Hoermann 2002.
Methods | Method of randomisation: Computer aided randomisation Assessor blinding: No Intention‐to‐treat: Yes | |
Participants | Location: Multicentre involving 23 sites in Germany, Hungary and Austria. Period of Study: 1996‐1999. Participant description: patients with Graves' disease treated with 12 to 15 months of ATD and stable euthyroid for 6 months. Inclusion criteria: Graves' disease as above. Exclusion criteria: <18 or >70 years. Recurrent disease. ATD less than 12 or greater than 15 months. Steroid or immunosuppressive therapy in past 6 months, Severe disease excluding thyroxine administration (CHD, arrhythmia). Sex M/F: Group A: 16/98, Group B: 13/98. Age(SEM): Group A; 41(1.1), Group B: 41(1.87). Baseline comparability: No statistically significant differences | |
Interventions | Description of intervention: Randomised after 12 to 15 months of ATD and confirmed euthroid 4 weeks after drug free period. Two groups: Group A: Levothyroxine for 1 year to keep TSH <0.3 and normal FT3 and FT4; Group B: Control, on no medication. At the end of first year: Group 1 was randomised further into groups: 1A: Second year of levothyroxine, 2A: Stop levothyroxine | |
Outcomes | Main outcome: Relapse of hyperthyroidism | |
Study details | Duration of therapy: 1 year Allocated: A: 114; B: 111 Completed at 1 year: A: 94;B: 98 Assessed at 1 year: A: 94;B: 98 Duration of Follow‐up: 1 year |
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Publication details | Language of Publication: English Publication status: Peer reviewed journal |
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Notes | Email communication with authors February 2004 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | |
Allocation concealment? | Low risk | |
Blinding? All outcomes | High risk | |
Incomplete outcome data addressed? All outcomes | Low risk |