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Pain Medicine 2010; 11: 518–523 Wiley Periodicals, Inc.

Effectiveness of Acupuncture in Patients with Category IIIB Chronic Pelvic Pain Syndrome: A Report of 97 Patients pme_794

Volkan Tugcu, MD,* Selim Tas, MD,* Gulay Eren, MD,† Bahar Bedirhan, MD,† Serdar Karadag, MD,* and Ali Tasci, Prof.* Departments of *Urology and †

Anesthesiology, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey Reprint requests to: Gulay Eren, MD, Department of Anaesthesiology and Intensive Care, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Zuhuratbaba, Bakirkoy, 34147, Istanbul, Turkey. Tel: +90-505-478-2578; Fax: +90-212-550-7984; E-mail: glyeren@mynet.com. Abstract Objective. Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is of significant interest in urology and unfortunately, the therapy modalities recommended are not fully effective. Therefore, we undertook a pilot study to determine whether acupuncture improves the pain, voiding symptoms, and quality of life in men with category IIIB CP/CPPS. Design. Prospective, one-group trial, cohort study. Setting. Outpatient urology clinic. Patients and Interventions. Ninety-seven CP/CPPS patients received six sessions of acupuncture to the BL-33 acupoints once a week. The National Institute of Health Chronic Prostatitis Symptom Index (NIHCPSI) was completed by each patient before and after the treatment and on 12th and 24th weeks following the treatment. Outcome Measures. Mean values of total CPSI score, pain subscore, urinary subscore, and quality of life subscore after the treatment and on follow-up after the treatment were compared with the baseline values. Results. There was a statistically significant decrease in all of the subscores evaluated at all periods compared with the baseline. Eighty-six patients out of 93 (92.47%) were NIH-CPSI responders (more than 50% decrease in total NIH-CPSI score from baseline) at the end of the treatment. 518

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Conclusions. The results of this study suggest that acupuncture appears to be a safe and potentially effective treatment in improving the symptoms and quality of life of men clinically diagnosed with CP/CPPS. Key Words. Acupuncture; BL-33

Chronic

Prostatitis;

Introduction Chronic prostatitis/chronic pelvic pain syndrome (CP/ CPPS) is of significant interest in urology and accounts for up to two million office visits per year [1]. The etiology for CP/CPPS has not been fully elucidated and the current treatment strategies for CP/CPPS are not universally accepted. The National Institute of Health (NIH) Prostatitis Collaborative Network developed a new classification system and symptom score because conventional diagnosis and classification systems were inadequate (Table 1). Assessments are made in three main categories (pain, voiding, and quality of life [QoL]) in symptom scoring. According to this classification, the most common form is category III, which is subdivided into category IIIA and category IIIB depending on the presence of inflammatory cells in the prostatic fluid [2]. Standard therapies for CP/CPPS include antibiotics, antiinflammatory agents, 5-alfa reductase inhibitors, and alfa-1 blockers [3–5]. But all of these therapy modalities proved not to be fully effective with success rates ranging between 19 and 56% reported with such therapies in different studies [6,7]. The chronic pain, persistent inflammation, voiding symptoms, and sexual disturbances may be neurogenically mediated by up-regulation of the local pelvic/perineal afferent sensory nervous system and “wind-up” within the spinal cord and central nervous system [8,9]. So, neuromodulatory therapies may provide amelioration of symptoms of CP/CPPS. 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 (TCM) over 2000 years ago. The needles are stimulated by manual manipulation, electrical stimulation, or heat [10]. The general theory of acupuncture is based on the premise that there are patterns of energy flow (Qi) through the body that are essential for


Acupuncture in Chronic Pelvic Pain Syndrome

Table 1 Classification of prostatitis syndromes by the International Prostatitis Collaborative Network established by the National Institutes of Health in 1995 Category I: II: III: A B IV:

Acute bacterial prostatitis Chronic bacterial prostatitis Chronic prostatitis/chronic pelvic pain syndrome Inflammatory Noninflammatory Asymptomatic inflammatory prostatitis

