From the Townsend Letter for Doctors & Patients
Highly Effective Treatment
of Fibromyalgia and Chronic Fatigue Syndrome: Results of a Placebo Controlled
Study and How to Apply the Protocol
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(Previously Published: Journal of Chronic Fatigue Syndrome Volume 8, Issue 2 – 2001)
Background: Hypothalamic dysfunction has been suggested in Fibromyalgia (FMS) and Chronic Fatigue Syndrome (CFS). This dysfunction may result in disordered sleep, subclinical hormonal deficiencies, and immunologic changes. Our previously published open trial showed that patients usually improve by using a protocol which treats all the above processes simultaneously. The current study examines this protocol using a randomized, double-blind design with an intent-to- treat analysis.
Methods: Seventy-two FMS patients (38 active: 34 placebo; 69 also met CFS criteria) received all active or all placebo therapies as a unified intervention. Patients were treated, as indicated by symptoms and/or lab testing, for: (1) subclinical thyroid, gonadal, and/or adrenal insufficiency, (2) disordered sleep, (3) suspected Neurally Mediated Hypotension (NMH), (4) opportunistic infections, and (5) suspected nutritional deficiencies.
Results: At the final visit, 16 active patients were "much better," 14 "better," 2 "same," 0 "worse," and 1 "much worse" vs. 3, 9,11, 6, and 4 in the placebo group (p < .0001, Cochran-Mantel-Haenszel trend test). Significant improvement in the FMS Impact Questionnaire (FIQ) scores (decreasing from 54.8 to 33.2 vs. 51.4 to 47.7) and Analog scores (improving from 176.1 to 310.3 vs. 177.1 to 211.9) (both with p < .0001 by random effects regression), and Tender Point Index (TPI) (31.7 to 15.5 vs. 35.0 to 32.3, p < .0001 by baseline adjusted linear model) were seen. Long term follow-up (mean 1.9 years) of the active group showed continuing and increasing improvement over time, despite patients being able to discontinue most treatments.
Conclusions: Significantly greater benefits were seen in the active group than in the placebo group for all primary outcomes. Using an integrated treatment approach, effective treatment is now available for FMS/CFS.
Why Have These Diseases
Been so Confusing?
How to Make the Diagnosis
• Have you had pain that lasted over 6 months that affects your upper and lower body and right and left side without a clear cause? If so, you likely have fibromyalgia.
• Are you exhausted, have 'brain fog' and can't sleep (with no known cause for over 6 months), the symptoms do not go away with rest, and they limit your activity significantly? If the answer is yes, you likely have CFS unless another cause is found.
Also ask the patient if he or she has the following symptoms:
• Feeling worse (often described as feeling as if he or she was "hit by a truck”) the day after exercise.
• Brain fog (difficulty with word finding and substitution, poor short term memory and poor concentration).
• Bowel dysfunction. Many people diagnosed with irritable bowel syndrome (IBS) or spastic colon have CFIDS/FMS.
• Recurrent infections including chronic sinusitis, and/or chemical/medication sensitivities.
The Causes of CFIDS/FMS
Current research and clinical experience show that these patients have a mix of disordered sleep, hormonal deficiencies (often with "normal” laboratory test results), low body temperature, and autonomic dysfunction (for example, low blood pressure, and neurally mediated hypotension [NMH]). This mix makes sense when you recognize that the hypothalamus is the major control center for all four of these functions.
Although still controversial, a large body of research also strongly suggests mitochondrial dysfunction as a unifying theory in CFIDS/FMS. In several genetic mitochondrial diseases, severe hypothalamic damage is seen (possibly because the hypothalamus has high energy needs).4 The mitochondrial dysfunction, combined with secondary hypothalamic suppression, can cause the poor function seen in tissues with high energy needs. This includes dysfunction of the immune system, liver (with medication/chemical sensitivities secondary to decreased ability to detoxify), gastrointestinal tract, muscles, and central nervous system (CNS) (brain fog and decreased neurotransmitters).
