Clinical Observation Report (10618 Patients) of YU XIAO SAN 8805 for Diabetes Study Group

China Beijing Chaoyang Red Cross Association Hospital

imageThe following is a 10618 case report of diabetics who used YU XIAO SAN 8805 during the period of February 1992 to October 1992.

I. Selecting Cases
1. Diabetics were confirmed patients under the diagnosis standard published by WHO.
2. Clinical fasting blood sugar was 7.8 mmol/L (140mg/L) or above, glucose in urine was positive and with obvious diabetic symptoms.
3. Blood sugar could not be controlled within the normal range after using Chinese and Western medicine for over 3 months. (equal to term 2)
4. Blood sugar was abnormal for or over 3 months without using any Chinese or Western medicine.

II. General Information

Among the 10618 cases, 5318 cases were provided by our hospital (1268 In-patient cases, 4050 out-patient cases). The rest 5300 cases were provided by other cooperative medical institutions.
1. Gender: 5204 males, 5414 females. The ratio between male and female is 1:1.04
2. Age: 1610 cases were under 40 years old, 15.16%: 7116 cases between 40-60 yeas old, 67.02%; 1892 cases over 60 years old, 17.82%.
3. Duration of illness: 2548 cases were between 3 months to within one year, 24%; 3398 cases were between one to five years, 32%; 2442 cases were between 5 to 10 years, 23%; 2230 cases were over 10 years, 21%.
4. Patient conditions: Fasting blood sugar of 4791 cases was between 7.8 to 11.1mmol/L (140-200 mg/L), 45.12%; fasting blood glucoses of 4486 cases were 11.2-16.6mmol/L(200-300mg/dl), 42.25%; fasting blood sugar of 1341 cases was 16.7 mmol/L (300mg/), 12.63%.
5. The state of using medicine: 1236 cases were confirmed insulin-dependent patients (IDDM), which was 11.64% of the total.  Among them, 136 of them used insulin more than 50 units every day, which was 11% of insulin dependent cases. 9832 cases were non-insulin dependent (NIDDM), which was 88.36% of the total. Among them, 3046 cases had taken sulfarea drugs, which was 28.69% of the total. 2395 cases had taken biguanide drugs, which was 22.56% of the total; 3198 cases had taken both drugs, which was 30.12% of the total; 342 cases without taking any drugs. 3.22%; 401 cases had taken other Chinese medicine such as YU QUAN WAN, which was 3.78%.

III. Observation Method
1. Comparison method. Observe 2 courses of treatment continuously, each course lasts 2 months.
2. Take YU XIAO SAN 8805, 8 tablets each time, 350mg/tablet, 4 times/day, one hour before each meal and before going to bed, with water.
3. For patients using antihyperglycemic drugs during the initial period of YU XIAO SAN 8805 intake, there is no dosage change of the original insulin injection or oral antihyperglycemic drugs. After taking YU XIAO SAN 8805, as fasting blood sugar and 2-hour-after-dinner blood sugar recover to normal levels, start reducing the original drugs (not YU XIAO SAN) one fourth of the original daily dosage, step by step each week (reduce the dosage but not the number of intake.) until the dosage reaches zero. As for insulin dependent diabetics, reduce 2 units of insulin intake each week, each time step by step, till the number of units reach zero. If during the reduction blood sugar and urine sugar rebound, return to the original dosage before the last reduction, until the blood sugar and urine sugar reach normal level.  And then, continue to reduce the dosage at a slower pace. After taking YU XIAO SAN 8805 exclusively, if the blood sugar test stays normal for the next continuous 3 months, YU XIAO SAN 8805 could also be stopped.
4. BUN Test, C-Ti, insulin release test, pancreatic glucagons test, sacharogenic hemoglobin test, renal function test, liver function test, blood rheology test, fasting blood sugar,  2-hour-after-dinner blood sugar, and urine sugar are to be taken at least once a month before and until four months after taking YU XIAO SAN 8805.
5. Patients are treated under the conditions of proper diet, moderate exercises, avoiding anger, exhaustion, and spicy food.

IV. Measurement of Clinical Result:
A. Clinical Recovery:
1. Fasting blood sugar is <6.1mmol/L(110mg/L), HbAlc<6.8%
2. Blood lipid is normal
3. Twenty-four hour urine sugar quantity is<5g
4. Clinical symptoms and complications are disappeared
5. Insulin or oral drugs are discontinued completely, for at least 3 months.

B. Obvious Effect:
1. Fasting blood sugar is <7.8mmol/L(140mg/L), HbAlc<8%
2. Blood lipid is reduced, and cholesterol level is <5.96mmol/L(230mg/L). Triglyceride <1.47mmol/L(130mg/L)
3. Twenty-four hour urine sugar quantity is <10g
4. Clinical symptoms and complications are significantly reduced.
5. Insulin or oral drugs are partially reduced.

