Low Dose Naltrexone for Autoimmune treatment, Parkinson’s, Pain, etc…
Do you suffer from: ALS
Irritable Bowel Syndrome
then you need to know about LDN!
“Low Dose Naltrexone (LDN) may well be the most important therapeutic breakthrough in over fifty years. It provides a new, safe and inexpensive method of medical treatment by mobilizing the natural defenses of one’s own immune system.
LDN substantially reduces health care costs and improves treatment of a wide array of diseases. Unfortunately, because naltrexone has been without patent protection for many years, no pharmaceutical company will bear the expense of the large clinical trials necessary for FDA approval of LDN’s new special uses. It is now up to public institutions to seize the opportunity that LDN offers.”
check out these studies as recent as this year and many more around the world are in trial………….
Recently Published Clinical Trials of LDN
[Note: all boldfacing, below, was so chosen by the editor.]
> LDN for MS—University of California, San Francisco
Bruce Cree, MD and co-researchers at the Multiple Sclerosis Center at UCSF published their study “Pilot Trial 0f Low Dose Naltrexone and Quality of Life in MS” in the online Annals of Neurology on 19 Feb 2010.
The study began in early 2007. Some 80 patients with MS were involved in this double-blind, “randomized, placebo-controlled, crossover-design study of the effects of low dose naltrexone on quality of life as measured by the multiple sclerosis quality of life inventory.” Each subject received either LDN or a placebo for 8 weeks, followed by one week without either, and then a further 8 weeks on the the alternate capsule. A substantial contribution toward the study was made by the voluntary LDN for MS Research Fund.
The results were published in February 2010 in the Annals of Neurology (full pre-publication text available here):
Pilot trial of low dose naltrexone and quality of life in MS
Bruce A.C. Cree, Elena Kornyeyeva, Douglas S. Goodin
Multiple Sclerosis Center at UCSF
To evaluate the efficacy of 4.5 mg nightly naltrexone on the quality of life of multiple sclerosis patients.
This single center, double-masked, placebo-controlled, crossover studied evaluated the efficacy of eight weeks of treatment with 4.5 mg nightly naltrexone (Low dose naltrexone or LDN) on self reported quality of life of MS patients.
80 subjects with clinically definite multiple sclerosis were enrolled and 60 subjects completed the trial. 10 withdrew before completing the first trial period: 8 for personal reasons, 1 for a non-MS related adverse event and 1 for perceived benefit. Database management errors occurred in 4 other subjects and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial’s statistical power. LDN was well tolerated and serious adverse events did not occur. LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3 point improvement on the Mental Component Summary score of the SF-36 (P=.04), a 6 point improvement on the Mental Health Inventory (P<.01), a 1.6 point improvement on the Pain Effects Scale (P=.04) and a 2.4 point improvement on the Perceived Deficits Questionnaire (P=.05).
LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted.
Figure 2: SF-36, PCS=physical component summary scale score, range 13.6 – 61.9 baseline 34.9. MCS=mental component summary scale score, range 15.6 – 70.0, baseline 44.2.
Figure 3: PES=pain effects scale, range 6 – 30, baseline 16.1. MHI=mental health inventory, range 0 – 100, baseline 63.5
> LDN for Fibromyalgia—Stanford University, Palo Alto, California
A single-blind, small clinical trial of LDN for the treatment of fibromyalgia was begun at Stanford Medical Center in June 2007; principal Investigator Sean Mackey and sub-investigator Jarred Younger. The results were published as “Fibromyalgia Symptoms are Reduced by Low-Dose Naltrexone: a Pilot Study” in Pain Med. 2009 May-Jun;10(4):663-72. Younger reports:
The LDN trial on 10 individuals gave us encouraging results. The findings warranted a larger, double-blind trial [involving] individuals with fibromyalgia, which is ongoing now in the San Francisco Bay area. We are also pursuing a small trial of LDN for pediatric fibromyalgia patients.
Additional information can be found here.
> LDN for MS—Milan, Italy
A long-awaited pilot study of low dose naltrexone therapy in multiple sclerosis was run by the Milan neurological researcher, Dr. Maira Gironi and colleagues. Several northern Italian hospitals began enrolling patients for the study during the first week of December 2006. Dr. Gironi reports that the 6 months of LDN treatment was completed in August 2007. Importantly, Dr. Gironi’s research team in Milan has long been a locus for significant research on endorphins in relation to illness, and this study has been tracking accurate assessments of the patients’ beta-endorphin levels in response to their LDN treatment.
The subjects were 40 patients affected with Primary Progressive MS. PPMS is an uncommon form of multiple sclerosis that progresses inexorably and for which neurologists have never had an approved treatment to offer.
Results were published in September 2008:
Multiple Sclerosis. 2008 Sep;14(8):1076-83.
A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis.
Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, Bucello S, Radaelli M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G.
Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy; Fondazione Don Carlo Gnocchi, IRCCS, Milan, Italy.
Abstract: A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltrexone (LDN) has been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The primary end points were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, depression, and quality of life. Clinical and biochemical evaluations were serially performed. Protein concentration of beta-endorphins (BE) and mRNA levels and allelic variants of the mu-opiod receptor gene (OPRM1) were analyzed. Five dropouts and two major adverse events occurred. The remaining adverse events did not interfere with daily living. Neurological disability progressed in only one patient. A significant reduction of spasticity was measured at the end of the trial. BE concentration increased during the trial, but no association was found between OPRM1 variants and improvement of spasticity. Our data clearly indicate that LDN is safe and well tolerated in patients with PPMS.
Please check out ldn.org or ldnscience.org for more information or contact us or our friends at Pacific Compounds Pharmacy (503)640-3208