A placebo-controlled, blinded and randomised study on the effects of recombinant human thyrotropin on quality of life in the treatment of thyroid cancer

Birte Nygaard, Lars Bastholt, Finn Noe Bennedbæk, Tobias Wirenfeldt Klausen, Jens Bentzen

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review


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.

STUDY DESIGN: Double-blind, randomised cross-over.

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

INTERVENTION: 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.

MAIN OUTCOME MEASURES: 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.

CONCLUSION: 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.

TidsskriftEuropean Thyroid Journal
Udgave nummer3
Sider (fra-til)195-202
StatusUdgivet - sep. 2013