Efficacy and Safety of an Herbal Therapy in Patients with Amnestic Mild Cognitive Impairment: A 24-Week Randomized Phase III Trial

Jinzhou Tian, Jing Shi, Tao Li, Lin Li, Zhiliang Wang, Xiaobin Li, Zhu Lv, Qingshan Zheng, Mingqing Wei, Yongyan Wang, Jinzhou Tian, Jing Shi, Tao Li, Lin Li, Zhiliang Wang, Xiaobin Li, Zhu Lv, Qingshan Zheng, Mingqing Wei, Yongyan Wang

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.

Figures

Figure 1
Figure 1
Diagnostic algorithm for aMCI inclusion. Notes. ADL = Instrument Activities of Daily Living; HAMD = Hamilton Depression Rating scale; HIS = Hachinski Ischemia scale; MRI = Magnetic Resonance Imaging; NINCDS-ADRDA = National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.
Figure 2
Figure 2
Study design, subject allocation, and subject course. Notes. 1The herbal group means the patients who took the herbal capsule and placebo donepezil tablets. 2The donepezil group means the patients who took donepezil and placebo herbal capsules.
Figure 3
Figure 3
ADAS-cog outcome: mean change from baseline in patients with aMCI (ITT-LOCF analysis). Notes. ADAS-cog = Alzheimer's Disease Assessment Scale-cognitive subscale. Graphs show data at baseline and each assessment point.
Figure 4
Figure 4
Secondary outcome: mean change of DSR scores from baseline in patients with aMCI (ITT-LOCF analysis). Notes. DSR = Delayed Story Recall.

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