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    You are here : Home » MS Research News » Drugs » Low Dose Naltrexone - Latest News

    Low Dose Naltrexone - Latest News

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    World of medicine divided by 'wonder drug'

    Low Dose NaltrexoneProponents of Low Dose Naltrexone (LDN) claim the cheap out-of-patent drug may well be the most important therapeutic breakthrough in more than 50 years, providing a new, safe and inexpensive way of treating MS and other autoimmune diseases.

    However, Irish and international medical professionals remain dubious about the claims surrounding LDN and the lack of any solid scientific evidence backing up these claims.

    New York neurologist Dr Bernard Bihari, who died in May 2010, is the man credited with having discovered the effectiveness of LDN in the treatment of not only MS and other autoimmune diseases such as HIV, but even cancer.

    The generic drug, which affects opiate metabolism, was first licensed by the FDA in the 1980s as a treatment for heroin addiction.

    Since 2002, a worldwide campaign has been under way to get LDN medically recognised as a treatment for MS and all autoimmune disorders. However, campaigners – including Galway woman Mary Bradley who lives in New Jersey with her husband Noel – claim the lack of any financial incentive for the big pharmaceutical companies to investigate new uses for the drug means there has been no large-scale clinical trial of LDN.

    Now, Dubliner John Donnelly is adopting another way to raise funds for the clinical trial he so fervently believes should take place. He has entered the Your Country, Your Call competition with his proposal to use LDN “to save millions of euro and many lives in Ireland”.

    His proposal is to investigate the use of LDN as a very cost-effective and efficacious treatment for a host of autoimmune system related illnesses such as MS, Crohn’s disease, cancer, chronic fatigue, fibromyalgia and others. His proposal received the highest number of votes (1,947) out of almost 7,000 proposals – the overall competition winner will be announced on September 17th.

    Approved in high-dose format, Naltrexone has been available for some 25 years but has only recently been used to treat conditions such as MS with a low dose of 4.5mg at a cost of about €1 per day.

    Donnelly’s interest in LDN began in August 2008 when his wife Jacinta was diagnosed with lung cancer and given only a few months to live. Determined to help her fight the disease, he found out about LDN on the internet and started his wife on the drug. Although he admits they still have a battle ahead, he says Jacinta is doing well at the moment. which he believes is down to LDN.

    “It is madness that this drug which is known to the Minister for Health is not being investigated and prescribed by every doctor in Ireland. Drugs which do very little for people with MS, etc, cost the country millions every month and these people could do a lot better, with no side effects, on LDN,” he states.

    The Your Country Your Call competition is designed to find two major proposals that will transform the economy – or significant elements of it – by creating jobs and opportunity, and a development fund of up to €500,000 is committed for the implementation of each of the winning proposals.

    If Donnelly wins, he will use his prize to invest in a full clinical trial to try to prove that LDN is a safe and effective treatment which should be freely available and prescribed by every doctor.

    However, Dr Orla Hardiman, consultant neurologist at Beaumont Hospital, advises patients to be very sceptical of unproven or alternative treatments for chronic disease, particularly where, like LDN, it is proposed that the drugs have beneficial effects in many different diseases.

    “What happens is that information becomes available on the internet on a regular basis about potential alternative or unvalidated treatments for a range of chronic illnesses, including MS.

    “I have a lot of patients regularly asking me about different treatments – everything from goat serum and snake venom to bee stings have done the rounds over the years. However, the rationale for all of these treatments, including LDN, is based on pseudoscience.”

    The bottom line, according to Hardiman, is that personal testimony does not equate to good science, and there is no scientific evidence for Naltrexone having any effectiveness in treating disease, either in the laboratory or clinical setting.

    She remarks: “We do know that LDN is a safe drug and on that basis, I would say the effect that people are describing is not a biological effect but a placebo effect. If you give somebody a dummy or placebo drug, it will be effective in up to 30 per cent of cases.

    “However, the placebo effect tends to wear off over time and obviously has no impact on the course of the illness. I think LDN falls into this category.”

    Hardiman takes great exception to the suggestion by LDN campaigners that clinical investigators are in the pocket of big pharma, pointing out that if a product looks like it has potential therapeutic benefit or if there is strong solid scientific basis, investigators will seek independent funding for studies.

    Co Kilkenny GP Dr Pat Crowley claims that LDN is a very effective drug but most people never hear about it. He currently has more than 80 patients from all over the country on the medication for a range of autoimmune illnesses including MS, lupus and various forms of arthritis.

    He is one of about four doctors prescribing LDN to patients and is trying to get more doctors involved. The drug is available from only a handful of pharmacies located in Dublin, Cork and Kilkenny.

    He explains: “I developed an interest in neurology during my time working in the US with a big neurology team in the 1960s. When I first read about LDN about six years ago, I decided to research it further because all of my patients with MS were getting worse despite being on treatment.”

    As part of his research, Crowley flew to New York to meet Dr Bihari and spoke to him at length about LDN. He says he started using it quite sceptically initially and even took a couple of patients off the drug, but gradually realised that it was having quite an impact on his patients with MS and other autoimmune diseases, particularly on younger patients.

    “I have found that LDN works in 70-80 per cent of my patients with auto- immune illness in stopping the progression of disease.

    “I am using it in rare forms of arthritis and am particularly impressed with how some of my younger patients are improving. I’m not saying it works for everybody because it doesn’t, and we don’t know why yet because there hasn’t been enough research done.”

    Since September 2002, Mary Bradley has spearheaded a global campaign to get LDN medically recognised and into the hands of as many people who need it as possible. After years of battling with the onslaught of her husband Noel’s primary progressive MS, Bradley stumbled on Bihari and LDN.

    The couple decided to put Bihari’s claims to the test and eight years on, Bradley says her husband’s disease has not progressed. So strongly does she feel about the need to spread the word about LDN that she has written a book about her experience called Up The Creek with a Paddle.

    The youngest son of Pulitzer Prize winning author Herman Wouk, Joseph has also written a book about his experience with the drug entitled Google LDN.

    Diagnosed with progressive relapsing MS, Wouk claims LDN halted the progression of his disease after he refused to accept his doctors’ opinion that there was nothing more to be done for the medical condition.

    Naltrexone has been around in a high dose form for 25 years €1 per day is the cost of a low dose of 4.5mg.

    “It is madness that this drug which is known to the Minister for Health is not being investigated and prescribed by every doctor in Ireland. Drugs which do very little for people with MS etc, cost the country millions every month."

    Source: The Irish Times © 2011 irishtimes.com (08/09/11)

    'Miracle’ MS drug under GP radar in the UK

    Low Dose NaltrexonePatients with multiple sclerosis (MS) in the UK are missing out on treatment with a ‘miracle drug’ for their disease because of lack of awareness among GPs and a fears over its potential cost.

    Naltrexone 300mg, sold under the trade name Nalorex in the UK, is approved to help addicts break their addictions to drugs such as heroin and other opiate-based substances, but low doses of the medicine have been used across the Atlantic since the mid-80s for the successful treatment of various autoimmune diseases.

    While not specifically licensed for the treatment of MS in the UK, doctors are allowed to prescribe low dose versions of the medicine if they think a patient will benefit from it, and some are already receiving treatment on this basis and have reportedly hailed its effects as miraculous.

    Martindale Pharmaceutical Company manufactures 3mg and 4.5mg forms of naltrexone in the UK under a special license, under which the company is prohibited from advertising its product but is allowed to supply pharmacies on request by a GP for use on an ‘individual patient’ basis, according to the Medicines and Healthcare products Regulatory Agency.

