gms | German Medical Science

54. Jahrestagung der Norddeutschen Orthopädenvereinigung e. V.

Norddeutsche Orthopädenvereinigung

16.06. bis 18.06.2005, Hamburg

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A randomised, active-controlled, mono-centric study of the herbal drug, Devil’s Claw (Harpagophytum procumbens) (ALLYA® tablets), Voltaren® and Vioxx® indicates equal efficacy in the treatment of patients with unspecific lumbar pain

Meeting Abstract

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  • corresponding author A. Lienert - University of Witten/Herdecke, St. Anna-Hospital Herne, Department Spine Surgery and Pain Therapy, Herne
  • S. Ruetten - Herne
  • M. Kuhn - Herne
  • A. Wartenberg-Demand - Herne

Norddeutsche Orthopädenvereinigung. 54. Jahrestagung der Norddeutschen Orthopädenvereinigung e.V.. Hamburg, 16.-18.06.2005. Düsseldorf, Köln: German Medical Science; 2005. Doc05novEP26

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/nov2005/05nov108.shtml

Published: June 13, 2005

© 2005 Lienert et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

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Background

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

Methods

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.

Results

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%).

Conclusions

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.