title: Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial.
abstract: Purpose This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. Design In this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1-3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient's global assessment of response to treatment. Results There were no statistically significant differences in AUC1-3between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Conclusion No significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain. ClinicalTrials.Gov Identifier: NCT02100670.
authors.affiliation: 1 Clinical Development and Medical Affairs, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.
authors.forename: Pamela M
authors.initials: PM
authors.lastname: Lai
authors.affiliation: 2 Biostatistics Department, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.
authors.forename: Agron
authors.initials: A
authors.lastname: Collaku
authors.affiliation: 1 Clinical Development and Medical Affairs, GlaxoSmithKline Consumer Healthcare, Warren, NJ, USA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Reed
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000842:Ankle / Q000503:physiopathology; D016512:Ankle Injuries / Q000188:drug therapy* / Q000503:physiopathology; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D019540:Area Under Curve; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008610:Menthol / Q000627:therapeutic use*; D008875:Middle Aged; D010146:Pain / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005782:Gels; D004008:Diclofenac; D008610:Menthol
keywords: Ankle sprain; diclofenac; menthol; pain; topical administration