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Supporting Mitochondrial Function in ME/CFS and Fibromyalgia Patients

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Dr. Jon Kaiser has been treating patients with Fibromyalgia, Chronic Fatigue Syndrome, HIV/AIDS, cancer and other immune system disorders for the past twenty-five years. He is a Clinical Instructor at the Department of Medicine, University of California, San Francisco Medical School and Chief Medical Officer of K-PAX Pharmaceuticals.
Dr. Kaiser has written two books on improving immune system health, Immune Power and Healing HIV, and has given many lectures on optimizing immune function. He was also the principle investigator of a study published in the Journal of AIDS in 2006 showing that broad-spectrum micronutrient therapy can strengthen the immune systems of people with immune deficiency disorders.
His proof-of-concept study investigating a mitochondrial support strategy for patients with chronic fatigue was published in the International Journal of Clinical and Experimental Medicine in 2015.
Dr. Kaiser’s approach utilizes an integration of both natural and standard medical treatments.


1) How did you become involved with treating patients suffering with chronic fatigue?

After several grueling years of medical training and working in emergency rooms, my health started to fail. Within a one-year period, I developed chronic fatigue and chronic pain. This condition caused me to quit working in emergency medicine and open up a private practice where I could set my own hours, with enough time to rest in between patients. That change allowed me to begin working toward finding a way out of this devastating disease.

With a combination of rest, pacing, micronutrient therapy, physical therapy, plus an aggressive stress reduction program, I began to steadily improve. It took five years to get to a place where I was no longer tired and in pain the majority of the time. However, for many years I experienced relatively severe relapses that often lasted from days to weeks.

Currently, after many years of doing everything I could to support my health, I feel that my condition is in remission. However, I know that there is always a chance that it might recur if I don’t stay focused on caring for my health.

During this time I also began caring for people with fibromyalgia and ME/CFS. Over the past twenty years I have cared for several hundred patients with these conditions. I am pleased to say that I have seen many patients improve and even completely recover from both fibromyalgia and ME/CFS.

2) What do you feel is the main difference between people with ME/CFS and Fibromyalgia?

It has been my experience that fibromyalgia and ME/CFS are closely related diseases. They certainly have many symptoms in common including chronic fatigue, chronic pain, cognitive slowing and memory issues. And they are both a significant cause of disability.

In my view, people with fibromyalgia have chronic pain as their number one symptom usually followed by fatigue as their next most prominent symptom. However people with ME/CFS have chronic fatigue as their primary symptom followed closely by pain and/or cognitive slowing.

It has been my experience that both groups of patients are likely to be suffering from a mitochondrial disease. There are two important criteria for being diagnosed with a mitochondrial disease. First, fatigue is a prominent symptom. This is logical because the mitochondria make all the energy for the cells of your body; this includes the cells of the brain and peripheral nerves. Second, the hallmark of a mitochondrial disease is that its symptoms span multiple systems of the body. In both fibromyalgia and ME/CFS, multiple systems are affected. These include the nervous, immune, endocrine, muscular, and GI systems.

A mitochondrial dysfunction mechanism can perfectly explain the wide-ranging symptomatology and variability of symptoms across different patients with these diseases. There is also a growing body of research demonstrating mitochondrial dysfunction is present in both disease states.

3) How did you become interested in treating mitochondrial dysfunction and ultimately develop the K-PAX formula? (The rationale behind it.)

At the beginning of the AIDS epidemic, several of the early antiviral drugs were shown to directly cause toxicity to the mitochondria, ultimately leading to fatigue, immune dysfunction, cognitive slowing, and many other serious side effects. My primary goal in developing the K-PAX micronutrient formula was to identify an antidote to this mitochondrial toxicity in my AIDS patients.

With initial funding from the pharmaceutical giant Bristol-Myers Squibb, I was able to demonstrate extremely positive effects of this mitochondrial support nutrient formula on the nervous and immune systems of AIDS patients who were experiencing mitochondrial toxicity. The results of this double-blind, placebo-controlled trial were published in the Journal of AIDS in 2006.

5) What is the K-PAX mitochondrial support formula? And how does it work?

The K-PAX mitochondrial formula contains a key combination of micronutrients that, based on research and clinical experience, helps to improve the health and energy production of the body’s mitochondria. This key combination includes nutrients that are not often found in your average multivitamin but are critically important for optimal mitochondrial functioning.

