gms | German Medical Science

The aim of this study was to compare the efficacy of a traditional herbal anti-inflammatory drug with Voltaren^® and Vioxx^®.

An open, randomised, active-controlled, parallel group, moncentric study was undertaken with 97 patients (median age, 53 years; range, 18.6-79.5 years) with unspecific lumbar pain. Three drug treatments (at standard recommended doses) were compared; ALLYA^® two film-coated tablets (each 240 mg) twice daily, Voltaren^® resinat one capsule (75 mg) twice daily and Vioxx^® one tablet (12.5 mg) once daily. The primary efficacy criterion was the North American Spine Society (NASS) Instrument.

In the PP sample, the median reductions in mean NASS scores after 6 weeks were 15.5% with ALLYA^®, 18.9% with Voltaren^® res. and 20.2% with Vioxx^®. In the ITT sample, median reductions in mean NASS scores after 6 weeks were 20.7% for ALLYA^®, 17.0% for Voltaren^® res. and 20.6% for Vioxx^®. Parametric statistical analysis indicated equality of treatment, although in the Vioxx^® group medication intake increased during the study. There were considerable differences in the number of possible causal adverse drug reactions. For Allya^®, this occurred in 16% of patients which was much less than for Vioxx^® (33%) and for Voltaren^® (56%).

Analysis of the PP sample indicates equivalent efficacy of the three treatments, but small sample size and data variability makes a definitive interpretation difficult. The difference between the medications in regard to probable causal adverse-effects indicate that the benefit risk-ratios very probably differ between the medications, with ALLYA^® being the superior medication on this basis.