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Big Antiviral Trial Could Usher in New Treatment Era for Fibromyalgia

 A New Approach to Fibromyalgia

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

woman questioning

So it’s going to be Fibromyalgia that gets the really big antiviral trial ….

That’s been changing  recently. A 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’s starting to get some respect in FM.

Now, in a surprising twist, it’s going to be fibromyalgia rather than chronic fatigue syndrome, that’s getting the big, placebo controlled, double-blinded multi-center antiviral trial.

Last year we heard that Dr. William Pridgen in  Alabama was getting his ducks in a row for a major antiviral trial. Four weeks ago in an email exchange he confirmed that the money – $3.3 million dollars – all gathered from ‘angel investors’ is in  hand, and the four-month 143 patient trial began  in early October.

Pridgen’s Innovative Med Concepts biotech startup is producing the study.

A Different Path

The pathways researchers and doctors take to get to disorders like FM or chronic fatigue syndrome are nothing but diverse, and it’s worth taking a look at how Dr. Pridgen, a surgeon, came to fibromyalgia. (Dr. Julia Newton’s pathway to ME/CFS was through elderly people experiencing dizziness and, to her surprise, a great deal of fatigue.) Dr. Pridgen’s pathway to fibromyalgia was through the gut.

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.

virus

Shorter and shorter relapses over time in his patients lead Pridgen to conclude that a virus must be involved.

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.

Pridgen’s theory fits glove and hand with several other fibromyalgia/chronic fatigue syndrome theories. As with Van Elzakkers’ vagus nerve infection theory for ME/CFS, Pridgen’s theory begins with a nerve loving virus that takes up residence – for life – in nerves in the sensory ganglia found across the body.

Instead of HHV6 or EBV Pridgen believes herpes simplex viruses, are the key in FM/ME/CFS. Other than a 1993 theory proposing herpes simplex virus was at play in ME/CFS, interest has been scanty. HSV-1′s ability to affect many of the genes and gene pathways suspected of playing a role in nervous system disorders such as Alzheimer’s, Parkinson’s, depression, chronic fatigue syndrome and autism, however, lead one researcher to propose it could play a role in all of them.

HSV-1 has been found in the esophagus, stomach and duodenum of the gastrointestinal system. In fact, HSV-1 was proposed to  cause ‘recurrent functional gastrointestinal disorders’ such as IBS, as far back as 1996.

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 can  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.)

Once  these neurons and ganglia are damaged, Pridgen believes they send out signals that ultimately muck up the pain processing centers in the central nervous system. The over-generation of neurotransmitters such as glutamate, Substance P, serotonin, norepinephrine, dopamine, brain-derived neurotrophic factor (BDNF) involved in this process then causes central sensitization.

Antiviral Plus

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

connections

Are two ‘antivirals’ better than one? We’ll find out sometime next year.

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 IMC formulation used in the trial. It’s 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 antinflammatory (NSAID) COX-2 inhibitor usually used  in the treatment of osteoarthritisrheumatoid arthritisacute 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.

Pridgen and Duffy are looking for herpes simplex virus, but other herpes viruses could be affected by this treatment. We won’t know if they are until further studies are done.

Inflammation Gone Awry

Pridgen and his partner, molecular virologist, Carol Duffy will also attempt to develop a diagnostic test for fibromyalgia using cytokine arrays they believe will document high levels of  pro-inflammatory cytokines and low levels of anti-inflammatory cytokines.

Like VanElzakker, Pridgen believes the body is over-reacting to the virus.

“It’s basically exaggerating its reaction to the virus. Any little stress reactivates the virus, and, rather than the body saying, ‘Oh, this is just a virus I’ve been living with this since I was five,’ the body keeps saying, ‘Oh, my God,’ and throws on all this inflammation, and that gives these people this pain.”

“There is a theory that all pain, one way or another, is inflammation,” Duffy says. “It’s inflammation gone awry.”

Not just Fibromyalgia

Pridgen and Duffy have their eyes on more than Fibromyalgia.  Pridgen’s provisional patent proposes this treatment will work for chronic fatigue syndrome, irritable bowel syndrome, chronic pain, chronic headache, chronic neck pain, chronic back pain, chronic depression, chronic clinical anxiety disorder, post-traumatic stress disorder (PTSD), brain fog, cognitive dysfunction and chronic interstitial cystitis.

Celebrex – The Antiviral?

We don’t hear anything about Celecoxib as a virus fighter in ME/CFS, but some evidence suggests it could be efficacious against herpes simplex virus. The ability of COX-2 inhibitors to decrease prostaglandin production is believed to push the immune system towards a Th1 (antiviral) response and away from the Th2 response often found in ME/CFS.

stop sign

Pridgen believes Celexicob’s antiviral properties, in concert with Valtrex, will knock down the herpes viruses causing FM and ME/CFS

Celebrex was shown to reduce stress induced herpes virus reactivation in the nervous systems of mice.  Another study found that reactivation of HSV-1 in mice was associated with upregulation of COX-2 gene expression in their nerve ganglia.  HHV-6 can also induce COX-2 expression.  Both COX-1 and COX-2 are needed for viral replication.

(One mother found that VIOXX (now off the market) reduced her daughters IL-6 levels and eliminated the ‘panic attacks’  she’d experienced following a central nervous system infection.)

(Aspirin and flavanoids, vitamin E and fish oils also inhibit COX-2. The efficacy some ME/CFS patients experience from using omega-3 fatty acids could be due to antiviral effects.)

Tissue Biopsies

Along with treating the virus, Pridgen and his partner, molecular virologist Carol Duffy, will be using PCR to test for the virus, not in the blood, but in gut tissue samples.

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 herpesviruses 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 herpesviruses particles themselves.

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

Dr. Pridgen reported in an email they are still trying to determine  the optimum doses and cautioned everyone to wait until the results of the phase three trial are done before starting this treatment.  He also stated he feels  they are ‘very close’ to helping many people with this condition.  The results of trial will be released mid-year, 2014. 

Conclusion

breakthrough arrow

A successful trial could usher in a new era of treatment for fibromyalgia and perhaps chronic fatigue syndrome

Pridgen and Duffy’s big multi-center antiviral trial in Fibromyalgia is nothing if not exciting in its scope and approach. Pridgen’s ability to come up with over $3,000,000 in startup funding suggests he and Duffy have got some solid data backing their trial up. .

If they results are positive, Pridgen and Duffy could usher in an entirely new way of treating both fibromyalgia and chronic fatigue syndrome.

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141 Comments

  • P.H. Coffman

    December 16, 2013 at 10:00 pm - Reply

    This indeed would be good news and a blessing for those of us who suffer with Fibromyalgia!

  • janet scott

    December 16, 2013 at 11:30 pm - Reply

    Could this apply also to recurring viral meningitis (also caused by HSV)? I have this, as well as FM, CFW, IC, IBS, & chronic post-herpetic pain.

    • Cort Johnson

      December 17, 2013 at 1:43 am - Reply

      I don’t know. Does valtrex/celebrex get up into the central nervous system? (I assume it’s in your CNS???) Maybe someone else knows..

      • Marcie Myers

        February 21, 2014 at 3:45 am - Reply

        Cort, I can remember when acyclovir and Valtrex were being used as “vehicles” to move chemotherapy and other meds across the blood/brain barrier intravenously so I assume that the answer is “yes” it does get into your brain and entire CNS. Most interesting Dr. Pridgen’s theory that the chaos created by the HSV1 virus is thought to cause TOO MUCH release of serotonin, norephinephrine, glutamate, Substance P., dopamine, etc. until the nervous system becomes overly-sensitive. We would all agree, I’d think, that our CNS is too sensitive to stressors in that the simplest thing gone awry can create a “crash”. I am WAY looking forward to the first week in March when the results to this Phase II study are given and trust you stand ready to avail us of the findings.

        • the shambler

          March 13, 2014 at 2:25 am - Reply

          The enigmatic Skip Pridgen has no published research record (outside surgery) nor is this trial yet registered. I’d be calling the bluff EXCEPT that I agree with the theory, and my figures for efficacy of these two meds individually are damn good. Hence the combo will be a winner, but now I gotta know – how do you get $3.3m for an idea out of leftfield?

          • Cort Johnson

            March 13, 2014 at 5:30 pm -

            I think he did his homework and had some really strong data :) . The formulation in the actual study is unclear, though. I believe it was still an antiviral and a COX-II inhibitor but I don’t know which ones.

            We should know within a month.

