMA. Thus, routinely giving a sedative before anesthesia to patients undergoing elective surgery seems unnecessary.

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ANESTHESIOLOGY

Diagnosed and Suspected Extrapulmonary Tuberculosis: A Study on Response to Anesthesia JAYASHREE SEN*, BITAN SEN†

ABSTRACT Aim: To evaluate the response to anesthesia in relation to different surgeries of diagnosed and suspected cases of extrapulmonary tuberculosis (EPTB). Material and methods: Out of 884 operative cases of either sex in the age group of 18-60 years of ASA I and II within a period of March 2013 to March 2014, 28 cases of diagnosed and 38 cases of suspected EPTB were found for the study. Results: Response to anesthesia of all the extratubercular suspected cases and also diagnosed cases where the patients were on antitubercular drugs, showed satisfactory outcome. Conclusion: Judiciously chosen anesthetic agents are safe having no risk of drug interaction.

Keywords: Anesthetics, drug interaction, extrapulmonary tuberculosis

ycobacterium tuberculosis affects nearly one-third of the world’s population approximately 1.7 billion people. In 2010, the World Health Organization (WHO) estimated 8.8 million cases worldwide.1 The estimated mortality rate of M. tuberculosis is 3 million people per year,2 which represents more than a quarter of the world’s preventable deaths.3 The average prevalence of all forms of tuberculosis (TB) in India is estimated to be 5.05 per thousand, prevalence of smear-positive cases 2.27 per thousand and average annual incidence of smear-positive cases at 84 per 1,00,000.4 In 2012, the data by WHO’s 182 member states, a total of 204 countries and territories has collectively reported more than 99% of the world’s TB cases.5 M. tuberculosis may affect any organ, presenting clinically as pulmonary and extrapulmonary. Fifteen percent of TB is extrapulmonary, although pulmonary TB is most common in communicable form6 and

*Associate Professor Dept. of Anesthesiology Gold Field Institute of Medical Sciences and Research, Chhainsa, Faridabad, Haryana †Junior Resident Dept. of Emergency Medicine Apollo Hospital, New Delhi Address for correspondence Dr Jayashree Sen Associate Professor Dept. of Anesthesiology Gold Field Institute of Medical Sciences and Research, Chhainsa, Faridabad, Haryana E-mail: jayashree_sen@rediffmail.com

the opportunistic infection associated with human immunodeficiency virus (HIV).7 Patients who are inadequately treated remain chronic carriers and can spread the disease to their families and communities. TB, including those with multidrug-resistant-TB (MDRTB), is a very serious problem and a threat to global TB control.6 Extrapulmonary TB (EPTB) is defined as TB of organs other than the lungs, such as pleura, abdomen, genitourinary tract, lymph nodes, skin, joints, bones, meninges, tuberculoma of the brain, etc.8,9 Surgery may be needed for therapeutic or diagnostic purpose of extrapulmonary lesions. HISTORY OF TB Tuberculosis has been prevalent in human beings since ancient times. In Greek literature, Hippocrates identified the most widespread disease of the times, ‘phthisis,’ a disease of wasting away and noted that it was almost always fatal.10 Egyptian mummies from 2400 BC show signs of tubercular decay.10 In 1679, Sylvius identified encapsulated bacilli i.e., tubercles, which were responsible for a consistent and characteristic change in the lungs and other areas and this was presented in his work Opera Medica,10 which also described the progression of tubercles to abscesses and cavities.10 The Italian medical literature of the 17th century referred to TB as an infectious disease and warned that, “henceforth, human health should no longer be endangered by objects remaining after the

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ANESTHESIOLOGY death of a consumptive. The names of the deceased should be reported to the authorities, and measures undertaken for disinfection”.10 In 1720, the English physician Benjamin Marten wrote in his book “A New Theory of Consumption” that TB could be caused by “wonderfully minute living creatures, which once they had gained a foothold in the body, could generate the lesions and symptoms of the disease”.10 Koch identified M. tuberculosis in 1882.11 Since, the discovery of X-rays in 1895 by Roentgen, radiographic diagnosis and treatment of TB became possible.11 In the 1800s, the treatment consisted of agents that reduce inflammation i.e., antiphlogistics, counterirritant therapies e.g., emetics, cathartics and dietary manipulation.11 From the mid- to late-1800s to the 1960s, the concept emerged that good nutrition, rest and fresh air would aid in the treatment of TB, while keeping the patient isolated from the general population. So, patients were to be moved to sanatoriums.12 The first sanatorium opened in Germany in 1850, and the trend quickly caught on in developed countries worldwide.11 Despite this, TB was 60% fatal at that time.11 In the 1900s, pneumothorax and thoracoplasty were thought to be a mode of treatment for collapsing diseased areas of the lungs.11 When streptomycin was discovered in 1946 and isoniazid in 1953, the two medications were combined for an 18-month treatment in the 1950s. The therapy time had decreased further to 6 months10,12 after the discovery of pyrazinamide in 1954 and rifampicin in 1963. In India, EPTB forms 10-15% of all types of TB. Lymph node TB (LNTB) is the commonest form of EPTB. Most studies described that pulmonary TB is more common in adult males and peripheral LNTB have a female preponderance.13 PATHOPHYSIOLOGY OF TB In the lung, the organism is taken up by alveolar macrophages and carried to lymph nodes, from which it may spread to multiple organs. Two to 8 weeks after infection, T-cell formation i.e., cell-mediated immunity and hypersensitivity develop. This causes the characteristic skin hypersensitivity reaction i.e., the Mantoux tuberculin test. In people with intact immune systems, the infection usually is contained,14 but inflammatory immune responses form tubercles, which eventually may result in lung damage in people with compromised immune systems.3

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PROGRESSION FROM LATENT TB INFECTION TO ACTIVE TB The infection may stay dormant and asymptomatic for years.6 The only evidence of the infection becomes a positive tuberculin test.2 Overt infection in the lung with inflammation and tissue necrosis can cause massive pulmonary damage, which may lead to respiratory failure, bronchopleural fistulas, pneumothorax. Infection may contaminate the surrounding tissue and spread through the lymphatic system and bloodstream as hematogenous dissemination to distant sites, such as the pleura, peritoneum, gastrointestinal (GI) tract, bones, joints, lymph nodes and meninges as EPTB. Without treatment, TB has a 50% mortality rate. DIAGNOSIS AND TREATMENT OF EPTB UNDER THE NATIONAL TB CONTROL PROGRAM Diagnosis is based on strong clinical findings consistent with active EPTB disease. Sputum examined for acid-test bacilli (AFB), histopathological, cytopathological and microbiological evidence and culture-positive specimen from tissue/relevant body fluid (cerebrospinal fluid and ascitic fluid) of the extrapulmonary site are taken. If no accessible tissue/fluid is available for analysis then, to secure tissue for diagnosis, radiologically-guided fine-needle aspiration cytology (FNAC) or biopsy may be required. The treatment of EPTB follows standard Revised National Tuberculosis Control Program (RNTCP) treatment guidelines depending on history, clinical and investigation criteria15,16 and is consistent with international recommendations by WHO and the International Union Against Tuberculosis and Lung Disease (IUATLD). SURGICAL MANAGEMENT OF TB The purpose of surgery is either therapeutic or diagnostic. The goal of surgery here is as an adjuvant to antimicrobial therapy to enhance the effectiveness of medications7 by removing the diseased tissue and cavities. Surgery may be performed also on multi-drug-resistant TB7 patients who: ÂÂ

In spite of having four or more medications have highly-resistant disease

ÂÂ

Persistently have positive 4-6 months of therapy

ÂÂ

Have relapses.

sputum

despite

ANESTHESIOLOGY CARE OF PATIENTS WITH TB WHO ARE UNDERGOING SURGERY

through an 18 G cannula. Choice of anesthesia would be as per the surgery concerned (Table 3).

Patients with TB who need surgical or endoscopic procedures may have several underlying risk factors along with TB, though, an intact immune system can protect a perioperative patient from invading organisms and infection.17 Diagnosed cases are to be prepared preoperatively with nutritional supplements, antitubercular drugs and chest physiotherapy to minimize the risk of pulmonary sepsis.7

In cases of general anesthesia, a bacterial filter which should be capable of filtering 99.97% of particles >0.3 μm was put in between the patient’s airway and the expiratory limb.

MATERIAL AND METHODS The study was conducted retrospectively in a teaching hospital during the period of March 2013 to March 2014, on 884 patients presented for surgery. Information to the ethical committee and written informed consent was obtained from all the participants. Patients were selected randomly of either sex, who had no known-sensitivity to local anesthetic drug lignocaine, nonalcoholics, not pregnant or lactating, aged between 18-60 years, belonging to American Society of Anesthesiologists (ASA) Grade I and II (Table 1), undergoing surgery for lymph node excision/biopsy, laparotomy for right iliac fossa mass, drainage of psoas abscess, empyema thoracis, diagnostic endoscopy for infertility, sequestrectomy for chronic osteomyelitis, synovial biopsy of joints, anterior fusion and decompression of vertebrae for gross instability in spinal TB, mastoidectomy or drainage of retropharyngeal abscess (Table 2). Preanesthetic checkup of the patients to be included in the study, were done a day before surgery with special reference to the drug history. Investigations were done according to the institution’s protocol. On arrival in the operation theater, multipara monitor for recording the patient’s oxygen saturation, heart rate, ECG, noninvasive arterial blood pressure, respiratory rate, was connected (Philips-Intellivue MP20). Ringer’s lactate solution at 2 mL/kg-1 was started intravenously

DISCUSSION Antitubercular drugs, following the induction of liver enzymes, interact with different anesthetic agents due to pharmacokinetic changes. Chronic preoperative or perioperative use of isoniazid, a hepatic enzyme inhibitor, may decrease the plasma clearance and prolong the duration of action of alfentanil18,19 and fentanyl as both the drugs are extensively metabolized by CYP450 3A4. We used IV fentanyl in 1 μg/kg-1 dose with titration in all the general anesthesia (GA) intubated and shortacting anesthetic agent (ketamine)-induced GA cases and the effect was found to be predictable. Long-term use prior to anesthesia, of rifampicin which is a hepatic enzyme inducing agent, increases anesthetic metabolism with hydrocarbon inhalation, except Table 2. Extrapulmonary TB Disease Site (n = 884) Site

Total

Percentage (%)

0.45

Lymph node excision/biopsy

2.03

Empyema thoracis

0.33

Psoas abscess

0.90

Laparotomy

0.56

Abdominal endoscopy

0.56

Sequestrectomy

1.13

Synovial biopsy

1.01

Mastoidectomy

0.33

Retropharyngeal abscess

0.56

Spinal TB (Pott’s disease)

Table 1. Extrapulmonary TB Finding with Gender Percentage (n = 884) Types of procedures conducted under different surgical streams

Diagnosed

Suspected

Male

Female

Total (%)

Male

Female

Total (%)

Neurosurgery

0.45

General surgery

1.35

2.48

0.56

Gyne Orthopedics

1.01

1.13.

ENT

0.90

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ANESTHESIOLOGY Table 3. Extrapulmonary TB Surgical and Anesthetic Procedures Surgical procedures

Anesthetic techniques

Agents used

Spine fixation

Propofol, fentanyl, isoflurane, vecuronium

LN biopsy

Short-acting anesthetics

Midazolam, ketamine, fentanyl

Decortication of GA empyema thoracis

Propofol, fentanyl, isoflurane, vecuronium

Abscess drain

Short-acting anesthetics

Midazolam, ketamine, fentanyl

Laparotomy

Propofol, fentanyl, isoflurane, vecuronium

Diagnostic endoscopy lower abdomen

Spinal

Heavy bupivacaine intrathecally

Sequestrectomy tibia

Spinal

Heavy bupivacaine intrathecally

Synovial biopsy, ankle joint

Spinal

Heavy bupivacaine intrathecally

Mastoidectomy

Propofol, fentanyl, isoflurane, vecuronium

Drainage of retropharyngeal abscess

Propofol, fentanyl, isoflurane, vecuronium

isoflurane, leading to increased risk of hepatotoxicity.20 CYP2E1, an isoenzyme has the potential to act as a hapten and can trigger an immune-related hepatitis by metabolizing halothane to trifluoroacetic acid. This isoenzyme CYP2E1 is induced by INH too. In our study, hydrocarbon inhalational agent used was only isoflurane, which is not known to cause hepatotoxicity with antitubercular drugs. Concurrent use of barbiturate with rifampicin may enhance the metabolism of hexobarbital by induction of hepatic microsomal enzymes, resulting in lower serum concentrations. But, the data on rifampicinâ&#x20AC;&#x2122;s effect on phenobarbital are conflicting and dosage adjustment may be required.20 This is the reason why we avoided barbiturate and took propofol as the inducing agent in all GA with intubation cases. Isoniazid may decrease the hepatic metabolism of benzodiazepines, such as diazepam, chlordiazepoxide, flurazepam and prazepam, which are metabolized by phase I reactions as N-demethylation and hydroxylation. Isoniazid may also decrease first-pass metabolism and elimination of midazolam in the liver, probably by

competitive inhibition at the cytochrome P450 binding sites, increasing steady-state plasma concentrations of midazolam.21,22 Concurrent use with rifampin may enhance the elimination of diazepam, resulting in decreased plasma concentrations, so adjustment of dosage may be necessary.23 As an anesthetic adjuvant with ketamine, midazolam IV in the dose of 0.4 mg/kg-1 was used by us but in none of the case, there was any prolongation of sedation for which active interference was required. Streptomycin may potentiate the effect of nondepolarizing blocking agents; therefore, the response should be titrated frequently with nerve muscle stimulator. Vecuronium in the dose 0.08 mg/kg-1 was our choice of muscle relaxant and the top up dose requirement was determined by the train of four phenomena using the peripheral nerve stimulator, so neuromuscular block reversal was as per expectation. CONCLUSION Patient with EPTB may also present with mycobacterium pulmonary infection. The presenting symptoms may interfere with the preconditions for accepting the patients for anesthesia. The drugs for the treatment of TB, which are primarily mediated through P450 enzyme system, have the potential for significant interactions with the anesthetics of choice. So, judicious use of anesthetic agents in the patients of diagnosed and suspected EPTB will make the procedures safe and free from drug interactions. REFERENCES 1. Floyd K, Baddeley A, Dias HM, et al. The sixteen global report of tuberculosis. World Health Organization. 2011.c2012. Available from: http://whqlibdoc.who.int/ publications/2011/9789241564380_eng.pdf. 2. Fraser A, Paul M, Attamna A, Leibovici L. Drugs for preventing tuberculosis in people at risk of multiple-drugresistant pulmonary tuberculosis. Cochrane Database Syst Rev 2006;(2):CD005435.

tuberculosis. Microbiologybytes. 3. Mycobacterium Available from: http://www.microbiologybytes.com/ video/Mtuberculosis.html. Accessed August 18, 2014. 4. Chakraborty AK. Epidemiology of tuberculosis: current status in India. Indian J Med Res 2004;120(4):248-76. 5. World Health Organization. Global Tuberculosis Report 2012. Available from: http://www.who.int/iris/ bitstream/10665/75938/1/9789241564502_eng.pdf. 6. Springhouse. Respiratory Care Made Incredibly Easy! Lippincott Williams &Wilkins: Philadelphia, PA 2005:p.344. 7. Lalloo UG, Naidoo R, Ambaram A. Recent advances in the medical and surgical treatment of multidrug

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ANESTHESIOLOGY resistant tuberculosis. Curr Opin Pulm Med 2006;12(3): 179-85. 8. Central TB Division (CTD), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Revised National TB Control Programme. Operational guidelines for TB Control. New Delhi: CTD, 1997. 9. Central TB Division (CTD). Managing the Revised National TB Control Programme in your area. A training course. Modules 1-4. New Delhi: CTD, 1998. 10. Brief History of TB. University of Medicine and Dentistry of New Jersey. Available from: http://www.umdnj. edu/~ntbcweb/history.htm. Accessed August 18, 2014. 11. Bastian I, Portaels F. Multidrug-resistant tuberculosis: resurgent and emerging infectious diseases. Springer: Boston, MA 2000:p.312. 12. Stout J. Drug-resistant tuberculosis (MDR TB and XDR TB). Presented at: Bad Bugs: Infectious Disease Update. September 2007; Chapel Hill, NC. 13. Balasubramanian R, Ramachandran R. Management of non-pulmonary forms of tuberculosis: review of TRC studies over two decades. Indian J Pediatr 2000;67 (2 Suppl):S34-40. 14. Sheldon LK. Oxygenation. 2nd edition, Jones and Bartlett Publishers: Sudbury, MA 2008:p.401.

15. Treatment of Tuberculosis: Guidelines for National Programmes. 3rd edition, World Health Organization: Geneva, 2003. (WHO/CDS/TB/2003.313). 16. International Union Against Tuberculosis and Lung Disease (IUATLD). Enarson DA, Rieder HL, Arnadottir T, Trébucq A. Management of Tuberculosis: A Guide for Low Income Countries. 5th edition, Paris: IUATLD, 2000. 17. Neil JA. Perioperative care of the immunocompromised patient. AORN J 2007;85(3):544-60; quiz 561-4. 18. Rifamate (Hoechst Marion Roussel). In: PDR Physicians’ Desk Reference. 54th edition, 2000. Medical Economics Data: Oradell, NJ 2000:p.1382-3. 19. Rifater (Hoechst Marion Roussel). In: PDR Physicians’ Desk Reference. 54th edition, 2000. Medical Economics Data: Oradell, NJ 2000:p.1383-7. 20. Baciewicz AM, Self TH. Rifampin drug interactions. Arch Intern Med 1984;144(8):1667-71. 21. Hansten PD. Isoniazid drug interactions. Interactions Newsletter 1983;3(2):7-11.

Drug

22. Shinn AF, Shrewsbury RP. EDI, Evaluation of drug interactions. 3rd edition, Mosby: St Louis l985: p.222, 446. 23. Ohnhaus EE, Brockmeyer N, Dylewicz P, Habicht H. The effect of antipyrine and rifampin on the metabolism of diazepam. Clin Pharmacol Ther 1987;42(2): 148-56.

■■■■

Parsing Out Best Practices for Endovascular Thrombectomy 'Time is brain' in endovascular thrombectomy, more evidence against general anesthesia. NASHVILLE, Tenn. Faster reperfusion, local anesthesia and more severe stroke after thrombolysis predicted greater benefit of endovascular thrombectomy, analyses of the MR CLEAN and IMS III trials showed. The spate of post-hoc, sub- and pooled analyses presented at the American Heart Association/American Stroke Association's International Stroke Conference here attempted to sort out best practices-important in the wake of three additional positive thrombectomy trials seen as a mandate for the procedure.

FDA Seeks Modification of Labels of Steroid Epidural Injections An FDA advisory committee urged the agency to modify labels of certain formulations of corticosteroids in an attempt to make epidural injections safer. The committee voted 15-7 in favor of calling so-called “particulate” steroids contraindicated for epidural injection because they appear to carry greater risk of adverse neurological effects than “nonparticulate” agents.

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CARDIOLOGY

Affect and Coping Mechanisms Among Coronary Heart Disease Patients POOJA BHATNAGAR VARMA*, WAHEEDA KHAN†

ABSTRACT The present retrospective study investigates the influence of positive and negative affect among heart disease patients in the capital of India. The Positive and Negative Affect Schedule (PANAS) was administered on the heart patients (myocardial infarction and angina pectoris) and control group (disease-free) (n = 120). Results indicated significant difference on the dimension of affectivity with disease group as compared to the disease-free group. The latter part of the study investigates the coping patterns among these patients through the brief cope inventory. The results of the study indicated the presence of various coping mechanisms like religion, active coping, humor, denial, self-distraction, substance use, venting, self-blame and behavioral disengagement among coronary heart disease patients. The control (disease-free) groups were more associated with the mechanisms like acceptance, positive reframing, planning, emotional support and instrumental support.

Keywords: Affect, brief cope, coronary heart disease, disease-free, coping mechanisms

n human beings, heart is one of the most vital organs of the body. By its pumping action, it supplies oxygen to various parts of the body, it starts functioning the moment it is formed in the mother’s womb and continues to beat till death intervenes. Considering the arduous work that this organ has to do day in and day out, without stopping even for a second, it is subject to few disorders. Yet much of this epidemic is self-made. What we eat, how we live, what stress we load from the environment, how we cope are important casual factors for the existence of cardiac problems? Coronary heart disease (CHD) takes two principal forms, Angina pectoris (AP) and Myocardial infarction (MI) or heart attack. AP is generally precipitated by physical or emotional exertion, but MI is a much more serious disorder and is the leading cause of death. In America, deaths from CHD have declined dramatically in recent years, but in India it is on

*Research Scholar †Professor Dept. of Psychology Jamia Millia Islamia University, New Delhi Address for correspondence Dr Waheeda Khan F-101, Bren Unity Appts. Chinnapanhalli, Bangalore, Karnataka E-mail: pvarma.179@gmail.com

the rise. CHD is one of the major causes of death in India with Indians having a 150-400% higher death rate.1 Dealing with the stress involves learning to balance the important elements in life, for example work, relationships, family or money and realizing that sometimes one needs to just let go off worries or situations which one can’t control. The present research throws light on the dimension of affectivity, which derives from emotions or affect. Affect is a biological pattern of events, triggered by a stimulus. There are three kinds of affect. First is the positive affect, for example: Interest, enthusiasm, boredom, laughter, empathy, action and curiosity; second is the neutral affect, also called the briefest affect. It arrives and is gone in a fraction of the second as eyebrows up, blink and mouth open. The last one is the negative affect as fear-terror, distress-anguish, anger-rage and shame-humiliation and so on. Affective style, one of the most salient characteristics of emotion, is the extraordinary heterogeneity in how different individuals respond to the same emotionally provocative challenge. Negative affectivity is most enduring vulnerability factor i.e., a pervasive negative mood marked by anxiety, depression and hostility. Certain individuals are predisposed by virtue of this pervasive negative mood to experience stress and distressing their lives, which may, in turn, affect both the illness behavior and their rates and types of illness. People high in negative affectivity are likely to report

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CARDIOLOGY physical symptoms and are at risk on a variety of health disorders. The study was conceptualized due to the need for making the people realize that small events in their life, their attitude, emotions and thoughts are all crucial components in making their health. Amidst this amalgam of negative emotions, positive emotions seem unwarranted, even inappropriate. However, positive emotions are known to co-occur alongside negative emotions during stressful circumstances.2 Until recently, scientists have lacked the technology and data needed to support or refute the centuriesold belief that emotions influence coronary health. The past two decades have witnessed dramatic advances in knowledge concerning the pathophysiology underlying CHD and the contribution of emotions and cognitions to disease processes. This progress, in combination with findings from a growing body of large, methodologically sound epidemiological studies, provides substantial evidence that negative emotions and cognitions, including hostility and related constructs and subfacets of negative affectivity (e.g., depression, anxiety) contribute to the initiation and progression of CHD. In contrast, research focused on the potential resilient contribution of positive emotions and cognitions has been notably absent from the literature. Furthermore, studies concerning emotions and health have often neglected important contextual factors and concomitant social processes. In the current scenario, the evidence regarding the roles of emotions, and cognitions in CHD risks and outcomes and attention to positive emotional constructs is warranted.3 The focus of mental healthcare has too often been on understanding and alleviating negative emotional states, such as anxiety, depression, abuse, prejudice and disharmony among others. Focus was lacking on how a majority of people manage to live lives of dignity and purpose, despite all difficulties and this is now being addressed.4 ‘Positive psychology’ is the study of ordinary human strengths and virtues. It asks, “What is the nature of the effectively functioning human being, who successfully applies evolved adaptations and learned skills”? Positive psychology recognizes that persons, who carry even the weightiest psychological burdens, can care about much more in their lives, than just the relief of their suffering. Troubled persons often want more satisfaction, contentment and joy with less sadness and worry. They want to build their strengths, not just

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correct their weaknesses or removal of their suffering. They want lives imbued with meaning and purpose. The fostering of positive emotion and the building of character may help-both directly and indirectly-to alleviate suffering and to undo its root causes.5 In this context, present research was designed to examine positive and negative affectivity in MI, AP and controls. For this purpose, a three-group design was being suited. Sample comprised of 120 males equally divided in three groups i.e., MI, AP and control groups. The main objectives and hypothesis formulated in the research were to compare MI, AP and control groups on the measures of positive and negative affectivity. The crux of the research is built on an established fact that disease of the heart has a strong relationship with the changing lifestyles. Emotions do have a strong control over the functioning of heart as exhibited by the results that negative emotions and hostile atmosphere of tension and worries of daily life are harmful for the heart. In addition to the crucial role played by NA in physical illness the PA serves as a healing component. It is clear that positive emotions such as gratitude, interest and love provide more pleasant subjective experiences than do negative emotions such as anger, sadness, fear and anxiety.6 To the extent that positive emotions reduce the focus on negative emotions, they can put people’s minds at ease. ‘Positive emotions prompt individuals to engage with their environments and partake in activities’. Positive emotions, therefore, ‘broaden and build’ i.e., they broaden people’s momentary thought-action repertoires and build their enduring resources, ranging from physical and intellectual resources to social and psychological ones.6 Negative emotions produce specific action tendencies (narrowing of a person’s momentary thought-action repertoire) e.g., to escape (from fear), attack (when angry) or expel (when disgusted), which promotes quick and decisive action assisting survival. In contrast, positive emotions do not bring immediate adaptive benefits, but build personal resources which can be drawn on to manage future threats. For example, joy broadens by creating the urge to play, push the limits and be creative; interest broadens by creating the urge to explore, take in new information and experiences; contentment broadens by creating the urge to savor current life circumstances and integrate these circumstances into a new view of self and the world; pride broadens by creating the urge to share news of achievements and love (an amalgam of joy, interest and contentment) broadens by creating recurring cycles

CARDIOLOGY of urges to play with, explore and savor experiences with loved ones thus improving on habitual modes of thinking and behavior.6 The benefits of positive emotions are: i) Physiological undoing, i.e., physiologically down-regulate lingering negative emotions;7 ii) cognitive broadening i.e., cognitive broadening which expands and improves the ways people cope during crises and iii) resource building i.e., the broadening triggered by positive emotions builds a range of personal resources, including physical resources (e.g., physical skills, health, longevity), social resources (e.g., friendships, social support networks), intellectual resources (e.g., expert knowledge, intellectual complexity) and psychological resources (e.g., resilience, optimism, creativity). Recurrent experiences of positive emotions results in promotion of two healthy traits: Psychological resilience and positive emotional granularity. Psychological resilience is the flexibility in response to changing situational demands and the ability to bounce back from negative emotional experiences.7 Resilient individuals experience positive emotions even in the midst of stressful events, which may explain their ability to rebound successfully despite adversity. These individuals bounce back from negative emotional arousal physiologically as well. Resilient people may understand the benefits associated with positive emotions and use this knowledge to their advantage when coping with negative emotional events. Positive emotions appeared to aid resilient individuals in their ability to build psychological resources that are essential for coping effectively with large-scale tragedy. Thus, the positive emotions experienced by resilient people may serve as protective factors useful in promoting shortterm health benefits as well as long-term advantages for coping in the future. There are individual differences in how people verbally report their affective experiences, with highly granular individuals reporting their emotional experience in differentiated terms with discrete emotion labels (happy, content, sad, angry, etc.) to capture their distinctiveness, in contrast to low granular individuals who express emotional experiences in a more global and undifferentiated manner (feeling good or feeling bad). Those individuals with higher positive emotional granularity i.e., who represent positive emotional experiences with precision and specificity, are less likely to mentally self-distract during stressful times, are more engaged in the coping process, are less automatic in their responding and are more likely to think through

their behavioral options before acting.8 While coping is traditionally seen as ‘reactive’ or something that occurs temporarily after a stressful event, the approaches to coping reported by individuals with positive emotional granularity seem ‘proactive’ and future-oriented, in that the individual takes preparatory steps before acting on stress. Thus, by prompting one to scan one’s array of coping options, positive emotional granularity may afford an individual with the ability to stretch capacities for regulating negative emotional experiences. Positive emotional granularity, then, may be a mechanism by which resilient people achieve superior coping abilities. This powerful tool reduces human suffering to some extent and also reduces the intensity of an illness. It’s also crucial to recognize that suffering from stress, as acknowledging it’s a problem is the first step in the coping procedure. In order to cope effectively one must have a variety of coping skills and match the coping behavior to the stressor at hand. Problem solving is a strategy that quickly comes to mind as an effective way of attempting to remedy a negative situation, whereas emotion-focused coping strategies are numerous and lessen emotional distress. A high level of covert coping in men and a low level of open coping in women showed the strongest association with CHD.9 Jain et al,10 found angina patients showed more use of avoidance positive approach and avoidance negative approach and less of active cognitive approach when faced with stressful situations. The current study aimed at finding out the ways of coping in MI, AP and control group. MATERIAL AND METHODS The present investigation was planned to assess the role of coping mechanisms among CHD (i.e., MI and AP) patients. The sample of the study comprized of 120 subjects, 40 subjects falling in three categories i.e., MI, AP and controls. The sample of CHD patients was obtained from Escorts Heart Institute and Research Center (EHIRC), New Delhi, India. The control group sample was drawn out of the general population in the hospital premises, mostly the attendants of the patients with proper matching in terms of all relevant details, like religion (Hindus), socioeconomic status (middle and upper class) and age (25-65 years) of subjects. These precautions were taken in order to control variance due to certain potential

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CARDIOLOGY sociodemographic variables that might otherwise affect the main findings of the study. The sample was confined to pre-surgical patients pertaining to the complexities subsequently in activities of daily living. Positive and Negative Affect Schedule (PANAS) developed by Watson and Clark (1988) assessed two hypothesized major dimensions of mood i.e., positive and negative affectivity (PA and NA), whereas the brief cope inventory developed by Carver11 was used to measure coping mechanisms, comprising of 28 items, which measure 14 conceptually differentiable coping; reactions. Some of these reactions are known to be generally adaptive; others are known to be problematic. Different people have different ways of coping and this can be a huge stress on the relationship. The patient group (n = 80) was divided in two groups, AP (n = 40) and MI (n = 40). An assurance was provided to each of them about the confidentiality of results taking into account the ethical factors. Descriptive and inferential statistics was used; obtained data were analyzed using one-way analysis of variance (ANOVA) on the various dimensions of coping mechanisms. Significant effect of group was further assessed by post-hoc mean comparisons. RESULTS Keeping in view, the objectives of the study, obtained raw scores were analyzed by using one-way ANOVA using Newman Keuls test of post-hoc mean comparisons. Summary results indicated that mean scores of control group on the measure of positive affectivity differed significantly from MI and AP groups; however, the latter two groups did not yield significant mean differences on this measure. Analysis of post-hoc mean comparisons on the measure of negative affectivity showed that means of AP and MI groups are significantly higher than control group. But, mean differences between MI and AP group were not statistically significant. Secondly, post-hoc mean comparisons of all coping dimensions showed that MI group scored higher on dimensions of venting, behavioral disengagement and self-blame. The AP group used more of humor in the time of stress. The control group, on the other hand, used active coping, planning, positive reframing and emotional support. Most of the coping dimensions were found significant except acceptance, religion, emotional support, self-distraction, instrumental support, denial and substance use.

