SUBSCRIBE
Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2008, Vol. 6 ›› Issue (1): 25-31.doi: 10.3736/jcim20080106

• Original Clinical Research • Previous Articles     Next Articles

A randomized, controlled, double-blind trial of Huannao Yicong capsule in senile patients with mild cognitive impairment

Hao Li(), Ming-jiang Yao, Wen-ming Zhao, Jie Guan, Lin-lin Cai, Ling Cui   

  1. Department of Geriatrics, China Academy of Chinese Medical Sciences, Beijing 100091, China
  • Online:2008-01-20 Published:2008-01-15
  • Contact: LI Hao E-mail:xyhplihao@vip.sohu.com

RichHTML

3

PDF (PC)

128

Like

Objective:To observe the effect and explore the mechanism of Huannao Yicong capsule in treating senile patients with mild cognitive impairment (MCI).

Methods:The investigational drugs were packed by blind method. A randomized, double-blind and controlled trial was conducted on ninety senile patients with MCI. Other forty-five senile healthy persons were recruited to the healthy control group. The ninety senile patients were randomly divided into the Huannao Yicong capsule-treated group (45 patients administered with three Huannao Yicong capsules and two aniracetam capsule analogues) and aniracetam-treated group (45 patients treated with two aniracetam capsules and three Huannao Yicong capsule analogues). Patients in the two groups were treated three times daily for 16 weeks. Memory, traditional Chinese medicine syndrome, cerebral blood flow, free radicals and inflammatory mediators, such as superoxide dismutase (SOD), malondialdehyde (MDA),acetylcholinesterase (AchE), interleukin-la (IL-la) and interleukin-6 (IL-6) were determined before and after the treatment. Blood lipids, including triglyceride (TG), total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), apolipoprotein A-l (ApoA-1) and apolipoprotein B-100 (ApoB-100), were detected before and after the treatment. The safety indexes, such as routine tests of blood and urine, hepatic and renal function tests and electrocardiogram (ECG) were taken before and after the treatment.

Results:Index score of clinical memory scale in senile healthy people was significantly higher than that in MCI patients before treatment (P<0. 01), and the content of AchE, IL-la and IL-6 was obviously lower (P<0.01, P<0.05), the activity of SOD was higher (P<0.05). No significant difference was found in direction memory of clinical memory scale between the two treatment groups. Other index scores of clinical memory scale and traditional Chinese medicine syndrome in patients of Huannao Yicong capsule-treated group were significantly improved as compared with those of the aniracetam-treated group (P<0.05, P<0.01). The blood flow parameters of anterior cerebral artery, posterior cerebral artery and resistant index in patients of Huannao Yicong capsule-treated group were increased significantly (P<0.01, P<0.05). Huannao Yicong capsule could significantly increase the activity of serum SOD and decrease the content of AchE, IL-la and IL-6 (P<0.01, P<0.05),better than aniracetam. Furthermore, Huannao Yicong capsule could significantly improve the blood lipid, such as the level of TG, LDL-C, HDL-C, ApoA-1 and ApoB-100 (P<0. 01, P<0.05), and better than aniracetam (P<0.01, P<0.05). No significant changes were found after treatment in safety indexes, such as routine tests of blood and urine, hepatic and renal function tests and ECG.

Conclusion:Huannao Yicong capsule has better therapeutic effect than aniracetam capsule in treating senile mild cognitive impairment.

Key words: herbal preparations: mild cognitive impairment, randomized controlled trial, double-blinded method, traditional Chinese medicine

CLC Number: 

  • R592

Table 1

Index score of clinical memory scale in senile healthy people and MCI patients before treatment (?x±s)"

Group n Directivity Association Image Figure Manikin Memory
Healthy 45 17.91±5.77 18.97±1.17 21.77±4.88 24.96±4.33 24.88±5.96 108.11±5.67
MCI 90 9.98±4.11** 12.07±5.01** 15.47±4.47** 18.33±5.01** 17.31±4.09** 77.89±7.61**

Table 2

Serum SOD, MDA, AchE, IL-1α and IL-6 in senile healthy people and MCI patients before treatment (?x±s)"

Group n SOD (kU/L) MDA (μmol/L) AchE mmol/L) IL-1α (ng/L) IL-6 (ng/L)
Healthy 45 119.74±17.55 4.05±0.47 34.88±6.63 0.488±0.32 2.87±1.49
MCI 90 91.47±15.42* 5.77±0.91* 49.09±7.01** 0.696±0.51** 3.84±2.09*

