BERLIN – Traumeel ointment and gel proved equal to diclofenac gel 1% in achieving pain reduction and improved joint function in patients with acute ankle sprain, according to a large randomized trial presented at the annual European Congress of Rheumatology.
The Traumeel Acute Ankle Sprain Study (TAASS) was a multicenter, double-blind clinical trial of 449 physically active patients aged 18-40 years with a grade 1 or 2 acute lateral ankle sprain. They were randomized to 2 g of Traumeel ointment, Traumeel gel, or diclofenac 1% gel applied three times daily for 2 weeks.
Traumeel is an over-the-counter homeopathic remedy containing a proprietary mix of 12 medicinal herbs, including arnica, calendula, hypericum, chamomile, witch hazel, belladonna, and monkshood, as well as two minerals. It is available in the United States and more than 60 other countries. Diclofenac gel 1% (Voltaren), in contrast, is a prescription medication that is approved for treating osteoarthritic joints.
Dr. Carlos G. de Vega explained that TAASS had two primary end points. One was change in self-assessed ankle pain between baseline and day 7 on a 0-100 visual analog scale. The Traumeel ointment group had a median 61% reduction from a baseline pain score of 53. Patients on Traumeel gel averaged a 71% reduction, while the diclofenac gel group had a median 69% reduction.
Total pain relief was reported on day 7 by 8.5% of the Traumeel ointment group, 5.0% of patients on Traumeel gel, and 5.9% on topical diclofenac.
The other primary end point in TAASS was change in the Activities of Daily Living 0-100 subscale of the Foot and Ankle Ability Measurement between baseline and day 7. The Traumeel ointment group improved by a median of 26.2 points from a baseline score of 51. The Traumeel gel group also improved by a median of 26.2 points, while the diclofenac gel group improved by 25 points, reported Dr. de Vega of the Medyr Clinic in Madrid.
At 6 weeks of follow-up, all participants reported total pain relief and normal functioning. The median time to normal activity was 19.1 days in the Traumeel ointment group and 19.4 days in each of the other two study arms.
All treatments were similarly well tolerated.
The clinical relevance of the TAASS findings lies in the fact that acute lateral ankle sprain is the most common ligamentous injury caused by sports and other physical activity. And a significant proportion of patients are more favorably disposed to a "natural" herbal therapy than to prescription medications, Dr. de Vega noted.
He reported receiving a research grant from Biologische Heilmittel Heel, which sponsored TAASS.