Wise Young
04-16-2002, 07:27 PM
[P06.081] A Double-Blind, Placebo-Controlled, Modified Crossover Pilot Study of the Effects of Ginkgo Biloba on Cognitive and Functional Abilities in Multiple Sclerosis
Christopher Kenney, Marc Norman, Mark Jacobson, Sara Lampinen, Dang P. Nguyen, Jody Corey-BloomÂ*La Jolla, CA
OBJECTIVE: To determine if Ginkgo biloba affects cognitive and functional abilities in multiple sclerosis (MS) as measured by sensitive neuropsychological and self-report measures.
BACKGROUND: Evidence suggests that Ginkgo biloba may slow cognitive decline in dementing conditions, such as Alzheimer disease (Oken, 1998). Cognitive deficits contribute significantly to the functional impairment of patients with MS. To date, few pharmacologic interventions have been shown to stabilize or improve these deficits.
DESIGN/METHODS: A double-blind, placebo-controlled, modified crossover pilot study of 23 patients with mild MS. Cognitive impairment at screening was defined on the basis of performance on the Digit Symbol and Letter-Number Sequencing tasks. One group was randomized to placebo for three months before crossing over to Ginkgo biloba (240 mg/day) for an additional three months. The second group was randomized to Ginkgo biloba for both three-month intervals. An extensive neuropsychological battery, including the Paced Auditory Serial Addition Test (PASAT), California Verbal Learning Test (CVLT II), and Delis-Kaplan Executive Measures Scale (DKEFS), was administered at baseline, 3 months and 6 months. Patients also completed subjective assessments of well-being, including the Beck Depression Index (BDI), the Multiple Sclerosis Quality of Life Index (MSQLI), and the Modified Fatigue Impact Scale (MFIS), at all three time points.
RESULTS: No statistically significant differences between the placebo- and Ginkgo-treated groups with regard to age, gender, education, or mean EDSS score were seen at baseline in 21 patients who completed three months of treatment. There have been no adverse events. In the Ginkgo-treated group, there was a statistically significant difference (p=0.04) in performance on the PASAT at 3 months (mean 120.2 = +/- 27.1) vs baseline (mean 105.2 +/- 23.6) that was not seen with placebo. There was also a statistically significant (p=0.02) deterioration in the placebo group on category fluency that was not seen in patients treated with Ginkgo. Ginkgo-treated patients showed statistically significant improvement (p=0.03) on the Perceived Deficits Questionnaire (PDQ) of the MSQLI. Interestingly, while there was no correlation between patients' self-report of cognitive abilities on the PDQ and performance on the PASAT, there was an extremely significant (p<0.0001) correlation [r=0.88) between patients' self-report of cognitive abilities and fatigue.
CONCLUSIONS: Ginkgo biloba, in doses of 240 mg/day, is well-tolerated and may show a beneficial effect on attention, memory, and functioning at three months in patients with mild MS. Larger sample sizes and longer durations of treatment will be necessary to confirm and extend these preliminary findings.
Supported By: Fellowship to Explore Complementary Therapies in the UCSD School of Medicine
Category - MS and Related Diseases
SubCategory - Therapeutic Trials
Christopher Kenney, Marc Norman, Mark Jacobson, Sara Lampinen, Dang P. Nguyen, Jody Corey-BloomÂ*La Jolla, CA
OBJECTIVE: To determine if Ginkgo biloba affects cognitive and functional abilities in multiple sclerosis (MS) as measured by sensitive neuropsychological and self-report measures.
BACKGROUND: Evidence suggests that Ginkgo biloba may slow cognitive decline in dementing conditions, such as Alzheimer disease (Oken, 1998). Cognitive deficits contribute significantly to the functional impairment of patients with MS. To date, few pharmacologic interventions have been shown to stabilize or improve these deficits.
DESIGN/METHODS: A double-blind, placebo-controlled, modified crossover pilot study of 23 patients with mild MS. Cognitive impairment at screening was defined on the basis of performance on the Digit Symbol and Letter-Number Sequencing tasks. One group was randomized to placebo for three months before crossing over to Ginkgo biloba (240 mg/day) for an additional three months. The second group was randomized to Ginkgo biloba for both three-month intervals. An extensive neuropsychological battery, including the Paced Auditory Serial Addition Test (PASAT), California Verbal Learning Test (CVLT II), and Delis-Kaplan Executive Measures Scale (DKEFS), was administered at baseline, 3 months and 6 months. Patients also completed subjective assessments of well-being, including the Beck Depression Index (BDI), the Multiple Sclerosis Quality of Life Index (MSQLI), and the Modified Fatigue Impact Scale (MFIS), at all three time points.
RESULTS: No statistically significant differences between the placebo- and Ginkgo-treated groups with regard to age, gender, education, or mean EDSS score were seen at baseline in 21 patients who completed three months of treatment. There have been no adverse events. In the Ginkgo-treated group, there was a statistically significant difference (p=0.04) in performance on the PASAT at 3 months (mean 120.2 = +/- 27.1) vs baseline (mean 105.2 +/- 23.6) that was not seen with placebo. There was also a statistically significant (p=0.02) deterioration in the placebo group on category fluency that was not seen in patients treated with Ginkgo. Ginkgo-treated patients showed statistically significant improvement (p=0.03) on the Perceived Deficits Questionnaire (PDQ) of the MSQLI. Interestingly, while there was no correlation between patients' self-report of cognitive abilities on the PDQ and performance on the PASAT, there was an extremely significant (p<0.0001) correlation [r=0.88) between patients' self-report of cognitive abilities and fatigue.
CONCLUSIONS: Ginkgo biloba, in doses of 240 mg/day, is well-tolerated and may show a beneficial effect on attention, memory, and functioning at three months in patients with mild MS. Larger sample sizes and longer durations of treatment will be necessary to confirm and extend these preliminary findings.
Supported By: Fellowship to Explore Complementary Therapies in the UCSD School of Medicine
Category - MS and Related Diseases
SubCategory - Therapeutic Trials