Background Acute lateral ankle sprain is generally accepted as the most common ligamentous sports and daily exercise injury associated with acute inflammation. When left untreated, these injuries can lead to joint instability and a limited range of motion.
Objectives To demonstrate that Traumeel (ointment and gel) is non-inferior to diclofenac gel 1% in the treatment of acute ankle sprain.
Methods In this multicenter study, 449 physically active patients (18–40 years) with unilateral ankle sprain were randomized blinded to receive 2 g of Traumeel ointment (n=152) or Traumeel gel (n=150) or diclofenac gel (n=147) administered topically three times a day for 14 days, with 6-weeks follow-up. Primary endpoints were patients’ assessment on a 0–100 mm Visual Analogue Scale (VAS) ankle pain and on the Activities of Daily Living (ADL, 0–100) subscale of the Foot and Ankle Ability Measurement (FAAM) on Day 7.
Results On Day 7, median percentage reductions in VAS pain score were demonstrated by all groups: Traumeel ointment, 60.6% (median: baseline 52.6 mm; change -33.0); Traumeel gel, 71.1% (median: baseline 53.1 mm; change -37.1); and diclofenac, 68.9% (median: baseline 55.7 mm; change -37.1). Total pain relief was reported by 8.5%, 5.0% and 5.9% of patients in each group, respectively. Mann-Whitney (MW) effect sizes and lower bound of the confidence intervals (LBCI; predefined benchmark 0.4) for Traumeel ointment and gel combined vs. diclofenac (MW=0.4910; LBCI=0.4321), Traumeel ointment vs. diclofenac (MW=0.4682; LBCI=0.4004) and Traumeel gel vs. diclofenac (MW=0.5142; LBCI=0.4464) demonstrated non-inferiority of both the Traumeel preparations vs. diclofenac for reducing pain. On Day 14, median percentage reductions in VAS pain score were 94.3%, 93.4% and 94.8% (median changes -46.4, -50.5 and -50.5 mm) for Traumeel ointment, Traumeel gel and diclofenac groups, respectively. On day 7, median improvements in FAAM ADL score were 26.2, 26.2 and 25.0 points (median baseline 51.2, 56.0 and 51.2 points) for Traumeel ointment, Traumeel gel and diclofenac groups, respectively. MW effect sizes and LBCI for Traumeel ointment and gel combined vs. diclofenac (MW=0.5260; LBCI=0.4656), Traumeel ointment vs. diclofenac (MW=0.5169; LBCI=0.4485) and Traumeel gel vs. diclofenac (MW=0.5352; LBCI=0.4666) demonstrated non-inferiority of both Traumeel preparations vs. diclofenac for functional improvement. On Day 14, median improvements in FAAM ADL score were 41.7, 40.5 and 41.7 points for Traumeel ointment, Traumeel gel and diclofenac groups, respectively. At 6 weeks, all patients reported total pain relief and normal functioning. Median time to normal function was 19.09, 19.35 and 19.39 days for Traumeel ointment, Traumeel gel and diclofenac groups, respectively. Adverse events (n=43) were reported by 31/447 patients (6.9%). Events were mostly mild or moderate in severity, none was serious and all treatments were equally well tolerated.
Conclusions In this large scale trial, Traumeel ointment and gel decreased pain and improved joint function to the same extent as diclofenac gel in acute ankle sprain, with a good tolerability profile. Trial ID: NCT01066520
Disclosure of Interest C. G. De Vega Grant/Research support from: Investigator, TAASS study, Biologische Heilmittel Heel GmbH: TAASS study supported by Biologische Heilmittel Heel GmbH, Consultant for: Advisory board member, Traumeel, Biologische Heilmittel Heel GmbH, J. González Grant/Research support from: Investigator, TAASS study, Biologische Heilmittel Heel GmbH: TAASS study supported by Biologische Heilmittel Heel GmbH
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