Lanzillo 2010.
Methods | An open‐label controlled trial, randomisation was mentioned in the original article but without details, allocation concealment was not mentioned. We could not obtain additional information after correspondence with the authors. Blinding: the study personnel and participants were unblinded. Drop‐outs: Intervention group: 2 (1 for depression, 1 for amenorrhoea and increased spasticity); Control group: 5 (1 for pregnancy, 2 for clinical disease activity, 1 for secondary progression and 1 for depression). Treatment duration: 24 months. Follow‐up period: 24 months. Intention‐to‐treat analysis: no description. | |
Participants | Country: Italy Setting: outpatients of the MS Center of the Federico II UniversityHospita 45 patients with clinically definite relapsing‐remitting MS according to McDonald criteria 21 in intervention group, F/M: 14/7, mean age 31.5 ± 9 years, disease duration 98.4 ± 68.1 months 24 in control group, F/M: 15/9, mean age 32.9 ± 7 years, disease duration 104.2 ± 64.3 months Characteristics of patients at baseline: similar | |
Interventions | Intervention group: IFN + 20 mg/d atorvastatin Control group: IFN |
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Outcomes | (1) Number of MRI CELs (2) Number of clinical relapses (3) EDSS score variation (4) Safety laboratory parameters |
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Notes |
Orefice 2007 reported 34 patients completed 12 months results of Lanzillo 2010, presented in the 23rd Congress of the European Committee for Treatment and Research in Multiple Sclerosis as an abstract. The study drug atorvastatin was donated by the manufacturer, Pfizer. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description |
Allocation concealment (selection bias) | Unclear risk | No description |
Blinding (performance bias and detection bias) All outcomes | High risk | No blinded. Described as open label in 12 months result of the study. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing data and reasons were carefully recorded, but unbalanced between groups. |
Other bias | Unclear risk | Conflict of interests may exist |