health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin. Over the years, NIH has funded a variety of research projects on acupuncture, including studies on the mechanisms by which acupuncture may produce its effects, as well as clinical trials and other studies. There is also a considerable body of international literature on the risks and benefits of acupuncture, and the World Health Organization lists a variety of medical conditions that may benefit from the use of acupuncture or moxibustion. Such applications include acupuncture as a complementary and symptomatic therapy for cancer patients undergoing chemotherapy or radiotherapy, for conditions involving pain such as migraines and back pain, prevention and treatment of nausea and vomiting; treatment of addictions to alcohol, tobacco, and other drugs; treatment of pulmonary problems such as asthma and bronchitis; and for relieving the impact of stress among patients with chronic conditions, just to name a few [11]. Recently, a multimodal treatment approach and the utilization of complementary and alternative medicine strategies such as acupuncture and phytotherapy have also been suggested as potential treatment options for CP/CPPS [12–15]. As there is some significant data about acupuncture in this respect, we undertook a pilot study to determine whether acupuncture improves the pain, voiding symptoms, and QoL in men with category IIIB CP/CPPS. Materials and Methods The study was performed between October 2006 and March 2008 and it was approved by the local ethics committee of our hospital. Patients applying to our outpatient clinic with lower urinary tract symptoms suggestive of prostatitis were evaluated for bacterial infection by Meares-Steamey criteria. Those patients who were found to be negative for leucocyte and culture (ureaplasma, mycoplasma, and chylamidia) were evaluated according to NIH consensus criteria. The patients with CP/CPPS

(NIH category IIIB), given informed consent and whose symptoms lasted more than at least 3 months, were enrolled into the study. All patients had previously received pharmacotherapy (antibiotics, alpha-blockers, antiinflammatory agents) or phytotherapy for 2 months that was unsuccessful. Exclusions were those who met the criteria for chronic bacterial prostatitis or category IIIA CPPS, or those who had had previous urinary tract infection or a uropathogen documented within the last year and those who had pathology at urinary system ultrasonography; or those who previously had acupuncture, localized skin infections, anticoagulated and those with bleeding diathesis, or with any severe chronic or uncontrolled co-morbid disease including cancer, or fear of needles. Ninety-seven patients who expressed a willingness to participate in the study were treated by acupuncture after informed consent was obtained. Acupuncture was performed using two disposable stainless steel needles (0.3 mm diameter, 60 mm length, Suzhou Jiangsu, China) that were inserted into the bilateral BL-33 (Zhongliao) points (the Urinary Bladder Meridian of Foot-Taiyang), as standardized by the World Health Organization, over the third posterior sacral foramina. The needles were inserted into each side with a sufficient depth to the sacral periosteum that is approximately 5 cm. The stimuli were generated by rotating the needles manually for 20 minutes. The sensation of ache or heaviness in the area surrounding the inserted needle (known as de qi) was always achieved. The treatment was repeated every week for 6 weeks without other treatment modalities. NIH Chronic Prostatitis Symptom Index (NIH-CPSI), comprised of a total of nine items (see Appendix), was completed by each patient before and after the treatment and on 12th and 24th weeks following the treatment. The patients were asked to report any adverse effects as well, on each session of treatment and control. Statistics Statistical analysis was performed by Number Cruncher Statistical System (NCSS) 2007 and Power Analysis and Sample Size (PASS) 2008 Statistical Software (Kaysville, UT). In addition to descriptive statistical methods (mean ⫾ standard deviation), assessment of parameters for normal distribution was done by Kolmogorov–Smirnov test. As they were not normally distributed, mean values of total CPSI score, pain subscore, urinary subscore, and QoL subscore after the treatment and on follow-up at 6th, 12th, and 24th weeks were compared using Friedman test; and post hoc comparisons of significant parameters were done by Wilcoxon signed rank test. A P value less than 0.05 was regarded as significant. Responders were predefined as patients who had experienced a decrease in CPSI score of more than 50%. Results Each patient underwent six sessions of acupuncture treatments and was followed up for 24 weeks. All the patients 519


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Table 2 Mean NIH-CPSI total score and pain, urinary, and QoL subscores at baseline, 6 weeks (end of the acupuncture therapy) and follow-up periods of 12 and 24 weeks NIHCPSI

Initial

6 Weeks* 12 Weeks* 24 Weeks*

Total 26.6 ⫾ 2.9 10.9 ⫾ 4.8 10.6 ⫾ 5.4 11.4 ⫾ 6.1 Pain 11.6 ⫾ 2.2 6.1 ⫾ 2.2 5.9 ⫾ 2.4 6.4 ⫾ 3.2 Urinary 5.03 ⫾ 1.3 2.1 ⫾ 2.3 2.1 ⫾ 2.2 2.3 ⫾ 2.09 QoL 9.9 ⫾ 1.3 2.6 ⫾ 2.7 2.5 ⫾ 2.1 2.76 ⫾ 2.6 * P < 0.01 statistically significant difference compared with baseline. NIH-CPSI = National Institutes of Health Chronic Prostatitis Symptom Index; QoL = quality of life.

