You are here: Simmaron ResearchTreatmentThrough the “Valley of Death”: Dr. Pridgen, Fibromyalgia and the Looming Trials

Through the “Valley of Death”: Dr. Pridgen, Fibromyalgia and the Looming Trials

First there were the anecdotal reports – FM patients were not just getting better but some, and not just a few, were getting well using something entirely new – an antiviral protocol, of all things, created not by a pain specialist or rheumatologist but by a surgeon.

Aside from a few doctors in the U.S., no one was treating FM with antivirals and virtually no research had examined the role of pathogens in the disease. A PubMed search of fibromyalgia and herpesviruses pulled up just two herpesvirus studies – both done over thirty years ago.

Skip Pridgen fibromyalgia

Dr. Pridgen’s hypothesis that FM is a herpesvirus disease may be put to the test by the end of this year.

But here was Skip Pridgen, a Tuscaloosa surgeon, not just asserting that herpesviruses were the cause of FM, but that an unusual antiviral protocol consisting of a herpesvirus antiviral and anti-inflammatory with antiviral properties (celecoxib) was doing the trick.  Plus, he asserted that herpes simplex virus – a virus that has gotten no attention in FM’s sister disease, chronic fatigue syndrome (ME/CFS) – was the culprit.

Pridgen, who’s treated thousands of patients with gastrointestinal issues, came up with the protocol after he noticed that his FM patients with IBS seemed to get better and then relapse. Figuring that a herpesvirus might be responsible, he gave them a herpesvirus drug and was surprised that not only their GI but also their FM symptoms improved. When celecoxib had the same effect in FM patients with arthritis, the idea of a drug combo – IMC-1 – was born.

Pridgen and Carol Duffy – his research partner at the University of Alabama – believe the drug combo is effective because each drug inhibits the virus at different points in its replication cycle and they stop viral reactivation as well.  (Hitting a virus at multiple points is a strategy employed to stop HIV.)

Pridgen created a startup Innovative Med Concepts – and put together a pretty hot team (including a past Vice President of Pfizer) and some respected researchers for its Scientific Advisory Board (including Daniel Clauw and surprise, surprise former ME/CFS researcher Dr. Dedra Buchwald) and got a Phase II clinical trial funded and going. (Dr. Buchwald was a surprise because she was so darn conservative in her approach to ME/CFS…)

The clinical trials are where it gets really serious, though. For all the reports of Pridgen helping FM patients, they mean nothing to Pridgen’s hopes of producing an FDA approved drug. The trials are where the action is, and with the recent publication of Pridgen’s Phase II clinical trial in the Journal of Pain Research, we finally have something we can really get our hands around.

The Trial

A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. William L Pridgen, Carol Duffy, Judy F Gendreau, R Michael Gendreau. Journal of Pain Research 2017:10 451–460

Pridgen has been almost relentlessly upbeat in his assertions about the effectiveness of his new protocol and he and his co-authors don’t pull any punches in the title of their journal article which boldly states that “A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia”.

Because the trial was distributed across twelve sites, it sampled a broad array of FM patients (and doctors). With 143 patients participating, it was a good size and was double-blinded (neither the patients nor doctors/researchers knew who got the drug or placebo), placebo-controlled 16-week study.

Six questionnaires were used to assess the drug combo’s effectiveness. The primary endpoint – the test the study really had to meet involved two questionnaires – a numerical pain rating scale (NRS) and a past week functional and symptom assessment questionnaire called the Fibromyalgia Impact Quotient (FIQ-R) score.

The first part of the FIQ-R asks how difficult it was over the past week to do things like walk continuously for 20 minutes, vacuum the floor, climb one flight of stairs, go shopping etc. The second part asks each patient to rate their pain, energy, sleep, depression, etc.

The study participants had to be off a variety of drugs (duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate, and opioids). Over ninety percent of the participants were women and their average age was 49.


Functionality and Symptoms – The FM patients on the IMC-1 protocol showed a statistically significant improvement in their functionality and overall symptom scores on the FIQ-R test relative to the patients not on the protocol.  (The average patient showed a 2.2 point improvement on the eleven point scale.)  Functionality, symptoms and overall impact of FM all showed significant improvement on the drug.

Pain Assessment – Past 24 Hours – With regard to the other primary endpoint – the NSR measurement of pain, only when the data was subjected to “imputation” did the patients report statistically significant improvement in their past 24-hour pain. (Imputation analyses were used to account for missing data.)

IMC-1 was statistically significantly superior to placebo in most of the tests

IMC-1 was statistically significantly superior to placebo in most of the tests

Overall Improvement – Another test called the PGIC which asked patients about how much they had improved. Patients had to report that they were much or very improved to pass the PGIC test. About 35% of patients on the IMC-1 protocol reported they were much or very much improved at weeks 12 or 16 vs about 18% of those on placebo – a statistically significant result.

Another Pain Analysis – Responder analyses used to assess what percentage of patients received a 30-50% reduction in pain found that about 30% of FM patients reported a greater than 50% reduction in pain over the past 24 hours on the IMC-1 drug combo.

Fatigue – Two fatigue assessments (MFI, PROMIS fatigue short form) had differing results; the older MFI test showed no significant improvements in fatigue while the more recently developed PROMIS test showed that those on the drug combo received statistically significant reductions in fatigue.

Depression – The depression findings were intriguing given that one does not ordinarily link depression with herpesvirus infections. When the imputation analyses to account for missing data were performed, however, IMC-1 produced a highly statistically significant (P=0.003) reduction in depression. (This data was not in the published paper.) Since the HSV-1 virus hangs out in three different nerve ganglia in the body, knocking it down could conceivably affect many symptoms – including depression and anxiety.

Safety and Tolerability

With more patients off the drug than on the drug reporting side effects, the IMC-1 drug combo passed the safety test with flying colors. That finding was bolstered by the much higher dropout rates in the placebo arm compared to the drug arm.

The Phase II clinical trials reported on here is a proof of concept trial done to demonstrate that the drug probably works and is safe. Because these trials are also used to help manufacturers determine the best dose to use in a Phase III trial, Phase II trials are also more experimental.

