Pregabalin for the Treatment of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Randomized Controlled Trial

Abstract

Background Evidence suggests that the urogenital pain of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) may be neuropathic. Methods This randomized, double-blind, placebo-controlled trial was conducted across 10 tertiary care centers in North America to determine whether pregabalin, which has been proved effective in other chronic pain syndromes, is effective in reducing CP/CPPS symptoms. In 2006–2007, 324 men with pelvic pain for at least 3 of the previous 6 months were enrolled in this study. Men were randomly assigned to receive pregabalin or placebo in a 2:1 ratio and were treated for 6 weeks. Pregabalin dosage was increased from 150 to 600 mg/d during the first 4 weeks. The primary outcome was a 6-point decrease in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score. Multiple secondary outcomes were assessed. Results Of 218 men assigned to receive pregabalin, 103 (47.2%) reported at least a 6-point decrease in the NIHCPSI total score at 6 weeks compared with 35.8% (38 of 106 men) assigned to receive placebo (P = .07, exact Mantel-Haenszel test, adjusting for clinical sites). Compared with the placebo group, men assigned to receive pregabalin experienced reductions in the NIH-CPSI total score and sub-scores (P < .05), a higher Global Response Assessment response rate (31.2% and 18.9%; P = .02), and improvement in total McGill Pain Questionnaire score (P = .01). Results for the other outcomes did not differ between groups. Conclusion Pregabalin therapy for 6 weeks was not superior to placebo use in the rate of a 6-point decrease (improvement) in the NIH-CPSI total score in men with CP/CPPS. Trial Registration clinicaltrials.gov Identifier: NCT00371033

Diagnosis and treatment of chronic bacterial prostatitis and chronic prostatitis/chronic pelvic pain syndrome: a consensus guideline

“…Compared with the placebo group, patients in the pregabalin arm had reductions in the NIH-CPSI total score and subscores (P < 0.05). However, pregabalin therapy for 6 weeks was not superior to placebo in the rate of a 6-point decrease in the NIH-CPSI total score [78] © 2015 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International 515 …”

“…The second analysis, based on only the rofecoxib and celecoxib trials, concluded that no significant differences in efficacy could be ascertained for NSAIDs vs placebo [64] No trials were identified that evaluated opioid analgesics in the CBP or CP/CPPS populations. For co-analgesics, only one RCT was identified, which evaluated pregabalin (n = 218) vs placebo (n = 106) in the CP/CPPS population [78]. Compared with the placebo group, patients in the pregabalin arm had reductions in the NIH-CPSI total score and subscores (P < 0.05).…”

Treatment of Nonbacterial Prostatitis: What’s New?

“…Compared with the placebo group, patients in the pregabalin arm experienced reductions in the NIH-CPSI total score and subscores ( p < 0.05). However, pregabalin therapy for 6 weeks was not superior to placebo in the rate of a 6-point decrease in the NIH-CPSI total score [ 35 ].…”

Recent trend of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) management

“…Study of pregabalin, an anticonvulsant that is approved for neuropathic pain such as postherpetic neuralgia, diabetic neuropathy, and fibromyalgia, had an effect that approached significance, but did not make the primary endpoint [43]. However, secondary endpoints were significantly improved.…”