Skip to comments.New drug relieves pain from Fibromyalgia
Posted on 02/17/2003 12:25:36 PM PST by GailA
New drug relieves pain from Fibromyalgia February 17, 2003
Conventional medications, such as Tylenol, Motrin or even morphine, provide little relief to sufferers of fibromyalgia, a mysterious and debilitating pain disorder. But a new drug might be able to thwart the nerve signals that scientists believe trigger the pain.
"This is a real breakthrough not only because it works, but it proves fibromyalgia can be treated," says Dr. Leslie Crofford, a rheumatologist at the University of Michigan in Ann Arbor who has studied the new drug, pregabalin.
The syndrome affects an estimated 5.6 million Americans.
Pregabalin reduces the release of specific brain chemicals, such as glutamate and noradrenaline, that may cause pain, says Terry Griesing, a neurology researcher with Pfizer Inc.
The drug, which still needs FDA approval, could be on the market as early as 2004.
I'll pass this info along.
Hold on to some of that enthusiasm. I wouldn't hold my breath waiting on FDA approval next year, especially when it comcerns pain relieving medication. I've had DJD for 26 years and I've never seen a slower or ineffective regulatory agency.
Be sure you've had your Thyroid functions checked as most FMS sufferers are also Hypothyroid too.
Pregabalin Improves Pain Associated with Fibromyalgia Syndrome in a Multicenter, Randomized, Placebo-Controlled Monotherapy Trial
Leslie Crofford, I. Jon Russell, Philip Mease, Ann Corbin, James Young, Jr., Linda LaMoreaux, Susan Martin, Uma Sharma, Lloyd Knapp, Mark Versavel, R. Michael Poole
Purpose: Fibromyalgia syndrome (FMS) patients experience chronic widespread musculoskeletal pain in association with fatigue and sleep disturbance. There are no approved therapies, and treatments that are used often do not provide adequate relief. This 8-week randomized, double-blind, placebo-controlled, parallel-group monotherapy trial evaluated the efficacy and safety of pregabalin up to 450mg/day (150 mg TID) for reducing pain and associated symptoms in patients with FMS.
Methods: Patients meeting the ACR criteria for FMS completed a 1-week baseline phase and an 8-week fixed dose treatment phase (6 required visits). Patients (n=529) were randomized to receive placebo, 150, 300 or 450mg/day pregabalin at Visit 2. The primary efficacy parameter was pain, recorded by patients in a daily pain diary, using an 11-point numeric rating scale. The primary analysis was based on the endpoint mean pain score. Secondary efficacy measures included the Short Form McGill Pain Questionnaire (SF-MPQ), sleep quality diary, Medical Outcomes Study (MOS)-Sleep Scale, Multidimensional Assessment of Fatigue (MAF), Patient and Clinical Global Impression of Change (PGIC, CGIC), and SF-36 Health Survey.
Results: Pregabalin-treated patients (450mg/day) showed significant improvement in the endpoint mean pain score (-0.93; p<0.001) compared to placebo, and were significantly more likely to have 50% reduction in pain from baseline (29% vs. 13%, p = 0.003). The mean SF-MPQ total pain descriptor and visual analog scale (VAS) scores were significantly improved at each visit and at endpoint for the pregabalin 450mg/day treatment group compared to placebo. Mean sleep quality, fatigue, CGIC and PGIC scores at endpoint were significantly improved for patients receiving 300 and 450mg/day pregabalin. The MOS-Sleep Index score was significantly improved at endpoint for all doses. Four of 8 domains of the SF-36 were significantly improved at endpoint for the 450mg/day treatment group. Overall, 48 patients (9%) withdrew due to adverse events and 44 patients (8%) due to lack of efficacy. The most common adverse events were dizziness and somnolence. Most patients (78%) completed the trial and entered a follow-on safety trial.
Conclusions: Pregabalin is effective and safe for the treatment of pain at 450mg/day in patients with FMS in this study. Pregabalin additionally improved sleep quality, fatigue, global measures of improvement and quality of life.
Keywords: fibromyalgia, pregabalin, pain
There have been something like 126 human studies and 29 animal studies.
DR Laura touts something called a Cuddleewe under quillt which is supposed to help too. There is a GOOD discription on FMS on the intro page Quilt
1990 American College of Rheumatology (ACR) FMS
(Source: The Fibromyalgia Help Book, Fransen and Russell, p. 9)
Patient History: Widespread Aching.
Examination: Local Tenderness at 11 of 18 Specified Sites. Lasting 3 or More Months.
Prevalence: 90% of FMS Patients are Women / 10% of FMS Patients are Men.