Evaluating and Treating
• The patient has fibromyalgia, and/or
• The patient's oral temperatures are generally less than 98.2°F, and/or
• The patient has symptoms and signs suggestive of hypothyroidism, and/or
• The patient's TSH test result is less than 0.95 or greater than 3.0, and/or
• The patient's T3 or T4 are below the fiftieth percentile of normal.
As physicians, we are trained to interpret a low-normal TSH-that is, 0.5 to 0.95 as a confirmation of euthyroidism. The rules, however, are different with CFIDS/FMS. In this setting, hypothalamic hypothyroidism is common and the patient's TSH can be low, normal, or high.5 This is why I recommend an empiric therapeutic trial of thyroid-hormone treatment if the TSH and T4 are both low normal. Also, if sub-clinical hypothyroidism is missed, the patient's fibromyalgia simply will not resolve. The inadequacy of thyroid testing is further suggested by studies that show:
• That most patients with suspected thyroid problems have normal blood studies.6
• That when these patients with symptoms of hypothyroidism and normal labs were treated with thyroid (Synthroid in an average dose of 120 mcg every day [qd]) a large majority improved significantly.7
In addition, I would add the following:
• If the patient does not respond to Synthroid, switch to Armour Thyroid, and vice versa. For every 50 mcg of Synthroid, have the patient take 1/2 gr (30 mg) of Armour Thyroid. If the free or total T3 result is low or low normal, begin with Armour Thyroid, which has both T3 and T4, instead of Synthroid, which has only T4. I usually recommend beginning with Armour Thyroid.
• Adjust the thyroid dose according to how the patient feels and also to keep oral temperatures greater than 98°F, as long as the T3 or T4 tests do not show hyperthyroidism. Do not use TSH to monitor thyroid replacement. Because of the hypothalamic suppression, it may be low despite inadequate hormonal dosing.
• Make sure that the patient does not take any iron supplements within six hours or calcium within two hours of the morning thyroid dose or the thyroid hormone will not be absorbed. Have the patient take the iron between 2:00 and 6:00 p.m. on an empty stomach and away from any hormone treatments.
• Thyroid supplementation can increase a patient's cortisol metabolism and unmask a case of subclinical adrenal insufficiency. If a patient with symptoms of low thyroid feels worse on low-dose thyroid replacement, the patient may have adrenal (or thiamine) insufficiency. Consider treating the adrenal insufficiency first, and add thiamine 500 mg 2x day and taurine 1000mg 3x day for 4-6 weeks and then retry the thyroid treatment.
In addition, if the midday temps are under 98.1°F, consider iodine 1500 mg/day for 1-2 months. This will often raise the temperatures and ease symptoms. Dr. Richard Shames has noted that iodine may flare symptoms in patients with Hashimoto's thyroiditis and should be stopped if this occurs.
Research by John Lowe DC suggests that thyroid receptor resistance occurs in fibromyalgia. Some patients who fail regular thyroid hormone treatment respond dramatically to high dose T3 sustained release. Remember that every patient is an individual and will respond differently to treatment.
To put it in perspective, if the early thyroid researchers had given ten times the physiologic dose of thyroid hormone (for example, 1,000 to 2,000 mcg qd instead of 100 to 200 mcg), a situation analogous to early adrenal research, many people would have had severe complications. Thyroid hormone would be viewed as very dangerous and we would only be treating hypothyroid patients on the verge of myxedema coma. In adrenal insufficiency, this is what occurs now. Many hypoadrenal patients are only treated when they are ready to go into Addisonian crisis. Research and clinical experience shows that this approach misses most hypoadrenal patients.11
Symptoms of an underactive adrenal include weakness, hypotension, dizziness, sugar craving, and recurrent infections – all of which are common in CFIDS/FMS. I evaluate CFIDS/FMS patients' adrenal function with a morning cortisol level and, when available, a cortrosyn stimulation test. The test must begin between 7:00 and 9:00 a.m. The patient should not eat anything the morning of the test and also have no caffeine for twenty-four hours before the test. Check a baseline cortisol level and, if convenient, then do the cortrosyn stimulation test by giving ACTH (Cortrosyn) 25 units or 1 unit IM (current data suggests the 1 unit Cortrosyn test is more reliable) and recheck cortisol levels at one-half hour and at one hour. Although a baseline of 6 mcg/dl is often considered "normal,” most healthy people run approximately 16 to 24 mcg/dl at 8:00 a.m.