    • Marcie Myers

      January 1, 2014 at 3:35 am - Reply

      I’d like to make everyone aware of a website: The HHV6 Foundation. I was shocked at how many diseases and disorders (including encephalitis which is similar to viral meningitis. Curious if your diagnosis has been confirmed by lumbar puncture and what type of virus? ) have been found to be positively caused by the virus HHV6. POSSIBLY causes CFS, FM, MS, and other autoimmune disorders. Kristin Loomis the Director of HHV6 Foundation is extremely helpful. Have your MD order BOTH types of HHV6 testing: the “regular” kind and your blood will be sent to the Mayo Clinic for testing and insurance billed AND the possibly inherited type which goes to Washington State U.and the $800 cost is covered by a Foundation grant I believe. Just make sure that the lab that draws your blood makes all the correct hook-ups so that your sample arrives via courier within 24 hours to each location. Luck to us all. marcie myers

      • Cort Johnson

        January 1, 2014 at 6:28 pm - Reply

        Agreed on the HHV-6 Foundation. We have a interview with Kristin Loomis coming up this week :)

  • shelly

    December 17, 2013 at 12:22 am - Reply

    This would be great news. I was diagnosed with ulcerative colitis* although it was more of an educated conclusion. I was then sent to a rheumatologist, to deal with muscle and joint pain. He diagnosed me with fibromyalgia

  • Karen

    December 17, 2013 at 12:25 am - Reply

    FANTASTIC NEWS!!!!!! I took Acyclovir 800 mg. four times a day for 6 months under the guidance of Dr. Daniel Dantini in Ormond Beach, Fl. He wrote the book, “The New Fibromyalgia Remedy.” Some of my FM symptoms went away but I am still in pain. He wanted me to take the med longer but I developed an allergy to it. Anyone interested can google Dr. Dantini. He consults with patients out of state, too!!!

    • Cort Johnson

      December 17, 2013 at 1:41 am - Reply

      I know someone helped alot…There’s another doctor in the midwest who treats FM patients in a similar fashion. I don’t know his name, though. Apparently some doctors here and there have stumbled on this therapy.

      • Marilyn

        December 17, 2013 at 4:06 pm - Reply

        Whom in the Midwest treats FM this way………..I’m in Iowa ..no one here is any further educated than they ever were as far as i can tell.

        • Cort Johnson

          December 17, 2013 at 6:36 pm - Reply

          David Johnson is his name – 801-425-2662 and 455-7555. The person who told me about him said she talked to him years ago..He’s in Indiana. He claimed he was getting good success rates with Valtrex and Valcyte.

        • Marcie Myers

          January 1, 2014 at 3:49 am - Reply

          I encourage everyone to find an MD that will allow YOU TO TEACH THEM. email them Health Rising and solveCFS.org. I have luckily found a female Rheumatologist that is trying to learn and help me out. PRINT OUT this type of article or the HHV6 Foundation info and mail it/take it. Many MD’s will agree to certain labwork if you can calmly justify it with a research or information article. For example: why we need to be tested for FREE T3 and T4 INSTEAD OF MERELY OUR TSH LEVELS because we have HPA axis dysfunction and our thyroid does not receive the correct message on how much thyroid hormone to release. And since our Central Nervous System tends to stay in the overdrive of the Sympathetic Nervous System is how we can actually reach adrenal (cortisol) burnout or insufficiency. Our adrenals have stayed in “fight or flight” mode until they just give out. The “bicycle VO2 test” is somewhat the gold standard to demonstrate that something is terribly wrong with us metabolically in that we go into non-oxygen aerobic metabolism within moments when it should not happen this way at all. This leads to lactic acid build-up. We are “acidic”. And it goes around in circles in a self-fulfilling prophesy of sorts that is so out of our control as stressors are the often invisible enemy. 2014: A BETTER YEAR FOR EVERYONE!!!! xoxox marcie

          • Cort Johnson

            January 1, 2014 at 6:27 pm -

            Thanks Marcie for all the good ideas :)

            Happy New Year!

    • Elizabeth

      February 22, 2014 at 2:42 am - Reply

      Hi Karen
      Three members of our family have Herpex Simplex, the kind that shows up in mouth ulcers. During an outbreak I experienced 2 years ago, I discovered that Olive Leaf extract stopped the blisters from emerging fully, and worked better than acyclovir. A friend who used to suffer from extremely severe HS blisters has found it to be a miracle cure, for her. The brand we use is sevenpointfive, and I’ve now started getting my son with CFS to use it daily. It seems to be good for viruses in general, herpes in partiicular.

  • Deborah Sweeney

    December 17, 2013 at 12:42 am - Reply

    I have asked my Doctors for years do they believe there is a connection between shingles (herpes zoster) and fibromyalgia. Of course they said no. I strongly believe there IS a connection and I am happy that studies likes this may help us. I am under a real time of stress presently and have a cold sore to show for it! Only those people who suffer with it know that we are NOT lazy and it takes a strong constitution to live most of your life with this condition. I am now 62 and started with symptoms in the early 1970′s … so I know how much we need support … for this is a fight every day, especially because family members refuse to believe it’s real. God bless all my fellow sufferers! You have my respect and prayers …

    • Stephanie Chastain

      December 17, 2013 at 4:35 pm - Reply

      I understand your story completely. I too, as most of us I am quite sure do, am my own Dr. most do not listen to their patients like they should. I can’t imagine living the rest of my life with this disease and all the other diseases it brings with it or vice versus. It is hard to let go of your life and dreams. We are not lazy…your right…we are devastated and in pain.

    • Carol

      December 17, 2013 at 10:02 pm - Reply

      I hear what you say and feel your pain…I too have suffered with this condition way too long…it is very much a struggle to get up everyday and face the world when family members just don’t want to understand…may you and all of us find some kind of relief soon…the above article is very interesting indeed..

    • Adriana

      December 18, 2013 at 8:35 am - Reply

      I’ve never had chicken pox. It’s my understanding that only people who’ve had it can develop shingles.

    • Danita

      February 17, 2014 at 8:24 pm - Reply

      Deborah: I had a terrible case of shingles at age 10 (I’m 54 now). The pain waa so bad I couldn’t sleep for 2 weeks. I never felt ‘well’ after that. no energy, etc.. I have FM, Celiac disease, seizure disorder, etc.. I take pain medication and muscle relaxers, but I want my life back! I hope you are having a good day.

    • Albert

      February 17, 2014 at 10:45 pm - Reply

      The training of the majority of conventional doctors comes from books that never covered more in-depth studies about these Herpesviruses. Naturally, these doctors are more inclined to believe these “scientific” sources instead of the average person. Overall, it’s straight arrogance on the part of these doctors. Moreover, it’s commonly known amongst the medical community that unless you are a Virology practitioner, the involvement of doctors with virology is like a Liberal Arts students taking those core Calculus classes — they don’t give a shit about it, and just want to pass and focus on their major. Virology is given the same dismissal. The difference between a non-virology doctor given directions about viruses vs. a Graphic Designer given directions about calculus is that the doctor will essentially bullshit us about their advice on what these viruses can do. It’s in their nature, given the medical system. No Graphic Designer is going to proclaim how triple-integrals and slopes work in the Calculus world!

      I’m sorry, but aside from the pioneers of auto-immune and neuro-immune diseases (Montoya, Klimas, Kolgenik, Peterson, etc.), practically any other doctor won’t even know and understand the fundamentals of latent-infecting viruses, and their implications.

    • K. Brown

      February 22, 2014 at 8:03 pm - Reply

      Hi Deborah,
      I used to get cold sores once or twice a year and finally used gentian violet on it. It is an immediate pain stopper and after 2-3 applications it was gone in a day or two. I routinely did that whenever I’d get one and I have not had one in many many years now. Other people I’ve told that used it found it also the most helpful treatment they’d ever used. I also put it on my son’s canker sores and it worked just as miraculously for those. You have to be extremely careful not to get it on clothes or floors or cabinet tops as it will leave a near permanent stain. I find it easiest to use a q tip. It’s a deep purple and looks awful but the pain outdid my vanity.

  • Kristina

    December 17, 2013 at 12:49 am - Reply

    Cort – Do you think that trying Celebrex alone would be helpful for ME/CFS? I’m tempted to ask my doctor for it, I know my inflammation rate is high. I have often wondered why anti-inflammatories haven’t been more widely used/prescribed for ME/CFS.

    • Cort Johnson

      December 17, 2013 at 1:40 am - Reply

      I don’t know alot about Celebrex but the woman I described used it to treat her daughter diagnosed with HHV-6 so its possible that it might..

      • Chris

        December 17, 2013 at 2:51 pm - Reply

        I did use Celebrex for a while and it did help my FM – not so much the pain but the fatigue was reduced. If the side effect profile was a little different I would still take it (but thats just me – dont let that sway you).

