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• RE: Reading Between the Lines of the RUTF trial, India
  Vandana Prasad
  Published on: 13 June 2018
• RE: Is it prudent to recommend RUTF in India based on the results of this trial?
  Dr. JP DADHICH
  Published on: 12 June 2018
• RE: Response of the authors to the E-letters
  NITA BHANDARI
  Published on: 12 June 2018

• Published on: 13 June 2018

  RE: Reading Between the Lines of the RUTF trial, India

  • Vandana Prasad, Community Paediatrician and Public Health Professional Public Health Resource Network

      Reading Between the Lines of the RUTF trial, India
  Nita Bhandari et al are to be congratulated for publishing the much-awaited findings of the trial conducted in India for home-based management of uncomplicated severe acute malnutrition; comparing the efficacy of ready-to-use-therapeutic-food (RUTF); centrally (RUTF-C) and locally produced (RUTF-L), with augmented home-foods (A-HPF). The rigorously conducted trial offers significant insights to this highly debated and discussed area of work i ii . However, its policy recommendations seem evasive and ill founded on the evidence.
  It is hardly in question that children with SAM benefit from being fed calorie-dense and protein rich foods, including RUTF. What the authors note, however, is that the rate, ease and extent of achieving ‘cure’ is far lower than that seen in African studies. In fact, this is the first trial where the advisory committee – the Data Safety Monitoring Board has had to recommend a treatment period as long as 16 weeks. It also has had to recommend the introduction of paid workers that visited each household ‘several times’ through the day to personally supervise feeding, to be able to achieve even this impact across the arms. This corresponds to an understanding that malnutrition cannot be sufficiently countered in the field without supporting care-givers in practical ways. In fact, comparing ready-to-use foods with the raw material that was supplied...

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      Reading Between the Lines of the RUTF trial, India
  Nita Bhandari et al are to be congratulated for publishing the much-awaited findings of the trial conducted in India for home-based management of uncomplicated severe acute malnutrition; comparing the efficacy of ready-to-use-therapeutic-food (RUTF); centrally (RUTF-C) and locally produced (RUTF-L), with augmented home-foods (A-HPF). The rigorously conducted trial offers significant insights to this highly debated and discussed area of work i ii . However, its policy recommendations seem evasive and ill founded on the evidence.
  It is hardly in question that children with SAM benefit from being fed calorie-dense and protein rich foods, including RUTF. What the authors note, however, is that the rate, ease and extent of achieving ‘cure’ is far lower than that seen in African studies. In fact, this is the first trial where the advisory committee – the Data Safety Monitoring Board has had to recommend a treatment period as long as 16 weeks. It also has had to recommend the introduction of paid workers that visited each household ‘several times’ through the day to personally supervise feeding, to be able to achieve even this impact across the arms. This corresponds to an understanding that malnutrition cannot be sufficiently countered in the field without supporting care-givers in practical ways. In fact, comparing ready-to-use foods with the raw material that was supplied in the augmented home foods category, but had to be cooked, also underplays this issue and complicates the results, as does the fact that peer support was different in each arm (though statistically insignificant) and this was adjusted for in the results, without offering details on these differences and adjustments.
  Nonetheless, results show that the differences between A- HPF and RUTF-C were not significant. RUTF-L (being different from RUTF-C only in texture) was found to be inexplicably better than A-HPF, achieving a 57% recovery rate compared to 43% in 16 weeks. However, 16 weeks after the intervention, the overall numbers of children cured had dwindled to 15%.
  Thus, the data clearly shows that the overall impact across all three arms is low, with over 40% children remaining in SAM even after a prolonged period of intervention in the strongest arm. Even these gains are unacceptably temporary. In addition, the element of supervised feeding ‘several times a day’ by a paid peer counselor seems quintessential to the results across the arms. Far from encouraging the use of RUTF in India, all these facts seem to suggest that, given a certain equivalence of quality, the choice of product is largely irrelevant for the community management of malnutrition.
  The question this paper should rather be discussing is, whether it is logical, practical, acceptable and cost- effective to have individualized paid workers offering supervised feeding of RUTF-L several times a day at sparsely scattered households, to be able to achieve only moderate and highly unsustained gains in treating SAM.
  Instead, the existing alternative hypothesis for SAM prevention and managementiii ; supporting families through comprehensive childcare programmes that organize care, health and nutrition using local resources, needs to be taken seriously and tested if required.
  Word count: 498
  i Sachdeva HPS, Kapil U, Gupta A, Prasad V. “Sustainable developmental solutions or product- based illusions for addressing severe acute malnutrition?” Paper submitted to the World Nutrition Conference2016, held in Cape Town, South Africa from 30th August to 2nd September 2016. Available http://www2.tulane.edu/publichealth/internut/magic-bullets-workshop.cfm
  ii Prasad V, Holla R, Gupta A. Should India use commercially produced ready to use therapeutic foods (RUTF) for severe acute malnutrition (SAM)? Social Medicine 2009; 4(1): 52-5.
  iii Prasad V, Sinha D. Potentials, Experiences and Outcomes of a Comprehensive Community Based Programme to Address Malnutrition in Tribal India. International Journal of Child Health and Nutrition, 2015, 4, 151-162
  