My treatment guidelines are that if the baseline cortisol is less than 16 mcg/dl or the cortisol level does not increase by at least 7 mcg/dl at thirty minutes and 11 mcg/dl at one hour, or does not double by one hour and is less than 35 mcg/dl, I treat for adrenal inadequacy. Natural treatments include:
1. Adrenal Glandulars.
2. Panax ginseng 100-500 mg 2 x day
3. Sustained release pantothenic acid (Vitamin B5) 1000 mg 2 x day
4. Vit C 500-2000 mg/day
5. Licorice(not DGL)
If these do not take care of the problem, consider a therapeutic trial of 5 to 15 mg Cortef in the morning, 2.5 to 10 mg at lunch time and 0 to 2.5 mg at 4:00 p.m. (maximum of 20 mg a day). Most patients find 5 to 7 1/2 mg qAM plus 2 1/2 to 5 mg at noon to be optimal (the equivalent of 1 1/2 to 3 mg prednisone daily). Cortef is much more effective than prednisone in CFIDS/FMS.
After nine to eighteen months, taper the treatments off over a period of one to four months. If the other physiologic stresses, such as infections or fibromyalgia, have been eliminated, the patient's adrenal function may be adequate or normalized. If symptoms recur after the treatments, continue treatment with the lowest optimal dose.
Improvement is often dramatic and is usually seen within two to four weeks. If using glandulars or Cortef, the dose should be doubled during periods of acute stress and raised even higher during periods of severe stress such as surgery. Consider also giving the patient 1,000 mg of calcium and 400 international units (IU) of vitamin D daily with Cortef.
There are different approaches to treatment and more is not better. High dose Cortisol taken at night will worsen already disrupted sleep patterns. A recent study by Strauss published in the Journal of the American Medical Association gave too high a dose (about 25 to 35 mg a day) and too much at night – severely disrupting patients' sleep (p<.02). Although he did not treat the sleep disorder, most patients felt somewhat better on treatment. A small percentage of the patients had significantly decreased post treatment Cortrosyn tests, without complications, and he, I believe incorrectly, recommends against using Cortef in CFIDS/FMS.12 Our study did not show adrenal suppression using lower Cortef dosing.13 Dr. Jefferies, with thousands of patient-years' experience in using low-dose Cortef, recommends an empiric trial of Cortef in all patients with severe, unexplained fatigue.14 Our research and clinical experience suggests this is the best approach.
The majority of CFIDS/FMS patients have suboptimal DHEA-S levels, and the benefit of treatment is often dramatic. Most females need 10 to 25 mg a day and most males 25 to 50 mg a day. Adjust to the dose that feels best, as long as the DHEA-S level stays under 200 mcg/dl in females and 480 mcg/dl in males.
Interestingly, as patients improve, their bodies begin to make DHEA on their own and the DHEA-S level can shoot up. If the level goes too high, the patient can get acne or darkening of the facial hair. Because of this, it is reasonable to initially check the DHEA-S level every 2-4 months in a female or every 3-6 months in a male. Although the body's DHEA-S level is fairly stable throughout the day, which is why I check the DHEA-sulfate level as opposed to the much more variable DHEA level, the DHEA-S level does show significant peaks and troughs when DHEA is taken by mouth. I recommend either prescribing timed-release DHEA (available at General Nutritional Centers) or using two to three times a day (b.i.d-t.i.d.) dosing and check blood levels two to four hours after taking a dose of DHEA. When the DHEA-S level rises over 200 mcg/dl in a female or 450 mcg/dl in a male, start to taper the dose.
Do not be surprised if a patient's gray hair turns back to its original color in six to eighteen months. This is one reason DHEA got the name "the fountain of youth hormone.”
