Methods |
Allocation: randomised‐ no further information. Blindness: single. Design: parallel group. Intention to treat not done. Duration: 18 months treatment/follow‐up. |
Participants |
RRMS N= 74 (40%); SPMS N= 111 (60%). N= 185 (azathioprine 93; placebo 92). N= 135 (73%) included in analysis (azathioprine 69; placebo 66). Baseline characteristics available for 135 patients: Sex: 88 females, 47 males. Age at onset: mean 26 years (RRMS); mean 30 years (SPMS). Disease duration: mean 5 years (RRMS); mean 7 years (SPMS). EDSS: mean 2.1 (range 1‐5) (RRMS); mean 3.7 (range 1‐7) (SPMS). Exclusion criteria: disease duration lower than 1 year and concomitant diseases controindicating immunosuppression. |
Interventions |
1. Azathioprine 2.5 mg/kg/daily. 2. No treatment. |
Outcomes |
Mean number of relapses in the two groups at 18 months. Patients defined worsened in relation to the difference between final and initial Kurtzke EDSS score. |
Notes |
50 (27%) people were lost to 18 monhs follow‐up (24 azathioprine, 26 placebo); reasons ‐ 13 persons (azathioprine) had adverse effects and 1 person (unclear about the treatment status) had surgical operation. No other data available. People who dropped‐out were not included in analysis. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment? |
Unclear risk |
B ‐ Unclear |