The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto’s thyroiditis
The effect of levothyroxine and selenomethionine on lymphocyte and monocyte cytokine release in women with Hashimoto’s thyroiditis: a six-month single-center, randomized, double-blind, placebo-controlled study
the Polish Committee of Scientific Research
211 participants
May 15, 2005
Interventional
Conditions
Summary
The aim of the study was to compare the effect of levothyroxine and selenomethionine on monocyte and lymphocyte cytokine release and systemic inflammation in patients with Hashimoto’s thyroiditis. The study was a six-month single-center, randomized, double-blind, placebo-controlled study. The included patients with Hashimoto’s thyroiditis were randomized in a double-blind manner to receive levothyroxine sodium (n=42), selenomethionine (n=43), levothyroxine sodium + selenomethionine (n=43), or placebo (n=42). Levothyroxine was administered at the daily dose of 0.5 µg/kg for patients with TSH levels below 1.0 mIU/mL, 0.75 µg/kg for individuals with TSH levels between 1.0 and 2.0 mIU/mL, and 1 µg/kg for patients with a TSH above 2.0 mIU/mL. In turn, the dose of selenomethionine (200 µg daily) was independent of plasma TSH levels. Taking history, clinical examination and venous blood sampling for evaluating safety laboratory parameters were performed every 2 weeks for first two months and then every 4 weeks thereafter. Compliance was be assessed by pill counts during each visit and will be considered satisfactory when the number of tablets taken by a patient is ranged from 90% to 110% Laboratory assays were performed three times: before treatment and after three and six months of levothyroxine and/or selenomethionine administration..We determined plasma levels of TSH, free thyroxine and free triiodothyronine, plasma thyroid peroxidase and thyroglobulin antibodies, lipid profile, plasma glucose and insulin and plasma high sensitivity C-reactive protein levels (hsCRP), as well as monocyte release of tumor necrosis factor-alpha (TNF-alpha), interleukin-1beta, interleukin-6 and monocyte chemoattractant protein-1 (MCP-1), and lymphocyte release of TNF-alpha, interleukin-2, interferon-gamma.
Eligibility
Inclusion Criteria8
- Hashimoto's thyroiditis patients:
- A) females between the ages of 18 and 60 years
- B) positive antibodies (>100 U/mL) against thyroid peroxidase
- C) the reduced echogenicity of the thyroid parenchyma on thyroid ultrasonography
- D) euthyroid function (TSH < 4.0 mU/L, normal values for free thyroxine and free triiodothyronine)
- Control Group II:
- age-, weight-, blood pressure-, and lipid-profile-matched healthy women
- Participants were medically stable, and, in the judgment of the investigators, otherwise acceptable for entry on the basis of the findings of medical history, physical examination, and routine laboratory tests
Exclusion Criteria15
- A) any acute and chronic inflammatory processes
- B) other autoimmune disorders
- C) positive serum antibodies against TSH receptor
- D) current treatment with thyroid hormones
- E) concomitant treatment with drugs that may affect inflammatory processes in the vascular wall
- F) concomitant treatment with other drugs known either to affect thyroid hormones or to interact with levothyroxine and selenomethionine
- G) BMI>40 kg/m2
- H) Turner or Down syndrome
- I) any form of coronary artery disease
- J) moderate or severe arterial hypertension (ESC/ESH grade 2 or 3)
- K) symptomatic congestive heart failure
- L) diabetes, impaired glucose tolerance or impaired fasting glucose
- M) impaired renal or hepatic function
- N) pregnancy or lactation
- O) poor patient compliance
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Interventions
The included Hashimoto’s thyroiditis patients were randomized in a double-blind manner to receive oral capsules of levothyroxine sodium (n=42) (arm 1), selenomethionine (n=43) (arm 2), levothyroxine sodium + selenomethionine (n=43) (arm 3), or of placebo (n=42) (arm 4) for six months. Levothyroxine was administered at the daily dose of 0.5 microg/kg for patients with TSH levels below 1.0 mIU/mL, 0.75 microg/kg for individuals with TSH levels between 1.0 and 2.0 mIU/mL, and 1 microg/kg for patients with a TSH above 2.0 mIU/mL. In turn, the dose of selenomethionine (200 microg daily) was independent of plasma TSH levels. The total duration of treatment: 6 months, the total duration of follow-up: 12 months
Locations(1)
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ACTRN12611000238976