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. 2007 Oct 17;2007(4):CD003982. doi: 10.1002/14651858.CD003982.pub2
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