Abstract
Objective In the 24-week randomized, double-blind, double-placebo, parallel-controlled trial, we aimed to test the effects of herbal therapy with amnestic mild cognitive impairment (aMCI). Methods A total of 324 patients with aMCI entered a 2-week placebo run-in period followed by 24 weeks' treatment of either (a) herbal capsule (5 shenwu capsules/administration, 3 times/day) and placebo identical to donepezil tablets (n = 216) or (b) donepezil (5 mg/day) and placebo identical to herbal capsule (n = 108). Results Herbal therapy showed a significant improvement on the primary efficacy measure, measured by Alzheimer Disease Assessment Scale-cognitive subscale (ADAS-cog), and showed a mean decrease from baseline of 4.23 points at the endpoint, without a significant difference from the donepezil group. Secondary efficacy measurement of the Logical Memory II Delayed Story Recall subtest (DSR) showed modest improvement in those taking herbal capsule compared to baseline, and there was no significant difference from donepezil group. The frequency of adverse events was much less in the herbal therapy group than the donepezil. Conclusion Herbal therapy demonstrated a significant improvement in cognition and memory, which were similar to the donepezil in patients with aMCI. Herbal therapy was safe and well tolerated. Trial Registration This study is registered with clinicaltrials.gov NCT01451749.
Highlights
Mild cognitive impairment (MCI) refers to a group of individuals who have cognitive impairments that are of insufficient severity to constitute dementia [1], which is a transitional stage between normal aging and dementia of Alzheimer’s disease (AD) [2]
One subject in the herbal therapy group and one subject in the donepezil group did not meet the inclusion criteria, 215 subjects were allocated to the herbal therapy group, and 107 subjects were allocated to the donepezil group
Premature discontinuations were because the subject did not complete the follow-up (14 patients in the herbal therapy group and 5 patients in the donepezil group), adverse events occurred (2 patients in the herbal therapy group), or a protocol violation occurred (14 patients in the herbal therapy group and 7 patients in the donepezil group)
Summary
Mild cognitive impairment (MCI) refers to a group of individuals who have cognitive impairments that are of insufficient severity to constitute dementia [1], which is a transitional stage between normal aging and dementia of Alzheimer’s disease (AD) [2]. In an interventional study of patients meeting Petersen’s criteria for aMCI, 16% progressed to dementia each year, 99% of whom received an AD diagnosis [4]. The well-studied conventional treatments for AD are generally considered to be symptom-relieving rather than disease-modifying; with that cholinesterase inhibitors (ChEI) treatment for mild to moderate AD may reach peak benefit for cognitive improvement at 3 months but drop below baseline level at 9 months [8, 9].
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