The effect of fenugreek on milk volume and prolactin level in mothers of premature infants: A randomized controlled clinical trial

Abstract

Abstract Background: Breast milk is the preferred source of nutrition for premature infants. Galactagogues are herbs that initiate, induce and maintain milk production and lactation. They are widely used to alleviate lactate-related complications. Therefore, this study was performed to examine the effect of fenugreek on milk volume and prolactin level (primary outcomes) and neonatal weight gain, breastfeeding satisfaction, and side effects (secondary outcomes) in mothers of preterm infants. Methods: This triple-blind randomized controlled clinical trial was performed on 68 mothers. Participants were randomly allocated into intervention (fenugreek) and control (placebo) groups. 500 mg fenugreek and placebo capsules were administered to the participants three times a day from the fifth day after delivery to the 14th day. Breast milk volume was measured on the fourth day after delivery (one day before the intervention), the seventh day, and the fifteenth day after the intervention. Prolactin levels were measured in the morning before and after the intervention. Independent t-tests, Chi-square, Mann-Whitney and ANCOVA were used to analyze the data. Results: There was no statistically significant difference between the two groups regarding demographic characteristics, milk volume, and baseline prolactin levels (p>0.05). On the seventh day of the intervention, milk volume was significantly higher in the intervention group than in the control group (p= 0.017). Nevertheless, there was no statistically significant difference between the two groups in milk volume (p= 0.073) and prolactin (p= 0.324) on day 15. Moreover, there was no statistically significant difference between the two groups regarding infant weight after intervention (p= 0.172) and breastfeeding satisfaction (p= 0.484). Finally, no side effects were reported by participants.Conclusions: Findings indicated that fenugreek increases milk volume but has no significant effect on prolactin levels. Further trials with larger sample sizes should be performed to conclusive results.