Thyroxine-Triiodothyronine Combination Therapy Versus Thyroxine Monotherapy for Clinical Hypothyroidism: Meta-Analysis of Randomized Controlled Trials

Grozinsky-Glasberg, Simona; Fraser, Abigail; Nahshoni, Ethan; Weizman, Abraham; Leibovici, Leonard

doi:10.1210/jc.2006-0448

Cited by 298Thyroid Disorders and TreatmentsThyroid and Parathyroid SurgeryThyroid Cancer Diagnosis and Treatment

Thyroxine-Triiodothyronine Combination Therapy Versus Thyroxine Monotherapy for Clinical Hypothyroidism: Meta-Analysis of Randomized Controlled Trials

Grozinsky-Glasberg, Simona, Fraser, Abigail, Nahshoni, Ethan, Weizman, Abraham, Leibovici, Leonard·2006·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.2006-0448

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Abstract

CONTEXT: In some patients symptoms of hypothyroidism persist despite therapy with T(4). OBJECTIVE: The objective of the study was to compare the effectiveness of T(4)-T(3) combination vs. T(4) monotherapy for the treatment of clinical hypothyroidism in adults. DATA SOURCES: PubMed, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched in September 2005. References of all included trials were scanned for additional studies. We put no restrictions on language, year of publication, or publication status. STUDY SELECTION: All randomized trials that compared the effectiveness of T(4)-T(3) combination vs. T(4) monotherapy for the treatment of clinical hypothyroidism in adults were included. DATA EXTRACTION: The data were extracted by two independent reviewers. DATA SYNTHESIS: We included 11 studies, in which 1216 patients were randomized. No difference was found in the effectiveness of combination vs. monotherapy in any of the following symptoms: bodily pain [standardized mean difference (SMD) 0.00, 95% confidence interval (CI) -0.34, 0.35], depression (SMD 0.07, 95% CI -0.20, 0.34), anxiety (SMD 0.00, 95% CI -0.12, 0.11), fatigue (SMD -0.12, 95% CI -0.33, 0.09), quality of life (SMD 0.03, 95% CI -0.09, 0.15), body weight, total serum cholesterol, triglyceride levels, low-density lipoprotein, and high-density lipoprotein. Adverse events did not differ between regimens. CONCLUSIONS: T(4) monotherapy should remain the treatment of choice for clinical hypothyroidism.

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Systematic reviews and meta-analyses of 18 trials of combination levothyroxine-liothyronine replacement found no clear benefit over levothyroxine monotherapy.
“However, systematic reviews and metaanalyses of 18 trials of combination levothyroxine-liothyronine replacement found no clear benefit over levothyroxine monotherapy.12,13”
From Hypothyroidism (2024) · cites this paper as [12]
A meta-analysis from two clinical trials found no benefit to hypothyroid symptoms and fatigue.
“a meta-analysis from two clinical trials found no benefit to hypothyroid symptoms and fatigue.12”
From Hypothyroidism (2024) · cites this paper as [12]
Four systematic reviews and meta-analyses of these trials found no clear benefit of combination levothyroxine-liothyronine therapy over levothyroxine monotherapy in terms of mood, health-related quality of life, or cognitive function.
“Furthermore, four systematic reviews and metaanalyses 12,13,180,181 of these trials found no clear benefit of combination levothyroxineliothyronine therapy over levothyroxine monotherapy in terms of mood, healthrelated quality of life, or cognitive function.”
From Hypothyroidism (2024) · cites this paper as [12]
Four systematic reviews/meta-analyses of these trials found no clear benefit of combination liothyronine/levothyroxine replacement over levothyroxine monotherapy in terms of mood, health-related QoL or cognitive function.
“four systematic reviews/meta -analyses 12,44 -46 of these trials found no clear benefit of combination liothyronine/levothyroxine replacement over levothyroxine monotherapy in terms of mood, health -related QoL or cognitive function.”
From Use of liothyronine (T3) in hypothyroidism: Joint British Thyroid Association/Society for endocrinology consensus statement (2023) · cites this paper as [44]
Trials do not show a benefit from thyroid hormone replacement in persistent subclinical hypothyroidism.
“or to those with persistent subclinical hypothyroidism, where trials do not show a benefit from thyroid hormone replacement. 12,15,16,44 -46”
From Use of liothyronine (T3) in hypothyroidism: Joint British Thyroid Association/Society for endocrinology consensus statement (2023) · cites this paper as [44]