(Source: The Fibromyalgia Help Book, Fransen and Russell, pp. 7-14)
Soft Tissue Pain is the primary symptom of FMS. Usually occurring at 11 of 18 specified Tender Point sites. Tender Points detected by palpation at certain characteristic sites, were discovered by researchers about 20 years ago, which have become the hallmark for diagnosing fibromyalgia.
Sleep Disturbance occurs in 90% of FMS patients in one or more of the following forms of insomnia: difficulty falling asleep, frequent awakenings, inability to fall back to sleep, tossing and turning all night and early morning awakenings.
Fatigue is a major symptom of fibromyalgia.
Neurological Symptoms occur in about 25% of FMS patients and are reported as numbness and tingling in arms and legs, hands feel clumsy and swollen.
Headaches as a regular experience are reported by over 40% of FMS patients.
Irritable Bowel Syndrome is reported by 30% of FMS patients, whose experience includes intermittent bouts of diarrhea, constipation, crampy abdominal pain, bloating, gas and other digestive difficulties.
Interstitial Cystitis (IC) which is an inflammatory (possibly autoimmune) disorder affecting the wall of the bladder.
Subjective Swelling frequently reported as a swelling sensation of the hands, feet and ankles when there is no visible or palpable swelling present.
Joint Pain in the hands, wrists, elbows, neck, chest wall, hip, knees, ankles and feet are frequently reported by FMS patients.
Chest Wall Pain is reported by about 33% of FMS patients and before diagnostic tests are performed is mistaken for heart abnormalities.
Cold Sensitivity is reported by many FMS patients and almost 40% also have symptoms similar to those of Raynauds phenomenon, a condition in which small blood vessels in the hand overrespond to cold and develop spasms.
Memory and Concentration Difficulties are reported by 25% of FMS patients.
Commonly Occurring Conditions with FMS (Source: The Fibromyalgia Help Book, Fransen and Russell, p.15)
Cervical and low back degenerative diseases
Systemic lupus erythematosus
Thoracic outlet syndrome
Chronic fatigue syndrome
Prolapsed mitral valve
Myofascial pain syndrome
OVERVIEW: Although thyroid disease was first noted in the lat 1800's and associated with obesity, swelling, and heart failure, the true importance of the thyroid gland in health escapes the focus of many physicians still today. Although many individuals suffer with exhaustion, mental dullness, depression, constipation, dry skin, brittle nails, joint aches and cold hands and feet, few doctors consider thyroid as the disease that is the cause.
ANATOMY: The thyroid gland is positioned below the Adam's apple and is shaped like a bow-tie. This walnut sized gland secretes the thyroid hormones that regulates all the functions of all the cells in the body. Thyroid hormone is necessary for every cell to forge energy (in the Krebs's cycle). Without thyroid, there is a lack of efficient energy product and therefore lethargy. This is called thyroid deficiency syndrome, A small decline in the production of thyroid hormones can have dramatic effects on the cells of the brain, heart, liver, kidney, skin and bones. Hypothyroidism, left untreated, is called myxedema. The swelling that is seen in the face of severe hypothyroid individuals can also occur in the lungs and heart. One hundred years ago, myxedema was a major cause of death.
What was recognized by Broda Barnes, M.D. in the 19330's is that there are more than one thyroid. The commonly prescribed thyroid preparations, Synthroid, Unithroid, and Levothryoid are varieties of thyroxin (T4). However, tri-iodothyronine (T3) which is marketed as Cytomel is the more active form of thyroid. Although young people are able to convert stored T4 to active T3, this does not occur as commonly in elderly. At 60 years of age, at least one-third of women are hypothyroid. Most of us in clinical practice and research believe that more than two-thirds of everyone over 55 is hypothyroid. Replacement of T4 without T3 often fails to relieve all the symptoms listed above: cold hands, fatigue, depression, and dry skin and nails. Medical references to the benefits of T3 can be found at MEDLINE.
CLINICAL MEASUREMENT: Broda Barnes, M.D. recognized that one of the primary effects of thyroid is to raise body temperature. A fat, hypothyroid child will be one degree Fahrenheit cooler than a thin, active child. The measurements of thyroid function include TSH, T3 (free), T4 (free). But normal blood tests do not tell the complete picture of thyroid disease.
The control of the thyroid gland is TRH, thyroid releasing hormone, in the hypothalamus, deep within the brain. With age, the hypothalamus fails to release adequate stimulation: it acts like it is asleep. This is called 'down-regulation.' Under normal conditions, the TRH triggers the pituitary in the midbrain to release TSH, thyroid stimulating hormone. TSH causes the thyroid to produce T3 and T4 from precursors: iodine, tryptophan and T2 (di-iodothyronine).
