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FACT
Focus on Alternative and Complementary Therapies

Assalix® for chronic low back pain and arthralgia: Interim analysis of a post-marketing surveillance study

Werner G1, März RW1, Schremmer D2
1BIONORICA AG, Medical Research and Science, Kerschensteinerstr. 11–15, Neumarkt (OPf.), D–92318, Germany
2GKM Gesellschaft für Therapieforschung mbH, Biostatistics, Munich, D–80469, Germany

Objective

A randomised, placebo-controlled clinical trial (210 patients) supported by open studies vs. active controls (679 patients) indicate that willow bark extract is dose-dependently effective in chronic low back pain and is also effective in osteoarthritis (78 patients). Therefore, the aim of this study was to determine the analgesic effect, doses administered in praxis and the tolerability of Assalix in general practice in a large number of patients.

Materials and methods

Between July and December 2001 about 5000 patients were observed for 6–8 weeks in 1000 centres. Each physician prospectively enrolled five consecutively presenting patients, for whom Assalix was prescribed for their chronic low back pain or arthralgia for the first time. According to a protocol, physicians described anamnesis of these patients, assessed intensity of pain on a visual analogue scale, and specified the Assalix dosage prescribed and concomitant treatment in standardised case report forms. At a second and third visit, they assessed pain intensity again, pointed out variations in Assalix dosage and concomitant treatment and reported adverse drug reactions, if any, in detail.

Results and conclusion

Results of an interim analysis and conclusions will be presented at the symposium.

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