Fibro/Virus Article

[DEL]

http://www.healthcentral.com/chronic-pain/c/5949/168435/fibromyalgia-caused/


Draw your own conclusions, people. I'm not sure what to believe.

[augoldminer]

I have fibro from sarcoidosis and there are clues like the higher then normal number of people in the medical professions that get sarcoidosis.
but doctors have been looking for a infectious agent for years and have found none.
http://thorax.bmj.com/content/43/4/342.full.pdf

But is it a virus??

Can anything be done after fibro has started or is the damage already done.

Is fibro one disorder???? and would antiviral treatment work what % of people with fibro and at what cost.

[Lonesome George]

I could see that being a possibility. I had a life threating staff infection in the late 1970's. A staff infection stays in a persons body for life, and recurring when the body gets run down, as mine does when I'm run down. That's why I can't lose too many nights sleep. It's been a pretty bad last two weeks for me, and now my staff infection is back again.  After my initial major infection, it has always reappeared in the area of the original infection, but has since tested as a Herpes variant.

I used to get this infection every 4-8 weelk for over 20 years, then the periods got farther and farther apart. The odd thing was, the days leading up to a breakout, during, and for a week after, I felt like I do with a bad Fibro flair, aching all over, extreme fatigue, fog to the extreme, irritability, ect.

So, with that said, there are a lot if simularities, with me at least, to lead me to believe there could be a connection. I do know my Fibro came on permanently when I wacked the snot out of my head. I don't know if the head trauma caused the seperate disease of Fibro, or caused my staph/herpes I already had to run wild from the head trauma, possibly caused by some shout circuit in the auto-immune system part of my brain.

Who knows. Interesting hypothesis though.

[looneylane]

I have heard before that my fibro could be related to a cetlomeglya virus I contracted back in the 90s

[Lonesome George]

Here is a June 2014 article about this study and the doctor's thinking process on fibro. It has a lot of interesting thoughts, but is an easy read.

https://fmsglobalnews.wordpress.com/2014/06/22/pro-healths-big-antiviral-trial-could-usher-in-new-treatment-era-for-fibromyalgia/


And here is a November 2014 article with some trial results. Lots of good info here. Looks like a 50-100 million dollar trial is up next for FDA approval.

http://simmaronresearch.com/2014/11/drug-combo-pridgen-antiviral-fibromyalgia-trial-identified-results-available/

Here is the clinical abstract of the study.

http://acrabstracts.org/abstracts/a-combination-of-celecoxib-and-famciclovir-is-efficacious-in-the-treatment-of-fibromyalgia-results-of-a-phase-iia-randomized-double-blind-placebo-controlled-study/

[Robby]

I will have to go back and read all these later, when my fog isn't so thick. But, I'm like DEL I'm not sure what to believe. I have heard the virus theory but never really thought about it until just now, of course my fibro symptoms actually started when I was about 6 y/o, give or take a year or two. The thing is, from the day I was born until I was 8 or 9, I stayed sick  in one form or another. I had to have sinus surgery a couple of times from age 5 to 8, I had to have ear surgery on both ears several times by the age of 4, so I could actually hear and understand the sounds around me, then I just stayed sick with colds, allergy attacks, and the flu. So yes I could easily believe that fibro is caused by a virus, or bacteria, or other type sickness, but I'm not jumping on that bandwagon just yet, but I am in the position to chase it down if needed.

[Sleep Mode zZ]

My 2 cents:

In the pain questionnaire the placebo group had a reduction of pain by an average of 1.1 while the NSAID + antiviral group had an average reduction of 1.9 points. The abstract does not reveal what was the total scale but it seems that it is normal to use a 11 point scale from 0 to 10.  The difference of 0.8 points is better than nothing but I'm not very excited by it. The result of the Fibromyalgia impact questionnaire is a bit more clear, although less impressive than duloxetine (Cymbalta) or pregabalin (Lyrica) - and we are not really excited about those drugs. Overall, while almost one fifth responded positively to placebo, one third responded to the combination drug. So, like with the currently accepted drugs, most people do not respond to them but they may help some. (Also, while it was a placebo controlled trial, it is not uncommon that some participants can correctly guess whether they got a placebo or something else because of some detectable side effects of the real drug. That is why I'm a bit suspicious of trials like this that just barely show some improvements.)