    In a survey by the LDN Research Trust, 79% of MS patients said their lives have been transformed by low dose naltrexone, and 60% claimed to feel with benefits of therapy within just seven days of embarking on a course of treatment.

    But despite its availability and glowing patient testimonials, less than one in 50 GPs in the UK is prescribing this therapy for MS, causing unnecessary hardship for a large number of disease sufferers, said LDN Research Trust founder Linda Elsegood.

    “LDN is used widely in the US to treat MS and a number of other autoimmune diseases. The UK has a lot of catching up to do,” she noted.

    Awareness and cost

    According to Elsegood, the key reason for the low prescription rate is lack of awareness among GPs, but those that do know about the drug are frightened off by cost. Most are told a month’s course of low dose naltrexone carries a price tag of between £130 and £355, but this can be cut to £30 if enough orders are placed through one outlet, she argues. In addition, less than a quarter of the Primary Care Trust’s in the country will fund LDN on prescription, leaving patients to fund treatment themselves.

    The Trust is currently holding its second annual international “LDN Aware” Conference in Birmingham, at which a range of users and health experts will campaign to raise the drug’s profile and secure funding for further clinical trials, in the hope that a growing number of patients will gain access to the drug in the UK.

    Source: PharmaTimes Online Copyright PharmaTimes 2010 (19/10/10)

    The effect of low-dose naltrexone on quality of life of patients with multiple sclerosis: a randomized placebo-controlled trial

    Low Dose NaltrexoneBackground: Low-dose naltrexone (LDN) may promote psychological well-being as well as generalized health especially in autoimmune disorders.

    The objective of this study is to assess the effect of LDN on the Quality of Life (QoL) of patients with relapsing-remitting and secondary progressive multiple sclerosis (MS) using the scales and composite scores of the MSQoL-54 questionnaire.

    Methods: A 17-week randomized, double-blind, placebo-controlled, parallel-group, crossover-design clinical trial was conducted in two universities. A total of 96 adult patients aged between 15 and 65 years with relapsing-remitting (RR) or secondary progressive (SP) clinically definite MS with disease duration longer than 6 months enrolled into the study. The primary outcome of the study was comparison of the scores of physical and mental health by conducting independent t-test of the results obtained in the middle and at the end of study between the two groups.

    Results: Variables including presence of pain, energy, emotional well-being, social, cognitive, and sexual functions, role limitation due to physical and emotional problems, health distress, and overall QoL did not show any meaningful statistically difference between the two groups. Factor analysis revealed that health perception scores were statistically different between the groups before starting, in the middle, and at the end of the study.

    Conclusion: The study clearly illustrates that Low Dose Naltrexone  is a relatively safe therapeutic option in RRMS and SPMS but its efficacy is under question and probably a long duration trial is needed in the future.

    Sharafaddinzadeh N, Moghtaderi A, Kashipazha D, Majdinasab N, Shalbafan B.

    Neurology Department, Jondi-Shapoor University of Medical Sciences, Ahwaz, Iran.

    Source: Mult Scler. 2010 Jun 9 Pubmed PMID: 20534644 (23/06/10)

    Multiple Sclerosis patient calls for drugs trial after finding LDN

    Low Dose NaltrexoneA woman from Oxfordshire is backing a campaign to get the Government to fund a drug she believes has stopped the progression of her incurable disease.

    Low Dose Naltrexone or LDN has been used for the treatment of multiple sclerosis, a disease of the immune system, for more than 25 years.

    But despite being cheap and highly effective, it is not routinely prescribed by GPs.

    The drug, which is also reported to help with the effects of cancer, Aids and rheumatoid arthritis, works by creating a surge in endorphins to restore patients’ immune systems.

    It costs between 50p to £1 per day and is already licensed to treat alcohol or drug addicts.

    Doctors can prescribe LDN for other conditions, but many are reluctant to do so because it has not been officially trialled and licensed for those uses, meaning they do not have proof of its effectiveness.

    Silvia Lane, 51, from Woodcote, was diagnosed with MS last year, and, after carrying out some research on the Internet, discovered LDN.

    Since she began taking it she said her life has been turned around.

    She said: “I found this drug before my disability became unbearable, before I was in a wheelchair, before I was a burden to my family and needed round- the-clock care, all things many people with autoimmune diseases need.

    “Finding this drug was amazing and it opened up a world I never knew existed.

    “Before, I had trouble with bladder control, fatigue and cramps in my legs. But within six weeks of taking LDN these problems had disappeared.”

    Clincal trials, which can be long and expensive, are usually funded by large drug companies. They are then given rights to make the drug.

    But Ms Lane, who has to buy her prescription from Scotland, from one of the few private doctors to routinely give out the drug, believes no pharmaceutical company will bear the expense of the large clinical trials, which could cost about £200m, because they would not make enough money from the sales.

    She is one of more than 10,000 people calling for the Government, via an online petition, to step in and pay for a trial instead.

    She said: “I won’t know for definite whether LDN has completely stopped the progression of my disease until I’m much older, but I believe it has.

    “It has certainly stopped the progression of any symptoms.

    “But there’s 25 years of patients’ evidence to prove that this drug works, and until there is a cure, it’s the best thing available.

    “But people don’t know about it. They aren’t told about it, unless they find out for themselves on the Internet.

    “We’re calling on the Government to save the NHS vast sums of money and make thousands of people’s lives better by doing the right thing, and properly trialling LDN.”

    To sign the petition visit the campaign website at http://petitions.number10.gov.uk/LowDNaltrexone/

    Source: The Oxford Times  © Copyright 2001-2009 Newsquest Media Group (13/11/09)

    Low Dose Naltrexone study indicates a possible new paradigm for the treatment of Multiple Sclerosis

    Low Dose NaltrexoneEndogenous Opioids Regulate Expression of Experimental Autoimmune Encephalomyelitis

    Preclinical investigations utilizing murine experimental auto-immune encephalomyelitis (EAE), as well as clinical observations in patients with multiple sclerosis (MS), may suggest alteration of endogenous opioid systems in MS.

    In this study we used the opioid antagonist naltrexone (NTX) to invoke a continuous (High Dose NTX, HDN) or intermittent (Low Dose NTX, LDN) opioid receptor blockade in order to elucidate the role of native opioid peptides in EAE. A mouse model of myelin oligodendrocyte glycoprotein (MOG)-induced EAE was employed in conjunction with daily treatment of LDN (0.1 mg/kg, NTX), HDN (10 mg/kg NTX), or vehicle (saline).

    No differences in neurological status (incidence, severity, disease index), or neuropathological assessment (activated astrocytes, demyelination, neuronal injury), were noted between MOG-induced mice receiving HDN or vehicle.

    Over 33% of the MOG-treated animals receiving LDN did not exhibit behavioural signs of disease, and the severity and disease index of the LDN-treated mice were markedly reduced from cohorts injected with vehicle.

    Although all LDN animals demonstrated neuropathological signs of EAE, LDN-treated mice without behavioural signs of disease had markedly lower levels of activated astrocytes and demyelination than LDN- or vehicle-treated animals with disease.

    These results imply that endogenous opioids, evoked by treatment with LDN and acting in the rebound period from drug exposure, are inhibitory to the onset and progression of EAE, and suggest that clinical studies of LDN are merited in MS and possibly in other autoimmune disorders.