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Table 1. Summary of ANOVA and Post-hoc Mean Comparisons on the Measure of Positive and Negative Affectivity Source of variation (Groups)

Sum of squares

F value

Positive affectivity

2254.55

1127.27

33.04*

Negative affectivity

2561.51

1280.75

25.53*

*P < 0.01.

Table 2. Summary of ANOVA on the Coping Dimension Source of Variation (Groups)

Sum of squares

F value

Active coping

24.21

12.10

6.30*

Planning

46.95

23.47

9.07†

Positive reframing

12.91

6.45

3.50‡

Acceptance

3.01

1.508

0.96

Humor

18.20

9.10

3.39‡

Religion

1.80

0.900

0.27

Emotional support

10.95

5.47

1.95

Instrumental support

35.11

17.55

6.57*

Self-distraction

2.11

1.05

0.46

Denial

12.35

6.17

2.68

Venting

12.95

6.48

3.15‡

Substance use

0.117

5.83

0.05

Behavioral disengagement

12.95

6.47

3.75‡

Self-blame

67.95

33.97

11.93†

*P < 0.001; †p < 0.01; ‡p < 0.05.

DISCUSSION The present research accentuates the influence of affect and various coping dimensions prominently used in today’s stressful lives by CHD patients (MI and AP) and control group. Positive affectivity is beneficial for the body in general and heart in particular. Negative affectivity, on the contrary, increase heart rate and blood pressure and are thus harmful for the heart. When these occur repeatedly, they may result in various damages to the heart and other vascular organ systems. Emotions have a strong control over the functioning of the heart and various cardiac arrhythmias have been reported to occur by creating emotional disturbances. Putting the young animals in a hostile environment

CARDIOLOGY resulted in having high blood pressure. Thus, it is important that affect should be balanced themselves, then a person experience a calm, flexible soberness, in which he/she can switch easily to the appropriate affect for the situation. Results on the dimension of negative affectivity found the control group scored lowest as compared to MI and AP groups, whereas on positive affectivity dimension, the highest scores was obtained by control group. Researches in the past also indicated that the heart attack patients experience more life changing events and perceived more life changing events and perceived these events to be more stressful than controls and had eroded their defenses and coping strategies.12 Over the years, retrospective studies have found, for e.g., that negative emotions are often present before the symptoms of depression and anxiety in CHD patients. Prospective studies have shown that the likelihood of CHD tends to be higher for people with negative emotions than for those without them.13 Accumulating research indicates that PA and NA have strongly different associations; former is related with wide range of specific activities and events while in latter case, the aspects of perceived stress and health complaints are crucial.14 Therefore, it underlies the role of NA in precipitating the cardiovascular disease incorporating the importance of anxiety, anger and type A behavior patterns. In addition to the crucial role played by NA in physical illness, the PA serves as a healing component. It has been accentuated that PA emerges with holding a unique ability to down regulate the lingering cardiovascular after effects of negative emotions6,15 and facilitating in the speed recovery from the cardiovascular dilemma of negative emotions. Another finding on the dimension of coping mechanisms showed that the control group used most of active coping in stresses, whereas among the heart patients, the myocardial-infarcted group as compared with angina pectoris scored higher on active coping, have the tendency to cope by dealing actively with the problem that tend to be better off, avoided negative or catastrophic thinking patterns to live better. They might have lower levels of pain and less emotional disability (such as depression) and physical disability, regardless of disease severity.16 On the contrary, AP group compared with MI group, used more of planning before executing any tasks whereas MI group coping directed more towards positively reframing the situation or try to look for

something good in what is happening. Rom17 described the coping strategies of individuals who were between 3 and 15 months after a first MI. The strategy most used was a positive thinking way of coping to count one’s blessings. Thinking positively is more than simply avoiding negative emotions.18 Subjects also preferred to face and solve their problems and denial was the least preferable strategy. The findings have interesting parallel with the study of Fischler et al19 who found that subjects having poor cardiac function seemed to use mechanisms such as accepting responsibility, emotion focused coping and escape avoidance. This was found more in angina group followed by MI and control group. Angina group, whenever they have conflict, they solve it by making themselves at ease and then handle the situation. The use of ‘Religion’ as a way of coping was high in MI group, followed by AP group. The findings showed the tendency of MI group to turn to religion in times of stress for widely varying reasons as religion might serve as a source of emotional support, as a vehicle for positive reinterpretation and growth, or as a tactic of active coping with a stressor. Research showed higher levels of social support related to lower levels of state and trait anxiety, religiosity was related to lower state anxiety, but only modestly related to lower trait anxiety, suggesting that religiosity and social support provide a buffer against anxiety in CHD patients and that higher levels of social support may account for the relationship between religiosity and trait anxiety.20 Summary of results demonstrated that the coping mechanism of emotional support yielded insignificant results. The control group was involved more in getting moral support, sympathy or understanding, when they felt insecure by a stressful environment. Instrumental support was found significant and concentrated on taking advice and help from other people about what do in a problem situation. A dysfunctional family situation, however, can be very detrimental. Cochrane21 assessed the hypothesis that interpersonal physical contact experience contributes to the capacity to cope with stress. The use of ‘self-distraction’ as coping mechanism was highest in AP group, followed by control and MI groups. Even though no significant difference was found for this coping behavior, angina patients showed more use of avoidance positive approach and avoidance negative approach and less of active cognitive approach when faced with stressful situations.10 AP group tends to distract themselves from the stressful situation in order

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CARDIOLOGY to reduce their unpleasant feelings being generated e.g., turning to other work or activities to take the mind off things. Avoidance might result in decreased compliance with cardiac treatments, which in turn could lead to worsened disease status. Accepting responsibility was positively correlated with health perception. Denial is a psychological coping strategy that allows people to engage in behavior with little conscious awareness of the consequences.22 Prolonged denial of negative emotions and problems may substantially increase the risk of developing CHD. The coping response of ‘Denial’ was used more by AP group, followed by control and MI group. In this research, MI group used most venting in their problem situation to get over their feelings. Especially in the case of anger and its association with CHD, it has often been found that not expressing one’s anger (anger-in) might be risky, especially for hypertension. Bereavement is a common stressful event in late life that sometimes result in substance use, which results in coping behaviors that jeopardize health e.g., drinking alcohol, smoking cigarettes or using drugs to regulate negative emotional states. Mean differences among groups were not significant, but it was high in AP group, followed by control and MI groups, indicating that AP group people relied on the way of coping based on substance use. Behavioral disengagement focuses on reducing one’s effort to deal with the stressor, even giving up the attempt to attain goals with which the stressor is interfering. Mean differences among groups were statistically significant, indicating that MI group used most this type of coping than the other groups. They might be less engaged in finding solutions of the problem rather choose to leave the way it is. The results suggest that behavioral disengagement in relation to coping with disease-related strain is a significant predictor of mortality among heart failure patients.23 The findings focused that MI group might criticize or blame themselves for all the unhappenings. It may be dysfunctional as this would increase their negative feelings and they would use less coping efforts and worsen their problems. It means its use in greater quantity can predispose a disease-free person to the edge of having a heart disease. CONCLUSION These coping mechanisms are used in combination or separately, depending upon one’s psychological attributes. Therefore, it may be concluded that the

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coping process is not a single event rather involves ongoing transactions with the environment. People use many different methods to try to manage the appraised discrepancy between the demands of the situation and their resources, depending upon their personality characteristics that predispose them to cope in certain ways. The crux of the research is built on an established fact that disease of the heart has a strong relationship with the changing lifestyles. Emotions do have a strong control over the functioning of heart as exhibited by the results that negative emotional state and hostile atmosphere of tension and worries of daily life are harmful for the heart. The primordial prevention of heart attacks could start at an early stage. The woman as a mother, sister, wife, or friend should try to understand well the intricacies of human behavior and change it in positive direction which goes a long way towards helping in the prevention of heart attacks. Thus, “If nature has been unkind to men in giving them a more fragile heart, at least the women should handle it more carefully to prevent it from breaking.” As it is said, ‘Kinship of healing; we are physicians to each other’. Moreover, data is emerging very clearly to find ways to involve patients with CHD in lifestyle intervention programs that involve low fat diets, exercise and a strong psychosocial overlay that reduces their psychosocial risk factors and gets them in a position where they can grasp a lifestyle education program, that can have a huge impact on the number one disease in the country. It is necessary that in future, standard therapy in patients with CHD, should involve a psycho-educational program that involves not only lifestyle therapy, but also a program that teaches people about relationship skills, taking care of themselves and about taking care of the people around them. No research work is complete in itself, there are many things overlooked in the study and there were many alternatives, which could have been taken. The duration of the disease might be an important factor because chronic patients are certainly different from patients recently diagnosed. Secondly, the quality of care in the hospitals is an important issue and factors as the timing of intervention or medication were not controlled for the data for present research would have added more information if taken through interview technique or open-ended questionnaires. During the course of data collection, some modifiers particularly the aspect of spirituality, regardless of religion, are considered to be the prime focus among Indian population, who associate the occurrence of illness with the will of God

CARDIOLOGY considering it as a punishment and also seek help from religion to cope with their illness which should be probed further in future research. REFERENCES 1. World Health Organization. The World Health Report 2003: Shaping the Future. Geneva: Switzerland, 2003. 2. Folkman S, Moskowitz JT. Positive affect and the other side of coping. Am Psychol 2000;55(6):647-54. 3. Gallo LC, Ghaed SG, Bracken WS. Emotions, cognitions in CHD: risk, resilience and social context. Cogn Ther Res 2004;28(5):669-94. 4. Sheldon KM, Houser-Marko L. Self-concordance, goal attainment, and the pursuit of happiness: can there be an upward spiral? J Pers Soc Psychol 2001;80(1):152-65. 5. Swaminath G, Ravi Shankar Rao BR. Going beyond psychopathology-positive emotions and psychological resilience. Indian J Psychiatry 2010;52(2):6-8. 6. Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol 2001;56(3):218-26. 7. Tugade MM, Fredrickson BL. Resilient individuals use positive emotions to bounce back from negative emotional experiences. J Pers Soc Psychol 2004;86(2):320-33. 8. Tugade MM, Fredrickson BL. Emotions: Positive emotions and health. In: Encyclopedia of Health and Behavior. Anderson N (Ed.), (Sage, Thousand Oaks, CA) 2004:p.306-10. 9. Härenstam A, Theorell T, Kaijser L. Coping with angerprovoking situations, psychosocial working conditions, and ECG-detected signs of coronary heart disease. J Occup Health Psychol 2000;5(1):191-203.

12. Siegrist J. Life changes and onset of disease: a medicalsociological study. 1981;33:132-47. 13. Smith DF. Negative emotions and coronary heart disease: causally related or merely coexistent? A review. Scand J Psychol 2001;42(1):57-69. 14. Clark LA, Watson D. Diurnal variation in mood: Interaction with daily events and personality. Paper presented at the meeting of the American Psychological Association: Washington, DC; 1986. 15. Fredrickson BL, Levenson RW. Positive emotions speed recovery from the cardiovascular sequelae of negative emotions. Cogn Emot 1998;12(2):191-220. 16. Vitaliano PP, DeWolfe DJ, Maiuro RD, Russo J, Katon W. Appraised changeability of a stressor as a modifier of the relationship between coping and depression: a test of the hypothesis of fit. J Pers Soc Psychol 1990;59(3):582-92. 17. Rom M. Stressors and coping after a first myocardial infarction. J Soc Health 1995;56:1348. 18. Kubzansky LD, Kawachi I. Going to the heart of the matter: do negative emotions cause coronary heart disease? J Psychosom Res 2000;48(4-5):323-37. 19. Fischler B, Kaufman L, Daubach. Confrontive coping and myocardial infarction. Psychosomatic Medicine 1992;24:32-6. 20. Hughes JW, Tomlinson A, Blumenthal JA, Davidson J, Sketch MH, Watkins LL. Social support and religiosity as coping strategies for anxiety in hospitalized cardiac patients. Ann Behav Med 2004;28(3):179-85. 21. Cochrane N. Physical contact experience and coping ability: A study of survivors of myocardial infarction. Br J Health Psychol 2001;6(Part 4):385-96.

10. Jain B, Chopra L, Sokhey G. A study of stressful life events, psychological distress and coping behavior of angina patients and normal controls. J Personal Clin Stud 2000;16:68-74.

22. Allan R, Scheidt S. The empirical basis for cardiac psychology. In: Heart & Mind: The Practice of Cardiac Psychology. Allen R, Scheidt S (Eds.), American Psychological Association: Washington DC 1996:p.63-123.

11. Carver CS. You want to measure coping but your protocol’s too long: consider the brief COPE. Int J Behav Med 1997;4(1):92-100.

23. Murberg TA, Bru E. Coping and mortality among patients with congestive heart failure. Int J Behav Med 2001;8: 66-79.

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Impact of Vitamin D Supplementation on Lipid Profile and Clinical Status in Coronary Artery Disease Patients JIGNA SHAH*, ASHVINI SONI*, DRASTY VORA*, NINAD BADRAKIA†, KAMAL SHARMA‡

ABSTRACT Objective: To observe association between vitamin D deficiency, vitamin D supplementation and patient outcomes and to correlate vitamin D levels, lipid profile and angina assessment in coronary artery disease (CAD) patients. Method: A nonrandomized, open-label, single-centric study was conducted involving 56 patients having chronic stable CAD. Patients were divided into eight groups in which there were two different treatments atorvastatin alone and atorvastatin with vitamin D. The dose of atorvastatin was 10 mg, 20 mg, 40 mg and 80 mg, whereas dose of vitamin D was 1,000 IU/day + 60,000 IU/week till 8 weeks along with atorvastatin. The patients were treated for 12 weeks. The lipid profiles, serum vitamin D levels, incidence of myalgia and angina assessment were assessed before and after the therapy. Results: Atorvastatin along with vitamin D showed significant improvement in patients having insufficient level of serum vitamin D. The lipid profile also showed improvement in LDL cholesterol. The % reduction in LDL cholesterol was significant in atorvastatin + vitamin D group compared to atorvastatin alone group. The incidence of myalgia was observed in 5 (8.92%) patients in atorvastatin group, whereas in atorvastatin + vitamin D group none of the patients had complaint of myalgia. The occurrence of angina attacks per week (2.19) and sublingual nitrate consumption per week (2.35) were significantly reduced (p = 0.019, p = 0.010), respectively in atorvastatin + vitamin D group as compared to atorvastatin alone group. Conclusion: The present study demonstrated that atorvastatin and vitamin D combination acts synergistically in reducing lipid profile particularly in low-density lipoproteins. Supplementation of vitamin D improved serum vitamin D levels resulting in reduced incidence of statin-induced myalgia. The event of angina attacks and sublingual nitrate consumption also reduced by vitamin D supplementation.

Keywords: Coronary artery disease, vitamin D, atorvastatin, angina assessment

oronary artery disease (CAD) occurs when the arteries of the heart that normally provide blood and oxygen to the heart are narrowed or even completely blocked.1 The four most common and serious complications of CAD are angina pectoris, unstable angina, myocardial infarction and sudden cardiac death as the result of arrhythmias.2 Coronary heart disease (CHD) is the leading cause of death

*Dept. of Pharmacology Institute of Pharmacy, Nirma University, Ahmedabad, Gujarat †Ethicare Clinical Trial Services, Ahmedabad, Gujarat ‡Interventional Cardiologist Sanjeevani Super Speciality Hospitals, Ahmedabad, Gujarat Address for correspondence Dr Jigna Shah Professor and Head Dept. of Pharmacology Institute of Pharmacy, Nirma University, Sarkhej-Gandhinagar Highway Ahmedabad - 382 481, Gujarat E-mail: jigna.shah@nirmauni.ac.in

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worldwide. CAD, or more specifically, coronary atherosclerotic heart disease, is the primary cause of death in the United States for both men and women. Previously thought to affect primarily high-income countries, CHD now leads to more death and disability in low- and middle-income countries, with rates that are increasing disproportionately compared to highincome countries. CHD affects people at younger ages in low- and middle-income countries, compared to high-income countries, thereby having a greater economic impact on low- and middle-income countries. Vitamin D status is an emerging risk marker of great interest in cardiovascular disease (CVD). Vitamin D is a fat-soluble vitamin mainly accountable for bone homeostasis and metabolism.1,3 Research studies confirm role of vitamin D deficiency in hypertension,4,5 CVD,5-7 immune disorders, osteoporosis, cancers5,8 and type 1 and 2 diabetes.5,7 Levels of 25-hydroxy vitamin D (25[OH]D) between 20 and 30 ng/mL are defined as a relative insufficiency in vitamin D, whereas levels over 30 ng/mL

CARDIOLOGY are thought to represent sufficient vitamin D stores.3,9 It is estimated that 1 billion people worldwide have either vitamin D deficiency or relative insufficiency.9 Lower serum levels of vitamin D are associated with both cardiac risk factors and prevalent CVD. Various animal studies suggestive of link between vitamin D deficiency and cardiovascular dysfunction, including cardiac hypertrophy, fibrosis, hypertension, as well as alterations of serum calcium, parathyroid hormone and renin levels are reported. Researchers also reported that vitamin D is responsible for maintenance of cardiovascular homeostasis through both a direct action of 1,25(OH)2D on cardiomyocyte’s vitamin D receptor and indirect actions on circulating hormones and calcium.5,10-12 Experimental data suggest that 1,25(OH)2D affects cardiac muscle directly, controls parathyroid hormone secretion, regulates the reninangiotensin-aldosterone system and modulates the immune system. Researchers have confirmed that vitamin D plays an important role in endothelial function, blood pressure control and calcification of the coronary vasculature, increased vascular resistance and prevention of CVD.5 The effect of vitamin D on regulation of the lipid profile is one of the proposed mechanisms for the relationship between vitamin D deficiency and CVD. Experimental animal studies have shown that vitamin D deficiency leads to increased secretion of parathyroid hormone and activation of the renin-angiotensinaldosterone system (RAAS) and immune system. A number of observational studies in humans have also linked vitamin D deficiency to CVD. Despite this fairly large body of observational data, very few prospective, randomized, controlled trials have evaluated the benefit of vitamin D supplementation on cardiovascular health. Also some literature has shown that vitamin D along with statins shows significant improvement in lipid profile.9 OBJECTIVE To observe association between vitamin D deficiency, vitamin D supplementation and patient outcomes and to correlate vitamin D levels, lipid profile and angina assessment in CAD patients. METHOD A nonrandomized, open-label, single-centric study was conducted involving 56 patients having chronic stable CAD. The study was approved by Institutional Human Ethical Committee. Ethical standard in accordance

with the declaration of Helsinki was strictly followed. The patients were excluded if they were confined to a nursing facility, institution or home, had vitamin D >30 ng/mL, presence of liver disease, hypercalcemia, New York Heart Association (NYHA) Class III or IV heart failure, current planned or emergent coronary artery bypass grafting/percutaneous transluminal coronary angioplasty (CABG/PTCA), prior gastric or small bowel surgery, pancreatitis, inflammatory bowel disease, autoimmune disease, current use of >800 IU/ day of vitamin D, current use of dilantin, phenobarbitol, immunosuppressant or immunostimulant therapy, use of drugs for weight loss (e.g., orlistat, sibutramine, phenylpropanolamine) within 3 months of screening, surgery within 30 days of screening, history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) and renal failure. Patients who met the selection criteria were enrolled in the study. Screening and baseline procedures were performed during the hospitalization in which lipid profile and vitamin D level of patients were recorded. The patients were assigned the treatment as per the physician’s discretion either to atorvastatin alone or to atorvastatin with vitamin D. The patients assigned to the first arm received vitamin D - 1,000 IU/day (60,000 IU once per week for 8 weeks) plus atorvastatin in the dose of either 10 mg or 20 mg or 40 mg or 80 mg and the patients assigned to the second arm received atorvastatin alone in the dose of 10 mg or 20 mg or 40 mg or 80 mg. The patients were divided into eight different groups who were administered different doses of atorvastatin (10 mg, 20 mg, 40 mg and 80 mg) with and without vitamin D (at dose of 1,000 IU/day and an additional dose of 60,000 IU once per week). AT = Atorvastatin; D = Vitamin D. AT10: Atorvastatin 10 mg/day; AT10 + D: Atorvastatin 10 mg/day + Vitamin D 1,000 IU/day and 60,000 IU/week; AT20: Atorvastatin 20 mg/day; AT20 + D: Atorvastatin 20 mg/day + Vitamin D 1,000 IU/day and 60,000 IU/week; AT40: Atorvastatin 40 mg/day; AT40 + D: Atorvastatin 40 mg/day + Vitamin D 1,000 IU/day and 60,000 IU/week; AT80: Atorvastatin 80 mg/day; AT80 + D: Atorvastatin 80 mg/day + Vitamin D 1,000 IU/day and 60,000 IU/week. The study lasted up to 12 weeks and patients enrolled in the study were observed for baseline lipid profiles, serum vitamin D levels, incidence of myalgia and angina assessment on the day of enrollment i.e., Day 0 and at the end of 12 weeks i.e., visit 1. Data were presented as the mean value ± SD or number and evaluated using student’s t-test by using Graphpad Prism software.

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CARDIOLOGY aspirin and hypoglycemic agents) along with the study drug. As depicted in Table 3, the baseline serum of vitamin D level was observed as 13.19 ± 4.03 in AT10 group and 10.66 ± 2.56 in AT10 + vitamin D group. Twelve weeks post administration serum vitamin D level was significantly increased to 22.37 ± 1.66 (p < 0.0001) in AT10 + vitamin D group. Post administration serum vitamin D level was observed as 13.50 ± 3.78 in AT10 group, which was not significant as compared to baseline serum vitamin D level of AT10 group. The increase in serum vitamin D level in AT10 + D group at

RESULTS A total of 56 patients who met the selection criteria were enrolled in this nonrandomized, open-label, single-centric study. Table 1 shows the baseline characteristics of all the patients enrolled in the study, which includes age, sex, serum vitamin D levels and lipid profile. Table 2 depicts past medical history of enrolled patients with reference to concomitant drug therapies being administered (b-blockers, nitrates, angiotensin-converting enzyme (ACE) inhibitors, Table 1. Baseline Characteristics of Patients Baseline characteristics

AT10 (n = 8)

AT10 + D (n = 6)

AT20 (n = 10)

AT20 + D (n = 7)

AT40 (n = 7)

AT40 + D (n = 8)

AT80 (n = 6)

AT80 + D (n = 4)

Age (mean ± SD)

46.25 ± 14.31

46.16 ± 5.60

53.70 ± 9.60

45.42 ± 7.65

53.0 ± 8.18

60.37 ± 9.76

58.50 ± 6.02

50.50 ± 7.18

Male No. (%)

5 (62.5)

4 (66.67)

5 (50)

4 (57.14)

5 (62.5)

3 (50)

2 (50)

Female No. (%)

3 (37.5)

2 (33.33)

5 (50)

3 (42.86)

3 (42.85)

3 (37.5)

3 (50)

2 (50)

Serum vit D (ng/ mL) (mean ± SD)

13.19 ± 4.03

10.66 ± 1.53

16.62 ± 1.35

13.80 ± 1.88

17.8 ± 2.97

16.36 ± 3.05

16.63 ± 3.71

16.00 ± 2.48

TC (mg/dL) (mean ± SD)

223.62 ± 11.57

212.66 ± 11.51

248.60 ± 25.60

243.85 ± 9.19

308.42 ± 64.71

297.00 ± 46.12

316.0 ± 50.97

326.75 ± 39.82

LDL (mg/dL) (mean ± SD)

109.87 ± 13.71

102.05 ± 14.92

126.50 ± 33.18

115.14 ± 16.14

141.85 ± 20.01

145.37 ± 27.69

162.50 ± 21.86

166.50 ± 16.52

HDL (mg/dL) (mean ± SD)

50.19 ± 6.12

48.38 ± 9.34

41.18 ± 7.62

39.11 ± 7.81

33.94 ± 5.24

36.01 ± 1.46

26.45 ± 4.63

24.02 ± 1.59

TGs (mg/dL) (mean ± SD)

153.00 ± 38.72

172.50 ± 30.41

162.10 ± 31.20

190.28 ± 44.86

206.5 ± 16.85

210.62 ± 24.67

229.0 ± 36.72

208.00 ± 32.13

Values are expressed as mean ± SD; AT = Atorvastatin, D = Vitamin D.

Table 2. Medical History of Patients AT10 (%)

AT10 + D (%)

AT20 (%)

AT20 + D (%)

AT40 (%)

AT40 + D (%)

AT80 (%)

AT80 + D (%)

Past PTCA or CABG

12.5

16.66

85.71

57.14

Previous angina

87.5

83.33

100

87.5

100

IHD

100

Hypertension

33.33

85.71

83.33

Diabetes

37.5

Medical history

Medications b-blockers

100

Nitrates

87.5

83.33

100

87.5

100

33.33

85.71

83.33

12.5

16.66

85.71

57.14

37.5

ACE inhibitors Aspirin + Clopidogrel Hypoglycemic agents

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CARDIOLOGY the end of 12 weeks was significant as compared to baseline (p < 0.0001) and also was significant when compared with follow up levels of AT10 alone group (p = 0.0005) (Fig. 1). As shown in Table 4, the baseline serum vitamin D level was observed as 16.62 ± 4.05 in AT20 group and 13.80 ± 1.88 in AT20 + vitamin D group. Twelve weeks post administration serum vitamin D level was significantly increased to 26.01 ± 2.47 (p < 0.0001) in AT20 + vitamin D group. Post administration serum vitamin D level was observed as 16.79 ± 4.18 in AT20 group, which was not significant as compared to

baseline serum vitamin D level of AT20 group. The increase in serum vitamin D level in AT20 + D group at the end of 12 weeks was significant as compared to baseline (p < 0.0001) and also was significant when compared with follow-up levels of AT20 alone group (p = 0.0002) (Fig. 2). As shown in Table 5, the baseline serum vitamin D level was observed as 17.82 ± 2.97 in AT40 group and 16.36 ± 3.05 in AT40 + vitamin D group. Twelve weeks post administration serum vitamin D level was significantly increased to 28.70 ± 4.20 (p < 0.0001) in AT40 + vitamin D group. Post

Table 3. Post Administration Differences in Serum Vitamin D Levels in AT10 and AT10 + D group Patients

Comparison of serum vitamin D level in AT20 and AT20 + D patients

Parameter (ng/mL)

AT10

AT10 + D

P value

Baseline

13.19 ± 4.03

10.66 ± 2.56

0.20

Follow-up

13.50 ± 3.78 22.37 ± 1.66*,#

Serum vitamin D 0.0005

<0.0001

20 ng/mL

0.09

15 10

All data are expressed as mean ± SD; *p < 0.05 as compared to baseline; #p < 0.05 as compared to AT10 follow-up.

5 0

Comparison of serum vitamin D level in AT10 and AT10 + D patients

20 ng/mL

Follow-up

Figure 2. Post administration difference of serum vitamin D in AT20 and AT20 + D group.

Table 5. Post Administration Differences in Serum Vitamin D Levels in AT40 and AT40 + D Group Patients

*,#

Parameter (ng/mL)

AT40

AT40 + D

P value

17.82 ± 2.97

16.36 ± 3.05

0.36

Serum vitamin D

Baseline

Follow-up Baseline

Table 4. Post Administration Differences in Serum Vitamin D Levels in AT20 and AT20 + D Group Patients Parameter (ng/mL)

AT20

AT20 + D

18.43 ± 2.41

P value

Follow-up

Figure 1. Post administration difference of serum vitamin D in AT10 and AT10 + D group.

0.29

28.70 ±

4.20*,#

<0.0001

All data are expressed as mean ± SD; *p < 0.05 as compared to baseline; #p < 0.05 as compared to AT40 follow-up.