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  Conflict of Interest:
  None declared.

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• Published on: 12 June 2018

  RE: Is it prudent to recommend RUTF in India based on the results of this trial?

  • Dr. JP DADHICH, Paediatrician Breastfeeding Promotion Network of India (BPNI)

  This RUTF trial from India has compared the efficacy of  RUTF (centrally produced and locally produced) with augmented energy-dense home-prepared foods (comparison group) for home based management of uncomplicated severe acute malnutrition (SAM). 

   

  I would like to draw attention of the authors on following issues. 

   

  1. The study reports that 40% children affected with SAM in the study did not recover even with a prolonged (16 weeks), supervised treatment with RUTF and other supportive measures like deworming, antibiotics at the initiation of treatment and increased access to healthcare for morbidity. The recovery rate was 17.3% with the use of locally produced RUTF and 12.1% with centrally produced RUTF at 16 weeks after the end of treatment phase. With such low recovery rates, is it prudent to make a recommendation for the policy that “Children with uncomplicated SAM can be managed at home with RUTF instead of through inpatient hospitalization”?

  2. In this trial, researchers aimed to achieve an intake of 175 kcal/kg body weight/ day for the enrolled children and collected consumption data for both the RUTF groups which were largely comparable. But they fail to do so for the comparison group stating greater difficulty in capturing valid information. Authors need to explain if this has led to a less th...

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  This RUTF trial from India has compared the efficacy of  RUTF (centrally produced and locally produced) with augmented energy-dense home-prepared foods (comparison group) for home based management of uncomplicated severe acute malnutrition (SAM). 

   

  I would like to draw attention of the authors on following issues. 

   

  1. The study reports that 40% children affected with SAM in the study did not recover even with a prolonged (16 weeks), supervised treatment with RUTF and other supportive measures like deworming, antibiotics at the initiation of treatment and increased access to healthcare for morbidity. The recovery rate was 17.3% with the use of locally produced RUTF and 12.1% with centrally produced RUTF at 16 weeks after the end of treatment phase. With such low recovery rates, is it prudent to make a recommendation for the policy that “Children with uncomplicated SAM can be managed at home with RUTF instead of through inpatient hospitalization”?

  2. In this trial, researchers aimed to achieve an intake of 175 kcal/kg body weight/ day for the enrolled children and collected consumption data for both the RUTF groups which were largely comparable. But they fail to do so for the comparison group stating greater difficulty in capturing valid information. Authors need to explain if this has led to a less than robust comparison of outcomes between the two RUTF groups and the augmented energy-dense home-prepared foods group as energy intake in the comparison group is not known.

  3. It will be useful if the authors provide opinion about efficacy of centrally produced RUTF in comparison to locally produced RUTF in treating SAM as adequate data in this regard are available to them in the study to do so. This information will be relevant from programmatic point of view as programmes for treatment of SAM in some states of India are using centrally produced RUTF.1

  4. The study has reported that centrally produced RUTF was not efficacious in comparison to nutrient-rich homemade foods to treat SAM. It will be useful if authors can provide some underlying factors for this finding, just like they have explained many other findings in the discussion.

   

  Reference:

  1. National Health Mission – Government of Rajasthan. Poshan. Available at: http://nrhmrajasthan.nic.in/POSHAN.asp

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  Conflict of Interest:
  None declared.