Table 3

Effect of Huannao Yicong capsule on index score of clinical memory scale in senile MCI patients (?x±s)"

Group n Directivity Association Image Figure Manikin Memory
Huannao Yicong capsule-treated
Before treatment 44 11.01±2.71 12.11±4.19 17.35±4.46 18.99±5.00 18.07±5.70 74.19±7.99
After treatment 44 17.32±4.71** 15.66±5.01**△△ 20.99±6.07*△△ 22.66±5.47*△△ 22.66±5.47**△△ 96.41±10.77**△△
Aniracetam-treated
Before treatment 43 11.70±2.07 11.96±4.37 16.99±3.47 19.89±6.46 18.88±6.17 75.02±7.84
After treatment 43 16.01±3.07** 14.88±4.96* 18.87±4.01 22.86±6.06 21.01±4.45 93.11±10.17**

Table 4

Effect of Huannao Yicong capsule on TCD test results in senile MCI patients (?x±s)"

Group n Middle cerebral artery Anterior cerebral artery Posterior cerebral artery
Vmean (cm/s) RI Vmean (cm/s) RI Vmean (cm/s) RI
Huannao Yicong capsule-treated
Before treatment 44 46.1±10.7 0.53±0.11 42.1±11.2 0.59±0.12 45.5±13.7 0.56±0.15
After treatment 44 49.3±11.2△ 0.39±0.24**△△ 59.3±12.7*△△ 0.41±0.09**△△ 53.7±14.3*△△ 0.46±0.13**△△
Aniracetam-treated
Before treatment 43 45.6±12.1 0.65±0.21 43.5±12.5 0.57±0.06 44.8±11.7 0.51±0.09
After treatment 43 47.3±13.1 0.52±0.11 48.6±14.2 0.47±0.11 48.6±13.7 0.47±0.15

Table 5

Effect of Huannao Yicong capsule on SOD, MDA, AchE, IL-1a and IL-6 in senile MCI patients (?x±s)"

Group n SOD (kU/L) MDA (μmol/L) AchE (mmol/L) IL-1α (ng/L) IL-6 (ng/L)
Huannao Yicong capsule-treated
Before treatment 44 92.09±14.11 5.25±0.55 50.11±8.17 0.715±0.37 3.88±1.96
After treatment 44 109.71±16.20**△△ 3.90±0.81** 43.13±9.02**△△ 0.531±0.29*△△ 2.17±0.67**△△
Aniracetam-treated
Before treatment 43 91.15±12.77 5.91±0.32 48.92±7.15 0.698±0.48 3.91±0.99
After treatment 43 100.9±15.67* 4.19±0.71** 44.05±8.01* 0.571±0.38 3.39±1.01

Table 6

Effect of Huannao Yicong capsule on blood lipids in senile MCI patiets (?x±s)"

