Center for Clinical Research and Drug Development, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea ; Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea.
Evid Based Complement Alternat Med. 2013;2013:424730. doi: 10.1155/2013/424730. Epub 2013 Sep 26.
Objective. This study was a multicenter, randomized, double-blind, and controlled trial with two parallel arms: the GJBNH group and the placebo group. This trial recruited 100 women aging 18 to 35 years with primary dysmenorrhea caused by blood stagnation. The investigational drugs, GJBNH or placebo, were administered for two menstrual periods (8 weeks) to the participants three times per day. The participants were followed up for two menstrual cycles after the administration. Results. The results were analyzed by the intention-to-treat (ITT) dataset and the per-protocol (PP) dataset. In the ITT dataset, the change of the average menstrual pain VAS score in the GJBNH group was statistically significantly lower than that in the control group. Significant difference was not observed in the SF-MPQ score change between the GJBNH group and the placebo group. No significant difference was observed in the PP analyses. In the follow-up phase, the VAS scores of the average menstrual pain and the maximum menstrual pain continually decreased in the placebo group, but they increased in the GJBNH group. Conclusion. GJBNH treatment for eight weeks improved the pain of the dysmenorrhea caused by blood stagnation, but it should be successively administered for more than two menstrual cycles. Trial Registration. This trial is registered with Current Controlled Trials no. ISRCTN30426947.
目的。本研究是一项多中心、随机、双盲、对照临床试验，设 GJBNH 组和安慰剂组两个平行组。共招募了 100 名年龄在 18 至 35 岁之间、因血瘀引起原发性痛经的女性患者。试验药物 GJBNH 或安慰剂，每天 3 次，连续服用两个月经周期（8 周）。给药后对患者进行了两个月经周期的随访。结果。采用意向性治疗（ITT）数据集和符合方案（PP）数据集对结果进行分析。在 ITT 数据集，GJBNH 组的平均月经疼痛 VAS 评分变化低于对照组，差异具有统计学意义。GJBNH 组与安慰剂组的 SF-MPQ 评分变化差异无统计学意义。PP 分析中无显著差异。在随访阶段，安慰剂组的平均月经疼痛和最大月经疼痛的 VAS 评分持续下降，但 GJBNH 组的评分增加。结论。GJBNH 治疗 8 周可改善血瘀型痛经疼痛，但应连续服用两个以上的月经周期。试验注册。本试验在当前对照试验注册中心注册，编号为 ISRCTN30426947。
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