The results were good but not spectacular. I asked Dr. Pridgen if he was satisfied with them. Considering that he felt that Innovative Med Concepts had a hand tied behind its back by the FDA he was:

Given that the FDA restricted our dose to that which we ultimately used, we were thrilled that we met statistical significance with our primary, secondary and even our exploratory endpoints. Being able to show statistically significant improvement in Pain, fatigue, depression, and a dramatic impact on IBS is truly unique. Honestly, I have never seen a proof of concept trial with this broad of an impact. Knowing that the recent toxicology results support our planned ideal dose, as you might imagine, we are incredibly confident in our Phase 3 trial. Dr. Pridgen

Pinpointing the Culprit

One of Pridgen’s and Duffy’s tasks includes demonstrating that herpes simplex one (HSV-1) – the virus they believe is responsible for FM – is, in fact, present. Pridgen reported that Duffy’s analysis of FM patients gut tissue is complete and that the data that emerged “far surpassed” their expectations. They are writing up the manuscript now.

Through the Valley of Death

Pridgen reported a couple of factors that may increase IMC-1’s effectiveness in the next trial. A higher dose will be used in the next trial and the screening process for the participants will be tighter to avoid the impact of confounding factors.

The huge Phase III clinical trials required for FDA approval are called the “Valley of Death” by some for good reason. Pridgen said that testing the drug combination – featuring two drugs that are already FDA approved – will require two 500-1000 person drug trials, each costing from $25-50 million. That’s on top of almost complete animal toxicology testing that’s been done and the large proof of concept Phase II trial.

Trials like that take some heavy lifting and Pridgen’s enrolled some top talent to get IMC-1 through the “Valley”. Rick Burch, the President of Innovative Med Concepts and the former Senior Vice President for Pfizer, oversaw divisions employing more than 6,500 employees and had a hand in launching Lyrica. As chief medical and safety officers, Drs. Michael and Judy Gendreau helped usher Savella to FDA approval.


Pridgen hopes to get IMC-1 through the “valley of death” and into its final clinical trials by the end of this year

Pridgen reported that Innovative Med Concepts met with 14 companies (half pharmaceutical, half companies that could provide financing) at JP Morgan in January of this year. He expects the trials to begin in late 2017.

He’s confident enough of the drug’s success to expect to employ in the next trial what he stated was the toughest primary endpoint ever used in an FM drug trial – a 50% or more reduction in pain.

Will Pridgen’s approach revolutionize our understanding and treatment of fibromyalgia? Could FM really come to be viewed as a herpesvirus induced disease – and if it is – what would that mean for chronic fatigue syndrome?

Intriguing questions all. The rubber will really meet the road for surgeon turned drug developer and the many FM patients looking for better treatment options probably at the end of this year.

 More on Dr. Pridgen and His Approach to Fibromyalgia


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  • Audrey Brimson

    March 27, 2017 at 5:21 am - Reply

    …” walk continuously for 20 minutes, vacuum the floor, climb one flight of stairs, go shopping etc. The second part asks each patient to rate their pain, energy, sleep, depression, etc.”… I have never been diagnosed with FM only ME/CFS. There is no way I can walk continuously for 20 mins, or the others, shopping not so bad as stopping frequently but exhausted on getting home, plus I do not claim to have depression. When I get a reaction there is something that happens which may be relevent, small vesicles appear on the hair line around my head and neck. I have also had many, many cold sores on my lips.Not always from being out in the sun! Thanks Cort, interesting and encouraging research for ME too..

    • Cort Johnson

      March 27, 2017 at 2:31 pm - Reply

      Hi Audrey, ME/CFS tends to be more disabling than FM. If you were to score yourself on that question you would probably give yourself the lowest score.

      Dr. Pridgen believes a similar situation occurs in ME/CFS as well and that his drug combo will work in ME/CFS. Let’s hope his FM trial is successful and he can move onto ME/CFS as well.

      • Diane

        October 12, 2017 at 4:58 pm - Reply

        Cort. Would you happen to know if Dr. Pridgen’s success stories include patients who also test positive for HHV6? I’m encouraged to hear some of his successes include ME/CFS patients as I’ve been disabled with this for 31 years. I just started on Valtrex 1 week ago, my first ever experience with an antiviral – a decision I made based on reading your articles about Dr. Pridgen and Dr. Lerner. Thank you!

        • Cort Johnson

          October 17, 2017 at 10:33 pm - Reply

          I’m afraid that I don’t know but good luck!


      March 28, 2017 at 1:01 am - Reply

      Hi Audrey, I get those little vesicles you are talking about also, I do not believe they are acne, I think they are lymphnodes…mine are in same areas you describe and along jaw neck, sometimes several on chest with a white lquidy sbstance that is different from a white head. I thave rained to be an esthetician, so I know these are NOT acne….and they seem significant to me also. Also get swollen areas in back of my head…and the headaches…..

  • Suzie

    March 27, 2017 at 12:27 pm - Reply

    This is very interesting, and seems like something we could ask a good, open-minded doctor to try. I think my neurologist might let me try a famciclovir + celecoxib combination on the back of this! I guess we’ll have to figure out dosage…
    Thank you so much Cort for such clearly communicated reporting – my fuzzy brain struggles. I don’t understand what the trials are aiming for – to get the drugs licenced as a package together and patented as a Fibro cure?

    • Angel

      October 12, 2017 at 5:00 pm - Reply

      Suzie, I researched this and asked my primary Dr to put me on these medications. I have been so much better, at 1st I was on 200mg Celebrex and 250mg Famvir, but I was getting headaches, so now I am trying 125mg Famvir and 200mg Celebrex. Really worked miracles 1st time around, hopefully it continues.

  • Jack DeWitt

    March 27, 2017 at 1:45 pm - Reply

    Our family is one that suffers from a genetic susceptibility to the spread of the Herpes Simplex virus and the havoc it can wreak throughout your body.

    For myself, all my life I’ve had the same symptoms Audrey mentions above. In addition, because the virus preoccupies my immune system, my teenage acne never cleared up until I started taking Skip’s anti-viral combo.

    And physical//mental stress seems to be a key component because I can have flare-ups in spite of the current treatment and the acne returns. But I think the higher anti-viral dosage in the Phase III trial will eliminate even that for me.

