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Is Fibromyalgia Caused by ‘Cold Sore’ Virus? Alabama Researchers Bet It Is

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“We may have found a rather big piece of the puzzle that no one has been able to figure out.” – 10-center phase II clinical trial of anti-herpes drug combo hopes to resolve the question

Fibromyalgia and various gastrointestinal disorders may all be caused by a virus – specifically herpes simplex type 1 – according to University of Alabama virologist Carol Duffy, PhD, and Tuscaloosa-based GI surgeon/chronic pain specialist William Pridgen, MD.

Assisted by UA’s Office for Technology Transfer, the two are partners in Innovative Medicine Concepts, a startup company that’s well on the way to funding a clinical trial of two ‘repurposed’ but undisclosed drugs with anti-herpes properties, as a novel therapy for fibromyalgia pain.

GI Patients’ Relapsing Problems Sparked Experiment

Dr. Pridgen, who has reportedly treated more than 3,000 patients with chronic gastrointestinal issues and, more recently, chronic pain, said his theory about a viral role began developing as he observed the periodic recurrences of problems among many of his patients with gastrointestinal “discomforts.”

Theorizing that the underlying cause might be a virus, he tried prescribing a drug for these patients that had previously been shown to be effective for treating herpes simplex type 1 (HSV1, the virus that causes ‘cold sores’). And in fact he found that patients responded positively.

Then, because some of them also voiced other complaints, he prescribed a second medicine, which also happened to possess anti-viral properties.

The result, Dr. Pridgen notes, is that patients began indicating that:

• Not only were their GI problems much better,

• But other problems, including chronic fatigue, fibromyalgia, depression and anxiety were improving,

• And their energy levels were rising.

Based on his observational study of these patients, he reports, he found the medicine combination had an efficacy rate of almost 90%.

Drug Combo Hits Herpes Simplex Virus 3 Ways

Herpes viruses persist in the body by becoming latent and hiding from the immune system in nerve cells. They are able to reactivate and travel along the nerve cell’s axon (the fiber that conducts nerve impulses from cell to cell).

The two medicines work in different ways to counter viruses, Dr. Duffy explains.

• “The first drug inhibits the virus from replicating at one stage of the virus life cycle,

• “While the other drug inhibits it at another stage

• “And, in addition to that, the second drug also inhibits the virus from reactivating.

“So, you are basically hitting this virus in three different ways.”

Encouraged by these results, Dr. Pridgen next filed a provisional patent on the repurposing of both of the drugs for the treatment of fibromyalgia and various gastrointestinal disorders. “Repurposing” because they had not previously been known as treatment options for those conditions.

The Planned Phase II Fibromyalgia Trial

The clinical trial Innovative Medicine Concepts has in the works, with FDA approval pending, will test the effectiveness of a combination of the two drugs in treating fibromyalgia. (Though a number of chronic conditions may be made better by this combination therapy, the researchers say they chose fibromyalgia as the first condition to study because it is the most severe.)

When fully funded, and pending the FDA’s approval, the trial will:

• Recruit 140 fibromyalgia patients

• At 10 sites around the country.

• With a projected launch date by February 2013.

Dr. Duffy’s part in the study of HSV1’s potential role in fibromyalgia will involve two objectives. The first is to confirm the presence of the HSV1 virus in the affected patients. And if it does appear to play a role, a second objective would be to work on developing a quantitative test to determine whether a person has fibromyalgia.

Presently, such diagnoses are based on patients’ subjective responses to physicians’ questions about their pain.

Trial Will Involve Measurement of Signaling Molecules

In potentially developing such a test, Dr. Duffy says she is focusing on signaling molecules in the body called cytokines. The body produces different levels and types of cytokines based on what it encounters, she explains.

Accordingly, Dr. Duffy will obtain blood samples from the clinical trial participants and measure cytokine levels. Participants will periodically rate their pain levels during the course of the trial, and Dr. Duffy will study whether there is a correlation between the patients’ reported pain levels and the cytokine levels.

If a correlation is shown, Duffy would then check cytokine levels in healthy people to gauge the typical difference in cytokine levels between pain-free people and people experiencing pain.

This could lead to potentially pinpointing a cytokine level where fibromyalgia treatment would be warranted.

And the lab work that Dr. Duffy does to document the trial findings could also lead to a potential diagnostic tool for physicians treating patients who exhibit fibromyalgia symptoms, the partners suggest.

