Skip to main content
Top
Published in: BMC Complementary Medicine and Therapies 1/2016

Open Access 01-12-2016 | Study protocol

Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial

Authors: Zongshi Qin, Zhiwei Zang, Jiani Wu, Jing Zhou, Zhishun Liu

Published in: BMC Complementary Medicine and Therapies | Issue 1/2016

Login to get access

Abstract

Background

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. The currently available therapies offer little or no proven benefit for CP/CPPS. We designed this study to assess the efficacy of acupuncture therapy for the treatment of CP/CPPS.

Methods

This study is designed as a randomized, sham acupuncture-controlled trial. We will compare patients with CP/CPPS in an acupuncture group and a sham acupuncture group. Sixty-eight patients will be randomly allocated to receive acupuncture or sham acupuncture. The treatments will consist of 30-min sessions, three times weekly, for 8 weeks. The primary outcome measure is change in the weekly mean National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline through the 8-week treatment period. Secondary measures include the NIH-CPSI subscale scores, the total International Prostate Symptom Score (IPSS), patients’ response rate, and patient satisfaction after treatment. We will also assess changes in the NIH-CPSI total score from baseline at the 20th and 32nd week of follow-up.

Discussion

This is a randomized, sham-controlled trial of acupuncture treatment for CP/CPPS. The results of this trial will provide more evidence on whether acupuncture is efficacious for treating CP/CPPS.