Comparison of serum vitamin D level in AT40 and AT40 + D Patients Atorvastatin 40 mg Atorvastatin + vitamin D 35 *,#

P value

30 25

16.62 ± 4.05

13.80 ± 1.88

16.79 ± 4.18 26.01 ±

2.47*,#

0.10 0.0002

ng/mL

Serum vitamin D

Follow-up

Baseline

Atorvastatin 10 mg Atorvastatin + vitamin D

Baseline

*,#

P value

Atorvastatin 20 mg Atorvastatin + vitamin D

20 15 10 5

P value

0.08

<0.0001

All data are expressed as mean ± SD; *p < 0.05 as compared to baseline; #p < 0.05 as compared to AT20 follow-up.

Baseline

Follow-up

Figure 3. Post administration difference of vitamin D in AT40 and AT40 + D group.

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Table 6. Post Administration Difference in Serum Vitamin D in AT80 and AT80 + D Group Patients Parameter (ng/mL)

AT80

AT80 + D

P value

16.66 ± 3.71

16.00 ± 2.48

0.76

Serum vit D Baseline Follow-up

17.38 ± 3.51 26.05 ±

P value

0.08

1.18*,#

0.0054

0.0007

All data are expressed as mean ± SD, *p < 0.05 as compared to baseline, #p < 0.05 as compared to AT80 follow-up.

Comparison of serum vitamin D level in AT80 and AT80 + D patients

Atorvastatin 80 mg Atorvastatin + Vitamin D *,#

25 20 ng/mL

administration serum vitamin D level was observed as 18.43 ± 2.41 in AT40 group, which was not significant as compared to baseline vitamin D level of AT40 group. The increase in serum vitamin D level in AT40 + D group at the end of 12 weeks was significant as compared to baseline (p < 0.0001) and also was significant when compared with follow-up levels of AT40 alone group (p < 0.0001) (Fig. 3). As shown in Table 6, the baseline serum vitamin D level was noted 16.66 ± 3.71 in AT80 group and 16.00 ± 2.48 in AT80 + vitamin D group. Twelve weeks post administration serum vitamin D levels was significantly increased to 26.05 ± 1.18 (p = 0.054) in AT80 + vitamin D group. Post administration serum vitamin D level was 17.38 ± 3.51 in AT80 group while 26.05 ± 1.18 in AT80 + vitamin D group, which was statistically significant (p = 0.0007) (Fig. 4). As shown in Table 7, the baseline total cholesterol level was 223.62 ± 11.57 in AT10 group and 212.66 ± 11.51 in AT10 + D group, while post administration, the total cholesterol level was decreased up to 184.00 ± 12.23 and 174.16 ± 11.88 in both groups, respectively and it was statistically significant (p < 0.0001). No significant difference was found between the two groups with regard to total cholesterol followup. The baseline low-density lipoprotein (LDL) level was observed as 109.87 ± 13.71 in AT10 group and 102.50 ± 14.92 in AT10 + vitamin D group, while the post administration LDL level after 12 weeks decreased up to 93.62 ± 09.60 and 80.00 ± 13.56 in both groups, respectively and it was statistically significant (p < 0.0001). Significant difference was also found between the two groups with regard to LDL follow-up (p = 0.04). With reference to the baseline, high-density lipoprotein (HDL) level was 50.19 ± 06.12 in AT10 group and 48.38 ± 09.54 in AT10 + vitamin D group, while the post administration HDL level after 12 weeks increased to 52.87 ± 05.64 and 51.07 ± 09.45 in both groups, respectively and it was statistically significant (p < 0.05). No significant difference was found between the two groups with regard to HDL follow-up. The baseline triglycerides level was 153.00 ± 38.72 in AT10 group and 172.50 ± 30.41 in AT10 + vitamin D group, while the post administration triglycerides level after 12 weeks was 127.37 ± 35.66 and 141.50 ± 30.47 in both groups, respectively and it was statistically significant (p < 0.05). No significant difference was found between the two groups with regard to triglycerides follow-up. As shown in Table 8, in AT20 group baseline total cholesterol was 248.60 ± 25.60, while in AT20 + vitamin D group, it noted was 243.85 ± 09.19 and in AT20 group, post administration total cholesterol was significantly decreased to 195.80 ±

15 10 5 0

Baseline

Follow-up

Figure 4. Post administration difference of serum vitamin D in AT80 and AT80 + D group.

Table 7. Lipid Profile Change in AT10 and AT10 + D Group Patient Parameter (mg/dL)

AT10 (n = 8)

AT10 + D (n = 6)

P value

Baseline

223.62 ± 11.57

212.66 ± 11.51

0.10

Follow-up

184.00 ± 12.23*

174.16 ± 11.88*

0.15

<0.0001

109.87 ± 13.71

102.50 ± 14.92

0.35

93.62 ± 09.60*

13.56*,#

0.04

P value LDL Baseline Follow-up P value

80.00 ±

<0.0001

Baseline

50.19 ± 06.12

48.38 ± 09.54

0.67

Follow-up

52.87 ± 05.64*

51.07 ± 09.45*

0.66

0.0002

0.005

HDL

P value TG Baseline

153.00 ± 38.72

172.50 ± 30.41

0.32

Follow-up

127.37 ± 35.66*

141.50 ± 30.47*

0.45

0.0002

<0.0001

P value

All data are expressed as mean ± SD; *p < 0.05 as compared to baseline; #p < 0.05 as compared to AT10 follow-up.

CARDIOLOGY 24.55 (p < 0.0001), while in AT20 + vitamin D group, it was also decreased to 187.28 ± 6.49 (p < 0.0001). Post administration, no significant difference was found between the two groups with regard to total cholesterol. In AT20 group, with reference to the baseline, LDL observed was 126.50 ± 33.18, while in AT20 + vitamin D group, it was 115.14 ± 16.14 and in AT20 group, post administration LDL was significantly decreased up to 100.09 ± 25.86 (p < 0.0001) while in AT20 + vitamin D group, it was also decreased up to 77.00 ± 15.09 (p < 0.0001). Post administration significant difference was found between the two groups with regard to LDL (p = 0.04). In AT20 group, baseline, HDL was 41.18 ± 07.62, while in AT20 + vitamin D group, it was 39.11 ± 07.81 and in AT20 group post administration HDL was significantly increased up to 44.09 ± 07.71 (p < 0.0001), while in AT20 + vitamin D group, it was also increased to 42.55 ± 08.41 (p < 0.0001). Post administration, no significant difference was found between the two groups with regard to HDL. In AT20 group, baseline triglycerides was 162.10 ± 31.20, while in AT20 + vitamin D group, it was 190.28 ± 44.86 and in AT20 group post administration, triglycerides was significantly decreased to 135.20 ± 27.50 (p < 0.0001), while in AT20 + vitamin D group, it was also decreased to 150.14 ± 39.18 (p < 0.0001). Post administration, no significant difference was found between the two groups with regard to triglycerides. As shown in Table 9, in AT40 group, baseline total cholesterol recorded was 308.42 ± 64.71, while in AT40 + vitamin D group, it was 297.00 ± 46.12 and in AT40 group, post administration total cholesterol was significantly decreased to 237.42 ± 60.87 (p < 0.0001) while in AT40 + vitamin D group, it was also decreased to 214.25 ± 47.54 (p < 0.0001). Post administration comparison showed no significant difference between the two groups with regard to total cholesterol. In AT40 group, with reference to the baseline LDL recorded was 141.85 ± 20.01 while in AT40 + vitamin D group, it was 145.37 ± 27.69 and in AT40 group, post administration LDL was significantly decreased to 109.00 ± 18.52 (p < 0.0001), while in AT40 + vitamin D group, it was also decreased to 90.75 ± 13.50 (p < 0.0001). Post administration comparison showed significant difference between the two groups in LDL (p = 0.04). In AT40 group, baseline HDL noted was 33.94 ± 05.24 while in AT40 + vitamin D group, it was 36.01 ± 01.46 and in AT40 group, post administration HDL was significantly increased to 36.71 ± 04.59 (p < 0.05), while in AT40 + vitamin D group, it was also increased to 39.51 ± 02.10 (p < 0.05). Post administration comparison showed no significant found between the two groups in HDL. In AT40 group,

Table 8. Lipid Profile Change in AT20 and AT20 + D Group Patients Parameter (mg/dL)

AT20 (n = 10)

AT20 + D (n = 7)

P value

Baseline

248.60 ± 25.60

243.85 ± 09.19

0.64

Follow-up

195.80 ± 24.55*

187.28 ± 6.49*

0.38

<0.0001

126.50 ± 33.18

115.14 ± 16.14

0.41

100.09 ± 25.86*

15.09*,#

0.04

P value LDL Baseline Follow-up P value

77.00 ±

<0.0001

Baseline

41.18 ± 07.62

39.11 ± 07.81

0.59

Follow-up

44.09 ± 07.71*

42.55 ± 08.41*

0.70

<0.0001

Baseline

162.10 ± 31.20

190.28 ± 44.86

0.14

Follow-up

135.20 ± 27.50*

150.14 ± 39.18*

0.36

<0.0001

HDL

P value TG

P value

All data are expressed as mean ± SD; *p < 0.05 as compared to baseline; #p < 0.05 as compared to AT20 follow-up.

Table 9. Lipid Profile Change in AT40 and AT40 + D Group Patients Parameter (mg/dL)

AT40 (n = 7)

AT40 + D (n = 8)

P value

Baseline

308.42 ± 64.71

297.00 ± 46.12

0.69

Follow-up

237.42 ± 60.87*

214.25 ± 47.54*

0.42

<0.0001

141.85 ± 20.01

145.37 ± 27.69

0.74

109.00 ± 18.52*

13.50*,#

0.04

P value LDL Baseline Follow-up P value

90.75 ±

<0.0001

Baseline

33.94 ± 05.24

36.01 ± 01.46

0.30

Follow-up

36.71 ± 04.59*

39.51 ± 02.10*

0.14

0.0024

0.0001

HDL

P value TG Baseline

206.57 ± 16.85

210.62 ± 24.67

0.72

Follow-up

165.42 ± 13.99*

162.12 ± 22.17*

0.74

<0.0001

P value

All data are expressed as mean ± SD; *p < 0.05 as compared to baselines; #p < 0.05 as compared to AT40 follow-up.

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

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CARDIOLOGY baseline triglycerides observed was 206.57 ± 16.85 while in AT40 + vitamin D group, it was 210.62 ± 24.67 and in AT40 group, post administration triglycerides was significantly decreased to 165.42 ± 13.99 (p < 0.0001) while in AT40 + vitamin D group, it was also decreased to 162.12 ± 22.17 (p < 0.0001). Post administration comparison showed no significant difference between the two groups with regard to triglycerides. As depicted in Table 10, in AT80 group baseline total cholesterol was noted 316.00 ± 50.97 while in AT80 + vitamin D group it was 326.75 ± 39.82 and in AT80 group post administration total cholesterol was significantly decreased to 226.00 ± 51.59 (p < 0.05) while in AT80 + vitamin D group, it was also decreased to 224.50 ± 32.72

Baseline

162.50 ± 21.86

166.50 ± 16.52

0.76

(p < 0.05). Post administration, no significant difference was found between the two groups with regard to total cholesterol. In AT80 group with reference to the baseline, LDL noted was 162.50 ± 21.86 while in AT80 + vitamin D group, it was 166.50 ± 16.52 and in AT80 group, post administration LDL was significantly decreased to 120.33 ± 12.54 (p < 0.05) while in AT80 + vitamin D group, it was also decreased to 100.00 ± 15.29 (p < 0.05). Post administration, significant difference was found between the two groups with regard to LDL (p = 0.04). In AT80 group, baseline HDL was observed to be 26.45 ± 04.63 while in AT80 + vitamin D group, it was 24.02 ± 01.59 and in AT80 group, post administration HDL was significantly increased to 29.83 ± 04.50 (p < 0.05) while in AT80 + vitamin D group, it was also increased to 27.35 ± 02.50 (p < 0.05). Post administration, no significant difference was found between the two groups with regard to HDL. Triglycerides level observed in AT80 group was 229.00 ± 36.72 while in AT80 + vitamin D group, it was 208.00 ± 32.13 and in AT80 group, post administration triglycerides was significantly decreased to 166.83 ± 34.09 (p < 0.05) while in AT80 + vitamin D group, it was also decreased to 133.25 ± 18.55 (p < 0.05). Post administration, no significant difference was found between the two groups with regard to triglycerides.

Follow-up

120.33 ± 12.54*

100.00 ± 15.29*,#

0.04

Formula to calculate (%) change:

0.0001

<0.0001

Baseline

26.45 ± 04.63

24.02 ± 01.59

0.34

Follow-up

29.83 ± 04.50*

27.35 ± 02.50*

0.35

0.0007

0.02

Baseline

229.00 ± 36.72

208.00 ± 32.13

0.38

Follow-up

166.83 ± 34.09*

133.25 ± 18.55*

0.11

<0.0001

0.0024

Table 10. Lipid Profile Change in AT80 and AT80 + D group Patients Parameter (mg/dL)

AT80 (n = 6)

AT80 + D (n = 4)

P value

TC Baseline

316.00 ± 50.97

326.75 ± 39.82

0.73

Follow-up

226.00 ± 51.59*

224.50 ± 32.72*

0.96

<0.0001

0.0002

P value LDL

P value

Difference of Post Administration and Pre Administration × 100 Pre Administration

HDL

P value TG

P value

All data are expressed as mean ± SD; *p < 0.05 as compared to baseline; #p < 0.05 as compared to AT80 follow-up.

As shown in Table 11 and Figure 5 the total cholesterol level was decreased to 17.71, 21.23, 23.02 and 28.48 in atorvastatin group while in atorvastatin + vitamin D group, it was reduced to 18.1, 23.19, 27.86 and 31.29, which was statistically insignificant. As observed in Table 11 and Figure 6, the LDL level was decreased to 14.71, 20.23, 23.15 and 25.95 in atorvastatin group, whereas in atorvastatin + vitamin D group, it was decreased up to 21.95, 33.12, 37.57 and 39.29, which was statistically significant

Table 11. Change (%) in Lipid Profile Parameters Parameters (mg/dL)

AT10 (n = 8)

AT10 + D (n = 6)

AT20 (n = 10)

AT20 + D (n = 7)

AT40 (n = 7)

AT40 + D (n = 8)

AT80 (n = 6)

AT80 + D (n = 4)

-17.71

-18.10

-21.23

-23.19

-23.02

-27.86

-28.48

-31.29

LDL

-14.79

-21.95

-20.23

-33.12

-23.15

-37.57

-25.95

-39.93

HDL

5.33

5.56

7.06

8.79

8.16

9.70

12.77

13.49

-16.75

-17.97

-16.59

-21.09

-19.92

-23.02

-27.14

-35.93

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Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

CARDIOLOGY (p < 0.05). As showed in Table 11 and Figure 7, HDL level was increased to 5.33, 7.06, 8.16, and 12.77 in atorvastatin group, whereas in atorvastatin + vitamin D group, it was increased to 5.56, 8.79, 9.7 and 13.49, Effect of drug therapy on total cholesterol (%)

which was statistically insignificant. As noted in Table 11 and Figure 8, triglycerides were decreased to 16.75, 16.59, 19.92 and 27.14 in atorvastatin group while in atorvastatin + vitamin D group, it was decreased to 17.97, 21.09, 23.02 and 35.93, which was statistically nonsignificant. The incidence of

0 % Reduction

-5

Effect of drug therapy on LDL (%) 0 -5 -10 -15 -20 -25 -30 -35 -40 -45

-10 -15 % Reduction

-20 -25 -30 -35 10

Atorvastatin

-17.71

-21.23

-23.02

-28.48

Atorvastatin + vitamin D

-18.1

-23.19

-27.86

-31.29

Figure 5. Post administration percentage reduction in total cholesterol.

Atorvastatin

-14.79

-20.23

-23.15

-25.95

Atorvastatin + vitamin D

-21.95

-33.12

-37.57

-39.93

Figure 6. Post administration percentage reduction in LDLs.

Effect of drug therapy on HDL (%) Effect of drug therapy on triglycerides (%) -0

-5

-10

% Reduction

% Change

10 8 6

-15 -20 -25

-30

-35

0 Atorvastatin Atorvastatin + vitamin D

-40 10 5.33

20 7.06

40 8.16

80 12.77

5.56

8.79

9.7

13.49

Figure 7. Post administration percentage changes in HDLs.

-16.75

-16.59

-19.92

-27.14

Atorvastatin + -17.97 vitamin D

-21.09

-23.02

-35.93

Atorvastatin

Figure 8. Post administration percentage reduction in triglycerides.

Table 12. Incidence of Myalgia in Patients AT10 (n = 8) 00

AT10 + D (n = 6)

AT20 (n = 10)

AT20 + D (n = 7)

AT40 (n = 7)

AT40 + D (n = 8)

AT80 (n = 6)

AT80 + D (n = 4)

02 (28.57%)

03 (50%)

Table 13. Angina Assessment of Patients Parameters

Atorvastatin (n = 25) Mean ± SD

Atorvastatin + Vitamin D (n = 25) Mean ± SD

P value

No. of angina attacks (per week)

2.58 ± 0.67

2.19 ± 0.44*

0.019

No. of sorbitrate consumption (per week)

2.85 ± 0.63

2.35 ± 0.65*

0.010

All data are expressed as mean ± SD; *p < 0.05 as compared to atorvastatin group.

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

943

CARDIOLOGY Angina assessment No. of angina attacks (per week) No. of sorbitrate consumption (per week)

4 3.5

3 *

2.5 2 1.5 1 0.5 0

Atorvastatin (n = 25)

Atorvastatin + vitamin D (n = 25)

Figure 9. Angina assessment of patients.

myalgia was observed more in atorvastatin group as compared to atorvastatin + vitamin D group (Table 12). Angina assessment was done for 50 patients as weekly record of patient diary of 50 patients only was available at the end of the study period. As shown in Table 13, number of angina attacks (per week) in atorvastatin group were 2.58 ± 0.67 while in atorvastatin + vitamin D group, angina attacks decreased to 2.19 ± 0.44, which was statistically significant (p = 0.019). The number of sorbitrate consumption (per week) in atorvastatin group was noted to be 2.85 ± 0.63 while in atorvastatin + vitamin D group, sorbitrate consumption decreased to 2.35 ± 0.65, which was also statistically significant (p = 0.010) (Fig. 9). DISCUSSION This open-label, single-centric, prospective study was designed to study the impact of vitamin D supplementation on lipid profile and clinical status in CAD patients. The study assessed the clinical status in terms of angina assessment in patients having CAD. In the present investigation, serum vitamin D level was significantly increased in atorvastatin group as compared to atorvastatin + vitamin D group. Also, the incidence of myalgia was observed more in atorvastatin group. A post analysis of the Treating to New Targets Trial6 that included 1,509 patients compared myalgia incidence between vitamin D deficient patients (<30 ng/mL) and those with normal levels. The analysis accounted for both baseline and 1 year vitamin D levels as well as their seasonal variation and found no relationship between vitamin D deficiency and myalgia incidence (hazard ratio [HR] 0.89, 95% confidence interval [CI] 0.62-1.27; p = 0.51). Another study of statin-treated patients7 noted that serum vitamin D levels at enrollment were lower in 128 patients with myalgia versus 493 asymptomatic patients (28.6

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Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

± 13.2 vs 34.2 ± 13.8 ng/mL, p < 0.0001). Of the 82 vitamin D deficient myalgic patients (vitamin D levels 20.8 ± 7.1 ng/mL), 38 were given vitamin D (50,000 units/week for 12 weeks), with an increase in serum vitamin D from 20.4 ± 7.3 to 48.2 ± 17.9 ng/mL (p < 0.0001) and resolution of myalgia in 35 (92%). Several studies have reported that vitamin D deficiency potentiates statin-induced myalgia. The mechanism is unclear, but vitamin D deficiency may decrease nuclear vitamin D receptor linked gene transcription and subsequent synthesis of protein required for repair of the T-tubular system and prevention of subsarcolemmal rupture.8 Vitamin D deficiency may lead to ‘preferential shunting’ of CYP3A4 for hydroxylation of vitamin D, reducing availability of CYP3A4 for statin metabolism, leading to statin-induced toxicity,13 but the relationship of vitamin D to statin-related muscle complaints and a possible mechanism are unclear. In our study, all patients suffering from vitamin D deficiency were having abnormal lipid profiles. It has previously been reported that people with vitamin D deficiency have increased vascular calcification, a sign of advanced atherosclerosis,14 as well as increased aortic stiffness.10 This vitamin D-related effects promote arterial disease. Gupta et al11 observed that vitamin D deficient high cholesterol diet produced significant vitamin D deficiency in swine. In earlier study, serum 25(OH)D was significantly lower in the peripheral artery disease (PAD) patients group as compared with the controls. Similarly, the result of a large epidemiological study indicated that there is a strong association between lower levels of 25(OH)D levels and prevalence of PAD.12 Anderson et al15 found that patients with vitamin D deficiency had a greater prevalence of cardiovascular risk factors at baseline (i.e., hypertension, diabetes, hyperlipidemia), and importantly, those deficient in vitamin D without previous cardiovascular risk factors were much more likely to develop them during followup. Beyond, the cardiovascular risk factors, vitamin D deficiency was associated with an up to 2-fold greater prevalence of several CVD categories, with those with severe deficiency at greatest risk. In the present study, vitamin D supplementation improved vitamin D. Previously,16 it was reported that benefits of vitamin D supplementation on survival were significant for those patients with a documented deficiency. This benefit was independent of the concomitant use of other cardioprotective drugs such as aspirin or statins. Our results showed that the percentage reduction in lipid profile was dose-dependent and there were significant reduction

CARDIOLOGY in LDL levels with vitamin D therapy, while other parameters like total cholesterol, HDL and triglycerides were insignificantly altered with vitamin D therapy against different doses of atorvastatin. By contrast, a similar study found that calcium and vitamin D supplementation resulted in significantly decreased serum LDL cholesterol levels,17 while a randomized controlled trial (RCT)18 in overweight subjects found that over 12 months of vitamin D supplementation resulted in a significant decrease in serum triglyceride concentrations, but not in serum LDL cholesterol levels. Vitamin D status may affect lipid changes during statin therapy, and some have suggested that adequate vitamin D levels >12 ng/mL may be required for atorvastatin to reduce lipid levels.19 Among 63 patients with acute myocardial infarction treated with low(10-20 mg) or high-dose (40-80 mg) atorvastatin, there was no reduction in total cholesterol (173 ± 47 mg/dL vs 164 ± 51 mg/dL), triglycerides (151 ± 49 mg/dL vs 177 ± 94 mg/dL) or LDL cholesterol (111 ± 48 mg/dL vs 92 ± 45 mg/dL) at 12 months in patients classified as vitamin D deficient (25[OH]D) <12 ng/mL. Patients classified as insufficient 12.0-20.0 ng/mL and normal >20.0 ng/mL had the expected reduction in total and LDL cholesterol and triglycerides. Similarly, in an additional study,20 supplemental vitamin D (800 IU/day) enhanced the effect of atorvastatin therapy (45 ± 33 mg/day) on total and LDL cholesterol (157 ± 37 vs 169 ± 35 mg/dL and 83 ± 30 vs 97 ± 28 mg/dL, respectively, (p < 0.005). The mechanism by which increased vitamin D potentiates the effect of atorvastatin on lipids may be mediated by vitamin D effects on hydroxymethylglutaryl coenzyme A (HMGCoA) reductase activity. Hydroxylated vitamin D derivatives inhibit HMG-CoA reductase activity so decreased 25-hydroxycholecalciferol would increase both HMG-CoA reductase and cholesterol levels. It is hypothesized that a sufficient, but unspecified concentration of vitamin D is required for a synergistic effect with statins on lipid levels. Consequently, even though vitamin D supplementation lowers serum levels of atorvastatin and its active metabolite,20 vitamin D actually magnifies the reduction in LDL cholesterol achieved during atorvastatin therapy.19 These results appear paradoxical since 1,25-dihydroxycholecalciferol activates CYP3A4, which metabolizes atorvastatin to its main metabolites21 in the intestine and liver.22 This should decrease atorvastatin levels and the efficacy of atorvastatin in reducing total and LDL cholesterol, but higher vitamin D levels appeared to enhance atorvastatin’s effect in this study.19

From all the above reported studies, it is evident that only a large, specifically designed RCT will be able to clarify possible effect of vitamin D on plasma lipids. A growing body of evidence suggests that vitamin D deficiency is associated with increased cardiovascular morbidity and mortality.11 Similarly, in healthy male health professionals aged 40-75 years with no histories of CAD, vitamin D deficiency (25[OH]D <15 ng/mL) was associated with a 2-fold increased rate of myocardial infarction over a 10-year period.23 In the Framingham Offspring Study, subjects with no histories of CVD and severe vitamin D deficiency (25[OH]D <10 ng/mL) had increased risk for developing a first cardiovascular event after 5-year of follow-up compared with subjects with 25(OH)D levels >15 ng/mL (HR 1.80, 95% CI 1.05-3.08).24 In >3,000 subjects, who underwent coronary angiography, those with severe vitamin D deficiency (<10 ng/mL) had 3-5 times the risk for death from sudden cardiac death, heart failure or fatal stroke during a 7-year follow-up period compared to those who had optimal levels of vitamin D (>30 ng/mL).25 In our study, number of angina attacks in atorvastatin group and also number of sorbitrate consumption per week were more as compared to the atorvastatin + vitamin D group. Vitamin D deficiency has been strongly associated with cardiovascular risk factors and outcomes but randomized trials have not yet been done to demonstrate that normalizing vitamin D levels will improve cardiovascular health and prognosis. Thus, it is reasonable to screen patients with acute myocardial infarction with vitamin D level and correct deficient levels according to nationally established consensus guidelines to optimize overall health.13 Our findings, taken in the context of previous observations, suggest that vitamin D deficiency represents important new cardiovascular link and might play a causal role in the development of symptom modulation of CVDs and it’s symptoms apart from lipid modulation when used with statin. When supplementation is used at studied doses, it appears safe and well-tolerated. Because vitamin D supplements are readily available, clinical trials are needed to determine whether vitamin D supplementation therapy can reduce the associated increase in cardiovascular risk. A single-centric, short duration study with limited sample size at single center was the limitation of our study. Possibilities of convenient sampling, which might increase the risk of selection bias especially in the light of small sample size cannot be ruled out. CONCLUSION

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

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CARDIOLOGY The present study demonstrated that vitamin D with atorvastatin acts synergistically in reducing lipid profiles particularly in LDLs. Supplementation of vitamin D used at studied doses appears safe and well-tolerated. Supplementation of vitamin D with atorvastatin reduced the incidence of statin-induced myalgia. The event of angina attacks and sorbitrate consumption also reduced by vitamin D supplementation. Vitamin D supplementation should not be routine practice, but may be considered in patients not adequately treated despite optimization of medical therapy. Further, large RCTs warranted to know whether vitamin D supplementation can prevent or treat CVDs. REFERENCES 1. Huffman DM. A report on coronary heart disease in India by Center for Chronic Disease Control. 2008. 2. Coronary artery disease information. January 2002. Available from: http://www.micromedex.com/products/ altmeddexprotocols/samples/coronaryartery.pdf. 3. Nemerovski CW, Dorsch MP, Simpson RU, Bone HG, Aaronson KD, Bleske BE. Vitamin D and cardiovascular disease. Pharmacotherapy 2009;29(6):691-708. 4. Rudisch B, Nemeroff CB. Epidemiology of comorbid coronary artery disease and depression. Biol Psychiatry 2003;54(3):227-40. 5. Rojas-Rivera J, De La Piedra C, Ramos A, Ortiz A, Egido J. The expanding spectrum of biological actions of vitamin D. Nephrol Dial Transplant 2010;25(9):2850-65. 6. Bittner V, Wenger NK, Waters DD, DeMicco DA, Messing M, LaRosa JC. Vitamin D levels are not related to myalgias in statin-treated patients with stable coronary disease. Am J Cardiol 2010;55(10A). 7. Ahmed W, Khan N, Glueck CJ, Pandey S, Wang P, Goldenberg N, et al. Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients. Transl Res 2009;153(1):11-6. 8. Schubert L, DeLuca HF. Hypophosphatemia is responsible for skeletal muscle weakness of vitamin D deficiency. Arch Biochem Biophys 2010;500(2):157-61. 9. Saedisomeolia A, Taheri E, Djalali M, Moghadam AM, Qorbani M. Association between serum level of vitamin D and lipid profiles in type 2 diabetic patients in Iran. J Diabetes Metab Disord 2014;13(1):7. 10. Reynolds JA, Haque S, Berry JL, Pemberton P, Teh LS, Ho P, et al. 25-Hydroxyvitamin D deficiency is associated with increased aortic stiffness in patients with systemic lupus erythematosus. Rheumatology (Oxford) 2012;51(3):544-51. 11. Gupta A, Thompson PD. The relationship of vitamin D deficiency to statin myopathy. Atherosclerosis 2011;215(1):23-9. 12. Melamed ML, Muntner P, Michos ED, Uribarri J, Weber C, Sharma J, et al. Serum 25-hydroxyvitamin D levels and

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the prevalence of peripheral arterial disease: results from NHANES 2001 to 2004. Arterioscler Thromb Vasc Biol 2008;28(6):1179-85. 13. Lee P, Greenfield JR, Campbell LV. Vitamin D insufficiency: a novel mechanism of statin-induced myalgia? Clin Endocrinol (Oxf) 2009;71(1):154-5. 14. Zagura M, Serg M, Kampus P, Zilmer M, Eha J, Unt E, et al. Aortic stiffness and vitamin D are independent markers of aortic calcification in patients with peripheral arterial disease and in healthy subjects. Eur J Vasc Endovasc Surg 2011;42(5):689-95. 15. Anderson JL, May HT, Horney BD, Bair TL, Hall NL, et al. Relation of Vitamin D deficiency to cardiovascular risk factors, disease status, and incident events in a general healthcare population. Am J Cardiol2010;963-7. 16. Vacek JL, Vanga SR, Good M, Lai SM, Lakkireddy D, Howard PA. Vitamin D deficiency and supplementation and relation to cardiovascular health. Am J Cardiol 2012;109(3):359-63. 17. Major GC, Alarie F, Doré J, Phouttama S, Tremblay A. Supplementation with calcium + vitamin D enhances the beneficial effect of weight loss on plasma lipid and lipoprotein concentrations. Am J Clin Nutr 2007;85(1): 54-9. 18. Rajpathak SN, Xue X, Wassertheil-Smoller S, Van Horn L, Robinson JG, Liu S, et al. Effect of 5 y of calcium plus vitamin D supplementation on change in circulating lipids: results from the Women’s Health Initiative. Am J Clin Nutr 2010;91(4):894-9. 19. Pérez-Castrillón JL, Abad Manteca L, Vega G, del Pino Montes J, de Luis D, Dueňas Laita A. Vitamin D levels and lipid response to atorvastatin. Intern J Endocrinol 2010;2010:320721. 20. Schwartz JB. Effects of vitamin D supplementation in atorvastatin-treated patients: a new drug interaction with an unexpected consequence. Clin Pharmacol Ther 2009;85(2):198-203. 21. Thummel KE, Brimer C, Yasuda K, Thottassery J, Senn T, Lin Y, et al. Transcriptional control of intestinal cytochrome P-4503A by 1alpha,25-dihydroxy vitamin D3. Mol Pharmacol 2001;60(6):1399-406. 22. Lennernäs H. Clinical pharmacokinetics of atorvastatin. Clin Pharmacokinet 2003;42(13):1141-60. 23. Giovannucci E, Liu Y, Hollis BW, Rimm EB. 25-hydroxyvitamin D and risk of myocardial infarction in men: a prospective study. Arch Intern Med 2008;168(11):1174-80. 24. Wang TJ, Pencina MJ, Booth SL, Jacques PF, Ingelsson E, Lanier K, et al. Vitamin D deficiency and risk of cardiovascular disease. Circulation 2008;117(4):503-11. 25. Pilz S, Dobnig H, Fischer JE, Wellnitz B, Seelhorst U, Boehm BO, März W. Low vitamin d levels predict stroke in patients referred to coronary angiography. Stroke 2008;39(9):2611-3.

