European LDN Conference 2009, Glasgow, LDN Research Summary - Dr Tom Gilhooly,
Essential Health Clinic, Glasgow
Although Low Dose Naltrexone (LDN) is just 1/50th of the standard dose of Naltrexone, a 30 year old drug with a good safety record, published research and science research is needed in order for UK NHS GPs and NHS clinicials in general to feel comfortable with prescribing LDN.
Summary of research -
Initial notable research - Penn State - A human study on Crohn's Disease patients showed great results. NOTE - With much larger doses than Dr T G is using.
Today - Dr Tom Gilhooly says we are 9 10ths of the way towards funding for the first trial in UK using LDN on Multiple Sclerosis (MS) patients (120 patients).
The patent protection for Naltrexone is long gone - So, it is unlikely there will be any studies carried out by any pharmaceutical company.
Therefore, University or - Charity funding is required
Hopefully government science funding in the UK will be available.
Again - Publication is required (Hence clinical use in Dr T G's clinic has not been written up - Not seen as relevant by most professionals)
Issue : Institutional resistance - Charities are wary of LDN
Accredited Funding needed - There is only 1 such MS charity, but they are not keen on LDN
Most research has concentrate on relatively large doses of 3 - 4 mg - Dr T G's clinic stat on 1mg and work up to optimum dose which is often not much more than 1 or even use 1mg -Therefore there is a need to educate researchers on dosage.
Short duration studies - 2 - 4 years needed for LDN. For use in cancer, 5 years - therefore more longer studies are more expensive, so need shorter cheaper studies with demonstrable results.
LDN in Cancer , MS - Dr Ian Zagon - Has been publishing results for 28 yrs. Has done multiple studies in animals (244 publications)
First in 1981 - Nalexone and cancer in mice.
Subsequently Dr Bernard Bihari became interested. He did lots of work but often unpublished. His work on HIV was refused publication by many journals so went unpublished.
Dr Ian Zagon - Found that opiate growth factor was increased by LDN and this seemed to naturally inhibit tumour growth in animals.
Used Experimental Allergic Encephalomyelitis (EAE) - This was induced in animals and treated wtih LDN
MS Society of America has funded research into this which will be published soon.
Dr I Z's MS study was presented at the September 2008 Montreal World Congress on MS.
Finding - High dose Naltrexone worsens EAE and makes humans feel worse.
Therefore, low dosages required and it is important to take once per day - So the effect us for a short duration.
Human Studies :
Fibromyalgia (FM) - Paper published last week.
There are 250,000 FM sufferers in the UK alone
Stanford - 10 FM patient study due to report in 2010.
Dr T G - Essential Health Clinic, Glasgow - Clinical findings -
Have been using LDN with FM for 6 months, much better than previous treatment - 80% improvement vs 20% with other approaches, e.g. Nutrition, lifestyle improvement.
Effect is very dosage dependant.
All studies used 4.5mg, TG - mostly 1 - 2 some people have trouble taking more than 1.
Penn State, Crohn's - Still the most impressive result.
Done by Professor Jill Smith, Penn State University.
17 patients over 12 weeks pilot study- Used 4.5 mg LDN (Again, note this is high compared with Dr T G's clinical experience).
Very rigourous - Close examination of colon.
Findings -
67% of patients went into remission.
89% responded positively in some way.
Dr T G's, EHC clinical findings - 3 patients , 2 with severe Crohn's - both entered remission with 1mg quite quickly. (NOTE - I am the 4th patient but I'm new! LOL)
One of Dr T G's NHS patients had bloody diarrhea so severe they had to have a blood transfusion. This patient is now in remission for over a year. The patient has actually stopped LDN as they didn't like to take drugs (!) but has maintained remission.
IBS Study- Kariv et al, Tel Aviv - 47 patients with 0.5mg (Very low dose) - Saw 76% improvement and increase in reduction in pain-free days.
Another study - 600 patients double-blind, randomised -
0.5 mg (Called PTI 901)
2 months of improvement, but no further improvement after 3 months.
Seems like too low a dose, so IBS not proven really.
Seifrabei et al AJAS 2008 - Study on Haematological cancers
5 months treatment with 3mg
Significant improvement in quality of life measurements at 1, 3 and 5 months follow up.
MS Study - Gironi et al Milan 2008
Dr T G's EHC Clinical experience - LDN is the best MS treatment.
Treated 40 primary progressive MS patients (Worst case scenario) over 6 months
Only 1 patient out of the 40 experienced any progression in their symptoms.
There was a significant reduction in spasticity found.
Cree et al - University of California at San Francisco
80 patients for 8 weeks, randomised controller trial using 4.5 mg
Significant improvement using MS Quality of Life Index.
Pain, mental health and cognition all improved significantly.
NOTE - Side Effects - No major adverse effects have been found in any of the studies done so far anywhere.
Therefore - There is no risk in prescribing LDN.
In Summary :
There have been numerous publications of results of using LDN.
LDN has been tested in use for a diverse range of medical conditions
LDN Seems to be useful for many conditions involving the immune system
Further Reading :
Dr Bihari - http://www.lowdosenaltrexone.org/bbihari_cv.htm
Dr Ian Zagon - http://fred.psu.edu/ds/retrieve/fred/investigator/isz1
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