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My PITCHES trial prediction

January 26, 2019

With one exception, all outcomes will be negative

This is a trial with which I am closely involved. Registered here. Protocol published here.  I’m co-chief investigator, involved in all aspects of conception and design, and recruited many participants. I registered this prediction on 5 Jan 2019 after recruitment was completed, the database locked and while analysis by others was ongoing, but before I had seen any data.  This is rather late, and sceptical readers will need to contact the trial statistician if they doubt me. Nevertheless my prediction is date stamped on Aspredicted here. Note dates are in US form, month/day/year.

I predict that the trial will be negative with one exception, that the drug, ursodeoxycholic acid will reduce maternal itch. I further predict that this effect on maternal itching will be statistically significant, but that the size of the reduction will be so small that the average woman will judge the effect as not worthwhile.  The basis for this opinion is the pilot study (click here) published in 2012.

The reason for my prediction that all other adverse outcomes will not be significantly reduced is that I am sceptical about most treatments in general. In this case, although the treatment with ursodeoxycholic acid is popular, it is not underpinned by strong basic science.

To read more about Aspredicted.org click here.

Jim Thornton

2 Comments leave one →
  1. March 3, 2019 12:30 pm

    I do not know if your readers have also seen the leader in this week’s
    Lancet. This not only discusses pruritis (sic) but also talks about increased still birth rate quoting a confidence interval the lower range being less than unity!
    Hmm

  2. March 3, 2019 1:08 pm

    Yes. That was the commentary on Caroline Ovadia’s IPD-MA. The CI for stillbirth risk excluded unity for the subset with bile acid >100. Hence the headline – Stillbirth not increased till BA above that level. Poor show that Lancet missed pruritis eh? Any spell checker would have got it. 🙂

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