Trial registration

Clinical Trials.gov NCT02588274
Literature
1.
go back to reference Krieger JN, Riley DE, Cheah PY, Liong ML, Yuen KH. Epidemiology of prostatitis: new evidence for a world-wide problem. World J Urol. 2003;21:70–4.CrossRefPubMed Krieger JN, Riley DE, Cheah PY, Liong ML, Yuen KH. Epidemiology of prostatitis: new evidence for a world-wide problem. World J Urol. 2003;21:70–4.CrossRefPubMed
2.
go back to reference Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001;165:842–5.CrossRefPubMed Nickel JC, Downey J, Hunter D, Clark J. Prevalence of prostatitis-like symptoms in a population based study using the National Institutes of Health chronic prostatitis symptom index. J Urol. 2001;165:842–5.CrossRefPubMed
3.
go back to reference Clemens JQ, Meenan RT, O’Keeffe-Rosetti MC, Gao SY, Brown SO, Calhoun EA. Prevalence of prostatitis-like symptoms in a managed care population. J Urol. 2006;176:593–6.CrossRefPubMed Clemens JQ, Meenan RT, O’Keeffe-Rosetti MC, Gao SY, Brown SO, Calhoun EA. Prevalence of prostatitis-like symptoms in a managed care population. J Urol. 2006;176:593–6.CrossRefPubMed
4.
go back to reference Liang CA, Li HJ, Wang ZP, Xing JP, Hu WL, Zhang TF, et al. The prevalence of prostatitis-like symptoms in China. J Urol. 2009;182:558–63.CrossRefPubMed Liang CA, Li HJ, Wang ZP, Xing JP, Hu WL, Zhang TF, et al. The prevalence of prostatitis-like symptoms in China. J Urol. 2009;182:558–63.CrossRefPubMed
5.
go back to reference Rees J, Abrahams M, Doble A, Cooper A. Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: a consensus guideline. BJU Int. 2015;116:509–25.CrossRefPubMedPubMedCentral Rees J, Abrahams M, Doble A, Cooper A. Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: a consensus guideline. BJU Int. 2015;116:509–25.CrossRefPubMedPubMedCentral
6.
go back to reference Schaeffer AJ. Etiology and management of chronic pelvic pain syndrome in men. Urology. 2004;63 Suppl 1:75–84.CrossRefPubMed Schaeffer AJ. Etiology and management of chronic pelvic pain syndrome in men. Urology. 2004;63 Suppl 1:75–84.CrossRefPubMed
7.
go back to reference Yang Q, Wei Q, Li H, Yang Y, Zhang S, Dong Q. The effect of alpha-adrenergic antagonists in chronic prostatitis/chronic pelvic pain syndrome: a meta-analysis of randomized controlled trials. J Androl. 2006;27:847–52.CrossRefPubMed Yang Q, Wei Q, Li H, Yang Y, Zhang S, Dong Q. The effect of alpha-adrenergic antagonists in chronic prostatitis/chronic pelvic pain syndrome: a meta-analysis of randomized controlled trials. J Androl. 2006;27:847–52.CrossRefPubMed
8.
go back to reference Anothaisintawee T, Attia J, Nickel JC, Thammakraisorn S, Numthavaj P, McEvoy M, et al. Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA. 2011;305:78–86.CrossRefPubMed Anothaisintawee T, Attia J, Nickel JC, Thammakraisorn S, Numthavaj P, McEvoy M, et al. Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA. 2011;305:78–86.CrossRefPubMed
9.
go back to reference Nickel JC, Baranowski AP, Pontari M, Berger RE, Tripp DA. Management of men diagnosed with chronic prostatitis/chronic pelvic pain syndrome who have failed traditional management. Rev Urol. 2007;9:63–72. Nickel JC, Baranowski AP, Pontari M, Berger RE, Tripp DA. Management of men diagnosed with chronic prostatitis/chronic pelvic pain syndrome who have failed traditional management. Rev Urol. 2007;9:63–72.
10.
go back to reference Anderson RU, Wise D, Sawyer T, Chan C. Integration of myo-fascial trigger point release and paradoxical relaxation training treatment of chronic pelvic pain in men. J Urol. 2005;174:155–60.CrossRefPubMed Anderson RU, Wise D, Sawyer T, Chan C. Integration of myo-fascial trigger point release and paradoxical relaxation training treatment of chronic pelvic pain in men. J Urol. 2005;174:155–60.CrossRefPubMed
11.
go back to reference Lee SH, Lee BC. Use of acupuncture as a treatment method for chronic prostatitis/chronic pelvic pain syndromes. Curr Urol Rep. 2011;12:288–96.CrossRefPubMed Lee SH, Lee BC. Use of acupuncture as a treatment method for chronic prostatitis/chronic pelvic pain syndromes. Curr Urol Rep. 2011;12:288–96.CrossRefPubMed
12.
go back to reference Lee SW, Liong ML, Yuen KH, Krieger JN. Acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain. Am J Med. 2008;121:79.e1–7. Lee SW, Liong ML, Yuen KH, Krieger JN. Acupuncture versus sham acupuncture for chronic prostatitis/chronic pelvic pain. Am J Med. 2008;121:79.e1–7.
13.
go back to reference Lee SH, Lee BC. Electroacupuncture relieves pain in men with chronic prostatitis/chronic pelvic pain syndrome: three-arm randomized trial. Urology. 2009;73:1036–41.CrossRefPubMed Lee SH, Lee BC. Electroacupuncture relieves pain in men with chronic prostatitis/chronic pelvic pain syndrome: three-arm randomized trial. Urology. 2009;73:1036–41.CrossRefPubMed
14.
