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MS TREATMENTS - LOW-DOSE NALTREXONE (LDN)
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lady_express_44



Joined: 22 May 2006
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Location: Vancouver, Canada

PostPosted: Sun Aug 06, 2006 11:15 am    Post subject: Reply with quote

beachbaby wrote:

I have more stats, research, quantitative analysis classes than anyone should ever have to take!!


Ditto, BB.
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beachbaby



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PostPosted: Sun Aug 06, 2006 11:27 am    Post subject: Reply with quote

Joy-

I read that where you had asked about LDN for TN. I have no experience with that at all , so i did not feel I could anwer anything towards that.
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PostPosted: Sun Aug 06, 2006 11:29 am    Post subject: Reply with quote Edit/Delete this post

beachbaby wrote:
Joy-

I read that where you had asked about LDN for TN. I have no experience with that at all , so i did not feel I could anwer anything towards that.


I understand, beachbaby.
Thank you anyway,
Joy
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liltex



Joined: 12 Jul 2006
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PostPosted: Sun Aug 06, 2006 11:36 am    Post subject: Reply with quote

There seems to be a "let's beat up Cherie" clique here (just like at "Fatalities" in General). In the words of the "clique" - SHUT UP!

I'm "getting it" over there and Cherie is "getting it" here!

As you would say - FUCK OFF!

Have a nice day! angryfire
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agate
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PostPosted: Sun Aug 06, 2006 4:10 pm    Post subject: Reply with quote

liltex, you're just a ray of sunshine spreading goodwill wherever you are. sunny

To anyone who wants to reply: There's one thing I don't understand about LDN people. Why are they such an enthusiastic bunch? It's almost as if they're trying hard to sell something--that they will profit from.

I'm not accusing anyone of being disguised as a salesperson. I am saying that the amount of energy and time some people who are on the LDN bandwagon put into persuading other people is simply astounding.

Will the supply of LDN dry up unless a certain number of people sign up for it? Or is it that some people on it are so eager for it to get FDA approval that they're busily keeping LDN in the public eye?

Not long ago every time I went to the BrainTalk MS board, I saw a lot of posts by two members, both having "LDN" as part of their user names. One of them seems to have vanished from that board but only after years of frequent posting.

Sometimes he would post "just to be posting," I think. His posts sometimes didn't contribute anything to the topic under discussion. I was wondering why he kept doing this, and then I realized that every time anyone saw his post, "LDN" was in his user name--AND he had links to several LDN Websites and message boards appearing regularly in his signature.

That looked a lot like advertising a product to me. Does anybody know what happened to him?

I'm discussing another board here, and I apologize. But I think I've given enough information for anyone not familiar with that board to follow what I'm saying, and I haven't named any names.

I'd really like to know. Usually you don't find such energy being put into a product a person happens to find good. The person might mention it in passing occasionally, but some LDN people are making it their life's work to promote it....

I'm afraid that this alone is a red flag for me when it comes to LDN. If there's this much of a campaign going on to promote it, something is a little off--sorry, but I'm just suspicious.

In fairness, too, I have to say that the ABCR drugs have been promoted on a grand scale by advertising and giveaways. Those companies had the dollars to spend on vast ad/promo campaigns. LDN probably doesn't.

But let's look at what's at stake here. Anyone claiming to have a drug that helps people with MS is looking at a goldmine.

Somebody diagnosed with MS at age 25, say, decides to take drug X--and we're looking at an expenditure of Y dollars FOR THAT PERSON'S LIFETIME, potentially for 60 years!
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PostPosted: Sun Aug 06, 2006 4:49 pm    Post subject: Reply with quote Edit/Delete this post

Agate, the person in question went through a huge personal crisis a few months ago which shook him to the core. He hasn't posted often anywhere since, but he is still a member in good standing of my home board.

He doesn't stand to receive any monetary gain for promoting LDN. As a matter of fact, nobody really does, since the drug is off-patent now and quite cheap. That's why there haven't been any large studies done yet; there's no financial incentive for the big pharmaceuticals to back research.

People whose lives have been made dramatically better by LDN want to spread the word, because they care about the wellbeing of other PWMS. It's as simple as that.

zenna
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lady_express_44



Joined: 22 May 2006
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PostPosted: Sun Aug 06, 2006 4:50 pm    Post subject: Reply with quote

agate wrote:

To anyone who wants to reply: There's one thing I don't understand about LDN people. Why are they such an enthusiastic bunch?

I am saying that the amount of energy and time some people who are on the LDN bandwagon put into persuading other people is simply astounding.


This disease is a bitch, and I wouldn't wish it on anybody. But, what I would wish for . . . even on my worst enemy . . . is that they find a way to get better.

LDN WORKS, for a lot of people, and that's why we want to SCREAM IT AT THE TOP OF OUR LUNGS.

Between some Neuros/Doctors/pharma companies/pharma company reps/pharma company investors & cynical PwMS (who usually haven't even tried the drug themselves), there is a lot of resistance to acceptance the of LDN. I don't think I even have to go into all the reasons there is such negativity . . . but, as you can well imagine, it gets very tiring to argue the same points over and over again.

Cherie
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Matt



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PostPosted: Sun Aug 06, 2006 4:52 pm    Post subject: Reply with quote

I feel just the same way agate.

If it seemed that I was beating up on Cherie, then I appologize to Cherie, not to anyone who has accused me of being in some kind of a nasty "clique".

I just get frustrated when I see people deciding not to take the CRABs because they may have read some posts which suggest that LDN is probably more effective than the CRABs.

Anecdotal evidence gets pumped way up, while clinical trial evidence gets ripped apart. I don't agree with that.

It's not about Cherie as a person, it's about the other people who get influenced by a really hyped up presentation.
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lady_express_44



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PostPosted: Sun Aug 06, 2006 4:53 pm    Post subject: Reply with quote

zenna wrote:
Agate, the person in question went through a huge personal crisis a few months ago which shook him to the core. He hasn't posted often anywhere since, but he is still a member in good standing of my home board.


I am very sorry to hear about that!! Please pass on my best wishes to him, Zenna.

zenna wrote:
People whose lives have been made dramatically better by LDN want to spread the word, because they care about the wellbeing of other PWMS. It's as simple as that.


Yep, you hit the nail on the head!

Cherie
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Sweetyhide



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PostPosted: Sun Aug 06, 2006 5:01 pm    Post subject: Reply with quote

I agree with what Zenna and Cherie said about LDN too.
But on a more selfish note:
If more attention is brought to the drug then maybe I can get a friggin' script!
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lady_express_44



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PostPosted: Sun Aug 06, 2006 5:04 pm    Post subject: Reply with quote

Matt wrote:
I feel just the same way agate.

If it seemed that I was beating up on Cherie, then I appologize to Cherie.

It's not about Cherie as a person, it's about the other people who get influenced by a really hyped up presentation.


No apology required from you, Matt.

Matt, I was very, very sick when I started seriously researching drug options. It took me 12 months of almost constant research to finally decide what to do to help myself.

It was another 6 months before I convinced my doctor that LDN was a valid option, then 6 more months to write up the "risk assessment" document that he demanded before he would rx it. Even then, he would initially only rx it for a month at a time.

Still, sometimes the amount of determination and perserverance that is required to get the LDN rx is ridiculous. That is the reason that some of us have "shared" our documentation (presentation) to help others get the rx, and why some of us maintain lists of doctors/neuros that are known to rx.

We have nothing to gain, except a sense of peace that we've done everything we can to help others get better. No doubt, the two people Agate referred to have burnt themselves out . . . but then there were new LDN users to pass the torch on to.

The same will happen with me, eventually, but in the meantime, I've personally helped hundreds of people have a better life already. That's pretty damn rewarding.

Cherie
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mmcc



Joined: 27 May 2006
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PostPosted: Sun Aug 06, 2006 6:10 pm    Post subject: Reply with quote

lady_express_44 wrote:
agate wrote:

To anyone who wants to reply: There's one thing I don't understand about LDN people. Why are they such an enthusiastic bunch?

I am saying that the amount of energy and time some people who are on the LDN bandwagon put into persuading other people is simply astounding.


This disease is a bitch, and I wouldn't wish it on anybody. But, what I would wish for . . . even on my worst enemy . . . is that they find a way to get better.

LDN WORKS, for a lot of people, and that's why we want to SCREAM IT AT THE TOP OF OUR LUNGS.

Between some Neuros/Doctors/pharma companies/pharma company reps/pharma company investors & cynical PwMS (who usually haven't even tried the drug themselves), there is a lot of resistance to acceptance the of LDN. I don't think I even have to go into all the reasons there is such negativity . . . but, as you can well imagine, it gets very tiring to argue the same points over and over again.


