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

ABSTRACT: BACKGROUND: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. METHODS: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. DISCUSSION:This study will provide robust evidence on whether acupuncture is effective for relieving symptoms of CP/CPPS. TRIALS REGISTRATION:ClinicalTrials.gov, NCT03213938. Registered on 5 July 2017.

SUBMITTER: Qin Z

PROVIDER: S-EPMC5741861 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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

Qin Zongshi Z Liu Yan Y Zhou Kehua K Wu Jiani J Pang Ran R Li Ning N Xu Chang C Kwong Joey S W JSW Liu Zhishun Z

Trials 20171222 1

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 29273095

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Project description:Acupuncture is a promising therapy for relieving symptoms in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), which affects >15% of adult men worldwide. The aim of the study was to assess the effects and safety of the use of acupuncture for CP/CPPS. MEDLINE, EMBASE, CENTRAL, Web of Science, CBM, CNKI, Wang-Fang Database, JCRM, and CiNii were searched from their inception through 30 November 2015. Grey literature databases and websites were also searched. No language limits were applied. Only randomized controlled trials (RCTs) with CP/CPPS treated by acupuncture were included. Two reviewers extracted data and assessed the risk of bias of RCTs using the Cochrane Risk of Bias Tools, respectively. Seven trials were included, involving 471 participants. The result of meta-analysis indicated that compared with sham acupuncture (MD: -6.09 [95%CI: -8.12 to -5.68]) and medicine (Levofloxacinand, Ibuprofen, and Tamsulosin) (MD: -4.57 [95%CI: -7.58 to -1.56]), acupuncture was more effective at decreasing the total NIH-CPSI score. Real acupuncture was superior to sham acupuncture in improving symptoms (pain, voiding) and quality of life (Qof) domain subscores. Compared to sham acupuncture and medicine, acupuncture appears to be more effective at improving the global assessment. Two trials found that there is no significant difference between acupuncture and sham acupuncture in decreasing the IPSS score. Acupuncture failed to show more favorable effects in improving both symptoms and the Qof domain compared with medicine. Overall, current evidence supports acupuncture as an effective treatment for CP/CPPS-induced symptoms, particularly in relieving pain. Based on the meta-analysis, acupuncture is superior to sham acupuncture in improving symptoms and Qof. Acupuncture might be similar to medicine (Levofloxacinand, Ibuprofen, and Tamsulosin) in its long-term effects, but evidence was limited due to high ROB among included trials as well as potential heterogeneity. Acupuncture is associated with rare and slightly adverse events. Protocol registration PROSPERO CRD42015027522.

Project description:ContextAcupuncture is a promising therapy for relieving symptoms in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), which affects 9-16% of adult men worldwide.ObjectiveThis study aims to explore the efficacy and safety of acupuncture for CP/CPPS.Evidence acquisitionNine electronic databases were searched. Only randomized controlled trials were included. Two reviewers extracted data and assessed the risk of bias of trials using the revised Cochrane risk-of-bias (RoB 2.0) tool. Stata 17.0 was used to analyze the data.Evidence synthesisTwelve trials were included. The results of a meta-analysis showed that acupuncture had larger effect sizes (standardized mean difference [SMD] = -1.20, confidence interval or CI [-1.69, -0.71], acupuncture compared with sham acupuncture; SMD = -1.01, CI [-1.63, -0.38], acupuncture compared with medication; SMD = -0.91, CI [-1.29, -0.54], acupuncture plus medication compared with medication) in reducing the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. In decreasing NIH-CPSI pain domain score, acupuncture also led to larger effect sizes (SMD = -0.94, CI [-1.18, -0.70], acupuncture compared with sham acupuncture; SMD = -1.04, CI [-1.29, -0.79], acupuncture compared with medication; SMD = -0.85, CI [-1.23, -0.48], acupuncture plus medication compared with medication), whereas the effect sizes in the reduction of NIH-CPSI urinary domain and quality of life domain scores were medium. Compared with sham acupuncture and medication, acupuncture appears to be more effective in improving the global response rate. Results from four trials indicated that acupuncture was better than sham acupuncture in decreasing the International Prostate Symptom Score. No serious adverse effects were found in the acupuncture treatment.ConclusionsCurrent evidence supports acupuncture as an effective treatment for CP/CPPS-induced symptoms, particularly in relieving pain. Comprehensive acupuncture treatment according to individual symptoms should be considered in future clinical practice and trials for CP/CPPS.Patient summaryIn this study, we further verified the efficacy of acupuncture in patients with chronic prostatitis/chronic pelvic pain syndrome, especially in reducing pain.

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

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

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