Administration of a probiotic with peanut oral immunotherapy: A randomized trial

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Administration of a probiotic with peanut oral immunotherapy: A randomized trial

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I've written to the lead author on clarifying the placebo group to confirm they did not receive any OIT.  Dr. Burks is named one of the co-authors.  If anyone is heading in to see Dr. B on other business would you consider asking him what the significance of the treatment group was compared to OIT success rates with same exclusion criteria and length of treatment, please?

The central question is what is novel in comparison with rates from the standing data on OIT?  What made this publishable, what is it being compared to?

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Two things:

(1) Confirmation that this PPOIT trial is double placebo for the control group meaning they received no OIT whatsoever.

(2) Comparing more apples to pears if not other apples the UK Clarke OIT results.

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2813%2962301-6/fulltext

Interpretation

To our knowledge, we did the first phase 2 study appropriately powered to derive an accurate estimate of the effect size of the treatment in children aged 7–15 years. By contrast with other studies, we assessed a representative UK population including children with severe reactions, with allergy confirmed by DBPCFC. 84% and 91% of participants could tolerate the equivalent of five peanuts per day, and a high rate of desensitisation (ability to tolerate the equivalent of roughly ten peanuts) was shown. There was a substantial effect size, and improvement in quality of life with a good safety profile. Tolerance after cessation of OIT was not assessed. Our data apply to the population studied and the doses employed, and there is a need for replication and expansion of populations studied. This study shows that peanut immunotherapy is an effective and well tolerated treatment in this age group.

The primary outcome, desensitisation, was recorded for 62% (24 of 39 participants; 95% CI 45–78) in the active group and none of the control group after the first phase (0 of 46; 95% CI 0–9; p<0·001). 84% (95% CI 70–93) of the active group tolerated daily ingestion of 800 mg protein (equivalent to roughly five peanuts). Median increase in peanut threshold after OIT was 1345 mg (range 45–1400; p<0·001) or 25·5 times (range 1·82–280; p<0·001). After the second phase, 54% (95% CI 35–72) tolerated 1400 mg challenge (equivalent to roughly ten peanuts) and 91% (79–98) tolerated daily ingestion of 800 mg protein.

I'm scratching my head over this one... 

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The paper itself needs to be read first.  There may be something novel in it about unreponsive duration if there was an established baseline for comparison prior to this trial.  I just have a hard time believing JACI would publish something that would be at the level of error a first year psych major would make.  Nor, do I think, Burks would sign on to it.  I have to read it to be sure.