Abstract

Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: an Acttion Systemic Review

Gewandter JS1, Chaudari J2, Iwan KB2, Kitt R2, As-Sanie S3, Bachmann G4, Clemens Q5, Lai HH6, Tu F7, Verne GN8, Vincent K9, Wesselmann U10, Zhou Q9, Turk J Pain. 2018 Feb 2. pii: S1526-5900(18)30055-5. doi: 10.1016/j.jpain.2018.01.007. [Epub ahead of print]DC11, Dworkin RH2, Smith SM2.
 
     

Author information

1 Department of Anesthesiology, University of Rochester, Rochester, NY, USA. Electronic address: jennifer_gewandter@urmc.rochester.edu.

2 Department of Anesthesiology, University of Rochester, Rochester, NY, USA.

3 Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI, USA.

4 Department of Obstetrics, Gynecology, and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.

5 Department of Urology, University of Michigan, Ann Arbor, MI, USA.

6 Departments of Surgery and Anesthesiology, Washington University, St. Louis, MO, USA.

7 Department of Obstetrics and Gynecology, NorthShore University HealthSystem Evanston, IL and University of Chicago Pritzker School of Medicine, Chicago, IL, USA.

8 Department of Medicine, Tulane University, New Orleans, Louisiana, USA.

9 Nuffield Department of Obstetrics and Gynecology, University of Oxford, Oxford, United Kingdom.

10 Departments of Anesthesiology, Neurology, and Psychology, University of Alabama at Birmingham, Birmingham, Alabama.

11 Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington.

Abstract Chronic pain conditions occurring in the lower abdomen and pelvis are common, often challenging to manage, and can negatively affect health-related quality of life. Methodological challenges in designing randomized clinical trials (RCTs) for these conditions likely contributes to the limited number of available treatments. The goal of this systematic review of RCTs of pharmacologic treatments for irritable bowel syndrome and 3 common chronic pelvic pain conditions are to (1) summarize the primary endpoints and entry criteria and (2) evaluate the clarity of reporting of important methodological details. In total, 127 RCTs were included in the analysis. The most common inclusion criteria were a minimum pain duration (81%), fulfilling an established diagnostic criteria (61%), and reporting a minimum pain intensity (42%). Primary endpoints were identified for only (57%) of trials. These endpoints, summarized in this article, were highly variable. The results of this systematic review can be used to inform future research to optimize the entry criteria and outcome measures for pain conditions occurring in the lower abdomen and pelvis, to increase transparency in reporting to allow for proper interpretation of RCT results for clinical and policy applications, and to facilitate the aggregation of data in meta-analyses.

PERSPECTIVE: This article summarizes entry criteria and outcome measures and the clarity of reporting of these important design features in RCTs of IBS and 3 common chronic pelvic pain conditions. These results can be used to improve design of future trials of these largely unaddressed pain conditions.

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