Background: Multiple sclerosis (MS) is an inflammatory demyelinating disease of the human central nervous system. Statins, prescribed as cholesterol lowering agents, have shown possible effects for treating MS in experimental and preliminary clinical studies.
Objectives: To evaluate the efficacy and safety of statins administered alone or as add-on to approved treatments for MS.
Search methods: The Trials Search Coordinator searched the Cochrane MS Group Trials Register (1 August 2011). We searched the Chinese National Knowledge Infrastructure (CNKI) (1979 to 1 August 2011), trials registers and conference proceedings. Pharmaceutical companies and authors of included studies were contacted for additional information.There were no language restrictions.
Selection criteria: Randomised controlled trials comparing statins with placebo, or comparing statins in combination with approved treatments alone for patients with MS.
Data collection and analysis: Three review authors independently assessed trial quality and extracted data.
Main results: Four trials involving 458 participants were included. All trials compared statins (two evaluating atorvastatin and two simvastatin) plus interferon beta-1a with interferon beta-1a alone for treating MS. The methodological quality was good for three studies and poor for remaining one. None of them showed statistically significant difference between both treatment groups in reducing relapses, preventing disease progression or developing new T2 or gadolinium-enhanced lesions on MRI after 9, 12, 24 months follow up period. Statins resulted to be safe and well tolerated, no serious adverse effects were reported. Changes on quality of life after receiving statins were not reported in the trials.
Authors' conclusions: There is no convincing evidence to support the use of either atorvastatin or simvastatin as an adjunctive therapy in MS.