Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen?
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Monday, 28 July 2014
Low-dose naltrexone for treatment of multiple sclerosis Are clin needed. Will they happen? Every time I talk about complementary/alternative medicine to MSers someone tells me
opioid receptor antagonist management of alcohol dependence and opioid dependence. Naltrexo confused with naloxone (which is used in emergency cases of opioid overdose about low dose naltrexone. Naltrexone is an
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Using naloxone in place of naltrexone can cause acute opioid withdrawal symptoms naltrexone in place of naloxone in an overdose can lead to insufficient opioid antagonism the overdose. Low Dose Naltrexone or LDN as it known has been hitting the problem is is that there is simple not enough good data to support this use.
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http://multiple-sclerosis-research.blogspot.com/2014/07/low-dose-naltrexone-for-treatment-of.html
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Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen?
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Blog Archive ▼ 2014 (994) ► December (5) ► November (90) ► October (82) ► September (103) ► August (98) ▼ July (80) Employment: Norway is tragically the exception No Oligoclonal bands in your CSF means that you do... Progression is this an easy mountain to CLIMB Mice work may send you down the wrong path becuase... PLEG RIDY arrives in Europe
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Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, B M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G.A pilo naltrexone in primary progressive multiple sclerosis. Mult Scler. 2008;14(8):1076-83.
A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltr been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The pri were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, quality of life. Clinical and biochemical evaluations were serially performed. Protein conce endorphins (BE) and mRNA levels and allelic variants of the mu-opiod receptor gene (OPRM Five dropouts and two major adverse events occurred. The remaining adverse events did n daily living. Neurological disability progressed in only one patient. A significant reduction o measured at the end of the trial. BE concentration increased during the trial, but no assoc between OPRM1 variants and improvement of spasticity. Our data clearly indicate that LD tolerated in patients with PPMS.
Sharafaddinzadeh N, Moghtaderi A, Kashipazha D, Majdinasab N, Shalbafan B. The effect o naltrexone on quality of life of patients with multiple sclerosis: a randomized placebo-cont Scler. 2010;16(8):964-9. BACKGROUND: Low-dose naltrexone (LDN) may promote psychological well-being as well health especially in autoimmune disorders. The objective of this study is to assess the effe Quality of Life (QoL) of patients with relapsing-remitting and secondary progressive multip using the scales and composite scores of the MSQoL-54 questionnaire. METHODS: A 17-week randomized, double-blind, placebo-controlled, parallel-group, cross trial was conducted in two universities. A total of 96 adult patients aged between 15 and 6 relapsing-remitting (RR) or secondary progressive (SP) clinically definite MS with disease du 6 months enrolled into the study. The primary outcome of the study was comparison of th and mental health by conducting independent t-test of the results obtained in the middle study between the two groups. RESULTS: Variables including presence of pain, energy, emotional well-being, social, cognit functions, role limitation due to physical and emotional problems, health distress, and ove show any meaningful statistically difference between the two groups. Factor analysis revea perception scores were statistically different between the groups before starting, in the m end of the study. CONCLUSION: The study clearly illustrates that LDN is a relatively safe therapeutic option i but its efficacy is under question and probably a long duration trial is needed in the future
Cree BA, Kornyeyeva E, Goodin DS Pilot trial of low-dose naltrexone and quality of life in m Ann Neurol. 2010;68(2):145-50. doi: 10.1002/ana.22006.OBJECTIVE: To evaluate the efficacy naltrexone on the quality of life of multiple sclerosis (MS) patients. METHODS: This single-center, double-masked, placebo-controlled, crossover study evaluat weeks of treatment with 4.5mg nightlynaltrexone (low-dose naltrexone, LDN) on self-repor MS patients. RESULTS: Eighty subjects with clinically definite MS were enrolled, and 60 subjects complet withdrew before completing the first trial period: 8 for personal reasons, 1 for a non-MS-re event, and 1 for perceived benefit. Database management errors occurred in 4 other subje life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject d management errors substantially reduced the trial's statistical power. LDN was well tolera adverse events did not occur. LDN was associated with significant improvement on the fol health quality of life measures: a 3.3-point improvement on the Mental Component Summ Short Form-36 General Health Survey (p = 0.04), a 6-point improvement on the Mental Hea 0.01), a 1.6-point improvement on the Pain Effects Scale (p =.04), and a 2.4-point improvem Perceived Deficits Questionnaire (p = 0.05). INTERPRETATION: LDN significantly improved mental health quality of life indices. Further MS are warranted.
