Interventions for Old World cutaneous leishmaniasis

Julio Heras‐Mosteiro; Begoña Monge‐Maillo; Mariona Pinart; Patricia Lopez Pereira; Ludovic Reveiz; Emely Garcia‐Carrasco; Pedro Campuzano Cuadrado; Ana Royuela; Irene Mendez Roman; Rogelio López‐Vélez

doi:10.1002/14651858.CD005067.pub5

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

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Figure 3

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.

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Figure 4

Forest Plot of Primary Outcome: Lesions Cured (Various comparisons)

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Figure 5

Forest plot of primary outcome: 1.2 Participants cured (Various comparisons)

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Analysis 1.1

Comparison 1 ILMA weekly versus ILMA fortnightly for up to 8 weeks, Outcome 1 Lesions cured.

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Analysis 2.1

Comparison 2 ILMA (every other day) versus IMMA (6 d/week) for up to 4 weeks, Outcome 1 Lesions cured.

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Analysis 3.1

Comparison 3 IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (30 mg/kg/d for 3 weeks) + placebo, Outcome 1 Lesions cured.

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Analysis 4.1

Comparison 4 IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Lesions cured.

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Analysis 5.1

Comparison 5 IMMA (60 mg/kg/d for 3 weeks) + placebo versus IMMA (30 mg/kg/d for 3 weeks) + placebo, Outcome 1 Lesions cured.

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Analysis 6.1

Comparison 6 IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.

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Analysis 6.2

Comparison 6 IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 2 Adverse effects.

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Analysis 7.1

Comparison 7 IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.

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Analysis 8.1

Comparison 8 IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.

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Analysis 9.1

Comparison 9 IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo, Outcome 1 Participants complete cure.

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Analysis 10.1

Comparison 10 ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 1 Lesions cured.

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Analysis 10.2

Comparison 10 ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 2 Adverse effects (itching and burning).

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Analysis 10.3

Comparison 10 ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 3 Adverse effects (oedema).

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Analysis 11.1

Comparison 11 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 1 Lesions cured.

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Analysis 11.2

Comparison 11 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 2 Adverse effects (itching and burning).

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Analysis 11.3

Comparison 11 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks), Outcome 3 Adverse effects (oedema).

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Analysis 12.1

Comparison 12 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing, Outcome 1 Lesions cured.

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Analysis 12.2

Comparison 12 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing, Outcome 2 Adverse effects (itching and burning).

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Analysis 12.3

Comparison 12 ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing, Outcome 3 Adverse effects (oedema).

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Analysis 13.1

Comparison 13 ILMA (weekly injections for 6 weeks) + gel mask twice a day versus ILMA (weekly injections for 6 weeks) + vehicle, Outcome 1 Participants complete cure.

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Analysis 14.1

Comparison 14 ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5) versus ILSSG (1000 mg/mL days 1, 3, 5), Outcome 1 Lesions cured.

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Analysis 15.1

Comparison 15 ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 d for 29 days) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 1 Participants complete cure.

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Analysis 15.2

Comparison 15 ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 d for 29 days) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 2 Adverse effects (mild heart symptoms).

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Analysis 16.1

Comparison 16 Ketoconazole 600 mg/d for 6 weeks versus ketoconazole 800 mg/d for 6 weeks, Outcome 1 Participants complete cure.

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Analysis 16.2

Comparison 16 Ketoconazole 600 mg/d for 6 weeks versus ketoconazole 800 mg/d for 6 weeks, Outcome 2 Adverse effects (nausea and vomiting).

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Analysis 17.1

Comparison 17 Ketoconazole 600 mg/d for 30 d versus ILMA (6 to 8 biweekly injections), Outcome 1 Participants cured.

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Analysis 17.2

Comparison 17 Ketoconazole 600 mg/d for 30 d versus ILMA (6 to 8 biweekly injections), Outcome 2 Adverse effect (liver enzymes increase).

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Analysis 18.1

Comparison 18 ILSSG (100 mg/mL days 1, 3, 5) + oral ketoconazole (600 mg/d for 4 weeks) versus ILSSG (100 mg/mL days 1, 3, 5), Outcome 1 Lesions cured.

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Analysis 19.1

Comparison 19 ILSSG (100 mg/mL days 1, 3, 5) + ketoconazole (600 mg/d for 4 weeks) versus ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5), Outcome 1 Lesions cured.

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Analysis 20.1

Comparison 20 Itraconazole (200 mg for 6 weeks) versus placebo, Outcome 1 Participants complete cure.

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Analysis 21.1

Comparison 21 Itraconazole (200 mg for 3 weeks) versus placebo, Outcome 1 Participants complete cure.

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Analysis 22.1

Comparison 22 Itraconazole (200 mg for 6 to 8 weeks) versus placebo, Outcome 1 Participants complete cure.

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Analysis 22.2

Comparison 22 Itraconazole (200 mg for 6 to 8 weeks) versus placebo, Outcome 2 Adverse effects.

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Analysis 22.3

Comparison 22 Itraconazole (200 mg for 6 to 8 weeks) versus placebo, Outcome 3 Microbiological cure of skin lesions.

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Analysis 23.1

Comparison 23 Itraconazole (200 mg for 6 to 8 weeks) versus no treatment, Outcome 1 Participants complete cure.

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Analysis 23.2

Comparison 23 Itraconazole (200 mg for 6 to 8 weeks) versus no treatment, Outcome 2 Adverse effects (headache and dizziness).

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Analysis 23.3

Comparison 23 Itraconazole (200 mg for 6 to 8 weeks) versus no treatment, Outcome 3 Microbiological cure of skin lesions.

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Analysis 24.1

Comparison 24 Fluconazole (200 mg for 6 weeks) versus placebo, Outcome 1 Lesions cured.

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Analysis 24.2

Comparison 24 Fluconazole (200 mg for 6 weeks) versus placebo, Outcome 2 Participants complete cure.

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Analysis 25.1

Comparison 25 Fluconazole (400 mg/d for 6 weeks) versus fluconazole (200 mg/d for 6 weeks), Outcome 1 Participants complete cure.

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Analysis 25.2

Comparison 25 Fluconazole (400 mg/d for 6 weeks) versus fluconazole (200 mg/d for 6 weeks), Outcome 2 Adverse effects.

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Analysis 26.1

Comparison 26 Oral dapsone (200 mg/d for 6 weeks) versus placebo, Outcome 1 Participants complete Cure.

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Analysis 26.2

Comparison 26 Oral dapsone (200 mg/d for 6 weeks) versus placebo, Outcome 2 Adverse effects.

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Analysis 27.1

Comparison 27 Allopurinol (15 mg/kg/d for 3 weeks) + IMMA (20 mg/kg/d for 2 weeks) versus allopurinol (15 mg/kg/d for 3 weeks), Outcome 1 Lesions cured.

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Analysis 28.1

Comparison 28 Allopurinol (15mg/kg/d for 3 weeks)+ IMMA (20 mg/kg/d for 2 weeks) versus IMMA (20 mg/kg/d for 2 weeks), Outcome 1 Lesions cured.

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Analysis 29.1

Comparison 29 Allopurinol (15 mg/kg/d for 3 weeks) versus IMMA (20 mg/kg/d for 2 weeks), Outcome 1 Lesions Cured.

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Analysis 30.1

Comparison 30 Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d), Outcome 1 Lesions cured.

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Analysis 30.2

Comparison 30 Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d), Outcome 2 Adverse effects.

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Analysis 30.3

Comparison 30 Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d), Outcome 3 Microbiological cure of skin lesions.

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Analysis 31.1

Comparison 31 Allopurinol (20 mg/kg/d for 3 weeks)+ IMMA (10 mg/kg/d for 20 d) versus IMMA (20 mg/kg/d for 28 d), Outcome 1 Adverse effects.

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Analysis 32.1

Comparison 32 Allopurinol (20 mg/kg/d for 3 weeks) versus IVSSG (20 mg/kg/d for 15 d), Outcome 1 Participants complete cured.

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Analysis 32.2

Comparison 32 Allopurinol (20 mg/kg/d for 3 weeks) versus IVSSG (20 mg/kg/d for 15 d), Outcome 2 Adverse effects.

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Analysis 33.1

Comparison 33 Oral rifampicin (10 mg/kg/d for 4 to 6 weeks) versus placebo, Outcome 1 Participants complete cure.

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Analysis 33.2

Comparison 33 Oral rifampicin (10 mg/kg/d for 4 to 6 weeks) versus placebo, Outcome 2 Microbiological cure of skin lesions.

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Analysis 34.1

Comparison 34 Oral rifampicin (10 mg/kg/d) + omeprazole (20 mg/d) for 6 weeks versus placebo, Outcome 1 Participants complete cure.

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Analysis 35.1

Comparison 35 Azythromicin (500 mg/d for 5 d/month up to 4 months) versus IMMA (60 mg/kg/d for 20 d), Outcome 1 Lesions cured.

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Analysis 35.2

Comparison 35 Azythromicin (500 mg/d for 5 d/month up to 4 months) versus IMMA (60 mg/kg/d for 20 d), Outcome 2 Adverse effects.

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Analysis 36.1

Comparison 36 Azythromicin (10 mg/kg/d) + allopurinol (10 mg/kg/d) for 1 month versus IMMA (20 mg/kg/d for 20 d), Outcome 1 Participants complete cure.

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Analysis 36.2

Comparison 36 Azythromicin (10 mg/kg/d) + allopurinol (10 mg/kg/d) for 1 month versus IMMA (20 mg/kg/d for 20 d), Outcome 2 Adverse effects.

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Analysis 37.1

Comparison 37 Oral pentoxifylline (400 mg 3 times daily) + IMMA (20 mg/kg/d) for 20 d versus placebo + IMMA (20 mg/kg/d) for 20 d, Outcome 1 Participants complete cure.

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Analysis 37.2

Comparison 37 Oral pentoxifylline (400 mg 3 times daily) + IMMA (20 mg/kg/d) for 20 d versus placebo + IMMA (20 mg/kg/d) for 20 d, Outcome 2 Adverse effects.

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Analysis 38.1

Comparison 38 Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks), Outcome 1 Participants complete cure.

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Analysis 39.1

Comparison 39 Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks), Outcome 1 Participants complete cure.

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Analysis 40.1

Comparison 40 Oral zinc sulphate 2.5 mg/kg/d for 45 days versus oral zinc sulphate 5 mg/kg/d for 45 d, Outcome 1 Participants complete cure.

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Analysis 40.2

Comparison 40 Oral zinc sulphate 2.5 mg/kg/d for 45 days versus oral zinc sulphate 5 mg/kg/d for 45 d, Outcome 2 Adverse effects.

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Analysis 41.1

Comparison 41 Oral zinc sulphate 2.5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 1 Participants complete cure.

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Analysis 41.2

Comparison 41 Oral zinc sulphate 2.5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 2 Adverse effects.

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Analysis 42.1

Comparison 42 Oral zinc sulphate 5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 1 Participants complete cure.

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Analysis 42.2

Comparison 42 Oral zinc sulphate 5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d, Outcome 2 Adverse effects.

