Desiccated thyroid extract

Desiccated thyroid extract

Combination of
Levothyroxine	Thyroid hormone
Liothyronine	Thyroid hormone
Clinical data
Pregnancy cat.	A
Legal status	℞-only (US)
Routes	Oral
Identifiers
ATC code	H03AA05
Y (what is this?)  (verify)

Desiccated thyroid or thyroid extract, refers to porcine (or mixed beef and pork) thyroid glands, dried and powdered for therapeutic use. Pork (or mixed beef and pork) thyroid preparations were developed in the late 19th century, and are still used today to treat hypothyroidism, the condition of having an underactive thyroid gland. This product is sometimes referred to as "natural thyroid", "natural thyroid hormones", "pork thyroid", thyroid USP, thyroid BP, or by the name of a commercial brand, such as "Armour Thyroid" or "Nature-Throid" & "Westhroid".

Desiccated thyroid has been described in the United States Pharmacopoeia for nearly a century as the cleaned, dried, and powdered thyroid gland previously deprived of connective tissue and fat... obtained from domesticated animals that are used for food by man (USP XVI). In the last few decades, pork alone is the usual source. Historically, before modern assays, the potency was specified only by iodine content ("not less than 0.17% and not more than 0.23%"), rather than hormonal content or activity.

Brands include Forest Lab's Armour, and Naturethroid & Westhroid by RLC Labs. Also available is a new generic NP thyroid (Manufactured for Acella Pharmaceuticals by unknown manufacturer). Canada's desiccated thyroid is made by Erfa and is called Thyroid. All consist of desiccated porcine thyroid powder, differing only in the binders and fillers.

Nature-Throid and Westhroid are available in the following strengths: 1/4 (16.25 mg), 1/2 (32.5 mg), 3/4 (48.75 mg), 1 (65 mg), 1.25 (81.25 mg), 1.5 (97.5 mg), 1.75 (113.75 mg), 2 (130 mg), 2.25 (146.25 mg), 2.5 (162.5 mg), 3 (195 mg), 4 (260 mg), & 5 (325 mg) grain. Each one grain (65 mg) contains 9 µg of T3, and 38 µg of T4.

All brands contain a mixture of thyroid hormones: T4 (thyroxine), T3 (triiodothyronine) in the proportions usually present in pig thyroids (approximately 80% T4 and 20% T3). Armour is made in the following strengths: 1/4, 1/2, 1, 2, and 3 grain as well as 4 and 5 grain tablets. One grain (about 60 mg) of desiccated thyroid contains about 38 µg of T4 and 9 µg of T3.^[1] Because the preparation is whole thyroid gland, each 60 mg tablet also contains over 59 mg of all of the other constituents of pork thyroid glands.

History

The earliest oral treatment for hypothyroidism consisted of thyroid extract. George Redmayne Murray of the United Kingdom first described treatment of myxedema with thyroid extract in 1891, and published a description of long-term successful treatment (28 years) of a patient with myxedema (severe hypothyroidism) in 1920^[2] His treatment was quickly adopted in North America and Europe. The first recorded American use dates to 1891 by a woman who was still taking it 52 years later at 84 years of age ^[3]

Desiccated thyroid extract is prepared from pig thyroid glands. The glands are dried (desiccated), ground to powder, combined with binder chemicals, and pressed into pills. This was a new use for parts that were previously unwanted slaughterhouse offal, and Armour and Company, the dominant American meatpacker in the 20th century, supplied the best-known brand of thyroid extract.

Replacement by thyroid extract in hypothyroidism was one of the most effective treatments of any disease available to physicians before the middle of the 20th century, and in severe cases afforded dramatic relief of the myriad symptoms. The decision to treat was usually based on the presence of signs and symptoms of hypothyroidism because there were no accurate, readily available laboratory tests of thyroid function. Many less severe cases of hypothyroidism went untreated.^{[citation needed]} Dosage was regulated by improvement of symptoms.