I am none of the things you mention escept that I have not taken it (although my daughter has, with my support) and as said before, I am NOT opposed to LDN, just to substituting and UNTESTED therapy for a tested one.

Is there any reason why a person should not take a tested therapy AND LDN?

Lots of the other non-snake oil therapies (and NOT I am NOT calling LDN snake-oil) are supported by people who do not advocate others getting off traditional therapies.

Novantrone worked for me, but I would never advocate it for someone unless they had tried the CRABs or were in desperate straights.

A little caution in pushing therapies so hard might be good.

Tysabri worked for lots of people, yet there were those demanding it not be returned to market for those of us who really needed it, including some of the same people pushing untested LDN so hard. Yet, there were scientific studies which let us decide based on the facts.

Those who were upset because Tysabri worked for them were blown off because of concerns about newbies being sucked in. Remember that, LE, YOU were one of those willing to deny some of us therapies because of fear of what newbies might think?

How about a little bit of balance?

Pushing LDN so hard is especially a concern for newly diagnosed people, people who are afraid of needles and those who are somewhat in denial about the dangers of disability as a very real possibility.

LDN, which according to those pushing it so hard has no risk attached (which is NOT known when it comes to MS and is not even true for those taking it for other reasons), and works like crazy.

There are risks to EVERY drug and NOTHING works for everyone with MS.
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mmcc



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PostPosted: Sun Aug 06, 2006 6:14 pm    Post subject: Reply with quote

Sweetyhide wrote:
...
If more attention is brought to the drug then maybe I can get a friggin' script!


Could you post the city you are from along with a request for the names of doctors who prescribe LDN here and on some other web sites?

I know that here (DC area) my daughter had no trouble getting a scrip. She had tried quite a few standard therapies without result, and although ultimately she got no help from LDN either, her doc was willing to try it.

Maybe someone who is taking it near you could suggest a doc willing to try it.
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lady_express_44



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PostPosted: Sun Aug 06, 2006 8:07 pm    Post subject: Reply with quote

mmcc wrote:

Is there any reason why a person should not take a tested therapy AND LDN?


Go back to the start of this thread. I already said that I advocate people staying on Copaxone with LDN, for their peace of mind.

mmcc wrote:
Tysabri worked for lots of people, yet there were those demanding it not be returned to market for those of us who really needed it, including some of the same people pushing untested LDN so hard.


If you look back through the old threads at BT, you will see that it was NOT that I absolutely DIDN'T want Tysabri to return, it was that I felt they definitely needed to work some issues (especially safety measures) before re-introducing it.

You were trying to get people to sign some sort of petition (or something similar), demanding the return of Tysabri. This was BEFORE the FDA meeting, where Biogen released their half-assed plan to put safety measures in place. Good thing the FDA was astute enough to LISTEN to those of us who were afraid for our PwMS comrades.

If ALL of us "Tysabri-negative" people had sat there and kept our mouths shut, it is very possible that Tysabri could have been back on the market without the stringent TOUCH program, and all the other safety precautions that have been NOW been implemented.

For now, or at least until the next report of PML, I am satisfied with the approach to the return of this drug.

mmcc wrote:
Pushing LDN so hard is especially a concern for newly diagnosed people, people who are afraid of needles and those who are somewhat in denial about the dangers of disability as a very real possibility.


I think that you just feel that you had to suffer through the needles and such, so everyone should have to.

Get over it.

Cherie
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mmcc



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PostPosted: Sun Aug 06, 2006 9:21 pm    Post subject: Reply with quote

lady_express_44 wrote:
I think that you just feel that you had to suffer through the needles and such, so everyone should have to.

Get over it.

Cherie


You're hostility and bitterness is showing. Get over what?

Personally I do not have a fear of needles and popping one under the skin is simply not a big deal compared to becoming disabled.

I wonder why you think I "suffered" from some minor shots and would want others to suffer to. That's a little vicious, don't you think?

Most people are a little nervous about giving themselves shots, but after doing it a few times it becomes routine for most.

However, some people have a genuine fear of needles. Better advice than avoiding the needles and therefore the therapy would be to offer helpful suggestions about how to get past the fear.
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lady_express_44



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PostPosted: Mon Aug 07, 2006 12:06 am    Post subject: Reply with quote

Make up your mind, mmcc.

First you lecture me about "pushing LDN to people who are afraid of needles"...:

mmcc wrote:
Pushing LDN so hard is especially a concern for newly diagnosed people, people who are afraid of needles


Then you say they are just "a little nervous"...:

mmcc wrote:

Most people are a little nervous about giving themselves shots, but after doing it a few times it becomes routine for most.


I think that if you asked around, you'd find that many of the people who have tried LDN, are those that:

- have previously tried the CRABs, and failed
- are too far along for the CRABs
- they are combining it with Copaxone anyway

I am probably one of few "exceptions to the rule", as far as having never tried anything else, prior to LDN. But "needles" was the least of my concerns with regard to the CRABs.

So . . . IMHO, this talk about "needles" is just another silly diversion to the discussion of the merits of LDN as a treatment option.

Cherie
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Sweetyhide



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PostPosted: Mon Aug 07, 2006 3:24 am    Post subject: Reply with quote

mmcc wrote:
Sweetyhide wrote:
...
If more attention is brought to the drug then maybe I can get a friggin' script!


Could you post the city you are from along with a request for the names of doctors who prescribe LDN here and on some other web sites?

I know that here (DC area) my daughter had no trouble getting a scrip. She had tried quite a few standard therapies without result, and although ultimately she got no help from LDN either, her doc was willing to try it.

Maybe someone who is taking it near you could suggest a doc willing to try it.


I already did that. Short list. It was a no go.

BTW~ I live in the south. I believe that down here Dr's arent as open about MS therapies. Maybe not even as experienced about MS? that may be a stretch though.

mmcc wrote:
Is there any reason why a person should not take a tested therapy AND LDN?


Cherie did encourage me to stay on Copaxone when I was willing to try LDN.
Actually several times I wanted to quit C. Mainly for the reason of just being sick,tired and a little depressed.
Between Cheries posts (at other boards and directed to other people and me)reading others experiences, and more research I decided to stick it out.

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mmcc



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PostPosted: Mon Aug 07, 2006 7:49 am    Post subject: Reply with quote

lady_express_44 wrote:
Make up your mind, mmcc.

First you lecture me about "pushing LDN to people who are afraid of needles"...:


LE - Actually I thought you felt this WAS an issue. If the following was purely meant as a personal attack and not part of the discussion, pardon me. It is frequently hard to tell.

lady_express_44 wrote:
I think that you just feel that you had to suffer through the needles and such, so everyone should have to.

Get over it


As to not discouraging people from continuing on proven therapies, apparently your tolerance only extends to copaxone, not the interferons.

While I think copaxone is certainly one of the most effective of the CRABs, many can't tolerate it or it doesn't help them. There are interferons which are also proven.

lady_express_44 wrote:
NOT that I am condoning it, but some people are using the interferons with LDN too...


Is your position that using LDN is okay with only ONE of the scientifically tested CRABs? If that is not your position, clarify it.
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PostPosted: Mon Aug 07, 2006 8:07 am    Post subject: Reply with quote Edit/Delete this post

mmcc, Copaxone is the only CRAB which is recommended for concurrent use with LDN. The reason is that the interferons (Rebif, Avonex, Betaseron) downregulate the immune system whereas LDN upregulates it, so the two would be likely to cancel each other out to some degree. Copaxone's mode of action is different and probably compatible with LDN.

There are a few people I know of who take LDN with one of the interferons without apparent loss of effectiveness, but as I said, it's not a recommended practice.

Cherie, I have to say that although I respect the work you're doing with LDN awareness, your tendency to take disagreements personally and get stuck on them gets in the way of your effectiveness as a source of information and support. I wish you could re-examine your priorities, for everyone's sake.

zenna
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mmcc



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PostPosted: Mon Aug 07, 2006 8:22 am    Post subject: Reply with quote

Zenna,

Thank you for the clarification. Maybe you could answer a few other questions, if you know.

Who is making the recommendation?

Also, since MS is an overactive immune system attacking the body, do you know what the rationale is for taking a drug which boosts the immune system?