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Analysis 43.1

Comparison 43 Oral zinc sulphate (10 mg/kg/d for 45 d) versus IMMA (20 mg/kg/d for 20 d), Outcome 1 Participants complete cure.

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Analysis 44.1

Comparison 44 Artesunate 400 mg + sulphamethoxypyrazine/pyrimethamine 1000 mg/50 mg 4 times daily for 4 d versus placebo, Outcome 1 Participants complete cure.

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Analysis 45.1

Comparison 45 Topical 2% miconazole (twice a day) versus topical 1% clotrimazole (twice a day) for 30 d, Outcome 1 Lesions cured.

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Analysis 46.1

Comparison 46 Topical ketoconazole (twice a day) versus vehicle (twice a day) for 30 d, Outcome 1 Participants complete cure.

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Analysis 47.1

Comparison 47 Topical amphotericin B (3 to 7 drops twice daily for 8 weeks) versus ILMA (max 2 mL) once a week for 8 weeks, Outcome 1 Participants complete cure (ITT).

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Analysis 47.2

Comparison 47 Topical amphotericin B (3 to 7 drops twice daily for 8 weeks) versus ILMA (max 2 mL) once a week for 8 weeks, Outcome 2 Adverse effects.

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Analysis 48.1

Comparison 48 Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d), Outcome 1 Lesions cured.

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Analysis 48.2

Comparison 48 Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d), Outcome 2 Scarring.

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Analysis 48.3

Comparison 48 Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d), Outcome 3 Microbiological cure of skin lesions.

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Analysis 49.1

Comparison 49 Paromomycin (twice daily for 30 d) versus vehicle (twice daily for 30 d), Outcome 1 Lesions cured.

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Analysis 50.1

Comparison 50 Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d), Outcome 1 Participants complete cure.

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Analysis 50.2

Comparison 50 Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d), Outcome 2 Adverse effects.

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Analysis 50.3

Comparison 50 Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d), Outcome 3 Microbiological cure of skin lesions.

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Analysis 51.1

Comparison 51 Paromomycin 15% (daily for 20 d) versus vehicle, Outcome 1 Participants complete cure.

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Analysis 52.1

Comparison 52 Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus vehicle, Outcome 1 Participants complete cure.

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Analysis 53.1

Comparison 53 Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus paromomycin 15% alone (daily for 20 d), Outcome 1 Participants complete cure.

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Analysis 54.1

Comparison 54 Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months), Outcome 1 Participants complete cure.

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Analysis 54.2

Comparison 54 Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months), Outcome 2 Recurrence.

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Analysis 54.3

Comparison 54 Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months), Outcome 3 Scarring.

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Analysis 55.1

Comparison 55 Paromomycin 15% + 10% urea (twice daily for 20 d) versus ILMA (weekly for up to 20 d), Outcome 1 Participants complete cure.

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Analysis 55.2

Comparison 55 Paromomycin 15% + 10% urea (twice daily for 20 d) versus ILMA (weekly for up to 20 d), Outcome 2 Adverse effects.

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Analysis 56.1

Comparison 56 Paromomycin + MBCL (twice daily for 15 d) versus ketoconazole (weekly for up to 30 d), Outcome 1 Participants complete cure.

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Analysis 56.2

Comparison 56 Paromomycin + MBCL (twice daily for 15 d) versus ketoconazole (weekly for up to 30 d), Outcome 2 Microbiological cure of skin lesions.

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Analysis 57.1

Comparison 57 Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks), Outcome 1 Lesions cured.

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Analysis 57.2

Comparison 57 Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks), Outcome 2 Scarring.

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Analysis 57.3

Comparison 57 Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks), Outcome 3 Microbiological cure of skin lesions.

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Analysis 58.1

Comparison 58 Paromomycin (4 weeks) versus paromomycin (2 weeks) + vehicle (2 weeks), Outcome 1 Participants complete cure.

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Analysis 58.2

Comparison 58 Paromomycin (4 weeks) versus paromomycin (2 weeks) + vehicle (2 weeks), Outcome 2 Microbiological cure of skin lesions.

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Analysis 59.1

Comparison 59 IL zinc 2% (twice a week for 2 weeks) versus ILSSG (100 mg/mL) for 2 weeks), Outcome 1 Lesions cured.

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Analysis 60.1

Comparison 60 IL zinc 2% (twice a week for 2 weeks) versus IL 7% HSCS for 2 weeks, Outcome 1 Lesions cured.

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Analysis 61.1

Comparison 61 ILSSG (100 mg/mL) for 2 weeks versus IL 7% HSCS for 2 weeks, Outcome 1 Lesions cured.

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Analysis 62.1

Comparison 62 IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks), Outcome 1 Lesions cured.

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Analysis 62.2

Comparison 62 IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks), Outcome 2 Participants complete cured.

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Analysis 62.3

Comparison 62 IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks), Outcome 3 Adverse effects.

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Analysis 63.1

Comparison 63 IL zinc 2% (twice a week for 2 weeks) versus ILMA (60 mg/kg/d for 2 weeks), Outcome 1 Lesions cured.

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Analysis 63.2

Comparison 63 IL zinc 2% (twice a week for 2 weeks) versus ILMA (60 mg/kg/d for 2 weeks), Outcome 2 Adverse effects.

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Analysis 64.1

Comparison 64 Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA, Outcome 1 Participants complete cure.

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Analysis 64.2

Comparison 64 Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA, Outcome 2 Participants with treated lesions that recur.

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Analysis 64.3

Comparison 64 Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA, Outcome 3 Adverse effects.

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Analysis 65.1

Comparison 65 IL 7% HSCS (0.2 mL to 7 mL per lesion) versus ILSSG (max 2 mL) max 5 injections, Outcome 1 Lesions cured.

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Analysis 66.1

Comparison 66 IL 5% HSCS (0.5 mL to 1 mL per lesion) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 6 to 10 weeks, Outcome 1 Lesions cured.

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Analysis 66.2

Comparison 66 IL 5% HSCS (0.5 mL to 1 mL per lesion) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 6 to 10 weeks, Outcome 2 Adverse effects.

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Analysis 67.1

Comparison 67 IL 7% HSCS (0.1 mL to 0.5 mL per lesion) versus IL 2% ciprofloxacin solution (0.1 mL to 0.5 mL per lesion), Outcome 1 Lesions cured.

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Analysis 68.1

Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 1 Lesions cured.

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Analysis 68.2

Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 2 Recurrence.

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Analysis 68.3

Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 3 Speed of healing (weeks).

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Analysis 68.4

Comparison 68 IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 4 Adverse effects.

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Analysis 69.1

Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 1 Lesions cured.

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Analysis 69.2

Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 2 Recurrence.

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Analysis 69.3

Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 3 Speed of healing (weeks).

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Analysis 69.4

Comparison 69 ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion), Outcome 4 Adverse effects.

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Analysis 70.1

Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 1 Lesions cured.

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Analysis 70.2

Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 2 Recurrence.

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Analysis 70.3

Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 3 Speed of healing (weeks).

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Analysis 70.4

Comparison 70 ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion), Outcome 4 Adverse effects.

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Analysis 71.1

Comparison 71 IL IFN‐γ (weekly for 5 weeks) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 5 weeks, Outcome 1 Lesions cured.

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Analysis 71.2

Comparison 71 IL IFN‐γ (weekly for 5 weeks) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 5 weeks, Outcome 2 Microbiological cure of skin lesions.

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Analysis 72.1

Comparison 72 WR279,396 (twice a day for 20 d) versus vehicle (twice a day for 20 d), Outcome 1 Participants complete cure.

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Analysis 72.2

Comparison 72 WR279,396 (twice a day for 20 d) versus vehicle (twice a day for 20 d), Outcome 2 Adverse effects.

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Analysis 73.1

Comparison 73 IL metronidazole (2.5 mg to 10 mg each lesion) versus ILMA (150 mg to 600 mg each lesion) for up to 8 weeks, Outcome 1 Participants complete cure.

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Analysis 73.2

Comparison 73 IL metronidazole (2.5 mg to 10 mg each lesion) versus ILMA (150 mg to 600 mg each lesion) for up to 8 weeks, Outcome 2 Adverse effects.

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Analysis 74.1

Comparison 74 Topical miltefosine 6% (once daily) versus ILMA (twice a week) for up to 28 d, Outcome 1 Participants complete cure.

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Analysis 75.1

Comparison 75 Dapsone gel 5% (twice a day) + ILMA (weekly) versus cryotherapy (every 2 weeks) + IMMA (weekly) for up to 16 weeks, Outcome 1 Lesions cured.

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Analysis 76.1

Comparison 76 DAC‐055 + MWT (for 15 min) versus DAC‐055 alone for up to 75 d, Outcome 1 Participants complete cure.

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Analysis 76.2

Comparison 76 DAC‐055 + MWT (for 15 min) versus DAC‐055 alone for up to 75 d, Outcome 2 Adverse effects.

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Analysis 77.1

Comparison 77 DAC‐055 + heat (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 1 Participants complete cure.

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Analysis 77.2

Comparison 77 DAC‐055 + heat (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 2 Adverse effects.

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Analysis 78.1

Comparison 78 DAC‐055 alone (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 1 Participants complete cure.

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Analysis 78.2

Comparison 78 DAC‐055 alone (for 15 min) versus ILSSG (0.6 mL) for up to 75 d, Outcome 2 Adverse effects.

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Analysis 79.1

Comparison 79 Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks, Outcome 1 Lesions cured.

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Analysis 79.2

Comparison 79 Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks, Outcome 2 Recurrence.

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Analysis 79.3

Comparison 79 Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks, Outcome 3 Adverse effects.

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Analysis 80.1

Comparison 80 CO₂ laser (30 W continuous) versus IMMA (50 mg/kg/d) for up to 15 d, Outcome 1 Lesions cured.

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Analysis 80.2

Comparison 80 CO₂ laser (30 W continuous) versus IMMA (50 mg/kg/d) for up to 15 d, Outcome 2 Adverse effects.

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Analysis 81.1

Comparison 81 CO₂ laser (30 W continuous) versus cryotherapy (fortnightly) + ILMA (weekly) for up to 12 weeks, Outcome 1 Lesions cured.

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Analysis 81.2

Comparison 81 CO₂ laser (30 W continuous) versus cryotherapy (fortnightly) + ILMA (weekly) for up to 12 weeks, Outcome 2 Adverse effects.

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$Comparison 82 Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser, Outcome 1 Partcipants complete cure.$

Analysis 82.1

Comparison 82 Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser, Outcome 1 Partcipants complete cure.

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$Comparison 82 Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser, Outcome 2 Adverse effects.$

Analysis 82.2

Comparison 82 Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser, Outcome 2 Adverse effects.

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Analysis 83.1

Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 1 Participants complete cure.

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Analysis 83.2

Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 2 Recurrence.

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Analysis 83.3

Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 3 Adverse effects.

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Analysis 83.4

Comparison 83 TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks), Outcome 4 Microbiological cure of skin lesions.

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Analysis 84.1

Comparison 84 Topical TCA 50% + local heat versus ILMA twice a week for up to 8 weeks, Outcome 1 Participants complete cure.

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Analysis 84.2

Comparison 84 Topical TCA 50% + local heat versus ILMA twice a week for up to 8 weeks, Outcome 2 Lesions cured.

