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Meta-Analysis
. 2020 May 18;5(5):CD011505.
doi: 10.1002/14651858.CD011505.pub2.

Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants

Siew Cheng Foong  1 , May Loong Tan  1 , Wai Cheng Foong  1 , Lisa A Marasco  2 , Jacqueline J Ho  1 , Joo Howe Ong  3
Affiliations
Meta-Analysis

Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants

Siew Cheng Foong et al. Cochrane Database Syst Rev. .

Abstract

Background: Many women express concern about their ability to produce enough milk, and insufficient milk is frequently cited as the reason for supplementation and early termination of breastfeeding. When addressing this concern, it is important first to consider the influence of maternal and neonatal health, infant suck, proper latch, and feeding frequency on milk production, and that steps be taken to correct or compensate for any contributing issues. Oral galactagogues are substances that stimulate milk production. They may be pharmacological or non-pharmacological (natural). Natural galactagogues are usually botanical or other food agents. The choice between pharmacological or natural galactagogues is often influenced by familiarity and local customs. Evidence for the possible benefits and harms of galactagogues is important for making an informed decision on their use.

Objectives: To assess the effect of oral galactagogues for increasing milk production in non-hospitalised breastfeeding mother-term infant pairs.

Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP), Health Research and Development Network - Phillippines (HERDIN), Natural Products Alert (Napralert), the personal reference collection of author LM, and reference lists of retrieved studies (4 November 2019).

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs (including published abstracts) comparing oral galactagogues with placebo, no treatment, or another oral galactagogue in mothers breastfeeding healthy term infants. We also included cluster-randomised trials but excluded cross-over trials.

Data collection and analysis: We used standard Cochrane Pregnancy and Childbirth methods for data collection and analysis. Two to four review authors independently selected the studies, assessed the risk of bias, extracted data for analysis and checked accuracy. Where necessary, we contacted the study authors for clarification.

Main results: Forty-one RCTs involving 3005 mothers and 3006 infants from at least 17 countries met the inclusion criteria. Studies were conducted either in hospitals immediately postpartum or in the community. There was considerable variation in mothers, particularly in parity and whether or not they had lactation insufficiency. Infants' ages at commencement of the studies ranged from newborn to 6 months. The overall certainty of evidence was low to very low because of high risk of biases (mainly due to lack of blinding), substantial clinical and statistical heterogeneity, and imprecision of measurements. Pharmacological galactagogues Nine studies compared a pharmacological galactagogue (domperidone, metoclopramide, sulpiride, thyrotropin-releasing hormone) with placebo or no treatment. The primary outcome of proportion of mothers who continued breastfeeding at 3, 4 and 6 months was not reported. Only one study (metoclopramide) reported on the outcome of infant weight, finding little or no difference (mean difference (MD) 23.0 grams, 95% confidence interval (CI) -47.71 to 93.71; 1 study, 20 participants; low-certainty evidence). Three studies (metoclopramide, domperidone, sulpiride) reported on milk volume, finding pharmacological galactagogues may increase milk volume (MD 63.82 mL, 95% CI 25.91 to 101.72; I² = 34%; 3 studies, 151 participants; low-certainty evidence). Subgroup analysis indicates there may be increased milk volume with each drug, but with varying CIs. There was limited reporting of adverse effects, none of which could be meta-analysed. Where reported, they were limited to minor complaints, such as tiredness, nausea, headache and dry mouth (very low-certainty evidence). No adverse effects were reported for infants. Natural galactagogues Twenty-seven studies compared natural oral galactagogues (banana flower, fennel, fenugreek, ginger, ixbut, levant cotton, moringa, palm dates, pork knuckle, shatavari, silymarin, torbangun leaves or other natural mixtures) with placebo or no treatment. One study (Mother's Milk Tea) reported breastfeeding rates at six months with a concluding statement of "no significant difference" (no data and no measure of significance provided, 60 participants, very low-certainty evidence). Three studies (fennel, fenugreek, moringa, mixed botanical tea) reported infant weight but could not be meta-analysed due to substantial clinical and statistical heterogeneity (I2 = 60%, 275 participants, very low-certainty evidence). Subgroup analysis shows we are very uncertain whether fennel or fenugreek improves infant weight, whereas moringa and mixed botanical tea may increase infant weight compared to placebo. Thirteen studies (Bu Xue Sheng Ru, Chanbao, Cui Ru, banana flower, fenugreek, ginger, moringa, fenugreek, ginger and turmeric mix, ixbut, mixed botanical tea, Sheng Ru He Ji, silymarin, Xian Tong Ru, palm dates; 962 participants) reported on milk volume, but meta-analysis was not possible due to substantial heterogeneity (I2 = 99%). The subgroup analysis for each intervention suggested either benefit or little or no difference (very low-certainty evidence). There was limited reporting of adverse effects, none of which could be meta-analysed. Where reported, they were limited to minor complaints such as mothers with urine that smelled like maple syrup and urticaria in infants (very low-certainty evidence). Galactagogue versus galactagogue Eight studies (Chanbao; Bue Xue Sheng Ru, domperidone, moringa, fenugreek, palm dates, torbangun, moloco, Mu Er Wu You, Kun Yuan Tong Ru) compared one oral galactagogue with another. We were unable to perform meta-analysis because there was only one small study for each match-up, so we do not know if one galactagogue is better than another for any outcome.

