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Effect of combination therapy with thyroxine (T4) and 3,5,3-triiodothyronine (T3) versus T4 monotherapy in patients with hypothyroidism, a double blind, randomized cross-over study.

B Nygaard, Dept of endocrinology J 106, Herlev hospital, Herlev, dk 2730, Denmark
E Jensen, Departments of Endocrinology, Herlev Hospital, Herlev, Denmark
J Kvetny, Departments of Endocrinology, Esbjerg Hospital, esbjerg, Denmark
A Jarlov, dept ofendocrinology, Frederiksberg hospital, Frederiksberg, Denmark
J Faber, Departments of Endocrinology, Herlev Hospital, Herlev, Denmark

Correspondence: Birte Nygaard, Email: birte.nygaard{at}dadlnet.dk

Treatment of hypothyroidism with T3 is controversial. A recent meta-analysis concludes that no evidence is present in favour of using T3. However, the analysis included a mixture of different patient groups and dose-regimens.

Purpose: To compare the effect of combination therapy with T4 and T3 versus T4 monotherapy in patients with hypothyroidism on stable T4 substitution.

Study design: Double blind, randomized cross-over. Fifty µg of the usual T4 dose were replaced with either 20 µg T3 or 50 µg T4 for 12 weeks, followed by cross-over for another 12 weeks. The T4 dose was regulated if needed, intending unaltered serum TSH levels.

Evaluation: Tests for quality of life (QOL) and depression (SF-36, Beck Depression Inventory (BDI), and SCL-90-R) at base line and after both treatment periods.

Inclusion criteria: Serum TSH between 0.1 and 5.0 mU/L on unaltered T4 substitution during 6 months

Results: Fifty-nine patients (55 women); median age 46 yrs.

When comparing scores of QOL and depression on T4 monotherapy versus T4/T3 combination therapy, significant differences were seen in 7 of 11 scores, indicating a positive effect related to the combination therapy.

Forty-nine percent preferred the combination and 15% monotherapy (p= 0.002). Serum TSH remained unaltered between the groups as intended.

Conclusion: In a study design, where TSH levels were unaltered between groups combination therapy, (treated with high dose of T3) was superior to monotherapy by evaluating several QOL, depression and anxiety rating scales as well as patients own preference.