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Analysis 85.1

Comparison 85 TCA + ILMA (weekly for up to 8 weeks) versus ILMA alone (twice a week for up to 8 weeks), Outcome 1 Participants complete cure.

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Analysis 85.2

Comparison 85 TCA + ILMA (weekly for up to 8 weeks) versus ILMA alone (twice a week for up to 8 weeks), Outcome 2 Speed of healing (weeks).

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Analysis 86.1

Comparison 86 Fractional laser + ILMA (fortnightly 2 sessions) versus ILMA alone (twice a week for up to 8 weeks), Outcome 1 Participants complete cure.

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$Comparison 87 TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions), Outcome 1 Participants complete cure.$

Analysis 87.1

Comparison 87 TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions), Outcome 1 Participants complete cure.

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$Comparison 87 TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions), Outcome 2 Speed of healing (weeks).$

Analysis 87.2

Comparison 87 TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions), Outcome 2 Speed of healing (weeks).

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Analysis 88.1

Comparison 88 TCA fortnightly up to 8 weeks + ILMA (twice a week) versus ILMA alone (weekly for up to 8 weeks), Outcome 1 Participants complete cure.

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Analysis 89.1

Comparison 89 Cryotherapy + ILMA (weekly) versus cryotherapy (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.

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Analysis 89.2

Comparison 89 Cryotherapy + ILMA (weekly) versus cryotherapy (weekly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 90.1

Comparison 90 Cryotherapy + ILMA (weekly) versus ILMA (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.

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Analysis 90.2

Comparison 90 Cryotherapy + ILMA (weekly) versus ILMA (weekly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 91.1

Comparison 91 Cryotherapy + ILMA (weekly) versus ILMA alone (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.

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Analysis 91.2

Comparison 91 Cryotherapy + ILMA (weekly) versus ILMA alone (weekly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 92.1

Comparison 92 Cryotherapy (weekly) versus ILMA (weekly) for up to 6 weeks, Outcome 1 Participants complete cure.

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Analysis 93.1

Comparison 93 Cryotherapy + ILMA (weekly) versus cryotherapy alone (weekly) for up to 6 weeks, Outcome 1 Lesions cured.

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Analysis 93.2

Comparison 93 Cryotherapy + ILMA (weekly) versus cryotherapy alone (weekly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 94.1

Comparison 94 Cryotherapy + ILMA (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 1 Lesions cured.

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Analysis 94.2

Comparison 94 Cryotherapy + ILMA (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 95.1

Comparison 95 Cryotherapy alone (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 1 Lesions cured.

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Analysis 95.2

Comparison 95 Cryotherapy alone (weekly) versus ILMA (fortnightly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 96.1

Comparison 96 Cryotherapy (fortnightly) + 15% paromomycin + 10% urea cream (twice a day) + ILMA (twice a day for 4 weeks) versus ILMA (twice a week) for up to 6 weeks, Outcome 1 Participants complete cure.

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Analysis 97.1

Comparison 97 Cryotherapy (weekly) + 3% salicylic + 3% sodium nitrite cream (twice a day) for up to 12 weeks versus cryotherapy (weekly) + 3% salicylic cream (twice a day), Outcome 1 Lesions cured.

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Analysis 97.2

Comparison 97 Cryotherapy (weekly) + 3% salicylic + 3% sodium nitrite cream (twice a day) for up to 12 weeks versus cryotherapy (weekly) + 3% salicylic cream (twice a day), Outcome 2 Adverse effects.

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Analysis 98.1

Comparison 98 Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks, Outcome 1 Lesions cured.

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Analysis 98.2

Comparison 98 Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks, Outcome 2 Participants complete cure.

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Analysis 98.3

Comparison 98 Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks, Outcome 3 Adverse effects.

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Analysis 99.1

Comparison 99 Radiofrequency waves (50 uCTM applied for 30 s) versus ILSSG (10 days of 20 mg/kg/d), Outcome 1 Lesions cured.

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Analysis 99.2

Comparison 99 Radiofrequency waves (50 uCTM applied for 30 s) versus ILSSG (10 days of 20 mg/kg/d), Outcome 2 Adverse effects (serious).

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Analysis 100.1

Comparison 100 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 1 Participants complete cure.

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Analysis 100.2

Comparison 100 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus IMSSG (20 mg/kg/d for 3 weeks), Outcome 2 Adverse event (secondary infection).

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Analysis 101.1

Comparison 101 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 days), Outcome 1 Participants complete cure.

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Analysis 101.2

Comparison 101 Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 days), Outcome 2 Adverse event (secondary infection).

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Analysis 102.1

Comparison 102 Radiofrequency waves versus ILSSG, Outcome 1 Participants complete cure.

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Analysis 103.1

Comparison 103 Electrocauterisation + DAC n‐055 (daily) versus electrocauterisation, Outcome 1 Adverse effects.

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Analysis 104.1

Comparison 104 PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks), Outcome 1 Lesions cured.

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Analysis 104.2

Comparison 104 PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks), Outcome 2 Scarring.

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Analysis 104.3

Comparison 104 PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks), Outcome 3 Microbiological cure of skin lesions.

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Analysis 105.1

Comparison 105 Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks, Outcome 1 Participants complete cure.

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Analysis 105.2

Comparison 105 Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks, Outcome 2 Adverse effects.

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Analysis 105.3

Comparison 105 Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks, Outcome 3 Development of cell‐mediated immunity.

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Analysis 106.1

Comparison 106 Diminazene aceturate solution (weekly) versus cetrimide + chlorhexidine solution for 50 d, Outcome 1 Participants complete cure.

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Analysis 107.1

Comparison 107 Topical garlic (twice a day) versus vehicle for 3 weeks, Outcome 1 Participants complete cure.

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Analysis 108.1

Comparison 108 Topical herbal extract + placebo (5 d) versus IMMA (15‐20/mg/kg/d) + vehicle for 20 d, Outcome 1 Participants complete cure.

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Analysis 109.1

Comparison 109 Topical honey (twice a day) + ILMA (weekly) versus ILMA (weekly) for 4 weeks, Outcome 1 Participants complete cure.

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Analysis 110.1

Comparison 110 Cassia fistula (topical gel) + ILMA (0.5 mL to 2 mL), twice a week versus ILMA (0.5 mL to 2 mL), twice a week + vehicle, Outcome 1 Participants complete cure.

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Analysis 110.2

Comparison 110 Cassia fistula (topical gel) + ILMA (0.5 mL to 2 mL), twice a week versus ILMA (0.5 mL to 2 mL), twice a week + vehicle, Outcome 2 Adverse effects.

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Analysis 111.1

Comparison 111 Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 1 Participants complete cure.

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Analysis 111.2

Comparison 111 Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 2 Speed of healing (weeks).

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Analysis 111.3

Comparison 111 Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 3 Adverse effects.

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Analysis 112.1

Comparison 112 Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 1 Participants complete cure.

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Analysis 112.2

Comparison 112 Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 2 Speed of healing (weeks).

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Analysis 112.3

Comparison 112 Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks, Outcome 3 Adverse reaction.

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Analysis 113.1

Comparison 113 Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks, Outcome 1 Participants complete cure.

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Analysis 113.2

Comparison 113 Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks, Outcome 2 Speed of healing (days).

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Analysis 113.3

Comparison 113 Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks, Outcome 3 Adverse effects.

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Analysis 114.1

Comparison 114 Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks, Outcome 1 Participants complete cure.

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Analysis 114.2

Comparison 114 Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks, Outcome 2 Adverse effects.

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Analysis 114.3

Comparison 114 Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks, Outcome 3 Microbiological cure of skin lesions.

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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 low^a	—
	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 low^b ⊕⊝⊝⊝ Very low^c	—
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 low^d	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).

Summary of findings for the main comparison. Itraconazole (200 mg for 6 to 8 weeks) versus placebo for Old World cutaneous leishmaniasis

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Summary of findings 2. Paromomycin ointment versus vehicle for Old World cutaneous leishmaniasis

Paromomycin ointment versus matched vehicle for Old World cutaneous leishmaniasis
Patient or population: patients with Old World cutaneous leishmaniasis Settings: primary health centres, Iran and Tunisia Intervention: paromomycin ointment (15% + 10% urea) twice daily for 14 days Comparison: vehicle
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)
	Assumed risk	Corresponding risk
	Vehicle	Paromomycin ointment (15% + 10% urea) twice daily for 14 days
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 1.00 (0.86 to 1.17)	383 (2 studies)	⊕⊝⊝⊝ Very low^a
	623 per 1000	623 per 1000 (536 to 729)
	Moderate
	619 per 1000	619 per 1000 (532 to 724)
Adverse effects Skin/local reactions	Study population		RR 1.42 (0.67 to 3.01)	713 (4 studies)	⊕⊝⊝⊝ Very low^b
	96 per 1000	136 per 1000 (64 to 287)
	Moderate
	90 per 1000	128 per 1000 (60 to 271)
Speed of healing (time taken to be 'cured')	Not measured in this comparison
Microbiological or histopathological cure of skin lesions Follow‐up: mean 2.5 months	Study population		RR 1.03 (0.88 to 1.2)	383 (2 studies)	⊕⊝⊝⊝ Very low^c
	859 per 1000	884 per 1000 (756 to 1000)
	Moderate
	792 per 1000	816 per 1000 (697 to 950)
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; N/A: not applicable.
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 (1 RCT has many uncertain risks), indirectness (2 levels because one of the studies focused on young people), and imprecision (the confidence interval around the estimate risk ratio ranges from a 14% reduction to a 17% increase in the risk ratio for healing with paromomycin). ^bDowngraded by 4 levels due to risk of bias (2 RCTs have many uncertain risks), indirectness (2 levels because one of the studies focused on young people), and imprecision (the confidence interval crosses the line of no effect). ^cDowngraded by 5 levels due to risk of bias (1 RCT has many uncertain risks), inconsistency (there is considerable heterogeneity ‐ I² = 84%), indirectness (2 levels because one of the studies focused on young people), and imprecision (the confidence interval around the estimate risk ratio ranges from a 12% reduction to a 20% increase in the risk ratio for healing with paromomycin).

