The effect of a self controlled dose of Levothyroxine on the quality of life and thyroid stimulating hormone in patients treated for hypothyroidism: a randomized, double blind, consecutive study.

Hypothyroidism is a chronical disease with a bad influence on quality of life
in this patients. Some researchers mean that self control in treatment and
medication is a potential good development that can improve medical condition,
make patients stronger and can positively influence attitude and behaviour. Our
hypothesis is that when patients can have influence on their dose of
Levothyroxine, this will have a positive influence on their quality of life. It
is also interesting what the role of placebo effect in this situation will be.

The goal of this study is to positively influence quality of life in patients
with hypothyroidism by giving them back control in their treatment. We also
want to see what the placebo effect will be. And at last we want to check if
patients have the urge to lower their TSH levels if they can choose their own
dose of Levothyroxine and if that has a relationship with their quality of
life.

A randomized, double blind, consecutive study on the outpatient clinic at the
department of internal medicine and endocrinology of the Maasstad Hospital
Rotterdam. Patients treated with Levothyroxine because of primary
hypothyroidism will be included.

Patients who are not content about the treatment of their hypothyroidism with
Levothyroxine get the chance to controle their own dose. There will be 2
moments during the study where they can decide if they want to raise their dose
of Levothyroxine. At the first time of choice randomization will follow and the
first half of the group will get 25 mcg extra Levothyroxine and the other half
will receive a placebo. After 6 weeks of treatment the placebo group will also
receive 25 mcg extra medication. So after 12 weeks the whole group has been
treated with 25 mcg extra Levohyroxine. At the second moment of choice patients
can either go back to their original dose, stay at 25 mcg extra or decide they
want another 25 mcg extra. There will be another randomization in group that
wants extra medication. Half will get extra 25 mcg extra and half will get an
placebo.

The risk of this intervention is small because this patients use Levothyroxine
for at least 6 months. This medication is also the first choice of treatment in
hypothyroidism for a very long time and the maximal raise is 50 mcg. In fact
this is te normal way of raise in the outpatient clinic, only a bit faster and
patients have a state of euthyroidism. We think this raise will not give any
problems.