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• Published on: 12 June 2018

  RE: Response of the authors to the E-letters

  • NITA BHANDARI, Doctor Society for Applied Studies Centre for Health Research and Development

  Drs. Dadhich and Prasad raise important issues in their comments and questions about our study on home-based management of children with uncomplicated severe acute malnutrition (SAM).  We are grateful for the opportunity to respond to them.

  In our view, there are two distinct goals in the management of children with SAM. The first, and more urgent, is to treat and move them away from severe malnutrition, a state of high risk of death. The second is to rehabilitate them to the point they are no longer malnourished. The treatments examined in the study achieved the first goal well. By the end of the treatment phase, 84.5% of the children in the RUTF-L group were no longer SAM. However, they did less well in achieving the second goal.  By the end of the treatment phase, 57% of those receiving RUTF-L had recovered to the point of no longer being malnourished. Should we have applied the same approach as most studies to calculate their WHZ - using height at enrolment and current weight, rather than concurrently measured height and weight - 81% of the children in the RUTF-L group would no longer be classified as malnourished by the end of the treatment phase.

  We note Dr. Prasad’s misunderstanding that over 40% of the children in our study remained SAM by the end of the treatment with RUTF-L. Should her interpretation have been correct, it would justify her expressed concern. However, as stated above, by the end of the treatment phase 84.5% of the c...

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  Drs. Dadhich and Prasad raise important issues in their comments and questions about our study on home-based management of children with uncomplicated severe acute malnutrition (SAM).  We are grateful for the opportunity to respond to them.

  In our view, there are two distinct goals in the management of children with SAM. The first, and more urgent, is to treat and move them away from severe malnutrition, a state of high risk of death. The second is to rehabilitate them to the point they are no longer malnourished. The treatments examined in the study achieved the first goal well. By the end of the treatment phase, 84.5% of the children in the RUTF-L group were no longer SAM. However, they did less well in achieving the second goal.  By the end of the treatment phase, 57% of those receiving RUTF-L had recovered to the point of no longer being malnourished. Should we have applied the same approach as most studies to calculate their WHZ - using height at enrolment and current weight, rather than concurrently measured height and weight - 81% of the children in the RUTF-L group would no longer be classified as malnourished by the end of the treatment phase.

  We note Dr. Prasad’s misunderstanding that over 40% of the children in our study remained SAM by the end of the treatment with RUTF-L. Should her interpretation have been correct, it would justify her expressed concern. However, as stated above, by the end of the treatment phase 84.5% of the children in the RUTF-L group were no longer SAM. 

  We also note the concern that the ease and extent of recovery in our study is less than reported in African trials. However, as indicated in the paper, the population in our trial was significantly different from that in African trials: only 0.2% of our children had oedema, while it ranged from 38-80% in African trials. The mean WHZ score in our trial population was -3.5 while the mean ranged from -2.0 to -2.8 in Africa.  Such differences make comparisons on ease and speed of recovery quite hazardous.  One informed expectation is that recovery in the Indian population would take longer as they were further from the target of WHZ ≥ -2 SD.

  We acknowledge Dr. Dadhich’s interest in the comparison of the performance of RUTF-C and RUTF-L. However, the trial was not designed to compare them.  Given the lack of power for this comparison, we refrained from examining possible differences in their efficacy.  We know that the composition of the two products was essentially the same and believe that any potential differences would likely be due to users’ preferences.

  We agree that additional ways need to be found to rehabilitate these children. We see that in responding to SAM needs actions at the hospital level for children with complicated SAM, and at the community level, for treatment of uncomplicated cases, rehabilitation and prevention.  Success requires that we provide treatment and also support families through comprehensive child care and promoting the best use of local resources.  The rehabilitation of malnourished children, the sustainability of improvements and prevention of SAM need greater attention and possibly new approaches. We may need to extend the period of treatment while scaling down the management with therapeutic foods, or we may be more successful by increasing efforts to improve complementary feeding while continuing to use therapeutic foods as a supplement, or we may focus our efforts on improving complementary feeding without recourse to supplements. These approaches – or other that may be identified – should be tested to guide future efforts.

  In the end, rehabilitation by whatever means must be a part of a comprehensive program and reach all target infants and children. This will require engagement at home, community and facility and not only facility-based interaction. It may be that some redesign of our overall strategy is needed. The issue of nutrition and growth in early life is critical and needs an evidence-based, thoughtful and yet practical way forward. 

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  Conflict of Interest:
  None declared.

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