Efficacy of Zhengtian Pill for migraine prophylaxis: A randomized, multicenter, double-blind, placebo-controlled, parallel-group study

IntroductionMigraine is a common neurological disorder characterized by recurrent headache attacks. Migraine treatment involves acute and prophylactic therapy. The objective of this study is to evaluate the efficacy and safety of Zhengtian Pill for migraine prophylaxis.MethodsA multicenter, randomized, double-blind, placebo-controlled, parallel-group study was carried out to compare the efficacy and safety of Zhengtian Pill versus placebo. A total of 247 subjects were enrolled in this study and 219 were randomized in a 1:1 ratio of Zhengtian Pill to placebo groups. After a four-week baseline period, subjects were administered Zhengtian Pill or placebo orally at a dose of 6 g, three times daily for 12 weeks. Changes from baseline in the frequency of migraine attacks, the number of days with migraine, migraine attack duration, and the number of days of acute migraine medication per four weeks in the intent-to-treat (ITT) and per-protocol (PP) populations were analyzed. The safety of Zhengtian Pill versus placebo was evaluated in the safety-evaluable population.ResultsAfter 12 weeks of treatment, Zhengtian Pill significantly reduced the frequency of migraine attacks, the number of days with migraine, migraine attack duration, and the number of days of acute migraine medication per four weeks in the ITT and PP populations compared with placebo. The proportion of patients experiencing any adverse event was similar between both treatment groups. Adverse events caused by Zhengtian Pill were generally mild.ConclusionsOur results demonstrate that Zhengtian Pill can be considered as an effective and safe Chinese patent medicine for migraine prophylaxis.