April 2014 Clinical Advisor

THE CLINICAL ADVISOR • APRIL 2014

A PEER-REVIEWED FORUM FOR NURSE PRACTITIONERS

NEWSLINE

■■Suicide warnings missed ■■Fibromuscular dysplasia ■■New risks of poor sleep

ADVISOR FORUM

■■Statins and BP meds ■■Homeopathic advice ■■More audible heart sounds

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APRIL 2 014

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THE PROSTATE SCREENING

CONTROVERSY Dye binds to proteins altered by cancer cells to form prostate specific antigen.

LEGAL ADVISOR

Missed signs of infection lead to a young man’s death.

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n Dermatology Clinic

SCALP PATCHES WITH SCALING PAGE 95

n Dermatologic Look-Alikes VOLUME 17, NUMBER 4

PRURITIC ERUPTION ON FOREARMS PAGE 99 Expanded job listings! www.ClinicalAdvisor.com/Jobs

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Editor Joe Kopcha, editor@ClinicalAdvisor.com Senior editor Delicia Yard Web editor Nicole Blazek Contributing editors Mark P. Brady, PA-C; Philip R. Cohen, MD; Deborah L. Cross, MPH, CRNP, ANP; Sharon Dudley-Brown, PhD, FNP; Abimbola Farinde, PharmD; Laura A. Foster, CRNP, FNP; Abby A. Jacobson, PA; Maria Kidner, DNP, FNP; Joan W. Kiely, MSN, CRNP; Debra August King, PhD, PA; Ann W. Latner, JD; Mary Newberry, CNM, MSN; Claire Babcock O’Connell, MPH, PA; Kathy Pereira, DNP, FNP; Sherril Sego, DNP, FNP; Julee B. Waldrop, DNP, PNP, FNP; Ann Walsh, PA-C, SCT(ASCP); Kim Zuber, PA-C Art director Andrew Bass Group art director, Haymarket Medical Jennifer Dvoretz Production director Kathleen Millea Grinder Circulation manager Paul Silver Audience development director John Crewe National accounts manager Alison McCauley, 646.638.6098 alison.mccauley @ haymarketmedical.com Publisher Thomas P. Hennessy, 646.638.6085 tom.hennessy @ haymarketmedia.com Editorial director Jeff Forster Senior vice president, digital products and medical magazines Jim Burke, RPh Senior vice president, clinical communications John Pal CEO, Haymarket Media, Inc. Lee Maniscalco All correspondence to: The Clinical Advisor 114 West 26th Street, 4th Floor, New York, NY 10001 For advertising sales, call 646.638.6085.

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CONTENTS APRIL 2014

NEWS AND COMMENT 20 Newsline ■■New measures of mortality emerge ■■Dual-arm BP may best foretell cardiovascular risk ■■Suicide signs missed at primary-care visits ■■Asthma drug treats food allergy ■■Early antiretroviral use for HIV ■■Screen kids for depression, cholesterol, HIV ■■Talk to the hand to assess knee osteoarthritis risk ■■Be on the lookout for fibromuscular dysplasia ■■Stethoscopes can be dirtier than hands ■■Health risks of poor sleep continue to mount

62 Diagnosing diseases of the vulva Vulvar biopsy is a helpful tool that clinicians should utilize to diagnose and guide the management of gynecologic abnormalities.

Fibromuscular dysplasia poorly understood 23

87 Legal Advisor A young man who presented with hip pain and a worsening rash dies after septic arthritis is misdiagnosed as a muscle strain or bursitis.

How to perform a vulvar biopsy 62

FEATURES 44 Prostate cancer data, dilemmas, and decisions Overdiagnosis of prostate cancer has led to more careful consideration of who should be screened with the PSA test or digital rectal examination.

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Follow us on Twitter @ClinicalAdvisor

91 Stat Consult Find out the most recent information on the diagnosis and treatment of falls among older adults.

Continues on page 15

Sports injury leads to septic shock 87

MAKING CONTACT

DEPARTMENTS 86 Derm Dx Read the clinical descriptions, view the images, and make your diagnosis at ClinicalAdvisor.com.

34 Drug Update ■■Novel therapy for menopausal symptoms ■■Dapagliflozin treats type 2 diabetes 111 Commentary

73 CME/CE The safe use of opioids in the treatment of pain To minimize the risk of abuse and addiction, evidence-based prescribing practices must be used when treating acute or chronic pain with opioids.

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CONTENTS 95 CME/CE Dermatology Clinic n Daily moisturizer and constant use of a back-scratcher provided no relief for a man with an intensely pruritic and worsening rash.

n Increasing steroid dose perioperatively

may not be necessary for prevention of hypotension in patients with recent or current steroid use. n Arthroscopic partial meniscectomy does not improve symptoms of degenerative medial meniscus tear in patients without knee osteoarthritis.

n An infant, aged 12 weeks, presented

with lightly adherent yellow patches on the scalp and mild scaling of the forehead and glabella.

Scaly patches on an infant’s scalp 95

99 CME/CE Dermatologic Look-Alikes Two patients presented with excoriated papules on the extensor surfaces.

ADVISOR FORUM

103 CME/CE Posttest 104 Alternative Meds Update Monk fruit is the most recent addition to the growing number of natural sweeteners.

106 Evidence-Based Medicine n In women with coronary artery disease, newer-generation drug-eluting stents are associated with reduced risks of MI and target vessel revascularization compared with bare-metal and early-generation drug-eluting stents.

n Buccal dextrose gel for hypoglycemia reduces admission to neonatal intensive care unit for hypoglycemia.

Linear erosions on the extremities 99

80 Consultations ■■The effect of statins on antihypertensive medications ■■When is it olay to examine a child alone?

■■And more 82 Clinical Pearls ■■Olive oil for a flaky scalp ■■Pump up the heart’s volume 82 Your Comments ■■Leave children in stitches rather than tears

HOW TO CONTACT US

TO CONTACT AN EDITOR: • Editor@ClinicalAdvisor.com • Call 646.638.6078

A PEER-REVIEWED FORUM FOR PHYSICIAN ASSISTANTS

NEWSLINE

■ Suicide warnings missed ■ Fibromuscular dysplasia ■ New risks of poor sleep ADVISOR FORUM

■ Statins and BP meds ■ Homeopathic advice ■ More audible heart sounds

APRIL 2 014

| www.ClinicalAdvisor.com

CONTROVERSY Dye binds to proteins altered by cancer cells to form prostate specific antigen.

Missed signs of infection lead to a young man’s death.

✶ FREE CME COURSES!

■ Dermatology Clinic

SCALP PATCHES WITH SCALING PAGE 95

■ Dermatologic Look-Alikes

PRURITIC ERUPTION ON FOREARMS PAGE 99 Expanded job listings! www.ClinicalAdvisor.com/Jobs

CA0414_Cover.indd 2

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THE PROSTATE SCREENING

LEGAL ADVISOR

VOLUME 17, NUMBER 4

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Statin eligibility expanded by 13 million The increase is largely driven by eligibility of adults aged 60 years and older without cardiovascular disease in the primaryprevention setting.

Genetics may influence weight gain from fried foods Individuals with a greater genetic predisposition to adiposity may be more susceptible to adverse outcomes from eating fried food.

Reminders via text message may improve vaccine adherence As more children live in wireless-only homes, text-message services have the potential to be effective immunization reminder tools.

Could the sun be good for cardiovascular health?

Our bodies get vitamin D from the sun, but sunlight may confer another surprising advantage.

New research shows that nitric oxide, a chemical transmitter stored in huge reserves in the skin, can be released by UV light, greatly benefiting BP and the cardiovascular system.

Medical homes do not reduce hospital visits or costs A patient-centered medical home aims to reduce unnecessary health-care spending and keep patients out of the hospital. A new study evaluated a group of medical home practices to see whether they were effective in improving these outcomes.

The Waiting Room Official Blog of The Clinical Advisor CliniAd.com/VwgfCl

Derm Dx Interact with your peers by viewing the images and offering your diagnosis and comments.

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Robyn Carlisle, MSN, CNM, WHNP Smartphone etiquette in the exam room Available time for questions and expressing needs and concerns is already too short, and smartphones further interfere with discussions between the patient and provider.

Sharon M. O’Brien, MPAS, PA-C Be mindful of patient bias A patient with insomnia is dubbed a substance abuser when seeking medication for his condition. But is this classification accurate?

Ridged fingernails and toenails All the nails on an 8-year-old’s fingers and toes have a roughened texture, as if they had been rubbed with coarse sandpaper.

MAKING CONTACT

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Jim Anderson, MPAS, PA-C, DFAAPA, ATC A physician assistant deep in the heart of Texas Clinicians in other states can learn something about organization and structure from the visionary leaders of the Texas Academy of Physician Assistants.

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Newsline

Signs of suicide often overlooked in primary care page 21

A P R I L 2 014

Early treatment for HIV can add years to life page 22

Fibromuscular dysplasia poorly understood page 24

© THINKSTOCK

New measures of mortality emerge

The new A Body Shape Index (ABSI) is based on waist circumference.

that A Body Shape Index (ABSI) is a more effective predictor of mortality than is the commonly used BMI. The ABSI score is based on waist circumference adjusted for height and weight.

An ABSI calculator can be found at www-ce.ccny.cuny.edu/nir/ sw/absi-calculator.html (accessed March 15, 2014).

The investigators evaluated ABSI scores in 7,011 persons aged 18 years and older who participated in Great Britain’s Health and Lifestyle Survey (HALS), representing 24 years of followup. As a predictor of mortality hazard, ABSI outperformed such other measures of abdominal obesity as waist circumference, waist-to-height ratio, and waistto-hip ratio. ABSI also was a consistent predictor of mortality hazard over at least 20 years of follow-up.

People who reported binge-drinking in the past month More than 15% of U.S. adults, or 33 million Americans, report binge drinking in the past 30 days.

30 25 Percentage

NOVEL takes on blood samples and body shapes were showcased as predictors of death in separate studies.

Four novel biological markers in the blood appear to strongly indicate a person’s risk of dying from cardiovascular disease, cancer, or other illnesses within the subsequent five years, according to a study in PLOS Medicine (2014;11[2]:e1001606). The group tested 9,842 blood samples from a representative subset of people in Estonia using nuclear magnetic resonance spectroscopy.

Health records showed that after providing the blood sample, 508 of the people had died during the median follow-up period of 5.4 years, mostly due to heart disease, cancer, and other, nonvascular diseases.

Statistical analysis revealed that the levels of plasma albumin, alpha-1-acid glycoprotein,

very-low-density lipoprotein particle size, and citrate appeared to accurately predict short-term risk of death. Similar results were found after repeating the study in a population-based validation cohort of 7,503 persons in Finland, 176 of whom died during the 5.4-year median followup. The association between the four biomarkers and shortterm risk of death remained unchanged after controlling for risk factors such as age, weight, tobacco and alcohol use, and such preexisting illnesses as diabetes and cancer. Incorporating the biomarkers into risk-prediction scores led to improved discrimination and reclassification of five-year mortality in the validation cohort.

New re se a rch i n a si s ter publication—PLOS One (2014;9[2]:e88793)—suggested

24.2%

25.6% 22.5% 17.8%

20 15

12.1%

10 3.8%

5 Source: CDC, Youth Risk Behavior Surveillance System and Behavioral Risk Factor Surveillance System, 2009

0 <18

18-24

25-34

35- 44

45-64

≥65

Age in years

20 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

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THE difference in systolic BP between a person’s arms recently was linked with a significantly increased risk for cardiovascular events (Am J Med. 2014;127: 209-215).

A team led by Ido Weinberg, MD, examined the association between differences in systolic BP between arms and incident cardiovascular disease in Framingham Heart Study original and offspring cohorts. The 3,390 men and women (56.3% female) were aged 40 years and older (mean age 61.1 years) and had been free of cardiovascular disease at baseline.

The mean absolute interarm systolic BP difference was 4.6 mm Hg (range 0–78). A total of 317 subjects (9.4%) had increased interarm systolic BP difference, defined as 10 mm Hg or more.

Over the median follow-up time of 13.3 years, 598 participants (17.6%) experienced a first cardiovascular event. Of these patients, 83 had increased interarm systolic BP difference, meaning that more than one-quarter of the original group of 317 patients (26.2%) with elevated interarm differences experienced a first cardiovascular event during follow-up.

Compared with participants who had normal interarm systolic BP difference, those with heightened levels were older (63 years vs.

60.9 years), had a greater prevalence of diabetes (13.3% vs. 7.5%), had higher systolic BP (136.3 vs.

129.3), and had higher total cholesterol (212.1 mg/dL vs. 206.5 mg/dL). Even after adjusting for traditional cardiovascular risk factors, the risk for cardiovascular

© THINKSTOCK

Dual-arm BP may best foretell CV risk

CVD was found in more than 25% of patients with interarm BP difference.

events conferred by differences in interarm systolic BP remained.

“Our findings support recommendations for measurement of blood pressure in both arms, both for accurate blood pressure detection and for detection of [interarm systolic BP difference],” Weinberg and coauthors concluded.

MANY individuals who commit suicide are seen by a primary-care provider or a medical specialist in the year before their death, but do not receive a mental health diagnosis.

“This study indicates that opportunities for suicide prevention exist in primary-care and medical settings, where most individuals receive services prior to death,” pointed out the investigators when reporting the results in Journal of General Internal Medicine. “Efforts may target improved identification of mental illness and suicidal ideation,

Women were more likely to make a visit prior to suicide.

as a large proportion may remain undiagnosed at death.”

Led by Brian K. Ahmedani, PhD, of the Center for Health Policy and Health Ser vices Research at Henry Ford Health System in Detroit, the research team reviewed medical records within eight Mental Health Research Network health-care systems serving eight states. A total of 5,894 health-plan members died by suicide from 2000 to 2010. The majority of persons committing suicide (83%) had received health care in the year prior to their death, but less than

half (45%) did not have a mental health diagnosis and only 24% had a mental health diagnosis in the 4-week period prior to death.

The most common visits made by patients who later committed suicide were medical specialty and primary-care visits without a mental health diagnosis.

Persons most likely to make a visit in the year prior to suicide were women, persons aged 65 years or older, residents of neighborhoods with annual incomes higher than $40,000, and persons who ultimately died by nonviolent means.

© THINKSTOCK

Suicide signs missed at primary-care visits

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Newsline Asthma Early antiretroviral use for HIV drug treats food allergy

People who initiated treatment early could expect to live 6.1 years longer.

below 350. The survival benefit was even greater for the earliest initiators of cART: Persons who began such treatment while their CD4 counts were higher than 500 could expect an additional 9.0 years of life.

Mortality risk among persons with HIV was found to be 28% higher if cART treatment began when CD4 counts were less than 350 rather than 350 to 500. Mortality risk was 1.16 times higher if cART were started at the below-350 level rather than at the above-500 level.

Separately, Patrick Kiser and colleagues reported in PLOS One (2014;9[3]:e88509) that they have developed an intravaginal ring that protected against both HIV and pregnancy in an animal model.

The polyurethane ring delivers controlled doses of both the antiretroviral agent tenofovir (Viread) and the contraceptive levonorgestrel (Next Choice, Plan B OneStep). The device is expected to be tested in women soon.

Screen kids for depression, cholesterol, HIV The American Academy of Pediatrics (AAP) has updated for 2014 its schedule of recommended screenings and health assessments for each well-child visit from infancy through adolescence to include the following guidance: • Youths aged 11 years through 21 years should be screened for depression.

• Children aged 9 years to 11 years should undergo cholesterol screening.

• Young adults aged 16 years to 18 years should be screened for HIV.

• Kids should undergo a risk assessment for hematocrit or hemoglobin at age 15 months and age 30 months.

• Adolescents should no longer undergo ­routine screening for cervical dysplasia until age 21 years.

• Newborns should be screened for signs of critical congenital heart disease using pulse oximetry before they are discharged from the hospital (Pediatrics. 2014; 133[3]: 568-570).

© PCMSP / BECKER

OMALIZUMAB (Xolair), used to treat exacerbations of allergic asthma, may serve an important role in helping people minimize food allergies as well, early research indicates.

Oral immunotherapy is under investigation as a treatment for food allergy. This desensitization method enables patients to build up a tolerance to the allergen by ingesting it in gradually increasing doses under medical supervision.

As Kari Nadeau, MD, PhD, and fellow investigators noted in their report in Allergy, Asthma & Clinical Immunology, pilot data have shown that omalizumab may hasten the person’s ability to tolerate more than 4 g of food-allergen protein.

The group conducted a phase 1 study in which 25 children and adults with multiple food allergies received oral immunotherapy for up to five allergens simultaneously, with omalizumab injections administered for eight weeks before and eight weeks following oral immunotherapy.

Compared with persons undergoing immunotherapy without omalizumab, patients receiving the drug could tolerate larger initial doses of the food allergens, and could safely eat 4 g of each food protein at a median of 18 weeks after the allergen-ingestion process began. Patients not receiving omalizumab did not reach the 4-g point until a median of 85 weeks after food doses began.

EARLY treatment for HIV can prolong the patient’s life by up to nine years, say health-care analysts (Health Aff [Millwood].

2014;33[3]:370-377).

Researchers assessed the effects of early HIV combination antiretroviral therapy (cART) initiation on life expectancy among persons with the disease. Earlystage disease was defined as the period when CD4 white blood cell counts were 350 per cubic millimeter of blood or higher.

The investigators looked at lifeexpectancy gains between 1996, when cART was introduced, and 2009, when U.S. guidelines for HIV treatment were revised to recommend cART initiation earlier in the disease course.

People who initiated cART treatment early—when their CD4 counts were in the 350-to-500 range—could expect to live 6.1 years longer than persons with late cART initiation, which was defined as cART not administered until the CD4 count fell

22 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

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Newsline THE closer in length a person’s index finger and ring finger are, the more likely that person is to have severe knee osteoarthritis requiring total knee replacement, according to a long-term study.

Anthropological studies suggest that the average ratio of lengths of the index (2D) and ring (4D) fingers are lower in men than in women. Previous studies of 2D:4D ratio and the risk of knee osteoarthritis have yielded inconsistent results. Yuanyuan Wang, PhD, and colleagues used photocopies of the hands of 14,511 persons to examine the relationship between 2D:4D and the risk of severe knee and hip osteoarthritis requiring total joint replacement.

Over an average of 10.5 years of follow-up, 580 subjects underwent total knee replacement and 499

underwent total hip replacement.

As the investigators described in Rheumatology, greater 2D:4D on the right hand and average 2D:4D on the right and left hands were associated with a reduced incidence of total knee replacement.

No associations between 2D:4D and the incidence of total hip replacement were noted.

When 830 participants were excluded from the analysis because their fingers had features that could have affected the validity of the measurements, a lower 2D:4D was again associated with a higher incidence of total knee replacement, and there was again no significant evidence of a link between 2D:4D and total hip replacement.

“Although these results may be explained in part by joint injuries associated with high-level

© CMSP

Talk to the hand to assess knee OA risk

Similar-sized index and ring fingers make knee OA more likely.

physical activity in those with lower 2D:4D and the greater susceptibility of knee [osteoarthritis] in response to injury than hip [osteoarthritis], they may also reflect hormonal influences on the growth of bone, cartilage, and soft tissue, which warrants further investigation,” stated the authors.

A NEW scientific statement from the American Heart Association calls attention to fibromuscular dysplasia (FMD), a condition the authors describe as “poorly understood by many providers.”

Many of the signs and symptoms of FMD are nonspecific, “thus leading the clinician down the wrong diagnostic pathway,” cautioned Jose Biller, MD, and coauthors in the statement, presented in the journal Circulation (2014;129:1048-1078). This nonatherosclerotic, noninflammatory vascular disease was first described in 1938, and given its current name

Many of the signs and symptoms of FMD are nonspecific.

20 years later. However, its prevalence in the general population remains unknown, although 91% of persons with FMD are female.

FMD may result in arterial stenosis, occlusion, aneurysm, or dissection. The disease most often affects the renal and extracranial carotid and vertebral arteries, but it has been reported in virtually every arterial bed.

The clinical manifestations of FMD are determined primarily by the involved vessels. Hypertension is the most frequent finding when the renal artery is involved, whereas carotid or vertebral

artery FMD can lead to dizziness, pulsatile tinnitus, transient ischemic attack, or stroke. The most common presentations are headache, dizziness, lightheadedness, tinnitus, and other nonspecific symptoms.

FMD is often mistaken for atherosclerosis or vasculitis. Partly due to the fact that FMD is often not considered in the differential diagnosis, the average delay from the time of first symptom or sign to diagnosis of this disease is four to nine years. The current gold standard for FMD diagnosis is a catheter-based angiogram.

© CMSP / SPL

Be on the lookout for fibromuscular dysplasia

24 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

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Newsline THE contamination level of a clinician’s stethoscope after a single physical examination may be substantial and may even exceed the level of contamination on the practitioner’s dominant hand, suggest the results of a Swiss study (Mayo Clinic Proc. 2014;89[3]: 291-299).

“By considering that stethoscopes are used repeatedly over the course of a day, come directly into contact with patients’ skin, and may harbor several thousands of bacteria, including [methicillinresistant Staphylococcus aureus] collected during a previous physical examination, we consider them as potentially significant vectors of transmission,” explained Didier Pittet, MD, MS, in a statement accompanying the release of his group’s study.

The study was conducted over a five-month period in 2009 in a Swiss university teaching hospital. One of three physicians examined a total of 71 patients while wearing sterile gloves and using a sterile stethoscope. After each examination, the stethoscope and the physician’s hands were measured for presence of bacteria.

The diaphragm of the stethoscope proved to be more contaminated than all four measured regions of the provider’s hand (back, fingertips, and thenar and hypothenar eminences), and the tube of the stethoscope was more contaminated than the back of the provider’s hand. “[F]ailing to disinfect stethoscopes could constitute a serious patient safety issue akin to

© THINKSTOCK

Stethoscopes can be dirtier than hands

Stethoscopes can harbor such bacteria as MRSA.

omitting hand hygiene,” noted Pittet and coauthors. “Hence, from infection control and patient safety perspectives, the stethoscope should be regarded as an extension of the [clinician’s] hands and be disinfected after every patient contact.”

CLINICIANS have even more reason to ask patients about any sleep-related troubles the person might be experiencing now that several recent studies have added to the evidence demonstrating the detrimental health effects of such problems.

• Vincent Yi-Fong Su, MD, and colleagues reported in CMAJ that sleep apnea appeared to confer a higher risk for pneumonia in an 11-year study of 6,816 persons with the sleep condition and 27,284 controls (available at www.cmaj. ca/content/early/2014/03/03/

Sleep apnea appeared to raise the risk for pneumonia.

cmaj.131547.long; accessed March 15, 2014).

