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 |