Desiccated Thyroid became a commercial treatment option in 1934 with Westhroid,^{[citation needed]} and has to this day, never been recalled for instability. In the early 1960s, desiccated thyroid hormones (thyroid extract) began to be replaced by levothyroxine (T4), or by combinations of T4 and T3. Replacement occurred faster in the United Kingdom than in North America, but by the 1980s more patients were being prescribed levothyroxine or T4/T3 combinations than desiccated thyroid extract.^{[citation needed]}

Several reasons have been identified as to why prescriptions changed from the previously-effective desiccated thyroid treatment. These factors included a desire for improved effectiveness, medical evidence, scientific theory, cultural fashion, and effective marketing.

• Although thyroid extract was useful and usually effective, some patients continued to complain of fatigue, weight gain, or other symptoms. Dosing until the 1960s was often a matter of prolonged adjustment trials.^[4]
• It was known that not all of the iodine content of thyroid extract was in the form of effective T4 and T3 and that actual content of available preparations varied more than the permitted 15%.^[5][6][7][8] It was hoped that better dosing precision with levothyroxine alone would increase the proportion of patients effectively treated. In 1980, a widely publicized investigation published in JAMA revealed continued large ranges of hormone content and potency in all of the available thyroid extracts on the American market.^[9]
• By the 1960s, it was known that thyroxine was the essential hormone produced by the thyroid gland, and that most T3 was manufactured in other parts of the body by deiodination of thyroxine. It was demonstrated in hypothyroid animals and people that replacement of thyroxine alone corrected the measurable manifestations (laboratory test results) of hypothyroidism.^[10] By the 1970s doctors could measure T4, T3, and TSH in human blood with approximate accuracy and confirmed that treatment with thyroxine alone could produce normal blood levels of both T4 and T3,^[11] but desiccated thyroid caused supraphysiologic levels of T3.^[12] In the majority of patients normalization of these levels eliminated all signs and symptoms of hypothyroidism.^[13]
• It was discovered that a healthy person varied the amount of T3 produced from T4 in response to changing needs and conditions^{[citation needed]} and it seemed wiser not to bypass this control system by providing larger amounts of T3 than were naturally produced each day.
• Furthermore, when T3 could be measured, it was discovered that thyroid extract and synthetic combinations of T4 and T3 produced significantly greater fluctuations of T3 throughout the day than occurred in healthy people or hypothyroid people treated with thyroxine alone.^[14]
• Endocrinologists found that treatment with thyroxine alone worked as well or better than thyroid extract for the majority of patients, although even thyroxine did not reverse all the symptoms of a minority.^[13]
• Cultural fashion and marketing played a role. In the middle of the 20th century, pharmaceutical chemists had been discovering the active molecules in a variety of plant and animal remedies, from aspirin and digitoxin to vitamins, and producing them synthetically with improvements in purity and dosage control. In that cultural context, it was easy to market pure levothyroxine as superior to dried animal glands.
• Synthroid, one of the most successful brand names in pharmaceutical marketing history, became as synonymous with thyroid replacement to generations of American primary care doctors as Kleenex or Xerox became with their respective products.^[15]

Thyroid care changed in other ways as well. Accurate T4 and T3 measurements became widely used in the 1970s, and by the late 1980s, TSH measurement had become sensitive enough to detect mild degrees of hyperthyroidism and overtreatment. To no one's surprise, blood levels of thyroid hormones and TSH were found to be the best predictors of objective benefits from thyroid replacement: those with the most severe measurable deficiency enjoyed the most dramatic and sustained benefits.^{[citation needed]} It was also discovered that even mild hyperthyroidism as defined by a suppressed TSH level, whether due to disease or overtreatment, was associated with poorer bone density in women, and with higher rates of atrial fibrillation in elderly patients.^{[citation needed]} Doctors began to trust the TSH measurement more and more as the index of optimal replacement dose.