    For my wife, I believe this virus was the culprit in her uncontrollable ulcerative colitis some 25 years ago. We both believe that some environmental exposure on a family vacation triggered the disease. As a result, she suffered through a colectomy and a reconstructive J-pouch .

    In the years since, she’s suffered the onset of fibromyalgia so severe it incapacitates her. And yes, depression is a factor. On two occasions over the last ten years or so, she’s stopped her medications only to again suffer periods of incapacitation.

    But thankfully, she’s returned to the combo and pretty much fully recovered. After being on the anti-viral combo for 4-6 months, she’s moved from a 2 to an 8 on a scale of 10 on both occasions.

    As for our son (and myself to a lesser extent) mutations occurring have in the past caused worsening of the cold sore blisters. Mine are now completely gone now.

    But if my son fails to take his medication, large cold sores erupt all over his face and body, and are followed by secondary staph infections.

    I applaud Skip’s perseverance and commitment to helping push his efforts to this point. And I know it will eventually make huge differences and benefits in the lives of so many people (and their families) in the years to com.

  • Cort Johnson

    March 27, 2017 at 2:33 pm - Reply

    Really interesting Jack – thanks for sharing and good luck with your family. It’s hard to imagine that there’s not a genetic underpinning to your families problems.

  • Denise

    March 27, 2017 at 2:35 pm - Reply

    I’ve always thought there might be a correlation between herpes and fibromyalgia. If herpes can turn into shingles, perhaps it can also cause fibromyalgia.. That’s the analogy I’ve used in the past trying to explain to people that I believe fibromyalgia is viral and something “sets it off.” Stress, accidents, surgeries, etc. Keep going to try and find an answer! You’ve got 5-20 million people who would love to have their lives back!

  • aquafit

    March 28, 2017 at 1:53 am - Reply

    I’d like to put out a word of caution and food for thought for anyone who suffers from fatigue, POTS, brain fog and ANS symptoms.

    It’s been found (I think by Klimas et al) that we may have a more permeable blood/brain barrier and skin barrier and gut mucosal barrier. The other cohort which has a more permeable blood/brain barrier are those over 65 years old. The elderly now have an anticholinergic drug orotocol. What that means is that anti-cholinergic drugs are found to pass through their more permeable blood/brain barrier and CAUSE Alzheimers.

    What is an anti-cholinergic drug. Most drugs with that start with the word “anti” like anti-viral, antihistamine (1st generation like Benadryl, 2nd generation like Reactine seem fine), etc. There are also drugs with anti-cholinergic effects like Warfarin. While these drugs may work for their intended purpose, they can at the same time penetrate our various barriers and cause long term irreversible damage over time. It’s my opinion that many CFS/ME patients are bedridden due to anti-virals whereas they may have had some quality of life if they had never been given antivirals or antidepressants. I’m thinking of Whitney Dafoe, for example. He went from bad to worse after antivirals and chemotherapy.

  • Greg

    March 28, 2017 at 6:56 am - Reply

    Please correct me if my observation is off base.
    So, if HSV-1 is the primary culprit, why doesn’t this drug combo lead to a remarkable improvement in many patients rather than just a “statistically significant” improvement in some. Is it possible that the major dysfunction that is going on in our bodies allows for some of these ever present viruses to activate more often in us than the general population?
    So many millions of dollars will be happily put forth for the expectation of a successful trial that will reap many more millions of dollars for Pridgen and associates, Big Pharma, and of course Wall Street financiers. The patients (some at least) at best will have some relief from the effects of HSV-1 but mostly they will remain very ill. And of course this drug combo will have to be taken forever as I haven’t read of any expectations of this virus being wiped out. So a new drug combo to be patented (big $’s) for a chronic condition = major potential windfall for many, many years (stand back Lipitor). I can understand the enthusiasm from the invested parties. Forgive me if my enthusiasm is more subdued. Is there anything about this study that has any real chance of understanding the basic cause of our illness? Conniving business schemes to extract more money from a group long denied any serious effort for real research and answers. Somebody explain to me why my cynicism is out of place.

    • Cort Johnson

      March 28, 2017 at 1:06 pm - Reply

      Good observation Greg. If I remember correctly, Dr. Pridgen believes that an immune problem exists in FM (and ME/CFS) patients which allows HSV-1 to flourish, and yes the drug combination will have to be taken as long as that immune problem exists.

      We will see how the IMC-1 combination does in the larger trial but my guess is that if it is successful and Dr. Pridgen’s hypothesis is correct, that identifying the herpesvirus culprit will be a lot easier than identifying the immune culprit.

      I think your cynicism is out of place for two reasons: one, about 30% of FM patients in this trial received over a 50% reduction in pain. Many FM patients also received significant reductions in fatigue, mood problems and improvements in functioning. Plus, Pridgen stated that the FDA required a lower dose than he wished to use (I believe because the toxicology studies had not been finished) which suggests the next trial will be more effective.

      Consider this possibility as well: if Pridgen’s drug combo does prove to be effective and is FDI approved for fibromyalgia, hopefully that would start a hunt for the immune dysfunction present. In that case, Pridgen’s trial would have helped greatly in finding the true cause of FM. In fact, without it, given the lack of interest in the immune system in FM, one wonders how it would ever have been found otherwise.

      • Dr Shiller

        December 24, 2017 at 7:37 am - Reply

        Dear Cort
        You say some good things here, but I respectfully disagree. The fact that 30% of patients got 50% reduction in pain is underwhelming. They also got celebrex. Some people with FMS feel better with Celebrex. I say that based on my own experience treating a thousand or so patients with FMS.
        I agree with you that the immune issue needs more attention. Especially with some of the research coming out showing elevation of inflammatory cytokines. But I think Pridgen and his team are misdirected by thinking that HSV is “The Cause” of FMS.
        Most of the data and clinical experience point to the likelihood that FMS comes from a immune/endocrine/neuro/GI system that is primed by genetics and past experience, and which responds to a trigger (like infection with a variety of agents, or other forms of chemical/psychological/physical trauma) with a cascade of vicious cycles that bring on the FMS.

        • Cort Johnson

          December 31, 2017 at 11:19 pm - Reply

          Thanks for your insights, Doctor. I agree that it is hard think of these diseases – FM and ME/CFS – as having one cause. They seem so complex but we shall see.