Summary of findings 2. Paromomycin ointment versus vehicle for Old World cutaneous leishmaniasis

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Table 1. Glossary

Term	Definition
Antimonials	Pharmaceutical agents containing antimony. Antimony‐containing compounds (meglumine antimoniate and sodium stibogluconate) are the principal medications used to treat leishmaniases, an infection caused by a protozoan parasite.
Arthralgia	Pain in the joints. The causes of arthralgia are varied and range, from a joints perspective, from degenerative and destructive processes such as osteoarthritis and sports injuries to inflammation of tissues surrounding the joints, such as bursitis.
Cardiac arrhythmia	An arrhythmia is an abnormal heart rhythm. Many types of arrhythmia have no symptoms. When symptoms are present these may include palpitations or feeling a pause between heartbeats. More seriously there may be lightheadedness, passing out, shortness of breath, or chest pain.
Cutaneous necrosis	The death of living tissues in response to disease or injury.
Cytolysis	The degeneration or dissolution of cell caused by the disruption of cell membrane.
Exudate	A fluid with a high content of protein and cellular debris that has escaped from blood vessels and has been deposited in tissues or on tissue surfaces, usually as a result of inflammation.
Human monocytes	Monocytes are the biggest type of white blood cell in the immune system. Originally formed in the bone marrow, they are released into our blood and migrate into the connective tissue where they differentiate into macrophages. When certain germs enter the body, they quickly rush to the site of attack.
Hypotension	A systolic blood pressure reading (the top number) of 90 millimetres of mercury (mmHg) or less a diastolic blood pressure reading (the bottom number) of 60 mmHg or less is generally considered low blood pressure. The causes of low blood pressure can range from dehydration to serious medical or surgical disorders.
Immune response modifier	Any of a broad family of biomolecules that up‐ or down‐regulate, or restore immune responsiveness, which are generated after T cells recognise an antigen present on the surface of a self‐antigen‐presenting cell, which, once activated, produce multiple cytokines.
Immunolabeling	A biochemical process that enables the detection and localisation of an antigen to a particular site within a cell, tissue, or organ. Antigens are organic molecules, usually proteins, capable of binding to an antibody. These antigens can be visualised using a combination of antigen‐specific antibodies as well as a means of detection, called a tag, that is covalently linked to the antibody. If the immunolabeling process is meant to reveal information about a cell or its substructures, the process is called immunocytochemistry. Immunolabeling of larger structures is called immunohistochemistry.
In vitro	Biological processes or reactions made to occur outside the living organism in an artificial environment, such as a culture medium.
Intralesional meglumine antimoniate	Meglumine antimoniate (or Glucantime) is a medicine used for treating leishmaniasis. It belongs to a group of compounds known as the pentavalent antimonials.
Lymphadenopathies	Lymph nodes that have an abnormal in size, number or consistency; often used as a synonym for swollen or enlarged lymph nodes. Common causes of lymphadenopathy are infection, autoimmune disease, or malignancy.
Lymphatic channels	The vessels that transport lymph throughout the body. Lymph is a clear fluid that contains cells important for forming antibodies that fight infection.
Lymphokine	Any of various soluble protein mediators released by sensitised lymphocytes on contact with antigen, and believed to play a role in macrophage activation, lymphocyte transformation, and cell‐mediated immunity. They regulate immune responses through differentiation, amplification, and inhibition of cell functions. Lymphokines may also have a cytotoxic effector function. Used as biologic response modifiers in the treatment of cancer.
Macrophages	White blood cells (activated monocytes) that protect the body against infection and foreign substances by breaking them down into antigenic peptides recognised by circulating T cells.
Miltefosine	An oral alkyl phosphocholine analogue used to treat cutaneous and visceral leishmaniasis. Interacts with lipids and sterols in the Leishmania membrane resulting in inhibition of mitochondria and apoptotic cell death.
Mucous membranes	The mucous membranes (or mucosae or mucosas; singular mucosa) are linings of mostly endodermal origin, covered in epithelium, which are involved in absorption and secretion. They line cavities that are exposed to the external environment and internal organs.
Myalgia	Myalgia, or muscle pain, is a symptom of many diseases and disorders. The most common causes are the overuse or over‐stretching of a muscle or group of muscles. Myalgia without a traumatic history is often due to viral infections. Long‐term myalgias may be indicative of a metabolic myopathy, some nutritional deficiencies or chronic fatigue syndrome.
Nodular lymphangitis	Nodular lymphangitis is a distinct clinical entity, separate from lymphangitis. This disorder is characterised by inflammatory nodules along the lymphatics draining a primary skin infection
Papule	A solid, rounded growth that is elevated from the skin, usually inflammatory but nonsuppurative. A papule is usually less than 1 cm across.
Parenteral	Administration of a medicinal or therapeutic substance, other than through the gastrointestinal or respiratory tracts, e.g. by intravenous, intramuscular or subcuticular injection.
Pentamidine	Pentamidine (e.g. isethionate) is an antiprotozoal and antifungal agent of the class of aromatic diamidines, administered intravenously or intramuscularly in treatment of early African trypanosomiasis and leishmaniasis, and intravenously, intramuscularly, or by oral inhalation in treatment and prophylaxis of Pneumocystis carinii pneumonia.
Pentavalent antimony	Pentavalent antimonials are a group of compounds used for the treatment of leishmaniasis. The first pentavalent antimonial used was urea stibamine: first introduced in the 1930s, it fell out of favour in the 1950s due to higher toxicity compared to sodium stibogluconate. The compounds currently available for clinical use are: sodium stibogluconate (Pentostam; manufactured by GlaxoSmithKline; available in the USA and UK), which is administered by slow intravenous injection, intralesional or intramuscular injection, and meglumine antimoniate (Glucantime; manufactured by Aventis; available in Brazil, France and Italy), which is administered by intramuscular, intralesional, or intravenous injection.
Promastigotes	Term now generally used instead of 'leptomonad' or 'leptomonad stage' to avoid confusion with the flagellate genus Leptomonas. It denotes the flagellate stage of a trypanosomatid protozoan in which the flagellum arises from a kinetoplast in front of the nucleus and emerges from the anterior end of the organism; usually an extracellular phase, as in the insect intermediate host (or in culture) of Leishmania parasites.
Protozoan	Any of a group of single‐celled, usually microscopic, eukaryotic organisms, such as amoebas, ciliates, flagellates, and sporozoans.
ThermoMed device	The ThermoMed is a battery‐operated device that delivers precisely controlled localised current field radiofrequency heat to selectively destroy certain diseased tissue and is recommended by the World Health Organization as an alternative therapy for cutaneus leishmaniasis.
Thermotherapy	The treatment of disease by the application of heat. Thermotherapy may be administered as dry heat with heat lamps, diathermy machines, electric pads, or hot water bottles or as moist heat with warm compresses or immersion in warm water. Warm soaks or compresses may be used to treat local infections, relax muscles and relieve pain in patients with motor problems, and promote circulation in peripheral vascular disorders such as thrombophlebitis.

Table 1. Glossary

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Table 2. Interventions for Old World cutaneous leishmaniasis

Drug	Doses
Systemic antimonials
Sodium stibogluconate (Pentostam, Stibanate) Meglumine antimonate (Glucantime) Combined with pentoxifylline	20 mgSb ^v+/kg/d intramuscularly or intravenously for 20‐30 days 400 mg orally 3 times a day for 10–20 days
Intralesional antimonials
Sodium stibogluconate (Pentostam, Stibanate) Meglumine antimonate (Glucantime)	1–5 mL per session every 3–7 days. Up to 10 sessions depending on the clinical response, but most patients require ≤ 5 sessions
Non‐antimonial systemic treatments
Fluconazole	200 mg orally daily for 6 weeks
Miltefosine	50 mg orally three times daily for 28 days
Liposomal amphotericin B	3 mg/kg/d IV on days 1‐5 and 10 (18 mg/kg total dose)
Non‐antimonial topical or intralesional therapies
15% paromomycin/12% methylbenzethonium chloride	Ointment twice daily for 10‐20 days
15% paromomycin/0.5% gentamicin sulphate	Twice a day for 20 days
Physical therapies
Cryotherapy with liquid nitrogen	Frozen for 10‐30 s and thaw applied locally 2‐3 times in each session, repeated every 1‐4 weeks to complete healing (usually 2‐4 sessions)
Local heat therapy	50°‐55ºC for 30 s by: Infrared light Direct current electrical stimulation Ultrasound Laser Radiofrequency waves ThermoMed device

Table 2. Interventions for Old World cutaneous leishmaniasis

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Table 3. Adverse effects of oral antibiotics

Study	Method of assessment	Timing	Interventions	Adverse effects
Kochar 2000	Quote: "Biochemical tests were done to detect any toxic effects of the drug."	Biochemical tests were done at the end of 1 week, 2 weeks and 4 weeks post‐ treatment.	I1: oral rifampicin 1200 mg/d I2: placebo	Intervention 23 participants evaluated for AEs. Quote: "The drug was well‐tolerated and no side‐effects were seen in any participant." Placebo 23 participants evaluated for AEs. Not reported
Jaffar 2006	Quote: "clinical examination, liver function tests, renal function tests"	Quote: "Before, during, and after completion of treatment"	I1: oral rifampicin 10 mg/kg/d I2: placebo	Intervention 46 participants evaluated for AEs. Elevation liver enzymes: 1 (2%) Placebo 16 participants evaluated for AEs. Not reported
Kochar 2006	Haemoglobin, leukocyte count, and liver test	Biochemical tests were done at the end of 2 week, 4 weeks and 6 weeks post‐treatment	I1: oral rifampicin + omeprazole I2: placebo	Intervention 1 23 participants evaluated for AEs. Intervention 2 21 participants evaluated for AEs. Quote: "All participants tolerated the drug and placebo very well and no side effect was reported."
Layegh 2007	Not described	Azythromycin group: monthly up to 4 months	I1: azithromycin 500 mg/d I2: IMMA 60 mg/kg/d	Intervention 1 22 participants evaluated for AEs (35 lesions). Nausea and vomiting: 2 (9%) Intervention 2 27 participants evaluated for AEs (58 lesions). Myalgia: 3 (11%); Erythema: 1 (3.7%).
Adam 2009	Quote: "Complete haemogram, including haemoglobin and liver and renal function tests Participants were questioned about expected adverse effects for 3 days (Days 5–7) following administration of the doses."	Haemogram: 1 and 2 months Clinical AEs: days 5‐7; 19‐21; 33‐35; 47‐19.	I1: artesunate I2: placebo	Intervention 1 20 participants evaluated for AEs. Placebo 21 participants evaluated for AEs. Skin rash with itching: 1 (4.7%) Quote: "There was no significant difference in biological tests (liver and renal function tests) in all the participants before and after treatment."
Ben Salah 2009	Interview, physical examination, laboratory test, evaluation for pain, standardised questionnaire for the occurrence of systemic side effects (e.g. vertigo, tinnitus). Diminished hearing was verified with audiometer. Laboratory test.	Quote: "Investigators observed each participant each day that the topical creams were administered and at follow‐up study visits (days 50‐100‐180). Clinical and laboratory evidence of side effects was determined on D10 and D20."	I1: WR 279,396 I2: placebo	Intervention 50 participants evaluated for AEs. Erythema at the site of application: 15 (30%); mild pain within 30 minutes of application: 7 (14 %); mild increases and decreases in hearing acuity from baseline: 14 (28%); change hearing acuity: 14 (28%); vertigo: 0 (0%); Increase serum creatinine: 0 (0%); Death: 0 (0%) Placebo 42 participants evaluated for AEs. Erythema at the site of application: 10 (24%); mild pain within 30 minutes of application: 6 (14 %); mild increases and decreases in hearing acuity from baseline: 9 (21%); change hearing acuity: 9 (21%); vertigo: 0 (0%); increase serum creatinine: 0 (0%); death: 0 (0%)
Dastgheib 2012	Quote: "Participants were interviewed and underwent laboratory tests three times"	Quote: "In Allopurinol group, the participants which were visited and received medication underwent laboratory tests three times (before, one month a2fter, and end of the treatment)	I1: azithromycin + allopurinol I2: IMMA	Intervention 1 36 participants evaluated for AEs. Gastrointestinal complaints and headache severe: 1 (2.7%); slight gastrointestinal complications (nausea, heartburn, and epigastric pain): 3 (8.3%) Intervention 2 35 participants evaluated for AEs. Myalgia: 2 (5.7%)
AE: adverse effect; IMMA: intramuscular meglumine antimoniate.

