中药辨证治疗偏头痛的安慰剂对照研究

Placebo-controlled study of traditional Chinese medicine in the treatment of migraine

目的:观察中药辨证治疗偏头痛的临床疗效。方法:采用多中心、随机、双盲、安慰剂对照的临床试验设计方法,选取偏头痛临床常见的肝风挟瘀证和寒凝血瘀证患者228例,其中治疗组150例,对照组78例,两组在规范管理的基础上,治疗组服用中药免煎颗粒及必要的止痛剂,对照组服用安慰剂模拟剂及必要的止痛剂;疗程均为12周,治疗结束4周后随访1次。观察两组偏头痛患者的发作次数、天数、头痛程度及中医证候积分的变化。结果:中药治疗组在随访期减少头痛发作次数、天数和缓解头痛程度上优于安慰剂对照组(P<0.05);治疗后两组患者的中医证候积分较治疗前均有改善(P<0.05),但组间比较无统计学差异。结论:中药辨证治疗偏头痛有较好的临床疗效。

Objective： To observe the clinical effect of traditional Chinese medicine （TCM） in the treatment of migraine. Methods： A multi-center, randomized, double-blind, placebo controlled clinical trial was conducted in this study, 193 cases of migraine patients with common clinical type of syndromes including the syndrome of liver wind with blood stasis and the syndrome of congealing cold with blood stasis were observed, which were divided into treatment group with 129 patients and placebo control group with 64 patients. Besides standard management, treatment group was orally given granules of Chuanxiong Dingtong Yin and necessary analgesics and control group was orally given placebo and necessary analgesics. The two groups were treated routinely for 12 weeks and one time of followup visit after 4 weeks of treatment. The aim was to compare changes of migraine attack times, days, pain extent and TCM syndrome scores between treatment group and placebo group. Results： The TCM treatment group was superior to placebo control group in reducing migraine attack times, days and relieving pain extent （P〈0.05）. After treatment, the scores of TCM syndromes of both groups were improved （P〈0.05）, but no significant difference between the two groups. Conclusion： TCM based on syndrome differentiation have a better therapeutic effect in migraine patients.