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May 6, 2014 Issue

Focus on Women’s Health


Medical Knowledge
Patient Care
Professionalism
High Value Care

Economic Return From the Women’s Health Initiative Estrogen Plus Progestin Clinical Trial. A Modeling Study

The results of the Women’s Health Initiative (WHI) surprised the medical community by showing that contrary to expectations, combined hormone therapy among postmenopausal women lead to more harm than benefit. Use of combined hormone therapy declined precipitously following publication of the WHI results. This study weighs the enormous costs of conducting the trial and societal savings resulting from its findings. An editorialist discusses the objections to such expensive studies but why they remain important and prudent.

Use these papers to:

  • Start a teaching session with a multiple-choice question. We’ve provided one below.
  • Review symptoms related to menopause and ask what interventions are helpful for their management. What are the other diagnostic considerations in women with symptoms suggestive of menopause? Use ACP Smart Medicine for a quick review and useful tables.
  • Ask whether hormone therapy should be used to prevent chronic conditions. Use a recent USPSTF guideline to review the risks and benefits of such use.
  • Ask your learners how they will counsel and treat women with hot flashes.
  • Review the key findings of the study and its accompanying editorial. Ask why there was criticism of the WHI at its initiation. What criteria should administrators consider when deciding which studies to invest public money in? How would your learners make choices between trials that might identify cures for very rare diseases versus trials to prevent morbidity (but not mortality) of more common diseases?


Medical Knowledge

Update in Women’s Health: Evidence Published in 2013

This Update summarizes studies published in 2013 that were considered highly relevant to internal medicine and, specifically, women’s health. Articles discussed are from a range of medical journals and include follow-up from the WHI study.

Use this paper to:

  • Discuss with your group the long-term risks following discontinuation of randomized treatment in the WHI. See the critique of the results in this article. Most risks and benefits of combined estrogen and medroxyprogesterone treatment did not persist after hormone treatment was stopped, except for an elevation in breast cancer risk during long-term follow-up.
  • Choose other topics to review with your team, including a trial of an intrauterine device for the treatment of menorrhagia and a study of disparities in the presentations, comorbidities, and outcomes of black and white women with breast cancer.

Clinical Practice Points


Medical Knowledge
High Value Care

Comparative Effectiveness of Cardiac Resynchronization Therapy With an Implantable Cardioverter-Defibrillator Versus Defibrillator Therapy Alone. A Cohort Study

Trials comparing implantable cardioverter-defibrillator (ICD) therapy with cardiac resynchronization therapy with a defibrillator (CRT-D) are limited to selected patients treated at centers with extensive experience. This study compares outcomes after CRT-D versus ICD therapy in contemporary practice outside of the trial setting. In older patients with reduced left ventricular ejection fraction and prolonged QRS duration, CRT-D was associated with lower risks for death and readmission than ICD therapy alone.

Use this study to:

  • Invite a cardiac electrophysiologist to explain to your team how an ICD is placed and what is involved in the placement of an additional coronary sinus lead capable of left ventricular pacing for resynchronization.
  • Ask your learners what the indications are for ICD and CRT-D placement. What are the risks?
  • Ask why results in randomized trials might differ from those in real-world practice.
  • Review what propensity matching is and why it was important in the design of this cohort study. What are the limitations of this study? (Several are discussed on page 609.)


Medical Knowledge

Update in Pulmonary, Sleep, and Critical Care Medicine: Evidence Published in 2013

This summary of important studies published in various journals includes trials comparing colloids and crystalloids for the management of hypovolemic shock, 5- versus 14-day courses of oral corticosteroids for exacerbations of COPD, prone positioning for ARDS, and more.

Use this paper to:

  • Assign members of your team to each read the summary of one study and present it in less than 5 minutes to your team during rounds as a quick way to pass along “pearls.”
  • Choose 1 or 2 papers to review in greater depth at a journal club.
  • Teach your team members how to sign up ACP JournalWise, a service that provides similar summaries of articles according to your interest, whether they should alter practice, the source journal, and more. Your team may share folders of articles that have interested them or that relate to patients on your service.


Medical Knowledge
Patient Care
In The Clinic:

Screening for Colorectal Cancer

Use this concise and eminently practical review to answer key questions related to screening for colorectal cancer.

Use this review to:

  • Ask your learners when colorectal cancer screening should be initiated and what the trade-offs are among the available methods.
  • Ask whether aspirin is recommended for primary prevention of colorectal cancer (the answer is in the “Prevention” section). Ask what CT colonography is and whether it is an appropriate method for screening (see page ITC5-7).
  • Use the multiple-choice questions at the end to introduce topics for discussion. And, log on and submit your answers to claim CME credit for yourself!

