UNLABELLED: In past studies, patients with cholera and cholera-like diarrhoea treated withrice oral rehydration solution (ORS) had lower purging rates and a shorter illness duration. We evaluated a new packet form of rice ORS (CeraLyte-90) in 167 boys aged 5 to 15 y, with acute, dehydrating cholera and cholera-like diarrhoea in Bangladesh. The patients were randomized to receive either CeraLyte-90 (n = 85) or glucose ORS (n = 82) and were given early feeding and early antibiotics. The efficacy of the two solutions was compared for stool output during the first 8 h, the first 24 h, and total output, duration of diarrhoea, hematocrit, serum electrolytes and requirement for unscheduled intravenous fluids. The clinical and laboratory characteristics of the two groups were comparable on admission, and most of the patients had cholera (88% and 84% in the CeraLyte and glucose groups, respectively). The mean (+/- SE) stool output was 20% less in the rice ORS group during the first 8 h of treatment (86.2+/-6.6 ml/Kg vs 108.8+/-7.9 ml/Kg, p < 0.05), but the outputs during the other time periods were similar in the two groups, although children in the rice ORS group had slightly more vomiting on day one (p < 0.05). The mean serum electrolyte concentrations in both groups of children remained within normal range. CONCLUSION: The study documents the safety and efficacy of the new, packaged rice ORS.
RCT Entities:
UNLABELLED: In past studies, patients with cholera and cholera-like diarrhoea treated with rice oral rehydration solution (ORS) had lower purging rates and a shorter illness duration. We evaluated a new packet form of rice ORS (CeraLyte-90) in 167 boys aged 5 to 15 y, with acute, dehydrating cholera and cholera-like diarrhoea in Bangladesh. The patients were randomized to receive either CeraLyte-90 (n = 85) or glucose ORS (n = 82) and were given early feeding and early antibiotics. The efficacy of the two solutions was compared for stool output during the first 8 h, the first 24 h, and total output, duration of diarrhoea, hematocrit, serum electrolytes and requirement for unscheduled intravenous fluids. The clinical and laboratory characteristics of the two groups were comparable on admission, and most of the patients had cholera (88% and 84% in the CeraLyte and glucose groups, respectively). The mean (+/- SE) stool output was 20% less in the rice ORS group during the first 8 h of treatment (86.2+/-6.6 ml/Kg vs 108.8+/-7.9 ml/Kg, p < 0.05), but the outputs during the other time periods were similar in the two groups, although children in the rice ORS group had slightly more vomiting on day one (p < 0.05). The mean serum electrolyte concentrations in both groups of children remained within normal range. CONCLUSION: The study documents the safety and efficacy of the new, packaged rice ORS.