-Chin J Intern Medicine Vol.37, No.6,1998-

The effect of Xuezhikang on Blood Glucose and Lipid Metabolism in Type II Diabetes Mellitus
Sun Meizhen, Tian Linhua, Chi Jiamin.
Beijing Hospital, Beijing 100730

ABSTRACT

Objective
To confirm the effect of Xuezhikang on sugar and lipid metabolism in type II diabetes mellitus (DM).
Methods: 100 cases of type II DM patients were divided into four groups based on previous measures for lowering blood sugar. This trial was carried out on 30 cases without (group A) and with (group B) hyperlipidemia respectively, took 2 capsules of Xuezhikang twice a day for two months. 40 cases compatible with group A and B serving as control groups (group C and group D), while no Xuezhikang was taken.
Results: Fasting blood glucose decreased by 7.6%7.7% and 10.8%9.6%, 2-hour
post-prandial blood sugar by 14.1%9.0% and 12.2%10.5%, HbAlc by 11.0%5.4% and 6.3%7.8%, serum total cholesterol by 9.0%9.0% and 15.0%9.0%, triglyceride by 4.0%13.0% and 21.0%26.0% in group A and B respectively. The parameters after treatment were significantly different from that before treatment (P<0.05 and <0.01 respectively). In group C and D there were no change of the parameters before and after the observation. No side effects were observed in those cases treated by Xuezhikang.
Conclusion: Xuezhikang not only can adjust disorders of lipidemia, but also have some effects on ameliorating hyperglycemia in type II DM.

Key Words

Diabetes mellitus; non-insulin-dependent; Xuezhikang

 

INTRODUCTION

Lipid metabolic disorders, hemorrheological abnormality and microcirculation disturbance have become one of the major reasons for the development of cardio-cerebrovascular diseases such as atherosclerosis, myocardial infarction and cerebrovascular accidents. In this study, we used Xuezhikang to treat 70 hyperlipoidemia patients to investigate its curative effects on lipid level, hemorrheology and nailbed microcirculation. Here is the detail.


PATIENTS AND METHODS

Patients
In out-patient-clinic (OPD) or on admission, patients were selected for clinical observation according to the diagnostic standard advocated by WHO (1985), after dietary adjustment and/or took drugs lowering blood sugar and condition stable for more than two months, whose 2-hour post-prandial blood sugar (2-hr BS) were measured successively twice (2-4 weeks interval) 10.6 mmol/L, or fasting blood sugar =8.3 mmol/L in type II DM.

Among those cases complicating abnormal blood lipid, after taking low fat and low cholesterol diet for one month, measured blood total cholesterol (TC) =5.9 mmol/L or triglyceride (TG)=2.3 mmol/L twice successively, belonging to the hyperlipidemic group, blood sugar (HDL-C) male <1.0 mmol/L or female <1.2 mmol/L belonging to low HDL-C group. In all cases excluded those with diabetic retinopathy over stage or massive fresh bleeding on foundus of eye; diabetic renopathy; proteinuria over (++) quantitatively or serum BUN >10.7 mmol/L and creatinine (Cr)>176.8mol/L; episode of diabetic ketosis accompanied with ketotic acidosis, hypertonic coma syndrome or lactic acidosis and serious infection with acute complication within three months; suffered from acute myocardial infarction; frequent attacks of angina pectoris; cerebral accidents; serious wound within half a year, and drugs induced abnormal lipid metabolism, etc.

Administration Method
Xuezhikang capsule, [(1995) approval code Z-94 by the Ministry of Public Health], developed by Beijing WBL Peking University Biotech Co., Ltd., was administrated by target patients with 0.6 g each time, twice a day. Each capsule contains 0.3 g Xuezhikang. The treatment lasted for 2 months.

Observation Methods
Open contrast study. Patients compatible with the requirements are divided into four groups. 30 case with (group A) and without (group B) hyperlipidemia respectively were selected. Another 20 cases, correspondent in sex, age, level of blood sugar, course of illness and not (group C) complicating with hyperlipidemia and with hyperlipidemia (group D) serving as contrast groups. The common clinical materials are shown in Table I.Open contrast study. Patients compatible with the requirements are divided into four groups. 30 case with (group A) and without (group B) hyperlipidemia respectively were selected. Another 20 cases, correspondent in sex, age, level of blood sugar, course of illness and not (group C) complicating with hyperlipidemia and with hyperlipidemia (group D) serving as contrast groups. The common clinical materials are shown in Table I.


