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REVIEW Doi: 10.12032/TMR20191102145 REVIEW doi: 10.12032/TMR20191102145 Traditional Chinese Medicine Efficacy and safety of traditional Chinese medicine kidney-nourishing formula for Alzheimer's disease in comparison with donepezil: a systematic review and meta-analysis Fei-Zhou Li1, Yi-Ni Zhang1, Tong Zhang1, Ling Liu2, Ping Wang3* 1Clinical College of Chinese Medicine, Hubei University of Chinese Medicine, Wuhan, China. 2Encephalopathy Department, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China. 3Institute of Gerontology, Hubei University of Chinese Medicine, Wuhan, China. *Corresponding to: Ping Wang, Institute of Gerontology, Hubei University of Chinese Medicine, No.1, Huangjiahu West Road, Hongshan District, Wuhan, China. Email: [email protected]. Highlights Compared with donepezil, the long-term treatment of kidney-nourishing (the change of pathological state of kidney deficiency by means of traditional Chinese medicine (TCM) treatment and so on) formula in TCM can significantly improve the Alzheimer's disease assessment scale-cognitive subscale score and the activities of daily living score. Traditionality The description of dementia-related symptoms can be found in historical book entitled Zuo Zhuan (The Spring and Autumn Annals) (722 B.C.E.–468 B.C.E.) in the Pre-Qin Dynasty, and the name of Chidai was first proposed by Sun Simiao in Huatuo Shenyi Mizhuan (Biography of Hua Tuo's Medicine) (618 B.C.E.–907 C.E.), a Chinese medicine classical book published in the Tang Dynasty. The Chinese medicine classical book entitled Huangdi Neijing (The Yellow Emperor's Internal Classic) (221 B.C.E.–220 C.E.) provides a theoretical basis for establishing a link between kidney and dementia. Therefore, nourishing kidney has become an important treatment for dementia by TCM clinicians nowadays. Submit a manuscript: https://www.tmrjournals.com/tmr TMR | September 2020 | vol. 5 | no. 5 | 337 doi: 10.12032/TMR20191102145 REVIEW Abstract Objective: Finding an effective therapy against Alzheimer’s disease (AD) has been associate increasingly pressing issue and traditional Chinese medicine (TCM) is widespread in the prevention and treatment of AD in China. The aim of this study was to judge the efficaciousness and safety of TCM kidney-nourishing (the changes of pathological state of kidney deficiency by means of TCM treatment and so on) formula (TKNF) for AD in comparison with donepezil. Methods: The retrieval period of seven databases was from the establishment of each database to April 2019. Two authors independently identified randomized controlled trials (RCTs), fetched data and assessed bias risk. Comprehensive analysis process was conducted with review manager for eligible and appropriate RCTs. Results: A complete of 981 AD patients from 13 studies were enclosed. Meta-analysis of RCTs showed that there was no significant difference in the improvement of Alzheimer's disease assessment scale-cognitive subscale score between 2 groups in short term, but the effect of long-term treatment may exceed donepezil; there was a significant difference in the improvement of activities of daily living score between 2 groups; there was a significant difference in TCM curative efficacy between 2 groups with long-term treatment. There was no significant difference in the incidence of adverse events between 2 groups. The quality of the evidence was high or moderate. Conclusion: Compared with donepezil, TKNF was an effective drug for AD patients and the clinical application of TKNF was safe. TKNF's long-term benefits need more evidence to verify. Key words: Alzheimer's disease, Traditional Chinese medicine, Kidney-nourishing formula, Donepezil, Systematic review, Meta-analysis Acknowledgments: This work was supported by a grant from the National Natural Science Foundation of China (No. 81573865). Abbreviations: Aβ, amyloid beta protein; AD, Alzheimer’s disease; ADAS-Cog, Alzheimer’s disease assessment scale-cognitive subscale; ADL, activities of daily living; CI, confidence interval; DSM, Diagnostic and Statistical Manual of Mental Disorders; GRADE, Grading of Recommendations Assessment, Development and Evaluation; MD, mean difference; RCTs, randomized controlled trials; RR, risk ratio; TCM, traditional Chinese medicine; TKNF, traditional Chinese medicine kidney-nourishing formula. Competing interests: The authors declare that they have no conflict of interest. The authors alone are responsible for the content of the paper. Citation: Fei-Zhou Li, Yi-Ni Zhang, Tong Zhang, et al. Efficacy and safety of traditional Chinese medicine kidney-nourishing formula for Alzheimer's disease in comparison with donepezil: a systematic review and meta-analysis. Traditional Medicine Research 2020, 5 (5): 337–354. Executive editor: Nuo-Xi Pi. Submitted: 23 