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Thyroid hormone replacement therapy in primary hypothyroidism: a randomized trial comparing L-thyroxine plus liothyronine with L-thyroxine alone.
Ann Intern Med 2005; 142(6):412-24AIM

Abstract

BACKGROUND

Substituting part of the dose of l-thyroxine with small but supraphysiologic doses of liothyronine in hypothyroid patients has yielded conflicting results.

OBJECTIVE

To evaluate combinations of L-thyroxine plus liothyronine in hypothyroid patients that match the proportions present in normal secretions of the human thyroid gland.

DESIGN

Randomized, double-blind, crossover trial.

SETTING

Academic research hospital.

PARTICIPANTS

28 women with overt primary hypothyroidism.

INTERVENTION

Crossover trial comparing treatment with l-thyroxine, 100 microg/d (standard treatment), versus treatment with L-thyroxine, 75 microg/d, plus liothyronine, 5 microg/d (combination treatment), for 8-week periods. All patients also received L-thyroxine, 87.5 microg/d, plus liothyronine, 7.5 microg/d (add-on combination treatment), for a final 8-week add-on period.

MEASUREMENTS

Primary outcomes included serum thyroid hormone levels, results of quality-of-life and psychometric tests, and patients' preference. Multiple biological thyroid hormone end points were studied as secondary outcomes.

RESULTS

Compared with standard treatment, combination treatment led to lower free thyroxine levels (decrease, 3.9 pmol/L [95% CI, 2.5 to 5.3 pmol/L]), slightly higher serum levels of thyroid-stimulating hormone (increase, 0.62 mU/L [CI, 0.01 to 1.23 mU/L]), and unchanged free triiodothyronine levels. No improvement was observed in the other primary and secondary end points after combination treatment, with the exception of the Digit Span Test, in which the mean backward score and the mean total score increased slightly (0.6 digit [CI, 0.1 to 1.0 digit] and 0.8 digit [CI, 0.2 to 1.4 digits], respectively). The add-on combination treatment resulted in overreplacement. Levels of thyroid-stimulating hormone decreased by 0.85 mU/L (CI, 0.27 to 1.43 mU/L) and serum free triiodothyronine levels increased by 0.8 pmol/L (CI, 0.1 to 1.5 pmol/L) compared with standard treatment; 10 patients had levels of thyroid-stimulating hormone that were below the normal range. Twelve patients preferred combination treatment, 6 patients preferred the add-on combination treatment, 2 patients preferred standard treatment, and 6 patients had no preference (P = 0.015).

LIMITATIONS

Treatment with L-thyroxine, 87.5 microg/d, plus liothyronine, 7.5 microg/d, was an add-on regimen and was not randomized.

CONCLUSIONS

Physiologic combinations of L-thyroxine plus liothyronine do not offer any objective advantage over l-thyroxine alone, yet patients prefer combination treatment.

Authors+Show Affiliations

Department of Endocrinology, Hospital Ramón y Cajal, Madrid, Spain. hescobarm.hrc@salud.madrid.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15767619

