SynthesisBMC musculoskeletal disorders2026
Tr14 gel compared to diclofenac gel after acute unilateral ankle sprain: an Individual Patient Data (IPD) meta-analysis of two multi-center trials.
Synthesis in BMC musculoskeletal disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundTraumeel (Tr14) and diclofenac gels are commonly prescribed topical treatments for Grade I-II acute lateral ankle sprain (LAS). A meta-analysis of two multi-center trials was performed to compare their clinical efficacy and supplement the evidence in support of topical treatments.
methodsData from two Phase III prospective, randomised, double-blind, reference-controlled clinical trials, TAASS (2013) and TRAUMED (2024) were examined. An Individual Patient Data (IPD) meta-analysis was performed on those with an initial pain VAS (Visual Analogue Scale) score ≥ 50 mm, using the statistical analysis plan from the latter to ensure methodological consistency.
resultsA total of 628 patients underwent meta-analysis (mean baseline pain VAS = 72.3, mean age = 32.5). The primary endpoint of the IPD meta-analysis, Area Under the Curve (AUC) of pain VAS scores, indicated beneficial effects of Tr14 gel compared with diclofenac gel, statistically significant on Days 4, 7, and 14 (Day 4 mean difference MD
conclusionThe IPD meta-analysis of the TAASS and TRAUMED trials confirms the efficacy of Tr14 gel. In-depth analysis reveals it is a statistically favourable treatment with respect to pain, and function, compared to the gold-standard diclofenac gel. Taking this together, Tr14 gel represents a statistically favourable treatment option for Grade I-II ankle sprain within the context of the analysed endpoints.
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