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

Authors


  • Disclosures

    JG and CGV received financial support for the study; CS, BW and CGV had financial support for the submitted work from Biologische Heilmittel Heel GmbH; CGV, BW and CS are advisory board members for Traumeel for Biologische Heilmittel Heel GmbH; CS and CGV have received consultancy fees from Biologische Heilmittel Heel GmbH; BW has received consultancy fees from Biologische Heilmittel Heel GmbH and Johnson & Johnson; BW has received payment for lectures, including as a speaker on speaker bureaus, from Biologische Heilmittel Heel GmbH, Astra Zeneca, Berlin Chemie, Bristol-Myers Squibb; CGV has received payment for developing and delivering educational presentations for Biologische Heilmittel Heel GmbH; BW has received payment for developing and delivering educational presentations for Johnson & Johnson; there are no other relationships or activities that could appear to have influenced the submitted work.

  • Trial registration

    NCT01066520

Correspondence to:

Dr Carlos González de Vega,

Medical Director

MEDYR Clinic, Sports Medicine & Rehabilitation Hernani 54,

28020, Madrid, Spain

Tel.: + 34 91 5360029

Fax: + 34 91 5530414

Email: cgdv@telefonica.net

Summary

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) (= 152) or Traumeel gel (T-G) (= 150) or diclofenac gel (D-G) (= 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 (= 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.

Ancillary