Investigating the Effectiveness of Fenugreek on the Quantity of Breast Milk and the Level of Prolactin in Mothers of Preterm Newborns: A Randomized Controlled Clinical Trial.

2025-11
Current drug research reviews 17(3)
- Mahsa Rouhi
- Mohammad Bagher Hossieni
- Laleh Khodaie
- Sakineh Mohammad-Alizadeh-Charandabi
- Mojgan Mirghafourvand

PubMed: 41239794
DOI: 10.2174/0125899775313919240822102906

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 68 mothers with preterm newborns less than 32 weeks
Methods: Triple-blind RCT, 500 mg fenugreek or placebo capsules three times a day from day 5 to day 14 after delivery
Blinding: Triple-blind
Duration: from day 5 to day 14 after delivery
Funding: Unclear

Introduction

Breast milk is the preferred source of nutrition for premature infants. Galactagogues are used in initiation, induction, and maintenance of lactation. This study examined the effectiveness of fenugreek on prolactin levels and milk volume (primary outcomes), neonatal weight gain, breastfeeding satisfaction, and side effects (secondary outcomes).

Methods

This triple-blind randomized controlled trial was conducted on 68 mothers with preterm newborns less than 32 weeks in Al-Zahra and Taleghani hospitals in Tabriz-Iran. Participants were randomly allocated into fenugreek and placebo groups. About 500 mg of 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.

Results

On the seventh day of the intervention, milk volume was significantly higher in the fenugreek group than in the placebo group (p =0.017). Nevertheless, no statistically significant difference was observed between groups in milk volume (p =0.073) and prolactin level (p =0.324) on day 15. Moreover, no statistically significant difference was observed between groups regarding newborn weight after intervention (p =0.172) or satisfaction with breastfeeding (p =0.484). None of the participants reported any side effects.

Conclusions

Fenugreek increases milk volume but has no significant effect on prolactin levels. Further trials with larger sample sizes should be performed to obtain conclusive results.

Clinical trial registration number

IRCT20120718010324N62.

Research Insights

Fenugreek→Improved Breastfeeding Satisfaction
no statistically significant difference was observed between groups regarding ... satisfaction with breastfeeding (p =0.484).
Effect
Neutral
Effect size
Small
Dose
500 mg three times a day
Fenugreek→Increased Breast Milk Volume
no statistically significant difference was observed between groups in milk volume (p =0.073) ... on day 15.
Effect
Neutral
Effect size
Small
Dose
500 mg three times a day
Fenugreek→Increased Newborn Weight
no statistically significant difference was observed between groups regarding newborn weight after intervention (p =0.172)
Effect
Neutral
Effect size
Small
Dose
500 mg three times a day
Fenugreek→Increased Prolactin Level
no statistically significant difference was observed between groups in ... prolactin level (p =0.324) on day 15.
Effect
Neutral
Effect size
Small
Dose
500 mg three times a day

Adverse Events Reported

Fenugreek→Overall tolerability
None of the participants reported any side effects.
Finding
Reported