Rifampicin in cutaneous leishmaniasis – a therapeutic trial in Saudi Arabia

Abstract

Objectives The aim of the present work is to evaluate the efficacy of oral rifampicin in the treatment of cutaneous leishmaniasis in a double-blind, placebo-controlled study. Patients and methods This randomized, double-blind, placebo-controlled trial assessed the efficacy of oral rifampicin in a dose of 10mg/kg/day for four to six weeks, in the treatment of smear or biopsy confirmed cutaneous leishmaniasis. The study was carried out at Dermatology Department,PrinceAbdullahBinAbdulAzizHospital, Bisha (Aseer region),Saudi Arabia from January, 1999 to January, 2000. Sixty-two patients suffering from single or multiple lesions of cutaneous leishmaniasis were studied, out of which 46 were given rifampicin and 16 received placebo. The results were also studied and compared in two age groups as group I - children (3 to 11 years) and group II - adults (12 to 65 years). Results Out of 62 patients, a total of 46 were assigned to receive rifampicin, and 16 to receive placebo. Follow up data were available for 34 (73.9%) and 7 (43.7%) patients, respectively. At the three months follow up, healing of the lesion was complete for 21 out of 34 patients in rifampicin group (61.8 percent) and 3 out of 7 patients in the placebo group (42.9%; relative risk of complete healing 1.44). According to intention to treat analysis, the rates of healing were 45.7% and 18.8% in the rifampicin and placebo group, respectively (relative risk of complete healing 2.43). The difference was statistically significant in favour of rifampicin (p<0.01). Amongst the two age groups, the results were more impressive in the group I - children. In group I, 24/32 patients and in group II, 22/30 patients received rifampicin. Fifteen (83.4%) out of 18 followed up patients amongst group I while 6 (37.5%) out of 16 followed up patients in group II, receiving rifampicin showed marked improvement. Eight patients served as control in each group to receive placebo. For the control group, 2 (66.6%) out of 3 followed up in group I and only one patient (25% ) of the 4 followed up in group II, showed complete healing. Conclusion Systemically administered rifampicin 10 mg/kg for 4-6 weeks may prove to be a valuable, safe, easy to administer and cheap modality for the treatment of cutaneous leishmaniasis. The results were more encouraging in children where other conventional injectable treatments are not acceptable, feasible or may be toxic. The study also suggested that rifampicin is worthy of a more extensive trial.