Journal of Andrology, Vol. 33, No. 1, January/February 2012 Copyright E American Society of Andrology Acupuncture for Chronic Nonbacterial Prostatitis/Chronic Pelvic Pain Syndrome: A Systematic Review Minireview PAUL POSADZKI,* JUNHUA ZHANG,{ MYEONG SOO LEE,*{ AND EDZARD ERNST* From the *Department of Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Exeter, United Kingdom; the Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, PR China; and the `Brain Disease Research Center, Korea Institute of Oriental Medicine, Daejeon, South Korea. ABSTRACT: The objective of this systematic review was to assess the effectiveness of acupuncture as a treatment option for chronic prostatitis/chronic pelvic pain syndrome. Eight databases were searched from their inception to October 2010. Randomized clinical trials (RCT) were considered if they tested acupuncture against any control intervention or no therapy in humans with chronic prostatitis/chronic pelvic pain syndrome. The selection of studies, data extraction, and validation were performed independently by 2 reviewers. The methodologic quality of all included RCTs was assessed using the Jadad scale. Studies of stimulation of acupoints other than by needles were excluded. Nine RCTs met the inclusion criteria. They all suggested that acupuncture is effective as a range of control interventions. Their methodologic quality was variable; most were associated with major flaws. Only one RCT had a Jadad score of more than 3. The evidence that acupuncture is effective for chronic prostatitis/ chronic pelvic pain syndrome is encouraging but, because of several caveats, not conclusive. Therefore, more rigorous studies seem warranted. Key words: Chronic abacterial prostatitis, effectiveness, complementary and alternative medicine. J Androl 2012;33:15–21 C affected with CP/CPPSs; however, the therapeutic effects of acupuncture for this condition remain uncertain (Capodice et al, 2005). Some studies suggested neuropathic mechanism of action involved in CP/CPPS (Chen and Nickel, 2003), but this is not supported by sound evidence. Wang and Han (2008) published a systematic review and meta-analysis of acupuncture for CP. However, this publication is burdened with a high risk of bias due to ambiguous inclusion criteria and lack of appropriately defined interventions, comprehensive search strategy, or quality appraisal. Significant heterogeneity of the trials included in meta-analysis was neither explained nor accounted for. Specifically, Wang and Han (2008) only included 3 of the 9 randomized clinical trials (RCT) we managed to locate. Moreover, the authors failed to critically evaluate the primary studies that they reviewed. Also, they included such disparate interventions as moxibustion (in 7 of 13 studies) or pricking needling and bloodletting (in one study). Therefore, a more rigorous systematic review is required in order to determine the best evidence on acupuncture for CP/CPPS. The aim of this systematic review is to summarize and critically evaluate the RCTs testing the effectiveness of acupuncture in treatment of CP/CPPS. hronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a clinical entity defined as urologic pain or discomfort in the pelvic region, associated with urinary symptoms and/or sexual dysfunction and lasting for at least 3 of the previous 6 months (Anothaisintawee et al, 2011). The syndrome can affect 10%–15% of the male population and results in nearly 2 million outpatient visits each year (Murphy et al, 2009). Collins et al (2000) concluded that CP/CPPS is difficult to diagnose, and the routine use of antibiotics and alphablockers to treat chronic abacterial prostatitis is not supported by sound evidence. Acupuncture is a traditional Chinese method of medical treatment involving the insertion of fine, single-use, sterile needles in acupoints according to a system of channels and meridians that was developed by early practitioners of traditional Chinese medicine more than 2000 years ago (Capodice et al, 2005). Acupuncture is a ‘‘natural’’ therapy, attractive to many patients Correspondence to: Paul