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Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen?
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So the same odd addage...Further studies are warranted.
However, this is the perennial problem...neuros and charities tend to fund small sca invariably too small to give definitive answers and not large enough to make a compell things forward
Pharma aren't really interested cos they can't make any money out of this in the present c
Should we be doing small trials that need another in the hope that pharma will work ou the drug or only support stuff that gives a definitive answer. Or should we keep the Stat with false hope peddling. Can pharma be incentivised to do these studies?
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A Barnett Monday, July 28, 2014 5:07:00 pm
Cognitive decline in young MSers
I always find that the studies quoted ever seem to look at the OGF-OGFr effect.. This is why I use LD McLaughlin who do the serious work on LDN have shown that this is where the therapeutic/clinically useful beta endorphin! OGF is met encephalin and OGFr is the zeta receptor on the cell nucleus that interacts with of cell proliferation, amongst other clinical outcomes of use. I think the biggest cause for LDN not getting rec in the wrong places. Please, read Zagon/Mclaughlins papers.
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Anonymous Monday, July 28, 2014 5:24:00 pm
Spasticity is associated with walking problems
After three years of reading what ms patients write about this and other treatments, it doesn't seem plausib Too many people write about new lesions and relapses while taking it.
Myelination is less effective with age Vitamin D birth levels do not affect risk of MS Levetiracetam for pain... no evidence of it workin... Tysabri works in the real world outside of trials Finding MS Sex and MS No link with vitamin D levels at birth and adult-o... Microbiome makes regulation
That said, based again on three years of stories from patients across the internet, it seems to help with at l possibly pain. That would be worth assessing with proper trials. Reply
Anonymous Monday, July 28, 2014 6:29:00 pm
There are duty of care and quality of life concerns that shouldn't be overlooked by an instrumental cost/ been trialled and approved, any repurposed use for MS should not carry the risk of toxicity - neuros shou would be doing no harm. Reply Replies
Animals move less when they have problems
MouseDoctor
Physical activity and disability
I understand but what is being treated?Progression or symtoms?
Monday, July 28, 2014 11:29:00 pm
Fear of Falling changes how you walk Leukaemia risk from mitoxantrone: higher than prev...
Anonymous Friday, August 01, 2014 9:21:00 pm
http://multiple-sclerosis-research.blogspot.com/2014/07/low-dose-naltrexone-for-treatment-of.html
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Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen?
In my wife's case progression, now for over 10 years. I think you need to understand that ultimately trial that matters to the patient, trying it on themselves. Most in the UK are not even offered the lice not experiment with those. When Evidence Based Medicine comes up with a safe effective treatmen is generally available then I am sure most will want it. Till that point I think it would get more respect spread fraud in the drug industry rather than trying to discourage people from using safe treatments David Taylor
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Anonymous Monday, July 28, 2014 8:30:00 pm
Can pharma be incentivised to do these studies? Only if they can "repurpose" the price. Clearly, pharma wil on a licensed drug if they cannot profit from its use, translation - set a new price. Regarding LDN, it is an o cannabidiol is an allosteric opioid receptor modulator. Are their pharmacologic effects similar? The pharmac Reply Replies MouseDoctor
Happy News Tuesday
I am writing a review about cannabidiol and was interested by your post however the data is ba concentrations so a bit like putting cells in a load of chip fat. At this concentrations cannabinoids things as they are killing or almost killing the cells they are incubated with so not compelling in my ey
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Monday, July 28, 2014 11:18:00 pm
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JLC Monday, July 28, 2014 9:08:00 pm
LDN is a ‘cell growth regulator’ and what we are now understanding by taking LDN is that we are taking adv chemistry and discovering a new biological pathway that has been shown to be effective in the treatment thereof). The biological pathway is the Opioid Growth Factor (OGF) – OGF receptor (OGF-OGFr axis).
Blockade of the interaction between OGF and its receptor OGFr for 4-6 hours using LDN inhibits and cont growth/activity of cells, specifically astrocytes, microglia/macrophages, inflammatory T and B lymphocytes w is no longer present (18-20 hours).