• A team in the United Kingdom discovered that among several factors measured, nonrestorative sleep was the strongest independent predictor of new-onset widespread pain

in a population-based study of 4,326 adults aged 50 years and older (Arthritis Rheumatol.

2014;66[3]:757-767).

• Children, too, are vulnerable to serious consequences of poor sleep: The Journal of Pediatrics carries a study conducted by Heidi B. IglayReger and associates showing that sleep duration inversely predicts cardiometabolic risk in obese adolescents, aged 11 to 17 years, even when the investigators controlled for various measures of physical activity, anthropometry, and adiposity. n

© THINKSTOCK

Health risks of poor sleep continue to mount

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 33

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DrugUpdate New drug information from the publishers of MPR

Novel therapy for menopausal symptoms Product: Duavee Company: Pfizer Pharmacologic class: Conjugated estrogens + estrogen agonist/antagonist Active ingredients:

Conjugated estrogens 0.45 mg, bazedoxifene 20 mg; tabs Indication: Treatment

of moderate-to-severe vasomotor symptoms associated with menopause. Prevention of postmenopausal osteoporosis.

Use for shortest duration consistent with treatment goals and risks.

Pharmacology: Conjugated estrogens agonize estrogen α/β receptors. Bazedoxifene agonizes some estrogensensitive tissues and antagonizes others (e.g., uterine). Bazedoxifene reduces the risk of endometrial hyperplasia that can occur with conjugated estrogens.

Clinical trials: The safety

and efficacy of Duavee for moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis was evaluated in several phase 3 clinical ­trials.

Results from one trial demonstrated that Duavee significantly reduced the number of moderate-tosevere hot flushes by 74% at 12 weeks, as compared with placebo (47%).

In addition, significant decreases in mean hot-flush severity were seen at 12

weeks (39%), as compared with placebo (13%).

In other clinical trials, at years one and two, Duavee significantly increased bone mineral density in the total hip and lumbar spine from baseline vs. decreases seen with placebo.

For more clinical trial data, see full labeling.

Adults: Swallow whole. One tablet daily.

Postmenopausal osteoporosis: may supplement diet with calcium and/or Vitamin D, if inadequate.

Dapagliflozin treats type 2 diabetes Product: Farxiga Companies: BristolMyers Squibb and AstraZeneca Pharmacologic class: Sodium-glucose cotransporter 2 (SGLT2) inhibitor Active ingredient:

Dapagliflozin 5 mg, 10 mg; tablets

Children: Not applicable.

Indication: Adjunct Contraindications:

Undiagnosed abnormal uterine bleeding. Known, Continued pg. 34

to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of use: not for treating type 1 diabetes mellitus or diabetic ketoacidosis.

Pharmacology: Dapagliflozin inhibits the SGLT2, which reduces reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion.

Clinical trials:

Farxiga was studied as Duavee is intended to treat hot flushes and prevent postmenopausal osteoporosis.

Continued pg. 38

For more products, visit www.eMPR.com

34 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

CA0414_DrugUpdate.indd 34

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Nurse Practitioner Associates for Continuing Education

NASHVILLE

Two great conferences, two great locations!

Primary Care Conference with Workshops September 4-7, 2014 Omni Nashville Hotel

Nashville’s newest luxury hotel, the Omni Nashville is conveniently located in the heart of Music City, across from the Music City Center and integrated with the Country Music Hall of Fame® and Museum.

PROGRAM

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22

PHOENIX

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Primary Care Conference & Pharmacology Update October 13-16, 2014

Wigwam Resort

A jewel of the desert, the Wigwam is one of the Southwest’s landmark resort destinations.

HOTEL AMENITIES:

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24

• Award-winning restaurants with “farm-to-table” cuisine

CONTACT HOURS AVAILABLE

Learn more and register online

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Attend every fourth conference for free!

For more information on Rewards Program, visit www.npace.org

Nurse Practitioner Associates for Continuing Education (NPACE) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

NPACE is a 501(c)3 non-profit.

DrugUpdate Duavee from pg. 34

suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active deep vein thrombosis (DVT), pulmonary embolism or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.

Pregnancy (Category X).

Women who may become pregnant. Nursing mothers.

Warnings/Precautions:

Not for prevention of cardiovascular disease.

Increased risk of cardiovascular disorders (e.g., stroke, DVT, venous thromboembolism); discontinue if occurs or

Farxiga is approved to improve glycemic control in adults with type 2 diabetes.

suspected. Discontinue at least four to six weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Endometrial, breast, or ovarian cancer. Gallbladder disease.

Visual abnormalities.

Hypertriglyceridemia.

Discontinue if cholestatic jaundice, pancreatitis, or retinal vascular lesions occur. Monitor thyroid function. Conditions aggravated by fluid retention. Renal impairment: not recommended.

Hypoparathyroidism.

Hereditary angioedema.

Caution in asthma, diabetes, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Do initial

complete physical and repeat yearly (include Pap smear, mammogram, BP).

Premenopausal women or women older than age 75 years: not recommended.

Risk of probable dementia in women older than age 65 years. Women with BMI >27: increased risk of endometrial hyperplasia.

Reevaluate periodically.

affected by ibuprofen, atorvastatin (Lipitor), azithromycin (Zithromax, Zmax), aluminum hydroxide, and magnesium hydroxide.

Duavee may interfere with lab tests (e.g., thyroid, prothrombin time, glucose tolerance, HDL/LDL, triglycerides, hormone concentrations, other binding proteins).

Interactions: Avoid concomitant progestins, additional estrogens, or estrogen agonist/ antagonists. Antagonized

by CYP3A4 inducers.

Potentiated by CYP3A4 inhibitors. Concomitant thyroid replacement; may need to increase thyroid dose. Bazedoxifene: may be antagonized by UGT inducers. May affect or be

Adverse reactions:

Farxiga from pg. 34

to Farxiga 5 mg or 10 mg once daily in either the morning or evening, or placebo. At week 24, Farxiga 10 mg in the morning provided significant improvements in hemoglobin (Hb)A1c and fasting plasma glucose (FPG) compared with placebo. The Farxiga 10 mg dose demonstrated a difference from placebo of −0.7 (95% CI: −1.0, −0.4; P <0.0001) for HbA1c reduction and −24.7 (95% CI:

−35.7, −13.6; P <0.0001) for reduction of FPG. In two 24-week activecontrolled studies, the safety and efficacy of Farxiga 5 mg or 10 mg in combination with metformin extended-release (XR) was studied in 1,241 treatmentnaïve patients with inadequately controlled type 2 diabetes. In one study, 638 patients were randomized to Farxiga 10 mg + metformin XR, Farxiga

monotherapy and in combination with metformin (Fortamet, Glucophage, Glumetza, Riomet), pio­ glitazone (Actos), glimepi­ ride (Amaryl), sitagliptin (Januvia), or insulin.

Farxiga was also compared with glipizide (Glucotrol) added on to metformin.

In a 24-week monotherapy study, 558 treatment-naïve patients with inadequately controlled diabetes were randomized

Muscle spasms, nausea, diarrhea, dyspepsia, upper abdominal pain, oropharyngeal pain, dizziness, neck pain.

How supplied:

Blisters—2 × 15 For more information, call 800.438.1985 or visit www.Duavee.com.

Continued pg. 443

For more products, visit www.eMPR.com

38 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

CA0414_DrugUpdate.indd 38

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DrugUpdate 10 mg + placebo, or metformin XR + placebo.

The Farxiga 10 mg + metformin XR combination provided statistically significant improvements in HbA1c (−0.5 difference from Farxiga, 95% CI: −0.7, −0.3; −0.5 difference from metformin XR, 95% CI: −0.8, −0.3; P <0.0001) and FPG (−13.9 difference from Farxiga, 95% CI: −20.9, −7.0; −25.5 difference from metformin XR, 95% CI: −32.6, −18.5; P <0.0001) compared with either monotherapy treatment and significant reduction in body weight compared with metformin XR alone. Farxiga 10 mg as monotherapy also showed a statistically significant reduction in body weight when compared

with metformin XR alone and was non-inferior to metformin XR monotherapy in lowering HbA1c.

Farxiga as an add-on to a sulfonylurea, thiazolidinedione, DPP-4 inhibitor, or insulin also showed statistically significant improvements in HbA1c, two-hour postprandial glucose, FPG, and weight loss.

For more clinical trial data, see full labeling.

Adults: Take in the morning. Initially 5mg once daily; if tolerated and need additional glycemic control, may increase to 10 mg once daily. Renal impairment: if estimated glomerular filtration rate (eGFR) <60, do not initiate. Discontinue if eGFR falls persistently <60.

Children: <18 years: not

established.

Pregnancy (Category C).

Nursing mothers: not recommended.

Contraindications:

Severe renal impairment, end-stage renal disease, or on dialysis.

Warnings/Precautions:

Correct volume depletion before starting therapy.

Monitor for signs/symptoms of hypotension (especially elderly, patients with renal impairment, or patients on diuretics).

Evaluate renal function prior to starting and monitor periodically thereafter.

Increased risk of genital mycotic infections; monitor and treat if occurs.

Monitor for increases in LDL; treat if occur.

Active bladder cancer: do not use. Severe hepatic impairment. Elderly.

Interactions:

Concomitant insulin or insulin secretagogue: consider a lower dose of insulin/insulin secretagogue to reduce risk of hypoglycemia. Hypotension with concomitant loop diuretics.

Adverse reactions:

Female genital mycotic infections, nasopharyngitis, urinary tract infections, back pain, increased urination; volume depletion and renal impairment.

How supplied: Tabs—30,

90, 500 For more information, call 855.332.7944 or visit www.Farxiga.com. n © The New Yorker Collection 2014 from cartoonbank.com. All Rights Reserved.

Farxiga from pg. 38

“My wife is recording everything the kids do until they leave for college. Then I’ll binge-watch them grow up.”

For more products, visit www.eMPR.com

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 43

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FEATURE: DORA McIVER, PA-C; JUDITH STALLINGS, EdD, MHE, PA-C; AND MICHAEL W. FELZ, MD

Prostate cancer data, dilemmas, and decisions Overdiagnosis of prostate cancer has led to more careful consideration of who should be screened with the PSA test or digital rectal examination.

P

rostate cancer (PC) is the most common male-related malignancy in the United States, the second most common cause of cancer-related death among U.S. men, and the fourth most prevalent male malignancy worldwide.1,2 There is some controversy as to whether screening techniques for PC reliably promote detection at an earlier stage. Equal uncertainty surrounds the benefits and risks of radical prostatectomy as opposed to watchful waiting for patients with early, organ-confined PC. Appropriate management, therefore, mandates reconsideration of benefits and harms of screening, preferred treatment options, and issues governing quality of life and overall survival.3 Primary-care providers occupy influential positions in assisting patients with data review and decision-making within an evolving menu of often confusing methodologies.

© SCIENCE SOURCE / MICHAEL ABBEY

Epidemiology

Disruption of the prostate gland leads to elevated levels of prostate specific antigen (shown).

According to the CDC, 206,640 U.S. men were diagnosed with PC in 2009.2 (Peak age at diagnosis is 66 years.) More than 80% were classified as having low-risk, clinically localized disease. Although the lifetime risk of PC disease is 15% (one man in seven), the risk of dying from PC is far less, at 3% (one man in 33). Of six newly diagnosed cases of PC per year, only one death occurs.4,5 These discrepancies suggest that PC often behaves as a biologically indolent neoplasm and indicate that conservative management is appropriate in many cases.4 Indeed, five- and 10-year survival rates are 100% and

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PROSTATE CANCER

92%, respectively, for all PC stages combined, reflecting the known tendency toward latency for most PC lesions.

PC is twice as common in black men as in white men, followed by men of Hispanic, Asian/Pacific Islander, and American Indian/Alaska Native origin.2,6 Death rates from PC are highest among black men, and white men rank second.6 Autopsy data reveal that 50% of men at age 50 years, and 75% of men at age 85 years, harbored histologic evidence of PC but died of other causes.7 The implication is that PC in large numbers of asymptomatic men tends to be biologically insignificant, unlikely to metastasize or kill, and compatible with long life.

in the peripheral aspect of the prostate, distant from the urethra. Obstructive and irritative urinary symptoms are consistent with larger-volume tumors involving the central tissue zone. Such symptoms are by no means restricted to PC and may be mimicked by such conditions as benign prostatic hyperplasia (BPH), urinary tract infection, and prostatitis. Progressive bone pain involving the spine, pelvis, or hips may herald the presence of metastases. Currently, the most typical initial scenario is an older asymptomatic man with an elevated PSA level who is found at subsequent biopsy to have an unanticipated histologic finding of PC. Fortunately, 90% of PC cases detected today are at a clinically localized stage.2,8

Etiology

A number of risk factors exist for PC. Cumulative exposure of the prostate gland to androgen influence correlates strongly with PC incidence, a reflection of the advanced age of most men with PC. Other factors include black ethnicity, high-fat diet, obesity, smoking, and elevated levels of testosterone and dihydrotestosterone.8 Although the disease is rarely documented in men younger than age 40 years, among black men, PC is diagnosed at an earlier age and more advanced stage than in white men. Incremental mortality in blacks may be related to genetics, diet, socioeconomic status, higher serum values of prostate specific antigen (PSA), and underutilization of medical care.8-11 Clinical presentation

Clinical aspects of PC vary widely, and in any two men with similar PC stage and PSA values, the disease can take sharply different paths. The fact that most men are asymptomatic at diagnosis is a reflection of the tendency of PC to arise TABLE 1. Age-specific PSA levels Age (years)

Normal PSA range ng/mL

≤40

0 to 2.0

45

0 to 2.4

50

0 to 2.8

55

0 to 3.3

60

0 to 3.8

65

0 to 4.5

70

0 to 5.3

75

0 to 6.2

≥80

0 to 7.2

Adapted from Cornett PA, Dea TO. Cancer. In: McPhee SJ, Papadakis MA, Rabow MW, eds.

CURRENT Medical Diagnosis & Treatment 2011. New York, N.Y.: McGraw-Hill; 2011:1564-1569.

Assessment and differential diagnosis

PC screening tools include the PSA blood test and the digital rectal examination (DRE).2 Since the introduction of PSA testing in 1987, PC incidence has increased sharply, and mortality rates have trended downward.12 Yet the cumulative risk/benefit comparisons for screening are not consistently persuasive due to the disturbing lack of randomized controlled trials demonstrating reduced mortality in screened populations. In fact, the U.S. Preventive Services Task Force currently recommends against PSAbased screening.13 In 1995, the U.S. congressional Office of Technology Assessment concluded that available evidence indicated PSA testing was of no proven mortality benefit.

The CDC, American Cancer Society, and American Urological Association endorse testing with PSA and DRE annually in men reaching age 50 years, with earlier screening, at age 40 years, for black men or those with a family history of PC. Since 90% of men with elevated PSA and normal DRE will be proven at biopsy to have disease confined to the prostate, most men can anticipate a favorable prognosis and a wide array of treatment options.2,12 PSA is a serine protease that functions to liquefy the ejaculate. The prostate gland is the predominant source of PSA in serum. Elevations of PSA occur with architectural disruption of the gland as in PC, BPH, prostatitis, prostate biopsy or massage, transurethral resection of prostate, and (transiently) ejaculation. PSA levels increase with advancing years of life, such that age-specific normal values have been established (Table 1). Healthy men typically have PSA values <4 mg/mL.2 Refinements capable of enhancing sensitivity and specificity include PSA density, PSA velocity, PSA doubling time, and free PSA vs. bound PSA. DRE allows for estimation of prostate size and detection of nodules, induration, asymmetry, or tenderness.2 The

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PROSTATE CANCER

POLL POSITION

Would you recommend annual prostate cancer screening for a healthy man aged 55 years? n=448 26%

74% n Yes n No

For more polls, visit CliniAd.com/10TDwDb.

palpating finger examines only the peripheral zone, where the majority of PC lesions arise. PSA and DRE in combination are slightly more effective in early detection of PC than either test alone.14 PSA results exceeding age-specific normal values, or abnormal DRE, usually leads to prostate ultrasound and biopsy to confirm the presence of PC or to document such benign conditions as BPH or prostatitis. Biopsy-proven PC is then graded according to the 10-point Gleason score and staged by the tumor-node-metastasis (TNM) system. Such radiologic imaging studies as CT, PET, and bone scan may be necessary if metastases are suspected.14 Treatment options

A number of treatment approaches are currently available for the management of PC. The choice of treatment is made based on the patient’s Gleason score, tumor volume, and differentiation of organ-confined disease from local or distant metastatic extension. The National Comprehensive Cancer Network (NCCN) guidelines15 are quite useful resources for patients and health-care providers searching for optimal modalities according to PC grade and stage.

NCCN data are evidence-based and descriptive of risk factors, treatment options, management strategies, tree diagrams, flow charts, and side effects, all intended for objective decision-making.

Conservative management. Conservative treatment of PC involves watchful waiting (WW) or hormonal therapy with luteinizing hormone-releasing hormone (LHRH) agonists.

The intent is not curative but palliative.15 The WW approach is appropriate for stage T1c PC (increased PSA, normal DRE, nonpalpable tumor), especially for men with limited life expectancy (i.e., <10 years). WW involves careful

observation, periodic testing every three to six months for progression, and no initial treatment.15 Evidence of disease progression in the form of rising PSA, new or enlarging prostate masses on DRE, and increasing tumor volume or Gleason score of 7 to 10 on biopsy would mandate active intervention with androgen deprivation therapy, radiation therapy, and perhaps taxane chemotherapy.

In a CDC survey of 3,300 men across seven states with localized PC, demographic preferences were apparent among men choosing radical prostatectomy (RP) (39.7%), radiation therapy (31.4%), WW (18.6%), and hormone therapy (10.3%). 3 Men opting for WW over RP were older, black, and single, and had non-screening-detected PC, normal DRE, low Gleason score (<8), and PSA >20.

While overall survival benefit was observed only at five years in the RP group, no reduction in PC mortality was evident. In addition, regional differences were also correlated with overall survival. These data indicate that how, and whether, PC is treated may depend significantly on one’s state of residence as much as on clinical variables.

The Prostate Cancer Intervention Versus Observation Trial (PIVOT) was the first randomized controlled tiral in the United States to compare RP with WW.4 Initiated in 1994, the study involved 731 men with localized PC followed for 12 years at 52 U.S. centers. Gleason scores were <6, and median PSA was 10. The results of the trial demonstrated no benefit for RP compared with WW in all-cause mortality or in PC-specific mortality at four and 12 years’ follow-up. These data lend support to WW strategies for men with localized PC, especially men with low PSA levels and definably low-risk disease.

Surgical management. Definitive therapy consists of RP or radiation therapy.2,15 Removal of all malignant PC tissue, including pelvic nodes, is the curative intent of RP. Retropubic and perineal operative approaches and robotic assistance enhance surgical precision for nerve-sparing procedures and reduce postoperative complications of erectile dysfunction (ED) and incontinence. The Scandinavian Prostate Cancer Group Study Number 4 demonstrated reductions in PC-related and all-cause mortality and risk of metastasis in men younger than age 65 years who elected RP over WW, especially with low-risk tumors.1,16 This trial, however, also revealed adverse decrements in quality of life, particularly in terms of waning erectile function, diminished continence, and adverse psychological effects after RP. The Veterans Administration Cooperative Urological Research Group trial involved 142 men with stage I or stage II PC treated with RP or placebo and followed the participants

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for 23 years. No advantage of RP over WW was seen in either stage or in both stages combined.17 For men with post-prostatectomy ED or incontinence, numerous treatment options exist. Pharmacologic therapies for ED include such oral phosphodiesterase-5 inhibitors as sildenafil (Revatio, Viagra), vardenafil (Levitra, Staxyn), and tadalafil (Adcirca, Cialis).15 Penile implants and inflatable prostheses are effective in men with ED. Kegel exercises, anticholinergics, and urethral dilation or stenting may be beneficial for incontinence. All of the above are intended to promote improved quality of life after RP.15 Available studies do not provide consistent evidence that RP lowers overall or PC-specific mortality.12 Nor does RP improve quality of life in men with organ-confined PC. It would seem that some men who undergo surgical intervention pay a substantial price in the short term in the hopes of an elusive long-term cure.

Practice implications

The choice of PC detection and treatment strategies are influenced by current scientific data, recommended therapies with narrow risk/benefit profiles, quality-of-life concerns, and the patient’s personal perceptions and values. Patient involvement in treatment choice is especially important in early-stage, low-risk PC, where WW is a viable option, especially in older men with a life expectancy of less than 10 years.3 Although evidence is conflicting, RP appears more appropriate for younger men with organ-confined malignancy and higher Gleason scores, in which case curative resection is clinically attractive for preventing disease progression, distant metastasis, and tumor recurrence in anticipation of more than 10 years of life expectancy.

Large-scale studies are under way to clarify treatment choices for men with PC. The Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial, involving 76,693 U.S. men over the span of 13 years, and the European Randomized Study of Screening for Prostate Cancer, involving 182,160 men in Europe over the span of nine years, are intended to further define relative mortality benefits of PC screening.

Criteria are being evaluated for selective identification of tumors destined to become more aggressive and metastatic, thereby warranting closer surveillance or more intensive oncologic intervention at earlier dates. New candidate biomarkers in prostate tissue may become useful in creating a genetic fingerprint of tumors likely to become aggressive and invasive. Current genes are still research-based and include such sequenced peptides as GSTP-1, RASSFIA, AMACR, PBOV1, hepsin, DD3, and NMP48.18 Future

CLINICAL SLIDESHOW For more information on the controversy surrounding prostate cancer screening, view the slideshow at CliniAd.com/175Fn8X.

laboratory developments may allow complementary determination of histologic features and molecular biology panels to predict transformation of PC from indolent to important clinical status.

It is worth noting that the researcher who discovered PSA—Richard Ablin, PhD—has decreed overdiagnosis of PC by PSA “a hugely expensive public health disaster.”19 Emerging data and applied technologies are being developed to predict which prostate tumors will awaken to progression and which will remain dormant. Such techniques should calm the PSA screening debate considerably. Clinical insights are emerging toward consensus for patients and providers searching for answers to the dilemma of whether or not to screen for PC. n Ms. McIver is a physician assistant at Peachtree Dunwoody Dermatology in Atlanta. Dr. Stallings and Dr. Felz are associate professors in the physician assistant department at Georgia Regents University in Augusta.

References 1. Hegarty J, Beirne PV, Walsh E, et al. Radical prostatectomy versus watchful waiting for prostate cancer. Cochrane Database Syst Rev. 2010;11:CD006590.

2. Centers for Disease Control and Prevention. Basic information about prostate cancer. Available at www.cdc.gov/cancer/prostate/basic_info/ index.htm.