Table 3. Adverse effects of oral antibiotics

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Table 4. Adverse effects of topical paromomycin

Study	Method of assessment	Timing	Interventions	Adverse effects
Asilian 1995	Clinical evaluation and laboratory tests	Days 15, 45 and 105	I1: paromomycin I2: placebo	126 participants evaluated for AEs. During treatment: oedema, local pain, vesiculation: 1 (0.7%) After treatment: redness, pain, vesiculation, and inflammation: 8 (6.3%) Quote: "There were no significant differences in four laboratory test results of safety (SGOT, BUN, Hb, and WBC) between the groups either before or after treatment."
Ben Salah 1995	Clinical evaluation, physical examination, advice to participants, laboratory test: liver function, haemoglobin and white blood cell count	Days 15, 45 and 105	I1: paromomycin I2: placebo	57 participants evaluated for AEs. Quote: "A local reaction (inflammation, vesication, pain and/or red ness) was recorded for 12 participants, with no significant difference between the 2 groups." Laboratory test changes: 0 (0%)
Özgöztasi 1997	Not described	At the end of treatment (day 30) and 1 month post‐treatment	I1: paromomycin + MBCL I2: oral ketoconazole	40 participants (62 lesions) evaluated for AEs Quote: "Treatment‐related adverse effects were only observed in the paromomycin group. The most common side‐effect was the development of irritant contact dermatitis. No subjects withdrew because of this adverse effect."
Asilian 2003	Clinical evaluation	Days 15, 29, 45 and 105	I1: paromomycin I2: placebo	108 participants evaluated for AEs. Quote: "Treatment was well tolerated, and no adverse reactions to the ointment were observed or reported in either group."
Faghihi 2003	Not described	Quote "Clinical evaluation and follow‐up were performed fortnightly until 1 month post treatment and then monthly until 3 months post treatment, and finally every 3 months until 1 year post treatment"	I1: paromomycin + urea I2: ILMA weekly	Not described
Shazad 2005	Not described	Week 1 and week 6 post‐treatment and at 6 months after treatment was completed	I1: paromomycin + urea I2: ILMA weekly	30 participants evaluated for AEs. Cutaneous reactions (erythematosus, urticaria or lymphadenitis with pain): 1 (3%) Quote: "No systemic toxic reaction attributable to the drug was observed."
Iraji 2005	Clinical evaluation	Days 7, 14, 21 and 30	I1: paromomycin I2: placebo	30 participants evaluated for AEs. Mild contact dermatitis: 3 (10%)
Asilian 2006	Not described	Weekly during treatment and monthly for up 2 months	I1: photodynamic therapy I2: paromomycin I3: placebo	19 participants (34 lesions) evaluated for AEs. Quote: "Adverse side‐effects seen in some participants in all groups were pruritus, burning, redness, discharge, oedema, and pain, but all were generally mild and tolerable."
Ben Salah 2009	Quote: "Renal toxic effects and ototoxic effects from aminoglycoside exposure were ascertained by means of serum creatinine measurements at the end of therapy (at 20 days) and participants' daily reports of tinnitus and vertigo."	Quote: "Safety end points were assessed daily during therapy (20 days)."	I1:Paromomycin ‐Gentamicin I2: paromomycin Alone I3: vehicle Control	Intervention 1: 125 participants evaluated for AEs. Erythema: 6 (5%); local infection: 0 (0%); inflammation: 0 (0%); vesicles mild‐moderate: 31 (25%); mild oedema: 2 (2%); pain: 2 (2%); mild bronchitis: 5 (4%); paronychia: 2 (2%); superinfection: 3 (2%); upper respiratory tract infection: 0 (0%); oropharyngeal pain: 4 (3%); skin irritation: 3 (2%); tinnitus: 0 (0%); vertigo: 0 (0%); creatinine serum changes: 0 (0%) Intervention 2: 125 participants evaluated for AEs. Erythema: 7 (6%); local infection: 0 (0%); inflammation: 0 (0%); vesicles mild‐moderate: 32 (26%); mild‐moderate oedema: 3 (3%); pain: 2 (2%); bronchitis mild‐moderate: 3 (3%); paronychia: 0 (0%); superinfection: 0 (0%); upper respiratory tract infection: 2 (2%); oropharyngeal pain: 3 (2%); skin irritation: 9 (7%); tinnitus: 0 (0%); vertigo: 0 (0%); creatinine serum changes: 0 (0%)
AE: adverse effect; BUN: blood urea nitrogen; Hb: haemoglobin; ILMA: intralesional meglumine antimoniate; SGOT: serum glutamic‐oxaloacetic transaminase; WBC: white blood cells.

Table 4. Adverse effects of topical paromomycin

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Table 5. Adverse effects of intralesional zinc sulphate

Study	Method of assessment	Timing	Interventions	Adverse effects
Sharquie 1997	Not described	Quote: "Participants were seen at 10‐15 day intervals after injection, and at 6 weeks post treatment"	I1: IL 2% zinc sulphate I2: IL 7% sodium chloride I3: ILSSG 2‐5 mL per lesion	19 participants evaluated for AEs. Quote: "Apart from pain at the time of injection, no appreciable side‐effect was noted."
Iraji 2004	Not described	Not described	I1: IL zinc sulphate I2: ILMA weekly	31 participants evaluated for AEs. Severe pain caused vasovagal shock: 2 (6.4%)
Firooz 2005	Not described	Not described	I1: IL zinc sulphate I2: ILMA weekly	36 participants evaluated for AEs. Pain: 13 (36.1%); burning at site injection: 3 (8.4%); itching: 3 (8.4%); inflammation: 7 (19.4%)
Maleki 2012	Not described	14, 28, 42, and 56 days after starting the treatment	I1: IL 2% zinc sulphate I2: ILMA weekly	24 participants evaluated for AEs. Quote: "The side effects seen in both groups were pain after injection and hyperpigmentation." Burning after injection and necrosis of the lesions: 24 (100%); inflammation and swelling: 3 (12.5%)
AE: adverse effect; IL: intralesional; ILMA: intralesional meglumine antimoniate; ILSSG: intralesional sodium stibogluconate.

Table 5. Adverse effects of intralesional zinc sulphate

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Table 6. Adverse effects of intralesional hypertonic sodium chloride solution

Study	Method of assessment	Timing	Interventions	Adverse effects
Sharquie 1997	Not described	Quote: "Participants were seen at 10‐15 day intervals after injection, and at 6 week post treatment"	I1: IL 2% zinc sulphate I2: IL 7% HSCS I3: ILSSG 2‐5 mL per lesion	17 participants evaluated for AEs. Quote: "No side‐effect other than pain at the time of injection was noted."
Sadeghian 2006b	Not described	Not described	I1: IL 5% HSCS I2: ILMA 0.5‐1 mL/week	36 participants evaluated for AEs. Allergic reaction (erythema, oedema, and pruritus): 0 (0%); sporotrichoid dissemination: 3 (8.3%)
Ranawaka 2010	Not described	Quote: "Participants were seen weekly for the first three injections; fortnightly for the fourth and fifth injections; then monthly until cure. Participants were followed‐up every 3 months after cure for 18 months to assess recurrences and evidence of visceralization."	I1: ILSSG I2: IL 7% HSCS	67 participants evaluated for AEs. Leishmaniasis recidivans: 0 (0%) Quote: "There were no systemic side effects with SSG or HS. Pain during injection was the only local side effect noted with both therapies. After healing, scarring was minimal, but postinflammatory hyperpigmentation was observed in all participants for both treatments, which faded out over 6–8 months."
AE: adverse effect; IL: intralesional; ILSSG: intralesional sodium stibogluconate; HSCS: hypertonic sodium chloride solution.

Table 6. Adverse effects of intralesional hypertonic sodium chloride solution

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Table 7. Adverse effects of laser

Study	Method of assessment	Timing	Interventions	Adverse effects
Asilian 2004b	Not described	1, 3, 4, 8, 12 and 24 weeks after treatment	I1: CO₂ I2: IMMA 50 mg/kg/d	123 participants evaluated for AEs. Quote: "Complications were seen in (4) 4.5% of participants and included hyperpigmentation, persistent redness." Hypertonic scars: 5 (4%)
Shamsi Meymandi 2011	Quote: "Follow‐up was performed and any side‐effects were recorded."	Quote: "Follow‐up evaluation was performed by clinical assessment of treated lesions at weeks 2, 6, 12 and 16."	I1: CO₂ I2: cryotherapy + MA	80 participants (95 lesions) evaluated for AEs. Hyperpigmentation + trivial scar: 20 (25%); atrophic scar: 7 (8.75%); hypertrophic scar: 1 (1.25%); sporotrichoid: 1 (1.25%); raised papular lesions: 1 (1.25%); persistent erythema: 3 (3.75%); hypopigmentation + trivial scar: 4 (5%)
Nilforoushzadeh 2014a	Not described	Quote: "Participants were followed in the first, third, and sixth months after treatment with the final evaluation in the sixth month."	I1: ablative CO₂ laser I2: fractional CO₂ laser	Intervention 1: 30 participants evaluated for AEs. Erythema: 2 (6.7%) Intervention 2: 30 participants evaluated for AEs. Erythema: 4 (13.3%)
AE: adverse effect; IMMA: intramuscular meglumine antimoniate; MA: meglumine antimoniate.