In other words, do you know how it is supposed to work?
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Sweetyhide



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PostPosted: Mon Aug 07, 2006 8:38 am    Post subject: Reply with quote

mmcc,

here is an article of one dr's theory.
http://www.bostoncure.org:8080/article.pl?sid=05/01/27/1748256

just something to peruse while you wait for the more experienced people to answer.
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PostPosted: Mon Aug 07, 2006 9:13 am    Post subject: Reply with quote Edit/Delete this post

I'm not the best person to ask, because I did a lot of reading on LDN a while back when I was considering taking it...but my memory isn't the best any more.

The recommendation comes from the "leaders" of the "LDN community" on the basis of their accumulated knowledge, and perhaps from Dr. Bihari himself (vague memory here). Unfortunately, in the absence of thorough research studies, all there is to go on is Bihari's information and what LDN users themselves have been able to piece together.

As for how LDN works (as I understand it), in MS the suppressor T-cells, which regulate the immune system, are reduced in number and the CD-4 T-cells run amok. LDN selectively increases the number of suppressor T-cells, thereby controlling the CD-4 T-cells and restoring balance to the immune system.

zenna
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PostPosted: Mon Aug 07, 2006 9:44 am    Post subject: Reply with quote Edit/Delete this post

That's a very interesting interview, sweetyhide! Thank you for posting the link.

It also reminded me that the Dr. Bob Lawrence (U.K.) referenced in the interview is the source of the theory on LDN's mode of action I mentioned...I think.

zenna
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mmcc



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PostPosted: Mon Aug 07, 2006 10:37 am    Post subject: Reply with quote

Zenna and Sweetyhide,

Thanks - that is very interesting information. I appreciate it.
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lady_express_44



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PostPosted: Mon Aug 07, 2006 11:27 am    Post subject: Reply with quote

zenna wrote:

Cherie, I have to say that although I respect the work you're doing with LDN awareness, your tendency to take disagreements personally and get stuck on them gets in the way of your effectiveness as a source of information and support. I wish you could re-examine your priorities, for everyone's sake.

zenna


Thanks for the feedback, Zenna.

Cherie
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PostPosted: Mon Aug 07, 2006 12:07 pm    Post subject: Reply with quote

zenna wrote:
As for how LDN works (as I understand it), in MS the suppressor T-cells, which regulate the immune system, are reduced in number and the CD-4 T-cells run amok. LDN selectively increases the number of suppressor T-cells, thereby controlling the CD-4 T-cells and restoring balance to the immune system.

zenna


Interesting. That sounds just like one of the proposed mechanisms of action of interferon-beta. There's an abstract posted over at BT about LDN. Maybe once that place is up again, I will get a copy of the abstract.
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PostPosted: Fri Aug 18, 2006 5:15 am    Post subject: Reply with quote Edit/Delete this post

Cherie,

Do you know of any antidepressants that are incompatible with LDN?

zenna
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lady_express_44



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PostPosted: Fri Aug 18, 2006 6:51 am    Post subject: Reply with quote

I guess, theoretically, they are all compatible. At least I haven't heard through the grapevine that there are any that aren't. However . . .

I was on Celexa for the first year on LDN, and although I found the LDN gave me much more energy, I was still very fatigued (slept several hours each day). I know that someone else who is on LDN and Celexa has mentioned the same thing (but most who are on LDN say the opposite).

I hadn't felt or originally test as clinically depressed, but the main reason I started on Celexa (Jan/05) was to see if it helped with the fatigue. Clearly it didn't, but it did take the edge off of the neuro pain so I kept with it.

After starting LDN (May/05), the neuro pain stopped almost completely. I tried a few times, but had a really hard time weaning off Celexa - YIKES! I thought maybe I did need an A/D after all . . . but was still interested in switching A/D's because Celexa packed about 25 lbs on me, and I was also hoping to quit smoking.

In May/06, my doctor had me "cold turkey" off of Celexa, and straight onto Wellbutrin. Although I crashed BIG TIME withdrawing from Celexa (and had to go back on to wean properly), the first thing I noticed is that the daily fatigue let up.

I think the Wellbutrin contributed to that positive result, but I also think the main reason was that the Celexa (with LDN, or just with me) was part of the reason that I had not experienced the "less fatigue" that many report on LDN.

I have since weaned off Wellbutrin too, and I still do not have the fatigue I had while on Celexa.

I still take Celexa 3 days a month, only 10 mg. It does help me with my PMS (takes the edge off), but I notice that I am more fatigued during those days too. I usually have a 2 - 4 hr nap each of those 3 days, whereas often I can go all day without one, or just have a short one (except on the really "bad" days.)

From my little experiments, my guess is that LDN can not combat the "fatigue" that Celexa caused (me), and without Celexa, LDN does seem to help the fatigue.

Other then that, I haven't heard anything necessarily good, bad or otherwise about LDN and A/D's.

I know a few people who are either on Cymbalta or Lyrica, and they swear by the combo. I'm not sure if those are classified as A/D's though. scratch

I guess it's hard to say anything for certain, because each of us reacts so differently to drugs, and drug combinations too.

Cherie
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PostPosted: Tue Feb 13, 2007 11:15 am    Post subject: (Article) MS patients fund first human trial of LDN Reply with quote

This came to me in an e-mail today:

Quote:
February 13, '07

MS Patients Fund First Human Trial Of LDN

The first human clinical trial of Low Dose Naltrexone (LDN) for MS will begin this March. The double-blind crossover study will involve 80 patients and will be conducted at the University of California, San Francisco Multiple Sclerosis Research Center.



Over the last decade, anecdotal reports indicated that a very low dose of naltrexone, an FDA-approved drug, provides effective symptom relief for many individuals with MS. Frustrated by the absence of scientific research, volunteers began raising money to fund a human clinical trial of Low Dose Naltrexone (LDN) for MS. This effort produced a $25,000 gift to the University of California, San Francisco Multiple Sclerosis Research Center.

Twenty years ago, naltrexone was approved for treating addiction, but researchers at Penn State University discovered its ability to normalize 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 SammyJo Wilkinson, a woman diagnosed with MS in 1995 at the age of 30, learned of it.

Despite years of using the FDA-approved disease-modifying drugs for MS, SammyJo’s condition worsened. By the end of 2003, she was falling so often that a motorized wheelchair was needed.

“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, formed a committee to raise funds toward research for LDN treatment of MS.

Because naltrexone is an inexpensive generic drug, it seemed there would be little commercial interest in research. Consequently, MS advocates felt it was up to them to get LDN into a clinical trial for MS. Besides SammyJo Wilkinson, Robert Lester and Art Mellor, founder of the Accelerated Cure Project, were also on the committee.

They created a website, http://www.LDNers.org, and received enthusiastic support from others who had benefited from LDN. The finale of the fundraising effort was a gala in California attended by over 250 people. The event organizer, Vicky Finlayson, had experienced positive results after taking LDN, and felt passionately about funding the research so that others with MS could also find relief.

To learn more, visit http://www.LDNers.org. To learn more about recruitment for the clinical trial, contact Elena Kornyeyeva, M.D., Ph.D., Clinical Research Manager, at 415-514-2467 or Elena.Kornyeyeva@ucsf.edu.

*Please Note: During the 17-week clinical trial, participants will be required to make three visits to the San Francisco MS Center and must do so at their own expense.

This article can be found at: http://www.msfocus.org/online_newsDetails.php?ID=111
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PostPosted: Tue Feb 13, 2007 11:21 am    Post subject: Reply with quote

It's really good to hear that this is being funded!
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PostPosted: Thu Jul 19, 2007 5:52 pm    Post subject: LDN in the UK Reply with quote

You can find out about LDN in the UK here:

http://www.theherald.co.uk/display.var.1494742.0.0.php
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PostPosted: Fri Jul 20, 2007 9:29 am    Post subject: Reply with quote

I know it doesn't work for everyone, but perhaps that is because there are different strains (or whatever) of MS. There are far too many people who have gotten substantial benefit though, so it's worth a try.

Cherie
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PostPosted: Sun Sep 23, 2007 3:34 pm    Post subject: LDN conference scheduled Reply with quote

Quote:
Low Dose Naltrexone (LDN) Conference Scheduled

Advocates, Physicians Scheduled to Gather for
Low Dose Naltrexone Conference



NASHVILLE, Tenn., Sept. 19 /PRNewswire/ -- 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.

For additional information, visit http://www.lowdosenaltrexone.org

Contact:
Brenda Powell
Third Annual Low Dose Naltrexone Conference
870-503-2830
TwisterAlley2@webtv.net
http://www.lowdosenaltrexone.org

This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.