        • Cort Johnson

          December 17, 2013 at 4:29 pm - Reply

          Interesting that it helped your fatigue :) . I believe alot of people are looking for better anti-inflammatories; hopefully some with a better side effect profile will emerge. I don’t remember how long Pridgen has the people on the trial on valtrex and celebrex; I believe its a couple of months. He clearly believes that the effect lasts…

          • Chris

            December 17, 2013 at 5:18 pm -

            I didn’t realize that the treatment was transient…I assumed it was long term/permanent. Short term use of celebrex is far less concerning.

            I wonder what the results would look like if Ketotifen (or some other mast cell stabalizer) was stacked on top of the Valtrex/Celebrex combo. There is a relationship between viral infections and mast cells, though I only have a rudimentary understanding. Ketotifen has been a miracle for me.

        • Stephanie Chastain

          December 17, 2013 at 4:42 pm - Reply

          Chris I agree with you. The side effects of Celebrex were to much for me. I wasn’t on it long enough to know if it helped because I just couldn’t take the side effects . It might help others because our molecular make up is all different but for me itjust sits in my medicine cabinet. I worry, as with most good things, will the side effects out way the benefits here. Sometimes we do find things that help to some degree but we have to exchange that positive for new negatives. If that is the case are we really discovering anything new and helpful? I will try Anything of course.

    • Lytha

      December 17, 2013 at 9:57 am - Reply

      I don’t think Celebrex alone would have much affect on ME/CFS or Fibro. I have been it multiple times and it offers no relief.

      • Cort Johnson

        December 17, 2013 at 4:32 pm - Reply

        Thanks for sharing your experience.

        • Cort Johnson

          December 17, 2013 at 6:43 pm - Reply

          If this is a protocol that works for you. I imagine you would need the other treatment to really knock it down. Pridgen apparently went through a lot of trial and error to come up with this combination.

  • Cee

    December 17, 2013 at 2:43 am - Reply

    I felt the best when I was on Bextra. I found it too late and they took it off the market too soon IMHO. I wonder if Mobic will work too. I am currently taking that for knee and hip issues. I am going to my IDisease Dr. tomorrow. I plan on going from famvir to valtrex. Hopefully she will address the celebrex issue too.
    If anyone here can answer the MOBIC question, I appreciate it. WHAT A TIMELY email. Cort, U R the best EVA!

    • Cort Johnson

      December 17, 2013 at 4:37 pm - Reply

      Thanks Dee :)

    • K. Brown

      February 22, 2014 at 8:08 pm - Reply

      My doctor prescribed Celebrex for a painful shoulder he called brachial tendonitis and I asked him to permit the generic version of it and that turned out to be Mobic. I’ve been taking it for over 3 yrs now as each time I try to quit the shoulder pain returns.

  • Bl Br

    December 17, 2013 at 2:49 am - Reply

    I have read several books with very similar theories and encouraging results. HSV in many forms does appear to be the cuplret. Some studies show amazing results with even stronger anti virals. I am with Kaiser and cant find a doctor in so. California who will let me try this protocol. I have been fighting symptoms for years and have been getting worse each year. Anyone know about the Guaifenesin protocol?

    • Cort Johnson

      December 17, 2013 at 4:39 pm - Reply

      It’s amazing what I’ve missed. I had no idea about HSV before this clinical trial. Health Rising is working on physician review program that will hopefully pop up some good options for you. (If you want to contribute to this program go to cortjohnson.org and use the donate button :) )

  • Nat V

    December 17, 2013 at 3:19 am - Reply

    I’m a 22 year old female from Australia with frequent cold sores,positive tests to shingles, fibromyalgia, chronic fatigue, irritable bowel syndrome, chronic pain, headache/migraine, neck pain, back pain, depression, anxiety disorder, brain fog, cognitive dysfunction and irritable bladder…….
    I hope that this trial is successful, I really do!

    • Cort Johnson

      December 17, 2013 at 4:37 pm - Reply

      I imagine you do Nat V – since with the shingles, IBS and irritable bladder it might fit you to a T :)

  • Noreen

    December 17, 2013 at 4:33 am - Reply

    In January 2012 a physician I needed to see for an unrelated matter prescribed to me Celebrex when hearing of my battle/diagnosis and dissbility due to Fibromyalgia. I was to tske 200 mg twice a day. I thought iit would take seversl weeks to be effective, if at all..No. it was immediate. A wonder drug!! Miracle.. nothing had ever worked and side effects were worse. I eas actually able to return to active employment. Now however, just recently, it doesnt seem to be working. Could be weather, age, many things. Or a resistance to it now, after two years.

    When I think back to the beginning of my healths decline, I wad originally diagnosed with CFS aftet a “something” eruptrd on my upper lip. A dr saI’d it was a complex herpes eruption that we think we traced to unclean barware ftom a nigh ty out the evening before. Since that time I have been diagnosed with I.B.S, T.S.D., Chronic Sinusitis, Chronic Depression. REYNAUD’S

    • Cort Johnson

      December 17, 2013 at 4:36 pm - Reply

      Very interesting Noreen, I wonder if the viruses found a way to get around celebrex (if it was indeed knocking them down). Maybe this two-shot approach is what you need.

      Look at all those diagnoses…could many of them be due to a spreading herpesvirus infection?

      • Noreen

        December 17, 2013 at 5:31 pm - Reply

        I don’t know Cort. I can’t say that I have ever been tested for any viral infections, especially herpes. I only ever had one physicsl outbreak in my life (I am 56) and thst particular incident was when I was 25. At that time I was also suffering from a dibilitating cervicsl injury and develooed a severe allergy to mold. Within that year I was disgnosed with cfs & tmj..Drs put me on muscle relaxers & opiates. After a yr & s half of no relief and not functioning I went to a chiropractor who had me off all neds in 4 visits. I maintained with them for another twelve yrs until surgery was perfected. Prior to the surgery I developed Primary Reynauds. I imagine virsl tests were done to determine primary but don’t remember results. Slso was duagnosed with a.d.d which I think wss a misdiagnosis. Later tested for narcolepdsy snd insomnia which I believe to be corrct. Tske Dexedrine for that. After my cervical surgery in 2000, I felt great for about 6-8 months and then the fatigue, pain and fibro fog appeared. Have been deveststed by that ever since although relocating has helped a great deal. No neds evet worked and sll had horrible side effects. . Celebrex is all that has worked and no side effects with me. I do recall back in 2000 reading of a dr that was convinced that the patients he treated all had 8-10 active viruses and obviously saw a pattern between that and Fibro.. I could not find a rheumy who believed in this possibility nor would test me. Unfortunately I fo not remember his name or location.. (this was found online).

  • equestrian111

    December 17, 2013 at 5:07 am - Reply

    I was treated by dr dantini about 12 yrs ago for FM with valtrax and symptoms went away completely. 2yrs ago developed CFS and went back on valtrax. Whenever I go off the valtrax the symptoms come back. Also added LDN..had infected dental Implants removed. Feel like I am coming back to life. Dr dantini was never given enough credit for FM. I have given his number to many FM stuffers over the years.

    • Cort Johnson

      December 17, 2013 at 4:34 pm - Reply

      Great to hear, Equestrian…that bodes well for the results of this study and a new and better treatment option for FM (and hopefully ME/CFS). I imagine there are people with ME/CFS who have not tested positive to viruses because they’re buried so deeply who might benefit..

  • Ellen Kimbrell

    December 17, 2013 at 5:07 am - Reply

    I had cold sores and shingles quite often and the pain was terrible…somehow i heard about lysine…I started taking it about a year ago…it helps…I don’t have them near as often and the pain and length of time they last is better…I am anxious to see how your study goes with the virus study

  • Gill Kime

    December 17, 2013 at 10:12 am - Reply

    It would be great however 143 patients makes this a very small study!

    • Cort Johnson

      December 17, 2013 at 4:31 pm - Reply

      :) (It’s pretty big comnpared to the chronic fatigue syndrome studies we’ve been seeing.)If it works out hopefully it will inspire bigger studies.

    • Carol

      December 17, 2013 at 10:09 pm - Reply

      It may be a small study but if all the participants have Fibro/CFS than it will be enough to get results..

  • Denise

    December 17, 2013 at 2:27 pm - Reply

    I would be willing to deal with my allergy to sulfanomides if this actually works! I’m tired of taking opiates for my pain but I just don’t have any choice!