In addition to the modest results, I'm a bit suspicious about it being a combination drug that was trialed. It seems that there is something like a dogma that because fibromyalgia is not an inflammatory disease, NSAIDs do not work for it. Try then find the proof for that dogma - something like a double blind trial with a statistically significant result showing that NSAIDs do not work. I could not find it - maybe it precedes the internet. Anyway, I'm suspecting that the NSAID part of of the drug - Celecoxib - could alone be responsible for the positive result because the difference between the NSAID + antiviral group and the placebo group because the difference was relatively small, and because currently it is not so clear that fibromyalgia does not have some inflammatory component to it. Even such a common thing as sleep deprivation causes increased inflammation and disturbed sleep is one symptom of fibromyalgia - some increased inflammatory activity would be expected for that reason alone. There are also several diseases or syndromes that are somewhat similar symptom wise to fibromyalgia and do have positive response to NSAIDs - the fibromyalgia group would be more likely include more people with undiagnosed NSAID responsive health problems than the healthy controls. So the question is if the antiviral part of the drug has some effect on fibromyalgia or could it all be explained with Celecoxib reducing pain and inflammation? The antiviral part certainly could effective because about 90% of people has one or another herpes virus in their system, and it could be that it has some effects on people with chronically weakened immune systems (compared to the healthy controls) that the antiviral drug would then reduce - I don't just see it confirmed by this trial because there is no comparison to Celecoxib alone.

[Lonesome George]

The first few years I had this I used aspirin for pain control. It worked very well, but my stomach can not handle it on a regular basis. I don't like the Celebrex factor either. I believe the pain relief is a result of reduced inflammation. That certainly was my experience. I still sometimes take an aspirin or two when I have the need to take a hydrocodone. It helps kick the pain relief up a notch.

[looneylane]

I sometimes worry what all the advil and tylenol is doing to me but the alternative was harder on me in other ways. Being pain free (Or a proximation thereof) came with such a huge price to my family. No matter what my stomach was already in rough shape before nay medications were put in play to treat my fibro. Just hoping they will someday have a way to treat it

[Lonesome George]

I believe I'll be long gone or way too old and weak for any treatment that may come down the line in my lifetime.

[Sleep Mode zZ]

Tylenol (paracetamol, acetaminophen) should not be dangerous to the stomach. On the other hand, it can be toxic to the liver even with quite modest overdoses. It seems to be currently preferred over real NSAIDs in the treatment of chronic pain. Unfortunately it has not been useful for me - even with the occasional headache. It also seemed to be useless when it was recommended for me to help with my osteoarthritis.

Advil (ibuprofen) can cause stomach bleeding and should be only used in short regimens for occasional pains and aches. Aspirin (acetylsalicylic acid) is even worse. And it is inevitable that some will combine their use with the use of alcohol - increasing the risk of stomach bleeding.

Acetylsalicylic acid can be used continually in very small doses to reduce blood clogging but I don't think it would be useful for combating pain with so small doses. Like paracetamol, it was not useful for me even even for the occasional headache. Ibuprofen is been for me the only OTC drug that worked with headaches (combined with a cup of coffee for better effect).

There are other NSAIDs that are more 'stomach friendly' than the OTC NSAIDs. I have used Mobic (meloxicam) almost continually for a year - with a 8 weeks on, 2 weeks off regimen. Ibuprofen had some beneficial effects but meloxicam has been better and it can be used more safely for longer periods. Officially it is only prescribed for me to be used 'when needed' - for psoriatic arthritis. It has really helped with the osteoarthritis of my knee that paracetamol was useless with. So I take it as much as allowed. Because I also take prednisolone (corticosteroid, steroid), that can also be problematic for the stomach, I have also been prescribed Somac (pantoprazole) that reduces stomach acidity - to reduce the risk of stomach bleeding. (I have now so many daily pills that I might get a pill dispenser to help me remember to take them all.)

