Clinical Trial to Compare Natural Desiccated Thyroid to Levothyroxine

NIH Recruiting Hypothyroid Patients for New Study

Close-up of mid adult woman taking medicine
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It's an exciting day for thyroid patients, and one that has been long-awaited. The U.S. National Institutes of Health has announced that a clinical trial has just been started in 2012 at the Walter Reed National Military Medical Center, in Bethesda, MD, to study natural desiccated thyroid drugs versus levothyroxine, for the treatment of primary hypothyroidism.

The randomized, cross-over study -- which goes through May of 2014 -- will evaluate the hypothesis that hypothyroid patients on natural desiccated thyroid (what they refer to as "dessicated thyroid extract" or DTE) may have "a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being / quality of life," when compared with levothyroxine.

The official title of the study is "Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study," and they are recruiting thyroid patients as study participants.

Eligibility

Exclusions

  • pregnancy or plan for pregnancy in the next 12 months
  • cardiac disease, especially coronary artery disease
  • chronic obstructive lung disease
  • malabsorption disorder
  • gastrointestinal surgeries
  • significant renal or liver dysfunction
  • seizure disorders
  • thyroid and non-thyroid active cancers
  • uncontrolled psychosis
  • psychotropic medication use
  • steroid use
  • amiodarone use
  • chemotherapy for cancer
  • iron supplement more than 325mg per day
  • carafate/ proton pump inhibitor use
  • cholestyramine use

Why is This Trial Important?

This trial is also important because there is a strong bias among conventional endocrinologists against prescribing natural desiccated thyroid drugs, but it is not based on research, but rather, their own opinions and preferences. Some endocrinologists, in fact, have even said that natural thyroid drugs like Armour are only taken by the "fringe", despite the fact that more than two million prescriptions for these drugs are written each year in the United States alone, and more around the world.

This trial is also important because we need research that looks specifically at the use of natural desiccated thyroid. Some studies, including the 2009 Danish study, have shown quality of life improvements with the addition of synthetic T3 to synthetic T4 (levothyroxine), but some physicians have said that these studies are not relevant when considering natural desiccated thyroid drugs (which naturally contain both T3 and T4) because they are different drugs.

To Participate in the Trial

The clinical Trials.gov identifier number for this trial is NCT01739972.

Questions About Clinical Trials?

If You Are Successfully Recruited Into This Trial

to keep me posted on how it goes for you.