Combination of Comfrey Root Extract Plus Methyl Nicotinate in Patients with Conditions of Acute Upper or Low Back Pain: A Multicentre Randomised Controlled Trial
Article first published online: 8 AUG 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Volume 27, Issue 6, pages 811–817, June 2013
How to Cite
Pabst, H., Schaefer, A., Staiger, C., Junker-Samek, M. and Predel, H.-G. (2013), Combination of Comfrey Root Extract Plus Methyl Nicotinate in Patients with Conditions of Acute Upper or Low Back Pain: A Multicentre Randomised Controlled Trial. Phytother. Res., 27: 811–817. doi: 10.1002/ptr.4790
- Issue published online: 7 JUN 2013
- Article first published online: 8 AUG 2012
- Manuscript Accepted: 14 JUL 2012
- Manuscript Revised: 11 JUN 2012
- Manuscript Received: 15 FEB 2012
- methyl nicotinate;
- acute back pain;
This randomised, multicentre, double-blind, three-arm, placebo-controlled trial compared a topical combination of 35% comfrey root extract plus 1.2% methyl nicotinate versus a single preparation of methyl nicotinate or placebo cream for relief of acute upper or low back pain. 379 patients were randomly assigned to three groups (combination, n = 163; methyl nicotinate, n = 164; placebo, n = 52). They applied a 12 cm layer of cream three times daily for 5 days. The primary efficacy variable was the area under the curve (AUC) of the visual analogue scale (VAS) on active standardised movement values at visits 1 to 4. Secondary measures included back pain at rest, pressure algometry, consumption of analgesic medication, functional impairment measured with Oswestry Disability Index, and global assessment of response. The AUC of the VAS on active standardised movement was markedly smaller in the combination treatment group than in the methyl nicotinate and in the placebo group (ANOVA: p < 0.0001). The combination demonstrated superiority to the two other treatment arms, while methyl nicotinate displayed a considerable effect as well. Copyright © 2012 John Wiley & Sons, Ltd.