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 |