were male and they were all of the same ethnic group. Mean age of the patients was 38.3 ⫾ 9.4 (23–57) years and the mean duration of symptoms of the disease was 4.5 ⫾ 2.1 month ranging between 3 and 20 months. Four patients out of 97 were dropped off the study as they did not come up to the controls. In the remaining patients’ evaluation, there was a statistically significant decrease in the mean total CPSI score (26.6 ⫾ 2.9–10.9 ⫾ 4.8) and pain subscore (11.6 ⫾ 2.2–6.1 ⫾ 2.2), urinary subscore (5.03 ⫾ 1.3–2.1 ⫾ 2.3), and QoL subscore (9.9 ⫾ 1.3–2.6 ⫾ 2.7) at 6 weeks at the completion of acupuncture treatment (P < 0.001, P < 0.001, P < 0.001, and P < 0.001). The total CPSI scores and pain, urinary and QoL subscores for baseline, after the treatment and on 12th and 24th week following the treatment are shown in Table 2. The scores decreased significantly on 12 and 24 weeks following, as well compared with baseline (P < 0.001). Eighty-six patients out of 93 evaluated (92.47%) were NIH-CPSI responders (more than 50% decrease in total NIH-CPSI score from baseline) at the end of the treatment. At long-term follow-up, the response rate was unchanged on 12th and 24th weeks after the treatment. The mean total CPSI score and pain, urinary and QoL subscores showed a slight, but insignificant difference on 12th and 24th week after treatment in comparison to those at the end of the treatment. No adverse event was recognized in any patient throughout the treatment period that was related to acupuncture. Discussion The precise physiological mechanism of action of acupuncture is unknown but a variety of hypotheses exist. For example, acupuncture analgesia is thought to be mediated by central nervous system (CNS) mechanisms of pain control via the release of specific neurotransmitters, such as endorphins [16–18]. This neuromodulation is believed to inhibit transmission of pain, as well as to 520

normalize the function of various midbrain nuclei in micturition control and sensory processing. Acupuncture is also believed to neuromodulate up-regulation and “wind-up” within the peripheral and CNSs. Ongoing research and expert consensus suggests that the end stage of CP/CPPS may be a neuropathic pain syndrome [8,9]. Chen and Nickel reported that acupuncture improved pain, voiding symptoms and QoL in 12 men with CP/CPPS and a significant decrease in total NIH-CPSI pain, urinary and QoL scores (P < 0.05) occurred over 6 weeks of treatment and an average 33 weeks of follow-up [12]. Similarly, the data in our study demonstrate the safety of acupuncture and a significant treatment effect on the overall and individual pain, urinary, and QoL symptoms. With regard to the pathogenesis of noninflammatory CPPS (category IIIB), it has been suggested that the symptoms might be associated with venous congestion around the prostate. Watanabe reported that the “sonolucent zone” recognized on transrectal ultrasonography was found frequently in patients with CP [19]. In addition, Terasaki et al. postulated that prostatitis was likely to be caused by intrapelvic venous congestion [20]. Honjo et al.’s study tested acupuncture treatment for CP/CPPS patients with intrapelvic venous congestion. This study of 10 patients receiving 5 weeks of acupuncture treatment also reported a significant decrease in NIHCPSI pain and QoL scores (P < 0.05, P < 0.01), while the study reported no serious adverse events [13]. Our study of 97 men with treatment-refractory CP/CPPS demonstrated significant amelioration of CP-related symptoms. A significant improvement in the average CPSI total score, as well as the separate domains of pain, urinary and QoL scores, were observed at the end of treatment. More than 92% of patients experienced a greater than 50% decrease in the NIH-CPSI score at 12 weeks. Alteration in the secretion of neurotransmitters and neurohormones and changes in the regulation of blood flow, both centrally and peripherally, have been documented. There is increasing evidence for the autonomic mechanisms of acupuncture analgesia, such as increased parasympathetic and decreased sympathetic activity [21,22]. Taken this information into account, the increased parasympathetic activity might be the explanation of decreased venous congestion after acupuncture treatment; although we did not investigate intrapelvic congestion that is a theoretical component of CPPS. This is especially interesting in light of evidence that some chronic pain conditions have a sympathetic component and the hypothesis that pain is a sympathetic homeostatic emotion. And we hypothesize that acupuncture alleviated pain decreasing sympathetic activity. Meanwhile, neuromuscular pelvic floor dysfunction, as well, has been postulated to cause chronic pelvic pain. It


