Traumeel vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-inferiority trial

Abstract

Background: Acute ankle sprains are common and activity limiting injuries, and topical diclofenac gel has proven efficacy in alleviating pain and restoring function. This trial aimed to compare a topical natural agent, Traumeel with topical diclofenac gel (1%) in the management of acute ankle sprain.

Methods: This prospective, multicentre, randomised, blinded, active-control and non-inferiority study involved 449 physically active adults sustaining unilateral grade 1 or 2 ankle sprain within the past 24 h. Participants were randomised to receive 2 g of Traumeel ointment (T-O) (n = 152) or Traumeel gel (T-G) (n = 150) or diclofenac gel (D-G) (n = 147), administered topically to the ankle three times a day for 14 days, with 6-weeks follow up.

Results: Day 7 median percentage reductions in Visual Analogue Scale pain score were 60.6%, 71.1% and 68.9% for the T-O, T-G and D-G groups, respectively. Total pain relief was reported by 12 (8.5%), 7 (5.0%) and 8 (5.9%) participants in each group, respectively. Median improvements in Foot and Ankle Ability Measure Activities of Daily Living subscale score were 26.2, 26.2 and 25.0 points for T-O, T-G and D-G groups, respectively. Mann-Whitney effect sizes and lower bound confidence intervals demonstrated non-inferiority of Traumeel vs. diclofenac for reducing pain and functional improvement. At 6 weeks, participants reported total pain relief and normal functioning. Adverse events (n = 43) were reported by 31/447 participants (6.9%). Treatments were equally well tolerated.

Conclusions: T-O and T-G decreased pain and improved joint function to the same extent as D-G in acute ankle sprain, and were well tolerated.

Trial registration: ClinicalTrials.gov NCT01066520.

© 2013 The Authors. International Journal of Clinical Practice published by John Wiley & Sons Ltd.

Figures

Figure 1

TAASS trial flowchart of study population with ankle sprain randomised and followed up in study monitoring efficacy. Exclusions, all circumstances leading to exclusion from Safety or Intent-To-Treat or Per Protocol populations; In/Ex criteria, inclusion/exclusion criteria; time first application, first time of first application of study drug; date of day 7, date of Visit 3 (day 7); premature discont., premature discontinuation (not efficacy related); administrative reasons including ‘lost to follow up’; * ‘severe’ violation of the VAS pain inclusion criterion (VAS

Figure 2

Pain Visual Analogue Scale score (percentage change from baseline; LOCF, Intent-To-Treat population). (A) VAS pain: percentage change from baseline (ITT population). (B) Traumeel ointment vs. diclofenac gel: effect sizes (Mann–Whitney) and one-sided 97.5% CI. (C) Traumeel gel vs. diclofenac gel: effect sizes (Mann–Whitney) and one-sided 97.5% CI. ITT, Intent-To-Treat; LB, Lower bound of the one-sided confidence interval; LOCF, Last Observation Carried Forward; MW, Mann–Whitney estimator; P, p-value of one-sided Wilcoxon–Mann–Whitney test; T/R, valid number of participants in Traumeel (test) group/valid number of participants in diclofenac gel (reference) group; Tr, Traumeel; VAS, Visual Analogue Scale; VAS200LP, day 4; VAS300LP, day 7; VAS400LP, day 14; VAS500LP, day 42.

Figure 3

Foot and Ankle Ability Measure Activities of Daily Living subscale (changes from baseline; LOCF, Intent-To-Treat population). (A) FAAM ADL subscale: changes from baseline (ITT population). (B) Traumeel ointment vs. diclofenac gel: effect sizes (Mann–Whitney) and one-sided 97.5% CI. (C) Traumeel gel vs. diclofenac gel: effect sizes (Mann–Whitney) and one-sided 97.5% CI. FAAM ADL, Foot and Ankle Ability Measure Activities of Daily Living subscale; FADL200LC, day 4; FADL300LC, day 7; FADL400LC, day 14; FADL500LC, day 42; ITT, Intent-To-Treat; LB, Lower bound of the one-sided confidence interval; LOCF, Last Observation Carried Forward; MW, Mann–Whitney estimator; P, p-value of one-sided Wilcoxon–Mann–Whitney test; T/R, valid number of participants in Traumeel (test) group/valid number of participants in diclofenac gel (reference) group; Tr, Traumeel.