Table I. Common clinical Material of Diabetes Mellitus Patient
Case
Age (y)
Course (y)
Body mass index

Main complication
incidence rate %

Group
Sex
xS
Range
Mean
Range
>
25
<=
25
Rretina nephritic lesion
Rretina nephritic syndrome
PN
HD
CHD
CD
Lower limb angiopathy
M F
Xuezhikang
A
17
13
55.09.1
35~70
7.976.16
2.00~16
2
28
36.7
30.0
70.0
43.3
26.7
20.0
13.3
B
18
12
54.79.2
35~70
6.144.22
0.17~15
5
25
43.3
33.3
80.0
50.0
23.3
20.0
10.0
Control
C
12
8
56.410.07
38~70
7.987.06
0.67~32
4
16
40.0
45.0
85.0
35.0
30.0
25.0
15.0
D
11
9
55.659.71
39~70
4.274.48
0.30~15
6
14
40.0
30.0
65.0
50.0
20.0
25.0
25.0
A,C: simple DM.; B,D: DM complicating with hyperlipemia. PN: peripheral neuropathy; HD: hypertensive disease; CHD: coronary heart disease; CD: Cerebral vessels disease

The living style is relatively stable. Drugs maintained basically unchanged during the course. Supper must be light before the days withdraw blood. In groups A and B, in addition to drugs for lowering blood sugar, added Xuezhikang 2 capsules (0.6g), bid, and Xuezhikang were taken on groups C and D, two months for the course. Before and after the treatment measured blood pressure, body weight, heart rate, withdraw blood with emptying stomach for 12 hours (over night) for fasting blood sugar, TC, TG, HDL-C, ALT, AST, bilirubin, BUN, Cr, CPK, ALP, LDH, test A1C(HbA1C) of whole blood, and 2-hr post-prandial blood sugar, urine routine and record drug reaction once month. Perform palpation of the liver and spleen, ECG, blood routine and platelet count before and after the treatment.


STANDARD OF EVALUATION OF EFFECT

According to 'Clinical Research Guidance Principle of Drugs', advocated by the Ministry of Health (1993), the effect for lowering blood are divided into evidently effective, effective, and invalid.

  • Evidently effective
    Fasting blood sugar <7.2 mmol/L, 2-hr post-prandial BS <8.3 mmol/L, 24h urine sugar <10g quantitatively or decreased >30% within 24 hours.
  • Effective
    Above criteria are <8.3mmol/L, <10mmol/L, <25g or decrease >10% respectively. Invalid: No obvious improvement of diabetic symptoms observed, and blood and urine sugar are not reach the above mentioned criteria.


STATISTICAL MANAGEMENT

Data were processed by personal computer after entered. Quality Material analyzed with t test, and count analyzed with chi-square test. The results of various groups are compared with that before treatment (self-contrast), inter-group effect are compared with changed percentage.

RESULTS

Influence of Xuezhikang on blood sugar of type II DM.
Compared with that before treatment, in all the 4 groups, there are no difference of average value (p>0.1 and 0.05> respectively) on clinical data, occurrance of complication and fasting blood sugar, 2h-BS, HbA1C, therefore it has comparability. Shown in Table II.

Table II: Blood sugar changes in various group of type II DM before and after Xuezhikang treatment (xS)
Fasting Blood Glucose

2-hr post-prandial
blood sugar

HbA1C
Group
Case
Pre
mmol/L
After 1 month(%)
After 2 month(%)
Pre
mmol/L
After 1 month(%)
After 2 month(%)
Pre
mmol/L
After 1 month(%)
After 2 month(%)
Xuezhikang
A
30
9.0
<7.3
<7.6
11.1
<10.9
<1.41
9.0
<7.6
<11.0
1.0
7.7
7.7**
0.7
8.6**
9**
1.2
5.1**
5.4**
B
30
8.4
<7.7
<10.8
10.9
<7.1
12.2
8.5
<4.0
<6.3
1.3
8.4**
9.6**
1.1
10.2**
10.5**
1.0
9.2**
7.8**
Control
C
20
8.5
<1.2
>0.0
10.8
>2.6
>2.1
8.6
<1.3
<1.8
1.7
9.4
9.6
0.9
10.3
6.6
1.6
7.6
9.8
D
20
8.1
<1.7
<3.9
10.8
<0.2
>2.3
8.5
<1.9
<1.4
0.9
8.4
6.3
1.0
12.9
7.2
1.5
6.5
7.1
t value, between groups comparison
A&B
0.41
2.10
2.27
2.57
4.60*
8.44**
A&C
8.71**
7.36**
9.36**
20.21**
17.30**
21.11**
B&D

15.70**

27.86**
4.00
13.50
8.02**
10.81**
<:decreased,>: increased. *P<0.05, **P<0.01; A,C simple DM; B,D: DM: complicating with hyperlipemia


Action of Xuezhikang on blood sugar of type II DM. (Table III.)

