Presented at the 2013 AAPM Annual Meeting « Back

Comfrey Root Extract Plus Methylnicotinate: A Topical Treatment Option for Patients with Acute Upper or Low Back Pain

Christiane Staiger, christiane.staiger@merckgroup.com¹, (1) EMD Consumer Health, Darmstadt, Germany

Many earlier and recent clinical trials have confirmed the efficacy of comfrey root extract (Symphytum officinale L.) for the topical treatment of painful muscle and joint complaints (1). The topical pharmacotherapeutic approach has generally included hyperaemising topical drugs such as nicotinates with the intention to soften and relax the contracted muscle area. Therefore, the extract has also been used in combination with methylnicotinate. This randomized, multicenter, 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 3 times daily for 5 days. The trial included four visits and was performed at the German Sport University in Cologne and 3 additional ambulatory centers. The primary efficacy variable was the AUC (area under the curve) of the VAS on active standardized 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 standardized 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. References: 1) Phytother. Res. (2012) DOI: 10.1002/ptr.4612 2) Phytother. Res. (2012) DOI: 10.1002/ptr.4790 3) Br J Sports Med 2010;44:637–641. doi:10.1136/bjsm.2009.058677.

Funding: This RCT was sponsored by EMD Consumer Health, Darmstadt, Germany