Comfrey extract ointment in comparison to diclofenac gel in the treatment of acute unilateral ankle sprains (distortions).

Abstract

OBJECTIVES:

A previously published study comparing the efficacy of comfrey extract to a commercial diclofenac (CAS 78213-16-8) preparation in the treatment of unilateral ankle sprains is critically re-evaluated. The study was designed to show non-inferiority of the comfrey extract. The data were re-evaluated for superiority according to CPMP guidelines. The study was an observer-blind, randomised, multi-centre clinical trial with two independent treatment groups "comfrey extract" and "diclofenac gel" (parallel group design) and included a total of 164 patients (82 in the comfrey group and 82 in the diclofenac group, intention-to-treat (ITT) analysis). Key variables were the area under the curve (AUC) from Visits 1 to 2 of the difference of the tenderness values contra-lateral minus injured side (primary variable), pain assessment (Visual Analogue Scale, VAS) at rest and on movement by patient, swelling (figure-of-eight method) and ankle movement (neutral zero method). On average (mean difference comfrey extract minus diclofenac), the AUC was +61.1 h x N/cm2 greater for patients treated with comfrey extract compared to diclofenac treated patients (95% confidence interval: 19.08; 103.09 h x N/cm2). The difference between the two treatment groups was statistically significant (analysis of variance with factors "study drug", "centre", and "drug x centre interaction"). Safety was excellent in both treatment groups. The re-evaluation of the data showed superiority of the plant based ointment over the diclofenac gel in the treatment of distortions. It is encouraging and impressive to realize that a natural product seems to be an effective and safe alternative to the standard topical treatment with diclofenac.

• Authors: Roberto D'Anchise, Michael Bulitta, Bruno Giannetti
• Journal: Arzneimittel-Forschung (Arzneimittelforschung) Vol. 57 Issue 11 Pg. 712-6 ( 2007) ISSN: 0004-4172 [Print] Germany
• PMID: 18193693 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Inflammatory Agents, Non-Steroidal
• Ointments
• Plant Extracts
• Diclofenac

Topics

• Acute Disease
• Administration, Topical
• Adult
• Anti-Inflammatory Agents, Non-Steroidal (administration & dosage, adverse effects, therapeutic use)
• Area Under Curve
• Comfrey (adverse effects, chemistry)
• Diclofenac (administration & dosage, adverse effects, therapeutic use)
• Edema (drug therapy, pathology)
• Female
• Humans
• Male
• Manometry
• Ointments
• Pain (drug therapy, etiology)
• Pain Measurement
• Phytotherapy (adverse effects)
• Plant Extracts (administration & dosage, adverse effects, therapeutic use)
• Single-Blind Method
• Sprains and Strains (complications, drug therapy)