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

Hashizume 1991.

Methods Method of randomisation: States randomised into 2 groups stratified by age and sex 
 Assessor blinding: No 
 Intention‐to‐treat: Yes
Participants Location: University School of Medicine, Matsumoto, Japan 
 Period of study: Before April 1991 
 Participant description: Initial episode of Graves' disease, recruited from OPD endocrine clinic. Diagnosis on basis of TFTs, absence of nodules by palpitation, Diffuse increased uptake on I123 thyroid scan 
 Inclusion criteria: Graves' disease as above 
 Exclusion criteria: Not mentioned 
 Sex: M/F: A: 14/46; B: 10/39 
 Age: mean (SD) 39(11) years 
 Baseline comparability: Comparable thyroid functions and TRAb levels. No statistically significant differences
Interventions Description of intervention: 
 All participants received methimazole (MMI) 10 mg t.d.s. for 6 months then divided into 2 groups; 1: TRAb > 15%, 2: TRAb < 15%. Then randomised into 2 groups 
 A: MMI 10mg with thyroxine 100 µg per day 
 Duration of therapy: 12 months then thyroxine alone for a further 3 years 
 B: MMI 10 mg per day with placebo 
 Duration of therapy: 12 months, then placebo alone for a further 3 years
Outcomes Main outcome: Relapse of hyperthyroidism
Study details A: MMI 10mg with thyroxine 100 µg per day 
 Duration of therapy: 12 months then thyroxine alone for a further 3 years 
 B: MMI 10 mg per day with placebo 
 Duration of therapy: 12 months, then placebo alone for a further 3 years
Allocated: A: 60; B: 49 
 Completed: A: 60; B: 49 
 Assessed: A: 60; B: 49
Length of follow‐up: 3 years after MMI therapy
Publication details Language of Publication: English
Publication status: Peer reviewed journal
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Blinding? 
 All outcomes Low risk  
Incomplete outcome data addressed? 
 All outcomes Low risk