Human Milk Expression After Domperidone Treatment in Postpartum Women: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract

Background: Insufficient milk production is among the most cited reasons by mothers for discontinuing breastfeeding. Medications that can increase milk production, such as domperidone, an off-label galactagogue, are often prescribed. Domperidone is controversial as it is not approved for any purpose in the United States and is approved only for gastrokinetic purposes in Canada and other countries. Research aim: The aim was to update the existing literature on the efficacy of domperidone as a galactagogue compared to placebo when given to mothers with insufficient human milk production. The primary outcome is the change in expressed human milk volume per day from baseline. Methods: The authors independently searched the literature from inception to May 2018. The search included any randomized controlled trials examining the efficacy of domperidone increasing mothers’ expressed human milk, measured via a human milk pump. Both authors independently assessed quality and risk of bias and extracted relevant data. Meta-analysis on expressed human milk volume per day was performed. Results: Seven studies met the inclusion criteria for review; two were excluded from the meta-analysis due to quality grading and insufficient reporting of the outcome of interest. Five studies ( N = 239) were combined in the meta-analysis. The effect size showed an increase in the mean difference of expressed human milk volume in mothers given domperidone, 93.97 mL per day (95% CI [71.12, 116.83 mL]; random effect, T2 0.00, I2 0%). Conclusion: This meta-analysis reports a significant improvement in expressed human milk volume per day with the use of domperidone in mothers experiencing insufficient human milk production.

Efficacy and safety of domperidone and metoclopramide in breastfeeding women: A systematic review and meta-analysis

“…The current findings are consistent with previous meta-analysis using domperidone to significantly increase human milk volume 17,18 . This consistence could be owing to the mechanism of domperidone, which is a dopamine antagonist that can enhance milk volume through stimulating prolactin release 5 .…”

“…Risk ratio (RR) was utilized for dichotomous variables, and mean difference (MD) for continuous variables. Formulas used to calculate the changes in human milk volume were adopted from the previous review evaluating the efficacy of domperidone on milk production 18 . Summary measures were presented using effect size with 95% confidence intervals (CI).…”

“…Previous systematic reviews have been published on the efficacy of domperidone in milk production [16][17][18] . However, there were some recent clinical trials (e.g., Rai 2016, Fazilla 2017) missing from these reviews.…”

“Fear of stopping” vs “wanting to get off the medication”: exploring women’s experiences of using domperidone as a galactagogue - a qualitative study

“…Recent systematic reviews and meta-analyses have demonstrated domperidone to be more effective than a placebo in improving breast milk volume in mothers of preterm infants [13,14], but evidence remains inconclusive outside of this setting [4]. There also remain uncertainties regarding the population that would most benefit from this treatment.…”

Is domperidone, used as a pharmacologic galactagogue, effective at increasing milk supply in a breastfeeding mother?

“…A 2019 meta-analysis of seven randomized controlled trials (RCTs; N=371) evaluated the effectiveness of domperidone in increasing milk supply in lactating mothers with insufficient production. 1 It should be noted that domperidone is not approved by the Food and Drug Administration for use in the United States and using it as a galactagogue is an off-label use of the drug. Patients were postpartum mothers 18 to 35 years old who were not producing a sufficient milk supply for their infants.…”