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Another tongue-tie trial

February 20, 2014

No benefit

Yesterday’s post (click here) about the NCT campaign to encourage baby tongue-tie cutting, in the hope of helping breast feeding, generated some interest.

It turns out I missed the latest, and in my humble opinion, the best quality trial (click here). It was run in Bristol between October 2011 and June 2013, funded by the National Institute for Health Research (NIHR), Research for Patient Benefit (RfPB) programme, and registered here in October 2011. It’s not yet appeared in print but has been available as an electronic pre-print since November.  For those with access problems here’s a copy, tongue tie emond.

The planned sample size was 100 and the primary outcome was the LATCH score, a mother and nurse reported measure of breastfeeding effectiveness. 107 infants were randomised (55 intervention, 52 control). As with the other four trials, follow-up was short. In this case surgery was offered to the control group after 5 days, and 35/52 of them accepted it.  The procedure worked, in the sense that the Hazelbaker Assessment Tool for Lingual Frenulum Function (HATLFF) improved. This measures the anatomical severity of the tongue-tie.

But the trial results were negative. At five days the LATCH score was the same in both groups. So also were the other two pre-specified secondary outcomes, a maternal pain VAS score, and the rate of breast feeding at eight weeks. The latter means little since so many of the control group had also been cut by that time.  But for what it’s worth exclusive breast feeding at 8 weeks slightly favoured controls; 30 (58%) intervention v 32 (64%) control.

The authors then did a scientifically bad thing. Having specified one primary and two secondary outcomes before starting, they then decided to measure two new outcomes, the Infant Breast Feeding Assessment Tool (IBFAT), and the Breastfeeding Self-Efficacy score – short form (BSES-SF).  A sceptic might wonder if they were going on measuring until eventually something showed a difference!  But I’m inclined to forgive them because they openly admitted that these were unplanned secondary outcomes. And it doesn’t matter anyway, because the IBFAT and BSES-SF were also the same in both groups.

Emond table 1

Nice trial. I wonder why the NCT doesn’t mention it on its campaign site.

Jim Thornton

 

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5 Comments leave one →
  1. pureform 2000 permalink
    February 21, 2014 2:04 pm

    Sounds OK to me.

    Cut away.

    Date: Thu, 20 Feb 2014 19:10:27 +0000 To: pureform2000@hotmail.com

  2. exuberance permalink
    March 2, 2016 5:13 pm

    It is mentioned in the NCT briefing https://www.nct.org.uk/system/files/related_documents/BF14%20Tongue-tie.pdf
    the difference with this trial is that all tongue-ties considered severe were excluded and, if it affected breastfeeding, babies were treated straight away, as it was considered unethical to do otherwise. Only ties considered mild-moderate were included. The group are trying to find funding to do another trail.

  3. March 2, 2016 7:59 pm

    Another trial would be a great idea. I’ve discussed the design with members of the Bristol group. They seem reluctant to have an untreated control group, because they are already convinced of the efficacy of treatment. We need a well conducted TT trial conducted by sceptics, happy to support controls through non treatment. Volunteers?

Trackbacks

  1. A tongue-tie trial | Ripe-tomato.org
  2. Irrational surgery | Ripe-tomato.org

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