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; Козлов, В. В.; Suvorov, А. Yu.; Spivak, Leonid; McFarland, Jonathan; Russo, Giorgio Ivan; Enikeev, Dmitry

doi:10.1002/pros.24311

Cited by 8 publications

(6 citation statements)

References 61 publications

(142 reference statements)

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“…Placebo and nocebo effects on pain have been extensively studied using experimental research designs [ 6 , 11 , 12 , 13 , 14 , 15 ]. Different approaches have been used to trigger pain amelioration or exacerbation: the two most common procedures are (1) the use of positive or negative expectations and (2) the use of conditioning approaches [ 11 , 12 ].…”

Section: State Of the Artmentioning

confidence: 99%

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

Rossettini,

Campaci,

Bialosky

et al. 2023

JCM

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(1) Background: In recent years, placebo and nocebo effects have been extensively documented in different medical conditions, including pain. The scientific literature has provided strong evidence of how the psychosocial context accompanying the treatment administration can influence the therapeutic outcome positively (placebo effects) or negatively (nocebo effects). (2) Methods: This state-of-the-art paper aims to provide an updated overview of placebo and nocebo effects on pain. (3) Results: The most common study designs, the psychological mechanisms, and neurobiological/genetic determinants of these phenomena are discussed, focusing on the differences between positive and negative context effects on pain in experimental settings on healthy volunteers and in clinical settings on chronic pain patients. Finally, the last section describes the implications for clinical and research practice to maximize the medical and scientific routine and correctly interpret the results of research studies on placebo and nocebo effects. (4) Conclusions: While studies on healthy participants seem consistent and provide a clear picture of how the brain reacts to the context, there are no unique results of the occurrence and magnitude of placebo and nocebo effects in chronic pain patients, mainly due to the heterogeneity of pain. This opens up the need for future studies on the topic.

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Section: State Of the Artmentioning

confidence: 99%

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

Rossettini,

Campaci,

Bialosky

et al. 2023

JCM

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“…CP/CPPS is often misdiagnosed as prostatitis and is commonly treated with antibiotics. However, in recent years, some studies have shown that pharmacological treatments do not have a significant effect and maybe even no difference from placebo [ 33 , 34 ]. The pathogenesis of CP/CPPS is currently unknown.…”

Section: Discussionmentioning

confidence: 99%

Comparing the effectiveness of extracorporeal shockwave therapy and myofascial release therapy in chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Huang,

Qin,

Sun

et al. 2023

Trials

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Background Chronic prostatitis/chronic pelvic pain syndrome is a highly prevalent syndrome. Previous studies showed that extracorporeal shockwave therapy and myofascial release therapy could improve the quality of life in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Theoretically, combined therapy with extracorporeal shockwave therapy and myofascial release therapy will likely have significant advantages in treating CP/CPPS. We, therefore, present a protocol for conducting a well-designed randomized controlled trial to compare the efficacy and safety of each therapy. Methods The proposed study will be a three-group randomized control trial (RCT) design that includes 150 participants from Zhongda Hospital Affiliated to Southeast University, with equal allocation of participants to the three intervention groups. The study duration will be 8 weeks, which includes a 4-week treatment period and a 4-week follow-up period. The primary outcome will be the changes in surface electromyography (sEMG) assessment and National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). The secondary outcomes will include the changes in three-dimensional quantification, shear wave elastography (SWE), and sympathetic skin response (SSR) testing. Assessments will be conducted before the intervention (T0), before the 5th intervention (T1), immediately after the 8th intervention (T2), and the 4th week after the end of the 8th intervention (T3). Discussion This trial will compare the differences in efficacy between single extracorporeal shockwave therapy, single myofascial release therapy, and combined therapy to select the most appropriate treatment option for patients with CP/CPPS. The possible pathogenesis of CP/CPPS would also be analyzed by comparing the intercorrelation between each objective and subjective measurement (NIH-CPSI score, sEMG, SWE, SSR). Trial registration The name of the registry: Extracorporeal Shockwave and Myofascial Release Therapy in Chronic Pelvic Pain Syndrome. Registration number: NCT05659199. Date of registration: December 2022.

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“…Then 299 articles were excluded after reviewing the titles and abstracts, leaving 107 records for fulltext screening. Finally, 62 records were further excluded and 45 SRs/MAs were included in our study [6,7,.…”

Section: Literature Searchmentioning

confidence: 99%

“…Based on the classification system of prostatitis syndromes established by the National Institute of Health (NIH) in 1999, CP/CPPS can be divided into two subtypes: IIIA (inflammatory), and IIIB (Noninflammatory), accounting for about 90-95% of all prostatitis cases [4]. The manifestations of CP/CPPS were heterogeneous, mainly including urogenital pain, lower urinary tract symptoms (LUTS), psychological problems, and sexual dysfunction [5,6]. The disorder not only impairs the quality of life (QOL) of patients but often leads to severe psychosocial and economic burdens [3,6].…”

Section: Introductionmentioning

confidence: 99%

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The methodological quality assessment of systematic reviews/meta-analyses of chronic prostatitis/chronic pelvic pain syndrome using AMSTAR2

Guan,

Lao,

Wang

et al. 2023

BMC Med Res Methodol

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Background This study aimed to assess the methodological quality of the systematic reviews/meta-analyses (SRs/MAs) of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) using A Measurement Tool to Assess systematic Reviews (AMSTAR2) and to explore the potential influencing factors. Methods PubMed, EMBASE and Cochrane Library databases were searched for relevant studies. AMSTAR2 was used for evaluating the methodological quality of eligible SRs/MAs. Differences between methodological characteristics of SRs/MAs were compared using chi-square tests. The intra-class correlation coefficient (ICC) was used to assess reviewer agreement in the pre-experiment. Multivariate regression analysis was used to identify potential factors affecting methodological quality. Results A total of 45 SRs/MAs were included. After AMSTAR2 evaluation, only two (4.4%) of 45 SRs/MAs were moderate, three (6.7%) were rated as low quality, and the remainder 40 (88.9%) were rated as critically low quality. Among the 16 items of AMSTAR2, item 3 and item 10 had the poorest adherence. Item 4 received the most significant number of "Partial Yes" responses. Univariable analysis indicated that there were significant differences in methodological quality in SRs between different continents (P = 0.027) as well as between preregistered SRs and those that were not (P = 0.004). However, in multivariate analysis, there was no significant association between methodological quality and the following research characteristics: publication year, continent, whether reporting followed Preferred Reporting Items for Systematic Reviews (PRISMA), preregistration, funding support, randomized controlled trials (RCT) enrollment, whether SR was published in the Cochrane Database of Systematic Reviews (CDSR), and whether with meta-analysis. Additionally, subgroup analysis based on interventional SRs/MAs showed that continent was independently associated with the methodological quality of SRs/MAs of CP/CPPS via univariable and multivariate analysis. Conclusions Our study demonstrates that the methodological quality of SRs/MAs of CP/CPPS was generally poor. SRs/MAs of CP/CPPS should adopt the AMSTAR2 to enhance their methodological quality.

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A systematic review and meta‐analysis of placebo effect in clinical trials on chronic prostatitis/chronic pelvic pain syndrome

Cited by 8 publications

References 61 publications

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

The Biology of Placebo and Nocebo Effects on Experimental and Chronic Pain: State of the Art

Comparing the effectiveness of extracorporeal shockwave therapy and myofascial release therapy in chronic pelvic pain syndrome: study protocol for a randomized controlled trial

The methodological quality assessment of systematic reviews/meta-analyses of chronic prostatitis/chronic pelvic pain syndrome using AMSTAR2

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