    Commenting on the study, Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said, “Although at a very early stage these results shore up the beliefs of  the many people with MS across the world who have been taking LDN for some time and have reported very good anecdotal results across a number of different MS symptoms including continence, spasms and sleep problems.

    MSRC is hopeful that this study's results will encourage further clinical examination of this drug in humans."

    Ian S. Zagon*,1, Kristen A. Rahn*, Anthony P. Turel and Patricia J. McLaughlin*
    * Departments of Neural & Behavioral Sciences, and  Neurology, The Pennsylvania State University College of Medicine, Hershey, Pennsylvania 17033

    Source: Experimental Biology and Medicine 234:1383-1392 (2009)  & MSRC (29/10/09)

    'Life-changing' MS drug, LDN, could save NHS £300 million a year

    Low Dose NaltrexoneThe lives of 100,000 Multiple Sclerosis sufferers in the UK could be greatly improved while saving the NHS £300 million a year.

    The claim comes from the LDN Research Trust as part of the first International LDN Awareness Week which began this Monday.

    Low Dose Naltrexone, or LDN, is already available on the NHS but not all GPs are prepared to prescribe it to treat MS - Naltrexone has been approved by the Food and Drug Administration (FDA) for treating alcoholism and drug addiction. LDN uses around 1% of that dose to treat MS.

    MS sufferer Linda Elsegood founded the LDN Research Trust charity to campaign for clinical trials and has already helped more than 5,000 people in the UK reclaim their lives.

    "Naltrexone is a generic drug that is out of patent, so very cheap to produce," says Elsegood. "The downside of that is drug companies will not fund trials as there is no money in it for them.

    "LDN can treat the crippling effects of MS without side effects and at a fraction of the cost of existing treatments. An annual prescription can cost just £180, while the interferon drugs currently favoured by the NHS cost £10,000.

    "The interferon drugs are only offered to a small selection of people with relapsing-remitting MS. Nothing is offered to people with secondary progressive or primary progressive LDN could help with MS whatever type you have."

    It is believed there are 100,000 sufferers in the UK, but the actual figure could be as much as double that.

    Research done by the LDN Research Trust suggests the NHS could save £300 million a year by prescribing LDN. The figure takes into account medication, professional care and disability aids.

    "We believe that the annual savings could be much higher - nearer £1 billion," says Elsegood. "Clinical trials would cost just £2 million and could benefit MS sufferers, their families and the NHS.

    "Accurate MS data is unfortunately hard to come by, but you can't put a price on the thousands of lives that have been transformed by LDN.

    "We urge the Government to fund these trials for people not only with MS but also Crohn's, cancer and other diseases."

    Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said,“MSRC has been providing information about LDN to people with MS for a considerable number of years.  This drug shows very good anecdotal results across a number of different MS symptoms including continence, spasms and sleep problems.  We wholeheartedly support the LDN Research Trust’s call for government backed research into the use of LDN in MS and a number of other conditions”

    The first International LDN Awareness Week is taking place from October 19-25, 2009.

    Source: MSRC, LDN Trust & Medical News Today © 2009 MediLexicon International Ltd (22/10/09)

    LDN, the drug that changed my life, should be available to all

    Low Dose Naltrexone
    Four years ago, MS sufferer Linda Elsegood was wheelchair-bound, half-blind and half-deaf.

    She slept 20 hours a day and spent much of the time she was awake in clinics waiting for treatment, often for ailments caused by the drugs  she was given to control her multiple sclerosis.

    Today it’s a different story. “I am transformed,” says Linda, 53, a busy mother and grandmother from Norfolk, who has regained her independence after taking the drug LDN. “It has given me back my quality of life,” she says.

    Diagnosed in 2000, Linda was told she had an aggressive form of progressive MS and it would simply get worse, leaving her more and more incapacitated. “It was as if I were a TV that wasn’t tuned in. Everything was fuzzy – sound, vision, understanding – and I couldn’t retrieve from my brain the words I needed.

    “Within weeks of taking LDN I was tuned in again. The burning sensation in my legs faded and I stopped needing the loo six times an hour.”

    LDN is Low Dose Naltrexone. Naltrexone was developed to help heroin addicts break their habit. It was while working with heroin users who also had HIV that a New York doctor noticed low doses seemed to boost their failing immune systems.

    Since the drug is not available on the NHS for MS patients, Linda got hers on private prescription but her GP agreed to monitor progress.

    “The effect was amazing,” says Linda. “I want to make sure as many people as possible know about the drug so they might be relieved of their MS symptoms.”

    People suffering from a wide variety of auto-immune diseases – including MS, Crohn’s disease, arthritis and psoriasis – are telling each other via the internet about the relief that LDN seems to give.

    The problem is the drug isn’t licensed anywhere in the world as a treatment for auto-immune diseases so GPs often don’t know about it and patients who want to try it have to find a doctor willing to prescribe it privately.

    LDN is cheap – a typical prescription costs £15 a month – yet that is what keeps the drug in unlicensed limbo. Trials to test its efficacy would cost around £2million. However LDN came out of patent in the Nineties so no company has a monopoly on production and anyone can make it.

    This means no commercial company will fund trials as they will not re-coup their costs. Yet, says Linda, there could be big savings for subsidised health services worldwide and for the NHS.

    “There is no treatment for MS but the effects of steroids and immuno-suppressant drugs can keep someone like me in the treatment system,” says Linda. “I was constantly treated for infections my body would have fought off if I hadn’t been given drugs that shut down my immune system. LDN seems to regulate the immune system and get it back on track for some.”

    Linda is spreading the word via her charity, the LDN Research Trust, supported by health professionals around the world. “I am careful not to raise false hopes,” she says.

    “LDN is not a cure or miracle drug and doesn’t work for everyone. However people with MS should have the chance to see if it works for them.”

    Source: The Daily Express ©2006 Northern and Shell Media Publications (13/10/09)

    MS sufferer's bid to force trials of low dose Naltrexone (LDN) that got him walking
    Low Dose NaltrexoneAn MS patient has launched a campaign to persuade the Government to fund a trial into a cheap and safe "wonder drug".

    Andrew Barnett, who has secondary progressive MS, believes low-dose Naltrexone (LDN) could revolutionise the treatment of multiple sclerosis and a number of other auto-immune diseases.

    The 50-year-old, who lives in Llanelli, said his quality of life has been transformed by the treatment.

    Naltrexone is currently only licensed in the UK for use in treating heroin addiction. It is safe in high doses, which are given to addicts, including pregnant women.

    LDN has been used as a treatment for MS in the US since 1985 - some 300 GPs in the UK are now prescribing it to patients with MS and other auto-immune conditions.

    More than 5,000 people have now signed a petition, devised by Mr Barnett and his partner Jayne Crocker, calling on the UK government to fund an LDN trial.

    Mr Barnett, who founded the LDN Now campaign group with Ms Crocker, from Milford Haven, was diagnosed with MS in 2003 and was initially prescribed beta interferon.

    "It left me unable to walk and, in 2008, I stopped the treatment. I was offered Mitoxantron, which is an off-label therapy that costs £12,000-a-year and is used in chemotherapy.

    "It destroys the heart valves and the liver and I refused to take it and was left with nothing at all.

    "I was getting worse week on week and going down very fast. I couldn't support my weight on my legs at all so walking with crutches was extremely difficult. I would park the car outside the front door and I would have great difficulty getting into it without crawling.

    "I was in pain all the time. I was considering having to give up driving - it was getting rough.

