A Cochrane review [Abstract] 1 included 3 studies with a total of 221 subjects. The patients had either relapsing remitting or secondary progressive MS. Different mitoxantrone dosages and time schedules were used in the studies. Mitoxantrone reduced the progression of disability at 2 years follow-up (proportion of participants with 6-months confirmed progression of disability (OR 0.30, 95% CI 0.09 to 0.99; one trial, n=128 and MD -0.36, 95% CI- 0.70 to -0.02; p = 0.04; 2 trials, n=175). Significant results were found regarding the reduction in annualised relapse rate (MD -0.85, 95% CI -1.47 to -0.23; p = 0.007; 2 trials, n=206), the proportion of patients free from relapses at one year (OR 7.13, 95% CI 2.06 to 24.61; p = 0.002; one trial, n=51) and two years (OR 2.82, 95% CI 1.54 to 5.19; p = 0.0008; 2 trials, n=179), and the number of patients with active MRI lesions at 6 months or one year only (OR 0.24, 95% CI 0.10 to 0.57; p = 0.001; 3 trials, n=132). Side effects reported in the trials (amenorrhoea, nausea and vomiting, alopecia and urinary tract infections) were more frequent in treated patients than in controls, while no major adverse events have been reported.
Comment: The quality of evidence is downgraded by imprecise results (limited study size for each comparison) and inconsistency (heterogeneity in patients and interventions).
Primary/Secondary Keywords