Author’s note: This article is based on tapes of Carol Sieverling’s October 2000 visit to Dr. Cheney. He gave permission to share this information, but has not reviewed or edited it. This article is likely to apply also to FM patients who experience cognitive difficulties in addition to pain and fatigue, since Dr. Cheney believes they may also have CFS.
Dr. Cheney has 16 patients poised to begin his most promising study yet. The six-month trial involves injections of growth hormone (GH) and five different kinds of bovine growth factors (bGFs). Dr. Cheney believes this may be helpful to phase III patients "who are symptomatically improved but physically limited", and some phase II patients who are treatment resistant.
Per Cheney, "The study is an ambitious but promising attempt to stimulate the body’s innate healing potential to repair damage done to it over years of CFS related pathology." An oversimplified explanation is that GH provides the construction workers and bGFs provide the blueprints to repair the damage to the brain and organ systems.
WHAT DOES GH DO? It stimulates the growth of muscles and bones, helps regulate metabolism, slows the production of fatty tissue, helps maintain blood sugar levels for the brain, helps regulate all other hormones, and mobilizes fat, making it available to the cells as an alternative fuel.
In healthy people, GH levels are near zero most of the time but spike in response to physical stress. Protein synthesis is the primary function of GH.
That is why it spikes in response to exercise – because exercise breaks down muscle. GH then repairs it better than before. It is called training and your body gets stronger. But if you try to train when you have no GH, you induce micro-trauma and your muscles break down instead of becoming stronger.
GH is associated with stage four sleep. A major spike should also occur in the middle of your "night", whenever that maybe. GH and stage 4 sleep are interdependent, like the chicken and the egg: no GH, no stage four sleep; no stage four sleep, no GH.
Dr. Cheney stated "At 3 a.m. the liver comes up and maximally detoxifies. Isn’t it interesting that the body spikes GH not long before the liver needs it? It primes the liver. If you don’t get the priming with GH at midnight, then your liver doesn’t work and you become more toxic." (Times are relative to your own sleep pattern.)
CFIDS IS A GH DEFICIENCY SYNDROME. Dr. Cheney first learned this when reading a Ph.D. thesis by Greta Moorkens published in May 2000. Using the Insulin Tolerance Test (ITT), Moorkens found that CFS patients had, on average, a 50% reduction in GH. Her patients, however, had only been ill an average of 18 months, a relatively short time. Dr. Cheney suspected patients who have been ill longer might have a more profound deficiency. He also knew he could no longer rely on the standard IgF-1 test to measure GH, since Moorkens’ paper showed it was not a reliable measurement of GH.
To compare two different testing methods, Dr. Cheney used both the ITT and a maximum exercise test – a bicycle stress test. He drew blood before the bike test, and again ten and twenty minutes after the test. The ITT was only done on a few patients because this test is so hard on them physically. Dr. Cheney believes the bicycle test is safer. Both tests gave the same shocking results in each patient: no growth hormone response at all, not even a tiny spike.
Dr. Cheney has tested three of our local members using the bike test. Two had no GH response. One had a small spike. Twenty minutes after the test she had a level of 5.6 ng/mL. The middle of the normal range is 24; anything under 10 is deficient.
DANGERS OF GH DEFICIENCY
Dr. Cheney explains that if your GH response is zero that means serious trouble. "You lack sufficient control of protein synthesis to respond to exercise, to respond to stage four sleep, to respond to the needs of detox, and all kinds of other problems."
To make matters worse, if your immune system is TH2 dominant (as is the case in most CFIDS patients – see next article), the only thing standing between you and cancer, viral infections and intracellular bacteria is RNase L, which you cannot make without GH. It is a very serious problem.
GH DOSING & FREQUENCY
Six months of experience in using GH injections in his patient population have convinced Dr. Cheney that it is one of the most powerful treatments for a CFIDS patient. However, the dose and the frequency of the dose are critical. The standard dose (0.1 to 0.2 cc’s given three times a week) put Dr. Cheney’s patients in bed. In his words, they crashed and burned. To give that much to a seriously deficient patient is a "command directive" to increase protein synthesis, including RNase L. That is very expensive in terms of energy. With no energy to spare, the body must redirect every ounce to protein synthesis. The GH may trigger the production of RNase L, which is both good and bad, but too much of it contributes to the crash.
Regarding the dose and frequency of the GH injections, Dr. Cheney's study protocol states "Previous clinical observations in CFS patients have suggested that optimal doses will range between 0.005 and 0.02 mg/kg administered every five days, up to three times a week. Begin subcutaneous injections of rhGH in the thigh with 0.005 mg/kg every five days when you receive the rhGH cartridge and sterile water dilutant. During the first several injections, you may note fatigue and lethargy. With time you should resolve these symptoms and can advance to between 0.01 mg/kg and 0.02 mg/kg given twice a week. The correct dose is achieved when you experience a slight boost in energy hours after the injection and even more energy the next day.
