Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2006; 11: 44
The aim of this study was to demonstrate the therapeutic efficacy of a comfrey root extract ointment (Extr. Rad. Symphyti) in the treatment of patients with painful osteoarthritis of the knee.
This randomised, double-blind, placebo-controlled study was performed in accordance with the Declaration of Helsinki/Hong Kong 1989/Somerset 1996 as well as ICH-GCPGuidelines. Two hundred and twenty patients (153 women, 67 men, mean age 57.9 years) received daily 6 g (3 × 2 g) of either an active ointment (Kytta-Salbe f, containing comfrey root fluid extract 1:2, 35.0 g) or a corresponding placebo, for 21 days.
In the course of the study, the VAS sum score (primary target variable) decreased by 51.6 mm (54.7%) in the active therapy group and by 10.1 mm (10.7%) in the placebo group. The mean group difference of 41.5 mm or 44.0% points is significant (P < 0.001). The WOMAC percentage sum score (secondary target variable) decreased and compared well with the VAS total score. At the end of the study, a reduction of 60.4 mm (58.0%) was observed in the active therapy group and of 14.7 mm (14.1%) in the placebo group. The mean group difference of 45.7 mm or 43.9% points is significant (P < 0.001). With regard to the exploratory target variables SF-36 (quality of life), angle measurement (knee mobility), clinical global impression and global efficacy assessment by investigator and patient, a significant superiority was also demonstrated (P < 0.001, respectively) for the phyto-therapeutic agent vs. placebo. A total of 22 adverse effects occurred in 22 patients (seven in the active therapy group, 15 in the placebo group). None presented as adverse drug reactions in the active therapy group.
The present clinical study has demonstrated that application of comfrey root extract is a sensible treatment option for painful osteoarthritis.