Doctors have been taught to look for elevated levels of TSH. This implies that the pituitary cannot recognize adequate blood levels of either T3 or T4. A TSH over 100 means the individual is severely hypothyroid. A TSH less than 1 (when not on thyroid replacement) implies that the thyroid is overactive and out-of-control.
But, those of us researching thyroid disease have learned that these thyroid tests are just 'tests at best.' If the patient complains of a low body temperature on awakening (basal body temperature) then there is inadequate thyroid hormone no matter what the blood tests show. If there is fatigue, dry skin, brittle hair and weight gain on a low calorie diet, then there is insufficient thyroid hormone.
THYROIDITIS: Some hypothyroidism, clinically diagnosed as thyroid deficiency syndrome, may be caused by a condition called Hashimoto's thyroiditis. Hashimoto's thyroiditis is an autoimmune disease in which the body's own immune defenses destroy its own thyroid gland. Most cases occur in women; the reason is unknown. Other cases of Hashimoto's thyroiditis occur in other autoimmune diseases, including insulin-dependent diabetes mellitus, pernicious anemia and myasthenia gravis. It may also occur with greater frequency in people who are left-handed or who have prematurely gray hair.
Hypothyroidism can also be caused by drug treatments (e.g. alpha-interferon, used to treat hepatitis C) or destruction of thyroid tissue by radioactive iodine treatment or surgery for conditions such as Grave's disease or thyroid cancer It can also have a genetic origin, in which case it may manifest shortly after birth.
NATURAL THYROID REPLACEMENT:
A major controversy in the treatment of hypothyroidism concerns the use of natural glandular concentrates or extracts containing thyroid hormone (e.g., Armour Desiccated Thyroid Hormone and other brands derived from the thyroid gland of the pig or cow) vs. Synthetic (laboratory-made) thyroid hormone (e.g. Synthroid, Levothroid, Unithyroid etc.). The synthetic product is promoted by pharmaceutical companies and most endocrinologists. Armour Thyroid and other natural thyroid preparations such as Thyrolar contain natural thyroid hormone. Although these preparations have been criticized by some for being "impure" or "inconsistent" from dose to dose, it should be noted that Armour Thyroid is most natural thyroid preparations. Armour Thyroid is F.D.A. approved and certified by the United States Pharmacopeia (U.S.P.). Armour Thyroid contains all four thyroid preparations (T4, T3, T2 and T1) and therefore, most closely resemble natural hormone thyroid hormone. At the proper dose, natural thyroid hormone works quite well and are preferred by nearly all "natural" or "alternative" physicians. Peer review journal articles have proven the benefit of 'natural thyroid' and T3 to improve general well being and decreasing depression.
We will continue patients on synthetic T4 if they insist and offer them the option of using a slow release compounded T3 product. The pharmacist mixes Cytomel (T3) into a medium to slow the absorption over 12 hours. Cytomel is not used because it is absorbed and destroyed in less than 2 hours.
According to a classic study conducted in 1974 by Dr. James Issacs, a pioneering cardiovascular surgeon from Baltimore, people who took ½ grain of thyroid along with vitamins and minerals over a period of ten years showed significant improvement in cardiovascular function. Some doctors recommend this for people over age 40 who have no overt endocrine disease. It has been pointed out that, even if one is not experiencing symptoms, all endocrine glands are beginning to slow down at this stage of life. The most common comment from people taking 1/4 grain of natural thyroid is "I just feel a little more energetic overall. My thinking seems a little clearer, and my bowel function is a little better."
Even if someone is already taking thyroid supplementation, most can still take a 1/4 - ½ grain of natural thyroid and tyrosine. "Unless you are in very brittle condition -- and brittle means to an endocrinologist that the amount you take has to be exactly right on -- you might consider adding 1/4 grain of the natural thyroid gland itself, as it also nourishes the rest of the endocrine network."
Our website is about "metabolic health." We define metabolic health in this way: A state in which the chemical processes in our cells are sufficient to provide us with at least two things: (1) resistance to sickness and disease, and (2) the vigor, stamina, and well-being needed to fully engage in all aspects of life. At drlowe.com, we focus on what impairs metabolic health, how to recover it, and how to optimize it.
We include a large amount of information on two common and potent causes of poor metabolic health hypothyroidism and thyroid hormone resistance. We also include information on other causes of poor metabolic health. Among the causes are poor diet, nutritional deficiencies, low physical fitness, hormone imbalances, and various medications and environmental pollutants.
