Context: Severe acute malnutrition (SAM) in children is a significant public health problem in India with associated increased morbidity and mortality. The current WHO recommendations on management of SAM are based on facility based treatment. Given the large number of children with SAM in India and the involved costs to the care-provider as well as the care-seeker, incorporation of alternative strategies like home based management of uncomplicated SAM is important. The present review assesses (a) the efficacy and safety of home based management of SAM using ‘therapeutic nutrition products’ or ready to use therapeutic foods (RUTF); and (b) efficacy of these products in comparison with F-100 and home-based diet.

Evidence Acquisition: Electronic database (Pubmed and Cochrane Controlled Trials Register) were scanned using keywords ‘severe malnutrition’, ‘therapy’, ‘diet’, ‘ready to use foods’ and ‘RUTF’. Bibliographics of identified articles, reviews and books were scanned. The information was extracted from the identified papers and graded according to the CEBM guidelines.

Results: Eighteen published papers (2 systematic reviews, 7 controlled trials, 7 observational trials and 2 consensus statements) were identified. Systematic reviews and RCTs showed RUTF to be at least as efficacious as F-100 in increasing weight (WMD=3.0 g/kg/day; 95% CI -1.70, 7.70) and more effective in comparison to home based dietary therapies. Locally made RUTFs were as effective as imported RUTFs (WMD=0.07 g/kg/d; 95% CI=-0.15, 0.29). Data from observational studies showed the energy intake with RUTF to be comparable to F-100. The pooled recovery rate, mortality and default in treatment with RUTF was 88.3%, 0.7% and 3.6%, respectively with a mean weight gain of 3.2 g/kg/day. The two consensus statements supported the use of RUTF for home based management of uncomplicated SAM.

Conclusions: The use of therapeutic nutrition products like RUTF for home based management of uncomplicated SAM appears to be safe and efficacious. However, most of the evidence on this promising strategy has emerged from observational studies conducted in emergency settings in Africa. There is need to generate more robust evidence, design similar products locally and establish their efficacy and cost-effectiveness in a ‘non-emergency’ setting, particularly in the Indian context.

Key words: Efficacy, Management, Severe acute malnutrition, Therapeutic nutrition product.

Given the grimness of the current situation, there is clearly a need to improve and improvise the current standard guidelines for the management of SAM in children. One of the suggested methods has been the use of ‘therapeutic nutrition products’ administered at home to children with uncomplicated SAM(4). A review was planned to study the efficacy and safety of various therapeutic nutrition products for home based management of SAM in children and to critically review the extendibility of this strategy to India with the following objectives:

Trials: Systematic Reviews; before and after observational studies; Individual, cluster, and quasi randomized and non-randomized controlled trials; consensus statements.

Participants: Children with severe acute malnutrition.

Intervention: Therapeutic nutrition product, basically derived from F-100 formulation, which is an integral part of the WHO Management Protocol for SAM but should have these additional properties: (i) does not need to be prepared in any form before consumption; (ii) resists microbial contamination; and (iii) can be stored at ambient temperature.

Control: No intervention or alternative intervention such as home based dietary management or facility based standard treatment.

Outcome Measures: For efficacy: (a)Recovery rate (as defined by the authors); (b)Weight gain (g/kg/day); and (c) Relapse.

For Safety: (a) Morbidities like diarrhea, malaria and respiratory infections; and (b) Mortality.

Identification of studies: An exhaustive literature search was done in the Cochrane Library and Pubmed using the search terms ‘severe malnutrition’, ‘therapy’, ‘diet’, ‘ready to use foods’ and ‘RUTF’ on April 20, 2010.

A total of 4073 citations were scanned to identify relevant studies. The bibliography of identified articles was also scanned and lateral search strategy in Pubmed was utilised to identify any additional trials. A total of 18 published studies(4-21) were identified and the information extracted was graded according to the CEBM guidelines(22) and is presented in Table I. Wherever possible and where the data from the published studies was extractable, the data was pooled statistically to get a precise quantitative estimate. The pooled estimates of the weighed mean difference (WMD) of the weight gain between the control and intervention group and the mean pooled weight gain in observational studies were calculated by meta-analyses using random effects model assumptions with the "metan" command in STATA software.

