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

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] 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.
[2] 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-.
[3] 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.
[4] 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.
[5] 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.
[6] 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.
[7] 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.
[8] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[9] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[10] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[11] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[12] Umesh Chandra Dash, Atish Kumar Sahoo. In vitro antioxidant assessment and a rapid HPTLC bioautographic method for the detection of anticholinesterase inhibitory activity of Geophila repens. Journal of Integrative Medicine, 2017, 15(3): 231-241.
[13] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[14] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[15] Maria Sousa Cláudia, Coimbra Daniela, Machado Jorge, J. Greten Henry. Effects of self-administered exercises based on Tuina techniques on musculoskeletal disorders of professional orchestra musicians: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(5): 314-318.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Jun Hu, Jian-ping Liu. Non-invasive physical treatments for chronic/recurrent headache. Journal of Chinese Integrative Medicine, 2008, 6(1): 31
[2] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[3] Dong Yang, Yong-ping Du, Qing Shen, Wei Chen, Yan Yu, Guang-lei Chen. Expression of alpha-smooth muscle actin in renal tubulointerstitium in patients with kidney collateral stasis. Journal of Chinese Integrative Medicine, 2008, 6(1): 41-44
[4] Zhi-chun Jin. Problems in establishing clinical guideline for integrated traditional Chinese and Western medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 5-8
[5] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[6] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[7] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[8] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[9] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[10] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88