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
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.
Chin J Integr Med. 2024 Sep;30(9):780-787. doi: 10.1007/s11655-024-3756-y. Epub 2024 Jul 24.
To assess the efficacy and safety of Sanjie Analgesic Capsule (SAC) in Chinese patients with endometriosis-associated pain.
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.
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).
SAC is well-tolerated and may improve dysmenorrhea in women with endometriosis-associated pain. (Trial registration: ClinicalTrials.gov, No. NCT02031523).
评估散结镇痛胶囊（SAC）治疗中国子宫内膜异位症相关性疼痛患者的有效性和安全性。
这是一项多中心、随机、双盲、安慰剂对照试验，于2013年11月至2017年7月在中国15个中心开展。323例符合条件的子宫内膜异位症患者按3:1的比例通过分层区组随机化法随机分为SAC组（241例）和安慰剂组（82例）。SAC组或安慰剂组患者自月经第一天起分别口服SAC或安慰剂，1.6 g，每日3次，连续3个月经周期。主要终点是在3个月和6个月时使用10分视觉模拟量表评估的痛经临床反应。次要终点是在3个月和6个月时通过视觉模拟量表（慢性盆腔疼痛、排便疼痛和性交疼痛）评估的疼痛评分，以及6个月时的疼痛复发率。研究期间记录不良事件（AE）。
SAC组共纳入241例女性，安慰剂组纳入82例。这些女性中，分别有217例（90.0%）和71例（86.6%）完成了干预。3个月时，服用SAC的女性总体缓解率（ORR）显著高于接受安慰剂的女性（80.1%对30.5%，P<0.01）。治疗6个月后，SAC组痛经的ORR为62.7%，安慰剂组为31.7%（P<0.01）。与安慰剂相比，SAC显著改善了慢性盆腔疼痛和排便疼痛（均P<0.05）。SAC组和安慰剂组总AE事件的发生率分别为6.6%和9.8%，两组间无显著差异（P=0.339）。
SAC耐受性良好，可能改善子宫内膜异位症相关性疼痛女性的痛经。（试验注册号：ClinicalTrials.gov，编号NCT02031523）
