Nutritional supplements for patients being treated for active visceral leishmaniasis.

BACKGROUND: Visceral leishmaniasis (VL) is a disease caused by a parasite, which can lead to death if untreated. Poor nutritional status hastens the progression of VL infection, and VL worsens malnutrition status. Malnutrition is one of the poor prognostic factors identified for leishmaniasis. However, the effects of nutritional supplementation in people treated for VL are not known. OBJECTIVES: To assess the effects of oral nutritional supplements in people being treated with anti-leishmanial drug therapy for VL. SEARCH METHODS: We searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register, CENTRAL, MEDLINE, Embase, LILACS, and two trial registers up to 12 September 2017. We checked conference proceedings and WHO consultative meeting reports, the reference lists of key documents and existing reviews, and contacted experts and nutritional supplement companies. SELECTION CRITERIA: Randomized controlled trials (RCTs), quasi-randomized controlled trials (quasi-RCTs), and non-randomized controlled trials (NRCTs) of any oral nutritional supplement, compared to no nutritional intervention, placebo, or dietary advice alone, in people being treated for VL. DATA COLLECTION AND ANALYSIS: Two review authors independently screened the literature search results for studies that met the inclusion criteria. We had planned for two review authors to independently extract data and assess the risk of bias of the included studies. We planned to follow the Cochrane standard methodological procedures for assessing risk of bias and analysing the data. MAIN RESULTS: We identified no eligible studies for this review, either completed or ongoing. AUTHORS' CONCLUSIONS: We found no studies, either completed or ongoing, that assessed the effects of oral nutritional supplements in people with VL who were being treated with anti-leishmanial drug therapy. Thus, we could not draw any conclusions on the impact of these interventions on primary cure of VL, definitive cure of VL, treatment completion, self-reported recovery from illness or resolution of symptoms, weight gain, increased skinfold thickness, other measures of lean or total mass, or growth in children.This absence of evidence should not be interpreted as evidence of no effect for nutritional supplements in people under VL treatment. It means that we did not identify research that fulfilled our review inclusion criteria.The effects of oral nutritional supplements in people with VL who are being treated with anti-leishmanial drug therapy have yet to be determined by rigorous experimental studies, such as cluster-randomized trials, that focus on outcomes relevant for patients.

Interventions for American cutaneous and mucocutaneous leishmaniasis.

BACKGROUND: Pentavalent antimonial drugs are the most prescribed treatment for American cutaneous and mucocutaneous leishmaniasis. Other drugs have been used with varying success. OBJECTIVES: To assess the effects of therapeutic interventions for American cutaneous and mucocutaneous leishmaniasis. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (January 2009), the Register of Controlled Clinical Trials in The Cochrane Library (Issue 1,2009), MEDLINE (2003 to January 2009), EMBASE (2005 to January 2009), LILACS (from inception to January 2009), CINAHL (1982-May 2007) and other databases. SELECTION CRITERIA: Randomised controlled trials (RCTs) assessing treatments for American cutaneous and mucocutaneous leishmaniasis. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. MAIN RESULTS: We included 38 trials involving 2728 participants. Results are based on individual studies or limited pooled analyses. There was good evidence in:Leishmania braziliensis and L. panamensis infections:Intramuscular (IM) meglumine antimoniate (MA) was better than oral allopurinol for 28 days (1RCT n=127, RR 0.39; 95% CI 0.26, 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 (1RCT n= 150, RR 0.24; 95% CI 0.11, 0.50; RR 0.69; 95% CI 0.53, 0.90; RR 0.64; 95% CI 0.44, 0.92 respectively). Oral allopurinol plus antimonials was better than IV antimonials (2RCT n= 168, RR 1.90; 95% CI 1.40, 2.59; I(2)=0%).L. braziliensis infections:Oral pentoxifylline plus IV sodium stibogluconate (SSG) was better than IVSSG (1RCT n= 23, RR 1.66; 95% CI 1.03, 2.69); IVMA was better than IM aminosidine sulphate (1RCT n= 38, RR 0.05; 95% CI 0.00, 0.78) and better than IV pentamidine isethionate (1RCT n= 80, RR 0.45; 95% CI 0.29, 0.71). Intramuscular MA was better than Bacillus Calmette-Guérin (1RCT n= 93, RR 0.46; 95% CI 0.32, 0.65).L .panamensis infections:Oral allopurinol was better than IVMA (1RCT n= 58, RR 2.20; 95% CI 1.34, 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 (1RCT n= 60, RR 0.23; 95% CI 0.07, 0.73; RR 0.23; 95% CI 0.07, 0.73 respectively). Oral ketoconazole for 28 days, oral miltefosine and topical PR-MBCL were better than placebo. AUTHORS' CONCLUSIONS: Most trials have been designed and reported so poorly that they are inconclusive. There is a need for large well conducted studies that evaluate long-term effects of current therapies to improve quality and standardization of methods.

Interventions for Old World cutaneous leishmaniasis.

BACKGROUND: Cutaneous leishmaniasis is caused by a parasitic infection and is considered one of the most serious skin diseases in many developing countries. Antimonials are the most commonly prescribed treatment but other drugs have been used with varying success. OBJECTIVES: To assess the effects of treatments for Old World cutaneous leishmaniasis (OWCL). SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (April 2008), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 2, 2008), MEDLINE (2003-April 2008), EMBASE (2005-April 2008), CINAHL (1982-August 2007), LILACS (from inception to April 2008) and ongoing trials databases (August 2007). SELECTION CRITERIA: Randomised controlled trials assessing treatments in immuno-competent people with OWCL confirmed by smear, histology, culture or polymerase chain reaction. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. MAIN RESULTS: We included 49 trials involving 5559 participants. Reporting quality was generally poor and only two studies contained sufficiently similar data to pool.In Leishmania major infections, there was good RCT evidence of benefit of cure around 3 months after treatment when compared to placebo for 200 mg oral fluconazole (1 RCT n = 200, RR 2.78; 95% CI 1.86, 4.16), topical 15% paromomycin + 12% methylbenzethonium chloride (PR-MBCL) (1 RCT n = 60, RR 3.09; 95% CI 1.14, 8.37) and photodynamic therapy (1 RCT n = 60, RR 7.02; 95% CI 3.80, 17.55). Topical PR-MBCL was less efficacious than photodynamic therapy (1 RCT n = 65, RR 0.44; 95% CI 0.29, 0.66). Oral pentoxifylline was a good adjuvant therapy to intramuscular meglumine antimoniate (IMMA) when compared to IMMA plus placebo (1 RCT n = 64, RR 1.63; 95% CI 1.11, 2.39)In Leishmania tropica infections, there was good evidence of benefit for the use of 200 mg oral itraconazole for 6 weeks compared with placebo (1 RCT n = 20, RR 7.00; 95% CI 1.04, 46.95), for intralesional sodium stibogluconate (1 RCT n = 292, RR 2.62; 95% CI 1.78, 3.86), and for thermotherapy compared with intramuscular sodium stibogluconate (1 RCT n = 283, RR 2.99; 95% CI 2.04, 4.37). AUTHORS' CONCLUSIONS: Most trials have been designed and reported poorly, resulting in a lack of evidence for potentially beneficial treatments. There is a desperate need for large well conducted studies that evaluate long-term effects of current therapies. We suggest the creation of an international platform to improve quality and standardization of future trials in order to inform clinical practice.