By modulating the OGF-OGFr axis, we are prolonging periods of remission and diminishing the numb relapses. Pre-clinical studies have shown that areas of demyelination and neuronal damage are markedly re
As the benefits from taking LDN come from the ‘rebound effect’ (the rebound effect is what happens when clears your system providing you with the benefits of its actions), it is going to be extremely difficult to con (double blind cross over). As shown in Dr Gironi’s clinical trial in Italy, the effects from taking LDN for six increased levels of beta endorphin continued to rise even after stopping LDN for one month.
Conducting long term clinical trials is going to be difficult for reasons you have outlined in your blog and LDN works through rebound effect. We know it’s safe, well tolerated and the fact it is nontoxic, inexpensive a is very attractive to people living with such a chronic progressive disease where most of the alternatives are with potential serious side effects.
The key to LDN’s success is dosing and this is where I see the downfall in the clinical trials so far – all taking decades of patients using LDN, it is now understood that 4.5mg is too high for a lot of people with MS (3mg dose especially for those who are living with terrible spasms), and that LDN interferes with many people’s rate in these trials. For this reason (lack of sleep) many are now taking LDN in the morning very successful after taking LDN for a couple of years, your body is able to start producing sufficient endorphins, enkephalin little help from LDN so there is no need to take as much LDN or as frequently. However further studies/trials get more answers to determine how to successfully use LDN long term.
It’s a shame that those Drs who are addicted to prescribing LDN having seen their patients disease progres not kept real data to publish! Reply Replies MouseDoctor
Monday, July 28, 2014 11:31:00 pm
So here it is a DMT dealling with relapses, but there are drugs that are accepted to work on relapses.
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JLC Tuesday, July 29, 2014 6:36:00 pm
http://multiple-sclerosis-research.blogspot.com/2014/07/low-dose-naltrexone-for-treatment-of.html
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Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen? ► 2010 (65) ► 2009 (11)
For Children of MSers
12/1/14, 9:35 AM
One has to ask why then only 12% of MS patients are using these 'approved' drugs. High toxicity wi makes it far too risky for some to even contemplate using. LDN being non-toxic, orally delivered an used long term to slow down disease progression is surely a far safer option?
We need to find a way for delivering better drugs to patients, sooner, and at a lower cost than t lengthy, costly clinical trial. The whole system for approving drugs needs to be looked at. LDN has be least 14 years and what matters for individual patients is the opportunity to choose a medical trea individual health status and risk tolerance and this doesn't often tie in with what NICE approves.
MouseDoctor
Tuesday, July 29, 2014 9:22:00 pm
A therapy that can be used long term to slow down disease progression is surely a far safer option?
I am sorry but where is the real evidence that it does anything real for disease progression, I am no am I not seeing. I agree we need a way to see if there is anything real happening...maybe the best way is to sign up and fess-up to CAMS and maybe in time they can seen if the anecdote has legs.
Brain Donation JLC Tuesday, July 29, 2014 10:29:00 pm
Some of us are willing to bet our lives on the science before the clinical proof goes through a tor (given the poor alternatives being offered). So we have to make good choices and that is why references (Zagon/McLaughlin).
Research into LDN is vital to the progress of medicine which leverages the bodies' own systems manage the disease. LDN is a therapy with minimal side effects and easy delivery methods, makin MS. People want medications that intervene in their independence as little as possible, and depend enough on its own.
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In a perfect world we would have already proven LDN to whatever level of efficacy is required. need rigorous research. To ignore it and not fund research might be unwise especially when the scie targeted drug choices are the major axis of 21st century medicine.
MouseDoctor
Tuesday, July 29, 2014 11:59:00 pm
Have just at a few of the references of Naltrexone and EAE highlighted. High dose naltrexone did cases low dose did not stop disease and it was not that marked. The claim is that it should be use why people use it? I Maybe when ProfG has time he can do a survey and so if it is symptomatic control, relapsing MS or want to take it.
A Barnett Wednesday, July 30, 2014 9:32:00 am
I don't expect a cure, but my relapses stopped after I started using LDN. Read Dr Zagons papers on might see the mechanism. MS has no cure so we need to live with it. OGF controls microglial ac spasticity formation. It also reduces the proliferation of T and B cells which is what drives EAE and Zagon has published the effect of OGF on EAE with good results. If ProfG could look at OGF we may s there too. Stopping MS is not possible as yet, so disease management is the way forward for us.
