Review Article

Pentavalent Antimonials Combined with Other Therapeutic Alternatives for the Treatment of Cutaneous and Mucocutaneous Leishmaniasis: A Systematic Review

Table 1

Baseline characteristics of clinical trials included in the analysis of combinations for the treatment of tegumentary leishmaniasis.

Study sourceArea, CountryStudy designPeriod of studyAge range, mean (years)GenderClinical formPatients enrolledLeishmaniasis diagnosisStatistics

Almeida et al., 2005Bahia, BrazilOpen-label
clinical trial
NR14-25, 18Male 60%
Female 40%
Cutaneous5Clinical and Laboratory (skin test, and isolation in culture)No

Arevalo et al., 2007Lima, PeruComparative study;
Randomized Controlled Trial
8/2005–10/200518-87, 34.9Male 55%
Female 45%
Cutaneous20Clinical and Laboratory (microscopy, culture, and/or PCR, and Montenegro skin test)Yes

Brito et al., 2017Bahia, BrazilRandomized -controlled trial12/2010–10/201318-62Predominance
of male
Cutaneous162Clinical and laboratorial (Leishmania skin test, and/or histopathology, culture and PCR)Yes

El-Sayed & Anwar, 2010Sanaa, YemenComparative study;
Randomized Controlled Trial
6/2006–6/200712-50, 23.5Male 53.3%
Female 46.7%
Cutaneous30Clinical and Laboratory (smear for amastigote and tissue culture)Yes

Farajzafeh et al., 2015IranRandomized clinical trial2011-20122-60, 18.52Male 34
Female 36
NR 10
Cutaneous80Laboratory (smear microscopy)Yes

Firooz et al., 2006Razavi, IranMulticenter Study;
Randomized Controlled Trial
8/2004-/200512-60, 27.0Male 44.5%
Female 55.5%
Cutaneous119Laboratory (smear or culture)Yes

Khatami et al., 2013Kashan, Iran Randomized Controlled Clinical Trial9/200–4/201012-60, 28.8Male 47%
Female 53%
Cutaneous83Laboratory (smear or culture)Yes

Llanos Cuentas et al., 2010Cusco, PeruRandomized Controlled Trial8/2004 – 6/200518-59Male 96%
Female 4%
Mucosal48Laboratory (microscopy, PCR or in vitro culture)Yes

Machado et al., 2007Bahia, BrazilRandomized Controlled TrialNR18-65Male 83%
Female 17%
Mucosal23Laboratory (Intradermal skin test, parasite isolation by culture, and/or histopathological)Yes

Meymandi et al., 2011Kerman, IranComparative Study;
Randomized Controlled Trial
11/2007-8/20097-60Male 46.6%
Female 53.4%
Cutaneous191Laboratory (smear or skin biopsy)Yes

Miranda-Verastegui et al., 2005Lima, Peru Randomized Controlled Trial2/2001 – 8/20021-78Male 57.5%
Female 42.5%
Cutaneous40Laboratory (aspiration, smear, biopsy, culture, and/or PCR)Yes

Miranda-Verastegui et al., 2009Lima and Cusco, PeruComparative Study;
Randomized Controlled Trial
12/2005-6/20064-52Male 77.5%
Female 22.5%
Cutaneous80Laboratory (smear microscopy, culture or PCR)Yes

Nascimento et al., 2010Minas Gerais, BrazilRandomized Controlled Trial10/2004–10/200618-59, 26.4Male 63.6%
Female 36.4%
Cutaneous44Laboratory (microscopy identification in biopsied tissue)Yes

Nilforoushzadeh et al., 2007Isfahan, Iran Randomized Controlled TrialNR7-70Male 67.7%
Female 32.3%
Cutaneous90Laboratory (smear microscopy)Yes

Nilforoushzadeh et al., 2008Tehran, IranComparative Study; Randomized Controlled TrialNR7-70Male 71.0%
Female 29.0%
Cutaneous124Laboratory (smear microscopy)Yes

Van Thiel et al., 2010Northern Afghanistan,Clinical Trial6/2005-11/2005NRDutch
Troops
Cutaneous163Laboratory (smear microscopy, culture, and PCR)Yes

NR, not reported; PCR, polymerase chain reaction.