COMMUNITY MEDICINE

Validation of Postnatal Care Health Data Reported Under Health Management Information System by the Primary Health Centers of Rural Vadodara, Gujarat SANGITA V PATEL*, HARSH BAKSHI†, DHARA ZALAVADIYA‡, PRAKASH KOTECHA#

ABSTRACT Background: Postnatal care (PNC) is a part of maternal and child health (MCH) and important for the good health of both mother and child, therefore present study was conducted with the aim to study the PNC data reported by primary health center/ subcenter (PHC/SC) and validate them at the village level and assess quality of care given. Material and methods: A sample of 20 PHCs, 13 rural and seven tribal, was selected using stratified random sampling. For every PHC, 2 SCs and for every SC, one village were selected. Data on PNC were collected from the PHC/SC records and validated by interviewing five beneficiaries from the village. Results: The district availability of PNC was 31.8%, while the overall accessibility was 52.2%. Adjusted utilization for the district was 74.7 for SBA and 14.7% for TBA. Effective coverage, adjusted for quality of care, for the district was 25.2%. Conclusions: The gap between the reported and validated data ranged from 15% to 51% of the reported.

Keywords: Postnatal care, validation, Health Management Information System, primary health care

ndia has adopted the concept of primary health care, as declared in Alma Ata Conference (1978), whereby the state provides health care to the population, through a network of primary health centers (PHCs) and subcentres (SCs). The community outreach services are provided by the SCs. Under the National Rural Health Mission (NRHM), every health facility is expected to formulate their local health plans based on their local health priorities. For planning, monitoring and evaluation purposes, the manager at the health facility needs data regarding population distribution, disease burden, beneficiaries for different

*Associate Professor Dept. of Community Medicine Baroda Medical College, Baroda, Gujarat †Assistant Professor Dept. of Community Medicine GMERS Medical College, Sola, Ahmedabad, Gujarat ‡Dept. of Community Medicine Baroda Medical College, Baroda, Gujarat #Technical Advisor A2Z Project India, New Delhi Address for correspondence Dr Sangita V Patel Gokul Society, Sindhwai Mata Road, Pratap Nagar, Baroda, Gujarat E-mail: sangita_psm@yahoo.co.in

health services and many others too.1,2 Health Management Information System (HMIS) is defined by the World Health Organization (WHO), at Conference on Health Information System, 1973 as, “a mechanism for the collection, processing, analysis and transmission of information required for organizing and operating health services, and also for research and training”.3 HMIS, thus, is an information system that is especially designed to assist in the management and planning of all health programs. Poor information systems do not only fail to portray the real health situation, but are themselves barriers for scaling-up health services.4 In any community, mothers and children constitute a priority group. They comprise, 71.14% of the population of the developing countries. In India also, women of childbearing age and children under 15 years of age comprise 57.5% of the total population. By virtue of sheer numbers only, they are the major consumers of health care services. They are also a vulnerable group, as far as health is concerned and improving their health can significantly contribute to the health of the general population.3 The time of highest risk of death is the same for mothers and for newborns—on the day of delivery

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COMMUNITY MEDICINE and over the next few days after delivery. These data offer compelling evidence that integrated maternal and newborn postnatal care (PNC) during the first few days after delivery should be provided to all newborns and their mothers as a concerted strategy to improve survival of both. This exercise was carried out to assess and understand the status of PNC activities in Vadodara district of Gujarat by validating the records using the format and guidelines as proposed in the Border District Cluster Strategy (BDCS). The tool, based on John Hopkins’s monitoring steps, was developed by the UNICEF to monitor minimum intervention package of Reproductive Child Health (RCH) activities in BDCS districts. OBJECTIVES ÂÂ

ÂÂ

To study the data pertaining to PNC in terms of availability, accessibility, utilization, coverage reported, validate and compare them between tribal and non-tribal areas at the SC/village level. To assess the progress or low performance of the indicators and analyze the possible causes of major bottlenecks for effective coverage. To assess the quality of care being provided as evident from the technical competence of the health provider and client satisfaction.

MATERIAL AND METHODS

Study Area and Sampling The district can be divided into tribal and non-tribal zones. Four talukas (blocks) form the east area, which is hilly and tribal. Rests are a part of the plane of middle Gujarat. Sample size was selected based on consultation with UNICEF. The health indicators and other related parameters differ widely in tribal areas as compared to non-tribal areas.5,6 So, stratified sampling was done so as to proportionately select 20 PHCs with tribal: Non-tribal distribution of 1:1.7. Two separate lists were made, one for the PHCs in the tribal blocks and the other containing the PHCs in the non-tribal blocks. With the help of Epi-Info 6 - Version 6.04d software 7 PHCs from tribal blocks and 13 PHCs from non-tribal blocks were randomly selected. For each of the PHCs, 2 SCs were selected, one situated near and the other distant from the PHC. From each of the SC, 1 village was selected. Thus, this exercise was carried out in 20 PHCs, 40 SCs and 40 villages of Vadodara district (Rural). Validation exercise was then conducted in each of these villages where five

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Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

beneficiaries were interviewed who got the PNC services.

Data Collection Study was conducted between April 2009 and August 2009. Reference period for the study was taken from April 2008 to March 2009. Data was collected in the prescribed formats for PHCs and SCs. It was checked for errors, entered and analyzed using Microsoft Excel software. District estimates for each of the interventions were then calculated using the monitoring tools described later. The guidelines used were the same as used by UNICEF for monitoring under the BDCS strategy.7 However, some modifications were made, incorporating the newer policy changes. Tools for validation included: Availability, accessibility, utilization, adequate coverage and effective coverage.

Ethics The study was approved by the Institutional Review Board Committee of the Institute. Data collection for natal and postnatal care Target Population Cumulative number of deliveries conducted during the reference period in the PHC area was the target population. To calculate the target population, the formula used was: Target population = Coverage Steps

Crude birth rate (CBR) × Population 1000

Availability This was defined as percentage of days disposable delivery kits (DDKs) were available in adequate quantity during the reference period. Stock register maintained at PHC provided the statement on date and quantity of items received and issued during the reference period. Based on stock register, availability was calculated as: No. of days DDKs available a) 365

× 100

In order to ensure clean delivery, DDKs are provided to the pregnant women and are expected to be used in case of home delivery. Therefore, proportion of home deliveries was taken in the denominator, while calculating the adequacy of DDKs. The district coverage for home delivery - 40%, was used for calculating adequacy.

COMMUNITY MEDICINE Total number of DDKs available b) × 100 Target population × proportion of home deliveries

This data was available at PHC from the RCH Form-7, which is collated from Form-6 of all the SCs.

Lower of these percentages was taken as the availability figure for the study PHC. Validation at SC: Whether the female health worker/ trained birth attendant (FHW/TBA) received DDKs as mentioned in the PHC stock register was checked and it was confirmed whether she was using it and/or gave them to TBAs/families. Accessibility Both skilled and trained birth attendants were considered separately. Even if FHW/FHS/MO (female health superviser/medical officer) were conducting deliveries, but not staying at the headquarter or viceversa, accessibility was taken as zero. No. of SC/PHCs with FHW/ LHV/MO residing in their area of posting and conduction on an average at a) Accessibility least one delivery in a month for skilled birth × 100 attendant (SBA) Total number of PHC and SCs in the PHC area No. of villages with resident trained birth attendant and conduction of at least one delivery alternate months b) Accessibility × 100 for TBA Total number of villages Validation at PHC, SC and village: In order to validate these data, the birth registers were checked for the deliveries, conducted by SBAs and TBAs. Utilization The initiation of the service is taken as the utilization. For intranatal care, utilization for SBAs was defined as percentage of deliveries attended by SBAs, i.e., MO/ FHS/FHW at institution or at home. This included deliveries conducted at private hospitals/nursing homes by doctor or nurses.

Validation at SC and village: Form-6 of any month of the SC was taken. The data were validated at explained earlier. Client satisfaction was assessed as described for earlier indicators. Adequate Coverage It indicates the continuity and complete utilization of services. For intranatal care and PNC, adequate coverage was defined as the percentage of women delivered by skilled attendant, newborn-weighed within 48 hours and received at least three PNC within 10 days. The district estimate was calculated for each of these three indicators by averaging the values obtained for each PHC. Cumulative number of women delivered by SBA a) × 100 Target population b)

Cumulative number of women received PNC3 Target population

× 100

Cumulative number of newborn weighed × 100 Target population

Validation at SC and village: Form-6 of any month of the SC was taken and the data validated in a similar fashion as explained earlier. Client satisfaction was also assessed. Correction factors, thus calculated were multiplied with the averaged estimates to give adjusted values for all the indicators. The lowest of the figures was taken as the district coverage. Effective Coverage

Total number of deliveries conducted by auxiliary nurse midwife (ANM)/LHV/MO a) Utilization × 100 for SBA Target population

It indicates the quality of services. For monitoring, effective coverage was defined as the percentage of pregnant women adequately covered by FHWs skilled to mange third stage of labor and gave basic newborn care. Depending upon her performance and knowledge, her skills were assessed as given in Annex IV. Correction factor for quality was calculated at the district level based on findings of all SCs.

For TBA, utilization was defined as percentage of deliveries attended by TBAs.

Adjustment of District Estimates based on Validation Exercise

b) Utilization for TBA

Total number of deliveries conducted by TBAs Target population

× 100

After the completion of monitoring and validation exercise in all the PHCs (or proportion of PHCs), district coverage was estimated and adjusted based on the PHC and SC data as explained in Table 1.

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COMMUNITY MEDICINE for SBA and TBA. The estimates for accessibility were as follows:

The formula for adjustment is: Availability = Average of PHC availability

The district estimate for accessibility of SBA was 30.9%. The SBA accessibility was higher in non-tribal (33.2%) as compared to tribal areas (12.1%). The estimates of accessibility of TBA were higher than those for SBA. Accessibility of TBA for the district, tribal and non-tribal areas was 50.6%, 55.1% and 52.2%, respectively (Table 2).

Accessibility = Average of SC accessibility Adj. Utilization-SBA = Average of PHC Utilization-SBA × correction factor for SBA Adj. Utilization-TBA = Average of PHC Utilization-TBA × correction factor for TBA Adj. Adequate coverage = Minimum of (Average of PHC Coverage SBA/PNC3/Newborn weighed × correction factor for that indicator)

Utilization The initiation of the service was taken as the utilization. For intranatal care, utilization for SBA was defined as percentage of deliveries attended by SBAs, i.e., MO/ FHS/FHW at institution or at home. This also included deliveries conducted at private hospitals/nursing homes by doctor or nurses. For TBA, utilization is defined

Effective coverage = Adj. Adequate coverage × CF for quality Natal and PNC services RESULT

Natal and Postnatal Care

31.8%

31%

33.3%

For DDKs, adequacy was higher than periodicity. Both were higher for non-tribal areas. The availability estimate form the district was 31.8%. It was higher for non-tribal areas (33.3%) as compared to tribal areas (28.5%) (Fig. 1).

36.8%

39.5%

Total

28.5%

51.1%

This is defined as percentage of days DDKs were available in adequate quantity during the reference period. Minimum of periodicity or adequacy was taken as availability for the PHC.

Vadodara - (Tribal) 49.6%

Vadodara - (Non-tribal) 60

46.2%

Availability

Accessibility Accessibility was taken as proportion of MO/FHS/ FHW/TBA residing at the head quarter and conducting at least one delivery a month. It was assessed separately

0 Periodicity DDK

Adequacy DDK

Availability DDK

Figure 1. Periodicity, adequacy and availability of DDKs.

Table 1. District Summary Sheet for Adjustment Accessibility for delivery and PNC Intervention

SC1

SC2

SCk

Total

Average (Z1, Z2, …Zk)

Correction factor

Sum Sum Sum Sum A B C D

(SumD x SumB)

Average (S1, S2,…Sk)

Avg (S1, S2,…Sk)

(SumC x SumA)

Delivered by SBA Delivery by TBA PNC3 within 10 days Birth weight within 48 hours FHW manage third stage of labor properly and give basic newborn care

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Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

COMMUNITY MEDICINE as percentage of deliveries attended by TBAs. The estimate of utilization of SBA, based on the reported data, for the district, tribal and non-tribal areas was 87.9%, 88.6% and 86.5%, respectively. The estimate of utilization of TBA, based on the reported data, for the district, tribal and non-tribal areas was 14.7%, 12.6% and 18.8%, respectively.

Adequate Coverage

Table 2. Accessibility of SBA and TBA

It indicates the continuity and complete utilization of services. For intranatal care and PNC, adequate coverage was defined as minimum of the percentage of women delivered by skilled attendant; newbornweighed within 48 hours and received at least three PNC within 10 days. PHC coverage was estimated based on the reported data. District estimates were calculated by averaging the PHC coverage for all the three indicators. Depending upon the extent to which the reported data was validated, a correction factor (CF) was calculated. Adequate coverage estimated was multiplied with this CF to obtain adjusted adequate coverage. Minimum of the four adjusted coverage was taken as the district estimate. Minimum adjusted coverage for the district, tribal and non-tribal areas was that of PNC3. Adjusted adequate coverage for the district was 37%. The coverage for non-tribal and tribal areas was 38.2% and 33.8%, respectively (Table 4 and Fig. 2).

Region

Effective Coverage

Following validation, 85% of the data was validated for deliveries conducted by SBA. Proportion validated was similar in both tribal and non-tribal areas. For, the delivery conducted by TBA, 100% validation was considered. Accordingly, the adjusted estimates thus obtained, for SBA were: District (74.7%), non-tribal (75.4%) and tribal (72.7%); and for TBA were: District (14.7%), non-tribal (12.6%) and tribal (18.8%) (Table 3).

Accessibility (in %) - SBA

Accessibility (in %) - TBA

Vadodara (Nontribal)

33.2

50.6

Vadodara (Tribal)

26.6

55.1

Vadodara

30.9

52.2

It indicates the quality of services. Effective coverage was defined as the percentage of pregnant women adequately covered by FHWs skilled to mange third stage of labor and gave basic newborn care. The skill assessment showed that FHWs of non-tribal

Table 3. Utilization and Adjusted Utilization for SBA and TBA Region

Utilization (in %) - SBA

Correction factor

Adj. utilization - SBA

Utilization (in %) - TBA

Correction factor

Adj. utilization - TBA

Vadodara (Non-tribal)

88.6

0.85

75.4

12.6

Vadodara (Tribal)

86.5

0.84

72.7

18.8

Vadodara

87.9

0.85

74.7

14.7

Table 4. Adequate and Adjusted Coverage of Components of Natal and Postnatal Care Region

PNC3 coverage (%)

Adj. PNC3 coverage (%)

Newborn weighed (%)

Adj. Newborn weighed coverage (%)

Adj. coverage SBA (%)

Vadodara (Non-tribal)

74.1

0.52

38.2

92.4

0.58

53.8

75.4

Vadodara (Tribal)

78.3

0.43

33.8

97.3

0.55

53.1

72.7

Vadodara

75.6

0.49

94.1

0.57

53.6

74.7

Table 5. Adjusted and Effective Coverage for Natal and Postnatal Care Region

Adj. adequate coverage (%)

Correction factor

Effective coverage (%)

Vadodara (Non-tribal)

38.2

0.71

27.2

Vadodara (Tribal)

33.8

0.63

21.3

0.68

25.2

Vadodara

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

951

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.

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

Drug Subsidy

Identity proof with proof of residence

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.

Income proof (preferably given by SDM)

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

COMMUNITY MEDICINE areas scored better than those of the non-tribal areas. Effective coverage for the district, non-tribal and tribal areas was 25.2%, 27.2% and 21.3%, respectively (Table 5 and Fig. 3). Most of the beneficiaries were satisfied with the services provided. DISCUSSION It is well-established that giving birth in a medical institution under the care and supervision of trained healthcare providers promotes child survival and reduces the risk of maternal mortality.

30 20 10 0 Adjusted coverage (PNC3)

Adjusted coverage (Newborn weighed)

Adjusted coverage (SBA)

Figure 2. Adjusted coverage for PNC3, newborn weighed and SBA.

Vadodara (Non-tribal)

90 80

Vadodara (Tribal)

Total

38.3% 33.7% 37.0%

Accessibility (SBA)

12.6% 18.8% 14.7%

Availability

12.6% 18.8% 14.7%

33.2% 26.6% 30.9%

33.3% 28.5% 31.8%

25.2%

27.2% 21.3%

50.6% 55.1% 52.2%

The adjusted utilization for SBA and TBA were found to be 9.9% and 30.7%, while those in our study were

75.4% 72.7% 74.7%

88.6% 86.5% 87.9%

100

Institutional deliveries increased across the district but the improvement was lower than the national average. In Vadodara, on the contrary, proportion of institutional deliveries is on the decline.11 A similar study was carried out in Surat, which showed that: The adequacy for DDKs was lower (33.9%) as compared to our study (49.6%). The accessibility for SBA and TBA in that study was 38.9% and 56.1%, which were similar to our estimate of 30.9% and 52.2%, respectively.

74.1% 78.3% 75.6%

53.6%

37%

33.8%

38.2%

53.1%

53.8%

Safe deliveries, which are greatly reflected by births attended by skilled personnel, though increasing, are still much below the desired level. NFHS II estimates that the proportion of births attended by skilled health personnel was 42% during 1998-99, an increase from 33% during NFHS I (1992-92).9 The proportion of births attended by skilled health personnel in rural areas of India is only 31.1%. The institutional deliveries amount to 39.1%. Gujarat estimates were better than the national estimates at 42.2% and 54.6%, respectively.10

74.7%

Total 72.7%

Vadodara (Tribal)

75.4%

Vadodara (Non-tribal)

Despite the many benefits associated with institutional delivery, Indiaâ&#x20AC;&#x2122;s maternal and child health programs have not aggressively promoted institutional deliveries, except in high-risk cases. Evidence from Bangladesh indicates the majority of maternal deaths occur between the third trimester and the end of the first week after pregnancy.8

10 0 Accessibility (TBA)

Utilization (SBA)

Utilization (TBA)

Figure 3. Natal and postnatal care - all indicators.

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Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

Adj. utilization Adj. utilization (SBA) (TBA)

Adequate coverage

Adj. adeq. coverage

Effective coverage

COMMUNITY MEDICINE observed to be 74.7% and 14.7%, respectively. Adjusted adequate coverage was estimated at 10.3% against our finding of 37%. Effective coverage was 6% against our estimate of 25.2%.12 Another study carried out by Patel et al regarding data validation of vitamin A13 and data validation of immunization data14 were also shown the over reporting of the data.

ÂÂ

Availability The data regarding the DDK stocks was not available from 4 (2 tribal and 2 non-tribal) of the 20 PHCs. The overall periodicity and adequacy were both low and showed wide variations. Availability, though higher for the non-tribal areas was accompanied with a wider variation.

ÂÂ

Some of the reasons for the low availability were: ÂÂ

Stock keeping of DDK kits was not there at many places

ÂÂ

Those issued were immediately distributed to the SC. Hence, there was nil stock for many months

ÂÂ

The kits are never distributed to the mothers. Whenever required the TBA takes the kits for delivery. FHW may also use them fully or components thereof as per her needs.

ÂÂ

Although, stock was found to be inadequate/absent at few places, the MOs opined that these kits were always available in plenty, wherever and whenever required

ÂÂ

At a few centers, some kits beyond the expiry date were also noted.

Accessibility The overall accessibility for SBA was low. It was lower in tribal areas as compared to the non-tribal, whereas the converse was true regarding the accessibility for the TBA. Some Observations ÂÂ

ÂÂ

As observed, the accessibility was very low for SBA. The reason being, that in spite of 60% of institutional deliveries, the FHW or MO are not staying at the center. Thirty percent of the posts of FHW were vacant. Also, the post of MO was vacant at 25% of the selected PHCs (2 in non-tribal and 3 in tribal). This is an issue of deep concern, known to all. The issue was more acute in tribal areas where very few posts (FHS, FHW, MPW-M, LT, Pharmacist) were filled. Forty-one percent posts for FHW and 45% posts of MO were vacant. Consequently, there was a wide variation across the PHCs leading to a wide CI.

Of the filled posts, very few MO (25%) and FHW (30%) were staying at the headquarter. Some of the reasons cited for not staying at the Headquarters:

No subcenter building/livable quarters

No good/English medium schools in the village for Child’s education (most common)

Salary not enough/No incentives to sacrifice the comforts of city life.

The accessibility for TBA was around 50%. When asked, most of the MOs said that there was at least 1 TBA per every village. However, the details regarding her training were often not clear and the same could not be validated. Also, many did not conduct one delivery every alternate month. The main focus now is on convincing the mothers for institutional deliveries.

When asked, why the HW did not stay at the HQ, one of them said; my son is in the 11th. There are no higher secondary schools in the village. Where will I get tuitions for him in this village… we are asked to stay in the village, but they don’t provide any facilities.

Utilization The utilization for SBA was same for both tribal as well as non-tribal areas, while that of TBA was slighter higher in tribal areas. There were almost no deliveries at the SC. The FHW at the SC used to deliver the child at the PHC premises only. The overall number of deliveries conducted across the district was higher than the target. Two of the PHCs had much higher number of deliveries (125% of target) than expected as per the target population. Utilization calculated after omitting that data showed very little difference. The deliveries conducted by SBA are thus higher than the district estimate of 60% for the previous year. Institutional deliveries are increasing, but the difference between the two figures is best explained by two different targets selected. Eighty-five percent of the reported data could be validated. Variability was higher for TBA utilization as few places recorded over 90% institutional deliveries and consequently very low TBA utilization. Some Observations ÂÂ

In some cases of deliveries by SBA, it was observed that the mother was delivered at institution, but not by the FHW, as claimed by her.

ÂÂ

Sometimes though the delivery was conducted by the TBA, it was counted as an institutional delivery conducted by a SBA.

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COMMUNITY MEDICINE ÂÂ

One of the reasons for lower TBA utilization is focus on institutional deliveries. Lots of factors have improved rates of institutional deliveries. Even the TBAs dissuade home deliveries. Their primary role now is to motivate and escort for institutional delivery.

One of the MOs explained: “…nowadays, we don’t ask TBA to conduct deliveries…. the TBA are now assigned the responsibility of motivating the clients for institutional delivery and escorting them. The deliveries conducted by them have significantly gone down. Lot of women now prefer institutional deliveries...”

Adequate Coverage The coverage values for PNC3 were the minimum. Only 49% of the reported data for PNC3 could be validated. Adjusted coverage was slightly better in non-tribal areas as compared to tribal.

ÂÂ

Few (12.5%) did not weigh the child during postnatal visits

ÂÂ

Most (87.5%) did not know the things to look for, during the postnatal visit

ÂÂ

Many (75%) did not counsel the mothers regarding hygiene and nutrition during the visits

ÂÂ

Regarding essential newborn care (ENBC), all knew about the basic CLEANS. Many (87.5%) did not know the correct order/method of resuscitation to be taken during delivery.

CONCLUSION ÂÂ

The gap between the reported and validated data ranged from 15% to 51% of the reported, for the various indicators.

ÂÂ

PHCs in non-tribal area performed better on all the indicators except those for SC clinic, where the reason could have been vacant posts of MO that lead to greater utilization of FHW for curative services.

ÂÂ

The posts of various health workers are vacant across all the PHCs. The problem is more severe in tribal areas as compared to non-tribal areas. This shortage has affected service availability, accessibility, utilization and coverage. Stock keeping and data recording are affected the most.

ÂÂ

FHW are entrusted with added responsibilities of fund management and various activities not related to health care. This has been given as one of the reasons, by the FHWs, for lack of focus on proper service delivery and quality care.

ÂÂ

During assessment of quality of care, the FHW were found to be lacking in skills for multiple elements. Many of the errors and irregularities of the FHWs were being perpetuated due to lack of monitoring and supervision of the superiors.

ÂÂ

Very few health providers, 18% MOs and 21% FHWs of the PHCs surveyed, are staying at the HQ. To some extent, this is due to lack of infrastructure, facilities and incentives.

Some Observations ÂÂ

Low-adjusted rates were due to false reporting. One of the MOs justified, off the record, that March is the month where we have to set data to reach anywhere near to the given targets and hence there is a higher degree of false reporting.

ÂÂ

If the parents knew the weight of the child, then the FHW would enter it as newborn weighed within 48 hours, without even weighing the child herself.

ÂÂ

All births taking place in institution were taken as newborn weighed in 48 hours.

ÂÂ

Also almost all women, especially those delivered at some institution were taken as having given three PNC. The first visit, in such cases, was considered done. At the most, one more visit was paid to these women but rarely three.

One FHW, regarding recording of newborns weighed in 48 hours, said: “all those delivered at institutions are always weighed. Hence, we take all institutional deliveries as newborn weighed in 48 hours.”

Effective Coverage Over an assessment score of 10, the observed quality of care for natal and post-natal services was rated at 6.8, full quality being 10. This, too, was slightly better for the non-tribal areas. Some of the observations made when FHWs skills were assessed: ÂÂ

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All knew the minimum number of visits required, but a few (12.5%) were unable to give correct information for the schedule in case the newborn was underweight

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

Acknowledgment We would like to acknowledge the UNICEF for giving training on data validation of MCH data.

REFERENCES 1. I nformation for action, HMIS, New Delhi. NHSRC (National Health System Resource Centre), 2008.

COMMUNITY MEDICINE 2. HMIS Tool kit, New Delhi. NHSRC (National Health System Resource Centre), 2008. 3. K Park. Textbook of Preventive and Social Medicine, 20th edition, Bhanot publications. 4. Papania M, Rodewald L. For better immunisation coverage, measure coverage better. Lancet 2006;367(9515):965-6. 5. Rao KM. Utilization of reproductive and child health services in tribal areas of Andhra Pradesh. Tribes and Tribals 2008;2:35-41. 6. Concept paper and proposed strategy for reproductive and child health project in Tribal Areas. Department of Family Welfare Training Division, Govt. of India, October 2000. 7. Monitoring Guideline for Minimum Intervention Package, Interstate Border District Cluster Strategy.UNICEF, June, 2004. 8. Ronsmans C, Graham WJ; Lancet Maternal Survival Series steering group. Maternal mortality: who, when, where, and why. Lancet 2006;368(9542):1189-200. 9. National Family Health Survey (NFHS-2), 1998-1999. International Institute for Population Sciences (IIPS) and Macro International, India: Mumbai: IIPS, 2000.

10. National Family Health Survey (NFHS-3), 200506. International Institute for Population Sciences (IIPS) and Macro International, India: Mumbai: IIPS, 2007. 11. District Level Household and Facility survey under Reproductive & Child Health project (DLHS3) District factsheet Vadodara, Gujarat, India. International Institute for Population Sciences (IIPS), 2007-08. 12. A report on Strengthening of Minimum Intervention Package (MIP) of RCH activities in Surat district. Dept. of Community Medicine, Government Medical College, Surat, December 2006. 13. Patel SV, Bakshi HN, Mazumdar VS, Popat CN, Kotecha PV, Dave MG. Validation of the vitamin A supplementation data reported under Health Management Information System by the Primary Health Centres of rural Vadodara. Res Rev J Immunol 2014;4(2). 14. Patel SV, Bakshi HN, Kotecha PV. Validation of the immunization data reported under Health Management Information System by the Primary Health Centres of rural Vadodara. J Health Manage

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New Data Suggest Water Fluoridation Linked to Hypothyroidism Higher levels of fluoride in drinking water appear to be associated with an increased risk for hypothyroidism in a new study from England, raising concerns about the validity of community fluoridation of water as a safe public-health measure. In particular, when a comparison was drawn between the West Midlands, a completely fluoridated area (0.7 mg/L or more) and Greater Manchester, a nonfluoridated area (0.3 mg/L or less), nearly twice the risk for hypothyroidism was detected in the West Midlands.

