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. 2010 Jan 20;2010(1):CD003420. doi: 10.1002/14651858.CD003420.pub4

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
Publication details Language of Publication: English
Publication status: Peer reviewed journal
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