title: Comparative study between the effects of replacement therapy with liquid and tablet formulations of levothyroxine on mood states, self-perceived psychological well-being and thyroid hormone profile in recently thyroidectomized patients.
abstract: Following thyroid surgery, levothyroxine therapy is used to replace deficient thyroid hormones and prevent postoperative thyroid hypofunction. We compared the effects of replacement therapy with either liquid or tablet formulation of levothyroxine on mood states, self-perceived mental well-being and thyroid hormone profile in recently thyroidectomized patients. Profile of mood states, General Heath Questionnaire 12-items and thyroid hormone profile were assessed in recently (5-7 days) thyroidectomized patients at baseline and 2 months after randomization to replacement therapy with either liquid (n = 77) or tablet (n = 78) formulation of levothyroxine. After 2 months under levothyroxine replacement treatment, significant improvements of Positive Affect Scale (p < 0.001) and Negative Affect Scale (p < 0.001) of Profile of mood states, as well as of General Heath Questionnaire 12-items (p < 0.001) were observed in the study population. However, there were greater variations observed in patients assigned to liquid levothyroxine formulation in comparison to those who were assigned to levothyroxine in the form of tablet (time × treatment interaction: Positive Affect Scale of Profile of mood states, p = 0.030; Negative Affect Scale of Profile of mood states, p < 0.0001; General Heath Questionnaire 12-items, p = 0.003). As expected, circulating TSH levels significantly decreased (p <0.001) while FT3 and FT4 levels significantly increased (p < 0.0001 for both) under levothyroxine replacement therapy. These changes were significantly greater in patients treated with liquid levothyroxine formulation (time × treatment interaction: TSH, p = 0.011; FT3, p = 0.016; FT4, p = 0.028). Our data indicate a greater efficacy of liquid formulation of levothyroxine in ameliorating mood states and self-perception of mental well-being and thyroid hormone profile after 2 months of replacement therapy in recently thyroidectomized patients.
authors.affiliation: Division of Endocrine and Metabolic Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Celestino Pio
authors.initials: CP
authors.lastname: Lombardi
authors.affiliation: Division of Endocrine and Metabolic Surgery, Università Cattolica del Sacro Cuore, Rome, Italy. rbocale@libero.it.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Bocale
authors.affiliation: Institute of Biochemistry and Clinical Biochemistry, Department of Laboratory Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Angelina
authors.initials: A
authors.lastname: Barini
authors.affiliation: Institute of Biochemistry and Clinical Biochemistry, Department of Laboratory Medicine, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Barini
authors.affiliation: Division of Endocrine and Metabolic Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: D'Amore
authors.affiliation: Division of Endocrine and Metabolic Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Boscherini
authors.affiliation: Division of Endocrine and Metabolic Surgery, Università Cattolica del Sacro Cuore, Rome, Italy.
authors.forename: Rocco
authors.initials: R
authors.lastname: Bellantone
mesh_terms: D000328:Adult; D000339:Affect / Q000187:drug effects; D004339:Drug Compounding; D005260:Female; D006304:Health Status; D020249:Hormone Replacement Therapy; D006801:Humans; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D019964:Mood Disorders / Q000209:etiology / Q000517:prevention & control*; D011569:Psychiatric Status Rating Scales; D057566:Self Report; D016037:Single-Blind Method; D013607:Tablets; D013959:Thyroid Diseases / Q000097:blood / Q000378:metabolism / Q000523:psychology / Q000601:surgery*; D013965:Thyroidectomy / Q000009:adverse effects*; D013972:Thyrotropin / Q000097:blood; D013974:Thyroxine / Q000008:administration & dosage* / Q000378:metabolism / Q000493:pharmacokinetics / Q000627:therapeutic use; D014284:Triiodothyronine / Q000097:blood
chemical_list: D013607:Tablets; D014284:Triiodothyronine; D013972:Thyrotropin; D013974:Thyroxine
keywords: Insulin resistance; Mental well-being; Mood states; Thyroid replacement therapy