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Clinical Experience in Treatment of Alzheimer’s Disease with Jiannao Yizhi Formula (健脑益智方) and Routine Western Medicine

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Abstract

Objective

To investigate the long-term therapeutic effects of the Chinese medicine Jiannao Yizhi Formula (健脑益智方, JYF) in the treatment of Alzheimer’s disease (AD).

Methods

Sixty mild-to-moderate AD participants were recruited and randomly allocated to the treatment (30 with JYF) and the control groups (30 with donepezil) for 6 months with the random numbers. The primary outcomes were scores of Alzheimer’s Disease Rating Scale-Cognitive (ADAS-Cog) and Chinese Medicine Symptom Scale (CM-SS). The secondary outcomes were scores of Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Activities of Daily Living (ADL). Safety assessments were conducted at baseline and the 6th month of treatment. Serum levels of acetylcholine (Ach), amyloid-β protein 42 (Aβ42), and the microtubule-associated protein tau (Tau) were also determined by enzyme-liked immunosorbent assay.

Results

Fifty-one participants were included in the final analyses (JYF n=27; donepezil n=24). Compared with baseline, both JYF and donepezil increased the MoCA and MMSE scores and decreased the ADAS-Cog and CM-SS scores (P<0.05 or P<0.01). Both drugs increased the serum levels of Ach and decreased the serum levels of Aβ42 and Tau (all P<0.05). There was no significant difference in these variables between the two groups, which showed that JYF was not inferior to donepezil. No obviously significant changes were observed in the ADL. No severe adverse events were observed in both groups.

Conclusion

The effect and safety of JYF for the treatment of AD were not inferior to those of donepezil.

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Acknowledgments

We appreciate the efforts of all the clinical, research and administrative staff who participated in the trial and recruitment of the participants.

Author information

Authors and Affiliations

  1. Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China

    Hui-chan Wang

  2. Department of Geratology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Nan-yang Liu, Shuai Zhang, Yang Yang, Zhi-Yong Wang, Yun Wei, Jian-Gang Liu, Hui Pei & Hao Li

Authors
  1. Hui-chan Wang
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  2. Nan-yang Liu
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  3. Shuai Zhang
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  4. Yang Yang
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  5. Zhi-Yong Wang
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  7. Jian-Gang Liu
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  8. Hui Pei
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  9. Hao Li
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Contributions

Li H conceived the study together with Pei H, and they were responsible for the design and supervision of the study. Wang HC and Liu NY participated in the study design were major contributors, both authors contributed equally. Liu JG, Wei Y and Pei H helped with implementation, provided statistical expertise in the clinical trial design. Wang ZY, Zhang S and Yang Y executed the statistical analysis.

Corresponding author

Correspondence to Hao Li.

Additional information

Competing Interests

The authors declare that they have no competing interests.

Supported by Beijing Municipal Science and Technology Project (Capital Characteristic Clinic Project, No. Z171100001017106) and Beijing Municipal Science and Technology Project “Ten Disease and Ten Medicine” (No. Z171100001717016)

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Wang, Hc., Liu, Ny., Zhang, S. et al. Clinical Experience in Treatment of Alzheimer’s Disease with Jiannao Yizhi Formula (健脑益智方) and Routine Western Medicine. Chin. J. Integr. Med. 26, 212–218 (2020). https://doi.org/10.1007/s11655-019-2718-2

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  • DOI: https://doi.org/10.1007/s11655-019-2718-2

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