SUBSCRIBE
Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2012, Vol. 10 ›› Issue (4): 390-397.doi: 10.3736/jcim20120407

Previous Articles     Next Articles

Effects of Chinese medicine for tonifying the kidney and resolving phlegm and blood stasis in treating patients with amnestic mild cognitive impairment: A randomized, double-blind and parallel-controlled trial

Ying-chun Miao1, Jin-zhou Tian1(), Jing Shi1, Min Mao2   

  1. 1. Department of Geriatrics, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China
    2. Department of Clinical Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China
  • Received:2011-12-14 Accepted:2012-01-04 Online:2012-04-20 Published:2018-04-15

RichHTML

4

PDF (PC)

584

Like

Background: It is important to detect and prevent Alzheimer disease (AD) at its early stage. Constituting the early stage sign of AD, amnestic mild cognitive impairment (aMCI) has drawn much attention. Studies have shown that donepezil could reduce the AD assessment scale-cognitive subscale (ADAS-Cog) score in MCI patients and improve the patient’s attention and speed of response; however, it also has many side effects. Therefore, the authors aim to explore the effects of Chinese herbal medicine for treating aMCI.
Objective: To explore the clinical efficacy and safety of Chinese medicine for tonifying the kidney, and resolving phlegm and blood stasis in the treatment of aMCI.
Design, setting, participants and interventions: This clinical trial used randomized, double-blind, double-dummy and parallel-controlled design. According to the randomized, double-blind principle, some aMCI patients were randomly divided into Chinese medicine group and donepezil group. Other patients who did not receive any treatment were enrolled as the control. Patients in the Chinese medicine group received oral administration of Chinese medicine, 1 bag/dose, two doses per day, while patients in the donepezil group received donepezil hydrochloride, 5 mg/day. Twelve weeks were allocated as the trial period.
Main outcome measures: After 12 weeks, the Chinese medicine group patients, the donepezil group patients and those patients who did not receive any treatment were accessed using the scores of ADAS-Cog and mini-mental status examination (MMSE).

Results: The ADAS-Cog and MMSE scores of the Chinese medicine group and the donepezil group were both improved from baseline (P=0.001, P=0.000), but the non-treatment group showed no change from baseline (P=0.151, P=0.125); furthermore, there was no significant difference between the Chinese medicine group and the donepezil group. The attention function of the Chinese medicine group was better than baseline (P=0.015), but no change was seen in the donepezil group (P=0.085) at the 12th week. Safety data showed that the occurrence of insomnia, nausea and diarrhea was greater in the donepezil group than in the Chinese medicine group (P=0.002,P=0.005, P=0.000), and both treatments had no influence in participants’ vital signs and laboratory examination results.
Conclusion: Both Chinese medicine and donepezil can improve global cognition in patients with aMCI after 12 weeks of treatment. Chinese medicine can also improve attention function and some clinical symptoms in patients with aMCI. Furthermore, Chinese medicine is safe for aMCI patients. Further study is necessary to explore the long-term effect of Chinese medicine for aMCI.


Key words: drugs, Chinese herbal, cognition disorders, Alzheimer disease, brief neuro-psychological rating scale, double-blinded method, randomized controlled trial

Figure 1

Flow diagram of this clinical trial"

"

Item Chinese medicine (n=45) Donepezil (n=24) Non-treatment (n=48) P value
Age (x±s, years) 65.00±7.54 67.25±7.05 63.00±7.23 0.227
Education (x±s, years) 9.68±4.24 8.04±4.46 9.37±4.95 0.134
Gender (n, %)
Male 21 (46.7%) 13 (54.2%) 20 (41.7%) 0.602
Female 24 (53.3%) 11 (45.8%) 28 (58.3%)
Race (n, %)
Han 40 (88.9%) 23 (95.8%) 48 (100%) 0.051
Others 5 (11.1%) 1 (4.2%) 0 (0.0%)
Neuropsychological score (x±s)
MMSE 25.71±1.26 25.63±1.56 25.77±2.05 0.130
ADAS-Cog 10.46±4.89 10.80±3.27 10.17±3.13 0.763
ISR 13.71±6.60 13.25±6.69 11.05±2.79 0.783
DSR 7.85±4.09 7.21±4.93 7.84±2.10 0.539
ADL 17.33±1.43 17.46±1.59 18.77±1.30 0.725
GDS 2.23±0.43 2.33±0.48 2.16±0.27 0.351
Syndrome score of TCM (x±s) 19.87±5.96 20.75±5.87 19.56±4.68 0.557

