葛根汤治疗原发性痛经的多基线单病例随机对照试验

Primary dysmenorrhea treated by Gegen Decoction: A multi-baseline randomized control trial in individual cases

目的:评价葛根汤治疗寒湿凝滞型原发性痛经的有效性及安全性,为其临床推广应用提供参考。方法:采用多基线单病例随机双盲安慰剂对照临床研究设计,纳入6例患者,区组随机分为治疗组与对照组,经过4-6个月基线期后,分别给予葛根汤和安慰剂治疗3个月经周期,并连续随访3个月。采用图示法,趋势模型及非趋势模型对数据进行分析。结果:对照组3例患者治疗前后无明显变化;治疗组3例患者治疗后症状明显减轻,与治疗前比较有显著差异;所有受试者均未出现不良反应。结论:葛根汤能够有效治疗寒湿凝滞型原发性痛经,作用持久、注意调摄不易复发,且无明显不良反应,值得临床进一步深入研究。

Objective： To evaluate the effect and safety of Gegen Decoction（GD） in treating primary dysmenorrhea in syndrome of cold-dampness stagnation, and to provide references for clinical popularization and application. Methods： Both the multi-baseline single subject design and randomized-double blind-placebo control design were adopted. Six patients were enrolled in and divided into treatment group and placebo group. After 4 to 6-month baseline periods, GD and placebo were administrated to treatment group and placebo group for 3 menstrual cycles, respectively. Moreover, 3-month follow-up for both groups were also completed. Combining graphical statistical methods were used to analyze the data. Results： No significant difference was observed before and after treatment in the placebo group; the treatment group could alleviate the symptoms after the treatment significantly. No adverse effects were observed. Conclusion： GD could treat primary dysmenorrhea in syndrome of cold-dampness stagnation effectively, with continuous effect, low recurrence rate and negligible side-effects, worth further study.