    • Stephanie Chastain

      December 17, 2013 at 4:53 pm - Reply

      Agreed!!! I can’t stand the dependence on opioids or the anxiety of not getting a refill on time and having to go through withdrawls nor do I enjoy the stigma of being on pain medication. A study is a great sign ….a prescription for the results would be better. We keep getting teased with studies and new information. I am ready for someone to out something on the table for us to actually take.

      • Danita

        February 17, 2014 at 8:29 pm - Reply

        I agree, Stephanie, I am soooo tired of my day consisting of worrying if it’s too early to take my next pain pill and counting to make sure I’m spreading them out so I don’t run out. I depise the side effects, but I despise the pain more.

  • Lesley

    December 17, 2013 at 2:42 pm - Reply

    Has anyone tried systemic enzymes? I’ve just started taking them and they are supposed to help with inflammation. They even have a therapeutic dose for chronic fatigue/fibro. I’ve only been on them for 2 weeks, so I don’t have much to report yet…They say you need to start slowly on them.

    • Cort Johnson

      December 17, 2013 at 4:30 pm - Reply

      Good luck with Lesley. Please report back and let us know how it went.

    • sue

      January 3, 2014 at 5:24 am - Reply

      I too have osteoarthritis and FM, I could bearly walk in the morning, then I tried Serra Peptase an emzyme from silk worm. 9 tablets a day for a week along with 6 tablets of probiotics in the evening, now I’m down to one of two a day, but always on an empty stomach and wow I can walk properly again. I also take lots of turmeric and have cut out wheat and milk which are major contributors to inflammation and 3 tablets of Magnesium Malate. I feel like I’m getting my life back. No side effects. Try it.

      • Cort Johnson

        January 3, 2014 at 4:26 pm - Reply

        Congratulations, Sue. Thanks for passing that on. :)

  • Marilyn

    December 17, 2013 at 4:09 pm - Reply

    Dr.s are really hesitant to use Celebrex because of the black-box labeling with Cox-2′s. It is usually given only to the severest of Arthritic patients..as a last ditch effort only, unless the patient is wiling to for-go any issues surrounding Cox2′s cardiovascular side effects that can include death!

  • Chanda

    December 17, 2013 at 6:39 pm - Reply

    I’m going to make a doctor appointment and have my doctor prescribe these two meds to me. My doctor will try anything for me. I’m going to print out this article and bring it with me. This doesn’t sound to risky to try for a couple of months.

    Do you think these were the two medications Biovista came up with to also do a study on?

    Thank you so much Cort!!! This is like a early Christmas present.

    Readyforlife

    • Cort Johnson

      December 17, 2013 at 6:46 pm - Reply

      The CAA came up with something entirely different; altho no one outside of them seems to know what they were – but they weren’t antivirals…

      I don’t know if the doses are mentioned in the patent application or not. That would be important to know. I think the trial finishes up in January..

    • Cort Johnson

      December 17, 2013 at 11:37 pm - Reply

      Dr. Pridgen sent an email to me today stating that they are still trying to determine the optimum dose and cautioned everyone to wait until the results of the phase three trial are done before starting this treatment. He also stated he feels they are ‘very close’ to helping many people with this condition.”

  • Chanda

    December 17, 2013 at 7:09 pm - Reply

    I emailed the CAA and asked them if they had any updates and below is the email they sent me. Doesn’t sound promising that’s for sure. Another year to just raise funds.

    Our team met with the FDA in September. The FDA provided important information on the clinical trial design. We are currently working on the documentation required to submit this clinical trial to the FDA for approval. We anticipate that it will take at least 1 year to raise the funds needed to conduct this trial. Thank you for your interest and we will keep our community up to date on the latest developments in research and clinical trials.

  • Diana Johnson

    December 17, 2013 at 7:36 pm - Reply

    Have you all seen what the UK is researching? The endocrine system is key in fighting illness, correct? Who has had hinky thyroid test results occasionally? Don’t dismiss these! Check this out! http://www.thyroiduk.org.uk/tuk/related_conditions/Fibromyalgia-medical-mystery-solved.html and good luck leading the blind medical community.

    • Cort Johnson

      December 17, 2013 at 7:50 pm - Reply

      I imagine it will all go together in the end. Yes, don’t forget the thyroid….I think Dr. Peterson sees autoimmune thyroiditis in some of his patients.

      • Noreen

        December 17, 2013 at 11:38 pm - Reply

        Regarding info posted by Diana Johnson.This makes perfect sense and much is abundently clear. I had always thought yhat my metabolism/thyroid was off, even as a child. Always had weight problems, often very tired and although extremely active I was not a “smalll” female. In jr.high (1960′s) I went on a diet/workout regime that I continued into the year 1998… to keep my weight down I never consumed more than 750 calories a day. To lose weight I would drop that and or increase my exercise. In my 30′s I became a triathlete with various cross training everday.. I felt good, but never as good as I should have due to the pain and lack of movement ftom my cervical injury. I had always asked my drs to check my thyroid and of course was always told it was “IN NORMAL RANGE”. My temperture had always been no higher than 97 .1 so if I read the norm of 98.6 I am sick with a low grade fever/temp. My resting heart rate was 28-32.. Hospitsls were amazed I was alive.. I felt fine. My blood pressure is very low. Never over 112/62 and have seen it much lower than that but drs never seemed alarmed. Recently my 33 yr old daughter was diagnosed with Hashimoto’s Thyroid Condition. Only now are my drs willing to test my thyroid numbers seriously.. I haven’t had the tests yet. Hope to very soon.

        • Lisa

          February 28, 2014 at 1:49 am - Reply

          Hi Noreen,
          I have the same cruddy low body temp. I did some research, and physically tried this myself and can confirmed it helped immensely- as long as I remained on the supplement which I did for over a year. I got lazy and quit taking it for about six months, and recently restarted it with the same beneficial effect which was an increase in body temp from 97.4 to 98.6. 98.6 is way hotter then you think!
          Use only methyl B12….not worthless cyanocobalamin. I take 15,000 micrograms (yes that is 15 milligrams – not an error!) daily. at one point I was using up to 40,000 micrograms daily to relieve my neuropathy from chemotherapy from 15 years ago…..and it did work beautifully (protocol for nerve repair also includes benfotiamine 150-300mg daily and methylcobalamine 5micrograms to 60 micrograms daily in increasing dosage until no more apparent improvement is seen.Then hold that dose as long as you chose- I peaked briefly at 40,000micrograms but notice no additional improvement over 20,000 micrograms so I stayed at the lower dose for a year) The increase in temperature was an accidental and much appreciated side effect which I ended up doing research on and found info that b12 as methylcobalamin does actually raise body temp (which I happened to read is also necessary for those who can not conceive!) My nerve damage did not return even when I quit supplementing. Per U of M, muscle and nerve testing, they felt my damage was mild, but it did not feel mild to me having constantly numb feet for 15 plus years.
          I really hope this helps someone-
          a) feel warmer (I became extremely warm as my body no longer understood what 98.6 felt like).

          b)relieve neuropathy from any cause but especially diabetic or chemotherapy induced nerve damage….ps…it hurts more initially and this is a very good sign to keep at it!! you will know within a month- I knew within a week as my feet started to scream /burn when they were just plain numb before the protocol then immediately began to improve.

          c) make babies- I love babies! just wish they weren’t such germy vectors to someone with poor immune function.

          • Cort Johnson

            March 9, 2014 at 6:00 pm -

            Thanks Lisa, how did you decide to take such large amounts?

  • Cort Johnson

    December 17, 2013 at 9:17 pm - Reply

    That is so interesting rrrr. Dr. Lerner says the same thing about his antiviral protocol – do not over exercise and watch the stress. I think Chia says the same thing; the protocol works best when you’re not under stress.

    Stress is definitely hard to get away from; I think it’s embodied in my ME/CFS – part and parcel of the disorder.

    • Cort Johnson

      December 17, 2013 at 11:38 pm - Reply

      Dr. Pridgen sent an email to me today stating that they are still trying to determine the optimum dose and cautioned everyone to wait until the results of the phase three trial are done before starting this treatment. He also stated he feels they are ‘very close’ to helping many people with this condition.”

    • Darlene

      December 19, 2013 at 8:07 pm - Reply

      Yes, the stress is part and parcel for me I’m sure. But the herpes simplex viruses have been stalking and pouncing on me for years. I’ll be very excited to see the results. Hurry up March!

  • John

    December 17, 2013 at 10:42 pm - Reply

    I started very gradually and progressively getting sicker starting around 1996. In Fall 2003 I’m pretty sure I contracted herpes simplex although I didn’t have an outbreak until Spring 2004. Within a month or two of the outbreak my functioning plummeted from about 40-50% to 10-15%, where it’s progressively gotten worse since then, so herpes simplex could be a culprit for me too.