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CRITICAL MEDICINE

Incidence, Susceptibility Profiles and Risk Factors of Multidrug-resistant Nonfermenting Gram-negative Bacilli Causing Ventilator-associated Pneumonia in a Tertiary Care Hospital KALIDAS RIT*, BIPASA CHAKRABORTY†, UDAYAN MAJUMDER‡, PARTHASARATHI CHAKRABARTY#, SASWATI CHATTOPADHYAY# HIRAK JYOTI RAJ*

ABSTRACT Background: Nonfermenting Gram-negative bacilli (NFGB) including Pseudomonas aeruginosa and Acinetobacter spp. have been implicated in a variety of nosocomial infections. Ventilator-associated pneumonia (VAP) associated with NFGB increases morbidity, mortality as well as cost of healthcare. Aims: This study was done to determine the incidence, susceptibility profile, and risk factors of VAP caused by NFGB. Material and methods: A prospective study was carried out in ICU for a period of 10 months, which included patients on mechanical ventilation for ≥48 hours and subsequently developed VAP. Endotracheal tube (ET) aspirate collected aseptically were put on culture for bacterial isolation and identification were carried out using standard microbiological methods. The antibiotic susceptibility tests were done using Kirby-Bauer disc diffusion method following Clinical Laboratory and Standards Institute (CLSI) guidelines. Results were statistically analyzed using Graph Pad Prism software. Results: Out of 175 patients included in this study, 52 (29.71%) developed VAP. Culture of ET aspirate from these 52 patients yielded 94 isolates. Our results revealed that NFGB that is P. aeruginosa, Acinetobacter spp. and Stenotrophomonas maltophilia represented 37.77% of VAP isolates. These were high-to-moderately sensitive to amikacin, gentamicin, tobramycin, piperacillin-tazobactam, meropenem, imipenem, colistin and polymyxin B, but showed increased resistance to cefepime and ceftazidime. Risk factors significantly associated with VAP caused by NFGB in ICU were concurrent surgical procedures, prior use of antibiotics, impaired consciousness, hospitalization for 5 days or more, mechanical ventilation for 5 days or more and age more than 50 years (p < 0.0001). Conclusion: NFGB bacilli including P. aeruginosa, Acinetobacter spp. and S. maltophilia were important causes of multidrug-resistant VAP in ICU.

Keywords: Nonfermenting Gram-negative bacilli, ventilator-associated pneumonia, P. aeruginosa, Acinetobacter spp., multidrug resistance

onfermenting Gram-negative bacilli (NFGB) including Pseudomonas aeruginosa, Acinetobacter spp. and Stenotrophomonas maltophilia, have

*Assistant Professor †Postgraduate Trainee (3rd Year) Dept. of Microbiology Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal ‡Assistant Professor Dept. of Anesthesiology North Bengal Medical College, Sushrutanagar, Siliguri, West Bengal #Demonstrator Dept. of Microbiology Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal Address for correspondence Dr Kalidas Rit 70B, TC Mukherjee Street, Rishra, Hooghly - 712 248, West Bengal E-mail: kalidasrit77@gmail.com

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been implicated in a variety of nosocomial infections like ventilator-associated pneumonia (VAP), bacteremia, urinary tract infection and secondary meningitis.1 VAP is one of the most frequent infection acquired by the patients during a stay in hospital. By definition, VAP is pneumonia with onset no less than 48-72 hours after hospital admission.2 VAP is a common and severe complication of critical illness that is associated with an increased length of stay in the ICU with a high case mortality rate. P. aeruginosa and Acinetobacter spp. are the predominant cause of nosocomial infection particularly in ventilated patients. These are intrinsically resistant to a number of antibiotics as well as they develop acquired resistance by mutation in chromosomally encoded gene transfers by antibiotic-resistant determinant.3

CRITICAL MEDICINE The resistance mechanisms of P. aeruginosa and A. baumannii include the production of b-lactamases, efflux pumps and target-site or outer membrane modifications. Resistance to multiple drugs is usually the result of the combination of different mechanisms in a single isolate or the action of a single potent resistance mechanism. S. maltophilia is emerging as an important nosocomial pathogens and the respiratory tract is the most common site of S. maltophilia infection particularly in patients with inefficient lung function.4 Thereby the purpose of this study was to know the incidence, risk factors, susceptibility profiles of Pseudomonas, Acinetobacter spp. and S. maltophilia associated VAP in our tertiary care hospital. MATERIAL AND METHODS This prospective study was carried out from May 2013 to February 2014 in our tertiary care hospital. Necessary clearance from Institutional Ethical committee was obtained prior to the study. A total of 175 patients on mechanical ventilation more than 48 hours were included in this study and prospectively reviewed. All these patients were monitored at 2-day interval for development of VAP using clinical and microbiological criteria. Details of antibiotic therapy, exposure to invasive devices, urinary catheter, central venous catheter, parenteral nutrition, concurrent surgical procedures,

other comorbid conditions (like diabetes mellitus, malignancy, corticosteroid intake, transplantation), duration of hospital stay, position of patient and other important parameters studied were summarized in Table 1. Patients with modified Clinical Pulmonary Infection Score (CPIS) >6 (CPIS is a clinical score of 0-12 based on six variables like body temperature, leukocyte count, volume and character of tracheal secretion, arterial oxygenation, chest X-ray findings, Gram stain result and results of culture of tracheal aspirate specimen) and quantitative culture of the endotracheal aspirate with growth thresholds ≥106 CFU/mL was taken as a case of VAP.3,5 From each 175 patients on ventilator for ≥48 hours, samples of endotracheal aspirate (EA) were collected aseptically at every 2-day intervals till patient was on ventilator or expired. EA samples were Gramstained and examined microscopically and also cultured quantitatively by preparing serial dilutions. All samples were homogenized by placing glass beads and vortexing for 1 minute. They were serially diluted using sterile normal saline at 1:1 ratio. Each dilution were further inoculated in blood agar, chocolate agar and MacConkey agar medium and incubated at 37°C for 24-48 hours under aerobic conditions. Bacterial isolates were further morphologically and biochemically identified by standard microbiological techniques. Antibiotic susceptibility of the bacterial

Table 1. Analysis of Risk Factors of VAP by Chi-square (and Fisher’s Exact Test) Risk factors

VAP (n = 52)

Non-VAP (n = 123)

P value

Prior antibiotic therapy

<0.0001

Exposure to invasive devices

0.0916

Concurrent surgical procedures

<0.0001

Diabetes mellitus

0.0651

Patients with malignancy

0.1279

Corticosteroid intake

1.0000

Transplantation

0.0714

Hospitalization for 5 days or more

<0.0001

Supine position

0.6807

Impaired consciousness

<0.0001

Neurological disorders

0.0145

Tracheostomy

0.0551

Emergency intubation

0.0716

Mechanical ventilation 5 days or more

<0.0001

Age more than 50 years

<0.0001

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CRITICAL MEDICINE isolates was tested using Kirby-Bauer disc diffusion method following Clinical Laboratory Standards Institute (CLSI) guidelines.6,7 Antibiotic discs manufactured by HiMedia were used. Piperacillin, aztreonam, ceftazidime, cefepime, amikacin, gentamicin, tobramycin, ciprofloxacin, levofloxacin, piperacillin-tazobactam, imipenem, meropenem, colistin and polymyxin B were tested against P. aeruginosa and Acinetobacter spp. as per CLSI guidelines, but for S. maltophilia levofloxacin, trimethoprim-sulfamethoxazole and chloramphenicol antibiotic discs were used as per CLSI guidelines given in Table 2.

28.88% P. aeruginosa (26/90), followed by Klebsiella pneumoniae (12/90), Acinetobacter spp. (7/90), Escherichia coli (5/90), Proteus spp. (4/90) and others as shown in (Fig. 1). NFGB constituted 37.22% (34/90) of bacterial isolates, majority contributed by P. aeruginosa (28.88%), then Acinetobacter spp. (7.77%) and single isolate of S. maltophilia (1.11%). All the important associated parameters studied and the most important risk factors significantly associated with VAP (p < 0.05) are summarized in Table 1. The antibiotic sensitivity profiles for various etiological agents of VAP are summarized in Table 2.

RESULTS Based on CPIS criteria 52 out of 175 patients were diagnosed as VAP. The incidence of VAP was observed to be 29.71%. Out of them, 71.15% (37/52) patients were male with mean age of 65 years. Early-onset VAP occurs within the first 4 days of ventilation and late-onset VAP occurs thereafter. Out of 52 VAP patients, 36 (69.23%) developed late onset VAP, whereas 16 (30.76%) had early-onset VAP. In the present study, a total of 94 isolates were obtained from 52 patients diagnosed as VAP of which four isolates were Candida spp. (4.25%). The most common isolated pathogens were Staphylococcus aureus, which constitutes 33.33% (30/90) followed by

2.2% 3.3% 4.5%

1.1%

S. aureus P. aeruginosa

5.6%

K. pneumoniae 30.33%

7.8%

Acinetobacter spp. E. coli Proteus spp.

12.13%

CONS S. pneumoniae 26.29%

S. maltophilia

Figure 1. Microbiological profile of aerobic bacterial isolates from VAP patients.

Table 2. Antibiotic Susceptibility Tests Result of Isolated NFGB Detected by Disc Diffusion Method Antibiotic discs

P. aeruginosa (%)

Acinetobacter spp. (%)

S. maltophilia (%)

Amikacin (30 μg)

17 (65.38)

4 (57.14)

Aztreonam (30 μg)

9 (34.62)

2 (28.57)

Cefepime (30 μg)

5 (19.23)

2 (28.57)

Ceftazidime (30 μg)

8 (30.76)

3 (42.85)

Ciprofloxacin (5 μg)

12 (46.15)

3 (42.85)

Levofloxacin (5 μg)

17 (65.38)

5 (71.42)

1 (100)

Gentamicin (10 μg)

15 (57.69)

4 (57.14)

Imipenem (10 μg)

20 (76.92)

5 (71.42)

Meropenem (10 μg)

21 (80.76)

6 (85.71)

Piperacillin (100 μg)

16 (61.53)

5 (71.42)

Piperacillin/tazobactam (100/10 μg)

21 (80.76)

7 (100)

Tobramycin (10 μg)

20 (76.92)

6 (85.71)

Colistin (10 μg)

25 (96.15)

7 (100)

Polymyxin B (300 units)

25 (96.15)

7 (100)

Trimethoprim-sulfamethoxazole (1.25/23.75)

1 (100)

Chloramphenicol (30 μg)

1 (100)

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CRITICAL MEDICINE DISCUSSION P. aeruginosa, Acinetobacter spp. and S. maltophilia have increasingly emerged as serious nosocomial pathogens causing infection in compromised ICU patients. The present study on VAP reported maximum bacterial isolation of S. aureus followed by P. aeruginosa and other bacteria, whereas only 4.25% of Candida species were isolated which is also similar to results reported by Stephan et al.8 In this study, 80% VAP cases showed polymicrobial infections. But, contrary to the overall incidence of 45% of VAP as reported by Dey et al,9 our study showed the incidence of 29.71% of VAP, which may be due to lower incidence of comorbid conditions and associated risk factors. Prevalence of Pseudomonas in VAP patients was 28.88%, which is corroborative with other study by Chastre et al, where they have reported 24.4% P. aeruginosa from 1,689 VAP patients.5 Predominant role of NFGB for causing VAP were also established in other studies.10 In this study, NFGB were isolated more from late-onset VAP, as they colonize more in immunocompromised state, hence prolonged hospitalization and mechanical ventilation acts as significant risk factors. Enterobacteriaceae were isolated more from early-onset VAP. Among the different parameters studied, significant risk factors associated with VAP were concurrent surgical procedures, prior use of antibiotics, impaired consciousness, hospitalization for more than 5 days, mechanical ventilation for more than 5 days and age more than 50 years (p < 0.0001). Similar parameters were studied and reported by Joseph et al,11 Giamarellou et al12 and Celis et al.13 Management of nosocomial VAP caused by NFGB is a therapeutic challenge due to increasing resistance seen among these organisms for most commonly used antimicrobial agents. Overall sensitivity pattern for NFGB as per this study showed maximum sensitivity for colistin and polymyxin B (both 97%), followed by piperacillintazobactam (85%), meropenem (81%), tobramycin (78%) and imipenem (75%). Among the fluoroquinolones, ciprofloxacin showed lower sensitivity (45%) than levofloxacin (66%). But, high resistance was seen among cefepime, ceftazidime and aztreonam. For S. maltophilia as per CLSI guidelines only levofloxacin, cotrimoxazole and chloramphenicol discs were tested and all were 100% sensitive. Therefore, a clear knowledge about the pathogens causing VAP and their susceptibility

pattern is very important. The NFGB are gradually becoming more resistant and the bacteriological as well as susceptibility pattern is changing from time to time requiring continuous surveillance of AST for effective management of VAP. REFERENCES 1. Morehead RS, Pinto SJ. Ventilator-associated pneumonia. Arch Intern Med 2000;160(13):1926-36. 2. Johanson WG Jr, Pierce AK, Sanford JP, Thomas GD. Nosocomial respiratory infections with gram-negative bacilli. The significance of colonization of the respiratory tract. Ann Intern Med 1972;77(5):701-6. 3. Koenig SM, Truwit JD. Ventilator-associated pneumonia: diagnosis, treatment, and prevention. Clin Microbiol Rev 2006;19(4):637-57. 4. Nseir S, Di Pompeo C, Brisson H, Dewavrin F, Tissier S, Diarra M, et al. Intensive care unit-acquired Stenotrophomonas maltophilia: incidence, risk factors, and outcome. Crit Care 2006;10(5):R143. 5. Chastre J, Fagon JY. Ventilator-associated pneumonia. Am J Respir Crit Care Med 2002;165(7):867-903. 6. Bauer AW, Kirby WM, Sherris JC, Turck M. Antibiotic susceptibility testing by a standardized single disk method. Am J Clin Pathol 1966;45(4):493-6. 7. CLSI. Performance standards for antimicrobial disk susceptibility tests. Approved standard, 9th edition, CLSI document M2-A9. Clinical and Laboratory Standards Institute: Wayne, PA; 2006. 8. Stéphan F, Cheffi A, Bonnet F. Nosocomial infections and outcome of critically ill elderly patients after surgery. Anesthesiology 2001;94(3):407-14. 9. Dey A, Bairy I. Incidence of multidrug-resistant organisms causing ventilator-associated pneumonia in a tertiary care hospital: a nine months’ prospective study. Ann Thorac Med 2007;2(2):52-7. 10. F errara AM. Potentially multidrug-resistant nonfermentative Gram-negative pathogens causing nosocomial pneumonia. Int J Antimicrob Agents 2006;27(3):183-95. 11. J oseph NM, Sistla S, Dutta TK, Badhe AS, Parija SC. Ventilator-associated pneumonia in a tertiary care hospital in India: incidence and risk factors. J Infect Dev Ctries 2009;3(10):771-7. 12. Giamarellou H, Antoniadou A, Kanellakopoulou K. Acinetobacter baumannii: a universal threat to public health? J Hosp Infect 2007;67:245-52. 13. Celis R, Torres A, Gatell JM, Almela M, Rodríguez-Roisin R, Agustí-Vidal A. Nosocomial pneumonia. A multivariate analysis of risk and prognosis. Chest 1988;93(2):318-24.

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Mutton Bone Ingestion Complicated by Terminal Ιleum Perforation D GOPAL RAO*, K SURYANARAYANA†, T SRINIVAS†, K RAGHU‡, SATISH‡, R NAGA S ASHOK‡, YAMUNA‡, NYNA SINDHU‡

ABSTRACT Background: Enteric perforation and tubercular perforation represent the most common causes of terminal ileum perforation, but other causes, like ingestion of mutton bone, should be taken into account. Case presentation: We report the case of a 60-yearold man presenting in our emergency department with a 2-day history of right lower abdominal pain, nausea, vomiting and lowgrade fever. Physical examination evocated mild pain with positive rebound tenderness in the right lower abdominal quadrant, and positive right costovertebral angle tenderness. Routine blood tests, abdominal X-rays were conclusive for perforation. At explorative laparotomy, a terminal ileal perforation due to mutton bone with localized peritonitis was found, and a resection and end-to-end anastomosis was performed. Histological examination confirmed the presence of a perforation caused by a piece of mutton bone of size 2.5 × 1.5 cm. Conclusions: Mutton bone ingestion should be taken into account in the evaluation of acute abdominal pain. A detailed patient’s history may be crucial for a correct diagnosis and treatment.

Keywords: Mutton bone, ingestion, perforation, peritonitis

nteric perforation and tubercular perforation present the most common causes of terminal ileum perforation. Other causes are iatrogenic perforation, penetrating abdominal trauma and ingestion of foreign bodies. When animal bones, needles, toothpicks or other sharp pointed objects are ingested, the risk of perforation is even higher. Mutton bone ingestion is a relatively rare event that may results in serious gut injuries with peritonitis, sepsis or even death.

CASE PRESENTATION We report the case of a 60-year-old man who was referred to our emergency department with a 2-day history of right lower abdominal pain, nausea, vomiting and lowgrade fever. His vital signs were normal, except for a

central body temperature of 38°C. There was no history of previous abdominal surgery. Physical examination revealed mild pain with positive rebound tenderness in the right lower abdominal quadrant and positive right costovertebral angle tenderness. There was no evidence of intra-abdominal masses. Routine blood tests were normal except for a WBC count of 11,860/mm3 with 84,6% neutrophils. On X-ray erect abdomen, pneumoperitoneum was seen (Fig. 1). The patient underwent explorative laparotomy. At explorative laparotomy, a terminal ileal perforation due to mutton bone with localized peritonitis was found; resection and end-to-end anastomosis was performed. The patient made an uneventful recovery and was discharged on postoperative Day 7. The histological examination confirmed the presence of a transmural terminal ileum perforation with abscess caused by a mutton bone (Fig. 2). LITERATURE REVIEW

*Associate Professor †Assistant Professor ‡Postgraduate Dept. of General Surgery Kakatiya Medical College/MGM Hospital, Warangal, Telangana State Address for correspondence Dr D Gopal Rao Associate Professor Dept. of General Surgery Kakatiya Medical College/MGM Hospital, Warangal, Telangana State E-mail: gdugyala@yahoo.com

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There are more than 300 cases1 of bowel perforation caused by foreign bodies reported in the literature. Fish bones, chicken bones, mutton bones and dentures are the commonest objects followed by toothpicks and cocktail sticks.2-11 Male gender, mutton bonecrushing habit, accompanied by alcoholic drinks were the main risk factors associated with mutton bone ingestion. Perforation of the ailmentary tract occurred

GASTROENTEROLOGY

Figure 1. X-ray of the abdomen showing free air under right dome of diaphragm confirming pneumoperitoneum.

Figure 2. Operative specimen showing the mutton bone (arrows) and the site of transmural terminal ileum perforation.

Figure 3 (a-d). Typical sites of mutton bone lodgement along the alimentary canal. in 80% of these patients; in one-third of them, the mutton bone had migrated into adjacent organs (liver, retroperitoneum, inferior vena cava, etc.). Figure 3 (a-d) depict the typical sites of mutton bone lodgement along the alimentary canal.

DISCUSSION Mutton bone ingestion is a medical emergency, since it leads to acute abdomen and gut perforation. Since, spontaneous elimination of these sharp foreign bodies

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GASTROENTEROLOGY through the gastrointestinal tract is unlikely, foreign body ingestion should be taken into account during the evaluation of acute abdominal pain. The clinical presentation may include frank peritonitis, localized abscess formation, enterovesical fistula, intestinal obstruction and intestinal hemorrhage.1,9 The correct diagnosis is very difficult because of the low sensitivity of diagnostic investigations. Endoscopy can be very helpful when the mutton bone is localized in the upper gastrointestinal tract.5 The CT scan may be able to identify the site of perforation and the extent of intra-abdominal inflammation either with or without abscess formation. Although, the diagnostic yield is quite low, upper gastrointestinal endoscopy and ultrasound examination may be recommended in asymptomatic patients who are aware of the mutton bone ingestion and seek medical advice. The most common site of perforation is the terminal ileum and colon, although an increased incidence of perforation has been reported in association with Meckel’s diverticulum, the appendix and diverticular disease.12-16 Perforation commonly occurs at the point of acute angulation and narrowing. Treatment usually involves resection of bowel, although occasionally repair has been described.1,13 X-ray abdomen showing pneumoperitoneum, considering the presence of an acute abdomen, with evidence of peritonitis, the patient was scheduled for surgical exploration and required resection and anastomosis. This case suggests that a potential cause of lethal hazard may be unknown to the patient, but most of all it emphasizes the difficulty of a correct diagnosis with the most widely used instrumental examination, as endoscopy, ultrasound or CT scan. Consent to publish the case was obtained from our patient prior to discharge. The patient allowed us to share his story and clinical images because he understood the importance of raising awareness among physicians on this unusual surgical entity.

REFERENCES 1. Singh RP, Gardner JA. Perforation of the sigmoid colon by swallowed chicken bone: case reports and review of literature. Int Surg 1981;66(2):181-3. 2. Ball JR. Complete perforation of appendix by a fish bone. Br J Clin Pract 1967;21(2):99. 3. Bunch GH, Burnside AF, Brannon LJ. Intestinal perforation by ingested fish bone. Am J Surg 1942;55(1):169-72. 4. Gunn A. Intestinal perforation due to swallowed fish or meat bone. Lancet 1966;1(7429):125-8. 5. Perelman H. Toothpick perforations of the gastrointestinal tract. J Abdom Surg 1962;4:51-3. 6. Dick ET. Cocktail stick perforation of the large bowel. N Z Med J 1966;65(412):986. 7. Read KE. Intestinal perforation by wood splinter. Brit Med J 1946;1(4443):315. 8. Lindsay R, White J, Mackle E. Cocktail stick injuries - the dangers of half a stick. Ulster Med J 2005;74(2):129-31. 9. Li SF, Ender K. Toothpick injury mimicking renal colic: case report and systematic review. J Emerg Med 2002;23(1):35-8. 10. Maleki M, Evans WE. Foreign-body perforation of the intestinal tract. Report of 12 cases and review of the literature. Arch Surg 1970;101(4):475-7. 11. Sejdinaj I, Powers RC. Enterocolonic fistula from swallowed denture. JAMA 1973;225(8):994. 12. McPherson RC, Karlan M, Williams RD. Foreign body perforation of the intestinal tract. Am J Surg 1957;94(4): 564-6. 13. McManus JE. Perforation of intestine by ingested foreign bodies: report of two cases and review of literature. Am J Surg 1941;53(3):393-402. 14. N oh HM, Chew FS. Small-bowel perforation by a foreign body. AJR Am J Roentgenol 1998;171(4):1002. 15. Maglinte DD, Taylor SD, Ng AC. Gastrointestinal perforation by chicken bones. Radiology 1979;130(3): 597-9. 16. Gregorie HB Jr, Herbert KH. Foreign body perforation of Meckel’s diverticulum. Am Surg 1967;33(3):231-3.

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A Laparoscopic Surprise SHWETA SURYARAJ*, MG DHANALAKSHMI†

ABSTRACT A 30-year-old female, gravida 2, para 1, live 1 at 6 weeks of gestational age was admitted through the outpatient department of our institution with complaints of spotting per vaginum for 1 day. Per speculum examination revealed minimal bleeding through the os. A bimanual examination revealed a normal-sized uterus with minimal posterior forniceal tenderness. With clinical suspicion of either a spontaneous abortion or an ectopic pregnancy, serum b-human chorionic gonadotropin (b-hCG) was done, which was 22,217 IU/L and a confirmatory ultrasound done showed left-sided unruptured ectopic gestation. A laparoscopic procedure was planned. Intraoperatively, a left-sided unruptured ovarian ectopic pregnancy was noted. Further in the article, we shall discuss the incidence, etiology, clinical features, diagnostic methods and criteria, management options and outcome for an ovarian ectopic pregnancy.

Keywords: Ovarian pregnancy, Spiegelberg criteria, laparoscopy

CASE REPORT A 30-year-old female, gravida 2, para 1, live 1 at 6 weeks of gestational age was admitted through the outpatient department of our institution with complaints of spotting per vaginum for 1 day. On examination, no pallor and vitals were stable. Per speculum examination revealed minimal bleeding through the external os and a per vaginal examination revealed a normal-sized uterus and minimal posterior forniceal tenderness. There was no cervical motion tenderness. On investigation, hemoglobin was 12.7 g/dL, total count 10,300 cells/mm3, platelets 2.12 lacs/ mm3 and blood group was B positive. With clinical suspicion of either a spontaneous abortion or an ectopic pregnancy, serum b-human chorionic gonadotropin (b-hCG) was done, which was 22,217 IU/L and an ultrasound done showed an empty uterine cavity with a left-sided unruptured ectopic gestation of size 3.2 × 2.8 cm close to the left ovary with a fetal pole (4.15 mm) and minimal free-fluid in the pouch of Douglas (Figs. 1 and 2).

*Postgraduate †Professor Dept. of Obstetrics and Gynecology Sri Ramachandra Medical University, Chennai, Tamil Nadu Address for correspondence Dr Shweta Suryaraj No. 257, Z-Block, 4A, Silver Springs Apartments 6th Street, Anna Nagar, Chennai - 600 040, Tamil Nadu Email: shwetasuryaraj@gmail.com

Figure 1. Empty uterine cavity with a thickened endometrium (7.55 mm).

Figure 2. Ectopic sac with fetal pole.

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Figure 3. Gestational sac seen in the left ovary.

Figure 5. Histopathology slide showing trophoblastic villi; stained with hematoxylin and eosin.

DISCUSSION Ovarian pregnancy is a rare event. They make-up 0.3-3%1 of all ectopic pregnancies. Incidence varies from 1 in 2,500 to 1 in 40,000 pregnancies.2 It occurs when the ovum has not been released and fertilization occurs in the ovary. It clinically and radiologically mimics a tubal pregnancy and can be life-threatening in case of rupture, causing intra-abdominal hemorrhage and hence it is a surgical emergency.

Figure 4. Gestational sac in left ovary.

In view of an elevated serum b-hCG value and ultrasound diagnosis of an ectopic pregnancy, the patient was planned for a laparoscopic procedure. Intraoperatively, the following findings were noted: An unruptured ovarian pregnancy 3 × 3 cm in size on the left side (Figs. 3 and 4), 50 mL of free-fluid, normal left fallopian tube, normal right ovary and fallopian tube and a normal uterus with no hemoperitoneum. A resection of the ectopic sac was done leaving the left ovary intact.

A few risk factors have been found to have a relationship with ovarian pregnancy. They are pelvic inflammatory disease, intrauterine contraceptive devices,3 endometriosis and assisted reproductive techniques.4 Incidence of ovarian ectopic in intrauterine contraceptive device users is 19.3% and those conceived by assisted reproductive techniques is 18.1%,5 being the two most important risk factors. An ovarian pregnancy can present with symptoms and signs of a normal intrauterine pregnancy or present with life-threatening symptoms of shock. Nausea, vomiting, abdominal pain, vaginal bleeding, tachycardia, hypotension and shock are the signs and symptoms a patient can present with. Rupture in the first trimester is the usual rule in an ovarian ectopy, but the pregnancy can advance to term.6

Histopathology of the specimen showed trophoblastic villi, but not ovarian tissue as we removed only the sac (Fig. 5).

Spiegelberg Criteria

Postoperatively, patient was stable and discharged on postoperative Day 1. On her review, a week later, serum b-hCG was 440.50 IU/L and it further dropped to 22 IU/L 3 weeks later.

ÂÂ

The gestational sac is located in the region of the ovary

ÂÂ

The gestational sac is attached to the uterus by the ovarian ligament

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The following criteria should be met in order to confirm an ovarian pregnancy:7

OBSTETRICS AND GYNECOLOGY ÂÂ

Ovarian tissue is histologically proven in the wall of the gestational sac

ÂÂ

The Fallopian tube on the involved side is intact.

Diagnosis of an ovarian ectopic pregnancy can be done with a good history and clinical examination, serum b-hCG value, ultrasound and histopathology. A history of nausea, vomiting, severe abdominal pain, bleeding per vaginum with a positive urine pregnancy test will usually give us a suspicion of an ectopic pregnancy. A per vaginal examination may reveal an adnexal mass, forniceal tenderness or cervical motion tenderness. A serum b-hCG value elevated much beyond that expected for the gestational age may be present. A transvaginal ultrasound usually confirms the diagnosis with an empty uterine cavity and an ovarian mass/adnexal mass.8 Histopathology proving the presence of ovarian tissue in the specimen confirms the diagnosis of an ovarian ectopic pregnancy.