There are also other risks with NSAIDs in addition to stomach bleeding. Maybe some NSAIDs could fare as well, if not better, as 'serotonin balancers', or other drugs targeting neurotransmitters. I think that risk-benefit considerations might have been steering away from trialing NSAIDs that have well known risks associated with their continual use. (Maybe there also were more money to make with drugs that target neurotransmitters - drug trials needs to be paid by someone with the prospect of getting that investment back with some added profit. This trial overcame that problem by patenting a combination of two existing drugs...) On the other hand, NSAIDs have an accepted place in the treatment of other chronic conditions.

[Sleep Mode zZ]

Some comments on the fmsglobalnews blog post by Cort Johnson:

Infections are a common trigger for fibromyalgia (FM), and fibromyalgia patients experience many 'sickness behavior' symptoms, but we haven't usually associated FM with viruses or immune system problems.

That has been changing recently. An immune biomarker has been proposed. Small fiber neuropathy – possibly caused by immune dysregulation – has been found. Dr. Dantini has been treating FM with antivirals for years. The immune system is starting to get some respect in FM.

The problem with this is that small fiber neuropathy is associated with many diseases, and not all of them are regarded as immunological diseases, like diabetes or alcoholism for an example. Maybe small fiber neuropathy could be the result of some immune system dysregulation - but why jump from that to antivirals? Immune system dysregulation is not usually treated with antivirals - as is not diabetes or alcoholism.

Daniel Dantini has been treating FM with antivirals for several decades, starting with himself. It has been very successful - according to him. No peer reviewed studies have been published. It is good to remember that FM has also been cured  also diet changes and whatnot - according to many books with glowing reviews and personal testimonials the back up effectiveness of the cures. Still no peer reviewed papers are published to confirm the cures and real research do not seem to point in the same direction.

Pridgen saw a pattern emerge in his treatment of thousands of patients with chronic gastrointestinal issues that intrigued him. A patient would get better, but then experience a stressful event that would send him/her back into the soup. They would get better, but during the next relapse they would stay sick longer and their recovery period would be shorter. Eventually they would be sick all the time.

The problem, he thought, had to be some sort of pathogen that was steadily increasing with every recurrence. Giving his patients antivirals helped, but problems remained. Then he found that adding an anti-inflammatory (which also had anti-viral properties) reduced their fatigue, gastrointestinal complaints, depression and anxiety markedly and improved their energy.

An observational study indicating that the combination drug approach had a 90% 'efficacy rate' led Pridgen to start a company, enlist investors and create the large treatment trial.

Anecdotes are good instruments to sell ideas in the lieu of actual evidence for them. Even if Pridgen's observational facts about the chronic gastrointestinal issues were true, the hypothesis that there has to be some pathogen causing the observations is not the only explanation. There are plenty of other valid reasons for such gradually worsening relapses with health problems.

"Giving his patients antivirals helped, but problems remained" seems to indicate that the improvement in patients was very obvious. Why then, if I read the results of the trial correctly, even the improvement gained by the the combined drug is so modest? I don't know what kind of 'observational study' is indicated here - apart from it being something unpublished that we should take on faith. Generally speaking, 'observational studies' "cannot be used as reliable sources to make statements of fact about the "safety, efficacy, or effectiveness" of a practice" (Wikipedia). Even less clear is what a 90% 'efficacy rate' means here. Did 90% of the patients improve with the help of the drug? How did they determine that improvement did occur? We can only guess.

Pridgen's patent application indicates that he believes that stressors and peptides and hormones released by the sympathetic nervous system and HPA axis set the stage for herpes simplex-1 reactivation. Pridgen proposes that repeated HSV reactivation could kill the sensory nerve cells (small fiber neuropathy?) and destroy part of the nerve ganglion. (Stress induced HSV-1 reactivation has been documented in laboratory animal studies.)

So is then the reason of FM in stress or HSV-1? It is good to remember that most people are infected with HSV-1 and the great majority of them are not suffering from FM. So it seems that Pridgen  points to the dysfunction of the sympathetic nervous system and the hypothalamic–pituitary–adrenal axis as the more fundamental causes of FM -  as many have before him. HSV-1 and its treatment with antivirals are more more like an added theme to the more familiar and better established facts of sympathetic nervous system and HPA axis dysregulation. That is all right if the antivirals really help to alleviate FM.