Table 7. Adverse effects of laser

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Table 8. Adverse effects of cryotherapy

Study	Method of assessment	Timing	Interventions	Adverse effects
Asilian 2004a	Not described	Fortnightly until 6 months post‐treatment and 2 weeks and 4 weeks post‐treatment	I1: cryotherapy + ILMA I2: cryotherapy alone I3: ILMA alone	Intervention 1: 100 participants evaluated for AEs. Postinflammatory hypopigmentation: 5 (5%) Intervention 2: 200 participants evaluated for AEs. Postinflammatory hypopigmentation: 10 (5%)
Salmanpour 2006	Not described	Not described	I1: ILMA alone I2: cryotherapy alone I3: cryotherapy + ILMA	Intervention 2: 20 participants evaluated for AEs. Erythema and oedema of the lesions and perilesional area: (28%) Intervention 3: 20 participants evaluated for AEs. Erythema and oedema of the lesions and perilesional area: (33%) Quote: "There were no serious side‐effects in any of the treatment groups"
Layegh 2009	Not described	Quote: "Weekly for up to six weeks of treatment and six months after."	I1: cryotherapy I2: ILMA	36 participants evaluated for AEs. Hypopigmentation: 2 (5.5%); hyperpigmentation: 7 (19.4%). Quote: "the most common adverse reactions were erythema and oedema of the treated site, which appeared during the initial hours of treatment, and blistering of the treatment site, which became evident 1–2 days after treatment and responded well to local treatment."
Shamsi Meymandi 2011	Quote: "Follow‐up was performed and any side‐effects were recorded."	Quote: "Follow‐up evaluation was performed by clinical assessment of treated lesions at weeks 2, 6, 12 and 16."	I1: CO₂ I2: cryotherapy + MA	80 participants (95 lesions) evaluated for AEs. Hyperpigmentation + trivial scar: 15 (18.7%); atrophic scar: 6 (7.5%); hypertrophic scar: 0 (0%); sporotrichoid: 0 (0%); raised papular lesions: 0 (0%); persistent erythema: 0 (0%); hypopigmentation + trivial scar: 15 (18.8%)
Jowkar 2012	Quote: "During these visits the healing process of the ulcer, change of diameter and induration of lesions and complications were assessed."	Quote: "The participants were evaluated every 2 weeks up to 12 weeks."	I1: cryotherapy + 3% salicylic + 3% sodium nitrite I2: cryotherapy + 3% salicylic + placebo	Intervention 1: 36 participants evaluated for AEs. Erythema, a burning sensation and skin irritation: 7 (19.4%) Intervention 2: 27 participants evaluated for AEs. Erythema, a burning sensation and skin irritation: 1 (3.7%)
AE: adverse effect; ILMA: intralesional meglumine antimoniate; MA: meglumine antimoniate.

Table 8. Adverse effects of cryotherapy

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Table 9. Adverse effects of thermotherapy

Study	Method of assessment	Timing	Interventions	Adverse effects
Reithinger 2005	Quote: "The occurrence of adverse effects was evaluated blindly by means of participant interviews and physical examinations."	Quote: "The occurrence of adverse effects was evaluated … during follow‐up visits."	I1: ILSSG 2‐5 mL per lesion I2: IMSSG 20 mg/kg I3: thermotherapy	138‐108 participants evaluated for AEs. Secondary infections: 8 (5.7%). Quote: "The original CL ulcer often increased in size immediately after and up to 2 weeks after treatment."
Sadeghian 2007	Quote: "Appearance of lesions at subsequent follow‐up visits and occurrence of unwanted side‐effects were also recorded on the form."	Weekly 4 weeks and monthly up to 6 months	I1: thermotherapy I2: ILMA weekly	57 participants (83 lesions) evaluated for AEs. Satellite lesions: 1 (1.7%)
Aronson 2010	Quote: "Interview, physical examination, laboratory testing (complete blood count, creatine phosphokinase, amylase, lipase, complete metabolic profile), and electrocardiograms."	Quote: "Daily for the first 10 days and follow‐up at 2, 6, and 12–24 months post treatment"	I1: thermotherapy I2: ILSSG	27 participants evaluated for AEs. Serious AE: 4 (15%); ECG changes: 10 (37%); abdominal discomfort: 1 (4%); wound infection: 5 (19%); musculoskeletal: 5 (19%); headache: 3 (11%); fatigue: 5 (19%); rash: 1 (4%); blister reaction: 25 (93%); erythema: 7 (26%); oozing: 21 (78%)
Safi 2012	Quote: "The occurrences of adverse effects were evaluated by means of participant interviews and physical examinations during follow‐up visits."	Quote: "During treatment, all participants were then followed for four visits at weekly intervals … After initial treatment, all participants were scheduled for four subsequent follow‐up visits: 10 days after baseline and 1‐month, 2 months and 6 months after treatment."	I1: thermotherapy I2: ILMA weekly	189 participants evaluated for AEs Not reported
Bumb 2013	Not described	Not described	I1: radiofrequency heat treatment I2: ILSSG	Quote: "RFHT was cosmetically acceptable because it was associated with less scarring and hyperpigmentation compared with intralesional SSG injections."
Jebran 2014	Quote: "In case of clinical signs for a superinfection, a smear was taken, Gram stained and microscopically evaluated for the presence of bacteria and/or fungi."	Quote: "Adverse events such as bacterial or fungal superinfections of the wounds, the formation or scars and the rate of re‐ulcerations were monitored during the treatment and follow‐up period."	I1: electrocauterisation + DAC N‐055. I2: electrocauterisation + placebo.	Intervention 1: 38 participants evaluated for AEs. Bacterial and fungal superinfections: 3 (8.0%); Keloïd formation: 2 (5%) Intervention 2: 32 participants evaluated for AEs. Bacterial and fungal superinfections: 3 (9.0%); Keloïd formation: 2 (6%)
AE: adverse effect; CL: cutaneous leishmaniasis; ILMA: intralesional meglumine antimoniate; ILSSG: intralesional sodium stibogluconate; IMSSG: intramuscular sodium stibogluconate.

Table 9. Adverse effects of thermotherapy

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Comparison 1. ILMA weekly versus ILMA fortnightly for up to 8 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 1. ILMA weekly versus ILMA fortnightly for up to 8 weeks

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Comparison 2. ILMA (every other day) versus IMMA (6 d/week) for up to 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 2. ILMA (every other day) versus IMMA (6 d/week) for up to 4 weeks

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Comparison 3. IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (30 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 3. IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (30 mg/kg/d for 3 weeks) + placebo

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Comparison 4. IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (60 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 4. IMMA (30 mg/kg/d for 3 weeks) + cimetidine versus IMMA (60 mg/kg/d for 3 weeks) + placebo

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Comparison 5. IMMA (60 mg/kg/d for 3 weeks) + placebo versus IMMA (30 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 5. IMMA (60 mg/kg/d for 3 weeks) + placebo versus IMMA (30 mg/kg/d for 3 weeks) + placebo

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Comparison 6. IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	2	148	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.71, 0.96]

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Serious adverse effects	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Skin reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Cardiac toxicity 'QT prolongation'	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 6. IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo

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Comparison 7. IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 7. IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo

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Comparison 8. IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 8. IMMA (30 mg/kg/d for 3 weeks) + placebo versus IMMA (60 mg/kg/d for 3 weeks) + placebo

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Comparison 9. IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 9. IMMA (30 mg/kg/d for 3 weeks) + 40 mg omeprazole versus IMMA (60 mg/kg/d for 3 weeks) + placebo

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Comparison 10. ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects (itching and burning) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects (oedema) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 10. ILMA + non‐silver polyester dressing versus ILMA (weekly injections for 6 weeks)

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Comparison 11. ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects (itching and burning) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects (oedema) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 11. ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks)

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Comparison 12. ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects (itching and burning) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects (oedema) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 12. ILMA (weekly injections for 6 weeks) + silver polyester dressing versus ILMA (weekly injections for 6 weeks) + non‐silver polyester dressing

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Comparison 13. ILMA (weekly injections for 6 weeks) + gel mask twice a day versus ILMA (weekly injections for 6 weeks) + vehicle

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 13. ILMA (weekly injections for 6 weeks) + gel mask twice a day versus ILMA (weekly injections for 6 weeks) + vehicle

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Comparison 14. ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5) versus ILSSG (1000 mg/mL days 1, 3, 5)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 14. ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5) versus ILSSG (1000 mg/mL days 1, 3, 5)

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Comparison 15. ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 d for 29 days) versus IMSSG (20 mg/kg/d for 3 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects (mild heart symptoms) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 15. ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 d for 29 days) versus IMSSG (20 mg/kg/d for 3 weeks)

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Comparison 16. Ketoconazole 600 mg/d for 6 weeks versus ketoconazole 800 mg/d for 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects (nausea and vomiting) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 16. Ketoconazole 600 mg/d for 6 weeks versus ketoconazole 800 mg/d for 6 weeks

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Comparison 17. Ketoconazole 600 mg/d for 30 d versus ILMA (6 to 8 biweekly injections)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effect (liver enzymes increase) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 17. Ketoconazole 600 mg/d for 30 d versus ILMA (6 to 8 biweekly injections)

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Comparison 18. ILSSG (100 mg/mL days 1, 3, 5) + oral ketoconazole (600 mg/d for 4 weeks) versus ILSSG (100 mg/mL days 1, 3, 5)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 18. ILSSG (100 mg/mL days 1, 3, 5) + oral ketoconazole (600 mg/d for 4 weeks) versus ILSSG (100 mg/mL days 1, 3, 5)

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Comparison 19. ILSSG (100 mg/mL days 1, 3, 5) + ketoconazole (600 mg/d for 4 weeks) versus ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 19. ILSSG (100 mg/mL days 1, 3, 5) + ketoconazole (600 mg/d for 4 weeks) versus ILSSG (20 mg/kg/d) + IMSSG (remaining total dose days 1, 3, 5)

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Comparison 20. Itraconazole (200 mg for 6 weeks) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

Comparison 20. Itraconazole (200 mg for 6 weeks) versus placebo

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Comparison 21. Itraconazole (200 mg for 3 weeks) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

Comparison 21. Itraconazole (200 mg for 3 weeks) versus placebo

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Comparison 22. Itraconazole (200 mg for 6 to 8 weeks) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	3	244	Risk Ratio (M‐H, Random, 99% CI)	3.70 [0.35, 38.99]

2 Adverse effects Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Mild abdominal pain and nausea	3	204	Risk Ratio (M‐H, Random, 95% CI)	2.36 [0.74, 7.47]
2.2 Mild abnormal liver function	3	84	Risk Ratio (M‐H, Random, 95% CI)	3.08 [0.53, 17.98]
2.3 Headache and dizziness	1	20	Risk Ratio (M‐H, Random, 95% CI)	2.63 [0.16, 43.63]
3 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

Comparison 22. Itraconazole (200 mg for 6 to 8 weeks) versus placebo

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Comparison 23. Itraconazole (200 mg for 6 to 8 weeks) versus no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

2 Adverse effects (headache and dizziness) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 23. Itraconazole (200 mg for 6 to 8 weeks) versus no treatment

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Comparison 24. Fluconazole (200 mg for 6 weeks) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 24. Fluconazole (200 mg for 6 weeks) versus placebo

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Comparison 25. Fluconazole (400 mg/d for 6 weeks) versus fluconazole (200 mg/d for 6 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Rise creatinine and liver enzymes	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Cheilitis	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Nausea	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 25. Fluconazole (400 mg/d for 6 weeks) versus fluconazole (200 mg/d for 6 weeks)

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Comparison 26. Oral dapsone (200 mg/d for 6 weeks) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete Cure Show forest plot	2	160	Risk Ratio (M‐H, Random, 95% CI)	24.08 [1.44, 403.43]

2 Adverse effects Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Nausea	2	160	Risk Ratio (M‐H, Random, 95% CI)	21.86 [3.04, 157.29]

Comparison 26. Oral dapsone (200 mg/d for 6 weeks) versus placebo

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Comparison 27. Allopurinol (15 mg/kg/d for 3 weeks) + IMMA (20 mg/kg/d for 2 weeks) versus allopurinol (15 mg/kg/d for 3 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1	100	Risk Ratio (M‐H, Random, 95% CI)	3.83 [1.71, 8.60]

Comparison 27. Allopurinol (15 mg/kg/d for 3 weeks) + IMMA (20 mg/kg/d for 2 weeks) versus allopurinol (15 mg/kg/d for 3 weeks)

