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Doxylamine

Doxylamine succinate is a highly sedating antihistamine used by itself as a short-term sleep aid, in combination with other drugs as a night-time cold and allergy relief drug, and a preparation is prescribed in combination with Vitamin B6 (pyridoxine) to prevent morning sickness in pregnant women. It is marketed alone as Unisom Sleep Tabs in the United States, and is also one of the active ingredients in NyQuil. more...

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In other Commonwealth countries, such as Australia, Canada, the UK New Zealand and South Africa, doxylamine is available prepared with paracetamol/acetaminophen and codeines under the brand name Syndol or Mersyndol, as treatment for tension headache and other types of pain, or as a general OTC sleep-aid branded as Somnil, DSozile and Restavit containing Doxylamine Succinate only.

It is a member of the ethanolamine class of antihistamines and has anti-allergy power far superior to virtually every other antihistamine on the market, with the exception of diphenhydramine (Benadryl®). It is also the most powerful over-the-counter sedative available in the United States, and more sedating than many prescription hypnotics. In a study, it was found to be superior to even the barbiturate, phenobarbital for use as a sedative.

The dosage required to induce hypnosis can be as low as 6.25 mg, but is usually indicated in dosages of 12.5 mg or 25 mg. This drug should never be taken before operating heavy machinery such as an automobile. The maximum over-the-counter dosage allowed by the FDA is 25mg, however, dosages up to 50mg are common in countries like Australia.

Doxylamine succinate is a potent anticholinergic and has a side-effect profile common to such drugs (including drymouth, ataxia, urinary retention, and drowsiness).

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An overview of CFS/Fibromyalgia, and effective therapies - Highly Effective Treatments for Pain and Fatigue
From Townsend Letter for Doctors and Patients, 2/1/04 by Jacob Teitelbaum

For years, patients have dreamt of the day when they would see the headline "Effective Treatment for Chronic Fatigue Syndrome and Fibromyalgia (CFS/FMS) Developed!" Using integrative Medicine approaches, it is time to let patients know that this day has arrived.

[ILLUSTRATION OMITTED]

The lead article in a recent edition of the Journal of Chronic Fatigue Syndrome is titled "Effective Treatment of Chronic Fatigue Syndrome and Fibromyalgia--the Results of a Randomized, Double-Blind, Placebo-Controlled Study." After decades of hard work by hundreds of researchers in the field, CAM has progressed to the point where effective treatment is now available for these illnesses. In our study, over 90% of patients improved with an Integrative Medicine treatment protocol.

In the average patient, after two years of treatment, the average improvement in quality of life was 90 percent. Pain decreased by over 50% on average. (P<. 0001 for all 4 outcome measures). Many patients no longer even qualified for the diagnosis of CFS or fibromyalgia after treatment. In addition, an editorial in the Journal of the American Academy of Pain Management noted that our treatment protocol was an "excellent and highly effective part of the standard of practice for the treatment of fibromyalgia and myofascial pain syndrome." The full text of our study and the editorial can be seen at www.vitality101.com. These also offer you legal protection when questioned by those who are unfamiliar with natural therapies.

That the vast majority of patients improved significantly in the active group while there was minimal improvement in the placebo group proves two very important things. The first is that these are very treatable syndromes. The second is that anyone who now says that these illnesses are not real or are all in the patient's head are clearly both wrong and unscientific. A new day is dawning in how CFS/fibromyalgia will be treated.

Most people who have disordered sleep along with widespread pain and fatigue have both CFS and fibromyalgia. I will therefore use CFS and Fibromyalgia interchangeably (CFS/FMS).

So what is going on in CFS/FMS?

I do not view these syndromes as the enemy. Rather, I see them as attempts on the body's part to protect itself from further harm and damage in the face of any of a number of overwhelming stresses. A simple way to look at fibromyalgia and CFS would be to view them as circuit breakers in a house. When certain systems are over-stressed, some of the circuit breakers will go off to prevent damage to the home's wiring. In milder cases, the "circuit breakers" can come back on and systems can return to healthy function by simply supplying the body with rest and proper nutrition. In CFS/FMS, however, it is as if the main circuit breaker (in this situation it's the hypothalamus--a master gland in the brain) has turned off. When this occurs, rest is no longer enough to restore proper function.

Despite the many diverse triggers that can cause these syndromes, most patients' symptoms seem to come from a common endpoint--dysfunction or suppression of the hypothalamus. This gland controls sleep, hormonal function, temperature regulation, and the autonomic nervous system (e.g. blood pressure, blood flow, and movement of food through the bowel). This is why patients can't sleep, have low body temperatures, gain weight, and (because poor sleep causes immune dysfunction) are prone to multiple and recurrent infections. The hypothalamic dysfunction by itself can therefore cause most of the symptoms we see in these patients. The diagnosis can be very straightforward. If the patient has exhaustion that does not go away with vacation, and they are paradoxically unable to sleep, suspect this process until proven otherwise (especially if they also have cognitive dysfunction and widespread pain). I suspect that problems with the mitochondria (the "energy furnaces" in the cells) often cause the hypothalamic suppression.

