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Two studies (including our RCT) showed an average 90 percent improvement rate when using the SHIN protocol for treating CFS and fibromyalgia. SHIN stands for treating Sleep, Hormonal dysfunction, and Infections, and optimizing Nutritional support.
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As discussed above, using the acronym SHIN will simplify treatment of these patients. Because of this, we will structure our treatment recommendations using this model. Let’s begin with S for sleep.
DISORDERED SLEEP
A foundation of CFS/FMS is the sleep disorder.10 Many patients can only sleep solidly for three to five hours a night with multiple wakings. Even more problematic is the loss of deep-stage three and four “restorative” sleep. Using natural therapies and/or medications that increase deep restorative sleep, so that patients get eight to nine hours of solid sleep without waking or hangover, is critical. If using medications, the next-day sedation that some patients experience often resolves in two to three weeks. Meanwhile, have patients take the medication earlier in the evening so that it wears off earlier the next day, or switch to shorter-acting agents such as Ambien, Sonata, and/or Xanax. Continue to adjust the medications each night until patients are sleeping eight hours a night without a hangover.
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. Therefore, they are not recommended. There are more than twenty natural and prescription sleep aids that can be tried safely and effectively in fibromyalgia and CFS. For the complete list, I am happy to e-mail you my free “long-form” treatment protocol (discussed below).
The natural sleep remedies that I recommend you begin with include the following:
Herbal preparations containing (per capsule):
Valerian (200 milligrams)
Passionflower (90 milligrams)
L-theanine (50 milligrams)
Hops (30 milligrams)
Wild lettuce (18 milligrams)
Jamaican dogwood (12 milligrams)
These are all combined in an excellent product called the Revitalizing Sleep Formula by Integrative Therapeutics. Patients (and anyone with poor sleep) can take one to four capsules at bedtime. These six herbs can help muscle pain and libido as well as improving sleep.11–15 Patients can take one to four capsules TID for anxiety and/or muscle pain. The effectiveness of valerian increases with continued use, but 5 to 10 percent of patients will actually find it stimulating and not be able to use it for sleep. I would note as an aside that, although I am very picky about what products I recommend, I have a policy of not taking money from any natural products or pharmaceutical companies, and 100 percent of the royalties for my products goes to charity.
Melatonin: 0.5 to 1 milligram at bedtime. All it takes to bring low levels to the mid-normal range is 0.5 milligram. The data show that in most patients the 0.5-milligram dose is as effective for sleep as 3, 5, and 10 milligrams. As we do not know the long-term effect of pharmacologic dosing of this critical hormone, I recommend that you don’t use a higher dose unless the patient finds it to be more effective. Having said this, many excellent practitioners use higher doses for “life-extension” purposes.
5-HTP (5-Hydroxy-L-Tryptophan): 200 to 400 milligrams at night. This naturally stimulates serotonin, but may take six to twelve weeks to be fully effective. Don’t give more than 200 milligrams a day if the patient is on antidepressants, as it theoretically could drive serotonin too high. 5-HTP can also help with pain and weight loss at 300 milligrams a day for at least three months.
Give calcium and magnesium at bedtime, as these can help sleep.
Cuddle Ewe mattress pad: Lying on this sheepskin pad can help if pain interferes with sleep (800-328-9493).
If natural remedies are not adequate to result in at least eight hours a night of sleep, consider these medications:
Zolpidem (Ambien): 5 or 10 milligrams. Use 5 to 20 milligrams at bedtime. This medication has fewer side effects than most other sleep medications. It is helpful for most CFS/FMS patients and is my first choice among the sleep medications. Experience shows that extended use is appropriate and safe in CFS/FMS. Patients can take an extra 5 to 10 milligrams in the middle of the night if they wake or switch to the sustained-release Ambien CR (6.25 to 12.5 milligrams). Neurontin (gabapentin), 100 to 900 milligrams, and/or Klonopin (clonazepam), 0.5 to 2 milligrams at bedtime, can help sleep, pain, and restless leg syndrome as well.
Cyclobenzaprine (Flexeril), 10 milligrams, and/or carisoprodol (Soma), 350 milligrams. Use half to two tablets at bedtime. These medications are often sedating but can be helpful if pain during the night is a major problem.
Trazodone (Desyrel): 50 milligrams. Take half to six tablets at bedtime. Use this medication first if anxiety is a major problem. Warn patients to call immediately if priapism (an erection that won’t go away) occurs.
Amitriptyline (Elavil) or doxepin: 10 milligrams. Use half to five tablets at bedtime. Elavil causes weight gain, and can worsen neurally mediated hypotension and restless leg syndrome.
Doxylamine (Unisom for Sleep): 25 milligrams at bedtime.