Pridgen proposes to stop the viral reactivation and the central sensitization with antivirals; an approach that has been tried before in chronic fatigue syndrome, but not in the way Pridgen's doing it.

One of Pridgen's patent applications suggests that one of his unique insights has been to combine valacyclovir (valtrex) with an anti-inflammatory, Celecoxib (Celebrex) that has antiviral properties. Other combinations are being tested and Pridgen stated they have not released the make-up of the IMC formulation used in the trial. It is not clear, then, what drugs at what doses were used in the study or which will prove most effective.

Celexcoxib (Celebrex) is a non-steroidal anti-inflammatory (NSAID) COX-2 inhibitor usually used in the treatment of osteoarthritis, rheumatoid arthritis, acute pain, painful menstruation and menstrual symptoms. It down regulates the activity of inflammation producing cells.

Pridgen proposes that the two drugs hit the virus at different stages of its life cycle. Pummeling the virus with that one-two punch, he believes, will finally stop the virus from reactivating.

For me this seems Pridgen tries hard to present celecobix as being an antiviral agent to keep with his theme of targeting HSV-1 with his treatment - it is the second stage in the antiviral pummeling. It seems that that the antiviral properties of celecobix are not widely known. It is usually seen as an COX-2 inhibiting NSAID among others. The antiviral properties seems to be linked more generally with the COX-2 inhibition. That would mean that all NSAIDs and paracetamol (acetaminophen) are likewise antiviral drugs targeting HSV-1. Cort Johnson adds also flavanoids, vitamin E, fish oils and omega-3 fatty acids to the list of antiviral agents.

One of the most intriguing aspects of the Pridgen-Duffy study is the search for HSV-1, not in the blood, but in the tissues. We know the Chronic Fatigue Initiative's Pathogen study failed to find evidence of viral infection in the blood. Now, Pridgen and Duffy are testing gut samples for herpes virus simplex in their study.

First PCR will be used to search for herpes viruses in both the control and FM gut samples. Then antibodies will be used to determine if an active infection is present. In subsequent studies, electron microscopy will look for the herpes viruses particles themselves.

In preliminary studies, 18/19 fibromyalgia patients with gut issues contained herpes simplex virus DNA in their gut tissues. No other herpes viruses were found. Immunoblot testing indicated that an active infection was present in eight of nine positive biopsies.

The most interesting question that is left unanswered above is whether gut tissues from healthy controls contains HSV-1 virus DNA. If they do, there is really nothing to report here. Then the presence of virus DNA in 18 of 19 persons would then not be a positive proof of virus activation but would be more or less what is expected because HSV-1 infection is really very common.

It is not too much to say that if successful, the Pridgen antiviral trials for Fibromyalgia would be a paradigm changer – turning FM from a poorly treated central nervous system disorder to a disorder characterized by a (hopefully) treatable herpesvirus infection.

I am more cautious because the antiviral drug is only one part of the combination drug that was tested - and it seems that valaciclovir alone was not enough to warrant a trial. What then, of the somewhat successful trial, is attributable to it and what to celecoxib? If valaciclovir really has some effect on fibromyalgia it would be quite minor - so it is not really "turning FM from a poorly treated central nervous system disorder to a disorder characterized by a (hopefully) treatable herpesvirus infection".

[foxgrove]

Well.. there is one sure fire way to use aspirin safely..  Absolutely guaranteed that the aspirin will not cause any harm to your body.  It's called the crushed aspirin method.  When someone is causing your headache, take two aspirin and a hammer, place the aspirin on the forehead of the person causing you the pain and crush them.  My headaches always get so much better!!! 

Well... maybe not... but I sure like to use that one in my visualization techniques.  Get's rid of a lot of stress!! 

[looneylane]

  Love it Fox I should try it sometime! I have a few candidates!

[Robby]

Fox, problem is if I visualized it, I might end up doing it for real