    "Neuropathic pain is like being dipped in acid, it's a burning sensation and I was also suffering muscle pains."

    Mr Barnett first became aware of LDN when Ms Crocker's father read an article about it. He now pays up to £400 a year for the treatment.

    "I tried it because I had nothing to lose," Mr Barnett said. "Within four days I was walking along a friend's country path with sticks, which was mostly to do with its pain-killing effects. Over the last year I have got ever so slightly better - I haven't had any progression of the disease at all. I'm feeling strong and living without pain."

    Ms Crocker has also taken LDN for ulcerative colitis and seen a dramatic improvement in her condition.

    Dr Bob Lawrence, who is based in Swansea, has been taking LDN to treat his MS for the past eight years.

    "My MS has stabilised and many features of the illness have slowly improved," he said.

    "LDN is very simple and very safe, there's no threat of side-effects or toxicity. It is a wonderful cheap and safe treatment which is very, very effective."

    A Welsh Assembly Government spokesman said: "The National Institute for Health and Clinical Excellence has looked at Naltrexone, but only in the context of opioid dependence, for which it is licensed.

    "Since there is no licensed product available for low dose administration in the UK it can only be obtained under a special manufacturing licence.

    "Products of this nature are obtained on the full clinical responsibility of the prescriber and any liability for any harmful effects caused rests with them.

    "The use of these treatments is best carried out under the scope of a well designed clinical trial so that robust evidence of their effectiveness can be obtained.

    "In Wales the All Wales Medicines Strategy Group will only consider developing guidance for medicines that are appropriately licensed by the Medicines and Healthcare Products Regulatory Agency.

    "This is to ensure that medicines used in Wales are effective, of an appropriate quality and are safe for patients to receive. They are not currently looking at Naltrexone."

    The LDN petition can be viewed at http://petitions.number10.gov.uk/LowDNaltrexone

    Source: WalesOnline.co.uk © 2009 Media Wales Ltd. (22/09/09)

    Low dose naltrexone: The next miracle drug?
    Low Dose Naltrexone

    Naltrexone is the generic name for a drug, approved by the FDA in 1984, used to treat alcohol and opioid addiction. Opioids are generally pain-management agents such as morphine, codeine, oxycodone, and fentanyl. Opioids also include heroin and methadone, as well as our own naturally occurring endorphins.

    Endorphins are a type of neurotransmitter, released when we are subject to pain or stress, which have the effect of reducing these sensations. More than that, endorphins promote modulation of the appetite, release of sex hormones, feelings of euphoria, and enhancement of immune response. Some foods—such as chili peppers (the hotter the better) and chocolate—are said to promote endorphin release. Acupuncture, sex, massage, and exercise have also been shown to activate endorphin release.

    Naltrexone is an opiate receptor antagonist; that is, it blocks cellular opiate receptors. As such, it removes the pleasurable feelings associated with alcohol and opioid abuse. In fact, the drug does such a good job of blocking the receptors that many heroin addicts would stop taking naltrexone, since it simply made them feel terrible all the time. As such, methadone became the drug of choice in the treatment of heroin addiction.

    Neurologist Bernard Bihari MD, who at the time was treating heroin addicts with naltrexone, discovered that a substantial number of them—who also suffered from AIDS—had extremely low levels of endorphins. He postulated that this may have been the reason they turned to heroin in the first place. While opioid (and thus endorphin) receptors are found throughout the body, they are especially prevalent on immune system related cells.

    Since many diseases stem from some sort of immune dysfunction, Bihari wondered if low endorphin levels were a factor. In 1985, Bihari discovered that a low dose of naltrexone (LDN) blocks the endorphin receptors for only about an hour, the net result being that the body responds by secreting much more of the endorphins—often by a factor of five.

    Within a few years, he was seeing the therapeutic benefits of LDN in patients with such varied conditions as lymphoma, lupus, and pancreatic cancer. But, as good as these results seemed to be, they were not observed in a controlled clinical study.

    The first study of LDN published in a US-based medical journal would come in 2007, with Dr. Jill Smith's article in the American Journal of Gastroenterology entitled "Low-dose naltrexone therapy improves active Crohn's disease" (e-published in January, print published in April). Smith and her team found that 67% of the patients went into remission and fully 89% showed some therapeutic benefit. This encouraging work led to an NIH grant and a Phase II placebo-controlled clinical trial, currently in progress.

    In September, 2008, results were published for a Phase II clinical trial in Italy in which LDN was used to combat multiple sclerosis (MS). Again, the results were highly promising. Since MS is thought to result from an autoimmune process whereby T cells mistake myelin - the coating around nerve cell fibers in the brain and spinal chord—for a foreign invader and attack it, many assumed that MS was the consequence of an overactive immune response. These results, though, would argue against that theory.

    In 2007, Burton Berkson MD, PhD and associates published an article in Integrative Cancer Therapies entitled "Reversal of signs and symptoms of a B-cell lymphoma in a patient using only low-dose naltrexone." Berkson's 2006 article in the same journal entitled "The long-term survival of a patient with pancreatic cancer with metastases to the liver after treatment with the intravenous alpha-lipoic acid/low-dose naltrexone protocol" described the incredible turnaround of a patient previously diagnosed as terminal in 2002.

    LDN is inexpensive with virtually no harmful side effects. However, since it is no longer a proprietary drug, the pace of rolling out clinical trials for the off-label effects described in this article will probably be slow, as will its acceptance by mainstream medicine. Still, there is nothing to prevent a patient from taking an FDA approved drug for an off-label indication, and this practice goes on all the time.

    Certainly, there is much appeal in a naturally-acting immune modulator that is cheap and effective. We await the publication of further results.

    Source: Dentalplans.com 1999-2009 DentalPlans.com, Inc (01/06/09)

    Low Dose Naltrexone shows promise in Multiple Sclerosis animal study

    Low Dose Naltrexone

    Another non-injectable drug that probably is already being overused against MS has shown promise in an animal study, researchers at Pennsylvania State University reported at the WCTRIMS. It is naltrexone, developed for treatment of drug abuse.

    "Thousands of people are taking this drug for MS on the basis of what other people have said," said Dr. Ian S. Zagon, distinguished university professor in neural and behavioral sciences at Penn State. "So, we decided to do animal studies about its efficacy."

    The study of animals with an MS-like condition found that low-dose naltrexone helped, but high doses worsened the disease, Zagon said. Penn State is organizing a human trial of low-dose naltrexone in MS, he said. Meanwhile, use of the drug for the condition is not recommended, Zagon said.

    Source: News & World Report  © 2008 U.S. News & World Report (19/09/08)

    Could low doses of a drug for alcoholics ease the agony for sufferers of MS?

    Low Dose Naltrexone

    For some multiple sclerosis sufferers, just getting out of bed is tough.

    For 43-year-old father-of-three Jon Salisbury, getting up took up to an hour and involved the help of his wife or his children.

    'At more than 6ft tall, having to haul me out of bed is no mean feat.

    'Once I had got up, which could take half an hour, I was dragged to the top of the stairs as I couldn't bend my legs.

    'I then had to shuffle down them on my backside, like a child,' he says.

    Once downstairs, the ordeal wasn't over. Jon, a writer, had to haul himself into a chair next to the stairs, which would then be pulled over to the computer where he tried to focus long enough to write a few sentences.

    'One of the aspects of MS is not being able to concentrate and, with a family to support, that was very frightening,' he says.

    Jon, who has since split from his wife, lives in Kings Langley, Hertfordshire, with his children aged between 15 and 21.

