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Crohn's Disease & LDN

What is Crohn's Disease?

Crohn’s disease (also known as regional ileitis, terminal ileitis or morbus Crohn) is an inflammatory condition that typically affects the small intestine, large intestine or both. It is named after Dr. Burrill B. Crohn, an American physician, who was one of the first to describe it. Crohn’s disease is part of a set of disorders classified as inflammatory bowel disease (IBD). It affects both males and females, of any age group, but its onset is more prevalent at a younger age. Since the cause of Crohn’s disease is uncertain, it is classified as an autoimmune disorder (i.e. when the immune system attacks the body’s own tissues for no apparent reason).

Crohn’s disease can manifest mildly, resulting mainly in inflammation leading to chronic diarrhea and malabsorption, or as a more severe illness leading to intestinal obstruction (due to formation of strictures) and fistula formation (abnormal connection between the intestines and nearby organs). In some cases, Crohn’s affects other areas of the digestive tract - including the mouth, esophagus and stomach. It is also possible to have systemic manifestations of the disease which can result in inflammation of the joints, kidneys, eyes and skin. Usual treatment for Crohn’s disease involves the use of immunosuppressive and antiinflammatory drugs, surgery and supportive care. There is no single approved drug treatment that works for every case of Crohn’s. At best, a single drug benefits 1 in 5 patients, resulting in the frequent need to try different drugs, to identify the best treatment for a patient.

What is LDN?

Naltrexone is a drug that was approved by the FDA in 1985 to treat opiate addiction and subsequently approved to treat alcoholism. Naltrexone is commonly used at a dose of 50 – 100 mg daily for treating opiate and alcohol dependency.

The term 'LDN' refers to the use of Naltrexone at low doses ­ less than 10 mg per day. LDN is a treatment discovered in 1980 by Drs. Ian Zagon and Patricia McLaughlin at Hershey Medical Center, Penn State University. Originally researched as a way to slow down the growth of cancer, LDN was found to work for certain autoimmune diseases such as multiple sclerosis by Dr. Bernard Bihari.

LDN and Crohn's Disease

In 2002, Moshe Rogosnitzky initiated the first-ever formal clinical trial for LDN in Crohn’s disease at Hershey Medical Center, under the leadership of Dr. Jill. P. Smith. The results of this trial, published in 2007 in the American Journal of Gastroenterology, showed that LDN benefited 89% of users, with 67% achieving remission. No significant toxicities were observed.

In 2010, researchers at the Cleveland Clinic Pediatric Institute presented a case of rare pediatric duodenal Crohn’s disease that responded well to LDN treatment.

Further successful studies followed. Two more trials were carried out at Hershey Medical Center, one in adults and one in children. A case series of LDN use in therapy-resistant Crohn’s disease was reported by physicians at Erasmus Medical Center, Amsterdam. In 2010 the FDA granted Orphan Drug Designation for LDN for treating pediatric Crohn’s disease.

From the collection of trials and case reports originating at various academic and medical centers, it is apparent that LDN can play an important role for a significant group of patients suffering from Crohn’s disease. Like all therapies, it doesn’t work for everyone. However, the risks associated with LDN use are minimal in comparison to those of the immune-suppressing drugs commonly used in Crohn’s disease. LDN undoubtedly has an important role to play in Crohn’s disease, especially in patients resistant to treatment.  Future trials will determine in which cases it may be appropriate to use as a first-line therapy for treating this disease.