Acupuncture in Chronic Pelvic Pain Syndrome is likely that one of the mechanisms through which acupuncture improves the symptoms of noninflammatory CPPS is the neuromodulation of neuromuscular pelvic floor dysfunction through again sympathetic deactivation. Acupuncture on the bilateral BL-33 points has been reported to inhibit detrusor hyperreflexia in patients with spinal cord injury [23]. Honjo et al. showed that acupuncture suppressed the hyperactivity of the external urethral sphincter during the voiding phase, consequently improving detrusor-external sphincter dyssynergia [23], as well as decreasing venous congestion and improving symptoms after acupuncture of BL-33 points in patients with category IIIB CPPS [24]. Yuting et al. [24] treated 360 cases of prostatitis with acupuncture and a number of combinations of TCM. He reported that 89% were cured, 10% had improvement, and only 1% failed treatment. In an experimental study using anesthetized rats, acupuncture stimulation suppressed proximal urethral electromyographic activities in the micturition reflex [25]. Besides the clearly seen effectiveness of acupuncture in the treatment of such patients, the nil report of adverse events related to acupuncture in our study is, by all means, an advantage. Because, in our previous study comparing alpha-blocker with triple therapy (alphablocker, anti-inflammatory, and muscle relaxant) and placebo for treatment of noninflammatory CPPS, many side effects including dizziness, postural hypotension, gastrointestinal complaints, palpitation, and flu-like symptoms compromised the effectiveness of the treatment [26]. So, in terms of adverse effects, acupuncture treatment proved to be safer. We have to express that it is a limitation that we did not have a control group in our study. But, to our knowledge, no study has used a sham or placebo arm. So, further studies are needed to clarify the effects of acupuncture treatment for noninflammatory CPPS, using a larger number of patients in a randomized, placebo controlled trial.

2 Kreiger JN, Nyberg LJ, Nickel JC. NIH consensus definition and classification of prostatitis. JAMA 1999;282:236–7. 3 Kreiger JN, Ross SO, Penson DF, Riley DE. Symptoms and inflammation in chronic prostatitis/chronic pelvic pain syndrome. Urology 2002;60:959–63. 4 Nickel JC. The three as of chronic prostatitis therapy: Antibiotics, alpha-blockers and inflammatories. What is the evidence? BJU Int 2004;94:1230–3. 5 Pontari MA, Ruggieri MR. Mechanisms in prostatitis/ chronic pelvic pain syndrome. J Urol 2004;172:839– 45. 6 Nickel JC, Downey J, Ardern D, Clark J, Nickel K. Failure of a monotherapy strategy for difficult chronic prostatitis/chronic pelvic pain syndrome. J Urol 2004; 172(2):551–4. 7 Cheah PY, Liong ML, Yuen KH, et al. Initial, long-term, and durable responses to terazosin, placebo, or other therapies for chronic prostatitis/chronic pelvic pain syndrome. Urology 2004;64(5):881–6. 8 Gun CC. Neuropathic pain: A new theory for chronic pain of intrinsic origin. Ann R Coll Physicians Surg Can 1989;22:327–30. 9 Nickel JC. Prostatitis and related conditions. In: Walsh PC, Retik AB, Vaughan ED Jr, et al., eds. Campbells’ Urology, 8th edition. Philadelphia, PA: WB Saunders; 2002:603–30. 10 Ellis A, Wiseman N, Boss K. Fundamentals of Chinese Acupuncture. Brookline, MA: Paradigm Publications; 1991. 11 Acupuncture. NIH Consensus Statement 1997;15(5): 1–34. 12 Chen R, Nickel JC. Acupuncture ameliorates symptoms in men with chronic prostatitis/chronic pelvic pain syndrome. Urology 2003;61(6):1156–9.

Conclusions Limitation of this study was that the group was not compared with a placebo/sham or active comparator treatment group. Despite these limitations, however, the results of the study suggest that acupuncture appears to be a safe and potentially effective treatment in improving the symptoms and QoL of men clinically diagnosed with CP/CPPS. However, we still believe that further controlled and blinded studies of acupuncture for this condition should be conducted.

References 1 Schaeffer AJ. Etiology and management of chronic pelvic pain syndrome in men. Urology 2004;63:75–84.

