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39 Case Study

Clinical Report on the Therapeutic Effect of
“C”  Formula & “Y” Formulas
from 39 Cases

Imported from Canada, “C” Formula and “Y” Formula are pure natural remedies which have been used in Canada and the United States for over seventy years. The three years’ promotion of the formulas in Hong Kong has also shown that the combined use of the two is very effective on prevention and treatment of cancers and diseases resulting from immunologic deficiency.

In order to evaluate the clinical effect of “C” Formula and “Y” Formula in China, we selected some cases from Guangdong province. The results are summarized as follows:

I. Selection of Clinical Cases

1.    Tumor, Cancer

The selection was based on the guidelines on clinical research specified in the Law of Medicine Anticancer Drugs. The standards of diagnosis met the requirements of “Practical Internal Medicine” (People’s Health Publishing House, 8th Ed., 1986).

(1) Cancer patients confirmed by pathological histology (or affirmed by cytologic diagnosis), or having definite marks of tumor. The histological and cytologic specimen of the patients was stored for re-check.

(2) The subjects should be those for whom no routine treatments were available or routine treatments had failed and were willing to receive current treatments.

(3) The performance status of the subject was between O and 3, and the subject was expected to live more than two months.

(4) Prior to the clinical test, the doctor in charge would explain the conditions of the patient to the patient or his/her family members (normally the family members), the nature of the test, the potential benefits and risks, and obtain a written agreement of the patient or his/her family members.

The variety of the tumors tested was as diversified as possible. In this test group, the distribution of the cases was as follows: nasopharyngeal carcinoma: 5; pulmonary carcinoma: 4; hepatic carcinoma: 3; carcinoma of colon: 1; metracarcinoma 1; mammary cancer: 1; adrenal tumor hepar metastasis: 1; carcinoma ventriculi: 3; hepatic cyst: 3; gall polypus: 1; with the total being 23 cases.

Among the cases selected, there were 13 male patients and 10 female patients, aged between 28 and 66, with an average of 48.6.

2.    Idiopathic and Secondary Immunologic Deficiency Diseases Caused by Imbalance of Immunologic System

The standards of diagnosis met the requirements of “Practical Internal Medicine” (People’s Health Publishing House, 8th Ed., 1986).

The selection of this group of cases was mainly concentrated on the patients with obvious clinical manifestation of secondary immunologic deficiency diseases. The distribution of the cases was as follows: chronic persisting hepatitis B: 4; pulmonary tuberculosis: 2; rhinallergosis: 2; coronary heart disease: 6; diabetes: 2; with a total of 16 cases.

Among the cases selected, there were 5 male and 11 female, aged between 22 and 56, with an average of 40.

II. Observation Indices and Estimation Standards

1.    Tumor

The tests were conducted according to the guidelines on clinical research specified in the Law of Medicine – Anticancer Drugs.

(1) Anticancer Effect

Objective Estimation Standards of Therapeutical Effect on Solid Tumor:

Complete Remission (CR): All observable pathologic changes disappeared and the effect lasted for at least 4 weeks.

Partial Remission (PR): The product of the largest perpendicular diameters of the tumor focus decreased by more than 50%, and remained so for at least 4 weeks.

Moderate Remission (MR): The product of the two diameters of the tumor focus decreased by more than 25%, but less than 50%, and no new tumor focus appeared.

Stabilized Development (SD): The product of the two diameters of the tumor focus decreased or increased less than 25%, and no new tumor focus appeared.

Pathologic Development (PD): The product of the two diameters of the tumor focus increased by more than 25%, or a new tumor focus appeared.

k Remission Rate: CR+PR (excluding MR and SD).

Note: For the estimation standard of therapeutical effect on leukemia and multiple myeloma, please refer to “Clinical Research Guidelines on Drugs of Hematopathy“.

 

(2) Classification Standards on Performance Status

 

Class Performance Status
0 Ability of movement was completely normal, and there was no any difference before and after the onset of the disease.
1 The patient could walk freely and perform some light physical activities, such as household chores, office work, but not heavy labor work.
2 The patient could walk freely and take care of himself/herself, but lost working capability. The patient might be active no less than half of the time during daytime hours.
3 The patient could only take care of himself/herself partially, and more than half of the time stayed in bed or was confined to a wheelchair.
4 The patient was confined to a bed, and could not take care of himself/herself.