    • Dr Shiller

      December 24, 2017 at 7:41 am - Reply

      Greg I think your cynicism is relevant.
      I don’t suspect Dr Pridgen and his associates of misconduct or any other ugly issues. But I think their paradigm is wrong.
      Conventional medicine has been imbued with a “one cause, one disease, on cure” obsession since the beginning of the antibiotic era. And it seems quite irrelevant in FMS.
      HSV reactivation may be relevant in some patients. But to say that HSV is THE CAUSE is wishful thinking that is not supported by his study results.
      See my comments to Mr Corts reply below.

    • Katherine

      August 8, 2018 at 4:07 pm - Reply

      Greg, I share your cynicism. “Feeling better” is not the same as “Being healthier”. People with infections will feel better, short term, on steroids, too, but with a suppressed immune system they will get much sicker long term. People might feel better on narcotics, but again, not a great long term solution and certainly not a CURE. I agree with you that it is dangerous attempting to treat a disease when no one understands its’ cause, but I also think we need some treatment options and many are willing to try anything. I also agree with you that the big pharma jump in for “cash cow” drugs (i.e., symptom management only, you have to take it for life) — not so much for drugs that actually eliminate disease.

  • Jack DeWitt

    March 28, 2017 at 12:23 pm - Reply

    Cort, I think this is a “Must See” video link to an episode of the Curiousity Series on the Discovery Channel.

    It tracks the destructive path of a common cold virus (not herpes) as it attacks healthy cells, ending after a 48 hour battle in which the virus wins.

    But the analogy is there for herpes virus–all in stunning high quality CGI animation.

    It truly enlightened me to the reality of it all. The episode is aptly named “Battlefield Cell.”

    • Cort Johnson

      March 28, 2017 at 1:06 pm - Reply

      Thanks for sharing that Jack.

  • Cynthia

    March 28, 2017 at 4:30 pm - Reply

    Hi, folks! This is exciting information for most people. However, I don’t tolerate antivirals or NSAIDS. But for others like me, I would humbly recommend L-lysine, a natural supplement you can get at your corner drug store CHEAP! You can Google the dosage and see if it helps you. I am by no means cured, but I do believe it helps me.

  • Titan

    March 28, 2017 at 7:09 pm - Reply

    Sorry to say that this is not the answer although I really wish it was. Whenever anyone is spending this amount of time and money on a solution they really want to believe the results and will skew the results either knowingly or with their own bias unknowingly. Tried this combo for about 9 months and didn’t do a darn thing. Dr. Pridgeon sure is great though. Glad there is research going on but when you hit a dead end it’s time to turn the corner to something else. We need more researchers.

    • aquafit

      March 29, 2017 at 2:18 pm - Reply

      Good to know, Titan. We have to politely ask and/or loudly demand that researchers step up instead of “do what is easy” as Dr. Ron Davis says researchers are prone to do.

      I can’t help but notice so many helps that people find link to connective tissue. L-lysine helps build collagen aand calcium mongst other things. I noticed when I attended the IACFSME conference how many patients have EDS or EDS like symptoms.

      Jack DeWitt linked to a very informative video. Something interesting about connective tissue – there’s about 28 different kinds and every symptom we have links to it. Faulty collagen can cause ATP cells to leak from adipose tissue. Bacteria is biocompatible with collagen cells. Susceptibility to viruses may be linked to the quality of our collagen. (we’re born with collagen as we’re born with a structure and organs and fluid of course, but throughout life our body makes, maintains and dissolves collagen). I’m not sure if this guy has things right as he’s a lay person who’s evaluating professional work, but please read this webpage and see if it opens up your mind to looking up some new directions to ask researchers about:

      I wonder if the researchers who found a drug which may be helpful for FOP would be helpful in collaborating with Dr. Ron Davis. Here’s a story about a person with FOP; interesting that EDSer bodies also make lumps but obviously not as hard as bone. I note the woman is fatigued – I’m sure no one’s sending her for CBT and GET! Interesting too that it’s tears and bruises that her body reacts to innapropriately by making the wrong kind of collagen (bone). I’m wondering if we don’t make faulty ATP but instead maybe we call upon our ATP reserves in our collagen (adipose tissue) when we’re doing things intensely or for a period of time and it’s been leaked out. And then when our body is called upon to repair microtears from daily activity or exercise it’s so very hard for our bodies to produce more collagen. Remember, the latest research seems to say that we don’t call on our fat energy production too soon, but rather that we call on gycolosis and fat energy production at the same time. Perhaps it’s not going for fat cells that’s the problem, perhaps it’s that the energy’s disappeared from the collagen vessel holding it?

      Not sure if this study might be related, seems so on he surface, “Mitochondrial Proton and Electron Leaks”.

      • Titan

        March 31, 2017 at 9:51 pm - Reply

        Thanks aquafit. This will take me some time to get to. I was diagnosed with Fibro/CFS for about 10 years. Problem is there is NO TEST for Fibro/CFS. Look into the work of Dr. Ritchie Shoemaker. I finally met a Dr. trained in his methods and had a positive Neuroquant MRI, was positive for MARCoNS, and my labs were all positive for what some call “biotoxin illness”. This goes by many different names, but his treatment is how I have gotten better. I still have a ways to go and have only been treating for a few months, but through the ‘Shoemaker Protocol’ I have finally been able to make some headway. I love Dr. Pridgeon, he is a great man, I just feel that this combo he’s been working on is going to lead many more people down the wrong path. I really appreciate that he is researching though. Most Dr.’s in the field Dr. Shoemaker works in have research showing over 90% of Fibro/CFS is really “biotoxin illness”. Question everything…If you suffer from symptoms of Fibro/CFS go to and you will learn how you can rule out what I talk about.

        • aquafit

          March 31, 2017 at 10:03 pm - Reply

          Thanks for the link Titan! Is that your site?

          I looked up biotoxin and sure enough, there’s research looking at it as a connective tissue disorder. In other words, in order to respond very badly to biotoxins, first our connective tissue must be compromised or damaged in some way.

          Transforming growth factor beta one (TGF b-1)- TGF b-1 is an inflammatory marker high in those with connective tissue disorders and especially prevalent in those with the 11-3-52B haplotype and those with ciguatera poisoning. High TGF beta-1 causes shortness of breath due to remodeling of lung tissue from normal, fluffy cells to fibrotic, stiff cells that have trouble taking in oxygen efficiently. TGF beta-1 also promotes autoimmunity.