JLC Wednesday, July 30, 2014 1:41:00 pm
High dose naltrexone did nothing and yet in low doses it worked for 30% of the people – similar figu toxic meds I believe. Wouldn’t this in itself justify further research? It doesn’t surprise me if the 30% “4.5mg dose to be taken every night” protocol.
It would be refreshing to find researchers and neurologists who understand that the benefit come OGF-OGFr axis and it is this that is responsible for repressing the action of microglia, astrocytes a LDN having been in use for two decades, we have now learnt that the 4.5mg dose does not have a v lower dose may give more favourable results for MS.
Suggested reading:“Prevention and diminished expression of experimental autoimmune encephalomyelitis by low do opioid growth factor (OGF) for an extended period: Therapeutic implications for multiple sclerosis”:http://www.sciencedirect.com/science/article/pii/S0006899311000977 Astrocyte Proliferation is Regulated by the OGF-OGFr Axis In Vitro and in Experimental Autoimmune http://multiple-sclerosis-research.blogspot.com/2014/07/low-dose-naltrexone-for-treatment-of.html
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Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen?
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http://sciencealerts.com/stories/1997397/Astrocyte_Proliferation_is_Regulated_by_the_OGFOGFr_Axi rimental_Autoimmune_Encephalomyelitis.html
It would be most welcome if Prof G did a comparison survey including what doses are being used t help slow down progression. Thank you for your blog and this opportunity.
MouseDoctor
Wednesday, July 30, 2014 10:04:00 pm
Have read the links but to me, it is not particularly compelling. There appears to be a weak immun much of the astrocyte effects are secondary to there being an anti-inflammatory effect, I think it mak . Reply
Anonymous Monday, July 28, 2014 9:16:00 pm
Well (in general), if it does have an effect in a number of patients and it is relatively safe to prescribe, can't y want it and record the effects, slowly building up the numbers and data? It's not randomised and class one longer, but surely it's a close second? There doesn't seem to be any progress on these sorts of drugs so body of evidence to say if the drug works or doesn't. There has to be some alternative to the pharma mo there that are now genetic.
Question: what would happen if the best efficiency MS drug so far discovered happened to be past i discovered through off label use, it is considered safe and it's definitely effective etc? Reply Replies MouseDoctor
Monday, July 28, 2014 11:25:00 pm
Who is collecting the data so that the effect is seen....I suspect no one so the efficacy is anecdote robust and do anything. Reply
Sue Wilders Monday, July 28, 2014 10:07:00 pm Yes, research please! Can LDN slow, or even stop, progression? I have SPMS and offered nothing, nada, nil LDN and OMS. What is there to lose? Is there everything to gain? Research! Yay!! Reply
Rollo Wednesday, July 30, 2014 2:01:00 am
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Anonymous Wednesday, July 30, 2014 9:39:00 pm Is the LDN popularity due to the placebo effect? http://www.ncbi.nlm.nih.gov/pubmed/20534644 Reply Replies MouseDoctor
Wednesday, July 30, 2014 11:48:00 pm
Could be Reply
MouseDoctor
Wednesday, July 30, 2014 10:12:00 pm
Rollo Wednesday, July 30, 2014 2:01:00 am I personally know about a dozen MSers using LDN. I guess the most shocking thing isn't that a huge numbe http://multiple-sclerosis-research.blogspot.com/2014/07/low-dose-naltrexone-for-treatment-of.html
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that the medical community seems unaware of them doing so. Just for a hoot Google a pharmacy in FLORI many prescriptions they fill have filled for LDN. Hint... ask XXXXXXXX to round it off in the tens of thousands.
Wonder if inexpensive, non-toxic, and satisfactory effectiveness have anything to do with LDN's popularity? to stop taking it and wait on evidence from a Phase 3 trial (which everyone knows damn well is never going t
Yes, we realize that in the research world there is not enough good data to support using LDN. But in the pr have no choice but to be fully engaged 24-7 LDN has been tried and found to be beneficial. There will ne because there will never be adequate funding to compile it, IMO.
Some MSers I know are very reluctant to talk about using LDN because they source it themselves and a pressure their legislative lap-dogs in Congress to cut off their supply. Some of the LDN users have no insura $4700 a month one family member pays for Tysabri. Dare I mention another family member getting 3 mon certain pharmacy in FLORIDA [EDITED] for $53 total cost? Wow, if that doesn't get Biogen jumping nothin would be chomping at the bit to prove how ineffective LDN is compared to their drugs.
