Treatment for Gastroesophageal Reflux

Metoclopramide for the Treatment of Gastroesophageal Reflux Disease in Infants: A Systematic Review. Hibbs AM and Lorch SA. Pediatrics 2006; Aug: 118(2):746-752. [Full text] [PDF]

OBJECTIVES: To conduct a systematic review of the efficacy of metoclopramide for the treatmentof gastroesophageal reflux disease in infants.

METHODS: We analyzed cohort, case-control,and intervention studies of the efficacy, effectiveness, ortoxicity of metoclopramide therapy for gastro-esophageal refluxdisease in infants.

RESULTS: Twelve articles met our inclusion criteria. Of these,11 were prospective trials, and 5 were randomized, blinded clinicaltrials. Study size ranged from 6 to 77 patients. Eight studiesshowed patient improvement with metoclopramide in at least 1measured outcome; 1 study showed worsening symptoms with metoclopramide.Of the 5 randomized, blinded trials, 2 showed no effect of metoclopramideon any outcome, and 2 showed a significant placebo effect. Fourstudies commented on adverse effects of therapy, with irritabilitybeing the most frequently reported potential adverse effectof therapy. Other reported adverse effects included dystonicreactions, drowsiness, oculogyric crisis, emesis, and apnea.Among studies, there was marked heterogeneity in the patientpopulations, dosing, and outcomes studied. Therefore, a meta-analysiswas not performed. Per the criteria of the US Preventive ServiceTask Force, we rated the level of evidence as “poor”, leadingto an "inconclusive" recommendation for the safety and efficacyof metoclopramide in infants.

CONCLUSIONS: The current literature is insufficient to eithersupport or oppose the use of metoclopramide for gastroesophagealreflux disease in infants. In the future, large blinded randomizedclinical trials are needed to determine the efficacy and toxicityof metoclopramide in this population.

Commentary: When cisapride was withdrawn from neonatal use, reglan (metoclopramide) reemerged as the pharmacologic choice for the management of “reflux-associated” apnea and bradycardia. Some practices restrict its use to infants with symptomatic GER documented by swallowing and videoesophogram studies. With this summation of the literature, perhaps a more conservative approach is indicated. Rather than trying to conduct a large RCT on reglan, might we want to assess in a careful and prospective manner the efficacy of a neonatal formulation of one of the proton pump inhibitors? - MLH

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METHODS: We analyzed cohort, case-control,and intervention studies of the efficacy, effectiveness, ortoxicity of metoclopramide therapy for gastro-esophageal refluxdisease in infants.

CONCLUSIONS: The current literature is insufficient to eithersupport or oppose the use of metoclopramide for gastroesophagealreflux disease in infants. In the future, large blinded randomizedclinical trials are needed to determine the efficacy and toxicityof metoclopramide in this population.

METHODS: We analyzed cohort, case-control, and intervention studies of the efficacy, effectiveness, or toxicity of metoclopramide therapy for gastro-esophageal reflux disease 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.

METHODS: We analyzed cohort, case-control,and intervention studies of the efficacy, effectiveness, ortoxicity of metoclopramide therapy for gastro-esophageal refluxdisease in infants.

CONCLUSIONS: The current literature is insufficient to eithersupport or oppose the use of metoclopramide for gastroesophagealreflux disease in infants. In the future, large blinded randomizedclinical trials are needed to determine the efficacy and toxicityof metoclopramide in this population.