Off-label medication use

Prescribing medications for off-label uses is not illegal. Off-label prescribing includes using medications for unapproved indications; using a drug outside of the recommended dosage range or duration of use; using a drug in certain unapproved patient populations, such as those defined by age, sex, or particular clinical parameters; or intentionally using a medication in a patient who has a known contraindication. Medications would be considered appropriate for off-label use based on their known clinical pharmacology, evidence from clinical studies, and sometimes from the personal experience of the prescriber. The decision to use a drug off label should be based on a careful assessment of the patient's treatment history and the drug's potential risks and benefits. Patients should be given adequate informed consent about how the drug is being used off label and why, along with appropriate information about known risks and side effects.     

Boater training, drinking and boating, and other unsafe boating practices

OBJECTIVES: Identify associations between lack of formal boater training, drinking and boating, and other unsafe boating practices. METHODS: A telephone survey queried respondents (age 16 or older in continental United States) about boating experience, type of boat used, and training. RESULTS: Of the 3,042 boaters surveyed (70% response), most had no formal training (73%). Boaters with formal training failed to use PFDs about as often as those without formal training and were equally or more likely to use alcohol while boating. CONCLUSIONS: The unexpected association between formal training and unsafe boating practices is probably due to reduced risk perception and inadequacies of boater training programs. Such programs seldom mention the risks of alcohol use while boating. Decisions to mandate formal training should be informed by these results; if mandated, training should address the risks of alcohol use while boating, and should be renewed frequently enough to offset reductions in risk perception.     

Use of endocrine hormones for treating depression

Disturbances in some endocrine hormones have been implicated in the pathophysiology of depression. Some of these hormones (and drugs that affect hormone function) have been used as therapeutic agents for the treatment of depression, especially adrenal, thyroid, and gonadal axis hormones. Open-label and controlled studies of various drugs that directly suppress or inhibit adrenal axis function have shown some benefit for the treatment of major depression, including treatment-resistant depression. Thyroid hormone augmentation is effective for nonresponders to antidepressant agents, although it has not been studied extensively. Estrogen may improve mild mood symptoms in perimenopausal women but may not be effective alone for major depression. Evidence of the antidepressant effects of testosterone in men is inconsistent, with mixed results from controlled studies. The adrenal steroid hormone dehydroepiandrosterone has an important role in mood regulation and may have significant antidepressant effects.     

The Savvy Caregiver Program: Impact of an Evidence-Based Intervention on the Well-Being of Ethnically Diverse Caregivers

This article reports on the impact of the Savvy Caregiver Program (SCP) on English-speaking caregivers of Hispanic, Black/African American, and Asian/Pacific Islander descent. Caregivers completed a questionnaire prior to study enrollment, at 6 and 12 months postenrollment. Caregivers in all 3 ethnic groups showed more caregiver competence, reduced depression, greater tolerance for care recipients’ memory problems, better management of their overall situation, and improved perception of that situation 6 months and 12 months post-enrollment. The study demonstrates that in the sample studied the SCP was as effective in helping ethnically diverse caregivers as it has shown to be with Caucasian caregivers.     

Publication bias and outcome reporting bias: agomelatine as a case example

Publication bias and outcome reporting bias contribute to distorted perceptions of drug efficacy and the underreporting of adverse events. To demonstrate these biases, this article describes how the clinical profile of the antidepressant agent agomelatine (Valdoxan(?)) has been presented in the literature. Agomelatine has been systematically assessed in 10 short-term placebo-controlled studies and three long-term placebo-controlled relapse prevention studies. Five published trials demonstrated clinically modest but statistically significant benefits over placebo. Five unpublished trials did not find agomelatine more effective than placebo, but in two of these studies the active comparison drug (fluoxetine [Prozac(?)] or paroxetine [Paxil(?)]) was more effective than placebo. Agomelatine was more effective than placebo in one of three relapse prevention studies, but only the positive study was published. Based on what is evident in the entire published and unpublished dataset, agomelatine does not have a tremendously superior sleep and sexual effects profile. The risk of liver toxicity is also not prominently highlighted in the published literature.