Guaifenesin protocol
Encyclopedia
Guaifenesin protocol is an experimental, alternative treatment for fibromyalgia
Fibromyalgia
Fibromyalgia is a medical disorder characterized by chronic widespread pain and allodynia, a heightened and painful response to pressure. It is an example of a diagnosis of exclusion...

 proposed in the 1990s by R. Paul St. Amand. The proposed treatment involves three parts: titrating to the proper guaifenesin
Guaifenesin
Guaifenesin INN or guaiphenesin , also glyceryl guaiacolate, is an expectorant drug sold over the counter and usually taken by mouth to assist the bringing up of phlegm from the airways in acute respiratory tract infections.-History:Similar medicines derived from the guaiac tree were in use as a...

 dosage, avoiding salicylates, and following a low-carbohydrate diet
Low-carbohydrate diet
Low-carbohydrate diets or low-carb diets are dietary programs that restrict carbohydrate consumption usually for weight control or for the treatment of obesity. Foods high in digestible carbohydrates are limited or replaced with foods containing a higher percentage of proteins and fats...

 if the patient is hypoglycemic. Guaifenesin
Guaifenesin
Guaifenesin INN or guaiphenesin , also glyceryl guaiacolate, is an expectorant drug sold over the counter and usually taken by mouth to assist the bringing up of phlegm from the airways in acute respiratory tract infections.-History:Similar medicines derived from the guaiac tree were in use as a...

 has not been approved by the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

 for the treatment of fibromyalgia, and the protocol has not been shown to be effective in clinical trials as of 2008. It has been adopted by many due to anecdotal evidence of success; however a clinical study in 1996 has cast doubt on the effectiveness of Guaifenesin.Lay summary and report:

Guaifenesin dosage

The dosage is individually determined by slowly titrating the dosage up until a worsening of symptoms is noticed and there is a decrease of the lesion
Lesion
A lesion is any abnormality in the tissue of an organism , usually caused by disease or trauma. Lesion is derived from the Latin word laesio which means injury.- Types :...

s that can be palpated in the muscle
Muscle
Muscle is a contractile tissue of animals and is derived from the mesodermal layer of embryonic germ cells. Muscle cells contain contractile filaments that move past each other and change the size of the cell. They are classified as skeletal, cardiac, or smooth muscles. Their function is to...

s. Patients begin with 300 mg twice a day and increase from there. The guaifenesin should be pure guaifenesin and not a preparation including other medications.

Avoiding salicylic acid

Salicylic acid
Salicylic acid
Salicylic acid is a monohydroxybenzoic acid, a type of phenolic acid and a beta hydroxy acid. This colorless crystalline organic acid is widely used in organic synthesis and functions as a plant hormone. It is derived from the metabolism of salicin...

 in even tiny amounts blocks guaifenesin from binding in the kidney
Kidney
The kidneys, organs with several functions, serve essential regulatory roles in most animals, including vertebrates and some invertebrates. They are essential in the urinary system and also serve homeostatic functions such as the regulation of electrolytes, maintenance of acid–base balance, and...

s. It is present in a large variety of foods. It can also be found in drugs such as aspirin
Aspirin
Aspirin , also known as acetylsalicylic acid , is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. It was discovered by Arthur Eichengrun, a chemist with the German company Bayer...

, Salsalate, Disalcid, Anacin, and Excedrin. Plants produce salicylic acid, so herbal medications must be avoided as well as plant oils, gels and extracts in cosmetics
Cosmetics
Cosmetics are substances used to enhance the appearance or odor of the human body. Cosmetics include skin-care creams, lotions, powders, perfumes, lipsticks, fingernail and toe nail polish, eye and facial makeup, towelettes, permanent waves, colored contact lenses, hair colors, hair sprays and...

 and any product that touches the skin. These ingredients include aloe
Aloe
Aloe , also Aloë, is a genus containing about 500 species of flowering succulent plants. The most common and well known of these is Aloe vera, or "true aloe"....

, castor oil
Castor oil
Castor oil is a vegetable oil obtained from the castor bean . Castor oil is a colorless to very pale yellow liquid with mild or no odor or taste. Its boiling point is and its density is 961 kg/m3...

