Efficacy and safety of a fixed combination of diosmin, bromelain, and Boswellia serrata in the management of acute ankle sprain: a randomized placebo-controlled study

BACKGROUND: Ankle sprains, common problem in medical care, are associated with significant pain and discomfort. Edema is part of the inflammatory response to injuries, and its persistence contributes to delay healing, and recovery. The early management of edema prevents healing complications. Effective treatments for edema include nutraceuticals. A nutraceutical product (Darfax®) with favorable effect on microcirculation, containing active ingredients with phlebotonic, anti-inflammatory and anti-pain actions, was developed. This study was aimed to evaluate the efficacy and safety of the product in reducing edema in acute ankle sprain in a placebo-controlled, randomized clinical trial.METHODS: A single center, randomized, double-blind, placebo-controlled trial was carried out in 90 adults with symptomatic acute tibio-peroneal-talar sprain. The nutraceutical product in tablets formulation or placebo were blindly given b.i.d. for 20 days. Edema, pain, and quality of life were measured at baseline, 7 and 20 days. The swelling reduction after 20-day of treatment versus baseline compared with placebo was the primary endpoint.RESULTS: Swelling significantly decreased in the active treatment group at day 7 and 20 with a high statistically significant difference versus placebo group. FAOS scores (pain, symptoms, daily living, sports, recreations, and QoL) significantly improved at both times in active treatment group, while in placebo group at day 20 only. Less patients in the active treatment group used pain killers as rescue medication (6.7 vs. 28.9%).CONCLUSIONS: The tested nutraceutical product showed to significantly reduce edema and pain, representing a valid treatment for a rapid recovery of the functio laesa after ankle sprain.