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Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study.

Abstract

In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Merck Selbstmedikation GmbH, Roesslerstr. 96, D-64293 Darmstadt, Germany.

    , , ,

    Source

    MeSH

    Adolescent
    Adult
    Ankle Injuries
    Area Under Curve
    Comfrey
    Diclofenac
    Female
    Gels
    Humans
    Male
    Middle Aged
    Ointments
    Pain Measurement
    Phytotherapy
    Plant Extracts
    Plant Preparations
    Plant Roots
    Single-Blind Method
    Sprains and Strains
    Treatment Outcome

    Pub Type(s)

    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    16323288

    Citation

    Predel, H G., et al. "Efficacy of a Comfrey Root Extract Ointment in Comparison to a Diclofenac Gel in the Treatment of Ankle Distortions: Results of an Observer-blind, Randomized, Multicenter Study." Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, vol. 12, no. 10, 2005, pp. 707-14.
    Predel HG, Giannetti B, Koll R, et al. Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study. Phytomedicine. 2005;12(10):707-14.
    Predel, H. G., Giannetti, B., Koll, R., Bulitta, M., & Staiger, C. (2005). Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study. Phytomedicine : International Journal of Phytotherapy and Phytopharmacology, 12(10), pp. 707-14.
    Predel HG, et al. Efficacy of a Comfrey Root Extract Ointment in Comparison to a Diclofenac Gel in the Treatment of Ankle Distortions: Results of an Observer-blind, Randomized, Multicenter Study. Phytomedicine. 2005;12(10):707-14. PubMed PMID: 16323288.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of a comfrey root extract ointment in comparison to a diclofenac gel in the treatment of ankle distortions: results of an observer-blind, randomized, multicenter study. AU - Predel,H G, AU - Giannetti,B, AU - Koll,R, AU - Bulitta,M, AU - Staiger,C, PY - 2005/12/3/pubmed PY - 2005/12/21/medline PY - 2005/12/3/entrez SP - 707 EP - 14 JF - Phytomedicine : international journal of phytotherapy and phytopharmacology JO - Phytomedicine VL - 12 IS - 10 N2 - In the treatment of minor blunt injuries several topical drugs are known to have anti-inflammatory and analgesic properties. They represent, however, two fundamentally different major pharmacological therapy approaches: the "chemical-synthetical" and the "phytotherapeutical" approach. The main objective of this trial (CODEC_2004) was to compare the efficacy and tolerability of an ointment of Comfrey extract (Extr. Rad. Symphyti) with that of a Diclofenac gel in the treatment of acute unilateral ankle sprain (distortion). In a single-blind, controlled, randomized, parallel-group, multicenter and confirmatory clinical trial outpatients with acute unilateral ankle sprains (n=164, mean age 29.0 years, 47.6% female) received either a 6 cm long ointment layer of Kytta-Salbe f (Comfrey extract) (n=82) or of Diclofenac gel containing 1.16 g of diclofenac diethylamine salt (n=82) for 7 +/- 1 days, four times a day. Primary variable was the area-under-the-curve (AUC) of the pain reaction to pressure on the injured area measured by a calibrated caliper (tonometer). Secondary variables were the circumference of the joint (swelling; figure-of-eight method), the individual spontaneous pain sensation at rest and at movement according to a Visual Analogue Scale (VAS), the judgment of impaired movements of the injured joint by the method of "neutral-zero", consumption of rescue medication (paracetamol), as well as the global efficacy evaluation and the global assessment of tolerability (both by physician and patient, 4 ranks). In this study the primary variable was also to be validated prospectively. It was confirmatorily shown that Comfrey extract is non-inferior to diclofenac. The 95% confidence interval for the AUC (Comfrey extract minus Diclofenac gel) was 19.01-103.09h*N/cm2 and was completely above the margin of non-inferiority. Moreover, the results of the primary and secondary variables indicate that Comfrey extract may be superior to Diclofenac gel. SN - 0944-7113 UR - https://www.unboundmedicine.com/medline/citation/16323288/Efficacy_of_a_comfrey_root_extract_ointment_in_comparison_to_a_diclofenac_gel_in_the_treatment_of_ankle_distortions:_results_of_an_observer_blind_randomized_multicenter_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0944-7113(05)00151-0 DB - PRIME DP - Unbound Medicine ER -