Nutritional supplements for patients being treated for active visceral leishmaniasis
- PMID: 29578237
- PMCID: PMC6494195
- DOI: 10.1002/14651858.CD012261.pub2
Nutritional supplements for patients being treated for active visceral leishmaniasis
Abstract
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.
Conflict of interest statement
Agustin Benito has no known conflicts of interest. Carmen Bouza has no known conflicts of interest. Carolina Jimenez has no known conflicts of interest. Estefanía Custodio has no known conflicts of interest. Jesus Lopez Alcalde has no known conflicts of interest. Jorge Alvar has no known conflicts of interest. Merce Herrero has no known conflicts of interest. Stefan Storcksdieck genannt Bonsmann has no known conflicts of interest. Teresa López‐Cuadrado has no known conflicts of interest. Theodora Mouratidou has no known conflicts of interest.
Update of
References
References to studies excluded from this review
Aruoma 2006 {published data only}
-
- Aruoma OI, Grootveld M, Bahorun T. Free radicals in biology and medicine: from inflammation to biotechnology. BioFactors 2006;27(1‐4):1‐3. - PubMed
Croft 1985 {published data only}
-
- Croft SL, Evans AT, Neal RA. The activity of plumbagin and other electron carriers against Leishmania donovani and Leishmania mexicana amazonensis. Annals of Tropical Medicine and Parasitology 1985;79(6):651‐3. - PubMed
Diro 2015 {published data only}
-
- Diro E, Lynen L, Gebregziabiher B, Assefa A, Lakew W, Belew Z, et al. Clinical aspects of paediatric visceral leishmaniasis in North‐west Ethiopia. Tropical Medicine and International Health 2015;20(1):8‐16. - PubMed
Duke 2011 {published data only}
-
- Duke T. Randomised trials in child health in developing countries 2011. Annals of Tropical Paediatrics 2011;31(4):283‐5. - PubMed
Maciel 2014 {published data only}
NCT01069198 {published data only}
-
- NCT01069198. A community trial for visceral leishmaniasis (VL) [A randomized, double blind, community trial to assess the efficacy of a combination of anti‐helminth, and vitamin A, zinc and iron supplementation in preventing visceral Leishmaniasis (VL) disease among asymptomatic individuals with VL]. clinicaltrials.gov/ct2/show/record/NCT01069198 (first submitted 14 February 2010).
Thakur 2010 {published data only}
Additional references
Actor 1958
-
- Actor P. Protein and vitamin intake and visceral leishmaniasis in the hamster [Masters thesis]. New Bruswick (US): Rutgers University, 1958.
Actor 1960
-
- Actor P. Protein and vitamin intake and visceral leishmaniasis in the mouse. Experimental Parasitology 1960;10:1‐20. - PubMed
Alvar 2006
-
- Alvar J, Yactayo S, Bern C. Leishmaniasis and poverty. Trends in Parasitology 2006;22(12):552‐7. - PubMed
Alvar 2008
Alvar 2012
Anstead 2001
Badaró 1986
-
- Badaró R, Jones TC, Lorenço R, Cerf BJ, Sampaio P, Carvalho EM, et al. A prospective study of visceral leishmaniasis in an endemic area of Brazil. Journal of Infectious Diseases 1986;154(4):639‐49. - PubMed
Boelaert 2014
Brown 2006
Burford 2013
-
- Burford B, Lewin S, Welch V, Rehfuess E, Waters E. Assessing the applicability of findings in systematic reviews of complex interventions can enhance the utility of reviews for decision making. Journal of Clinical Epidemiology 2013;66(11):1251‐61. - PubMed
Bush 2017
-
- Bush JT, Wasunna M, Alves F, Alvar J, Olliaro PL, Otieno M, et al. Systematic review of clinical trials assessing the therapeutic efficacy of visceral leishmaniasis treatments: a first step to assess the feasibility of establishing an individual patient data sharing platform. PLoS Neglected Tropical Diseases 2017;11(9):e0005781. - PMC - PubMed
