Spyridoula Maraka, Richard R Owen, Naykky M Singh Ospina, Micheal Knox, Terri Dodds, Jeff D Thostenson, Katherine Dishongh, Rebecca A Raciborski, Arwa Albashaireh, Aashka Shah, Sabah Syed, Syeda Naqvi, Hooman Motahari, Soumya Thumma, Freddy Toloza, Elena Ambrogini, Juan P Brito
{"title":"亚临床甲状腺功能减退患者停用左旋甲状腺素治疗：一项随机临床试验","authors":"Spyridoula Maraka, Richard R Owen, Naykky M Singh Ospina, Micheal Knox, Terri Dodds, Jeff D Thostenson, Katherine Dishongh, Rebecca A Raciborski, Arwa Albashaireh, Aashka Shah, Sabah Syed, Syeda Naqvi, Hooman Motahari, Soumya Thumma, Freddy Toloza, Elena Ambrogini, Juan P Brito","doi":"10.1007/s12020-025-04371-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Randomized clinical trials (RCTs) have shown no benefit of levothyroxine for subclinical hypothyroidism (SCH) in improving well-being, cardiovascular outcomes, or mortality. We aimed to evaluate study procedures' feasibility, safety, and preliminary effects of levothyroxine discontinuation in adults with SCH.</p><p><strong>Methods: </strong>We conducted a pilot, double-blind, placebo-controlled RCT with 6-month follow-up at a Veterans Affairs Medical Center. Adults with SCH on levothyroxine ≤75 mcg daily were randomized to continue levothyroxine or switch to placebo. The primary outcome was feasibility.</p><p><strong>Results: </strong>Fifty participants were randomized (32% enrollment rate); five were excluded post-randomization due to unconfirmed SCH, yielding 45 participants (21 levothyroxine, 24 placebo). One patient in the placebo group withdrew for personal reasons (98% completion rate). Participants' mean age was 68.2 years (SD 9.7); 80% were male, and 86.7% were White. At 6 months, there was no statistically significant difference between the placebo and levothyroxine groups in ThyPRO-Hypothyroid Symptoms [28.3 (22.8) vs. 22.9 (19.5)], Tiredness [27.6 (22.8) vs. 32.8 (22.1)], and EQ-5D score [0.750 (0.232) vs. 0.741 (0.180)]. The only notable adverse event was rib fractures in a placebo group participant (TSH 3.04 mIU/L at 6 months). Two participants in the placebo group restarted levothyroxine (n = 1, TSH > 10 mIU/L; n = 1, fatigue).</p><p><strong>Conclusion: </strong>We demonstrated feasibility of study procedures for discontinuing levothyroxine in patients with SCH and obtained preliminary effects on well-being. The low occurrence of adverse events suggests that levothyroxine discontinuation may be well-tolerated. These findings support conducting a larger multi-site RCT to comprehensively assess the effects of levothyroxine discontinuation.</p><p><strong>Clinical trial registration number: </strong>NCT04288115.</p>","PeriodicalId":49211,"journal":{"name":"Endocrine","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12364413/pdf/","citationCount":"0","resultStr":"{\"title\":\"Discontinuation of levothyroxine therapy in patients with subclinical hypothyroidism: a pilot randomized clinical trial.\",\"authors\":\"Spyridoula Maraka, Richard R Owen, Naykky M Singh Ospina, Micheal Knox, Terri Dodds, Jeff D Thostenson, Katherine Dishongh, Rebecca A Raciborski, Arwa Albashaireh, Aashka Shah, Sabah Syed, Syeda Naqvi, Hooman Motahari, Soumya Thumma, Freddy Toloza, Elena Ambrogini, Juan P Brito\",\"doi\":\"10.1007/s12020-025-04371-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Randomized clinical trials (RCTs) have shown no benefit of levothyroxine for subclinical hypothyroidism (SCH) in improving well-being, cardiovascular outcomes, or mortality. We aimed to evaluate study procedures' feasibility, safety, and preliminary effects of levothyroxine discontinuation in adults with SCH.</p><p><strong>Methods: </strong>We conducted a pilot, double-blind, placebo-controlled RCT with 6-month follow-up at a Veterans Affairs Medical Center. Adults with SCH on levothyroxine ≤75 mcg daily were randomized to continue levothyroxine or switch to placebo. The primary outcome was feasibility.</p><p><strong>Results: </strong>Fifty participants were randomized (32% enrollment rate); five were excluded post-randomization due to unconfirmed SCH, yielding 45 participants (21 levothyroxine, 24 placebo). One patient in the placebo group withdrew for personal reasons (98% completion rate). Participants' mean age was 68.2 years (SD 9.7); 80% were male, and 86.7% were White. At 6 months, there was no statistically significant difference between the placebo and levothyroxine groups in ThyPRO-Hypothyroid Symptoms [28.3 (22.8) vs. 22.9 (19.5)], Tiredness [27.6 (22.8) vs. 32.8 (22.1)], and EQ-5D score [0.750 (0.232) vs. 0.741 (0.180)]. The only notable adverse event was rib fractures in a placebo group participant (TSH 3.04 mIU/L at 6 months). Two participants in the placebo group restarted levothyroxine (n = 1, TSH > 10 mIU/L; n = 1, fatigue).</p><p><strong>Conclusion: </strong>We demonstrated feasibility of study procedures for discontinuing levothyroxine in patients with SCH and obtained preliminary effects on well-being. The low occurrence of adverse events suggests that levothyroxine discontinuation may be well-tolerated. 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Discontinuation of levothyroxine therapy in patients with subclinical hypothyroidism: a pilot randomized clinical trial.
