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Randomized Controlled Trial
. 2019 May;35(2):261-271.
doi: 10.1177/0890334418819465. Epub 2019 Jan 10.

Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial

Laurie Nommsen-Rivers  1 , Amy Thompson  1 , Sarah Riddle  1   2 , Laura Ward  1   2 , Erin Wagner  1 , Eileen King  1   2
Affiliations
Randomized Controlled Trial

Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial

Laurie Nommsen-Rivers et al. J Hum Lact. 2019 May.

Abstract

Background: Metformin improves insulin action, but feasibility in treating low milk supply is unknown.

Research aim: To determine the feasibility of a metformin- versus-placebo definitive randomized clinical trial in women with low milk production and signs of insulin resistance.

Methods: Pilot trial criteria included: Mother 1-8 weeks postpartum (ideally 1-2 weeks), low milk production, and ≥1 insulin resistance sign; and singleton, healthy, term infant. Eligible mothers were randomly assigned 2:1 (metformin:placebo) and instructed in frequent milk removal for 28 days with option to stop at 14 days.

Results: From 02/2015 through 06/2016, we screened 114 women, completed baseline assessments on 46, and trialed 15 (median, 36 days postpartum). Comparing metformin-assigned ( n = 10) to placebo ( n = 5), 70% versus 80% continued to day 28; peak median change in milk output was +8 versus -58 mL/24 hr ( p = .31) and 80% peaked at Day 14 for both groups; 0% versus 20% desired to continue assigned drug after study completion; 44% versus 0% reported nausea/vomiting. Post-hoc, median peak change in milk output was +22 (metformin completers, n = 8) versus -58 mL/24 hr (placebo + non-completers, n = 7, p = .07). At baseline assessment, median milk production was significantly lower in those with ( n = 31), versus those without ( n = 15) signs of insulin resistance ( p = .002).

Conclusions: Although results trend toward hypothesized direction, trial feasibility concerns include late enrollment and only 20% of metformin-assigned participants sustaining improved milk output to Day 28, with none perceiving metformin worthwhile. Better tools are needed to identify and treat metabolically-driven low milk production. Registered at ClinicalTrials.gov (NCT02179788) on 02/JUL/2014.

Keywords: Breastfeeding; human milk production; insufficient milk; lactation; maternal health Randomized Controlled Trials.

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Conflict of interest statement

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Participant Flow.
Figure 2.
Figure 2.
Maximum Improvement in Milk Production from Baseline.
See this image and copyright information in PMC

Comment in

  • Reply to Letter to the Editor by Frank Nice.
    Nommsen-Rivers L, King E, Wagner E, Riddle S, Ward L, Thompson A. Nommsen-Rivers L, et al. J Hum Lact. 2020 Feb;36(1):196. doi: 10.1177/0890334419879116. Epub 2019 Oct 9. J Hum Lact. 2020. PMID: 31596640 No abstract available.
  • Letter to the Editor.
    Nice FJ. Nice FJ. J Hum Lact. 2020 Feb;36(1):195. doi: 10.1177/0890334419879110. Epub 2019 Oct 9. J Hum Lact. 2020. PMID: 31596654 No abstract available.

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