    He was diagnosed with MS in 1995. By 2000, he couldn't work full-time and had to rely on a wheelchair to get around.

    His neurologist could offer only the two conventional types of treatment on the NHS: steroid injections which reduce inflammation or the drug interferon, which works on MS patients' dysfunctional immune system.

    Jon wasn't keen to take more steroids as his dose was already high, and he disliked the flu-like side-effects.

    He discovered a drug called Naltrexone on the internet. Anecdotal evidence showed this to be effective in treating MS.

    Within three months of taking it, he could leave his wheelchair and get about with a walking stick. Jon's concentration also improved.

    'I got some independence back,' he says.

    Naltrexone is licensed to treat alcohol and drug dependency; in large doses it blocks the pleasure receivers - opiate receptors - in the brain, dulling cravings.

    It was Dr Bernard Bihari in the 1980s, who found that, at low doses, it could improve MS patients' immunity.

    Dr Bihari has now retired, but his work is continued by Dr David Gluck, a specialist in internal and preventive medicine in New York.

    He says: 'MS patients have a dysfunctional immune system which attacks its own tissues.

    'In MS sufferers, the insulation surrounding nerve cells becomes a target. This can cause partial paralysis and muscle spasms.

    'Low-Dose Naltrexone (LDN) briefly obstructs the effects of endorphins, the brain's natural painkillers.

    'This increases the production of these same endorphins, stimulating the immune system and reducing the activity of the MS.

    'It's possible patients with MS who use LDN will have no further progression of their illness. They may also gain relief from some symptoms.'

    But the drug is seldom prescribed by doctors in the UK, where there have been no clinical trials for its use in treating MS.

    Some patients get it by private prescription - £15 for the liquid form, £24 for capsules per month.

    It is hoped that the first placebo-controlled, double-blind trial will begin in Glasgow later this year.

    It is being lead by GP Dr Tom Gilhooly with consultant neurologist Dr Jonathan O'Riordan.

    So what do experts think?

    'Potential treatments like Naltrexone have become popular without proper trials because, in the past, there has been a vacuum in effective MS treatments,' says Professor Alan Thompson, a professor of neurology and MS expert at London's National Hospital for Neurology and Neurosurgery.

    And then there's the issue of the drug being licensed.

    Dr Bob Lawrence, a GP in Swansea, has been taking LDN for his MS for eight years.

    'No drug company will apply for a license to prescribe Naltrexone at a low dose for MS, because to do so they will have to invest possibly millions in a trial to prove it is safe and it works.'

    However, the results of these trials are of little consequence to MS sufferers such as Jon, who don't need convincing.

    He bought it on private prescription through a doctor he was directed to by the LDN Research Trust.

    'I can now move around the house on a frame and need the wheelchair only for longer outdoor trips,' he says.

    To get LDN, a patient needs it prescribed 'off-label' - where a drug is licensed for use in treating one illness, but is prescribed for another.

    Dr Laura Bell, The MS Society's research communications officer, says: 'The MS Society was initially reticent on LDN as we felt there wasn't enough clinical evidence to support it.

    'However, as more anecdotal evidence comes to light, there is a clear need for research to prove or disprove claims, and we support this.'

    Jon hopes one day he will walk unaided again. Only time will tell, but LDN has given him something many with MS don't have - hope.

    • LDN Research Trust: 0871 989 96 66.
    • The Multiple Sclerosis Resource Centre 01206 226500

    Source: The Daily Mail © 2008 Associated Newspapers Ltd (26/08/08)

    LDN Trial in Primary Progressive Multiple Sclerosis

    A pilot study of LDN therapy in MS was carried out by the Milan neurological researcher, Dr. Maira Gironi in 2007.

    Dr. Gironi’s research team has long been a locus for significant research on endorphins in relation to illness, and this study tracked accurate assessments of the patients’ beta-endorphin levels in response to their LDN treatment.

    This was a 6-month pilot, multicentric, open-label, therapeutic study of 40 patients with Primary Progressive Multiple Sclerosis (PPMS) between the age of 18 and 60. The subjects were over 3 and less than 6 on the expanded disability severity scale (EDSS). They were affected with spasticity, pain, and/or fatigue. Optimisation of gabaergic or serotoninergic drugs before entering the study was requested. Any opioid-containing drug, immunosuppressive or immunomodulator medicines were not allowed.

    All 40 patients were treated with LDN at a final dose of 5 mg after a 2-week titration of 2.5 mg. Common involvement of the spinal cord mostly in the primary progressive form of MS explains a high prevalence of spasticity, pain, and fatigue accompanying the disease. People with PPMS are known to have low levels of beta-endorphins and a possible mild, diffuse inflammatory reaction. Conventional anti-inflammatory drugs seem to fail to cross the blood brain barrier in people with PPMS.

    During the 32 weeks of the study, participants underwent periodic clinical and biomedical analyses to evaluate any adverse events. Neurological evaluations, using scales of spasticity, pain, and fatigue, were periodically performed. The measurement of peripheral blood mononuclear cells’ beta-endorphin levels both before and after treatment were used to confirm or deny the supposed increase of this opioid during LDN treatment. An LDN-driven increase in beta-endorphins was expected to have an anti-inflammatory effect. This would suggest that LDN can cross the blood brain barrier.

    The treatment phase of the study was completed, as scheduled, in Autumn 2007, analysis of the data is ongoing.

    Dr. Gironi and her colleagues presented a poster summary of their 6-month study of LDN for Primary Progressive MS to the AAN conference in Chicago in April 2008.

    The open label study used a 5mg dosage of LDN in 40 patients. There were 5 dropouts, most of which appeared unrelated to the drug. Endorphin levels were measured at intervals and were seen to gradually increase throughout. This correlated with a general trend of improvement in a number of efficacy measures. Significant improvements were seen by the study’s conclusion in both fatigue and depression.

    Common adverse events reported during the study were urinary tract infections, some increases in liver enzymes, mild agitation and sleep disturbance. To date no serious adverse events have been reported for the study.

    Full study results are awaited and expected be published in a relevant medical journal. (20/06/08)

    Advocates, Physicians Scheduled to Gather for Low Dose Naltrexone Conference

    On October 20, 2007, physicians and patient advocates will gather at the Third Annual Low Dose Naltrexone (LDN) Conference ( http://www.lowdosenaltrexone.org) at Vanderbilt University's Student Life Center in Nashville, Tennessee to bring awareness to a promising treatment for HIV/AIDS, cancer, multiple sclerosis (MS) and a host of other life-altering autoimmune conditions, and autism.

    Naltrexone was originally approved by the FDA in 1984 at the 50mg level for narcotics addiction. But around the world, physicians and researchers are discovering that at much lower doses - most commonly in the 4.5mg range - the compounded medication, taken nightly, stimulates the immune system and helps the body fight off devastating diseases. LDN has no known harmful side effects, and at an average price of well under $50 per month's supply, the compound is very affordable.

    Still, LDN remains largely unknown in the U.S. - and according to Brenda Powell, coordinator of the Third Annual LDN Conference, big pharma remains uninterested in LDN, perhaps because of naltrexone's status as a generic drug and LDN's extremely low cost to the patient.

    But if Powell and the speakers at the Third Annual LDN Conference have anything to say about it, many more patients will soon know about LDN.