Low Estrogen and Testosterone
In her book on estrogen and testosterone deficiency, Dr. Elizabeth Vliet gives a well referenced foundation for evaluation and treatment of these problems.18 To summarize, the initial symptoms of estrogen deficiency are poor sleep, poor libido, brain fog, achiness, PMS, and decreased neurotransmitter function. Dr. Vliet feels that estradiol levels at midcycle should be at least 100 pg/ml. If a woman's CFIDS/FMS symptoms are worse at ovulation and the ten days before her period, or if there is inadequate vaginal lubrication and/or hot flashes, then a trial of estrogen is warranted. It is reasonable to use natural 17-B-estradiol instead (for example, Estrace or Climara patches). Transdermal estrogen has the added benefit of raising growth hormone (which is low in FMS), where oral estrogen does not. Some women feel better with bi-estrogen (developed by Dr. Jonathan Wright) which also contains the estrogen of pregnancy. Interestingly, women with FMS usually feel better during pregnancy.
The usual dose of Climara is one 0.05 to 0.1-mg patch a week, Estrace is 1/2 to 2 mg a day, and Bi-est is 1 1/4 - 2 1/2 mg 1-2 x day adjusted to what feels best to the patient. In the absence of a hysterectomy, progesterone should be added to prevent uterine cancer. Natural progesterone (available from most pharmacies as Prometrium 100 mg), is better tolerated than Provera. The dose is 100 mg at bedtime (qhs), instead of Provera 2.5 mg, or 200 mg a day for ten to fourteen days a month, instead of Provera 10 mg. Progesterone helps sleep and is best taken at night. It is appropriate to try progesterone even in women who have had a hysterectomy if it helps their symptoms. Many practitioners give only progesterone, an approach popularized by Dr. John Lee.
For men, the standard dose is about 100 to 125 mg by intramuscular injection (IM) every seven to ten days. It can also be given as 200 mg each two weeks, but this can result in peak levels (right after the shot) that are too high, and levels that go too low for a few days before the next shot. Adding the testosterone patches on day nine through fourteen (when getting the shot every fourteen days) can avoid the levels going too low. I feel that giving the shot weekly is much better, however. I use Delatestryl 200 mg/cc and give 1/2 or 6/10 cc every seven to ten days. Unfortunately, the skin patches alone are not adequate for the job. Although I've avoided using testosterone tablets in men, testosterone cream (100 mg/gm in PLO Gel) 25 to 50 mg 1-2 x day (available from most compounding pharmacists) can be very effective. I will sometimes wait until after a patient has been on the shots for eight weeks so he can tell what the optimum effect is. The problem (for men) with taking tablets instead of transdermal creams is that oral testosterone goes to the liver first. The higher dose in men (versus women) can sometimes raise cholesterol levels (cholesterol is produced by the liver). Avoiding other possible side effects by taking the transdermal hormone daily, instead of getting high and low levels by taking it IM every week or two, may be another benefit of the transdermal creams. The benefits of treatment (it takes six to eight weeks to see the effect) are often dramatic. Androderm gel (25 and 50mg/5cc) is also now available in most pharmacies, but is much more expensive than compounded testosterone.
For women, the treatment is easier. Natural micronized testosterone (and natural estrogen and progesterone) are available through most compounding pharmacies. Belmar pharmacy and Cape Drugs are two of many that do mail-order prescriptions. The usual dose is 2 mg one to two times a day by mouth (po) or transdermally (4mg/gm cream). If the patient needs estrogen or progesterone, these hormones can be combined in the same capsule for a lower cost.
I check free testosterone blood levels (in men and women) six to eight weeks after starting therapy (in men, before their eight-week shot) and adjust the dosing accordingly. Blood levels are not reliable, however, if the patient is taking synthetic methyl testosterone instead of natural testosterone. In addition, blood levels for oral or transdermal dosing peak at about two to three hours and are back to baseline by five hours, so the blood level should be checked two to three hours after oral or transdermal dosing.
