• Shannon M Smith, Mark P Jensen, Hua He, Rachel Kitt, James Koch, Andrew Pan, Laurie B Burke, John T Farrar, Michael P McDermott, Dennis C Turk, and Robert H Dworkin.
• Department of Anesthesiology, University of Rochester Medical Center, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu.
• J Pain. 2018 Sep 1; 19 (9): 953-960.

AbstractIdentifying methods to improve assay sensitivity in randomized clinical trials (RCTs) may facilitate the discovery of efficacious pain treatments. RCTs evaluating pain treatments typically use average pain intensity (API) or worst pain intensity (WPI) as the primary efficacy outcome. However, little evidence is available comparing the assay sensitivity of these 2 measures. In this systematic review and meta-analysis, we comprehensively reviewed all low back pain, osteoarthritis pain, fibromyalgia, diabetic peripheral neuropathy pain, and postherpetic neuralgia RCTs that used a parallel group design. Eligibility required: 1) primary RCT report published between 1980 and 2016, 2) comparing 1 or more active, efficacious pharmacologic pain treatment(s) with placebo, and 3) providing data on the standardized effect size (SES) for API as well as WPI for all treatment arms. Twenty-seven active versus placebo comparisons were identified in 23 eligible articles. Using a random-effects meta-analysis, API SES and WPI SES did not differ significantly (difference = -.021, 95% confidence interval = -.047 to .004, P = .12). The findings indicate that, depending on the objectives of the study, either API or WPI could be used as a primary outcome measure in clinical trials for the chronic pain conditions included in this analysis.Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

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