Some patients will sleep well with the Revitalizing Sleep Formula herbal and/or 5 to 10 milligrams of Ambien, while others will require all of the above treatments combined. Because the malfunctioning hypothalamus controls sleep, and muscle pain also interferes with sleep, it is often necessary, and appropriate to use multiple sleep aids. Zanaflex, Gabatril, and many other nonbenzodiazepines can also help sleep, and many other options are listed on the available treatment protocol. Because of next-day sedation and each medication having its own independent half-life, CFS/ FMS patients do better with combining low doses of several medications than with a high dose of one.
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It is critical that these patients get at least eight hours of deep sleep a night. Because of the hypothalamic dysfunction, they often need aggressive assistance to treat their insomnia. Begin with herbal mixes such as the Revitalizing Sleep Formula, and then add in calcium, magnesium, 5-HTP, and melatonin at bedtime as needed. If additional pharmaceutical support is needed, I recommend beginning with Ambien, Desyrel, Klonopin, and/or Neurontin.
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Although less common, three 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/or hypertensive. If two of these three conditions are present and the patient does not improve with our treatment, I would consider a sleep apnea study. Ask the sleep lab to also look for upper airway resistance syndrome (UARS), which mimics CFS and is associated with snoring, decreased airflow in the nose or throat, low blood pressure, and autonomic dysfunction. I would get preapproval from the patient’s insurance company, as the sleep testing usually costs about two thousand dollars. Some patients prefer to do their own inexpensive screening by videotaping themselves one night during sleep. This will screen for apnea and the third sleep disturbance, restless leg syndrome (RLS), but, unfortunately, will not pick up UARS. If there is no snoring at night, then both UARS and obstructive sleep apnea are unlikely.
Sleep apnea and UARS are treated with nasal Cpap or dental appliances that move the lower jaw forward during sleep. A sleep study or having patients videotape themselves while sleeping will also detect RLS, which is also fairly common in fibromyalgia.16 Asking the patient if the bedsheets 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. It is treated with supplemental magnesium and Ambien, Klonopin, and/or Neurontin and by keeping ferritin levels over 50.
Evaluation and Treatment of Associated Hormonal Dysfunction
Hormonal imbalance is associated with FMS. Sources of this imbalance include hypothalamic dysfunction and autoimmune processes such as Hashimoto’s thyroiditis. When the hypothalamus is not able to efficiently regulate hormone balance, medical management
can do so until hypothalamic function is restored. When focusing on achieving hormonal balance, the standard laboratory testing aimed at identifying a single hormone deficiency is not effective. For example, increased hormone binding to carrier proteins is often present in CFS/FMS. Because of this, total hormone levels are often normal while the active hormone levels are low. This creates a functional deficiency in the patient. Also, most blood tests use two standard deviations to define blood test norms. By definition, only the lowest or highest 2.5 percent of the population is in the abnormal (treatment) range. This does not work well if more than 2.5 percent of the population has a problem. For example, it is estimated that as many as 20 percent of women over sixty have positive anti-TPO antibodies and may be hypothyroid. Other tests use late signs of deficiency such as anemia for iron or B12 levels to define an abnormal lab value.
The goal in CFS/FMS management is to restore optimal function while keeping labs in the normal range for safety. One way to convey the difference between the “normal” range based on two standard deviations and the optimal range that patients would maintain if they did not have CFS/FMS is as follows.
Pretend your lab test uses two standard deviations to diagnose a “shoe problem.” If you accidentally put on someone else’s shoes and had on a size 12 when you wore a size 5, the normal range derived from the standard deviation would indicate you had absolutely no problem. You would insist the shoes did not fit, although your shoe size would be in the normal range. Similarly, if you lost your shoes, the doctor would pick any shoes out of the “normal range pile” and expect them to fit you.
Thyroid Function
Suboptimal thyroid function is common and important in CFS/FMS. Because thyroid-binding globulin function and conversion of T4 to T3 may be altered in CFS/FMS, it is important to check a free T4. It is also important to treat all chronic myalgia patients with thyroid-hormone replacement if their T4 blood levels are below even the 50th percentile of normal (Janet Travell—personal communication). Many CFS/FMS patients also have difficulty converting T4, which is fairly inactive, to T3, the active hormone. Additionally, T3 receptor resistance may be present, requiring higher levels.17–18
Synthroid has only inactive T4, while Armour Thyroid has both inactive T4 and active T3. Many clinicians will give an empiric trial of Armour Thyroid, half to three grains every morning, adjusted to the dose that feels best to the patient as long as the free T4 is not above the upper limit of normal. I am likely to try an empiric trial of thyroid-hormone therapy in patients who feel poorly if one or more of the following is true:
The patient has fibromyalgia, and/or
The patient’s oral temperature is generally less than 98.0°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 is below the 50th percentile of normal.
