Journal of Family Practice - What is the best treatment for gastroesophageal reflux and vomiting in infants?

* Evidence-Based Answer
The literature on pediatric reflux can be divided into studies addressing clinically apparent reflux (vomiting or regurgitation) and reflux as measured by pH probe or other methods (TABLES 1 AND 2). Sodium alginate reduces vomiting and improves parents’ assessment of symptoms (strength of recommendation [SOR]: B, small randomized controlled trial [RCT]). Formula thickened with rice cereal decreases the number of postprandial emesis episodes in infants with gastroesophageal reflux disease (GERD) (SOR: B, small RCT).

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There are conflicting data on the effect of carob bean gum as a formula thickener and its effect on regurgitation frequency (SOR: B, small RCTs). Metoclopramide does not affect vomiting or regurgitation, but is associated with greater weight gain in infants over 3 months with reflux (SOR: B, low-quality RCTs).
Carob bean gum used as a formula thickener decreases reflux as measured by intraluminal impedance but not as measured by pH probe (SOR: B, RCT). Omeprazole and metoclopramide each improve the reflux index as measured by esophageal pH probe (SOR: B, RCT).
Evidence is conflicting for other commonly used conservative measures (such as positional changes) or other medications for symptomatic relief of infant GERD. There is very limited evidence or expert opinion regarding breastfed infants, particularly with regard to preservation of breastfeeding during therapy.
* Evidence Summary
Regurgitation (”spitting up”) and gastroesophageal reflux are common in infants. In a cross-sectional survey of 948 parents of healthy infants aged 0 to 13 months, regurgitation occurred daily in half of infants from birth to 3 months old, peaked to 67% at age 4 months, and was absent in 95% by age 12 months. (1) Gastroesophageal disease (GERD) is characterized by refractory symptoms or complications (pain, irritability, vomiting, failure to thrive, dysphagia, respiratory symptoms, or esophagitis) and occurs in the minority of infants with reflux. (2) This distinguishes the “happy spitter,” whose parents may simply require reassurance, from infants who require treatment.
Unfortunately, most of the available studies do not make this distinction in their subjects. Also, available data primarily regard formula-fed infants, and are insufficient to make recommendations for breastfed infants. Esophageal pH probe monitoring is the gold standard for measuring reflux in research; however, its correlation with symptoms is questionable and it is infrequently used in clinical practice. (3) Therefore, recommendations are focused primarily on treating only clinically-evident reflux (emesis and regurgitation).
Five small RCTs studied the practice of using formula thickeners (TABLES 1 AND 2). In 1 study, formula thickened with rice cereal decreased emesis episodes. (4) Two studies of carob bean gum-thickened formula vs plain formula yielded conflicting results. (5,6) In the study showing improvement with carob bean gum, the parents were not blinded to the treatment, which may have led to bias favoring the treatment. (5) An uncontrolled, comparative trial of carob bean gum vs rice cereal suggested superiority of carob bean gum as a thickener, although both treatments yielded improvement. (7) Carob bean gum is available in the UK as a powder (Instant Carobel) but is not widely available in the US.
Three trials studied the effects of other conservative therapies such as positional changes and pacifiers on reflux measured by pH probe; unfortunately, none assessed clinical outcomes such as emesis or regurgitation. (3) Reflux by pH probe was worsened in a trial studying the infant seat for positioning. In the trial studying elevating the head of the bed to 30 [degrees] in the prone position, reflux measured by pH probe was also unchanged; prone positioning is no longer recommended due to the risk of Sudden Infant Death Syndrome (SIDS). (8) The trial of pacifier use showed improvement of reflux by pH probe when used in the seated position, but worsening in the prone position. Since pH probe does not necessarily reflect clinical symptoms, the utility of the information from these studies is limited.
Only I trial of drugs used to treat infant reflux measured clinical symptoms. This large manufacturer-sponsored RCT found that sodium alginate (9) significantly reduced emesis episodes in treated infants. Sodium alginate is marketed in the UK as Gaviscon Infant. While this trial included breastfed infants, it did not report the numbers of breastfed infants in the 2 treatment groups or present data separately for breastfed infants. Small RCTs of metoclopramide (10) and omeprazole (11) show significant improvement in reflux index measured by pH probe. However, metoclopramide yielded no improvement in symptom counts, and the omeprazole study resulted in no differences in “cry-fuss time” between treatment groups.
* Recommendations from Others
The North American Society for Pediatric Gastroenterology and Nutrition recommends thickening agents or a trial of hypoallergenic formula for vomiting infants. (2) They caution against prone positioning and favor proton pump inhibitors over H2 blockers for symptomatic relief and healing of esophagitis. They found insufficient evidence to recommend surgery over medication.