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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.
Phytomedicine 2005; 12(10):707-14P

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.

Authors+Show Affiliations

Merck Selbstmedikation GmbH, Roesslerstr. 96, D-64293 Darmstadt, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 -