          • Titan

            March 31, 2017 at 10:11 pm -

            This is Dr. Shoemaker’s site not mine. He and others have done tons of research in exactly what you say. TGFB1 is one of the many labs that can identify inflammation and exposure. In my opinion this site gives the best overall understanding of not only how one is diagnosed, but what the science is behind it and how one should treat this chronic illness. Call it Fibro/CFS/ME/Whatever, it’s all basically the same thing and Dr. Shoemaker’s success rate is real, unbiased, has been duplicated by many other Dr.’s, and is where researchers should be spending their time. Your response proves you’re light years ahead of most researchers in this field. Good luck!

  • aquafit

    March 29, 2017 at 3:06 pm - Reply

    Just had a further thought regarding the bedridden – it would be great if someone would research that anti-cholinergic drugs like antivirals and first generation antihistamines and pain relievers etc. are doing to their collagen and if it’s the reason they’ve gone from bad to worse. As CFS is considered a “central nervous system disorder” which is considered psychiatric, it’s no wonder no one has studied this as a biological disorder. t

  • Katie

    March 29, 2017 at 6:17 pm - Reply

    This is great news.Any medication that brings even 30-40% improvement on symptoms is a success!
    I’d be jumping for joy if I improved 30-40%!!!
    It’s not wasting valuable money on large expensive trials that show improvement of any disease even by 30-40%. It leads to answers, a direction at least in understanding the very complicated enigma and etiology of ME/FM

    • FLT

      January 15, 2019 at 2:45 pm - Reply

      Yes, I totally agree and I find it puzzling that people are discounting this. Even if it’s not a cure, per se, it could improve quality of life for so many people if it works.

  • Greta

    April 4, 2017 at 9:01 am - Reply

    Anyone know anything about dosage?
    This make a lot of sense to me and I’d like to try it and not having to wait 5 years. 🙂

    • Cort Johnson

      April 4, 2017 at 9:35 pm - Reply

      I think you would have to go directly to Dr. Pridgen. He does work with other doctors…

      • Titan

        April 4, 2017 at 10:06 pm - Reply

        I know the dose, but am not sure if I am allowed to say it. I was on the higher dose that Dr. Pridgeon recommended and it did not work at all. Cort is correct, Dr. P will work with your Dr. and have them sign a non-disclosure agreement. Because my chronic illness seemed to start the day I got Epstein Barr, and because I also tested positive for the CMV and HHV6 virus’s I should have been the perfect test case. Turned out I had “biotoxin illness” the entire 10 years. Look into the work of Dr. Ritchie Shoemaker at With Fibro/CFS/ME there is no test whatsoever to show you have it. With “CIRS” you can be tested and treated. Most Dr.’s in this field believe that 90% or more of Fibro is really “CIRS” and I agree with them.

      • Ed

        May 30, 2017 at 6:19 pm - Reply

        Hi Court,
        I was wondering if I am already HSV1 positive with symptoms of Fibro/CFS if there is additional testing/screening? Is Dr. Pridgen testing viral titers on HSV1?

        Is my PCP able to reach out to him directly?

        • Lindy

          October 13, 2017 at 9:42 pm - Reply

          Ed .. I’m passing on this info to some of the posters here, because I really believe, as many researchers and Lyme specialists believe – that most Fibro and CF patients, really suffer from Lyme disease and maybe Babesia too. Please get yourself tested for Lyme Disease at IgeneX Labs. You can call them for a kit and have your dr off. do the blood draw. If you have bad fatigue too, get tested for Babesia, as well. Do NOT get tested by a common lab. They’re only 30% accurate with Lyme. IgeneX is a top lab. I posted a link to a documentary on lyme, below. It won an award.

  • Ed

    May 18, 2017 at 9:44 pm - Reply

    If I am already HSV-1 positive with symptoms of MF/CFS is there additional testing to get a diagnosis? Is Dr. Pridgen testing the viral titers on HSV-1?

  • Catalina

    May 19, 2017 at 11:53 am - Reply

    My FM also started as EBV and I tested positively for EBV…Ig M 4 months ago and now I have muscle pain,fatigue and headaches all the time…FM has been activated by a trigger..thw trigger was EBV. I don’t know what to do with this information since no treatment is available but I do hope not to stay my entire life like this…this is not life. Cort, tell dr P that that are patients who their FM started just like Epstein Barr(enlarged lymph nodes,sore throat, positive IgM,muscle pain,fatigue,fever)…know I am still fatigue and in pain.

    • Lindy

      October 13, 2017 at 9:39 pm - Reply

      Catalina .. Please get yourself tested for Lyme Disease at IgeneX Labs. You can call them for a kit and have your dr off. do the blood draw. If you have bad fatigue too, get tested for Babesia, as well. Do NOT get tested by a common lab. They’re only 30% accurate with Lyme. IgeneX is a top lab. I posted a link to a documentary on lyme, below. It won an award.

  • Steve

    July 3, 2017 at 6:17 pm - Reply

    @Cort one thing this study is missing is an actual diagnosis of HSV-1 for people who suffer from FM/ME/CFS.

    “Figuring that a herpesvirus might be responsible”

    What in the world led him to “figure” this? Obviously it’s not something that comes up frequently in literature about FM. If he treated FM patients regularly, I could imagine him being in a position to notice a pattern, however he was a surgeon prior to forming IMC and I don’t see how he could have made such an observation.

    Prior to treating FM patients on a hunch, did they bother to confirm this diagnosis? I know there are blood tests for HSV-1, but even asking participants if they’ve ever had symptoms would be a good place to start.

    In my opinion, this is entirely unconvincing. I have much greater hope for research into neural inflammation and suppressing glial activation.

  • Shy

    July 5, 2017 at 10:08 pm - Reply

    I think it’s worth nothing that from some reports, one I believe Cort reported previously? the approximate effectiveness of the existing fibro treatments stand (don’t quote me) but around… cymbalta (27%) for a similar pain reduction, with lyrica (26%) and Savella (26%) around there as well. For that alone, if the side effects aren’t that bad (such as the cymbalta-lawsuit hell…) it is worthwhile for those it will help to have it approved if it self justifies via the studies. I don’t believe it is the answer for everyone, however.