Posadzki, Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth, Veysey Building, Salmon Pool Line, Exeter EX2 4SG, United Kingdom (e-mail: [email protected]). Received for publication February 1, 2011; accepted for publication March 17, 2011. DOI: 10.2164/jandrol.111.013235 15 16 Journal of Andrology N January February 2012 Table 1. Quality assessment of the included studies Author (year) Random Sequence Generation Appropriate Randomization Blinding of Participants or Personnel Blinding of Outcome Assessors He et al (2004) He and Xu (2007) Hu et al (2005) Huang et al (2005) Jin and Ji (2008) Lee et al (2008) Li and Wang (2006) Wang (1997) Zhang (2009) 1 1 1 1 1 1 1 1 1 1 1 0 0 0 1 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 Materials and Methods Literature searches were performed to identify RCTs of acupuncture for CP/CPPS. The following databases were used: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, Chinese Journal Full-Text Database, and Weipu Scientific Journal Database (from their respective inceptions to October 2010) using the following search terms: acupuncture, prostatitis, chronic nonbacterial prostatitis, chronic abacterial prostatitis, chronic pelvic pain syndrome, and prostatodynia to identify all relevant RCTs on the subject. The reference lists of the initially identified papers were scanned for further relevant literature. No language barriers were imposed. All retrieved data, including uncontrolled trials, case studies, and preclinical and observational studies were reviewed for safety information. However, only RCTs testing acupuncture in adults with CP/CPPS were included. Studies were excluded if they were uncontrolled (eg, Chen and Nickel, 2003; Honjo et al, 2004) or used different a method of stimulation of acupoints (eg, warm needling moxibustion; Yu and Kang, 2005; Zhong-Xin, 2009) or electroacupuncture (Li, 2005; Lee and Lee, 2009). Two independent reviewers validated data using a predefined standardized form and assessed the methodologic quality using the 5-point Jadad scale (Jadad et al, 1996). Any differences were resolved by discussion. For the purpose of this review, CP/CPPS was defined as urologic pain or discomfort in the pelvic region, associated with urinary symptoms and/or sexual dysfunction and lasting for at least 3 of the previous 6 months (Anothaisintawee et al, 2011). Results The search strategy generated a total of 128 references, of which 61 were considered to be potentially relevant. We did not locate any unpublished trials. A total of 27 clinical trials were retrieved for further evaluation, of which 9, involving 890 patients, were eligible for inclusion (Wang, 1997; He et al, 2004; Hu et al, 2005; Withdrawals and Dropouts Sum (Jadad Score) 0 0 0 0 0 1 0 0 0 2 2 1 1 1 4 1 1 2 Huang et al, 2005; Li and Wang, 2006; He and Xu, 2007; Jin and Ji, 2008; Lee et al, 2008; Zhang, 2009). Eight RCTs originated from China, (Wang, 1997; He et al, 2004; Hu et al, 2005; Huang et al, 2005; Li and Wang, 2006; He and Xu, 2007; Jin and Ji, 2008; Zhang, 2009) and one from Malaysia (Lee et al, 2008). The quality of studies ranged between 1 and 4 on the Jadad scale. The study of Lee et al (2008) was well designed in terms of randomization, partial blinding, dropouts, and intention to treat analysis, and it used the standardized National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) as a primary outcome. We scored this study as 4. All of the Chinese-language studies were described as randomized; however, only 3 of them reported the methods of sequence generation (ie, ‘‘table of random number’’ [He et al, 2004; He and Xu, 2007] and softwareStatistical Analysis System [Zhang, 2009]). None of the Chinese RCTs described allocation concealment or blinding procedures. None of the trials described dropout rate or intention-to-treat analyses. Overall, the methodologic quality of the Chinese trials was poor (Table 1). Other sources of bias in these studies included lack of standardized/validated primary outcome measures, power calculations, clearly defined inclusion and exclusion criteria, and adequately performed