3. Schymura MJ, Kahn AR, German RR, et al. Factors associated with initial treatment and survival for clinically localized prostate cancer: results from the CDC-NPCR Patterns of Care Study (PoC1). BMC Cancer. 2010;10:152.

Available at www.biomedcentral.com/1471-2407/10/152.

4. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367:203-213. Available at www.nejm.org/doi/full/10.1056/NEJMoa1113162.

5. Surveillance, epidemiology, and end results program. SEER cancer statistics review (CSR) 1975-2010. Available at seer.cancer.gov/csr/1975_2010/.

6. Centers for Disease Control and Prevention. Prostate cancer rates by race and ethnicity. Available at www.cdc.gov/cancer/prostate/statistics/race.htm.

Continues on page 61

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PROSTATE CANCER

7. Abouassaly R, Thompson IM, Platz EA, et al. Epidemiology, etiology, and

statement. Ann Intern Med. 2012;157:120-134. Available at annals.org/article.

prevention of prostate cancer. In: Campbell-Walsh Urology 2007; 9th ed.

aspx?articleid=1216568.

Wain AJ, ed. Philadelphia, Pa.: Saunders; 2854-2873.

14. UPMC CancerCenter. Prostate and urologic cancers. Available at

8. PubMed Health. Prostate cancer. Available at www.ncbi.nlm.nih.gov/

www.upmccancercenter.com/prostateUrologicCancer/.

pubmedhealth/PMH0001418/.

15. National Comprehensive Cancer Network. NCCN Guidelines for

9. Chornokur G, Dalton K, Borysova ME, Kumar NB. Disparities at presenta-

Patients. Prostate cancer. Available at www.nccn.org/patients/guidelines/

tion, diagnosis, treatment, and survival in African American men, affected by

prostate/index.html.

prostate cancer. Prostate. 2011;71:985-997. Available at www.ncbi.nlm.nih.gov/

16. Bill-Axelson A, Holmberg L, Ruutu M, et al. Radical prostatectomy versus

pmc/articles/PMC3083484/.

watchful waiting in early prostate cancer. N Engl J Med. 2011;364:1708-1717.

10. Zeigler-Johnson C. CYP3A4: a potential prostate cancer risk factor for

Available at www.nejm.org/doi/full/10.1056/NEJMoa1011967

high-risk groups. Clin J Oncol Nurs. 2001;5:153-154.

17. Byar DP, Corle DK. VACURG randomised trial of radical prostatectomy

11. Bostwick DG, Burke HB, Djakiew D, et al. Human prostate cancer risk

for stages I and II prostatic cancer. Veterans Administration Cooperative

factors. Cancer. 2004;101:2371-2490. Available at onlinelibrary.wiley.com/

Urological Research Group. Urology. 1981;17:7-11.

doi/10.1002/cncr.20408/full.

18. De Angelis G, Rittenhouse HG, Mikolajczyk SD, et al. Twenty years

12. Wilt TJ, MacDonald R, Rutks I, et al. Systematic review: comparative

of PSA: from prostate antigen to tumor marker. Rev Urol. 2007;9:113-123.

effectiveness and harms of treatments for clinically localized prostate

Available at www.ncbi.nlm.nih.gov/pmc/articles/PMC2002501/.

cancer. Ann Intern Med. 2008;148:435-448. Available at annals.org/article.

19. The New York Times. The great prostate mistake. Available at

aspx?articleid=740046.

www.nytimes.com/2010/03/10/opinion/10Ablin.html.

13. Moyer VA; U.S. Preventive Services Task Force. Screening for pros-

“And, for what we don’t cover, there’s insurance insurance.”

All electronic documents accessed March 15, 2014.

“The wealth gap is easy to explain—I merely work one billion times harder than you.”

© The New Yorker Collection 2014 from cartoonbank.com. All Rights Reserved.

tate cancer: U.S. Preventive Services Task Force recommendation

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 61

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FEATURE: SUSAN HOFFSTETTER, PHD, WHNP

Diagnosing diseases of the vulva Vulvar biopsy is a helpful tool that clinicians should utilize to diagnose and guide the management of gynecologic abnormalities.

I

nspection of the vulva is an essential part of a complete pelvic examination, yet the area is often overlooked or given only a very cursory examination by clinicians. For their part, patients can be confused by terminology and are often not aware of the difference between the vagina and the vulva when they are trying to report the location of a symptom or abnormality. A brief overview of the anatomy and diseases of the vulva may prove helpful for both clinicians and, ultimately, patients.

© CMSP

Normal anatomy

After performing a biopsy, provide the patient with follow-up care instructions.

A review of normal vulvar anatomy is critical before moving on to a discussion of evaluation, diagnosis, and biopsy. The vulva includes the mons pubis, the labia majora, the labia minora, the clitoris, and the vestibule. The most obvious feature of the vulva is hair that should cover the mons pubis and the labia majora. Unfortunately, in our society, hair on the vulva is now being routinely removed by laser, waxing, or shaving. Although hair on the vulva is deemed an unwanted and unnecessary feature, it serves a definite purpose, protecting the Skene and Bartholin glands from vaginal secretions, perspiration, and contact irritants. Hair also provides a cushion against impact during intercourse.

Women should be informed of the purpose of vulvar hair during examinations.

The mons pubis comprises stratified squamous epithelium with a fat layer and lies over the pubic symphysis. The labia majora are two raised folds of adipose tissue that can be pigmented and that

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DISEASES OF THE VULVA

FIGURE 1. Epithelial thickening and hyperkeratosis of lichen ­simplex chronicus

FIGURE 2. In lichen sclerosus, light-complected skin can take on a whitish hue.

bear hair. The labia are composed of stratified squamous epithelium, sebaceous glands, and apocrine sweat glands.

Fordyce spots are sebaceous glands on the medial aspect of the labia majora.1 In postmenopausal women, loss of adipose tissue and hair from the mons pubis and labia is normal.

The labia minora, which lie within the labia majora and extend from the clitoris to the fourchette, are smooth and hairless. In some women, the labia minora can be covered by the labia majora, but in others, the labia minora protrude between the labia majora. The texture of the labia minora is highly individualized, and the color varies from shades of pink to brown.

The medial aspects of the labia minora join to form the clitoral hood, which covers the glans clitoris and provides protection for it. The glans is the receptor of sexual stimuli and responds by increasing in size. In some women, the clitoral hood retracts easily whereas in others, it is adhered to the glans itself and cannot be pulled back. Either finding is normal.

The area between the labia minora is the vestibule, which contains the urethral meatus, Skene glands, vaginal introitus, and Bartholin glands. Remnants of the hymenal ring are seen around the margins of the introitus. Hart’s line marks the lower edge of the vestibule. The minor glands found throughout the vestibule become more evident in postmenopausal women.1

identify any abnormalities. A vulvar examination begins with inspection of the vulvar tissues and the vestibule. Note any structural abnormalities, lesions, or changes (including changes in pigmentation) on the mons, labia majora, and labia minora and within the vestibule. Once the vulva has been assessed, introduce the speculum into the vagina. Repeat the steps, looking for lesions and structural and pigmentary changes. When establishing a differential diagnosis for the presumed abnormality, start with basic vulvar changes, such as normal variants and infections, and move up in level of complexity to inflammatory conditions and neoplasia.

Consistency is key

When performing a vulvar examination, it is important to be consistent. By being consistent, the clinician will improve his or her ability to perform a thorough assessment and to

Diseases of the vulva

A common normal variant that is often misdiagnosed is papillomatosis, which is characterized by papillary growth of the vestibular mucosa located within Hart’s line. These growths are often misidentified as condylomas arising from infection with the human papillomavirus (HPV).

Inappropriate treatment of the papillomas as condylomas can lead to acute or chronic symptoms of burning or pain in the vulva and the vestibule.

Contact or allergic vulvitis is very common following exposure to irritants. As many as 54% of symptomatic women turn out to have contact vulvitis.² Vulvitis resulting from contact with an irritant is more common than allergic vulvitis.

Contact vulvitis does not necessarily cause erythema, but it can lead to symptoms of burning, rawness, and irritation.

Allergic vulvitis can be mild, manifesting with erythema, swelling, and itching, or it can be severe, with bright red swelling, discomfort, and, possibly, blistering. Allergic reactions can take longer to develop and range from mild

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to severe. Identifying and removing the offending irritant while giving supportive care to the affected tissues is the initial treatment step. If the symptoms fail to respond, biopsy of the affected area could be considered. However, biopsies of tissues demonstrating persistent erythema in a setting of normal vulvar anatomy are not helpful in management or treatment, as the pathology report usually gives a nonspecific diagnosis, such as chronic inflammation.

Organisms that can cause infection of the vulva include yeast, herpes simplex virus, HPV, methicillin-resistant Staphylococcus aureus (MRSA), and group B streptococci.

These infections tend to be clinically evident, and biopsy is not usually indicated. If the lesions are atypical, biopsy is advisable. If a woman who is compliant with treatment recommendations does not respond to therapy, consider biopsy to ensure that the diagnosis is correct.

Obese women and women with diabetes mellitus are often treated for vaginal/vulvar symptoms without examination, especially if their hemoglobin A1c levels are abnormal. Yeast infection is commonly assumed in these patients, and oral therapy is frequently prescribed. An examination is advised to ensure that no other skin condition or abnormality is causing the symptoms. A biopsy is indicated to confirm any abnormality.

Inflammatory conditions seen on the vulva include lichen simplex chronicus (LSC), lichen sclerosus (LS), lichen planus (LP), Crohn disease, and vulvar psoriasis. LSC is a common condition resulting from a chronic itch-scratch cycle or rubbing that leads to the development of epithelial thickening and hyperkeratosis (Figure 1). The onset of symptoms can relate to an irritant, an allergic response, or chronic yeast

infection. Dermal keratin causes an increased texture to the area involved, with accentuations of normal skin markings. Dark-complected skin will take on a gray hue and light-complected skin will take on a whitish hue. In some women, distinguishing LSC from LS is difficult without a biopsy (Figure 2).

Autoimmune conditions often manifest in the vulva.

Compared with other women, a woman who has a systemic autoimmune illness such as thyroid disease, diabetes mellitus, systemic lupus erythematosus, fibromyalgia, or irritable bowel disease will have a higher risk of developing an autoimmune vulvar disease. LS is an autoimmune chronic skin condition that is found most commonly in postmenopausal women and prepubescent girls. It causes structural changes in the anatomy, with resorption of the labia minora, clitoral phimosis, and whitening of the vulvar skin. It is important to remember that any inflammatory disorder can cause resorption of normal vulvar architecture, so biopsy can be very helpful in making an accurate diagnosis. Vulvar carcinoma occurs in approximately 2% to 5% of women who have LS, extensive involvement, and poor control and management.

Carcinoma can develop under the thickened white skin of the vulva (Figure 3).

LP is an autoimmune condition that can affect the mucosa of the vulva and the vagina and is typically found on the gums in the mouth. Mild disease consists of fine, subtle, white, interlacing papules (Wickham striae), whereas more severe disease presents as erosive tissue in the vestibule surrounded by white epithelium. Erythematous plaques can be found deep within the vaginal vault. Without early identification and treatment, the introitus or vagina can become completely

FIGURE 3. Carcinoma can develop under the thickened white skin of the vulva.

FIGURE 4. When obtaining a biopsy sample, rotate the punch into the skin until you reach the desired depth.

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DISEASES OF THE VULVA

If skin surfaces or mucous membranes appear normal in an area of perceived symptoms, such as pain or burning, biopsy is not necessary. obliterated. The intense erythematous tissues are often misdiagnosed for candidiasis or a contact or allergic dermatitis. A biopsy will confirm LP. Women with a confirmed diagnosis should be referred to a specialist for long-term management.

Crohn disease can occur in the vulva as a direct extension of the involved bowel or as granulomas separated from the bowel by normal tissue. Vulvar inflammation with abscesses, draining sinuses, edema, and ulceration is common. In some patients, the lesions take on the appearance of knifelike fissures. Vaginal granulomas and enteric fistulas from the rectum, ileum, proximal colon to the vagina, perineum and/or vulva can develop. A biopsy is necessary in these women, especially those without a diagnosis of Crohn disease. These women require referral to a gastroenterologist for management, because once the Crohn disease is under control, the vulvar symptoms will subside.

Psoriasis, a common skin condition, is often found on the elbows, knees, scalp, and nails. In psoriasis, the skin appears silvery with scaly patches. Psoriasis can occur in the vulva without affecting other areas of the body. The disorder occurs commonly on the labia majora and often spreads to the groin folds and the mons pubis. Psoriasis lesions on the vulva can appear as they do on other areas of the body, or they can be salmon-pink with a very well-demarcated edge.

If the woman has psoriasis on other areas of the body, vulvar psoriasis is more likely to come to mind and be identified. A family, rather than a personal, history of psoriasis should also raise suspicion of vulvar psoriasis, but making the diagnosis can be difficult without the aid of a biopsy.

Neoplasias include vulvar intraepithelial neoplasia (VIN); squamous cell carcinoma of the vulva; and anal cancers, which arise from HPV. VIN is not cancer but may develop into an invasive cancer if not treated. VIN can occur anywhere on the vulva or around the anal area. Diagnosis of VIN is challenging, as it can manifest as a single lesion or as multiple lesions that vary in color from white to brown to red and can be rough, smooth, flat, or raised. The lesions can be easily confused with condylomas or even a common mole. When an abnormal or new lesion is identified, vulvar biopsy is indicated.

When to do a biopsy

A vulvar biopsy will help to identify or confirm your suspicions about a lesion or abnormality because histologic analysis can differentiate benign from neoplastic lesions. Biopsy that results in removal of the entire lesion can be a curative

treatment as well as a diagnostic procedure. Clinicians tend to treat and re-treat rather than perform a biopsy to determine a diagnosis. More errors result from not doing a biopsy.

Consider a biopsy when you observe a pigmented lesion (white, red, or dark), skin texture that is rough or has heightened architecture, areas that appear to be altered or changed, or any obvious abnormal growth or lesion. If you are suspicious that a pigmented lesion might be a melanoma, referral to dermatology for biopsy is advised.

Another indication for vulvar biopsy is as an aid in treatment. If a woman has persistent symptoms or does not seem to respond to prescribed therapy, a biopsy might be necessary.

Consider poor adherence to the prescribed treatment before deciding that the treatment was ineffective. It is hoped that a conversation with the woman will uncover issues with adherence. Also review and rethink your original diagnosis.

Reevaluate for infection and for irritant or allergic contact dermatitis. Consider the possibility that the original diagnosis was inaccurate or that there are multiple diagnoses.

Choosing the biopsy site

Once the decision has been made to obtain a biopsy, site selection is the most important decision to make. Look for areas of change. Examine the thickest portion of the lesion, the area with the most irregular color change, or the edge of the lesion. If possible, remove the entire lesion.

As previously noted, taking a biopsy sample from an area that is simply erythematous will likely show inflammation, which is apparent, and the results will not be specific enough to direct management. If possible, avoid the clitoris, as the woman may experience postbiopsy neuropathic pain because of the high concentration of nerve endings in this sensitive area. The urethra is also an area to be avoided. If this is the area of concern, referral to a urogynecologist or urologist should be considered.

If skin surfaces or mucous membranes appear normal in an area of perceived symptoms, such as pain or burning, biopsy is not necessary. In these cases, symptoms are usually neuropathic in origin. Often, clinicians will biopsy to prove to the patient that there is no abnormality. This can be helpful in directing the management for some patients.

How to do a biopsy

A punch biopsy is a simple and clean procedure with minimal risk of infection or bleeding. Inform the woman that

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Documentation of the biopsy is necessary and should include the reason for biopsy and a description of the procedure. description of the lesion or abnormality, and your suspicions regarding the diagnosis. The more information you are able to give to the pathologist, the more focused the results will be. If you have the option, request a dermatopathologist or a pathologist with an interest in skin disease.

Unfortunately, many dermatoses have nonspecific histopathology, so clinical judgment and skills need to guide your treatment/management. Be aware that if you just keep treating and treating, but the symptoms are not resolving, the best approach is to stop and reevaluate. If you are fortunate enough to have a vulvar specialist in your area, refer the patient for evaluation and management. n Dr. Hoffstetter is an associate professor in the Department of Obstetrics, Gynecology and Women’s Health Services, Division of Urogynecology, Saint Louis University School of Medicine, and a fellow of the International Society for the Study of Vulvovaginal Disease.

References 1. Wilkinson EJ, Stone IK. Atlas of Vulvar Disease. Philadelphia, Pa.: Lippincott Williams & Wilkins; 2008:2-3.

2. Fisher GO. The commonest causes of symptomatic vulvar disease: a dermatologist’s perspective. Australas J Dermatol. 1996;37:12-18.

3. Grekin RC. Simple dermatological surgical procedures. Res Staff Phys.

1989;35:61-67.

4. Dinehart SM, Hanke CW, Geronemus RG. Dermatologic Surgery for Medical Students. Schaumburg, Ill.: Association of Academic Dermatologic Surgeons; 1993.

“That’s the doctor who is treating me for paranoia.

I don’t trust him.”

© The New Yorker Collection 2010 from cartoonbank.com. All Rights Reserved.

the biopsy will leave a scar. Many women today are very concerned with the cosmetic appearance of the vulva, and it is important that they know what to expect postbiopsy.

Obtaining informed consent is advised. Local anesthesia using 1% lidocaine applied with a small-gauge needle will provide comfort for your patient during the biopsy.

Using a punch is straightforward (Figure 4). A biopsy need not be deep to yield useful clinical information; a punch size between 4 mm and 6 mm will provide sufficient tissue for pathology. The procedure involves the following steps: • Stabilize the skin with the thumb and forefinger, and stretch slightly in a direction perpendicular to the skin tension lines.

• Hold the punch perpendicular to the surface, and rotate into the skin with a firm, constant pressure until the desired depth has been reached.

• Do not remove the punch to check your progress, as this will result in a ragged wound and a shredded biopsy sample.

• Once you have reached the desired depth, remove the punch and apply downward finger pressure at the sides of the wound to pop up the core.

• Grasp the specimen with forceps and cut it off at the base.3,4 Another approach is to use fine-toothed forceps and fine scissors. Inject the local anesthesia, grasp the abnormal tissue with the pickups, and then cut off the lesion at the base.

After the biopsy sample has been obtained, apply direct pressure to the wound. Hemostasis with silver nitrate sticks or Monsel’s solution is adequate. Suturing is not normally necessary with the use of a Keyes punch or fine-toothed forceps, as long as the biopsy was not performed too deeply.

The site will heal by secondary intention. Instruct the woman to keep the biopsy site clean. Rinsing the area after voiding or moving the bowels is helpful. An ice pack or nonsteroidal anti-inflammatory medication can be used, if needed, to relieve local discomfort.

Documentation of the biopsy is necessary and should include the reason for biopsy and a description of the procedure, including skin preparation, type of local anesthetic used, and size of Keyes punch. Specify the location of the biopsy, the disposition of the specimen, and the follow-up care instructions for the patient. Schedule an appointment to review the pathology results and inspect the biopsy site.

Adequate communication with the pathologist is crucial.

Take the time to complete the pathology request form carefully, so that it includes a brief clinical history, a visual

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CME CE

n LEARNING OBJECTIVES: • Explain how changes in prescribing practices have affected the rise in opioid abuse.

• Describe the five schedules of controlled substances.

• Review the components of a comprehensive pain assessment.

• Identify the potential patient risks associated with prescribing opioid medications.

• Discuss appropriate prescribing practices as they pertain to opioid medications. n COMPLETE THE POSTTEST: Page 103

FEATURED COURSE

n ADDITIONAL CME/CE CREDIT: Pages 95, 99

This activity is jointly sponsored by Medical Education Resources (MER) and Haymarket Medical Education (HME).

Release Date: April 2014 Expiration Date: April 2015 Estimated time to complete the educational activity: 30 minutes Statement of Need: Substance use disorder has become a growing concern in the United States thanks to changes in prescribing practices. To effectively minimize substance use disorder, a thorough pain assessment is used to determine when treatment of pain with opioids is appropriate.

Once that determination has been made, the clinician must follow evidencebased prescribing practices to maximize safety when prescribing these medications.

Target Audience: This activity has been designed to meet the educational needs of primary-care physicians, physician assistants, and nurse practitioners who treat patients with substance use disorder.

Faculty Mary Atkinson Smith, DNP, FNP-BC Starkville Orthopedic Clinic Starkville, Miss.

Scott Hambleton, MD, FASAM Mississippi Professionals Health Program Ridgeland, Miss.

Accreditation Statements Physician Credit: This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of MER and HME. MER is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: MER designates this educational activity for a maximum of 0.5 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Credit: MER is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Credit Designation: This CE activity provides 0.5 contact hour of continuing nursing education.

MER is a provider of continuing nursing education by the California Board of Nursing Registered Nursing, Provider #CEP 12299, for 0.5 contact hours.

American Academy of Physician Assistants AAPA accepts certificates of participation for educational activities certified for Category I credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 1 hour of Category I credit for completing this program.

Accreditor Disclosure of Conflicts-of-Interest Policy MER ensures balance, independence, objectivity, and scientific rigor in all our educational programs. In accordance with this policy, MER identifies conflicts of interest with its instructors, content managers, and other individuals who are in a position to control the content of an activity. Conflicts are resolved by MER to ensure all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards

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of experimental design, data collection, and analysis. MER is committed to providing its learners with high-quality CME/CE activities that promote improvements or quality in health care and not a commercial interest.

Faculty Disclosures The faculty reported the following financial relationships or relationships to products or devices that they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity: Mary Atkinson Smith, DNP, FNP-BC, and Scott Hambleton, MD, FASAM, have no relevant financial relationships to disclose.

Staff/Planners’ Disclosures The planners and managers reported the following financial relationships or relationships to products or devices that they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity: The following HME planners and managers hereby state the following financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months: Joe Kopcha, Editor; Delicia Yard, Senior Editor; and Nicole Blazek, Web Editor, have no real or apparent conflicts of interest to report.

The MER planners and managers, and Veronda Smith, FNP-BC, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

Method of Participation: There are no fees for participating in and receiving CME/CE credit for this activity. During the period of April 2014 through April 2015, participants must: 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) complete the posttest and submit it online (physicians may register at www.myCME.com); and 4) complete the evaluation form online.

A statement of credit will be issued only upon receipt of a completed activity evaluation form and a completed posttest with a score of 70% or better.

Disclaimer: The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of MER or HME. The authors have disclosed if there is any discussion of published and/or investigational uses of agents that are not indicated by the FDA in their presentations. The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of MER or HME. Before prescribing any medicine, primary references and full prescribing information should be consulted. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. The information presented in this activity is not meant to serve as a guideline for patient management.