  • Robert Buelteman

    September 15, 2017 at 6:25 pm - Reply

    Dr. Pridgen’s protocol is a wonder of medical ingenuity. My wife and Iwere sick and disabled for 10 years from neurologic Lyme Disease. Once the Lyme was gone our symptoms persisted. I saw Dr. P in March, and awoke two weeks ago to a new world – no pain – no nightmares – new energy – a whole new world!! For this of you wondering, YES it does work!!

  • Beth Miller

    October 12, 2017 at 3:59 pm - Reply

    I am so excited for my upcoming appointment with Dr. Pridgen. Fibromyalgia has consumed my life. I am no longer the same vibrant person I once was. My only worry is that I have an awful side effect/allergy with Celebrex. I have tried it twice now and it makes my tongue swell and leaves my mouth and throat so sore. I hope there is an alternative.

    • ness

      February 9, 2018 at 7:22 am - Reply

      plcan you kindly tell me what is involved in seeing Dr. Pridgen? Does he see out of state patients? Is it very prohibitive? Thank you.

      • Cort Johnson

        February 12, 2018 at 7:54 pm - Reply

        He does see out of state patients and if you have a primary care doctor who supports your seeing him he will work with him. I don’t know but I don’t get the sense that his costs are very prohibitive. He’s based in Tuscaloosa Alabama

      • Rob Buelteman

        February 12, 2018 at 8:06 pm - Reply

        Dr. Pridgen is the most effective, lowest cost doctor I have seen in my 64 years. He and his staff are extremely polite, kind, well-informed and action oriented. Saw him in March 2017 and am now largely free of my chronic Lyme Disease. He will also work with your doctor, provided they sign a non-competition agreement.

        • Cort Johnson

          February 12, 2018 at 8:30 pm - Reply

          Thanks for passing that on 🙂

      • Rob Buelteman

        February 12, 2018 at 8:07 pm - Reply

        Dr. Pridgen is the most effective, lowest cost doctor I have seen in my 64 years.

      • Titan

        February 12, 2018 at 8:16 pm - Reply

        Not sure if Dr. Pridgeon still does this, but he was kind enough to have my Dr. sign an NDA and did this for free. I got the formula Dr. Pridgeon recommended and under my primary care Dr. I tried for 9 months with absolutely no success. I ended up finally getting better once I found out I had CIRS/Mold Illness/Biotoxin Illness. I got better with the Shoemaker protocol.

  • Lindy

    October 13, 2017 at 7:43 pm - Reply

    Anyone and everyone who’s been diagnosed with Fibro, should absolutely have a LYME Disease and Babesiosis/Babesia test! But … ONLY have the test done by IgeneX Labs! Lyme tests are only about 30% accurate! Igenex Labs is only one of about 3 Premier labs in the states. They’re not absolutely 100% accurate.. maybe 88% ,, but THEY ARE THE BEST! Lyme is insidious, and is known as The Great Imitator. Anyone with an AUTO-IMMUNE Disease could really have Lyme, cause it mimmicks exactly, MS, ALS, RA, etc… I kept telling docs I thought it was Lyme, and had 3 tests by Quest and another lab, but was neg. IgeneX is a Lab that ONLY has been testing for Tick diseases for many years. If you are on Disability and you have Medicare, they’ll submit for you. I paid nothing.

    I can’t SCREAM this enough!! Get TESTED!! Then get yourself to a LLMD (Lyme-Literate Doc) or – go to an LLMD first, and get tested thru the doc! I FINALLY got a Positive for Lyme AND Babesia (a malaria cousin), after 23 yrs of living with horrible pain and fatigue.

  • Lindy

    October 13, 2017 at 7:59 pm - Reply

    P.S. Here’s a Tribecca Film Festival Award Documentary about Lyme Disease called ‘Under Our Skin’. Everyone should watch and become informed for themselves and their loved ones.. It’s being called a Pandemic now!


    December 19, 2017 at 12:06 pm - Reply

    Riley Elijah
    I was diagnosed with herpes since I was a child. My mother has them too, and does nothing to stop the spread. it was hard to not kiss my children all the time, but they grow up knowing that “when mommy has a lip owie, she can’t kiss.” They give me kisses on my forehead instead and we have extra hugs. It was also very painful to not kiss my husband. However, I was 100% determined to not pass this on to anyone, especially those I love.I mostly want to thank those who feel the way I do.
    Good health herbs home helped me and my family to find happiness and peace ,their herbal remedies for herpes works like miracle,i was totally cured of herpes virus within 5 weeks of usage,please if you are out there searching for herpes cure contact good health herbs home

  • Dr Shiller

    December 24, 2017 at 7:27 am - Reply

    As an MD who has seen a few thousand people with FM, and who regularly keeps up on the research, and employs and ‘out of the box’ functional medicine approach, I have some objections to the blanket statement that “FMS is caused by reactivation of HSV virus”.

    The big problem in conventional medicine is looking for “one cause for one disease with one solution”. That’s fine for acute illnesses. But all the evidence and clinical experience suggests that FMS (Fibromyalgia Syndrome) is a complex process that develops from the interaction of multiple factors. Some of those factors are underlying characteristics of the patient (genetics, lifestyle, previous toxic, infections, stress exposures). And some of those factors are related to the trigger for the illness. Triggers can include physical trauma, psycho-emotional trauma, or biochemical stress like infections, chemical/toxin exposure, etc.

    Sure, reactivation of HSV can be a biochemical/infections stressor that triggers a previously-primed immune system to enter a cascade of viscious cycles that lead to the biochemical changes that are associated with FMS (stress axis dysfunction, gut dysfunction, pro-inflammatory cytokines, hormonal dysfunction, sleep disturbance, chronic pain, etc).

    I have no problem with the assertion that for some patients, HSV reactivation can trigger the disease.

    But to assume its true for all patients is way over the top. It flies in the face of so much research and clinical experience.

    And the trial is really problematic. Basically they gave fibromyalgia patients a combination of an antiviral and celebrex for 15 weeks, and looked at their health up to 16 weeks.
    You could probably get the same results by just using celebrex. We know some people respond to it. Add in a few patients for whom HSV is relevant, and BANG, you’ve got a positive study result.