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Comparison 28. Allopurinol (15mg/kg/d for 3 weeks)+ IMMA (20 mg/kg/d for 2 weeks) versus IMMA (20 mg/kg/d for 2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1	100	Risk Ratio (M‐H, Random, 95% CI)	1.92 [1.08, 3.41]

Comparison 28. Allopurinol (15mg/kg/d for 3 weeks)+ IMMA (20 mg/kg/d for 2 weeks) versus IMMA (20 mg/kg/d for 2 weeks)

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Comparison 29. Allopurinol (15 mg/kg/d for 3 weeks) versus IMMA (20 mg/kg/d for 2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions Cured Show forest plot	1	100	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.35, 1.62]

Comparison 29. Allopurinol (15 mg/kg/d for 3 weeks) versus IMMA (20 mg/kg/d for 2 weeks)

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Comparison 30. Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Mild abdominal pain	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Skin eruption	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Muscle pain and weakness	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Microbiological cure of skin lesions Show forest plot	1	72	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.88, 1.41]

Comparison 30. Allopurinol (20 mg/kg/d for 3 weeks) + IMMA (30 mg/kg/d for 20 days) versus IMMA (60 mg/kg/d for 20 d)

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Comparison 31. Allopurinol (20 mg/kg/d for 3 weeks)+ IMMA (10 mg/kg/d for 20 d) versus IMMA (20 mg/kg/d for 28 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 Secondary infection	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 Myalgia	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 ECG changes	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.4 Chest pain	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.5 Pain injection site	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.6 Abscess	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 31. Allopurinol (20 mg/kg/d for 3 weeks)+ IMMA (10 mg/kg/d for 20 d) versus IMMA (20 mg/kg/d for 28 d)

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Comparison 32. Allopurinol (20 mg/kg/d for 3 weeks) versus IVSSG (20 mg/kg/d for 15 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Abdominal symptoms	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Liver abnormalities	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Myalgia	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.4 Rash	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 32. Allopurinol (20 mg/kg/d for 3 weeks) versus IVSSG (20 mg/kg/d for 15 d)

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Comparison 33. Oral rifampicin (10 mg/kg/d for 4 to 6 weeks) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 Evaluated 3 months after treatment	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 Evaluated after treatment	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 33. Oral rifampicin (10 mg/kg/d for 4 to 6 weeks) versus placebo

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Comparison 34. Oral rifampicin (10 mg/kg/d) + omeprazole (20 mg/d) for 6 weeks versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 34. Oral rifampicin (10 mg/kg/d) + omeprazole (20 mg/d) for 6 weeks versus placebo

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Comparison 35. Azythromicin (500 mg/d for 5 d/month up to 4 months) versus IMMA (60 mg/kg/d for 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Nausea and vomiting	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 35. Azythromicin (500 mg/d for 5 d/month up to 4 months) versus IMMA (60 mg/kg/d for 20 d)

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Comparison 36. Azythromicin (10 mg/kg/d) + allopurinol (10 mg/kg/d) for 1 month versus IMMA (20 mg/kg/d for 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Gastrointestinal complaints and headache	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Gastrointestinal complications	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Myalgia	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 36. Azythromicin (10 mg/kg/d) + allopurinol (10 mg/kg/d) for 1 month versus IMMA (20 mg/kg/d for 20 d)

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Comparison 37. Oral pentoxifylline (400 mg 3 times daily) + IMMA (20 mg/kg/d) for 20 d versus placebo + IMMA (20 mg/kg/d) for 20 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Allergic macule‐papular	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 37. Oral pentoxifylline (400 mg 3 times daily) + IMMA (20 mg/kg/d) for 20 d versus placebo + IMMA (20 mg/kg/d) for 20 d

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Comparison 38. Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 38. Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks)

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Comparison 39. Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 39. Oral miltefosine (2.5 mg/kg/d for 4 weeks) versus IMMA (60 mg/kg/d for 2 weeks)

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Comparison 40. Oral zinc sulphate 2.5 mg/kg/d for 45 days versus oral zinc sulphate 5 mg/kg/d for 45 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Nausea and vomiting	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 40. Oral zinc sulphate 2.5 mg/kg/d for 45 days versus oral zinc sulphate 5 mg/kg/d for 45 d

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Comparison 41. Oral zinc sulphate 2.5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Nausea and vomiting	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 41. Oral zinc sulphate 2.5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d

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Comparison 42. Oral zinc sulphate 5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Nausea and vomiting	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 42. Oral zinc sulphate 5 mg/kg/d for 45 d versus oral zinc sulphate 10 mg/kg/d for 45 d

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Comparison 43. Oral zinc sulphate (10 mg/kg/d for 45 d) versus IMMA (20 mg/kg/d for 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 43. Oral zinc sulphate (10 mg/kg/d for 45 d) versus IMMA (20 mg/kg/d for 20 d)

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Comparison 44. Artesunate 400 mg + sulphamethoxypyrazine/pyrimethamine 1000 mg/50 mg 4 times daily for 4 d versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 44. Artesunate 400 mg + sulphamethoxypyrazine/pyrimethamine 1000 mg/50 mg 4 times daily for 4 d versus placebo

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Comparison 45. Topical 2% miconazole (twice a day) versus topical 1% clotrimazole (twice a day) for 30 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 45. Topical 2% miconazole (twice a day) versus topical 1% clotrimazole (twice a day) for 30 d

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Comparison 46. Topical ketoconazole (twice a day) versus vehicle (twice a day) for 30 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 46. Topical ketoconazole (twice a day) versus vehicle (twice a day) for 30 d

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Comparison 47. Topical amphotericin B (3 to 7 drops twice daily for 8 weeks) versus ILMA (max 2 mL) once a week for 8 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure (ITT) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Hypersensitivity	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Mild pruritus	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Erithema and oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 47. Topical amphotericin B (3 to 7 drops twice daily for 8 weeks) versus ILMA (max 2 mL) once a week for 8 weeks

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Comparison 48. Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Scarring Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 48. Paromomycin 15% + 12% MBCL (twice daily for 28 d) versus vehicle (twice daily for 28 d)

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Comparison 49. Paromomycin (twice daily for 30 d) versus vehicle (twice daily for 30 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.25, 2.06]

Comparison 49. Paromomycin (twice daily for 30 d) versus vehicle (twice daily for 30 d)

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Comparison 50. Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	2	383	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.86, 1.17]

2 Adverse effects Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 Skin/local reaction	3	463	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.45, 1.93]
3 Microbiological cure of skin lesions Show forest plot	2	383	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.88, 1.20]

Comparison 50. Paromomycin 15% + 10% urea (twice daily for 14 d) versus vehicle (twice daily for 14 d)

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Comparison 51. Paromomycin 15% (daily for 20 d) versus vehicle

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 51. Paromomycin 15% (daily for 20 d) versus vehicle

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Comparison 52. Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus vehicle

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 52. Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus vehicle

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Comparison 53. Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus paromomycin 15% alone (daily for 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 53. Paromomycin 15% + gentamicin 0.5% (daily for 20 d) versus paromomycin 15% alone (daily for 20 d)

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Comparison 54. Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Recurrence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Scarring Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 54. Paromomycin 15% + 10% urea (twice daily for 45 d) versus ILMA (weekly for up to 3 months)

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Comparison 55. Paromomycin 15% + 10% urea (twice daily for 20 d) versus ILMA (weekly for up to 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Cutaneous reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 55. Paromomycin 15% + 10% urea (twice daily for 20 d) versus ILMA (weekly for up to 20 d)

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Comparison 56. Paromomycin + MBCL (twice daily for 15 d) versus ketoconazole (weekly for up to 30 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 56. Paromomycin + MBCL (twice daily for 15 d) versus ketoconazole (weekly for up to 30 d)

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Comparison 57. Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Scarring Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

3 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 57. Paromomycin (15% + 12% MBCL twice daily for 28 days) versus PDT (weekly for 4 weeks)

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Comparison 58. Paromomycin (4 weeks) versus paromomycin (2 weeks) + vehicle (2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 58. Paromomycin (4 weeks) versus paromomycin (2 weeks) + vehicle (2 weeks)

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Comparison 59. IL zinc 2% (twice a week for 2 weeks) versus ILSSG (100 mg/mL) for 2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 59. IL zinc 2% (twice a week for 2 weeks) versus ILSSG (100 mg/mL) for 2 weeks)

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Comparison 60. IL zinc 2% (twice a week for 2 weeks) versus IL 7% HSCS for 2 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 60. IL zinc 2% (twice a week for 2 weeks) versus IL 7% HSCS for 2 weeks

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Comparison 61. ILSSG (100 mg/mL) for 2 weeks versus IL 7% HSCS for 2 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 61. ILSSG (100 mg/mL) for 2 weeks versus IL 7% HSCS for 2 weeks

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Comparison 62. IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Participants complete cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Pain	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 Burning	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 Itching	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.4 Inflammation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.5 Pruritus and erythema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.6 Severe pain	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 62. IL zinc 2% (weekly for up to 6 weeks) versus ILMA (max 2 mL weekly for up to 6 weeks)

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Comparison 63. IL zinc 2% (twice a week for 2 weeks) versus ILMA (60 mg/kg/d for 2 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Inflammation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 63. IL zinc 2% (twice a week for 2 weeks) versus ILMA (60 mg/kg/d for 2 weeks)

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Comparison 64. Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Participants with treated lesions that recur Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Itch and burning	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 64. Imiquimod (5% 3 times/week for 28 d) + IMMA (20 mg/kg/d for 14 d) versus vehicle + IMMA

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Comparison 65. IL 7% HSCS (0.2 mL to 7 mL per lesion) versus ILSSG (max 2 mL) max 5 injections

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 65. IL 7% HSCS (0.2 mL to 7 mL per lesion) versus ILSSG (max 2 mL) max 5 injections

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Comparison 66. IL 5% HSCS (0.5 mL to 1 mL per lesion) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 6 to 10 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Sporotrichotic dissemination	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Allergic reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 66. IL 5% HSCS (0.5 mL to 1 mL per lesion) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 6 to 10 weeks

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Comparison 67. IL 7% HSCS (0.1 mL to 0.5 mL per lesion) versus IL 2% ciprofloxacin solution (0.1 mL to 0.5 mL per lesion)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 67. IL 7% HSCS (0.1 mL to 0.5 mL per lesion) versus IL 2% ciprofloxacin solution (0.1 mL to 0.5 mL per lesion)

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Comparison 68. IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Recurrence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

4 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 Ulceration and necrosis	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 68. IL 15% HSCS (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion)

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Comparison 69. ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Recurrence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

4 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 Ulceration and necrosis	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 69. ILSSG (0.2 mL to 4 mL per lesion) max 5 injections versus IL 10% HSCS (0.2 mL to 4 mL per lesion)

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Comparison 70. ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Recurrence Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

3 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

4 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4.1 Ulceration and necrosis	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 70. ILSSG (0.2 mL to 4 mL per lesion) maximum 5 injections versus IL 15% HSCS (0.2 mL to 4 mL per lesion)

