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When they underwent metabolic evaluation, some patients were not taking thyroid hormone. Others were taking either T4 alone, T3 alone, a synthetic T4/T3 combination, or natural desiccated thyroid. We will do statistical analyses to determine whether the measurements of patients using different thyroid hormone therapies were significantly different in any ways. We consider this part of the study to be a pilot sub-study of Study #3 below.
What remains to be done in this study is the final tabulation of a large amount of data, final statistical analyses, preparing the study report, and submission for publication.
Study #2. Electrocardial Function and Patient Perceptions at Peak Serum Free T3 Levels: Measured by Holter Monitor in Subjects Taking Exogenous Cynomel, Cytomel, and Nature-Throid.
For the last forty years, many advocates of T4 replacement therapy have argued that an advantage to this form of treatment is that it avoids peak serum T3 levels. They have stated that the peak levels are associated with possible cardiac arrhythmias (disordered rhythms of heart beat) and "troublesome palpitations" that concern patients. Some clinicians have extended this proposition to a more extreme one—that taking T3 may induce a heart attack.
In many journal papers, authors have written as thought it is factual that peak T3 levels after ingesting T3-containing products cause arrhythmias and troublesome palpitations. Despite this, we can find no studies of changes in the electrical function of the heart at peak serum T3 levels. This study, as far as we know, will be the first to actually test the proposition.
I've taken synthetic T3 (and occasionally desiccated thyroid) for some twenty-five years. I've never experienced a perception of altered cardiac function after taking my single daily dose of 150 mcg of synthetic T3. I've also carefully queried thousands of patients who took T3-containing products about their perceptions of cardiac effects. Only the rarest individual has reported such perceptions. However, because of the timing of their T3 intake and in relation to their putative cardiac reactions, I'm not convinced that any patient's report reactions have been accurate.
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Hence, I personally don't believe the proposition is true. However, in quality science, researchers organize studies so that their prejudices and presumptions may be proven wrong. This study is organized that way. Therefore, if the study results show my belief to be false, I'll have no choice but to concede that my belief is wrong. But at least at that point, we will at long last have objective verification that peak serum T3 levels are associated with arrhythmias and/or trouble palpitations. Clinicians can then incorporate the confirmed proposition into their clinical decisions for patients who use T3-containing products.
However, if the study results refute proposition, we'll have objectively verified that it is an institutionalized falsehood. In that case, no one henceforth can legitimately claim that peak serum T3 levels as associated with arrhythmias and troublesome palpitations. This possible study outcome will neutralize the proposition as an argument against the use of products that contain T3, such as synthetic T3 and natural desiccated thyroid.
Study #3. Comparison of Patients Treated with Natural Desiccated Thyroid to Patients Treated with T4 Replacement: A Multicenter Study.
Between 1932 and 2001, researchers publish at least 14 reports of studies in which they had compared the effects on humans of synthetic T4 and natural desiccated thyroid. Based on results of the studies, a specific proposition was warranted: 1 grain of desiccated thyroid was equivalent to 100 mcg of T4. These equivalent doses of the two preparations maintained the basal metabolic rate and lowered elevated cholesterol. Clinicians believed they could use these equivalent doses to switch patients from one of the thyroid hormone preparations to the other and maintain the same benefits as the other preparation had provided.
Despite major medical journals publishing those study
reports,
the endocrinology specialty has denounced
desiccated thyroid. The specialty has contended that compared to T4,
desiccated thyroid is less stable, less
effective, and potentially harmful. My assessment of the
available evidence led me to the diametrically opposite
conclusion: compared to natural desiccated thyroid, synthetic
T4 appears to be less stable, less effective, and potentially
harmful to patients. Thyroid Science
published my assessment of the relevant published evidence as a
rebuttal to the British Thyroid Association:
http://www.thyroidscience.com/Criticism/lowe.3.16.09/bta.rebuttal.htm)
One intention of this study is to objectively either verify or
refute the endocrinology specialty's assertions that desiccated
thyroid is ineffective and potential harmful to patients.
The specialty's assertions appear jaundiced to me; if they are,
this study should verify it.
To my knowledge, this will be the first large multicenter study that compares the benefits and associated adverse effects of T4 replacement and desiccated thyroid. The study will be a valuable addition to the 14 other studies in which researchers compared T4 and desiccated thyroid.
Several medical practices are needed to participate in the study. It is likely that in some practices, T4 replacement is the standard thyroid hormone treatment prescribed. In others, desiccated thyroid will be the standard treatment. It is likely, then, that we will have two sets of medical practices, based on the thyroid hormone therapy customarily used.
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The study will include control patients who are not undergoing treatment with thyroid hormone. Each control subject will be of the same age and sex as another patient who is being treated with either T4 or desiccated thyroid.
The larger the patient groups in the study, the more likely we are to identify small but possibly important statistically significant differences between the three groups.
We see three possible outcomes of the study. We may find that on average, patients using T4 replacement benefits more. Or may find that this is true of desiccated thyroid. On the other hand, we may find no significant difference between patients in the two treatment groups. We are designing the study so data will be collected, tabulated, and analyzed in an entirely impartial fashion. This will ensure that the study outcome cannot be questioned on the basis of bias.
We'll be thankful if you are a practicing clinician and offer to include your clinic in the study. If you're a patient or patient advocate, we'll be grateful if you'll mention the study to any clinician you know who might be interested in including his or her clinic in the study. You can communicate with either Tammy, our Executive Director, Michele, our Foundation Coordinator, or me through the contact methods on our Contact Us page.
"To measure is to know."
—Lord Kelvin (19th-century mathematical physicist). Kelvin also wrote,
“If you cannot
measure it, you
cannot
improve
it.”
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Our ultimate purpose in conducting studies through FRF is to improve the health and well-being of fibromyalgia/thyroid patients. We measure so that we can improve the patients' plight (à la Lord Kelvin). Guided by that ultimate purpose, we conduct studies to sort truth from falsehood. To sort with exacting accuracy, we take relevant measurements and then assess their meaning by various means, such as statistical analyses. The measurements we take, the analyses we perform, and the conclusions we reach are not influenced by a compromising desire for more funding from Big Pharma or the National Institutes of Health. They are instead influenced by our ultimate purpose—improving the health and well-being of fibromyalgia/thyroid patients. |