World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Wang Y, Li Q, Yuan Z, Ma S, Shao S, Wu Y, Wang Z, Li Q, Gao L, Zhao M, Zhao J. Unable to load your collection due to an error, Unable to load your delegates due to an error. Two patients who were excluded because the thyrotropin level reverted to less than 4.60 mIU per liter also had an additional exclusion of galactose intolerance. The use of levothyroxine to treat subclinical hypothyroidism is controversial. Winther KH, Cramon P, Watt T, et al. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery. There was no significant excess of serious adverse events prespecified as being of special interest. Would you like email updates of new search results? In patients with central hypothyroidism, treatment is tailored according to free or total T4 levels, which should be maintained in the upper half of the normal range for age. 1992 Jun;92(6):631-42. doi: 10.1016/0002-9343(92)90782-7. J Neurol Neurosurg Psychiatry 2002;73:385-389, 20. Observations: Subclinical hypothyroidism is most often caused by autoimmune (Hashimoto) thyroiditis. The mean Hypothyroid Symptoms score at 12 months (with adjustment for baseline score) was 16.7±17.5 in the placebo group and 16.6±16.9 in the levothyroxine group (P=0.99). Subclinical hyperthyroidism is a milder form of hyperthyroidism characterized by low or undetectable serum TSH level, but with a normal serum free thyroxine level. Treatment of subclinical hypothyroidism depends on a number of factors. PLoS One 2016;11:e0156925-e0156925, 23. The minimum follow-up was 1 year, and the maximum follow-up was 3 years. Subclinical Hypothyroidism: when to treat? The inclusion criteria were an age of 65 years or more and persistent subclinical hypothyroidism, defined as an elevated thyrotropin level (4.60 to 19.99 mIU per liter) that was measured on at least two occasions that were 3 months to 3 years apart, with the free thyroxine level within the reference range. However, guidelines from experts found no benefit in treating individuals whose TSH falls between 5-10 mlU/L, 1,2 unless you are planning a pregnancy or are pregnant and have confirmed subclinical hypothyroidism. Careers. The numbers of patients who were included in the analyses are presented in Figure 1. #1: Subclinical hypothyroidism often improves on its own. Prescrire Int. Subclinical hypothyroidism does not typically cause any symptoms and does not appear to have any significant health effects. Hypothyroidism may not cause noticeable symptoms in the early stages. J Hand Surg Am 2008;33:558-565, 19. Transient Hyperthyrotropinemia in Outpatient Children with Acute Infections of the Respiratory System. National Library of Medicine The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. In contrast, an observational study of the treatment of autoimmune hypothyroidism in middle-age participants (median baseline thyrotropin level, 8.1 mIU per liter) showed that the Tiredness score improved markedly (reduction of 12 points at 6 months) and that the Hypothyroid Symptoms score also was reduced (by 2 points).22 A small reduction in tiredness has previously been shown in a short-term trial of levothyroxine for the treatment of subclinical hypothyroidism in 120 middle-age participants.23 There are limited data from high-quality, randomized, controlled trials regarding the effects of levothyroxine replacement in older persons with subclinical hypothyroidism.1 Studies have generally been small (≤120 participants) and underpowered, often focusing on younger participants and with a short duration of follow-up.9,10. For example, your doctor may treat your subclinical hypothyroidism if you have symptoms like fatigue, constipation, or depression, or you have another autoimmune disease, … Monzani F, Di Bello V, Caraccio N, et al. Studies of illness in the aged — the Index of ADL: a standardised measure of biological and psychosocial function. 8600 Rockville Pike The authors vouch for the accuracy and completeness of the data and analyses reported and for the fidelity of the trial to the protocol. Prepare to become a physician, build your knowledge, lead a health care organization, and advance your career with NEJM Group information and services. The Colorado Thyroid Disease Prevalence Study. Importance: Subclinical hypothyroidism, defined as an elevated serum thyrotropin (often referred to as thyroid-stimulating hormone, or TSH) level with normal levels of free thyroxine (FT4) affects up to 10% of the adult population. Study protocol: Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism — a randomised placebo controlled Trial (TRUST). Screening for subclinical hypothyroidism . Details regarding how the dose was adjusted and the mock adjustment in the placebo group are provided in the Supplementary Appendix, available at NEJM.org. Wong CK, Lang BH, Lam CL. Prevalence and follow-up of abnormal thyrotrophin (TSH) concentrations in the elderly in the United Kingdom. Prespecified analyses according to sex and baseline thyrotropin level did not reveal any subgroups of patients who benefited from treatment with levothyroxine. Health Policy 1990;16:199-208, 17. We assumed standard deviations for data at 1 year of 13.3 and 18.3 on the 100-point scales, respectively, after adjustment for baseline values. The score on the ThyPRO Hyperthyroid Symptoms scale was recorded as a measure of possible adverse effects (on a scale from 0 to 100, with higher scores indicating more symptoms; minimum clinically important difference has been estimated as 9 points).14, The Hypothyroid Symptoms and Tiredness scores from the ThyPRO14 were the two primary outcomes, with the required P value for statistical significance split equally to each test (0.05/2=0.025 for each test). All neoplasms, whether functionally active or not, are classified in Chapter 2. Results regarding cardiovascular events and total and cardiovascular mortality are provided in Table 3 and in Figures S1 and S2 in the Supplementary Appendix. Functional evaluation: the Barthel Index. Similarly, it has been suggested that the speed of information processing is slowed in persons with subclinical hypothyroidism.4 However, we found no benefit with levothyroxine with regard to executive cognitive function as measured by the letter–digit coding test. ... E02 Subclinical iodine-deficiency hypothyroidism . A total of 337 participants (91.3%) who were randomly assigned to the placebo group completed 12-month follow-up, as did 332 (90.2%) in the levothyroxine group. Hypothyroidism (underactive thyroid) is a condition in which your thyroid gland doesn't produce enough of certain crucial hormones. Instrument-defined estimates of the minimally important difference for EQ-5D-5L index scores. Drugs Aging. Thyrotropin Levels in the Placebo Group and Levothyroxine Group. 