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Levothyroxine treatment and pregnancy outcome in women with subclinical hypothyroidism undergoing assisted reproduction technologies: systematic review and meta-analysis of RCTs

BACKGROUND Previous meta-analyses of observational data indicate that pregnant women with subclinical hypothyroidism have an increased risk of adverse pregnancy outcome. Potential benefits of levothyroxine (LT4) supplementation remain unclear, and no systematic review or meta-analysis of trial findings is available in a setting of assisted reproduction technologies (ART). METHODS Relevant trials published until August 2012 were identified by searching MEDLINE, EMBASE, Web of Knowledge, the Cochrane Controlled Trials Register databases and bibliographies of retrieved publications without language restrictions. RESULTS From 630 articles retrieved, we included three trials with data on 220 patients. One of these three trials stated 'live delivery' as outcome. LT4 treatment resulted in a significantly higher delivery rate, with a pooled relative risk (RR) of 2.76 (95% confidence limits 1.20-6.44; P = 0.018; I(2) = 70%), a pooled absolute risk difference (ARD) of 36.3% (3.5-69.0%: P = 0.030) and a summary number needed to treat (NNT) of 3 (1-28) in favour of LT4 supplementation. LT4 treatment significantly lowered miscarriage rate with a pooled RR of 0.45 (0.24-0.82; P = 0.010; I(2) = 26%), a pooled ARD of -31.3% (-48.2 to -14.5%: P < 0.001) and a summary NNT of 3 (2-7) in favour of LT4 supplementation. LT4 treatment had no effect on clinical pregnancy (RR 1.75; 0.90-3.38; P = 0.098; I(2) = 82%). In an ART setting, no data are available on the effects of LT4 supplementation on premature delivery, arterial hypertension, placental abruption or pre-eclampsia. CONCLUSIONS Our meta-analyses provide evidence that LT4 supplementation should be recommended to improve clinical pregnancy outcome in women with subclinical hypothyroidism and/or thyroid autoimmunity undergoing ART. Further research is needed to determine pregnancy outcome after close monitoring of thyroid function to maintain thyroid-stimulating hormone and free T4 levels within the trimester-specific reference ranges for pregnancy.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Does perioperative thyroxine have a role during adult cardiac surgery?

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was whether the use of prophylactic perioperative thyroxine therapy during cardiopulmonary bypass in the euthyroid adult patient undergoing routine cardiac surgery can result in an improved cardiac output leading to better clinical outcomes. Altogether 86 papers were identified on Medline and 113 on Embase using the reported search. A further paper was identified by hand-searching of reference lists. Thirteen papers represented the best evidence on the topic. The author, journal, date and country of publication, patient group studied, study type, relevant outcomes, results and study weaknesses were tabulated. We conclude that it is clear that triiodothyronine levels decrease by 50% or more during cardiopulmonary bypass. However, there is conflicting evidence that prophylactic perioperative thyroxine/triiodothyronine therapy is a useful inotropic adjunct in adult patients undergoing routine cardiac surgery and whilst some studies report improved haemodynamic parameters in the immediate post-bypass period there is no evidence that its use influences postoperative morbidity, mortality or length of stay in the elective patient. It may, however, have a role as rescue therapy in supporting some high risk cases during weaning from CPB or bridging to LVAD or transplant.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2006

High versus low dose of initial thyroid hormone replacement for congenital hypothyroidism

Congenital hypothyroidism is a condition that affects infants from birth and results from a missing or abnormally developed thyroid gland, abnormal production of thyroid hormones or a failure of the pituitary gland to stimulate thyroid hormone production. It affects approximately 1 in 3000 to 4000 newborn infants and early diagnosis and treatment is very important to achieve a good outcome.Treatment of congenital hypothyroidism consists of a daily dose of thyroid hormone (thyroxine). However, the initial dose of thyroxine required to improve outcomes for infants with this condition is unclear and has been the subject of several studies. Some studies have suggested that when infants with congenital hypothyroidism are treated with a higher dose of thyroxine compared with the standard dose, this results in earlier normalisation of the their thyroid hormones and leads to better developmental outcome and intelligence.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Postnatal thyroid hormones for respiratory distress syndrome in preterm infants