go back to reference Sahin S, Bicer M, Eren GA, Tas S, Tugcu V, Tasci AI, et al. Acupuncture relieves symptoms in chronic prostatitis/chronic pelvic pain syndrome: a randomized, sham-controlled trial. Prostate Cancer Prostatic Dis. 2015;18:249–54.CrossRefPubMed Sahin S, Bicer M, Eren GA, Tas S, Tugcu V, Tasci AI, et al. Acupuncture relieves symptoms in chronic prostatitis/chronic pelvic pain syndrome: a randomized, sham-controlled trial. Prostate Cancer Prostatic Dis. 2015;18:249–54.CrossRefPubMed
15.
go back to reference Küçük EV, Suçeken FY, Bindayı A, Boylu U, Onol FF, Gümüş E. Effectiveness of acupuncture on chronic prostatitis-chronic pelvic pain syndrome category IIIB patients: a prospective, randomized, nonblinded, clinical trial. Urology. 2015;85:636–40.CrossRefPubMed Küçük EV, Suçeken FY, Bindayı A, Boylu U, Onol FF, Gümüş E. Effectiveness of acupuncture on chronic prostatitis-chronic pelvic pain syndrome category IIIB patients: a prospective, randomized, nonblinded, clinical trial. Urology. 2015;85:636–40.CrossRefPubMed
16.
go back to reference Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ. 2013;346:e7586.CrossRefPubMedPubMedCentral
17.
go back to reference Krieger JN, Hyberg L, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999;282:236–7.CrossRefPubMed Krieger JN, Hyberg L, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA. 1999;282:236–7.CrossRefPubMed
18.
go back to reference Nickel JC, Shoskes D, Wang Y, Alexander RB, Fowler Jr JE, Zeitlin S, et al. How does the pre-massage and post massage 2-glass test compare to the Meares-Stamey 4-glass test in men with chronic prostatitis/chronic pelvic pain syndrome? J Urol. 2006;176:119–24.CrossRefPubMed Nickel JC, Shoskes D, Wang Y, Alexander RB, Fowler Jr JE, Zeitlin S, et al. How does the pre-massage and post massage 2-glass test compare to the Meares-Stamey 4-glass test in men with chronic prostatitis/chronic pelvic pain syndrome? J Urol. 2006;176:119–24.CrossRefPubMed
19.
go back to reference Xie H. Huangdi Neijing. Publishing House of Ancient Chinese Medical books. 2001. Xie H. Huangdi Neijing. Publishing House of Ancient Chinese Medical books. 2001.
20.
go back to reference Yuan SY, Qin Z, Liu DS, Yin WQ, Zhang ZL, Li SG. Acupuncture for chronic pelvic pain syndromes (CPPS) and its effect on cytokines in prostatic fluid. Zhongguo Zhen Jiu. 2011;31:11–4.PubMed Yuan SY, Qin Z, Liu DS, Yin WQ, Zhang ZL, Li SG. Acupuncture for chronic pelvic pain syndromes (CPPS) and its effect on cytokines in prostatic fluid. Zhongguo Zhen Jiu. 2011;31:11–4.PubMed
21.
go back to reference Siegel S, Paszkiewicz E, Kirkpatrick C, Hinkel B, Oleson K. Sacral nerve stimulateon in patients with chronic intractable pelvic pain. J Urol. 2001;166:1742–5.CrossRefPubMed Siegel S, Paszkiewicz E, Kirkpatrick C, Hinkel B, Oleson K. Sacral nerve stimulateon in patients with chronic intractable pelvic pain. J Urol. 2001;166:1742–5.CrossRefPubMed
22.
go back to reference Chen R, Nickel JC. Acupuncture ameliorates symptoms in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2003;61:1156–9.CrossRefPubMed Chen R, Nickel JC. Acupuncture ameliorates symptoms in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2003;61:1156–9.CrossRefPubMed
23.
go back to reference Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352:364–5.CrossRefPubMed Streitberger K, Kleinhenz J. Introducing a placebo needle into acupuncture research. Lancet. 1998;352:364–5.CrossRefPubMed
24.
go back to reference Hong K, Xu QQ, Jiang H, Wang XF, Zhu JC. Chronic Prostatitis Symptom Index of Chinese. Zhonghua Nan Ke Xue. 2002;8:38–41.PubMed Hong K, Xu QQ, Jiang H, Wang XF, Zhu JC. Chronic Prostatitis Symptom Index of Chinese. Zhonghua Nan Ke Xue. 2002;8:38–41.PubMed
25.
go back to reference Litwin MS. A review of the development and validation of the national institutes of health chronic prostatitis symptom index. Urology. 2002;60:14–8.CrossRefPubMed Litwin MS. A review of the development and validation of the national institutes of health chronic prostatitis symptom index. Urology. 2002;60:14–8.CrossRefPubMed
26.
go back to reference Edmond PH, Cindy LK, Weng YC. Validation of the international prostate symptom score in Chinese males and females with lower urinary tract. Health Qual Life Outcomes. 2014;12:1–9.CrossRef Edmond PH, Cindy LK, Weng YC. Validation of the international prostate symptom score in Chinese males and females with lower urinary tract. Health Qual Life Outcomes. 2014;12:1–9.CrossRef
27.
go back to reference Szeto PS. Applilcation of the Chinese version of the international prostate symptom score for the management of lower urinary tract symptoms in a primary health care setting. Hong Kong Med J. 2008;14:458–64.PubMed Szeto PS. Applilcation of the Chinese version of the international prostate symptom score for the management of lower urinary tract symptoms in a primary health care setting. Hong Kong Med J. 2008;14:458–64.PubMed
28.
go back to reference Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O’Leary MP, et al. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004;141:581–9.CrossRefPubMed Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, O’Leary MP, et al. Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med. 2004;141:581–9.CrossRefPubMed
