Effect of dilute apple juice and preferred fluids vs. electrolyte maintenance solution on treatment failure among children with mild gastroenteritis. A randomized clinical trial.

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Freedman SB, et al. "Effect of Dilute Apple Juice and Preferred Fluids vs Electrolyte Maintenance Solution on Treatment Failure Among Children With Mild Gastroenteritis: A Randomized Clinical Trial". JAMA. 2016. 315(18):1966-1974.
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Clinical Question

In children with acute gastroenteritis, will the implementation of dilute apple juice and preferred fluids compared to electrolyte maintenance solution alone reduce overall treatment failure?

Bottom Line

In children with acute gastroenteritis, the implementation of dilute apple juice and preferred liquids, compared to electrolyte maintenance solution alone, reduces overall treatment failure. Treatment with dilute apple juice proved to be more effective in children greater than 24 months of age with acute gastroenteritis.

Major Points

Pediatric patients with gastroenteritis commonly experience dehydration as a side effect of diarrhea. World Health Organization (2005) guidelines have suggested oral rehydration for prevention, primarily with electrolyte maintenance solution and strongly avoided commercial fruit juices.1 However, this method is very costly to patients. Electrolyte maintenance solution is also limited to its taste, which can become an adherence issue for pediatric patients.

A single-center, randomized, single-blind non-inferiority trial was performed on 647 patients who were between 6 and 60 months and presented with: 3 or more episodes of vomiting or diarrhea in the previous 24 hours, symptoms lasting less than 96 hours, weight greater than 8 kg and minimal dehydration. Patients were randomly assigned in a 1:1 ratio to receive either half-strength apple juice/preferred liquids or electrolyte maintenance solution. The primary outcome of treatment failure was observed in 16.7% of patients in the apple juice/preferred liquids group and 25.0% in the electrolyte maintenance solution group (NNT=12). The secondary outcome of intravenous rehydration administration within the emergency room showed no statistical significance in the apple juice/preferred juice group compared to electrolyte maintenance group. The trial was limited for reasons including the application to other populations and the lack of blinding of the liquid’s tastes to the children. The intervention was most effective for children older than 24 months.

Guidelines

World Health Organization (2005)

  • Children should be provided with fluids that contain salt to treat dehydration
    • These fluids include:
      • Oral Rehydration Salts (ORS) solution, salted drinks, vegetable or chicken soup with salt
  • Fluids that should be avoided include:
    • Commercial carbonated beverages, commercial fruit juices, sweetened tea

Design

  • Randomized, single-blind, non inferiority trial
  • N=647
    • Half-strength apple juice/preferred fluids(n=323)
    • Apple-flavored electrolyte maintenance solution(n=324)
  • Setting: Tertiary pediatric emergency department in Tononto, Ontario, Canada
  • Enrollment: 2010-2015
  • Analysis: Intention-to-treat
  • Primary outcome:
    • Composite of treatment failure

Population

Inclusion Criteria

  • Aged 6 to 60 months
  • Gastroenteritis (3 or more episodes of vomiting or diarrhea in the preceding 24 hours, less than 96 hours of symptoms, weight of 8 kg (17.7 lb) or higher)
  • Minimal dehydration (clinical dehydration scale lower than 5 and capillary refill of less than 2 seconds)

Exclusion Criteria

  • History of chronic gastrointestinal disease (inflammatory bowel disease, celiac disease) or other diseases (diabetes mellitus, metabolic diseases)
  • Prematurity with correct postnatal age <30 weeks
  • Bilious vomiting
  • Hematemesis
  • Hematochezia
  • Clinical abdomen concern

Baseline Characteristics

  • Age: 28.3 months of age
  • Male: 51.1%
  • Weight: 14.8 kg
  • Enrollment Time: 15:26
  • History of Vomiting: 94.3%
  • Time interval between vomit onset and ED visit: 30.7 hours
  • Vomiting episodes in preceding 24 hrs: 5
  • History of diarrhea: 42.4%
  • Time interval between diarrhea onset and ED visit: 36.6 hours
  • Diarrhea episodes in preceding 24 hrs: 3
  • Rotavirus vaccine received: 28.1%
  • Baseline Clinical Dehydration Scale Score median: 0
  • Normal general appearance: 79.1%
  • Thirsty, restless, lethargic but irritable when touched general appearance: 20.1%
  • Drowsy, limp, cold, sweaty, comatose general appearance: 0.8%
  • Ondansetron Administered: 67.4%

Interventions

  • Upon discharge, pediatric patients were randomly assigned (allocation concealed) to receive color matched half-strength apple juice and preferred liquids or apple-flavored electrolyte maintenance solution. *Oral rehydration protocol was followed during hospitalization.

Outcomes

Comparisons are half-strength apple juice/preferred fluids failure vs. electrolyte maintenance therapy.

Primary Outcomes

Composite Primary Outcome of Overall Treatment Failure
16.7% vs. 25% (P-Value < 0.001; NNT 12)

Secondary Outcomes

IV Rehydration at Index ED Visit
0.9% vs. 6.8% (P-Value < 0.001; NNT 17)
IV Rehydration During Follow-Up Within 7 days of Index Visit
1.9% vs. 3.4% (P-Value = .33)
Hospitalization at Index Visit
0.3% vs. 1.9% (P-Value = .12)
Hospitalization at Follow-Up within 7 days of Index Visit
0.9% vs. 1.5% (P-Value = .73)
Diarrhea episodes
Rate ratio: 1.14% (P-Value = .60)
Vomiting episodes
Rate ratio: 1.07% (P-Value = .39)

Subgroup Analysis

Age and Treatment Failure (P =.01; Threshold OR = 1.44)
< 24 months: 23.9% vs. 24.1%, difference 0.1% [95% CI, -9.5% to 9.2%]
≥ 24 months: 9.8% vs. 25.9%, difference -16.2% [95% CI, -24.2% to -8.0%]

Adverse Events

Hyponatremia
1 patient in each group

Criticisms

Internal
  • Children of low- and middle- income countries have a higher risk of contracting gastroenteritis-related complications, but this study was only conducted in a high-income country.
  • It’s not certain if the results of this study can be applied to other settings and with different electrolyte maintenance solutions.
  • The liquids consumed were the same color, however, the children were not blinded to the taste.
  • Parents were also not blinded as to what solution their child consumed to guide their management of them.
  • Some variables that were not measured include the volume of fluids the children consumed, patient adherence, and crossover at home.
External
  • Some situations where dilute apple juice may not produce reduced treatment failure include severe upset stomachs, children under six months, and children who are already severely dehydrated.2

Funding

This study obtained funding from Freedman, Boutis, and Schuh, which supported a grant provided by the Physician Services Incorporated Foundation (grant 10q1011).

Further Reading

1. World Health Organization. “The treatment of diarrhoea: A manual for physicians and other senior health workers.” 2011. Available from: http://apps.who.int/iris/bitstream/10665/43209/1/9241593180.pdf 2. Dilute apple juice 'as good as' rehydration drinks for children - National Library of Medicine - PubMed Health [Internet]. PubMed Health. 2017 [cited 19 April 2017]. Available from: https://www.ncbi.nlm.nih.gov/pubmedhealth/behindtheheadlines/news/2016-05-04-dilute-apple-juice-as-good-as-rehydration-drinks-for-children/