Efficacy and safety of a new apple-flavoured oral rehydration solution in children with acute gastroenteritis: a double-blind randomized controlled trial : Efficacy and safety of a new apple-flavoured ORS

To review the relative efficacy and safety of enteral vs intravenous (IV) rehydration therapy in treating childhood gastroenteritis. MEDLINE, EMBASE, and the Cochrane Controlled Trials Register databases were searched. Known investigators and expert bodies were contacted to locate unpublished and ongoing studies. Studies were selected based on the following criteria: randomized or quasi-randomized trials; children younger than 15 years with a clinical diagnosis of gastroenteritis of less than 1-week duration; interventions comprising enteral and IV treatment arms; and at least 1 of the following: major adverse event rates, treatment failure rates, weight gain with treatment, measurement of ongoing losses, length of hospital stay, costs of treatment, and satisfaction with treatment. Data were extracted from eligible studies, which were then combined using a random-effects model. Sixteen trials involving 1545 children and conducted in 11 countries were identified. Compared with children treated with IV rehydration, children treated with oral rehydration had significantly fewer major adverse events, including death or seizures (relative risk, 0.36; 95% confidence interval [CI], 0.14-0.89), and a significant reduction in length of hospital stay (mean, 21 hours; 95% CI, 8-35 hours). There was no difference in weight gain between the 2 groups (mean, -26 g; 95% CI, -61 to 10 g). The overall failure rate of enteral therapy was 4.0% (95% CI, 3.0%-5.0%). For childhood gastroenteritis, enteral rehydration is as effective if not better than IV rehydration. Enteral rehydration by the oral or nasogastric route is associated with significantly fewer major adverse events and a shorter hospital stay compared with IV therapy and is successful in most children.

A randomized, double-blind, placebo-controlled multicenter study to evaluate efficacy and safety of a mixture of non-digestible carbohydrates (NDC) as an adjunct to oral rehydration therapy in treatment of acute infectious diarrhea in children with mild to moderate dehydration. 144 boys aged 1 to 36 months with diarrhea defined as three or more watery stools per day for >1 day but <5 days with mild or moderate dehydration (World Health Organization criteria) were randomly assigned to receive hypotonic oral rehydration solution (ORS) (Na 60 mmol/L, glucose 111 mmol/L) with or without a mixture of NDC (soy polysaccharide 25%, alpha-cellulose 9%, gum arabic 19%, fructooligosaccharides 18.5%, inulin 21.5%, resistant starch 7%). Intention-to-treat analysis did not show significant differences in mean 48 hour stool volume (ESPGHAN-ORS with NDC versus ESPGHAN-ORS, 140 +/- 124 g/kg versus 143 +/- 114 g/kg; P = 0.41). Duration of diarrhea after randomization was similar in both groups (82 +/- 39 hours versus 97 +/- 76 hours, P = 0.24). There were no significant differences in the duration of hospital stay (111 +/- 44 hours versus 126 +/- 78 hours; P = 0.3). Unscheduled intravenous rehydration was similar in both groups (21.4% versus 16.2%, P = 0.42). In boys with acute non-cholera diarrhea with mild to moderate dehydration a mixture of non-digestible carbohydrates was ineffective as an adjunct to oral rehydration therapy.