Physicians generally interpret a low-normal TSH—that is, 0.5 to 0.95—as confirmation of euthyroidism. The rules, however, are different with CFS/ FMS. In this setting, hypothalamic hypothyroidism is common, and the patient’s TSH can be low, normal, or high.19 This is why I recommend an empiric therapeutic trial of thyroid-hormone treatment even if the TSH and T4 are both low normal. Also, if subclinical hypothyroidism is missed, the patient’s fatigue and fibromyalgia/MPS 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.20, 21
That when patients with symptoms of hypothyroidism and normal labs were treated with thyroid (in this study, Synthroid at an average dose of 120 micrograms per day) a large majority improved significantly.20
In addition, I recommend adding the following:
If the patient does not respond to Synthroid, switch to Armour Thyroid, and vice versa. For every 50 micrograms of Synthroid, have the patient take half a grain (30 milligrams) 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. In most patients, however, I usually recommend beginning with Armour Thyroid.
Adjust the thyroid dose clinically using the dose that feels the best to the patient, as long as the free T4 test does not show hyperthyroidism. Do not use TSH or T3 levels to monitor thyroid replacement.21 Because of the hypothalamic suppression, TSH may be low despite inadequate hormonal dosing. As T3 is largely produced and functions intracellularly, we do not have normal ranges for exogenously given T3. Therefore, I predominantly use free T4 levels to monitor therapy.
Make sure that the patient does not take any iron supplements within six hours or calcium within two to four hours of the morning thyroid dose or the thyroid hormone will not be absorbed. Have the patient take the iron between 2 and 6 p. m.—on an empty stomach and away from any hormone treatments.
Thyroid supplementation can increase patients’ cortisol metabolism and unmask subclinical adrenal insufficiency. If patients feel worse on low-dose thyroid replacement, they may need adrenal support as well.
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Because of the hypothalamic dysfunction, hormonal deficiencies are common in CFS/FMS despite normal blood tests. If symptoms suggest deficiencies, treat hypothyroidism with Armour Thyroid (a therapeutic trial is warranted in most of these patients), adrenal insufficiency (suggested by low blood pressure, irritability when hungry/hypoglycemia, and recurrent respiratory infections and sore throats) with Cortef, and natural adrenal support (e. g., Adrenal Stress-End, by ITI) and low estrogen/testosterone with bioidentical hormones.
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Adrenal Insufficiency
The hypothalamic-pituitary-adrenal (HPA) axis does not function well in CFS/FMS.4, 22, 23 This and adrenal exhaustion from chronic/severe stress are two key causes of inadequate adrenal function. Because early researchers studying adrenal insufficiency and cortisol did not know the optimal physiologic doses for cortisol, they treated with high doses and their patients developed severe complications. These side effects are not seen with adrenal glandular/herbal/nutritional support or with physiologic dosing of hydrocortisone (Cortef), that is, up to 20 milligrams a day.24 Twenty milligrams of Cortef is approximately equivalent in potency to 4 to 5 milligrams of prednisone.
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 micrograms daily instead of 100 to 200 micrograms), a situation analogous to early adrenal research, most 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 and 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 show that this approach misses many hypoadrenal patients.2, 3, 24, 25
Symptoms of underactive adrenal glands include weakness, hypotension, dizziness, sugar cravings with irritability when hungry, and recurrent infections—all of which are common in CFS/FMS. I recommend natural adrenal support for most patients with CFS/FMS—especially if they have any of the above symptoms. The needed natural therapies include:
Adrenal glandulars, which contain most of the “building blocks” needed for adrenal repair.
Licorice extract, which contains glycyrrhizin, a compound that raises adrenal hormone levels. Licorice also protects against stomach irritation, which can occur with Cortef and occasionally even with glandulars.
Pantothenic acid, vitamin C, vitamin B6, betaine, and tyrosine, nutrients that are critical for adrenal function and energy, and high doses are often needed.
All of these are present in an excellent glandular/herbal for adrenal support called Adrenal Stress-End (from Integrative Therapeutics), which is safe and effective. I usually prescribe one to two capsules each morning (or one to two in the
morning and one at noon), and they can be taken along with Cortef. This helps both symptoms and with adrenal repair.
In addition, you can evaluate CFS/FMS patients’ adrenal function with an adrenocorticotropic hormone (ACTH) stimulation test to determine whether Cortef should be added, although I consider it appropriate to use adrenal support based simply on symptoms and/or a morning cortisol < 16 mcg/dl (up to 20 milligrams a day of Cortef). The test must be begun between 7 a. m. and 9 a. m. The patient should be NPO and have had no caffeine for twenty-four hours before the test. Check a baseline cortisol level and then give ACTH (Cortrosyn) 25 units or one unit IM (current data suggest that the one-unit Cortrosyn test is more reliable) and recheck cortisol levels at thirty minutes and at one hour. Although a baseline cortisol of 6 mcg/dl is often considered “normal,” most healthy people run approximately 16 to 24 mcg/dl at 8 a. m.
From Fatigued to Fantastic! Page 39