 

 

(3) Acute and Subacute Toxicity Classification Standards of Anticancer Drugs

 

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Hb(g)

> 11.0

9.5~10.9

< 9.5

WBC (k)

> 4.0

3.0~3.9

2.0~2.9

1.0~1.9

< 1.0

Granulocyte (k)

> 2.0

1.5~1.9

1.0~1.4

0.5~0.9

< 0.5

Platelet (k)

> 100

75~99

50~74

25~49

< 25

Bleeding

No

Light

Moderate

Heavy

Life Threatening

Gastrointestinal
Tract Nausea &Vomiting

No

Nausea

Intermittent
Nausea
Controllable

Vomiting
Need
Treatment

Vomiting Uncontrollable

Diarrhea

No

Short Term
(2 Days)

Bearable
(>2 Days)

Need Treatment

Hematic
Diarrhea

Bilifuscin

< 1.25N

(1.26~2.5)N

(2.6~5)N

(5~10)N

> 10N

Serum
Aminotransferase

< 1.25N

(1.26~2.5)N

(2.6~5)N

(5~10)N

> 10N

Note: N = Normal Value;

Stomatitis

No

Painful
Erythema

Ulcer
Could Eat

Ulcer, Intake
Liquid Only

Ulcer
No Intake

 

 

 

 

 

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Urinary System

BUN (mg%)

 

< 20

21~40

41~60

> 60

Symptomatic
Uremia

Creatinine

Proteinuria

 

< 1.2

No

1.3~2.0

+

2.1~4.0

++

> 4.0

+++

(Same As Above)
++++

Hematuria

No

Microscope
Observable

Naked Eye
Observable

Naked Eye
Observable,
Blood Clot

Complicating
Urinary Tract
Obstruction

Toxic Symptoms
of the Lung
(Record
Observations
from x-ray Film of the Chest)

No

Light

Breathing
Difficulty
after Activity

Breathing Difficulty at Rest

Always Confined in Bed

Heart Rate & Rhythm

Normal

Sinus
Tachycardia
100/min at Rest

Single-focus Premature Beat

Multi-focus Premature Beat

More Acute Arrhythmia

Heart Function

Normal

No Symptom Physical Sign Abnormal

Short Period Cardiac Insufficiency, No Treatment Needed

Symptomatic Cardiac Insufficiency, Need Treatment

Congestive Heart Failure

Skin

Normal

Erythema, Pigmentation

Blisters, Itching, Dry Desquamation of Skin

Moist Desquamation of Skin, Ulcer

Exfoliative Dermatitis Necrosis

Hair

Normal

Light
Alopecia

Moderate
Alopecia

Complete
Alopecia
Regeneratable

Complete
Alopecia
Non-
Regeneratable

Nervous System

Mentality

 

Lucid

Short-time
Lethargy

<50% Time
Lethargy

>50% Time
Lethargy

Coma

Peripheral
Nerve

Normal

Sensation
Abnormal or
Tendon
Hyporeflexia

Acute
Sensation
Abnormal or Light Asthenia

Unbearable Sensation Abnormal or Obvious Dyskinesia

Paralysis

Constipation

No

Light

Moderate

Abdominal
Distension

Enteroparalysis

 

 

 

Calculation methods of remission stage and survival period.

Remission stage: CR (Complete Remission): The time period between the onset of CR and the onset of recurrence. PR (Partial Remission): The time period between the onset of PR and the time when the product of the two diameters increased to 1/2 of that before the treatments.

Survival Period: The time period between the commence of chemotherapy and the time when the patient died or the last treatment (specifying if the patient was still alive).

Anosis Survival Period: The time period between the commence of chemotherapy and the onset of recurrence or the time when the CR patient died (not applicable for non-CR patient).

 

2. Low or Deficient Immunologic Function

(1)    Immunologic Indices:

        (i) T Cell Subgroup OKT3, OKT4, OKT, OKT4/PKT6

Effective: Before treatment, the T cell subgroup index was lower or higher than normal, while after treatment, the T cell index returned to normal or near normal.

No Change: After treatment, the abnormal index value had no statistically significant change compared to the value before treatment or that of a control group.

Exacerbation: After treatment, the abnormal index value became more obvious compared to that of the control group.

        (ii) Lymphocyte Transformation Test

Effective: Abnormal Iymphocyte transformation rate became normal or close to normal after treatment.

Ineffective: The abnormal Iymphocyte transformation rate had no significant change after treatment.

Exacerbating: The treatment made the Iymphocyte transformation rate more abnormal (lower) compared to that of the control group.

        (iii) B Cell Function and Determination of Immunoglobulin

Determine the values of IgG, IgM, IgE and IgA.

(2)    General Indices

(i) General check: Complete physical examination, pulse rate, breath, blood pressure.