C. Regular Effect:
1. Fasting blood sugar is <8.9mmol/L(160mg/L), HbAlc<9%
2. Blood lipid is reduced, and cholesterol level is <6.48mmol/L (250mg/L). Triglyceride< 1.70mmol/L(150mg/L)
3. Clinical symptoms and complications are reduced, or with little development.
4. Twenty-four hour urine sugar quantity is <15g
5. No decrease of insulin units or oral drugs.

D. No Effect: All indexes have no inclination of improvement.

V. Treatment Result
1. In total, 1878 cases were fully recovered, which is 17.69% of total; 2452 cases had obvious effect, 23.09%; 3979 cases were effective, 37.47%; 23309 cases had no effect, 21.75%. (see Table 1)

Table 1: Treatment Result of 10618 Cases of Diabetic Patients (NIDDM & IDDM)

  Clinical Recovery Obvious Effect Effect No Effect
Cases 1878 2452 3979 2309
Percentage 17.69% 23.09% 37.47% 21.75%

2. Of 5204 male cases, 921 cases were recovered, which is 17.70%; obvious effect 1201 cases, 23.08%. 1950 cases were effective, 37.47%. 1132 cases had no effect, 21.75%. Of 5414 female cases, 957 cases were recovered, which is 17.68%; 1251 cases had obvious effects, 23.11%; 2029 cases were effective, 37.48%; 1177 cases had no effect, 21.74%. (see Table 2)

Table 2: Relation between Gender and Effect

  Clinical Recovery Obvious Effect Effect No Effect
Male 921(17.70%) 1201(23.08%) 1950(37.47%) 1132(21.75%)
Female 957(17.68%) 1251(23.11%) 2029(37.47) 1177(21.74%)

3. Among 2548 cases whose courses of the disease lasted between 3 months to one year, 570 cases were recovered, which is 22.37%, obvious effect 667 cases, 26.18%, effect 899 cases, 35.28%, no effect 412 cases, 16.17%. Among those between 1 year and 5 years, there were 3398 cases. 672 cases were recovered, which is 19.78%; 863 cases had obvious effect, which is 25.40%; 1300 cases were effective, 38.26%; 563 cases had no effect, 16.57%. Among those between 5 year and 10 years, there were 2442 cases, in which 398 cases clinically recovered, which is 16.30%; 539 cases obvious effect, 22.07%; 949 cases effect, 38.86%; 556 cases no effect, 22.77%. There were 2230 cases whose course of disease were more than 10 years, among which 238 cases were clinically recovered, which is 0.67%; 383 cases with obvious effect, 17.17%; 831 cases were effective, 37.26%; 778 cases with no effect, 34.89%. (see Table 3)

Table 3: Relation between Courses of Disease and Curative Effects
  Clinical Recovery Obvious Effect Effect No Effect
3-12 months 570(22.37%) 667(26.18%) 899(35.28%) 412(16.17%)
1-5 years 672(19.78%) 863 (25.40%) 1300(38.26%) 563(16.57%)
5-10 years 398(16.30%) 539(22.07%) 949(38.86%) 556(22.77%)
>10 years 238(10.67%) 383(17.17%) 831(37.26%) 778(34.89%)

4. Among 1236 IDDM cases, 84 cases were fully recovered, 6.8%; 106 cases had obvious effects, 8.58%; 144 cases were effective, 1165%; 902 cases had no effect, 72.98%. Among 3046 NIDDM cases administered by Sulfaurea medicine, 557 were cured, 18.29%; 736 had obvious effects, 24.16%; 1478 were effective, 48.52%; 275 had no effect, 9.03%. Among 2395 cases administered by Biguanide medicine, 575 cases were fully recovered, 24.01%; 647 cases had obvious effects, 27.01%; 936 cases were effective, 39.08%; 237 cases had no effect, 9.90%. Among 3198 cases combined with both two types of medicines, 476 were fully recovered, 14.88%; 748 cases had obvious effects, 23.39%; 1109 cases were effective, 34.68%; 865 cases had no effect, 27.05%. Among 401 cases administered by other Chinese herbs, 96 cases were fully recovered, 23.94%; 125 cases had obvious effect. 31.17%; 166 cases were effective, 41.4%; 14 cases had no effect, 3.49%. Among 342 cases that are without the use any medicine, 90 cases were fully recovered, 26.32%; 90 cases had obvious effects, 26.32%; 146 cases were effective, 42.69%; 16 cases had no effect, 4.68%. (see Table 4)

Table 4: Effect relation between Type I And Type II

  Clinical Recovery Obvious Effect Effect No effect Total Effect
Type I 84(6.80%) 106(8.58%) 144(11.65%) 902(72.98%) 27.02%
Type II         85.00%
*Sulf 575(18.29%) 736(24.16%) 1478(48.52%) 275(9.03%)  
*! *Bigu 575(23.94%) 647(27.01%) 936(39.08%) 237(9.03%)  
***Chn 96(23.94%) 125(31.17%) 166(41.40%) 14(3.49%)  
No Medicine 90(26.32%) 90(26.32%) 146(42.69%) 16(4.68%)  

*sulf-patients: patients that take sulfaurea medicine orally
**bigu-patients: patients that take Biguanide medicine orally
***Chn-Patiients: patients that take other Chinese medicine orally

5. IDDM: Among 136 cases whose daily dosage of Insulin is over 50 units, 5 cases were fully recovered, 3.68%; 7 cases had obvious effects, 5.15%; 8 cases were effective, 5.88%; 116 cases had no effect, 85.29%.

