Table 2.
Clinic, therapeutic, and epidemiological characteristics of clinical trials included in the study.
| Study source | Leishmania species | Treatment | Patients at the end | Previous treatment | Clinically healed | Therapy failed | Relapse or Recurrence |
|---|---|---|---|---|---|---|---|
| Almeida et al., 2005 | L. braziliensis | G1 (MA + GM-CSF) | 5 | Yes | 100% (before 120 days AS) Follow-up: 12 months AH |
0% (12 months AH) | 0% (12 months AH) |
|
| |||||||
| Arevalo et al., 2007 | Leishmania spp. | G1 (IM) | 6 | No | 0% Follow-up: 3 months AS |
67% (20 days AS) | 33% (3 months AS) |
| G2 (MA) | 7 | No | 57% (3 months AS) Follow-up: 3 months AS |
43% (3 months AS) | 0% (3 months AS) | ||
| G3 (MA + IM) | 7 | No | 100% (3 months AS) Follow-up: 3 months AS |
0% (3 months AS) | 0% (3 months AS) | ||
|
| |||||||
| Brito et al., 2017 |
L. braziliensis (62% of cases) |
G1 (MA + PE) | 82 | NR | 45% (6 months AE) | 55% (6 months AE) | NR |
| G2 (MA + placebo) | 82 | 43% (6 months AE) | 57% (6 months AE) | NR | |||
|
| |||||||
| El-Sayed & Anwar, 2010 | NR | G1 (il SSG) | 10 (12 lesions) | No | 50%/58.3% (12 weeks AS; patients/lesions) Follow-up: 6 months AE |
50%/41.7% (12 weeks AS; patients/lesions) | NR |
| G2 (il SSG + im SSG) | 10 (15 lesions) | No | 90%/93.3% (12 weeks AS; patients/lesions) Follow-up: 6 months AE |
10%/6.7% (12 weeks AS; patients/lesions) | NR | ||
| G3 (il SSG + KE) | 10 (13 lesions) | No | 90%/92.3% (12 weeks AS; patients/lesions) Follow-up: 6 months AE |
10%/7.7% (12 weeks AS; patients/lesions) | NR | ||
|
| |||||||
| Farajzadeh et al., 2015 | NR | G1 (Terbinafine + cryotherapy) | 40 | No (within the past 90 days) | 37.5% complete (28 days AS) 10 partial cure# |
15 (28 days AS) | NR |
| G2 (MA + cryotherapy) | 40 | No | 52.5% (21 days AS) 7 partial cure# |
12 (21 days AS) | NR | ||
|
| |||||||
| Firooz et al., 2006 ∗∗ | L. tropica | G1 (MA + IM) | 42 | No | 18.6% (4 weeks AS) 44.1% (8 weeks AS) 50.8% (20 weeks AS) Follow-up: 16 weeks AE |
49.2% (20 weeks AS) | 3.1% (16 weeks AS) |
| G2 (MA + placebo) | 47 | No | 30.0% (4 weeks AS) 48.3% (8 weeks AS) 53.3% (20 weeks AS) Follow-up: 16 weeks AE |
46.7% (20 weeks AS) | 8.1% (16 weeks AS) | ||
|
| |||||||
| Khatami et al., 2013 | L. major | G1 (il MA) | 23 (40 lesions) | No | 12.5% (6 weeks AS) lesions 40.0% (10 weeks AS) lesions Follow-up: 5 months AE |
65.0% (6 weeks AS) 42.5% (10 weeks AS) |
0% (5 months AE) |
| G2 (il MA + non-silver PD) | 21 (46 lesions) | No | 6.5% (6 weeks AS) lesions 42.2% (10 weeks AS) lesions Follow-up: 5 months AE |
80.4% (6 weeks AS) 55.6% (10 weeks AS) |
0% (5 months AE) | ||
| G3 (il MA + silver PD) | 29 (55 lesions) | No | 12.7 (6 weeks AS) lesions 36.4 (10 weeks AS) lesions Follow-up: 5 months AE |
74.6% (6 weeks AS) 49.1% (10 weeks AS) |
3.4% (5 months AE) | ||
|
| |||||||
| Llanos Cuentas et al., 2010 | L. braziliensis | G1 (SSG + placebo) | 12 | No (within the past 30 days); 22.0% had received previously |
50% (84 days AS) 100% (336 days AS) Follow-up: 336 days AS |
25% (168 days AS) 0% (336 days AS) |
8% (336 days AS) |
| G2 (SSG + (LEISH-F1 + MPL-SE)) | LEISH-F1 5µg = 11 | 59% (84 days AS) 94% (336 days AS) Follow-up: 336 days AS |
13% (168 days AS) 6% (336 days AS) |
0% (336 days AS) | |||
| LEISH-F1 10 µg = 12 | |||||||
| LEISH-F1 20 µg = 11 | |||||||
|
| |||||||
| Machado et al., 2007 | L. braziliensis | G1 (MA + placebo) | 12 | No∗ | 41.6% (90 days AS) Follow-up: 150 days AS |
42% (150 days AS) | 0% (2 years AE |
| G2 (MA + PE) | 11 | No∗ | 82% (90 days AS) Follow-up: 150 days AS |
0% (150 days AS) | 0% (2 years AE) | ||
|
| |||||||
| Meymandi et al., 2011 | L. tropica | G1 (C02 laser) | 80 | No | 56.8% (2 weeks AS) 67.6% (6 weeks AS) 44.4% (12 weeks AS) 93.7% (89/95 lesions) Follow-up: 16 weeks AS |
