title: Quality of life, clinical outcomes and safety of early prophylactic levothyroxine administration in patients with Graves' hyperthyroidism undergoing radioiodine therapy: a randomized controlled study.
abstract: OBJECTIVE
  While radioiodine therapy is commonly used for treating Graves' disease, a prolonged and clinical hypothyroidism may result in disabling symptoms leading to deterioration of quality of life (QoL) of patients. Introducing levothyroxine (LT4) treatment in the early post-therapeutic period may be an interesting approach to limit this phenomenon.
  
  
  METHODS
  A multicenter, prospective, open-label randomized controlled trial enrolled 94 patients with Graves' hyperthyroidism randomly assigned to the experimental group (n=46) (group A: early prophylactic LT4 treatment) or the control group (n=48) (group B: standard follow-up). The primary endpoint was the 6-month QoL. The secondary endpoints were other QoL scores such as Graves' ophthalmopathy (GO) outcomes, thyroid function tests and safety.
  
  
  RESULTS
  The primary endpoint at 6 months was achieved: the mental composite score (MCS) of Short Form 36 (SF-36) was significantly higher in group A compared to group B (P=0.009). Four other dimension scores of the SF-36 and four dimension scores of the thyroid-specific patient-reported outcome (ThyPRO) significantly differed between the two groups, indicating better QoL in group A. After adjustment for variables, the early LT4 administration strategy was found as an independent factor for only two scores of SF-36: the MCS and the general health (GH) score. There were no differences in GO, final thyroid status and changes in the anti-TSH receptor antibodies (TRAbs) levels between the two groups. No adverse cardiovascular event was reported.
  
  
  CONCLUSIONS
  Early LT4 administration post-radioactive iodine (RAI) could represent a safe potential benefit for patients with regard to QoL. The optimal strategy taking into account administered RAI activities and LT4 treatment dosage and timing remains to be determined.
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology an
authors.forename: David
authors.initials: D
authors.lastname: Taïeb
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Bournaud
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Eberle
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Bogdan
authors.initials: B
authors.lastname: Catargi
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Schvartz
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Marie-Béatrice
authors.initials: MB
authors.lastname: Cavarec
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Faugeron
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Marie-Elisabeth
authors.initials: ME
authors.lastname: Toubert
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Danielle
authors.initials: D
authors.lastname: Benisvy
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Cendrine
authors.initials: C
authors.lastname: Archange
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Mundler
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Caron
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Ahmad Esmaeel
authors.initials: AE
authors.lastname: Abdullah
authors.affiliation: Department of Nuclear MedicineLa Timone University Hospital, European and Center for Research in Medical Imaging, Aix-Marseille University, 264 rue Saint-Pierre 13385 Marseille Cedex 5, FranceInserm UMR1068 Marseille Cancerology Research CenterInstitut Paoli-Calmettes, Marseille, FranceDepartment of Endocrinology and Nuclear MedicineGHE-Hospices Civils de Lyon and Lyon 1 University, Lyon, FranceDepartment of Nuclear MedicineLapeyronie University Hospital, Montpellier, FranceUniversity Hospital of BordeauxBordeaux, FranceDepartment of Nuclear MedicineJean Godinot Institute, Reims, FranceDepartment of Nuclear MedicineBrest University Hospital, Brest, FranceDepartment of Nuclear MedicineSaint-Antoine Hospital, Paris, FranceDepartment of Nuclear MedicineSaint-Louis Hospital, Paris, FranceDepartment of Nuclear MedicineUniversity of Nice, Nice, FranceDepartment of Endocrinology and Metabolic DiseasesCHU Larrey, Toulouse University Hospital, Toulouse, FranceDepartment of Public HealthEA3279 Self-perceived Health Assessment Research Unit, La Timone University, Aix-Marseille University, Marseille, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Baumstarck
mesh_terms: D000328:Adult; D018890:Chemoprevention / Q000009:adverse effects / Q000379:methods; D004334:Drug Administration Schedule; D061345:Early Medical Intervention / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006111:Graves Disease / Q000188:drug therapy / Q000532:radiotherapy; D006801:Humans; D006980:Hyperthyroidism / Q000188:drug therapy / Q000532:radiotherapy; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D013974:Thyroxine / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D007457:Iodine Radioisotopes; D013974:Thyroxine