Does flare trial design affect the effect size of non-steroidal anti-inflammatory drugs in symptomatic osteoarthritis? A systematic review and meta-analysis

Smith, Toby O, Zuo, Kun, Abdullah, Natasya, Chen, Xi, Kingsbury, Sarah R, Doherty, Michael, Zhang, Weiya and Conaghan, Philip G. (2016) Does flare trial design affect the effect size of non-steroidal anti-inflammatory drugs in symptomatic osteoarthritis? A systematic review and meta-analysis. Annals of the Rheumatic Diseases, 75 (11). pp. 1971-1978. ISSN 0003-4967

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Abstract

Objectives: It is thought that the clinical trial benefits of oral non-steroid anti-inflammatory drugs (NSAIDs) may relate to flare designs. The aim of this study was to examine the difference in NSAID (including COX-2 inhibitors) response in osteoarthritis (OA) trials based on different designs.  Methods: Systematic review was undertaken of the databases MEDLINE, EMBASE, AMED, CINAHL and the Cochrane library to February 2015. Randomised controlled trials assessing pain, function and/or stiffness following commencement of NSAIDs in flare and non-flare designs were eligible. Trials were assessed using the Cochrane Risk of Bias tool. Meta-analyses were conducted to assess the effect sizes of NSAIDs for OA with flare versus non-flare trial designs.   Results: Fifty-seven studies including 33,263 participants assessing 26 NSAIDs were included. Twenty-two (39%) were flare design, 24 (42%) were non-flare designs, 11 (19%) were possible flare designs. On meta-analysis, there was no statistically significant difference in effect size of NSAIDs versus placebo between flare and non-flare trial designs for absolute pain and function or stiffness at immediate (1 week), short (2 to 4 week) or longer (12 to 13 week) follow-up periods (p>0.05). However there was a lower effect size for mean change in pain in flare and possible flare trials compared to non-flare trials at short-term follow-up (0.36 versus 0.69; p=0.05).   Conclusions: Contrary to previous understanding, flare trial designs do not result in an increased treatment effect for NSAIDs in people with OA compared to non-flare design. Whether flare design influences other outcomes such as joint effusion remains unknown.

Item Type: Article
Uncontrolled Keywords: randomised controlled trial,nsaids,osteoarthritis,effect size,methodology
Faculty \ School: Faculty of Medicine and Health Sciences > School of Health Sciences
Depositing User: Pure Connector
Date Deposited: 22 Mar 2016 09:24
Last Modified: 22 Jul 2020 00:38
URI: https://ueaeprints.uea.ac.uk/id/eprint/57747
DOI: 10.1136/annrheumdis-2015-208823

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