  • karen copus

    December 17, 2013 at 11:04 pm - Reply

    That will be wonderful for a lot of people. What bothers me is the fact that there will be not a lot of help (meds) for those of us that are allergic to those particular drugs.

  • rrrr

    December 18, 2013 at 2:42 am - Reply

    I just heard that Dr. Pridgen is asking people to wait until the end of phase 3 of the trial (maybe mid- 2014?) to inquire further about this protocol. He is too involved in the trial to field a lot of inquiries at the moment.

  • Judy

    December 18, 2013 at 5:36 am - Reply

    I was diagnosed in 2007. I was put on Lyrica & Cymbalta. One of the results are I am now on dialysis & waiting for a kidney transplant. Plus I was sent by my GI Dr for a pancreas transplant. My pancreas is shriveled up & is no longer working properly. They won’t give me a transplant because I’m not type 1 diabetic. But I am fairly young & living life is really a struggle. But all the things described in the dr findings is me up & down.

  • Mich

    December 18, 2013 at 11:28 am - Reply

    I suffer from Fibro and most of the others but also Serotonin Syndrome which makes it quite scary to take any medication. Would the combination of drugs in this trial be life threatening to me?

  • Nina

    December 18, 2013 at 12:27 pm - Reply

    As a small child I was ill. For five years our family doctor treated me with monthly injections of penicillin… ostensibly for Rheumatic Fever (I had elevated sed rates). This was in the early 1950′s, And because I had constant low grade fevers and ‘fever blisters’ on my lips and down my chin non-stop for 5 years, my doctor administered five smallpox vaccines. He did not see improvement of my symptoms. Years later I began to faint without prodrome.. in high school, Having no idea why this was happening, I wanted any help I could find and so contacted my retired doctor to inquire about the antibiotics and vaccinations, It was not until I was 42 , Feb. of 1993, that I was stricken by CFIDS …as if it were a thunderbolt. I said, ” I have to sit down”, I never got back up. The era of CFIDS/ME/FM had begun. I now take Celebrex. I need it. I like it. It is far from a cure for me, perhaps an ameliorator…I cannot get any doctor to prescribe large IV doses of Valgancyclovir. I do however notice slightly positive effects from a Valtrex ointment…prescribed for fever blisters. of which I have none at all anymore..until oddly enough…today. . I have long though that my original propensity to ‘something viral’ , something inflammatory…non-responsive to years of penicillin, or smallpox vaccine experiments ..should, uh, lol, be taken into consideration. Physicians have one person they always look out for, give first consideration..and that is themselves. Cannot blame them. But I need access to some Valgancyclovir,. Got Celebrex. Have had thyroidectomy , have taken Armour , since the gland ballooned to enormous the day I was stricken so ill that I have been mostly supine every single day for the last 20 years. Hope is good. This all sounds promising.

  • Elsie Owings

    December 18, 2013 at 3:05 pm - Reply

    Sounds logical to me. I’m a CFS patient, not an FM patient, but the best luck I’ve had so far is with Famvir, another antiviral medication. It doesn’t help everybody, but it helps me. As long as I’m on the Famvir, I don’t get the awful post-exertional relapses that I used to get. There is no doubt in my mind that viruses, in some form or another, are part of the problem.
    I also take CoQ10, acetyl L-carnitene, and fish or flax oil with my Famvir. Had no idea that the fish or flax oil could have anti-inflammatory properties, but it’s helpful to know that.
    With that said, though, I am a bit reluctant to endorse Celebrex because I took Vioxx back when it was on the market, and although I loved it, it nearly killed me. I don’t know the differences/similarities between Celebrex and Vioxx.

    • K. Brown

      February 22, 2014 at 8:25 pm - Reply

      I read once that more Americans died of Vioxx than died in the Vietnam war. Celebrex couldn’t be as bad since it is still on the market, but according to Wikipedia:

      Side effects include a 37% increase in incidence of major vascular events, which include non-fatal myocardial infarction, non fatal stroke or death from a vascular cause.[1] Additionally there is an 81% increase in incidence of upper gastrointestinal complications which include perforations, obstructions or bleeds.[1]

  • Cort Johnson

    December 18, 2013 at 5:24 pm - Reply

    Dr. Pridgen reported that The results of trial will be released in a press release in the first week of March 2014. That’s just 3 months away :) A publication and Phase 3 trial will follow. He believes the optimum dose will be found during the Phase three trial

  • david

    December 19, 2013 at 2:48 pm - Reply

    Cort a questions.
    So Dr. Pridgen claims complete elimination of some form of hv’s, (if not all CFS associated viruses). Does this translate into complete restoration of health and the complete elimination of symptoms including PEM?
    a heartfelt thanks Cort.

    david

    • Cort Johnson

      December 19, 2013 at 5:59 pm - Reply

      I would be careful about ‘elimination’; my guess is that he would say he’s able to bring them under control. He very much believes that herpes simplex viruses are the key; some of the other herpes viruses are found in ME/CFS/FM, but he feels the vast majority of the damage is caused by herpes simplex.

      I don’t know about complete restoration of health, either; all I say is that he’s sounds very confident! Let’s at least say very significant improvements in health…We’ll see how it goes. :)

      • Albert

        December 22, 2013 at 6:37 am - Reply

        I think Dr. Pridgen can greatly benefit from more and more FM, CFS/ME sufferers each confirming Herpes infection AND all people who know that they have HSV-1 & 2 to become aware of the overlap between Herpes & CFS/ME and FM. I have already created some posts in the Herpes Coldsore forum speaking to this connection, referencing Simmaron, and referencing other sources, e.g. Dr. Jose Montoya’s presentations

  • tomturbo

    December 20, 2013 at 3:26 pm - Reply

    Very exciting treatment! My wife was just pretty much diagnosed with CFS/ME and it sounds like this treatment is very promising!

  • stephanie

    December 20, 2013 at 4:53 pm - Reply

    Hi, I am from the UK and the drug names are meaningless to me but this article and research has given me so much hope. I have fm/cfs and many co morbid conditions plus an under active thyroid. I have had cold sores too, always when my body became under too much stress. I also was treated for the helocabator pluri virus. Probably spelt that wrong. It’s an acid resistant virus which lives in the stomach and was treated with strong antibiotics and anti inflammatory pills if I remember correctly after which I had nearly 3 years good health but stress levels increased and in 2008 after an attack on person I had a nervous breakdown and subsequent diagnosis of fm and cfs. My flares of those conditions have increasingly got worse and now I hardly get any period of good health to speak of. I am very hopeful of this research and will pass it on to my doctor……for him to ignore as he does me.

    • Cort Johnson

      December 20, 2013 at 4:56 pm - Reply

      Good luck, Stephanie

    • K. Brown

      February 22, 2014 at 8:30 pm - Reply

      I was treated for H. Pylori many years ago and felt better for a couple years, but I believe I have it again since all the symptoms are back. Testing for it a second time is more difficult and must be done in some other way than a blood test. I just began taking monolaurin which I ordered from Amazon after reading it was very effective against H. Pylori and a number of other viruses. Only on it for 2nd day so I’m keeping my fingers crossed I’ll get good results.

  • Albert

    December 21, 2013 at 3:38 am - Reply

    From what i’ve gathered, I see Fibromayalgia as a “subset” of the entire disease spectrum that Herpes (HSV 1, 2, etc.) can cause. It’s almost limitless. As mentioned in some of these posts, doctor’s are back in the stone age when it comes to their knowledge of HSV. They don’t even understand the fundamentals of it. In short, HSV can either be devastating or innocent — it all depends on different circumstances and factors. Just when you think you were safe with these “cold sores”, think again! Doctors and “Specialists” don’t tell you about “autoinnoculation” — that you can infect other parts of your body (usually between mouth and anus) when the opportune time comes up. It’s not so simple to think that just because you have antibodies that you are safe. In fact, people are most vulnerable within the first 1 to 3 months after being infected. Moreover, once the virus infects something (stomach, esophagus, intestine, airway, lung, throat, etc.), the virus will always “remember” that location. So, when it comes out of hiding, it can re-infect the originally-infected area in various ways. This brings me to the other point.

    The virus can present itself either as sores or invisibly. So you may not even know if your stomach has the infection, even if you make it all the way to having your GI doctor perform an endoscopy. There are several articles and case studies from years ago that discussed patients who had various neurologic problems following HSV infection in the mouth.

