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Evidence summaries

Interventions for American Cutaneous and Mucocutaneous Leishmaniasis

Antimonials (sodium stibogluconate and meglumine antimoniate) might possibly be a good treatment option for leishmaniasis despite their toxicity and prohibitive cost especially in developing countries, but the evidence is insufficient. Level of evidence: "D"

A Cochrane review [Abstract] 1 included 38 studies with a total of 2 728 subjects. The efficacy of at least 16 different interventions for the treatment of American cutaneus and mucocutaneus leishmaniasis was assessed. There was evidence in:

Leishmania braziliensis and L. panamensis infections: Intramuscular (IM) meglumine antimoniate (MA) was better than oral allopurinol for 28 days (1 RCT n=127, RR 0.39; 95% CI 0.26 to 0.58). Intravenous (IV)MA for 20-days was better than 3-day and 7-day IVMA plus 15% paromomycin plus 12% methylbenzethonium chloride (PR-MBCL) or 7-day IVMA (1 RCT n= 150, RR 0.24; 95% CI 0.11 to 0.50; RR 0.69; 95% CI 0.53 to 0.90; RR 0.64; 95% CI 0.44 to 0.92 respectively). Oral allopurinol plus antimonials was better than IV antimonials (2 RCT:s n= 168, RR 1.90; 95% CI 1.40 to 2.59).

L. braziliensis infections: Oral pentoxifylline plus IV sodium stibogluconate (SSG) was better than IVSSG (1 RCT n= 23, RR 1.66; 95% CI 1.03 to 2.69); IVMA was better than IM aminosidine sulphate (1 RCT n= 38, RR 0.05; 95% CI 0.00 to 0.78) and better than IV pentamidine isethionate (1 RCT n= 80, RR 0.45; 95% CI 0.29 to 0.71). Intramuscular MA was better than Bacillus Calmette-Guérin (1 RCT n= 93, RR 0.46; 95% CI 0.32 to 0.65).

L. panamensis infections: Oral allopurinol was better than IVMA (1RCT n= 58, RR 2.20; 95% CI 1.34 to 3.60). Aminosidine sulphate at doses of 12 mg/kg/day and 18 mg/kg/day for 14 days were better than aminosidine sulphate 12 mg/kg/day for 7 days (1 RCT n= 60, RR 0.23; 95% CI 0.07 to 0.73; RR 0.23; 95% CI 0.07 to 0.73 respectively). Oral ketoconazole for 28 days, oral miltefosine and topical PR-MBCL were better than placebo.

There was complete absence of RCT evidence on alternative treatments, surgery, oral itraconazole and fluconazole, oral antibiotics like rifampicin, metronidazole and cotrimoxazole, intravenous or topical amphotericin B, oral dapsone, photodynamic therapy, promoting healing therapies, laser, and cryotherapy treatments. Moreover, none of the studies reported quality of life, "microbiological or histopathological cure of skin lesions", changes in ability to detect the parasite by diagnostic methods (e.g. smear or culture) or mortality.

Comment: The quality of evidence is downgraded by study quality (lack of blinding, unclear sequence generation and allocation concealment, losses to follow-up), by inconsistency (heterogeneity in interventions and outcomes) and by poor quality of reporting.

    References

    • González U, Pinart M, Rengifo-Pardo M, Macaya A, Alvar J, Tweed JA. Interventions for American cutaneous and mucocutaneous leishmaniasis. Cochrane Database Syst Rev 2009 Apr 15;(2):CD004834. [PubMed]

Primary/Secondary Keywords