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PostPosted: Mon Feb 25, 2008 6:36 pm    Post subject: AAN conference in April -LDN & MS quality of life Reply with quote

The AAN (American Academy of Neurology) is meeting in April, and its schedule is now available. Here is an abstract about LDN:

Quote:
[P02.151] A Single Center, Randomized, Placebo-Controlled, Double-Crossover Study of the Effects of Low Dose Naltrexone on Multiple Sclerosis Quality of Life
Bruce Cree, Michael Ross, Ivo Violich, Brendan Berry, Azadeh Beheshtian, Elena Kornyeyeva, Douglas Goodin, San Francisco, CA

OBJECTIVE:

To assess the efficacy of low dose naltrexone (LDN, 4.5mg) versus placebo on the Multiple Sclerosis Quality of Life Inventory (MSQOL54) and visual analog scale (VAS) in subjects with multiple sclerosis (MS).

BACKGROUND:

Anecdotal reports from some MS patients suggest that LDN may improve their quality of life. There are no published studies of LDN in MS.

DESIGN/METHODS:

This is a single-center, randomized, double-masked, placebo-control, cross-over trial to assess the efficacy LDN on MS patients quality of life. Subjects with MS between 18 and 75 years of age, taking glatiramer acetate, interferon beta, or no disease modifying treatment were enrolled in the study.

Subjects were randomized to either 4.5 mg LDN or placebo nightly for 8 weeks. Following a one-week wash out, subjects were switched to the alternate study drug for an additional 8 weeks. All subjects were evaluated using the MSQOL54 questionnaire and VAS at baseline and at weeks 8 and 17.

RESULTS:

89 patients were randomized. 57 women with mean age of 49.1 years and 32 men with mean age of 47.8 years participated. 49 relapsing remitting, 16 secondary progressive, 23 primary progressive, and 1 progressive relapsing MS subjects enrolled. 16 subjects were on glatiramer acetate, 23 on interferon beta and 50 subjects were not on disease modifying therapies. 73 patients will complete the study by November 8th, 2007. 15 subjects voluntarily withdrew. 1 subject withdrew due to an unrelated medical condition. No subjects were withdrawn due to adverse events attributable to study drug. The efficacy of LDN versus placebo on the subscales of the MSQOL54 and the VAS will be presented. In addition, interactions between LDN and interferon beta or glatiramer acetate will be assessed.

CONCLUSIONS/RELEVANCE:

This study will establish LDN's safety and efficacy on MS quality of life.

Supported by: Gifts from private donors.
Category - MS and Related Diseases
SubCategory - Clinical Science

Tuesday, April 15, 2008 11:30 AM

Poster Sessions II: Multiple Sclerosis and Related Diseases: Therapeutics (11:30 AM-2:30 PM)

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PostPosted: Mon Feb 25, 2008 6:43 pm    Post subject: Pilot trial of LDN in PPMS (AAN conference abstract) Reply with quote

Here's another abstract of a presentation at the upcoming AAN conference in April 2008:

Quote:
[P02.149] A Pilot Trial of Low Dose Naltrexone in Primary Progressive Multiple Sclerosis

Maira Gironi, Filippo Martinelli, Paola Sacerdote, Claudio Solaro, Genova, Italy, Rosella Cavarretta, Mauro Zaffaroni, Lucia Moiola, Marta Radaelli, Valentina Pilato, Gallarate, Italy, Sebastiano Bucello, Vittorio Martinelli, Marco Cursi, Raffaello Nemni, Giancarlo Comi, Gianvito Martino, Milano, Italy

BACKGROUND:

Naltrexone is an orally semi synthetic opiate antagonist licensed, in a 50 mg dose, for the treatment of heroin addiction. However, its opiate antagonist activity is completely abrogated at lower doses while triggering a prolonged up-regulation of b -endorphins (BE), an endogenous opioid with immunomodulatory functions. A symptomatic effect on spasticity, pain and fatigue of low dose naltrexone (LDN) in multiple sclerosis (MS) has been reported, but only anecdotal observations are available so far.

DESIGN/METHODS: A sixth-month pilot, multicentre, open-label, therapeutic trial with LDN (5 mg/die) has been carried out in 40 patients (pts) with a diagnosis of primary progressive (PP)MS (19 male, mean age 53.4, mean EDSS 5.5). Safety and efficacy of LND on spasticity, pain and fatigue were the major outcome measure of the study. Opioid-containing, immunosuppressive or immunomodulator drugs were considered as a contraindication to the study enrolment.

Clinical and biochemical evaluations were serially performed (basal, 1- 3-6 months of therapy, 1 month after discontinuation) as well as BE levels (measured by radioimmunoassay) in peripheral blood mononuclear cells (PBMC). Appropriate scales for testing spasticity, pain and fatigue (e.g. Ashworth, Fatigue Severity Scale, Visual Analogue Scale) were used.

RESULTS:

Thirty-five pts completed the 6 months of therapy (5 drop outs occurred). Transitory hematological abnormalities (increase of liver enzymes), urinary tract infections, mild agitation and sleep disturbance were the commonest adverse events. An increase of PBMC BE levels was measured as soon as 3 months after the start of therapy. BE levels became statistically significant compared to base line values only after 6 months of therapy (p< 0.01). The increase was still statistically significant 1 month after therapy discontinuation (p<0.01 vs basal and 3 month). Efficacy results are under scrutiny.

This study has been supported by a grant of Italian Federation of Multiple Sclerosis.

Category - MS and Related Diseases
SubCategory - Clinical Science

Tuesday, April 15, 2008 11:30 AM

Poster Sessions II: Multiple Sclerosis and Related Diseases: Therapeutics (11:30 AM-2:30 PM)

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PostPosted: Sat Aug 30, 2008 5:24 pm    Post subject: (Abstract) Pilot trial of LDN in PPMS (again) Reply with quote

Another abstract about the study described in the post above, from PubMed, August 30, 2008:

Quote:
Mult Scler. 2008 Sep;14(8):1076-83.

A pilot trial of low-dose naltrexone in primary progressive multiple sclerosis

Gironi M, Martinelli-Boneschi F, Sacerdote P, Solaro C, Zaffaroni M, Cavarretta R, Moiola L, Bucello S, Radaelli M, Pilato V, Rodegher M, Cursi M, Franchi S, Martinelli V, Nemni R, Comi G, Martino G.
Institute of Experimental Neurology (INSPE) and Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 58, Milan, Italy; Fondazione Don Carlo Gnocchi, IRCCS, Milan, Italy.

A sixth month phase II multicenter-pilot trial with a low dose of the opiate antagonist Naltrexone (LDN) has been carried out in 40 patients with primary progressive multiple sclerosis (PPMS). The primary end points were safety and tolerability. Secondary outcomes were efficacy on spasticity, pain, fatigue, depression, and quality of life. Clinical and biochemical evaluations were serially performed. Protein concentration of beta-endorphins (BE) and mRNA levels and allelic variants of the mu-opiod receptor gene (OPRM1) were analyzed.

Five dropouts and two major adverse events occurred. The remaining adverse events did not interfere with daily living. Neurological disability progressed in only one patient. A significant reduction of spasticity was measured at the end of the trial. BE concentration increased during the trial, but no association was found between OPRM1 variants and improvement of spasticity.

Our data clearly indicate that LDN is safe and well tolerated in patients with PPMS.

PMID: 18728058


Wonder what the "two major adverse events" might have been--?
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PostPosted: Fri Sep 19, 2008 12:28 pm    Post subject: LDN in an animal study Reply with quote

From US News and World Report, September 19, 2008. I've emphasized the part about LDN:

Quote:
Red Wine Molecule Might Battle MS

Other promising therapies reported at meeting in Montreal

By Ed Edelson
HealthDay Reporter

FRIDAY, Sept. 19 (HealthDay News) -- Resveratrol, the compound in red wine that previous research has linked to longevity, has shown promise in an animal model of multiple sclerosis.

Mice with the MS-like condition called Wallerian degeneration slow (WldS) showed an initial weight gain when given resveratrol, researchers at the University of Utah reported Thursday at the World Congress on Treatment and Research in Multiple Sclerosis, in Montreal.

The weight gain occurred in the first two weeks of treatment. A microscopic study of nerve cell tissue at five weeks did not show any positive effect.

"They didn't look at the tissue under the microscope in the first two weeks," said Dr. John Richert, executive vice president for the research and clinical program of the Multiple Sclerosis Society. "Obviously, lots of things can make animals gain weight."

But weight gain of any kind is an encouraging sign in MS treatment, Richert said. "In inflammatory animal models of MS, one of the tell-tale clinical signs of the disease is weight loss. Weight loss often goes hand in hand with loss of neurological function."

