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LDN (low dose naltrexone) factsheet

Date of issue: March 2010

Naltrexone (Nalorex) is a drug used to treat people with addictions. In the 1980s, a doctor in New York called Bernard Bihari discovered that low doses seemed to help the symptoms of people with a wide range of conditions, including cancer, AIDS and MS.

Research

The first formal clinical research into LDN took place at Penn State University's Hershey Medical Center. This was looking at its effect on people with Crohn's Disease, an inflammatory disease of the digestive tract. In the open label study, 17 people took LDN daily in addition to their other medication. All bar two of the participants exhibited a response to therapy. The treatment was well tolerated with the most common side effect being sleep disturbances, which affected seven participants[1]. The Center is now conducting larger trials of LDN in Crohn's Disease.

Trials involving LDN and MS:

  • An Italian pilot study involved 40 people with primary progressive MS. Participants received 4mg of LDN for six months, with researchers looking primarily at safety but also at the effect on spasticity, pain, fatigue, depression, and quality of life. The results were published in September 2008 and showed LDN was safe and well-tolerated. There was a significant reduction of spasticity during the trial, but half the participants reported an increase in pain. There were no significant changes to measures of fatigue, depression or quality of life during the trial.[2]
  • The University of California in San Francisco (UCSF) has studied the effects of LDN on quality of life in 80 people with MS. Results reported at conferences in 2008 showed LDN significantly improved quality of life (specifically, mental health, pain, and self-reported cognitive function) as measured by the MS Quality of Life Inventory. However, no impact was observed on symptoms such as fatigue, bowel and bladder control, sexual satisfaction, and visual function. Vivid dreaming was reported during the first week of treatment, but no other adverse effects were reported.
  • A study at the MindBrain Consortium in Akron, Ohio examined the effect of LDN on symptom severity, changes in quality of life, sleep patterns and affective states in 36 people with either progressive or relapsing remitting MS but reported in late 2008 that there was little apparent difference between the placebo and treatment groups. However, the trial had not exclude people already taking disease modifying drugs which reduce immune system activity. As LDN stimulates the immune system, the two drugs may have cancelled each other out. [4]

In 2006, the Evers Klinik, a private clinic in Germany, conducted a short study of the symptomatic effect of LDN on 60 people with progressive MS. Over a ten day treatment period, half the group received LDN and half a placebo. Ten of the 30 people in the treatment group showed some improvement in symptoms as did five people in the placebo group.

Treatment with LDN

A British group called the LDN Research Trust has been established by users of the treatment to raise money to fund a trial of LDN for use in MS. According to the LDN Research Trust, the treatment aims to stop progression by helping to improve symptoms. It is thought that LDN works by encouraging the body to produce endorphins and by stimulating the immune system - an approach that differs from most MS treatments, which attempt to reduce immune activity.

Because LDN stimulates the immune system, it should not be taken by people also taking one of the beta interferon drugs or other drugs that suppress the immune system.

The full strength drug should not be used in conjunction with an opioid-containing medication or with people with hepatitis or liver problems. The low dose treatment is not associated with significant side effects.

As naltrexone is a licensed drug in the UK, it can be prescribed for conditions other than that for which it is licensed if a doctor feels that it is an appropriate treatment. Drugs prescribed 'off licence' are the direct responsibility of the prescribing doctor, who will need to be convinced that the treatment is safe and potentially effective. Although LDN is relatively inexpensive, funding for off licence prescriptions may or may not be accepted by the local primary care trust.

Reference

  1. Smith JP, Stock H, Bingaman S, et al.
    Low-dose naltrexone therapy improves active Crohn's Disease.
    American Journal of Gastroenterology 2007;102:1-9.
    abstract
  2. Gironi M, Martinelli-Boneschi F, Sacerdote P, et al.
    A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis.
    Multiple Sclerosis 2008;14(8):1076-1083.
    abstract
  3. Cree B, Kornyeyeva E, Goodin DS.
    Pilot trial of low dose naltrexone and quality of life in MS.
    Annals Of Neurology 2010 Feb 19 [epub ahead of print].
    abstract
  4. Low Dose Naltrexone website. Clinical trials for LDN.
    [updated 10 November 2008; cited 3 March 2010].
    Available from: www.lowdosenaltrexone.org/ldn_trials.htm