    I AM a Herpes sufferer — the worst of its kind. Shortly after contracting the virus back in May ’13, I have endured roughly 30 symptoms and about 5 different, chronic complications since then. i’m 35 and have had a clean bill of health all my life! Never had antibiotics, was a x-training athlete (cross-fit, P90x, martial arts, football, basketball), bowel movement 2x daily, ate very healthy, able to have alcoholic drinks with no problems, never any pains other than muscle soreness from workouts, only got colds once every 1.5 years, and had a very sharp and quick cognition.

    • Cort Johnson

      December 21, 2013 at 7:24 pm - Reply

      My gosh, Albert what a change! I wish you the best man!

      Thanks for all the information…I think you’re going to like the next blog coming out on Simmaron…

  • Albert

    December 21, 2013 at 9:43 pm - Reply

    I’ve been making this connection between Herpes Simplex and all of these morbid symptoms and complications since I realized that Valtrex was working (anti-viral). Aside from the numerous, Neurological-suffering Herpes people, it’s is extremely refreshing that there is someone in the medical and research field that recognizes this common sense (practical sense) connection with HSV 1 & 2. It’s been damn frustrating on my part to continually have heads shaking from the clinicians when I tell them that Valtrex is the only thing that brings significant comfort and therapy.

    I feel like all these “doctors” and clinicians are simply widgets that are pumped out of a factory. As soon as they hit the market — so-to-speak — they’re immediately depricated. That is, they don’t learn anything beyond their previous studies. So if a sure for cancer comes up and is available for 5 years, 1/2 of the clinicians wouldn’t have realized this. (Okay, cancer wouldn’t be a good example because it’s on EVERYONE’s radar, but i’m sure many of you get my point).

  • Albert

    December 21, 2013 at 9:50 pm - Reply

    Checkout these 2 articles about Herpes Simplex being the cause of Neurological problems:

    1) Gut Dysmotility (dysfunction of the involuntary muscle) in Rat Models: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0072648

    2) Autonomic Neuropathy in several patients following HSV infection: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1027866/?page=2

    There are other case studies that speak to Herpes Simplex causing all these morbid problems, but you never hear about them in the clinical setting (e.g. when you go to see the doctor). Unfortunately, as someone mentioned in one of these posts, we have to be our own doctor!!! And when it comes to Fibromyalgia, or Multiple Sclerosis, or any other “Autoimmune Disease”, WE become the real doctors, NOT the doctors!

    • Cort Johnson

      December 22, 2013 at 4:39 pm - Reply

      Thanks Albert for the info! :)

    • K. Brown

      February 22, 2014 at 8:37 pm - Reply

      Hi Albert,
      You might be a good candidate to try the monolaurin since it’s supposed to work so well for HSV1 (among others). I’m on my second day and hoping it will offer significant relief. I’m on Valtrex and find that when I am not on it the worst of my symptoms come raging back. I think it might turn out like in HIV that some people just will need to stay on antivirals since they can be impossible to eradicate.

  • Albert

    December 22, 2013 at 12:16 am - Reply

    When it comes to identifying the root-cause of these really weird diseases (FM, MS, CFS, etc.), the process of doing so has to practically be an art-form. I truly believe that there are 3 fundamental causes of all chronic diseases: 1) genetics, 2) environmental, or 3) pathogen (most likely a virus that stays around for life, e.g. Herpes Simplex, CMV, EBV, etc.).

    Therefore, it’s almost as if the thinking in the research and medical field should be “flipped”. Look at either of these 3 areas and determine WHAT can problems can be possible. An example, “Gut Dysmotility” was proved to be caused by a Herpes Simplex infection in rats. In other words, the innate functionality of the intestines has been impaired. One of the mainstream diseases today is “Irritable Bowel Syndrome”, where the bowels are not FUNCTIONING properly, and the patient has so many ailments such as over-abundant gas, stomach pains, diarreah, cramps, etc.

  • Just Me

    December 22, 2013 at 12:31 am - Reply

    I have had confirmed HSV for many years. I am 50, guessing I was diagnosed 8-10 years ago. I have been on valacyclovir 1g per day ever since. When I am not on it, I get rash breakouts. I was diagnosed with FM this year. I have suspected that the HSV was at least partially to blame. If not for the FM, then at least for my peripheral neuropathy. Very interested to see what they find in this trial.

  • Albert

    December 22, 2013 at 1:32 am - Reply

    I wonder if the thought of developing a test to check any and all ganglion nerve clusters for the existence of Herpes Simplex viruses besides the common tests: PCR blood test or CSF, or any of the existing blood tests (IGM or IGGs).

  • david

    December 22, 2013 at 2:30 pm - Reply

    Cort considering the short duration of the trials, and treatment, how long before a recognizable symptom improvement for those who respond? I ask this because of the significant length of time most require for antiviral treatment symptom relief.
    I’m very tired of riding the wave of the latest “cure”, lately rituximab, and then vistide, both of which I have no chance of receiving. This at least seems more available.

  • Celeste Cooper

    December 22, 2013 at 6:09 pm - Reply

    Brilliant reporting Cort. I have copied for my doctors and am spreading the news.

  • Raoul

    December 25, 2013 at 5:39 am - Reply

    I have low to moderate high EBV titer CFS which I believe is a latent b cell infection because when I tried high dose Famvir and Valtrex for a couple of months (Famvir was much more tolerable) I just found my symptoms worse and it was as if my system was reving high and running up against a wall. In the end there was no reduction in my symptoms and I just resorted back to my original condition.. I still have some of these meds left and may try to augment them with Celebrex and see if I can somehow break through. If it works this seems like a much better solution than Rituximab.

  • Maureen

    December 25, 2013 at 11:17 pm - Reply

    I’m leery that this is just another study paid for by big pharma to show results they want in order to push their drugs. After nearly being killed by two of the leading FM medications, I finally found a doctor who advised me to go on a vegan/alkaline diet and treat my pain and fibromyalgia with diet, supplements and other natural measures. When I cut out all refined foods, especially sugar and gluten, and night shades, things slowly started to turn around. The longer I continue with the healthier lifestyle, the better I feel. I still have FM, but we are also still dealing with other problems like mercury overload and tick infections. I had numerous imbalances, deficiencies, system overloads, sensitivities and infections to address, but giving the body optimal conditions through diet and supplements to heal itself has really made a huge difference. I use all natural measures to fight pain and symptoms…and I’m doing as well, if not better, than when i was on medications.

    • Cort Johnson

      December 26, 2013 at 4:50 pm - Reply

      Congratulations Maureen and thanks for spreading the news. Big pharma is not involved in this study so far as I know (it was produced by a startup), but if you can get it done naturally – so much the better. I do better without gluten and nightshades as well. Here’s to your continued improvement :)

  • Raoul

    December 26, 2013 at 4:35 am - Reply

    Herpes Simplex viruses make sense. Renowned author and research psychiatrist E. Fuller Torrey, M.D., specializes in schizophrenia and bipolar disorder and was able to determine that the brains of persons with depressive conditions all had Herpes Simplex compared to normal brains. For a long time now I was trying to make some sort of connection and this feature does it.. Dr. Lerner states that many people with CFS are misdiagnosed as having some form of mental illness. I loath even mentioning the term mental illness here because I believed it should be removed from the medical vocabulary. It is so derogatory and discriminatory and has such a negative connotation toward illnesses that are most often biological rooted and cause a broad spectrum and varying degrees of symptoms of which depression happens to be one of them.

  • Raoul

    December 26, 2013 at 9:46 pm - Reply

    I have noticed that since I went off antidepressants almost 3 years ago I have had to deal with increased inflammation especially during the early morning between 1 am and 5 am. This inflammation consists of stiff and sore fingers upon waking, congested nasal passages increased depression and anxiety. When I take antivirals either prescription or natural regardless of high or low levels of physical or emotional stress these inflammatory symptoms seem to worsen. I’m wondering, are the viruses fighting back by using an inflammation defense mechanism which prevents them from being attacked or killed and unless their defense mechanism is neutralized they cannot be attacked. I’m hoping this theory may have some merit versus the viruses being antiviral resistant and contained in the b cell dna protein theory. I hope to soon find out.

  • Lifefromabed

    December 28, 2013 at 5:22 pm - Reply

    I can only hope this could work for dysautonomia as that has very similar symptoms to me/cfs

  • Albert

    December 29, 2013 at 5:33 am - Reply

    I wonder if the various CFS/ME, Fibro, MS, Lupus, et. al. scientists believe the same: http://www.prweb.com/releases/2013/10/prweb11182863.htm.