Campbell 2012
-
- Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661. - PubMed
Carrillo 2015
-
- Carrillo E, Carrasco‐Antón N, López‐Medrano F, Salto E, Fernández L, San Martín JV, et al. Cytokine release assays as tests for exposure to Leishmania, and for confirming cure from leishmaniasis in solid organ transplant recipients. PLoS Neglected Tropical Diseases 2015;9(10):e0004179. - PMC - PubMed
Cerf 1987
-
- Cerf BJ, Jones TC, Badaro R, Sampaio D, Teixeira R, Johnson WD Jr. Malnutrition as a risk factor for severe visceral leishmaniasis. Journal of Infectious Diseases 1987;156(6):1030‐3. - PubMed
Chappuis 2007
-
- Chappuis F, Sundar S, Hailu A, Ghalib H, Rijal S, Peeling RW, et al. Visceral leishmaniasis: what are the needs for diagnosis, treatment and control?. Nature Reviews Microbiology 2007;5(11):873‐82. - PubMed
Chartres 2016
-
- Chartres N, Fabbri A, Bero LA. Association of industry sponsorship with outcomes of nutrition studies: a systematic review and meta‐analysis. JAMA Internal Medicine 2016;176(12):1769‐77. - PubMed
Cheeran 2010
-
- Cheeran MM, Shyam S, Sumar R, Abul F, Pascal M, Olliaro P. A review of clinical trials of treatments for visceral leishmaniasis in the Indian subcontinent (India, Bangladesh and Nepal). TropIKA.net [serial on the Internet] 2010;1(1):0‐0. [Available from: http://journal.tropika.net/scielo.php?script=sci_arttext&pid=S2078‐8...
Cochrane 2017
-
- Cochrane. Glossary. community.cochrane.org/glossary (accessed 26 November 2017).
Collin 2004
-
- Collin S, Davidson R, Ritmeijer K, Keus K, Melaku Y, Kipngetich S, et al. Conflict and kala‐azar: determinants of adverse outcomes of kala‐azar among patients in southern Sudan. Clinical Infectious Diseases 2004;38(5):612‐9. - PubMed
Covidence 2017 [Computer program]
-
- Veritas Health Innovation. Covidence systematic review software. Version accessed 22 December 2017. Melbourne, Australia: Veritas Health Innovation, 2017.
Dye 1993
-
- Dye C, Williams BG. Malnutrition, age and the risk of parasitic disease: visceral leishmaniasis revisited. Proceedings of the Royal Society B: Biological Sciences 1993;254(1339):33‐9. - PubMed
Elmahallawy 2015
-
- Elmahallawy EK, Agil A. Treatment of leishmaniasis: a review and assessment of recent research. Current Pharmaceutical Design 2015;21(17):2259‐75. - PubMed
Equator Network 2017
-
- Equator Network. Library for health research reporting. www.equator‐network.org/library/ (accessed 26 November 2017).
FAO/WHO/UNICEF 2001
-
- Food and Agriculture Organization of the United Nations/World Health Organization/United Nations University. Human energy requirements. Report of a Joint FAO/WHO/UNICEF Expert Consultation. Rome, 2001 October 17‐24. Food and Nutrition Technical Report Series. www.fao.org/3/a‐y5686e.pdf. Rome, (accessed 17 December 2017).
Ferreira 2018
-
- Ferreira GR, Castelo Branco Ribeiro JC, Meneses Filho A, Jesus Cardoso Farias Pereira T, Parente DM, Pereira HF, et al. Human competence to transmit Leishmania infantum to Lutzomyia longipalpis and the influence of human immunodeficiency virus infection. American Journal of Tropical Medicine and Hygiene 2018;98(1):126‐33. [DOI: 10.4269/ajtmh.16-0883] - DOI - PMC - PubMed
Food and Nutrition Board 2006
-
- Food, Nutrition Board. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington DC: National Academy Press, 2006.