Humanism and Professionalism


Professionalism

On Being a Doctor: A Labor of Love

In this essay, Dr. Sodhi recalls the sacrifices made to be present at some of our patients’ most important moments.

Use this essay to:

  • Play the audio recording of the essay available online.
  • Ask your team what personal sacrifices they have made during residency training.
  • Do they think they are worth it?
  • Do they feel resentful? Lucky? Both?

mksap16

A 61-year-old woman is evaluated for hot flushes, which have been persistent for the last 10 years. They occur at least 7 times per day, last for approximately 60 seconds, and are associated with severe sweating, palpitations, and occasional nausea. She is awakened several times per night. She has tried herbal medications, including soy and black cohosh, but has not experienced any benefit. She has hypertension, type 2 diabetes mellitus, and hyperlipidemia. Five years ago, she developed deep venous thrombosis after hip replacement surgery. Her current medications are ramipril, metformin, atorvastatin, calcium, and vitamin D.

On physical examination, vital signs are normal. BMI is 29. The remainder of the examination is normal.

Which of the following is the most appropriate treatment?

A. Citalopram
B. Oral estrogen therapy
C. Oral estrogen/progesterone therapy
D. Topical (vaginal) estrogen
E. Venlafaxine

Correct Answer
E. Venlafaxine

Key Point
Owing to cardiovascular and thromboembolic risks, systemic hormone therapy is not recommended for treatment of menopausal vasomotor symptoms in women older than 60 years who experienced menopause at the median age.

Educational Objective
Treat menopausal vasomotor symptoms.

This 61-year-old woman with cardiovascular risk factors and a history of deep venous thrombosis should be started on a nonhormonal therapy for her hot flushes. Certain antidepressants, including serotonin-norepinephrine reuptake inhibitors such as venlafaxine, are effective nonhormonal medications for reducing menopausal vasomotor symptoms.

Approximately 10% of menopausal women experience hot flushes for 7 to 10 years after the cessation of menses. This patient is continuing to experience frequent and severe hot flushes which have been refractory to conservative therapy and are decreasing her quality of life; thus, pharmacologic therapy is warranted. Systemic estrogen therapy is the most effective treatment for the relief of menopausal hot flushes and must be coadministered with progesterone in women with an intact uterus. However, combined estrogen and progesterone therapy has been shown to increase the risk of several adverse outcomes, including coronary heart disease, stroke, invasive breast cancer, and venous thromboembolism. The North American Menopause Society guideline notes that women older than 60 years who experienced natural menopause at the median age and have never used hormone therapy will have elevated baseline risks of cardiovascular disease, venous thromboembolism, and breast cancer; hormone therapy, therefore, should not be initiated in this population without a compelling indication and only after appropriate counseling and attention to cardiovascular risk factors. Moreover, this patient has a history of deep venous thrombosis, which is an absolute contraindication to initiating hormone therapy.

Several nonhormonal medications have been found to be effective for the treatment of menopausal hot flushes. Notably, there is a significant placebo effect: in most studies, approximately one-third of women will experience relief of hot flushes, even if they do not receive active treatment. In numerous studies, venlafaxine, administered at doses of 37.5 mg/d to 150 mg/d, decreases hot flush severity and frequency in approximately 60% of patients (as compared with 30% who experienced benefit with placebo treatment). Paroxetine is similarly beneficial; in contrast, few studies have shown efficacy with fluoxetine or citalopram. Gabapentin and clonidine are two additional nonhormonal treatments that reduce hot flushes, but attendant side effects may limit their use in some patients.

Vaginal estrogen therapy is typically used for the isolated treatment of vaginal dryness, pruritus, and dyspareunia. Treatment with vaginal estrogen tablets will improve local vaginal symptoms, but will not improve menopausal vasomotor symptoms.

Bibliography
Nelson HD, Vesco KK, Haney E, et al. Nonhormonal therapies for menopausal hot flashes: systematic review and meta-analysis. JAMA. 2006;295(17):2057-2071. PMID: 16670414

This question was derived from MKSAP® 16, the Medical Knowledge Self-Assessment Program.


From the Editors of Annals of Internal Medicine and Education Guest Editor, Gretchen Diemer, MD, FACP, Program Director in Internal Medicine, Thomas Jefferson University.

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