LDN to treat Autoimmune Diseases - Clinical Trials

LDN Clinical Trials:

'via Blog this'

Clinical Trials

Am J Gastroenterol. 2007 Apr;102(4):820-8. Epub 2007 Jan 11.

Low-dose naltrexone therapy improves active Crohn's disease.

Smith JP, Stock H, Bingaman S, Mauger D, Rogosnitzky M, Zagon IS.

Department of Medicine, Pennsylvania State University College of Medicine, Hershey, Pennsylvania 17033, USA.

OBJECTIVES: Endogenous opioids and opioid antagonists have been shown to play a role in healing and repair of tissues. In an open-labeled pilot prospective trial, the safety and efficacy of low-dose naltrexone (LDN), an opioid antagonist, were tested in patients with active Crohn's disease.

METHODS: Eligible subjects with histologically and endoscopically confirmed active Crohn's disease activity index (CDAI) score of 220-450 were enrolled in a study using 4.5mg naltrexone/day. Infliximab was not allowed for a minimum of 8 wk prior to study initiation. Other therapy for Crohn's disease that was at a stable dose for 4 wk prior to enrollment was continued at the same doses. Patients completed the inflammatory bowel disease questionnaire (IBDQ) and the short-form (SF-36) quality of life surveys and CDAI scores were assessed pretreatment, every 4 wk on therapy and 4 wk after completion of the study drug. Drug was administered by mouth each evening for a 12-wk period.

RESULTS: Seventeen patients with a mean CDAI score of 356 +/- 27 were enrolled. CDAI scores decreased significantly (P=0.01) with LDN, and remained lower than baseline 4 wk after completing therapy. Eighty-nine percent of patients exhibited a response to therapy and 67% achieved a remission (P < 0.001). Improvement was recorded in both quality of life surveys with LDN compared with baseline. No laboratory abnormalities were noted. The most common side effect was sleep disturbances, occurring in seven patients.

CONCLUSIONS: LDN therapy appears effective and safe in subjects with active Crohn's disease. Further studies are needed to explore the use of this compound.

PMID: 17222320

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Integr Cancer Ther. 2007 Sep;6(3):293-6.

Reversal of signs and symptoms of a B-cell lymphoma in a patient using only low-dose naltrexone.

Berkson BM, Rubin DM, Berkson AJ.

Integrative Medical Center of New Mexico, Las Cruces, USA.

PMID: 17761642

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Mult Scler. 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.

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.

PMID: 18728058

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Pain Med. 2009 May-Jun;10(4):663-72. Epub 2009 Apr 22.

Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study.

Younger J, Mackey S.

School of Medicine, Department of Anesthesia, Division of Pain Management, Stanford University, 780 Welch Road, Suite 208, Palo Alto, CA 94304-1573, USA.

jarred.younger@stanford.edu

OBJECTIVE: Fibromyalgia is a chronic pain disorder that is characterized by diffuse musculoskeletal pain and sensitivity to mechanical stimulation. In this pilot clinical trial, we tested the effectiveness of low-dose naltrexone in treating the symptoms of fibromyalgia.

DESIGN: Participants completed a single-blind, crossover trial with the following time line: baseline (2 weeks), placebo (2 weeks), drug (8 weeks), and washout (2 weeks).

PATIENTS: Ten women meeting criteria for fibromyalgia and not taking an opioid medication.

INTERVENTIONS: Naltrexone, in addition to antagonizing opioid receptors on neurons, also inhibits microglia activity in the central nervous system. At low doses (4.5 mg), naltrexone may inhibit the activity of microglia and reverse central and peripheral inflammation.

OUTCOME MEASURES: Participants completed reports of symptom severity everyday, using a handheld computer. In addition, participants visited the lab every 2 weeks for tests of mechanical, heat, and cold pain sensitivity.

RESULTS: Low-dose naltrexone reduced fibromyalgia symptoms in the entire cohort, with a greater than 30% reduction of symptoms over placebo. In addition, laboratory visits showed that mechanical and heat pain thresholds were improved by the drug. Side effects (including insomnia and vivid dreams) were rare, and described as minor and transient. Baseline erythrocyte sedimentation rate predicted over 80% of the variance in drug response. Individuals with higher sedimentation rates (indicating general inflammatory processes) had the greatest reduction of symptoms in response to low-dose naltrexone.

CONCLUSIONS: We conclude that low-dose naltrexone may be an effective, highly tolerable, and inexpensive treatment for fibromyalgia.

PMID: 19453963

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Inflamm Bowel Dis.. [Epub ahead of print]

Low-dose naltrexone for treatment of duodenal Crohn's disease in a pediatric patient.

