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  • Title: A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose.
    Author: Santosham M, Fayad I, Abu Zikri M, Hussein A, Amponsah A, Duggan C, Hashem M, el Sady N, Abu Zikri M, Fontaine O.
    Journal: J Pediatr; 1996 Jan; 128(1):45-51. PubMed ID: 8551420.
    Abstract:
    OBJECTIVE: To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea. METHODS: One hundred ninety boys, aged 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours. RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups. CONCLUSION: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea. Between July 1993 and March 1994, clinical researchers in Egypt enrolled 190 male children aged 1-24 months with acute diarrhea at the Abu El Reeche Hospital in Cairo in a randomized double-blind clinical trial to evaluate the relative efficacy of a reduced osmolarity oral rehydration solution (ORS) containing 75 mmol/l of both sodium and glucose (total osmolarity, 245 vs. 311 mmol/l for the standard ORS recommended by the World Health Organization and UNICEF) for treating acute noncholera diarrhea. They measured intake and output every three hours. Over the entire course of the study, the mean stool output was significantly lower in the reduced osmolarity ORS group than the standard ORS group (4.3 vs. 5 g/kg/hour; p 0.05). During the rehydration phase, the mean stool output was 36% lower in the reduced osmolarity ORS group than in the standard ORS group (p 0.05). The proportion of children vomiting during rehydration was much lower in the reduced osmolarity ORS group than the standard ORS group (17% vs. 33%; relative risk [RR] = 2.4; p 0.01). During the maintenance phase, the two groups shared similar stool output, mean intake of food and ORS, duration of diarrhea, and weight gain. Treatment failure was significantly more common in the standard ORS group than the reduced osmolarity ORS group (8% vs. 1%; RR = 7.9; p 0.01). The mean serum sodium level at 24 hours were much lower in the reduced osmolarity ORS group (134 vs. 138 mEq/l; p 0.001) but remained within the normal range in both groups. Children in both groups developed hyponatremia or their hyponatremia worsened at the same rate. Urine output was about the same in both groups. These findings suggest that the reduced osmolarity ORS has advantages over the standard ORS as a treatment for acute noncholera diarrhea. This safe and effective rehydration treatment reduces stool output and vomiting during rehydration as well as reduces the need for supplemental intravenous therapy.
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