Embargoed news from Annals of Internal Medicine

Older men with localized prostate cancer and other serious health conditions may not benefit from aggressive treatment for their cancer. Surgery and radiation therapy are associated with serious side effects (erectile dysfunction, urinary incontinence, bowel problems) and are not likely to prolong life. Older men with several comorbid conditions are more likely to die of something other than prostate cancer within 10 years of diagnosis. Patients should consider this information when deciding on a treatment plan for low- or intermediate-risk prostate cancer. Researchers studied 3,183 men newly diagnosed with localized prostate cancer to determine the effect of age, comorbidity, and tumor risk on mortality by either prostate cancer or other causes. Within six months of diagnosis, patients were asked to report comorbid conditions by answering "yes" or "no" to having one of 12 major conditions: diabetes, bleeding gastrointestinal ulcer, chronic lung disease, congestive heart failure, stroke, myocardial infarction, angina or chest pain, cirrhosis or liver disease, arthritis, inflammatory bowel disease, hypertension, and depression. The researchers assessed comorbidity, tumor characteristics, initial treatment, and overall and disease-specific mortality through 14 years of follow-up. They found that the 10-year risks of dying from causes other than prostate cancer in men 61 to 74 and men older than 75 with three or more comorbidities were 40 percent and 71 percent, respectively. In comparison, the 14-year risks of dying from low- or intermediate-risk prostate cancer were 3 percent and 7 percent, respectively. The risk of death from high-risk prostate cancer was 18 percent over the 14-year study period and did not vary by number of comorbid conditions. According to the authors, knowing these risks may help physicians and patients make informed decisions about prostate cancer management. The link to this article will go live at 5:00 p.m. on May 20 http://www.annals.org/article.aspx?doi=10.7326/0003-4819-158-10-201305210-00001.

Note: For an embargoed PDF, please contact Megan Hanks or Angela Collom. To interview the lead author, please contact Craig Boerner at craig.boerner@vanderbilt.edu or 615-322-4747.

The Chair of the DSM-IV Task Force charges that the new Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) lacks sufficient scientific support, defies clinical common sense, and was prepared without adequate consideration of risk-benefit ratios and the economic cost of expanding the reach of psychiatry. He recommends that physicians use the DSM-5 cautiously, if at all. In 1980, the DSM-III was developed to give physicians specific parameters by which to define and diagnose mental disorders. It was thought that the DSM-III could make psychiatric diagnosis more reliable and accurate. However, psychiatric diagnosis still relies exclusively on subjective judgments rather than objective biological tests, and diagnostic inflation is at crisis level, the author writes. The fourth edition of the DSM, the DSM-IV, addressed some of the issues of the previous edition by taking a conservative stance of discouraging all changes and requiring substantial scientific evidence for them. Of 94 suggested new diagnoses, only two were added. But according to the author, market-driven diagnostic fads resulted in significant increases in the diagnosis of attention-deficit disorder (tripled), bipolar disorder (doubled), and autism (20-fold increase). The recently published fifth edition, or DSM-5, ignored the risk of overdiagnosis and introduced several high-prevalence diagnoses that may actually be everyday problems labeled as psychiatric disorders. The author argues that drug companies will take marketing advantage of the loose DSM definitions by promoting medications to address the chemical imbalances that cause those "disorders." According to the author, the DSM-5 review process was secretive, closed, and disorganized, with deadlines being consistently missed. The American Psychiatric Association refused a petition for an independent scientific review of the DSM-5 that was endorsed by more than 50 mental health associations. The author asserts that publishing profits trumped public interest. This article will be posted online first at http://www.annals.org at 5:00 p.m. on May 20.

Note: For an embargoed PDF, please contact Megan Hanks or Angela Collom. To interview the lead author, please contact Allen Frances, MD directly at allenfrances@vzw.blackberry.net.

Oxandrolone is no better than placebo for healing pressure ulcers or increasing the percentage of them that remain closed after eight weeks of treatment. Chronic pressure ulcers are a major source of morbidity and mortality in persons with spinal cord injury. Weight loss associated with protein depletion is directly related to poor wound healing and increased surgical risk. Anabolic steroids have been used to promote healing and weight gain in persons with burns, surgical wounds, and pressure ulcers. Oxandrolone is an anabolic steroid approved for the treatment of involuntary weight loss or chronic infections. Researchers sought to determine the efficacy of oxandrolone to heal chronic subdermal pressure ulcers of the pelvic region in patients whose wounds did not respond to standard treatment methods. Two-hundred-twelve inpatients with spinal cord injury and stage III or IV target pressure ulcers (TPUs) were randomly assigned to oxandrolone, 20 mg/d (n=108) or placebo (n=104) for 24 weeks or until ulcers healed. After 24 weeks, a total of 24 percent of the TPUs had healed for patients in the oxandrolone group, and 30 percent of the TPUs had healed for patients in the placebo group. This outcome shows that oxandrolone would have no treatment benefit over placebo for chronic pressure ulcers. A link to this article will go live at 5:00 p.m. on May 20 http://www.annals.org/article.aspx?doi=10.7326/0003-4819-158-10-201305210-00002.

Note: For an embargoed PDF, please contact Megan Hanks or Angela Collom. To interview the lead author, please contact Jim Connell at jim.connel@va.gov 718 584-9000, ext. 6620.

Fecal microbiota therapy, or fecal transplant, should be considered for treating C. difficile in HIV-infected patients. C. difficile is common and difficult to manage, especially in patients with HIV. Fecal microbiota therapy includes testing the donor for infections that could be transmitted to the recipient, preparing the sample the same day of the procedure, and administering it through nasogastric or colonic routes. Physicians observed what they believe to be the first reports of fecal microbiota therapy in two HIV-infected persons. Both patients were 48 years old, had AIDS, and were receiving highly active antiretroviral therapy. The first patient, a male, presented with recurrent diarrhea for eight months secondary to C. difficile infection. A fecal sample donated by the patient's mother was administered via nasogastric tube. The patients' diarrhea and abdominal pain resolved the next day with no adverse effects. At five years follow-up, the patient still had no recurrences. The second patient, a female, was hospitalized for recurrent C. difficile infection that responded to vancomycin therapy, but recurred each time therapy was discontinued. A fecal sample donated by the patient's son was administered through a nasogastric tube. The next day, her diarrhea decreased and there were no adverse effects. At six weeks follow-up, the patient still had no further recurrences. A link to this article will go live at 5:00 p.m. on May 20 http://www.annals.org/article.aspx?doi=10.7326/0003-4819-158-10-201305210-00021.

Note: For an embargoed PDF, please contact Megan Hanks or Angela Collom. To interview the lead author, please contact Clinton Colmenares at ccolmena@uab.edu or 205-996-7593.