Combined therapy with levothyroxine and liothyronine in two ratios, compared with levothyroxine monotherapy in primary hypothyroidism: a double-blind, randomized, controlled clinical trial.
JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM(2013)
摘要
Controversy remains about the value of combined treatment with levothyroxine (LT(4)) and liothyronine (LT(3)), compared with LT(4) alone in primary hypothyroidism. We compared combined treatment with LT(4) and LT(3) in a ratio of 5: 1 or 10: 1 with LT(4) monotherapy. We conducted a double-blind, randomized, controlled trial in 141 patients (18-70 yr old) with primary autoimmune hypothyroidism, recruited via general practitioners. Inclusion criteria included: LT(4) treatment for 6 months or more, a stable dose for 6 wk or more, and serum TSH levels between 0.11 and 4.0 mu U/ml (mU/liter). Randomization groups were: 1) continuation of LT(4) (n = 48); 2) LT(4)/LT(3), ratio 10:1 (n = 46); and 3) LT(4)/LT(3), ratio 5:1 (n = 47). Subjective preference of study medication after 15 wk, compared with usual LT(4), was the primary outcome measure. Secondary outcomes included scores on questionnaires on mood, fatigue, psychological symptoms, and a substantial set of neurocognitive tests. Study medication was preferred to usual treatment by 29.2, 41.3, and 52.2% in the LT(4), 10:1 ratio, and 5:1 ratio groups, respectively (chi(2) test for trend, P = 0.024). This linear trend was not substantiated by results on any of the secondary outcome measures: scores on questionnaires and neurocognitive tests consistently ameliorated, but the amelioration was not different among the treatment groups. Median end point serum TSH was 0.64 mu U/ml (mU/liter), 0.35 mu U/ml (mU/liter), and 0.07 mu U/ml (mU/liter), respectively [ANOVA on ln(TSH) for linear trend, P < 0.01]. Mean body weight change was +0.1, -0.5, and -1.7 kg, respectively (ANOVA for trend, P = 0.01). Decrease in weight, but not decrease in serum TSH was correlated with increased satisfaction with study medication. Of the patients who preferred combined LT(4)/LT(3) therapy, 44% had serum TSH less than 0.11 mu U/ml (mU/liter). Patients preferred combined LT(4)/LT(3) therapy to usual LT(4) therapy, but changes in mood, fatigue, well-being, and neurocognitive functions could not satisfactorily explain why the primary outcome was in favor of LT(4)/LT(3) combination therapy. Decrease in body weight was associated with satisfaction with study medication.
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