Summary of findings for the main comparison.
Itraconazole (200 mg for 6 to 8 weeks) versus placebo for Old World cutaneous leishmaniasis
| Itraconazole (200 mg for 6‐8 weeks) versus placebo for Old World cutaneous leishmaniasis | ||||||
| Patient or population: patients with Old World cutaneous leishmaniasis Settings: Kuwait, India, and Iran Intervention: itraconazole (200 mg for 6‐8 weeks) Comparison: placebo | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Itraconazole (200 mg for 6‐8 weeks) | |||||
| Percentage of lesions cured after the end of treatment | Not measured in this comparison | |||||
| Percentage of participants with complete cure Follow‐up: mean 2.5 months | Study population | RR 3.70 (0.35 to 38.99) | 244 (3 studies) | ⊕⊝⊝⊝ Very lowa | — | |
| 454 per 1000 | 1000 per 1000 (159 to 1000) | |||||
| Moderate | ||||||
| 100 per 1000 | 370 per 1000 (35 to 1000) | |||||
|
Adverse effects Mild abdominal pain and nausea Adverse effects Mild abnormal liver function |
40 per 1000 0 per 1000 |
95 per 1000 (30 to 302) 0 per 1000 (0 to 0) |
RR 2.36 (0.74 to 7.47) RR 3.08 (0.53 to 17.98) |
204 (3 studies) 84 (3 studies) |
⊕⊝⊝⊝ Very lowb ⊕⊝⊝⊝ Very lowc |
— |
| Speed of healing (time taken to be 'cured') | Neither of the studies reported speed of healing (time taken to be 'cured') in this comparison. | |||||
| Microbiological or histopathological cure of skin lesions Follow‐up: mean 2.5 months | Not estimable | Not estimable | RR 17.00 (0.47 to 612.21) | 20 (1 study) | ⊕⊝⊝⊝ Very lowd | There were zero events in the placebo group |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence High quality/certainty: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality/certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality/certainty: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality/certainty: we are very uncertain about the estimate. | ||||||
aDowngraded by 4 levels due to: risk of bias (2 RCTs have many uncertain items), inconsistency (there is considerable heterogeneity ‐ I² = 73%), and imprecision (2 levels due to wide 95% confidence intervals, crossing the line of no effect). bDowngraded by 3 levels due to: risk of bias (many uncertain items in the risk of bias judgment), and imprecision (2 levels due to wide 95% confidence intervals, crossing the line of no effect). cDowngraded by 3 levels due to: risk of bias (many uncertain items in the risk of bias judgment), and imprecision (2 levels due to wide 95% confidence intervals, crossing the line of no effect). dDowngraded by 3 levels due to: risk of bias (many uncertain items in the risk of bias judgment), and imprecision (2 levels due to wide 95% confidence intervals; this outcome is only reported for one study involving 20 participants).