Authors' conclusions: Due to extremely limited, very low certainty evidence, we do not know whether galactagogues have any effect on proportion of mothers who continued breastfeeding at 3, 4 and 6 months. There is low-certainty evidence that pharmacological galactagogues may increase milk volume. There is some evidence from subgroup analyses that natural galactagogues may benefit infant weight and milk volume in mothers with healthy, term infants, but due to substantial heterogeneity of the studies, imprecision of measurements and incomplete reporting, we are very uncertain about the magnitude of the effect. We are also uncertain if one galactagogue performs better than another. With limited data on adverse effects, we are uncertain if there are any concerning adverse effects with any particular galactagogue; those reported were minor complaints. High-quality RCTs on the efficacy and safety of galactagogues are urgently needed. A set of core outcomes to standardise infant weight and milk volume measurement is also needed, as well as a strong basis for the dose and dosage form used.

Trial registration: ClinicalTrials.gov NCT00851591 NCT00284024 NCT00264719 NCT00477776 NCT02190448 NCT02233439 NCT02740751.

PubMed Disclaimer

Conflict of interest statement

Siew Cheng Foong: none known May Loong Tan: none known Wai Cheng Foong: none known Lisa A Marasco is co‐author of a breastfeeding book 'Making More Milk: The Breastfeeding Guide to Increasing Your Milk Production' (published by McGraw‐Hill) which discusses galactogogues. She also speaks on various lactation‐related topics, including galactogogues, providing training and continuing education units to lactation consultants and other health care providers. Jacqueline J Ho is co‐coordinator of the local governance board of the World Alliance for Breastfeeding Action (WABA). A member of her family works for a pharmaceutical company. Joo Howe Ong: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Pharmacological oral galactagogues versus placebo or no treatment, Outcome 1: Infant weight (where they were only receiving own mother's milk) at the end of the study (grams)
1.2
1.2. Analysis
Comparison 1: Pharmacological oral galactagogues versus placebo or no treatment, Outcome 2: Milk volume subgroup by type of galactagogue(please refer to footnotes for details on units used)
2.1
2.1. Analysis
Comparison 2: Natural oral galactagogues versus placebo or no treatment, Outcome 1: Infant weight subgroup by type of galactagogue (where they were only receiving own mother's milk) at the end of the study (grams)
2.2
2.2. Analysis
Comparison 2: Natural oral galactagogues versus placebo or no treatment, Outcome 2: Milk volume subgroup by type of galactagogue (refer to footnotes for details on units used)
2.3
2.3. Analysis
Comparison 2: Natural oral galactagogues versus placebo or no treatment, Outcome 3: Volume of supplement beyond mother's own milk (mL)
2.4
2.4. Analysis
Comparison 2: Natural oral galactagogues versus placebo or no treatment, Outcome 4: Quality of life using WHO QOL Scale
2.5
2.5. Analysis
Comparison 2: Natural oral galactagogues versus placebo or no treatment, Outcome 5: Breastfeeding self‐efficacy
2.6
2.6. Analysis
Comparison 2: Natural oral galactagogues versus placebo or no treatment, Outcome 6: Postpartum Depression Scale
3.1
3.1. Analysis
Comparison 3: Oral galactagogue versus another galactagogue: infant weight (grams), Outcome 1: Fenugreek tea versus Fennel tea
4.1
4.1. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 1: Chanbao oral liquid versus Bu Xue Sheng Ru capsules
4.2
4.2. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 2: Domperidone versus Moringa leave capsules
4.3
4.3. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 3: Fenugreek versus Palm dates
4.4
4.4. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 4: Fenugreek capsules versus Torbangun soup
4.5
4.5. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 5: Fenugreek capsules versus Moloco tablets
4.6
4.6. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 6: Mu Er Wu You soup versus Kun Yuan Tong Ru soup
4.7
4.7. Analysis
Comparison 4: Oral galactagogue versus another galactagogue: milk volume (mL), Outcome 7: Torbangun soup versus Moloco tablets
5.1
5.1. Analysis
Comparison 5: Oral galactagogue versus another galactagogue: volume of supplementary feeds (mL), Outcome 1: Chanbao oral liquid versus Bu Xue Sheng Ru capsules
5.2
5.2. Analysis
Comparison 5: Oral galactagogue versus another galactagogue: volume of supplementary feeds (mL), Outcome 2: Mu Er Wu You soup versus Kun Yuan Tong Ru soup
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De Leo 1986 {published data only}
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Demirci 2016 {published data only}
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Deshpande 1962 {published data only}
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Douglas 1962 {published data only}
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Erb 1968 {published data only}
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Ertl 1991 {published data only}
