Fourteen RCTs (<1,200 patients) were included for the review. One RCT was a cross-over design (39 patients). Seven RCTs were double-blinded; two were double-blinded only to topical treatment. Six trials adequately concealed treatment allocation. Five trials blinded outcome assessment. Five trials used intention-to-treat analysis. There was no evidence of publication bias using Egger's or Begg's tests.
Any paromomyocin regime significantly increased the likelihood of clinical cure compared to placebo (RR 1.49, 95% CI 1.04 to 2.13, p=0.031; eight RCTs; 730 patients). There was evidence of significant statistical heterogeneity (p=0.002); meta-regression analyses revealed that type of paromomyocin regimen was the main source of heterogeneity (p=0.024).
Paromomyocin significantly improved the chances of clinical cure in New World cutaneous leishmaniasis (RR 2.34, 95% CI 1.48 to 3.71, p<0.001; two RCTs; 129 patients) but not Old World cutaneous leishmaniasis when compared to placebo.
Paromomyocin significantly improved the chances of clinical cure when combined with methylbenzethonium chloride (RR 2.58, 95% CI 1.76 to 3.76, p<0.001; three RCTs; 198 patients) but not when used alone compared to placebo.
Any paromomyocin regimen was significantly less likely than pentavalent antimony compounds to result in clinical cure (RR 0.77, 95% CI 0.59 to 0.99, p=0.043; six RCTs; 491 patients). There was evidence of significant statistical heterogeneity (p=0.007).
Topical paromomyocin was significantly less effective than parenteral meglumine antimoniate (RR 0.67, 95% CI 0.54 to 0.82, p<0.001; two RCTs; 270 patients) but not significantly different from parenteral pentavalent antimony compounds in the treatment of New World cutaneous leishmaniasis. There were no significant differences between paromomyocin and intralesional meglumine antimoniate in the treatment of Old World cutaneous leishmaniasis.
The authors reported that similar results were observed for the outcome of clinical improvement, but did not present the results. The authors reported that local side effects were more common with topical treatments and that systemic side effects were more common with parenteral treatment.