In preterm infants with breathing problems after birth, there is no evidence that thyroid hormone treatment given immediately after delivery reduces the severity of breathing difficulties or improves outcomes. Infants born prematurely are at risk of breathing problems due to lack of surfactant production by the lungs in the first days after birth. In animal research, thyroid hormones given before birth stimulate surfactant production and reduce the incidence and severity of breathing problems. This review found two small trials that compared the use of thyroid hormones to no treatment in infants with breathing problems in the first hours after birth. No benefit was found from use of these hormones on severity of breathing problems or complications that occurred as a result of these breathing problems. The effect on longer term development was not reported.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2008

Antithyroid drug regimen for treating Graves' hyperthyroidism

People who have Graves' hyperthyroidism have thyroid glands which are releasing too much thyroid hormone. This can cause goitres (swelling in the neck around the thyroid gland), sweating, bowel or menstrual problems, and other, especially eye symptoms (ophthalmopathy). Treatments include anti‐thyroid drugs, surgery or radiation to reduce thyroid tissue. There are several choices to be made when considering the drug treatment of Graves' hyperthyroidism including the choice of drug, dose, duration of therapy, addition of thyroid hormone (thyroxine) and when to discontinue therapy. The antithyroid drugs which were used in the included randomised controlled trials (RCTs) comprised carbimazole, propylthiouracil and methimazole.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2010

Prophylactic postnatal thyroid hormones for prevention of morbidity and mortality in preterm infants

A systematic review of the data from randomised controlled trials provides no evidence that routine thyroid hormone therapy is effective in preventing problems in preterm babies or improves their developmental outcomes. Thyroid hormones are needed for the normal growth and maturity of the central nervous system, as well as the heart and lungs. Children born without sufficient thyroid hormones can develop serious mental retardation. It is believed that low levels of thyroid hormones in the first few weeks after birth (transient hyperthyroxinaemia) in preterm babies born before 34 weeks may contribute to this abnormal development. The review of trials found no evidence that using thyroid hormones routinely in preterm babies is effective in reducing the risk of problems caused by transiently low levels of thyroid hormones.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2008

Interventions to reduce harm to women and their children from untreated low levels of thyroid hormone in pregnancy

The thyroid is a butterfly‐shaped gland at the front of the oesophagus/throat that produces thyroid hormone. Thyroid hormone helps the body to make energy, keeps body temperature regulated and assists other organs in their functions. Hypothyroidism (a deficiency of thyroid hormone) is a relatively common illness that can cause fatigue, constipation, muscle cramps and weakness, hair loss, dry skin, intolerance to cold, depression and weight gain. Medication is with levothyroxine. Selenium is a trace element that changes the expression of selenoproteins. These act as antioxidants and appear to decrease thyroid inflammation in autoimmune thyroiditis. Pregnant women with subclinical hypothyroidism have abnormal thyroid hormone levels but no symptoms. They are at a increased risk of miscarriage, pre‐eclampsia and preterm birth with impaired neuropsychological development in the child.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Thyroid hormone replacement for subclinical hypothyroidism

Subclinical hypothyroidism is a condition where some laboratory findings point at a thyroid gland not working properly. Patients with subclinical hypothyroidism may have vague, non‐specific symptoms of actual hypothyroidism (for example dry skin, cold skin or feeling colder, constipation, slower thinking, poor memory) but these thyroid‐related symptoms are not specific, that is why the diagnosis is based on test results. The fundamental question regarding people with subclinical hypothyroidism is whether they should be treated with thyroid hormones. To answer this question twelve studies of six to 14 months duration involving 350 people were analysed. Thyroid hormone therapy for subclinical hypothyroidism did not result in improved survival or decreased cardiovascular morbidity (for example less heart attacks or strokes). Data on health‐related quality of life and symptoms did not demonstrate significant differences between placebo and thyroid hormone therapy. Some evidence indicated that thyroid hormone had some effects on blood lipids and technical measurements of heart function. Adverse effects were inadequately addressed in most of the included studies and have to be urgently investigated in future studies, especially in older patients.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Postnatal thyroid hormones for preterm infants with transient hypothyroxinaemia

A systematic overview of randomised trials does not provide sufficient evidence to determine whether thyroid hormone treatment of preterm infants with transiently low thyroid hormone levels results in changes in neonatal outcomes or reductions in developmental impairments. Extremely premature infants frequently have transiently low thyroid hormone levels in the first weeks after birth. These low thyroid hormone levels are associated with an increased incidence of complications and death in the newborn period and longer term developmental impairments. Thyroid hormone therapy might prevent these problems. One small trial comparing thyroid hormone treatment to no treatment of infants with transiently low thyroid hormone levels reported no benefit from treatment of these infants. However, this is insufficient evidence to determine if thyroid hormone treatment is effective. Further research is needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2008

