Use of Galactogogues in Initiating or Augmenting Maternal Milk Production

Publication Date: September 11, 2018
Last Updated: March 14, 2022

Recommendations

Pharmaceutical Galactogogues

  • Human growth hormone
()
(lB, llA)
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  • sulpride
(IIB)
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  • and thyrotropin-releasing hormone
(IB)
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may be helpful as galactogogues in some populations, but are not currently used in most countries.
Domperidone and metoclopramide are the most commonly used pharmaceutical galactogogues at present.
(llA, lll)
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Domperidone

A Cochrane systematic review published in 2012 included two studies with a total of 59 mothers with preterm infants and found a moderate benefit (mean increase of 99 mL per day) when using domperidone, 30 mg per day, for 7 or 14 days. Other systematic reviews have similar findings, with the most recent review that included one finding a mean increase of 88.3 mL per day (95% confidence interval 56.8– 119.8). (IA)
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There have been four RCTs using domperidone since the Cochrane review. In one study of 45 women, 22 were given domperidone, 30 mg per day, for 4 days postcesarean section and were found to have increased milk production during that time compared with the control group. (IB)
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In a second study of only 15 women with low milk supply who were expressing for preterm infants, there was a 300-mL per day difference in milk production for women given domperidone, 60 mg per day, for 4 weeks compared with women given domperidone, 30 mg per day, for a similar length of time. (IB)
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A third trial in the United Kingdom compared the effects of domperidone, 30 mg per day, with metoclopramide, 30 mg per day. Women had 24-hour milk production measured from 10 days before the commencement of medication administration and during the 10 days of medication administration. The 51 women were expressing for their preterm infants and had documented low milk supply. They all received high-quality breastfeeding assistance throughout the study. Milk production almost doubled from the steady premedication level with both medications and plateaued after about 7 days of treatment. (IB)
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The fourth and largest trial to date (EMPOWER) included 90 women who had low milk supply when expressing for preterm infants. They were randomized between 8 and 21 days postpartum to receive domperidone, 30 mg per day, for 28 days or a placebo for 14 days and then domperidone, 30 mg per day, from day 15 to 28. At 14 days, 77.8% of women in the first group had increased their milk production by 50% compared with 57.8% in the second group. By 28 days, there were no significant differences between the two groups, nor were there differences at term or at 6 weeks post-term. (IB)
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The results of one older very small study (n = 6) suggested that individual women may be responders or nonresponders and that primiparas may respond to domperidone with higher prolactin levels than multiparas. (IB)
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With respect to potential risks, there is evidence that domperidone increases the QTc interval and it has been implicated in ventricular arrhythmias and sudden cardiac death, particular in older and unwell adults. ()
(lA, lV)
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The risk for domperidone to increase the incidence of arrhythmias in postpartum women with no other risk factors appears to be very small, but may increase with other factors such as a past history of ventricular arrhythmias, high BMI, higher dosages, and concomitant use of medications that inhibit CYP3A4. (III)
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Metoclopramide

Five randomized, placebo-controlled blinded studies researching the effect of metoclopramide have been published between 1980 and 2011. Of these, participants in three studies commenced metoclopramide within 4 days of birth without a diagnosis of low milk supply, one study investigated women who were relactating, and one recruited women whose infants had not gained 500 g within the first month of life. None of these studies found differences in milk volumes and/or breastfeeding duration between metoclopramide and placebo groups, even with optimal breast expression and counseling. However, as mentioned above, Ingram et al. found similar positive effects with metoclopramide and domperidone. (IB)
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In addition,
  • a number of older randomized controlled trials
(lB, llA)
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  • controlled trials
(IIB)
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  • and observational studies
(III)
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reported a significant increase in milk yield using metoclopramide, 5–20 mg, three times a day for periods of 5 days to 4 weeks. The one study that compared different doses of metoclopramide found no response with 15 mg per day, but similar responses with 30 and 45 mg per day. The scientific rigor of these older studies may not be as strong as more recent studies, so their results should be interpreted with caution. As for potential risks, metoclopramide may cause neurological side effects in the mother.

