Highlights
- •Clinical trial design for abdominal and pelvic pain conditions is challenging.
- •A review of randomized clinical trial entry criteria and end points is provided.
- •Encouraged future research areas to inform trial design are discussed.
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 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.
Perspective
This article summarizes entry criteria and outcome measures and the clarity of reporting
of these important design features in RCTs of irritable bowel syndrome and 3 common
chronic pelvic pain conditions. These results can be used to improve design of future
trials of these largely unaddressed pain conditions.
Key words
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Article info
Publication history
Published online: February 02, 2018
Footnotes
The study was funded by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-private Partnership. This article was reviewed and approved by the Executive Committee of the ACTTION public-private partnership with the United States Food and Drug Administration (FDA).
The views expressed in this article are those of the authors and no official endorsement by the FDA or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public-private partnership should be inferred. Sawsan As-Sanie has received compensation for consulting from Abbvie and Daiichi Sankyo. Frank Tu has received compensation for consulting from and performed industry-sponsored trials for AbbVie. Katy Vincent has received honorarium for consulting from Bayer Healthcare and Grunenthal GmbH and hold an investigator initiated grant from Bayer Healthcare. In her capacity as a special government employee of the FDA, Ursula Wesselmann serves as a member of the FDA Anesthetic and Analgesic Drug Products Advisory Committee. Dr. Wesselmann has served as a consultant for Grünenthal GmbH and Ironwood Pharmaceuticals, Inc. The remaining authors have no conflicts of interest to declare.
Supplementary data accompanying this article are available online at www.jpain.org and www.sciencedirect.com.
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© 2018 by the American Pain Society
