title: Comfrey extract ointment in comparison to diclofenac gel in the treatment of acute unilateral ankle sprains (distortions).
abstract: 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.affiliation: Istituto Ortopedico Galeazzi, Milano, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: D'Anchise
authors.forename: Michael
authors.initials: M
authors.lastname: Bulitta
authors.forename: Bruno
authors.initials: B
authors.lastname: Giannetti
mesh_terms: D000208:Acute Disease; D000287:Administration, Topical; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D020844:Comfrey / Q000009:adverse effects / Q000737:chemistry*; D004008:Diclofenac / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004487:Edema / Q000188:drug therapy / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry; D009824:Ointments; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D010147:Pain Measurement; D008517:Phytotherapy / Q000009:adverse effects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016037:Single-Blind Method; D013180:Sprains and Strains / Q000150:complications / Q000188:drug therapy*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009824:Ointments; D010936:Plant Extracts; D004008:Diclofenac