    I know Dr. Chia has already has promising findings of Enterovirus proteins in mucosal tissue…

  • EffiBriest

    December 29, 2013 at 10:10 pm - Reply

    For those interested in nonpharmaceutical remedies, Curcumin (the active ingredient in the spice Turmeric) is a natural COX-2 inhibitor. It is available in capsule form. A good antiviral, lauric acid, is in coconut oil. It does raise cholesterol a little, but it prevents herpes viruses from replicating.

    • Cort Johnson

      December 30, 2013 at 12:58 am - Reply

      Good to know…Thanks :)

  • Mya

    January 3, 2014 at 3:48 am - Reply

    I have a combination of Fibromyalgia and osteoarthritis. I took Valcyclovir and Celebrex together for at least 6 months after a doctor decided to take me off my old arthritis medicine. I was using Diclofenac before that. The Diclofenac worked far better than the Celebrex for both the arthritis and fibromyalgia inflammation. The Celebrex did nothing for the Fibromyalgia pain. I know I am just one person; however, I don’t think the combination of these two medicines are the answer; although, I do strongly believe that herpes viruses combined with bacterial infections have a role in causing Fibromyalgia.

    • Cort Johnson

      January 3, 2014 at 4:00 pm - Reply

      Thanks for passing on your experience, Mya.

  • Bridget Gilbert

    February 19, 2014 at 11:40 pm - Reply

    Hi, Drs reckon I’ve suffered with hypothyroidism, IBS, tonsilitis, clinic depression etc since a child. They though my Fibromyalgia was brought on by trauma. Perhaps when I found out the only reason I was one was to try heal a broken marriage. Who knows…. I too gave suffered with cold sores, mainly on the upper left lip. I also had a virus that made me lose my voice for roughly six months and had to have speech therapy to learn to talk again. I know everyone reacts differently to meds and that there is no cure. I do pray and hope that that this trail is successful in helping to control chronic pain and fatigue. The UK is lagging behind the USA. I do hope that information is being shared. Soft hugggzzzz to all sufferers with a chronic illnesses.

  • Mary

    February 21, 2014 at 8:54 am - Reply

    I think there may be many different reasons why someone has fibro/cfs. Herpes viruses which do run in families may be one.
    The two most prominent researchers in herpes viruses that have made the most strides in finding a cure to herpes viruses are Bryan Cullen, PHD at Duke University and Professor David Bloom at the University of Florida. They lack the funds to do the research at the pace that is needed. I would like to know how one can have a biopsy of the gut or neck (I have one sided chronic neck pain and pulling) and vesitbular problems to determine if one has an active herpes virus. What we need are doctors who are willing to do these biopsies that will tell us whether we have herpes viruses. Until then we can try anti-virals. But I would be putting my $$ into the Cullen-Bloom labs as they have been researching how to cure the viruses for the longest and desperately need funds.

  • K. Brown

    February 22, 2014 at 6:51 pm - Reply

    I am on both Valtrex and Celebrex and have been for 3+ yrs. The symptoms of my CFS, most notably the encephalopathic brain and spine burning pain and the neuropathy in my legs are greatly diminished by the Valtrex and the pain in my shoulder especially is controlled by the Celebrex. It has been no panacea or cure for my CFS and I quit my job and went on disability in Aug. 2011. I can’t say I’m too excited for this study to end up being more than helpful for a handful of symptoms, certainly not likely to be a cure, at least by my own experience. When I finished my first yr of treatment with Valtrex my symptoms returned within 4 months and when I don’t take my Celebrex my pain in the shoulder will return. I do believe it is nerve infection with some virus though. I’ve been nervous about taking the Celebrex (I take 200mg/day) because of it’s history. According to Wikipedia:
    Side effects include a 37% increase in incidence of major vascular events, which include non-fatal myocardial infarction, non fatal stroke or death from a vascular cause.[1] Additionally there is an 81% increase in incidence of upper gastrointestinal complications which include perforations, obstructions or bleeds.[1]

  • Marg

    February 22, 2014 at 9:46 pm - Reply

    One of the first questions Dr. Klimas asked and it was also on her humungous questionnaire was did I get cold sores. I did, starting I think around 30.. Any stress would bring them, even spring sun and winter wind. I have been on Acyclovir now for about 3 years and have not had a cold sore.

    I am feeling quite good but my first and always worst symptom pain in the legs has not budged.

    I live in Alabama and have called about the study a couple times. I hoped to get in the study but by the time I contacted them it was underway.

    I will be going to Florida in May for all my immune testing. There has been improvement every time.. My natural killer cells are now above normal and were only working at 5% with the first testing. .No one else does the immune testing like Dr. Klimas. . I will see what she says about going to B’ham.. I am very anxious to hear the outcome of the study.. I am concerned about Celebrex. I have discovered herbal cox 2 inhibiters. One is Cox 2 Tame and the other Zanaflex or something like that cannot recall. They are both sold by iherb or were

    I will be going to Nova for the first time and on a day that both Klimas and Rey should be there. I will report after I return…

    All these latest reports are exciting to say the least.

  • Sandra Cortez

    February 24, 2014 at 12:09 pm - Reply

    I believe that when I received the flu vaccine I contracted Fibromyalgia. It’s been 14 years living with this disease and the pain gets worse by the cold climate. I hope and pray they find a cure for us living with this chronic disease. Have a Blessed Day! Love & soft Hugs!

  • Carla H.

    March 1, 2014 at 5:26 am - Reply

    Hi!

    It is 12:22 on March 1st. I will be checking daily as to the early findings of this study! I have awful insurance so can have only limited tests. My insurance will only pay up to $500 for the family this year. We are required to pay a remaining outpatient/doctor visit deductible of $2700 per person before they will cover at 80%. God forbid if one of us had to go to the hospital for a few days because then we have to pay out $6000 before they will pay a penny. I’m on disability so neither scenario works. I have a great doc who says she is willing to call these two drugs in for me when the results of the study are out! It’s been a while since I’ve had hope so I’m excited!

    Hoping for us all!!!
    Carla

    Have a great night!

    • Cort Johnson

      March 9, 2014 at 5:59 pm - Reply

      Glad you got a doctor but I wonder if the Affordable Care Act would have something for you? That sounds like horrible insurance.

      Hope says she heard that it will be mid-year. I’m trying to get in touch with him and will let you know if I find out anything.

  • Hope H

    March 9, 2014 at 4:04 am - Reply

    I’m now hearing we won’t hear anything until at least mid year. Originally I read the beginning of March and I have been counting the days. I hope this helps us! It is so hard to be patient when you have been this sick for sooo long! Xoxo

    • Cort Johnson

      March 9, 2014 at 5:57 pm - Reply

      Got it. I just emailed him yesterday. I’m not surprised, though. Remember the XMRV stuff? It ALWAYS seemed to take longer than expected and this is their first go at this – so I would think it would take even longer.

  • Audra

    March 11, 2014 at 5:47 pm - Reply

    I actually participated in this study and am VERY anxious to hear the results!!! I really want to find out if I was on the placebo or not.

    • Cort Johnson

      March 11, 2014 at 8:59 pm - Reply

      Thanks Audra. When did you stop taking whatever you were taking?

      • Marcie Myers

        March 11, 2014 at 9:36 pm - Reply

        The article stated that he would be providing the results the first week in March, I believe. I look forward to the results of this Phase II (?III) study as well as future findings re: if the virus residing at the sensory (NOT motor) roots and it’s subsequent inflammatory process with release of cytokines can cause vertebral degeneration and spinal stenosis as well. This has been an additional problem of mine. Anyone else have a diagnosis of spondylosis, spondolithiasis, ankylosing spondylosis, etc?

      • Audra

        March 14, 2014 at 4:32 pm - Reply

        I stopped the study medication in November 2013, after the study my rhuematolgist tried me on Mobic and Acyclovir since insurance would not likely cover the Famvir and Celebrex since that was the purpose of the study to get it FDA approved for the treatment of Fibro in order for insurance companies to cover the costs. I can honestly say I do not notice very much improvement from them. Hopefully it has to be the magic combo and right dosage of the study meds.

  • Pen Richmond

    March 11, 2014 at 9:30 pm - Reply

    Hi Cort! Will you please send out the results of this wonderful trial for FM/CFS/ME as soon as you can access it ?

    I too have suffered for many years with herpes simplex outbreaks, on occasions so severe to warrant 800mg Zovirax (anti-virals) x 5 per day, instead of the normal 200mg x 5 pd. These work very quickly to reduce the Herpes pain and length of blister eruption. However, I have since then (in my early 20s) been diagnosed with FM/CFS/ME, and have always thought that the herpes virus was to blame. I also have IBS, Renaud’s syndrome, Sjorgren’s syndrome, and arthritis. I used to take Bextra (Cox II Prostaglandin anti-inflammatory) until it was discontinued, but never in combination.