Patients are miles (kilometers, perhaps) ahead of researchers regarding the use of LDN in MS. It is a shame as neglectful of LDN as the drug companies. But that's story for a different day. Bottom line... don't exp researchers play catch-up. Life is too short for MSers, anyway Reply Replies MouseDoctor
Wednesday, July 30, 2014 10:14:00 pm
Ask howmany people go to Wal Worths for Vit D and it is millions but where is the prove it works...s worth...millions buy lottery tickets few are millionaires
Rollo Thursday, July 31, 2014 2:21:00 pm
True, sales do not prove worth. But trials do, and several small trials have demonstrated LDN effect personal trial for thousands of MSers convinced of the futility in waiting for larger trials. Reoccurr found beneficial by disease sufferers settles the question of worth individually, at least.
Sales do not prove worth; practical experience does. Thousands of people taking LDN for mult pharmacy alone has filled tens of thousands of prescriptions. Patients are more interested in wha reading about a percentage from a trial.
But why no one seems interested in funding follow-up to early promising trials is quite a mystery to the pharmas are not interested in an inexpensive competitor but what about disease societies who disease sufferers? My queries in that regard to the NMSS in New York brought this response: “We funded a pilot study results and would have expected more grant applications to come in on the basis of that.” When I as NMSS further clarified, “We have funded the one pilot study in EAE; we have received one addition LDN in 2008 that wasn’t recommended for funding; we have received no other LDN proposals.” End Q
Since several applications to the NMSS for studying LDN have been submitted by multiple research alone (Penn State) I find the NMSS response lacking credibility. It begs the question… why characterized as positive? Makes me wonder how many applications beyond the 9 I know abou makes me wonder if there is a conflict between MS sufferers and drug company interests or if a donations organization is an abysmal record keeper relative to the 450 research applications they rec
If MSers are deluded about LDN wouldn’t it be worthwhile to prove them wrong? Wouldn’t that be t to do? Little chance we will ever see definitive studies about LDN. Pharma isn’t interested; dise acknowledge even receiving applications to study it and university researchers have surprisingly limi
The reality is that many MSers who trial LDN on a personal level find it effective enough for them point MouseDoctor, but most will view prescription renewals slightly more rigorous than lottery sales
I express my gratitude on behalf of all MSers and caregivers for the dissemination of knowledge thro is irreplaceable for providing lights of knowledge which assist our way. Thank You for all your wor receive something which you have no ability to repay save gratitude. Reply
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Multiple Sclerosis Research: Low-dose naltrexone for treatment of multiple sclerosis Are clinical trials needed. Will they happen?
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3,174,770 New comments at a glance are up 0.54 percent this morning. MS Reserach Blog Comments It could be worse. You could be Americans and convinced that your mediocrity is actually some form of grandness. That'd be even more embarrassing. Dec 1, 2014 10:10:57 PM multiple-sclerosis-research.blogspot.com "If you keep on doing what you've always ... "If you keep on doing what you've always done, you'll get the same as you always got before" - and this can be applied to so many situations! Dec 1, 2014 9:15:35 PM multiple-sclerosis-research.blogspot.com Always a pleasure. Looks like your suspicions are ... Always a pleasure. Looks like your suspicions are confirmed, which rather confirms what we saw in our mouse study (we hate to say we told them so). Shame but there are much better neuroprotectants out there that we need to get into MSers, particularly progressive MSers Dec 1, 2014 8:53:00 PM multiple-sclerosis-research.blogspot.com "Gilenya failing in PPMS, was it expected&quo... "Gilenya failing in PPMS, was it expected" Since all previous drug trials that are effective in RRMS proved to be useless in progressive ms with the same endpoints, the answer is yes. Insanity: doing the same thing over and over again and expecting different results. Albert Einstein Dec 1, 2014 8:46:10 PM multiple-sclerosis-research.blogspot.com Does this mean you are no longer so hopeful that G... Does this mean you are no longer so hopeful that Gilenya will help in SPMS? Thanks Dec 1, 2014 7:49:11 PM multiple-sclerosis-research.blogspot.com RSS Feed Widget My ďŹ rst infographic - version 4.0
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