Thyroid hormones for preventing neurodevelopmental impairment in preterm infants

No evidence from trials that thyroid hormone therapy is effective in preventing problems such as respiratory distress syndrome in preterm babies. Thyroid hormones are needed for the normal growth and maturity of the central nervous system, as well as the heart and lungs. Children born without sufficient thyroid hormones can develop serious mental retardation. It is believed that low levels of thyroid hormones in the first few weeks of life (transient hypothyroxinemia) in preterm babies born before 34 weeks may cause this abnormal development. The review of trials found no evidence that using thyroid hormones in preterm babies is effective in reducing the risk of problems caused by insufficient thyroid hormones.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

The effect of levothyroxine therapy on bone mineral density: a systematic review of the literature

This review assessed the effects of levothyroxine therapy on bone mineral density. The authors concluded that current studies suggest no significant influence of levothyroxine on bone mineral density, but no firm conclusions could be drawn due to the diversity and poor quality of the studies. However, the review itself had some methodological limitations and may not be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2003

Thyroxine alone or thyroxine plus triiodothyronine replacement therapy for hypothyroidism

The review concluded that thyroxine plus triiodothyronine replacement therapy did not improve well-being, cognitive function, or quality of life compared with thyroxine alone (which may be beneficial in improving psychological or physical well-being). The review's sometimes poor or inconsistent reporting, coupled with the questionable quality of several included trials, indicate that the authors' conclusions should be interpreted with caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

A systematic review and meta-analysis of clinical trials of thyroid hormone administration to brain dead potential organ donors

OBJECTIVES: To review all published clinical studies of thyroid hormone administration to brain-dead potential organ donors.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Neonatal Jaundice

Jaundice is one of the most common conditions requiring medical attention in newborn babies. Approximately 60% of term and 80% of preterm babies develop jaundice in the first week of life, and about 10% of breastfed babies are still jaundiced at 1 month of age. In most babies with jaundice thevre is no underlying disease, and this early jaundice (termed ‘physiological jaundice’) is generally harmless. However, there are pathological causes of jaundice in the newborn, which, although rare, need to be detected. Such pathological jaundice may co-exist with physiological jaundice.

NICE Clinical Guidelines - National Collaborating Centre for Women's and Children's Health (UK).

Version: May 2010
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Effects of treatment with metformin on TSH levels: a meta-analysis of literature studies

CONTEXT: Some data suggest that metformin affects the thyroid profile in patients with type 2 diabetes, but contrasting results are reported in different settings.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Efficacy of thyroid hormone suppression for benign thyroid nodules: meta-analysis of randomized trials

OBJECTIVE: To determine the efficacy of thyroid hormone suppressive therapy (THST) to decrease benign thyroid nodule volume.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2005

Association between thyroid autoantibodies and miscarriage and preterm birth: meta-analysis of evidence

This review evaluated the effectiveness of levothyroxine on pregnancy outcomes in women with normal thyroid function who tested positive for thyroid autoantibodies and concluded that treatment can attenuate the risks of miscarriage and pre-term birth. The authors' conclusions reflect the evidence, but the evidence was very limited.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

The effects of thyrotropin-suppressive therapy on bone metabolism in patients with well-differentiated thyroid carcinoma

The authors concluded that postmenopausal women taking thyrotropin-suppressive therapy may be at greatest risk of osteoporosis, but studies generally found no increased risk in premenopausal women and men. Poor reporting of review methods, an inadequate quality assessment of the included studies, and the reliance upon studies with small sample sizes make commenting on the reliability of the conclusions difficult.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2006

Thyroid hormone therapy for obesity and nonthyroidal illnesses: a systematic review

This review found insufficient data on the effectiveness or otherwise of thyroid hormone therapy for treatment of euthyroid adults who were obese or had non-thyroidal illnesses. The review was generally well-conducted and authors' cautious conclusions reflect the limitations of the evidence presented.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Chinese herbal medicines for benign thyroid nodules in adults

To assess the effects of Chinese herbal medicines in the treatment of benign thyroid nodules in adults.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

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