, camphor
Camphor
Camphor is a waxy, white or transparent solid with a strong, aromatic odor. It is a terpenoid with the chemical formula C10H16O. It is found in wood of the camphor laurel , a large evergreen tree found in Asia and also of Dryobalanops aromatica, a giant of the Bornean forests...

, and mint
Mentha
Mentha is a genus of flowering plants in the family Lamiaceae . The species are not clearly distinct and estimates of the number of species varies from 13 to 18. Hybridization between some of the species occurs naturally...

. Any plants can be eaten, however, because the small amount of salicylic acid present in food is broken down in the digestive system and tagged with glycine
Glycine
Glycine is an organic compound with the formula NH2CH2COOH. Having a hydrogen substituent as its 'side chain', glycine is the smallest of the 20 amino acids commonly found in proteins. Its codons are GGU, GGC, GGA, GGG cf. the genetic code.Glycine is a colourless, sweet-tasting crystalline solid...

 by the liver
Liver
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of biochemicals necessary for digestion...

 before reaching the kidneys.

Treating hypoglycemia

Many symptoms of hypoglycemia
Hypoglycemia
Hypoglycemia or hypoglycæmia is the medical term for a state produced by a lower than normal level of blood glucose. The term literally means "under-sweet blood"...

 (or perhaps more aptly titled Carbohydrate Intolerance) are similar to fibromyalgia, and, while leaving hypoglycemia untreated will not hinder the reversal of the disorder with guaifenesin, the symptoms will continue to plague the patient. The only treatment is a life-long avoidance of simple sugars
Sucrose
Sucrose is the organic compound commonly known as table sugar and sometimes called saccharose. A white, odorless, crystalline powder with a sweet taste, it is best known for its role in human nutrition. The molecule is a disaccharide composed of glucose and fructose with the molecular formula...

, caffeine
Caffeine
Caffeine is a bitter, white crystalline xanthine alkaloid that acts as a stimulant drug. Caffeine is found in varying quantities in the seeds, leaves, and fruit of some plants, where it acts as a natural pesticide that paralyzes and kills certain insects feeding on the plants...

, starch
Starch
Starch or amylum is a carbohydrate consisting of a large number of glucose units joined together by glycosidic bonds. This polysaccharide is produced by all green plants as an energy store...

y foods, and any other foods that cause insulin
Insulin
Insulin is a hormone central to regulating carbohydrate and fat metabolism in the body. Insulin causes cells in the liver, muscle, and fat tissue to take up glucose from the blood, storing it as glycogen in the liver and muscle....

 spikes.

Theory of fibromyalgia cause

This theory involves phosphate
Phosphate
A phosphate, an inorganic chemical, is a salt of phosphoric acid. In organic chemistry, a phosphate, or organophosphate, is an ester of phosphoric acid. Organic phosphates are important in biochemistry and biogeochemistry or ecology. Inorganic phosphates are mined to obtain phosphorus for use in...

 accumulation in cells that eventually reach a level to impede the ATP
Adenosine triphosphate
Adenosine-5'-triphosphate is a multifunctional nucleoside triphosphate used in cells as a coenzyme. It is often called the "molecular unit of currency" of intracellular energy transfer. ATP transports chemical energy within cells for metabolism...

 process, possibly caused by a kidney dysfunction or missing enzyme
Enzyme
Enzymes are proteins that catalyze chemical reactions. In enzymatic reactions, the molecules at the beginning of the process, called substrates, are converted into different molecules, called products. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates...

 that prevents the removal of excess phosphates from the blood stream. This theory posits that fibromyalgia is an inherited disorder
Genetic disorder
A genetic disorder is an illness caused by abnormalities in genes or chromosomes, especially a condition that is present from before birth. Most genetic disorders are quite rare and affect one person in every several thousands or millions....

