Skip to main content
. 2011 Dec 7;2011(12):CD008386. doi: 10.1002/14651858.CD008386.pub3

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
Outcomes (1) Number of MRI CELs
(2) Number of clinical relapses
(3) EDSS score variation
(4) Safety laboratory parameters
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.
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