The study "poses some questions," Richert said. "Obviously, a lot more needs to be done to see if the weight gain shows a beneficial effect on the disease process. This is evidence that it should be studied further."

Another report at the meeting was on positive results of a human trial of a new drug, laquinimod, which is given in pill form. Developed in the United States, it acts to prevent the body's immune system from attacking nerve cells.

An international study led by Italian physicians had two different doses of laquinimod given to 376 people with MS. "The higher dose was quite effective in reducing the lesions which characterize multiple sclerosis," said study author Dr. Giancarlo Comi, a professor of neurology at the University Vita-Salute and Scientific Institute San Raffaele, in Milan.

The higher dose reduced brain lesions by about 50 percent, Comi said. The people who got it also had a 30 percent reduction in MS flare-ups, which can cause vision loss and lack of coordination severe enough to prevent someone from walking, he said.

There will be a larger study that will recruit more than 1,000 people with MS and will last for two years, Comi said. If all goes well, it could be available for clinical use in three years.

A great advantage of the drug is that it can be taken by mouth, Comi said. "All the available therapies are injectable," he said. "Can you imagine how large an advantage this therapy would be?"

Another noninjectable drug that probably is already being overused against MS has shown promise in an animal study, researchers at Pennsylvania State University reported at the same meeting. 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.


_________________
MS diagnosed 1980.

Avonex 2002-2005. Copaxone 2007-2010.


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PostPosted: Wed Sep 24, 2008 6:42 pm    Post subject: (Abstract) LDN improves quality of life in PwMS... Reply with quote

From the WCTRIMS in Montreal, September 20, 2008:

Quote:

Presentation Category:
Disease Modifying Therapy




Low dose naltrexone improves quality of life in patients with multiple sclerosis: a randomized, masked, placebo-controlled trial

B. A. Cree; D. S. Goodin; M. Ross; E. Kornyeyeva1

Neurology, University of California San Francisco, San Francisco, CA, USA.



Naltrexone is a mu opiate receptor antagonist. In low dose, naltrexone has partial opiate agonist properties and is anecdotally reported to improve MS quality of life.

To determine whether 8 weeks of nightly 4.5 mg naltrexone improves MS quality of life.

This is a single center, randomized, double masked, placebo controlled, double-cross over study of naltrexone (4.5mg daily) on MS quality of life as measured by the multiple sclerosis quality of life inventory (MSQLI). MSQLI questionnaire was administered to each subject at week zero, week 8 and week 17. Analysis used time series regression modeled for random effects and clustered by study subject and adjusted for sex, age, disease course, immunomodulator treatment, race, study drug order and baseline score.

80 subjects entered the study. During the course of the study 9 patients withdrew voluntarily, 1 withdrew secondary to an unrelated medical condition. 70 completed the trial. 10 subjects were dropped due to incomplete data (4 data management errors and 6 incomplete surveys). Relative to placebo, naltrexone significantly improved: the mental health component summary score of the SF-36 (3.3 point difference, P=0.04), the mental health inventory (6.0 point difference, P<0.01), the pain effects scale (-1.6 point difference, P=0.04) and the perceived deficits questionnaire (-2.4 point difference, P=0.05). Quality of life benefits for all mental health subscales, but not for physical functioning, were observed. The only covariate significantly associated with the outcome was the baseline MSQLI score. Naltrexone was well tolerated. The sole naltrexone related adverse event reported was vivid dreaming during the first week of treatment in several patients.

Short term (8 week) use of naltrexone appears to benefit mental, but not physical, quality of life measures in multiple sclerosis. Benefits on mental health might be due to the partial agonist effects of naltrexone on opiate receptors. Naltrexone was well tolerated and further studies in MS are warranted.







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PostPosted: Thu Jan 15, 2009 8:54 pm    Post subject: Book about LDN Reply with quote

I haven't seen this book but it may be of interest:

The Promise Of Low Dose Naltrexone Therapy: Potential Benefits in Cancer, Autoimmune, Neurological and Infectious Disorders (Paperback)

by Elaine A. Moore in collaboration with Samantha Wilkinson, with a foreword by Dr. Yash P. Agrawal
(McFarland, 2008, 223pp.)ISBN-10: 0786437154

Elaine A. Moore is a medical technologist with more than 30 years of experience working in hospital laboratories. Samantha Williams is described as a patient advocate.

(Information from Amazon.com)
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PostPosted: Thu Feb 12, 2009 8:26 pm    Post subject: Article on LDN in Momentum (National MS Society) Reply with quote

From Momentum (National MS Society publication), Spring 2009:

Quote:
CAM: Low-dose naltrexone (LDN)
The “411” on LDN

by Allen C. Bowling, MD, PhD

Low-dose naltrexone, also known as LDN, is an
unconventional treatment that is claimed to be effective for treating a number of medical
conditions. It has attracted a good deal of attention on the Internet, including Web sites run by low-dose naltrexone organizations.

Over the past several years, there have been personal stories and hypotheses suggesting
that LDN is specifically beneficial for people with MS, but there were no formal studies of LDN in MS—
until now. Recently, several research studies have evaluated the safety and effectiveness of
LDN in an animal model of MS and in people with MS.

What is LDN?

Naltrexone is an oral drug that is approved by the Food and Drug Administration (FDA) for treating
opiate and alcohol addiction. For addiction, the usual dose is about 50 milligrams daily. Much
lower doses, ranging from 1.5 to 4.5 milligrams daily, are claimed to prevent attacks, slow disability progression, and relieve symptoms
in people with MS. This “low-dose” approach, or LDN,
is also claimed to be an effective
treatment for other immune-related
diseases, including AIDS, cancer, rheumatoid arthritis, and Crohn’s disease.

The LDN studies, to date

In the past year, multiple reports of small or preliminary LDN studies in people with MS and in “EAE,” the animal model of MS, have become
public. Two preliminary EAE studies, reported at the annual meeting of ECTRIMS, or European
Congress for Treatment and Research in MS, found that LDN decreased immune cell activation, nervous system inflammation, and disease severity.

Preliminary results of a rigorously designed clinical trial in people with MS
were also reported at the ECTRIMS meeting by Dr. Bruce Cree at the University of California-San
Francisco (UCSF). In this eight-week study, 80 people with relapsing as well as progressive
forms of MS were treated with LDN or inactive placebo. LDN treatment had no effect on physical functioning but it did produce improvement in measures of mental health and pain.

A smaller Italian study, published in 2008 in the journal Multiple Sclerosis, evaluated the
effects of LDN in 40 people with primary-progressive MS over six months. It’s important to note that there was no placebo-treated control group in this study. The primary goal of this study was to assess safety. LDN was generally well tolerated. Only one person had neurological worsening during the study period. In terms
of symptoms, LDN treatment was associated with
improvement in spasticity, but no effect on
depression, fatigue, or overall quality of life,
and, surprisingly, a worsening of pain.

These contradictory findings illustrate how much more scientists still have to unravel about the
actual effects of LDN.

What do we know now?


Overall, these reports seem encouraging, but it must be emphasized that they are not definitive. With the exception of the Italian clinical trial, they have not been published in professional journals. Thus, they have not undergone a rigorous
review process.

In addition, EAE is an animal model for MS, and
positive EAE results must always be interpreted with caution. Finally, the clinical trials have
some limitations. As noted, the Italian trial did not include a placebo group, and, thus, some
of the beneficial effects could have been due to a “placebo response.” The UCSF trial was
short term, involved a relatively small number of people, was conducted in only one research
center, and was not designed to assess LDN’s effects on disease activity rigorously.

Does LDN have side effects?

The safety of LDN use in MS, especially on a long-term basis, is not yet known. The two clinical trials reported that LDN was generally well tolerated. In the UCSF study, several people reported “vivid dreaming” during the first week of treatment. In the Italian study, some people
had mild abnormalities in liver function, blood count and cholesterol. Irritability, which has
been noted by some as associated with LDN use, was not a significant issue in either study.

How could LDN work?


There are several theories about how LDN could
produce therapeutic effects. One is that LDN, which is an inhibitor of opiate effects, may,paradoxically, increase opiate effects in the
body by sparking production of the body’s own opiate
chemicals, the endorphins, and by increasing
the body’s sensitivity to them. Endorphins may have
beneficial effects on symptoms such as pain and mood, and may reduce inflammation. The Italian
study found that LDN treatment was associated with increased endorphin levels, which supports
this hypothesis. Another theory holds that LDN may decrease the formation of harmful chemicals
known as free radicals, protecting nerve cells from injury.