Freitas‐Junior 2012
Garg 2004
-
- Garg R, Singh N, Dube A. Intake of nutrient supplements affects multiplication of Leishmania donovani in hamsters. Parasitology 2004;129(Pt 6):685‐91. - PubMed
Harhay 2011
-
- Harhay MO, Olliaro PL, Vaillant M, Chappuis F, Lima MA, Ritmeijer K, et al. Who is a typical patient with visceral leishmaniasis? Characterizing the demographic and nutritional profile of patients in Brazil, East Africa, and South Asia. American Journal of Tropical Medicine and Hygiene 2011;84(4):543‐50. - PMC - PubMed
Hayes 2000
-
- Hayes RJ, Alexander ND, Bennett S, Cousens SN. Design and analysis issues in cluster‐randomized trials of interventions against infectious diseases. Statistical Methods in Medical Research 2000;9(2):95‐116. - PubMed
Higgins 2011
-
- Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Hoffmann 2014
-
- Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687. - PubMed
Hotez 2004
-
- Hotez PJ, Remme JH, Buss P, Alleyne G, Morel C, Breman JG. Combating tropical infectious diseases: report of the Disease Control Priorities in Developing Countries Project. Clinical Infectious Diseases 2004;38(6):871‐8. - PubMed
Ioannidis 2004
-
- Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Annals of Internal Medicine 2004;141(10):781‐8. - PubMed
Ioannidis 2016
-
- Ioannidis JP. We need more randomized trials in nutrition ‐ preferably large, long‐term, and with negative results. American Journal of Clinical Nutrition 2016;103(6):1385‐6. - PubMed
Jakobsen 2013
-
- Jakobsen JC, Gluud C. The necessity of randomized clinical trials. British Journal of Medicine & Medical Research 2013;3(4):1453‐68.
Laville 2017
Lefebvre 2011
-
- Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Liberati 2009
Lin 2012
Luz 2001
-
- Luz KG, Succi RC, Torres E. Vitamin A serum level in children with visceral leishmaniasis [Nível sérico da vitamina A em crianças portadoras de leishmaniose visceral]. Revista de Sociedade Brasileira de Medicina Tropical [Journal of the Brazilian Society of Tropical Medicine] 2001;34(4):381‐4. - PubMed
López‐Alcalde 2015
-
- López‐Alcalde J, Mateos‐Mazón M, Guevara M, Conterno LO, Solà I, Cabir Nunes S, et al. Gloves, gowns and masks for reducing the transmission of meticillin‐resistant Staphylococcus aureus (MRSA) in the hospital setting. Cochrane Database of Systematic Reviews 2015, Issue 7. [DOI: 10.1002/14651858.CD007087.pub2] - DOI - PMC - PubMed
Maki 2014
Malafaia 2009
-
- Malafaia G. Protein‐energy malnutrition as a risk factor for visceral leishmaniasis: a review. Parasite Immunology 2009;31(10):587‐96. - PubMed
Mittra 2000
MRC 2008
-
- Medical Research Council. Developing and evaluating complex interventions: new guidance, 2008. www.mrc.ac.uk/documents/pdf/complex‐interventions‐guidance/ (accessed 17 November 2017).
Murray 2005
-
- Murray HW, Berman JD, Davies CR, Saravia NG. Advances in leishmaniasis. Lancet 2005;366(9496):1561‐77. - PubMed
NVBDCP Programme 2017
-
- National Vector Borne Disease Control Programme, Government of India. Kala‐azar cases and deaths in the country since 2010. nvbdcp.gov.in/ka‐cd.html (accessed 17 December 2017).
Olliaro 2005
-
- Olliaro PL, Guerin PJ, Gerstl S, Haaskjold AA, Rottingen JA, Sundar S. Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980‐2004. Lancet Infectious Diseases 2005;5(12):763‐74. - PubMed
Ortiz‐Moncada 2011
-
- Ortiz‐Moncada R, González‐Zapata L, Ruíz‐Cantero MT, Clemente‐Gómez V. Priority issues, study designs and geographical distribution in nutrition journals. Nutrición Hospitalaria 2011;26(4):784‐91. - PubMed
Porta 2008
-
- Porta M, Greenland S, Last JM. A Dictionary of Epidemiology. 5th Edition. New York: Oxford University Press, 2008.