29.
go back to reference He TY, Xu YL. Clinical observation on acupuncture at “san yin points” plus “yin san points” for treatment of chronic prostatitis. World J Clin Acupunct Moxibust. 2007;23:12–3. He TY, Xu YL. Clinical observation on acupuncture at “san yin points” plus “yin san points” for treatment of chronic prostatitis. World J Clin Acupunct Moxibust. 2007;23:12–3.
30.
go back to reference Hu BC, Wang S, Zhou ZK, Cai YY. Point-through-point acupuncture for treatment of chronic non-bacterial prostatitis. Cap Med. 2005;21:8–9. Hu BC, Wang S, Zhou ZK, Cai YY. Point-through-point acupuncture for treatment of chronic non-bacterial prostatitis. Cap Med. 2005;21:8–9.
31.
go back to reference Jin XH, Ji LX. Clinical study on acupuncture for the treatment of chronic non-bacterial prostatitis and prostatodynia. Chin Naturopath. 2008;5:9. Jin XH, Ji LX. Clinical study on acupuncture for the treatment of chronic non-bacterial prostatitis and prostatodynia. Chin Naturopath. 2008;5:9.
32.
go back to reference Chen ZS. Observation of therapeutic effect on chronic non-bacterial prostatitis treated with warm needling moxibustion. World J Acupunct Moxibust. 2009;19:19–29. Chen ZS. Observation of therapeutic effect on chronic non-bacterial prostatitis treated with warm needling moxibustion. World J Acupunct Moxibust. 2009;19:19–29.
33.
go back to reference Li C, Wang HS. Clinical study of acupuncture for the treatment of chronic prostatitis. Beijing J Tradit Chin Med. 2006;25:680–1. Li C, Wang HS. Clinical study of acupuncture for the treatment of chronic prostatitis. Beijing J Tradit Chin Med. 2006;25:680–1.
34.
go back to reference Posadzki P, Zhang J, Lee MS, Ernst E. Acupuncture for chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a systematic review. J Androl. 2012;33:15–21.CrossRefPubMed Posadzki P, Zhang J, Lee MS, Ernst E. Acupuncture for chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a systematic review. J Androl. 2012;33:15–21.CrossRefPubMed
35.
go back to reference Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, et al. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–25.CrossRefPubMed Linde K, Streng A, Jürgens S, Hoppe A, Brinkhaus B, Witt C, et al. Acupuncture for patients with migraine: a randomized controlled trial. JAMA. 2005;293:2118–25.CrossRefPubMed
36.
go back to reference Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicenter randomized controlled clinical trial. Lancet Neurol. 2006;5:310–6.CrossRefPubMed Diener HC, Kronfeld K, Boewing G, Lungenhausen M, Maier C, Molsberger A, et al. Efficacy of acupuncture for the prophylaxis of migraine: a multicenter randomized controlled clinical trial. Lancet Neurol. 2006;5:310–6.CrossRefPubMed
37.
go back to reference Birch S. A review and analysis of placebo treatments, placebo effects and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006;12:303–10.CrossRefPubMed Birch S. A review and analysis of placebo treatments, placebo effects and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006;12:303–10.CrossRefPubMed
38.
go back to reference Vickers AJ. Placebo controls in randomized trials of acupuncture. Eval Health Profess. 2002;25:421–35.CrossRef Vickers AJ. Placebo controls in randomized trials of acupuncture. Eval Health Profess. 2002;25:421–35.CrossRef
39.
go back to reference Liu B, Xu H, Ma R, Mo Q, Yan S, Liu Z. Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study. Medicine. 2014;93:e 200.CrossRef Liu B, Xu H, Ma R, Mo Q, Yan S, Liu Z. Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study. Medicine. 2014;93:e 200.CrossRef
40.
go back to reference Wang Y, Liu B, Yu J, Wu J, Wang J, Liu Z. Electroacupuncture for moderate and severe benign prostatic hyperplasia: a randomized controlled trial. PLoS ONE. 2013;8:e59449.CrossRefPubMedPubMedCentral Wang Y, Liu B, Yu J, Wu J, Wang J, Liu Z. Electroacupuncture for moderate and severe benign prostatic hyperplasia: a randomized controlled trial. PLoS ONE. 2013;8:e59449.CrossRefPubMedPubMedCentral
41.
go back to reference Nickel JC. The overlapping lower urinary tract symptoms of benign prostatic hyperplasia and prostatitis. Curr Opin Urol. 2006;16:5–10.CrossRefPubMed Nickel JC. The overlapping lower urinary tract symptoms of benign prostatic hyperplasia and prostatitis. Curr Opin Urol. 2006;16:5–10.CrossRefPubMed
42.
go back to reference Altman DG, Dore CJ. Randomisation and baseline comparisons in clinical trials. Lancet. 1990;335:149–53.CrossRefPubMed Altman DG, Dore CJ. Randomisation and baseline comparisons in clinical trials. Lancet. 1990;335:149–53.CrossRefPubMed
Metadata
Title
Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial
Authors
Zongshi Qin
Zhiwei Zang
Jiani Wu
Jing Zhou
Zhishun Liu
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Complementary Medicine and Therapies / Issue 1/2016
Electronic ISSN: 2662-7671
DOI
https://doi.org/10.1186/s12906-016-1428-y

Other articles of this Issue 1/2016

BMC Complementary Medicine and Therapies 1/2016 Go to the issue