Do we need a new procedure for the assessment of adverse events in anti-migraine clinical trials?

Do we need a new procedure for the assessment of adverse events in anti-migraine clinical trials? Recent Pat CNS Drug Discov. 2011 Jan;6(1):41-7 Authors: Amanzio M Abstract The large number of randomized controlled clinical trials on migraine have drawn the attention of some authors to the need to improve the design of such trials. In particular, adequate methodology is a critical issue in their planning and execution, as different methodological approaches can translate into different results. The side-effects observed in both the active medication arm and the placebo arm--considering anti-migraine randomized clinical trials--are often influenced by non specific factors. This issue can be quantified by using a systematic review approach to study the rates of adverse events reported in the placebo arms of clinical trials. Such a study requires increased standardization of the methods used to collect adverse data in clinical trials. This focused review article provides a critical re-analysis of the results obtained, by our group, in a recent systematic review of adverse events reported in the placebo groups of clinical trials for three classes of anti-migraine drugs: NSAIDs, triptans and anticonvulsants [Amanzio et al., 2009]. We consider the need for caution in interpreting side-effect profiles of the different placebo groups. In particular, since the side-effects observed in both the active medication and placebo arms of randomized ...
Source: Recent Patents on CNS Drug Discovery - Category: Drugs & Pharmacology Tags: Recent Pat CNS Drug Discov Source Type: research