3/26/14 4:23 PM

MARY ATKINSON SMITH, DNP, FNP-BC; SCOTT HAMBLETON, MD, FASAM

The safe use of opioids in the treatment of pain To minimize the risk of abuse and addiction, evidence-based prescribing practices must be used when treating acute and chronic pain with opioids.

F

© THINKSTOCK

or the better part of the 20th century, most health-care providers believed that the longterm use of opiods to treat chronic pain was contraindicated by the risk of addiction, increased disability, and lack of efficacy over time.1 Beginning in the 1990s, however, changes in available drug formulations and prescribing practices contributed to an increase in the use of opioid medication among patients with chronic pain conditions.2 Perhaps inevitably, a corresponding rise in the prevalence of opioid abuse and addiction has followed.3 Treating acute and chronic noncancer pain (CNCP) in the primary-care setting can be challenging. Health-care providers should be knowledgeable of the various classes of controlled substances as well as the potential for abuse among these classes. To minimize the potential for abuse and addiction and to ensure patient safety, evidencebased prescribing practices should be used when treating pain with opioid medications. In response to the current epidemic of opioid abuse, the FDA recently made dramatic changes to its indications for the use of powerful long-acting and extendedrelease opioid medications: This medication class is no longer indicated for chronic pain of moderate severity. The updated information states that such drugs are indicated for the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”4

Changes in prescribing practices have led to an increase in the use of opioids for chronic pain.

Overview

In 2011, the CDC reported 12 million nonmedical users of opioids, up from 3.8 million in 2000.5 Opioid abuse represents 75% of the overall problem www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 73

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SAFE USE OF OPIOIDS

Prior to the 1990s, opioids were rarely used for pain associated with such conditions as fibromyalgia, headache, and low-back pain. of prescription drug abuse in the United States.6 The rate of unintentional overdose deaths grew by 124% in the United States between 1999 and 2007, primarily due to the increased incidence of overdoses related to prescription opioids.7 Accidental overdose deaths from opioid use have increased at an alarming rate among females, approaching 400% from 1999-2010, compared with a 250% increase among males during the same period.8 Current data demonstrate a fourfold increase in the prescribing of opioids over the past decade, along with an associated sixfold increase in the number of individuals seeking professional treatment for opioid-related addiction.5 In 2010, U.S. pharmacies dispensed the equivalent of 111 tons of opioids, including 69 tons of pure oxycodone (Oxecta, Oxycontin, Roxicodone) and 42 tons of pure hydrocodone, enough to medicate every individual in the United States for an entire month.9 A 2011 report from the Institute of Medicine (IOM) states that pain is a major reason that individuals seek care from clinicians and recommends that the treatment of pain be considered a nationwide priority.10 The IOM supports updating the prevention, care, education, and research related to pain through an evidence-based model. Despite the tremendous number of opioids consumed in the United States, 116 million Americans per year experience undertreated chronic pain, according to the IOM report.10 Given the severity of the current crisis of prescription drug abuse, health-care providers must be cognizant of the appropriate indications for prescribing opioids, familiar with the individual classes of controlled substances and their abuse potential, and knowledgeable about the potential patientrelated risks of prescribing opioids. Comprehension of and familiarity with these factors will support and encourage TABLE 1. Potentially harmful prescribing trends Prescribing opioids for chronic noncancer pain Prescribing large quantities of opioids for acute conditions Prescribing large quantities of opioids without appropriate monitoring or follow-up Lack of thorough pain assessment prior to prescribing opioids Prescribing opioids to patients who are at high risk for adverse effects Co-prescribing opioids with benzodiazepines or other sedatives/hypnotics Not providing detailed patient education prior to prescribing opioids or other controlled substances

the utilization of evidence-based prescribing practices when treating pain. In turn, these practices will minimize inappropriate prescribing and the potential of abuse, addiction, and harm among patients.

Prescribing opioids

Data have not shown that opioids are a safe or effective treatment for CNCP. The decision to prescribe potentially addictive substances for chronic and non-life-threatening conditions should only be made following careful consideration. Prior to the 1990s, opioids were rarely used for pain associated with such conditions as fibromyalgia, headache, and low-back pain. The primary indications for opioid medications were for cancer-related pain or for such acute conditions as fractures or surgical interventions. The concern was that use of these powerful substances could lead to addiction, thereby possibly converting a non-lifethreatening condition (chronic pain) into a life-threatening one (addiction).

Prescribing trends

A recent study involving 128 health-care providers revealed that 58% were likely to recommend and prescribe opioids for the treatment of chronic pain–related conditions.11 The beliefs and attitudes expressed by health-care providers in the study indicated that educational gaps exist pertaining to the prescription of opioids. Finally, the study showed that the number of pain-management specialists available to assist primary-care providers is insufficient; therefore, there is an increasing need for education among primarycare providers regarding the abuse potential of opioids and the use of recommended evidence-based practices when prescribing opioids.

Deyo et al. conducted an analysis of the electronic health records of 26,014 patients with a diagnosis of low back pain.12 The main purpose of this study was to examine prescribing characteristics associated with long-term opioid use and identify ways to improve safety of opioid prescribing in the primary-care setting. Electronic pharmacy data and medical-record data for each patient were reviewed for six months before and after an evaluation for low back pain.

A total of 15,830 patients (61%) studied were prescribed at least one opioid. Of the patients being prescribed opioids, 4,883 (18.8%) had a history of long-term opioid use during the year they were being treated for low-back pain. In this

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Narcotics are defined as psychoactive analgesic compounds that affect the CNS and are known to have sleep-inducing or pain-relieving properties. study, 92% of the opioids prescribed consisted of the following: hydrocodone and acetaminophen, acetaminophen and codeine, oxycodone and acetaminophen, oxycodone, and morphine. Sedative-hypnotics were co-prescribed for 44% of patients, with benzodiazepines being the most common sedative-hypnotic prescribed. Finally, the number of diverse opioid prescribers increased among patients with increasing duration of opioid use. Table 1 lists other potentially harmful prescribing trends.

Inappropriate prescribing trends and wasteful medication decisions can also have a significant detrimental economic impact. Research shows that the most costly prescribing decisions disproportionately affect the poorest states. The country’s lowest median household income is found in the state of Mississippi, which also has the most wasteful medication-related spending at $1,622.76 per resident.13 Other low-income states that have wasteful medicationrelated prescribing include Alabama, Arkansas, Kentucky, Louisiana, New Mexico, Oklahoma, South Carolina, and Tennessee. Interestingly, states with the highest utilization rates of narcotic medications include Alabama, Mississippi, Oklahoma, Tennessee, and West Virginia.14 The highest spending per capita related to narcotics, including cost-perprescription and utilization, is found is Alabama, Nevada, Oklahoma, Ohio, and Utah.14 Schedule classifications of controlled substances

Controlled substances are determined by the U.S. Drug Enforcement Administration and are classified into five schedules that are based on the drug’s accepted medical use, the drug’s relative potential for abuse, and the likelihood of dependency following abuse of the drug.15 For example, Schedule I controlled substances have the highest abuse potential, and Schedule V controlled substances have the lowest abuse potential. There are also narcotic and nonnarcotic categories within the schedules. Narcotics are defined as psychoactive analgesic compounds that affect the central nervous system (CNS) and are known to have sleep-inducing or pain-relieving properties. Such opioids as heroin and morphine as well as similar substances that are derived from these opioids (e.g., hydrocodone), are considered narcotics. Non-narcotic controlled substances are substances that do not affect the CNS. Examples of non-narcotic substances include anabolic steroids, ketamine, benzphetamine, and phendimetrazine.

Schedule I controlled substances have a high abuse potential, a lack of accepted safety for use under medical supervision, and a high potential for abuse.15 Examples of Schedule I controlled substances include marijuana, methylenedioxymethamphetamine (MDMA, commonly known as Ecstasy or Molly), heroin, methaqualone, and lysergic acid diethylamide (LSD).

Schedule II controlled substances have a high potential for abuse that may lead to severe psychological or physical dependence and include such narcotics as hydromorphone (Dilaudid, Exalgo), oxycodone, meperidine (Demerol), morphine, fentanyl (Durgesic), opium, and codeine, in addition to such non-narcotic stimulants as methamphetamine, amphetamine, and methylphenidate (Concerta, Metadate, Methylin, Ritalin).

Schedule III controlled substances have a lower potential for abuse than substances in Schedules I or II, and abuse may lead to moderate or low physical dependence or high psychological dependence. Examples of Schedule III narcotics include combination-type products comprised of <15 mg hydrocodone per unit dose, <90 mg codeine per unit dose, and buprenorphine (Subutex). Schedule III non-narcotics include ketamine, benzphetamine, phendimetrazine, and anabolic steroids.

Schedule IV controlled substances have a lower abuse potential in relation to Schedule III controlled substances and include lorazepam (Ativan, Lorazemap Intensol), diazepam (Valium, Valrelease), alprazolam (Alprazolam Intensol, Niravam, Xanax), clonazepam (Klonopin), clorazepate (GenXene, Tranxene), midazolam (Versed), triazolam (Halcion), and temazepam (Restoril). Schedule V controlled substances mainly consists of preparations that contain limited amounts of specific narcotics. Examples of Schedule V controlled substances include cough preparations that contain <200 mg codeine per 100 mL or per 100 g.15 Types of opioids

Opioids are available in short-acting and long-acting forms.

Short-acting opioids include rapid-onset medications, and long-acting opioids include extended-release or sustainedrelease medications. Short-acting opioids are used to treat pain for brief periods of time and are taken by patients as needed for pain. Long-acting opioids may be used to manage pain that is persistent and chronic in nature. Long-acting opioids lead to prolonged pain relief that lasts for several hours, as these medications are taken on a consistent scheduled basis at the same time every day.

Continues on page 76

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SAFE USE OF OPIOIDS

Mechanism of action

Opioids relieve pain by binding with opioid receptors in the body. Opioid receptors are specific proteins on the surface of cells, located mainly in the CNS, the peripheral nervous system, and the GI tract. The most common opioid receptors are epsilon, mu, delta, sigma, and kappa; however, an opioid may bind and act on several different opioid receptors at the same time, which means patient response will vary with each opioid.16 Once an opioid binds to an opioid receptor, it blocks the transmission of pain signals to the brain. The use of opioids does not eliminate the pain, but leads to a reduction and alteration in the perception of pain. Opioids also affect the limbic system of the brain, which creates an alteration in the emotional response to pain.

Determining treatment of pain with opioids

Deciding whether to treat pain with opioids begins with a comprehensive evaluation of the patient’s medical history that includes background information regarding the chief complaint, followed by a thorough physical examination, complete pain assessment, appropriate diagnostic laboratory tests, and imaging. It is also important to find out if the patient is under the care of another practitioner for the treatment of acute or chronic pain. The prescribing practitioner should also inquire about a history of substance abuse, risky drug-related behavior, and the presence of psychosocial conditions. Addressing these points will encourage an evidence-based and patient-centered approach regarding the treatment of pain and the need to prescribe opioids.

Comprehensive assessment of pain

A thorough pain assessment provides the health-care practitioner with an objective measurement of a patient’s pain, which is very subjective in nature. The patient’s selfreporting of pain is the hallmark of pain assessment. An extensive pain evaluation begins with obtaining a thorough history of the complaint. This assessment should include the following questions: Where is the source of the pain?

Is there a specific precipitating factor? Is the pain acute or chronic in nature? What is the quality of the pain? What is the duration of the pain? What increases or decreases the pain? How does the patient rate the pain on a scale of 0 to 10?

Acute pain occurs suddenly, may be intermittent, and usually does not last beyond six months in duration.

Musculoskeletal fractures, ligamentous injuries, surgical procedures, and burns are examples of events that may lead to acute pain. Chronic pain lasts longer than six months.

Examples of sources of chronic pain include traumatic injuries

that cause alterations in normal function, osteoarthritis, neurogenic disorders, and cancer.

A comprehensive evaluation of pain should also include an assessment of the quality of the pain and patient description of his or her pain. Determining the specific type of pain will guide the clinician toward appropriate interventions.

Neuropathic pain, which is poorly managed with opioids, is typically described as shooting, burning, radiating, tingling, and numbness. Somatic pain is characterized as throbbing, dull, and achy, in addition to being localized in nature, and may require a multimodal treatment approach. Visceral pain is characterized as dull, deep, cramping, or squeezing.

Visceral pain is most often seen following surgery of the abdominal or thoracic areas. This type of pain may also be present as a secondary result of liver metastases. Visceral pain will likely require opioids for adequate relief and may require a multimodal approach as well.

Quantification is an extremely valuable tool when it comes to treating acute and chronic pain. The universal use of the Numeric Rating Scale (NRS) to assess pain intensity in adults is highly recommended.17 The NRS allows healthcare practitioners to quantify the patient’s perceived intensity of the pain (i.e., 0 represents no pain and 10 represents the worst pain). The NRS may not be appropriate for children, the elderly, or patients with language barriers. In such cases, the Wong-Baker FACES Pain Rating Scale, a visual version of the NRS, is a good alternative.18 When determining the location of pain, the practitioner can ask the patient to point directly to the area. Also, ask if pain is felt in more than one area. Assess for the duration of pain by asking whether the discomfort is constant or intermittent. Breakthrough pain is transient pain that occurs even though the patient is on a pain-management regimen of analgesics. It is also important to inquire about specific aggravating and alleviating factors related to the pain. Finally, ask the patient about sleeping habits, changes in appetite, changes in lifestyle activities, sexual dysfunction, irritability, or anger. The presence of these factors may indicate such underlying mental health comorbidities as depression and anxiety.

Recommended prescribing practices

The initiation of a pain treatment plan of care should always begin with such OTC and non-narcotic analgesics as acetaminophen or a nonsteroidal anti-inflammatory drug (NSAID) in tandem with such conservative modalities as heat/ice application, topical analgesics, a therapeutic exercise regimen, acupuncture, or formal physical therapy

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modalities. The CDC recommends prescribing opioids for acute or chronic pain only when other conservative treatments have failed.5 If an opioid is prescribed as an adjunct, always start with the lowest dose and monitor the patient’s response before increasing the dosage, and remember to prescribe the smallest quantity of opioid necessary to treat pain. Close follow-up and monitoring is also required to determine the effectiveness of the treatment plan. In most cases, acute conditions require a small quantity of opioids for a short period of time, which may not be the case with chronic pain. Whenever a patient requests an increase in the quantity of opioids or continues to ask for prolonged pain treatment with opioids (in the absence of a chronic condition), a thorough follow-up assessment is warranted.

The World Health Organization (WHO) designed a useful tool called the analgesic ladder (Figure 1).19 The purpose of the analgesic ladder is to guide practitioners in following recommended prescribing practices by providing a logical treatment plan for managing pain in a variety of cases. The WHO analgesic ladder also helps clinicians understand the practice of multimodal analgesia by dividing the prescribing of opioids into four groups: simple analgesics, weak opioids, strong opioids, and adjuvants. The basis of each step of the WHO analgesic ladder consists of nonopioid analgesics, which creates a multimodal approach to pain treatment.

Based on the WHO analgesic ladder, acetaminophen or an NSAID should be prescribed with weak or strong opioids.

By providing more effective pain management that requires lower amounts of opioids, this multimodal approach reduces the risk of side effects and adverse events.

Severe pain Strong opioid ± nonopioid

Moderate to severe pain Weak opioid and/or nonopioid analgesia • Codeine • Tramadol Mild to moderate pain Nonopioid analgesia • Codeine • Tramadol • NSAID

±Adjuvant

±Adjuvant

±Adjuvant

Used with permission from the World Health Organization.

Figure 1. The WHO analgesic ladder

to cravings that can trigger a relapse to active addiction.

Prescribing practitioners should keep in mind that using opioids to treat chronic pain in addicted patients is rarely considered appropriate. Treating acute pain in the addicted patient should involve prescribing only the quantity necessary to address the acute episode, avoiding as-needed dosing, using medication around the clock for an appropriate period of time, closely evaluating the patient’s medication use, increasing recovery-related activities during episodes of pain, and promptly destroying of all unused medications.

Prescribing opioids for chronic non-cancer pain

Special considerations

Practitioners should always exercise caution when prescribing opioids to a patient with a history of addiction or a patient with CNCP. Clinicians should also be aware of the potential for adverse effects pertaining to the use of opioids.

It is vital to follow recommended standards of prescribing to ensure appropriate pain treatment with opioids and safe self-administration of opioids among patients who are at risk for abuse.

Pain treatment in a patient with a substance use disorder

IN some situations, controlled substances are a necessary part of a treatment plan of care for the patient with a history of addiction. Extreme caution must be used when prescribing controlled substances to such individuals. The use of controlled substances in recovering patients can lead

Data do not support the prescribing of opioids for the safe and effective treatment of CNCP; however, if conservative treatment measures fail and the prescribing of opioids is inevitable, patients with CNCP should be screened very carefully prior to the initiation of therapy. Some experts believe that the available risk-screening tools have not been proven valid in the prediction of benefits or harmful adverse events related to the use of opioids in the treatment of CNCP.20 Other experts say such screening tools such as the Screener and Opioid Assessment for Patients with Pain (SOAPP), the Opioid Risk Tool (ORT), and the Diagnosis, Intractability, Risk, Efficacy (DIRE) instrument have acceptable validity.20,21 Practitioners should consider the presence of the following to be relative contraindications for prescribing opioids to treat CNCP: history of alcohol, tobacco or other substance abuse; active presence of alcohol, tobacco, or other substance

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CME CE

SAFE USE OF OPIOIDS

Clinician guidelines pertaining to chronic opioid therapy should also include regular documentation of patient functionality. abuse; borderline and/or antisocial personality disorders, mood disorders, or psychotic disorders.

Before initiating chronic opioid therapy (COT), practitioners should document the failure of other modalities and perform a detailed assessment that addresses substance abuse and psychiatric history. Screening tools that assess for the presence of alcohol/drug abuse, depression, and the potential for opioid abuse are valid and helpful.22 A baseline drug screen should be considered as well. COT guidelines should include a written patient-provider agreement that addresses treatment goals and outlines such parameters as that clinician being the single provider of opioids, the patient utilizing a single pharmacy, commitment to follow-up visits, and random urine drug testing.

Once COT has been initiated, the following screening tools may be used to identify opioid misuse: Prescription Drug Use Questionnaire (PDUQ), Current Opioid Misuse Measure (COMM), and Pain Medication Questionnaire (PMQ).21 Clinician guidelines pertaining to COT should also include regular documentation of patient functionality and referral to a chronic-pain-management specialist if a patient gets to the point that high-dose therapy is required (i.e., >120 mg/day morphine equivalent dose or whenever the prescribing practitioner feels uncomfortable managing the patient’s COT).

Adverse effects related to opioids

Before prescribing opioids, practitioners should be aware of the potential adverse effects (AEs) associated with these TABLE 2. Safe practices for prescribing opioids Use statewide prescription drug monitoring programs (PDMPs).

Always be aware of the potential harmful adverse effects related to the prescribing of opioids and other controlled substances.

Conduct a thorough pain assessment that includes a complete history regarding substance abuse or mental illnesses prior to initiating chronic opioid therapy (COT).

Create a patient-provider agreement prior to initiating COT. Include the patient’s family members and caregivers in opioid utilization and safe-handling education whenever appropriate.

Promptly identify and treat opioid-related adverse effects.

Utilize screening tools and drug screening prior to and during COT. Refer to a specialist when the patient’s pain management requires increasing, at-risk levels of opioids.

Play an active role in the development and implementation of policy measures to ensure opioid-related safety.

controlled substances. Prompt identification and treatment of AEs may be necessary to improve patient compliance.

Constipation is the most common AE pertaining to opioid therapy20 and can be addressed by increasing fluid and fiber intake and with the utilization of stool softeners and laxatives. Other common AEs include nausea and vomiting, which may be treated with oral and rectal antiemetic medications. Opioids may also lead to myoclonus, pruritus, incoordination, decreased reflexes, somnolence, inability to concentrate, and clouded mentation. Studies have shown the use of extended-release opioids to be related to hypogonadism and decreased testosterone levels, which may lead to sexual dysfunction, decreased libido, and fatigue.20 Significant and potentially fatal AEs include respiratory depression and overdose.

Ensuring safety when prescribing opioids

Safety can be promoted by educating the patient prior to and during COT. The patient-provider agreement is an ideal start to ensuring safe practices among persons receiving COT. Prescribing practitioners should also consider involving the patient’s family members and caregivers in COT safety education. Safe practices for patients receiving COT include following a treatment plan that specifies appropriate dosage, storage, duration of therapy, and disposal of opioids.

Clinicians should try to avoid prescribing combinations of opioids and benzodiazepines, which can contribute to CNS depression and is a major cause of fatal overdoses.

One of the best ways clinicians can maximize safety when prescribing controlled substances is by accessing their state prescription drug monitoring program (PDMP) for every patient receiving these medications. The PDMP is an electronic database that has been implemented in most states to assist with the identification of patients who are potentially diverting opioids or engaging in the practice of “doctor shopping,” which is a felony. Table 2 provides an overview of the ways safety can be maximized when prescribing opioids.

Conclusion

With the increasing prevalence of opioid abuse and addiction in the United States, it is vital for prescribers to be aware of recommended practices to treat pain appropriately while minimizing the potential for opioid abuse and addiction.

Practitioners can play an instrumental role in reducing

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Prescribers must be aware of recommended practices to treat pain appropriately while minimizing the potential for opioid abuse. the incidence of opioid abuse and addiction by conducting a thorough pain assessment prior to considering use of opioids, following evidence-based prescribing practices, and maximizing safety when prescribing these medications. Practitioners may also play an influential role in the development of policy measures to promote appropriate opioid prescribing among health-care providers and safer utilization among patients. n

women—United States, 1999-2010. MMWR Morb Mortal Wkly Rep. 2013;62:537-542. Available at www.cdc.gov/mmwr/preview/mmwrhtml/ mm6226a3.htm.

9. Substance Abuse and Mental Health Services Administration.

Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. Available at www.samhsa.gov/data/ NSDUH/2k10ResultsRev/NSDUHresultsRev2010.htm.

10. National Research Council. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, D.C.:

Dr. Smith is a nurse practitioner at Starkville Orthopedic Clinic in Starkville, Miss., and an adjunct faculty at Capstone College of Nursing, University of Alabama, in Tuscaloosa. Dr. Hambleton is the medical director of the Mississippi Professionals Health Program in Ridgeland, which is the state Physician Health Program.

The National Academies Press, 2011. Available at www.nap.edu /openbook.php?record_id=13172 11. Hooten WM, Bruce BK. Beliefs and attitudes about prescribing opioids among healthcare providers seeking continuing medical education. J Opioid Manag. 2011;7:417-424.

