(i) F-100 milk was given from admission
onwards at a constant rate of 100kcal/kg/day, instead of having two
phases with F-75 milk (100kcal/kg/day) in the initial phase and F-100
ad libitum (150-220kcal/kg/day) in the rehabilitation phase;
(ii) standard ORS was given for oral
rehydration, instead of ReSoMal;
(iii) locally-prepared mineral solutions and
multivitamins were given separately, instead of a combined
mineral-vitamin mix (CMV); and
(iv) feeds were made with liquid cows’ milk
instead of milk powder.
Only the first two of these ‘adaptations’ are
substantive as the WHO guidelines already provide recipes for local
preparation of mineral solutions (K, Mg and Zn) and for making feeds from
fresh cows’ milk(2).
Finding simpler ways to manage severely malnourished
children is desirable, but can we be confident that the ICMH feeding and
rehydration adaptations are safe and efficacious on the evidence presented
in this paper? I do not believe so, due to limitations in design and
interpretation.
First it is not clear if the children in the two groups
were comparable at admission. For example, no comparative anthropometric
or morbidity data are reported. If the ICMH children were less wasted or
fewer had severe infections or diarrhea or anorexia, then this would lead
to bias which could invalidate the findings.
Second, the sample size is too small to detect an
increased risk of mortality with any confidence, as the authors correctly
indicate.
Third, although the ICMH protocol provides an energy
intake from F-100 of 100kcal/kg/day in keep-ing with the WHO target for
the initial phase, the protein and lactose intakes are 2.5 times higher.
High lactose at admission may cause or exacerbate diarrhea, and high
protein intake stresses the liver and kidneys and may increase the risk of
death in children with a compromised metabolic state. According to the WHO
guidelines, children are considered ready for the rehabilitation phase and
F-100 only when they demonstrate a good appetite and no or reduced edema.
Whether the ICMH’s omission of the initial phase poses dangers will depend
on the children’s metabolic state and too few details are provided about
the proportion with medical compli-cations or poor appetite, or the degree
of edema.
Fourth, the number of children who received oral
rehydration is not reported and no specific outcome measures related to
rehydration were included, apart from mortality. Severely malnourished
children have excess body and intracellular sodium, even though plasma
sodium may be low. The WHO guidelines state that sodium should be
restricted and a low-sodium rehydration solution (ReSoMal) containing
45mmol Na/L is advised. The new standard ORS contains 75mmol Na/L. When
the WHO guidelines were first developed, the standard ORS had 90mmol Na/L.
In a randomized double-blind therapeutic trial of ReSoMal vs 90mmol ORS in
130 severely malnourished children with acute diarrhea, fewer in the
ReSoMal group developed overhydration (5% vs 12%) but the
difference was not significant(3). A trial to compare ReSoMal with the new
75mmol ORS, with a sample large enough to detect differences in mortality,
has been recom-mended to determine the optimum Na concen-tration(4). It
would be inappropriate to draw conclusions regarding the efficacy of this
particular adaptation from the evidence in this study.
Fifth, the authors report rapid weight gain (average
11g/kg/day) in the ICMH children with a fixed intake of F-100 of
100kcal/kg/day. The reason for the rapid weight gain is that children were
allowed as much family food as they could eat. Intakes of at least
150kcal/kg/day are needed to support this rate of weight gain.
Efficacious simplifications to the WHO guidelines would
be welcomed but they must be based on sound evidence, and this requires
robust methodology and sufficient sample size. In severe malnutrition,
cells, organs and systems cease to function normally. Repairing the
damaged metabolic machinery is best done in an orderly manner and before
any attempt is made to promote weight gain. Adaptations that do not
accord with well-established principles could be harmful. Although a case
fatality rate of 6.7% is encouraging, one wonders if the ICMH children who
survived in this study happen to be ones whose metabolic machinery was not
severely compromised and who were able to withstand the additional stress
imposed on them by the feeding and rehydration adaptations.
I do not consider that this study is sufficiently
robust to warrant a switch to standard ORS or omitting the initial phase
of treatment.
Competing interests: None stated.
Funding: None.
1. Hossain MM, Hassan MQ, Rahman MH, Kabir ARML, Hannan
AH, Rahman AKMF. Hospital management of severely malnourished children:
comparison of locally adapted protocol with WHO protocol. Indian Pediatr
2009: 46: 213-217.
2. World Health Organization. Management of the child
with a serious infection or severe malnutrition. Guidelines for care at
the first-referral level in developing countries. Geneva: WHO; 2000. From
http://whqlibdoc.who.int/hq/2000/WHO_FCH_CAH_00.1/pdf. Accessed Feb 5,
2009.
3. Alam NH, Hamadani JD, Dewni N, Fuchs GJ. Efficacy
and safety of a modified oral rehydration solution (ReSoMal) in the
treatment of severely malnourished children with watery diarrhea. J
Pediatr 2003; 143: 614-619.
4. World Health Organization. Severe malnutrition:
Report of a consultation to review current literature. Geneva: WHO; 2005.
From
http://www.who.int/nutrition/publications/severemalnutrition/Lit_review_report.pdf.
Accessed Feb 5, 2009.