    The event's theme, "Breaking Down Barriers," reflects the strides made in LDN research and clinical trials in the past year. On the schedule are: Dr. David Gluck, who will present a brief review of the progress LDN has made in recent years; Dr. Jill Smith, professor of gastroenterology at Pennsylvania State University, who will discuss her phase II LDN clinical trial, in which she studied the compound's effects on Crohn's disease; and Dr. Jacqueline McCandless, whose slides (in absentia) will report details about her current study in Mali, using LDN for HIV/AIDS.

    Additional presentations will be made by US physicians Dr. Burt Berkson and Dr. Terry Grossman, and UK physicians who are seeing remarkable improvement in patients treated with LDN for cancer, multiple sclerosis, and other autoimmune diseases. Pharmacists Dr. Skip Lenz and Dr. Brendan Quinn will also present their impressions of LDN in clinical practice.

    The conference is co-sponsored by Irmat Pharmacy, New York City, and Skip's Pharmacy, Boca Raton, Florida. Because of this sponsorship, registration for the conference is free and open to the public.

    The Third Annual LDN Conference will be held on the campus of Vanderbilt University, Student Life Center (Ballroom A), 310 25th Avenue South, Nashville, Tennessee, 8am to 5pm.

    Source: Third Annual Low Dose Naltrexone Conference (19/09/07)

    MS hope from heroin addiction drug
    A Scottish doctor is raising money to fund his own drug trial, testing a treatment for heroin addicts on multiple sclerosis patients.

    The pill, naltrexone, is available free on the NHS to substance abusers. It blocks the pleasurable effects of opioids and helps the battle against cravings.

    However, growing numbers of MS sufferers report that, in low doses, the same medication relieves a number of their symptoms.

    Many are paying to buy the treatment privately because it has not been licensed for use in small quantities against MS. While GPs will prescribe 50mg of the drug to heroin addicts, many are unwilling to prescribe 3 or 4mg to MS patients.

    Now Glasgow GP Dr Tom Gilhooly, along with consultant neurologist from Tayside Dr Jonathan O'Riordan, have unveiled plans to conduct their own research on low-dose naltrexone (LDN).

    It is hoped if they can provide good evidence the drug works in MS cases, that will lead to patients receiving the treatment on the NHS.

    The LDN Research Trust, which was set up in England, has raised £9500 through charitable donations from patients to help pay for a trial and plans to support the Scottish project.

    Dr Gilhooly also undertook a 28-mile sponsored mountain-bike ride yesterday to raise extra money for the charity. He said £50,000 was needed to fund the trial and he intended to apply to Scotland's Chief Scientist Office for further assistance.

    Dr Gilhooly said: "I have seen with my own eyes in my own practice over the last three years the significant improvements in people who really do not have much in the way of options.

    "Many of these patients have primary or secondary MS. I passionately feel that everyone with MS at least deserves a chance to try this. It does not work for everyone but in some people it works so well. It suffers because it is not a profitable drug."

    He said the research would meet the required standards as a randomised, double-blind, placebo-controlled trial. The intention is to recruit 120 patients from Glasgow and Tayside and record improvements in a symptom of MS which can be measured - frequency of urination.

    Linda Elsegood, who set up the research trust, said it would be a fantastic day when the trial began.

    She said: "Doctors cannot open a book where it says in a low dose, naltrexone can be used for MS'. They have not got time to find out for themselves if it is going to make the person ill.

    "If they are not confident about giving it, they say no. We hope the trial would change that situation.

    "I think if you get some-thing in writing, if we can get it in a medical journal, there is that security of it saying in black and white it has been trialled, it is safe, and doctors will be more willing to prescribe it."

    Dr Lee Dunster, head of research and information for the MS Society, said they wanted to see innovative, safe and effective therapies on the market. "The situation with LDN is there is a lot of anecdotal information out there and, clearly, we need to do the trials.

    "The society has last year and this year received applications for funding LDN trials but when they are looked at the applications that have come in so far have fallen way below the standards in terms of numbers and methods used.

    "There was an application which has come from Scotland, there was feedback given back to that group that submitted that. There were some key things that needed to be looked at."

    Dr O'Riordan, director of the Tayside MS Research Unit, said it was difficult to set up trials and there were strict guidelines governing methods.

    He also warned it was difficult to judge an MS treatment on the basis of anecdotes because patients naturally experienced flare-ups and periods of improvement.

    However, he continued: "There does appear to be enough anecdotal evidence to suggest a clinical trial of some sort should be performed. If data is not obtained, we are left with the status quo. We do not know whether it works or not. People who benefit might have benefited anyway because they might have been in a good period. But if it works, then we are withholding it from patients."

    Patient hails the 'return of freedom'

    Lorna McDevitt notices the difference as soon as she gets up in the morning. The 50-year-old, who has suffered multiple sclerosis for more than a decade, said after waking she used to stretch her legs and they would jerk under the covers.

    Then she would climb out of bed, sit for a few minutes, before walking stiffly to the bathroom. Taking a shower, she said, was like 10 rounds in a boxing ring and after drying she would have to lie down again.

    "It's not like that now. It's not been like that for four years," she added.

    In 2003, she began taking low dose naltrexone, a treatment used in larger quantities to treat heroin addicts, after reading about it on the internet. She learned that a New York doctor had experimented with the drug on patients, including MS sufferers.

    The first difference Mrs McDevitt noticed was the numbness in her back reduced, then the stiffness and fatigue. It began to give her back some of the freedom which had been stolen by her illness.

    Four years on, she said the treatment was still giving her a better quality of life. While she experiences some tougher days, she believes the drug is keeping symptoms at bay.

    It costs her £25 a month to obtain the drug on a private prescription through her GP. She said recognition of the treatment's potential is growing in other countries and she believes it will be available on the NHS to MS patients in the future.

    "It is definitely going to happen," she said. "I feel very confident about that."

    Source: The Herald Copyright © 2007 Newsquest (Herald & Times) Limited. All Rights Reserved (26/06/07)

    Patient Advocates With Multiple Sclerosis Fund Clinical Trial Of Promising Drug That Has Already Helped Thousands
    Over the last decade, anecdotal reports suggested that a very low dose of an FDA-approved drug called naltrexone provides effective symptom relief for many patients who have Multiple Sclerosis. Frustrated by the lack of scientific research, volunteers began raising money to fund a human clinical trial of Low Dose Naltrexone (LDN) for MS. This effort culminated in awarding a $25,000 gift to the University of California, San Francisco Multiple Sclerosis Research Center.

    Naltrexone was approved by the FDA 20 years ago for treating addiction, but researchers at Penn State University discovered its ability to normalise a dysfunctional immune system when used in very low doses. Dr Bernard Bihari, a Harvard trained neurologist in New York City, observed positive results in his patients using LDN for MS and other immune system disorders. His observations were published at http://www.ldninfo.org, which is where an MS patient named SammyJo Wilkinson learned of it.

    Wilkinson was diagnosed with MS in 1995 at age 30. For years she used the injectable drugs approved by the FDA for MS but to no avail; the disease progressed to walking with a cane, and she had to give up her technology career. By the end of 2003, she was falling so often that a motorised wheelchair was on order.

    "In February of 2004 I took my first 4.5 mg capsule" recalls Wilkinson, "and I have recovered without setbacks ever since." In 2005 she attended the 1st LDN Conference, and in conjunction with other patient advocates including the nonprofit Accelerated Cure Project for MS, formed a committee to raise funds to stimulate research for LDN treatment of MS. Because naltrexone is an inexpensive generic drug, the concern was that there would be little commercial interest in research, so they felt it was up to patients themselves to lead the way. In addition to Wilkinson, this committee also consisted of Robert Lester and Art Mellor.