12. Deyo RA, Smith DH, Johnson ES, et al. Opioids for back pain patients:

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1. Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the

Med. 2011;24:717-727. Available at www.jabfm.org/content/24/6/717.long.

treatment of chronic pain: controversies, current status, and future direc-

13. Express Scripts. Bad Rx decisions cost poor U.S. states most. Available

tions. Exp Clin Psychopharmacol. 2008;16:405-416. Available at www.ncbi.

at lab.express-scripts.com/pharmacy-waste/poor-u-s-states-pay-most

nlm.nih.gov/pmc/articles/PMC2711509/.

-for-bad-rx-decisions/.

2. Compton WM, Volkow ND. Major increases in opioid analgesic abuse

14. Express Scripts. Patterns of narcotic use and abuse. Available at lab.

in the United States: concerns and strategies. Drug Alcohol Depend.

express-scripts.com/prescription-drug-trends/patterns-of-narcotic-use

2006;81:103-107.

-and-abuse/.

3. Zacny J, Bigelow G, Compton P, et al. College on Problems of Drug

15. U.S. Department of Justice. Controlled substance schedules. Available

Dependence taskforce on prescription opioid non-medical use and abuse:

at www.deadiversion.usdoj.gov/schedules/.

position statement. Drug Alcohol Depend. 2003;69:215-232.

16. Vera RL. Brief reports from the pain management symposium. Opioid

4. U.S. Food and Drug Administration. FDA announces safety labeling

therapy in chronic pain management. Proc (Bayl Univ Med Cent). 2000;13:

changes and postmarket study requirements for extended-release and

249-250. Available at www.ncbi.nlm.nih.gov/pmc/articles/PMC1317050/.

long-acting opioid analgesics. Available at www.fda.gov/NewsEvents/

17. Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain

Newsroom/PressAnnouncements/ucm367726.htm.

intensity rating scales. Pain. 2011;152:2399-2404.

5. Centers for Disease Control and Prevention (CDC). Vital signs: over-

18. Garra G, Singer AJ, Taira BR, et al. Validation of the Wong-Baker

doses of prescription opioid pain relievers—United States, 1999-2008.

FACES Pain Rating Scale in pediatric emergency department patients. Acad

MMWR Morb Mortal Wkly Rep. 2011;60:1487-1492. Available at www.cdc.

Emerg Med. 2010;17:50-54.

gov/mmwr/preview/mmwrhtml/mm6043a4.htm.

19. World Health Organization. Cancer Pain Relief. With a guide to opioid

6. Colliver JD, Kroutil LA, Dai L, Gfroerer JC. Misuse of prescription

availability. 2nd ed., Geneva: World Health Organization; 1996.

drugs: Data from the 2002, 2003, and 2004 National Surveys on Drug

20. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of

Use and Health (DHHS Publication No. SMA 06-4192, Analytic Series

chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10:113-130.

A-28). Rockville, Md.: Substance Abuse and Mental Health Services

Available at www.guideline.gov/content.aspx?id=16165.

Administration, Office of Applied Studies; 2006.

21. Passik SD, Kirsh KL, Casper D. Addiction-related assessment tools

7. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opi-

and pain management: instruments for screening, treatment planning, and

oid prescribing patterns and opioid overdose-related deaths. JAMA.

monitoring compliance. Pain Med. 2008;9:S145–S166.

2011;305:1315-1321. Available at jama.jamanetwork.com/article.

22. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths,

aspx?articleid=896182.

United States, 2010. JAMA. 2013;309:657-659.

8. Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers and other drugs among

All electronic documents accessed March 15, 2014.

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Advisor Forum These are letters from practitioners around the country who want to share their clinical problems and successes, observations, and pearls with their colleagues. Responding consultants are identified below. We invite you to participate.

Inside the Forum APRIL 2014

Consultations The effect of statins on antihypertensive medications . . . . . . 80 When is it okay to examine a child alone?. . . . . . . . . . . . . . . . . .80 Blood glucose test reliability. . . . . . . . 81 Topical immunotherapy for alopecia areata. . . . . . . . . . . . . . . . . 81 Homeopathic advice. . . . . . . . . . . . . 82

Clinical Pearls Olive oil for a flaky scalp. . . . . . . . . . 82 Pump up the heart’s volume. . . . . . . . 82

Your Comments Leave children in stitches rather than tears . . . . . . . . . . . . . . . . . . . . 82

Send us your letters with questions and comments to: Advisor Forum, The Clinical Advisor, 114 West 26th Street, 4th Floor, New York, NY 10001.

You may also fax (646) 638-6117, or contact us by e-mail at letters@ clinicaladvisor.com.

If you are writing in response to a published letter, please indicate so by including the number in parentheses at the end of each item. Letters are edited for length and clarity. The Clinical Advisor’s policy is to print the author’s name with the letter.

No anonymous contributions will be accepted.

CONSULTATIONS THE EFFECT OF STATINS ON ANTIHYPERTENSIVE MEDICATIONS What effect do statins – specifically lovastatin (Altoprev, Mevacor) and simvastatin (Zocor) – have on calcium channel blockers (CCBs)?—KATHLEEN MAHONEY, ANP, PhD, Philadelphia The combined use of a CCB (e.g., amlodipine [Norvasc]) with simvastatin has the potential to increase the serum concentration of simvastatin. Concomitant use of amlodipine with simvastatin should be avoided whenever possible. I have found no interaction between CCBs and lovastatin.—Abimbola Farinde, PharmD, Staff Pharmacist, Clear Lake Regional Medical Center, Webster, Tex. (186-1)

WHEN IS IT OKAY TO EXAMINE A CHILD ALONE? When is it appropriate to ask a parent to leave when examining a pediatric patient? Do you have any advice on how to do this diplomatically?—TAMARA AGUILAR, FNP, Chico, Calif.

The answer to this question largely depends on the age and development of the child and the extent of the intended physical exam.

OUR CONSULTANTS

Rebecca H. Bryan, APRN, CNP,

Eileen Campbell, MSN, CRNP,

is a lecturer in the Family Health NP Program, University of Pennsylvania School of Nursing, Philadelphia.

is associate program director, Family Health NP Program, University of Pennsylvania School of Nursing, Philadelphia.

Deborah L. Cross, MPH, CRNP, ANP-BC, is associate program

director, Gerontology NP Program, University of Pennsylvania School of Nursing, Philadelphia.

Abby A. Jacobson, PA-C,

Maria Kidner, DNP, FNP-C,

is a physician assistant at Delaware Valley Dermatology Group in Wilmington, Del.

is a nurse practitioner with Cheyenne Cardiology Associates in Cheyenne, Wyo.

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Generally speaking, both parents and prepubertal children are comfortable remaining in the room together during the physical exam; however, this can change as children enter puberty and begin to develop a sense of privacy. There is also the consideration of when a practitioner should begin providing confidential services to adolescents and what the reason for the exam is. Finally, you must remember that examination of reproductive organs requires a chaperone for the safety of the patient and the clinician. In more than 20 years of experience, I have only had one parent refuse to allow me some private time with a patient, as long as a chaperone was present when the purpose was explained. The American Academy of Pediatrics has published a wonderful resource for providing quality care for adolescents (available at brightfutures.aap. org/pdfs/AHU1109.pdf, accessed February 15, 2014).—Julee B. Waldrop, DNP (186-2)

BLOOD GLUCOSE TEST RELIABILITY As a clinician specializing in the treatment of diabetes, I frequently assess hemoglobin (Hb)A1c values. It is well known that anemia of chronic disease associated with end-stage renal disease renders the HbA1c test invalid. At what level of anemia is the HbA1c affected? In which disease states or at what stages of chronic kidney disease is the HbA1c test no longer reliable?—PAMELA A. TETRO, MSN, FNP, NDE, Charlottesville, Va. Since the HbA1c assay is dependent on a naturally functional and structural Hb molecule, any alteration in that molecule or its integrity will diminish the assay’s accuracy. Similarly, any condition altering the size or longevity of the RBCs will also change the results because the assay measures the amount of glycosylation (or binding) of serum glucose and the hemoglobin molecules in the red corpuscle. Since these cells live an average of 60 to 90 days in a healthy person, an

Debra August King, PhD, PA,

is senior physician assistant at New York-Presbyterian Hospital, New York City.

Mary Newberry, CNM, MSN,

provides well-woman gynecologic care as a midwife with Prima Medical Group, Greenbrae, Calif.

index is derived to infer a daily glucose level based on the degree of saturation (or binding) that exists.

When either the hemoglobin or the RBC itself is impaired, the result can be erroneously high or low. Conditions known to interfere with hemoglobin glycosylation include genetic variants or hemoglobinopathies, renal failure, and large amounts of ingested aspirin.

Conditions affecting RBC survival include recovery from acute blood loss, anemia (specifically, the iron-deficient variety), hemolytic anemia, and increased RBC turnover attributable to other pathologies.

Additional factors affecting the HbA1c assay are ingestion of large amounts of vitamin C and/or vitamin E, chronic alcoholism, and chronic opiate use. There is no direct linear scale to use for correlation of values, so clinical assessment is key. Consistently elevated serum glucose levels that seem to oppose a low or normal HbA1c should be given consideration in light of any other compounding factors, and the HbA1c assay should not be used as the sole diagnostic indicator.—Sherril Sego, FNP-C, DNP (186-3)

TOPICAL IMMUNOTHERAPY FOR ALOPECIA AREATA Alopecia areata can be a difficult condition to treat and is very distressing for patients that suffer from this disease. Has squaric acid dibutylester (SADBE) been shown to be successful in managing this condition? If so, what dose do you recommend? How often should the patient be seen in the office?

Has SADBE shown better efficacy than topical and injectable cortisones?—ANDREA BREZILL, PA-C, Chicago You are absolutely correct that alopecia areata is a psychologically disturbing disease that can significantly impact a patient’s mental health and quality of life. Patients with alopecia areata should be screened for an underlying autoimmune disease, such as thyroid disease, diabetes, inflammatory bowel disease, lupus, rheumatoid

Claire O’Connell, MPH, PA-C,

teaches in the PA Program at the New Jersey Medical School and Rutgers University, Piscataway, N.J.

Sherril Sego, FNP-C, DNP,

is a primary-care nurse practitioner at the Department of Veterans Affairs Medical Center in Kansas City, Mo.

Julee B.Waldrop, DNP,

is associate professor at the University of Central Florida (UCF), and practices pediatrics at the UCF Health Center.

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Advisor Forum recommending. I realize that my advice is a reflection of my knowledge and my professional liability. How should I handle these situations in the future?—SEAN GREEN, MSN, APRN, FNP-BC, Fort Worth, Tex.

© CMSP / SPL

Engage in some research in your spare time to become more knowledgeable about the most commonly used homeopathic remedies. You do not need to be an expert, but your patients will appreciate any insight you can provide. Of course, it is important to inform patients to always consult a primary-care clinician before trying any homeopathic or other alternative therapy.—Abimbola Farinde, PharmD, Staff Pharmacist, Clear Lake Regional Medical Center, Webster, Tex. (186-5) Alopecia areata (shown) features localized loss of hair in patches.

CLINICAL PEARLS

arthritis, or psoriasis. Alopecia areata can wax and wane over the years, progress, or spontaneously go into remission.

Intralesional and topical corticosteroids are traditional first-line therapy for alopecia areata. Response should be re-evaluated monthly. Patients should be reminded that regrowth occurs very slowly, and it may take up to three months of corticosteroid injections and topical creams before any progress is noted. In one study, six out of 10 patients with extenisive alopecia areata saw regrowth with intralesional triamcinolone acetonide (Kenalog) alone (J Drugs Dermatol. 2009;8:909-912).

When using intralesional steroid injections, special attention must be paid to avoid systemic absorption and such unwanted side effects such as localized atrophy or permanent indentation of the area.

Most studies of SADBE as immunotherapy for alopecia areata indicate a 30%-to-50% success rate, with a median length of time for regrowth of 12.2 months (J Am Acad Dermatol. 1998;39:751-761).

The success rate varied greatly depending on the extent of hair loss and age of onset. In general, the patient’s scalp is first sensitized with 2% SADBE and then re-examined weekly while the concentration is slowly increased until a mild, tolerable contact dermatitis is achieved.

Once regrowth is observed and stabilized, larger areas can be treated.

Applications can be very slowly decreased after ideal regrowth has been achieved. It is notable that the FDA has not approved SADBE for this use, and the purity of the formula is difficult to ensure. This is not a first-line therapy and should only be used under the direction of an experienced clinician after receiving full informed consent from the patient.—Abby A. Jacobson, PA-C (186-4)

OLIVE OIL FOR A FLAKY SCALP When treating a child with extremely dry skin and a dry flaky scalp, comb olive oil liberally through the hair and scalp and then shampoo the hair as usual. Olive oil removes and reduces the production of scalp flakes, does not irritate the skin, and is odor-free once rinsed out.—ALICIA NOSSOV, FNP-C, Raleigh, N.C. (186-6)

HOMEOPATHIC ADVICE Patients often ask for feedback on homeopathic treatments.

While I can offer prescriptive options or OTC suggestions, there are very few herbal medications that I feel comfortable

PUMP UP THE HEART’S VOLUME Heart sounds can be difficult to hear in someone whose lungs are hyperinflated (e.g., a patient with longstanding chronic obstructive pulmonary disease). Placing the stethoscope over the epigastrium makes the heart sounds much easier to detect.—ANNETTE O’GORMAN, FNP-C, Yarmouth, Me. (186-7)

YOUR COMMENTS LEAVE CHILDREN IN STITCHES RATHER THAN TEARS Instead of involving the parent when suturing a child (Item 185-7), I include the child whenever possible. After first explaining that we need to add medicine to make him or her more comfortable (1% lidocaine diluted with sodium bicarbonate in a 10:1 ratio), I then help the child put on sterile gloves and hand over the scissors. When I am done tying, the child gets to cut the sutures. The kids seem to love being involved, and it helps them get past the stick of the needle (which is usually far less painful than they imagined).— DOUGLAS KAUTZ, PA-C, Rochester, Minn. (186-8) n

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Top Reasons to Attend the

AANP 2014 National Conference!

June 17 – 22, 2014

1. Continuing Education (CE) • Up to 42 contact hours of CE (number includes workshop attendance) 2. Largest National Conference for NPs of All Specialties • Eight featured tracks – Acute Care, Dermatology, Emergent/Urgent Care, Military/Uniformed Services Healthcare, Orthopedics, Pain Management, Pharmacology and Women’s Health • Approximately 260 concurrent sessions throughout the conference focusing on diverse topics affecting the NP profession • Approximately 38 skill enhancement workshops throughout the conference (includes two workshop days: Tuesday, June 17, and Sunday, June 22) • Podium and poster presentations, regional meetings and interest forums add to the variety of session opportunities • Fundamental Critical Care Support (FCCS) course, structured to enhance the learning environment and accommodate more registrants, will be held at The Inn at Opryland, a Gaylord Hotel (across the street from Gaylord Opryland) • A diverse range of expert speakers include Dr. Mary Wakefield, Administrator, Health Resources and Services Administration (HRSA) and Dave deBronkart, also known as “e-Patient Dave” for the Opening General Session and Dr. Scharmaine Baker, President/CEO, Advanced Clinical Consultants, LLC, New Orleans, for the Closing General Session • Discussions on current national, state and local legislative, regulatory and practice issues affecting nurse practitioners 3. Networking • Visit with friends and make new acquaintances at the conference, in support of our Stronger Together... Improving Health theme.

4. Location • Music City – Nashville, TN! • The Gaylord Opryland Resort and Convention Center­– Nashville’s premier hotel offering guests all the excitement and energy of Music City under one spectacular roof, with nine amazing acres of indoor gardens, beautiful landscaping, cascading waterfalls, an indoor river, restaurants, and shops 5. Country Music • The Grand Ole Opry is next door to the main conference site, Gaylord Opryland. What more could a country music lover want?

6. Industry Supported/Sponsored Events • Registered attendees may receive complimentary access, on a first-come first served basis, to a limited number of educational presentations (with food service) by attending the CE symposia and non-CE product theaters.

7. Exhibit Hall • Approximately 280 exhibits with up-to-date information on products and services • AANP Market Place – appeals to attendees’ personal interests for a little retail therapy 8. On-line Conversation • AANP shares the latest NP news through social media.

• Get involved today at LinkedIn, Facebook, Twitter, YouTube, ENP Network, and Generation NP. • AANP 2014 National Conference (#AANP14) – the perfect event to integrate social media into your professional life 9. AANP Store • Show your organization pride by purchasing AANP-branded apparel and specialty items.

10. Shopping Mall • More retail therapy and restaurant selections are across the street at the Opry Mills® shopping center.

There are so many reasons to attend! Register today at http://www.aanp.org/nashville and receive housing information on your conference registration receipt.

For questions or assistance, contact conference@aanp.org or 512-442-4262.

Derm Dx

EXCLUSIVE TO THE WEB

INTERACT WITH YOUR PEERS by viewing the images and offering your diagnosis and comments. To post your answer, obtain more clues, or view similar cases, visit CliniAd.com/10KIbCF. Learn more about diagnosing and treating these conditions, and see how you compare with your fellow colleagues.

An asymptomatic purplish bump A woman, aged 45 years, complains of a purplish bump on the back of her left arm. The lesion is asymptomatic, and no prior trauma is reported. On physical examination, the papule displays the “dimple sign.”

WHAT IS YOUR DIAGNOSIS?

• Dermatofibroma • Dermatofibrosarcoma protuberans • Atypical fibroxanthoma • Pseudolymphoma ● See the full case at CliniAd.com/1fudPuF.

Neutropenia and purpura in a cocaine user A 36-year-old woman presents with fever and tender patches on her ears and trunk. A urine toxicology screen is positive for cocaine. Other significant labs include neutropenia and a positive test for peripheral antineutrophil cytoplasmic antibodies (p-ANCA).

WHAT IS YOUR DIAGNOSIS?

• Calciphylaxis • Levamisole toxicity • Warfarin-induced skin necrosis • Disseminated intravascular coagulation ● See the full case at CliniAd.com/1dAv3dw.

Have you missed any recent Derm Dx cases? Go to CliniAd.com/10KIbCF for a complete archive of past quizzes as well as additional images of last month’s other cases.

Ridged fingernails and toenails

A pruritic, scaly beard rash

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LEGAL ADVISOR CASE #1

Missed signs of infection after injury

BY ANN W. LATNER, JD

Mr. B, aged 12 years, felt ill during class on a Thursday and was sent to the school nurse.

The nurse took his temperature, which was normal, and called his mother to pick him up.

The boy’s mother took him to a federal clinic, where he was seen by Ms. M, a 35-year-old nurse practitioner (NP).

Mr. B reported mild to moderate pain in his left groin that had begun two days earlier. Ms. M noted that the boy’s left thigh muscle was tender to the touch but showed no bruising. Mr. B’s BP was 135/68 mm Hg. When asked about athletic activities, Mr. B told Ms. M that he had been playing softball on the day that the pain began.

Ms. M diagnosed the boy with muscle strain, gave him an injection of ketorolac (Toradol) for pain relief, and prescribed ibuprofen. She also told Mr. B to rest for the next few days and to apply ice to the area.

The boy was then discharged. Later, Mr. B’s mother called the clinic to ask whether she could give her son liquid acetaminophen instead of ibuprofen, as the child had difficulty swallowing the pill. Ms. M told her that that would be fine.

© THINKSTOCK

A young man dies after septic arthritis of the hip is misdiagnosed as a muscle strain or bursitis.

The boy had to be carried into the ED by his father and fell asleep on the exam table while waiting to be seen.

Two days later, Mr. B’s condition had worsened, and his father brought him to the emergency department (ED) of the clinic. The boy had to be carried in by his father and fell asleep on the exam table while waiting to be seen. The treating clinician in the ED was Mr. D, an experienced NP. Mr. D had been working at the clinic for a decade and had worked elsewhere as a licensed practical nurse and a registered nurse prior to getting his advanced-practice degree. Triage notes indicated that Mr. B’s complaint was severe pain to the left hip, and the triage nurse indicated that he had been evaluated at the clinic on Thursday and was prescribed ibuprofen/acetaminophen.

On this visit, the boy’s pulse was 150 beats per minute and his BP was 97/57. In addition to the hip pain, Mr. B exhibited a rash. A hip x-ray revealed no fractures. Lab work ordered Cases presented are based on actual occurrences.

Names of participants and details have been changed.

Cases are informational only; no specific legal advice is intended. Persons pictured are not the actual individuals mentioned in the article.

www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 87

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LEGAL ADVISOR

by Mr. D showed a normal WBC count and an elevated erythrocyte sedimentation rate (18 mm/hr). The percentage of granulocytes was elevated at 95.1%, outside the normal range of 37% to 79%, and the boy’s lymphocytes were 2.9%, well outside the normal range of 20% to 45%.

A CT scan was read remotely by an on-call radiologist in another state. The radiologist noted that the boy had been in pain for five days and was unable to ambulate and that the scan showed fluid to the left greater trochanter, which could indicate bursitis or a bursal tear. The radiologist also recommended an MRI. Mr. D contacted a local orthopedist and set up an appointment for Mr. B in two days. After preparing the referral, he diagnosed Mr. B with “possible

A bacterial culture showed that the infection would have been treatable with broad-spectrum antibiotics earlier on. bursitis vs. possible bursa tear” and sent him home with prescriptions for acetaminophen and hydrocodone (Lortab), diphenhydramine (Benadryl), and acetaminophen.

Mr. B spent the rest of the day in bed, unable to walk and with a worsening rash. The next morning, he was having difficulty breathing, so his father brought him back to the ED, where he was found to be profoundly neutropenic and in septic shock. Mr. B was given IV fluids and antibiotics and was airlifted to a university medical center, where he was diagnosed with septic arthritis of the hip. A bacterial culture showed that the infection would have been treatable with broad-spectrum antibiotics earlier on, but at this point, the boy was in acute respiratory distress and had ischemia in all of his extremities. He remained in the pediatric intensive care unit for two months before passing away.

After his death, his bereaved parents sought legal counsel.

After studying the medical records, the plaintiff’s attorney filed a lawsuit in federal court against the clinic, alleging that the boy’s death was caused by negligence.

At trial, the plaintiffs argued that the clinicians should have ruled out a possible infection, since, at least at the second visit, all signs pointed to one. The plaintiffs also argued that the standard of care was breached by the clinicians and that a CT was not a suitable method to differentiate a systemic bacterial sepsis from an orthopedic injury. The defendants countered that infection was not suspected because the boy had no fever.

The court sided with the plaintiffs and awarded the family $1.9 million.

Legal background

The court found no negligence in the first clinic visit in which Mr. B was treated by Ms. M. However, the court determined that Mr. D was negligent and did not meet the standard of care in his treatment of the patient at the second clinic visit.

The court pointed to a number of factors that led to this conclusion. Although the defendants claimed that a lack of fever was a strong argument in defense of Mr. D’s failure to diagnose infection, the court disagreed for several reasons.

