An Alabama doctor believes fibromyalgia, related chronic pain syndromes and even digestive disorders have gastrointestinal viral infection at their heart. His planned Phase II anti-viral drug trial will put this theory to the test.
In the clinical trials that will start as early as February 2013, surgeon Dr. William Pridgen and colleagues will look at over 100 fibromyalgia patients in the hopes that Pridgen's theory is correct. In the best case scenario this would move the fibromyalgia community a step closer to a treatment option that targets the cause of symptoms rather than simply suppressing them as is the case with current painkilling and anti-inflammatory therapies.
Dr. Carol Duffy, a University of Alabama assistant professor in the Department of Biological Sciences, will assist Dr. Pridgen by analyzing lab results for specific immune system markers in the hope this will lead to a diagnostic tool for physicians.
Pridgen has been developing his theory over the past decade. He initially noticed many of his patients with gastrointestinal issues had recurring symptoms that appeared to get worse when they were under greater stress. After some priliminary investigation, he concluded these problems may be caused by the herpes simplex virus, the very same virus that causes cold sores, and prescribed an anti-viral drug. At the same time, some of those patients also complained of other symptoms, for which he prescribed another anti-viral medication. When the patients returned, not only were their GI symptoms better, but co-morbid conditions including depression, chronic fatigue syndrome and fibromyalgia were also improving with the drug combination.
The theory that viral infections are involved in fibromyalgia is not new. Dr. Mark J. Pellegrino, MD has seen the same connection in his patients for years and provides a list of possible viral infections in fibromyalgia sufferers in his book Fibromyalgia: Up Close and Personal. What might be particularly interesting with this new investigation is the gut connection thrown into the mix.
In the upcoming study Duffy will look at the blood work of an estimated 140 fibromyalgia patients to ascertain levels of specific immune signaling chemicals known as 'cytokines', before and after anti-viral treatment. It has been noted by other researchers that fibromyalgia patients typically have elevated levels of one type of cytokine and reduced amounts of another.
Pridgen and Duffy expect that their work will show that as the anti-viral drug therapy takes effect the patients will show a self-reported reduction in symptoms and a corresponding normalization of cytokine levels - essentially showing the immune system has regained balance and chronic inflammatory processes have stopped.
If results from the Phase II trial are positive, the next step would be Phase III trials, which involve thousands of patients.
"Some of these patients' stories are just heartbreaking. They are in a lot of pain, they can't work anymore, are on disability," Duffy told The Tuscaloosa News. "There's a real need for this, and I really hope this is the answer. It will give a lot of people a much better quality of life."
Pridgen added that he hopes it will be possible: "... to pursue this treatment for other chronic pain conditions, irritable bowel syndrome, headaches and more. If this proves what we think it will, it is going to change the way people think about chronic pain and chronic conditions. It will have a huge impact on a lot of people."
Promising work indeed yet fibromyalgia is undoubtedly a complex illness. Patients may be interested in reading about other possible underlying causes and symptom triggers relating to their condition here.