Amphotericin B is superior to sodium antimony gluconate in the treatment of Indian post-kala-azar dermal leishmaniasis.

Parasitologically confirmed cases of post-kala-azar dermal leishmaniasis (PKDL) were treated by infusion with amphotericin B deoxycholate (ABD; 1 mg/kg.day on days 1-20, 21-40 and 61-80) or by intramuscular injection with sodium antimony gluconate (SAG; 20-day courses at 20 mg/kg day, with 20-day, drug-free intervals). Of the 11 patients given ABD, all were cured with the three courses, none relapsed in 12 months of follow-up, all developed mild adverse effects (shivering and fever) because of the infusion, five lost their appetites, and three showed increases in their serum creatinine concentrations (although none exceeded 'normal' limits). In contrast, only seven (63%) of the 11 patients given SAG were considered treatment successes (improvement in lesions by the end of the third course) and these took six courses (two cases), nine courses (four cases) or 10 courses (one case) to cure completely. Two of the patients given SAG developed arthralgia and two others developed non-specific ST changes in their electrocardiograms (ECG), although their ECG were normal between courses. The better cure rate with ABD was not statistically significant, probably because of the small sample size. However, ABD appears to be a superior to SAG in terms of the speed of response and cure, although it is more expensive and has some nephrotoxicity. As the effectiveness of SAG against PKDL is apparently declining over time and the cost of ABD is prohibitive in poor countries such as India, a safe, cheap and more effective drug for the treatment of PKDL is needed.

RCT Entities:   Population Interventions Outcomes