Ready-to-use therapeutic food for home-based treatment of severe acute malnutrition in children from six months to five years of age.

The Cochrane database of systematic reviews

Jun 2013

DOI: 10.1002/14651858.CD009000.pub2

Citations:66

Influential Citations:4

Systematic Reviews / Meta-Analyses

Enhanced Details

Methods

Participants were children aged 6–60 months with severe acute malnutrition in Malawi. Four trials (three cluster-randomized, one individually randomized) studied RUTF regimens; HIV status varied with one trial including HIV-infected children and Oakley 2010 enrolling HIV-uninfected children.

Intervention

RUTF regimens included: (1) RUTF meeting daily energy and nutrient requirements as a total dietary replacement vs standard diet (flour porridge); (2) RUTF used as a supplement to habitual diet vs RUTF meeting daily requirements; (3) cheaper RUTF containing 10% milk powder vs standard RUTF containing 25% milk powder. Peanut-based formulations; some trials used commercially produced products (e.g., Plumpy'nut) and others locally produced; durations varied across studies (roughly 8 weeks to several months).

Results

RUTF meeting daily nutritional requirements versus standard diet may improve recovery (RR 1.32; 95% CI 1.16–1.50; low quality). Effects on relapse, mortality, or weight gain are uncertain. When RUTF is used as a supplement versus meeting daily requirements, evidence is very low quality and effects are unclear. Cheaper RUTF with 10% milk powder versus standard 25% milk powder yields similar recovery (RR 0.97; 95% CI 0.93–1.01; moderate quality) but slightly higher relapse (RR 1.33; 95% CI 1.03–1.72) and lower weight gain (MD −0.5 g/kg/day; 95% CI −0.75 to −0.25; low quality). Mortality effects remain uncertain. Overall, definitive conclusions cannot be drawn; more high-quality pragmatic randomized trials are needed in both HIV-infected and HIV-uninfected children to evaluate recovery, relapse, mortality and growth, including cost and safety considerations.

Limitations

Four trials (2894 participants; effective sample size 2594 after clustering) with three quasi-randomized studies at high risk of bias; cluster trials not properly adjusted for clustering; limited HIV-infected data; predominantly Malawi-based; heterogeneity in RUTF formulations and outcomes; short follow-up and incomplete reporting of adverse events and cognitive outcomes; potential differential sharing of foods; outcome definitions varied across studies.

Abstract

BACKGROUND Malnourished children have a higher risk of death and illness. Treating severe acute malnourished children in hospitals is not always desirable or practical in rural settings, and home treatment may be better. Home treatment can be food prepared by the carer, such as flour porridge, or commercially manufactured food such as ready-to-use therapeutic food (RUTF). RUTF is made according to a standard, energy-rich composition defined by the World Health Organization (WHO). The benefits of RUTF include a low moisture content, long shelf life without needing refrigeration and that it requires no preparation. OBJECTIVES To assess the effects of home-based RUTF on recovery, relapse and mortality in children with severe acute malnutrition. SEARCH METHODS We searched the following electronic databases up to April 2013: Cochrane Central Register of Clinical Trials (CENTRAL), MEDLINE, MEDLINE In-process, EMBASE, CINAHL, Science Citation Index, African Index Medicus, LILACS, ZETOC and three trials registers. We also contacted researchers and clinicians in the field and handsearched bibliographies of included studies and relevant reviews. SELECTION CRITERIA We included randomised and quasi-randomised controlled trials where children between six months and five years of age with severe acute malnutrition were treated at home with RUTF compared to a standard diet, or different regimens and formulations of RUTFs compared to each other. We assessed recovery, relapse and mortality as primary outcomes, and anthropometrical changes, time to recovery and adverse outcomes as secondary outcomes. DATA COLLECTION AND ANALYSIS Two review authors independently assessed trial eligibility using prespecified criteria, and three review authors independently extracted data and assessed trial risk of bias. MAIN RESULTS We included four trials (three having a high risk of bias), all conducted in Malawi with the same contact author. One small trial included children infected with human immunodeficiency virus (HIV). We found the risk of bias to be high for the three quasi-randomised trials while the fourth trial had a low to moderate risk of bias. Because of the sparse data for HIV, we reported below the main results for all children together. RUTF meeting total daily requirements versus standard dietWhen comparing RUTF with standard diet (flour porridge), we found three quasi-randomised cluster trials (n = 599). RUTF may improve recovery slightly (risk ratio (RR) 1.32; 95% confidence interval (CI) 1.16 to 1.50; low quality evidence), but we do not know whether RUTF improves relapse, mortality or weight gain (very low quality evidence). RUTF supplement versus RUTF meeting total daily requirementsWhen comparing RUTF supplement with RUTF that meets total daily nutritional requirements, we found two quasi-randomised cluster trials (n = 210). For recovery, relapse, mortality and weight gain the quality of evidence was very low; therefore, the effects of RUTF are unknown. RUTF containing less milk powder versus standard RUTFWhen comparing a cheaper RUTF containing less milk powder (10%) versus standard RUTF (25% milk powder), we found one trial that randomised 1874 children. For recovery, there was probably little or no difference between the groups (RR 0.97; 95% CI 0.93 to 1.01; moderate quality evidence). RUTF containing less milk powder may lead to slightly more children relapsing (RR 1.33; 95% CI 1.03 to 1.72; low quality evidence) and to less weight gain (mean difference (MD) -0.5 g/kg/day; 95% CI -0.75 to -0.25; low-quality evidence) than standard RUTF. We do not know whether the cheaper RUTF improved mortality (very low quality evidence). AUTHORS' CONCLUSIONS Given the limited evidence base currently available, it is not possible to reach definitive conclusions regarding differences in clinical outcomes in children with severe acute malnutrition who were given home-based ready-to-use therapeutic food (RUTF) compared to the standard diet, or who were treated with RUTF in different daily amounts or formulations. For this reason, either RUTF or flour porridge can be used to treat children at home depending on availability, affordability and practicality. Well-designed, adequately powered pragmatic randomised controlled trials of HIV-uninfected and HIV-infected children with severe acute malnutrition are needed. show less