(ii) Blood routine examination, routine uronoscopy, feces routine examination.

(iii) Liver function, blood bilirubin, serum glutamic pyruvic transaminase, alkaline phosphatase, albumin-globulin ratio

(iv) Renal function, urea nitrogen.

 

(3)    Electrocardiogram

 

(4)    Overall Evaluation:

Healing: Symptoms disappeared; physical signs basically returned to normal; objective indices returned to normal, especially the immunologic indices. Effects were stable after withdrawal of drugs for a long time (more than one year).

Notably Effective: Symptoms basically disappeared; physical signs and objective indices, especially immunologic indices, basically returned to normal.

Effective: Symptoms, physical signs and objective indices improved obviously compared to those of the control group.

Ineffective: Symptoms, physical signs and laboratory examination results fluctuated, immunologic indices had little change compared to those of the control group.

Exacerbating: Symptoms, physical signs and laboratory examination results exacerbated, and the sickness became notably more severe compared to those of the control group, and the immunologic indices became more abnormal.

 

 

III. Observation Methods

 

1.    Among the tumor patients, three were on their advanced stage and were of multiple and metastatic type, hence were treated with the addition of “C Formula” and “Y Formula” to their existing treatment plan. For the rest twenty patients, all the related drugs were stopped to give way to the two testing drugs.

2.     For the patients of immunologic deficiency, all the other related drugs were stopped in order to use these two drugs.

3.     Before observation, the patient was given a complete examination with the results recorded, and then the tumor patient underwent a clinical observation daily.

A complete re-examination was conducted monthly; patients of immunologic deficiency were re-examined weekly; the course of treatment for both tumor and immunologic deficiency patients was one month. Estimation was performed by comparing the examination records before and after the treatment.

4.     Method of administration and dosage: Oral administration was used for all patients.

(1) Tumor patien

“C” Formula: 90 ml T.I.D. x 90 Days
“Y” Formula: 20 ml B.I.D. x 90 Days

(2) Immunologic deficiency patients:

“C” Formula: 60 ml B.I.D. x 30 Days or 90 ml B.I.D. x 30 Days
“Y” Formula: 30 ml Q.D. x 30 Days

Note: “C” Formula was administered with empty stomach and with same amount of warm distilled water.

5. Criteria for exclusion

(1) Pregnant or breast feeding women, infants.

(2) When the patient or his/her family members did not agree to receive the current medicine treatment.

 

 

IV. Results

 

1. Therapeutic Effect on Tumor

 

(1)    Anticancer effect: complete remission (CR)1 case, partial remission (PR) 6 cases, and death 3 cases.

Total remission rate: 7 cases (7/23 ~ 30.43%); Improvement (MR) + Stabilization (SD) 13 cases ~ 56.52%; death 3 cases ~ 13.04%.

 

(2)     Performance status (Number of cases, before and after the treatment)

 

Grade

0

1

2

3

4

Time
Before Treatment

0

3

5

3

12

After Treatment

1

8

6

3

2

3 death

 

(3)     Other effect: Among the 23 cases of tumor patients, 21 had various degrees of improvement on spirit, appetite, and digesting ability. Their defecation function (hard to defecate, no shape) also improved. Their faces looked much more healthy. Six cases of low WBC had their WBC returned normal. Three cases with high SGPT all had decreased SGPT, and two of the three returned normal.

 

(4) Toxic side reaction:

    (i)    Among the 23 cases, 9 had dizziness the next morning following the administration of the drugs, lasting from 2 to 6 days; of the 9 cases, 2 remitted through intravenous injection of 50% GS, other cases were bearable, and the symptom disappeared naturally in 3 to 7 days. The effectiveness of the drugs was not affected.

    (ii)    Among the 23 cases, 5 had more frequent defecation with pulpy excrement 2 to 7 days following the administration of the drugs. No measures were taken and the symptom remitted spontaneously. For these patients, there were no abdominalgia and diarrhea, and they felt comfortable after defecation. Three patients had constipation.

    (iii)    For the 20 surviving patients, throughout the observation period, no abnormal changes were shown on their blood routine examination, routine uronoscopy, SGPT, or BUN.

    (iv)    Three cases had periodic hematochezia (carcinoma ventriculi and hepatic carcinoma patients), and one case had intermittent blood tinged sputum (pulmonary carcinoma patient). The above symptoms were treated and eased without stopping the main treatment drugs. The effectiveness of the testing drugs was not affected.

    (v)    For the 19 cases with ECG records to compare, no abnormal changes were observed.

