• J Pain · Jul 2018

    Review

    Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: An ACTTION Systematic Review.

    • Jennifer S Gewandter, Jenna Chaudari, Katarzyna B Iwan, Rachel Kitt, Sawsan As-Sanie, Gloria Bachmann, Quentin Clemens, H Henry Lai, Frank Tu, G Nicholas Verne, Katy Vincent, Ursula Wesselmann, QiQi Zhou, Dennis C Turk, Robert H Dworkin, and Shannon M Smith.
    • Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York. Electronic address: jennifer_gewandter@urmc.rochester.edu.
    • J Pain. 2018 Jul 1; 19 (7): 717-726.

    AbstractChronic 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 end points 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 end points were identified for only 57% of trials. These end points, 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.Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

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