Annals of Internal Medicine tip sheet for July 1, 2014

ACP's new guideline suggests a major change in clinical practice

In a new evidence-based clinical practice guideline being published in Annals of Internal Medicine (http://www.annals.org/article.aspx?doi=10.7326/M14-0701), the American College of Physicians (ACP) says physicians should not offer routine pelvic examinations to asymptomatic, average risk, non-pregnant women. ACP's analysis of the evidence found that routine pelvic examination has no demonstrated benefit, rarely detects important disease, does not reduce mortality, and is associated with discomfort, false positive and negative examinations, and extra cost.

ACP's guideline does not apply to Pap smear screening, only the pelvic examination. ACP states that when screening for cervical cancer, the recommended examination should be limited to visual inspection of the cervix and cervical swabs for cancer and for some women human papillomavirus (HPV), and does not need to include the bimanual examination. ACP found that the diagnostic accuracy of the pelvic examination for detecting gynecologic cancer or infections is low. ACP advises that the pelvic examination is appropriate for women with symptoms such as vaginal discharge, abnormal bleeding, pain, urinary problems, or sexual dysfunction.

ACP's guideline includes High Value Care advice to help doctors and patients understand the benefits, harms, and costs of the pelvic examination so they can pursue care together that improves health, avoids harms, and eliminates wasteful practices.

The guideline is based on a systematic review of 52 published studies that found little evidence to support routine pelvic exams for average-risk women with no gynecological symptoms. Among the findings, research showed that pelvic exams cause pain, discomfort, fear, anxiety, or embarrassment for about a third of women and some studies suggest that up to eight in 10 women experience emotional distress because of the test. In addition, false-positive results may lead to unnecessary, invasive, and potentially harmful diagnostic procedures.

The authors of an accompanying editorial predict that ACP's guideline will be controversial because it recommends against an exam that has long been considered a fundamental component of the well-woman visit. They write, "Regardless of whether the ACP statement changes practice among obstetrician-gynecologists, it should provide a needed prompt for champions of this examination to clarify its goals and quantify its benefits and harms. Even if net benefit is ultimately demonstrated, the question of value will need to be addressed to understand the resources required to achieve that benefit."

Note: The URLs will go live at 5:00 p.m. on Monday, June 30 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks or Angela Collom. To speak with an author of the guideline, please contact Steve Majewski at smajewski@acponline.org or 215-351-2514. To speak with an author of the evidence review, please contact Ralph Heussner at Ralph.Heussner@va.gov.

Initial treatment for HIV infection with an efavirenz-containing antiretroviral regimen doubles a patient's risk for suicidal thoughts, attempts, or completion, according to an article being published in Annals of Internal Medicine (http://www.annals.org/article.aspx?doi=10.7326/M14-0293). Efavirenz is a common and highly effective component of antiretroviral therapy for HIV infection that has been associated with central nervous system side effects, including suicide. But because there has been no clear evidence of association between efavirenz and suicide, psychiatric history has not excluded patients from efavirenz treatment. Given the widespread use of efavirenz and uncertainty about its relationship to suicide, researchers sought to compare the hazard of suicidality between adults assigned to an efavirenz-containing antiretroviral regimen (n=3,241) versus those on an efavirenz-free regimen (n=2,091) for initial treatment of HIV. Suicidality was defined as suicidal ideation, attempted suicide, or completed suicide. The researchers found that patients taking efavirenz had twice the risk of suicidality compared to patients not taking efavirenz. In addition, eight of nine completed suicides during the trial were in the efavirenz group.

Note: The URL will go live at 5:00 p.m. on Monday, June 30 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks or Angela Collom. To speak with an author, please contact Todd Datz at 617-432-8413 or tdatz@hsph.harvard.edu.

Daily oral preexposure prophylaxis (PrEP) with a tenofovir-based regimen protects against herpes simplex virus 2 (HSV-2) acquisition, according to an article being published in Annals of Internal Medicine (http://www.annals.org/article.aspx?doi=10.7326/M13-2471). PrEP using the antiretroviral tenofovir alone or in combination with emtricitabine has been shown to significantly reduce the risk for HIV-1 infection among high-risk populations. HSV-2 infection is common worldwide and is prevalent among HIV-1 infected persons. HSV-2 is also a significant risk factor for HIV-1 acquisition, so finding an effective primary prevention strategy for HSV-2 is a public health priority. Researchers conducted a secondary analysis of HSV-2 acquisition among participants who were initially seronegative for HIV-1 and HSV-2 in a large randomized, placebo-controlled trial of PrEP for HIV-1 prevention among HIV-1-serodiscordant heterosexual couples. They found that patients receiving tenofovir were 30 percent less likely to acquire HSV-2 than those in the placebo group. The researchers conclude that protection against HSV-2 acquisition may be an important added benefit to PrEP for HIV-1 prevention with oral tenofovir.

Note: The URL will go live at 5:00 p.m. on Monday, June 30 and can be included in news stories. For an embargoed PDF, please contact Megan Hanks or Angela Collom. To speak with an author, please contact Toni Maddox at 206-520-3825 or tmaddox@uw.edu.