A double-blind randomized clinical trial of a topical herbal extract (Z-HE) vs. systemic meglumine antimoniate for the treatment of cutaneous leishmaniasis in Iran

A double-blind randomized clinical trial was undertaken to compare the effi cacy of meglumine antimoniate solution (Glucantime), administered intramusc ularly, with a topical herbal extract consisting of a pure extract mixture of Althaea rosa, Althaea officinalis, and members of the families Leguminos ae, Faliaceae, Malvaceae, and Lythraceae (named Z-HE) on patients with Old World cutaneous leishmaniasis, The reason for undertaking such a study is t hat many patients fail to respond to the conventional treatment of cutaneou s leishmaniasis (CL), the pentavalent antimonials. Many alternative treatme nt modalities have been proposed, and one such modality has been the use of herbal extracts applied topically to the lesions. Herbal remedies have bee n used for a long period of time in Iran for the treatment of many dermatos es, including CL; however, a systematic scientific evaluation of the effica cy of herbal extracts has rarely been performed. A total number of 171 patients who had been referred to the Cutaneous Leish mania Clinic in our center and who were diagnosed as having CL were include d in the study. All patients underwent a complete clinical evaluation, and patients were excluded if they were pregnant or nursing or if they had seri ous concomitant diseases. A diagnosis of CL was based on positive smears fr om the lesions, and in some cases cultures and histopathologic studies were also performed. The duration of disease in all cases was less than 4 month s. The patients were divided randomly into two treatment groups. In the first group (A), 86 patients were treated with the topical herbal extract Z-HE as a black paste applied to the lesions and covered by a dressing for five co nsecutive days, as well as with 0.5 mt of sterile normal saline used as a p lacebo and injected intramuscularly for 20 consecutive days. In the second group (B), 85 patients were treated with meglumine antimoniate (Glucantime) , 15-20 mg/kg/day, as intramuscular injections for 20 consecutive days, as well as with a topical placebo which consisted of petrolatum mixed with cha rcoal powder and which was applied on the lesions as a black paste covered by a dressing for five consecutive days. Prior to the initiation of treatme nt with Z-HE, an animal toxicologic study was undertaken and the plant extr act was declared safe to use in human clinical trials. Clinical evaluation was performed 6 weeks post-treatment, Complete cure was defined a clinical improvement with complete healing and re-epithelializat ion of the lesion(s), partial cure was defined as partial clinical improvem ent with reduction in infiltration, erythema, and size of the lesion(s), an d failure was defined as the absence of any changes in the lesion(s) or pro gression and worsening of the lesion(s).