Poor metabolic health affects different people in different ways, resulting in a variety of symptoms. Doctors usually give people with different symptoms different diagnoses. For example, the most prominent symptoms of some people are chronic widespread aches and pains. These people's doctors are likely to give them the diagnosis of "fibromyalgia." The main symptoms of other people are lethargy and fatigue. Their doctors may diagnose their condition as "chronic fatigue syndrome." Still other people may have depression, and others poor concentration and memory. The entire list of potential symptoms is too long to include here. But we discuss them on many pages of drlowe.com. Few conventional doctors search out and correct the underlying metabolism-impeding factors we mentioned above. Instead, they prescribe one or more medicines, hoping to relieve the patients' troubling symptoms. The diagnoses the doctors give the patients are convenient labels needed to justify their prescribing the medicines.
Our view is that different sets of symptoms, diagnosed as different disorders, have a common underlying mechanismabnormally slow metabolism (called "hypometabolism") caused by one or more of the metabolism-impairing factors we mentioned above. To clarify this concept is one of our goals on drlowe.com.
Another of our goals is to provide information about the treatment we've developed and refined for hypometabolism patients, whatever their symptoms and diagnoses. We call the treatment "metabolic rehabilitation." Metabolic rehab is a comprehensive treatment program designed to eliminate, control, or correct factors that are impairing the metabolism of the patient. The aim of rehab is for the patient to acquire normal metabolism and freedom from symptoms of slow metabolism. The rehab program is tailored to meet each patient's individual needs.
At drlowe.com, we also deal with a range of subjects related to fibromyalgia (often called fibromyalgia syndrome or FMS). These subjects include myofascial pain syndrome and trigger point therapy, chronic fatigue syndrome or CFS, fatigue and fibromyalgia, chronic pain, chronic pain management, T3, T4, TSH, the TRH stimulation test, Armour Thyroid (desiccated thyroid), Cytomel, Synthroid, so-called "Wilson's Syndrome," the wise use of caffeine and coffee, silicone breast implants, c Dr. Paul St. Amand and guaifenesin treatment for fibromyalgia, thyroid disease, metabolism of thyroid hormone, Chiari malformation and fibromyalgia, and surgery for fibromyalgia.
These two sites I turned up with Google using Armour Thyroid for search words.
BTW, being partially disabled has also given me time for FreeRepublic and turned me into something of a political activist...got to have some outlet ; ^ ) I've bookmarked this thread and will keep in touch. Thanks again.
But thanks for noting the correction in case anyone might be considering asking their physician about the drug. Cyclobenzaprine (Flexeril), IMHO, is a miracle drug and has probably saved my life as well as my sanity, and aside from the obvious sleepiness, has very few side effects.
It is called Alpha-Stim. The FACTORY can be found at http://www.alpha-stim.com .
1) It WORKS, typically effective on the FIRST use of 20 minutes (or hour).
2) One-time cost and no drug-interations.
3) Effective for a LOT of ailments.
4) Can be used by people who can't take certain drugs.
1) Because they ARE FDA-approved, they REQUIRE a PRESCRIPTION.
2) Many Doctors are not familiar with Alpha-Stim and are "stuck" on prescribing drugs (with their recurring cost and drug-interactions) instead of something with a one-time cost and no negative interactions.
3) The factory will NOT sell to individuals...only through protected-territory Distributors (i.e. regular Distributors, NOT Multi-Level).
4) Since they ARE FDA-approved and REQUIRE a prescription, they are not pocket-change, but they CAN be covered by insurance.
I think I have opened a sticky situation, because although I do NOT sell them, after having found the Alpha-Stim to be EXTREMELY EFFECTIVE for several members of my own family, I WANT to sell them so I can help people who have never found anything which gives them relief.
Whether I get to sell them or not, I still like to tell people about them as often as I can. They WORK! And they work FAST.
I don't think I should really discuss it any more here. Send me a private FReepmail if you want to hear about my family's personal experience with Alpha-Stim.
The problem the guy you are referring to had is that he was using MEGA-doses as a PREVENTATIVE measure, not as a result of NEEDING it at the time.
I use Colloidal Silver whenever I have a sore throat or sinus infection and the problem goes away quickly. It's GREAT! And it is MUCH faster than antibiotics.
You mean like cough syrup, the kind that is an expectorant?
My fibro started about a year after our 16 year old son Jeremy was murdered. Emotional upheavels are a frequent cause of FMS from what I've read. I also have Osteo-A in the C 6, 7, L 4 & 5 disc, and arthritis setting in in the index finger of my right hand.
I can't take Estrogen because of the gastro-intestinal side effects it produces, the natural as well as the chemical produce the same side effects.