2021 ICD-10-CM Range E00-E89. Razvi S, Weaver JU, Butler TJ, Pearce SH. Development of a short version of the Thyroid-Related Patient-Reported Outcome ThyPRO. Rodondi N, den Elzen WP, Bauer DC, et al. The proportions of patients who discontinued the trial regimen or who withdrew from follow-up were similar in the two groups (Table 3). Statin Use and Benefits of Thyroid Function: A Retrospective Cohort Study. Bethesda, MD 20894, Copyright Subclinical hypothyroidism is defined as an elevated TSH with a normal free T4 (Cooper 2012).Depending on the studied population, treatment of subclinical hypothyroidism has been associated with prevention of adverse cardiovascular outcomes, improved hyperlipidemia and improvement in menstrual … EuroQol Group. 2005;22(1):23-38. doi: 10.2165/00002512-200522010-00002. MRC guidelines for good clinical practice in clinical trials. NCI CPTC Antibody Characterization Program. Md State Med J 1965;14:61-65, 21. A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 μg daily, or 25 μg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. JAMA 2010;304:1365-1374, 9. Elevated levels of Reverse T3, even though TSH and Free T3 values may be within normal range indicate a thyroid problem at the cellular level, often called “cellular hypothyroidism”. Panday P, Arcia Franchini AP, Iskander B, Anwer F, Oliveri F, Kakargias F, Hamid P. Cureus. However, levothyroxine therapy may be associated with iatrogenic thyrotoxicosis, especially in elderly patients, and there is no evidence that it is beneficial in persons aged 65 years or older. Subclinical thyroid dysfunction is relatively common; it occurs in about 15% of older women and 10% of older men, particularly in those with underlying Hashimoto thyroiditis . The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). Borson-Chazot F, Terra JL, Goichot B, Caron P. J Clin Med. Günther CM, Bürger A, Rickert M, Crispin A, Schulz CU. Value Health (in press). 2021 Mar 2;12:578909. doi: 10.3389/fendo.2021.578909. Research suggests that even if your TSH level is within the "normal" range, slight variations may contribute to weight gain. J Clin Endocrinol Metab 2010;95:3623-3632, 5. DOI: 10.1056/NEJMoa1603825, Tap into groundbreaking research and clinically relevant insights. Arch Intern Med 2012;172:811-817, 27. Out-of-whack thyroid test results may be a temporary blip, not your new normal. ), the Robertson Centre for Biostatistics, Institute of Health and Wellbeing (I.F., S.K., A.M., M. Messow, R.W. The median dose of levothyroxine at 1 year was 50 μg. The EQ-5D descriptive index showed a small deterioration at 12 months (mean difference between the levothyroxine group and the placebo group, −0.025; P=0.05) but a minor improvement at extended follow-up (mean difference, 0.040; P=0.03); there were no significant between-group differences at 6 to 8 weeks. If a patient's TSH falls in the normal range, thyroid tests for free T4 and free T3 and thyroid antibodies can rule out hypothyroidism and hyperthyroidism. London: Medical Research Council, 1998. Privacy, Help Staub JJ, Althaus BU, Engler H, Ryff AS, Trabucco P, Marquardt K, Burckhardt D, Girard J, Weintraub BD. J Clin Endocrinol Metab 2007;92:1715-1723. Randomization, Follow-up, and Dose Levels. 2019 Jul 9;322(2):180. doi: 10.1001/jama.2019.9508. Analyses were adjusted for stratification variables (country, sex, and starting dose of levothyroxine) and baseline thyrotropin level with the use of linear regression; data for the extended follow-up visit were additionally adjusted for time to visit. Having subclinical hypothyroidism may increase a person’s risk of cardiovascular disease so you might say, “treat me. Increased atherogenic low-density lipoprotein cholesterol in untreated subclinical hypothyroidism. A Critical, Narrative Review. Evaluation of Thyroid Function in Patients Hospitalized for Acute Heart Failure. Treatment might be indicated for patients with subclinical hypothyroidism and serum thyrotropin levels of 10 mU/L or higher or for young and middle-aged individuals with subclinical hypothyroidism and symptoms consistent with mild hypothyroidism. None of the sponsors had any involvement in the analysis or the reporting of the results. Per-protocol analyses and sensitivity analyses with the use of multiple imputation of missing values showed no significant differences between the levothyroxine group and the placebo group (Tables S4 and S5 in the Supplementary Appendix). — all in the Netherlands; and the Departments of Medicine, Epidemiology, and Biostatistics, University of California, San Francisco, San Francisco (D.C.B.). 24. Razvi S, Ingoe L, Keeka G, Oates C, McMillan C, Weaver JU. The funder, the trial sponsors (NHS Greater Glasgow and Clyde Health Board and University of Glasgow, United Kingdom; University College Cork, Ireland; Leiden University Medical Center, the Netherlands; and University of Bern and Bern University Hospital, Switzerland), and Merck played no role in the design, analysis, or reporting of the trial. The beneficial effect of L-thyroxine on cardiovascular risk factors, endothelial function, and quality of life in subclinical hypothyroidism: randomized, crossover trial. If a symptom benefit was to have occurred, it would have been expected to be seen at 12 months. The effects we observed were in opposite directions at these different time points and were of very small magnitude (−0.025 at 12 months and 0.040 at extended follow-up), and therefore these are likely to be random chance findings.
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