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Big Antiviral Trial Could Usher in New Treatment Era for Fibromyalgia

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Reprinted with the kind permission of Cort Johnson and Simmaron Research.

A New Approach to Fibromyalgia

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’s 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’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.

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, led 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.

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’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 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.

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.

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 biopsies.

Dr. Pridgen reported in an email they are still trying to determine the optimum dose and cautioned everyone to wait until the results of the Phase 3 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 the trial are expected to be released in mid-year.


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

Editor’s update: You can read about the preliminary results of this trial in “Drug Combo in Pridgen Antiviral Fibromyalgia Trial Identified – Some Results Available.”


About the Author:  Cort Johnson has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, Cort has contributed hundreds of blogs on chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort’s and other bloggers’ work at Health Rising.

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11 thoughts on “Big Antiviral Trial Could Usher in New Treatment Era for Fibromyalgia”

  1. Billie44 says:

    I was doing fine taking vioxx and had no pain. After they took it off the market, I have had years of pain with no relief. I cannot sleep at nite because of the pain, and uncomfortable spasms. I would love to be able to get vioxx again because it gave me complete control over this disease. The only thing I found after that was darvon or darvosette. Of course they took it off the market also. Come on fda. Let us have something to take.

  2. ldylarke says:

    Truly, thanks to Cort and ProHealth, I’m always up-to-date with recent findings and doings regarding FM research.

    This truly sounds promising. I’m already on the Canadian approved FM prescriptions (Cymbalta and Lyrica), but they only help marginally. I’m taking 660mg of Naproxen every 12 hours and 250mg of Nucynta every 12 when I can afford it. The Naproxen is going to eat my stomach lining eventually. The Nucynta has been the *only* thing that takes my pain down to a “comfortable” level. Otherwise I’m stiff as a board and suffering daily.

    Thanks so much for sharing what you find Cort! Truly.

    Shannon @ livingwithfibromyalgia.ca

    1. SiSiRN says:

      I have seen many studies suggesting that FM patients have a dampened and dysfunctional immune system making us more susceptible to viruses, and there is certainly a breakdown in the gut of FM patients as evidenced by one of the major comorbid conditions IBS. The question is, “Does the virus occur as a primary problem or because our immune system is inadequate to handle it? My opinion is that CFS/ME is caused by an indwelling viral pathology, perpetuated by a dampened immune system. There is no doubt that both FM and CFS/ME have cross over symptoms, but symptoms can mean many things. For instance, low blood pressure can be from an acute bleeding, diuretics, hypovolemic (low blood volume) or neurogenic shock, NMH and/or POTS, or it can be a normal variant. The other thing to consider is the diagnostic criteria used for screening participants. We know FM and CFS/ME can, and do, co-occur in the same patient, but not always. Study participants should be closely screened and those with this dual diagnosis should not be participants in an effort to get results that are not skewed.

      Many studies have been done regarding the immune dysfunction in FM, to name just a few more recent ones, Ahmad J, et al. 2014 Jan 18, Behm FG, et al. 2012 Dec 17, Blanco I, et al., 2010 Dec, Cordero MD, et al. 2011 Oct, Giacomelli C, et al. 2013 Oct, Pernambuco AP, et al. 2013 Sep, Fava A, et al. 2013 Jul, Feng J, et al. 2013 Jun, Hackshaw KV, et al. 2013 Aug Oaklander AL, et al. 2013 Jun, Yigit S, et al. 2013. Though studies may not be bill boarded as immunological (in the title of the study), there are many to suggest that FM is immune mediated.

    2. Juloo says:

      I’ll be looking forward to hearing results!

    3. LeeWright says:

      This article is very exciting, I am always trying new things to keep the symptoms at bay but I would love to actually find out the cause and potentially cure this horrible disease. I am taking Cymbalta and many supplements so that I can lead a remotely normal lifestyle however I want more for the long-term as it seems to get worse each year. I wonder how long after this trial it will take to actually get approved so that doctors can start prescribing. I had found Dr. Dantini’s office online a few months ago and I considered going to see him. I think I will wait one month and if no news comes out about this current trial, I am going to Dr. Dantini and get started with this approach.

    4. susand1964 says:

      I also am still upset that Vioxx was taken off the market. It helped me where nothing else has. My pain & headaches were so much better! I am on the highest possible dose of Cymbalta and it does nothing for my FMS. Tramadol is somewhat of a help these days.

      My pain has worsened a lot this past year comparatively to the past 25 years. I don’t know why or what’s different either. Keep working to help us, please.

    5. JanisMarie says:

      I am 63, and have had IBS since I was in junior high! Was diagnosed with fibro about five years ago, but evidently had it for some time, blaming everything on diagnosed arthritis and menopause! I was also diagnosed with a retched disease, collagenous colitis. There is no known cause of it, but it is thought to be caused by the overuse of NSAIDs! Warning to all sufferers who take Naproxen, ibuprophen, etc. I had awful migraines and tremendous dental work and took ibuprophen by the handfuls.

      Oh yes, it was also discovered I have pernicious anemia, due to the absence of intrinsic factor in my gut, which causes Periphial neuropathy! An even more retched disease!

      While I took Cymbalta for the fibro for about 18 months, until it became ineffective, I began taking it again for the neuropathy. It has now become somewhat ineffective for that, too. That’s all I take, except Tylenol.

      I pray every day for treatment and/or relief.

      I do not know what caused the fibro for sure, but twenty years ago, I nearly died from toxic shock syndrome I’ve often wondered if it was the root cause of my issues. I’ve always been a healthy person until these last years, and feel that all,these things must somehow be related. Sadly, none of these things are curable….yet.

    6. jsomyak says:

      Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). If you have been taking this drug over a long period of time, you should have your kidney’s checked. They warn you if you have kidney disease not to take NSAID’s, what they don’t tell you is high doses of NSAID’s over a long period of time can cause Kidney Disease. Because we were not told this my husband is in Stage 3 kidney failure.

    7. DianaP819 says:

      I have been diagnosed with Fibromyalgia. Approx.5 years ago, I contracted HSV-1. Since that time, my Fibro symptoms have become increasingly worse….in particular pain. I am having a significant amount of pain with symptoms much worse at night making it impossible for me to get enough sleep. I have tried Tramadol, Hydrocodone and now, Oxycodone for the pain. Although these drugs help somewhat during the day….they do not work hardly at all at night. I have read that pain caused by nerve damage is very difficult to treat. I might add that I also have IBS. I found your article mentioning combining Celebrex with Valtrex very interesting. Have there been any clinical trials?
      I need help… I feel the quality of my life has diminished significantly. Any suggestions or direction would be greatly appreciated. Thank you

    8. lj.crosby@yahoo.com says:

      I hope something comes up soon about this project.

  3. lorreann says:

    Dr Dantini in Ormond Beach, FL has been treating Fibromyalgia patients with Antivirals for many years. I did a phone consultation and he ordered testing..which were positive for a couple viruses, but I haven’t gotten down there yet to receive treatment.

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