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My FROSTTIE Prediction

February 25, 2020

Negative, & sceptical if positive

The FROSTTIE (FRenotomy Or breastfeeding Support for babies with Tongue-TIE) trial is testing the hypothesis that frenotomy, cutting the fold of skin under the front of the tongue, improves breast feeding in babies with ankyloglossia or tongue tie.  Commissioned by the UK Health Technology Assessment Programme (click here) and funded to the tune of over £1M, it is run by the National Perinatal Epidemiology Unit in Oxford (click here), chief investigator Professor Marian Knight, and registered here.

P – Mother baby dyads with breast feeding troubles. The baby is less than 10 weeks old and has been judged to have a tongue tie.

I – Frenotomy plus standard breast feeding support.

C – Standard breast feeding support alone.

O – Any breast feeding at age three months according to maternal self-report.

Sample size 870 dyads.  435 per group.  Apart from the misleading “Or” in the acronym, the science is great. My Aspredicted.org prediction that the result will be negative is here. What follows is no criticism of the triallists.

The trial is not justified by any meaningful science. It’s been funded because thousands of babies undergo this nonsensical “treatment” every year, such that a clear negative result would protect many in future.  But what if the result was apparently positive? By chance alone, at conventional levels of statistical significance, there is a one in twenty risk that it will be. There must also be some risk of bias; although parents are not told which treatment their baby got, it is likely that some will notice some bleeding or the lack of it, and the primary outcome is self-reported. Finally there are nine secondary outcomes; if even one is nominally “significant” enthusiasts will use it to confuse parents in future.

Why so hostile?

For hundreds, maybe thousands, of years, charlatans and the unsophisticated have blamed tongue tie for a whole range of problems (click here), including speech difficulties and stammering (click here), dribbling, poor feeding, and even autism (click here). The reason is simply that affected individuals have a frenulum connecting the underside of the tongue to the floor of the mouth. They ignore the fact that everyone has one. It’s a normal part of anatomy. It varies slightly in thickness and length but the charlatans provide no evidence that it systematically differs in affected individuals. Blaming the tongue tie and treating it with frenotomy is magical thinking.

Even if there was an anatomical tongue variant associated with breast feeding or speech problems, consider for a moment how plausible it is that dividing an adjacent band of tissue could help. The tongue is a large muscular organ, attached to the inner aspect of the lower jaw, the hyoid bone and various other ligaments and structures in the neck, and filling the whole oral cavity.

   

The anatomy varies. Some people, notably Gene Simmons the lead singer of the rock band Kiss, can protrude theirs a long way, some hardly at all, some people can roll their tongue, some not.

 

But none of these anatomical variants are anything to do with tongue tie or the lack of it. More importantly you can’t alter the function of a large muscle by diving a little skin fold at the edge of it. The only surgical way to alter a muscle’s function is to remove it from an attachment and reattach it somewhere else.  Orthopaedic surgeons occasionally do that sort of thing, but it’s major surgery, and no-one has ever contemplated it for breast-feeding problems. In the unlikely event that an adjacent band of tissue was really restricting tongue movement, the treatment would be stretching exercises or massage. Surgical release of movement-restricting tissue elsewhere, requires special techniques, such as z-plasty, to avoid worsening the problem.

The logic of frenotomy amounts to this; “Here’s a problem. Here’s a relatively avascular fold of skin conveniently to hand. Let’s cut it and claim credit if the problem improves.”

A few years ago similar nonsense affected my specialty of gynecology. Surgeons blamed a convenient, but entirely innocent part of a pelvic ligament, for otherwise unexplained pelvic pain. They divided a superficial bit of it, and claimed credit for any improvement that followed (click here). Only when a large trial with sham surgery in controls (click here) showed no effect did they stop. But imagine if the LUNA trial had by chance been positive. The logic of cutting part of a random ligament near the uterus to treat unexplained pelvic pain would not have altered, but unless gynaecologists had been appropriately sceptical, thousands of women would have gone on getting an expensive placebo, and some would have been injured.

It’s easy to be sceptical if a treatment – homeopathy for example – simply cannot work.  Believing in substances in such high dilution that not a single molecule remains, means disbelieving all of physics and chemistry. Sensible people don’t even read homeopathy trials.

Cutting tongue tie isn’t quite in that class, but it’s pretty near. Be sceptical if, by chance, FROSTTIE appears to show benefit.

Jim Thornton

 

One Comment leave one →
  1. February 26, 2020 6:32 pm

    This article would have maybe a hint of credibility if the anatomy shown was of a neonate or infant. Opinions do not have credibility either. Evidence does, see NICE guidance on ankyloglossia.
    Suzanne Barber RM IBCLC & Tongue Tie Practitioner.

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