Efficacy and Safety of Aceclofenac in Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials

Eur J Rheumatol. 2017 Mar;4(1):11-18. doi: 10.5152/eurjrheum.2017.160080. Epub 2017 Mar 1.


Objective: To analyze the effects on pain, function, and safety of aceclofenac compared with other nonsteroidal anti-inflammatory drugs (NSAIDs) or pain relief medications in patients with osteoarthritis.

Material and methods: Two investigators independently searched the database. We included randomized controlled trials evaluating efficacy and/or safety of aceclofenac compared with control interventions (NSAIDs or acetaminophen) in patients with osteoarthritis. We did not include placebo, opioid analgesics, NSAID combinations, and topical analgesics for the control groups. We summarized the efficacy data as standardized mean differences (SMD) with 95% confidence intervals (CI) and safety outcomes as risk ratios (RR) with 95% CI using the inverse variance random effect model. We assessed the heterogeneity by the I2 test. We used the GRADE approach to evaluate the quality of the evidence for all outcome parameters.

Results: We included 9 trials (8 double blind and 1 single blind) that evaluated pain (7 trials), function (8 trials) and safety (7 trials). We observed no significant difference in pain reduction between aceclofenac and control interventions [SMD: -0.30 (-0.62, 0.01); I2=88%; GRADE evidence- low]. Aceclofenac was more beneficial than control interventions in improving physical function [SMD: -0.27 (-0.50, -0.03); I2=88%; GRADE evidence- low]. We observed less gastrointestinal adverse events for aceclofenac than in control interventions [RR 0.69 (95% CI: 0.57, 0.83); I2=12%; GRADE evidence- moderate]. We observed no difference in overall adverse events occurrence and dropout rate between aceclofenac and control interventions.

Conclusion: We observed that aceclofenac was beneficial over control analgesics for function improvement and to minimize gastrointestinal adverse events. Our findings could be biased due to the heterogeneity of the sample, the fact that the trials were small and methodological issues.

Keywords: Osteoarthritis; aceclofenac; function; meta-analysis; pain; safety.