Table I



Role of Therapeutic Nutrition Products in Home Based Management of Severe Acute Malnutrition 

in Children: Summary of Evidence

A 2008 systematic review(4) on severe malnutrition identified 276 articles on management of SAM, of which 21 were eventually included in the final analyses. Of these, nine studies evaluated the efficacy of WHO guidelines for facility based management of severe acute malnutrition; pooled data from these trials showed a reduction in mortality (Risk Ratio 0.45; 95% CI 0.32, 0.62). The authors could not identify any randomized controlled trials studying the effect of RUTF on mortality. However, obtaining the observational data collected from 21 field programs on 23,511 children on community based management of SAM, the authors showed the case fatality rate to be 4.1%, recovery rate was 79.4% and default was 11%; figures which were noted to be comparable to data from facility based trials. The authors also conducted two meta-analyses of RCTs conducted in children recovering from SAM as part of this review. The first one compared the use of RUTF with F-100, and revealed an advantage of weight gain of 3.0 g/kg/day (WMD = 3.0; 95% CI= –1.70, 7.70) in favour of RUTF; however, the results were not statistically significant (P=0.21). Meta-analyses comparing RUTF with maize/soy flour included only one study(9) and found significantly increased weight gain (WMD= 2.10 g/kg/day; 95% CI= 1.97, 2.23; P<0.001).

Another review, conducted by Ashworth, et al.(5), studied the effectiveness of rehabilitating severely malnourished children in community settings. Effectiveness was defined as mortality of less than 5% or weight gain of more than 5 g/kg/day. 16 trials of home based management of SAM children were identified; of these, seven were considered to be effective. Amongst these, two programs were home based programs where no food was distributed, while 5 trials utilised RUTF. The authors noted that all successful programs aimed at providing the child with high protein, high energy diet at frequent intervals. None of the programs within the existing health systems was effective without external assistance. Home based treatment with nutrition education was shown to be effective in Bangladesh, even without the provision of RUTF or any other food. However, this involved considerable effort in educating the mothers.

A total of seven controlled trials were identified. Three trials compared home based management of RUTF with the standard practise using F-100 formula at therapeutic centres. Of these, two studies started home therapy after initial stabilization at a facility(6-8). A previously conducted meta-analysis showed an advantage of weight gain of 3.0 g/kg/day (WMD = 3.0; 95% CI= –1.70, 7.70) in favour of RUTF against F-100; however, the results were statistically not significant(4). The third study(8) in this group followed a purposive selection method, where more sick patients and those with complications were referred to a facility; subjects without complications and with good appetite were selected for home based management using RUTF. Expectedly, the mortality in the F-100 group was much higher (18.9% versus 92.7%) because of the unequal baseline status between the two groups.

Two studies were identified that compared the efficacy of therapeutic nutrition products with traditionally available foods at home. Manary, et al.(9) compared RUTF with maize soy flour and observed higher weight gain and recovery, and lower morbidity in RUTF group, in comparison to home based foods. The study had been included in the systematic review mentioned above and details are given in that section. The second study(10) used Misola (a local product made from millet, soya, peanut kernal, sugar and salt) that supplies energy almost equivalent to conventional RUTFs. The authors found that Misola fortified with Spirulina led to higher weight gain, in comparison to use of traditional foods.

Two trials(11,12) compared the efficacy of a locally made RUTF with imported RUTF. A meta-analysis was done from the data derived from the two studies doing a comparative assessment of the impact of locally made RUTF and imported RUTF. The pooled data from the two studies done amongst 321 subjects, of whom 165 received locally made RUTF and 156 received imported RUTF, showed no difference in the weight gain between the two groups (WMD = 0.07 g/kg/d; 95% CI = -0.15, 0.29, 1.244, P=0.15) (Fig 1).

Fig. 1 Forest Plot showing the effectiveness of imported RUTF in comparison with local RUTF in weight gain of severe malnourished children.

A total of 7 observational trials(13-19) were identified. Of these, one trial(19) estimated the adequacy of energy intake with ready to use foods in comparison to F-100 and found them to be comparable. Most of the trials (4 out of 5) reported a recovery rate (recovery variably defined by the authors) of more than 80%.

