MONDAY, April 23 (HealthDay News) -- Low-dose naltrexone may be a safe and effective treatment for Crohn's disease, according to the results of an open-labeled pilot prospective trial published in the April issue of the American Journal of Gastroenterology.
Jill P. Smith, M.D., of Pennsylvania State University College of Medicine in Hershey, Pa., and colleagues conducted a study of 17 patients with confirmed, active Crohn's disease who were treated with a 4.5-mg dose of naltrexone via compounded capsules every day for 12 weeks. Subjects did not take infliximab for eight weeks prior to enrollment while other treatments were continued at stable doses for the four weeks prior to the study.
At the start of the study, the mean Crohn's disease activity score of the patients was 356, which decreased significantly with naltrexone therapy. The reduction was sustained for at least four weeks after completion of the treatment. Overall, 89 percent of patients responded to the therapy and 67 percent achieved remission. Quality-of-life scores reported by the patients showed improvements after the therapy.
The authors suggest randomized phase 2 trials for the drug with a longer time frame. "Because the present study found that subjects were still unchanged and improved four weeks after stopping naltrexone therapy, a longer follow-up period should be observed to determine the durability of response," they conclude.
The study was funded by the National Institutes of Health.
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