First, the combination of other signs and symptoms did indicate potential infection, which should have been ruled out. Second, the fact that the boy was taking acetaminophen could have accounted for the lack of fever.

Another factor that the court looked at was lethargy. Mr. B was found sleeping on the table in the ED, which is unusual behavior for a 12-year old and an abnormal sign. The rash was also an indication of infection and should have pointed to sepsis rather than a hip injury.

Finally, the lab work showed multiple indications of infection. According to the court, the standard of care at that point would be to rule out infection. This could have been done with a blood culture on-site, or the boy could have been referred to a facility with the means to aspirate the hip for a sample to culture, neither of which was done.

The court found that Mr. D had not met the standard of care owed to his patient.

Protecting yourself

This tragic story highlights the importance of ruling out the most serious differential diagnoses first. For a more complete picture, Mr. D should have looked at all of the signs, lab work, and symptoms rather than focusing on the boy’s hip.

By focusing solely on the hip, even in the face of abnormal lab work, Mr. D missed something that he should have caught.

There were numerous signs of infection despite the lack of fever: the blood work showed indications of infection, the boy’s BP had dropped significantly from the first visit, his pain had increased, he had developed a new rash since the previous visit, and he was far too lethargic for a child his age. In light of all of these signs, Mr. D should have suspected infection and should have ruled that out as a potential diagnosis before treating it solely as an orthopedic injury. n Ms. Latner, a former criminal defense attorney, is a freelance medical writer in Port Washington, N.Y.

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Download the new app for the iPhone, iPad,and Android— created specifically for nurse practitioners and physician assistants from the publishers of the highest rated journal for these health-care professionals.

With the Clinical Advisor app you can: • Take Derm Dx quizzes to learn about difficultto-identify dermatology conditions, and then see how you performed against your peers.

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• Read the latest news about breakthrough treatments, disease outbreaks, drug approvals and recalls, and clinical research.

• Use the medical slideshows to educate patients in-office about clinically relevant topics, including the detrimental effects of smoking, the benefits of breastfeeding, diabetes complications and healthy lifestyle tips, etc.

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• Search the NPPR/PAPR drug database

The best part? IT’S FREE! So don’t wait.

Download the Clinical Advisor app today to start experiencing the benefits of this essential resource at the point-of-care.

Writers’ Guidelines The Clinical Advisor welcomes submissions from its readers. Writing for us is an opportunity to share your knowledge and experience with your colleagues — and to collect a fee in the bargain! We pay an honorarium for every submission we accept.

We’ll be glad to work with you to develop your ideas into compelling articles. As for length, that depends on which kind of article you submit.

CLINICAL FEATURES update our readers on the latest information about conditions seen in everyday practice. Running approximately 2,500 to 5,000 words, including the references, features can be written either as regular narratives or as a series of questions and answers. Topics should be selected with the busy primary-care clinician in mind; specialists should review specialty topics from the primary-care point of view.

If at all possible, articles should be accompanied by clinical photos.

Charts, tables, and algorithms are also encouraged. Please include your title and affiliation.

CLINICAL CHALLENGE is our popular department comprising histories of difficult cases. Each case is presented as a step-by-step, chronological account, revealing the author’s thought processes along the way. It is divided into sections in this order: the patient presentation; the patient history; the twists and turns eventually leading to a diagnosis; the treatment and outcome; and a discussion of the lessons learned or of the condition in general.

The length should be about 1,500 words, and accompanying images are encouraged. Please include your title and affiliation.

DERMATOLOGY CLINIC is a department that presents photos of actual cases and asks readers to identify the condition. Each case opens with one or two color photos and a 75-to-100-word description of the patient presentation, without giving away the diagnosis.

This is followed by a 750-to-1,000-word summary that includes a fuller description of the ailment, an explanation of how the correct diagnosis was reached, a general review of the condition along with a differential diagnosis, and a description of the patient’s treatment and outcome. Topics must be approved by the editor prior to submission. Please include your title and affiliation.

COMMENTARY is our guest editorial page. It gives you the opportunity to sound off on an issue of importance to your colleagues nationwide. A typical Commentary runs about 600 words in length. Please include your title and affiliation.

To discuss your editorial ideas, contact us by phone at 646.638.6078; by e-mail to editor@ClinicalAdvisor.com; or by mail to The Clinical Advisor, 114 West 26th Street, 4th Floor, New York, NY 10001.

90 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

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Stat Consult

A quick review of common conditions, using the best global evidence

Background

Falls in older adults

BY ALAN DRABKIN, MD

Dr. Drabkin is a clinical editor for DynaMed (www.ebscohost.com/ dynamed), a database of comprehensive updated summaries covering more than 3,200 clinical topics, and assistant clinical professor of population medicine at Harvard Medical School.

• Falls are a common and serious problem for elderly patients; 16% of U.S. adults aged 65 years and older reported a fall in the prior three months.

——Most fatal injuries in older adults are caused by falls.

——Approximately 20% of falls need medical attention, with fracture resulting in about 5% of these cases.

■■ Fractures of the hip and proximal humerus are the most common.

■■ Percentages of fractures may be twice as high for women aged 75 years and older.

• Falls, or even fear of falling, can result in ——Depression, anxiety ——Social withdrawal ——Loss of confidence/independence ——Admission to long-term care (LTC) • The most significant risk factors for falling in the elderly are history of falling and abnormalities in gait or balance.

——Other risk factors include muscle weakness, visual impairment, and sleep disorders.

——Some classes of medications, especially psychotropic drugs, muscle relaxants, antihypertensive agents, and opioids, are associated with increased risk of falls.

© SCIENCE SOURCE / PAUL RAPSON

Screening and assessment

A number of fatal injuries in older adults are caused by falls.

• Ask all older individuals about ——History of falls in the past year ——Frequency and circumstances of falls ——Difficulties with walking or balance • Older persons reporting only a first single fall in the past 12 months and reporting or demonstrating no difficulty or unsteadiness during evaluation of gait and balance do not require additional fall-risk assessment.

• In other older persons with a history of falls, assess gait and balance using a validated assessment tool.

• Recommended screening tools include ——Get-Up-and-Go Test—ability to stand independently from seated position, walk short distance, turn, walk back, and sit down again ——Timed Up-And-Go Test—ability to stand www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 91

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Stat Consult independently from seated position, walk short distance, turn, walk back, and sit down again ——Ability to stand from sitting position without using arms ——Tinetti Performance-Oriented Mobility Assessment—a task-oriented test that measures gait and balance ——Timed Gait—time to walk 20 feet, turn, and return • Perform multifactorial risk assessment for community-dwelling older persons who ——Present for medical attention because of fall ——Report recurrent falls in past year ——Report difficulties in walking or balance (with or without activity curtailment) ——Cannot perform or perform poorly on standardized gait and balance test ——Have difficulty or demonstrate unsteadiness during the evaluation of gait and balance • Multifactorial risk assessment should include ——Focused history ■■ History of falls, including detailed description of circumstances of fall(s), frequency, symptoms at time of fall, injuries, other consequences ■■ Medication review (all prescribed and nonprescription medications with doses) ——Physical examination ■■ Detailed assessment of gait, balance, and mobility levels and lower extremity joint function ■■ Visual acuity ■■ Cardiovascular assessment, including heart rate and rhythm, postural pulse, BP, and, if appropriate, heart rate and BP responses to carotid sinus stimulation ■■ Neurologic function, including cognitive evaluation, lower-extremity peripheral nerves, proprioception, reflexes, tests of cortical, extrapyramidal, and cerebellar function ■■ Lower-extremity muscle strength ■■ Examination of feet and footwear ——Assessment of activities of daily living (including use of adaptive equipment and mobility aids) ——Assessment of individual’s perceived functional ability and fear related to falling ——Home-safety and environmental assessment • Multifactorial fall-risk assessment should be followed by direct interventions tailored to identified risk factors, coupled with an appropriate exercise program.

Exercise programs for fall prevention

• For community-dwelling individuals ——Exercise program that targets strength, gait, and balance (e.g., tai chi or physical therapy)

——Strength and balance retraining program have been associated with reduction in mortality in older adults.

——Flexibility and endurance training should also be offered, but not as sole components of an exercise program.

——Exercise may be performed in groups or as individual (home) exercises.

——The physical capabilities and health profile of the individual need to be considered when prescribing specific exercises.

——Exercise program should include regular review, progression, and adjustment of exercise prescription as appropriate.

Vitamin D supplementation

• Vitamin D may help by improving muscle strength and musculoskeletal performance.

• Give vitamin D supplements of at least 800 units/day to older persons who are community-dwelling with proven or suspected vitamin D deficiency.

• Consider vitamin D supplements of at least 800 units/day for older persons who are at increased risk for falls, such as those with abnormal gait or balance.

Fall-prevention strategies for community-dwelling adults

• Review all medications.

——Attempt to reduce the total number of medications and the doses of individual medications.

——In particular, minimize or discontinue psychoactive medications and antipsychotics (including sedative hypnotics, anxiolytics, and antidepressants), with appropriate tapering if indicated.

• Treat postural hypotension, if present.

• Consider dual-chamber cardiac pacing for older persons with cardioinhibitory carotid sinus hypersensitivity who experience unexplained recurrent falls.

• Education about fall prevention should not be the only intervention to reduce falls in older persons living in the community.

• Other specific targeted interventions ——Home-safety interventions should include modification of hazards in the home and the promotion of safe performance of daily activities.

——Wearing shoes with low heel height and high surface contact area may reduce risk of falls.

——Gait-stabilizing outdoor winter footgear (e.g., Yaktrax Walker) may reduce rate of outdoor winter falls and injuries in older community-dwelling adults.

——Advise older people not to wear multifocal lenses while walking, especially on stairs.

——Expedite cataract surgery, when necessary. n

92 THE CLINICAL ADVISOR • APRIL 2014 • www.ClinicalAdvisor.com

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d

CME CE

n LEARNING OBJECTIVES:

For Dermatology Clinic • Identify and diagnose dermatologic conditions and review up-to-date treatment.

For Dermatologic Look-Alikes • Distinguish and properly treat dermatologic conditions with similar presentations. n COMPLETE THE POSTTEST: Page 103

DERMATOLOGY COURSES

n ADDITIONAL CME/CE CREDIT: Pages 73

This activity is jointly sponsored by Medical Education Resources (MER) and Haymarket Medical Education (HME).

Release Date: April 2014 Expiration Date: April 2015 Estimated time to complete the educational activity: 30 minutes Statement of Need: Undertraining in dermatology for primary-care providers is a common phenomenon. Thus, primary-care providers need additional educational outlets devoted to identifying and treating dermatologic conditions. For clinicians out of training, CME/CE becomes the most accessible route.

Target Audience: This activity has been designed to meet the educational needs of primary-care clinicians who treat patients with various dermatologic conditions.

Faculty Geoffrey A. Bader; Julia R. Nunley, MD Medical College of Virginia Hospitals, Virginia Commonwealth University, Richmond, Va. Esther Stern, NP-C Advanced Dermatology & Skin Surgery, P.C., Lakewood, N.J. Kerri Robbins, MD Baylor College of Medicine, Houston Accreditation Statements Physician Credit: This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of MER and HME. MER is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation: MER designates this educational activity for a maximum of 0.5 AMA PRA Category 1 CreditsTM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Credit: MER is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Credit Designation: This CE activity provides 0.5 contact hour of continuing nursing education.

MER is a provider of continuing nursing education by the California Board of Nursing Registered Nursing, Provider #CEP 12299, for 0.5 contact hour.

American Academy of Physician Assistants AAPA accepts certificates of participation for educational activities certified for Category I credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 1 hour of Category I credit for completing this program.

Accreditor Disclosure of Conflicts of Interest Policy MER ensures balance, independence, objectivity, and scientific rigor in all our educational programs. In accordance with this policy, MER identifies conflicts of interest with its instructors, content managers, and other individuals who are in a position to control the content of an activity. Conflicts are resolved by MER to ensure all scientific research referred to, reported, or used in a CME/CE activity conforms to the generally accepted standards

CA0414_DermClinic.indd 94

of experimental design, data collection, and analysis. MER is committed to providing its learners with high-quality CME/CE activities that promote improvements or quality in health care and not a commercial interest.

Faculty Disclosures The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity: Geoffrey A. Bader; Julia R. Nunley, MD; Esther Stern, NP-C; and Kerri Robbins, MD, and have no relevant financial relationships to disclose.

Staff/Planners’ Disclosures The planners and managers reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity: The following HME planners and managers hereby state the following financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months: Joe Kopcha, Editor; Delicia Yard, Senior Editor; and Nicole Blazek, Web Editor, have no real or apparent conflicts of interest to report.

The MER planners and managers, and Veronda Smith, FNP-BC, hereby state that they or their spouse/life partner do not have any financial relationships or relationships to products or devices with any commercial interest related to the content of this activity of any amount during the past 12 months.

Method of Participation: There are no fees for participating in and receiving CME/CE credit for this activity. During the period of April 2014 through April 2015, participants must: 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) complete the posttest and submit it online (physicians may register at www.myCME.com); and 4) complete the evaluation form online.

A statement of credit will be issued only upon receipt of a completed activity evaluation form and a completed posttest with a score of 70% or better.

Disclaimer: The content and views presented in this educational activity are those of the authors and do not necessarily reflect those of MER or HME. The authors have disclosed if there is any discussion of published and/or investigational uses of agents that are not indicated by the FDA in their presentations. The opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of MER or HME. Before prescribing any medicine, primary references and full prescribing information should be consulted. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. The information presented in this activity is not meant to serve as a guideline for patient management.

3/26/14 5:09 PM

CME CE

Dermatology Clinic n LEARNING OBJECTIVES: To identify and diagnose dermatologic conditions and review up-to-date treatment. n COMPLETE THE POSTTEST: Page 103

n ADDITIONAL CME/CE: Pages 73, 99

Turn to page 72 for additional information on this month’s CME/CE courses.

CASE #1

Hyperpigmented patches on the back GEOFFREY A. BADER AND JULIA R. NUNLEY, MD

A 56-year-old Asian-American man presented with an intensely pruritic rash on his back that had worsened over the past several months. Initially attributing the itch to dry skin, he began to use a daily moisturizer, but the itch did not improve. The man reported constant use of a back-scratcher. No associated fevers, myalgia, joint pains, paresthesias, or prior injuries to his back were noted.

Examination revealed excoriations and poorly demarcated, linear, hyperpigmented patches down the back. A punch biopsy was obtained from one of the darker patches.

What is your diagnosis? Turn to page 96

CASE #2

Yellow scalp patches with mild scaling ESTHER STERN, NP-C

A male infant, aged 12 weeks, developed scaly patches and dandruff on his scalp. The condition did not seem bothersome to the child, but his mother expressed cosmetic concerns. The patient was born at full term via uncomplicated caesarean section due to failure of labor to progress and was discharged home at age 4 days without complication. He was otherwise healthy and up to date on recommended vaccinations. The patient was exclusively breastfed and given a daily dose of a multivitamin with vitamin D. There was no family history of skin disease. Physical exam revealed lightly adherent yellow scales on the vertex of the scalp and mild scaling of the forehead and glabella.

What is your diagnosis? Turn to page 97 www.ClinicalAdvisor.com • THE CLINICAL ADVISOR • APRIL 2014 95

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CME CE

CASE #1

Dermatology Clinic

Macular amyloidosis

Appropriate staining of histologic sections from the punch biopsy conf irmed the suspected diagnosis of macular amyloidosis, a type of primary localized cutaneous amyloidosis (PLCA). Amyloidosis is a broad and heterogeneous group of disorders; thus, to best recognize and manage macular amyloidosis, it is essential to understand the disease in its proper context.

It is said that to know amyloidosis is to know medicine.

The term amyloid was first used by Virchow in 1854 to describe tissue deposits noted in numerous organs that, when stained with iodine, resembled similarly stained amylum, better known as starch.1 Today, amyloid itself is recognized not as a singular distinct substance but rather as a group of insoluble, extracellular, fibrillar, and proteinaceous materials sharing some common physiochemical properties. These common properties allow for distinctive and characteristic staining patterns with Congo red and crystal violet dyes for amyloid from all sources. Approximately 18 distinct forms of amyloid and amyloid precursors have been identified, each derived through unique and multifaceted processes (e.g., protein misfolding). When viewed under electron microscopy, amyloid will appear as a meshwork of rigid and nonbranching linear fibers.2 The clinical variability of amyloidosis reflects the different pathogenic processes that result in amyloid production.

Amyloidosis is classified broadly into three categories: primary systemic amyloidosis (PSA), secondary systemic amyloidosis (SSA), and organ localized amyloidosis, including PLCA. Although amyloid production in PSA may be idiopathic, it is often associated with either a plasma cell dyscrasia or myeloma, with the amyloid fibrils being composed of such processed precursor proteins as immunoglobulin light chains. The precursor proteins are soluble, extensively distributed by the circulatory system, and deposited in multiple organ systems, including mucous membranes, skin, vasculature, neuronal pathways, kidneys, and heart.

Cutaneous findings in PSA may be subclinical, but when visible, skin signs are highly variable, ranging from smooth, waxy skin-colored papules a few millimeters in diameter, to purpuric papules, to nodules and plaques; macroglossia may be present as well. While diffuse cutaneous deposition

is possible, involvement of the palms, face, neck, and anogenital regions is most common. Vascular amyloid deposition causes vascular fragility, making vessels prone to rupture after such minor trauma as a pinch or simple rubbing (socalled “pinch purpura”).2 SSA is a reactive complication of a host of chronic inflammatory conditions, including rheumatoid arthritis, tuberculosis, leprosy, osteomyelitis, and systemic lupus erythematosus.

Distinctively, cutaneous findings in SSA are exceedingly rare.2 The three distinctive subtypes of PLCA are macular amyloidosis (MA), lichen amyloidosis (LA), and nodular amyloidosis. Of these, nodular amyloidosis is the rarest, developing in association with localized plasma cell aggregates. Amyloid in MA and LA is exclusively and uniquely keratinocyte-derived, and these two conditions may actually represent a clinical spectrum of the same disease process.2 LA typically develops as confluent, discrete, firm, fleshcolored or hyperpigmented papules, most commonly on the extensor surfaces; the lesions of MA are characteristically found on the upper back presenting as poorly demarcated brown or gray macules or patches (diffuse involvement including the chest and face may occur).3 Although the pathogenesis of MA and LA remains speculative, a widely accepted theory suggests that apoptotic keratinocytes release cellular contents that are uniquely metabolized, producing amyloid K from cytokeratin. Other suspected etiologic cofactors include environmental influences, genetic predisposition, and repetitive or prolonged friction. Friction (e.g., itching, scratching) is believed to be a critical pathogenic factor in both MA and LA, evoking a self-perpetuating cycle of mechanically induced apoptosis of keratinocytes with subsequent release of cytokeratin, which is intensely pruritic and induces further itching and scratching. The diseases often follow a chronic course, most commonly associated with intractable pruritus (some patients may be asymptomatic). Unlike systemic amyloidosis, cutaneous vascular involvement does not occur in MA and LA.3,4 MA is more common in young adults, with a female predominance of 2:1 to 3:1. The condition predominantly occurs in individuals of South American, Southeast Asian, or Chinese ancestry and is rare in whites; however, an increased incidence has been observed among people living near the equator.5,6 Since the cutaneous lesions are notoriously variable, the clinical differential of MA is broad. MA is commonly misidentified as notalgia paresthetica, post-inflammatory hyperpigmentation, poikiloderma, atopic eczema, lichen simplex chronicus, and fixed drug reactions.3

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The diagnosis of MA can be made based on the patient’s history and physical findings; however, confirmation of the diagnosis requires a punch biopsy with appropriate staining or electron microscopy, if available. Amyloid deposits may be small dermal aggregates that are easily overlooked with routine hematoxylin and eosin staining. Tissue staining with either Congo red or crystal violet dyes will allow the amyloid deposition to become visible; with Congo red staining the sections show a typical apple-green birefringence under polarized light. If electron microscopy is performed, then linear, nonbranching, aggregated fibrils that are 7 nm to 10 nm thick and of indefinite length can be seen arranged in a loose meshwork, typical for amyloid.2,7 Given the relative rarity of the disease, large-scale studies regarding management of MA are scarce. Without a known pathogenic mechanism to manipulate or correct, current therapies focus on symptomatic relief. Patient education on such environmental and behavioral factors as avoiding scratching and excess/chronic friction are essential to break the pathogenic cycle. Use of antihistamines can provide some relief. Milder cases may respond to potent topical corticosteroids. Other modalities used with varying degrees of success include such mild topical keratolytic agents as salicylic acid, topical or oral dimethyl sulfoxide (DMSO), phototherapy, and oral retinoids. In certain cases of limited disease, surgical excision may be an option.4,8 Health-care providers must balance treatment benefits with potential side effects on a case-by-case basis.

The man described in this case was educated about MA and the paradoxical role that scratching plays in worsening the severity of his pruritus. He was prescribed antihistamines and started on a trial of a high-potency topical corticosteroid.

Mr. Bader is a third-year student at Medical College of Virginia Hospitals, Virginia Commonwealth University, in Richmond, where Dr. Nunley is a professor of dermatology.

References 1. Wong CK. History and modern concepts (cutaneous amyloidosis). Clin Dermatol. 1990;8:1-6.

2. Breathnach SM. Amyloid and amyloidosis. J Am Acad Dermatol.

1988;18:1-16.

3. Wang WJ. Clinical features of cutaneous amyloidosis. Clin Dermatol.

1990;8:13-19.

4. Schreml S, Szeimies RM, Vogt T, et al. Cutaneous amyloidoses and systemic amyloidoses with cutaneous involvement. Eur J Dermatol.

2010;20:152-160.

5. Ollague W, Ollague J, Ferretti H. Epidemiology of primary cutaneous amyloidoses in South America. Clin Dermatol. 1990;8:25-29.

6. Tan T. Epidemiology of primary cutaneous amyloidoses in southeast Asia. Clin Dermatol. 1990;8:20-24.

7. Li WM. Histopathology of primary cutaneous amyloidosis and systemic amyloidosis. Clin Dermatol. 1990;8:30-35.

8. Wong CK. Amyloid treatment. Clin Dermatol. 1990;8:108-111.

CASE #2

Infantile seborrheic dermatitis

Seborrheic dermatitis is a very common inflammatory skin condition among infants and children. When it affects the scalp it is commonly referred to as “cradle cap.” Infantile seborrheic dermatitis causes f laking and thick yellow, white, or brown greasy patches to appear on the scalp and other sebaceous-gland-rich areas of the skin, such as the eyebrows, eyelids, ears, nasal creases, base of neck, and intertriginous areas. The scaling predominates on the scalp,1 usually appears in a symmetric distribution, and may be accompanied by a background of erythema. Erythema tends to predominate in the flexural folds and intertriginous areas.1 Seborrheic dermatitis frequently spreads to the diaper area and should be considered in the evaluation of diaper dermatitis.2 Although the exact cause of seborrheic dermatitis is unknown, overproduction of sebum in the sebaceous glands and hair follicles and overproduction of the lipophilic yeast Malassezia furfur (previously known as Pityrosporum ovale) are thought to be involved.3 The resulting scale is accumulated epithelial debris that is adherent to the scalp.4 In addition, maternal hormone stimulation and genetic factors are thought to influence infantile seborrheic dermatitis.