The energy boost should then decline with every day thereafter until the next rhGH injection. We recommend the shots be given when you arise or during the daytime just before heightened activity begins. Some patients will prefer to give the injections just before bedtime as it may substantially improve sleep quality. Some patients may wish to advance the injection frequency to three times a week if there is no adverse response to this. We recommend you experiment, within the boundaries we set, with dose (0.005 – 0.02 mg/kg), frequency (every fifth day to three times per week) and time of day (AM to PM)."
The study protocol continues "One common manufacturer of rhGH uses a dual cartridge with 5.8 mg of rhGH powder on one side and 1.17 cc of sterile water on the other side. The cartridge is shipped overnight and must be refrigerated immediately upon receipt. Following a puncture and mixing procedure within the cartridge itself, the final solution contains 5.0 mg per cc in 1.17 cc. It is important to note that after mixing, the rhGH is only good for three weeks. At a 0.01 mg/cc dose given twice a week, about 40% of the cartridge would be discarded. Another manufacturer requires that the patient mix the 5.8 mg (15 units) of rhGH powder himself with 1-3 cc's of sterile water from a separate vial of sterile water supplied through a kit.
It also will last three weeks and is 30% cheaper. RhGH is also supplied in a 1.5 mg cartridge but it only lasts 24 hrs after mixing. However, a special dilution procedure done by the patient will extend the product life for three weeks. Choosing which product to use can be a complicated choice between ease of use and expense, and hinges on dose or frequency, which will be changing and cannot be predicted."
The previous two paragraphs can seem confusing if not contradictory because of the different units used. All that can be said at this time is that the Cheney Clinic confirms that despite the mg/kg used in the first paragraph on dosage, body weight is not a factor, and that all study participants begin with only the top fraction of a one cc syringe filled with GH.
TWO SUCCESSFUL CASES
One very ill patient was sensitive to everything: vitamins, drugs, supplements, food, and the environment. He was very sallow from liver dysfunction and his white count was 2. He has been the most dramatic response so far. His liver function has come back; his immune system has come back. He is now responding to interventions that have never worked in the past.
Another patient was menopausal and was on thyroid medication, estrogen and progesterone. After beginning GH injections, she cut her thyroid medication in half. Her periods resumed and she no longer needs to take progesterone.
According to Dr. Cheney, growth hormone encodes the receptors for all the other hormones. If you do not have any GH, none of your other hormones can work properly. Many female CFIDS patients appear menopausal, yet estrogen levels in their saliva and urine are sky high. Estrogen goes right through them because there are no longer any receptor cites encoded to receive it.
BALANCE THE IMMUNE SYSTEM FIRST. Growth hormone raises immune function, but it activates the TH2 side in particular. Thus, it is important to balance the immune system before beginning GH injections.
RISKS OF TAKING GROWTH HORMONE
(1) It is expensive. However, if a deficiency is documented with the ITT or a maximum exercise challenge, insurance companies will usually pay.
(2) CFIDS patients are sensitive to it, so it is imperative to get the dose and frequency right.
(3) Growth hormone does not cause cancer, but it will increase the growth rate of any undetected cancer. Patients should have routine screening exams.
Dr. Cheney also strongly recommends the AMAS test (Anti-Malignant Antibody Screen). This blood test detects all forms of cancer, even in the early stages. It is based on the well-published discovery by two Harvard professors that all cancers express a substance that triggers the production of certain antibodies. It is covered by Medicare and costs about $135. (Call 1-800-922-8378 for information or a test kit.)
(4) Axis Suppression [The author believes Dr. Cheney is referring to the HPA axis – hypothalamus, pituitary and adrenal.] Dr. Cheney commented, "If I give GH, will I suppress your own endogenous capacity to make it? If I did that, I commit you to GH forever. But this is not a concern if you have no axis to begin with!"
REPAIRING THE DEFICIENCY
Dr. Cheney asked the rhetorical questions, "Can the damage that caused the GH deficiency be repaired? Can we resuscitate your hypothalamus and your axis?
Yes, we can. How? The same way they cured the Parkinsonian patients featured in the May 22 issue of Newsweek." Parkinson’s Disease involves the death of certain brain cells, causing a progressive loss of muscle control that eventually leads to paralysis and death. In this revolutionary study, doctors grafted fetal stem cells into nineteen Parkinsonian recipients. Sixteen of the grafts "took.” Of those, the stem cells repaired the damage to the brain and cured the disease in patients who were under 60 years of age. If they were over 60, the process did not work. The difference? Growth hormone! For stem cells to work, the body has to have enough GH.”
Stem cells are embryonic, undifferentiated cells capable of becoming virtually any cell of the body. According to Dr. Cheney, "Stem cell differentiation into a neuron and integration to repair the brain is a highly protein synthesis-intensive process. Without GH, the stem cells do not work."