, and that phosphate build up in cells is gradual (but can be accelerated by trauma
Physical trauma
Trauma refers to "a body wound or shock produced by sudden physical injury, as from violence or accident." It can also be described as "a physical wound or injury, such as a fracture or blow." Major trauma can result in secondary complications such as circulatory shock, respiratory failure and death...

 or illness
Illness
Illness is a state of poor health. Illness is sometimes considered another word for disease. Others maintain that fine distinctions exist...

). Calcium
Calcium
Calcium is the chemical element with the symbol Ca and atomic number 20. It has an atomic mass of 40.078 amu. Calcium is a soft gray alkaline earth metal, and is the fifth-most-abundant element by mass in the Earth's crust...

 is required to buffer the excess phosphate when it enters the cells. The additional phosphate slows down the ATP process; however the excess calcium prods the cell to action. The causative mechanism in the kidneys is unknown.

The phosphate build-up theory is said to explain the myriad symptoms present in fibromyalgia and provides an underlying cause, but remains theoretical; there is no clinical evidence that the phosphate build-up theory is correct, or that Guaifenesin protocol is effective.

Results of the only reported randomized clinical trial in 1996 found that guaifenesin had no significant effects on pain, other symptoms, or laboratory measures (serum and urinary levels of uric acid and phosphate) over 12 months in a sample of people diagnosed with fibromyalgia syndrome, The lead author of the study has suggested a number of reasons why some patients may have previously reported benefits on this protocol, concluding "St. Amand has unknowingly used guaifenesin as a powerful focus in a program of cognitive behavioral therapy, in which his empathy, enthusiasm and charisma were the real instruments in effecting a beneficial change." St. Amand has stated that the study did not control for salicylate use, and therefore did not study the protocol as a whole. He has recommended a follow-up study be conducted which controls for all elements of the protocol.

History

This theory arose when St. Amand noticed that patients with fibromyalgia symptoms had an increase of tartar
Calculus (dental)
In dentistry, calculus or tartar is a form of hardened dental plaque. It is caused by the continual accumulation of minerals from saliva on plaque on the teeth...

 on the teeth in the form of calcium phosphate. Crystals are also often found on urinalysis
Urinalysis
A urinalysis , also known as Routine and Microscopy , is an array of tests performed on urine, and one of the most common methods of medical diagnosis...

, which further points to calcium phosphate, and muscle biopsies show an steady state of phosphate in the cytosol as well as a dearth of ATP and phosphocreatine. The implication is that insufficient energy formation is the basis for the generalized cellular fatigue expressed in many tissues of fibromyalgia. Lesions of muscles, tendon
Tendon
A tendon is a tough band of fibrous connective tissue that usually connects muscle to bone and is capable of withstanding tension. Tendons are similar to ligaments and fasciae as they are all made of collagen except that ligaments join one bone to another bone, and fasciae connect muscles to other...

s, and ligament
Ligament
In anatomy, the term ligament is used to denote any of three types of structures. Most commonly, it refers to fibrous tissue that connects bones to other bones and is also known as articular ligament, articular larua, fibrous ligament, or true ligament.Ligament can also refer to:* Peritoneal...

s can be felt by simple palpation. St. Amand calls this 'mapping' and uses it to confirm the diagnosis and in followup reversal of fibromyalgia. He feels that a genetically induced retention of phosphate also draws excess quantities of calcium into cells and exhorts them into overdrive. Contracted musculoskeletal tissues are the result and they produce the palpable lesions.

The treatment was discovered serendipitously when the physician found that uricosuric
Uricosuric
Uricosuric medications are substances that increase the excretion of uric acid in the urine, thus reducing the concentration of uric acid in blood plasma. In general, this effect is achieved by action on the proximal tubule...

 drugs for treating gout
Gout
Gout is a medical condition usually characterized by recurrent attacks of acute inflammatory arthritis—a red, tender, hot, swollen joint. The metatarsal-phalangeal joint at the base of the big toe is the most commonly affected . However, it may also present as tophi, kidney stones, or urate...

also coincided with relief of fibromyalgia symptoms. Guaifenesin is mildly uricosuric but, unlike standard uricosuric drugs, has almost no side-effects. St. Amand therefore began to study whether guaifenesin might relieve the symptoms of fibromyalgia while causing fewer side-effects than the earlier medications.

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