Unanswered questions

While these recent studies increase our interest in LDN, larger and more rigorous studies
are needed to get definitive answers to important and still unanswered questions:

• Does LDN truly decrease the severity of MS symptoms?

• Does LDN slow down relapsing or progressive MS?

• Is LDN safe to use in MS over the long term?

• Does LDN interact with conventional MS medications?

Like most of my colleagues, I believe we need answers before LDN can be considered a reasonable
MS therapy. But because the medication is already FDA-approved for other uses, it can be acquired. Some people with MS may be interested in considering
this therapy now. They should be aware of all the limitations of the current scientific information as well as liability and insurance issues (typically
insurance will not cover LDN for MS) and discuss the
information in detail with a knowledgeable health care professional.

***********************
Dr. Allen Bowling is a clinical
associate professor of neurology
at the University of Colorado-Denver and Health
Sciences Center and author of
Complementary and Alternative
Medicine and Multiple Sclerosis
,
2nd edition (Demos Health).

For a list of references to professional articles supporting this column, please seehttp://nationalMSsociety.org/LDN
or call your Society chapter for a printed copy.

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PostPosted: Thu Apr 23, 2009 8:36 am    Post subject: LDN Conference in Glasgow April 25 Reply with quote

A conference on LDN is being held in Glasgow on April 25. You can find out more here.
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PostPosted: Thu Jul 23, 2009 12:05 pm    Post subject: Dr. Timothy Vollmer in Rocky Mtn eMS News on LDN Reply with quote

Dr. Timothy Vollmer, head of the Rocky Mountain MS Center, has been publishing a series of "MS Therapies in the Pipeline" in the Rocky Mountain eMS News bulletin. The most recent issue (7/23/09) contains his views on LDN:

Quote:
MS Therapies in the Pipeline: Low-Dose Naltrexone

A web search of low dose naltrexone (LDN) brings up countless sites, each of which offers a differing account of the efficacy and safety of the therapy as a treatment for MS.
Most of the sites contain what scientists and physicians refer to as "anecdotal evidence" – stories of personal experiences with LDN. In the medical world "scientific evidence" – data from clinical trials that prove the safety and efficacy of drug therapies – is necessary for most practitioners to prescribe medications. With MS, anecdotal evidence from various medications has been unreliable because MS is extremely variable – although a therapy benefits one person, it will not necessarily benefit others. Therefore, LDN is not widely prescribed for MS and to this day continues to be a medically unsupported therapy option.

Naltrexone was approved by the FDA in 1984 – in a 50mg dose – to treat opium and heroin addiction. A year later, Dr. Bernard Bihari, a physician in New York City, found that a much lower dose of naltrexone affected the body’s immune system. Initially, LDN was used off-label to treat HIV-positive patients and, in the 1990s, certain types of cancer. However, very limited scientific data has been collected on these treatment uses, and LDN has not been approved by the FDA to treat either disease. More recently, LDN has been promoted as an off-label treatment for MS.


How does LDN work? The proposed effect of the therapy is that LDN causes an artificial blockade in the brain of endorphin/opioid receptors. The larger dose – used to treat addictions – causes a constant blockade, whereas the lower dose only blocks the endorphin receptors for a few hours. The blocking effect means that because endorphins aren’t able to attach to receptors, the body compensates by producing more endorphins, which are reported to boost the immune system and normalize immune function. However, there is very little scientific data to support this.

Proponents of LDN point to recent studies that conclude that immunodeficiency exists in MS – meaning the disease causes low levels of beta-endorphins. This claim remains controversial, and researchers insist that additional studies are necessary in order to more thoroughly understand the role of endorphins in MS.

Although many physicians have publicly encouraged the pursuit of more clinical trials on LDN and MS, few studies have been done. To date, all the studies have been brief, small, and with a focus on subjective outcomes – all facts that concern many MS specialists. Specialists point to the lack of scientific evidence, and insist that the variable nature of MS makes it essential for the therapy to be tested on a larger scale, for longer periods of time, and with more scientifically based criteria.

One Italian pilot study, the results of which were released in 2008, involved 40 patients with primary progressive MS who took LDN for 6 months. The study was set up to primarily evaluate the safety and tolerability of LDN, and to secondarily look at the effect of LDN on spasticity, pain, fatigue, depression, and quality of life. During the course of the study, investigators analyzed protein concentration of beta-endorphins.

Of the 40 study participants, 5 dropped out, two of those due to major adverse events. Of those remaining, investigators were encouraged to see that only one participant experienced neurological disease progression during the course of the study. Despite this seemingly positive result, the fact that the study lasted only 6 months – a very short amount of time in terms of neurological progression – left many MS specialists unconvinced of the efficacy of LDN. Study investigators also noted a possible reduction in spasticity, as well as an increase in the concentration of beta-endorphins.

In another recent clinical trial on LDN and MS, the results of which were also presented in 2008, investigators measured study participants quality of life using the MS Quality of Life Inventory. The Inventory focuses were subjective outcomes such as mental health, pain, and self-reported cognitive function. Among the 80 study participants who were given either LDN or placebo, those on LDN experienced "significantly improved quality of life," although no physical benefits were seen. During the 8-week trial, the therapy was well-tolerated and the only side-effect that study participants experienced was vivid dreams.

Most MS physicians agree that further studies on LDN and MS are necessary before they will be able to comfortably prescribe the drug off-label, and most remain skeptical that there is a place for LDN in the world of MS treatment. Despite this, patient interest persists and websites on LDN continue to pop up. Supporters of LDN remain hopeful that the therapy will soon become a more available treatment for MS.

_____________________________________________________
Quote:
Dr. Timothy Vollmer, medical director of the Rocky Mountain MS Center. Dr. Vollmer, widely recognized as one of the world's leading experts on MS, has been working with MS patients for more than 20 years. He joined the Rocky Mountain MS Center in August.




The article can be seen here.
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PostPosted: Tue Sep 22, 2009 6:39 pm    Post subject: (Abstract) Effects of LDN on MS Quality of Life Inventory Reply with quote

Presented at the annual ECTRIMS conference in Germany, September 11, 2009:

Quote:
A randomised, placebo-controlled, crossover-design study of the effects of low dose naltrexone on Multiple Sclerosis Quality of Life Inventory (MSQLI54)

N. Sharafaddinzadeh, D. Kashipaza, A. Mogthaderi (Ahwaz, Zahedan, IR)

Objective:

Multiple sclerosis (MS) significantly affects the quality of life (QoL) of patients. The use of low doses of naltrexone (LDN) for the treatment of MS enjoys a worldwide following among MS patients. There is overwhelming anecdotal evidence about beneficial effects of LDN on relapse reduction and disability and in general patients treated with LDN report improvements in a sense of well being, fatigue, as well as bowel, bladder and sexual function.

To evaluate the efficacy of LDN on the QoL of MS patients we run a randomized, double-blind, placebo-controlled, parallel assignment, crossover-design clinical trial were done. This study assess[ed] the impact of LDN compared to placebo on QoL as measured by the scales and composite scores of the multiple sclerosis quality of life inventory (MSQLI54) in adult subjects with relapsing-remitting MS.

Materials and Methods:

50 clinically definite MS patients [were] randomly assigned to one of two groups. Both groups received 4.5 mg naltrexone (LDN) for eight weeks and a placebo for eight weeks. One of the groups received the LDN first, and the other group received it last. Patients continue[d] to take any MS medications that [they were] already taking. For eight weeks, patients [took] either the LDN or the inactive placebo every night before going to bed between the hours of 9:00 PM to 3:00 AM. Patients [took] neither drug for the ninth week. Finally, patients [took] the other drug for the last eight weeks of the trial. Patients [were] asked to answer a Persian version of the MSQoL54 questionnaire at the baseline and at weeks 8 and 17.

Results:

After comparison of the mean score between treated and placebo groups, adjusting for differences in the baseline score between the two groups, we compare the scales and composites of the MSQOL54 during the active treatment and placebo cycles between active treatment and placebo groups. Data were analyzed by one-way analysis of variance (ANOVA). There were no statistically significant differences between each scale and the mean physical and mental Health composite scores of MSQoL54 of treatment versus placebo groups.

Conclusion:

LDN is not higher than placebo in improvement of the scales and Physical or Mental Health composite scores of the MSQOL54. Thus LDN has no treatment effect on the QoL of MS patients.




This abstract is nearly incomprehensible in parts. I've tried to edit it to get the meaning across.

