Low-dose naltrexone for the treatment of irritable bowel syndrome: a pilot study.

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Low-dose naltrexone for the treatment of irritable bowel syndrome: a pilot study.
Kariv R, Tiomny E, Grenshpon R, Dekel R, Waisman G, Ringel Y, Halpern Z.Department of Gastrointestinal and Liver Diseases, 6 Weizmann Street, Tel-Aviv, 64239, Israel.Preclinical
studies have shown that a very low dose of naltreoxone hydrochloride
(NTX), an opiate antagonist, can block excitatory opioid receptors
without affecting inhibitory opioid receptors, resulting in analgesic
potency without side effects. The present study assessed the efficacy
and safety of PTI-901 (low-dose NTX) treatment in Irritable bowel
syndrome (IBS) patients. Forty-two IBS patients participated in an
open-label study. Participants received 0.5 mg PTI-901/day for 4 weeks
and were evaluated during baseline, during treatment, and at 4-week
follow-up. Patients recorded degree of abdominal pain, stool urgency,
consistency, and frequency. Primary outcomes were number of pain-free
days and overall symptom relief, evaluated by a global assessment
score. Data were analyzed per protocol. Global assessment improved in
76% of 42 patients. During treatment, the mean weekly number of
pain-free days increased from 0.5+/-1 to 1.25+/-2.14 (P=0.011). There
were no significant adverse reactions. PTI-901 improves pain and
overall feeling, and is well tolerated by IBS patients. A large,
randomized, double-blind, placebo-controlled study is justified.