Yuanjie Sun1, Yan Liu2, Baoyan Liu1, Kehua Zhou3, Zenghui Yue4, Wei Zhang5, Wenbin Fu6, Jun Yang7, Ning Li8, Liyun He9, Zhiwei Zang10, Tongsheng Su11, Jianqiao Fang12, Yulong Ding13, Zongshi Qin1, Hujie Song14, Hui Hu15, Hong Zhao16, Qian Mo17, Jing Zhou1, Jiani Wu1, Xiaoxu Liu1, Weiming Wang1, Ran Pang1, Huan Chen1, Xinlu Wang1, Zhishun Liu1. 1. Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China (Y.S., B.L., Z.Q., J.Z., J.W., X.L., W.W., R.P., H.C., X.W., Z.L.). 2. Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (Y.L.). 3. ThedaCare Regional Medical Center - Appleton, Appleton, Wisconsin (K.Z.). 4. Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China (Z.Y.). 5. The First Hospital of Hunan University of Chinese Medicine, Changsha, China (W.Z.). 6. Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China (W.F.). 7. The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China (J.Y.). 8. West China Hospital of Sichuan University, Chengdu, China (N.L.). 9. China Academy of Chinese Medical Sciences, Beijing, China (L.H.). 10. Yantai Hospital of Traditional Chinese Medicine, Yantai, China (Z.Z.). 11. Shaanxi Provincial Hospital of Traditional Chinese Medicine, Xi'an, China (T.S.). 12. The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China (J.F.). 13. Beijing Fengtai Hospital of Integrated Traditional and Western Medicine, Beijing, China (Y.D.). 14. Xi'an TCM Brain Disease Hospital, Xi'an, China (H.S.). 15. Dongfang Hospital Beijing University of Chinese Medicine, Beijing, China (H.H.). 16. Luohu District Hospital of Traditional Chinese Medicine, Shenzhen, China (H.Z.). 17. Guizhou University of Traditional Chinese Medicine, Guiyang, China (Q.M.).
Abstract
BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.
BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.