RevMan 2014 [Computer program]
-
- Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Ritterson 1949
-
- Ritterson AL, Stauber LA. Protein intake and leishmaniasis in the hamster. Proceedings of the Society for Experimental Biology and Medicine 1949;70(1):47‐50. - PubMed
Safdar 2008
-
- Safdar N, Abad C. Educational interventions for prevention of healthcare‐associated infection: a systematic review. Critical Care Medicine 2008;36(3):933‐40. - PubMed
Schulz 2010
Serafim 2010
-
- Serafim TD, Malafaia G, Silva ME, Pedrosa ML, Rezende SA. Immune response to Leishmania (Leishmania) chagasi infection is reduced in malnourished BALB/c mice. Memórias do Instituto Oswaldo Cruz 2010;105(6):811‐7. - PubMed
Smith 2008
-
- Smith DH, Kramer JM, Perrin N, Platt R, Roblin DW, Lane K, et al. A randomized trial of direct‐to‐patient communication to enhance adherence to beta‐blocker therapy following myocardial infarction. Archives of Internal Medicine 2008;168(5):477‐83; discussion 483; quiz 447. - PubMed
Sterne 2014
-
- Sterne JAC, Higgins JPT, Reeves BC, the development group for ACROBAT‐NRSI. A Cochrane Risk Of Bias Assissment Tool: for Non‐Randomized Studies of Interventions (ACROBAT‐NRSI). Version 1.0.0, 24 September 2014. Available from http:/www.riskofbias.info (accessed 19 November 2014).
Sterne 2016a
Sterne 2016b
-
- Sterne JAC, Higgins JPT, Elbers RG, Reeves BC, the development group for ROBINS‐I. Risk of bias In non‐randomized studies of Interventions (ROBINS‐I): detailed guidance, updated 12 October 2016. Available from www.riskofbias.info (accessed 12 November 2017).
van Griensven 2014
Van Weyenbergh 2004
Welch 2017
-
- Welch VA, Norheim OF, Jull J, Cookson R, Sommerfelt H, Tugwell P. CONSORT‐Equity 2017 extension and elaboration for better reporting of health equity in randomised trials. BMJ 2017;359:j5085. - PubMed
WHO 2007
-
- World Health Organization. Report of the first global partners' meeting on neglected tropical diseases. 2007: a turning point; 2007 April 19‐20. Geneva, Switzerland. apps.who.int/iris/bitstream/10665/69740/1/WHO_CDS_NTD_2007.4_eng.pdf (accessed 29 November 2017).
WHO 2010
-
- World Health Organization. Control of the leishmaniases. Report of a meeting of the WHO Expert Committee on the Control of Leishmaniases; 2010 March 22‐26. Geneva, Switzerland. WHO Technical Report Series: no. 949. apps.who.int/iris/bitstream/10665/44412/1/WHO_TRS_949_eng.pdf (accessed 14 December 2017).
WHO 2012
-
- World Health Organization. Accelerating work to overcome the global impact of neglected tropical diseases: a roadmap for implementation (Executive summary). apps.who.int/iris/bitstream/10665/70809/1/WHO_HTM_NTD_2012.1_eng.pdf (accessed 29 November 2017).
WHO 2013
-
- World Health Organization. Maternal, infant and young child nutrition in East and Southern African countries: moving to national implementation. Report of a World Health Organization workshop; 2013 November 26‐28. Entebbe, Uganda. apps.who.int/iris/bitstream/10665/134903/1/9789241508875_eng.pdf?ua=1 (accessed 29 November 2017).
WHO 2014a
-
- World Health Organization. Strategic framework for leishmaniasis control in the WHO European Region 2014‒2020. www.who.int/leishmaniasis/resources/9789289050166/en/ (accessed 29 November 2017).
