A total of 41 studies, including RCTs or quasi-RCTs assessing the effectiveness of either pharmacological galactagogues or natural galactagogues were included in the meta-analysis.
The natural galactagogues studied include examples such as banana flower, fennel, fenugreek, ginger, moringa, and palm dates. Whereas studies on pharmacological galactagogues looked at domperidone, metoclopramide, and the thyrotropin-releasing hormones.
Findings showed that there was only low-certainty evidence on the effectiveness of galactagogues, both natural and pharmacological, in increasing milk production volume in nursing mothers.
“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,” the researchers said.
Responding to queries from NutraIngredients-Asia, the researchers pointed out that this was due to issues such as different research parameters used in the RCTs.
“Unfortunately, problems with the research methods used, and the way the research was reported, as well as the sheer variety of galactogogues that we identified – not very many studies on any one substance – prevented us from drawing firm findings,” the researchers told us.
Standardising measurements
For example, different RCTs have assessed the effectiveness of galactogogues based on different sets of parameters.
In the case of the 27 studies on natural galactagogues, only 17 reported the nursing mothers’ milk production volume. Eventually, only 13 had data that could be analysed.
In order to strengthen future findings, the researchers have recommended future studies to standardise the measurements used to determine the effect of galactagogues.
"In considering future research, a set of core outcomes to standardise measurements...could improve the certainty of the evidence," they said.
Safety concerns
The review also highlighted the need to explore safety concerns in future research.
The researchers told us that safety testing was especially a concern for natural galactogogues as compared to pharmacological ones, since the latter tend to undergo rigorous testing before they were registered for use.
Furthermore, natural products are usually perceived to be less risky than pharmacological products and thus, the more likely option for most consumers.
For pharmacological products, safety information printed on the label allows doctors to weigh the risks and benefits before making prescriptions, which may not be the case for natural products.
“Thus, any such information on natural remedies derived from animal research, human studies or anecdotal experience should be explored as part of the development, and then if applicable, disclosed on labels to help consumers to choose wisely,” the researchers told us.
Fenugreek is an example where its potential adverse side effects could be further explored, despite it being a traditional galactagogue.
This is because animal models have shown that it could lead to thyroid-lowering effects.
“While we don’t know whether this applies to humans, there are anecdotal reports in humans suggesting that therapeutic levels of fenugreek may not be appropriate for hypothyroid mothers.
“But no research study to date has screened for or reported on this potential negative effect,” said the researchers.
At present, some of its known side effects include loose stools, lower blood sugar, and light headedness.
The researchers also pointed out that future research and product development should provide a rationale for the forms and dosages used, as well as exploring the degree of effectiveness at different dosage levels.
Source: Cochrane Systematic Review
Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non‐hospitalised term infants
https://doi.org/10.1002/14651858.CD011505.pub2
Authors: Foong, et al