    Like anything else with FMS clinical care…at this point we need to treat each patient as an individual. We need to think out of the box and address the underlying physiologic dysfunctions that cause the symptoms.

    In some cases NSAIDs and antivirals may be useful.
    But I’m not jumping to think that “Finally here is THE ANSWER to fibromyalgia”.
    Lets see what the phase III trial shows.

    And in the meantime, sure, treat patients who have proven HSV activation and FMS with antivirals.

    • Cort Johnson

      December 31, 2017 at 11:21 pm - Reply

      Thanks again for taking the time post, Dr. Hopefully we will know more about the effectiveness of Dr. Pridgen’s protocol in 2018.

    • hayley

      February 28, 2018 at 10:41 pm - Reply

      i completely agree with this statement. having lived with CFS for 12 years and now recent fibro pain (with related random cold sore that never goes through the stages of a cold sore but thats what im being treated for with antivirals because the doc is out of ideas). I have gone through so many specialist over the year of different things in my body being triggered. I have also have other things like endometriosis and constant other immune system problems that has only convinced me deep to the bone that it isnt onevirus being triggered but many. and that there is something inherently wrong with my immune system that is why i am having so many probs and also why one persons CFS or fibro is different than the others. it would be wonderfully simplistic to think one thing cures one thing, but sadly not. That said yes, diff things over the years can help work to turn off different things. sadly its not going to cure the cluster of immune stuff ups we have. 🙁 Even before I got CFS my body struggled to get over bugs that normal people got over, everything always went secondary (and now sometimes my immune system under responses so the same bugs my family get and respond normally well ill get and on and off sore throat and sniffles or whatever for months. for instance ill get one day feeling fluish, but then the next day fine, my cfs will flare but i wont get the virus or bug properly). im guessing someone found this out from this study since its been awhile since this article and possibly phase 3 shoud have finished by now? thats why its not working for all people in the study i would think, not just the mg of the drug load.

  • B. K.

    January 7, 2018 at 12:56 am - Reply

    Please, keep in mind, (along the lines of Dr. Schiller comment), FMS, CFS/Me are syndromes. A whole body breakdown of homeostasis due to an insult to the bodies defenses. It’s fairly evident to most if us who’ve been severely affected by these illnesses, that people who get better by any definition all do so by varying means. I believe that if you can find a way to eliminate the major player/players that cause the insult to your unique physiology (for some its gluten or dairy free, or mold, etc) then those persons bodies can have a remission until the stressor are to much for the body to handle again. This is why there are “subsets” of subjects in studies who respond to other some treatment but not others. By focusing on only one virus, without looking at other viruses and determining if just having it present, and not looking at the viral load (how much is the virus present, as is done with HIV research and drug/treatment development… We do a disservice to the thousands of patients who have other insults to homeostasis who will have no hope. Putting it bluntly, THERE IS NO ONE CAUSE for these syndromes. All the physiological changes to HPA axis, muscle fibers, collagen, etc are more likely the RESULT of the bodies reaction to varying causes and NOT the cause themselves. Who am I to say so? I am a Masters of Science, former federal investigator and fellow suffering soul with 16 years of searching research and treatment options paying attention to those who have had remissions. Those people have something to say that shouldn’t be ignored. But that’s my opinion. I respect the opinions of others, yet caution all to keep an open mind to all possibilities. The human body is complex. One last thing; therapies using protease enzymes used to theoretically break down the protein protective bio-layer supports theories of metabolic processes involving viral (several viral types are possibilities; see also Dr. Dantini’s work; he’s been treating with antivirals and eliminating food allergies detected immunologically, for years! ). Good luck to all in getting well.

  • Ruthie-Marie

    March 26, 2018 at 3:00 pm - Reply

    I sought Dr. Pridgen out as a private patient when I first learned of this as a possible treatment prior to the Phase II trials. He was kind enough to treat me with a prescription combination of both famvir and celecoxib. At the time, two years ago, I was working part time and considering whether to apply for disability due to my fibromyalgia symptoms. Following this treatment, along with surgery for reflux, my symptoms diminished to the point that I was able to accept full time employment in a highly stressful job and relocate to Washington, DC. My flare-ups went from 2-3 per month to 2-3 per year. I still have to be very careful with stress and managing fatigue, but for me, this approach has changed my life. The one common factor that made me believe that the Herpes Simplex Virus may be involved, at least for some patients, is that I had a long history of cold sores when stressed and fatigued. I have not had a recurrence of those since I began this treatment as well.

    I sincerely hope that this proves beneficial to other patients like myself. It may be very likely that other factors contribute to the onset of fibromyalgia, but for me the anecdotal cause and effect has been very dramatic.

  • Beth

    June 14, 2018 at 2:17 am - Reply

    Cort, what ended up happening in the rest of the trials. I need some reliefso bad.

    • Cort Johnson

      June 14, 2018 at 12:14 pm - Reply

      I should know more in a couple of weeks. Right now Dr. Pridgen is still trying to raise money for the trials.

  • DL Hawkins

    November 5, 2018 at 3:49 am - Reply

    I’ve seen Dr. Pridgen twice this year, and I’ve had dramatic improvement in my CFS under his treatment.

    I went from having 2- to 3-day periods where I was largely incapacitated to being able to take a challenging full-time job and fly around the country for work. I still have some mild crashes and fatigue, but none of the sustained sinus infections that used to plague and incapacitate me. In March, I was still using an electric scooter for any sort of longer outing; by the end of the summer, after 4-5 months on his protocol, I was able to take my daughter to an amusement park on foot (tho I did have a mild “crash” the day after). I’d say I’m back to about 80% of my old self, which is better than I’d really hoped for after a decade of extreme illness.

    On a personal level, Dr. Pridgen is kind and approachable, and nothing about his treatment was prohibitively expensive. There’s no telling for sure how broadly it will work until the Phase III trial, I guess, but he’s extremely confident that his treatment has helped the majority of the CFS patients he’s seen. I think it’s worth a shot for anybody who can get themselves to Tuscaloosa.

    • Cort Johnson

      November 8, 2018 at 12:09 am - Reply

      Congratulations on your success DL and thanks for sharing your experience.