Shannon A, Alkhouri N, Mayacy S, Kaplan B, Mahajan L.

Department of Pediatric Gastroenterology, Cleveland Clinic Pediatric Institute, Cleveland, Ohio.

PMID: 20014017

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Annals of Neurology, Volume 9999, Issue 999A, Feb 2010

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 Univ. of Calif. in San Francisco 350 Parnassus Ave., Suite 908, San Francisco, CA 94117  USA

bruce.cree@ucsf.edu

Objective: To evaluate the efficacy of 4.5 mg nightly naltrexone on the quality of life of multiple sclerosis patients.

Methods: 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.

Results: 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).

Interpretation: LDN significantly improved mental health quality of life indices. Further studies with LDN in MS are warranted.

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Who is LDNscience?  This is what they say......

LDNscience™ is a public information project of theMedInsight^® Research Institute.

The MedInsight^® Research Institute is a U.S.-based 501(c)(3) nonprofit working to bridge the ever-widening gap between medical research and actual medical practice. We are dedicated to bringing relief to those who suffer from cancer or chronic medical conditions by raising awareness of:

• • Commercially unsponsored medications.
• • Off-label or secondary uses for approved medications.
• • Specialized tests that enable treatments to be tailored to the individual.

MedInsight's co-founder, Moshe Rogosnitzky, is an expert in the clinical application of Low Dose Naltrexone (LDN), Opioid Growth Factor (OGF) and related therapies, which have made incredible inroads with Crohn’s disease, cancer and other serious diseases. He collaborates in research with the discoverers of LDN and OGF, Dr. Ian S. Zagon and Dr. Patricia J. McLaughlin of Hershey Medical Center, Penn State University, as well as with Dr. Jill P. Smith of Hershey Medical Center, who conducts clinical research into LDN and OGF.

This site is intended to provide you with general information on the background, use of and evidence forLDN, OGF and related therapies, and to answer any questions on these therapies and our work.  If you cannot find the answer to your particular question, please submit your question and we will respond to you as soon as possible.

To become a much-valued supporter of this site or of our life-changing research into LDN, OGF and related therapies, please visit:  Join Our Supporters.

Thank you,

The LDNscience™ Team

Nick Cannon - Just 1 More Case Of The so called "non curable" Auto-Immune Disease

I'm so damn sick of hearing the word "AUTOIMMUNE DISEASE".  If the immune system doesn't work as it should and is "diseased" because it's attacking  areas of the body that are perfectly healthy, how in the world did this begin, when did it start, why do the majority of elderly people and even people aged 50 and up not have he threat of these disease?  & if you know about Autoimmune conditions, there are at least over 20 conditions that fall into the category... if not more.  
Our generation, up coming generation, and our poor children's generation are faced with these, or will be faced with these horrible health challenges.  They are almost doomed once they are conceived because they are already being fed the trash that comes from the food of the mother.  
I don't want to raise my family here, in the US with the health care only becoming more bleak as the years go on.  Our health 20 years ago compared to today is TERRIBLE.... &only getting worse.  Our nation  has all some of the greatest medical advances, technology, drugs, so WTF is the problem???  It's sickening that so many people are suffering with these diseases that the doctors say "can only be managed".  
That's a lie and I'm beginning to have hatred toward the entire medical system.


Before I forget to mention, someone will think to themselves. 'Well, death rates are much older than they used to be.  People are living to be well into their 80's.  That's true... but what kind of qualityof life are they living.  Are they existing, in chronic pain, spending all their money on health care to "manage" their health condition.  
My guess.... is that they aren't living the best life they could possibily be living, unless they are just solid and healthy people, if they refuse to just take the pill and live (putting up with the pain). Other's don't suffer from the condition in a way that it interferes in their daily life, so those people only complain, call the doctor and get more meds to give temp. relieve, but most likely, so many meds these days, precipitate more health problems.


This is my vent.  I'm fed up and annoyed!!  I hear AUTOIMMUNE way to much, but why isn't anything being done to treat the person in a way that wont harm them further, if not send them to their grave!!!!! 

Nick Cannon: I have an auto-immune disease - 21 News Now, More Local News for Youngstown, Ohio -

A Short Article That Says A Lot About LDN

I like this short article because it covers the history of the drug LDN, how it started to get used for autoimmune diseases and why the FDA hasn't approved it for conditions other than drug addiction.  This article is from 2007 however, it's now 2011 and people still haven't heard about low dose naltrexone as an alternative treatment for many diseases.  I began doing research for SAFE and effective treatment for Crohn's Disease because I was on Remicade.  In my opinion, Remicade and other biologic drugs that weaken the immune system are not SAFE options.  Read the side-effect and safety indications for any of the biologics that are being used for many inflammatory diseases.  After reading this for yourself, you will understand why I consider this an unsafe treatment. Next, look up the side-effect and safety warnings for LDN/naltrexone.  