Group n TG (mmol/L) TC (mmol/L) LDL-C (mmol/L) HDL-C (mmol/L) ApoA-1 (g/L) ApoB-100 (g/L)
Huannao Yicong capsule-treated
Before treatment 44 1.76±0.78 5.31±0.69 2.71±0.61 1.07±0.19 1.32±0.33 0.96±0.18
After treatment 44 1.39±0.61*△△ 5.22±0.71 1.98±0.74**△△ 1.21±0.16*△ 1.49±0.15*△ 0.76±0.21**△△
Aniracetam-treated
Before treatment 43 1.70±0.69 5.23±0.70 2.64±0.59 1.20±0.16 1.35±0.18 0.92±0.17
After treatment 43 1.69±0.71 5.22±0.69 2.59±0.48 1.11±0.18 1.44±0.20 0.81±0.21
[1] Wen HB , Zhou HB. Changes of cerebral blood flow in patients with mild cognitive impairment. Zhongguo Lin Chuang Kang Fu. 2005; 9(37):6-7. Chinese with abstract in English.
doi: 10.3321/j.issn:1673-8225.2005.37.005
闻红斌, 周宏斌 . 轻度认知障碍患者的脑血流变化. 中国临床康复. 2005; 9(37):6-7.
doi: 10.3321/j.issn:1673-8225.2005.37.005
[2] American Psychiatric Association . Diagnostic and statistical manual of mental disorders (DSM-JY). 4th ed. Washington: American Psychiatric Association. 1994: 143-147.
[3] Petersen RC, Smith GE, Waring SC , et al. Mild cognitive impairment: clinical characterization and outcome. Arch Neurol. 1999; 56(3):303-308.
doi: 10.1001/archneur.56.3.303
[4] Reisberg B , Ferris SH, de Leon MJ, et al. The Global Deterioration Scale for the assessment of primary degenerative dementia. Am J Psychiatry. 1982; 139(9):1136-1139.
[5] Hughes CP, Berg L, Danziger WL , et al. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982; 140:566-572.
doi: 10.1192/bjp.140.6.566 pmid: 7104545
[6] Folstein MF, Folstein SE , McHugh PR. "Mini-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
[7] Clinical Memory Scale Editing Cooperation Group. Handbook of clinical memory scale. Beijing: Institute of Psychology, Chinese Academy of Sciences. 1996: 27-35. Chinese.
’’临床记忆量表’’编制协作组. 临床记忆量表手册.北京:中国科学院心理研究所. 1996: 27-35.
[8] Zheng XY. The clinical research principle of new traditional Chinese medicine. Beijing: China Medical- Pharmaceutical Science and Technology Publishing House. 2002: 92-96. Chinese.
郑筱萸 . 中药新药临床研究指导原则.北京: 中国医药科技出版社. 2002: 92-96.
[9] Panza F, Capurso C, DIntrono A , et al. Mild cognitive impairment : risk of Alzheimer disease and rate of cognitive decline. Neurology. 2007; 68(12):964-965.
doi: 10.1212/01.wnl.0000259691.26674.d3
[10] Gao P, Qin SS, Liu YH , et al. Study on the correlation between cognitive functions and regional blood flow in Alzheimer disease and mild cognitive impairment. Zhongguo Shen Jing Mian Yi Xue He Shen Jing Bing Xue Za Zhi. 2006; 13(4):205-208. Chinese with abstract in English.
doi: 10.3969/j.issn.1006-2963.2006.04.003
髙平, 秦绍森, 刘银红 , 等. Alzheimer病和轻度认知功能障碍患者认知功能与局部脑血流灌注的相关性研究.中国神经免疫学和神经病学杂志. 2006; 13(4):205-208.
doi: 10.3969/j.issn.1006-2963.2006.04.003
[11] Fu H, Wang XM, Liu GX, et al. Study on relationship between mild cognitive impairment and oxygen free radical metabolism, acetylcholinesterase. Zhongguo Lao Nian Xue Za zhi. 2004; 24(1):17-18. Chinese with abstract in English.
doi: 10.3969/j.issn.1005-9202.2004.01.008
富宏, 王学美, 刘庚信 , 等. 轻度认知障碍与氧自由基代谢和胆碱酯酶相关性的研究.中国老年学杂志.2004; 24(1):17-18
doi: 10.3969/j.issn.1005-9202.2004.01.008
[12] Weisman D, Hakimian E, Ho GJ . Interleukins, inflammation, and mechanisms of Alzheimer's disease. Vitam Horm. 2006; 74:505-530.
doi: 10.1016/S0083-6729(06)74020-1
[13] Ma LH, Dong WQ , Lin GZ. Metabolism of serum lipids in elder patients with mild cognitive impairment. Xin Nao Xue Guan Bing Fang Zhi. 2005; 5(6):28-29. Chinese.
doi: 10.3969/j.issn.1009-816X.2005.06.011
马立华, 董万青, 林桂珍 . 轻度认知障碍患者血脂水平的关系.心脑血管病防治. 2005; 5(6):28-29.
doi: 10.3969/j.issn.1009-816X.2005.06.011
[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] Wan-jun Guo, Yi Wang, Yu Deng, Lin-yan Cheng, Xin Liu, Ruo-fan Xi, Sheng-jie Zhu, Xin-yi Feng, Liang Hua, Kan Ze, Jian-yong Zhu, Dong-jie Guo, Fu-lun Li. Therapeutic effects of the extract of Sancao Formula, a Chinese herbal compound, on imiquimod-induced psoriasis via cysteine-rich protein 61. Journal of Integrative Medicine, 2022, 20(4): 376-384.
[3] Shang-jin Song, Xuan Liu, Qing Ji, Da-zhi Sun, Li-juan Xiu, Jing-yu Xu, Xiao-qiang Yue. Ziyin Huatan Recipe, a Chinese herbal compound, inhibits migration and invasion of gastric cancer by upregulating RUNX3 expression. Journal of Integrative Medicine, 2022, 20(4): 355-364.
[4] 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.
[5] 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.
[6] Marisa Casal. Improving the health and treatment success rates of in vitro fertilization patients with traditional chinese medicine: need for more robust evidence and innovative approaches. Journal of Integrative Medicine, 2022, 20(3): 187-192.
[7] Ning Guo, Fei Wu, Mei Wu, Yuan Wang, Qing Lang, Xiao Lin, Yi Feng. Progress in the design and quality control of placeboes for clinical trials of traditional Chinese medicine . Journal of Integrative Medicine, 2022, 20(3): 204-212.
[8] 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.
[9] Yan-jun Lin, Kun-li Jiao, Bo Liu, Lu Fang, Shu Meng. Antiplatelet and myocardial protective effect of shexiang tongxin dropping pill in patients undergoing percutaneous coronary intervention: A randomized controlled trial. Journal of Integrative Medicine, 2022, 20(2): 126-134.
[10] Jia-jia Li, Qing Liang, Guang-chun Sun. Traditional Chinese medicine for prevention and treatment of hepatocellular carcinoma: A focus on epithelial-mesenchymal transition. Journal of Integrative Medicine, 2021, 19(6): 469-477.
[11] Rui-jin Qiu, Min Li, Jia-yuan Hu, Jing Chen, Hong-cai Shang. Methods for development of a core outcome set for clinical trials integrating traditional Chinese medicine and Western medicine. Journal of Integrative Medicine, 2021, 19(5): 389-394.
[12] Mao-xing Pan, Chui-yang Zheng, Yuan-jun Deng, Kai-rui Tang, Huan Nie, Ji-qian Xie, Dong-dong Liu, Gui-fang Tu, Qin-he Yang, Yu-pei Zhang. Hepatic protective effects of Shenling Baizhu powder, a herbal compound, against inflammatory damage via TLR4/NLRP3 signalling pathway in rats with nonalcoholic fatty liver disease . Journal of Integrative Medicine, 2021, 19(5): 428-438.
[13] 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.
[14] Ning Zhang, Xiao-he Xiao. Integrative medicine in the era of cancer immunotherapy: Challenges and opportunities. Journal of Integrative Medicine, 2021, 19(4): 291-294.
[15] Thomas Efferth, An-long Xu, Roxana Damiescu, Mita Banerjee, Norbert W. Paul, David Y.W. Lee. Can eastern wisdom resolve western epidemics? Traditional chinese medicine therapies and the opioid crisis. Journal of Integrative Medicine, 2021, 19(4): 295-299.
Viewed
Full text