"

Group n Score of MMSE Score of ADAS-Cog
Baseline After 12 weeks Difference Baseline After 12 weeks Difference
Non-treatment 48 25.77±2.05 25.71±1.21 –0.06±1.01 10.17±3.13 11.55±3.12 1.38±1.01
Donepezil 24 25.63±1.56 25.99±1.41 0.36±1.24 10.80±3.27 7.22±2.21△△ –3.58±2.48**
Chinese medicine 45 25.71±1.26 25.82±0.96 0.11±1.36 10.46±4.89 7.50±2.11△△ –2.96±1.47**
[1] Perry EK, Tomlinson BE, Blessed G, Bergmann K, Gibson PH, Perry RH . Correlation of cholinergic abnormalities with senile plaques and mental test scores in senile dementia. BMJ. 1978; 2(6150):1457-1459.
doi: 10.1136/bmj.2.6150.1457
[2] Perry EK . The cholinergic hypothesis — ten years on. Br Med Bull. 1986; 42(1):63-69.
doi: 10.1093/oxfordjournals.bmb.a072100
[3] Giacobini E . From molecular structure to Alzheimer therapy. Jpn J Pharmacol. 1997; 74(3):225-241.
doi: 10.1254/jjp.74.225
[4] Giacobini E . Invited review : Cholinesterase inhibitors for Alzheimer 5 s disease therapy : from tacrine to future applications . Neurochem Int. 1998 ; 32(5-6) : 413-419.
doi: 10.1016/S0197-0186(97)00124-1
[5] Burns A, Rossor M, Hecker J, Gauthier S, Petit H, Moller HJ, Rogers SL, Friedhoff LT . The effects of donepezil in Alzheimer’s disease — results from a multinational trial. Dement Geriatr Cogn Discord. 1999; 10(3) : 237-244.
doi: 10.1159/000017126
[6] Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT . A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer 5 s disease . Neurology. 1998; 50(1):136-145.
doi: 10.1212/WNL.50.1.136
[7] Tariot PN, Solomon PR, Morris JC, Kershaw P, Lilienfeld S, Ding C . A 5-month, randomized, placebo- controlled trial of galantamine in AD. The Galantamine USA-10 Study Group. Neurology. 2000; 54(12):2269-2276.
doi: 10.1212/WNL.54.12.2269
[8] Salloway S, Ferris S, Kluger A, Goldman R, Griesing T, Kumar D, Richardson S; Donepezil 401 Study Group. Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. Neurology 2004; 63(4) : 651-657.
doi: 10.1212/01.WNL.0000134664.80320.92
[9] Tian JZ, Song CS, Ren Y, Liu XH Yuan ZX. Effects of compound rhubarb preparation on memory of mice with D-galactose-induced subacute senility. Zhongguo Lao Nian Xue Za Zhi. 1996 ; 16(1) : 39-40. Chinese.
田金洲, 宋崇顺, 任映, 刘新槐, 袁致祥 . 复方大黄制剂对D-半乳糖所致小鼠亚急性衰老模型记忆的影响. 中国老年学杂志. 1996; 16(1):39-40.
[10] Li H, Liu F, Xu LR, Hou LF, Cui L Luo ZG. Effect of Huannao Yicong Capsule on senile mild cognitive impairment. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2004; 24(8) : 689-693. Chinese with abstract in English.
李浩, 刘芳, 徐立然, 侯留法, 崔玲, 罗增刚 . 还脑益聪胶嚢对老年轻度认知障碍的影响.中国中西医结合杂志. 2004; 24(8) : 689-693.
[11] TianJZ, ShiJ, Zhang XQ, Bi Q, Ma X, Wang ZL, Li XB, Sheng SL, Li L, Wu ZY, Fang LY, Zhao XD, Miao YC, Wang PW, Ren Y, Yin JX, Wang YY . Guiding principles of clinical research on mild cognitive impairment (protocol) . J Chin Integr Med. 2008; 6 (1) : 9-14. Chinese with abstract in English.
田金洲, 时晶, 张新卿, 毕齐, 马辛, 王志良, 李晓斌, 盛树力, 李林, 吴振云, 房立岩, 赵晓东, 苗迎春, 王蓬文, 任映, 尹军祥, 王永炎 . 轻度认知损害临床研究指导原则(草案).中西医结合学报. 2008; 6(1):9-14.
[12] Tian JZ, Shi J, Zhang XQ, Bi Q, Ma X, Wang ZL, Li XB, Sheng SL, Li L, Wu ZY, Fang LY, Zhao XD, Miao YC, Wang PW, Ren Y, Yin JX, Wang YY . An explanation on a guiding principles of clinical research on mild cognitive impairment (protocol) ”. J Chin Integr Med. 2008; 6(1): 15-21. Chinese.
田金洲, 时晶, 张新卿, 毕齐, 马辛, 王志良, 李晓斌, 盛树力, 李林, 吴振云, 房立岩, 赵晓东, 苗迎春, 王蓬文, 任映, 尹军祥, 王永炎 . 《轻度认知损害临床研究指导原则(草案)》编制说明.中西医结合学报. 2008; 6(1) : 15-21.
