Many people with Fibromyalgia and/or Chronic Fatigue Syndrome combine prescription drugs with supplements, but this is one of the rare studies that combines both to maximize the benefits of each. The genesis of this trial, however, stretches back to the HIV/AIDS days when Dr. John Kaiser in the San Francisco Bay area was supporting HIV/AIDS patients’ health with supplements.
The HIV drugs that came out saved lives, but they also hit the mitochondria hard. When that happened he tweaked his immune formula and saw the toxicity problems — the neuropathy, pain, inflammation, and fatigue they were experiencing — reverse. A double-blinded study bore out his clinical findings: the HIV/AIDS patients’ immune systems showed improvement on the supplements.
People with Chronic Fatigue Syndrome, however, were a harder case. They showed signs of mitochondrial and immune dysfunction, but only a small number responded to his mitochondrial/immune formula. If they didn’t improve after a couple of months Dr. Kaiser would add what he called ‘a touch’ of methylphenidate to ‘catalyze’ the mitochondrial boosting elements in his formula — and often it worked. The drug/supplement combination produced far superior results to taking either the drug or the supplements by themselves.
He suspected that the supplements provided more energy by enhancing mitochondrial functioning, and helped overall by supporting the immune, nervous, and endocrine systems. With the energy production system in better shape, the low-dose stimulant actually had something to stimulate. Instead of depleting those systems, it engaged them. The patients had more energy without the payback they might see otherwise.
Ritalin is a drug that’s been around for over sixty years. (Check out a History of Ritalin here ) Ritalin increases extracellular levels of dopamine by blocking the transporters which remove dopamine from the system. Higher levels of dopamine at the nerve ending results in increased dopamine signaling.
This translates into increased activation of the reward and pleasure centers of the brain, reduced ‘hyperactivity’, increased concentration and reduced stimulus overload. Some people report increased feelings of well-being as well.
Successful Proof of Concept Trial
A proof of concept trial suggested he was on the right track. Over seventy percent of Chronic Fatigue Syndrome patients experienced at least a 25% reduction in their fatigue (CIS) scores, and this reduction was sustained over a three month period. A 34% reduction in brain-fog/concentration problems and a significant reduction in visual analog scores (a pain measurement) were also seen.
If you’ve tried methylphenidate (Ritalin) by itself without success, don’t think this means it won’t work for you. While a 2006 trial found that Ritalin (10-20 mg/day) reduced fatigue and improved concentration in only 17% and 22% of ME/CFS patients, the success rate may be far higher when this stimulant is combined with the appropriate supplement support.
From Rituximab to Valtrex to the Lightning Process, some people with ME/CFS always seem to respond in dramatic fashion, and this was true here as well. He mentioned one 33 year old woman who had been disabled and unable to work for seven years. She suffered from headaches, insomnia, and exercise intolerance. She could not get to an ME/CFS specialist for treatment. Six weeks into the trial she took on a full-time job and has not only continued to work, but since then has had a child, dropped the treatment — and was fine. He stated that several people who had been unable to work are now able to work.
The Current Trial
The real test, of course, is the placebo-controlled, double-blinded trial now underway. The trial is being run at four ME/CFS experts centers at Palo Alto, CA (Dr. Montoya – Stanford University), Manhattan, NY (Enlander? Levine?),Salt Lake City, UT (Dr. Bateman), and Fort Lauderdale, FL (Dr. Klimas). Dr. Montoya is interested enough in this study that he’s banking patients’ blood in order to perform sophisticated mitochondrial and immune tests, including change in oxygen consumption, if the trial is successful.
Showing improved health and improved mitochondrial functioning would be a huge win in several ways. It would validate that there are mitochondrial problems possibly present, provide a new and relatively inexpensive treatment option, and help to legitimize the disorder.
Nobody is saying it’s going to cure ME/CFS, but it could provide help and insights into what’s going on. ME/CFS physicians and experts have clearly embraced this work. The doctor thanked Drs. Podel, Bateman, Klimas, Natelson, Levine, and Montoya as well as Suzanne Vernon for their support during the two years it took to design the trial.
The trial includes taking the nutrient supplements and 5-10 mgs of Ritalin twice a day, a significantly smaller dose, Dr. Kaiser said than was typically prescribed. It requires four visits to the site over a period of 12 weeks. Volunteers will receive a $150 stipend to help with the costs of the visits. If you are a volunteer and you complete the trial, you’ll get an additional three months of the supplement free.
Key Need – Patients!
Somehow, patient recruitment is the most expensive part of any clinical trial, and with the debility and sensitivity to medications present in ME/CFS I’ll bet it’s worse in recruiting for ME/CFS. He noted that less than 10% of patients ever take part in a clinical trial, and 30% of clinical trials never succeed in recruiting anyone.
That brings to mind a Sildenafil ME/CFS trial begun maybe ten years by a researcher at UCLA. The trial, which was designed to increase blood flow to the brain (the big brain… not the little one typically associated with Sildenafil) made sense, but I’ve heard nothing of it since.
This trial has widespread support from ME/CFS experts. Let’s get it enrolled!
Synergy Webinar On Wednesday
“The Synergy Trial-Pursuing an FDA-Approvable Treatment for CFS” is a free one hour webinar that will be conducted by Jon Kaiser, M.D., Medical Director of K-PAX Pharmaceuticals on Wednesday, May 21st at 4pm EST/1pm PST.
This webinar will:
- Describe the treatment being studied by the Synergy Trial.
- Describe how the goal of this treatment is to healthfully improve mitochondrial energy production across all cell lines.
- Describe previous study data utilizing this intervention.
- Review key enrollment criteria for participating in the Synergy Trial.
Participants will also be able to take part in a live Q & A session with Dr. Jon Kaiser. The Synergy Trial is testing a hybrid therapy of an available medication (low-dose methylphenidate) combined with a potent CFS Nutrient Formula as a treatment for CFS/ME. Enrollment is ongoing at 4 research sites across the United States.
To register click: https://attendee.gotowebinar.com/regist … 6332231938
After years of work it’s time to attempt what we’ve never been able to do before – get Congress to force the NIH to double its funding for ME/CFS. Support the historic bill to increase research funding, add new ME/CFS research centers, require the development of a strategic plan, etc.. It will take less than 5 minutes.