Combination of Comfrey Root Extract Plus Methyl Nicotinate in Patients with Conditions of Acute Upper or Low Back Pain: A Multicentre Randomised Controlled Trial

• Published in: Phytotherapy research 2013-06, Vol.27 (6), p.811-817
• Main Authors: Pabst, Helmut, Schaefer, Axel, Staiger, Christiane, Junker-Samek, Marc, Predel, Hans-Georg
• Format: Article
• Language: English
• Subjects: acute back pain; Adult; comfrey; Comfrey - chemistry; Double-Blind Method; Female; Humans; Low Back Pain - drug therapy; Male; methyl nicotinate; Nicotinic Acids - therapeutic use; Pain Measurement; Phytotherapy; Plant Extracts - therapeutic use; RCT; Young Adult
• ISSN: 0951-418X; 1099-1573
• DOI: 10.1002/ptr.4790

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