Table 5: IDDM Patients With Insulin Daily Dosage Over 50 Unites

Clinical Recovery Obvious Effect Effect No effect Total effect
5(3.68%) 7(5.15%) 8(5.88%)  116(85.29%) 14.71%

6. Changes of blood sugar, blood insulin and blood pancreatic glucagons. Blood sugar and pancreatic glucagon reduced significantly after the treatment. It proves "YU XIAO SAN 8805" can reduce blood sugar level significantly. (see Table 6)

Table 6: Comparison Blood Insulin, Glucose and Glucagon Before and After the Treatment

  Glucose (mmol/L) Insulin (uu/ml) Glucagon (Pg/ml)
Before 13.41+-2.11 8.81+-1.51 133.59+-25.85
After 7.51**+-0.83 10.20*+-2.03 82.41**+-21.31
  *p<0.05 **p<0.001    

7. Blood lipid and rheology. cholesterol, triglyceride reduced significantly (p<0.001). Blood viscosity, plasma viscosity, PCV, and hemomcyte electrophoresis time reduced obviously. (p<0.01), Blood sedimentation equation K went down significantly. (p<0.01). Fibrinogen decreased. It indicates blood viscosity lowered accordingly.

Table 7: Comparison blood lipid and blood rheology before and after the treatment

  Cholesterol Triglyceride Blood Viscosity Plasma Viscosity HET PCV Blood Sedimentation K Fibrinogen
  mmol/L mmol/L ratio ratio mm/s m% ratio g/u
Before 6.52+-0.57 1.86+-0.15  4.90+-0.79 1.87+-0.15 19.74+- 0.88 47.64+-
43.72+-9.33 4.44+-0.29
After 5.04+-0.39 1.13+-0.35 33.98+-0.66 1.64+-0.15 16.45+-
37.71+-7.56 4.26+-0.24

Note: The above data are kindly provided by corporate units.

The results of clinical and laboratorial (animal test) research indicate:
1. YU XIAO SAN 8805 can improve function of the pancreas, increasing the secretion of insulin and decreasing blood sugar. Meanwhile, it can decrease blood lipid that is similar to the finding of the laboratory report of Stanford University Medical School of YU XIAO SAN 8805.
2. The effective rate of YU XIAO SAN 8805 for IDDM is 27.02%, in which, among the patients who were followed for at last six months after the experiment, 6.8% no longer use insulin. 8.85% of the patients decreased their insulin intake dosage, showing the increased function of the pancreas. 11.65% patients' symptoms lessened notably.
3. The effective rate of YU XIAO SAN 8805 for NIDDM is 85%. Among the 8639 patients who took western medicines, 1608 patients stopped taking  western medicine, which is 18.61% of the total; 2131 patients reduce the intake dosage of western medicine, 24.67%; 3523 patients' symptoms lessened, 40.78%. Therefore, YU XIAO SAN 8805 is effective on patients taking either Sulfured or Biguanide type of medicine.  It is also effective even on patients who failed to react on western medicines. It is clear to us that the mechanism of YU XIAO SAN is different from that of the western medicine.
4. YU XIAO SAN 8805 can improve symptoms for those who took western medicine (Sulfurea and Biguanide) without any side effects. The effective rate has no relation with the gender or age but with the length of the disease and degree of the complications.
5. YU XIAO SAN 8805 showed effects to NIDDM patiens. For patients whose insulin daily dosage of over 50 units, 3.68% of them were recovered, 5.15% of them decreased the dosage of insulin intake, and 5.88% of their blood sugar was lower. The mechanism of this phenomenon needs further study.
6. YU XIAO SAN 8805's effect of reducing blood sugar and lipid level is superior than other Chinese medicines that are currently under use (for example, YU QUAN WAN, which is produced in BEIJING and SICHUAN). If patients took decoction prescribed using traditional Chinese medicinal theory based on YU XIAO SAN 8805, the effective rate reached to 95.96%. This is the symbol that YU XIAO SAN 8805 could be improved from its present form and extraction.
7. Clinical observations show that YU XIAO SAN 8805 reduced blood lipid, decreased blood viscosity, promoted blood circulation and abated and prevented symptoms and complications.
8. The bile is an essential organ for producing insulin. YU XIAO SAN 8805 is composed of the herbs which can stimulate the secretion of the bile, thus the increase of the secretion of insulin is important during the course of blood sugar reduction.
9. During analysis of the YU XIAO SAN 8805, minor essential mineral traces had been found. The relation between essential mineral traces and herbs should be considered.

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