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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.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Istituto Ortopedico Galeazzi, Milano, Italy.

    ,

    Source

    Arzneimittel-Forschung 57:11 2007 pg 712-6

    MeSH

    Acute Disease
    Administration, Topical
    Adult
    Anti-Inflammatory Agents, Non-Steroidal
    Area Under Curve
    Comfrey
    Diclofenac
    Edema
    Female
    Humans
    Male
    Manometry
    Ointments
    Pain
    Pain Measurement
    Phytotherapy
    Plant Extracts
    Single-Blind Method
    Sprains and Strains

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    18193693

    Citation

    D'Anchise, Roberto, et al. "Comfrey Extract Ointment in Comparison to Diclofenac Gel in the Treatment of Acute Unilateral Ankle Sprains (distortions)." Arzneimittel-Forschung, vol. 57, no. 11, 2007, pp. 712-6.
    D'Anchise R, Bulitta M, Giannetti B. Comfrey extract ointment in comparison to diclofenac gel in the treatment of acute unilateral ankle sprains (distortions). Arzneimittelforschung. 2007;57(11):712-6.
    D'Anchise, R., Bulitta, M., & Giannetti, B. (2007). Comfrey extract ointment in comparison to diclofenac gel in the treatment of acute unilateral ankle sprains (distortions). Arzneimittel-Forschung, 57(11), pp. 712-6. doi:10.1055/s-0031-1296672.
    D'Anchise R, Bulitta M, Giannetti B. Comfrey Extract Ointment in Comparison to Diclofenac Gel in the Treatment of Acute Unilateral Ankle Sprains (distortions). Arzneimittelforschung. 2007;57(11):712-6. PubMed PMID: 18193693.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Comfrey extract ointment in comparison to diclofenac gel in the treatment of acute unilateral ankle sprains (distortions). AU - D'Anchise,Roberto, AU - Bulitta,Michael, AU - Giannetti,Bruno, PY - 2008/1/16/pubmed PY - 2008/1/25/medline PY - 2008/1/16/entrez SP - 712 EP - 6 JF - Arzneimittel-Forschung JO - Arzneimittelforschung VL - 57 IS - 11 N2 - 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. SN - 0004-4172 UR - https://www.unboundmedicine.com/medline/citation/18193693/Comfrey_extract_ointment_in_comparison_to_diclofenac_gel_in_the_treatment_of_acute_unilateral_ankle_sprains__distortions__ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0031-1296672 DB - PRIME DP - Unbound Medicine ER -