[13] Miao YC, Tian JZ, Shi J, Mao M, Zhao XD, Fang LY, Long ZY, Sun WJ, Lu HM, Wang ZL Li XB. Characteristics of TCM syndromes of amnestic mild cognitive impairment. Zhong Yi Za Zhi. 2009 ; 50(3): 244-247. Chinese with abstract in English.
苗迎春, 田金洲, 时晶, 毛敏, 赵晓东, 房立岩, 龙子弋, 孙文军, 芦红梅, 王志良, 李晓斌 . 遗忘型轻度认知损害的中医证候特征.中医杂志. 2009; 50(3):244-247.
[14] Petersen RC, Thomas RG, Grundman M, Bennett D, Doody R, Ferris S, Galasko D, Jin S, Kaye J, Levey A, Pfeiffer E, Sano M, van Dyck CH, Thai LJ; Alzheimer 5 s Disease Cooperative Study Group. Vitamin E and donepezil for the treatment of mild cognitive impairment. N Engl J Med. 2005; 352(23):2379-2388.
[15] Folstein MF, Folstein SE, McHugh PR . aMini-mental state”. A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975; 12(3) : 189-198.
doi: 10.1016/0022-3956(75)90026-6
[16] Rosen WG, Mohs RC, Davis KL . A new rating scale for Alzheimer 5 s disease. Am J Psychiatry. 1984 ; 141(11) : 1356-1364.
[17] Lawton MP, Brody EM . Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969; 9(3):179-186.
doi: 10.1093/geront/9.3_Part_1.179
[18] Mohs RC, Cohen L . Alzheimer’s Disease Assessment Scale (ADAS). Psychopharmacol Bull. 1988; 24(4):627-628.
[19] Mobs RC, Rosen WG . The Alzheimer’s disease assessment scale: an instrument for assessing treatment efficacy. Psychopharmacol Bull. 1983; 19(3):448-450.
[1] Chiung-Hui Huang, Mei-Ling Yeh, Fang-Pey Chen, Daphne Wu. Low-level laser acupuncture reduces postoperative pain and morphine consumption in older patients with total knee arthroplasty: A randomized placebo-controlled trial. Journal of Integrative Medicine, 2022, 20(4): 321-328.
[2] Maryam Azimi, Hanieh Niayesh, Mahboobeh Raeiszadeh, Sedigheh Khodabandeh-shahraki. Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation: A double-blind randomized controlled tria. Journal of Integrative Medicine, 2022, 20(3): 230-236.
[3] Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Ana Elisa Madureira Padula, Livia Mitchiguian Hotta, Amarilysde Toledo Cesar, José Nelson Martins Diniz, Helen de Freitas Santos, Edson Zangiacomi Martinez. Homeopathy for COVID-19 in primary care: A randomized, double-blind, placebo-controlled trial (COVID-Simile study). Journal of Integrative Medicine, 2022, 20(3): 221-229.
[4] Xin Wang, Wen-juan Song, Yi Ruan, Bing-chu Li, Can Lü, Nian Huang, Fan-fu Fang, Wei Gu. Core muscle functional strength training for reducing the risk of low-back pain in military recruits: An open-label randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 145-152.
[5] Meng-zhu Zhao, Chen Zhao, Shuang-shuang Tu, Xu-xu Wei, Hong-cai Shang. Evaluating the methodology of studies conducted during the global COVID-19 pandemic: A systematic review of randomized controlled trials. Journal of Integrative Medicine, 2021, 19(4): 317-326.
[6] Si-chun Gu, Jie Zhou, Qing Ye, Can-xing Yuan. Pingchan granule for depressive symptoms in Parkinson’s disease: A randomized, double-blind, placebo-controlled trial. Journal of Integrative Medicine, 2021, 19(2): 120-128.
