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Table 3 Trial Meeting Inclusion Criteria: Characteristics and Quality Assessment

From: Deflazacort for the treatment of Duchenne Dystrophy: A systematic review

Study A. Bonifati, 2000 B. Angelini, 1994 F. Angelini, 1998 G. Angelini, 1995 N. Brooke, 1996
Design RCT RCT 2:1 treatment to controls RCT RCT 4 arm RCT 1. Placebo 2. Prednisone 3. DFZ low dose 4. DFZ high dose
Blinding Double blind Double blind Not mentioned Not mentioned Double blind
Jadad Score 3 3 1 0 2
Allocation Concealment Not stated Not stated Not stated Not stated Not stated
Sample size: Treatment 18 patients total randomized 17 13 14 196 patients total randomized
Sample Size: Controls Unclear 11 13 9 Unclear
Treatment dose 0.9 mg/kg/day 2 mg/kg/dose on alternate days 1 mg/kg/day 1. DFZ 1 mg/kg/day for 6 months then 2 mg/kg/dose on alternate days 2. DFZ 2 mg/kg/dose on alternate days Low dose = 0.9 mg/kg/day High dose = 1.2 mg/kg/day
Comparator (dose of active control Prednisone (0.75 mg/kg/day) Placebo Prednisone (0.75 mg/kg/day) Placebo 1. Placebo 2. Prednisone (0.75 mg/kg/day)
Mean age at baseline Treated 8.6 y Controls 7.5 y Treated 98.65 m Controls 96.55 m Not stated Not stated Not stated
Disease Status at baseline 1. Ability to walk 2. No prior steroids Ability to walk Not stated Not stated Not stated
Co-interventions Not stated Diet advice Not stated Not stated Not stated
Duration of Follow-up (months) 12 months 24 months (Data taken at 12 months due to excessive drop out after this time) 12 months Not stated 1. 3 months for placebo vs. DFZ 2. Efficacy: 3 months for prednisone vs. DFZ 3. Side Effects: 12 months for prednisione vs. DFZ