Thursday, 13 May 2010

Abstract of Phase II Trial Results for Low Dose Naltrexone (LDN) for Crohn's Disease from Dr Jill Smith, Penn State University

Abstract Link

This is a highly significant result for Low Dose Naltrexone as it's a Phase II study which was carried out under randomised, double-blind, placebo-controlled conditions.

Summary -

45% of 40 patients achieved remission inside 12 weeks.
(Note, clinical experience shows it can take more than 3 months to really get results with LDN and certainly 4.5mg is often too high a dose too).

82% of the 40 patients had their Crohn's improve by around 20% or more in terms of its activity.
Healing was reported in the endoscopy studies too.

Although this is not quite as impressive a result as the first study, it is at least as good as many other treatments and with a lot, lot less side effects (Only reversible liver enzyme changes reported).

For comparison, this anti-TNF treatment managed 40% remission after 5 years, chances are LDN could be 5%+ better than that :

http://www.medpagetoday.com/MeetingCoverage/DDW/19885

Remicade + azathioprine managed roughly 50% remission after 26 weeks, but that is of course at a big price financially and in terms of side-effects -

http://www.webmd.com/ibd-crohns-disease/crohns-disease/news/20100414/combination-therapy-treats-crohns-disease

Obviously a Phase III study will be interesting now as it will have a much bigger patient population and maybe run longer too.
Would be interesting to see how the remission rate is after another 3 months.
Would be even more interesting to see how it was if the patients were allowed to decrease dose too.

Note that Dr Smith has another study starting on Vitamin D with Crohn's too.

1 comment:

  1. Can you link to the source of this statement:

    "Note, clinical experience shows it can take more than 3 months to really get results with LDN and certainly 4.5mg is often too high a dose too"

    What clinical experience? who else is testing?

    ReplyDelete