WHO 2014b
-
- World Health Organization. Manual for case management of cutaneous leishmaniasis in the WHO Eastern Mediterranean Region. www.who.int/leishmaniasis/resources/978‐92‐9021‐945‐3/en/ (accessed 29 November 2017).
WHO 2014c
-
- World Health Organization. Framework for action on cutaneous leishmaniasis in the Eastern Mediterranean Region 2014–2018. www.who.int/leishmaniasis/resources/978‐92‐9021‐943‐9/en/ (accessed 29 November 2017).
WHO 2014d
-
- World Health Organization. Leishmaniasis: strengthening cross‐border collaboration for control in Central Asian and Middle Eastern countries of the WHO European and Eastern Mediterranean Regions. apps.who.int/iris/bitstream/10665/190168/1/9789241509657_eng.pdf?ua=1 (accessed 29 November 2017).
WHO 2014e
-
- World Health Organization. Cutaneous leishmaniasis: control in selected countries of the WHO Eastern Mediterranean and African Regions. www.who.int/leishmaniasis/resources/9789241508773/en/ (accessed 29 November 2017).
WHO 2015a
-
- World Health Organization. Visceral leishmaniasis: control strategies and epidemiological situation update in East Africa. apps.who.int/iris/bitstream/10665/190168/1/9789241509657_eng.pdf?ua=1 (accessed 29 November 2017).
WHO 2015b
-
- World Health Organization. Kala‐Azar elimination programme. www.who.int/leishmaniasis/resources/9789241509497/en/ (accessed 29 November 2017).
WHO 2016a
-
- World Health Organization. Daily iron supplementation in postpartum women. apps.who.int/iris/bitstream/10665/249242/1/9789241549585‐eng.pdf?ua=1 (accessed 29 November 2017).
WHO 2016b
-
- World Health Organization. Daily iron supplementation in infants and children. apps.who.int/iris/bitstream/10665/204712/1/9789241549523_eng.pdf?ua=1&am... (accessed 29 November 2017).
WHO 2016c
-
- World Health Organization. Daily iron supplementation in adult women and adolescent girls. www.who.int/nutrition/publications/year_list/en/ (accessed 29 November 2017).
WHO 2016d
-
- World Health Organization. Leishmaniasis in high‐burden countries: an epidemiological update based on data reported in 2014. Weekly Epidemiological Record 2016;91(22):285‐96. - PubMed
WHO 2017a
-
- World Health Organization. Global leishmaniasis update, 2006–2015: a turning point in leishmaniasis surveillance. Weekly Epidemiological Record 2017;92(38):557‐65. - PubMed
WHO 2017b
-
- World Health Organization. Accelerating nutrition improvements in SubSaharan Africa: scaling up nutrition interventions. apps.who.int/iris/bitstream/10665/255422/1/WHO‐NMH‐NHD‐17.6‐eng.pdf?ua=1 (accessed 29 November 2017).
WHO 2017c
-
- World Health Organization. Ambition and action in nutrition 2016‐2025. www.who.int/nutrition/publications/nutrition‐strategy‐2016to2025/en/ (accessed 29 November 2017).
WHO 2017d
-
- World Health Organization. Nutritional anaemias: tools for effective prevention and control. apps.who.int/iris/bitstream/10665/259425/1/9789241513067‐eng.pdf?ua=1 (accessed 29 November 2017).
WHO/The Carter Center 2008
-
- World Health Organization, The Carter Center. Integral control of the neglected tropical diseases. A neglected opportunity ripe for action. Paper presented to the Global Health and the United Nations meeting. 2008 May 8‐9; Carter Center, Atlanta, Georgia, USA. WHO/HTM/NTD/2008.1. www.who.int/neglected_diseases/NTD_integrated_control.pdf (accessed 17 December 2017).
Williamson 2012
Williamson 2017
Zijlstra 2003
-
- Zijlstra EE, Musa AM, Khalil EA, el‐Hassan IM, el‐Hassan AM. Post‐kala‐azar dermal leishmaniasis. Lancet Infectious Diseases 2003;3(2):87‐98. - PubMed
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