International studies probed the safety and efficacy of a potential treatment for multiple sclerosis in pill form.
By Ronald Hoffman, MD
In January 2008, Action published an article about low-dose naltrexone (LDN), detailing a brief history of this drug and how it works. Originally developed as a treatment for opioid and alcohol addiction, beginning in 1985, researchers began to test it at low doses for treating conditions of the immune system like multiple sclerosis (MS).
In the February 2008, we reported on three on-going clinical trials of LDN for the treatment of MS.
Those trials are now complete. Following is a summary of the findings.
San Raffaele Scientific Institute in Milan, Italy
Dr. Maira Gironi and colleagues successfully completed a six month study of beta-endorphin levels in patients who were treated with LDN. The aim of the trial was to evaluate and document the safety and tolerability of LDN. A secondary outcome was the evaluation of efficacy on spasticity, pain, fatigue, depression and quality of life experienced by the participants. The trial was carried out with 40 patients with Primary Progressive Multiple Sclerosis (PPMS). The data of the trial clearly indicated that LDN is safe and well tolerated by patients with PPMS.
Neurological disability progressed in only one patient. A statistically significant reduction in spasticity and an improvement in fatigue, depression and quality of life were measured at the end of the trial. Beta-endorphin concentration increased during the trial and paralleled clinical improvement, adding evidence of a biological activity of the drug. The results of this trial were published in Multiple Sclerosis Journal. If you would like more information, please contact action@ unitedspinal.org.
University of California at San Francisco Multiple Sclerosis Center
In a randomized, double-masked, placebo controlled, double-crossover eight-week trial, Dr. Bruce Cree and Associates found that LDN improves MS quality of life. Using an MS Quality of Life Questionnaire with approximately 60 participants, the study found that benefits on the quality of life for physical functioning were not observed. Improvements in mental health and pain were observed. Naltrexone was well tolerated. The only adverse event reported was vivid dreaming during the first week of treatment in several patients. A peer-reviewed paper with full details of the study is pending publication.
MindBrain Consortium, Summa Hospitals and Case-Western Reserve University
The findings of Dr. David Pincus and his colleagues were not significant. They do not conclude, from this, however, that LDN is not effective in MS patients. They are compelled by findings out of Italy, and the findings from others, including the UCSF trial, suggesting that allowing patients into their study who were on autoimmune inhibitors may have blunted the effect of the LDN readjusting the dynamics of the immune system. Further research is indicated. Also, severity of symptoms may also be a factor, and patients who are less far along in their MS should be grouped separately from those with milder MS.
If you would like more information about LDN, please visit the website: www.lowdosenaltrexone.org
Ronald Hoffman, MD, is founder and medical director of the Hoffman Center in New York City, author of numerous books and articles for the public and for health professionals, and host of the nationally syndicated radio program Health Talk.
Thank you for this update Dr Hoffman.
You may also be interested in a book that features 47 patient testimonies as case studies, an explanatory article, and interviews with 9 professionals familiar with this treatment:
Case Studies:
29 Multiple Sclerosis case studies
2 HIV/AIDS case studies
1 Hepatitis B case study
1 Primary Lateral Sclerosis case study
4 Cancer case studies
4 Crohn’s Disease case studies
3 Fibromyalgia case studies
1 Rheumatoid Arthritis
2 Multiple Benefits case study
Interviews:
Dr. David Gluck, USA
Dr. Tom Gilhooly, Scotland
Dr. Jaquelyn McCandless, USA
Dr. Skip Lenz, Compounding Pharmacist, USA
Dr Bob Lawrence, UK
Dr Burton M Berkson, New Mexico
Prof Jill Smith, Pennsylvania State Univ, USA
Dr Phil Boyle, Ireland
Antony Condina, Pharmacist, Australia
The book is entitled ‘Those Who Suffer Much, Know Much’, and the 2009 edition is available free of charge or expectation from the LDN Research Trust website in the UK: http://www.ldnresearchtrustfiles.co.uk/docs/2009.pdf
Some MS sufferers treated with LDN do not benefit at all but many notice lack of disease progression, improved symptoms and bladder control, and some achieve major symptom improvement.
This treatment may not be for everyone, but everyone should, at the very least, be made aware of it as a treatment option, especially where all other treatments have failed.
You’ll find links to conferences videos of patient and professional testimony, as well as a comprehensive list of references in the back of the book.
Cris – Is there anywhere I can get a copy of the book without printing the 270 pages from the web? Brad Spotts