Low-dose naltrexone therapy improves active Crohn's disease.

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Low-dose naltrexone therapy improves active Crohn's disease.Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS.Department of Medicine, Pennsylvania State University College of Medicine, Hershey, Pennsylvania 17033, USA.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 4.5 mg naltrexone/day.
Infliximab was not allowed for a minimum of 8 wk prior to study
initiation. Other therapy for Crohn's disease that was at a stable dose
for 4 wk 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 wk on therapy and 4 wk after completion
of the study drug. Drug was administered by mouth each evening for a
12-wk 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 wk 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.Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11