REFERENCES 1. Salas Valien JS, Reyero Alvarez MP, González Morán MA, García Merayo M, Nieves Díez C. Ectopic ovarian pregnancy. An Med Interna 1995;12(4):192-4. 2. Gerin-Lajoie L. Ovarian pregnancy. Am J Obstet Gynecol 1951;62(4):920-9. 3. Mehmood SA, Thomas JA. Primary ectopic ovarian pregnancy (report of three cases). J Postgrad Med 1985;31(4):219-22. 4. Qublan H, Tahat Y, Al-Masri A. Primary ovarian pregnancy after the empty follicle syndrome: a case report. J Obstet Gynaecol Res 2008;34(3):422-4. 5. Joseph RJ, Irvine LM. Ovarian ectopic pregnancy: aetiology, diagnosis, and challenges in surgical management. J Obstet Gynaecol 2012;32(5):472-4. 6. Darbar RD, Reddy CC, Despande NR, Nagalotimath SJ. Primary ovarian pregnancy (a case report). J Obstet Gynecol India 1976;28:310. 7. Spiegelberg O. Zur casuistik der ovarialschwanger schaft. Arch Gynaekol 1878;13:73-5.

Though medical management options are available, surgery is the treatment of choice. Methotrexate can be used for the treatment of tubal ectopic pregnancy with a success rate of >82%, with a b-hCG value between 10,000 and 14,999 IU/L.9 However, failure rates are high with an ovarian ectopic pregnancy. It can be used when there may be remnant tissue left behind after surgery. Surgical options are laparoscopic oophorectomy and partial wedge resection.10

8. Russell JB, Cutler LR. Transvaginal ultrasonographic detection of primary ovarian pregnancy with laparoscopic removal: a case report. Fertil Steril 1989;51(6):1055-6.

In our case, we removed the sac in toto without removing any ovarian tissue. Fertility after ovarian pregnancy usually remains unmodified.11

11. Portuondo JA, Ochoa C, Gomez BJ, Uribarren A. Fertility and contraception of 6 patients with ovarian pregnancy. Int J Fertil 1984;29(4):254-6.

9. Lipscomb GH, McCord ML, Stovall TG, Huff G, Portera SG, Ling FW. Predictors of success of methotrexate treatment in women with tubal ectopic pregnancies. N Engl J Med 1999;341(26):1974-8. 10. Chahtane A, Dehayni M, Rhrab B, Kharbach A, el Amrani S, Chaoui A. Ovarian pregnancy. Four cases with review of the literature. Rev Fr Gynecol Obstet 1993;88(1):35-8.

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Mercury Exposure may be a Risk Factor for Autoimmune Diseases in Women Exposure to high levels of mercury is known to cause damage to the nervous system, and it is believed to be particularly harmful for the developing fetus. But a new study by researchers from the University of Michigan claims that even at levels considered to be safe, mercury exposure may be hazardous to health; it may be a risk factor for autoimmune disorders among women of childbearing age. The research team, led by Dr Emily Somers - an associate professor in the Dept. of Internal Medicine, Environmental Health Sciences and Obstetrics and Gynecology at the University of Michigan Medical and Public Health Schools - publishes its findings in the journal Environmental Health Perspectives.

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Rapidly Progressing Tuboovarian Abscess in a Young Woman SEETHA MOHAN*, JAYA VIJAYARAGHAVANâ&#x20AC;

ABSTRACT Tuboovarian abscess (TOA) is a major complication of pelvic inflammatory disease (PID). TOA is usually a delayed diagnosis. The key to diagnosis of TOA is inflammatory adnexal mass. Physical examination alone cannot accurately diagnosis TOA. Confirmation should be done by imaging when suspicion arises. TOA is polymicrobial with a preponderance of anaerobic organisms. An initial conservative antimicrobial approach to the management of the unruptured TOA is appropriate, if the antimicrobial agents used can penetrate abscesses, remain active within the abscess environment, and are active against the major pathogens in TOA, including the resistant Gram-negative anaerobes. Ruptured TOA requires surgical intervention. We describe the clinical course of a 36-year-old lady with acute TOA, which rapidly progressed to rupture of abscess and sepsis.

Keywords: Tuboovarian abscess, pelvic inflammatory disease, delayed presentation

bdominal pain in a woman is often considered to be due to pelvic inflammatory disease (PID) until proven otherwise. This may result in delayed diagnosis of conditions with serious morbidity or mortality like ruptured ectopic pregnancies, ruptured tuboovarian abscess (TOA), ruptured appendix, etc.1,2 TOA is a major complication of cases of PID. TOA occurs most frequently during the reproductive years of life. Even with advances in antibiotic coverage and perioperative care, the mortality rate from ruptured TOA can approach 10%. Surgical intervention will be required in unruptured cases not responding to broad-spectrum antibiotics and ruptured cases. Surgical modalities include drainage, unilateral salpingo-oophorectomy and total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH and BSO). The most common microorganisms that were recovered from these TOAs were Escherichia coli, Bacteroides fragilis, Bacteroides species, Peptostreptococcus,

*Postgraduate â&#x20AC; Professor and Head Division of Obstetrics and Gynecology Sri Ramachandra Medical College, Porur, Tamil Nadu Address for correspondence Dr Seetha Mohan Postgraduate Division of Obstetrics and Gynecology Sri Ramachandra Medical College, Porur, Tamil Nadu E-mail: seethamoh@gmail.com

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Peptococcus and aerobic streptococci. We describe the clinical course of a 36-year-old lady with acute TOA and sepsis.3,4 CASE REPORT A 36-year-old lady presented with complaints of polymenorrhea for 2 months, fever and abdominal pain for 1 month, vomiting and loose stools for 4 days and breathing difficulty for 1 day. She was apparently normal 2-month back and then developed intermittent fever with episodes every 2 days, associated with chills. Abdominal pain, which also developed 1 month back, was initially intermittent and mild. She was the mother of a girl; the delivery was full-term normal vaginal delivery. There was no other history of conception. She attained menarche at 15 years of age with regular menstrual cycles till 3 months ago. For past 2 months, she is menstruating every 15 days. She is a known case of vitiligo for 3 years not on any medication. There is no other past medical history or family history of other diseases. On clinical examination, lower abdominal tenderness was present. Spleen was palpable 2 cm below costal margin. Bowel sounds were audible and were normal. Baseline revealed blood hemoglobin concentration of 7.9 mg/dL, positive stool occult blood test and an elevated C-reactive protein (CRP) of 1.2. An ultrasound examination of abdomen showed right hydroureteronephrosis. So, a contrast-enhanced

OBSTETRICS AND GYNECOLOGY computed tomography (CECT) scan was done, which gave impression of bilateral TOA causing right moderate hydroureteronephrosis, left adrenal adenoma, right hydroureteronephrosis, mild ascites and right minimal pleural effusion. The patient was started on parenteral broad-spectrum antibiotics. The patient’s signs and symptoms worsened rapidly in spite of conservative measures and she developed sepsis. Patient was taken up for laparotomy on the next day. Intraoperatively, there was florid pus collection. Bilateral tuboovarian mass was noted measuring 8 × 7 cm. The mass was adherent to the rectum posteriorly and lateral pelvic wall laterally. TAH and BSO was done. Adhesions were released. Intraoperatively, patient was transfused with 2 units of packed red cells. Postoperative period was uneventful. Pus culture report sent had growth of E. coli susceptible to amikacin and patient was started on IV amikacin. Hemoglobin returned to normal in 2 days. Histopathology findings showed both tubes having extensive areas of necrosis, inflammatory infiltrate with giant cell reaction. There was chronic cervicitis. There were no features suggestive of tuberculosis. Patient symptomatically improved and was afebrile and symptom free. Sutures were removed on 9th postoperative day. DISCUSSION

An initial conservative antimicrobial approach to the management of the unruptured TOA is appropriate, if the antimicrobial agents used can penetrate abscesses, remain active within the abscess environment and are active against the major pathogens in TOA, including the resistant Gram-negative anaerobes. If there is no response to antimicrobial therapy within 2-3 days surgical intervention should be planned. Suspicion of rupture should remain an indication for immediate operation.1 In patients deserving fertility, if no rupture is suspected and patients are treated with medical management alone, reported pregnancy rates vary between 4% and 15%. If no rupture is suspected, and the treatment is medical management with immediate laparoscopic drainage within 24 hours, reported pregnancy rates vary between 32% and 63%.7 CONCLUSION The definitive treatment for ruptured TOA includes TAH and BSO. TAH and BSO is associated with increased surgical morbidity and hormonal impairment. Unruptured TOA can be treated conservatively, which considerably reduces morbidity and mortality associated with more radical procedures. Thus early presentation, treatment and management are crucial in TOA. REFERENCES

Tuboovarian abscesses (TOAs) are a major complication of female upper genital tract infections, occurring most frequently in third and fourth decades of life. TOA most commonly occurs after exposure to sexually-transmitted diseases (STDs). The incidence of TOA is expected to increase as a result of the current epidemic of STDs and their squealae.3 The initial clinical impression may be correct in only 30% of cases. TOAs frequently result in irreversible tubal and ovarian damage and can cause fertility impairments. Approximately 3-16% cases of PID lead to TOA. They are found predominantly in sexually active women of low parity who have been exposed to STDs, multiple partners or to partners with multiple sexual partners, regardless of race, marital status or contraceptive choice.5 Patients with TOA most commonly present with lower abdominal pain and an adnexal mass. Fever and leukocytosis may be absent. Ultrasound, CT scans, laparoscopy or laparotomy may be necessary to confirm the diagnosis.6

1. Landers DV, Sweet RL. Current trends in the diagnosis and treatment of tuboovarian abscess. Am J Obstet Gynecol 1985;151(8):1098-110. 2. Osborne NG. Tubo-ovarian abscess: pathogenesis and management. J Natl Med Assoc 1986;78(10):937-51. 3. Landers DV, Sweet RL. Tubo-ovarian abscess: contemporary approach to management. Rev Infect Dis 1983;5(5):876-84. 4. Humber, et al. Clinical pharmacology review. In: Trauma: Critical Care. Volume 2, Wilson WC, Grande CM, Hoyt DB (Eds.), CRC Press: New York 2007:p.1386. 5. Weström L. Incidence, prevalence, and trends of acute pelvic inflammatory disease and its consequences in industrialized countries. Am J Obstet Gynecol 1980;138 (7 Pt 2):880-92. 6. Clark JF, Moore-Hines S. A study of tubo-ovarian abscess at Howard University Hospital (1965 through 1975). J Natl Med Assoc 1979;71(11):1109-11. 7. Rosen M, Breitkopf D, Waud K. Tubo-ovarian abscess management options for women who desire fertility. Obstet Gynecol Surv 2009;64(10):681-9.

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Effects of Intrathecal Midazolam with Bupivacaine on Postoperative Analgesia Following Cesarean Delivery and Neonatal Outcome AMITAVA PAL*, DEBASIS SAHA†, SARBARI SWAIKA‡, SUMANTA GHOSH MAULIK#, SIBRAM CHATTERJEE$, RUPALI MODAK¶

ABSTRACT Objectives: To determine the incidence and degree of postoperative analgesic effect of intrathecal midazolam-bupivacaine mixture in women undergoing cesarean section and also to evaluate the neonatal outcome. Study design: Prospective, randomized double-blind. A total of 100 patients (parturient) belonging to American Society of Anesthesiology (ASA) I or II scheduled for cesarean section under spinal anesthesia were randomly allocated to receive injection midazolam 2 mg along with bupivacaine (0.3 mg/kg) intrathecally (Group I; n = 50) and only injection bupivacaine (Group II; n = 50). Level of sensory block, sedation score, assessment of pain using visual analog score (VAS) were recorded in both the groups at regular time intervals. Condition of the neonates was reviewed by Apgar score following delivery. Results: The time period of sensory block was significantly longer in Group I (242 ± 6.2 min) than Group II (155 ± 5.6 min) (p < 0.0001). Duration of analgesia was significantly prolonged in Group I (320 ± 10.2 min) than Group II (183 ± 11.2 min) (p < 0.0001). Forty-eight (96%) patients received rescue analgesia in Group II at a mean duration of 183 ± 11.2 minutes, whereas only one patient in Group I required supplement analgesia within this period. A significantly higher VAS score was seen in Group II as compared to the score observed in Group I (p < 0.0001). In Group I, 45 (90%) patients had good sedation with score ≥1, which was statistically significant (p < 0.0001). Postoperative nausea and vomiting (PONV) were more common in Group II patients and no significant number of asphyxiated babies were observed in any of the groups following cesarean delivery. Statistical analysis was done by Chi-square (χ2) test and student t-test. A p value of <0.05 was considered significant. Conclusions: The result suggests that addition of midazolam to bupivacaine intrathecally provides better postoperative analgesia without any adverse effects on mother and neonates.

Keywords: Postoperative analgesia, sedation, amnesia, cesarean section

ptimum pain management following cesarean section remains controversial. Intramuscular opioids, patient controlled analgesia systems and epidural/intrathecal opioids all have their risks and benefits. Intrathecal midazolam hydrochloride has been demonstrated to have antinociceptive properties.1

*Associate Professor, Dept. of Obstetrics and Gynecology †Associate Professor, Dept. of Anesthesiology Burdwan Medical College, Burdwan, West Bengal ‡Associate Professor, Dept. of Anesthesiology Bankura Sammilani Medical College, Bankura, West Bengal #Assistant Professor, Dept. of Anesthesiology $Assistant Professor, Dept. of Obstetrics and Gynecology Burdwan Medical College, Burdwan, West Bengal ¶Senior Medical Officer, Dept. of Obstetrics and Gynecology RG Kar Medical College, Kolkata, West Bengal Address for correspondence Dr Amitava Pal 12/3J, Northern Avenue Sundaram Apartment, Kolkata - 37, West Bengal E-mail: amitava.628@rediffmail.com

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The segmental analgesia produced by intrathecal midazolam is mediated by the benzodiazepine Gammaaminobutyric acid (GABA) receptor complex.2 The GABA receptors are present in the spinal cord. There is now considerable evidence that midazolam, when given intrathecally, produces antinociceptive effects without any neurotoxicity and may be useful in the treatment of somatic pain. Dosage up to 12 mg has been described without adverse effects.3 Continuous epidural or intrathecal administration of local anesthetics and opioids are widely used for postoperative analgesia. To reduce the toxicity and hypotension due to overdoses of local anesthetics, opioids are commonly added. However, this combination may induce itching, nausea, vomiting or respiratory depression by opioids. Several investigators reported that intrathecally or epidurally administered midazolam produces a dosedependent modulation of spinal nociceptive processing in both rat and humans without respiratory depression. Midazolam has been used in epidural space as a spinal

OBSTETRICS AND GYNECOLOGY anesthetic in human and has been shown to have no neurological side-effects. This study was carried out to compare the degree of postoperative analgesia, amnesia and sedation effect of the mixture of injection midazolam and bupivacaine with injection bupivacaine alone used intrathecally during cesarean section and also to assess the adverse effects of the drugs to the mother. The immediate neonatal outcome was also evaluated following delivery. MATERIAL AND METHODS This study was conducted from January 2009 to December 2009 in the Dept. of Obstetrics and Gynecology, Burdwan Medical College and Hospital, Burdwan, which is a rural teaching hospital with low resource set up, having 18,029 deliveries in the reference period of 1 year with 2,731 (15.2%) lowersegment cesarean sections (LSCS). After approval of the Ethical Committee, written informed consent was obtained from American Society of Anesthesiology (ASA) I or II patients4 selected for elective or emergency cesarean section with regional anesthesia. Patients were randomly allocated to two groups of 50 each by random numbers. The solutions for anesthesia were prepared by a second anesthetist otherwise uninvolved with the case. The anesthetists performing the block and postoperative assessments was blind to the solution administered. Patients were excluded from the study, if there was a contraindication to regional anesthesia (hypersensitivity to drugs, chronic back pain on medication, fetal prematurity (GA <36 weeks), coagulopathy.5 Age and body weight of patients were compared in both the groups. All patients were premedicated with 1 ampoule of injection metoclopramide and injection ranitidine each IM 1 hour prior to surgery. Group I were randomized to receive intrathecal midazolam 2 mg along with bupivacaine (0.3 mg/kg) and Group II was given only bupivacaine (0.3 mg/kg). Monitoring was established with ECG, pulse oxymetry and blood pressure measurement. A 18-gauze IV cannula was placed and a preload of 800-1,000 mL ringer solution administered over 30 minutes to prevent hypotension. Dural puncture was performed at L4-L5 interspace using the midline approach in the sitting or lateral position using a 25 g Whitacre needle. After free-flow of cerebrospinal fluid (CSF) was obtained intrathecal anesthesia was performed. Subarachnoid block was assessed by loss of sensation to cold and pinprick, a dermatomal sensory loss from T6 to S4 was considered adequate. Time to

regression of analgesia was determined as the point at which the cephalad level of sensory anesthesia receded two segments.6 Cesarean delivery was performed by pfannenstiel incision and uterus was sutured in double layers. Injection syntocinon 10 units were given at the time of umbilical cord clamping. Neonatal Apgar score was noted by pediatrician at 0, 1 and 5 minutes. IV volume replacement was given as clinically indicated. After skin closure SaO2, blood pressure, pulse rate, respiration rate, temperature, analgesic effect, sedation and amnesia were assessed in all the patients at 60 minutes intervals for 24-hour postoperatively. Additional analgesia like IM nonsteroidal antiinflammatory drugs (NSAIDs) or narcotics was given on patient demand or when the visual analog scale (VAS) was >40 mm. VAS consisting of 100 mm line with 0 = No pain and 100 = Worst possible pain was explained to all patients preoperatively. Sedation score (wide awake = 0, sleeping comfortably, responding to verbal commands = 1, deep sleep, but arousable = 2, deep sleep not arousable = 3)7 was noted every hour for 6 hours following arrival in the postanesthetic care unit (PACU). The result of the study was analyzed by using student t-test and Chi-square (χ2) test. However, statistical difference between the two groups were significant only at p < 0.05. RESULT Table 1 summarizes the patient’s profile. Body weight, age and duration of surgery in both the groups did not show any statistical significance. No clinical significant changes were observed in heart rate, arterial blood pressure and respiratory rate in both the groups. Table 2 shows that 48 (96%) patients received rescue anesthesia in Group II at a mean duration of 183 ± 11.2 minutes, whereas only one patient in Group I required supplementary analgesia within this period (p < 0.0001). In Group II, 45 patients did not have any sedation, whereas in Group I, 45 (90%) patients had a good sedation with score ≥1 at 3-hour of postoperative period, which was statistically significant (Table 3). Side-effects of postoperative nausea and vomiting (PONV), hypotension were noted only in 3 (6%) cases in Group I and in 20 (40%) cases in Group II, respectively (Table 4). As shown in Table 5, there was no significant increase in number of babies born asphyxiated with spinal anesthesia in Group I patients. In Figure 1, a significantly higher VAS score (13.780 ± 3.95 to 65.68 ± 9.92) was observed, in Group II from 180 to 480 minutes

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OBSTETRICS AND GYNECOLOGY Table 1. Patient Profile Profile

Group Ι (n = 50)

Group ΙΙ (n = 50)

P value

Age (years)

22.18 ± 2.939

22.22 ± 3.278

0.9489

Weight (kg)

65.34 ± 12.587

67.64 ± 11.302

0.3387

Heart rate/min

79.52 ± 8.543

80.6 ± 7.959

0.515

Systolic BP (mmHg)

129.74 ± 13.749

126.32 ± 22.616

0.363

Diastolic BP (mmHg)

75.50 ± 8.28

77.78 ± 9.636

0.208

Respiratory rate/min

16.04 ± 1.526

15.9 ± 1.111

0.601

Duration of surgery (min)

49.98 ± 8.491

50.08 ± 8.047

0.952

Hemoglobin (g/dL)

9.94 ± 1.649

10.36 ± 1.085

0.135

Mean ± SD, p > 0.05 (not significant).

Table 2. Duration of Analgesia and Sensory Block Group II (n = 50)

80 70

Duration of analgesia (min)*

320 ± 10.2

183 ± 11.2

Duration of sensory block (min)*

242 ± 6.2

155 ± 5.6

Mean ± SD; *p < 0.0001 (significant).

VAS (0-100 mm)

Group I (n = 50)

Parameters

50 40 30 20 10 0 -10

Table 3. Sedation Score at 3 Hours Sedation score

Group I (n = 50)

Group II (n = 50)

5 (10)

45 (90)

≥1

45 (90)

5 (10)

n (%), χ2 (Pearson) = 64.000; p < 0.0001(significant).

Table 4. Side-effects Group I (n = 50)

Group II (n = 50)

Yes

03 (6)

47 (94)

20 (40)

30 (60)

PONV = Postoperative nausea and vomiting; n (%); χ2 = 14.4 (Yates’ correction); p < 0.0001, Relative risks (95% CI) = 0.156 (0.048- 0.473).

Table 5. Neonatal Apgar Score <8 Group I (n = 50)

Group II (n = 50)

At 0 minute

7 (14)

9 (18)

At 1 minute

4 (8)

At 5 minutes

2 (4)

postoperatively as compared to the score observed in Group I during this period (6.00 ± 1.860 to 35.58 ± 10.705) (p < 0.0001).

972

100

-20

Side-effects (PONV)

Group Ι Group ΙΙ

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

200

300

400

500

600

Time intervals (min)*

Figure 1. Mean VAS score at various time intervals.

DISCUSSION The result of our study showed that addition of midazolam to spinal bupivacaine caused prolongation of postoperative analgesia when compared to spinal bupivacaine alone. The management for postoperative pain relief following cesarean section remains controversial. There are well-documented problems associated with IM opioids i.e., nausea, vomiting sedation, etc. Patient controlled analgesia (PCA) system provides an excellent pain control, but they are relatively expensive and not available in a rural set up and also have a high incidence of respiratory depression.8 Midazolam hydrochloride is a potent, short-acting water-soluble imidazobenzodiazepine (pH 3.5). It is preservative free and becomes highly lipophilic when injected into the body at neutral pH. In the early 1980s, intrathecal midazolam was shown to have antinociceptive properties. In different studies, it was shown that midazolam was free from neurotoxicity.9,10 However, another study performed with rabbits demonstrated a significant incidence of reactions on histological examination.11 Intrathecal midazolam up to 2 mg has been used in humans with no side-effects being reported in the different

OBSTETRICS AND GYNECOLOGY world literatures. Midazolam has been demonstrated to be effective in the treatment of chronic low back pain,5,12 acute postoperative pain and control of the cardiovascular response to surgery in humans.13 Later on, it was demonstrated that adding midazolam to a continuous epidural infusion of bupivacaine resulted in better analgesia, greater amnesia and sedation than bupivacaine alone, without any side-effects in patients undergoing laparotomy.14 Analgesia produced by intrathecal midazolam can be reversed by the benzodiazepine antagonist flumazenil and by the opioid antagonist naloxone.12 There is no direct effect on nerve conduction and reversal of antinociceptive effects can be achieved by specific antagonists. This suggests that local anesthetic action is unlikely. Motor neuron blockade has been demonstrated but only at extremely high doses.15 GABA is synthesized from glutamate in the pre-synaptic nerve terminal. Most GABAminergic neurons have short interneurones with local connections and their actions are generally inhibitory. GABA, on binding to GABAA receptors, opens ligandgated chloride channels. Chloride conductance is increased leading to hyperpolarization and pre-synaptic inhibition of afferent terminals in the spinal cord. This result in less excitatory neurotransmitter being released on to the post-synaptic neuron and decreased central propagation of the action potential. The effects of GABA are terminated by reuptake of neurotransmitter into the surrounding glial cells and into the never terminal. The GABA antagonists picrotoxin and bicuculine bind to post-synaptic GABAA receptors and high doses of these antagonists cause convulsions.16 Benzodiazepines alone lacks GABA mimetic effects. The high-density of binding sites in spinal cord are found within lamina 2 of the dorsal horn,17 a region strongly associated with the processing of noxious stimuli. So, GABA is involved in the spinal analgesic effect of midazolam.1 CONCLUSION To conclude, intrathecal midazolam along with bupivacaine produced good analgesia and sedation for several hours after cesarean section. Midazolam, in a dose of 2 mg with bupivacaine 0.3 mg/kg is found to be reliable dose for optimum postoperative analgesia (within a mean period of 5 hours 20 min) following cesarean delivery without any potential side-effects of mother. No significant neonatal jeopardy (checked by Apgar score) was noted.

2. Möhler H, Okada T. Benzodiazepine receptor: demonstration in the central nervous system. Science 1977;198(4319):849-51. 3. Valentine JM, Lyons G, Bellamy MC. The effect of intrathecal midazolam on post-operative pain. Eur J Anaesthesiol 1996;13(6):589-93. 4. Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology 1978;49(4):239-43. 5. Serrao JM, Marks RL, Morley SJ, Goodchild CS. Intrathecal midazolam for the treatment of chronic mechanical low back pain: a controlled comparison with epidural steroid in a pilot study. Pain 1992;48(1):5-12. 6. Pittoni G, Toffoletto F, Calcarella G, et al. Spinal anesthesia in outpatient knee surgery: 22-gauge versus 25-gauge Sprotte needle. Anesth Analg 1995;81(1):73-9. 7. Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, et al. Validity and reliability of the Observer’s Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol 1990;10(4):244-51. 8. Eisenach JC, Grice SC, Dewan DM. Patient-controlled analgesia following cesarean section: a comparison with epidural and intramuscular narcotics. Anesthesiology 1988;68(3):444-8. 9. Serrao JM, Mackenzie JM, Goodchild CS, Gent JP. Intrathecal midazolam in the rat: an investigation of possible neurotoxic effects. Eur J Anaesthesiol 1990; 7:115-22. 10. Schwieger IM, Jorge-Costa M, Pizzolato GP, Forster A, Morel DR. Intrathecal midazolam reduces isoflurane MAC and increases the apnoeic threshold in rats. Can J Anaesth 1994;41(2):144-8. 11. Baaijens PFJ, Van Dongen RTM , Crul BJP. Intrathecal midazolam for the treatment of chronic mechanical low back pain: a randomized double-blind placebo-controlled study. Br J Anaesth 1995:74-Suppl 1:A470. 12. Yáñez A, Peleteiro R, Camba MA. Intrathecal administration of morphine, midazolam, and their combination in 4 patients with chronic pain. Rev Esp Anestesiol Reanim 1992;39(1):40-2. 13. Goodchild CS, Noble J. The effects of intrathecal midazolam on sympathetic nervous system reflexes in man - a pilot study. Br J Clin Pharmacol 1987;23(3):279-85. 14. Batra YK, Jain K, Chari P, et al. Addition of intrathecal midazolam to bupivacaine produces better post-operative analgesia without prolonging recovery. Int J Clin Pharmacol Ther 1999;37(10):519-23. 15. Crawford ME, Jensen FM, Toftdahl DB, Madsen JB. Direct spinal effect of intrathecal and extradural midazolam on visceral noxious stimulation in rabbits. Br J Anaesth 1993;70(6):642-6.

REFERENCES

16. Goodchild CS. GABA receptors and benzodiazepines. Br J Anaesth 1993;71(1):127-33.

1. Edwards M, Serrao JM, Gent JP, Goodchild CS. On the mechanism by which midazolam causes spinally mediated analgesia. Anesthesiology 1990;73(2):273-7.

17. Faull RL, Villiger JW. Benzodiazepine receptors in the human spinal cord: a detailed anatomical and pharmacological study. Neuroscience 1986;17(3):791-802.

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A Study of Antepartum Cardiotocography in Mothers with Reduced Fetal Movement at Term and its Correlation with Fetal Outcome MONALISA NEOGI*, TAPAN KUMAR LAHIRI†, BANDANA BISWAS‡, TARASANKAR BAG‡, PALLAB KUMAR MISTRI#, AVISHEK BHADRA§

ABSTRACT Maternal perception of fetal movement is one of the first signs of fetal life and is regarded as a manifestation of fetal wellbeing. Reduced or absent fetal movements may be a warning sign of impending fetal death. According to the various tracings obtained on cardiotocography (CTG) categorization can be done into normal, suspicious or abnormal/pathological and thereby fetal jeopardy can be reliably predicted. This study was designed to evaluate the CTG findings in mothers with complaint of reduced fetal movement and their fetal outcome at term. It was seen that an abnormal and suspicious CTG were more commonly associated with meconium-stained liquor at delivery, also they were associated with a higher rate of cesarean section with fetal distress being the most common indication among these two groups.

