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A systematic review and meta-analysis of placebo effect in clinical trials on chronic prostatitis/chronic pelvic pain syndrome.
Morozov, Andrey; Bazarkin, Andrey; Babaevskaya, Diana; Taratkin, Mark; Kozlov, Vasily; Suvorov, Aleksandr; Spivak, Leonid; McFarland, Jonathan; Russo, Giorgio I; Enikeev, Dmitry.
Afiliación
  • Morozov A; Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.
  • Bazarkin A; Institute for Clinical Medicine, Sechenov University, Moscow, Russia.
  • Babaevskaya D; Institute for Clinical Medicine, Sechenov University, Moscow, Russia.
  • Taratkin M; Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.
  • Kozlov V; Department of Public Health and Healthcare, Sechenov University, Moscow, Russia.
  • Suvorov A; "Digital Biodesign and Personalized Healthcare" World-Class Research Center, Sechenov University, Moscow, Russia.
  • Spivak L; Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.
  • McFarland J; Institute of Linguistics and Intercultural Communication, Sechenov University, Moscow, Russia.
  • Russo GI; Faculty of Medicine, Universidad Autónoma Madrid, Madrid, Spain.
  • Enikeev D; Department of Surgery, Urology Section, University of Catania, Catania, Italy.
Prostate ; 82(6): 633-656, 2022 05.
Article en En | MEDLINE | ID: mdl-35133667
BACKGROUND: It is a common practice to control efficacy of pharmacological treatment with a placebo group. However, placebo itself may affect subjective and even objective results. The purpose of this study was to evaluate the placebo effect on symptoms of CP/CPPS to improve future clinical trials. METHODS: A search at three databases (Scopus, MEDLINE, and Web of Science) was conducted to identify double-blind placebo-controlled clinical trials on the treatment of CP/CPPS published until April 2021. The primary outcome - National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score. SECONDARY OUTCOMES: Qmax, PVR, IPSS, and prostate volume. RESULTS: A total of 3502 studies were identified. Placebo arms of 42 articles (5512 patients, median 31 patients) were included in the systematic review. Systematic review identified positive changes in the primary endpoint, meta-analysis of 10 articles found that NIH-CPSI total score results were significantly influenced by placebo, mean difference -4.2 (95% confidence interval [CI]: -6.31, -2.09). Mean difference of NIH-CPSI pain domain was -2.31 (95% CI: -3.4, -1.21), urinary domain -1.12 (95% CI: -1.62, -0.62), quality of life domain -1.67 (95% CI: -2.38, -0.96); p < 0.001 for all. In case of the objective indicator - Qmax, there were three articles included in the meta-analysis. Qmax mean change from baseline was 0.68 (95% CI: -0.85, 2.22, p = 0.38). Systematic review showed no significant changes in pain, measured by VAS or other scores, IPSS and PVR. CONCLUSIONS: Placebo significantly affected the subjective parameters (NIH-CPSI) and limitedly affected various other measurements of pain (visual analog scale, McGill pain questionnaire). There was no long-term effect on IPSS and objective measurements (Qmax, PVR). This study can be used in further clinical trials to develop general rules of CPPS treatment assessment.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prostatitis / Dolor Crónico Tipo de estudio: Clinical_trials / Prognostic_studies / Systematic_reviews Aspecto: Patient_preference Límite: Humans / Male Idioma: En Revista: Prostate Año: 2022 Tipo del documento: Article País de afiliación: Rusia Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prostatitis / Dolor Crónico Tipo de estudio: Clinical_trials / Prognostic_studies / Systematic_reviews Aspecto: Patient_preference Límite: Humans / Male Idioma: En Revista: Prostate Año: 2022 Tipo del documento: Article País de afiliación: Rusia Pais de publicación: Estados Unidos