Abstract

Cited
  Shared   
  Discussed   
[1] Jin-rong Fu. Establishment of multivariate diagnosis and treatment system of modern gynecology of traditional Chinese medicine. Journal of Chinese Integrative Medicine, 2008, 6(1): 22-24
[2] 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
[3] 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
[4] 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
[5] Ning-qun Wang, Liang-duo Jiang, Zong-xing Li. Research progress in asthma-related quality of life. Journal of Chinese Integrative Medicine, 2008, 6(1): 93-97
[6] Jing-yuan Mao, Chang-xiao Liu, Heng-he Wang, Guang-li Wei , Zhen-peng Zhang, Jie Xing, Wang Xian liang , Ying-fei Bi . Effects of Shenmai Injection on serum concentration and pharmacokinetics of digoxin in dogs with heart failure. Journal of Chinese Integrative Medicine, 2010, 8(11): 1070-1074
[7] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[8] Gui Yu, Jie Wang. Thinking on building the network cardiovasology of Chinese medicine. Journal of Chinese Integrative Medicine, 2012, 10(11): 1206-1210
[9] Pedro Saganha João, Doenitz Christoph, Greten Tobias, Efferth Thomas, J. Greten Henry. Qigong therapy for physiotherapists suffering from burnout: a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(11): 1233-1239
[10] Dong-tao Li, Jian Wang , Hong-yang Jiang , Feng-lei Shi , Fu-yu Li , Ji-hong Liu , Yong-mei Cheng , Nan Yan , Ai-hua Hu, Mei-zeng Zhang , Jie Li, Ling-bo Wei , Rong-qin Jiang. Quantitative evaluation of the degrees of traditional Chinese medicine qualitative syndromes of osteoporosis. Journal of Chinese Integrative Medicine, 2012, 10(11): 1254-1262
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