The 40 Clinical Observation Of Tianshu Capsule For Treatment Of Migraine

AIM:To assess the clinical efficacy and safety of Tianshu capsule in the prevention and treatment of migraine (pattern of hyperactivity of liver yang with combination of blood stasis), and explore the possible mechanism.METHOD: A randomized, double-blind, positive-drug controlled trial was applied. 40 subjects meeting the inclusion criteria were randomly divided in to receive Tianshu capsule treatment (treatment group,24 cases) or flunarizine hydrochloride capsule treatment (control group A,8 cases) or Yuanhu zhitong capsule treatment (control group B,8 cases). The outcome measurements were score of TCM syndrome, attack frequency and the safety at the end of treatment, intensity of headache.RESULTS:â‘ Through the headache therapeutic index, all the three groups were efficient. And then we made a paired comparison approach with the three groups and found that the non-inferiority margin of flunarizine hydrochloride capsules is 10%, which was carried out by non-inferior test with the headache curative effect index between the flunarizine hydrochloride capsules and tianshu capsule. the effective differentials of the two capsule was 97.5%CI,and the Lower Limit was-19.01%, which proved the curative effect of tianshu capsule is not worse than the Flunarizine Hydrochloride Capsules. And the between tianshu capsule and analgesic capsule of corydalis tuber, the third group, p is 0.001(p<0.05), which proved that the curative effect of tianshu is better that the third one.â‘¡comparing the curative effect to Attack frequency of migraine between the three group, the difference was statistical significance. Through the non-inferior test about the first two group of the curative effect to the Attack frequenc, the non-inferiority margin was 10%. the effective rate of the two capsule was 97.5%CI with a Lower Limit of-19.01%, which proved that the curative effect to the Attack frequency of tianshu capsule was not worse than the Flunarizine Hydrochloride Capsules. Comparing the tianshu capsule and analgesic capsule of corydalis tuber, the p was 0.018 (p<0.05), which proved the tianshu capsule has a better curative effect to Attack frequency.â‘¢comparing the traditional Chinese medical syndrome, the difference of the dates had statistical significance. Between treating group with tianshu capsule and the contrast group with the flunarizine hydrochloride capsules, the non-inferiority margin was 10%, effective rate was 97.5%CI and the Lower Limit was-24.46%.the dates proved the traditional Chinese medical syndrome of tianshu capsule is not worse. To the tianshu capsule and the analgesic capsule of corydalis tuber, the p was 0.11(p<0.05>, from which we could find the tianshu capsule had a better curative effect than the last one.â‘£about the drug-safety, taking 40 cases as ensamples, the patients who took tianshu capsule had no adverse reaction. The contrast group of 8cases with the flunarizine hydrochloride capsules had one people feeling dizzy, one sleepiness and one tiredness. The second contrast group of 8 cases with analgesic capsule of corydalis tuber had one people feeling Chest tightness and one one getting skin eruption. From the future multiple comparison of the treating group and contrast group, the adverse reaction rate of tianshu capsule group is obviously lower than the flunarizine hydrochloride capsules group with the p of 0.0000(p<0.05). but between the tianshu capsule group and analgesic capsule of corydalis tube group, the date of adverse reaction had no statistical significance. The tianshu capsule had a very low side effect and was available as preventive medicine to migraine in long term.CONCLUSION:Tianshu capsule is effective in preventing and treating migraine. Except to relieve headache, Tianshu capsule shows better effect in improving TCM syndromes. Due to its high safety, Tianshu capsule demonstrates superiority to other migraine-free drugs.