Ready-to-use therapeutic food as home-based treatment for severely malnourished children between six months and five years old

Malnourished children have a higher risk of death and illness. Treating severely 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. Typically, RUTF is made from full-fat milk powder, sugar, peanut butter, vegetable oil, and vitamins and minerals. The benefits of RUTF include a low moisture content, a long shelf life without needing refrigeration and that it requires no preparation.

We assessed RUTF compared with a standard diet (flour porridge) for treatment, and examined whether a cheaper RUTF treatment (smaller amounts or using cheaper ingredients) can achieve similar health outcomes in severely malnourished children between six months and five years old. The main health outcomes that we investigated were recovery from severe malnutrition, relapse (getting more malnourished), death and weight gain.

We carried out a comprehensive search of trials up to April 2013 and found four studies. All studies were conducted in Malawi, with one small study that included children infected with human immunodeficiency virus (HIV). The extent to which results of the studies can be believed based on how the studies were done was poor for three studies, while the fourth study had stronger methods. Because of the sparse data for HIV, we report the main results for all children together.

For RUTF given as a total dietary replacement compared to flour porridge, we found three studies with 599 children. RUTF may improve recovery slightly, but we do not know whether RUTF improves relapse, death or weight gain as the quality of evidence was very low.

When comparing RUTF used as a supplement to their ordinary diet with RUTF used as a total dietary replacement, we found two small studies with 210 children. For recovery, relapse, death and weight gain, the quality of evidence was very low and, therefore, we do not know what the effects are.

When comparing a cheaper RUTF containing less milk powder (10%) with standard RUTF (25% milk powder), we found one study that randomised 1874 children. For recovery, there probably was little or no difference between the groups. RUTF containing less milk powder may lead to slightly more children relapsing and to less weight gain than standard RUTF. We do not know whether the cheaper RUTF reduces the number of children dying.

Current evidence is limited and, therefore, we cannot conclude that there is a difference between RUTF and flour porridge as home treatment for severely malnourished children, or between RUTF given in different daily amounts or with different ingredients. In order to determine the effects of RUTF, more high-quality studies are needed.

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. Well-designed, adequately powered pragmatic randomised controlled trials of HIV-uninfected and HIV-infected children with severe acute malnutrition are needed.

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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 strategy: 

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 diet

When 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 requirements

When 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 RUTF

When 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).

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