HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.
Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.
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Ginkgo biloba produced no significant, short-term improvements in cognitive function in patients with multiple sclerosis.
A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.
However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.
There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.
The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.
While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.
Dr. Per Soelberg Sørensen
Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.
Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.
In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.
The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.
More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).
"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.
Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.
Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.
Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.