    They set up a website, http://www.LDNers.org, and received enthusiastic support from other patients who had benefited from LDN. The culmination of the fundraising effort was a gala benefit in California attended by over 250. The organizer, Vicky Finlayson, had experienced an amazing recovery from 10 years of painful MS attacks after taking LDN, and felt passionately about funding the research, so that others with MS could gain the relief she had.

    Following the benefit, $25,000 had been raised, and word arrived that the UCSF Multiple Sclerosis Center was interested in conducting the first human trial in the US, to measure the impact of LDN on MS. The funds were donated to UCSF, and a 3 month double-blind crossover trial involving 80 patients is expected to start this Spring.

    Source: Medical News today © 2007 MediLexicon International Ltd

    Plea for MS drug to be made widely available
    An Orkney woman has joined the national call to make the drug LDN (Low Dose Naltrexone>) more available on the National Health Service for the treatment of Multiple Sclerosis.

    Naltrexone is more commonly used to treat addiction to drugs such as heroin or morphine, but, according to the LDN Research Trust, it has been used as a treatment for MS in the USA since 1985, but is relatively new to the UK.

    As the name suggests, low dose naltrexone is taken in a very small dose, compared to the amounts prescribed for addiction, and there are reportedly little or no side -effects according to users.

    Forty-five year old Christine Taylor from Kirkwall, discovered LDN on the website www.remedyfind.com and found the treatment a huge benefit. She now gets the drug in liquid form through a private prescription. It is not available on the NHS as it has not been clinically trailed and approved.

    She explained: ''I was prescribed Betaferon which has flu likeside-effects but after learning about LDN I decided to take it instead and it has made a huge difference to me.

    ''Not everyone gets the same amazing relief as I have but it certainly worked for me. I feel really brilliant now compared to what I used to. I can sleep all night now and I couldn't before. I am now quite happy whereas before I used to be depressed. Although I still have some of the symptoms I had before taking LDN I feel a whole lot better.

    I am still not strong but it I have a lot more energy than before,'' she added. Christine said that she wished that the drug was more available on the NHS to help other people with MS.

    ''I have had a major reduction in my symptoms. I would like people to know how much benefit I have had by using LDN, it may not help everyone but I did not want to sit on the information. I want to let people know about it so they can make up their own mind.''

    The LDN Research Trust also states that the benefits 'are due to the temporary inhibition of brain endorphins which are a natural painkiller, produced in the brain. This results in an increase in the production of endorphins, resulting in the reduction of painful symptoms and an increased sense of well-being.'

    On their website, www.ldnresearchtrust.org there are testimonials from people who use the drug, telling of how much their lives have improved as a result.

    Dr Tom Gilhooly who works in Glasgow where he runs the only private MS clinic in the UK said: ''I have been prescribing LDN for the past two years to MS patients and in many cases it has produced a significant improvement in symptoms. It appears to be safe and well tolerated bythe majority of patients.

    ''I now feel that all MS patients should at least be allowed a trial of LDN to see whether they have a good response to it since it can improve the quality of life for patients who have few other options. It is not an expensive treatment costing around £15 per month as opposed to hundreds or thousands for some of the conventional treatments.

    ''I am involved in preparing for a trial of LDN in MS next year, which will be the first in the world to properly assess its use in this condition."

    A spokesman for NHS Orkney said: ''There have been no requests from our Community Pharmacy for Low Dose Naltrexone. In the UK the drug has not yet been licensed for use by the Department of Health. NHS Orkney would advise anyone considering the use of such presently non-licensed drugs to consult their GP.''

    A spokesman for the MS Society said: ''There is anecdotal evidence that some people with MS have experienced benefit from LDN but as for any potential treatment for this highly variable and fluctuating condition, we should like to see clinical trials carried out and their results published so its effectiveness can be properly assessed."

    Source: Orkney Today

    Advocates, Physicians and Entertainers to Gather for Low Dose Naltrexone Conference
    On April 7, 2006, physicians, patient advocates and entertainers will gather at the Second Annual Low Dose Naltrexone (LDN) Conference (http://www.lowdosenaltrexone.org) to bring awareness to a promising treatment for HIV/AIDS, cancer, multiple sclerosis (MS), autism and a host of other life-altering autoimmune conditions.

    Naltrexone was originally approved by the FDA in 1984 at the 50mg level for narcotics addiction. But around the world, physicians and researchers are discovering that at much lower doses -- most commonly in the 4.5mg range -- the compounded medication, taken nightly, stimulates the immune system and helps the body fight off devastating diseases. LDN has no known harmful side effects, and at an average price of under $50 per month's supply, the compound is extremely affordable.

    Still, LDN remains largely unknown in the U.S. - and according to Susan Sedlock, coordinator of the Second Annual LDN Conference, big pharmas remains uninterested in LDN, perhaps because of naltrexone's status as a generic drug and LDN's extremely low cost to the patient.

    But if Sedlock and the speakers at the Second Annual LDN Conference have anything to say about it, many more patients will soon know about LDN.

    The event's theme, "The Future Is Now," reflects the strides made in LDN research and clinical trials in the past year. On the schedule are: Dr. David Gluck, host of last year's conference, with a brief review of the year in LDN; keynote speaker Dr. Jill Smith, professor of gastroenterology at Pennsylvania State University, who will discuss her impressions of the first LDN clinical trial in the U.S., in which she studied the compound's effects on Crohn's disease; Dr. Jacqueline McCandless, who will present her achievements using LDN in treating childhood autism and report findings from parents whose children with bipolar disorder are responding to LDN; Dr. Phil Boyle, a family physician in Ireland, who will discuss some "stunning clinical results"; and Dr. Pat Crowley, also from Ireland, who will show his documentary on LDN treatment.

    Singer/songwriter Paul Nicholas, who debuted his hit song "Please Remember Me," now the anthem in the fight against MS, on the Montel Williams Show in June, will perform at the Second Annual LDN Conference. Nicholas, who has MS, recently began taking LDN and has experienced dramatic improvements. As a result, Nicholas has waived his performance fee for the conference in an effort to promote recognition of LDN as a viable treatment for MS.

    The Second Annual LDN Conference will be held on the campus of the National Institutes of Health in the Lister Hill Center Auditorium of the National Library of Medicine. For additional information, visit http://www.lowdosenaltrexone.org.

    Source: Second Annual Low Dose Naltrexone Conference

    Low Dose Naltrexone Explained
    Naltrexone (Low Dose Naltrexone)

    The following explains Low Dose Naltrexone (also known as LDN) from a layperson's perspective that everyone should be able to understand.

    Please note that we are not medical doctors, and that there is no formal proof of the following statements; they are merely informed hypotheses. You should always do your own research and consult with your doctor before undertaking any medical treatment.

    The simple explanation: Naltrexone is an FDA approved drug (1984) that was originally intended to treat people suffering from opium (e.g., heroin) addiction. It treated these addictions by blocking the "pleasant" effects from the drug, so addicts who took it did not get "high" anymore.

    How does it block the "high?" There are receptors in our brain that an opioid like heroin would use to get into the cell and do its deed. Naltrexone blocks those receptors, so the heroin can't have an effect. Think about it like a puzzle piece-- some brain cells have a piece that accepts opium and its derivatives, and the Naltrexone simply matches that piece. When the heroin floats around, it has no where to go.

