(with apologies for horrible quoting as posting directly from the Lactnet site!)

Maureen Minchin wrote: 

<Sarah, I agree that this is the one week outcome, in one sense, but doesn't it strike you as strange that we are NOT TOLD how much formula was given by these mums while they were in hospital, and that separated from what they did after going home?>

Not really, no. I find that it's quite normal for research articles of this sort not to have a detail which you wish they'd included. ;-) (After all, researchers are having to explain some complicated stuff within a word limit, and can't possibly anticipate every detail everyone reading the article might want to know!) 

I think it unlikely the babies had extra supplements in the hospital, as the article does say that all infants were treated according to protocol (which would mean the 10ml supplements only for the intervention group and no formula for the other group), but, either way, the question is still the same - why are the babies who were deliberately supplemented with small amounts ending up with so much less formula overall, and does that mean that trying to avoid all supplementation is backfiring?


 <That this fourfold use of formula was not then accentuated and related to the later outcomes? Clearly if by one week you've had 4 times as much formula there's less chance you'll be exclusively breastfeeding at three months!>

Not quite sure what you're saying here? Yes, that could very well be how it worked - that, because the mothers who had been told to avoid all supplements in hospital ended up giving *more* formula once they got home, they were less likely to be successful at breastfeeding. Once again, the main point is still the same - contrary to usual belief on the subject, the mothers who were deliberately taught to give small, limited amounts of formula in the early days ended up giving *less* formula overall and being *more* likely to end up successfully breastfeeding, and this is something we should look into further in case it turns out that this could be a useful strategy for increasing overall breastfeeding (or, at the least, that being too rigid about avoiding supplementation is backfiring).


< Also, that mothers were not asked about whether they had used the 'soothing' techniques so carefully taught to them, rather than putting a merely-days-old baby to the breast whenever he/she was unsettled?>

I think it would be very useful to know whether the teachings on soothing technique included a clear instruction that they should only be tried on babies who still seemed unsettled after being fed  (or, to phrase it better, that the first soothing technique should be to put baby to the breast!) and I'm thinking of e-mailing Flaherman to ask about this. However, although this is a concern, I also think that the very fact that the control group babies had had so much more formula by the end of the first week suggests that on the whole the mothers in this group *weren't* using soothing techniques in place of feeding a hungry baby. If that were the case then the babies might well not have been getting enough breastmilk - which would then show up as a higher rate of breastfeeding cessation/mixed feeding a bit further down the line - but you wouldn't have expected them to be getting that much formula. That suggests that the mothers *were* interpreting their babies' cues as hunger and were trying to feed them when hungry.



<I read this study as saying that in a community where mothers are taught not to feed their baby when it cries, but to 'soothe' it, severely RESTRICTING the use of formula results in better outcomes that allowing its use ad lib (hardly a novel finding); that truly exclusive breastfeeding is seen as impossible and not encouraged by the staff, who expect it will result in more unsettled babies and so tell mothers how to shush them - not by feeding, but by distraction.>

Then I would say you're reading some colossal assumptions into it without evidence that any of that is the case - and with evidence that much of it probably isn't. 

There is nothing to indicate that the mothers taught soothing techniques were taught to use them *instead* of feeding the baby. Indeed, although there are valid concerns that the session on soothing may have inadvertently transmitted this message, it's extremely unlikely that researchers would have arranged for the sessions to contain this message *overtly*, as it would be such a blatantly obvious flaw in the study. 

The study states that the control group were EBF and that all babies stayed with the protocol. That certainly doesn't fit with formula use being allowed 'ad lib' in the hospital. 

As for the staff's views on exclusive breastfeeding and distraction of babies, that's pure speculation on your part.


<  Those getting such tiny quantities of formula presumably were given reasons for the restriction, which should mean that those mothers knew that breastmilk was valuable and that larger quantities formula interfere with lactation. What were the others told?>

In order to obtain informed consent, the researchers would have had to explain the study to all mothers prior to enrolling them. All the mothers therefore would have to have been given the information that they would be randomised to either tiny limited quantities of formula or to no formula, and would have had the option of refusing consent if they did not feel comfortable with either of those options. So I would expect that all mothers would understand the reason for the restriction before giving consent to enter the study in the first place.

< The book I'm finalising describes how formula alters not only microbiomes but genomes and has intergenerational effects.>

Hey - if you're writing a book on the subject, you'd be the perfect person for me to ask a question I've wondered about for some time. Is there actually any evidence as to *outcomes* of small amounts of formula supplementation? I know there's much theory and speculation around the subject, but, as yet, I've not been able to find much on outcomes (and the little I can find has been reassuring, on the whole).

< Sorry, but to my mind this is criminal conduct, assault and battery, not research, however usual it may be in some hospitals.>

(blink) I'm wondering - would you have felt the same way of a trial of a medication with possible benefits and possible risks in a group of infants at risk of problems?

<It is typical of damaging articles like this to be published in journals where they can only be accessed by paying customers, while their abstract and press releases go world-wide.>

It's annoying, but I'm not sure how it could be done differently. The journal editors and authors are getting paid for their work, and can't simply do it for free, any more than IBCLCs could routinely work for free however helpful that would be. Abstracts are made freely available so that people can make a decision as to whether they want to pay for the article or not. You can't *stop* people from buying the article, so there's nothing to stop a formula company from paying for it and using it as the basis of their publicity (or even arranging publicity based just on the abstract). I'm not too sure how that could be avoided. On the plus side, the article is only $12, which is a much better rate than the usual rate for purchasing articles on-line.

< So as yet I haven't got a copy, and am relying on others comments, which I dislike doing.  >

Well, good grief, I'd suggest being a bit less hasty with the assumptions in that case!  ;-)


<Another thought I had was that it could also be that mothers who felt that they were NOT ALLOWED to give formula in hospital resented this and used it as soon as they got home, a direct result of the restrictions imposed on them. But that I can't tell. It is a usual reaction for some mothers here in Oz, however.>

Highly unlikely in this case, as all mothers would have had to have given informed consent to enter the trial and this would include the understanding that there would be a 50:50 chance of them ending up in a group where they wouldn't get any supplementation. However, your experience is certainly one of those that raises questions about overly strict no-supplementation policies and whether they do more harm than good. That sort of story is why I'm pleased to see research like this being done, and hope the authors do manage to follow this up with a larger and more conclusive study.



Best wishes,

Dr Sarah Vaughan
MBChB MRCGP

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