A pooled analysis of data from 5 studies (giving information on 9145 severely malnourished children) reveals a recovery rate of 88.3%, mortality of 0.7%, default rate of 3.6% and 6.7% babies had failure of treatment or needed referral to a facility. Using meta-analytic methods the pooled mean weight gain with the use of RUTF was 3.2 g/kg/day (95% CI 3.06, 3.34 g/kg/d) (Fig 2). Of these trials, one(14) used a locally designed RUTF and found weight gain comparable, as with the use of commercially available RUTFs in other trials.

Fig. 2 Forest Plot showing the pooled estimates for weight gain in severe malnourished children using RUTF.

Two consensus statements(20,21) were identified from published literature. Both the statements emphasized the need to treat uncomplicated severely malnourished children at home, and on the efficacy of therapeutic nutrition products like RUTF for this purpose. They also stated the need for micronutrient supplementation as per WHO guidelines, exclusive breastfeeding in the first 6 months of life, monitoring of the children to ensure compliance and adequate response to treatment and need to develop local products to increase acceptability and decrease cost.

Review of presently available published peer reviewed literature shows that the use of ‘therapeutic nutrition products’ like RUTF are efficacious in treating children with severe acute malnutrition, who do not have any associated complications, and during the rehabilitation phase when prolonged hospitalization may not be desirable. Systematic reviews and randomized controlled trials on the topic show that this modality of treatment may be as efficacious as standard (WHO) treatment using F-100. Furthermore, these products are more effective than home based foods with lower energy density in treating SAM. Locally designed ready to use foods are as effective as the commercially available products. The overall recovery rate with the use of RUTF is more than 85% with a mortality of less than 1%.

However, the currently available level of evidence does have some drawbacks that preclude the direct incorporation of such a strategy into a program or a policy, and even its extendibility to India. First is the fact that there is paucity of data, that too of robust quality, available on the topic. Most of the information is available from observational studies conducted in disaster situations, where no other alternative strategy was feasible. The other noteworthy issue is the fact that all the studies available so far were conducted in Africa. The results of extending it to countries like India, in non-emergency situations, with unknown efficacy and acceptability, are at present unpredictable.

A number of studies, especially the controlled trials which constitute a higher level of evidence are conducted in controlled situations, under the supervision and monitoring of health care workers. No doubt, this enables early identification of complications and institution of early treatment, wherever indicated but digresses from the basic rationale of using this strategy in areas where the health infrastructure is poor or non-existent. Such supervised management also increases the cost of management of SAM children. Based on the cost of RUTF alone, Ashworth, et al.(5) estimated the cost to rehabilitate a SAM child to be $55; for a HIV positive child it would double to $110. To put it in perspective, in 2006, the per capita health care cost spent by India was $39(23). These are substantial costs for the health system of any developing country to absorb and emphasize the need for product innovation at a local level.

The use of home treatment, using medical nutrition products, as a public health strategy, therefore, should be treated as a possibility in infancy, with its need to study its feasibility and cost effectiveness in the Indian setting in an operational research format, before suggesting its integration into the current health programs. The effectiveness of cheaper locally designed ready to use foods is encouraging, and should stimulate the scientific community to design appropriate food(s) which are culturally acceptable in various parts of our large country, as well as cost-effective.

Most important is the need to communicate to the policy planners the urgency to address the problem of severe acute malnutrition. Despite the fact that severe malnutrition is often a co-morbidity in large proportion of avoidable child mortality, it does not get the attention it deserves. It should be emphasized that the treatment of SAM is cost effective – in fact, even hospital based management of SAM is more cost effective in reducing mortality than many other child survival intervention programs including the extremely visible vitamin A supplementation program(24,25). The availability of alternative strategies like home based management using locally made therapeutic nutrition products is likely to add to the cost effectiveness. India needs multi-pronged strategies to address the problem of severe malnutrition, given the geo-graphic, cultural and financial barriers that exist across this large country; home based management is likely to be one of them.

Funding: None.

Competing Interests: None stated.

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