"You might say, 'Dr. Cheney, they used stem cells and you are talking about growth factors, not stem cells.' Well, ten years ago when they started this research, they did not think there were any stem cells in the body, especially at the 60-year mark. But recent research has proven that there are stem cells in the body. All we have to do is turn them on. And growth factors turn them on!"
Cheney explained how scientists have repaired brain injuries in monkeys; it was not necessary to give them stem cells. Stem cells were already there just waiting for a message and enough protein synthesis to work. Scientists were able to repair the monkey's brains using bovine growth factors, which trigger the stem cells.
However, the monkeys already had plenty of GH before their bGF therapy. Cheney stated, "So what we need to do is give you GH, then add bovine growth factors. If this works, then we repair your hypothalamus, and your axis comes back, your endogenous capacity to make GH comes back, and then we get you off GH."
Cheney said, "I don't like the idea of injecting this patient population with GH for the rest of their lives. I'd rather just give it to you for a short time, while you heal your systems. But I have yet to determine that. Worst case, you're committed to GH for the duration. Best case, just until such time as we repair the injury that causes the GH deficiency. And if that works, of course, then we have a lot of good things to do in the area of CFIDS. Almost everything else is somewhat secondary to these central features."
DOCUMENTING BRAIN REPAIR
"How do we prove that we have repaired the brain? One way is functional: give the bicycle test to show that your growth hormone response to exercise, which
was deficient initially, comes back after therapy."
The other way to prove brain injury is to actually measure the injury itself. Cheney sends his patients to Columbia Medical Center in New York for an MRS (Magnetic Resonance Spectroscopy) for this measurement. He recommends it to many of his patients, not just those in this study. This is a good test for disability documentation. The readout of this test is a horizontal line with periodic spikes of different heights. Each spike represents a particular substance or chemical.
This particular MRS scan is of the hypothalamus and the cerebrospinal fluid in the body in the left ventricle of the brain. Dr. Shungu, a spectroscopy expert and a professor of radiology, does the test.
Dr. Shungu examines four particular spikes in CFS patients:
1) Coline. It is involved in the myelin sheath, and a decrease indicates Multiple Sclerosis.
2) Creatine Phosphate. It is usually elevated in CFS patients and indicates the increased stored energy of the anaerobic system. The author believes this may be related to the injured aerobic energy pathway so typical of CFS, and the corresponding increased reliance on the anaerobic pathway.
3) NAA. If this is decreased, as is typical in CFS, it indicates brain cell death.
4) Lactic Acid. There should be none present; this is what is glaringly elevated in most CFS patients tested. It indicates a high degree of tolerance to the damage to the aerobic system.
Cheney commented "If the viability spike, NAA, increases after therapy and the lactic acid spike decreases, it means we are repairing the brain."
HISTORY OF GF USE
Growth Factors (GF) were used eighteen years ago at UCLA to repair bones that would not heal. The first publication of their use was in 1982. In Europe, they have been in use much longer. Cheney noted, "Pope Pius XII received injections on his death bed in 1952 and lived four more years. GFs have been around a long time, but it has only been in the last ten years that we have begun to discover how they really work."
"You do not have to use human growth factors. You can use mammalian GFs. They inaugurate stem cell differentiation. It will become whatever is needed. The stem cell will repair any injury. All you need are growth factors and sufficient growth hormone."
YOUNG PEOPLE WITH CFS – 90% RECOVERY
"Nine times out of ten, young people with CFIDS recover. But past 20, you’re lucky to see one out of ten get through it. Why? Growth Hormone. You have to have enough GH to get through it. Young people still get hit, some very hard, but they have so much GH that they can loose 50% and still have enough. Once you reach 20, your GH is half what is was at 15. It drops precipitously after puberty."
"I think this syndrome transforms you into a very low GH state, and once that happens you can't really repair the damage. You can get through the syndrome, maybe; get through the pathophysiology of the disease, maybe; but then you're locked in, you're limited. So, to repair the damage – and the focus of that damage is the hypothalamus – you need GH. And since GH seems to be the center of aging, essentially the treatment of Phase III CFIDS is going to mimic the treatment of age-related injury."
Cheney believes that younger people may only need GH, not the Bovine Growth Factors (bGF), since they could still have functioning growth factors. Older patients will certainly need the bGFs. Even if they have some functioning GFs, taking the bGFs is expected to accelerate the healing process.
WHICH BOVINE GROWTH FACTORS?
Those in the study will take GH the entire six months. They will begin mesenchyme fetal bGF the second month and continue it for the duration. The four remaining bGFs, liver, thymus, adrenal and brain, are taken consecutively for a period of one month each. The study protocol states "GH is expected to significantly increase the bGFs healing potential as orchestrators of endogenous stem cell migration, differentiation and integration to effect tissue healing. The target tissues for healing in this study are liver, immune system, adrenal gland and especially the hypothalamus."
© 2002 Carol Sieverling. Web site: http://virtualhometown.com/dfwcfids/menu.html