For example, acetyl-L-carnitine, which is present in food, helps to naturally stimulate the mitochondria to generate energy from fat molecules. Since fat molecules possess twice the energy generating capacity per gram as sugar molecules, supplementing this nutrient can stimulate the mitochondria to generate more energy.

The dosages of most of the key ingredients in this formula are administered at pharmacologic dosages. This means that they are not being supplemented to treat vitamin deficiencies but instead are being delivered at levels designed to produce a positive physiologic effect in their own right.

Since there is evidence that people with fibromyalgia and ME/CFS both have some degree of mitochondrial dysfunction, providing them with a potent and clinically tested mitochondrial support supplement makes a good deal of sense. Furthermore, our recently published proof-of-concept study showed that when this particular supplement is simultaneously taken with a low dosage stimulant, a significant reduction in fatigue and alertness symptoms can occur.

6) Tell us about the K-PAX formula’s clinical trials.

The K-PAX mitochondrial support formula, also known as K-PAX Immune formula, has been tested in three different groups of patients suffering with chronic fatigue. The initial testing was performed in my clinic in over a dozen patients suffering from both fibromyalgia and ME/CFS. I observed profound improvement in a short period of time in both fatigue and alertness in this group.  

The second group of patients was those studied in the recently published proof-of-concept study. This was a prospective study meaning that patients who had never taken this treatment before were provided it as a single intervention.

After 12-weeks on treatment, 87% of the ME/CFS patients experienced at least a 25% reduction in both fatigue symptoms and concentration difficulties. The treatment was also very well tolerated.

The third group of patients to receive this treatment were those in a recently completed double-blind, placebo controlled trial known as the Synergy trial. The patients who received the treatment experienced an almost 20% reduction in their fatigue symptoms. The treatment was also well tolerated in this study.

The results of this trial provided K-PAX very important information about things like safety, dosage, and study design that justify moving forward with performing an even larger study of this treatment.

7) Does the K-PAX formula treat the chronic pain of fibromyalgia?

In the short term, the only FDA-approved treatments for chronic pain in fibromyalgia are Cymbalta, Savella, and Lyrica. These treatments have performed well enough in clinical trials to receive FDA approval specifically to lessen chronic pain. However, these medications do nothing to improve the chronic fatigue that is often present in this disease.

I believe people with fibromyalgia need to address the high probability that mitochondrial dysfunction is at the core of their disease and support their mitochondria with high potency, broad-spectrum micronutrient therapy.

If chronic fatigue is a prominent symptom, it is my belief that adding a low dosage of a stimulant medication (even something as mild as pharmaceutical grade caffeine) to your mitochondrial support program can be extremely effective at lessening and often completely eliminating chronic fatigue.

8) When will the K-PAX formula be made available to the public?

The K-PAX mitochondrial support formula that was used in the recently published journal article is currently available as “K-PAX Immune Formula”. It contains all of the micronutrients necessary for optimal mitochondrial functioning including acetyl-L-carnitine, alpha lipoic acid, N-acetyl-cysteine, B-vitamins, and many others. It now also contains Coenzyme Q-10 and methyl-folate (Quatrafolic®). It is manufactured using pharmaceutical-grade raw materials and adheres to strict quality control practices.

Note: You can purchase K-PAX Immune Formula HERE.

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2 thoughts on “Supporting Mitochondrial Function in ME/CFS and Fibromyalgia Patients”

  1. HypoGal says:

    Thank you for your work in M.E. I have been taking Low Dose Naltrone for six months and I have noticed the improvement with my Fibromyalgia Brain Fog and improved energy levels. Low Dose Naltrexone may help your patients. My Best #HypoGal #LowDoseNaltrexone

  2. charliecrow says:

    Fibromyalgia and CFS are successfully treated with guaifenesin (Mucinex). I am 51 and it is currently reversing a lifetime of pain and exhaustion for me, hands down. Everything else only treats symptoms but this safe protocol/treatment actually reverses the disease like a charm when done properly.
    Without the decades-old knowledge that Dr. R Paul St.Amand, MD has put forth, you are not treating any FMS/CFS causes.
    Please see: or Google “guaifenesin and fibromyalgia” or better yet, read the book “What your doctor may not tell you about fibromyalgia” by above named MD. It is treating me and tens of thousands more. Thank you. PS If you discount this info due to a lack of trials, (almost impossible to have trials under the protocol rules) you are missing the boat and the bigger picture here. Anyone who TRULY wants to get well needs this info to get any better at all.

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