A placebo-controlled, blinded and randomised study on the effects of recombinant human thyrotropin on quality of life in the treatment of thyroid cancer.
BACKGROUND
It is well known that thyroid hormone withdrawal (THW) in thyroid cancer patients can induce a decrease in quality of life (QOL). Recombinant human thyrotropin (rh-TSH) has been used to avoid this; however, no blinded studies have ever documented the effect.


OBJECTIVE
To compare QOL in patients with differentiated thyroid cancer (DTC) treated with either rh-TSH or liothyronine (L-T3) THW for 10 days.


METHODS
Double-blind, randomised cross-over.


METHODS
Fifty-six patients with DTC treated by total thyroidectomy and indication for postsurgery radioiodine (RI) ablation therapy.


METHODS
Randomisation to either L-T3 and rh-TSH prior to the first RI course and following this to ingest placebo tablets and receive placebo injections before a second RI uptake measurement 4-6 months later, or to receive placebo before the primary RI ablation and active therapy 4-6 months later.


METHODS
QOL was measured by SF-36 and 2 visual analogue scale (VAS) scores at baseline and during RI therapy or RI uptake.


RESULTS
A significant difference in QOL was seen in 2 of 4 predefined SF-36 domains (7.2 and 6.6%) and 2 VAS scales (10 and 14%), favouring rh-TSH therapy.


CONCLUSIONS
This is the first blinded randomised clinical trial describing the effect of rh-TSH compared to L-T3 THW on QOL in DTC patients. A significant difference was demonstrated, though smaller than described in previous non-blinded studies.
Department of Endocrinology, Herlev University Hospital, Herlev, Denmark.
Birte
B
Nygaard
Department of Oncology, Odense University Hospital, Odense, Denmark.
Lars
L
Bastholt
Department of Endocrinology, Herlev University Hospital, Herlev, Denmark.
Finn Noe
FN
Bennedbæk
Department of Haematology, Herlev University Hospital, Herlev, Denmark.
Tobias Wirenfeldt
TW
Klausen
Department of Oncology, Herlev University Hospital, Herlev, Denmark.
Jens
J
Bentzen
Quality of life; Recombinant human thyrotropin; Thyroid cancer; Triiodothyronine