So how does one effectively treat CFS/FMS, pain and fatigue? Also, why are there so many treatments?

There are 5 key categories that need to be evaluated and treated in order to help these patients (i.e. to turn their circuit breakers back on). Most treatments are directed at one or a few of these areas. Treatments are most effective, however, when they are given as an integrated whole. The five categories that require treatment are:

1. Nutritional support--This is critical as these patients are often deficient in numerous nutrients and have poor digestive and bowel function.

2. Sleep--Because sleep is dependent on healthy hypothalamic function, these patients have insomnia which is often profound.

3. Hormonal deficiencies--Most lab norms are based on healthy hypothalamic function. Hormonal status needs to be assessed by symptoms and physical exam, as well as with lab tests, and treated accordingly.

4. Opportunistic infections--Because of the immune dysfunction, many unusual infections (e.g. fungal, parasitic, viral, mycoplasma, etc) are often present. Some need to be treated directly. Most clear on their own when healthy immune function is reestablished.

5. Detoxification (e.g.--toxic metals, etc) Fortunately, the body will often detoxify itself with proper nutritional support and elimination of infections. Many other approaches can, of course, also be helpful for detoxification.

In addition, the initial stresses that caused the hypothalamic "circuit breaker" to shut down in the first place need to be dealt with or it will simply shut down again. This includes mind/body/spirit issues. My new book Three Steps to Happiness! Healing through Joy is a small, inexpensive book that will help your patients psychologically. It is available at www.vitality101.com.

The 4 main categories of problems that need to be treated

1. Disordered sleep. Most patients with these illnesses find that they are unable to get the 8-9 hours of deep sleep a night that is critical to their getting well without aggressive treatment. In part, this occurs because hypothalamic function is critical to deep sleep. Unfortunately, many of the most common sleep medications actually aggravate the sleep problems by decreasing the amount of time spent in deep sleep. For patients to get well, it is critical that they get 8 to 9 hours sleep at night. Although nine hours may seem like a lot, until 100 years ago, the average night's sleep for Americans was nine hours.

The best herbal/natural remedies for sleep/insomnia include extracts of Wild Lettuce (18-72 mg), Jamaican Dogwood (12-48mg), Passionflower (90-360mg), Valerian (200-800mg), hops (30-120 mg), and Theanine (50-200 mg). All six of these are combined in the Revitalizing Sleep Formula by Integrated Therapeutics (1-800-931-1709). The patient can take 1-4 capsules an hour before bedtime. It is excellent for insomnia, and it is all that most people who have insomnia will need. Unfortunately, the hypothalamic sleep dysfunction in CFS/fibromyalgia is so severe that it is usually necessary to have patients take a number of treatments together to get the 8-9 hours of sleep a night that is essential for getting well.

Other natural remedies that help sleep are magnesium glycinate or Chelate (e.g. 100-300 milligrams) and calcium (500-600 mg), 5-HTP (100-300mg), and/or melatonin (3/10-1mg) at bedtime. Some patients find that over-the-counter antihistamines such as doxylamine (Unisom for sleep) or Benadryl can also help. Other medications that can be helpful include Ambien, Trazodone, Flexeril, and doxepin. In the first six months of treatment, it is not uncommon to sometimes need to take six to eight different products simultaneously to get 8 hours of sleep at night. After 6-18 months of feeling well, most people can come off of most sleep (and other) treatments. This approach is safe and critical to people getting well.

2. Hormonal deficiencies. The hypothalamus is the main control center for most of the body's hormonal systems. Most of the normal ranges for our blood tests were not developed in the context of hypothalamic suppression or these syndromes. Because of this (and for a number of other reasons) it is usually necessary to treat with thyroid (Armour thyroid), adrenal (very low dose cortef or adrenal glandulars such as Adrenal Stress End, DHEA), and natural ovarian and testicular hormones--despite normal blood tests. These hormones have been found to be reasonably safe when used in low doses. Growth hormone has also been shown to be helpful in fibromyalgia. We don't use it because, unfortunately, it can cost over $15,000 a year and is given by injection. Fortunately, there may be a cheaper way to raise a low growth hormone. Most growth hormone is made during deep sleep. This may be another reason why getting 8 to 9 hours of deep-sleep a night can be critical!

3. Unusual infections. Many studies have shown immune system dysfunction in FMS/CFS. Although there are many causes of this, I suspect that poor sleep is a major contributor. The immune dysfunction can result in many unusual infections. These include viral infections (e.g. HHV-6, CMV, and EBV), parasites and other bowel infections, infections sensitive to long-term treatment with the antibiotics Cipro and Doxycycline (e.g. mycoplasma, chlamydia, Lyme, etc) and fungal infections. Yeast overgrowth is the most important infection to treat for (avoid sugar, use Acidophilus Pearls, nystatin, Diflucan, and other natural therapies--see treatment checklist).

