PURPOSE: To investigate the efficacy of Traumeel® S versus Diclofenac and placebo ointment in non-traumatic tendinous pain in elite athletes.
METHODS: We conducted a randomized, double blind, three-armed, parallel groups clinical trial in Chilean Elite athletes with various tendinopathies. Eligible patients who provided written informed consent were randomized into receiving topical treatment with either Traumeel® S ointment, Diclofenac ointment or placebo ointment. Treatment took place three times daily, plus night use for a period of at least 21 days, after which a follow up echographic assessment took place.
The clinical assessment was based on a 10 point Visual Analogue Scale for Pain, return to sports (number of days), tolerability.
Echographic assessment was based on measurement of peritendinous diameter and oedema. The assessor was blind to treatment allocation and the same assessor compared the before and after treatment recordings. Statistical analysis was by intention-to-treat, use was made of STATA 8.1
RESULTS: 252 professional athletes (169 male, 83 female, average age 23.5 years) affiliated with the Chilean Olympic Committee, tennis federation, Davis Cup Team and Professional Soccer League were recruited in the trial between December 2005 and September 2006. The Traumeel® S group consisted of 89 athletes (59 male, 30 female), diclofenac group of 87 athletes (60 male, 27 female) and the placebo group of 76 athletes (50 males, 26 females).
The mean pain reduction (VAS-P) in the Traumeel® S group was 5.2 points versus 3.6 in the diclofenac and 1.4 in the placebo groups (P=0.000 for pairwise between group comparisons). The average number of days to return to sports was 20.3 in the Traumeel® S group, 24.6 in the Diclofenac group and 30.6 in the placebo group (P=0.000 for pairwise comparisons to placebo).
The percentage reduction in the echographic assessment of the peritendinous diameter and oedema was 88.2% in the Traumeel® S group versus 69.1% in the diclofenac and 24.6% in the placebo groups (P=0.000 for pairwise between group comparisons). Treatments were generally well tolerated: i4 patients dropped out (all in diclofenac group due to allergic skin reactions).
CONCLUSION: Traumeel® S is an efficacious and safe alternative in the treatment of non-traumatic tendinopathies in athletes.