Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 490
To collect information on the effectiveness and adverse events of long-term treatment with Doloteffin.
After a 6-week randomised, double-blind pilot comparison of effectiveness of Doloteffin and rofecoxib in twice 44 patients (Rheumatology 42 (2003) 141–48), 38 ex-Doloteffin (ex-D) and 35 ex-rofecoxib (ex-R) patients were prescribed Doloteffin for up to 54 weeks. Outcome measures were the number of patients remaining in follow-up, diary recordings of daily verbal pain ratings, 6-week assessments of additional analgesic requirements, Arhus index and health assessment questionnaire (HAQ). The ex-D and ex-R patients were compared by intention-to-treat (on the basis of last observation carried forward) and per protocol analyses.
Pain, Arhus Index and HAQ improved slightly overall throughout the follow-up (manova P < 0.016) despite individual fluctuations. VRS was rated no, mild, moderate, severe and excruciating, respectively, in 28%, 39%, 22%, 8.5% and 1.5% of the 21761 patient-days. Few patients requested additional analgesia. The ex-D and ex-R patients were not confidently distinguishable in daily pain scores, use of additional analgesics, Arhus Index and HAQ. Three patients suffered from minor adverse reactions possibly related to Doloteffin.
Improvements observed in the first 6 weeks of treatment with either Doloteffin or rofecoxib were slightly increased overall over the subsequent year, irrespective of the initial treatment. Long-term treatment with Doloteffin was well tolerated.
