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Evidence-Based Lactation Care

What Is Evidence-Based Lactation Care?

Evidence-based medicine has become a widely discussed topic, and the COVID-19 crisis highlighted for the general public the importance of reliable, high-quality studies in guiding healthcare recommendations. The mere fact that a scientific journal publishes a study on a given topic does not establish certainty.

Recently, the Ministry of Health held a symposium on health misinformation, highlighting the lightning speed at which false information spreads on social media: fake news is 70% more likely to be shared.


With this in mind, we propose to discuss evidence-based lactation care: breastfeeding support (and perinatal care more broadly) grounded in scientific evidence.

In the field of breastfeeding, many myths and dogmas are circulating — including among healthcare professionals — that are based on beliefs or low-quality evidence.

In perinatal care more broadly, there is a proliferation of all manner of offerings that promise miracle solutions to families' problems.

Parents primarily receive information through social media: individuals (with what training? with what commercial interests?) who make sometimes questionable claims in 3 lines and 4 emojis.

In breastfeeding support, it is important to provide information by indicating the level of evidence (when it exists), and to specify whether the recommendations come from scientific sources or from clinical experience.

Evidence-based lactation support means empowering parents to make informed choices.



  1. What are the different levels of evidence in scientific studies?

According to the HAS (French National Health Authority): “The level of evidence of a study characterizes the study’s ability to answer the question posed.” The ability of a study to answer the question is assessed based on, among other things: the presence or absence of significant bias in its design; the power of the study, and in particular, the sample size.

The following pyramid illustrates the levels of evidence of different scientific publications

pyramid of levels of evidence
Evidence pyramid — credit WIKIPEDIA

The level of evidence is the degree of confidence one can place in the results of a study.

For example, a case report — that is, the description of one or several clinical cases — is considered low-level evidence.

Example: a scientific article reports the case of 5 breastfeeding mothers who drank a galactagogue herbal tea and expressed more milk → this is low-level evidence.

  • Was it the effect of the herbal tea?

  • Was it a placebo effect? (The belief that the herbal tea would help)

  • Was it the natural progression of lactation? (Simply due to the passage of time)

  • Who funded the study: the herbal tea manufacturer? (Confirmation bias, conflict of interest)

  • What was the actual observed effect: how many additional milliliters expressed, and is that clinically significant?

A double-blind randomized controlled trial, by contrast, is considered higher-level evidence, as it attempts to eliminate biases. Using the same example: two groups are formed — one group of mothers receiving the supposed galactagogue herbal tea, and one group receiving a placebo.

It is "double-blind" in that:

  • The mother does not know whether she is receiving a galactagogue herbal tea or flavored hot water: this aims to control for the placebo effect.

  • Those administering the product and analyzing the data do not know which product she is receiving: the placebo or the experimental herbal tea → This prevents knowledge of the intervention from influencing the measurement of the outcome (classification bias).

But again, there will be limitations:

  • What is the size of the herbal tea and placebo groups? The larger the sample size, the greater the statistical power.


Meta-analyses and systematic reviews represent an even higher level of evidence: multiple randomized controlled trials are pooled together, and the results are combined in an attempt to eliminate biases.

There are also Cochrane reviews, which are high-level systematic reviews.

To illustrate this point, here are the conclusions of a Cochrane review on galactagogues:

“Due to extremely limited data and very low confidence, we do not know whether galactagogues have any effect on the proportion of mothers who continued breastfeeding at 3, 4, and 6 months. There is little evidence to suggest that pharmacological galactagogues increase milk volume. Some subgroup analyses show that natural galactagogues may have a beneficial effect on infant weight and milk volume in mothers of term, healthy infants, but due to substantial heterogeneity across studies, imprecision of measurements, and incomplete reporting, we are very uncertain about the magnitude of the effect.”

And finally, there are Clinical Practice Guidelines, or consensus conferences, issued by expert scientific societies following a comprehensive review of the scientific literature, to provide a recommendation on a given topic. Still on the topic of galactagogues, the Academy of Breastfeeding Medicine states: “Although the long-standing use of these herbs without apparent harm is reassuring, there is little or no scientific evidence of their efficacy or safety.”

Does this mean galactagogues should not be used? Not exactly: it means we cannot be certain they are effective.

When a mother asks for my recommendation,we prioritize improving feeding frequency (nursing or pumping) and latch positioning (or flange fit), as the evidence for these measures improving lactation is stronger than for galactagogues.



2. Evidence-Based Approach and Breastfeeding: What Does "Low Level of Evidence" Mean in Practice?

When evaluating a healthcare intervention, stating that there is a low level of evidence does not necessarily mean the method works or does not work. It means that scientists do not know — that the efficacy of the method has not been proven.

  • Perhaps the method is effective.

  • Perhaps the method is not effective, but there is a placebo effect. In perinatal care: perhaps simply being heard, listened to, and supported empathically relaxed the parent and had an impact on the baby’s behavior (through emotional co-regulation).

  • Perhaps the natural progression of the situation was already moving toward improvement.

So in the face of uncertainty, why not try, you might ask?

Well, before proceeding, it seems important to also consider the following:

  • The benefit/risk balance: what are the potential risks, and for what benefit?

  • The cost-effectiveness ratio: what is the cost of the intervention, for what level of efficacy? For medications, this typically refers to financial cost. But one can also consider the mental load if the proposed approach requires a significant time investment from parents.

Finally, in this troubled era — where competing ideologies clash on the international stage and scientists face increasing pressure — evidence-based practice seems more important than ever. Informing parents about the level of evidence surrounding a given topic is not intended to make them feel guilty or to prevent them from deciding to try a particular approach, but to enable them to make decisions with full knowledge of the facts, free from guilt.

Definitions

  • A systematic review aims to identify, appraise, and synthesize all empirical evidence meeting predefined eligibility criteria to answer a specific research question. Researchers conducting systematic reviews use explicit and systematic methods, selected to minimize bias, in order to produce more reliable findings and inform decision-making.

  • A meta-analysis is a systematic scientific method combining the results of a series of independent studies on a given problem, following a reproducible protocol. More specifically, it is a statistical synthesis of the studies included in a systematic review.

  • A bias may be statistical — an error in study methodology — or cognitive — a distortion, conscious or unconscious, in the processing and analysis of information.

  • Placebo effect. The Academy of Medicine states: “The expectation-based placebo effect is a scientifically established neurobiological phenomenon, whose reality is confirmed by controlled clinical trials, and whose mechanisms are illuminated by neuroscience, particularly neuroimaging. It is proven that its strength depends on patient expectation, the communication provided, and what is offered (charisma of the therapist, reputation of the method, complexity of the device). The conditioning effect is linked to the repetition of prior experiences of improvement under active medication, and depends on deep brain structures such as the amygdala. It is specific to the symptom being treated and reproduces under placebo. These effects are at the heart of the perceived benefits of homeopathy, as they are of any well-conducted therapeutic act, whether or not it is part of a complementary therapy.”


Bibliography


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