The abstract can be seen in its unedited form here.
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PostPosted: Tue Sep 22, 2009 10:16 pm    Post subject: Reply with quote

Hmmm....

Sure wasn't that way for me.

Cherie
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PostPosted: Fri Sep 25, 2009 11:07 am    Post subject: Reply with quote

I wanted to post this at NT, but the link doesn't work when I copy and paste ... and I'm not allowed to post the whole article there ...
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PostPosted: Fri Sep 25, 2009 1:03 pm    Post subject: Reply with quote

The link should work. You clicked on the word "here" and went to the actual abstract page, and then highlighted the URL in the browser address window?

I could try it for you at NT if you tell me where you'd like it to go. And as a separate thread or in an existing thread--?
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PostPosted: Fri Sep 25, 2009 4:40 pm    Post subject: Reply with quote

Yeah, it works when I do it here, but if I copy the "properties", or just copy the URL, it doesn't.

The LDN sticky thread is the one I was trying to post it too. Thanks, if you can do it!

Cherie
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PostPosted: Fri Sep 25, 2009 7:23 pm    Post subject: Reply with quote

Done!
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PostPosted: Sat Sep 26, 2009 9:24 am    Post subject: Reply with quote

Thanks so much, Agate!!

Gotta share the good news and the bad. geek

Cherie
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PostPosted: Fri Oct 23, 2009 3:13 pm    Post subject: Reply with quote

From Medical News Today, October 22, 2009:

Quote:
'Life-Changing' MS Drug Could Save NHS £300 Million A Year, UK

The 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 ahead of the first International LDN Awareness Week which begins 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 and remitting MS. Nothing is offered to people with Secondary Progressive or Primary Progressive. LDN could help with MS whatever type you have."

The MS Society believes 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."

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

Source
LDN Research Trust



The article can be seen here.


Last edited by agate on Mon Mar 15, 2010 7:47 pm; edited 1 time in total
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PostPosted: Wed Mar 03, 2010 9:11 am    Post subject: (Abstract) LDN pilot trial & quality of life in MS Reply with quote

In Annals of Neurology, February 19, 2010:

Quote:
Research Article
Pilot trial of low dose naltrexone and quality of life in MS

Bruce A.C. Cree *, Elena Kornyeyeva, Douglas S. Goodin
Multiple Sclerosis Center at UCSF, 350 Parnassus Ave., Suite 908, San Francisco, CA 94117

email: Bruce A.C. Cree (bruce.cree@ucsf.edu)

*Correspondence to Bruce A.C. Cree, Multiple Sclerosis Center at UCSF, 350 Parnassus Ave., Suite 908, San Francisco, CA 94117

Objective:

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

Methods:

This single center, double-masked, placebo-controlled, crossover studied evaluated the efficacy of eight weeks of treatment with 4.5 mg nightly naltrexone (Low dose naltrexone or LDN) on self reported quality of life of MS patients.

Results:

80 subjects with clinically definite multiple sclerosis were enrolled and 60 subjects completed the trial. 10 withdrew before completing the first trial period: 8 for personal reasons, 1 for a non-MS related adverse event and 1 for perceived benefit.

Database management errors occurred in 4 other subjects and quality of life surveys were incomplete in 6 subjects for unknown reasons. The high rate of subject dropout and data management errors substantially reduced the trial's statistical power. LDN was well tolerated and serious adverse events did not occur.

LDN was associated with significant improvement on the following mental health quality of life measures: a 3.3 point improvement on the Mental Component Summary score of the SF-36 (P=.04), a 6 point improvement on the Mental Health Inventory (P<.01), a 1.6 point improvement on the Pain Effects Scale (P=.04) and a 2.4 point improvement on the Perceived Deficits Questionnaire (P=.05).

Interpretation:

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



The abstract can be seen here.
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PostPosted: Sun Mar 07, 2010 11:48 am    Post subject: The article itself (see above post) Reply with quote

You can see the entire article here.
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PostPosted: Mon Mar 15, 2010 7:46 pm    Post subject: Reply with quote

More about this study:

(from the MS Society (UK), March 1, 2010)

Quote:
LDN phase II trial results published

Results of a phase II clinical trial on the safety and effectiveness of low dose naltrexone (LDN) as a symptom-relief treatment for people with MS have been published in the journal Annals of Neurology.
The results of the study suggest that LDN is safe and may have positive effects on the mental quality of life in people with MS; but no effect on a patient’s physical quality of life.

The work, led by Dr. Bruce Cree at the University of California in San Francisco, is the first placebo controlled clinical trial to look at the effects of LDN in people with MS.

Researchers found vivid dreaming was the only symptom reported as a result of taking LDN but due to a high drop out rate among trial participants, concluded that larger scale trials are needed to determine the effect of LDN on overall quality of life.

Dr Susan Kohlhaas, Research Communications Officer at the MS Society said, “We are really pleased to see results of this study published. The next step will be to complete larger, more detailed clinical trials to determine the potential of LDN as a symptom relief therapy for people with MS.”
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PostPosted: Tue Apr 06, 2010 6:53 pm    Post subject: MSIF on LDN and MS Reply with quote

MS in Focus, the newsletter of the Multiple Sclerosis International Federation, devotes its April 6, 2010, issue to complementary and alternative therapies for MS--including an article on LDN:

Quote:
Low-dose naltrexone and MS

Maira Gironi MD, PhD, Don Carlo Gnocchi Foundation and San Raffaele Hospital, Milan; Analysis and Diagnostic Centre of Monza, Italy



Naltrexone, which is an antagonist to opiates, causes an artificial blockade of the endorphin/opioid receptors in the brain. At a ‘normal ‘dose of 50-100 milligrams (mg) per day it is used to treat drug addiction, and works by maintaining this blockade continuously, preventing any derived pleasure from taking drugs such as heroin or alcohol.

“Low dose naltrexone” (LDN) refers to the use of naltrexone at a fraction of its usual dose. It is hypothesised that LDN (~3mg to 5mg) blocks the endorphin receptors for only a few hours.

The theory is that during that time, endorphins are unable to attach to the receptors and the body compensates by creating more. Once the LDN has been metabolised, the amount of endorphins in the body returns to a level comparable to that of a healthy person. The link between endorphins and immune system regulation is not completely clear.

In terms of symptomatic relief, it has been proposed that endorphins reduce inflammation and can reduce unpleasant sensations of fatigue, pain and depression. Given this, LDN may potentially have an effect on some disease symptoms.

LDN and MS

There is a lot of talk in the MS community about LDN treatment. Much of it is confusing and controversial. On one hand, there are widespread anecdotal reports claiming that LDN is effective for treating MS symptoms and slowing down the disease course. Moreover, there are reports that LDN is an effective treatment for immune diseases such as Crohn’s disease, lupus, arthritis and fibromyalgia.

Studies of LDN in MS

A study on mice with EAE, the animal model of MS, found that LDN decreased inflammation in the nervous system, decreased disease severity and decreased activation of immune cells. Another study included 80 people with relapsing-remitting and progressive MS.

While LDN did not appear to improve physical functioning in this study, it did show important improvements (statistically significant) on some aspects of quality of life such as mental health, pain and self-reported cognitive functioning. During a third study 40 people with primary progressive MS were treated with LDN for six months in a phase II study. Phase II studies assess the safety and tolerability of a drug.

Subjects were administered 4mg of LDN per day. Although the study was not designed to specifically assess efficacy, a significant effect on spasticity was found. Approximately one-third of subjects reported worsened pain. Neurological disability progressed in only one person.

The study demonstrated an increase in Beta-endorphins, the most important endogenous opioid found in the neurons of the central nervous system as well as in the peripheral cells of the immune system. The increase in beta-endorphins was present three months after beginning the therapy and still evident one month after subjects stopped therapy.

There is a lot of talk in the MS community about LDN treatment. Much of it is confusing and
controversial.

Currently LDN is prescribed “off label” because it has not been approved specifically for MS. Rigorous safety data on LDN use in MS is not currently available. We do know that, considering the low doses used, few side effects have been reported. Vivid dreaming has been reported by some subjects at the beginning of treatment. LDN may be associated with mild abnormalities in cholesterol, blood counts and liver function. It may cause irritability in some individuals.

LDN should not be combined with any opiate-based medications such as narcotics or pain medications, including oxycodone, hydrocodone or codeine.

Before beginning treatment with LDN a complete evaluation should be performed, including a neurological examination and the assessment of spasticity, pain, fatigue and depression, as well as complete biochemical and urinary analyses. These evaluations should also be performed periodically during treatment.

