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 efficacy of meglumine antimoniate solution (Glucantime), administered intramuscularly, with a topical herbal extract consisting of a pure extract mixture of Althaea rosa, Althaea officinalis, and members of the families Leguminosae, Faliaceae, Malvaceae, and Lythraceae (named Z-HE) on patients with Old World cutaneous leishmaniasis, The reason for undertaking such a study is that many patients fail to respond to the conventional treatment of cutaneous leishmaniasis (CL), the pentavalent antimonials. Many alternative treatment modalities have been proposed, and one such modality has been the use of herbal extracts applied topically to the lesions. Herbal remedies have been used for a long period of time in Iran for the treatment of many dermatoses, including CL; however, a systematic scientific evaluation of the efficacy of herbal extracts has rarely been performed. A total number of 171 patients who had been referred to the Cutaneous Leishmania Clinic in our center and who were diagnosed as having CL were included in the study. All patients underwent a complete clinical evaluation, and patients were excluded if they were pregnant or nursing or if they had serious concomitant diseases. A diagnosis of CL was based on positive smears from the lesions, and in some cases cultures and histopathologic studies were also performed. The duration of disease in all cases was less than 4 months. 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 consecutive days, as well as with 0.5 mt of sterile normal saline used as a placebo 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 charcoal 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 treatment with Z-HE, an animal toxicologic study was undertaken and the plant extract 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-epithelialization of the lesion(s), partial cure was defined as partial clinical improvement with reduction in infiltration, erythema, and size of the lesion(s), and failure was defined as the absence of any changes in the lesion(s) or progression and worsening of the lesion(s).