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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

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**△△
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**△△
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**△△
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**△△
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
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