statistical analyses. Additional threats to internal validity included lack of appropriate sampling method, wide confidence intervals, incomplete outcome data, and selective outcome reporting. None of these trials used placebo or sham acupuncture to control adequately for nonspecific effects. Eight Chinese-language studies used effective rate as the primary outcome measure. According to the different type of control treatments, the 8 articles were classified into 4 subgroups (Figure). Needle acupuncture treatments seem more effective than Pule’an pian (He et al, 2004; He and Xu, 2007; Zhang, 2009), conventional drugs for prostatic hyperplasia (Hu et al, 2005; Li and Wang, 2006), antibiotics (Huang et al, 2005), or herbal medicines (Wang, 1997; Jin and Ji, 2008). Posadzki et al N Acupuncture for Prostatitis 17 Figure. Forest plots—effect of acupuncture for chronic nonbacterial prostatitis/chronic pelvic pain syndrome. M-H indicates Mantel-Haenszel. Discussion In their article, Wang and Han (2008) concluded that ‘‘acupuncture therapy exhibited a definite effect in the treatment of chronic prostatitis.’’ Our evaluation suggests that these conclusions are not supported by the best available evidence. The review by Wang and Han was wide open to bias. Therefore, our aim was to provide a rigorous evaluation of the available RCT data. The 9 trials that met our eligibility criteria suggested that acupuncture is effective for chronic CP/CPPS (Wang, 1997; He et al, 2004; Hu et al, 2005; Huang et al, 2005; Li and Wang, 2006; He and Xu, 2007; Jin and Ji, 2008; Lee et al, 2008; Zhang, 2009). Thus, to some extent we arrive at conclusions similar to those by Wang and Han (2008). The important difference, however, is that our results are based on higher quality and quantity of the data. Treatment groups received needle acupuncture (Wang, 1997; He et al, 2004; Hu et al, 2005; Huang et al, 2005; Li and Wang, 2006; He and Xu, 2007; Jin and Ji, 2008; Lee et al, 2008; Zhang, 2009), whereas control Table 2. Details of the acupuncture intervention Author (Year) He and Xu (2007) He et al (2004) Hu et al (2005) Huang et al (2005) Jin and Ji (2008) Li and Wang (2006) Lee et al (2008) Wang (1997) Zhang (2009) Acupuncture Points Used (Direct Quote Where Appropriate) 1. Sanyin points; 2. Sanyin points plus Yinsan points, retaining needle for 30 min, 1 time per d, 30 treatments (36 d) Sanyin points (points at perineum, named by the author) and other acupoints, retaining needle for 30 min, 1 time per d, 30 treatments (36 d) CV3-to-CV2, BL32-to-BL34; BL54-to-BL35, retaining needle for 20 min, 1 time per d for 30 d CV6, CV4, CV3, BL54, BL23, BL28, BL22, ST28, SP9, SP6, KI3, retaining needle for 20–30 min, 1 time per d. Total treatment duration: 2–4 wk. (Not uniform for all patients) BL54 to ST28. Other acupoints were selected individually according to the principle of traditional Chinese medicine. Retaining needle for 30 min, 1 time per d, duration 2 mo CV1 and CV3. Other acupoints were selected individually according to the principle of traditional Chinese medicine. Retaining needle for 30 min, 3 times per wk, total treatment duration 8 wk CV1 inserted with a depth of 50 mm, CV4 with 60 mm, and SP6 and SP9 with 40 mm. Two weekly sessions for 10 wk, 30 min each session CV1. Duration: 1 time per d, without retaining needle, 4 wk (1 d stopping per wk) BL54-to-ST28, retaining needle, 30 min per treatment, tertian treating, duration 8 wk Study Design CP/CPPS CP and prostatodynia CP CP CP CP Condition 90 (51/39) 89 (44/45) 60 (30/30) 84 (42/42) 90 (48/42) 115 (T1 40/T2 45/ C 30) 90 (60/30) Sample Size (T/C) T: 21–52 (mean, 35) C: 19–55 (mean, 33) T: 40.9 C: 42.8 T: 25–50 (mean, 37.5) C: 24–51 (mean, 37.5) 20–49 (mean age, 32.98) 18–65 T1: 22–76 T2: 18–72 C: 20–72 T: 19–76 C: 20–72 Mean Age of Participants or Age Range, y Needle acupuncture Acupuncture Needle acupuncture Needle acupuncture Needle acupuncture Needle acupuncture Needle acupuncture Treatment Group (Regimen) Primary Outcome Measure NIH-CPSI Adverse Effects No information No information No information No information No information