In developed countries, use of oral rehydration salts (ORS) solution w
ith osmolarity lower than that of plasma has been recommended because
of the risk of hypernatraemia. We compared the clinical efficacy of re
duced-osmolarity ORS and standard ORS solutions in children with acute
diarrhoea in four developing countries. 447 boys aged 1-24 months, ad
mitted to hospitals in four countries with acute diarrhoea and signs o
f dehydration, were randomly assigned either standard ORS (311 mmol/L)
or reduced-osmolarity ORS (224 mmol/L) solution. Total stool output w
as 39% greater (95% CI 11-75), total ORS intake 18% greater (3-33), an
d duration of diarrhoea 22% longer (2-45) in the standard ORS group th
an in the reduced-osmolarity ORS group. The risk of requiring intraven
ous infusion after completion of the initial oral rehydration was grea
ter in children given standard ORS solution than in those given reduce
d-osmolarity ORS solution in three of the four countries (all-country
relative risk 1.4 [0.9-2.4]). This relative risk was significantly inc
reased only in non-breastfed children (2.0 [1.0-3.8], p<0.05). in brea
stfed children, the relative risk of requiring intravenous infusion wa
s not affected by the ORS solution (0.9 [0.4-2.0]). The mean sodium co
ncentration 24 h after admission was significantly lower in the reduce
d-osmolarity ORS group than in the standard ORS group (135 [134-136] v
s 138 [136-139] mmol/L, p<0.01). Reduced-osmolarity ORS solution has b
eneficial effects on the clinical course of acute diarrhoea. Our findi
ngs support the use of reduced-osmolarity ORS solution in children wit
h acute non-cholera diarrhoea in developing countries. Further studies
are needed to find the best formulation and whether such a solution w
ould be satisfactory for the treatment of cholera.