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Comparison 71. IL IFN‐γ (weekly for 5 weeks) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 5 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 71. IL IFN‐γ (weekly for 5 weeks) versus ILMA (0.5 mL to 1 mL per lesion) weekly for 5 weeks

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Comparison 72. WR279,396 (twice a day for 20 d) versus vehicle (twice a day for 20 d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Erythema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Mild pain	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Hearing acuity problems	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 72. WR279,396 (twice a day for 20 d) versus vehicle (twice a day for 20 d)

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Comparison 73. IL metronidazole (2.5 mg to 10 mg each lesion) versus ILMA (150 mg to 600 mg each lesion) for up to 8 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Local inflammatory reactions	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 73. IL metronidazole (2.5 mg to 10 mg each lesion) versus ILMA (150 mg to 600 mg each lesion) for up to 8 weeks

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Comparison 74. Topical miltefosine 6% (once daily) versus ILMA (twice a week) for up to 28 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 74. Topical miltefosine 6% (once daily) versus ILMA (twice a week) for up to 28 d

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Comparison 75. Dapsone gel 5% (twice a day) + ILMA (weekly) versus cryotherapy (every 2 weeks) + IMMA (weekly) for up to 16 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 75. Dapsone gel 5% (twice a day) + ILMA (weekly) versus cryotherapy (every 2 weeks) + IMMA (weekly) for up to 16 weeks

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Comparison 76. DAC‐055 + MWT (for 15 min) versus DAC‐055 alone for up to 75 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Reulceration	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Keloïd scars	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 76. DAC‐055 + MWT (for 15 min) versus DAC‐055 alone for up to 75 d

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Comparison 77. DAC‐055 + heat (for 15 min) versus ILSSG (0.6 mL) for up to 75 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Reulceration	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Keloïd scars	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 77. DAC‐055 + heat (for 15 min) versus ILSSG (0.6 mL) for up to 75 d

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Comparison 78. DAC‐055 alone (for 15 min) versus ILSSG (0.6 mL) for up to 75 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Reulceration	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Keloïd scars	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 78. DAC‐055 alone (for 15 min) versus ILSSG (0.6 mL) for up to 75 d

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Comparison 79. Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Recurrence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Dizziness and nausea	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 Hypersensitive reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 79. Thio‐Ben (1 mL to 2 mL daily) + cryotherapy (fortnightly) versus ILMA (0.5 mL to 2 mL per lesions) weekly + cryotherapy (fortnightly) for up to 12 weeks

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Comparison 80. CO₂ laser (30 W continuous) versus IMMA (50 mg/kg/d) for up to 15 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1	433	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.53, 1.55]

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Hyperpigmentation and redness	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Hypertrophic scarring	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Systemic symptoms	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 80. CO₂ laser (30 W continuous) versus IMMA (50 mg/kg/d) for up to 15 d

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Comparison 81. CO₂ laser (30 W continuous) versus cryotherapy (fortnightly) + ILMA (weekly) for up to 12 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Hyperpigmentation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 Atrophic scar	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 Hypopigmentation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 81. CO₂ laser (30 W continuous) versus cryotherapy (fortnightly) + ILMA (weekly) for up to 12 weeks

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Comparison 82. Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Partcipants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Erythema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 82. Ablative CO₂ laser (25 kW for 1 session) versus 3 weeks fractional CO₂ laser

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Comparison 83. TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Recurrence Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Mild erythema and itch	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 Microbiological cure of skin lesions Show forest plot	1	80	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.74, 1.26]

Comparison 83. TCA (50% wt/vol) fortnightly up to 3 times versus ILMA alone (weekly for up to 6 weeks)

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Comparison 84. Topical TCA 50% + local heat versus ILMA twice a week for up to 8 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

2.1 Males	1		Risk Ratio (M‐H, Random, 99% CI)	0.0 [0.0, 0.0]
2.2 Females	1		Risk Ratio (M‐H, Random, 99% CI)	0.0 [0.0, 0.0]

Comparison 84. Topical TCA 50% + local heat versus ILMA twice a week for up to 8 weeks

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Comparison 85. TCA + ILMA (weekly for up to 8 weeks) versus ILMA alone (twice a week for up to 8 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 85. TCA + ILMA (weekly for up to 8 weeks) versus ILMA alone (twice a week for up to 8 weeks)

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Comparison 86. Fractional laser + ILMA (fortnightly 2 sessions) versus ILMA alone (twice a week for up to 8 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 86. Fractional laser + ILMA (fortnightly 2 sessions) versus ILMA alone (twice a week for up to 8 weeks)

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Comparison 87. TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 87. TCA + ILMA (weekly for up to 8 weeks) versus fractional laser + ILMA (fortnightly 2 sessions)

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Comparison 88. TCA fortnightly up to 8 weeks + ILMA (twice a week) versus ILMA alone (weekly for up to 8 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 88. TCA fortnightly up to 8 weeks + ILMA (twice a week) versus ILMA alone (weekly for up to 8 weeks)

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Comparison 89. Cryotherapy + ILMA (weekly) versus cryotherapy (weekly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Erythema and oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 89. Cryotherapy + ILMA (weekly) versus cryotherapy (weekly) for up to 6 weeks

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Comparison 90. Cryotherapy + ILMA (weekly) versus ILMA (weekly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Erythema and oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 90. Cryotherapy + ILMA (weekly) versus ILMA (weekly) for up to 6 weeks

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Comparison 91. Cryotherapy + ILMA (weekly) versus ILMA alone (weekly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Erythema and oedema	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 91. Cryotherapy + ILMA (weekly) versus ILMA alone (weekly) for up to 6 weeks

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Comparison 92. Cryotherapy (weekly) versus ILMA (weekly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 92. Cryotherapy (weekly) versus ILMA (weekly) for up to 6 weeks

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Comparison 93. Cryotherapy + ILMA (weekly) versus cryotherapy alone (weekly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Hypopigmentation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 93. Cryotherapy + ILMA (weekly) versus cryotherapy alone (weekly) for up to 6 weeks

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Comparison 94. Cryotherapy + ILMA (weekly) versus ILMA (fortnightly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Hypopigmentation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 94. Cryotherapy + ILMA (weekly) versus ILMA (fortnightly) for up to 6 weeks

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Comparison 95. Cryotherapy alone (weekly) versus ILMA (fortnightly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1	390	Risk Ratio (M‐H, Random, 95% CI)	14.64 [0.86, 247.99]

2.1 Hypopigmentation	1	390	Risk Ratio (M‐H, Random, 95% CI)	14.64 [0.86, 247.99]

Comparison 95. Cryotherapy alone (weekly) versus ILMA (fortnightly) for up to 6 weeks

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Comparison 96. Cryotherapy (fortnightly) + 15% paromomycin + 10% urea cream (twice a day) + ILMA (twice a day for 4 weeks) versus ILMA (twice a week) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 96. Cryotherapy (fortnightly) + 15% paromomycin + 10% urea cream (twice a day) + ILMA (twice a day for 4 weeks) versus ILMA (twice a week) for up to 6 weeks

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Comparison 97. Cryotherapy (weekly) + 3% salicylic + 3% sodium nitrite cream (twice a day) for up to 12 weeks versus cryotherapy (weekly) + 3% salicylic cream (twice a day)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Mild skin symptoms	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 97. Cryotherapy (weekly) + 3% salicylic + 3% sodium nitrite cream (twice a day) for up to 12 weeks versus cryotherapy (weekly) + 3% salicylic cream (twice a day)

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Comparison 98. Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Participants complete cure Show forest plot	2	499	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.97, 1.55]

3 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Allergic reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 98. Radiofrequency waves versus ILMA (1 mL to 7 mL per lesion) weekly for 4 weeks

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Comparison 99. Radiofrequency waves (50 uCTM applied for 30 s) versus ILSSG (10 days of 20 mg/kg/d)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects (serious) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 99. Radiofrequency waves (50 uCTM applied for 30 s) versus ILSSG (10 days of 20 mg/kg/d)

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Comparison 100. Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus IMSSG (20 mg/kg/d for 3 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse event (secondary infection) Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

Comparison 100. Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus IMSSG (20 mg/kg/d for 3 weeks)

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Comparison 101. Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 days)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse event (secondary infection) Show forest plot	1		Risk Ratio (M‐H, Random, 99% CI)	Totals not selected

Comparison 101. Radiofrequency waves (1 treatment of > 1 consecutive application at 50ºC for 30 s) versus ILSSG (5 injections of 2 mL to 5 mL every 5 to 7 days)

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Comparison 102. Radiofrequency waves versus ILSSG

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 102. Radiofrequency waves versus ILSSG

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Comparison 103. Electrocauterisation + DAC n‐055 (daily) versus electrocauterisation

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

1.1 Superinfection	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 Keloid formation	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 103. Electrocauterisation + DAC n‐055 (daily) versus electrocauterisation

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Comparison 104. PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Lesions cured Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Scarring Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 104. PDT (weekly for 4 weeks) versus placebo (twice a day for 4 weeks)

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Comparison 105. Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Allergic reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Development of cell‐mediated immunity Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 105. Mesotherapy gun (0.5 mL of MA weekly) versus ILMA (0.1 mL weekly) for up to 6 weeks

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Comparison 106. Diminazene aceturate solution (weekly) versus cetrimide + chlorhexidine solution for 50 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 106. Diminazene aceturate solution (weekly) versus cetrimide + chlorhexidine solution for 50 d

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Comparison 107. Topical garlic (twice a day) versus vehicle for 3 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 107. Topical garlic (twice a day) versus vehicle for 3 weeks

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Comparison 108. Topical herbal extract + placebo (5 d) versus IMMA (15‐20/mg/kg/d) + vehicle for 20 d

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 108. Topical herbal extract + placebo (5 d) versus IMMA (15‐20/mg/kg/d) + vehicle for 20 d

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Comparison 109. Topical honey (twice a day) + ILMA (weekly) versus ILMA (weekly) for 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 109. Topical honey (twice a day) + ILMA (weekly) versus ILMA (weekly) for 4 weeks

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Comparison 110. Cassia fistula (topical gel) + ILMA (0.5 mL to 2 mL), twice a week versus ILMA (0.5 mL to 2 mL), twice a week + vehicle

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Itching	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 110. Cassia fistula (topical gel) + ILMA (0.5 mL to 2 mL), twice a week versus ILMA (0.5 mL to 2 mL), twice a week + vehicle

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Comparison 111. Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Allergic reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 111. Cassia fistula boiled (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks

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Comparison 112. Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Speed of healing (weeks) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Adverse reaction Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Allergic reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 112. Cassia fistula hydroalcoholic (topical) versus ILMA (0.5 mL to 2 mL), twice a week for 4 weeks

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Comparison 113. Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Speed of healing (days) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

3.1 Allergic reaction	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]

Comparison 113. Cassia fistula boiled (topical) versusC fistula hydroalcoholic (topical) for 4 weeks

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Comparison 114. Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participants complete cure Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Adverse effects Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2.1 Itching	1		Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3 Microbiological cure of skin lesions Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 114. Topical gel Achilles millefollium (twice daily) + ILMA (weekly 20 mg/kg/d) versus ILMA (weekly 20 mg/kg/d) + vehicle (twice daily) for 4 weeks

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