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 conduc...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.展开更多
文摘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.
