OBJECTIVES. Metoclopramide is a commonly used drug to treat gastroesophageal reflux disease in infants. Given its widespread use and growing concern about toxicity in this population, we conducted a systematic review of metoclopramide for the treatment of gastroesophageal reflux disease in infants.

METHODS. We performed a systematic search of PubMed and bibliographies of relevant review articles. We included cohort, case-control, and intervention studies of the efficacy, effectiveness, or toxicity of metoclopramide therapy for gastroesophageal reflux disease in infants. We excluded case reports, case series, review articles, and abstracts.

RESULTS. Twelve articles met our inclusion criteria. Of these, 11 were prospective trials, and 5 were randomized, blinded clinical trials. Study size ranged from 6 to 77 patients. Eight studies showed patient improvement with metoclopramide in at least 1 measured outcome; 1 study showed worsening symptoms with metoclopramide. Of the 5 randomized, blinded trials, 2 showed no effect of metoclopramide on any outcome, and 2 showed a significant placebo effect. Four studies commented on adverse effects of therapy, with irritability being the most frequently reported potential adverse effect of therapy. Other reported adverse effects included dystonic reactions, drowsiness, oculogyric crisis, emesis, and apnea. Among studies, there was marked heterogeneity in the patient populations, dosing, and outcomes studied. Therefore, a meta-analysis was not performed. We both agreed on a US Preventive Service Task Force rating of “poor” for the level of evidence, leading to an “inconclusive” recommendation for the safety and efficacy of metoclopramide in infants.

CONCLUSIONS. The current literature is insufficient to either support or oppose the use of metoclopramide for gastroesophageal reflux disease in infants. In the future, large blinded randomized clinical trials are needed to determine the efficacy and toxicity of metoclopramide in this population.

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