Baoyan Liu1, Yan Liu2, Zongshi Qin1, Kehua Zhou3, Huangfang Xu4, Liyun He2, Ning Li5, Tongsheng Su6, Jianhua Sun7, Zenghui Yue8, Zhiwei Zang9, Wei Zhang10, Jiping Zhao11, Zhongyu Zhou12, Lian Liu13, Dongning Wu2, Jiani Wu1, Jing Zhou1, Ran Pang1, Yang Wang1, Jia Liu2, Jinna Yu1, Zhishun Liu14. 1. Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China. 2. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China. 3. Catholic Health System Internal Medicine Training Program, University at Buffalo, Buffalo, NY. 4. Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China. 5. West China Hospital of Sichuan University, Chengdu, China. 6. Shaanxi Province Hospital of Traditional Chinese Medicine, Xi'an, China. 7. Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, China. 8. Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China. 9. Yantai Hospital of Traditional Chinese Medicine, Yantai, China. 10. The First Hospital of Hunan University of Chinese Medicine, Changsha, China. 11. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China. 12. Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. 13. Qingdao Haici Medical Center, Qingdao, China. 14. Guang'an Men Hospital, China Academy of Chinese Medical Sciences, Beijing, China. Electronic address: zhishunjournal@163.com.
Abstract
OBJECTIVE: To evaluate the efficacy and safety of electroacupuncture vs pelvic floor muscle training (PFMT) plus solifenacin for women with mixed urinary incontinence (MUI). PATIENTS AND METHODS: This randomized controlled noninferiority trial was conducted at 10 hospitals in China between March 1, 2014, and October 10, 2016. Participants were randomized 1:1 to receive electroacupuncture (36 sessions) over 12 weeks with 24 weeks of follow-up or PFMT-solifenacin (5 mg/d) over 36 weeks. The primary outcome was percentage change from baseline to week 12 in mean 72-hour incontinence episode frequency (IEF) measured by the 72-hour bladder diary. It was analyzed in the per-protocol set with a prespecified noninferiority margin of 15%. RESULTS: Of 500 women with MUI who were randomized, 467 (239 in the electroacupuncture group and 228 in the PFMT-solifenacin group) completed treatment per protocol and were included in the primary outcome analysis. At weeks 1 through 12, the percentage of reduction from baseline in mean 72-hour IEF was 37.83% in the electroacupuncture group and 36.49% in the PFMT-solifenacin group (between-group difference, -1.34% [95% CI, -9.78% to 7.10%]; P<.001 for noninferiority), which demonstrates noninferiority; the treatment effect persisted throughout follow-up. Statistically significant improvements were found for secondary outcomes in both groups, with no meaningful difference between treatments. CONCLUSION: In women with moderate to severe MUI, electroacupuncture was not inferior to PFMT-solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02047032.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of electroacupuncture vs pelvic floor muscle training (PFMT) plus solifenacin for women with mixed urinary incontinence (MUI). PATIENTS AND METHODS: This randomized controlled noninferiority trial was conducted at 10 hospitals in China between March 1, 2014, and October 10, 2016. Participants were randomized 1:1 to receive electroacupuncture (36 sessions) over 12 weeks with 24 weeks of follow-up or PFMT-solifenacin (5 mg/d) over 36 weeks. The primary outcome was percentage change from baseline to week 12 in mean 72-hour incontinence episode frequency (IEF) measured by the 72-hour bladder diary. It was analyzed in the per-protocol set with a prespecified noninferiority margin of 15%. RESULTS: Of 500 women with MUI who were randomized, 467 (239 in the electroacupuncture group and 228 in the PFMT-solifenacin group) completed treatment per protocol and were included in the primary outcome analysis. At weeks 1 through 12, the percentage of reduction from baseline in mean 72-hour IEF was 37.83% in the electroacupuncture group and 36.49% in the PFMT-solifenacin group (between-group difference, -1.34% [95% CI, -9.78% to 7.10%]; P<.001 for noninferiority), which demonstrates noninferiority; the treatment effect persisted throughout follow-up. Statistically significant improvements were found for secondary outcomes in both groups, with no meaningful difference between treatments. CONCLUSION: In women with moderate to severe MUI, electroacupuncture was not inferior to PFMT-solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02047032.