In women, if acne, intense dreams, or darkening of facial hair occurs (as can occur with DHEA as well), the dose is too high and should be decreased (these are usually reversible). These side effects can also be caused by estrogen being too low, relative to the testosterone level and may be avoided in women by supplementing both together. In men, acne suggests the dose is too high. It is important to monitor levels because (as in body builders who abuse testosterone by taking many times the recommended physiologic dose) elevated levels can cause elevated blood counts, liver inflammation, decreased sperm counts with infertility (also usually reversible) and elevated cholesterol with increased risk of heart disease. Because of this, in men, I would monitor a CBC, cholesterol, and liver enzymes intermittently. Testosterone supplementation can also cause elevated thyroid hormone levels in those taking thyroid supplements. If the patient is on thyroid supplements, I would recheck thyroid hormone levels after six to twelve weeks or sooner if they get palpitations or anxious or hyper feelings. Raising a low testosterone level has been shown repeatedly to lower cholesterol, decrease angina and depression, and improve diabetes. Unfortunately, our training mostly focused on the effects of abusing testosterone with pharmacologic and illicit dosing.
I do not recommend most addictive sleeping pills. Most addictive sleep remedies, except for clonazepam (Klonopin) and alprazolam (Xanax), actually decrease the time that is spent in deep sleep and can worsen fibromyalgia.
The treatments that I do recommend include the following:
• I have designed a wonderful herbal sleep formula containing valerian root, hops, Jamaican Dogwood, Wild Lettuce, L-theanine, and passion flower. It is much more effective than any other sleep formula I've tried and is wonderful. I have a strict policy of not taking money from any company whose products I recommend and all of my royalties are donated to charity (often further helping holistic causes).
The product "Revitalizing Sleep Formula" can be found in health food stores and practitioner's offices (from Enzymatic Therapies/PhytoPharmica)
• Melatonin-1/2 mg /night is optimal for most patients, although some benefit from higher doses.
• 5-HTP at 300 mg/ night has been shown to decrease pain and improve sleep.20 but it is expensive. The dose should be lowered to ~150 mg /day in those on anti-depressants.
• Kava kava is helpful but may cause liver problems.
• Calcium and Magnesium taken at bed time can improve sleep.
• Lemon balm is somewhat helpful.
• Pregnenolone 150 mg/night may also help.
If the natural remedies do not result in at least 8 hours of deep sleep a night, consider adding these meds:
• Doxylamine (Unisom for Sleep), 25 mg qhs.
• Zolpidem (Ambien), 5 or 10 mg. Use 5 to 20 mg qhs.
• Cyclobenzaprine (Flexeril), 10 mg, and/or carisprodol (Soma), 350 mg. Use 1/2 to 2 tablets qhs.
• Trazodone (Desyrel), 50 mg. Use 1/2 to 6 tablets qhs.
• Amitriptyline (Elavil), 10 mg. Use 1/2 to 5 tablets qhs. This drug causes weight gain and can worsen NMH.
Some patients will sleep well with the natural remedies, and others will require all of the above combined. Because the malfunctioning hypothalamus controls sleep and the muscle pain also interferes with sleep, it is often necessary and appropriate to use multiple sleep aids. Because of next-day sedation and possibly slow liver clearance, CFIDS/FMS patients do better combining low doses of several treatments than with a high dose of one.
Although less common, two other sleep disturbances must be considered and, if present, treated. The first is sleep apnea. This should especially be suspected if the patient snores and is overweight and hypertensive. Sleep apnea is treated with weight loss and nasal C-pap. Restless leg syndrome (RLS or PLMs), is also more common in fibromyalgia.21 (Yunus, 1996). Asking the patient if the bed sheets are scattered about when he or she awakes and/or if the patient kicks his or her spouse during the night will often let you know RLS is present. RLS is treated with iron if the ferritin level is under 40,Vit E 400 units/day, Kava, Ambien, or Klonopin. If these conditions are present and the patient does not improve with our treatment, I would consider a sleep apnea study. I would get pre-approval from the patient's insurance company, as the test usually costs $1,500 to $2,000. Another cheaper option is to have the patient video tape themselves at night to look for apnea or PLMs.