Currently there is no evidence that LDN is superior to any conventional therapy for MS. LDN could be effective as a symptomatic and a neuroprotective agent although randomised, placebo-controlled, double-blind trials are needed to further investigate the efficacy of LDN in people with MS.




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PostPosted: Fri Mar 18, 2011 10:46 am    Post subject: (Abstr.) Long-term effects of LDN & OGF on EAE Reply with quote

From the MS International Federation newsletter, March 8, 2011 (the abstract is from PubMed):

Quote:
Prevention and diminished expression of experimental autoimmune encephalomyelitis by low dose naltrexone (LDN) or opioid growth factor (OGF) for an extended period: Therapeutic implications for multiple sclerosis


summary:

The use of low dose naltrexone (LDN) in patients with MS in clinical practice is controversial. This study examined the long term effects of the opioid growth factor (OGF, [Met5]-enkephalin) and LDN on expression of myelin oligodendrocyte glycoprotein (MOG)-induced EAE. The results indicate that treatment with LDN and OGF had no deleterious long-term repercussions and did not exacerbate EAE, but i) halted progression of disease, ii) reversed neurological deficits, and iii) prevented the onset of neurological dysfunction across a considerable span of time.

authors: Rahn KA, McLaughlin PJ, Zagon IS.

source: Brain Res. 2011 Mar 24;1381:243-53.





The abstract can be seen here.
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PostPosted: Wed Sep 07, 2011 4:51 pm    Post subject: Tricking the body to heal itself w/LDN Reply with quote

From Medical News Today, September 6, 2011:

Quote:
Tricking The Body To Heal Itself With Low-Dose Naltrexone (LDN)

Researchers at The Pennsylvania State University College of Medicine, Hershey, Pennsylvania have discovered the mechanism by which a low dose of the opioid antagonist naltrexone (LDN), an agent used clinically (off-label) to treat cancer and autoimmune diseases, exerts a profound inhibitory effect on cell proliferation. It has been postulated that opioid receptor blockade by LDN provokes a compensatory elevation in endogenous opioids and opioid receptors that can function after LDN is no longer available. Using a novel tissue culture model of LDN action, the mechanism of LDN has been found to target the opioid growth factor (OGF, [Met5]-enkephalin) and OGF receptor (OGFr) axis.

This discovery, reported in the September 2011 issue of Experimental Biology and Medicine, provides new insights into the molecular pathway utilized by an increasingly important clinically prescribed agent that serves as a basic biological regulator of cell proliferative events related to pathobiological states such as cancer and autoimmune diseases.

Although the antitumor effects of opioid antagonists were first noted by Drs. Zagon and McLaughlin in 1981 (Life Sci. 28:1095-1102, 1981), the first full reports about opioid antagonists modulating growth processes occurred in 1983 (Science 221:671-673; ibid, 221:1179-1180). This led to the hypothesis that endogenous opioid systems play a role in cancer, development, and cellular renewal (Life Sci. 35:409-416, 1984; ibid, 35:2057-2064, 1984). These papers revealed that a short-term opioid receptor blockade with naltrexone (NTX), a general opioid receptor antagonist devoid of intrinsic activity, results in an elevation in endogenous opioids and opioid receptors in response to the opioid receptor blockade. Interference of opioid peptide-opioid receptor interactions for a short time each day (4-6 hr) with LDN provided a subsequent window of time (18-20 hr) for the increased levels of endogenous opioids and opioid receptors to interface and elicit a robust functional response: inhibition of cell proliferation.

The question that now can be addressed is which endogenous opioid(s) and opioid receptor(s) are responsible for LDN's effects on cell proliferative processes.

The present study was structured to focus on the relationship of endogenous opioid pathways and the repercussions of intermittent opioid receptor blockade with regard to cell proliferation. A unique tissue culture model of LDN using a short-term exposure to NTX was developed, thereby avoiding the confounding variables introduced by systemic influences and allowing a dissection of the biological events involved. Screening of a wide variety of opioids (some selective for specific opioid receptors) revealed that only exogenous OGF had a profound effect on depressing cell proliferation. Removal of endogenous OGF by antibody neutralization in cultures given a short-term opioid receptor blockade by NTX eliminated the repressive effects of this peptide on cell proliferation, indicating that the repercussions of short-term NTX exposure in vitro was dependent on OGF. Short-term NTX blockade continued to exert a negative effect on cell proliferation even when the classical opioid receptors, μ, δ, and κ, were knocked down by siRNA technology. However, short-term NTX treatment did not repress cell proliferation when cells were subjected to siRNA to the non-classical opioid receptor, OGFr.

These results indicate that the effects of short-term NTX in vitro are dependent on the OGF-OGFr axis. Previous studies have shown that the OGF-OGFr axis regulates cell proliferation by altering the G1/S phase of the cell cycle through the cyclin-dependent inhibitory kinases p16 and p21. Knockdown experiments with siRNA show that a short interval of exposure to NTX in tissue culture required p16 and/or p21 in order to have a functional outcome on cellular processes.

The research team was comprised of Dr. Ian S. Zagon, Distinguished University Professor, and Dr. Patricia J. McLaughlin, Professor, along with Dr. Renee N. Donahue, in the Department of Neural & Behavioral Sciences. Drs. Zagon and McLaughlin not only discovered the phenomenon of LDN, and subsequently the OGF-OGFr axis, but have been at the forefront of translating their findings of LDN - and OGF - from the bench to the bedside. LDN has proven successful in Phase I and II clinical trials in the treatment of Crohn's disease, and OGF has been reported to be safe and efficacious for the treatment of advanced pancreatic cancer. Co-author Dr. McLaughlin states: "Now that we know LDN uses the OGF-OGFr axis as the pathway to control the cell cycle, this expands our arsenal of biological-based treatment modalities to bring about a change in disease states reliant on cell proliferation that not only includes LDN, but exogenous OGF and the imidazoquinoline, imiquimod. This information also provides the basis for a rational approach to the design of diagnostic tools and measures of therapeutic efficacy."

Dr. Donahue, who has devoted a concentrated effort on improving the health of women through research explains: "This study joins a series of other investigations (Amer. J. Physiol. 296:R1716-1725, 2009; ibid, 297:R1154-R1161, 2009; Gynecol. Oncol. 122:382-388, 2011; J. Cancer Therapy 2:110-124, 2011; Exp. Biol. Med., in press, 2011) demonstrating that both LDN and OGF offer powerful treatments to combat a devastating cancer that strikes over 20,000 women in the U.S. each year and stands as the 5th leading cause of cancer-related deaths in females. Thus, one should not lose sight that the OGF-OGFr axis is a new frontier in understanding the pathogenesis and treatment of a cancer that has been, up to now, recalcitrant to conventional therapies." Dr. Zagon adds that "The exciting results that the mechanism of LDN uses the OGF-OGFr axis, brings together two very important opioid-based treatment modalities under one umbrella. This common denominator in a physiological pathway does much in now directing our attention to how the OGF-OGFr system works, and explains why an opioid agonist (i.e., OGF) and antagonist (NTX in the form of LDN) have the same effects. Moreover, LDN is an oral medication, generic, inexpensive, and non-toxic, and has been documented to alter the course of both neoplasias and autoimmune diseases such as Crohn's and multiple sclerosis, making this drug especially attractive as a therapeutic agent. The fact that OGF has been found to be a potent anti-inflammatory agent (Immunobiology 216:173-183, 2011; ibid, 216:579-590, 2011) also opens the door to the potential treatment of diseases of the immune system (HIV/ADS) infections, hypersensitivity, and neurodegeneration, which involve cell proliferation, thereby widening the benefit from therapeutic manipulation of the OGF-OGFr axis by LDN."

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology and Medicine, said, "These researchers from the Milton S. Hershey Medical Center have made the important discovery of the mechanism by which a low dose of the opioid antagonist naltrexone (LDN) can suppress cell proliferative-related disorders such as cancer and autoimmune diseases. This is an exciting new direction for future therapy".


The article can be seen here.
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PostPosted: Sat Oct 29, 2011 6:07 pm    Post subject: Article in Fall 2011 MS Focus Reply with quote

Daniel Kantor, M.D., has written an article, "LDN: Miracle or Myth?" that appears in the Fall 2011 issue of MS Focus, the publication of the MS Foundation.

I haven't been able to get this article online, but anyone with access to the print version can find it on pages 56-58.

The author concludes that more research is needed.
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PostPosted: Thu Jan 12, 2012 1:46 pm    Post subject: Reply with quote

In December 2011 the MS Society of the UK came out with a report on LDN, based on three clinical trials. Details are available here.
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