The effect of Ginkgo biloba on functional outcome of patients with acute ischemic stroke: a double-blind, placebo-controlled, randomized clinical trial.

ABSTRACT

BACKGROUND: Acute ischemic stroke is a major cerebrovascular disease with potential morbidity and mortality. Despite the availability of thrombolytic therapy in some centers, risk factor modification and rehabilitation therapy are the mainstays of stroke management. There is supporting evidence that Ginkgo biloba may afford neuroprotection and improve the outcomes of patients with acute ischemic stroke. METHODS: In a double-blind, placebo-controlled, randomized controlled trial, we assessed the efficacy of G biloba on functional outcome in patients with acute stroke. The National Institutes of Heath Stroke Scale (NIHSS) was used to measure functional outcome. A total of 102 patients with acute ischemic stroke were studied. All patients received either G biloba or placebo tablets for 4 months. This trial was registered to the Iranian Registry of Clinical Trials (www.irct.ir; trial IRCT138804212150N1). RESULTS: There were 52 patients who received G biloba and 50 patients who were in the placebo group. Age, sex distribution, previous medical condition, and laboratory data did not have any significant difference between the 2 groups (P>.05). The mean difference of 4-month follow-up NIHSS scores and NIHSS scores at admission was 4.7±2.7 and 4.1±3.0 in the G biloba and placebo groups, respectively (P>.05). The primary outcome-a 50% reduction in the 4-month follow-up NIHSS score compared to the baseline NIHSS score-was reached in 17 patients (58.6%) and 5 patients (18.5%) in the G biloba and placebo groups, respectively (P<.05). The risk ratio and number needed to treat were 3.16 (confidence interval 1.35-7.39) and 2.50 (confidence interval 1.58-5.90), respectively. In addition, multivariate regression adjusted for age and sex revealed a significant NIHSS decline in the G biloba group compared to the placebo group (P<.05). CONCLUSIONS: Our data suggest that G biloba may have protective effects in ischemic stroke. Therefore, the administration of G biloba is recommended after acute ischemic stroke.