Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2002; 7: 89
In addition to checking estimates of effectiveness and safety of using Doloteffin for osteoarthritic knee and hip pain and non-specific low back pain, this post-marketing surveillance compared various disease-specific and generic measures of effect.
We enrolled 250 patients (groups were: Back, n = 104; Knee, n = 85; Hip, n = 6). They took an 8-week course of Doloteffin with 60 mg harpagoside/day. The measures of effect on pain and disability included the percentage changes from baseline of established instruments (Arhus low back pain index, WOMAC index, German version of the HAQ) and unvalidated measures (total pain index, three score index, each patient’s global assessment of the effectiveness of treatment). Patients also received a diary for the daily recording of their pain and any additional treatments for it.
A total of 227 patients completed the study. In all groups, the generic and disease-specific outcome measures had improved by week 4 and further by 8, but the pattern of association between the measures was complex, with effects of group (Back, Knee or Hip), time (initial, 4 weeks, 8 weeks) and type of measure (generic vs. disease-specific). Multivariable modelling could identify a significantly greater improvement in the Hip group than in the other two after adjustment for confounders. About 10% of the patients suffered from minor adverse events that could possibly have been attributable to Doloteffin.
Because between 50% and 70% of the patients benefited from Doloteffin with few adverse effects, this herbal treatment is well worth considering for osteoarthritic knee and hip pain and non-specific low back pain.