[7] Jie Wu, Shu-wei Duan, Hong-tao Yang, Yue-yi Deng, Wei Li, Ya-ni He, Zhao-hui Ni, Yong-li Zhan, Shan Lin, Zhi-yong Guo, Jun Zhu, Jing-ai Fang, Xu-sheng Liu, Li-hua Wang, Rong Wang, Nian-song Wang, Xiao-hong Cheng, Li-qun He, Ping Luo, Shi-ren Sun s, Ji-feng Sun, Ai-ping Yin, Geng-ru Jiang, Hong-yu Chen, Wen-hu Liu, Hong-li Lin, Meng Liang, Lu Ma, Ming Chen, Li-qun Song, Jian Chen, Qing Zhu, Chang-ying Xing, Yun Li, Ji-ning Gao, Rong-shan Li, Ying Li, Hao Zhang, Ying Lu, Qiao-ling Zhou, Jun-zhou Fu, Qiang He, Guang-yan Cai, Xiang-mei Chen. Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial. Journal of Integrative Medicine, 2021, 19(2): 111-119.
[8] Xian Wang, Xuan Yin, Xiu-tian Guo, Yan Wang, Wen-qi Jin, Ai-jun Mao, Lixing Lao, Zhang-jin Zhang, Jie Zhang, Shi-fen Xu. Effects of the pestle needle therapy, a type of acupoint stimulation, on post-hemorrhoidectomy pain: A randomized controlled trial. Journal of Integrative Medicine, 2020, 18(6): 492-498.
[9] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[10] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[11] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[12] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[13] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[14] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[15] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
[1] Wei-xiong Liang. Problems-solving strategies in clinical treatment guideline for traditional Chinese medicine and integrative medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 1-4
[2] Zhao-guo Li. Discussion on English translation of commonly used sentences in traditional Chinese medicine: part one. Journal of Chinese Integrative Medicine, 2008, 6(1): 107-110
[3] Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[4] Xue-mei Liu, Qi-fu Huang, Yun-ling Zhang, Jin-li Lou, Hong-sheng Liu, Hong Zheng. Effects of Tribulus terrestris L. saponion on apoptosis of cortical neurons induced by hypoxia-reoxygenation in rats. Journal of Chinese Integrative Medicine, 2008, 6(1): 45-50
[5] . Uniform requirements for manuscripts submitted to biomedical journals: Writing and editing for biomedical publication (Chinese version, part two). Journal of Chinese Integrative Medicine, 2010, 8(11): 1001-1005
[6] Daniel Weber, Janelle M Wheat, Geoffrey M Currie. Inflammation and cancer: Tumor initiation, progression and metastasis,and Chinese botanical medicines. Journal of Chinese Integrative Medicine, 2010, 8(11): 1006-1013
[7] Hong Liu , Guo-liang Zhang, Li Shen , Zhen Zeng, Bao-luo Zhou, Cheng-hai Liu, Guang Nie . Application and evaluation of a pseudotyped virus assay for screening herbs for anti-H5Nl avian influenza virus. Journal of Chinese Integrative Medicine, 2010, 8(11): 1036-1040
[8] Zhao-guo Li . A discussion of English translation of 1995 and 1997 Chinese National Standards of Traditional Chinese Medical Terminologies for Clinical Diagnosis and Treatment. Journal of Chinese Integrative Medicine, 2010, 8(11): 1090-1096
[9] Rui Jin, Bing Zhang. A complexity analysis of Chinese herbal property theory: the multiple formations of herbal property (Part 1). Journal of Chinese Integrative Medicine, 2012, 10(11): 1198-1205
[10] Hui-min Liu, Xian-bo Wang, Yu-juan Chang, Li-li Gu. Systematic review and meta-analysis of randomized controlled trials of integrative medicine therapy for treatment of chronic severe hepatitis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1211-1228
Journal of Integrative Medicine, ISSN: 2095-4964 CN 31-2083/R
Copyright © Journal of Integrative Medicine
Powered by Beijing Magtech Co. Ltd
沪公网安备31010602003416号      沪ICP备18017633号-3