Every year in the United States there are an estimated 178.8 million episodes of acute gastroenteritis resulting in 473,832 hospitalizations. Most of the evidence surrounding oral rehydration centers around Oral Rehydration Therapy (ORT) studies in low-income countries where children suffer from more extensive gastrointestinal losses. Theoretically, electrolyte maintenance solutions are recommended in order to prevent increasing diarrheal losses through the osmotic diuresis that can occur with glucose-rich drinks like juice. However, these electrolyte maintenance solutions can cost up to $10 for a 1-liter bottle and are unpalatable to some children. Refusal to drink often results in the need for IV hydration and can potentially result in disease progression and hospitalization. This study attempted to look at whether a dilute apple juice solution or preferred fluids was equal to, if not superior to oral hydration with an electrolyte maintenance solution.
Is dilute apple juice non-inferior to electrolyte maintenance solutions in the treatment of mild gastroenteritis with minimal dehydration in children aged 6 to 60 months?
Children aged 6 to 60 months presenting to the ED of a tertiary care pediatric hospital in Ontario, Canada with 3 or more episodes of vomiting or diarrhea in the preceding 24 hours, less than 96 hours of symptoms, weight > 8 kg, and minimal dehydration as quantified using a Clinical Dehydration Scale
Half-strength apple juice or preferred fluids given in 5 mL aliquots every 2-5 minutes in the ED, then 10 mL/kg for each episode of diarrhea or 2 mL/kg for each episode of vomiting on discharge
Apple flavored, sucralose sweetened Pharmascience pediatric electrolyte maintenance solution given in 5 mL aliquots every 2-5 minutes in the ED, then 10 mL/kg for each episode of diarrhea or 2 mL/kg for each episode of vomiting following discharge
Primary: Treatment failure (hospitalization, need for IV rehydration, unscheduled subsequent physician encounter (office, urgent care, or ED) for same complaint, protracted symptoms > 7 days, physician request to administer alternate solution causing allocation crossover, weight loss > 3% or Clinical Dehydration Score > 5 on follow-up)
Secondary: Frequency of diarrhea and vomiting, percent weight change at 72 to 84 hours, IV rehydration at initial visit versus subsequent visit, hospitalization at initial visit versus subsequent visit
Randomized, single-blinded non-inferiority study
History of chronic GI disease or other disease complicating clinical picture, prematurity, bilious vomiting, hematemesis, hematochezia, or concern for acute abdomen, need for immediate IV rehydration
- 647 children with similar baseline characteristics between groups and 99.5% follow-up
- Intention-to-treat analysis with pre-specified non-inferiority margin of +7.5%, p < 0.001
Treatment failure rate: 25 % (electrolyte solution group) vs. 16.7 % (dilute apple juice/preferred fluid group)
- 8.3% difference: significant for non-inferiority (97.5% CI).
- Significantly higher IV rehydration rate in electrolyte solution group (9% vs 2.5%)
- Slightly higher rate of hospitalization in electrolyte group, but not significant
- No difference in subsequent unscheduled visits, protracted symptoms, cross-over at initial ED visit, weight loss or dehydration at follow-up visit
Benefit of dilute apple juice/preferred fluids over electrolyte solution was most apparent in children > 24 months (Fig 2)
- Large, well-designed randomized control trial with heterogenous population
- Randomization was appropriately performed (computer-generated randomization kept in sealed envelopes)
- Highly applicable to pediatric population of United States where complicated gastroenteritis is uncommon
- Physicians and researchers were blinded to treatment allocation
- Follow up rate of 99.5%
- Patients were not consecutively recruited. Enrollment was only performed 12 hours/day 6 days/week
- External validity: applicable to high income countries and not the third world where children are sicker
- Results may not apply to other electrolyte rehydration solutions
- Composite primary endpoint: all included endpoints not equivalent (i.e. hospitalization is more clinically important than an unscheduled visit)
- Patients were not blinded to taste
- No information about preferred fluids or how many children refused to drink dilute apple juice
“Among children with mild gastroenteritis and minimal dehydration, initial oral hydration with dilute apple juice followed by their preferred fluids, compared with electrolyte maintenance solution, resulted in fewer treatment failures. In many high income countries, the use of dilute apple juice and preferred fluids may be an appropriate alternative to electrolyte maintenance solution use in children with mild gastroenteritis and minimal dehydration.”
Children in Ontario, Canada with mild gastroenteritis and minimal dehydration who were allowed to drink dilute apple juice or their preferred fluids did just as well, if not better than children who were given an electrolyte maintenance solution. Children who were orally hydrated with electrolyte maintenance solution were more likely to undergo IV hydration, but otherwise did not have significantly different outcomes, including hospitalization.
Potential Impact To Current Practice
Apple juice is cheaper, better tasting, and more widely available than electrolyte maintenance solutions. Previously, we had been taught that juice would cause increased fluid loss through osmotic diuresis. This study shows that this risk is theoretical, and that dilute apple juice or preferred fluids did not increase the risk of IV hydration, hospitalization, protracted symptoms, or worsen dehydration. When children have mild gastroenteritis and require oral hydration, hydration does not have to be done with electrolyte solutions, especially if children do not want to drink them or if electrolyte solutions are too expensive or difficult to access for caregivers.
Children with mild gastroenteritis requiring oral hydration should be encouraged to drink an adequate amount of fluids. Focus should be on the amount of fluid be taken in instead of the type of fluid.
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