A surgical procedure (frenotomy) to correct tongue-tie in newborns is presented to many new parents as the solution to breastfeeding problems, but is it? The long awaited results of a trial of tongue-tie surgery, the FROSTIEE trial, were quietly published last year with little fanfare. We discuss the findings here. But first, let’s recap.
A Cochrane review published in 2017 looked at the evidence for tongue-tie surgery to resolve breastfeeding problems. The reviewers identified five randomised controlled trials, which included only 302 infants. The review found not very strong evidence that frenotomy reduced nipple pain in the short term, as rated by mothers, but no evidence it improved breastfeeding. It found no evidence of harm.
We are not impressed. But despite this underwhelming evidence, surgery to cut a baby’s tongue-tie has become popular, leading to long NHS waiting lists and a very willing army of midwives, health visitors and lactation consultants in private practice offering to do the procedure. Parents often ask for more frenotomy to be available on the NHS and complain that they cannot access this procedure, which they sincerely believe will resolve their painful breastfeeding, their low milk supply or their baby’s issue with latching.
So, in stepped FROSTIEE, a large multi-site randomised controlled trial (RCT) comparing breastfeeding support only with breastfeeding support and frenotomy. Well, sort of. After the first 20 participants, the researchers decided not to blind participants, as this was seen as a barrier to recruitment (yikes!)
Issues with blinding aside, did frenotomy save breastfeeding? Do we have the evidence we have all been waiting for to justify en masse frenotomy services within the NHS? Alas, we still cannot answer this question, because 74% of participants in the breastfeeding support only arm of the trial had a frenotomy procedure! The researchers offered ‘just in case’ appointments for frenotomy for women allocated to breastfeeding support only, as they weren’t willing to delay the procedure for more than a few days.
So, it seems we have high demand for a procedure of uncertain benefit: the situation that evidence-based medicine seeks to avoid by doing research before rolling out interventions. Any procedure carries potential risks, as well as potential benefits. And though the Cochrane review did not find evidence of harm, FROSTIEE found that 1 in 50 babies experienced an adverse event. These included: bleeding (severe enough to be reported as an adverse event), one baby with salivary duct damage and another with an accidental cut to the tongue and salivary duct damage.
By any standard, this means harm to babies from frenotomy is common, yet the benefits are uncertain. Read that again: harm from frenotomy is common and there is no evidence of benefit.
The FROSTIEE researchers were not able to recruit the target number of participants and the study was brought to an end early. They blame the Covid-19 pandemic for their problems with recruitment, but, really, would the situation be any different if the study was repeated today? When parents are so convinced that frenotomy is the solution to their breastfeeding problems, would they be willing to potentially be allocated to the breastfeeding support only arm of the trial?
In a staggering statement, the researchers suggest ‘other study designs will need to be considered’, but RCT is the only way to confidently establish the benefits and risks of any procedure! When it comes to conducting surgery on newborns, we should be confident that the benefits outweigh any harms. Parents should accept no less before agreeing to a surgical intervention on their newborn!
So what is the solution? The very unpopular answer is to have no availability of frenotomy outside of a clinical trial until there is sufficient evidence to recommend it as a surgical procedure. This is what should have happened in the first place. However, it is very hard to put a genie back in a bottle once it has been let out, even when the genie turns out to be quite wicked.
What a mess! Let this stand as a lesson about rolling out procedures ahead of good evidence. And remember: 1 in 50 babies harmed by frenotomy and no evidence of benefit.
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