The quality of evidence is downgraded by study limitations (lack of allocation concealment and blinding), and by imprecise results (few patients).
A Cochrane review [Abstract] 1 included 1 study with 32 subjects. Treatment response, defined as 20% improvement from basal conditions by clinical, serological and specific neurological measures, was found in more patients using cyclophosphamide compared with the methylprednisolone group at 24 months (table T1); the number needed to treat for an additional beneficial outcome (NNTB) of treatment response is 3. No statistically significant differences between the groups in damage index measurements (Systemic Lupus International Collaborating Clinics (SLICC)) were found. The median SLE Disease Activity Index (SLEDAI) rating favoured the cyclophosphamide group. Cyclophosphamide use was associated with a reduction in prednisone requirements. All the patients in the cyclophosphamide group had electroencephalographic improvement but there was no statistically significant difference in decrease between groups in the number of monthly seizures. No statistically significant differences in adverse effects, including mortality, were reported between the groups.
Outcome | Follow-up (mean) | Relative effect (95% CI) | Methylprednisolone | Cyclophosphamide (95% CI) | Participants (studies) |
---|---|---|---|---|---|
*Response to treatment = 20% improvement from basal conditions on clinical, laboratory or specific neurological testing variables | |||||
Response to treatment (20% improvement)* | 24 months | RR 2.05 (1.13 to 3.73) | 462 per 1000 | 947 per 1000 (522 to 1000) | 32 (1 study) |
Seizures | 24 months | RR 2.57 (0.92 to 7.14) | 333 per 1000 | 856 per 1000(306 to 1000) | 11 (1 study) |
Adverse events - Urinary tract infections | 24 months | RR 0.86 (0.47 to 1.57) | 615 per 1000 | 529 per 1000 (289 to 966) | 32 (1 study) |
Adverse events - Death | 24 months | RR 0.23 (0.03 to 1.96) | 231 per 1000 | 531 per 1000 (7 to 453) | 32 (1 study) |
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