Objective: To investigate the efficacy and safety of Tianshu capsule in prophylactic treatment of migraine. Method: A multicenter stratified block randomized

double blind

positive drug parallel controlled clinical trials were conducted. 600 cases of migraine patients were divided into three groups

the treatment group was treated with oral Tianshu capsule 4 pills

tid; the control group was treated with oral sibelium capsules 2 pills

bid; the other control group was treated with oral Yuanhu Zhitong capsule 4 pills

tid. The treatment time was 12 weeks. Headache frequency

duration

VAS score of headache severity

symptom and adverse events of patients were recorded in follow-up study respectively on the First day

fourth weeks

eighth weeks

Twelfth weekend. Result: After 12 weeks treatment

Tianshu capsule improved the efficacy on relieving headache and TCM syndromes (syndrome of blood stasis mingled with hyperactivity of liver Yang)

reduced headache frequency compared with those before treatment The curative effect was equivalent with flunarizine hydrochloride capsules

better than Yuanhu Zhitong capsule control group. The incidence of adverse reactions was equivalent with Yuanhu Zhitong capsule control group

lower than flunarizine hydrochloride. Conclusion: Tianshu capsule is the effective and safety drug for treatment and prevention of migraine.