Citation

Escobar-Morreale, Héctor F., et al. "Thyroid Hormone Replacement Therapy in Primary Hypothyroidism: a Randomized Trial Comparing L-thyroxine Plus Liothyronine With L-thyroxine Alone." Annals of Internal Medicine, vol. 142, no. 6, 2005, pp. 412-24.
Escobar-Morreale HF, Botella-Carretero JI, Gómez-Bueno M, et al. Thyroid hormone replacement therapy in primary hypothyroidism: a randomized trial comparing L-thyroxine plus liothyronine with L-thyroxine alone. Ann Intern Med. 2005;142(6):412-24.
Escobar-Morreale, H. F., Botella-Carretero, J. I., Gómez-Bueno, M., Galán, J. M., Barrios, V., & Sancho, J. (2005). Thyroid hormone replacement therapy in primary hypothyroidism: a randomized trial comparing L-thyroxine plus liothyronine with L-thyroxine alone. Annals of Internal Medicine, 142(6), pp. 412-24.
Escobar-Morreale HF, et al. Thyroid Hormone Replacement Therapy in Primary Hypothyroidism: a Randomized Trial Comparing L-thyroxine Plus Liothyronine With L-thyroxine Alone. Ann Intern Med. 2005 Mar 15;142(6):412-24. PubMed PMID: 15767619.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Thyroid hormone replacement therapy in primary hypothyroidism: a randomized trial comparing L-thyroxine plus liothyronine with L-thyroxine alone. AU - Escobar-Morreale,Héctor F, AU - Botella-Carretero,José I, AU - Gómez-Bueno,Manuel, AU - Galán,José M, AU - Barrios,Vivencio, AU - Sancho,José, PY - 2005/3/16/pubmed PY - 2005/3/22/medline PY - 2005/3/16/entrez SP - 412 EP - 24 JF - Annals of internal medicine JO - Ann. Intern. Med. VL - 142 IS - 6 N2 - BACKGROUND: Substituting part of the dose of l-thyroxine with small but supraphysiologic doses of liothyronine in hypothyroid patients has yielded conflicting results. OBJECTIVE: To evaluate combinations of L-thyroxine plus liothyronine in hypothyroid patients that match the proportions present in normal secretions of the human thyroid gland. DESIGN: Randomized, double-blind, crossover trial. SETTING: Academic research hospital. PARTICIPANTS: 28 women with overt primary hypothyroidism. INTERVENTION: Crossover trial comparing treatment with l-thyroxine, 100 microg/d (standard treatment), versus treatment with L-thyroxine, 75 microg/d, plus liothyronine, 5 microg/d (combination treatment), for 8-week periods. All patients also received L-thyroxine, 87.5 microg/d, plus liothyronine, 7.5 microg/d (add-on combination treatment), for a final 8-week add-on period. MEASUREMENTS: Primary outcomes included serum thyroid hormone levels, results of quality-of-life and psychometric tests, and patients' preference. Multiple biological thyroid hormone end points were studied as secondary outcomes. RESULTS: Compared with standard treatment, combination treatment led to lower free thyroxine levels (decrease, 3.9 pmol/L [95% CI, 2.5 to 5.3 pmol/L]), slightly higher serum levels of thyroid-stimulating hormone (increase, 0.62 mU/L [CI, 0.01 to 1.23 mU/L]), and unchanged free triiodothyronine levels. No improvement was observed in the other primary and secondary end points after combination treatment, with the exception of the Digit Span Test, in which the mean backward score and the mean total score increased slightly (0.6 digit [CI, 0.1 to 1.0 digit] and 0.8 digit [CI, 0.2 to 1.4 digits], respectively). The add-on combination treatment resulted in overreplacement. Levels of thyroid-stimulating hormone decreased by 0.85 mU/L (CI, 0.27 to 1.43 mU/L) and serum free triiodothyronine levels increased by 0.8 pmol/L (CI, 0.1 to 1.5 pmol/L) compared with standard treatment; 10 patients had levels of thyroid-stimulating hormone that were below the normal range. Twelve patients preferred combination treatment, 6 patients preferred the add-on combination treatment, 2 patients preferred standard treatment, and 6 patients had no preference (P = 0.015). LIMITATIONS: Treatment with L-thyroxine, 87.5 microg/d, plus liothyronine, 7.5 microg/d, was an add-on regimen and was not randomized. CONCLUSIONS: Physiologic combinations of L-thyroxine plus liothyronine do not offer any objective advantage over l-thyroxine alone, yet patients prefer combination treatment. SN - 1539-3704 UR - https://www.unboundmedicine.com/medline/citation/15767619/Thyroid_hormone_replacement_therapy_in_primary_hypothyroidism:_a_randomized_trial_comparing_L_thyroxine_plus_liothyronine_with_L_thyroxine_alone_ L2 - https://www.annals.org/aim/fullarticle/doi/10.7326/0003-4819-142-6-200503150-00007 DB - PRIME DP - Unbound Medicine ER -