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A randomized, double-blind, vehicle-controlled, half-side comparison with a herbal ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica for the treatment of mild-to-moderate atopic dermatitis.

Abstract

OBJECTIVE

Only a few clinical trials have been published on the topical treatment of atopic dermatitis with herbal ointments. An ointment containing extracts from Mahonia aquifolium, Viola tricolor and Centella asiatica has previously been studied in open uncontrolled trials with children. However, no data exist on adult patients in a randomized controlled trial.

METHODS

A total of 88 patients with mild-to-moderate atopic dermatitis were enrolled in a double-blind, vehicle-controlled, randomized, half-side comparison. Patients between 18 and 65 years of age were treated for 4 weeks with an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica. The primary endpoint was a summary score for erythema, edema/papulation, oozing/crust, excoriation and lichenification according to a 4-point scale. Secondary efficacy variables were assessment of pruritus severity (10 cm VAS) and a global assessment of effectiveness as well as tolerability.

RESULTS

The study ointment reduced the primary and secondary endpoints slightly more than the base cream which was used as vehicle; the differences were not statistically significant. Since the climatic conditions during the study duration varied from very mild and sunny to very cold and dry, a post-hoc subanalysis was performed with a subset of 64 patients whose treatment was at a mean outside temperature of 10 degrees C or less. Under these conditions the primary endpoint showed high statistical significance.

CONCLUSION

In this trial, an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica could not be proven to be superior to a base cream for patients with mild-to-moderate atopic dermatitis. However, a subanalysis indicated that the cream might be effective under conditions of cold and dry weather.

Authors+Show Affiliations

,

Dermatology Practice, Gilching, Germany. dr.kloevekorn@t-online.de

,

Source

MeSH

Adolescent
Adult
Aged
Centella
Dermatitis, Atopic
Double-Blind Method
Female
Humans
Magnoliopsida
Mahonia
Male
Middle Aged
Ointments
Patient Compliance
Phytotherapy
Plant Preparations
Severity of Illness Index
Skin
Treatment Outcome
Viola

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18077922

Citation

Klövekorn, W, et al. "A Randomized, Double-blind, Vehicle-controlled, Half-side Comparison With a Herbal Ointment Containing Mahonia Aquifolium, Viola Tricolor and Centella Asiatica for the Treatment of Mild-to-moderate Atopic Dermatitis." International Journal of Clinical Pharmacology and Therapeutics, vol. 45, no. 11, 2007, pp. 583-91.
Klövekorn W, Tepe A, Danesch U. A randomized, double-blind, vehicle-controlled, half-side comparison with a herbal ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica for the treatment of mild-to-moderate atopic dermatitis. Int J Clin Pharmacol Ther. 2007;45(11):583-91.
Klövekorn, W., Tepe, A., & Danesch, U. (2007). A randomized, double-blind, vehicle-controlled, half-side comparison with a herbal ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica for the treatment of mild-to-moderate atopic dermatitis. International Journal of Clinical Pharmacology and Therapeutics, 45(11), pp. 583-91.
Klövekorn W, Tepe A, Danesch U. A Randomized, Double-blind, Vehicle-controlled, Half-side Comparison With a Herbal Ointment Containing Mahonia Aquifolium, Viola Tricolor and Centella Asiatica for the Treatment of Mild-to-moderate Atopic Dermatitis. Int J Clin Pharmacol Ther. 2007;45(11):583-91. PubMed PMID: 18077922.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, vehicle-controlled, half-side comparison with a herbal ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica for the treatment of mild-to-moderate atopic dermatitis. AU - Klövekorn,W, AU - Tepe,A, AU - Danesch,U, PY - 2007/12/15/pubmed PY - 2008/4/1/medline PY - 2007/12/15/entrez SP - 583 EP - 91 JF - International journal of clinical pharmacology and therapeutics JO - Int J Clin Pharmacol Ther VL - 45 IS - 11 N2 - OBJECTIVE: Only a few clinical trials have been published on the topical treatment of atopic dermatitis with herbal ointments. An ointment containing extracts from Mahonia aquifolium, Viola tricolor and Centella asiatica has previously been studied in open uncontrolled trials with children. However, no data exist on adult patients in a randomized controlled trial. METHODS: A total of 88 patients with mild-to-moderate atopic dermatitis were enrolled in a double-blind, vehicle-controlled, randomized, half-side comparison. Patients between 18 and 65 years of age were treated for 4 weeks with an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica. The primary endpoint was a summary score for erythema, edema/papulation, oozing/crust, excoriation and lichenification according to a 4-point scale. Secondary efficacy variables were assessment of pruritus severity (10 cm VAS) and a global assessment of effectiveness as well as tolerability. RESULTS: The study ointment reduced the primary and secondary endpoints slightly more than the base cream which was used as vehicle; the differences were not statistically significant. Since the climatic conditions during the study duration varied from very mild and sunny to very cold and dry, a post-hoc subanalysis was performed with a subset of 64 patients whose treatment was at a mean outside temperature of 10 degrees C or less. Under these conditions the primary endpoint showed high statistical significance. CONCLUSION: In this trial, an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica could not be proven to be superior to a base cream for patients with mild-to-moderate atopic dermatitis. However, a subanalysis indicated that the cream might be effective under conditions of cold and dry weather. SN - 0946-1965 UR - https://www.unboundmedicine.com/medline/citation/18077922/A_randomized_double_blind_vehicle_controlled_half_side_comparison_with_a_herbal_ointment_containing_Mahonia_aquifolium_Viola_tricolor_and_Centella_asiatica_for_the_treatment_of_mild_to_moderate_atopic_dermatitis_ L2 - http://www.diseaseinfosearch.org/result/9652 DB - PRIME DP - Unbound Medicine ER -