Pharma Co. Would Be Needed to Produce & Market the Therapy

If the clinical trial and tissue study prove Dr. Pridgen’s theory correct, Innovative Med Concepts would then potentially approach pharmaceutical companies to gauge their interest in buying the patent and in making the drugs available for fibromyalgia and a number of other conditions.

So, speaking of their potential ability to supply a big piece of the fibromyalgia puzzle, “It’s an exciting time for me, Carol and The University of Alabama,” Dr. Pridgen says.


Dr. Carol Duffy, 205/348-0310, cduffy3@as.ua.edu

Dr. William Pridgen, wlpridgen@comcast.net

InnovativeMedConcepts ContactUs@InnovativeMedConcepts.com


Source: Based on University of Alabama press release, Sep 7, 2012

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15 thoughts on “Is Fibromyalgia Caused by ‘Cold Sore’ Virus? Alabama Researchers Bet It Is”

  1. caulkwoman says:

    How does one get in the trials?

  2. ntucek says:

    I’m very interested in participating in this study. What do I need to do?

  3. amkat says:

    I did not acquire HSV1 until 20+ years after having issues with FMS. When having or just before an outbreak I do have more FMS like symptoms but it is more my body trying to fight back the HSV

  4. FSTJACK says:

    I went to a naturopathic MD in Scottsdale for about a four + years. I live in the San Diego area.
    At the beginning he found that I had 2 viruses, Cytomegallo and Epstein Barr.

    What he said that he was going to do was try to jump start my immune system with injections and infusions to take care of the viruses. He also had me taking Acyclovar, which gave me very bad headaches, worse than I normally had.
    For the first 3-4 months it looked like I was getting better. Then the effects seemed to diminish. He changed and adjusted the protocol many times during the total 4 years that I saw him.

    For the 15+ years I have been diagnosed with Fibro I have been sure that it is caused by a virus. The way It ebbs and flows throughout the year mimics a severe bout of the flue. What with the pain and other symptoms I am satisfied that it is a virus that is causing the troubles, I have had and am having.

  5. ProHealth says:

    Please use these contacts if you have any questions about the trials:

    Dr. Carol Duffy, 205/348-0310, cduffy3@as.ua.edu

    Dr. William Pridgen, wlpridgen@comcast.net

    InnovativeMedConcepts ContactUs@InnovativeMedConcepts.com

  6. penniefaye says:

    I do hope that this is true. My daughter and I both have fibro and get cold sores. I would be willing to do a trial on this subject. Hope it works.

  7. pycasey says:

    I really would like to participate in this trial. I have CFS/fibro and the Herpes Simplex Visus. I’ve retired because of this illness.

  8. joydolly says:

    This very interesting and I believe it is a breakthrough. I have had a severe case of Mononucleosisin university. I also have had atypical cervical sores caused by similiar virus..I always get extreme sores in my mouth when my fybro flares. ways been convinced it is from having Mono. I would like to join the study..but I live in South Korea. I have already completely gone off All the synthetic drugs and now take ProHealth supplements..which have bbeen a Godsend. Feel better but flareups continue…I also it is connected to endometriosis and my cycle…Thanks for researching.

  9. BeckieC says:

    I acquired Cytomegalovirus (CMV) through military vaccines. CMV is a Green African monkey virus from monkey kidney tissue used to culture several vaccines. Vaccine manufacturers do not filter vaccines before injecting humans. So live viruses like polio, Hep B and tetanus, along with all animal diseases from the particular animal that donated kidney tissue for culturing go straight in and kill humans.

    1. BeckieC says:

      CMV has been confused as a human herpes virus. In reality it is a Green African monkey virus derived from several vaccins that are cultured on monkey kidney tissue.

      CMV causes many diseases and damage to the gastrointestinal sytem, which is home to 90 percent of the immune system. CMV also causes neuropsychological problems such as cognitive dysfunction, memory loss, tremors, shakes, muscle cramps, spasms, lack of B12 bypassing the blood-brain barrier to interrupt muscle cramps and boost memory, boost energy.

      CMV can be found initially before gastroparesis, small intestinal disease that causes its victim to feel full before finishing eating. Just one extra bite, and everything comes back up. To the radiologist, gastroparesis looks like a blockage in the intestine. Yet, patient has no history of constipation or impacted bowels, or irregular BMs. In fact patient is likely too thin, athletic, and complains of being hungry all the time.

