Trial of Ginkgo as a Treatment for Cognitive Problems in Multiple Scle
Ginkgo Biloba for Cognitive Impairment in Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. | Mean Difference (Final Values) -0.5 | -0.9–-0.1 | 0.007 |
| Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. | Mean Difference (Final Values) -0.2 | -0.5–0.1 | .1 |
| Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. | 0.19 | ||
| Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. | Mean Difference (Final Values) 0 | -0.2–0.3 | 0.5 |
| Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test. | Mean Difference (Final Values) 0 | -0.3–0.3 | 0.5 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Ginkgo
Placebo
- Placebo
Results by group
Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.
12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Ginkgo Baseline | -1.4 z-scores | 0.8 (Standard Deviation) | 61 |
| Ginkgo Exit | -1.3 z-scores | 0.9 (Standard Deviation) | 61 |
| Placebo Baseline | -1.2 z-scores | 0.9 (Standard Deviation) | 59 |
| Placebo Exit | -1.0 z-scores | 1.1 (Standard Deviation) | 59 |
| Ginkgo Baseline | -0.9 z-scores | 1.6 (Standard Deviation) | 61 |
| Ginkgo Exit | -0.8 z-scores | 1.8 (Standard Deviation) | 61 |
| Placebo Baseline | 01.0 z-scores | 1.4 (Standard Deviation) | 59 |
| Placebo Exit | -0.3 z-scores | 1.1 (Standard Deviation) | 59 |
| Ginkgo Baseline | -0.9 z-scores | 1 (Standard Deviation) | 61 |
| Ginkgo Exit | -0.7 z-scores | 1 (Standard Deviation) | 61 |
| Placebo Baseline | -1.0 z-scores | 1 (Standard Deviation) | 59 |
| Placebo Exit | -0.8 z-scores | 1 (Standard Deviation) | 59 |
| Ginkgo Baseline | -0.5 z-scores | 1.2 (Standard Deviation) | 61 |
| Ginkgo Exit | -0.4 z-scores | 1.2 (Standard Deviation) | 61 |
| Placebo Baseline | -0.5 z-scores | 1.2 (Standard Deviation) | 59 |
| Placebo Exit | -0.4 z-scores | 1.2 (Standard Deviation) | 59 |
p = .1; Mean Difference (Final Values) -0.2 (95% CI -0.5–0.1)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 59 | 0 (0.0%) | |
| Ginkgo | 61 | 2 (3.3%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Primary Outcome is Performance on the Interference Condition of the Stroop, the Long Delay Free Recall Portion of the California Verbal Learning Test II, the 2 Second Paced Auditory Serial Addition Test and the Controlled Oral Word Association Test.
12 weeks
Thinking and memory
Other measures (1)
Secondary Outcome: Measures of Self-report as Well as Family Reports of Subject's Cognitive Deficits and Assessment of Social Integration.
12 weeks
Thinking and memory
Who could take part
MS (type not specified) · 18 to 65 · EDSS 0 to 7.5
Show the full criteria
Inclusion criteria
* A diagnosis of multiple sclerosis by McDonald's criteria * Age 18 to 65 years, inclusive * A score minus one standard deviation below the mean on one or more of the following tests: PASAT, COWAT, CVLT-II, Stroop * EDSS 0 - 7.5, inclusive * No Ginkgo biloba in preceding 30 days * Native English speaker
Exclusion criteria
* Current substance abuse disorder, psychosis, or significant depression (score on the Beck Depression Inventory II (BDI -II) greater than 28 * Any significant uncontrolled medical problem including diabetes requiring insulin * Relapse of multiple sclerosis within the 30 days before screening * Abnormalities of coagulation or current use of anticoagulants or antiplatelet agents * Elective surgery planned for the study period or the following four weeks * Epilepsy or history of seizures * Use of nifedipine, nicardipine, Saint John's Wort, papaverine, mono amine oxidase inhibitors * Pregnancy or women not using a reliable form of contraception * Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color Plates or sustained nystagmus or diplopia on primary gaze * Inability to complete the neuropsychological test battery at the screening visit * History of alcohol abuse or illicit drug use in the prior six months
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to see if treatment with Ginkgo improves cognitive function in people with multiple sclerosis who have cognitive problems.
Papers
Results
Ginkgo biloba does not improve cognitive function in MS: a randomized placebo-controlled trial.Neurology · 2012
Results
Hughes AJ, Parmenter BA, Haselkorn JK, Lovera JF, Bourdette D, Boudreau E, Cameron MH, Turner AP. Sleep and its associations with perceived and objective cognitive impairment in individuals with multiple sclerosis. J Sleep Res. 2017 Aug;26(4):428-435. doi: 10.1111/jsr.12490. Epub 2017 Jan 17.
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History
Started
Jan 2009
Main results due
Nov 2010
Finished
Dec 2010
Results posted
May 2014