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Evidence-Based Complementary and Alternative Medicine
Volume 2013, Article ID 424730, 6 pages
http://dx.doi.org/10.1155/2013/424730
Research Article

Effects and Safety of Gyejibongnyeong-Hwan on Dysmenorrhea Caused by Blood Stagnation: A Randomized Controlled Trial

1Center for Clinical Research and Drug Development, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea
2Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul 130-701, Republic of Korea
3Department of Preventive Medicine, College of Korean Medicine, Daejeon University, Daejeon 300-716, Republic of Korea
4Department of Obstetrics and Gynecology, College of Korean Medicine, Won-Kwang University, Iksan 570-749, Republic of Korea
5Department of Obstetrics and Gynecology, College of Korean Medicine, Gachon University, Seongnam 461-701, Republic of Korea
6Department of Korean Medicine Rehabilitation, College of Korean Medicine, Gachon University, Seongnam 461-701, Republic of Korea

Received 5 April 2013; Revised 16 August 2013; Accepted 19 August 2013

Academic Editor: Chang-Sik Yin

Copyright © 2013 Jeong-Su Park et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.