This trial was held on 17 patients who have active Crohn's Disease, and consisted of oral administration of 4.5mgs of naltrexone nightly for 12 weeks. Crohn's is an inflammatory bowel disorder (IBD)-- considered to be auto-immune-- that, along with its partner illness ulcerative colitis, has been linked with multiple sclerosis (IBD'ers are 1.7 times as likely to have MS than controls). Crohn's patients have a relapsing-remitting course disease, with periods of flareups and remission that are all too familiar to MS'ers. Also, remember that the MS-therapy-in-waiting Tysabri was being tested in parallel with Crohn's patients with promising results. As such, the impact of LDN on Crohn's patients likely has some relevance to MS'ers.

The results of the study are intriguing. 15 patients demonstrated some positive response (using a numeric scale called the Crohn's Disease Activity Index), and 11 went into remission. Quality of life was reported to have improved significantly and no abnormal side effects were noted in the lab work.

Now there are a few obvious and significant problems with this trial, which members of This is MS are probably adept at quickly identifying by now. First, this was a very small trial held over a short period of time. Second, and more importantly, there were no controls patients- this was an open label study and everyone knew that they were taking LDN, so the placebo effect cannot be entirely excluded. Finally, the gold standard of Crohn's diagnosis and evaluation is endoscopy (or direct imaging of the digestive tract). That methodology was not part of the trial constructs, which instead had to rely on necessarily less accurate questionnaires and laboratory studies. Incidentally, one patient had an endoscopic procedure unrelated to the trial, and demonstrated healing of the digestive tract.

On the other hand, the results are clearly very positive (and include improvements on quality of life parameters), low dose naltrexone is affordable and easy to administer, and negative physiological effects (limited to what can be detected with bloodwork) were not seen for the 3 month duration of the trial. Certainly, for those looking for an adjunct therapy, this trial-- even with its rather significant flaws-- might be something worthwhile to discuss with your doctor.

On an aside, we also cannot help but congratulate the LDN community on achieving this rather significant milestone. Hopefully this will tip the scales for a larger and placebo-controlled trial for the utility of low dose naltrexone in multiple sclerosis patients.

Click "read more" for the full abstract of this study.

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Full Abstract

Low-Dose Naltrexone as a Treatment For Active Crohn's Disease

J. P. Smith1; H. E. Stock1; S. I. Bingaman1; D. T. Mauger2; I. S. Zagon3 1. Medicine, The Pennsylvania State University College of Medicine, Hershey, PA, USA. 2. Health Evaluation Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA. 3. Neural and Behavioral Sciences, The Pennsylvania State University College of Medicine, Hershey, PA, USA.

Background and Aims: Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone (LDN), an opioid antagonist given at a dosage that exacerbates opioid-opioid receptor interactions, was tested in humans as a treatment for active Crohn’s disease. Methods: Eligible subjects with histologically and endoscopically confirmed active Crohn’s disease with a Crohn’s Activity Index (CDAI) score of 220-450 were enrolled in a study using 4.5 mg naltrexone/day. Subjects were required to be off infliximab for at least 8-weeks, and this medication was not allowed during the trial. Other drug therapy for Crohn’s disease utilized 4 or more weeks prior to enrollment was continued at the same dosages. Patients completed the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short-form (SF-36) quality of life (QOL) surveys before treatment, every four weeks on therapy, and 4-weeks after completion of the study drug. Drug was administered orally each evening for a 12-week period. Laboratory tests, erythrocyte sedimentation rates, C-Reactive protein, and CDAI scores were assessed monthly and 4 weeks after discontinuing the medication. Results: Seventeen patients with a mean initial CDAI score of 356 ± 27 were enrolled in the study. CDAI scores decreased significantly (p<0.01) with LDN, and remained statistically lower than baseline 4-weeks after completing therapy (see Figure). Eighty-nine percent of patients exhibited a response to therapy (>70-point decrease in CDAI, p<0.001) and 67% achieved remission (CDAI score <150). QOL surveys indicated marked improvement with LDN. No laboratory abnormalities were noted. One subject undergoing routine endoscopic procedures showed healing of the intestinal mucosa. In both subjects with open fistulas, closure was noted with LDN. The most common side effect of LDN was sleep disturbances (7 patients). Conclusions: LDN therapy offers an alternative safe, effective, and economic means of treating subjects with active Crohn’s disease

Link to Abstract

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