Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2002; 7: 90
This pilot study compared the effectiveness of the Harpagophytum extract Doloteffin and the selective COX-2 inhibitor rofecoxib (Vioxx) in treatment of low back pain.
We enrolled 88 patients suffering from exacerbations of chronic low back pain. In a randomised double-blind study over 6 weeks, they received either Doloteffin with 60 mg harpagoside/day (PAID) or 12.5 mg Vioxx (NSAID). Outcome measures were: (1) the number of patients free of pain without rescue medication for at least 5 days in week 6, and the percentage reduction from initial baseline of (2) the weekly averaged pain scores from the patients’ diaries, (3) the Arhus low back pain index, its pain component and (4) the HAQ.
Groups were well matched and 79 patients completed the study. After 6 weeks, the number of pain-free patients (10 in PAID group and five in NSAID group) did not differ significantly between the groups. Neither did the percentage changes from baseline in the Arhus index, its pain component and HAQ (standard deviations of about 29, 49 and 8, respectively), or the number of patients whose average pain scores changed at 6 weeks by more than 20–50% from baseline. Gastrointestinal adverse events tended to be more severe in the NSAID group.
There was no significant difference between the effectiveness of the two treatments at the chosen doses.