13 Honjo H, Kamoi K, Naya Y, et al. Effects of acupuncture for chronic pelvic pain syndrome with intrapelvic venous congestion: Preliminary results. Int J Urol 2004;11:607–12. 14 Potts JM. Therapeutic options for chronic prostatitis/ chronic pelvic pain sydrome. Curr Urol Rep 2005;6:313–7. 15 Shoskes DA. Phytotherapy and other alternative forms of care for the patient with prostatitis. Curr Urol Rep 2002;3:330–4. 16 Clement-Jones V, Mcloughlin L, Tomlin S, et al. Increased beta-endorphin but not metenkephalin 521


Tugcu et al. levels in human cerebrospinal fluid after acupuncture for recurrent pain. Lancet 1980;2:946–9. 17 Han J, Pomeranz B, Stux G. Scientific Bases of Acupuncture: Central Neutransmitters and Acupuncture Analgesia. New York: Springer-Verlag; 1989:7–33. 18 Pomeranz B, Chiu D. Naloxone blockade of acupuncture analgesia: Endorphin implicate. Life Sci 1976;19:1757–62. 19 Watanabe H. Transrectal sonography: A personal review and recent advantages. Scand J Urol Nephrol 1991;137(suppl):75–83. 20 Terasaki T, Watanabe H, Saitoh M, et al. Magnetic resonance angiography in prostatodynia. Eur Urol 1995;27:280–5. 21 Haker E, Egekvist H, Bjerring P. Effect of sensory stimulation (acupuncture) on sympathetic and parasympathetic activities in healthy subjects. J Auton Nerv Syst 2000;79:52–9. 22 Seminowicz DA. Acupuncture and the CNS: What can the brain at rest suggest? Pain 2008;136(3): 230–1. 23 Honjo H, Naya Y, Ukimura O, Kojima M, Miki T. Acupuncture on clinical symptoms and urodynamic measurements in spinal-cord-injured patients with detrusor hyperreflexia. Urology 2003;61:1156– 9. 24 Yuting C. Clinical observation on combined treatment of 360 cases of prostatitis with acupuncture of Sishenchong Point, etc. and self-drafted prescription I, II and III. World J Acupunct Moxibust 2000;10:1–4. 25 Kitakoji H, Nebeta T, Kawakita K. Suppressive effects of acupuncture and pinching on micturition reflex activities in the rat proximal urethra. Auton Nerv Syst 1994;31:309–15. 26 Tugcu V, Tasci AI, Fazlıoglu A, et al. A placebocontrolled comparison of the efficiency of triple and monotherapy in category III B chronic pelvic pain syndrome. Eur Urol 2007;51:1113–18.

Appendix NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) A) Pain or Discomfort 1. In the last week, have you experienced any pain or discomfort in the following areas? a. Area between rectum and testicles (perineum) yes 1 no. 0 522

b. Testicles yes 1 no. 0 c. Tip of the penis (not related to urination) yes 1 no. 0 d. Below your waist, in your pubic or bladder area yes 1 no. 0 2. In the last week, have you experienced: a. Pain or burning during urination? yes 1 no. 0 b. Pain or discomfort during or after sexual climax (ejaculation)? yes 1 no. 0 3. How often have you had pain or discomfort in any of these areas over the last week? 0 Never 1 Rarely 2 Sometimes 3 Often 4 Usually 5 Always 4. Which number best describes your AVERAGE pain or discomfort on the days that you had it, over the last week? 0 1 2 3 4 5 6 7 8 9 10 NO PAIN PAIN AS BAD AS YOU CAN IMAGINE B) Urination 5. How often have you had a sensation of not emptying your bladder completely after you finished urinating,over the last week? 0 Not at all 1 Less than 1 time in 5 2 Less than half the time 3 About half the time 4 More than half the time 5 Almost always 6. How often have you had to urinate again less than two hours after you finished urinating, over the last week? 0 Not at all 1 Less than 1 time in 5 2 Less than half the time 3 About half the time 4 More than half the time 5 Almost always

Impact of Symptoms 7. How much have your symptoms kept you from doing the kinds of things you would usually do, over the last week? 0 None 1 Only a little 2 Some 3 A lot 8. How much did you think about your symptoms, over the last week? 0 None 1 Only a little 2 Some 3 A lot


Acupuncture in Chronic Pelvic Pain Syndrome C) Quality of Life 9. If you were to spend the rest of your life with your symptoms just the way they have been during the last week, how would you feel about that? 0 Delighted 1 Pleased 2 Mostly satisfied 3 Mixed (about equally satisfied and dissatisfied)

4 Mostly dissatisfied 5 Unhappy 6 Terrible Scoring the NIH-Chronic Prostatitis Symptom Index Domains Pain: Total of items 1a, 1b, 1c, 1d, 2a, 2b, 3, and 4 = Urinary Symptoms: Total of items 5 and 6 = Quality of Life Impact: Total of items 7, 8, and 9 =

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Effectiveness of Acupuncture in Patients withCategory IIIB Chronic Pelvic Pain Syndrome