    I would be so pleased if this new trial can reveal a cure or potential reduction in symptoms, which become increasingly difficult to manage on a day by day basis to normal living functions.

  • Cort Johnson

    March 11, 2014 at 9:56 pm - Reply

    Please note that an important section of the blog has been changed to reflect the following information;

    Pridgen’s patent application suggests that his unique insight has been to combine valacyclovir (valtrex) with an anti-inflammatory, Celecoxib (Celebrex) that has antiviral properties. Pridgen stated, though, that they have not released yet the make-up of IMC formulation used in the trial. It’s not clear, then, what drugs at what doses were used in the study.

    The drugs and doses listed in the former iteration of the blog were from the patent application.

    • Hope H.

      March 12, 2014 at 3:21 am - Reply

      I’m trying to understand exactly. Does this mean this study may have totally changed and he didn’t study Valtrex with Celebrex like we all thought and read so much about? I’m so confused and worried now. I’m not sure what you mean by “the make-up of IMC formulation used in the trial”. Did you hear back from him and this is what he is saying? Any idea if you did hear back when the results might be out?

      Thanks for everything!

      • Cort Johnson

        March 13, 2014 at 5:28 pm - Reply

        Only the blog has changed. Pridgen contacted me and asked me to change the blog. He did not say which formulation was used. I took the information off the sole patent I could find, but he said they were testing other forumulations. My guess is that another formulation of antiviral and COX-2 inhibitor were used in the end.

        They believe the results will be out within a month, and we’ll know.

    • Marcie Myers

      March 12, 2014 at 5:48 pm - Reply

      What is IMC formulation?

      • Cort Johnson

        March 13, 2014 at 5:30 pm - Reply

        We’ll know about the drugs used in the trial in about a month.

  • Mary

    March 12, 2014 at 9:42 pm - Reply

    Could someone please respond to my question earlier about who can diagnose herpes virus through biopsy?
    I have one sided neck pain (& torticollis) head turning and shaking–vesitbular lesion (also goes along with neck turning and shaking) and burning mouth syndrome. I have neuropathy in legs.
    I have very bad reactions to injection of any cigarette smoke. I have had problems with IBS. My mother (now dead) had many autoimmune problems, ending up with Common Variable Immune deficiency syndrome. Sister also has many autoimmune problems with reactivated herpes virus 2.
    Can we respond to each other’s postings, rather than just listing our particular problems.
    I would Cort to address this—Who is doing PCR or biopsy testing to determine if herpes viruses are culprit.
    Why is there no mention of the years and years of work of Cullen (Duke) and his partner at University ofFlorida who are the furtherest along in ELIMINATING HERPES VIRUSES. They can’t progress with their reserach because they are desperately in need of funds. Could Cort reply to these two questions. Why is the Simmaron group not dealing with these issues. Yes we can stay on Valtrex indefinitely which can or cannot be effective in eliminating herpes symptoms, but why are we donating to research when the Cullen Duke lab team needs funds.They are woking on ELIMINATIONN OF VIRUS.
    COULD CORT RESPOND TO QUESTION OF WHO IS CAPABLE OF DOING ADVANCED TESTING TO DETERMINE IF WE HAVE HERPES VIRUESES AND WHAT DOCTORS CAN BE CONSULTED BY A LOCAL DOCTOR TO FIND OUT WHERE TO GET THIS TESTING. i have tried contacting ARUP Lab associated with University of Utah that does some testing but they don’t have any doctors to advise you. The folks at the University of Washington are impossible to reach–not patient caring or firendly at all.

    • Cort Johnson

      March 13, 2014 at 5:37 pm - Reply

      The answers are

      Carol Duffy is doing the analyses of the biopsies
      I have no idea about the Cullen or Duke connection. I imagine that if Pridgen is successful it could only boost their cause. (I didn’t know about them at all.)
      Simmaron has a lot on their plate now. They’re doing retrospective studies on the efficacy of antivirals and immunomodulators in ME/CFS and they have several other immune studies underway. Pridgen managed to gather a lot of money from private investors to do the trial. That’s the first time I’ve ever seen that. It’s rather amazing, really.
      Pridgen does believe with the right formulation he can knock down the virus enough for many people to regain health.
      The Herpesvirus 6 Foundation has good testing information on it. I believe the Stanford Chronic Fatigue Syndrome site does as well.

      Hey, if this and future trials work out you’ll see a lot more labs doing this stuff!

      Cross your fingers. We should know the results of this first trial in about a month. :)

      • Hope H.

        March 14, 2014 at 3:38 am - Reply

        Thank you, thank you Cort! I’m so excited that I can hardly contain myself!

  • Pen Richmond

    March 13, 2014 at 1:05 pm - Reply

    This might help with IMC?

    http://en.wikipedia.org/wiki/Isothermal_microcalorimetry

    • Audra

      March 14, 2014 at 4:33 pm - Reply

      IMC is the name of the company sponsoring the study. Innovative Medical Concepts

  • lorraine rud

    March 19, 2014 at 1:51 pm - Reply

    Let me know on the new information

  • IanHodgson PhD

    March 21, 2014 at 4:49 am - Reply

    This study will need to identify those people with spinal stenosis. A significant number of people with FM (but not ME) have spinal stenoses, mainly at the cervical level but also thoracic and lumbar. For those people FM is a symptom set of the stenotic irritation causing immune system involvement. Giving these patients celecoxib will reduce their FM symptoms. Hence some confounding of self reports of symptoms should be controlled. Assaying HSV1 will not control for this and it is possible that pain reduction can occur concurrent with reduced titre of HSV1 when celecoxib is present. This would then just be a correlation.

    I suspect their is an association between herpes viruses, including HHV1. However as we have just seen from the study taking place in the UK that HERVs may be implicated in MS, possibly (re-)activated by herpes viruses. The drug being used is Raltegravir. A similar situation could be the case in ME and FM.
    http://www.medpagetoday.com/Neurology/MultipleSclerosis/44861?isalert=1&uun=g417550d946R5517152u&utm_source=breaking-news&utm_medium=email&utm_campaign=breaking-news&xid=NL_breakingnews_2014-03-20

    http://www.ncbi.nlm.nih.gov/pubmed/17493688

    • Cort Johnson

      March 26, 2014 at 8:29 pm - Reply

      Interesting! Thanks Ian :)

  • Pamela

    March 26, 2014 at 8:25 pm - Reply

    I’m anxiously awaiting to hear results of the trial.
    If anyone knows where there’s an update please let me know.

  • Cheryl Bruni Stewart

    April 4, 2014 at 8:12 pm - Reply

    I read this article. I have been plagued with Herpes Simplex most of my life. I thought I outgrew them. I told my dic of this study. I asked my doc for Valtrex. I have been taking Valtrex for one week and notice an incredible difference.in pain and fatigue. I am hoping this is the drug. It was as if my cold sores stopped on the outside and turned inward. I have not added Celebrex. My doc is awesome and was willing try.

    • Cort Johnson

      April 4, 2014 at 9:43 pm - Reply

      Congratulations Cheryl. Valtrex does work against herpes viruses and it definitely works very well for some people with chronic fatigue syndrome. We now don’t think it was the drug used in this trial but that doesn’t mean it wouldn’t work for you. We’ll learn more about that drug and the doses probably in a couple of weeks. Good luck with the Valtrex.

      • Cheryl Bruni Stewart

        April 4, 2014 at 10:02 pm - Reply

        Great, because I definately notice I am not crazy fatigued. I happy I am one if the ones it helped. Thanks for responding. I am grateful I found this site. Thanks again.

        • marcie myers

          April 5, 2014 at 8:41 pm - Reply

          The antivirals Acyclovir, Famvir, Valtrex, Valcyte, IV Valgangcyclovir and others available to date are in use for various but specific viruses. Some are targeted for Herpes Simplex Viruses (HSV) while others are utilized for Hepatitis C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV) involved in retinal infections, etc. There is no one antiviral medication that covers all viruses in question re: CFS/ME. The major problem with these meds (aside from some considerable side effects such as neutropenia, lowered levels of neutrophils, a type of WBC) is the inherent tendency for all viruses to mutate or change their genetic makeup rendering the current meds ineffective. Proper dosing and continuing with MD’s instructions is imperative to help prevent any deleterious side effects. We don’t know which, if any, virus is the actual cause of ME/CFS although a virus may be a secondary cause due to immune changes. Sadly, the jury is still out on all of this to the best of my knowledge. marcie

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