NR | NR |
| G2 (il MA + cryotherapy) | 80 | No | 15.8% (2 week AS) 57.5% (6 week AS) 38.2% (12 week AS) 78% (74/95) lesions) Follow-up: 16 weeks AS |
NR | NR | ||
|
| |||||||
| Miranda-Verastegui et al., 2005 |
L. peruviana L. braziliensis |
G1 (MA + IM) | 18 (35 lesions) | Yes | 6% (20 days AE) 50% (1 month AE) 61% (2 months AE) 72% (3 months AE) 72% (6 months AE) 72% (12 months AE) Follow-up: 12 months AE |
27.8% (12 months AE) | NR |
| G2 (MA + Vehicle) | 20 (40 lesions) | Yes | 5% (20 days AE) 15% (1 month AE) 25% (2 months AE) 35% (3 months AE) 50% (6 months AE) 75% (12 months AE) Follow-up: 12 months AE |
25% (12 months AE) | NR | ||
|
| |||||||
| Miranda-Verastegui et al., 2009 |
L. peruviana L. guyanensis L. braziliensis |
G1 (SSG + vehicle cream) | 36 | No | 17.5% (20 days AS) 33% (1 month AS) 30% (2 months AS) 60% (3 months AS) 63% (6 months AS) 58% (9 months AS) 53% (12 months AS) Follow-up: 12 months AS |
41.7% (12 months AS) | NR |
| G2 (SSG + IM) | 39 | No | 5% (20 days AS) 43% (1 month AS) 60% (2 months AS) 78% (3 months AS) 75% (6 months AS) 75% (9 months AS) 75% (12 months AS) Follow-up: 12 months AS |
23.1% (12 months AS) | NR | ||
|
| |||||||
| Nascimento et al., 2010 | Leishmania spp. | G1 (MA + (LEISH-F1 + MPL-SE)) | LEISH-F1 5µg = 9 | No | 80% (84 days AS) Follow-up: 336 days AS |
24% (84 days AS) | 4% (84 days AS) |
| LEISH-F1 10µg = 8 | |||||||
| LEISH-F1 20µg = 8 | |||||||
| G2 (MA +MPL-SE) | 8 | No | 50% (84 days AS) Follow-up: 336 days AS |
50% (84 days AS) | NR | ||
| G3 (MA +Saline) | 8 | No | 38% (84 days AS) Follow-up: 336 days AS |
62% (84 days AS) | 38% (84 days AS) | ||
|
| |||||||
| Nilforoushzadeh et al., 2007 | Leishmania spp. | G1 (il MA + topical honey) | 33 | No | 51.1% (6 weeks AS) Follow-up: 4 months AS |
48.9% (6 weeks AS) | NR |
| G2 (il MA) | 35 | No | 71.1% (6 weeks AS) Follow-up: 4 months AS |
28.9% (6 weeks AS) | NR | ||
|
| |||||||
| Nilforoushzadeh et al., 2008 |
L. tropica L. major |
G1 (MA 60 mg/kg/day + placebo) | 43 | No | 93% (12 weeks AS) Follow-up: 12 weeks AS |
7% (12 weeks AS) | NR |
| G2 (MA 30 mg/kg/day + OM) | 36 | No | 89% (12 weeks AS) Follow-up: 12 weeks AS |
11% (12 weeks AS) | NR | ||
| G3 (MA 30 mg/kg/day + placebo) | 45 | No | 80% (12 weeks AS) Follow-up: 12 weeks AS |
20% (12 weeks AS) | NR | ||
|
| |||||||
| Van Thiel et al., 2010 | L. major | G1 (il SSG) | 118 | No | 55.1% (6 months AE) Follow-up: 6 months AE |
20.3% (6 months AE) | 15.3% (6 months AE) |
| G2 (il SSG + cryotherapy) | 45 | No | 66.7% (6 months AE) Follow-up: 6 months AE |
13.3% (6 months AE) | 11.1% (6 months AE) | ||
NR, not reported; G1, Group 1; G2, Group 2; G3, Group 3.
MA, meglumine antimoniate; PE, pentoxifylline; GM-CSF, granulocyte macrophage colony-stimulating factor; IM, imiquimod; il SSG, intralesional sodium stibogluconate; im SSG, intramuscular sodium stibogluconate; KE, ketoconazole; il MA (intralesional meglumine antimoniate); non-silver PD, non-silver containing polyester dressing; silver PD, silver containing polyester dressing; SSG, sodium stibogluconate; LEISH-F1, lyophilized LEISH-F1 protein; MPL-SE, adjuvant; OM, omeprazole.
AS: after the start of treatment, AE: after the end of treatment, and AH: after the healing of the lesion.
∗No previous treatment of mucosal leishmaniasis. Some patients had previous cutaneous leishmaniasis, but there are no references to previous treatment or not.
∗∗Clinical cure rate, therapy failure, and relapse or recurrence given by Firooz et al., 2006, based on the initial number of patients allocated in each group.
#Partial cure Farajzadeh: decrease in induration size between 25 and 75%.