Cochrane · systematic review · CD004834

Interventions for American cutaneous and mucocutaneous leishmaniasis

Pinart, M, Rueda, J-R, Romero, GAS, et al. · Cochrane Database of Systematic Reviews · 2020 · Cochrane Library

SkinAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
21
current version
GRADE rated
16
No studies
5
Included studies
NR
No studies 5 · 23.8%Ungraded 0 · 0%Very low 0 · 0%Low 3 · 14.3%Moderate 10 · 47.6%High 3 · 14.3%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Meglumine antimoniate (IMMA) (20 mg/kg/d for 20 days) compared to placebo (3 tablets/4 times a day for 28 d) in L. braziliensis and L. panamensis for American cutaneous and mucocutaneous leishmaniasis

Population: People with American cutaneous and mucocutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Meglumine antimoniate (IMMA) (20 mg/kg/d for 20 days) vs placebo (3 tablets/4 times a day
RR 4.23 [0.84, 21.38]2 studies · 157 participantsModerate
Downgraded: imprecision
Adverse effects (number of participants who had at least one adverse effect)
Meglumine antimoniate (IMMA) (20 mg/kg/d for 20 days) vs placebo (3 tablets/4 times a day
RR 1.51 [1.17, 1.96]1 study · 134 participantsModerate
Downgraded: imprecision
Recurrence
Meglumine antimoniate (IMMA) (20 mg/kg/d for 20 days) vs placebo (3 tablets/4 times a day
RR 1.79 [0.17, 19.26]1 study · 127 participantsLow
Downgraded: imprecision

Oral miltefosine (50 mg for 28 days) compared to placebo (same regimen) in L.mexicana, L.panamensis and L.braziliensis for American cutaneous leishmaniasis

Population: People with American cutaneous and mucocutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Oral miltefosine (50 mg for 28 days) vs placebo (same regimen)
RR 2.25 [1.42, 3.38]1 study · 133 participantsModerate
Downgraded: imprecision
Adverse effects (number of participants who had the event)
Oral miltefosine (50 mg for 28 days) vs placebo (same regimen)
RR 3.96 [1.49, 10.48]1 study · 133 participantsModerate
Downgraded: imprecision
Recurrence
Oral miltefosine (50 mg for 28 days) vs placebo (same regimen)
RR 2.97 [0.37, 23.89]1 study · 133 participantsLow
Downgraded: imprecision

Oral miltefosine (1.2 to 3.3 mg/kg/d 28 days) compared to meglumine antimoniate (20 mg/kg 20 days) in L. braziliensis, L. panamensis,L. guyanensis and L. amazonensis for American cutaneous and mucocutaneous leishmaniasis

Population: People with American cutaneous and mucocutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Oral miltefosine (1.2 to 3.3 mg/kg/d 28 days) vs meglumine antimoniate (20 mg/kg 20 days)
RR 1.05 [0.9, 1.23]7 studies · 676 participantsLow
Downgraded: risk of bias, inconsistency
Adverse effects (number of participants who had the event)
Oral miltefosine (1.2 to 3.3 mg/kg/d 28 days) vs meglumine antimoniate (20 mg/kg 20 days)
RR 2.45 [1.72, 3.49]3 studies · 464 participantsModerate
Downgraded: risk of bias
Recurrence ‐ not measured
Oral miltefosine (1.2 to 3.3 mg/kg/d 28 days) vs meglumine antimoniate (20 mg/kg 20 days)
no estimate extractedNRNo studies

Azithromycin (500 mg 20 ‐ 28 days) compared to meglumine antimoniate (15 ‐ 20 mg/kg/d for 20 ‐ 28 days) in L. braziliensis for American cutaneous and mucocutaneous leishmaniasis

Population: People with American cutaneous and mucocutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Azithromycin (500 mg 20 ‐ 28 days) vs meglumine antimoniate (15 ‐ 20 mg/kg/d
RR 0.51 [0.34, 0.76]2 studies · 93 participantsModerate
Downgraded: risk of bias
Adverse effects
Azithromycin (500 mg 20 ‐ 28 days) vs meglumine antimoniate (15 ‐ 20 mg/kg/d
no estimate extracted1 study · 45 participantsModerate
Downgraded: risk of bias
Recurrence ‐ not measured
Azithromycin (500 mg 20 ‐ 28 days) vs meglumine antimoniate (15 ‐ 20 mg/kg/d
no estimate extractedNRNo studies

Topical imiquimod 5% (3 times/week) + meglumine antimoniate (IVMA) (20 mg/kg/d for 20 days) compared to placebo + IVMA in L. braziliensis, L. guyanensis and L. peruviana for American cutaneous leishmaniasis

Population: People with American cutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Topical imiquimod 5% (3 times/week) + meglumine antimoniate (IVMA) (20 mg/kg/d for 20 days) vs placebo + IVMA
RR 1.3 [0.95, 1.8]1 study · 80 participantsModerate
Downgraded: imprecision
Adverse effects (number of participants who had the event)
Topical imiquimod 5% (3 times/week) + meglumine antimoniate (IVMA) (20 mg/kg/d for 20 days) vs placebo + IVMA
no estimate extracted1 study · 80 participantsHigh
Recurrence ‐ not measured
Topical imiquimod 5% (3 times/week) + meglumine antimoniate (IVMA) (20 mg/kg/d for 20 days) vs placebo + IVMA
no estimate extractedNRNo studies

Thermotherapy one session (at 50 ºC for 30 seconds) compared to meglumine antimoniate (20 mg Sb5/kg/day for 20 days) in L. panamensis and L. braziliensis for American cutaneous leishmaniasis

Population: People with American cutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Thermotherapy one session (at 50 ºC for 30 seconds) vs meglumine antimoniate (20 mg Sb5/kg/day
RR 0.8 [0.68, 0.95]1 study · 292 participantsHigh
Adverse effects
Thermotherapy one session (at 50 ºC for 30 seconds) vs meglumine antimoniate (20 mg Sb5/kg/day
no estimate extracted1 study · 292 participantsHigh
Recurrence ‐ not measured
Thermotherapy one session (at 50 ºC for 30 seconds) vs meglumine antimoniate (20 mg Sb5/kg/day
no estimate extractedNRNo studies

Pentoxifylline (oral 400 mg thrice daily) plus meglumine antimoniate (IMMA) (20 mg/ kg /day for 20 days) compared to IMMA plus placebo for American cutaneous and mucocutaneous leishmaniasis

Population: People with American cutaneous leishmaniasis
3 questions
OutcomeEffectEvidenceStatus / GRADE
Complete cure, at least 3 months after the end of treatment
Pentoxifylline (oral 400 mg thrice daily) plus meglumine antimoniate (IMMA) (20 mg/ kg /day for 20 days) vs IMMA plus placebo
RR 0.86 [0.63, 1.18]1 study · 70 participantsModerate
Downgraded: imprecision
Adverse effects
Pentoxifylline (oral 400 mg thrice daily) plus meglumine antimoniate (IMMA) (20 mg/ kg /day for 20 days) vs IMMA plus placebo
no estimate extracted1 study · 70 participantsModerate
Downgraded: imprecision
Recurrence ‐ not measured
Pentoxifylline (oral 400 mg thrice daily) plus meglumine antimoniate (IMMA) (20 mg/ kg /day for 20 days) vs IMMA plus placebo
no estimate extractedNRNo studies