September 2019, Accepted: 25 November 2019, Online: 27 November 2019. TMR | September 2020 | vol. 5 | no. 5 | 338 Submit a manuscript: https://www.tmrjournals.com/tmr REVIEW doi: 10.12032/TMR20191102145 toxicity and multi-target [8]. Western medicine for Background AD is limited by single-targeted therapy, which may not be suitable for the treatment of AD. So TCM Alzheimer's disease (AD) is seen as a degenerative compound has great potential in preventing and brain disease with a slow and gradual decline in treating AD by multi-link, multi-target, and cognitive function and disposing capacity. The multi-channel integration effect [9]. number of individuals living with dementedness Considering that consensus on diagnosis and worldwide nowadays is calculable at 50 million, 2/3 treatment of AD in TCM recommends the of which are AD, and this figure is predicted to reach kidney-nourishing (the change of pathological state 152 million by 2050. Since global health costs for of kidney deficiency by means of TCM treatment and dementia patients are estimated to reach $1 trillion in so on) therapy as the basic principle for the treatment 2018 and are expected to be doubled by 2030, which of AD [7], we organized this systematic review with implies AD has been identified as one of the world's meta-analysis, to assess the clinical efficacy and health priorities, the growing burden of malady can safety of traditional Chinese medicine challenge the current health care system and national kidney-nourishing formula (TKNF) in AD patients, economy [1, 2]. At the same time, AD has constituted compared with donepezil. a serious threat to human health. The average life span of typical AD patients after diagnosis is just Methods over 101 months or about 8.5 years [3]. In England and Wales, AD has even become the number one This systematic review and meta-analysis adhered to killer of health [1]. Moreover, within the coming the preferred reporting items in systematic reviews back years, the low-income and middle-income and meta-analyses statement [10]. This study has countries are predicted to be the main force in been registered on Prospero platform with an increasing the prevalence of dementia [4], which assigned number CRD42019132880. deserves the eye of researchers. Since 1998, clinical trials of 100 drugs have been Database and search strategies conducted, but solely 4 were approved for the treatment of AD, and these medications can only Two reviewers (Fei-Zhou Li and Yi-Ni Zhang) improve some of the symptoms [1]. Therapy that can independently searched the subsequent electronic alter the potential pathology of AD has not yet been databases from their inception to April 2019: discovered [5]. Donepezil, a cholinesterase inhibitor, Cochrane Central Register of Controlled Trials, is currently recommended as a drug to delay the Excerpta Medica Database, PubMed, China progression of cognitive impairment in AD. Biological Medicine Database, China National Nevertheless, its side effects cannot be ignored [6]. Knowledge Infrastructure, Wanfang Database, Therefore, it is urgent to seek new drugs for the Chinese Scientific Journals Database. The following treatment of AD. search terms were employed in combination: AD is generally diagnosed as Chidai in traditional (Alzheimer's disease OR senile dementia) AND Chinese medicine (TCM) [7]. The description of (traditional Chinese medicine OR kidney-nourishing) dementia-related symptoms can be found in AND (donepezil OR cholinesterase inhibitor OR historical book entitled Zuo Zhuan (The Spring and aricept) AND (randomized controlled trial OR Autumn Annals) (722 B.C.E.–468 B.C.E.) in the controlled clinical trial OR randomized clinical trial). Pre-Qin Dynasty, and the name of Chidai was first The retrieval strategy for PubMed can be found proposed by Sun Simiao in Huatuo Shenyi Mizhuan (Supplementary Table 1). Only Chinese and English (Biography of Hua Tuo's Medicine) (618 B.C.E.–907 documents were included. Besides, the authors also C.E.), a Chinese medicine classical book published hand-searched the reference lists to look for relevant in the Tang Dynasty. For a long time, TCM has been literature. known for its wide variety of herbs and long-standing clinical practice, who accumulated Inclusion criteria and exclusion criteria abundant clinical experience in the struggle against AD. The Chinese medicine classical book entitled Types of participants Huangdi Neijing (The Yellow Emperor's Internal All included participants were definitively diagnosed Classic) (221 B.C.E.–220 C.E.) provides a theoretical with AD according to the Diagnostic and Statistical basis for establishing a link between kidney and Manual of Mental Disorders [11], or dementia. Therefore, nourishing kidney has become Recommendations from the
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