Risk factors that can cause and/or aggravate seborrheic dermatitis include temperature extremes, infrequent shampooing or soaping, use of lotions containing alcohol, and immunodeficiency. Unlike adult seborrheic dermatitis, infantile seborrheic dermatitis usually does not cause itching.

The condition typically appears between the second and tenth week of life, peaks in incidence at age 3 months, and resolves spontaneously by age 8 to 12 months. Seborrheic dermatitis will likely not reappear until after puberty.

Continues on page 98

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Dermatology Clinic

Although seborrheic dermatitis of the scalp can be easily diagnosed, when it involves the skin the condition is often confused with atopic dermatitis.5 Age at onset and the presence or absence of pruritus can help distinguish between the two conditions.2 Seborrheic dermatitis usually begins in the first month of life, and pruritus is uncommon; atopic dermatitis typically begins after age 3 months, and pruritus is ubiquitous. Scales of seborrheic dermatitis appear more greasy and moist whereas atopic dermatitis is dryer and rougher. Occasionally, the two conditions can occur simultaneously or even consecutively. Other less common conditions that may mimic seborrheic dermatitis include psoriasis, Langerhans cell histiocytosis, and Leiner disease (a group of nutritional and immunologic disorders). These should be considered in cases that are resistant to standard antiseborrheic treatments. Generalized seborrheic dermatitis accompanied by failure to thrive and diarrhea should prompt an evaluation for immunodeficiency.1 Infantile seborrheic dermatitis is usually self-limited and resolves within several weeks to several months.5 Although no treatment is necessary, and watchful waiting is appropriate, many parents will request recommendations to treat the scaling on the scalp. Daily shampooing with a gentle baby shampoo can be followed by the use of a soft brush to remove the scales. Alternatively, a fine-tooth comb can be used. If the scales are thick and more adherent, parents can apply an emollient—such as mineral oil, baby oil, or white petrolatum—overnight to soften the scale. In the morning a soft brush can be used to massage and loosen the scales. Shampooing with a baby shampoo afterwards will help remove the scales. Soaking the scalp overnight with vegetable oil and then shampooing in the morning has also proven effective.5 For more severe cases of infantile seborrheic dermatitis that have an inflammatory component, a mild cortisone cream can be prescribed in conjunction with the use of a baby shampoo. Antiseborrheic shampoos, such as ketoconazole (Nizoral Shampoo), are beneficial in resistant cases but are often irritating, and use in infants should be avoided if possible.6 Parents should be cautioned not to use shampoos containing salicylic acid, sulfur, or selenium sulfide, as these can be toxic to infants if absorbed.

Seborrhea of the skin in infants can be treated with a topical antifungal cream applied once or twice daily.

Alternatively, a low-strength hydrocortisone cream can be used sparingly. If the diaper area is involved, care should be taken to rule out secondary infections with bacteria or candida. If necessary, a culture should be taken and topical

antibacterial or anticandidal creams should be prescribed as indicated.

The mother in this case was counseled regarding the benign and self-resolving nature of the condition and educated on recommended methods to remove the scalp scales.

Several weeks later, she reported a significant improvement in the quantity and thickness of the scales but noted that the condition had not yet completely resolved. n Ms. Stern is a family nurse practitioner at Advanced Dermatology & Skin Surgery, P.C., in Lakewood, N.J. References 1. Janniger CK. Infantile seborrheic dermatitis: an approach to cradle cap.

Cutis. 1993;51:233-235.

2. Williams ML. Differential diagnosis of seborrheic dermatitis. Pediatr Rev. 1986;7:204-211.

3. Tollesson A, Frithz A, Stenlund K. Malassezia furfur in infantile seborrheic dermatitis. Pediatr Dermatol. 1997;14:423-425.

4. James WD, Berger TG, Elston DM. Andrews’ Diseases of the Skin: Clinical Dermatology. 11th ed. Philadelphia, Pa.: Saunders Elsevier; 2011:188-189.

5. O’Connor NR, McLaughlin MR, Ham P. Newborn skin: Part I. Common rashes. Am Fam Physician. 2008;77:47-52. Available at www.aafp.org/ afp/2008/0101/p47.html.

6. Paller AS, Mancini AJ. Hurwitz Clinical Pediatric Dermatology: A Textbook of Skin Disorders of Childhood and Adolescence. 4th ed. Philadelphia, Pa.: Saunders Elsevier; 2011:56-57.

All electronic documents accessed March 15, 2014.

“We have a new financial model where you don’t get paid anything.”

© The New Yorker Collection 2014 from cartoonbank.com. All Rights Reserved.

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CME CE

Dermatologic Look-Alikes n LEARNING OBJECTIVE: To distinguish and properly treat dermatologic conditions with similar presentations. n COMPLETE THE POSTTEST: Page 103

n ADDITIONAL CME/CE: Pages 73, 95

Turn to page 72 for additional information on this month’s CME/CE courses.

Excoriations on extensor surfaces KERRI ROBBINS, MD

CASE #1

CASE #2

A white woman, aged 36 years, presented with a severely pruritic eruption on her upper and lower extremities and on her lower back. The rash had been present for six months and tended to wax and wane with no alleviating or aggravating factors. Erythematous excoriated papules were noted on bilateral extensor forearms, elbows, lower back, buttocks, and knees. Hypopigmented macules were appreciated in a similar distribution. Medical history was significant for celiac disease, and the woman admitted having trouble adhering to a gluten-free diet.

A 41-year-old woman sought treatment for a severely pruritic rash that had been present for eight months.

Excoriated papules and linear erosions were appreciated on bilateral upper- and lower-extensor extremities and upper back. Hyperpigmented and hypopigmented macules were present in a similar distribution. The woman had been seen by her primary-care clinician and had no evidence of renal or liver disease and was up to date on age-appropriate cancer screening. No household contacts had symptoms of pruritus or a similar rash.

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CME CE

CASE #1

Dermatologic Look-Alikes

Dermatitis herpetiformis

Dermatitis herpetiformis (DH) is a cutaneous manifestation of celiac disease.

The skin disease was f irst described in 1884, but it was not until 1967 that the association between DH and celiac disease was discovered. Approximately 90% of patients will have evidence of a gluten-sensitive enteropathy on pathologic examination of the small intestine. However, only 20% of patients with DH will have GI symptoms of celiac disease.1 Nearly 90% of persons with DH and celiac disease have the HLA class II DQ2 genotype or, less commonly, the DQ8 genotype, suggesting a strong genetic association. A Utahbased study conducted in 1987 found the prevalence to be 11.2 per 100,000 and the incidence to be 0.98 per 100,000 per year.2 DH is seen more commonly in individuals who are of northern European descent. The mean age of onset of the disease is in the fourth decade, and male patients outnumber female patients by a ratio of 2:1.

Dietary wheat is digested into gliadin peptides, which are then transported across the GI mucosal epithelium.

Within the GI tract, tissue transglutaminase deamidates glutamine residues within gliadin peptides to glutamic acid. Tissue transglutaminase may also become covalently cross-linked to the gliadin peptides, which results in the production of cytokines and matrix metalloproteinases that cause GI epithelial cell damage. Tissue transglutaminasespecific B cells present gliadin peptides to helper T cells, which stimulate the B cells to produce anti-tissue transglutaminase immunoglobulin (Ig)A antibodies. These anti-tissue transglutaminase antibodies cross-react with epidermal transglutaminase, and immune complexes form.

The immune complexes lead to granular IgA deposition within the dermal papillae. This deposition, in turn, leads to neutrophil chemotaxis, proteolytic cleavage of the weakest part of the basement membrane (lamina lucida), and subepidermal blister development.

Primary lesions of DH present as erythematous urticarial papules, plaques, and/or vesicles. Grouped vesicles often appear on an erythematous base; hence the term herpetiform.

Patients with DH tend to have intense pruritus, and by the time they present to the clinician, the lesions are secondarily excoriated and crusted. When this occurs, the characteristic

distribution of the lesions on the posterior neck, elbows, extensor forearms, back, buttocks, and knees help alert the clinician to the diagnosis.

The best histologic lesions are seen when biopsies are taken from erythematous skin adjacent to the vesicles.

Histologically, DH forms subepidermal bullae with neutrophilic microabscesses that congregate in the dermal papillae. Early lesions of DH are multiloculated. However, as the separation between the tips of the dermal papillae and overlying epidermis become more severe, the lesions become unilocular. Direct immunofluorescence (DIF) of adjacent nonaffected skin will show granular IgA deposition within the dermal papillae. A strict gluten-free diet may result in the disappearance of IgA from within the skin. However, the presence of IgA is not altered by dapsone therapy.

Other blistering disorders, such as linear IgA, bullous pemphigoid (BP), and bullous lupus erythematosus, may be considered in the differential diagnosis. Clinically, linear IgA presents as small vesicles or large bullae. Histologically, linear IgA may appear similar to DH as subepidermal bullae with neutrophils. However, on DIF, and linear IgA features fine linear IgA deposition along the basement membrane zone, in contrast to the granular IgA deposition within the dermal papilla of DH. Patients with BP present with large tense bullae on the trunk and extremities. Histologically, subepidermal bullae with eosinophils are present, linear IgG and complement component 3 (C3) are seen along the basement membrane zone on DIF. Bullous lupus erythematosus may also have a histologic picture that is similar to DH and linear IgA. However, patients often have clinical and serologic (i.e., positive antinuclear antibody) features of systemic lupus erythematosus, and DIF reveals multiple immunoglobulins in a granular and bandlike pattern along the basement membrane zone. Given the characteristic involvement of extensor surfaces, erythema multiforme may also be considered. Since the lesions are often excoriated at the time of presentation, the diagnosis of scabies, arthropod bite, and/or neurotic excoriations may be entertained.

The cutaneous manifestations of the disease improve after implementing a gluten-free diet and/or therapy with dapsone. Typically within 48 hours of dapsone therapy, the pruritic skin lesions of DH improve. However, while GI symptoms resolve quickly with gluten avoidance, skin lesions may take up to two years to dissipate.3 The initial dosage of dapsone is usually 25 mg to 50 mg for adults, and the average maintenance dose is 100 mg. The dose should be tapered to the minimal effective dose with a goal of one to two new lesions per week. Increasing the

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dapsone dose beyond that only increase the toxicity with little cutaneous benefit.

Other autoimmune disorders may also be associated with DH, most commonly diabetes mellitus or thyroid disease, specifically Hashimoto thyroiditis. Patients with celiac disease are also at an increased risk of developing an enteropathy-associated T-cell lymphoma. Implementing gluten avoidance may decrease this risk. However, recent studies have shown that those with both celiac disease and DH may not be at an increased risk for developing lymphoma.4 Interestingly, patients with DH tend to have a milder degree of villous atrophy in the GI tract when compared with those with frank celiac disease; this is hypothesized to account for the decreased risk of lymphoma.4 Given the intense pruritus and desire for immediate relief, the woman in this case was treated with dapsone.

She was also encouraged to avoid gluten. She continues to have regular follow-up with her gastroenterologist for celiac disease. Evaluation for diabetes mellitus and thyroid disease was negative.

CASE #2

Neurotic excoriation

Neurotic excoriation, also known as psychogenic excoriation, describes a condition in which a patient has the excessive fixation to pick at his or her normal or seemingly normal skin. Eventually, the tendency becomes so persistent that one makes excoriations of the skin.

Some people have the episodic or continuous desire to unconsciously pick at such irregularities as acne, arthropod bites, or keratin plugs, and this is considered a simple habit. In contrast, patients with neurotic excoriations consciously and uncontrollably have the desire to pick or scratch at their skin, causing characteristic lesions.

The excessive desire to pick or scratch may happen as the hand notices an irregularity on the skin, or it may occur in a ritualistic fashion. Unlike such other self-inflicted dermatoses as dermatitis artefacta and malingering, patients with neurotic excoriation acknowledge the self-inflicted nature of the lesions.

Because there is no underlying pathology in the skin, neurotic excoriation may be best understood as a psychological

process with dermatologic manifestations. The most common psychopathologies associated with the disorder include depression, bipolar disorder, stress, anxiety, and obsessivecompulsive disorder.5 The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), estimates that the lifetime prevalence of excoriation disorder is at least 1.4% in the general population.6 It has also been estimated that approximately three-fourths of these patients are females. While the disorder may occur at any age, the most severe cases start in the third to fifth decades.6 The DSM-5 places excoriation (skin-picking) disorder in the category of obsessive-compulsive and related disorders.

The specific criteria for the disorder are the following: (1) recurrent skin-picking, resulting in skin lesions; (2) repeated attempts to decrease or stop skin-picking; (3) the skin-picking causes clinically significant distress or impairment in social, occupational, or other important areas of functioning; (4) the skin-picking cannot be attributed to the physiologic effects of a substance or other medical condition; (5) the skin-picking cannot be better explained by the symptoms of another mental disorder (eg, delusions or tactile hallucinations [psychotic disorder], attempts to improve a perceived defect or flaw in one’s appearance [body dysmorphic disorder], sterotypies [stereotypic movement disorder], or intention to harm oneself [nonsuicidal self-injury]).6 The self-inflicted excoriations are characterized as superficial or deep erosions that are clean-based or covered with a scab. The erosions are often linear and are usually of similar size and shape but at various stages of healing.

Hypopigmented or hyperpigmented macules represent healed erosions and are also appreciated among the active excoriations. The most commonly affected body sites include the face, the upper back, and the extensor surfaces of the extremities.

Persons with neurotic excoriations may best be divided into two categories: those with primarily facial disease and those with primarily body disease. Those with primarily facial disease are said to have acne excoriée. Patients often have the uncontrollable desire to manipulate acne. Those with primarily body disease present with characteristic lesions located on the accessible upper back and the extensor surfaces of the extremities.

When a patient presents with neurotic excoriations, the clinician must rule out arthropod bites, dermatitis herpetiformis, folliculitis, lymphoma, delusions of parasitosis, and other obvious dermatologic or medical explanations for pruritus. The appropriate workup is indicated by the

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Dermatologic Look-Alikes

patient’s history. Histologically, epidermal ulceration with a mild superficial mixed infiltrate is often appreciated. Older lesions may demonstrate dermal scar tissue and/or changes of lichen simplex chronicus.

Patients with acne excoriée are best treated with acne medications and encouraged to avoid manipulation of the acne lesions. For those afflicted by primarily body disease, treatment is based on symptom severity. When pruritus is severe, such topical antipruritics as doxepin 5% cream (Prudoxin, Zonalon) or lotions containing pramoxine or menthol and phenol may provide relief. Such antihistamines as diphenhydramine or hydroxyzine (Vistaril) may provide sedative and antipruritic therapy. Doxepin cream is often a treatment of choice because of its antidepressant and antipruritic effects.

In 2005, Kirshnan and Koo reported that pathology of the central nervous system and the opioid neurotransmitter system are the basis for neurotic excoriations.7 This report led to the suggestion that psychiatric medications could be used to treat the condition. Such selective serotonin reuptake inhibitors as paroxetine (Paxil), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra), and sertraline (Zoloft) have demonstrated efficacy in the treatment of neurotic excoriation.8 Other psychiatric medications that have been employed include clomipramine (Anafranil), desipramine (Norpramin), olanzapine (Zyprexa), lithium (Lithobid), buspirone (BuSpar), and quick-acting benzodiazepines.8 All treatments for neurotic excoriation are off-label.

A mental health professional can help to teach the patient diversion strategies to avoid picking at the lesions. In all cases of neurotic excoriation, the clinician, the patient, and the psychiatrist and/or psychologist should work together as a team to provide the best possible therapeutic approach.

Neurotic excoriation can be controlled if the underlying psychological illness is effectively treated. However, patients frequently have difficulty abstaining from the habit of picking. Without proper medical and psychiatric treatment, the disorder tends to be a chronic condition and can result in significant scarring.

This woman was treated with doxepin as well as with a menthol/phenol lotion. She was also referred to psychiatry. n

2. Smith JB, Tulloch JE, Meyer LJ, et al. The incidence and prevalence of dermatitis herpetiformis in Utah. Arch Dermatol. 1992;128:1608-1610.

3. Thrash B, Patel M, Shah KR, et al. Cutaneous manifestations of gastro­ intestinal disease: part II. J Am Acad Dermatol. 2013;68:211.e1-33.

4. Lewis HM, Renaula TL, Garioch JJ, et al. Protective effect of gluten-free diet against development of lymphoma in dermatitis herpetiformis. Br J Dermatol. 1996;135:363-367.

5. Brodin MB. Neurotic excoriations. J Am Acad Dermatol. 2010;63:341-242.

6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, Va.: American Psychiatric Association; 2013:254-7.

7. Krishnan A, Koo J. Psyche, opioids, and itch: therapeutic consequences.

Dermatol Ther. 2005;18:314-322.

8. Arnold LM, Auchenbach MG, McElroy SL. Psychogenic excoriation.

Clinical features, proposed diagnostic criteria, epidemiology and approaches to treatment. CNS Drugs. 2001;15:351-359.

“I’m giving you one last chance to talk before Vinny says ‘Please.’”

Dr. Robbins is an instructor in the Department of Dermatology at Baylor College of Medicine in Houston.

References 1. Alonso-Llamazares J, Gibson LE, Rogers RS 3rd. Clinical, pathologic, and immunopathologic features of dermatitis herpetiformis: review of the Mayo Clinic experience. Int J Dermatol. 2007;46:910-919.

“Hey, would you mind taking a quick scultture of me and my family?”

© The New Yorker Collection 2014 from cartoonbank.com. All Rights Reserved.

CME CE

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CE

POSTTEST Expiration date: April 2015

Physician Credit This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Medical Education Resources (MER) and Haymarket Medical. MER is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation Medical Education Resources designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Academy of Physician Assistants AAPA accepts cer tificates of par ticipation for educational activities cer tified for

Category I credit from AOACCME, prescribed credit from AAFP and AMA PRA Category 1 Credit™ from organizations accredited by ACCME or a recognized state medical society. Physician assistants may receive a maximum of 1 hour of Category I credit for completing this program.

Nursing Credit Medical Education Resources is accredited as a provider of continuing nursing education by the American Nur ses Credentialing Center’s Commission on Accreditation.

This CE activity provides 1 contact hour of continuing nursing education.

Medical Education Resources is a provider of continuing nursing education by the California Board of Registered Nursing, Provider #CEP 12299, for 1 contact hour.

CREDITS: 0.5

CREDITS: 0.5

Feature

Dermatology Clinic

Dermatologic Look-Alikes

page 73

page 95

page 99

1. Which of the following is a Schedule II controlled substance? a. Morphine b. Heroin c. Methaqualone d. Diazepam (Valium, Valrelease)

Case #1

Case #1

2. What is the hallmark of pain assessment? a. Differentiating between acute and chronic pain b. Determining location of the origin of the pain c. Patient’s self-assessment of pain d. Dose of narcotic needed for pain relief 3. What is a feature of the type of pain that is poorly managed with opioids? a. Throbbing b. Shooting c. Deep d. Non-radiating 4. What should be included in a written patient-provider agreement? a. Being the single provider of narcotics b. Commitment to follow-up visits c. Random urine drug testing d. All of the above

TO TAKE THE POSTTEST please go to CliniAd.com/1h2KzMO

1. What sign is associated with 1. What is the appearance of the primary primary systemic amyloidosis? lesions of dermatitis herpetiformis (DH)? a. Rubbing causes an urticarial flare. a. Erythematous urticarial papules, b. Vessels are prone to rupture plaques, and/or vesicles after minor trauma. b. Greasy-looking macules and papules c. Pressure produces a depression. c. Plaques with satellite papules d. Rubbing results in exfoliation. d. Inflammatory papules and crusts 2. Where are the lesions of macular amyloidosis characteristically found? a. Extensor surfaces b. Ano-genital region c. Upper back d. Palms Case #2 3. What risk factor can cause and/or aggravate seborrheic dermatitis? a. Temperature extremes b. Infrequent shampooing c. Immunodeficiency d. All of the above 4. What characteristic of seborrheic dermatitis distinguishes it from atopic dermatitis? a. Presence or absence of pruritus b. Clinical appearance of lesions c. Response to corticosteroids d. Season during which most commonly affected

2. What is the treatment for DH? a. Acyclovir (Zovirax) b. Dapsone c. Rimantadine (Flumadine) d. Corticosteroids Case #2 3. What psychopathology is associated with neurotic excoriation? a. Borderline personality b. Schizophrenia c. Obsessive-compulsive disorder d. Eating disorder 4. Which treatment for neurotic excoriation has both antidepressant and antipruritic effects? a. Topical doxepin (Prudoxin, Zonalon) b. Bupropion (Aplenzin, Forfivo, Wellbutrin, Zyban) c. Fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra) d. Trazodone (Desyrel, Oleptro, Trazamine)

TO TAKE THE POSTTEST please go to CliniAd.com/1g9lLXo

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ALTERNATIVE MEDS UPDATE

What you should know about the herbs and supplements patients use

By Sherril Sego, FNP-C, DNP. Ms. Sego is a staff clinician at the VA Hospital in Kansas City, Mo., where she practices adult medicine and women’s health. She also teaches at the nursing schools of the University of Missouri and the University of Kansas.

Monk fruit

© THINKSTOCK

China provides the world with an abundant supply of natural therapies. Many of these herbal ­substances are classified as “functional foods,” which means that they are consumed for daily nutritional requirements but also possess unique medicinal properties. Monk fruit, a gren fruit that looks like a melon, is named after the group of monastic practitioners who popularized its use as both a natural sweetener and a medicine. It is the latest nutritional treasure to emerge from the Far East.

Background Monk fruit, scientifically known as Siraitia grosvenorii, first surfaced in Chinese culture in the 13th century.1 Buddhist monks who were the medical practitioners of that era cultivated this member of the gourd family for many uses, primarily for the treatment of respiratory illnesses.The species name was chosen in honor of Gilbert Grosvenor, who was president of the National Geographic Society and funded an expedition in the 1930s to find the living plant in its native habitat of southern China.2 Monk fruit made its way into the United States in the early 20th century, but serious research into the fruit’s potential as a sweetening agent did not being until after 1975.1

Science An estimated 150 million Americans use so-called sugarfree or low-calorie supplements, and that number has tripled

over the past two decades to create a $1.5-billion industry.3 Until the introduction of the natural sweetener stevia, all of the artificial sweeteners in the United States were synthetic and therefore popular targets of the health-food movement for their potential toxicities.

