Efficacy of Modified Wuzhuyu Decoction Granule (加减吴茱萸汤颗粒剂) for Migraine Patients with Cold and Stasis Obstructing Meridian Syndrome： A Randomized, Double-Blind, Placebo-Controlled Trial

Objective： To study the efficacy of modified Wuzhuyu Decoction Granule （加减吴茱萸汤颗粒剂, MWDG） in the treatment of migraine patients with cold and stasis obstructing meridian syndrome. Methods： This study was a randomized, double-blind, placebo-controlled trial. A total of 78 migraine patients with cold and stasis obstructing meridian syndrome were recruited and randomly assigned by a ratio of 2：1 into a treatment group （51 cases） and a placebo group （27 cases）. Patients in the treatment group were treated with MWDG while placebo granules were applied in the control group. The treatment course lasted for 12 weeks with a follow-up of 4 weeks. The primary outcome measures included frequency and days of migraine attacks and the secondary outcome measures were analgesics consumption and visual analogue scale （VAS） scores. All outcome assessments were conducted respectively at baseline, the 4th, 8th and 12th week, and the end of follow-up. Results： In the treatment group, significant decrease in frequency of migraine attacks were observed since the 4th week and that of analgesics consumption since the 8th week （both P〈0.05）. While, in the placebo group, significant decrease in frequency of migraine attacks were observed since the 8th week and that of analgesics consumption since the 12th week （both P〈0.05）. No significant decrease in days of migraine attacks and VAS scores of migraine pain were observed in both groups. Between the two groups, there were significant differences in VAS scores and intensity of pain appeared in the 8th week （P〈0.05）. However, no significant differences were found in days and frequency of migraine attacks and analgesics consumption （P〉0.05）. Conclusions： MWDG was probably effective in the treatment of migraine especially for alleviating pain intensity. Furthermore, MWDG could reduce the frequency of migraine attacks and analgesics consumption sooner than the placebo.

不同灸量艾灸治疗寒凝血瘀型原发性痛经:随机对照试验

Objective:To explore the clinical effect differences of moxibustion with different doses on primary dysmenorrhea with cold congelation and blood stasis type.Methods:A total of 60 patients of primary dysmenorrhea were randomized into an intensified dose group and a conventional dose group.All of the patients were treated with moxibustion.In the intensified dose group,the treatment was given three times daily(once every morning,afternoon and at bedtime successively) and during the trial,1 case was dropped out and 29 cases were included in the statistical analysis finally.In the conventional dose group,the treatment was given once daily and 1 case was dropped out during trial and 29 cases were included in the statistical analysis.The score of visual analogue scale(VAS) at the worst painful time point,the score of dysmenorrhea symptoms and recurrence rate were observed and compared before and after treatment in the patients between the two groups.The clinical therapeutic effects were observed in the two groups too.Results:VAS difference value(D-value) and dysmenorrhea symptoms D-valuebefore and after treatment in the intensified dose group were higher than those in the conventional dose group respectively(both P<0.05).The recurrence rate was 14.29% in the intensified dose group,lower than 42.31% in the conventional dose group,with the statistical significance(P<0.05).The total clinical effective rate was 96.55%in the intensified dose group,higher than 89.66% in the conventional dose group,with the statistical significance(P<0.05).Conclusion:Compared with the conventional dose moxibustion,moxibustion with intensified dose achieves satisfactory therapeutic effect on primary dysmenorrhea of cold congelation and blood stasis type.This therapy is low in recurrent rate and convenient in manipulation,thus it deserves to be promoted in clinical application.