Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common condition affecting men of all ages. Acupuncture may be an effective treatment option for CP/CPPS, but evidence is limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.

Ten hospitals will recruit 440 participants with CP/CPPS in China from October 2017 to December 2019. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The whole study consists of 2-week baseline, 8-week treatment, and 24-week follow up. Twenty 30-mintute sessions of acupuncture or sham acupuncture treatment will be provided between week 1 and 8. The two co-primary outcomes are the proportion of responders at week 8 and week 32. Secondary outcomes include proportion of responders in the two groups at different time points; change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score; change in the NIH-CPSI subscales; change in the International Prostate Symptom Score; change in the Hospital Anxiety and Depression Scale; expectation assessments; proportions of participants in each response category of the Global Response Assessment; change in the International Index of Erectile Function 5; change in the five-level EuroQol five-dimensional questionnaire and a visual analogue scale; and changes in peak and average urinary flow rate.

This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS.

ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017.

Trials. 2017 Dec 22*** epublish ***

Zongshi Qin, Yan Liu, Kehua Zhou, Jiani Wu, Ran Pang, Ning Li, Chang Xu, Joey S W Kwong, Zhishun Liu

Department of Acupuncture and Neurology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China., Data Centre of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing, China., Catholic Health System Internal Medicine Training Program, Sisters of Charity Hospital, University at Buffalo, Buffalo, NY, USA., Department of Urology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China., West China Hospital, Sichuan University, Chengdu, China., Chinese Evidence-Based Medicine Center and Chinese Cochrane Center, West China Hospital, Sichuan University, Chengdu, China., JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Hong Kong., Department of Acupuncture and Neurology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China. .

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