Keywords: Cardiotocography, reduced fetal movement, fetal distress, meconium-stained liquor

aternal perception of fetal movement is one of the first signs of fetal life and is regarded as a manifestation of fetal well-being.1,2 Movements are first perceived by the mother between 18 and 20 weeks of gestation and rapidly acquire a regular pattern. Fetal movements have been defined as any discrete kick, flutter, swish or roll.3 A significant reduction or sudden alteration in fetal movement is a potentially important clinical sign. It has been suggested that reduced or absent fetal movements may be a warning sign of impending fetal death. Studies of fetal physiology using ultrasound have demonstrated an association between reduced fetal movement (RFM) and poor perinatal outcome.4,5 The majority of women (55%) experiencing a stillbirth perceived a reduction in fetal movements prior to diagnosis.6 Maternal perception of fetal movement is reassuring to pregnant

*Senior Resident †Principal ‡Professor #Associate Professor §Assistant Professor Dept. of Obstetrics and Gynecology Medical College, Kolkata, West Bengal Address for correspondence Dr Bandana Biswas 69, Chandi Ghosh Road, PS Regent Park, Kolkata - 40, West Bengal E-mail: bandana.biswas2010@gmail.com

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women and doctors, whereas RFM is a common reason for concern. In our hospital, many mothers come with the complaint of RFM. Also, there is a high rate of perinatal complications. RFM can be a sign of ongoing central nervous system (CNS) hypoxia and injury. A cardiotocograph or electronic fetal monitoring is nowadays more commonly used for monitoring fetal heart rate (FHR) along with RFM. There is an observed association of FHR acceleration with fetal movements, which when present indicates a healthy fetus. It can reliably be used as a screening test. According to the various tracings obtained on cardiotocography (CTG) categorization can be done into normal, suspicious or abnormal/pathological and thereby fetal jeopardy can be reliably predicted. So by doing a CTG in mothers with complaint of RFM (as per the Royal College of Obstetricians and Gynecologists [RCOG] guidelines), we can find out whether actual fetal distress is present or not and plan for management accordingly. Fetal movement commences as early as 7 weeks and becomes coordinated by the end of pregnancy. Between 20 and 30 weeks gestational age, general body movement becomes organized and fetus starts showing rest activity cycles. Perception of fetal movements typically begins in the second trimester and occurs earlier in parous women than nulliparous women.7 In 1973, Sadovsky and Yaffe described seven case reports of pregnancies with reduced fetal activity that preceded

OBSTETRICS AND GYNECOLOGY fetal death. Since then, various methods have been described to quantify fetal movement as a prognostic factor of fetal well-being. There are several methods of counting fetal movement like daily ‘kick count chart’, Cardiff count to 10 formula, daily fetal movement count (DFMC), etc. Currently, fetal movement is thought to be reassuring if mother perceives 10 fetal movements in up to 2 hours.8 Incidence rate of mothers presenting with RFM is variable. Harrington et al reported that 7% of 6,793 women delivered at a London Hospital presented with a complaint of RFM.9 It is clear that complaints of RFM are significant and warrant further evaluation.

B surface antigen, urine and stool examinations were done as usual. CTG, umbilical cord blood pH estimation (2 mL blood was drawn from in a heparinized syringe and cord blood pH was determined) and estimation of Apgar score at 1 and 5 minutes after birth were done in all cases. All relevant data was collected for statistical analysis. In this study, test for means were conducted using the data analysis add-in functionality of Chi-square analyses of contingency tables and test. Calculation of proportions reported in the study was derived.

Monitoring the fetal well-being in the uterus during pregnancy is often undertaken using a CTG. A CTG assesses the pattern of FHR alongside the size of uterine contractions; however, it is not very accurate so monitoring of fetal movements is a useful addition to predict babies in difficulty. It is seen that a normal nonstress CTG is a reliable indicator of fetal well-being in mothers with complaint of RFM. In third trimester, pregnant women with complaint of RFM, abnormal pregnancy outcomes are more common where the initial CTG were abnormal.10

A total 100 women who had complained of RFM were selected according to inclusion criterias. Table 1 shows age, gravida and gestational age in weeks distribution among the selected population. Majority of our study population belonged to younger age group (74% <25 years of age), primigravida (61%) and most of the study population had a period of gestation between 39 and 40 weeks. Cardiotocographical monitoring was done for the selected pregnant women with RFM and they were grouped under normal CTG (Group A), suspicious CTG (Group B) and abnormal CTG (Group C). It was seen that normal, suspicious and abnormal CTG were 70%, 16% and 14%, respectively (Table 2). Distribution of different CTG interpretation groups with the different outcome measures such as incidence of fetal distress, meconiumstained liquor, mode of delivery, cord blood pH, Apgar score at 1 minute/5 minutes and stillbirth rate are shown in Tables 3 and 4.

This study was designed to evaluate the CTG findings in mothers with complaint of RFM and their fetal outcome at term. The aim of this study was to find out the sensitivity and specificity of CTG in relation to fetal outcome in such cases. MATERIAL AND METHODS The prospective observational study was carried out in the Dept. of Obstetrics and Gynecology, Eden Hospital, Medical College, Kolkata from June 2012 to May 2013. The study was conducted after obtaining clearance from Ethics Committee. An informed consent was taken and signed by them before recruitment. One hundred cases of antepartum women at or more than 37 weeks to 42 completed weeks of gestation with singleton fetus complaining of RFM were selected randomly for our study. Pregnant women with multiple pregnancy, diagnosed intrauterine fetal death, thickly meconium-stained liquor at admission, highrisk factors like antepartum hemorrhage, congenitally malformed fetus, active labor and doubtful fetal maturity were excluded from our study. Clinical examination was done after taking proper history. Antenatal investigations such as complete hemogram, blood sugar estimation, blood grouping, Rh typing, human immunodeficiency virus (HIV) I and II, Venereal Disease Research Laboratory (VDRL), hepatitis

RESULT AND ANALYSIS

Table 1. Baseline Characteristics Parameters Age (years)

Distribution (n = 100)

Percentage (%)

≤20

21-25

26-30

30-35

≥35

Gravida Primi Multi Gestational age (weeks)

37-38

>38-39

>39-40

>40-41

>41-42

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OBSTETRICS AND GYNECOLOGY Table 2. Interpretation of CTG CTG

Number

Percentage (%)

Normal (Group A)

Suspicious (Group B)

Abnormal (Group C)

Table 3. Different CTG Interpretation Groups with the Different Outcome Measures Parameters

Group A (n = 70)

Group B (n = 16)

Group C (n = 14)

Total (n = 100)

Incidence of fetal distress

Incidence of meconium-stained liquor

Vaginal delivery

LSCS

Mode of delivery

Incidence of stillbirth

Table 4. Cord Blood pH and Apgar Score at 1 Minute and 5 Minutes Parameters

Group A (n = 70) Group B (n = 16)

Cord blood pH <7.2

Group C (n = 14)

Total (n = 100)

No depression

Mild depression

Severe depression

No depression

Mild depression

Severe depression

Apgar score at 1 minute

Apgar score at 5 minutes

Table 5. Sensitivity and Specificity of CTG in RFM Live

Stillborn

Total

Normal

CTG

Suspicious + Abnormal

Total

100

DISCUSSION Reduced fetal movement (RFM) is a common reason for concern for mothers as well as doctors, whereas maternal perception of fetal movement is reassuring to both. There is a possibility of intrauterine fetal death and other perinatal complications in such cases. Fetal movement count by Cardiff count to 10 formula1 or by DFMC2 is one of the biophysical tests used to assess fetal well-being in late pregnancy. In the present study, a total of 100 cases were taken.

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All of them presented with RFM. The 100 cases were divided into three groups. Group A were those who had a normal CTG. Those with suspicious CTG belonged, to Group B and patients with abnormal CTG were allotted Group C. Majority of the cases belonged to the young age group, that is 74% were <25 years old and primigravida (61%). Study conducted by Miller, Eden et al, Usher et al and Steer et al showed that fetal distress and meconium-stained liquor are more common in postdated cases. But, in our study majority of patients with suspicious and abnormal CTG had period of gestation between 39 and 40 weeks. In Table 2, it is seen that among the patients of RFM 70% had a normal CTG, 16% had a suspicious CTG and 14% had an abnormal CTG. Accordingly, we have divided our study population into three groups A, B and C, respectively. It was seen that in all three groups A, B, and C the majority of the women belonged to younger age group, mostly between 21-25 years and â&#x2030;¤20 years.

OBSTETRICS AND GYNECOLOGY The p value is 0.279, which is >0.05, therefore not significant. This means that there was no correlation between age and patients presenting with RFM, which is true. It was seen that mothers of all ages can equally present with RFM. In our country, there is a trend towards early marriage and early childbearing so most of our study population belonged to younger age groups. Sixty-one percent mothers were primigravida. The p value is 0.482, which is not significant. All mothers can present with the complaint of RFM irrespective of their parity. A similar study conducted by Fitzgerald and Miller demonstrated that the incidence of suspicious and abnormal CTG in primigravida was more than multipara, whereas Rosario found no significant difference. Table 3 shows the incidence of fetal distress in different groups. Approximately 71.4% of babies in group Chad fetal distress, whereas only 1.4% of Group A had fetal distress. One hundred percent of Group C had meconium-stained liquor at delivery, whereas 7.1% of Group A, had meconium-stained liquor at delivery. In Group A, 57.1% of patients had a vaginal delivery. In Group B and C, 75% and 71.4% underwent lowersegment cesarean section (LSCS), respectively. The p value is 0.02, which is significant. It was seen that the incidence of LSCS was more in the suspicious and abnormal CTG groups. In the suspicious and abnormal CTG group, it was seen that 91.7% and 100%, respectively underwent LSCS for fetal distress. The p value is 0.0001, which is highly significant. The incidence of fetal distress was much higher in suspicious and abnormal CTG group and therefore the incidence of LSCS due to fetal distress in these two groups was also higher. Chitra and Neeru demonstrated operative delivery for fetal distress was 1.16% in the normal CTG group, 32% in the equivocal group and 70% in the abnormal CTG group. Kulkarni and Shroti showed progressive rise of operative delivery for fetal distress from 5.17% in reactive group to 28.5% in ominous group.12 Elimian et al were also in favor that women with nonreactive admission test (CTG) were more likely to be delivered by cesarean section, to have fetal distress resulting in LSCS and to have longer neonatal hospital stay.13 In Group A, 92.9% had clear liquor at delivery; in Group B, 81.3% had meconium-stained liquor; in Group C, 100% had meconium-stained liquor at delivery. The p value is 0.0001, which is highly significant. So, in the suspicious and abnormal CTG group, the incidence of meconium-stained liquor was much higher. In a retrospective study, â&#x20AC;&#x153;Study of meconium-stained liquor

and its fetal outcomeâ&#x20AC;? conducted by M Priyadarshini and S Panicker, it was seen that meconium-stained liquor with abnormal CTG was associated with poor outcome, increased cesarean section rates and increased neonatal complication. Table 4 shows the distribution according to the fetal outcome in different groups. In Group A, 97.1% babies were live; in Group B, 100% babies were live and in Group C, 71.4% babies were live and 28.6% were stillborn. The p value is 0.001, which is significant. So, we can say that abnormal CTG is a good predictor of adverse fetal outcome. The stillborn rate in the present study was 6%, which is comparable to similar studies taken by Hellman, Gaud and Krishna and Narang. Whereas a study by Fujikura and Klionsky showed a neonatal mortality rate of 3%. In Groups A and B, 97.1% and 87.5% had cord blood pH >7.2, respectively. In Group C, 92.9% had a cord blood pH <7.2 and 7.1% had cord blood pH >7.2. The p value is 0.0001, which is highly significant. Metabolic acidosis was more common among the abnormal CTG group. Smith et al analyzed the umbilical cord arterial blood gas in 21 patients undergoing cesarean section because of abnormal CTG. They found minor degrees of respiratory acidemia and concluded that abnormal CTG traces may be associated with hypoxia, but were unrelated to asphyxia. The small number of the study population was a limitation of the study.14 The distribution of Apgar score at 1 minute in different groups was seen. In Group A, 97.1% babies had no depression and 2.9% had mild depression. In Group B,11 62.5% babies had mild depression and 37.5% had no depression. In Group C, 70% babies had severe depression and 30% babies had mild depression. The p value is 0.0001, which is significant. So, 1 minute low Apgar score was more in the abnormal CTG group and in cases of meconium-stained liquor. This is in accordance with observations made by Walkar, 1954; Desmond, 1954; Miller, 1975 and Mies, 1978. The distribution of Apgar score at 5 minutes in different groups was seen. In Group A, 100% of babies had no depression. In Group B, 12.5% babies had mild depression and 87.5% had no depression. In Group C, 10% babies had severe depression, 50% had mild depression and 40% had no depression. The p value is 0.0001, which is significant. So, there was a significant improvement in babies with severe depression (Apgar score 0-3) at 1 minute compared to 5 minute, Apgar score. In a study by Hogan et al, it was shown that a 5 minutes Apgar score <4 is a good proxy for asphyxia.15

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OBSTETRICS AND GYNECOLOGY Table 5 shows the sensitivity of CTG was 72.34% and the specificity was 66.7%. In a similar study conducted by Prof. Dilsath, Meena “Admission test and its correlation with fetal outcome” the sensitivity of CTG was found 78%, specificity as 87%. CONCLUSION We can conclude that RFM can be a complaint of any mother irrespective of her age and parity. It was seen that an abnormal and suspicious CTG were more commonly associated with meconium-stained liquor at delivery, also they were associated with a higher rate of cesarean section with fetal distress being the most common indication among these two groups. The incidence of stillborn was 28.6% among the abnormal CTG group, which is quite high. The incidence of cord blood pH <7.2, low Apgar scores at 1 minute and 5 minutes were higher among the abnormal CTG group. The necessity for early intervention could be reduced in those patients with normal CTG. Also mothers with normal CTG were assured to some extent. In our study, we have found the sensitivity of CTG to be 72.3%. Hence, we can say that RFM, if detected early and with the help of antepartum CTG, we can reduce the rate of perinatal mortality and intrauterine fetal death (IUFD). This can be done simply and also CTG is more acceptable as it is a noninvasive procedure. So, in a country like India, mothers should be more adequately counseled about the importance of RFM and CTG so that pregnancy outcome can be optimized with adequate antenatal care and supervision. RFM is an important cause of adverse perinatal outcome and it may be a sign of CNS hypoxia and injury. By doing a CTG in mothers with complaint of RFM, we can find out whether actual fetal distress is present or not. REFERENCES 1. Marsál K. Ultrasonic assessment of fetal activity. Clin Obstet Gynaecol 1983;10(3):541-63.

2. Rayburn WF. Fetal body movement monitoring. Obstet Gynecol Clin North Am 1990;17(1):95-110. 3. Neldam S. Fetal movements as an indicator of fetal wellbeing. Dan Med Bull 1983;30(4):274-8. 4. Grant A, Elbourne D, Valentin L, Alexander S. Routine formal fetal movement counting and risk of antepartum late death in normally formed singletons. Lancet 1989;2(8659):345-9. 5. Harrington K, Thompson O, Jordan L, Page J, Carpenter RG, Campbell S. Obstetric outcome in women who present with a reduction in fetal movements in the third trimester of pregnancy. J Perinat Med 1998;26(2):77-82. 6. E fkarpidis S, Alexopoulos E, Kean L, Liu D, Fay T. Casecontrol study of factors associated with intrauterine fetal deaths. MedGenMed 2004;6(2):53. 7. Gillieson M, Dunlap H, Nair R, Pilon M. Placental site, parity, and date of quickening. Obstet Gynecol 1984;64(1):44-5. 8. RCOG Release - Reduced Fetal Movements (New Greentop Guidelines). 9. Lenstrup C, Haase N. Predictive value of antepartum fetal heart rate non-stress test in high-risk pregnancy. Acta Obstet Gynecol Scand 1985;64(2):133-8. 10. Chitra R, Neeru T. The role of admission test in intrapartum surveillance. In: Abstract 44th AICOG Conference, Ahmedabad 2000:p.36. 11. Kulkarni AA, Shrotri AN. Admission test: a predictive test for fetal distress in high risk labour. J Obstet Gynaecol Res 1998;24(4):255-9. 12. Elimian A, Lawlor P, Figueroa R, Wiencek V, Garry D, Quirk JG. Intrapartum assessment of fetal well-being: any role for a fetal admission test? J Matern Fetal Neonatal Med 2003;13(6):408-13. 13. Smith JH, Anand KJ, Cotes PM, Dawes GS, Harkness RA, Howlett TA, et al. Antenatal fetal heart rate variation in relation to the respiratory and metabolic status of the compromised human fetus. Br J Obstet Gynaecol 1988;95(10):980-9. 14. Hogan L, Ingemarsson I, Thorngren-Jerneck K, Herbst A. How often is a low 5-min Apgar score in term newborns due to asphyxia? Eur J Obstet Gynecol Reprod Biol 2007;130(2):169-75.

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Fetal Death Risk Climbs with First Signs of Pre-eclampsia Pregnancies diagnosed with pre-eclampsia in the preterm period have a very high relative risk for fetal death, according to findings of a population-based cohort study published online February 4 and in the March issue of Obstetrics & Gynecology."Although the pathologic origins of pre-eclampsia likely occur during placentation, the clinical signs and symptoms typically do not emerge until after 20 weeks of gestation," write Quaker E. Harmon, MD, PhD, from the Epidemiology Branch and Biostatistics Branch, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, North Carolina, and colleagues. "The most relevant estimate of fetal risk in the presence of preterm pre-eclampsia would be one that considers the timing of pre-eclampsia diagnosis - a diagnosis that often occurs well before the time of delivery.

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OPHTHALMOLOGY

External Ophthalmomyiasis Due to Oestrus ovis: A Case Report SUMANGALA B*, TEJASHREE†

ABSTRACT Myiasis is the infestation of the human and vertebrate animals with fly larvae. Ophthalmomyiasis refers specifically to infestation that involves the eye and ocular adnexa. A case of external ophthalmomyiasis presenting with foreign body sensation in the eye due to Oestrus ovis was diagnosed on microscopy.

Keywords: Oestrus ovis, sheep bot fly, myiasis

ot flies though look-like plain house flies are myiatic flies. Myiasis is the infestation of the human and vertebrate animals with fly larvae. Less than 5% of human myiasis involve the eye. Ophthalmomyiasis refers specifically to infestation that involves the eye and ocular adnexa. External ophthalmomyiasis occurs when lids and conjunctiva are involved.1 Oestrus ovis usually causes internal ophthalmomyiasis. External ophthalmomyiasis is caused commonly by cattle bot fly. Myiasis of eyelid due to cuterebra larva and Dermatobia hominis has been reported.2

CASE REPORT An adult male patient, aged 22 years, came to JSS Hospitals Ophthalmology OPD with history of the foreign body sensation and increased watering in the right eye, few hours after being hit by an insect in the field. On examination, the palpebral and bulbar conjunctiva were injected. The discharge was clear. Multiple actively motile white organisms measuring 0.3-0.4 cm in length, 0.1-0.2 cm in width were seen. Ophthalmoscopic

*Professor and Head Dept. of Microbiology Mandya Institute of Medical Sciences, Mandya, Karnataka †Professor Dept. of Microbiology JSS Medical College, Mysore, Karnataka Address for correspondence Dr Sumangala B # 367, 18th Main, D-Block, Ist Stage JP Nagar, Mysore - 570 008, Karnataka E-mail: sharadasuma7@gmail.com

examination did not reveal any abnormality or similar organism inside the eye. Left eye was normal. These maggots, removed by blunt forceps, were received in our laboratory for identification. The patient was treated with ciprofloxacin and steroid eye drops following which patient recovered completely. Light microscopy revealed rows of small spines on external surface and large, black oral hooks connected to an internal cephalopharyngeal skeleton confirmed the identification of Oestrus ovis.2,3

Life Cycle of Oestrus ovis4 The larvae of sheep bot/nasal bot/head bot fly has 4 stages: ÂÂ

Adult: Hairy, yellowish fly 12-14 mm in length. They are rarely seen.

ÂÂ

Egg: Present within female fly.

Figure 1. Larva of Oestrus ovis under high power magnification (45x).

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OPHTHALMOLOGY ÂÂ

Larva: Female fly is ovoviviparous and releases 50 larvae at a time into the inner canthus of the eye or nostrils. Larvae when fully grown are 20-30 mm long.

ÂÂ

Pupa: Pupal stage is seen in soil.

DISCUSSION Symptoms of external ophthalmomyiasis are those of acute catarrhal conjunctivitis. Patient complains of foreign body sensation, burning, itching, photophobia, epiphora. Edematous eyelid, injected conjunctiva are the common signs. Conjuctival pseudomembrane may be seen. Organisms are seen crawling along the conjunctiva. It clings to the conjunctiva with its powerful hooklets and is difficult to remove. They may penetrate into the eye resulting in iridocyclitis, endophthalmitis, subretinal tracks. Subretinal track is pathognomonic

of internal myiasis.5 They may burrow into paranasal sinuses, nasopharynx resulting in congestion, pruritus and headache. REFERENCES 1. Doxanas MT, Walcher JR, Ludwig RA. Ophthalmomyiasis externa: a case report. Md Med J 1992;41(11): 989-91. 2. Albert DM, Jakobiec FA. Principles and Practice of Ophthalmology. 2nd edition, Volume 4. 3. Paul Chester Beaver, Rodney Clifton Jung, Eddie Wayne Cupp. Clinical Parasitology. 9th edition, Lea & Febiger: Philadelphia, PA; 1984. 4. Hennessy DJ, Sherrill JW, Binder PS. External ophthalmomyiasis caused by Estrus ovis. Am J Ophthalmol 1977;84(6):802-5. 5. Ziemianski MC, Lee Ky, Sabates FN. Ophthalmomyiasis interna. Arch Ophthalmol 1980;98(9):1588-9.

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Stents as Effective as Prostaglandin in Glaucoma Trabecular micro-bypass stents reduce intraocular pressure in glaucoma patients just as well as the prostaglandin analog travoprost, according to a new study. Although hypotension medication helps many people with openangle glaucoma, some can't tolerate it or have trouble adhering to their prescriptions. These patients might benefit from microinvasive glaucoma surgery using stents, said investigator Steven Vold, MD, who has an ophthalmology practice in Fayetteville, Arkansas.

Daily 2-hour Patching Improves Moderate, Severe Amblyopia Children with moderate or severe amblyopia saw significant improvement in visual acuity with the use of daily 2-hour patching of the stronger eye, according to data collected in a trial's run-in phase published online February 19 in JAMA Ophthalmology. The study results were not unexpected. "This study confirms what many clinicians have suspected: That small amounts of patching, such as 2 hours per day, can lead to improvement in amblyopia, even with severe amblyopia," K. David Epley, MD, clinical spokesperson for the American Academy of Ophthalmology, told Medscape Medical News in an email. Dr Epley, who was not involved in the current study, will help lead the academy's online Pediatric Clinical Research and Education Center.

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PEDIATRICS

Freeman-Sheldon Syndrome with Pulmonary Hypoplasia: A Rare Case Report SOURAJIT ROUTRAY*, SAMARENDRA MAHAPATRO†, NIJWM MAHILARY*

ABSTRACT The Freeman-Sheldon syndrome is a rare congenital dysplasia characterized by facial and skeletal abnormalities. Facial abnormalities are typical mask like face with distal arthrogryposis. There are many clinical features depicting the syndrome, but the presence of all in a single patient is not necessarily required for the diagnosis. Our case is a newborn with typical facial presentation as described in the syndrome along with respiratory distress. Basically by presenting this case, we hope to create an awareness regarding this clinical entity.

Keywords: Freeman-Sheldon syndrome, congenital dysplasia, facial skeletal abnormalities, respiratory distress

reeman-Sheldon syndrome otherwise termed as the ‘Whistling face’ syndrome is a rare congenital dysplasia characterized by facial and skeletal abnormalities secondary to a generalized myopathy.¹ It is also termed as distal arthrogryposis type 1, 2A.¹ These individuals have a full forehead and masklike face with a small mouth giving a whistling face appearance. The mask-like face is attributed to increased tone and fibrosis of facial muscles. The eyes are deeply set below the supraorbital ridge with blepharophimosis and ptosis. They have a short nose and broad nasal bridge, long philtrum, deep nasolabial folds, full cheeks, high- arched palate, small tongue, an H-shaped cutaneous dimpling on the chin, flexion of fingers, equinovarus feet with contracted toes, kyphosis and scoliosis.² The syndrome may be suspected clinically. All the patients may or may not necessarily have all the features described under this syndrome.³

respiratory distress, later on diagnosed clinically as Whistling face syndrome. CASE REPORT This outborn case (product of nonconsanguineous marriage) was a term (39 weeks), female neonate, delivered through cesarean section of a 32-year-old multipara, Hindu mother from Orissa. There was a bad obstetric history with one spontaneous abortion at 5th week and death of two term babies during neonatal period (one at Day 2 and other at Day 11 of life).

We report a case of a female neonate with distal arthrogryposis and mask-like face presented to us with

None of the babies had any physical deformity, as per the history, but documentation regarding previous issues were not available. The present issue was conceived after 2 years of the previous delivery. This mother had gone through proper antenatal check-up. No history of any drug intake other than the routine drugs prescribed to her during antenatal period. No other family member has history of any congenital deformity.

*Postgraduate Student †Professor Dept. of Pediatrics Hi-Tech Medical College and Hospital, Bhubaneswar, Odisha Address for correspondence Dr Sourajit Routray C/o Dr Nijwm Mahilary Flat no - 401, Block B, BT Residency GGP Colony, Near Canal Road, Rasulgarh - 751 025 Bhubaneswar, Odisha E-mail: sourajitroutray@gmail.com

The baby was received in the emergency department at 4 hours of birth. Birth weight was 3 kg and head circumference was 34 cm. The child was tachypneic (respiratory rate of 80/min), heart rate 158/min, diminished breath sound over left lung field, heart sounds normal, no murmur. Oxygen saturation on room air was 86% and rose to 94% with 5 L/min oxygen supplementation through oxygen hood. Abdominal examination was found to have no abnormality. The baby was having flat-mask like face (whistling face), club feet, joint contractures

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PEDIATRICS

Figure 3. Feet showing clubfoot and flexion contracture.

Figure 1. Picture showing mask-like face (whistling face), club feet, joint contractures.

Figure 4. Chest X-ray revealed opaque left hemithorax.

involving hand and feet, congenital dislocation of hip which was later confirmed by an X-ray findings (Figs. 1-3). Routine hemogram and electrolytes were normal. Sepsis screenings were negative. Chest X-ray revealed pulmonary hypoplasia (L) (Fig. 4).

Ultrasonography of the abdomen and the pelvis revealed normal findings. Neurosonogram, ECG, Echo also revealed no abnormality. Serum creatinine kinase level was within normal limit. Muscle biopsy showed fibrosis of the muscles. b

Figure 2 (a and b). Right and left hand showing flexion contractures of the fingers (clinodactyly and camptodactyly).

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The baby died on Day 6 of life inspite of proper medical management and ventilator support due to pulmonary hemorrhage.

PEDIATRICS DISCUSSION ‘Whistling face’ syndrome was first described by Freeman and Sheldon in 1938.¹ The incidence and sex ratio is not known, as it has been estimated that only 100 cases had been reported throughout the world till date.¹ It is an autosomal dominant disorder.² In 1984, Fitzsimmons et al reported some families having autosomal recessive inheritance.² Sporadic occurrence has also been reported.⁴ All the cases are not equally affected, as described in the spectrum of disorders and disabilities that are found in the Freeman-Sheldon syndrome. The mechanism behind skeletal and muscular dystrophy coming in combination has not been described clearly.³ Sauk et al suggested that it may be due to hypoplasia of the muscle bundles that are supplied by the major branch of the major nerves.4 The biopsy of the muscles which are affected reveals fibrosis, which may contribute to contractures.³ Stevenson et al published the strict diagnostic criteria for Freeman-Sheldon syndrome in March 2006.⁵ These included two or more of the following: Microstomia, whistling face, deep nasolabial folds, H- or V-shaped chin dimpling.⁵ Toydemir et al studied on 28 patients in 2006 and found mutation in MYH3 gene (embryonic myosin heavy chain 3) on chromosome no 17p-13.1-pter, among 26 patients, two patients had no mutation.⁶ The pulmonary hypoplasia in this syndrome has not been described previously. Our case with respiratory distress was due to pulmonary hypoplasia. We clinically diagnosed the case as Whistling face syndrome under the context of the diagnostic criteria set up in 2006 by Stevenson et al (distal arthrogryposis, broad nose, long philtrum, full cheeks, deep nasolabial fold, pursed out lower lip, mask-like face and the muscle biopsy showing fibrosis, confirming myopathy of the muscles). The life expectancy, intelligence and cognitive functions are normal. Rarely, any patient dies due to respiratory failure in infancy. Antenatal diagnosis can be done at 20-week of gestation, in case of positive family history.⁷ The ultrasonography shows abnormality in the extremities and the mouth.⁷ The treatment is surgical

correction of club foot and craniofacial abnormality by combined efforts of both orthopedic and craniofacial surgeon.⁸,⁹ Medical intervention is required during repeated episodes of bronchitis and pneumonia. CONCLUSION The motto of presenting this case is to enlighten the pediatricians and general practitioners regarding the existence of this clinical entity and to take necessary intervention at the earliest. REFERENCES 1. Freeman EA, Sheldon JH. Cranio-carpo-tarsal dystrophy. Arch Dis Child 1938;13(75):277-83. 2. Hall JG. Overwiew of Arthrogryposis (Chapter 1). In: Arthrogryposis: A Text Atlas. Staheli LT, Hall JG, Jaffe KM, et al. Pg. 4-13. 3. Attia A, Suleman M, Abd Al Aziz Al Nwasser. Freeman-Sheldon syndrome with respiratory failure: a case report. Respiratory Medicine CME 2008;1(4):274-7. 4. Sauk JJ Jr, Delaney JR, Reaume C, Brandjord R, Witkop CJ Jr. Electromyography of oral-facial musculature in craniocarpaltarsal dysplasia (Freeman-Sheldon syndrome). Clin Genet 1974;6(2):132-7. 5. Stevenson DA, Carey JC, Palumbos J, Rutherford A, Dolcourt J, Bamshad MJ. Clinical characteristics and natural history of Freeman-Sheldon syndrome. Pediatrics 2006;117(3):754-62. 6. Toydemir RM, Rutherford A, Whitby FG, Jorde LB, Carey JC, Bamshad MJ. Mutations in embryonic myosin heavy chain (MYH3) cause Freeman-Sheldon syndrome and Sheldon-Hall syndrome. Nat Genet 2006;38(5):561-5. 7. Robbins-Furman P, Hecht JT, Rocklin M, Maklad N, Greenhaw G, Wilkins I. Prenatal diagnosis of FreemanSheldon syndrome (whistling face). Prenat Diagn 1995;15(2):179-82. 8. Malkawi H, Tarawneh M. The whistling face syndrome, or craniocarpotarsal dysplasia. Report of two cases in a father and son and review of the literature. J Pediatr Orthop 1983;3(3):364-9. 9. Call WH, Strickland JW. Functional hand reconstruction in the whistling-face syndrome. J Hand Surg Am 1981;6(2):148-51.