      To the victim, the mid-section of small intestine hurts all the time, as though it is constantly raw. Victim is always hungry for lack of susfficient food intake, malnutrition. Victim could eat as often as 6 times per day, and still wake hungry in the middle of sleepcycle.

      Victim also experiences rapid transit, bowel running loose constantly, just water, acids and whole food from previous meal 4 hours before or less. No odor, because food hasn’t had time to ferment or break down before it passes through – unexpectedly. Bowel incontinence, for women causes even more infections – UTIs and bowel bacteria travelling up the female reproductive organs for enterococcus bacterial infection of the uterus. Not vaginitis at all, fecal matter growing inside the uterus is extremely painful, hard to treat with flagyl, and hard to detect for the first 6 months, except for chronic, burning pain, deep inside between layers of small intestine, all below the naval or belly button.

      CMV may attribute to other diseases that Hep B vaccines introduce – Chronic Fatigue Syndrome, pancreatitis and colonitis. Pancreatitis is a neurological disruption that starts in the brain, as CMV does. Neuro messages are disrupted, so the pancreatic duct fails to open, fails to release pancreatic juices that must blend with bile, mix together to open bile duct and introduce to food in the first 10 inches of the small intestine – duodenum, just past the stomach.

      Pancreatic duct misfires for a couple weeks or a month, while CMV victim passes whole bits of food and water – no sign of bile or enzymes within the duodenum that break down oils and fats. Patient loses weight for food not breaking down.

      Eventually starves almost to death for lack essential nutrients such B-6, anything that provides energy or sleep-wake cycles. Patient may go for days without sleep. Sleep deprivation has nothing to do with sleep hormones. More to do with neuro-synapses misfiring for heavy metals in all vaccines, aluminum to “boost” effectiveness and thimerisol as preservative (mercury). Sleep is never restful, usually causes more confusion upon waking than rest.

      Vaccines can also re-kindle chronic Epstein-Barr virus, which is the chronic form of Infectious Mononeclosis that early vaccines trigger in infants, toddlers and pre-schoolers.

    2. MichelleG805 says:

      Beckie – Please get in touch with me. You described me to a T and I am so scared and incredibly desperate for help and guidance. You sound so knowledgeable and I’d love to hear from you. I’ve started a high dose vitamin regimen and feel much better, but I feel there has to be an actual cure out there for people like me (us?). Hate to put it out there, but…My e-mail is: m.granville08@yahoo.com.

  10. blueskiz2010 says:

    I’ve always had IBS issues & Sept 2011 I started getting really bad migraines. After many differant migraine medicine I was diagnosed with Fibromyalgia 07/26/12. I started on Cymbalta 30mg then 60mg for 5 weeks. At first it helped with my migraines but not the over all body pain. My migraines came back after 5 weeks so last week I was switched to effexor. So far I have not found any relief from the pain or the migraines. I will try anything. After reading this article I am very interested. As a child I got cold sores all the time. Now I’m 30 & i haven’t had a cold sore for many years but I know the virus stays in your system. I really want to get away from the anti-depressants since I don’t think they are the correct medication for Fibro.


  11. teagoddess says:

    I live in Clorado and am currently experiencing classic symptoms of CFS and FMS with the last two flare ups I have noticed a group of “cold sore” like lesions on my face just before the rest of the symptoms present. I would REALLY like to be involved in these study groups IF one comes to Denver CO because I do not have a regular physician and need treatment. I care for my mother who has dementia and I am suffering.

  12. ginnie@aeronagency.com says:

    Go to ushapehealth.com or download the app in the app store. By buying the app you are indirectly taking part in the study with Dr. Pridgen and it will evaluate your symptoms and see how far along you are in your pain as well as give you advice to help your pain. This is the same app used by Dr. Pridgen to evaluate pain within his clinic, this is a self evaluation. By purchasing the app the money is being donated to the clinical trial. He is looking for test subjects, to know more contact his clinic, Tuscaloosa Surgical Associates. For press information or interview scheduling please contact Ginnie Littrell at Aeron Agency at (205) 535-4421.

  13. MaggzD says:

    First, shouldn’t one PROVE that HSV I is present in a person?

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