gms | German Medical Science

54. Jahrestagung der Norddeutschen Orthopädenvereinigung e. V.

Norddeutsche Orthopädenvereinigung

16.06. bis 18.06.2005, Hamburg

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

  • 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

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Veröffentlicht: 13. Juni 2005

© 2005 Lienert et al.
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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.