Comparison of oral itraconazole and intramuscular meglumine antimoniate in the treatment of cutaneous leishmaniasis.

Objective: To compare the efficacy and tolerability of oral itraconazole against intramuscular meglumine antimoniate in the treatment of Cutaneous Leishmaniasis (CL).

Design: Quasi-experimental study.

Place And Duration Of Study: Dermatology department of PNS Shifa Hospital, Karachi, from June 2004 to December 2006.

Patients And Methods: Two hundred eligible and consenting patients of Cutaneous Leishmaniasis (CL) were divided in two groups with 100 patients in each. The number and location of the lesions were documented and clinical types of cutaneous leishmaniasis were noted. The diagnosis was confirmed by skin slit smear and histopathology of the lesional skin. Culture on Nicolle Novy MacNeal (NNN) medium and Leishmanin test was done in all patients. All the patients in both groups were subjected to complete blood picture, urine examination, serum urea and creatinine levels and ECG examination. One group was given itraconazole 100 mg twice daily orally for a duration of 6-8 weeks. The other group was given meglumine antimoniate 10 cc in the form of deep intramuscular injections for 15-30 days. The efficacy of the treatment was judged by clinical and parasitological response. Side effects of the agents were also noted during treatment.

Results: Out of 200 patients studied, 185 were males and 15 were females. The mean age of presentation was 30 + 6.6 years. Single lesion was seen in 132 (66%) subjects whereas 68 (34%) subjects had multiple lesions. Slit skin smears were positive in 50 (25%) of the patients. Skin biopsy yielded the presence of LT bodies in 150 (75%) subjects. The culture was positive in 102 (51%) cases. Leishmanin test was positive in 94% subjects. Seventy-five (75%) patients on itraconazole therapy showed complete clinical and parasitological cure in 4-8 weeks duration. A rise in ALT was seen in 12% subjects. Five (5%) subjects did not show any improvement till the end of therapy. Sixty-five (65%) subjects on meglumine antimoniate showed complete healing in 15-30 days. In 35 (35%) of the patients, the treatment had to be stopped due to intolerable side-effects. Four cases of lupoid leishmaniasis and 4 cases of sporotrichoid leishmaniasis did not respond to itraconazole therapy and were successfully treated later by meglumine antimoniate.

Conclusion: Itraconazole is more effective, economical and has fewer side effects as compared to meglumine antimoniate in the treatment of dry and wet types of cutaneous leishmaniasis. The latter is superior for lupoid type of lesions and for the control of lymphatic spread.