No fewer than 500,000 Dutch people use drugs for an underactive thyroid
The Department of Internal Medicine of Erasmus MC will start this month with a study into a common ailment: the underactive thyroid.
The T3-4-Hypo Trial aims to answer a question that has puzzled patients and doctors around the world for years: why does the treatment for an underactive thyroid not work adequately for some patients?
No fewer than 500,000 Dutch people use medicines for an underactive thyroid. However, about ten percent continue to have complaints, without doctors knowing why. Because the blood values of these patients are normal. Endocrinologist Marco Medici and his research group are going to investigate why this is in a large-scale study. They will receive 1.9 million euros from ZonMw for this.
Invaliderend
The standard medication that people take for hypothyroidism, as the underactive thyroid is called in medical jargon, is the thyroid hormone T4. ‘That works fine for most patients. But in 10 percent, despite normalized blood values, there are permanent disabling complaints, such as severe fatigue, concentration and memory problems or depressive complaints. These complaints lead to a poor quality of life’, explains lead researcher Marco Medici.
The thyroid makes two hormones that are necessary for cells in the body to work properly: T4 and T3, explains Medici. ‘T4 is the precursor hormone. The tissues take up that hormone and convert it themselves into T3, which is the active hormone. The organs absorb as much as they need.’
No proof
However, the thyroid itself also produces a small amount of T3 hormone in addition to T4. An underactive thyroid makes little or no T4 and T3. If you treat a patient with only T4, you miss the T3 that is made by a healthy thyroid gland. In some patients, administration of T3 hormone in addition to T4 seems to solve the problems. But there is no conclusive evidence.’
In the study by Medici and his research group, people can participate who, despite their normalized blood values under T4 therapy, suffer from severe fatigue and other complaints. ‘We mean fatigue that has a major negative impact on their daily lives,’ adds Medici.
These patients, Medici wants 600 to participate, are all temporarily placed on the same T4 preparation to start with. ‘There are 7 different preparations in the Netherlands. For reliable study results, it is important that patients take the same drug before we start the comparative study.’
The group is then split in two. One group receives T4 and a placebo, the other T4 and additional T3. They follow this treatment for a year. If adding T3 makes sense, it should be clear after a year. All 600 patients will be fully screened again after that year.
solace
The best thing would of course be that the study proves that adding T3 to the therapy offers solace. Medici hopes that the patients will then be rid of their severe fatigue and other residual complaints. But that remains to be seen. ‘Because this study is so thorough, we also hope to find clues that explain why normal T4 therapy doesn’t work in those 10 percent.’
The T3-4-Hypo Trial was actually supposed to start in 2020, but the corona pandemic threw a spanner in the works. The research group is happy that it can finally start. ‘Approximately 3 percent of the world’s population suffers from such an underactive thyroid. So there is also a lot of international attention for this study and the final results are being looked forward to,’ says Medici. He hopes to announce it in about four years.
Participate?
More information about the study can be found on a website. Erasmus MC has already started the study and over time fourteen other hospitals throughout the Netherlands will participate.
This study has been set up and/or is being conducted by: Karin Deckers (trial coordinator), Edward Visser (endocrinologist), Anita Boelen (medical biologist Amsterdam UMC), Merel Stegenga and Lizette Blankers (doctor-researchers) Barbara van der Linden (nursing specialist ), and researchers from 14 other Dutch hospitals.
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