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A Quantification of the Placebo Response
in Migraine Prophylaxis
P-HM van der Kuy and JJHM Lohman
Posted: January 2003  
Cephalalgia 2002; 22:265-270

To quantify the placebo response of prophylactic therapy in migraine, a meta-analysis of prophylactic, double-blind, placebo controlled migraine studies was performed. The total analysis included 22 studies testing 19 different products, including 2013 patients, of which 828 were treated with placebo.

A reduction in migraine attacks of 50% or more was seen in 23.5% of the patients in the placebo groups and 45.5% in the active groups. A reduction in migraine attacks of 16.8% was observed in the placebo groups and 41.8% in the active groups.

We propose that if the percentage of responders in an open-label prophylactic trial in migraine is above 35-40%, or if a reduction in migraine attack frequency is found of 40% or more, further studies are indicated to determine the prophylactic activity of the drug. In all studies included in this analysis, no placebo response was seen above these limits.