The refined products of monk fruit are 200 to 300 times sweeter than traditional table sugar.1 Although research is ongoing, early in vitro and animal testing indicate that serum glucose levels are actually lowered by consuming this supplement, most likely due to its stimulation of pancreatic insulin secretion. Bench research studying diabetic mice compared blood glucose levels of untreated animals with those exposed to four weeks of S. grosvenorii supplementation.4 Corresponding reductions in total cholesterol were found as well as an increase in HDL. A similar but longer trial measured serum glucose levels as was hepatic function, and the antioxidative effect on lipid peroxidation resulted in similar findings.5 While still hypothetical, there is also an assumed simultaneous reduction in cellular insulin resistance.

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ALTERNATIVE MEDS UPDATE As noted earlier, one of the most common uses of monk fruit mentioned in Chinese literature is as a treatment for respiratory illness. Thought to exert a combination of analgesic, antihistaminic, and expectorant activities, teas made from monk fruit remain staples in the treatment of colds, bronchitis, and pneumonia.6 However, there are no current clinical trials exploring these effects.

Monk fruit is also being studied as an anticarcinogenic agent. In laboratory testing, the active chemical component group of S. grosvenorii that appears to show promise in this capacity is that of the cucurbitane glycosides.7 Under the theory that some cancer cells are triggered by viral insult, an extract of monk fruit was evaluated for its effect on Epstein-Barr virus early antigen activation. The monk fruit extract inhibited activation of viral antigen at equal or greater levels than did the control agent beta-carotene.

In a similar study, two monk fruit extracts were given to mice inoculated with a skin cancer cell line.8 There were fewer and slower-growing lesions in the mice fed the monk fruit extracts than there were in the control mice.

Safety, interactions After an extensive review, FDA issued a “Generally Recognized as Safe” statement for monk fruit.9 The summary statement stipulated that no toxicities were detected as a whole food (i.e., the fruit or dried pulp) or as a sweetener.

Cost, how supplied

sweeteners, more health-care providers are coming to be on the alert for safer alternatives.

Although sugar in any form will always be something that clinicians should urge patients to use in moderation, the increased availability of palatable, safe, and healthy substitutes is welcome. n References 1. Institute for Traditional Medicine. Sweet fruit used as sugar substitute and medicinal herb. Available at www. itmonline.org/arts/luohanguo.htm.

2. Swingle, WT. Momordica grosvenori Sp. Nov. the

No toxicities have been detected in sweeteners derived from monk fruit.

In China, teas made from monk fruit remain staples in traditional treatment of colds, bronchitis, and pneumonia.

source of the Chinese Lo han kuo. Journal of the Arnold Arboretum. 1941;22:197-203.

3. Kinghorn AD, Soejarto DD. Discovery of terpenoid and phenolic sweeteners from plants. Pure and Applied Chemistry. 2002;74:1169-1179. Available at pac.iupac.org/ publications/pac/pdf/2002/pdf/7407x1169.pdf.

4. Qi XY, Chen WJ, Zhang LQ, Xie BJ. Mogrosides extract from Siraitia grosvenori scavenges free radicals in vitro and lowers oxidative stress, serum glucose, and lipid levels in alloxan-induced diabetic mice. Nutr Res. 2008;28:278-284.

5. Suzuki YA, Tomoda M, Murata Y, et al. Antidiabetic effect of long-term supplementation with Siraitia grosvenori on the spontaneously diabetic Goto-Kakizaki rat. Br J Nutr. 2007;97:770-75.

6. Hossen MA, Shinmei Y, Jiang S, et al. Effect of Lo Han Kuo (Siraitia grosvenori Swingle) on nasal rubbing and scratching behavior in ICR mice. Biol Pharm Bull. 2005; 28:238-241. Available at www.jstage.jst.go.jp/article/ bpb/28/2/28_2_238/_pdf.

7. Ukiya M, Akihisa T, Tokuda H, et al. Inhibitory effects of cucurbitane glycosides and other triterpenoids from the fruit of Momordica grosvenori on epsteinbarr virus early antigen induced by tumor promoter

Monk fruit is available as a refined liquid extract, a granular sweetener, and a dried fruit pulp. The granular sweetener costs approximately $10 for 40 single-serving packets.

Summary

12-O-tetradecanoylphorbol-13-acetate. J Agric Food Chem.

2002;50:6710-6715.

8. Takasaki M, Konoshima T, Murata Y, et al.

Anticarcinogenic activity of natural sweeteners, cucurbitane glycosides, from Momordica grosvenori. Cancer Lett.

2003;198:37-42.

9. U.S. Food and Drug Administration. Generally recognized as Safe (GRAS) determination for the use of luo han fruit concentrate as a flavor modifier and sweetener.

Available at www.accessdata.fda.gov/scripts/fcn/gras_notices/grn000301.pdf.

All electronic documents accessed March 15, 2014.

© THINKSTOCK

It is still too early to claim that monk fruit is an antioxidant with cancer-preventing capabilities.

However, there appears to be little doubt that monk fruit is now a major player as a healthy sweetening agent. As more mainstream literature discusses the negative aspects of artificial

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Evidence-Based Medicine This department uses the best available scientific findings to offer practice guidance on a wide range of conditions seen in primary care.The author, Alan Ehrlich, MD, is a deputy editor for DynaMed, Ipswich, Mass., and assistant clinical professor in Family Medicine, University of Massachusetts Medical School in Worcester. DynaMed (www.ebscohost.com/dynamed/) is a database that provides evidence-based infor-­­ mation on more than 3,000 clinical topics and is updated daily through systematic surveillance covering more than 500 journals.The most important evidence identified is summarized here.

IN WOMEN WITH CORONARY ARTERY DISEASE, NEWERGENERATION DRUG-ELUTING STENTS ARE ASSOCIATED WITH REDUCED RISKS OF MI AND TARGET VESSEL REVASCULARIZATION COMPARED WITH BAREMETAL AND EARLY-GENERATION DRUG-ELUTING STENTS Level 2: Mid-level evidence Drug-eluting stents are used to reduce the risk of restenosis in patients having percutaneous coronary intervention. A Cochrane review has demonstrated that, compared with bare-metal stents, drug-eluting stents reduce the risk of target lesion revascularization (Cochrane Database Syst Rev. 2010;5:CD004587). However, a large majority of patients with coronary artery disease (CAD) recruited for clinical studies are men, and these trials may not have been adequately powered to make similar conclusions in women.

A recent pooled analysis of individual patient data has evaluated the long-term safety and efficacy of drug-eluting stents compared with bare-metal stents in a subgroup of female patients with CAD (Lancet. 2013;382:1879-1888).

A systematic review identified 26 randomized trials comparing drug-eluting stents with bare-metal stents in 43,904 patients with CAD. Individual data from 11,557 women (26.3% of randomized patients) with a mean age of 67 years and a mean follow-up time of 2.9 years were included in the analysis. Drugeluting stents were classified as either newergeneration stents (including everolimus-eluting Xience and Promus stents, zotarolimus-eluting Endeavor and Resolute stents, biolimus-eluting Biomatrix and Nobori stents, and sirolimuseluting Yukon stents) or early-generation stents

Newer drug-eluting stents were also associated with lower rates of definite or probable stent thrombosis.

(sirolimus-eluting Cypher stents and paclitaxeleluting Taxus stents). At baseline, women receiving drug-eluting stents had lower rates of diabetes and higher rates of previous MI compared with those receiving bare-metal stents. The minimum duration of dual antiplatelet therapy ranged from two months to 12 months.

The cumulative incidence of MI over three years was 4.8% in 6,278 women who received newer-generation drug-eluting stents, which was significantly lower than the rates in the other groups (6% of 4,171 women with early-generation drug-eluting stents and 7.7% of 1,108 women with bare-metal stents). Similarly, the cumulative incidence of target lesion revascularization over three years was significantly reduced in the newer-generation drug-eluting stent group (6.3%) compared with the other groups (7.8% with early-generation and 18.6% with bare-metal stents). Newer-generation drug-eluting stents were also associated with significantly lower rates of definite or probable stent thrombosis.

The mortality rate was 5.7% overall, with no significant differences among treatment groups.

These results are consistent with previous findings observed for drug-eluting stents in trials evaluating populations of both women and men. Collectively, these data support the use of newer-generation drug-eluting stents compared with early-generation drug-eluting stents or bare-metal stents in women with coronary artery syndrome having percutaneous coronary intervention. It is important to remember that The quality of the evidence supporting each item is rated from Level 1 (highest) to Level 3 (lowest). Absolute risk reductions are presented as the number needed to treat (NNT) for one patient to benefit. Absolute risk increases are presented as the number needed to harm (NNH).

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INCREASING STEROID DOSE PERIOPERATIVELY MAY NOT BE NECESSARY FOR PREVENTION OF HYPOTENSION IN PATIENTS WITH RECENT OR CURRENT STEROID USE Level 2: Mid-level evidence Patients having major colorectal surgery while receiving steroid treatment are routinely given high-dose corticosteroids to prevent acute perioperative adrenal insufficiency.

This practice has become standard, even for patients not receiving steroids at the time of surgery but who had taken steroids in the previous year. However, high-dose steroids are associated with an increased risk of postoperative complications, such as wound infection or anastomotic dehiscence. Furthermore, observational studies in patients with inflammatory bowel disease (IBD) undergoing colorectal surgery have previously shown no significant differences in the risk of hemodynamic instability between patients receiving high-dose steroids and those receiving low-dose steroids (Am J Surg. 2012;204:481-486) or no steroids (Am Surg. 2011;77:1295-1299). Now, a prospective randomized noninferiority trial compares low-dose steroids with highdose steroids in patients with IBD with current or recent steroid use who were scheduled to have major colorectal surgery (Ann Surg. 2014;259:32-37).

A total of 121 patients with inflammatory bowel disease who were receiving steroids or had been treated with steroids in the previous year were randomized to low-dose hydrocortisone (Cortef ) (IV equivalent to presurgical oral dosing) vs. high-dose hydrocortisone (100 mg IV three times daily). Hydrocortisone doses were gradually tapered for both groups. Among patients not taking steroids at the time of surgery, the median time from last steroid dose to surgery was three months for the low-dose steroid group and four months for the high-dose steroid group (not significant). Orthostatic, or postural, hypotension was defined as a decrease in systolic BP of at least 20 mm Hg after sitting up from a supine position. Hemodynamic instability was defined as the presence of hypotension, tachycardia (heart rate >100 beats per minute) or bradycardia (heart rate <60 beats per minute).

The efficacy analysis excluded 29 patients (24% of those randomized) due to protocol violations or due to their

© CMSP / YALE ROSEN

drug-eluting stents are not the preferred option in patients unable to take dual antiplatelet therapy reliably for 12 months (Circulation. 2011;124:e574-651; available at circ.ahajournals. org/content/124/23/e574.long, accessed March 15, 2014).

No significant difference between low-dose and high-dose perioperative steroids was found in patients with IBD (shown).

having been mistakenly randomized for a second time during a staged surgical procedure. Overall, 96% of those receiving low-dose steroids had an absence of orthostatic hypotension through postoperative day 1, compared with 95% of those receiving high-dose steroids (not significant; noninferiority criterion met). Similarly, orthostatic hypotension was absent in 78% of those receiving low-dose steroids through postoperative day 7, compared with 79% of those receiving high-dose steroids (not significant). An absence of hemodynamic instability through postoperative day 7 was observed in 12% of patients in both groups. No patients in either group were treated with rescue high-dose steroids for adrenal insufficiency during the trial.

This randomized trial builds on previous retrospective cohort studies performed by the same group, and similarly demonstrates no significant differences between low-dose and high-dose steroids for patients with IBD having major colorectal surgery with steroid use in the previous 12 months.

These findings also add to those of a systematic review of two randomized trials and seven cohort studies evaluating perioperative stress dose of corticosteroids in 315 patients taking daily corticosteroids. In that review, there were no differences in hemodynamic profiles between patients receiving stress dose and those receiving their regular steroid dose in the two randomized trials, and there were no episodes of unexplained hypotension or adrenal crisis in patients who did not receive stress dose in five cohort studies (Arch Surg. 2008;143:1222-1226; available at archsurg .jamanetwork.com/article.aspx?articleid=402330, accessed March 15, 2014). Collectively, these data do not support increased perioperative dosing of steroids for the purposes of preventing adrenal insufficiency.

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© CMSP / SPL

ARTHROSCOPIC PARTIAL MENISCECTOMY DOES NOT IMPROVE SYMPTOMS OF DEGENERATIVE MEDIAL MENISCUS TEAR IN PATIENTS WITHOUT KNEE OSTEOARTHRITIS Level 1: Likely reliable evidence Arthroscopic surgeries for patients with established knee osteoarthritis are becoming less common due to a lack of clinical evidence supporting their use. A Cochrane review found that arthroscopic surgery is ineffective for unselected patients with knee osteoarthritis (Cochrane Database Syst Rev. 2008;1:CD005118), based partly on the findings of a randomized trial showing no significant improvement in pain or function scores with either arthroscopic debridement or arthroscopic lavage compared with placebo surgery (N Engl J Med. 2002;347:81-88). Another randomized trial subsequently showed that the addition of arthroscopic surgery to physical and medical therapies did not improve function or pain scores in individuals who had moderate-to-severe knee osteoarthritis (N Engl J Med. 2008;359:1097-1107).

More recently, a randomized trial in patients with meniscal tear and knee osteoarthritis showed that arthroscopic partial meniscectomy plus physical therapy did not improve symptoms more than physical therapy alone (N Engl J Med. 2013;368:1675-1684; available at www.nejm.org/doi/ full/10.1056/NEJMoa1301408, accessed March 15, 2014).

However, the implications for patients without clearly established knee osteoarthritis have remained unclear.

A recent randomized trial comparing meniscectomy to strengthening exercises in patients presenting with degenerative medial meniscus tear and no clear evidence of osteoarthritis (Kellgren-Lawrence grade 0-1) found no significant between-group differences in function, pain, or patient satisfaction scores (Am J Sports Med. 2013;41:1565-1570).

Now, a randomized trial compares arthroscopic partial meniscectomy to sham surgery in patients with medial meniscus tear without knee osteoarthritis (N Engl J Med 2013;369:2515-2524).

A total of 146 patients aged 35 years to 65 years with symptomatic degenerative medial meniscus tear without knee osteoarthritis were randomized to arthroscopic partial meniscectomy vs. sham surgery and followed for 12 months.

Postoperative care, including walking aids and instructions for graduated exercises, was identical for both groups, and all patients were instructed to take OTC analgesics as required.

Symptoms were assessed using the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores, which both range from 0 to 100; higher scores indicate less severe

Endoscopy reveals a tear in the medial meniscus of the knee (shown).

symptoms. Knee pain was assessed after exercise using a numeric rating scale with a range of 0 to 10, with higher scores indicating greater pain severity.

Both groups had a significant improvement from baseline in symptom and knee pain scores, but there were no significant between-group differences for these outcomes at 12 months. The mean improvement in the Lysholm score was 21.7 points with arthroscopic partial meniscectomy vs.

23.3 points with sham surgery, with a difference of 11.5 points considered clinically meaningful. Similarly, the mean improvement in the WOMET score was 24.6 points with partial meniscectomy vs. 27.1 points with sham surgery, with a difference of 15.5 points considered clinically meaningful.

The mean improvement in knee pain was 3.1 points with partial meniscectomy vs. 3.3 points with sham surgery, with a difference of 2 points considered clinically meaningful. There were also no significant differences in the rate of subsequent knee surgery, patient-reported satisfaction, patient-reported improvement, or serious adverse events.

Recent clinical evidence from randomized trials has consistently shown a lack of efficacy of arthroscopic surgeries for patients with knee osteoarthritis, including patients with meniscus tears. This trial extends those findings to patients with meniscus tears but without established knee osteoarthritis, showing no significant difference in symptom or pain scores between patients receiving arthroscopic partial meniscectomy and those receiving sham surgery. It should be noted that the Lysholm and WOMET scores used in this trial for symptom assessment are primarily focused on basic activities of daily living, and may not adequately describe high-level function as may be required for strenuous work or sports.

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BUCCAL DEXTROSE GEL FOR HYPOGLYCEMIA REDUCES ADMISSION TO NEONATAL INTENSIVE CARE UNIT FOR HYPOGLYCEMIA Level 1: Likely reliable evidence Neonatal hypoglycemia is reported to occur in 5% to 15% of otherwise healthy babies and is considered a risk factor for brain injury or adverse neurodevelopmental outcomes.

Many newborns with low blood glucose levels are separated from their mothers and admitted to the neonatal intensive care unit (NICU), where they are treated with IV dextrose. This separation may inhibit maternal bonding and disrupt the establishment of breastfeeding. The use of buccal dextrose gel in newborns with hypoglycemia was previously evaluated in a randomized trial that showed no significant difference in blood glucose concentrations compared with no treatment. However, this earlier trial did not evaluate patient-oriented outcomes. Now, a randomized trial compares buccal dextrose gel with placebo in newborns with hypoglycemia and evaluates both glycemic outcomes and the need for admission to the NICU (Lancet.

2013;382:2077-2083).

The study screened babies born at ≥35 weeks gestational age who were at risk of neonatal hypoglycemia. A total of 242 infants (gestational age 35 weeks to 42 weeks) developed hypoglycemia, defined as blood or interstitial glucose level <2.6 mmol/L (46.8 mg/dL), and were randomized to receive dextrose 40% gel 200 mg/kg massaged into the buccal mucosa vs. placebo gel. Afterward, infants were encouraged to feed. If feeding was poor, infants were given expressed breast milk or formula by syringe, according to maternal preference. Blood glucose levels were assessed at 30 minutes following the first treatment. If hypoglycemia persisted or recurred, infants received another dose, up to a maximum of six doses over 48 hours. Treatment failure was defined as blood glucose level <2.6 mmol/L at 30 minutes following the second dose of study gel. Infants who met the criteria for treatment failure were admitted to the NICU and treated with open-label dextrose gel, infant formula, or IV dextrose, according to clinical guidelines and clinician preference.

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Evidence-Based Medicine

Admission to neonatal intensive care may disrupt breastfeeding.

Each group received a median of two doses of study gel.

After excluding five infants who had been randomized in error, 237 infants (98%) were included in a modified intention-to-treat analysis. The rate of admission to the NICU for hypoglycemia was 14% in the dextrose group compared with 25% in the placebo group (p=0.03, NNT 10). The overall admission rate to the NICU was 38% with dextrose gel vs. 46% with placebo, but this difference was not statistically significant. Treatment failure occurred in 14% of infants receiving dextrose gel compared with 24% receiving placebo gel (p=0.04, NNT 10). In addition, the need for other sources of dextrose (either open-label dextrose gel after treatment failure or IV dextrose) was 10% in the dextrose group compared with 24% in the placebo group (p=0.01, NNT 8). There were no significant differences in the number of rebound or recurrent hypoglycemia episodes, and no serious adverse events occurred.

Many specialists agree that newborns with hypoglycemia and neurologic symptoms should receive urgent treatment and glucose monitoring. In addition, several risk factors have been identified that might suggest increased neonatal risk, including maternal diabetes, obesity, and low birth weight. However, optimal management of neonatal hypoglycemia in other groups should find a proper balance between reducing the risk of long-term complications and minimizing the effect of an abnormal screening result on neonatal adaptation and feeding. This new randomized trial shows that dextrose gel reduces admission to the NICU for hypoglycemia. In doing so, it minimizes the need for unnecessary interventions that separate newborns from their mothers. Furthermore, the gel is inexpensive and well-tolerated. n

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COMMENTARY Judi Greif, RN, MS, APN-C, is a family nurse practitioner currently residing in East Brunswick, N.J.

Distorted body image not just for girls I read an interesting article in a fashion magazine that discussed how women are no longer alone in fretting about facing themselves in the mirror during that dreaded swimsuit season: More and more men are becoming just as anxious about their weight and appearance. Advertisements and other media images increasingly feature men who are leaner yet more muscular, wearing fewer clothes. Perhaps the most impressionable and most vulnerable to being influenced by these images are adolescent boys and young men—some of whom have become drawn to the world of celebrity athletes, bodybuilders, and even such reality–television stars as Mike “The Situation” Sorrentino

Nearly half of the boys reported some unhealthy behavior related to muscle dysmorphia.

from the onetime much-publicized hit series, Jersey Shore, with his “six-pack abs.”

In one survey of more than 11,000 youngsters aged 9 to 16 years, more than one-fourth of boys (27%) reported making an effort to look like media figures ( J Adolesc Health. 2004; 35[1]:41-50). In addition, a team of sociologists found that underweight boys are extremely distressed—much more so than are overweight boys—and are at greater risk of depression than are overweight girls ( J Health Soc Behav.

2010;1[2]:215-228). As a result, clinicians are seeing more boys who suffer from eating disorders and/or from complications related to inappropriate diets, supplement use, and steroid use.

In a survey of nearly 2,800 adolescents from 20 urban middle and high schools, more than two-thirds of boys reported changing their eating habits to increase their muscle mass or tone, and nine out of 10 boys exercised to accomplish the same goal (Pediatrics. 2012;130[6]:10191026, available at pediatrics.aappublications. org/content/early/2012/11/14/peds.20120095.full.pdf+html; accessed March 15, 2014).

While this may not seem cause for concern, compulsive dieting and exercising are detrimental to the development of young minds and bodies. Moreover, nearly half of the boys reported some unhealthy behavior related to muscle dysmorphia, with nearly 35% using protein powders or shakes, about 6% using

steroids, and almost 11% using another type of so-called muscle-enhancing product. The investigators noted that boys of Asian descent and boys on sports teams are most likely to practice these muscle-enhancing behaviors.

Overall, participation in these activities has jumped dramatically in recent years. Pressure from coaches and other boys frequently exacerbates the problem.

The use of non-FDA-regulated protein supplements (powders and shakes) and steroids can have serious adverse effects. Their illegal status for this purpose aside, anabolic steroids can cause cardiac problems, psychiatric issues, severe acne, and short stature, and can affect male genital development and fertility.

In light of these data, clinicians should regularly question their adolescent male patients as well as the parents about the boy’s nutritional habits and exercise routines and his use of any muscle-enhancing agents—especially steroids.

Also, it is important for health-care providers to help educate patients, parents, teachers, and coaches about the potential dangers of these practices and explain that certain media images and behaviors by star athletes are not the norm and should not be emulated. We must learn to strike a balance between healthy eating plus appropriate physical training versus an unhealthy, unrealistic obsession with being lean and muscular and “manly.” n

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