A meta-analysis of randomized controlled trials by Grozinsky-Glasberg et al showed no significant increase in adverse-event risk for LT3 compared to LT4.
“A meta-analysis of RCTs by Grozinsky-Glasberg et al showed similar results to ours with no significant increase in AE risk for LT3 compared to LT4 (12).”
From Risk of Death and Adverse Effects in Patients on Liothyronine: A Multisource Systematic Review and Meta-analysis (2025) · cites this paper as [12]
Systematic reviews on LT3 safety are limited and have been confined to analyses of short-term adverse outcomes in treatment efficacy trials.
“Systematic reviews on LT3 safety are limited and have been confined to the analyses of short-term adverse outcomes in treatment efficacy trials (11, 12).”
From Risk of Death and Adverse Effects in Patients on Liothyronine: A Multisource Systematic Review and Meta-analysis (2025) · cites this paper as [12]
Adverse-event risks in randomized controlled trials were only specifically addressed in a few previous systematic reviews.
“AE risks in RCTs were only specifically addressed in a few previous systematic reviews (11, 12).”
From Risk of Death and Adverse Effects in Patients on Liothyronine: A Multisource Systematic Review and Meta-analysis (2025) · cites this paper as [12]
These previous meta-analyses were limited to trials that met criteria for efficacy analysis.
“However, these meta-analyses were limited to trials that met criteria for efficacy analysis.”
From Risk of Death and Adverse Effects in Patients on Liothyronine: A Multisource Systematic Review and Meta-analysis (2025) · cites this paper as [12]
In that meta-analysis, adverse events did not differ between L-T4 monotherapy and L-T4 + L-T3 combination therapy (RR 1.19, 95% CI 0.63-2.24).
“Adverse events did not differ between regimens (RR 1.19, 95% CI 0.63, 2.24).”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
The meta-analysis was unable to demonstrate a relation between the proportion of athyreotic patients included in the study and the effect of combination therapy on symptoms.
“The metaanalysis was unable to demonstrate a relation between the proportion of athyreotic patients included in the study and the effect of combination therapy on symptoms [34] .”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
The earliest study from 1970 and the most recent one from 2009 are not included in the meta-analysis, but all other studies performed between 1999 and 2005 are included.
“The earliest study from 1970 [37] and the most recent one from 2009 [5] are not included in the meta-analysis, but all other studies (performed between 1999 and 2005) are included in the meta-analysis [34] .”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
The meta-analysis of all RCTs listed in table 2 (not incorporating [5] and [37]) concluded that L-T4 + L-T3 combination therapy used as replacement therapy for patients treated for hypothyroidism provided no advantage when compared with standard L-T4 monotherapy.
“The meta-analysis of all RCTs listed in table 2 (not incorporating [5] and [37] ) concluded that L-T4 + L-T3 combination therapy used as replacement therapy for patients treated for hypothyroidism provided no advantage when compared with standard L-T4 monotherapy [34] .”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
The meta-analysis observed similar effects on outcome parameters when comparing parallel and crossover designs.
“Moreover, the metaanalysis observed similar effects on outcome parameters when comparing parallel and crossover designs [34] .”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
The meta-analysis did not perform a quantitative analysis of patient's preference.
“The meta-analysis did not perform a quantitative analysis of patient's preference [34] .”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
The meta-analysis found combination therapy was not better than monotherapy by assessment of QoL, mood, symptoms and cognition.
“The meta-analysis found combination therapy was not better than monotherapy by assessment of QoL, mood, symptoms and cognition [34] .”
From 2012 ETA Guidelines: The Use of L-T4 + L-T3 in the Treatment of Hypothyroidism (2012) · cites this paper as [34]
Four systematic reviews and meta-analyses based on RCTs failed to show any advantages in quality of life, mood states, or psychometric performance for patients receiving combination therapy.
“Four systematic reviews and meta-analyses based on RCTs failed to show any advantages in quality of life, mood states, or psychometric performance for patients receiving combination therapy (160–163).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [161]

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“The first, a 2006 meta-analysis analyzed 1216 patients in 11 RCTs resulting in no advantage of synthetic therapy in bodily pain, depression, anxiety, fatigue, quality of life, body weight, and serum cholesterol.(30) A second metaanalysis in 2009 found some benefits in synthetic therapy for psychological and physical w…”
Background
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Authors: Grozinsky-Glasberg, S., Fraser, A., Nahshoni, E., Weizman, A., & Leibovici, L.
Affiliations: Endocrine Institute (S.G.-G.) Petah-Tiqva 49100, Israel
Department of Medicine E (A.F., L.L.) Petah-Tiqva 49100, Israel
Tel Aviv University (IL)
Corresponding author: Leibovici, Leonard
ORCID: Fraser, Abigail
Weizman, Abraham
Leibovici, Leonard
Venue: The Journal of Clinical Endocrinology & Metabolism
Publisher: The Endocrine Society
Published: 2006-07-01
Volume: 91
Issue: 7
Pages: 2592-2599
ISSN: 0021-972X (ISSN-L)
1945-7197
DOI: 10.1210/jc.2006-0448
OpenAlex: W2127290117
Cited by: 296
References: 35
Citations by year: 2026: 3 · 2025: 13 · 2024: 6 · 2023: 8 · 2022: 19 · 2021: 10 · 2020: 13 · 2019: 15 · 2018: 22 · 2017: 16 · 2016: 20 · 2015: 19 · 2014: 22 · 2013: 23 · 2012: 25
FWCI: 1.94
Type: journal article
Language: en
Open access: closed
Locations: The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
PubMed (publishedVersion)
Bristol Research (University of Bristol) (submittedVersion)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Cancer Diagnosis and Treatment
Keywords: overt hypothyroidism, thyroxine, triiodothyronine, combination thyroid hormone therapy, levothyroxine monotherapy, hypothyroidism symptoms, quality of life, lipid profile, adverse events, treatment effectiveness
MeSH terms: Adult, Body Weight, Cognition, Drug Therapy, Combination, Humans, Hypothyroidism, Lipids, Quality of Life, Thyrotropin, Thyroxine, Triiodothyronine, Randomized Controlled Trials as Topic, Treatment Outcome

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Thyroxine-Triiodothyronine Combination Therapy Versus Thyroxine Monotherapy for Clinical Hypothyroidism: Meta-Analysis of Randomized Controlled Trials

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