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Comparison of 3 assessment modes of acupuncture effect on patients with chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessment regarding the therapeutic effects of acupuncture. METHODS:Sixty patients with CP/CPPS will be randomly assigned to receive either acupuncture or sham-acupuncture (30 patients, each). Treatment will be conducted 3 times/week, for 4 weeks. The coprimary outcomes will each be the change from baseline of the total NIH (National Institutes of Health) CPSI (Chronic Prostatitis Symptom Index) score associated with 3 modes of assessment: Mode 1, the scale recorded at the hospital within 10?minutes after the last session of 4 weeks of acupuncture treatment, in the company of the outcome assessors; Mode 2, the scale recorded the same day, but not at the hospital; and Mode 3, the scale recorded at the hospital 1 to 3 days after the last acupuncture session. The 3 key secondary outcomes include will be the 3 modes assessment of the changes from baseline of the NIH-CPSI total scores in the acupuncture group at week 4 after treatment. Analysis was by intention-to-treat, and multiplicity was controlled for with a step-down closed-testing procedure. DISCUSSION:To our knowledge, previous studies did not include the details of assessment scales when determining the efficacy of acupuncture in CP/CPPS. Furthermore, it is not clear which mode was used to assess the effect. The answers provided by the proposed study may improve the reproducibility of acupuncture research and the reliability of results.

SUBMITTER: Zhou J

PROVIDER: S-EPMC6211918 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Comparison of 3 assessment modes of acupuncture effect on patients with chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.

Zhou Jing J Liu Yan Y Li Chunbin C Liu Zhishun Z

Medicine 20181001 42

<h4>Background</h4>Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a common disorder. Some studies have indicated that acupuncture may ameliorate the symptoms of CP/CPPS. However, results are varied and range widely, perhaps due to different modes of assessment including timepoints, places of assessment, and especially subjective scales. We propose to determine the efficacy of acupuncture relative to sham acupuncture for patients with CP/CPPS, and compare different modes of assessm ...[more]

PMID: 30335011

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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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Comparison of 3 assessment modes of acupuncture effect on patients with chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.

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Comparison of 3 assessment modes of acupuncture effect on patients with chronic prostatitis/chronic pelvic pain syndrome: A study protocol for a randomized controlled trial.

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