Abstract
Breastfeeding medicine providers rely on Academy of Breastfeeding Medicine (ABM) protocols for useful evidence-based information. However, we have been negatively surprised by the latest protocol #36. 1 It is lacking in evidence and full of hypotheses that should not be included in a protocol.
The definition of mastitis given is: a common maternal complication of lactation. In medicine, illnesses have complications, not natural processes. Pneumonia is not a complication of breathing.
Changing the term “mastitis” to “mastitis spectrum” seems a step backward, as it implies losing scientific accuracy. It disperses the predisposing factors, the illness itself, and its complications under the term “spectrum.” More solid studies on mastitis are needed, but it is an entity that has a clear clinical definition, which we know how to diagnose and manage. Inserting it within a spectrum adds complicated nuances that are not scientifically justified. Authors state that mastitis encompasses a spectrum of conditions and point to Figure 1 of their article; however, they cite no supporting evidence for either.
General Principles
Authors state that ductal lumen can be narrowed by edema and hyperemia associated with hyperlactation and dysbiosis. The reference cited (no. 5) is a study coauthored by one of the authors, J.M. Rodriguez (JMR), about mammary candidosis, in which neither of the terms hyperlactation or dysbiosis appears. The text gives a confusing and unreferred account of predisposing factors, instead of the clear list of previous protocol. 2
Engorgement
Authors state it is a distinct clinical entity. We agree, and do not understand why it should now be considered part of a mastitis spectrum.
Ductal Narrowing
We find the same lack of evidence for the relationship between ductal narrowing, dysbiosis, or even the concept of ductal narrowing itself. Authors state that repeated feeding and/or breast massage has a negative impact on this condition, but once again this hypothesis, which contradicts others, 3 is not supported by evidence.
Bacterial Mastitis
Authors state it is an entity necessitating antibiotics or probiotics to resolve—again, no evidence. Acute mastitis resolves in many instances with conservative measures, and the efficacy of probiotics is unproven. 4 They then list an unreferenced number of pathogens that they suggest may cause mastitis, without stating clearly that the only one we have evidence for is Staphylococcus aureus. A recent study found no association between Staphylococcus epidermidis and mastitis. 5 Authors downplay the importance of nipple trauma, while citing a review of risk factors for mastitis 6 that precisely states the opposite.
Subacute Mastitis
This term is not defined in the literature, much less its cause. The articles cited by the authors (no. 19–22) give different clinical symptoms to define it. Reference no. 22 bases its conclusions once more on the mentioned article on candidosis (no. 5), so we have a circular citation wheel based on opinions and no facts.
That subacute mastitis is an entity and that it is caused by biofilms in chronic mammary dysbiosis is supported by no evidence. Authors again cite the article about candidosis (no. 5) that does not support their claim. Human microbiome researchers are increasingly critical of the term dysbiosis, since the concept is based on an outdated assumption of a normative eubiotic state; 7 pathological biofilm formation in a lactating breast is likely to be a late-stage manifestation of severe inflammation or tissue necrosis, not causative. 7
Spectrum-Wide Recommendations
A shift in management is proposed, barely mentioning breastfeeding technique to assure a comfortable latch and adequate milk removal. It also deviates—without supporting evidence—from the basic recommendation that mothers should be encouraged to breastfeed more frequently, starting on the affected breast. Instructions as to how to manage the acute phase regarding breastfeeding the infant are confusing.
Medical Interventions
Protocol states that lecithin may be taken to reduce inflammation, emulsify milk, and be effective for “nipple blebs.” Neither of the studies they cite support this.
In treating hyperlactation, once again they imply it has to do with dysbiosis and refer to ABM protocol #32 (hyperlactation) that itself makes no mention of dysbiosis.
About therapeutic ultrasound, again no evidence. Reference no. 42 is not an original study but a review that refers to no. 43, a study that has no control group and confusing methodology.
Consider probiotics
Authors say that data are “mixed” and cite reference no. 47, a review in which only five randomized controlled trials (RCTs) made the cut, and all five had significant methodological limitations concerning appropriately described baseline characteristics, study hypotheses, lack of power calculations, definitional issues, and potential conflicts of interest.8,9 In the two largest studies reviewed, the authors acknowledge that they are employed by Biosearch Life, the owners of the patent of the probiotic used in both trials. As detailed in the latest Cochrane review, evidence is low and risk of bias high. 10
It is, therefore, surprising that the authors of this protocol award the use of probiotics a level of evidence 1–2. Strangely, in the Recommendations for bacterial mastitis, authors state that probiotics have not been shown to alter human milk microbiota—which is akin to confirming they do not work.
Recommendations for recurrent mastitis
Surprisingly detailed are the recommendations for a condition for which, according to the authors (page 365), there is no consensus on its definition.
Directions on when to do a milk culture are scattered in the text and there are no instructions (as there is no evidence) on how to interpret the results.
Authors state although coagulase-negative staphylococci are commonly present in breast milk, they have also been identified as opportunistic pathogens in mastitis, and they cite a study (no. 67) with so many methodological flaws that it only scored 2/13 on the JBI Critical Appraisal Checklist for RCTs. There is no evidence to support that statement. They go on to suggest that we Consider daily probiotic use with Lactobacillus fermentum or, preferably, Lactobacillus salivarius for prevention once more, referencing the same authors (J.M.R. and his workgroup) who have had strong ties to the probiotic industry and who have not obtained supporting evidence for the efficacy and safety of probiotics in mastitis. Eight of the 77 references in this protocol are articles by these authors.
The recommendations for subacute mastitis are again riddled with inconsistencies, and references 70–72 are irrelevant to said recommendations.
There are an excessive number of irrelevant photographs that add no clarity to the protocol.
Conclusions
This protocol is, overall, confusing and scarcely evidence based. It supports terms that are not endorsed by scientific literature and that muddle, not clarify, the mastitis panorama. It suggests the use of treatments that are not evidence based, instead of stating that there are not enough data to support the use of probiotics, ultrasound, or lecithin. All this creates confusion in health care workers, excessive medicalization and has an economic cost for families.
Footnotes
Disclosure Statement
The authors declare they have no conflicts of interest.
Funding Information
No funding was received for this article.