Immune Dysfunction and
In my experience, chronic sinusitis responds well to anti-fungals and poorly to antibiotics. Conservative measures (for example, saline nasal rinsing, avoiding milk products, and so on) are also helpful. These are discussed in my book, and are reviewed at length in the wonderful book Sinus Survival written by Dr. Robert Ivker (Tarcher Putnam, 2000).23 Avoiding antibiotics also decreases the risk of secondary fungal overgrowth in the sinuses and GI tract. Many patients find that a nose spray containing Bactroban, Xylitol, and sporanox can also be very helpful (compounded by Cape Drug by prescription: 410-757-3522)
Bowel infections with alterations of normal bacterial flora, fungal overgrowth, and parasitic infections (parasites are seen in one-sixth of my patients) are the norm in this disease. This is reflected by the patient's bowel symptoms. Because of the lack of a definitive test for yeast overgrowth, I treat for yeast empirically based on the patient's history. Stool testing for all infections by Great Smoky Mountain Labs can also be very helpful.
A history of frequent yeast vaginitis, frequent antibiotic use (especially tetracycline for acne), onchomycosis, chronic sinusitis, or gas, bloating, diarrhea or constipation, in my experience with over 1,000 CFIDS/FMS patients, warrants an empiric therapeutic trial of anti-fungal therapy. Many CFIDS/FMS patients who failed other therapies for spastic colon have responded dramatically to anti-infectious treatments. This was also shown in our 1995 study.24
Treating for fungal infections is critical in most CFS/FMS patients. Natural remedies include:
1. Acidophilus and other probiotics. Unfortunately, many have been found to not maintain their potency when tested. The product made by Enzymatic Therapies has, however been proven to have the labeled potency. Take 3-6 billion units (bacteria) daily – preferably on an empty stomach.
2. Caprylic acid 650 mg 3 x day.
3. Oregano oil – Must be enteric coated to avoid reflux
4. Citricidal, Pau D' Arco and lavender oil can also be helpful.
Prescription treatment consists of nystatin, two 500,000-IU tablets po bid or t.i.d. (start slowly) for five months. The patient's symptoms, especially fibromyalgia pain, may flare initially as the yeast die off. Therefore, begin with one 500,000-unit tablet of nystatin once a day and increase by one tablet every one to three days, as tolerated, up to two tablets t.i.d. After four weeks on the nystatin, add 200 mg of fluconazole (Diflucan) or itraconazole (Sporanox) qd for six weeks. Mild liver enzyme elevations are sometimes seen with Diflucan and Sporanox, but taking lipoic acid, 200 mg/d, seems to markedly decrease this side effect. The other major side effect of both Diflucan and Sporanox is the price – a six-week course can cost more than $600. If symptoms recur after the first six weeks on Diflucan or Sporanox, I recommend repeating the 200 milligrams per day for another six weeks. If no benefit is derived from the first course, I do not recommend repeating it. Have your patient stay on the nystatin for a total of five to eight months. I recommend patients be on nystatin while they are taking Sporanox or Diflucan to avoid development of resistant organisms.
Parasitic infections, often with "nonpathogenic” or normally self-limiting organisms (again, as seen in AIDS patients) are common. Stool samples can be sent to your local lab for antigenic and chemical testing for giardia, cryptosporidium, and especially clostridium difficile (which was present in approximately 22% of our CFIDS study patients versus approximately 1% of the healthy populace). The only labs I would use for microscopic O&P (parasite) testing, however, are the Great Smokies Diagnostic Laboratory or the Parasitology Center. Sending the O&P to most other labs is a waste of money. Most labs will often report stool O&P's as being negative, even if parasites are present. If the patient has any parasites (even if nonpathogenic) treat them. If he or she uses well water, I would recommend a water filter that eliminates parasites (most do not) such as the Multi-Pure filter.
In patients with low-grade fevers (anything over 98.6°F in CFIDS/FMS patients), occult infections (for example, Chlamydia and mycoplasma incognitus) are being found. Empiric therapy with doxycycline 100 mg bid for six months to two years (while on nystatin) can be very helpful. Recent research is showing that HHV-6, CMV, and EBV are also commonly active in CFIDS/FMS. Natural therapies with olive leaf 500-2000 mg 3-4 x day may be helpful as is immune stimulation with Thymic Protein A (Pro Boost). The latter is a wonderful product and is my favorite way to stimulate thymic immune function. In my experience, it knocks out most acute infections within 24 hours!
