The study recruited 3,069 participants aged between 72 and 96 years who were randomly assigned to treatment with gingko biloba 120mg twice daily or a matching placebo and were followed up for a median of 6.1 years.
Participants were reviewed annually and were assessed using modified-mini mental state examination (3MSE), cognitive subscale of the Alzheimer Disease Assessment Scale (ADAS-Cog) and in neuropsychological domains of memory, attention, visual-spatial construction, language and executive functions.
Annual rates of decline over the first four years in the neuropsychological domains were not different between the two groups. 3MSE and ADAS-Cog were assessed annually for the entire study and did not differ between the two treatment groups. It was noted that those patients with mild cognitive impairment diagnosed at baseline experiences a more rapid decline. After correcting for age, gender, ethnicity and education (measured by years in education) there were still no differences between the two treatment groups.
The authors conclude that gingko biloba "did not result in less cognitive decline in older adults with normal cognition or with mild cognitive impairment". They also note that there are limitations in the study including baseline differences in the two groups favouring the placebo group but they point out that these were not clinically significant and were corrected in the analysis. Additionally, the neuropsychological assessment schedule was not ideally suited to this study but secondary analysis of 3MSE and ADAS-Cog were consistent with the primary analysis.
Action: Clinicians should be aware of this study. Gingko biloba should not be recommended for preventing cognitive decline in older patients.
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