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Widespread pain phenotypes impact treatment efficacy results in randomized clinical trials for interstitial cystitis/bladder pain syndrome: a Multidisciplinary Approach to the Study of Chronic Pelvic Pain network study

间质性膀胱炎 医学 膀胱疼痛综合征 临床试验 盆腔疼痛 慢性疼痛 人口 物理疗法 临床意义 随机对照试验 统计显著性 内科学 外科 泌尿系统 环境卫生
作者
John T. Farrar,Kenneth T. Locke,J. Quentin Clemens,James W. Griffith,Steven E. Harte,Ziya Kırkalı,Karl J. Kreder,John N. Krieger,H. Henry Lai,Robert Moldwin,Chris Mullins,Bruce D. Naliboff,Michel A. Pontari,Larissa V. Rodríguez,Anthony J. Schaeffer,Andrew Schrepf,Alisa Stevens,Siobhan Sutcliffe,Bayley J. Taple,David A. Williams,J. Richard Landis
出处
期刊:Pain [Ovid Technologies (Wolters Kluwer)]
被引量:1
标识
DOI:10.1097/j.pain.0000000000003455
摘要

Abstract Pain clinical trials are notoriously complex and often inefficient in demonstrating efficacy, even for known efficacious treatments. A major issue is the difficulty in the a priori identification of specific phenotypes to include in the study population. Recent work has identified the extent of widespread pain as an important determinant of the likelihood of response to therapy, but it has not been tested in clinical trials for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). We explored this hypothesis using data from 3 previously published trials testing treatments for IC/BPS, which suggested modest benefits but did not meet a priori primary outcome statistical significance criteria. Importantly, these studies also collected symptom questionnaire data that allowed us to retrospectively identify participants with and without widespread pain. Analyzing the treatment by the degree of widespread pain revealed a difference in outcome and statistical significance level for each trial. Participants with predominately local pain (ie, limited widespread pain symptoms) responded to therapy targeting local symptoms, whereas those with widespread pain did not. Alternatively, participants with widespread pain beyond their local pelvic pain responded to more centrally acting treatments. Our results suggest that differentiating patients based on widespread vs more localized pain is a key consideration for designing future clinical trials for conditions with variable pain profiles, such as IC/BPS and potentially other pain-based syndromic disorders.

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