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This Article Full Text Full Text (PDF) All Versions of this Article: EJE-09-0542v1 161/6/895    most recent Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Nygaard, B. Articles by Faber, J. PubMed PubMed Citation Articles by Nygaard, B. Articles by Faber, J.

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

Department of Endocrinology, Herlev Hospital, University of Copenhagen, Herlev Ringvej, DK-2730 Herlev, Denmark¹ Department of Endocrinology, Esbjerg Hospital, Esbjerg, Denmark² Department of Endocrinology, Frederiksberg Hospital, Frederiksberg, Denmark

(Correspondence should be addressed to B Nygaard; Email: binyg{at}heh.regionh.dk)

Background: Treatment of hypothyroidism with 3,5,3'-triiodothyronine (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.

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

Study design: Double-blind, randomised cross-over. Fifty micrograms of the usual T₄ dose was 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, and SCL-90-R) at baseline and after both treatment periods.

Inclusion criteria: Serum TSH between 0.1 and 5.0 mU/l on unaltered T₄ substitution for 6 months.

Results: A total of 59 patients (55 women); median age 46 years. When comparing scores of QOL and depression on T₄ monotherapy versus T₄/T₃ combination therapy, significant differences were seen in 7 out 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 morning TSH levels were unaltered between groups combination therapy, (treated with T₃ 20 µg once daily) was superior to monotherapy by evaluating several QOL, depression and anxiety rating scales as well as patients own preference.