Now which one would you choose ?   

LDN - An Emerging Treatment - Article By Carl Frankel, Care2 Green Living contribution writer

If you’re one of the millions of people with auto-immune disease, there may be help for you. It’s a drug with a mouthful of a name—Low-Dosage Naltrexone, or LDN for short.

LDN is best known for its effect on multiple sclerosis. Thousands of people with MS are persuaded that it has halted the disease’s downward progression, and even reversed their symptoms. People with lupus, fibromyalgia, chronic fatigue syndrome, Crohn’s disease, and psoriasis also report benefits.

The good news doesn’t stop here. LDN is affordable—a bit over a dollar a day. Side effects——and many people don’t have them—are mild and short-term. It’s even FDA-approved, sort of. (It has “off-label” approval, meaning the FDA okayed it for a different purpose.)

The story of LDN is an intriguing saga of one man’s pioneering work, followed by a grass-roots, Internet-driven movement.

Naltrexone, without the “low-dosage” part, was developed by Dupont to treat drug addition, and approved in 1984 by the FDA for that purpose. The standard dosage was 50 milligrams, and it didn’t pan out as a treatment. Naltrexone blocks the opiate receptors in the brain. It works, in other words, by taking the fun out of taking opiates. The problem is, it takes the fun out of just about everything else, too. The result: People wouldn’t stay with the program.

Bernard Bihari, a Harvard-trained neurologist, began researching naltrexone and discovered something remarkable. When people took the drug in very low doses (3.0—4.5 milligrams instead of the standard 50 mg. dosage), it appeared to have a dramatic effect on auto-immune diseases. Bihari hypothesized that this essentially homeopathic dosage caused the body to manufacture more endorphins, which are centrally involved in supporting and regulating the immune system. He also came to believe it helped fight cancer and HIV.

Over the past 15 years or so, many thousands of people have taken LDN, to positive effect. The “anecdotal” evidence, so-called because it’s derived from stories, not studies, is overwhelmingly positive. It is also hugely persuasive, if you’re not the sort of person (your typical doctor, for instance) who requires clinical trials to be persuaded.

Where has the medical establishment been during this explosion of grassroots interest? Until recently, unmotivated and indifferent. Because the patent has expired and the drug is so inexpensive, there’s little money to be made from LDN, and therefore little reason to conduct clinical trials.

This can make it difficult to get a prescription for LDN. Because it hasn’t been clinically proven to be an effective auto-immune disease treatment, many doctors won’t prescribe it.

Recently, the medical establishment has started turning its attention to LDN, for a very simple reason: The anecdotal evidence is that overwhelming. Three national conferences on LDN have been held, and clinical trials have been launched in the United States and elsewhere. The first study to report results came out of Penn State University: “LDN therapy appears effective and safe in subjects with active Crohn’s disease.”

If you’re interested in learning more about LDN, a wealth of information is available at
www.ldninfo.org.

As for whether or not to try LDN, at the end of the day, there’s only one person who knows what’s right for you. And that’s you.

Carl Frankel is a journalist and author who has been writing about green business, green products, and integral living for the past 20 years.

More on Alternative Therapies (184 articles available)
More from Carl Frankel (12 articles available)

Read more: http://www.care2.com/greenliving/ldn-an-emerging-treatment.html#ixzz1LfORWCGV

Interesting article - IBD patients and the dangers of C diff

I thought this article was worth reading.  This info was found by London researchers.   

Bug linked to bowel disease deaths

(UKPA) – 1 day ago

A common hospital bug increases the risk of death for patients with inflammatory bowel disease (IBD) six-fold, research has shown.

Scientists called for all IBD patients to be screened on admission to hospital to protect them against Clostridium difficile (C diff).

IBD, which includes Crohn's disease and ulcerative colitis, affects about 240,000 people in the UK.

The autoimmune conditions cause symptoms of abdominal pain and diarrhoea, which can be severe enough to warrant admission to hospital.

Researchers in London looked at NHS admission records from 2002 to 2008 and found a strong link between IBD, C diff, and death in hospital.

IBD patients infected with C diff were six times more likely to die than those who escaped the bug. After 30 days, their mortality rate was as high as 25%.

The findings, reported in the journal Alimentary Pharmacology and Therapeutics, also showed that IBD patients with C diff had longer stays in hospital and were almost twice as likely to need gastrointestinal surgery.

Typically, they remained in hospital for 26 days, compared with five days for patients without C diff.