4. Nutritional supplementation. Because the Western diet has been highly processed, nutritional deficiencies are a common problem. In addition, bowel infections can cause poor absorption, and the illness itself can cause increased nutritional needs. The most important nutrients include: a) vitamins--especially the B vitamins (most at 25-100 mg/day), vitamin B12 (500 mcg/day), antioxidants and their precursors/cofactors (e.g. vitamin C and E, NAC, glutamine, glycine, cysteine, selenium, zinc, etc.); b) Minerals--especially magnesium, zinc, iron, and selenium; c) Essential fatty acids; and d) amino acids (proteins). There is a product that contains most of the needed nutrients (except for calcium, iron, coenzyme Q10 and essential fatty acids) in one scoop of a good tasting powder and one capsule taken daily. It is called the Energy Revitalization System (also from Integrated Therapeutics) and supplies an incredible foundation for nutritional support for almost everyone--including those with CFS/fibromyalgia. It supplies an excellent foundation for nutritional support, is easy to use and fairly inexpensive, and literally replaces the need for 35 capsules of nutritional supplements a day.

Although not needed by everyone, and usually only needed for three to nine months, there are a few other nutrients worth mentioning. Iron should only be given if iron deficiency (which I define as a ferritin under 40 and an iron percent saturation under 22 percent) is present. If the patient has dry eyes or dry mouth, I add fish oil (Eskimo 3 by Tyler-many others are rancid or have mercury or other toxins in them). CoEnzyme Q10 200 mg/day can also be helpful.

What other new approaches are being developed?

Happily, 85 to 90% of our patients improve significantly by treating the problems that we have discussed above. There are many other treatments that can also be very helpful.

1. Dr. Jay Goldstein's protocol. Dr. Goldstein focuses on medications that are rapidly active in the brain. Remarkably, in a subset of patients, some of these can reduce or eliminate the symptoms within 45 minutes. He uses over 80 different medications, testing them sequentially, to see if they will help patients. My favorite ones to try include Nimotop 30 mg, naphzoline S.1% eye drops, TRH eye drops, and oxytocin 10 units by IM injection. These are fairly safe, and the effect is usually seen within 45 minutes.

2. Guaifenisin, a safe and inexpensive medication, has been found, when used for an extended period, to decrease pain in some patients. Although a well-done study by an excellent researcher (Dr. Robert Bennett) showed no benefit from this medication, many patients have written to me saying that they found it to be helpful and another study is underway. Unfortunately, one must avoid anything with aspirin/salicylates or the treatment will not work. This is much harder than it seems, as this includes almost all natural products. It is a treatment that I have only rarely needed to use.

3. Heparin, the body's blood clotting systems seem to be over activated in these syndromes. Oddly enough, this can result in easy bruising. It also seems to cause problems with getting nutrients out of the blood vessels and into the tissues where they are needed. About half of my patients who use the blood thinner heparin twice a day by injection get significant relief of their symptoms. Unfortunately, there are potential risks and side effects that are life-threatening. Because of this, I have only been willing to use heparin in a small subset of patients. Interestingly, some physicians have noted that long-term antibiotics work better in these syndromes when they are combined with heparin.

There are many other treatments available as well. Although space does not allow for a full discussion of these in this article, I discuss them at length in the current, updated edition of my book From Fatigued to Fantastic!

How do I make pain go away?

Pain is one of the easier problems to treat! If usually will improve dramatically and then go away if the patient gets 8 hours of deep sleep a night, takes the Energy Revitalization System for nutritional support, takes thyroid hormone, and treats the underlying yeast infections. Aspirin family medications (including ibuprofen) are not very effective for most patients. I avoid Tylenol because it can markedly deplete glutathione (which is already deficient in CFS/FMS). The medications I find to be most helpful for pain include Celebrex (celecoxib) and Skelaxin (which are not sedating) and Neurontin, Baclofen, and Ultram which can be sedating. There are many other medications and other natural and highly effective ways to treat pain as well. These can be used to help keep the patient comfortable while we go after the pain's underlying causes. You can almost always make pain go away!

Because determining which treatments are needed by any given individual, and then teaching them how to use them, can be very difficult and time consuming (even for doctors that are very skilled in treating these syndromes--a new patient visit in my office usually takes at least four hours of my "one on one" time), I've created a sophisticated patented computer program on my website (www.Vitality101.com) that is like a computerized CFS/FMS specialist! The good thing about it being a computer program is that it has both the time and ability to guide almost everyone with these syndromes back to health!

Dr. Teitelbaum is a board certified internist and director of the Annapolis Research Center for Effective CFS/Fibromyalgia Therapies. Having suffered with and overcome these illnesses in 1975, he spent the next 25 years creating, researching, and teaching about effective therapies. He sees patients from all over the world at his clinic in Annapolis, Maryland (410-573-5389). He lectures internationally. He is also the author of the best-selling book From Fatigued to Fantastic! His web site can be found at: www.Vitality101.com. He accepts no money from any companies whose products he recommends, and 100% of his royalties for his products go to charity.

by Jacob Teitelbaum, MD

COPYRIGHT 2004 The Townsend Letter Group
COPYRIGHT 2004 Gale Group

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