Purpose: Randomized clinical trials (RCTs) have shown no benefit of levothyroxine for subclinical hypothyroidism (SCH) in improving well-being, cardiovascular outcomes, or mortality. We aimed to evaluate study procedures' feasibility, safety, and preliminary effects of levothyroxine discontinuation in adults with SCH.
Methods: We conducted a pilot, double-blind, placebo-controlled RCT with 6-month follow-up at a Veterans Affairs Medical Center. Adults with SCH on levothyroxine ≤75 mcg daily were randomized to continue levothyroxine or switch to placebo. The primary outcome was feasibility.
Results: Fifty participants were randomized (32% enrollment rate); five were excluded post-randomization due to unconfirmed SCH, yielding 45 participants (21 levothyroxine, 24 placebo). One patient in the placebo group withdrew for personal reasons (98% completion rate). Participants' mean age was 68.2 years (SD 9.7); 80% were male, and 86.7% were White. At 6 months, there was no statistically significant difference between the placebo and levothyroxine groups in ThyPRO-Hypothyroid Symptoms [28.3 (22.8) vs. 22.9 (19.5)], Tiredness [27.6 (22.8) vs. 32.8 (22.1)], and EQ-5D score [0.750 (0.232) vs. 0.741 (0.180)]. The only notable adverse event was rib fractures in a placebo group participant (TSH 3.04 mIU/L at 6 months). Two participants in the placebo group restarted levothyroxine (n = 1, TSH > 10 mIU/L; n = 1, fatigue).
Conclusion: We demonstrated feasibility of study procedures for discontinuing levothyroxine in patients with SCH and obtained preliminary effects on well-being. The low occurrence of adverse events suggests that levothyroxine discontinuation may be well-tolerated. These findings support conducting a larger multi-site RCT to comprehensively assess the effects of levothyroxine discontinuation.
期刊介绍：
Well-established as a major journal in today’s rapidly advancing experimental and clinical research areas, Endocrine publishes original articles devoted to basic (including molecular, cellular and physiological studies), translational and clinical research in all the different fields of endocrinology and metabolism. Articles will be accepted based on peer-reviews, priority, and editorial decision. Invited reviews, mini-reviews and viewpoints on relevant pathophysiological and clinical topics, as well as Editorials on articles appearing in the Journal, are published. Unsolicited Editorials will be evaluated by the editorial team. Outcomes of scientific meetings, as well as guidelines and position statements, may be submitted. The Journal also considers special feature articles in the field of endocrine genetics and epigenetics, as well as articles devoted to novel methods and techniques in endocrinology.
Endocrine covers controversial, clinical endocrine issues. Meta-analyses on endocrine and metabolic topics are also accepted. Descriptions of single clinical cases and/or small patients studies are not published unless of exceptional interest. However, reports of novel imaging studies and endocrine side effects in single patients may be considered. Research letters and letters to the editor related or unrelated to recently published articles can be submitted.
Endocrine covers leading topics in endocrinology such as neuroendocrinology, pituitary and hypothalamic peptides, thyroid physiological and clinical aspects, bone and mineral metabolism and osteoporosis, obesity, lipid and energy metabolism and food intake control, insulin, Type 1 and Type 2 diabetes, hormones of male and female reproduction, adrenal diseases pediatric and geriatric endocrinology, endocrine hypertension and endocrine oncology.
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