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Filippova 1975 {published data only}
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Friedman 1961 {published data only}
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Ghosh 1986 {published data only}
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Gokhale 1965 {published data only}
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Gupta 1966 {published data only}
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Guzman 1979 {published data only}
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Gyõry 1968 {published data only}
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Hale 2009 {published data only}
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Heiss 1968 {published data only}
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Hofmeyr 1985 {published data only}
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Huntingford 1961 {published data only}
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Huynh 2016 {published data only}
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Ivanyi 2006 {published data only}
    1. NCT00284024. Effectiveness of domperidone to increase breastmilk supply in mothers with low supply. clinicaltrials.gov/show/NCT00284024 (first received 31 January 2006).
Janke 1941 {published data only}
    1. Janke G. Agnus castus oligoplex as a galactagogue [Agnus castus Oligoplex als Laktagogum]. Fortschritte Der Therapie 1941;17(6):198-200.
Joglekar 1967 {published data only}
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Kauppila 1981 {published data only}
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Kavurt 2013 {published data only}
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Kawakami 2003 {published data only}
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Keldenich 1976 {published data only}
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Knoppert 2013 {published data only}
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Lal 1980 {published data only}
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Lewis 1980 {published data only}
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Luhman 1963 {published data only}
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Mennella 1991 {published data only}
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Mennella 1993 {published data only}
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Milsom 1992 {published data only}
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Milsom 1998 {published data only}
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Mohr 1954 {published data only}
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Narimatsu 2001 {published data only}
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Nicholson 1948 {published data only}
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Noack 1943 {published data only}
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Nommsen‐Rivers 2019 {published data only}
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Patel 1982 {published data only}
    1. Patel BC, Parikh MV, Patel LB. "Leptaden" a nonhormonal ayurvedic drug for deficient lactation in mothers of an urban community. Medicine & Surgery 1982;22(6):25-8.
Peters 1991 {published data only}
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Petraglia 1985 {published data only}
    1. Petraglia F, De Leo V, Sardelli S, Pieroni ML, D'Antona N, Genazzani AR. Domperidone in defective and insufficient lactation. European Journal of Obstetrics & Gynecology and Reproductive Biology 1985;19:281-7. - PubMed
Pontuch 1970 {published data only}
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Qi 1996 {published data only}
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Rajarathnam 1986 {published data only}
    1. Rajarathnam S, Vijaya, Rathnakumar. Lactare (herbal galactagogue) to improve lactation- a clinical study of 75 cases. TTK Pharma Limited, Madras 1986.
Rath 1983 {published data only}
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Reeder 2011 {published data only}
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Robinson 1947 {published data only}
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Rolfini 1989 {published data only}
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Ruis 1981 {published data only}
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Sapak 1969 {published data only}
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Seema 1997 {published data only}
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Srinivas 2014 {published data only}
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Stegaĭlo 1980 {published data only}
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Subramaniam 1986 {unpublished data only}
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Tablb 1977 {published data only}
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Tagliareni 1977 {published data only}
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Ylikorkala 1984 {published data only}
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References to ongoing studies

