首页|Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain:A Multicenter,3∶1 Randomized,Double-Blind,Placebo-Controlled Trial

Efficacy and Safety of Sanjie Analgesic Capsule in Patients with Endometriosis-Associated Pain:A Multicenter,3∶1 Randomized,Double-Blind,Placebo-Controlled Trial

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Objective:To assess the efficacy and safety of Sanjie Analgesic Capsule(SAC)in Chinese patients with endometriosis-associated pain.Methods:This was a multicenter,randomized,double-blind,placebo-controlled trial conducted at 15 centers between November 2013 and July 2017 in China.Eligible 323 patients with endometriosis were randomized at a 3:1 ratio to the SAC group(241 cases)and placebo group(82 cases)by stratified block randomization.Patients in the SAC or placebo groups were given SAC or placebo 1.6 g 3 times per day,orally,respectively since the first day of menstruation for 3 consecutive menstrual cycles.The primary endpoint was clinical response to dysmenorrhea evaluated using a 10-point Visual Analogue Scale at 3 and 6 months.The secondary endpoint was the pain score evaluated by VAS(chronic pelvic pain,defecation pain,and dyspareunia)at 3 and 6 months,and the pain recurrence rate at 6 months.Adverse events(AEs)were recorded during the study.Results:A total of 241 women were included in the SAC group,and 82 were in the placebo group.Among these women,217(90.0％)and 71(86.6％)completed the intervention,respectively.At 3 months,overall response rate(ORR)was significantly higher in women administered SAC(80.1％)compared with those who received a placebo(30.5％,P＜0.01).Six months after treatment,the ORR for dysmenorrhea was 62.7％in the SAC group and 31.7％in the placebo group(P＜0.01).Chronic pelvic pain and defecation pain were significantly improved by SAC compared with placebo(both P＜0.05).The incidence rates of total AEs events in the SAC and placebo groups were 6.6％and 9.8％,respectively,and no significant difference was shown between the two groups(P=0.339).Conclusion:SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain.(Trial registration:ClinicaITrials.gov,No.NCT02031523)

endometriosispainSanjie Analgesic Capsulerandomized controlled trialChinese medicine

LENG Jin-hua、DUAN Hua、GUAN Zheng、ZHOU Ying-fang、QU Hong、XU Kai-hong、ZHANG Shao-fen、ZHANG Qin、WANG Xin、LIN Kai-qing、LANG Jing-he

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Department of Obstetrics and Gynecology,Peking Union Medical College Hospital,Beijing 100730,China

Department of Gynecology,Beijing Obstetrics and Gynecology Hospital,Capital Medical University,Beijing(100006),China

Department of Gynecology,Chinese PLA General Hospital,Beijing(100039),China

Department of Gynecology,Peking University First Hospital,Beijing 100034,China

Department of Gynecology,Beijing Chao-yang Hospital,Beijing(100020),China

Department of Gynecology,Womens Hospital School of Medicine,Zhejiang University,Hangzhou,Zhejiang Province(310006),China

Department of Gynecology,Obstetrics and Gynecology Hospital of Fudan University,Shanghai 200090,China

Department of Gynecology,Hangzhou Hospital of Traditional Chinese Medicine,Hangzhou(310007),China

Department of Gynecology,Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang(110032),China

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2024

10.1007/s11655-024-3756-y

中国结合医学杂志(英文版)
中国中西医结合学会 中国中医研究院

中国结合医学杂志(英文版)

CSTPCD
影响因子：1.056
ISSN：1672-0415
年,卷(期)：2024.30(9)