Low-dose naltrexone may help inflammatory bowel disease.
Article Type: Clinical report
Subject: Inflammatory bowel diseases (Drug therapy)
Inflammatory bowel diseases (Research)
Naltrexone (Dosage and administration)
Author: Klotter, Jule
Pub Date: 10/01/2009
Publication: Name: Townsend Letter Publisher: The Townsend Letter Group Audience: General; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2009 The Townsend Letter Group ISSN: 1940-5464
Issue: Date: Oct, 2009 Source Issue: 315
Topic: Event Code: 310 Science & research
Geographic: Geographic Scope: United States Geographic Code: 1USA United States
Accession Number: 211561645
Full Text: Low-dose naltrexone (LDN) has shown promise in small clinical studies as a safe and effective treatment for inflammatory bowel disease, including Crohn's disease. Naltrexone, an opiate antagonist, is FDA approved for treating narcotic and alcohol addiction. A dosage of 50 mg/day blocks the euphoria caused by opiate drugs by competitively binding to opiate receptors. At much lower doses, naltrexone appears to increase production of endorphins and enkephalins--the body's natural opioids. This, in turn, leads to an upregulation of the immune system.

Bernard Bihari, MD, a New York physician, initiated the use of low-dose naltrexone--4.5 mg/day or less--to boost immune function in AIDS patients. Since 1985, Dr. Bihari (retired in 2007) and other physicians have observed that LDN can cause marked improvements in people with different cancers, autoimmune diseases (particularly multiple sclerosis), HIV/AIDS, central nervous system disorders, and bowel dysfunctions. "[These] disorders ... share a particular feature: in all of them, the immune system plays a central role. Low blood levels of endorphins are generally present, contributing to the disease-associated immune deficiencies" (http://lowdosenaltrexone.org).

In 2007, the American Journal of Gastroenterology published "Low-Dose Naltrexone Therapy Improves Active Crohn's Disease," a pilot study conducted by Dr. Jill Smith and colleagues at Pennsylvania State University's College of Medicine. Seventeen people with active Crohn's disease took part in the study. The participants took 4.5 mg of naltrexone each evening for 12 weeks. "Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (p < 0.001)," the authors state. Inflammation decreased, and ulcers healed. Copyrighted, before-and-after endoscopic pictures are available at http://lowdosenaltrexone.org. Seven patients experienced sleep disturbance, the most common adverse effect. Since the publication of this pilot study, Dr. Smith has nearly completed a phase II placebo-controlled clinical trial involving 40 patients and initiated a double-blind placebo-controlled study of youngsters, ages 6 to 17, with active Crohn's.

Crohn's disease is not the only bowel disease that responds to LDN. It was also the subject of a 2006 open-label pilot study with 42 IBS patients performed by Israeli researchers R. Kariv and colleagues. The 42 participants took 0.5 mg/day for four weeks. Seventy-six percent reported improvement in abdominal pain, stool urgency, consistency, and frequency.

At this time, low-dose naltrexone is only available from a compounding pharmacy by doctor's prescription. The website http://lowdosenaltrexone.org lists several pharmacies with experience in compounding the medication. Compounding LDN in a slow-release form or with calcium carbonate as a filler inhibits the medicine's effectiveness. Difficulty sleeping, the most common adverse effect, is usually resolved by reducing dosage to 3 mg. LDN has not been tested on pregnant women.

Kariv R, Tiomny E, Grenshpon R, et al. Low-dose naltrexone for the treatment of irritable bowel syndrome: a pilot study [abstract]. Dig Dis Sci. 2006 Dec; 51(12):2128-2133. Available at: www.ncbi.nlm.nih.gov/pubmed/17080248. Accessed July 1, 2009.

LDN for Crohn's disease--Penn State College of Medicine, Hershey PA. Available at: www.lowdosenaltrexone.org/Idn_trails.htm. Accessed July 1, 2009.

Low dose naltrexone. Available at: http://lowdosenaltrexone.org. Accessed May 9, 2008.

McCandless J. New therapy: Low-dose naltrexone for immunomodulation. Autism Res Rev Int. 2005; 19(2): 1-2.

Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS. Low-dose naltrexone therapy improves active Crohn's disease [abstract]. Am I Gastroenterol. 2007 Apr; 102(4):820-828. Available at: www.ncbi.hlm.nih.gov/pubmed/17222320. Accessed July 1, 2009.

WISTV. Health Alert: Treating Crohn's disease [Web page]. Available at: www.wistv.com/Global/story.asp?s=7281968. Accessed July 1, 2009.

briefed by Jule Klotter

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