Effect of domperidone on insufficient lactation in puerperal women: a systematic review and meta-analysis of randomized controlled trials.

Background. There is a controversy within the medical community regarding the role of domperidone as a galactagogue and the drug has been removed from the US market owing to safety concerns. Objective. To perform a systematic review and meta-analysis of the available data assessing the effect of domperidone on breast milk production in women experiencing insufficient lactation. Study Selection. Randomized controlled trials (RCTs) examining the effect of domperidone on breast milk production of puerperal women were eligible for inclusion. Data Analysis. Absolute and relative changes from baseline were calculated for individual studies and pooled using a random effects model. Results. Three RCTs including 78 participants met the inclusion criteria. All showed a statistically significant increase in breast milk production following treatment with domperidone. The analysis of pooled data demonstrated a statistically significant relative increase of 74.72% (95%  CI = 54.57; 94.86, P < 0.00001) in daily milk production with domperidone treatment compared to placebo. No maternal or neonatal adverse events were observed in any of the trials. Conclusions. Evidence from a few small RCTs of moderate to high quality suggests that domperidone produces a greater increase in breast milk supply than placebo.