As more doctors prescribed thyroxine instead of thyroid extract, the use of thyroid extract became associated with those whose medical practices deviated in many ways from standard care. (See complementary and alternative medicine.) This association became a disincentive for using thyroid extract as those prescribing it were considered to be unscientific and irrational practitioners.^{[citation needed]}

Thyroid extract proponents

Desiccated thyroid is preferred by a growing body of patients and doctors who claim better relief of symptoms such as fatigue and depressed mood. Many proponents of desiccated thyroid feel passionately about the issue.^{[citation needed]}

A number of claims by patients are commonly made about thyroid extract:

• Patients prefer thyroid extract as they experience less symptoms.
• Thyroid extract is better than thyroxine because it contains T4, T3, diiodothyronine (T2), monoiodothyronine (T1), and calcitonin.^[16] In comparison, synthetic treatments only contain T4 or a mixture of both T4 and T3.
• Doses should be increased until symptoms are relieved regardless of laboratory tests.
• The product is made from "natural" ingredients as opposed to "synthetic" ones.
• Doctors are biased towards synthetic thyroxine due to financial incentives from drug manufacturers.^[17] However, those making this argument may also argue that doctors have a tendency to underdose their patients due to an overreliance on lab results. If physicians wished to increase pharmaceutical profits, they would push for higher dosages.

One double-blind controlled study comparing desiccated thyroid extract to levothyroxine concluded: "DTE therapy did not result in a significant improvement in quality of life; however, DTE caused modest weight loss and nearly half (48.6%) of the study patients expressed preference for DTE over L-T4. DTE therapy may be relevant for some hypothyroid patients."^[18] Another version of the article redacts the last sentence of the conclusion.^[19]

Current opposition to desiccated thyroid use

Most endocrinologists and professional associations (such as the Royal College of Physicians^[20]) oppose the use of desiccated thyroid. They recommend synthetic levothyroxine as the preferred treatment. Some practitioners refuse to use desiccated thyroid and will try to steer their patients away from it.^[21]

Arguments against desiccated thyroid include:

1. Desiccated thyroid preparations have a greater variability from batch to batch than synthetic ones.^[21] Proponents of natural thyroid argue that synthetic preparations also suffer from variability.^[22]
2. Desiccated thyroid has roughly a 4:1 ratio of thyroxine (T4) to triiodothyronine (T3). In humans, the ratio is 11:1.^[23]
3. A combination of various ratios of T3 and T4 may not provide benefits over T4 alone. Some controlled trials have shown inconsistent benefits of various ratios of T4 and T3.^[24][25][26] The merits of T3+T4 versus T4 alone remain controversial among the endocrinology community.
4. The use of desiccated thyroid is usually accompanied with the practice of dosing according to symptoms instead of dosing to achieve "ideal" lab results (e.g. serum levels of TSH). While there is debate as to what the ideal serum levels are, dosing according to symptoms often results in higher dosages. Most endocrinologists are opposed to these higher dosages as there may be risks of hyperthyroidism and osteoporosis.^[27]
5. The widespread preference for "natural" treatment stems from philosophical belief as opposed to science.^[28]

Books

There are several books promoting thyroid hormone replacement with desiccated thyroid:

• Janie A. Bowthorpe. "Stop the Thyroid Madness: a Patient Revolution Against Decades of Inferior Treatment". Laughing Grape Publishing, 2008. ISBN 978-0-615-14431-3 Revised Edition: 2011. ISBN 978-0-615-47712-1
• Dr. David Brownstein. Overcoming Thyroid Disorders. Medical Alternatives Press, 2002. ISBN 0-9660882-2-0.
• Barry Durrant-Peatfield. The Great Thyroid Scandal and How To Survive It. Barons Down Publishing, 2002. ISBN 0-9544203-0-6.
• Steven F. Hotze. Hormones, Health, and Happiness. Forrest Publishing, 2005. ISBN 0-9765751-0-8.
• Mary Shomon. Living Well With Hypothyroidism: What Your Doctor Doesn't Tell You...That You Need to Know. HarperCollins, 2005. ISBN 0-06-074095-7.

• Starr, Mark (2005). Hypothyroidism Type 2, the Epidemic. New Voice. ISBN 0-9752624-0-8. 

• Langer, Stephan (2006). Solved: The Riddle of Illness. McGraw-Hill. ISBN 0-658-00293-7. 

References

External links

• Forest Labs Armour insert (PDF)