ACTRN12619000704190 {published data only}
    1. ACTRN12619000704190. Randomised controlled study of the effects of yeast based supplement on milk production in breastfeeding women. anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619000704190 (first received 6 May 2019).
CTRI/2016/01/006547 {published data only}
    1. CTRI/2016/01/006547. A clinical study to evaluate the stanyjanana (Galactogogue) effect of promolact capsules and granules. ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=13618 (first received 20 January 2016).
JPRN‐UMIN000027159 {published data only}
    1. JPRN-UMIN000027159. Effect of chicken extract on breast milk production of primiparous mothers in Japan: A randomized experimental study. upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031125http... (first received 27 April 2017).
NCT00264719 {published data only}
    1. NCT00264719. Metoclopramide to aid establishment of breastfeeding: a randomised controlled trial. clinicaltrials.gov/show/NCT00264719 (first received 13 December 2005).
NCT00477776 {published data only}
    1. NCT00477776. Metoclopramide to improve lactogenesis II in diabetic women: a randomized controlled trial. clinicaltrials.gov/show/NCT00477776 (first received 24 May 2007).
NCT02190448 {published data only}
    1. NCT02190448. Randomized, placebo-controlled study of an herbal tea to support lactation. clinicaltrials.gov/show/NCT02190448 (first received 15 July 2014).
NCT02233439 {published data only}
    1. NCT02233439. Double-blind, placebo controlled a randomized trial on the efficacy of herbal galactogogues. clinicaltrials.gov/show/NCT02233439 (first received 8 September 2014).
NCT02740751 {published data only}
    1. NCT02740751. Efficacy of herbal galactogogues on weight gain of the newborns within the first month of life in breastfeeding mothers. clinicaltrials.gov/show/NCT02740751 (first received 15 April 2016).
TCTR20170811003 {published data only}
    1. TCTR20170811003. Efficacy of Wang Nam Yen herbal tea on breast milk production: a factorial randomized controlled trial (Tea4Milk) (Tea4Milk ). www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&amp... (first received 10 August 2017).
TCTR20180808007 {published data only}
    1. TCTR20180808007. Effectiveness of Prasaplai as a galactagogue. www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&amp... (first received 3 August 2018).
TCTR20190218004 {published data only}
    1. TCTR20190218004. Effectiveness of Ayurved Siriraj Prasa-Nam-Nom recipe on breast milk volume in early postpartum women: a randomized, double-blind, placebo-controlled trial. www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&amp... (first received 15 February 2019).
TCTR20190716001 {published data only}
    1. TCTR20190716001. The clinical study of Lysiphyllum Strychifolium on breast milk production. www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&amp... (first received 14 July 2019).

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