Adverse effects occurred in 13 participants, 8 (18.1%) in the acupuncture group (6 hematomas and 2 with pain at needling sites), and 5 (11.1%) in the sham group (1 hematoma, 3 with pain at needling sites, and 1 with acute urinary retention) Pharmacotherapy 1. Effective rate No adverse effects (terazosin (in %)a occurred in the hydrochloride) 2. WBCb treatment group; 2 3. The amount cases of postural of lecithin hypotension occurred lipophore in in drug group prostatic fluid Sham acupuncture Sitz bath in Effective rate decoction of (in %)a herbal medicine Pharmacotherapy Effective rate (ofloxacin) (in %)a Pharmacotherapy Effective rate (Cernilton (in %)a Prostat) Pharmacotherapy Effective rate (Pule’an pian) (in %)a Pharmacotherapy Effective rate (Pule’an pian) (in %)a Control Intervention N Open-label RCT CP with 2 parallel groups To find effective Open-label RCT remedies for with 2 CP parallel groups To find effective Open-label RCT remedies for with 3 CP parallel groups To evaluate the Open-label RCT effectiveness with 2 of pointparallel through-point groups acupuncture for CP. To evaluate the Open-label RCT efficacy of with 2 acupuncture parallel for CP groups To evaluate the Open-label RCT efficacy of with 2 acupuncture parallel for CP groups To compare Patient-blind ‘‘the efficacy RCT with 2 of acupuncture groups to sham acupuncture for CP/CPPS’’ Objective (Quote) Journal of Andrology Li and Wang To evaluate the (2006) efficacy of acupuncture for CP. Lee et al (2008) Jin and Ji (2008) Huang et al (2005) Hu et al (2005) He and Xu (2007) He et al (2004) Author (Year) Table 3. Randomized clinical trials of acupuncture chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) 18 January February 2012 b Effective rate is the percentage of patients with improved status of disease divided by the sample size of each group and multiplied by 100. The amount of white blood cells (WBC) in prostatic fluid after treatment. 19 a Abbreviations: C, control group; NIH-CPSI, National Institutes of Health Chronic Prostatitis Symptom Index; RCT, randomized clinical trial; T, treatment group; T1, acupuncture at Sanyin points; T2, acupuncture at Sanyin plus Yinsan points. No information Elongatedneedle acupuncture T: 47.1 C: 45.1 104 (54/50) Pharmacotherapy Effective rate (Pule’an pian) (in %)a Two cases of hematuria cased by acupuncture and recovered 1 d later. Decoction of Effective rate Chinese herbal (in %)a medicine T: 17–45 (mean, Needle 29.5); acupuncture C: 16–40 (mean, 28.5) Adverse Effects Condition Acupuncture for Prostatitis 168 (84/84) Primary Outcome Measure Control Intervention Treatment Group (Regimen) Mean Age of Participants or Age Range, y Sample Size (T/C) Study Design Objective (Quote) Author (Year) Table 3. Continued N Wang (1997) ‘‘To evaluae the Open-label RCT CP efficacy of with 2 needle parallel acupuncture groups for CP’’ Zhang ‘‘To evaluate the Open-label RCT CP (2009) effectiveness with 2 of pointparallel through-point groups acupuncture for chronic prostatitis’’ Posadzki et al groups received pharmacotherapy (He et al, 2004; Hu et al, 2005; Li and Wang, 2006; He and Xu, 2007; Zhang, 2009; Zhong-Xin, 2009), herbal medicine (Wang, 1997; Jin and Ji, 2008), or sham acupuncture (Lee et al, 2008). In order to lead to any firm conclusion regarding the effectiveness of acupuncture superiority, RCTs need to control for placebo effects. Only one study made serious attempts to do this (Lee et al, 2008). Equivalence trials can only lead to interpretable results if they compare the experimental treatment against an intervention of proven efficacy. Unfortunately, all of the Chinese studies failed to do so, and therefore no firm conclusions can be drawn from such studies. The exact psychologic or other mechanisms of action of acupuncture remain unclear (Lewith and Kenyon, 1984; Kavoussi, 2009).Whether certain patient groups respond to acupuncture differently than others and whether suggestibility is an essential factor for any response remain unclear. The possible mechanism of action may therefore include the patients’ expectations—a part of the placebo