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Insulin-like Growth Factor Promising for Rare Autism Type Insulin-like growth factor-1 (IGF-1) is safe, effective and significantly improves social withdrawal in children with a rare type of autism spectrum disorder (ASD), but may also have treatment implications for other ASDs, early research suggests. Known as Phelan-McDermid syndrome (PMS), the disorder, which affects about 1,200 individuals worldwide, is caused by a deficiency in the SHANK3 gene. The disorder likely accounts for only about 1% of all ASDs.

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IMAGE AND INVESTIGATION

Porencephalic Cyst MONIKA MAHESHWARI

IMAGES IN NEUROLOGY A porencephalic cyst is a cavity within the cerebral hemisphere, filled with cerebrospinal fluid, that communicates directly with the ventricular system. It is a rare condition and usually congenital. Etiologies include - perinatal cerebral ischemia, trauma, infection and antenatal intraparenchymal hemorrhage. Porencephaly is often associated with various ophthalmic and neurologic signs, including visual-field defects, abnormal pupillary responses, optic nerve hypoplasia, decreased vision, nystagmus, strabismus, hemi-inattention, seizures and mental deficiencies. Treatment include physical therapy, rehabilitation, antiepileptic drugs (valproate, carbamazepine and clobazam), shunt or neurosurgery. Recently, a 30-year-old female presenting in casualty with left hemiparesis, on neuroimaging was diagnosed to have a c cyst (Fig. 1). Hence, it was worth describing this rare congenital cephalic disorder. Patient responded well to medical therapy alone and was discharged after 1 week.

Associate Professor Jawaharlal Nehru Hospital, Ajmer, Rajasthan E-mail: opm11@rediffmail.com

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Figure 1. CT scan brain showing a hypodense area communicating with left lateral ventricle.

AROUND THE GLOBE

News and Views ÂÂ A nationally representative survey shows that

ÂÂ According to researchers from Brazil, in addition

ÂÂ The illness that has been called “chronic fatigue

ÂÂ Patients with type 2 diabetes who lowered their

natural product use in the United States has shifted since 2007, with some products becoming more popular and some falling out of favor. Overall, natural products (dietary supplements other than vitamins and minerals) remain the most common complementary health approach. syndrome” (CFS) in the United States and “myalgic encephalomyelitis” (ME) elsewhere is a “serious, complex, multisystem disease” that physicians need to view as “real” and diagnose, the Institute of Medicine (IOM) says in a new 235-page report. To reflect the condition’s hallmark defining symptom, postexertional malaise, the report proposes a new name be adopted, “systemic exertion intolerance disease (SEID),” defined in both adults and children by the following:

Substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion and is not substantially alleviated by rest Postexertional malaise (often described by patients as a “crash” or “collapse” after even minor physical or mental exertion) Unrefreshing sleep Cognitive impairment and/or orthostatic intolerance. ÂÂ A mixed-methods survey of 120 clinicians who

provide mental health services showed that 58% reported that burnout had a negative impact on either work quality or productivity. Other reported negative effects included decreased empathy, communication and patient engagement. In addition, those who reported higher levels of depersonalization were significantly more likely to report that burnout affected their interaction with patients. The study is published in the February issue of Psychiatric Services.

to causing significant weight loss, gastric bypass surgery appears to significantly reduce gastroesophageal reflux disease (GERD) symptoms and incidence in morbidly obese individuals long after the procedure. The findings are published in Annals of Surgery. systolic blood pressure (BP) had a significantly decreased risk for death and cardiovascular events, especially stroke, in the largest meta-analysis to examine this relationship to date. Specifically, a 10 mmHg reduction in systolic BP was associated with an 11% to 17% lower relative risk of death, cardiovascular events, heart disease, retinopathy and albuminuria and a 27% lower relative risk of stroke in this review of 40 trials by Connor A Emdin, HBSc, from the George Institute for Global Health, Oxford University, United Kingdom, and colleagues, published in the February 10 issue of Journal of the American Medical Association.

ÂÂ In asymptomatic and symptomatic patients at low-

risk for coronary artery disease, the use of coronary artery calcium (CAC) imaging improves longterm prediction of risk beyond that established by the Framingham Risk Score (FRS) and exercisetreadmill and stress-perfusion testing, according to the results of a new study published February 9, 2015 in JACC: Cardiovascular Imaging.

ÂÂ Middle-school children who consume heavily

sweetened energy drinks are 66% more likely to be at risk for hyperactivity and inattention symptoms, as per findings of a new study led by the Yale School of Public Health and published in the journal Academic Pediatrics. The finding has implications for school success and lends support to existing recommendations to limit the amount of sweetened beverages schoolchildren drink. The authors also recommend that children avoid energy drinks, which in addition to high levels of sugar also often contain caffeine.

ÂÂ Fetal

alcohol syndrome (FAS) is widely underdiagnosed in young children, preventing them from receiving crucial support services early in life as reported in the January 30 issue of the Morbidity and Mortality Weekly Report.

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AROUND THE GLOBE ÂÂ New

data from the National Center for Complementary and Integrative Health (NCCIH) show that from 2002 to 2012, the use of yoga doubled among adults. Overall, 34% of adults used any complementary approach in 2012, of whom about 21 million, about 10% of the population, reported using yoga, according to the most recent complementary health questionnaire, conducted by the National Institutes of Health’s NCCIH and the Centers for Disease Control and Prevention’s National Center for Health Statistics.

ÂÂ Rates of treatment failure and death are lower in

patients who receive a kidney transplant than in those treated with intensive home hemodialysis, according to a study presented here at the American Society of Nephrology 35th Annual Dialysis Conference.

ÂÂ Smartphone pedometer applications can accurately

measure steps and may be more precise than some wearable devices, according to a new study by Mitesh Patel, an assistant professor of medicine and healthcare management at Perelman School of Medicine and the Wharton School, University of Pennsylvania in Philadelphia, and colleagues published February 10 in JAMA.

ÂÂ Treatment with cognitive behavioral therapy (CBT)

may help relieve insomnia and pain among patients with knee osteoarthritis (KOA), according to a new double-blind, randomized placebo-controlled clinical trial. The study findings were published online January 26 in Arthritis and Rheumatology.

ÂÂ According to a new study in the Journal of Clinical

Endocrinology & Metabolism, brief 30-min daytime naps might protect you against the harmful health effects of a poor night’s sleep. Specifically, naps appeared to restore hormones and proteins involved in stress and immune function to normal levels in the study.

ÂÂ In patients with acute ischemic stroke, those who

had confirmed large vessel anterior circulation occlusions treated with thrombolysis, rapid treatment with the Solitaire FR (Flow Restoration) stent retriever (Covidien) reduced poststroke disability and increased the proportion of patients alive and independent at 3 months, in the SWIFT PRIME trial presented at the International Stroke Conference (ISC) 2015 and published simultaneously in the New England Journal of Medicine.

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ÂÂ Rapid endovascular treatment improved functional

outcomes and halved mortality in ischemic stroke patients with a proximal vessel occlusion in the ESCAPE trial. The study was presented at the International Stroke Conference (ISC) 2015 on February 11 and published online simultaneously in the New England Journal of Medicine.

ÂÂ Trends from multiple studies suggest preschoolers

in the United States may be bridging a caloric gap, researchers report in a commentary published online February 9 in Pediatrics. The results suggest the recent decline in obesity rates in 2- to 5-yearold may continue. The caloric gap estimates how many calories children must eliminate from their daily diet to bring obesity rates down to the 1970s pre-obesity epidemic levels. Among children aged 2 to 5 years, the gap is about 30 kcal daily.

ÂÂ Premature birth is associated with an increased

use of prescription asthma medication through adolescence, but this tendency disappears by young adulthood, according to a Danish National Cohort Study published in PLoS One 2015.

ÂÂ Researchers from the University of Surrey in the

UK have found that 25% of a driver’s total exposure to pollutant nanoparticles can come from passing through intersections controlled by traffic lights. Signalized traffic intersections had the highest levels of pollution, attributable to the frequent changes in driving conditions. Remaining in the same place for a period of time and revving up to move quickly when the lights changed resulted in high particle number concentrations.

ÂÂ A new study, with a follow-up period of almost

20 years, from UK has found that serum levels of an amino acid are strongly associated with the risk for type 2 diabetes in South Asian men, potentially offering a target for novel treatments and prevention strategies. Increases in serum levels of tyrosine are associated with a 50% increased risk for diabetes in South Asian men, compared with an increase of just 10% among Europeans.

ÂÂ Low-value items on Choosing Wisely (CW) lists

may be diverting attention from procedures that truly drive up costs, according to authors of a new study in JAMA Internal Medicine. They found that although cardiac stress testing before low-risk surgeries was rarely being done before the CW effort launched, seven specialty societies included it on their lists of top procedures to watch for overuse.

AROUND THE GLOBE ÂÂ French researchers report in the American Journal

of Gastroenterology that in patients with Lynch syndrome, colonoscopy with chromoscopy can detect adenomas that may be unseen with standard colonoscopy. Lynch syndrome is a genetic predisposition to colon cancer.

ÂÂ A 43-patient Spanish cohort study in Seminars in

Arthritis & Rheumatism has found tumor necrosis factor (TNF) inhibition with etanercept is relatively safe and quite effective over the long-term for refractory systemic lupus erythematosus (SLE).

ÂÂ According to a new study presented at the

International Stroke Conference (ISC) 2015, older patients without diabetes or kidney disease who have a systolic blood pressure (SBP) of 140-149 mmHg have a risk for stroke higher than that of similar patients with a SBP under 140 mmHg and a risk similar to that of patients with a level of 150 mmHg and over.

ÂÂ In ambulatory older adults aged 65 years or older

without AF at baseline, circulating troponin T levels appear to be significantly associated with incident atrial fibrillation, according to recent findings published in Heart Rhythm.

ÂÂ The American Academy of Pediatrics released

updated measles guidelines online in response to the national outbreak of the disease. The new guidelines from the academy’s Red Book: 2015 Report of the Committee on Infectious Diseases feature changes in the evidence required for measles immunity, the use of immune globulin, vaccination for healthcare personnel, and the management of patients with HIV infections and other susceptibilities.

ÂÂ Pediatric atopic dermatitis was linked with key

features of metabolic syndrome, including central obesity and high blood pressure, in a multicenter prospective case-control study in JAMA Dermatol 2015;151:144-152. Given the findings, clinicians should routinely measure body mass index and waist circumference in children with atopic dermatitis (AD), said Dr. Jonathan I. Silverberg of Northwestern University, Chicago and his associates.

ÂÂ Achillion Pharmaceuticals Inc said its experimental

hepatitis C drug, when used in combination with Gilead Sciences Inc’s Sovaldi, eradicated signs of the virus after 6 weeks of therapy, sending its shares up before the opening bell. If the combination of Sovaldi and Achillion’s ACH-3102 continues to

show this level of effectiveness, the treatment could eventually rival offerings from Gilead and AbbVie Inc to fight the liver-destroying virus. ÂÂ Meditation may slow age-related brain atrophy,

suggests new research published online in Frontiers in Psychology.

ÂÂ Hormone replacement therapy (HRT) seems to

be significantly associated with an increased risk for ovarian cancer in postmenopausal women, reported an extensive meta-analysis from the Collaborative Group on Epidemiological Studies of Ovarian Cancer. The findings were published online February 13 in the Lancet.

ÂÂ Obesity is a complex medical problem that requires

a multimodal approach beyond merely advising patients to go on a diet and exercise, suggest obesity experts in a new opinion piece published online February 12 in Lancet Diabetes & Endocrinology.

ÂÂ Low vitamin D levels are associated with larger

brain infarct volume and worse outcomes in patients with ischemic stroke, reported a new study presented at the International Stroke Conference (ISC) 2015.

ÂÂ Marathon training seems perfectly safe for middle-

aged adults and engaging in a structured training program translates into significant and healthy improvements in the heart’s size and function, suggests a new study published in the February 2015 issue of Circulation: Cardiovascular Imaging.

ÂÂ In a large study of patients who were hospitalized

for HF, those who were newly diagnosed with sleep-disordered breathing (sleep apnea) were more likely to die within a few years compared with their peers. Specifically, the hazard ratio for allcause mortality within 3 years of hospital discharge was 1.57 for HF patients with sleep apnea, after adjustment for multiple variables, in this study by Dr Rami Khayat (Ohio State University, Columbus) and colleagues, published online January 29, 2015 in the European Heart Journal.

ÂÂ New research suggests that 13-month-olds use

their understanding about others’ perspectives and social evaluation skills to make sense of social interactions. The findings are published in Psychological Science.

ÂÂ Parents’ lifestyles, rather than their genes, are

primarily responsible for their children being overweight, reports new research by the Centre for

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AROUND THE GLOBE Economic Performance based at the London School of Economics and Political Science (LSE).

ÂÂ In a pooled analysis of five major clinical trials

that randomized patients to receive implantable cardioverter defibrillators (ICDs) or usual care for primary prevention, ICD patients of all ages had improved survival. Additionally, age did not have any effect on rehospitalization after ICD implantation. The study was published in Circulation: Cardiovascular Quality and Outcomes.

ÂÂ A new study has shown that healthy older adults

with elevated levels of amyloid-beta (Aβ) and symptoms of anxiety had a greater decrease in various cognitive functions, including verbal memory and language, over time than those without anxiety symptoms. The study is published online in JAMA Psychiatry.

ÂÂ A new observational real-world study, being

presented at the American Stroke Association’s International Stroke Conference 2015, suggested that using long-term, continuous cardiac monitoring with Reveal LINQ Insertable Cardiac Monitor (ICM) led to an AF detection rate of 12.2% at 182 days, which was nominally 37% higher than the rate observed in CRYSTAL AF at the same time point.

ÂÂ The inability to regulate emotion in patients with

autism spectrum disorders (ASDs) appears to be due to impaired brain activity, suggests a new research published online in the Journal of Autism Developmental Disorder.

ÂÂ Autologous hematopoietic stem cell transplant

seemed “unequivocally” superior to mitoxantrone in reducing imaging evidence of disease activity in patients with multiple sclerosis refractory to conventional therapy in a phase 2 randomized controlled trial published online February 11 in Neurology.

ÂÂ The US Food and Drug Administration has recently

approved lenvatinib for refractory differentiated thyroid cancer (DTC) which has progressed despite radioactive iodine therapy.

ÂÂ Low levels of 25-OH vitamin D in childhood are

associated with subclinical atherosclerosis over 25 years later in adulthood, reported a new study published in the Endocrine Society’s Journal of Clinical Endocrinology & Metabolism.

ÂÂ A new study led by researchers at Washington

ÂÂ HIV-positive patients with end-stage renal disease

(ESRD) can safely receive kidney transplants from HIV-positive donors, suggests new research published online February 11 in The New England Journal of Medicine. ■■■■

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University School of Medicine indicates that supplementary feeding for a set time period of 12 weeks makes an impact as an approach to malnutrition but may not be as important as treating children until they reach target weights and measures of arm circumference. The study is published online in the Journal of Pediatric Gastroenterology and Nutrition.

MEDILAW

Ethical Advertising and Doctor-Pharma Relationship KK AGGARWAL

What are the violations in advertising in Indian Penal Code? Sec. 292(2) (d) of Indian Penal Code, 1860, makes it a punishable offence to publish, distribute, sell, hire or circulate any obscene advertisement. Section 292 in The Indian Penal Code 260[292.

Sale, etc., of obscene books, etc.â&#x20AC;&#x201D; 261]

(1) For the purposes of Sub-section (2), a book, pamphlet, paper, writing, drawing, painting, representation, figure or any other object, shall be deemed to be obscene if it is lascivious or appeals to the prurient interest or if its effect, or (where it comprises two or more distinct items) the effect of any one of its items, is, if taken as a whole, such as to tend to deprave and corrupt person, who are likely, having regard to all relevant circumstances, to read, see or hear the matter contained or embodied in it. 262[(2)]

Whoeverâ&#x20AC;&#x201D;

(a) Sells, lets to hire, distributes, publicly exhibits or in any manner puts into circulation, or for purposes of sale, hire, distribution, public exhibition or circulation, makes, produces or has in his possession any obscene book, pamphlet, paper, drawing, painting, representation or figure or any other obscene object whatsoever, or (b) Imports, exports or conveys any obscene object for any of the purposes aforesaid, or knowing or having reason to believe that such object will be sold, let to hire, distributed or publicly exhibited or in any manner put into circulation, or (c) Takes part in or receives profits from any business in the course of which he knows or has reason to believe that any such obscene objects are for any of the purposes aforesaid, made, produced, purchased, kept, imported, exported, conveyed, publicly exhibited or in any manner put into circulation, or

Senior Physician and Cardiologist, Moolchand Medcity, New Delhi Group Editor-in-Chief, IJCP Group and eMedinewS

(d) Advertises or makes known by any means whatsoever that any person is engaged or is ready to engage in any act which is an offence under this section, or that any such obscene object can be procured from or through any person, or (e) Offers or attempts to do any act which is an offence under this section, shall be punished 263[on first conviction with imprisonment of either description for a term which may extend to 2 years, and with fine which may extend to two thousand rupees, and, in the event of a second or subsequent conviction, with imprisonment of either description for a term which may extend to 5 years, and also with fine which may extend to five thousand rupees].

Can a doctor give or receive commissions? Section 6.4 MCI Act, which talks of Rebates and Commission (as below) is self-explanatory. 6.4.1: A physician shall not give solicit or receive nor shall he offer to give solicit or receive, any gift, gratuity, commission or bonus in consideration of or return for the referring, recommending or procuring of any patient for medical, surgical or other treatment. A physician shall not directly or indirectly, participate in or be a party to act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment. 6.4.2: Provisions of para 6.4.1 shall apply with equal force to the referring, recommending or procuring by a physician or any person, specimen or material for diagnostic purposes or other study/work. Nothing in this section, however, shall prohibit payment of salaries by a qualified physician to other duly qualified person rendering medical care under his supervision.

Can a doctor use touts to procure patients? 7.19 MCI Act: A Physician shall not use touts or agents for procuring patients.

What is the code of conduct for violation of doctor-pharma relationship? The same is defined in MCI-211(1)/2009 (Ethics)/55667. In exercise of the powers conferred by Section 33 of the Indian Medical Council Act, 1956 (102 of 1956), the MCI

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

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MEDILAW with the previous sanction of the Central Government, hereby makes the following Regulations to amend the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”. 1. (i) These Regulations may be called the “Indian Medical Council (Professional Conduct Etiquette and Ethics) (Amendment) Regulations, 2009 Part I.”

(ii) They shall come into force from the date of their publication in the Official Gazette.

2. In the “Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002”, the following additions/modifications/deletions/ substitutions, shall be, as indicated therein: 3. The following clause shall be added after clause 6.7: 6.8: Code of Conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry. 6.8.1: In dealing with pharmaceutical and allied health sector industry, a medical practitioner shall follow and adhere to the stipulations given below: a) Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives. b) Travel facilities: A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations, etc. from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, CME programme, etc. as a delegate. c) Hospitality: A medical practitioner shall not accept individually any hospitality like hotel accommodation for self and family members under any pretext. d) Cash or monetary grants: A medical practitioner shall not receive any cash or monetary grants from any pharmaceutical and allied healthcare industry for individual purpose in individual capacity under any pretext. Funding for medical research, study, etc. can only be received through approved institutions by modalities laid down by law/rules/ guidelines adopted by such approved institutions, in a transparent manner. It shall always be fully disclosed. e) Medical research: A medical practitioner may carry out, participate in, work in research projects funded by pharmaceutical and allied healthcare

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industries. A medical practitioner is obliged to know that the fulfillment of the following items (i) to (vii) will be an imperative for undertaking any research assignment/project funded by industry for being proper and ethical. Thus, in accepting such a position a medical practitioner shall: i) Ensure that the particular research proposal (s) has the due permission from the competent concerned authorities; ii) Ensure that such a research project (s) has the clearance of national/state/institutional ethics committee/bodies; iii) Ensure that it fulfills all the legal requirements prescribed for medical research; iv) Ensure that the source and amount of funding is publically disclosed at the beginning itself; v) Ensure that proper care and facilities are provided to human volunteers, if they are necessary for the research project (s); vi) Ensure that undue animal experimentations are not done and when these are necessary they are done in a scientific and a humane way; vii) Ensure that while accepting such an assignment a medical practitioner shall have the freedom to publish the results of the research in the greater interest of the society by inserting such a clause in the MoU or any other document/agreement for any such assignment. f) Maintaining professional autonomy: In dealing with pharmaceutical and allied healthcare industry a medical practitioner shall always ensure that there shall never be any compromise either with his/her own professional autonomy and/or with the autonomy and freedom of the medical institution. g) Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare industries in advisory capacities as consultants, as researchers as treating doctors or in any other professional capacity. In doing so, a medical practitioner shall always: i) Ensure that his professional integrity and freedom are maintained; ii) Ensure that patients interest compromised in any way;

are

not

iii) Ensure that such affiliations are within the law; iv) Ensure that such affiliation/employments are fully transparent and disclosed.

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INSPIRATIONAL STORY

Be Content About Your Life

onder if any of you ever had the feeling that life is bad, real bad…and you wish you were in another situation. Do you find that life seems to make things difficult for you, work sucks, life sucks, and everything seems to go wrong? It was not until yesterday that I totally changed my views about life; after a conversation with one of my friends. He told me despite taking 2 jobs, and bringing back barely above 1K per month, he is happy as he is. I wonder how he can be as happy as he is now, considering that he has to skimp his life with the low pay to support a pair of old-age parents, in-laws, wife, 2 daughters and the many bills of a household. He explained that it was through one incident that he saw in India…… That happened a few years ago when he was really feeling low and was touring India after a major setback. He said that right in front of his very eyes, he saw an Indian mother chopped off her child’s right hand with a chopper. The helplessness in the mother’s eyes, the scream of the pain from the innocent 4 years old child haunted him until today. You may ask why did the mother do so, has the child been naughty, was the child’s hand infected? No, it was done for two simple words — to beg. The desperate mother deliberately caused the child to be handicapped so that the child can go out to the streets to beg. I cannot accept how this could happen, but it really did, just in another part of the world which I don’t see.

Taken aback by the scene, he dropped a small piece of bread he was eating half–way. And almost instantly, flock of 5 or 6 children swamp towards this small piece of bread which was then covered with sand, robbing of bits from one another. The natural reaction of hunger. Stricken by the happenings, he instructed his guide to drive him to the nearest bakery. He arrived at two bakeries and bought every single loaf of bread he found in the bakeries. The owner is dumb folded, but willing sold everything. He spent less than $100 to obtain about 400 loaf of bread (this is less than $0.25/per loaf) and spend another $100 to get daily necessities. Off he went in the truck full of bread into the streets. As he distributed the bread and necessities to the children (mostly handicapped) and a few adults, he received cheers and bows from these unfortunate. For the first time in life he wonders how people can give up their dignity for a loaf of bread which cost less than $0.25. He began to ask himself how fortunate he is as a Singaporean. How fortunate he to be able to have a complete body, have a job, have a family, have the chance to complain what food is nice what isn’t, have the chance to be clothed, have the many things that these people in front of him are deprived of…… Now I begin to think and feel it, too. Was my life really that bad? Perhaps…no,… it should not be bad at all… What about you? Maybe the next time you think you are, think about the child who lost one hand to beg on the streets.

“Wisdom is knowing what to do next, skill is knowing how to do it, and virtue is doing it.” ―David Starr Jordan “The only good luck many great men ever had was being born with the ability and determination to overcome bad luck.” ―Channing Pollock ■■■■

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

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LIGHTER READING

LAUGH-A-WHILE

Lighter Side of Medicine DREAM OF A NECKLACE

TRAFFIC COURT

After she woke up, a woman told her husband, “I just dreamed that you gave me a pearl necklace for our anniversary.

A New York man was forced to take a day off from work to appear for a minor traffic summons. He grew increasingly restless as he waited hour after endless hour for his case to be heard. When his name was called late in the afternoon, he stood before the judge, only to hear that court would be adjourned for the next day and he would have to return the next day. “What for?” he snapped at the judge.

What do you think it means?” “You’ll know tonight.” he said. That evening, the man came home with a small package and gave it to his wife. Delighted, she opened it to find a book entitled “The Meaning of Dreams.” I’LL TRUST YOU THAT YOU PAID A man walks into a bar and has a couple of beers. Once he is done the bartender tells him he owes $9.00.

His honor, equally irked by a tedious day and sharp query roared, “Twenty dollars contempt of court. That’s why!” Then, noticing the man checking his wallet, the judge relented. “That’s all right. You don’t have to pay now.” The young man replied, “I’m just seeing if I have enough for two more words.”

“Okay,” says the bartender, “If you said you paid, you did.” The man then goes outside and tells the first person he sees that the bartender can’t keep track of whether his customers have paid. The second man then rushes in, orders a beer and later pulls the same stunt. The barkeep replies, “If you say you paid, I’ll take your word for it.” Soon the customer goes into the street, sees an old friend, and tells him how to get free drinks. The man hurries into the bar and begins to drink high-balls when, suddenly, the bartender leans over sand says, “You know, a funny thing happened in here tonight. Two men were drinking beer, neither paid and both claimed that they did.

QUOTES

“But I paid, don’t you remember?” says the customer.

“Dream as if you’ll live forever, live as if you’ll die today.”

– James Dean

Dr. Good and Dr. Bad SITUATION: A patient on aspirin was to go for noncardiovascular surgery.

Stop aspirin fOr 2 days

Stop aspirin for 7 days

©IJCP Academy

The next guy who tries that is going to get punched right in the nose.” “Don’t bother me with your troubles,” the final patron responds. “Just give me my change and I’ll be on my way.” LAW OF BAG/BOX OCCUPANCY All bags and boxes in a given room must contain a cat within the earliest possible nanosecond.

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Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

LESSON: Based on POISE-2, we recommend discontinuing aspirin about 7 days before noncardiovascular surgery.

Information for Authors Manuscripts should be prepared in accordance with the ‘Uniform requirements for manuscripts submitted to biomedical journals’ compiled by the International Committee of Medical Journal Editors (Ann. Intern. Med. 1992;96: 766-767). Indian Journal of Clinical Practice strongly disapproves of the submission of the same articles simultaneously to different journals for consideration as well as duplicate publication and will decline to accept fresh manuscripts submitted by authors who have done so. The boxed checklist will help authors in preparing their manuscript according to our requirements. Improperly prepared manuscripts may be returned to the author without review. The checklist should accompany each manuscript. Authors may provide on the checklist, the names and addresses of experts from Asia and from other parts of the World who, in the authors’ opinion, are best qualified to review the paper. Covering letter –

–

The covering letter should explain if there is any deviation from the standard IMRAD format (Introduction, Methods, Results and Discussion) and should outline the importance of the paper. Principal/Senior author must sign the covering letter indicating full responsibility for the paper submitted, preferably with signatures of all the authors. Articles must be accompanied by a declaration by all authors stating that the article has not been published in any other Journal/Book. Authors should mentioned complete designation and departments, etc. on the manuscript.

Manuscript Three complete sets of the manuscript should be – submitted and preferably with a CD; typed double spaced throughout (including references, tables and legends to figures). –

The manuscript should be arranged as follow: Covering letter, Checklist, Title page, Abstract, Keywords (for indexing, if required), Introduction, Methods, Results, Discussion, References, Tables, Legends to Figures and Figures.

–

All pages should be numbered consecutively beginning with the title page.

Note: Please keep a copy of your manuscript as we are not responsible for its loss in the mail. Manuscripts will not be returned to authors. 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,

name of the corresponding authors, acknowledgment of financial support and abbreviations used. – The title should be of no more than 80 characters and should represent the major theme of the manuscript. A subtitle can be added if necessary. – A short title of not more than 50 characters (including inter-word spaces) for use as a running head should be included. – The name, telephone and fax numbers, e-mail and postal addresses of the author to whom communications are to be sent should be typed in the lower right corner of the title page. – A list of abbreviations used in the paper should be included. In general, the use of abbreviations is discouraged unless they are essential for improving the readability of the text. Summary – The summary of not more than 200 words. It must convey the essential features of the paper. – It should not contain abbreviations, footnotes or references. Introduction – The introduction should state why the study was carried out and what were its specific aims/objectives. Methods – These should be described in sufficient detail to permit evaluation and duplication of the work by others. – Ethical guidelines followed by the investigations should be described. Statistics The following information should be given: – The statistical universe i.e., the population from which the sample for the study is selected. – Method of selecting the sample (cases, subjects, etc. from the statistical universe). – Method of allocating the subjects into different groups. – Statistical methods used for presentation and analysis of data i.e., in terms of mean and standard deviation values or percentages and statistical tests such as Student’s ‘t’ test, Chi-square test and analysis of variance or non-parametric tests and multivariate techniques. –

Confidence intervals for the measurements should be provided wherever appropriate.

Results – These should be concise and include only the tables and figures necessary to enhance the understanding of the text.

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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.

Indian 1.____________Foreign 1.________________

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. –

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The legend must include enough information to permit interpretation of the figure without reference to the text.

Indian Journal of Clinical Practice, Vol. 25, No. 10, March 2015

6. Suggestions for reviewers (name and postal address)

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

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