"Purely speculative"?? Actually, not speculative at all...the clinical trial showed LDN DID reduce inflammation - in fact, corroborated by lab tests and colonoscopy which showed that it not only reduced, but eliminated inflammation, resulting in mucosal healing. Unlike Entocort, which reduces (but does not necessarily eliminate) inflammation, but does NOT appear to induce mucosal healing.
I wouldn't say your GI isn't good just because she trusts traditional meds more, and has not had time to read the published LDN results. There is no need to rely on "anecdotal evidence" from the Internet -- the trial was well documented and published in the American Journal of Gastroenterology. I downloaded the published clinical trial and handed it to my daughter's docs.
As for FDA approval:
a) the FDA is slow -- didn't approve budesonide (Entocort) until more than a decade after it had already been used extensively for Crohn's in Western Europe and elsewhere.
b) because naltrexone is an orphan drug, pharmaceutical companies are not going to make a pile of money on it, so it is not worth their while to run or fund clinical trials using LDN...which, in turn, slows down FDA approval.
Furthermore, the FDA has never approved any mesalamine (Pentasa, Asacol, Lialda) for Crohn's...these meds are FDA approved only for ulcerative colitis. It has never approved Flagyl or Cipro for Crohn's. Azathioprine (Imuran) has been around for ages, but has never been FDA approved for Crohn's. What does that tell you? That FDA approval certainly is not a prerequisite for using even standard traditional meds.
Yes, people do know the long-term effects of naltrexone at a high dosage...for instance, 50 mg. The lower dosage or 4.5 mg is thought to result in little or no side effects...docs have been using LDN off label for Crohn's, MS, and other conditions for years and have not reported any side effects other than those uncovered in the clinical trial. What has not been evaluated fully is how long LDN, if it works, can keep a patient in remission. And like any med, it doesn't work for everybody.
I often think of the mantra "First, do no harm" and of how traditional meds fall short. The risks of azathioprine and other traditional meds are substantial: immunosuppression, lymphoma, bone marrow suppression, neutropenia, etc. They ALL attack symptoms, but do not cure Crohn's (because of course we don't know what causes Crohn's). If recent research, gaining traction, turns out to be true -- that Crohn's patients have underactive immune systems, then this means we have really been on the wrong track in using meds that suppress the immune system.
LDN does not suppress the immune system and its side effects pale in comparison to those of traditional meds. I don't expect any doc to recommend LDN but I do expect docs to cooperate with patients who have done their homework, are informed about the risks (mainly the risk of it not working), and want to try it, anyway.