effect (Dawn and Lee, 2004; Verbeek et al, 2004). Patients have explicit expectations on diagnosis, instructions, interpersonal management, or course of treatment (Verbeek et al, 2004), and they expect that these expectations will be met (Dawn and Lee, 2004). Recently, it was shown that the communication style of the acupuncturist is a more important determinant of the response than the question of whether a patient receives real or sham acupuncture (Suarez-Almazor et al, 2010). All of the Chinese language RCTs included effective rate as a primary outcome measure, and one of those trials also used white blood cell level and the amount of lipophore in prostatic fluid (Li and Wang, 2006). Only one RCT used standardized NIH-CPSI (Lee et al, 2008). There was also a wide variety of acupuncture points used in the treatment groups (Table 2). The duration of therapeutic intervention ranged from 2 to 4 weeks (Huang et al, 2005), 1 month, (Wang, 1997; He et al, 2004; Hu et al, 2005; He and Xu, 2007), and 2 months (Li and Wang, 2006; Lee et al, 2008; Jin and Ji, 2008; Zhang, 2009). Given such variability in terms of length and diversity of the therapeutic intervention, it is difficult to draw any definite conclusions. The quality of the included studies was predominantly poor. Eight (88.8%) scored less than 2 on the Jadad scale (Wang, 1997; He et al, 2004; Hu et al, 2005; Huang et al, 2005; Li and Wang, 2006; He and Xu, 2007; Jin and Ji, 2008; Zhang, 2009). Only one RCT scored 4 on the Jadad scale (Lee et al, 2008). Five Chinese RCTs (55.5%) failed to describe sequence generation sufficiently (Wang, 1997; Hu et al, 2005; Huang et al, 2005; Li and Wang, 2006; Jin and Ji, 2008). None of the Chinese RCTs described allocation concealment or 20 blinding procedures. None of the Chinese trials described dropout rates or included an intention-to-treat analysis or a power calculation. Adverse events (AE) were not reported in most trials (Table 3; He et al, 2004; Hu et al, 2005; Huang et al, 2005; He and Xu, 2007; Jin and Ji, 2008; Zhang, 2009). Three RCTs reported the incidence of AEs (Wang, 1997; Li and Wang, 2006; Lee et al, 2008). STRICTA guidelines, and indeed medical ethics, require the reporting of AEs. Underreporting distorts the overall picture of what we know about the safety of acupuncture. Our review has several limitations. First and foremost, the potential incompleteness of the reviewed evidence may have limited the validity of the results. Second, publication and location biases, which are wellknown phenomena, may also influence the results of this systematic review. Third, the total number of trials included in our review and analysis, and the total sample size are too small to allow definitive judgments. Fourth, although all of these studies were considered to have relatively homogenous CP/CPPS populations, statistical pooling was not possible because of lack of reporting of sufficient raw data. Another possible source of bias is the fact that almost all (88.8%) of the included trials were carried out in China, where they have appeared to produce almost no negative studies (Vickers et al, 1998). However, this review has several strengths, including the comprehensive search strategy, the inclusion of only the highest-quality trial design, and use of suggested methods for systematic reviews of interventions for CP/CPPS. Future studies of acupuncture in CP/CPPS should be of adequate sample size based on power calculations; provide sufficient details on needling, frequency, duration of therapeutic regimen, and practitioners’ background; use validated outcome measures; control for nonspecific effects; and minimize other threats to internal and external validity. Reporting of these studies should be such that results can be independently replicated. In conclusion, the evidence that acupuncture treats CP/CPPS is encouraging. However, the quantity and quality of the existing evidence prevent firm conclusions. References Anothaisintawee T, Attia J, Nickel JC, Thammakraisorn S, Numthavaj P, McEvoy M, Thakkinstian A. 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