September 4, 2013 — A recent study shows that Traumeel, a topical pain medicine made of 12 natural ingredients (out of 14 actives), is as effective as a current standard therapy, 1 percent diclofenac gel, in reducing pain and improving function in adults with ankle sprain injuries. The findings, from the Traumeel in Acute Ankle Sprain Study (TAASS), were recently highlighted in the online International Journal of Clinical Practice as well as an issue of Current Medical Research and Opinion,1 and first reported at the European League Against Rheumatism (EULAR) conference in June 2012.2
“Diclofenac gel is a current ‘gold standard’ therapy for ankle sprains and other types of musculoskeletal pain, but it can have serious side effects such as gastrointestinal bleeding and increased cardiovascular disease risks,”3 said Polina Karmazin, MD. “These findings, from a well-controlled study (449 patients), are good news for people with ankle injuries and for the physicians who treat them because they show Traumeel, which has rare side effects, is just as effective as 1 percent diclofenac gel.”
The study found that after seven days of treatment, topical Traumeel was shown to be non-inferior to 1 percent diclofenac gel for the primary endpoints of pain and function. Traumeel is a combination of 12 natural active ingredients out of 14 actives and has been shown in other studies to be beneficial in ankle sprains,4 tendonitis and injuries,5,6 “tennis elbow” (epicondylitis)7 and musculoskeletal injuries.8 Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for various types of joint pain, ankle sprains and musculoskeletal pain.3,9,10,11
“These results provide clinical evidence and validate Traumeel as an effective treatment option for musculoskeletal disorders,” said Dr. Alta Smit, director global medical affairs & research at Heel Inc. “The findings from this study add to the growing evidence base that Traumeel Ointment and Gel, which other studies have shown have better tolerability and fewer side effects than NSAIDs, are as effective as NSAIDs.”7,8
Based on the findings from TAASS and other studies, as well as their personal experience with Traumeel, a group of international experts developed an algorithm for treating both acute and chronic musculoskeletal conditions that includes Traumeel along with complementary and alternative medicine, NSAIDs and non-drug therapies. The algorithm also includes dosing frequency and duration of Traumeel topical, oral, and injected medicines.12
About the study: TAASS was a randomized, controlled, multicenter trial comparing Traumeel Ointment and Gel with 1 percent diclofenac gel for the treatment of acute ankle sprain. It included 449 physically active participants aged 18–40 years who had a mild to moderate ankle sprains.
Patients were randomly assigned to treatment with Traumeel ointment (n = 152), Traumeel gel (n= 150) or 1 percent diclofenac gel (n = 147), and instructed to apply two grams of product topically three times a day for 14 days, with six weeks of follow up. The primary endpoints were patients’ assessment, on day seven, of ankle pain on a standard 0–100 mm Visual Analogue Scale (VAS), and of their ability to function on the Activities of Daily Living (ADL, 0–100) subscale of the Foot and Ankle Ability Measurement (FAAM). Investigators also assessed a number of secondary endpoints, including ankle swelling, performance in sports activities, patients’ global assessment of efficacy and other measures.
After seven days of treatment, for the primary endpoints of pain and function, both Traumeel formulations were shown by statistical analysis to be non-inferior to 1 percent diclofenac gel. The median reductions in VAS pain scores were similar for the Traumeel Ointment, Traumeel Gel and diclofenac gel groups: 60.6 percent, 71.1 percent, and 68.9 percent, respectively. Complete pain relief was reported by 8.5 percent, 5.0 percent and 5.9 percent of patients in each group, respectively. The median improvements in ADL-FAAM scores were 26.2, 26.2 and 25.0 points (median baseline scores: 51.2, 56.0 and 51.2 points), respectively. At six weeks, all patients reported total pain relief and normal functioning. Median time to normal function was 19.09, 19.35 and 19.39 days, respectively. Adverse events (n = 43) were reported by 31/447 patients (6.9 percent). Events were mostly mild or moderate in severity, none were serious and all three treatments were equally well tolerated.
Source: Heel Inc., heelusa.com
*These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.
1Wolfarth B, de Vega CG. Make an impact on your daily practice: the potential role for a natural multi-target medication. Curr Med Res Opin. 2013;29 Suppl 2:15-19.
2De Vega CG, Gonzalez J; on behalf of Traumeel Acute Ankle Sprain Spain (TAASS) Study Investigators. A randomized, controlled, multicenter study on the effectiveness of Traumeel (ointment and gel) in terms of pain reduction and function improvement compared with diclofenac gel in acute ankle sprain. Ann Rheum Dis 2012;71(Suppl 3):SAT0423. Available at: http:// www.abstracts2view.com/eular/
3Prescribing information: Voltaren® Gel (diclofenac sodium topical gel) 1%. Endo Pharmaceuticals Inc., Chadds Ford, PA, 19317. October 2009. (In Warnings and Precautions section)
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