TC

TG

HDL-C
Group
Case
Pre
(mmol/L)
After 1 month change(%)
After 2 month
change(%)
Pre
(mmol/L)
After 1 month change(%)
After 2 month
change(%)
Pre
(mmol/L)
After 1 month
change(%)
After 2 month
change(%)
Xuezhikang group
A
30
5.30.5
<75**
<9.09.0**
1.90.2
<213
<413*
1.10.2
>4.06.0
>5.08.0
B
30
6.01.0
<107**
<15.09.0**
3.21.4
<1421
<2126**
1.10.2
>7.014.0
>10.018.0
Control group
C
20
4.90.6
>0.19.5
<0.78.5
1.40.5
<4.420.9
>2.418.3
1.30.4
>3.215.4
<1.87.7
D
20
6.20.5
>3.23.4
>4.04.2
2.1.07
>3.55.3
<0.516.8
1.20.3
>3.28.1
<1.76.6
t value, between groups comparison
A&B
2.69
4.38*
10.87**
13.99**
0.008
1.55
A&C
8.71**
12.43**
1.71
0.16
2.55
1.99
B&D
18.72**
23.64**
7.36**
13.28**
0.002
3.93*
<:decreased,>: increased. *P<0.05, **P<0.01


Effect of Xuezhikang after 2 months on type II DM.(Table IIII)

Treated with Xuezhikang for 2 months, compared with that before treatment on group A and B, shown that the fasting blood sugar evidently decreased by 7.6%7.7% and 10.8%9.6% (P<0.01), 14.1%9.0% and 12.2%10.5% 2h post-prandial blood sugar(P<0.01), 11.0%5.4% and 6.3%7.8% HbAlc(P<0.01 and <0.05), 9.0%9.0% and 15.0%9.0% respectively, TC(P<0.01), 4%13% and 21%26%TG(P<0.05 and <0.01, respectively. The decrease of TC and TG are much more evident than group A (P<0.05 and <0.01, respectively). Changes of blood sugar and blood lipid in contrast group C, D are not evident (P>0.05).

Table IV: Effect of Xuezhikang on blood sugar after 2 months on type II DMS
Fasting blood glucose
2-hr post prandial blood sugar
Group
Case
Evidently
Effective
Total Effective(%)
Evidently
Effective
Total Effective(%)
Xuezhikang Group
A
30
3
15
60.0
3
23
86.7
B
30
6
19
83.3
3
19
73.3
Control Group
C
20
3
8
55.0
0
3
15
D
20
2
9
55.0
0
6
30
x2 value, between groups
A&B
15.75**
0
A&C
0.16
2.09
B&D
10.85**
2.09
*P<0.05, **P<0.01



SIDE-EFFECTS

Patients took Xuezhikang orally had no complaints in group A and B. All the results were in normal range such as hepatic and renal function, CPK, AKP, LDH, AST as well as blood and urine routine examinations, checked monthly.


DISCUSSION

Accompanied with the elevation of living level, changes of living style, social population aging gradually and accompanied with improvement of the monitoring measures, there is a tendency of increase the occurrence of patient suffered from diabetes mellitus especially that of type II. Accordingly, population over 40 years old, every 10 years of age promoted, the modality rate increases 0.1%. Induced various chronic complications, are the main important cause of handicap and death, and also are the basis arousing cerebro-cardio-vasular diseases. To prevent and cure diabetes mellitus and its complications, except control blood sugar to an ideal level, adjusting abnormal blood lipid eventually play an important roll [3] in this respect. Xuezhikang contains HMG-CoA reductase inhibitor, multiple unsaturated fatty acids amd essential amino acids that the human body needs, and various effective components, dealing with the action of modulating abnormal blood lipid [4].The mechanism of lowering the sugar probably is due to multiple unsaturated fatty acids inhibit the synthesis of triglyceride and fatty acids, and accelerate its metabolism, therefore increase insulin secretion from the islet cell of the pancreas or promote sensitivity of peripheral tissue to insulin [5]. But there may be some other pathway that not discovered yet, further research is waiting for.


REFERENCES

1.
Shen Zhiwei, Yu Pulin, Sun Meizhen et al. Prospective Study of Xuezhikang in Treatment of Primary Hyperlipidemia. Natl Med J China. 1996,76:156-157
2.
Li C,Li Y, Hou Z. Toxicology of Xuezhikang. Inf Chin Pharmacol Soc. 1995;12:12
3.
The diabetes control and Complications Trial Research group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med, 1993, 329:977-986.
4.
Brown MS, Goidstein JL. A Receptor-mediated pathway for cholesterol homeostasis. Science, 1986, 232:34-47.
5.
Yang W, Xing X, Lin H, et al. Hypertriglyceridemia is the Risk Factor for NIDDM. Chin J Intern Med, 1995, 34:583-586
 
 
2013 Asiapharm Biotech Pte Ltd. All rights reserved.

Notices and Legal Disclaimer


Information on this web site is provided for informational purposes only and is not a substitute for professional medical advice. You should not use the information on this web site for diagnosing or treating a medical or health condition. You should carefully read all product packaging. If you have or suspect you have a medical problem, promptly contact your professional healthcare provider.

Statements and information regarding dietary supplements have not been evaluated or approved by the U.S. Food and Drug Administration. Please consult your healthcare provider before beginning any course of supplementation or treatment.