Effect of a plaster containing DHEP and heparin in acute ankle sprains with oedema: a randomized, double-blind, placebo-controlled, clinical study

Abstract

Objective:

Ankle sprains are the most frequent injuries in sport and daily life, and are usually treated with anti-inflammatory drugs or compounds that have an effect on microcirculation. The efficacy and tolerability of a novel plaster containing both diclofenac epolamine (DHEP) and heparin in the treatment of acute painful ankle sprains with oedema was investigated in a randomized, double-blind, placebo-controlled study.

Research design and methods:

This study, carried out in 32 French medical centres, enrolled 233 patients (148 male and 86 female, aged 18–65 years) with an ankle sprain that had occurred within the previous 48 hours. Patients were treated once daily with DHEP heparin or placebo plaster for 7 days.

Main outcome measures:

Reduction in ankle joint swelling measured by submalleolar circumference was the primary efficacy endpoint; secondary endpoints were pain (at rest, in active mobilization, by passive stretch and by pressure), functional disability and global judgement of efficacy and tolerability.

Results:

DHEP heparin-treated patients experienced a significantly greater reduction in joint swelling compared with placebo (p = 0.005). The reduction in pain was also in favour of DHEP heparin patients, with significantly lower pain in DHEP heparin-treated than placebo-treated patients within 3 hours of the first application (p < 0.05). Only two patients in the DHEP heparin plaster group and six in the placebo group experienced minor adverse events, all of which resolved spontaneously. By design, the study was limited to a placebo-controlled comparison, and there was no test for possible selection bias (subsequently ruled out by choice of efficacy parameters and measures) that may have resulted in a baseline imbalance between patient groups.

Conclusions:

Results confirm the efficacy of DHEP heparin plaster compared with placebo for the treatment of painful ankle sprain with oedema. Prompt control of pain and oedema may shorten the time to initiation of a rehabilitation programme, thus reducing the risk of ankle disability recurrence and the development of chronic injury.

Key words::

• Ankle sprain
• diclofenac epolamine
• Heparin
• Oedema
• Plaster

Transparency

Declaration of funding

This research and subsequent paper were supported by IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.

Declaration of financial/other interests

J-M.C. and F.de V. have disclosed that they have no conflicts of interest.

Acknowledgements

The authors acknowledge all the physicians who participated in this study and without whom this study could not have been performed: E. Desandre-Navarre, S. Ramare, Ph. Donnou, J.-P. Desmons, F. Le Gall, Ph. Auguste, C. Boyer, Y. Lambert, J.-P. Pedelucq, J.-Y. Petit, H. Garnier DeLabareyre, J.-Ph. Hager, S. Laidi, F. Moyere, Ch. Baudot, F. Merle, P. Aboukrat, D. Le Quere, R. Morin, D. Maille, H. Tisal, P. Schmitt, K. Mekki, J.-M. de Lustrac, Ch. Fur, J.-P. Lahire, J. Le Follic, Y. Runavot, H. Schulc, F. Levecque, J. Hautin. The authors also thank Mary Hines of inScience Communications who provided assistance with technical revisions and native-English editing after peer review. The editorial support was supported by IBSA.

Notes

* IBSA Institut Biochimique SA, Pambio-Noranco, Switzerland.