    OK, that's all well and good, but what relevance is there to Multiple Sclerosis? Well, those opiod receptors in our brains are not JUST for receiving drugs like heroin-- our bodies actually produce opiods every day, among other things, we produce a set of hormones called endorphins. So if you were to take Naltrexone, you would actually block the reception of something your body produces. These hormones, as it turns out, play a very important part in controlling the immune system. Keep this in mind for what we'll talk about below.

    The FDA-approved dosage for heroin addicts was 50 milligrams per day. This ensured that those receptors were blocked all day and there was no chance that any heroin could connect with a cell and give the user a "high." BUT a medical doctor named Dr. Bihari found that if you give someone a much lower dose, say THREE milligrams instead of 50, you would not block the receptors all day, but just for a couple of hours. After that, everything would function as normal.

    But the human body is funny-- when you block something, it often responds by producing more. In other words, if you were to take Naltrexone at a low dose (Low Dose Naltrexone, even!) you would block the receptors for a couple hours. The body would notice that it was not receiving the endorphins it produced, so it would think "Since they're not getting though, I must not be producing enough-- turn it up!"

    The gland responsible for producing the endorphins, called the pituitary, would respond by producing significantly more. Not enough to cause any problems, but enough to make a difference. So how can this all matter for Multiple Sclerosis? Remember how we discussed above that the endorphins actually regulate the immune system? Well, in Multiple Sclerosis, the immune system is malfunctioning-- it's attacking it's own body. Anything that helps regulate, control, and tame the immune system could potentially have a positive effect on MS. And that's exactly what some people who take LDN report-- a halt of the progression of the disease, and even some improvement in symptoms.

    Adding some scientific validity are studies that show that in MS patients, the pituitary gland (which produces endorphins) shrinks as the disease progresses. This shrinkage can be assumed to correspond with less endorphin production, though the link is not concrete. The million dollar question is: is the pituitary gland shrinking BECAUSE of the MS, in which case fixing the pituitary is more like treating a symptom rather than the cause, OR is the pituitary smaller in people who have multiple sclerosis and could potentially be a, if not the, cause of the disease in the first place? In other words, is a shrunken pituitary a cause of MS or is it an effect?

    If it's a cause, making up for the lower endorphin output by taking something like LDN could have significant positive implications. There is a catch to all of this-- there are no formal, clinical trials on taking low dose naltrexone for multiple sclerosis. All there is is speculation, a few doctors backing it, and most remarkably, many positive testimonials from patients.

    Source: This Is MS Unbiased Multiple Sclerosis Community http://www.thisisms.com

    First Low Dose Naltrexone Study

    LDN Research Trial  By Dr Tom Gilhooly

    One of the challenges for those of us involved in prescribing LDN, is the lack of research to support what we do. “Where’s the evidence?” is a common question asked by other medics, when we explain what we are doing with their patients. Most are understanding and keen to see anything help their MS patients, but some are suspicious, and some downright hostile. The problem with research into LDN is that there is no monetary incentive for the pharmaceutical industry to fund this, and in fact, for some, there is a distinct disincentive. If LDN was shown to be as effective as some of the much more expensive treatments, it would be inevitably bad for business. There is no conspiracy to suppress LDN research, but even the MS Society has failed to support it.

    The LDN Research Trust is dedicated to bringing that research to the wider public, and the problem that faces us is one of funding and of expertise. My experience in prescribing LDN has been a positive one; it is beneficial for the vast majority of patients who have been taking it. It is difficult, however, to demonstrate this improvement using the standard rating scales such as Expanded Disability Status Scale (EDSS). It is perfectly feasible for someone to feel better, and indeed be better, but when seen by the neurologist, the rating with EDSS remains the same. The problem is not LDN or the patient, but the sensitivity of the tool.

    It would be pointless to design a study using an insensitive tool, as this could fail to demonstrate any positive impact on the patient’s health. This would only confirm the bias against LDN in the medical community, and may close the door on any further research on the subject.

    What we need is a well designed study, using a tool sensitive enough to measure improvements that may not show up on the EDSS. One of the most common areas of improvement is in bladder function; even at doses as low as 1mg of LDN, which is regarded as sub-therapeutic by many, patients report improved bladder function. One patient in particular informed me that his night time visits to the toilet were reduced from 5 - 10 per night to none! This had had a significant effect on his quality of life, considerably reducing his fatigue. As bladder dysfunction affects 70% or more MS patients, it struck me that this would be a prime area for study.

    I have some research experience, and a few publications in the addiction field, so I have a fair idea of how to structure a good research project. Dr Bob Lawrence and myself are currently working on the design of a study into the impact of LDN on bladder dysfunction. We face several obstacles (as always) with research, but we have no doubts this study will not only be completed, but will be the first to demonstrate to the world that LDN has an impact on quality of life for people with MS. One of the challenges is funding, but we intend to design this as cheaply as possible, and fully expect the cost to be met from sales of the MS Baseline, our multi-nutrient capsule, which will be on sale from January 2006.

    The study will be a randomised double blind placebo control trial which, for the layman, means that neither the patient nor the researcher will know if they are taking active LDN or a placebo. Most of the work will be done by post, so we cut out the costs of researchers. We are hopeful of receiving the LDN and placebo free of charge, which will again keep prices low. The trial will be on MS patients with bladder problems, specifically: frequency, nocturia (getting up at night), and incontinence. It will last for three months, and we will start recruiting as soon as ethical approval has been obtained. We will be looking for individuals who have MS confirmed by MRI scan and lumbar puncture, with significant bladder dysfunction. They will have to understand that this is not a way to get onto LDN, but a trial of a limited period, and that they may well end up getting a placebo for the duration of the trial. We would of course make every effort to continue prescribing for those who were doing well on the drug after the three month period, although this would be by way of a private prescription.

    This is a very exciting time, but we must make absolutely sure that this study is as scientifically rigorous and robust as possible. The results, if positive, will make it much harder to ignore LDN, and that will not please the medical establishment, who would rather bury the whole subject. Expect this study, no matter how good, to be rubbished by many so-called “experts”. As George Bernard Shaw said: “all progress depends on unreasonable man”. We have a duty, in this case, to be unreasonable. We will have more details of the study in the New Year, but it will probably take about three months to get everything in place. As a wise old researcher once told me: “double your expected timescales”, so it may be the summer before we get it going; but the most important thing is, we are now closer to realising the ambition of getting LDN into the regime of MS patients throughout the world.

    If you know of anyone who may be willing to take part in this study, please send your details to Linda at the Trust. They would have to be UK residents, and meet the criteria outlined here.

    LDN Research Trial Summary

    Eligibility for the LDN Bladder Trial

    Ø MS diagnosis, by MRI and lumbar puncture. (All types of MS.)

    Ø Have significant bladder problems, frequency, urgency, nocturia (getting up at night), or incontinence.

    Ø Aged 18 – 60 years.

    Exclusions

    Ø Must not self-catheterise, or use a catheter.

    Ø People who have previously tried LDN.

    Ø Pregnant women.

    Taking part in the trial doesn’t guarantee that you will be able to be prescribed LDN once the trial has finished, although, every effort will be made to supply LDN with a private prescription to those that have responded positively.

    We will be looking for 80 people with MS that fit the above criteria; it doesn’t matter where people live, as long as they are UK residents.

    Please spread the word to people you think might be interested; they will be added to our database, and contacted in due course. Email Linda Elsegood at  [email protected]. All emails will be responded to.

    © Multiple Sclerosis Resource Centre

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