Herbals, Foods, and Beverages as Galactogogues

In non-Western cultures, postpartum women are assisted in a number of ways that are intended to ease their transition to motherhood and to optimize breastfeeding. Many cultures keep new mothers very warm and insist on a period of rest of ~1 month. Many also have traditional foods and herbs for postpartum women that are meant to increase the mother’s strength and enhance lactation. (IV)
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Many of these herbal remedies have been used throughout history to enhance milk supply. Some herbs commonly mentioned as galactogogues include fenugreek, goat’s rue, milk thistle (Silybum marianum), oats, dandelion, millet, seaweed, anise, basil, blessed thistle, fennel seeds, marshmallow, moringa leaf, shatavari, and torbangun among others. (IA)
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LactMed (https://toxnet.nlm.nih.gov/newtoxnet/lactmed.htm) has further information about the effect on lactation of some of these herbs. Although beer is used in some cultures to increase milk supply, hops appear to be the active ingredient, while alcohol may actually reduce milk production. (IA)
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It is important to note that caution is required for the use of herbal preparations because of the lack of standardized dosing preparations (other than in research settings), possible contaminants, allergic potential, and drug interactions.
  • Adverse effects for both mother and infant from several herbs have been reported,
(IV)
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  • and some will increase patient blood levels of warfarin, heparin, and other anticoagulants, while others may affect insulin resistance and blood sugars. There are several reports of severe maternal allergic reactions to fenugreek.
(III)
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Practice Recommendations

Evaluate the mother for medical causes of low milk supply: pregnancy, medications, primary mammary glandular insufficiency, breast surgery, polycystic ovarian syndrome, hypothyroidism, retained placenta, ingestion of placenta capsules, theca lutein cyst, loss of prolactin secretion following postpartum hemorrhage, heavy smoking or alcohol use, or other pertinent conditions. Treat the condition as indicated if treatment is available. For many of these women, a galactogogue should not be recommended or prescribed.
Assess and increase the frequency and effectiveness of milk removal. Use nonpharmacologic measures to increase the overall rate of breast milk synthesis. For women whose infants are not effective at milk removal or are unable to feed at the breast (e.g., premature, hospitalized, hypotonic, and anatomical problems), regularly expressing by hand and/or breast pump is necessary. Ensure that the expressing technique and any breast pumps used are effective. Galactogogues will not increase the milk supply if there is infrequent or inadequate breast drainage.
Although there are more high-quality studies of domperidone and some studies of herbal galactogogues since the last revision of this protocol, current research of both pharmaceutical and herbal galactogogues is still relatively inconclusive and all agents have potential adverse effects. Therefore, ABM cannot recommend any specific galactogogue at this time. (-)
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If the healthcare provider chooses to prescribe a galactogogue after weighing potential risks versus potential benefits of these agents, they should follow the guidelines below.
  1. Inform women about available data concerning efficacy, timing of use, and duration of therapy of galactogogues.
  2. Inform women about available data concerning potential adverse effects of galactogogues.
  3. Screen the mother for contraindications to, allergies to, or drug interactions with the chosen medication or other substance.
(IV)
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If prescribing domperidone:
  • It is particularly important to screen mothers for a past history of cardiac arrhythmias and concomitant use of medications such as fluconazole, erythromycin, and other macrolide antibiotics.
  • While no studies have been undertaken, some practitioners perform an electrocardiogram on women of concern before commencement of the medication and at 48 hours. If there is prolongation of the QTc interval, the medication is ceased.
  • Provide ongoing care to, supervise ongoing care of, or transfer care of both mother and infant to ensure appropriate follow-up and attention to any side effects.
  • Prescribe galactogogues at the lowest possible doses for the shortest period of time; do not exceed recommended therapeutic doses.
  • Consider gradually discontinuing the drug (tapering the dose) rather than abruptly discontinuing the therapy; some studies simply stop the drug at the conclusion of therapy and others gradually discontinue the drug, with no clear advantage to either method.
  • If milk production wanes after stopping the drug and improves again with resumption of medication, attempt to gradually decrease the drug to the lowest effective dose and then discontinue the drug at a later date if possible.
  • Consider documenting that there has been a discussion about contraindications and that the mother has been provided with information about the benefits and risks of any galactogogue being prescribed.
()
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Recommendation Grading

