In this study, we have compared the effects of the World Health Organization oral rehydration solution (WHO ORS) and an ORS containing short polymers of glucose (Amylyte ORS) at a high caloric density (five times) and comparable osmolality, on stool output, duration of diarrhea, weight gain and fluid and electrolyte balance, in randomized, open-labeled, controlled clinical trials in five centers. A total of 198 male children (4 months to 10 years) with acute diarrhea ( <72 h after onset) were assigned by random allocation to either WHO ORS or Amylyte ORS at five centers in Asia. Children were stratified according to grade of dehydration (mild, moderate or severe) and the initial purging rates during the first 6 h (low ( < 2 ml/kg/h), moderate (2-5 ml/kg/h) and high ( > 5 ml/kg/h) purgers). The clinical characteristics of the children in the two treatment groups were comparable. Amylyte ORS reduced stool volumes significantly in children with severe dehydration (285.4 +/- 74.2 versus 75.5 +/- 20.0 ml/kg; p < 0.05) and in children with a high initial purging rate (200.3 +/- 42.8 versus 130.5 +/- 9.1 ml/kg; p < 0.05). This was accompanied by a significant (276.4 +/- 14.6 versus 227.6 +/- 11.8 ml/kg; p < 0.01) reduction in ORS requirements in the Amylyte ORS treated group, the effect being greatest in children with severe dehydration (491.5 +/- 108.5 versus 155.7 +/- 27.3 ml/kg; p < 0.01) or high initial purging rates (394.2 +/- 66.2 versus 316.8 +/- 34.8 ml/kg; p < 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)
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