Treating sleep, hormonal and nutritional deficiencies also will usually allow the person's immune system to heal so they can eliminate most infections without antibiotics.
I would treat CFIDS/FMS patients with:
1. Daily Energy Enfusion Powder (1 scoop /day in water) and one tablet of the accompanying B-complex (both made by Enzymatic Therapies. Because of my frustration with the incredible number of tablets a day these patients needed to take for proper nutritional support, I developed these products so that 1 scoop and 1 tablet a day replaces ~25 tablets while supplying solid nutritional support (for most people-not just those who are ill!).
2. If the iron percent saturation is under 22% or the ferritin is under 40 mg/ml (check both!), give iron. Food decreases absorption by over 60%. Iron should not be taken within six hours of thyroid (and possibly other hormones), as it blocks thyroid absorption. This is not in the powder as you only want to give iron if it is low.
3. If B12 is under 540 pg/ml, I recommend B12 injections, 3,000 micrograms IM three times a week times for twelve weeks, then as needed (prn). Recent reports on CFIDS are showing absent or near-absent CSF B12 levels with low normal serum B12 levels (Regland, B).26 Metabolic evidence of B12 deficiency is seen even at levels of 540 pg/ml or more.27 Severe neuropsychiatric changes are seen from B12 deficiency even at levels of 300 pg/ml (a level over 209 is technically normal).28 As an editorial in The New England Journal of Medicine notes, the old-time doctors may have been right about giving B12 shots.29 Compounding pharmacies can make B12 at 3,000 mcg/cc concentrations. I use hydroxycobalmin. The powder has a very high amount of B12 (500 mcg).
4. Coenzyme Q10, 200 mg a day is often helpful during the first 3-6 months of treatment. Take with oil to improve absorption.
5. Essential fatty acids ~ 5000 mg /day can be helpful if the patient has dry eyes, mouth and/or skin. I would use fish or flaxseed oil (or 3-4 servings of tuna or salmon a week) with some added borage or primrose oil.
6. K-Mg aspartate. This is very helpful in fatigue states.30 The dose is 500 milligrams, 2 bid for three months (then stop). Most brands may not work as they are not chemically fully reacted (Hicks, 1964).31 General Nutrition Centers' house brand appears to be an effective product.
7. The patient should avoid sugar, caffeine, and excess alcohol (warn him or her that there may be a seven to ten-day withdrawal period when coming off the sugar and caffeine).
Because of the cost of developing (~$500,000 in time and programming costs) and maintaining the program (>$3000/mo) we do charge a modest $160 for a patient to do the program. Practitioners can get the codes wholesale @$95 and Medicaid patients can get a code for free.
To assist patients in finding practitioners, the Web site also has a referral list that any practitioner can add their name to (at no charge) if they use a significant part of our protocol (simply click on "physicians" and enter your info). We will be beginning 2-day workshops for both prescribing and non-prescribing practitioners on November 2-3, 2002. Those who take the training will be highlighted on the referral list. E-mail Amy@endfatigue.com for more information.
The Web site has the full text of both studies and many other free resources.
My nutritional and sleep formulas by Enzymatic Therapies will be a dramatic benefit for most of your patients who need nutritional or sleep support. We will likely develop a line of products to help your patients. As my entire royalty goes to charity, this money can then be used for other wonderful causes!
In treating over 2,000 CFIDS/FMS patients, a treatment protocol has now evolved that offers effective therapy for the >6 million Americans unnecessarily crippled with CFS/FMS. Our initial pilot study and our follow-up randomized trial show that over 85% of patients improved with treatment (Teitelbaum, Bird, 1995 and 2001) (see www.endfatigue.com).32 These very ill patients require time and compassion – as well as an organized treatment approach.
References available on request or in the Appendix A section of my book From Fatigued to Fantastic!
Jacob Teitelbaum, MD
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|February 11, 2003|