The available evidence suggests that the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly e ective as standard antidepressants; c) and have fewer side e ects than standard antidepressants. The association of country of origin and precision with e ects sizes complicates the interpretation.
In clinical practice many adult patients with attention deficit hyperactivity disorder (ADHD) ask for an additional psychotherapeutic intervention besides the medical therapy. In this paper we present a structured skill training program particularly tailored for adult patients with ADHD. The program is based on the principles of cognitive-behavioral treatment for borderline personality disorder developed by M. Linehan. It was modified to suit the special needs of adult patients with ADHD. In this exploratory pilot study we tested this program in a group setting. The following elements were presented: neurobiology of ADHD, mindfulness, chaos and control, behavior analysis, emotion regulation, depression, medication in ADHD, impulse control, stress management, dependency, ADHD in relationship and self respect. In an open study design patients were assessed clinically using psychometric scales (Attention Deficit Hyperactivity Disorder Checklist according to DSM-IV, 16 items of the SCL-90-R, Beck-Depression Inventory, visual analogue scale) prior to and following group therapy. This treatment resulted in positive outcomes in that patients improved on all psychometric scales.
The results of placebo-controlled trials (RCTs) with acamprosate or naltrexone vary substantially. Those differences have been attributed to differing patient characteristics, recruitment strategies, treatment settings and remuneration systems. We tested these assumptions by comparing a new double-blind, placebo-controlled randomized trial conducted in Germany (called PREDICT Study) with data from the US COMBINE Study. PREDICT was designed according to the protocol of the COMBINE Study. A total of 426 alcohol-dependent patients were compared to 459 COMBINE Study patients corresponding to the treatment cells in PREDICT. All patients received acamprosate, naltrexone or placebo for 3 months (PREDICT) or 4 months (COMBINE). Biweekly manualized 'medical management' to enhance compliance was delivered in both studies. Time until the first occurrence of heavy drinking was the main outcome measure. PREDICT found neither acamprosate nor naltrexone to supply any additional benefit compared with placebo, which is at variance with a positive naltrexone effect being reported in the COMBINE Study. A secondary comparison between both studies showed better overall treatment outcomes in PREDICT, although these patients had been more severely affected than their COMBINE counterparts. The divergence in results may be attributable to basic differences in the treatment environments (such as in-patient pre-treatment versus primary outpatient care). We suggest that identically designed RCTs conducted in different parts of the world may help improve the external validity of RCTs. This approach could be called 'comparative efficacy research'.
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