Low Dose Naltrexone (LDN)

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The following discussion of Low Dose Naltrexone (LDN)is presented for informational purposes only. Since LDN is often mentioned on the Yahoo SCD list serve, btvc-scd@yahoogroups.com. SCDWiki felt that persons might want to be informed about the subject. This article is not intended as medical advice nor is any opinion offered about whether or not to use LDN. Considering whether to use LDN or not is a decision that should only be made in consultation between a person and their physician.

Naltrexone is a well known, FDA approved, prescription drug. Since Naltrexone is an opioid antagonist, it's FDA approved use is for treating drug and alcohol dependence.

However, Low Dose Naltrexone has been found by some doctors to be very useful in treating a wide range of other diseases that have auto-immune components including: Crohn's disease, ulcerative colitis, HIV, fibromyalgia and some cancers.

The problem is that using LDN for treatment other than for drug and alcohol dependence are "off-label" uses. "Off-label means that these are not applications that have been officially sanctioned by the FDA. Large scale clinical trials are needed for official FDA approval of low dose naltrexone to treat these other conditions.

Here is the problem, the pharmaceutical manufacturers, who usually sponsor these clinical trials have no incentive to invest in the required large scale trials. Clinical trials are expensive. Naltrexone is an old drug. The patents have expired. LDN no longer exclusively belongs to any one company. As a result, there is competition and the profit margin on LDN is low, too low to cover the costs of a clinical trial. Furthermore, the drug companies are concerned that LDN might replace some of their more profitable drugs, drugs in which they have made a significant investment and that are currently FDA approved for the above ailments.

As a result of this dilemma, there is a movement within the medical profession to get Low Dose Naltrexone approved for a wide variety of uses. There have been some small scale studies. Part of the problem is the wide spectrum of conditions that it is believed that the use of LDN would benefit. Current FDA procedures favor a narrow application of usage for a drug. Some believe that even aspirin would have problems gaining FDA approval today because aspirin has a benefit over a wide range of medical situations.

Some have written that in LDN for Crohn's or Ulcerative Colitis, the cream form is preferred. Some have posted that the dose that they had been taking may be too high. In addition, LDN users must be gluten free (no problem here - SCD is definitely gluten free), and not have a yeast problem.

Below are two websites about low dose naltrexone where you can get information about the drug and lists sources of how and where to obtain it. Be informed so that you can discuss the situation with your doctor. Some on the list serve, btvc-scd@yahoo.com believe that the ultimate treatment is LDN and SCD. All medical decisions such as low dose naltrexone should be discussed with your physician.

www.lowdosenaltrexone.org

www.ldnscience.org - Doctors studying Low Dose Naltrexone


How do I know if I need to take LDN?

Answer - If the diet alone does not seem to be working as optimally as you would wish, and you have other issues (for example, asthma, rheumatoid arthritis or other auto-immune symptoms) it is very likely that LDN will help you.

Since the private drug companies are not interested, slowly, the government (NIH) is funding some LDN studies.

LDN for Crohn’s Disease—Studies at Penn State College of Medicine, Hershey, PA

Background. Dr. Jill P. Smith’s original article, "Low-Dose Naltrexone Therapy Improves Active Crohn’s Disease," was published in the Jan 11, 2007 online edition of the American Journal of Gastroenterology (2007;102:1–9) [print edition Apr '07]. This was the first clinical study of LDN published by a US medical journal. Dr. Smith, Professor of Gastroenterology at Pennsylvania State University's College of Medicine, found that two-thirds of the patients in her pilot study went into remission and fully 89% of the group responded to LDN treatment to some degree.

She concluded that “LDN therapy appears effective and safe in subjects with active Crohn’s disease.” That open-label Penn State trial demonstrated the efficacy of LDN in a small group of patients. As a result, Dr. Smith received an NIH grant that permitted the more definitive Phase II placebo-controlled clinical trial.

Phase II. Dr. Smith and her colleagues have now published the results of their Phase II study of 40 adults with Crohn’s disease, “Therapy with the Opioid Antagonist Naltrexone Promotes Mucosal Healing in Active Crohn’s Disease: A Randomized Placebo-Controlled Trial”, in the online journal Digestive Diseases and Sciences, March 8, 2011.

The 4.5mg daily dose of naltrexone proved to have very positive results, with significant improvements in the Crohn’s Disease Activity Index scores and with substantial healing demonstrated by endoscopy.

In December 2012, there has been some writing on the yahoo list serve that the researchers are reconsidering this dosage (4.5mg) as too high and are shifting to 3 mg.

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