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Low-Dose Naltrexone therapy improves active Crohn's disease

Title
Low-Dose Naltrexone therapy improves active Crohn's disease
Publication Type
Journal Article
Research Type
Human
Reported as
Clinical Trial
Date
April 01, 2007
Authors
Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS.
Institution
Pennsylvania State University
Link
Abstract

OBJECTIVES: 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, were tested in patients with active Crohn's disease.

METHODS: Eligible subjects with histologically and endoscopically confirmed active Crohn's disease activity index (CDAI) score of 220-450 were enrolled in a study using 4.5mg Naltrexone/day. Infliximab was not allowed for a minimum of 8 weeks prior to study initiation. Other therapy for Crohn's disease that was at a stable dose for 4 weeks prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 weeks on therapy and 4 weeks after completion of the study drug. Drug was administered by mouth each evening for a 12 week period.

RESULTS: Seventeen patients with a mean CDAI score of 356 +/- 27 were enrolled. CDAI scores decreased significantly (P=0.01) with LDN, and remained lower than baseline 4 weeks after completing therapy. Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared with baseline. No laboratory abnormalities were noted. The most common side effect was sleep disturbances, occurring in seven patients.

CONCLUSIONS: LDN therapy appears effective and safe in subjects with active Crohn's disease. Further studies are needed to explore the use of this compound.