Dr Sonia Saxena, one of the researchers from the School of Public Health at Imperial College London, said: "Hospitals must do everything they can to control infections such as C difficile. We are asking for these high-risk patients to be screened for C difficile proactively on admission to hospital so that if they are exposed, they can be diagnosed and treated more quickly."

Co-author Dr Richard Pollok, from St George's Healthcare NHS Trust, said: "At St George's Hospital, we have seen a 70% reduction in hospital-acquired infections after implementing a range of control measures, such as careful handwashing and reduced use of broad spectrum antibiotics. But we need to do more to protect vulnerable patients such as those with IBD."

Copyright © 2011 The Press Association. All rights reserved.

BOSWLLIA Herb Reduces Inflammation - Helps Crohn's,arthritis, colitis, more....

Here's the Article....Boswellia Reduces Inflammation
The ancient herb boswellia (Boswellia serrata) has been used for thousands of years to treat conditions that, in recent years, have been found to be caused by inflammation. Originating in Africa, China, and the Middle East, boswellia herbal extract is derived from the sappy resin of the boswellia tree. In the 1970s, German scientists discovered that boswellia produces therapeutic effects similar to those of the non-steroidal anti-inflammatory (NSAID) compounds ibuprofen and aspirin. Unlike boswellia, however, NSAIDs work by inhibiting the cyclooxygenase-2 (COX-2) enzymes. Unfortunately, medications that inhibit COX-2 often inhibit COX-1, which is needed to maintain a healthy stomach lining and common side effects include gastrointestinal bleeding.
Boswellia differs from the NSAIDs in its mode of action. Boswellia has been shown to reduce inflammation in both osteoarthritis and rheumatoid arthritis, inflammatory bowel disease, and other autoimmune conditions by blocking the lethal pro-inflammatory enzyme 5-lipoxygenase (5-LOX). A number of immune system chemicals released during the inflammatory response contribute to the chronic inflammation seen in atherosclerosis, osteoarthritis and certain autoimmune diseases. Blocking these pro-inflammatory chemicals reduces symptoms of inflammation and helps taper the autoimmune mechanism.

The Actions of Boswellia
Although the benefits of boswellia are similar to those of the non-steroidal anti-inflammatory drugs, boswellia works by blocking 5-LOX, which is the first enzyme released in the metabolic pathway leading to the synthesis of the immune system cytokines known as leukotrienes. Leukotrienes are harmful inflammatory substances thought to directly influence the disease process in a number of different disorders, including rheumatoid arthritis, cancer, and asthma.
The active ingredients of boswellia, the boswellic acids, decrease the activity of another pro-inflammatory enzyme known as human leukocyte elastase (HLE). HLE and leukotriene levels are increased in many inflammatory diseases and allergic reactions. To date, boswellia is the only substance known to reduce levels of both HLE and leukotrienes. In 2005, researchers found that boswellia works in part by altering the expression of the cytokine tumor necrosis factor alpha (TNF-α), another integral component in inflammation. An excess of TNF-α promotes chronic inflammation. Applying boswellia to cells has been shown to decrease the TNF-α-induced expression of cell adhesion and matrix metalloproteinase proteins, which are biochemicals related to endothelial dysfunction, cancer metastasis (spreading), arthritis, and other disease processes.

Benefits in Arthritis and Crohn's Disease
Researchers have found that boswellia helps prevent the deterioration of cartilage and joint tissue. This suggests that boswellia may relieve symptoms in arthritis by inhibiting the breakdown of connective tissues that is caused by tumor necrosis factor-alpha-induced expression of matrix metalloproteinase enzymes. Studies in both humans and dogs show after as little as two weeks of boswellia therapy include reduced pain, stiffness, and lameness.
In patients with rheumatoid arthritis and Crohn's disease, boswellia can help reduce the immune cells that promote inflammation while increasing the number of immune cells that inhibit inflammation (anti-inflammatory cells). In studies of patients with inflammatory bowel disease, ulcerative colitis and Crohn's disease boswellia reduced gastrointestinal inflammation and tissue damage.

http://www.suite101.com/blog/daisyelaine/boswellia_reduces_inflammation 

LDN Study/Trial for Active Crohn's - *link*

Low Dose Naltrexone study results - show that LDN did help Crohn's Disease sufferers. 


I'm searching to find out why this drug that is said to help people with autoimmune diseases - Crohn's being just one of the diseases, is not approved by the FDA yet for the treatment of autoimmune diseases.

There are so many positives for prescribing this drug vs all the biologics that come with the risk of some very dangerous side effects. Not to mention, naltrexone is super reasonable in price, few side-effects and is effective!

I just wanted to share my findings when searching on the FDA site for clinical trials. Let me know if you find this encouraging or helpful to you.