      • DL Hawkins

        November 18, 2018 at 7:12 pm - Reply

        Thanks, Cort! I should have added–I heard about him from your site. So thanks for all you do here. It made a big difference for me.

        • Cort Johnson

          November 19, 2018 at 12:55 am - Reply

          🙂 🙂 🙂

  • Robin

    January 8, 2019 at 6:25 pm - Reply

    I really do hope someone figures this out. I’m 49 and have been suffering from FMS for 13 years. I do have HSV-1 since childhood. It take everything I have to hold down a full time job and survive. I no longer have the life I once had. Going to the gym, camping, hiking, etc. I love the outdoors so much and now when I’m not at work I just sit at home. Even going for a walk is taxing. I’ve been on every commercial drug available and they either make me sick, don’t work or mess with my brain too much. I already have depression from all of this so I don’t need anything making it worse. I pray and hope in my lifetime a treatment will be found so I can at least enjoy what’s left of my life.

  • Lynn Crews

    January 22, 2019 at 6:42 pm - Reply

    I am interested in joining this study on Fibromyalgia and HSV with Dr. Pridgen. Can you send me any information?

  • Aaron M.

    February 18, 2019 at 8:34 am - Reply


    Did you overcome your Lyme Disease? If so, how? And, how long did it take?


  • Aaron M.

    February 19, 2019 at 9:02 am - Reply

    Hi. Can anyone help guide me on how to reply to a specific comment? I’ve tried three different browsers — Chrome, Opera, and Internet Explorer — and I get the same behavior from all three. In short, when I click “Reply” to a comment, no dialogue box opens under that specific comment. So, instead, I went to the bottom of the page and submitted a reply. Once approved, however, my reply was not placed under the appropriate comment. Rather, it appeared at the bottom of the page. I disabled my pop-up blockers, too. Thank you. -Aaron

  • Katherine Autry

    February 19, 2019 at 11:04 pm - Reply

    Well I just tried replying to you to see if I could….i noticed that i had to wait a bit longer than normal for the dialogue box to load….not sure that is your issue but you might try again and just wait a bit to see if it comes up. Good luck!

  • Sodapop

    April 18, 2019 at 5:07 am - Reply

    Shocking that in 2020 they have no cure for any disease………. 50% pain reduction what abou the other 50%…… Pain is pain you either are in pain or your not its like saying your a little pregnant…… Give me a break the drug will be useless just like all the other drugs that don’t work they’ll make tons of money but FM patients will keep on suffering its all BS…… And why does it take decades for a drug to be approved everyone I know will be dead by the time this drug is on the market….. I blame the 99% for letting western medicine controlled by the government get away with never curing anything….. The human race won’t last long we are dumb a smarter race will wipe us out we are our own worst enemy instead of helping eachother we destroy eachother its crazy but true the aliens are eyeing us up and down and laughing their asses offabout how easy its gonna be to wipe us off the planet (the wheels are in motion), remember I said it will happen…… By the way the drug will kill viruses but why does the body keep replicating the virus in people with go fibromyalgia in the first place how about curing FM instead of another pill that won’t work on everyone and only help with 30% of the pain CURE the damn disease wipe it the hell out that would be impressuve0

  • sodapop

    April 18, 2019 at 5:15 am - Reply

    If these two drugs are already on the market why not just get them from your doctor and take them together…… Aren’t they already FDA approved

  • sodapop

    April 20, 2019 at 4:21 am - Reply

    Hello everyone does anyone know what dosage Dr. Pridgen used another words what milligram the medication was in his trial…… Thanks All the best

  • sodapop

    April 20, 2019 at 4:41 am - Reply

    What states is Dr. Pridgen doing the trials in thanks All the best

  • sodapop

    April 21, 2019 at 4:37 am - Reply

    Dr. Shiller my dads on gout medicine he has no pain but if he goes off the medicine the pain comes back…… Would Dr. Pridgens medicine work the same for fibromyalgia no pain as long as your on the medicine…. All the best

  • Sodapop

    May 26, 2019 at 3:04 am - Reply

    Hello everyone I know I have HHV-6 from blood work years ago…….. Do you know if people with fibromyalgia have HHV-6 virus Thank you very much

  • cb

    September 22, 2019 at 6:09 pm - Reply

    Riley Elijah
    did you have a consult with good health herbs and they advised you want to take? I am so glad you found relief. I would love to know what process you followed. thank you so very much 🙂 I hope you are still doing well.

  • Dooley

    September 26, 2019 at 4:26 pm - Reply

    I have FB but not IBS, would this be a good option for me?

  • Stephanie Jones

    August 6, 2020 at 2:45 pm - Reply

    I have suffered from CFS, Fibromyalgia and Myofascial pain syndrome since I was in my 20’s. I’m 51 now, plus suffer from Diabetes and experience horrible Neuropathy and I have neuralgia. Diagnoses of IBS, RLS, Mild Lupus, endometriosis, chronic Fatigue, Chronic depression and anxiety, TMJ, PTSD, pulmonary hypertension, hyperlipidemia, Vit D deficiency, Brainfog….list keeps going. I moved to Arkansas back end 2016, then 2017 I applied for disability and won in 2018. Living here in Arkansas finding a physician or NP that is knowledgeable in all my diagnoses, and one that would do actual test (rather than prescribe something or just ignore me when comes to Fibromyalgia and CFS or ME. I’m seeing NP for my primary then i have a pain dr too, and therapist. And yet nobody has done anything to rule out possible MS, or if i have Lyme, for my pain is fierce now. And i just want to make sure I’m on the right regimen. Do y’all know of physicians in my state specializing in Fibromyalgia and won’t treat me like Fibromyalgia is not real???? I saw a rheumatologist at UAMS, he flat out told me Fibromyalgia was in my head. I said hmmm, I was diagnosed mid 20’s and had 15 of 18 triggers points. I got to my car and just cried my eyes out, If I cried in front of him he’d write me off as crazy probably. I cant see one for my Lupus due to fact they won’t recognize all my illnesses. I’m sure y’all wouldn’t know a place to go, I just needed to vent the pain I’m caused for not being treated for what I’m suffering from and proper lab work not getting done to continue on the right regimen path.