Overview

Title

Use of Galactogogues in Initiating or Augmenting Maternal Milk Production

Authoring Organization

Academy of Breastfeeding Medicine

Publication Month/Year

September 11, 2018

Last Updated Month/Year

June 9, 2022

Supplemental Implementation Tools

Document Type

Guideline

External Publication Status

Published

Country of Publication

US

Inclusion Criteria

Female, Adult

Health Care Settings

Ambulatory, Home health, Hospital, Outpatient

Intended Users

Nurse midwife, dietician nutritionist, counselor, nurse, nurse practitioner, physician, physician assistant

Scope

Counseling, Prevention, Management

Diseases/Conditions (MeSH)

D007225 - Infant Food, D007231 - Infant, Newborn, D007228 - Infant Nutrition Disorders, D064186 - Prenatal Education, D048070 - Fetal Nutrition Disorders

Keywords

Breastfeeding, promote breastfeeding, Promote Breastfeeding, Galactogogues, lactagogues

Supplemental Methodology Resources

Data Supplement

Methodology

Number of Source Documents
64
Literature Search Start Date
January 1, 1976
Literature Search End Date
December 31, 2018
Description of External Review Process
Yes. The draft protocol is peer reviewed by individuals outside of contributing author/expert panel, including specific review for international applicability. The Protocol Committee's sub-group of international experts recommends appropriate international reviewers. The Chair and/or protocol resource person institutes and facilitates this process. Reviews are submitted to the committee Chair and resource person. The contributing author/expert panel and/or designated members of protocol committee work to amend the protocol as needed. The draft protocol is submitted to the Academy of Breastfeeding Medicine (ABM) Board for review and approval. Comments for revision will be accepted for three weeks following submission. The Chair, resource person and protocol contributor(s) amend the protocol as needed. Following all revisions, the protocol has the final review by original contributor(s) to make final suggestions and ascertain whether to maintain contributing authorship. The final protocol is submitted to the Board of Directors of ABM for approval. A two-thirds majority of Board members' positive vote is required for final approval.
Specialties Involved
Family Medicine, Obstetrics And Gynecology, Pediatrics, Psychiatry, Neonatology And Perinatology, Pediatrics
Description of Systematic Review
Yes. Expert Consensus from systematic reviews with evidence tables.
List of Questions
Yes. What is the suggested dosage, length/duration of therapy, herbal consideration, effect of lactation, and potential side effects from being prescribed commonly used galactogogues?
Description of Study Criteria
Yes. Inclusion: key drug names, transgender, human growth hormone, transgender, female, clinical trials – and more. The inclusion criteria used for the searched were: humans, review articles, primary research articles, and English.
Description of Search Strategy
Yes. See methods. below.
Description of Study Selection
Yes. Consensus-based. Led by Chair.
Description of Evidence Analysis Methods
General Methods An initial search of relevant published articles written in English in the past 75 years in the fields of medicine, psychiatry, psychology, and basic biological science is undertaken for a particular topic. Once the articles are gathered, the papers are evaluated for scientific accuracy and significance. Specific Methods The search was conducted using PubMed. In addition, a search of the original references and literature searches (from the previous version) were used to look for additional supportive articles. The time frame for the literature search was January 1976 to December 2018. General Methods An initial search of relevant published articles written in English in the past 75 years in the fields of medicine, psychiatry, psychology, and basic biological science is undertaken for a particular topic. Once the articles are gathered, the papers are evaluated for scientific accuracy and significance. Specific Methods The search was conducted using PubMed. In addition, a search of the original references and literature searches (from the previous version) were used to look for additional supportive articles. The time frame for the literature search was January 1984 to December 2016. The inclusion criteria used for the searched were: humans, review articles, primary research articles, and English. The specific search terms used were: breastfeeding, primary care, physician, pediatrician, obstetrician, family physician.
Description of Evidence Grading
U.S. Preventative Services Taskforce Recommendations. An expert panel is identified and appointed to develop a draft protocol using evidence-based methodology. An annotated bibliography (literature review), including salient gaps in the literature, is submitted by the expert panel to the Protocol Committee.