Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2003; 8: 133
This short-term follow-up investigated the impact of pretreatment with the selective COX-2 inhibitor rofecoxib on treatment outcome after 6 weeks.
After a randomised double-blind pilot study comparing the effectiveness of Doloteffin (D) versus rofecoxib (R) over 6 weeks, 73 (88) patients agreed to participate in the follow-up study with Doloteffin. Outcome measures were: (1) the number of days with pain scores zero (NDS0); (2) additional consumption of analgesics (CA); (3) the Arhus index (AI) and its components, including current pain (VAS 0–10); and (4) the health assessment questionnaire scores (HAQ). Measures (3) and (4) were done before, after 6 weeks (end of pilot) and at 12 weeks (end of follow-up). Results were analysed by intention-to-treat (ITT, last observation carried forward) and per protocol (PP) analysis. The 95% confidence interval (CI) was calculated for the mean difference in percentage change of current pain (D-R).
Between Doloteffin and rofecoxib recipients, NDS0, CA, AI and HAQ did not differ in the pilot and follow-up period. The mean difference was 3% (CI –17 to +23; ITT) and –7% (–29 to +15; PP) after 6 and 12% (–8 to +32, ITT) and 13% (–6 to +32; PP).
Pretreatment with rofecoxib had no impact on treatment outcome in the short-term follow-up study. This result confirms that treatment with Doloteffin may not be worse than treatment with rofecoxib.
