Background: Multiple sclerosis is an inflammatory demyelinating disease of the human central nervous system. Statins, prescribed as cholesterol lowering agents, have shown beneficial 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 strategy: We searched the Cochrane MS Group Trials Register (April 2010), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 3, 2010), MEDLINE (PubMed) (January 1966 to April 2010), EMBASE (January 1974 to April 2010), the Chinese Biomedical Database (CBM) (1979 to April 2010) and the Chinese National Knowledge Infrastructure (CNKI) (1979 to April 2010). We searched trials registers and conference proceedings and contacted pharmaceutical companies and authors of included studies included 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 in for patients with MS.
Data collection and analysis: Three review authors independently assessed trial quality and extracted data.
Main results: Two trials involving 71 participants were included. Both trials compared atorvastatin plus beta interferon with beta interferon alone for treating MS. Only one was assessed of good methodological quality while the other one of poor methodological quality. Neither 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 or 24 months follow up period. When combined with beta interferon, atorvastatin 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. Six trials which assess simvastatin or atorvastatin monotherapy or added to beta interferon for MS are still ongoing or awaiting publication.
Authors' conclusions: There is insufficient evidence to support statins as an effective treatment for patients with MS. Future high quality randomised controlled trials are needed.Improvements in methodology in trials which are ongoing or awaiting publication, are required for meaningful synthesis of data.