Introduction: Migraine 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. Methods: A 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. Results: After 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. Conclusions: Our results demonstrate that Zhengtian Pill can be considered as an effective and safe Chinese patent medicine for migraine prophylaxis. (C) 2014 Elsevier GmbH. All rights reserved.
[1]Beijing Univ Chinese Med, Dongzhimen Hosp, Dept Neurol, Beijing 100700, Peoples R China;
[2]Beijing Univ Tradit Chinese Med, Hosp 3, Dept Emergency Med, Beijing 100029, Peoples R China;
[3]Capital Med Univ, Beijing Tiantan Hosp, Dept Chinese Tradit Med, Beijing 100050, Peoples R China;
[4]Changchun Univ Tradit Chinese Med, Hosp 1, Dept Neurol, Changchun 130021, Peoples R China;
[5]Peking Univ, Hosp 1, Dept Chinese Tradit Med, Beijing 100034, Peoples R China;
[6]Southern Med Univ, Nanfang Hosp, Dept Chinese Tradit Med, Guangzhou 510515, Guangdong, Peoples R China;
[7]Anhui Univ Tradit Chinese Med, Hosp 1, Dept Neurol, Hefei 230022, Anhui, Peoples R China;
[8]Hubei Hosp Tradit Chinese Med, Dept Neurol, Wuhan 430061, Hubei, Peoples R China;
[9]China Acad Chinese Med Sci, Xiyuan Hosp, Dept Neurol, Beijing 100091, Peoples R China;
[10]Fudan Univ, Huashan Hosp, Dept Neurol, Shanghai 200431, Peoples R China
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