 

 

2. Therapeutic Effect on Immunologic Deficiency

 

(1) Overall Evaluation

Notably effective, 5 cases: rhinallergosis: 2; chronic persisting hepatitis B: 2; coronary heart disease: 1.

Effective, 8 cases: chronic persisting hepatitis B: 2; pulmonary TB: 2; coronary heart disease: 3; diabetes: 1.

Ineffective, 3 cases: coronary heart disease: 2; diabetes: 1.

(2) Immunologic Indices Evaluation

Of the 16 cases in this group, 7 had immunoglobulin determination results before and after the treatment to compare with. The results are as follows (The in-column figures are the results).

 

Patient

1

2

3

4

5

6

7

Index
IgA Before

0.9

0.94

1.0

1.0

0.4

0.5

1.8

After

1.35

1.55

1.8

1.68

1.0

1.1

1.8

IgG Before

6.3

6.0

8.0

8.0

5.0

5.5

15.58

After

9.8

10.8

10.35

10.3

9.5

10.2

11.6

IgM Before

1.0

1.25

1.1

0.9

0.6

0.5

0.78

After

1.15

1.35

1.25

1.25

1.1

1.1

1.8

IgE Before

0.06

1.33

1.15

1.2

1.3

1.58

0.06

After

0.4

0.78

0.9

0.8

0.82

0.82

0.3

 

 

Normal values: IgA: 1.2~2.3     IgG: 8.0~14.5   IgM: 0.8~1.95    IgE: 0.1~0.9

 

Patient 1: Li, chronic persisting hepatitis B;
Patient 2: Hu, coronary heart disease;
Patient 3: Wu, rhinallergosis;
Patient 4: Chen, pulmonary TB;
Patient 5: Ou, chronic persisting hepatitis B;
Patient 6: Liang, rhinallergosis;
Patient 7: Lu, chronic persisting hepatitis B.

 

(3) Various specific determination results

 

        (i) Chronic persisting hepatitis B. 4 cases:

 

Case

Li, Female
Age: 24

Zhong, Female
Age: 43

Lu, Male
Age: 38

Chen, Female
Age: 19

Index
HBS Ag Before
After

+
+

+
+

+

+
+

HBS Ab Before
After




+


HBe Ag Before
After

+
+

+

+

+

HBe Ab Before
After



+

+

+
+

HBC Ab Before
After

+
+

+
+

+
+

+
+

HBs Titer Before
After

>1:256
>1:64

>1:256
>1:8

>1:256
>1:16

SGPT Before
After

25
24

35
22

27
23

93
22

Dizziness Before
After


+


+

Sodium
Difference
Before
After

+

++

+

+

Asthenia Before
After

+

++

++

++

Acne Before
After

++

++

+

++

Pigmented
Spots
Before
After

++

+++


++

Abdominal
Distention
Before
After

+

++

+

+

Hepatalgia Before
After


+

+

+

Estimation

Effective

Notably
Effective

Effective

Notably
Effective

 

 

 

 

(ii) The symptoms of the two patients with pulmonary TB had notable improvement: the afternoon hectic fever basically disappeared, physical strength was recovered, cough largely disappeared, appetite was improved, body  weight gained, X-Ray TB shadow had no expansion.

(iii) The two cases of rhinallergosis had no occurrence during the administration of the drugs and 20 to 30 days after the withdrawal of the drugs.

(iv) Of the six cases of coronary heart disease, the ST-T ECG of the four patients with ischemic symptom had improvement, with one having notable improvement, and none of the four had angina pectoris occurrence during the administration of the drugs. The rest two cases had no change.

(v) Of the two cases of diabetes, both had improvement on their spirit and physical strength, and the fasting blood-glucose concentration of one of the two patients dropped from 8g/L to 6.8g/L; the other one had no improvement.

 

(4) Toxic side reaction: Of the sixteen cases in this group, two had light morning dizziness 2 to 5 days after the commence of the drug administration, and no treatment was involved before spontaneous remission. Blood and urine routine examinations showed no abnormal results, and the occult blood in stool was negative. Other cases had no notable toxic side reaction.

 

 

V. A Typical Case

 

Patient name: Ma; gender: male; Age: 36; occupation: electrician.

In the beginning of August, 1993, feeling tinnitus and hypoacusis the patient visited the People’s Hospital of Guangdong Province. Physical examination revealed that in his nasopharynx, there were cauliflower-like foci on the top back, right side and above. The illness was diagnosed as nasopharyngeal carcinoma through biopsy. At that time, the patient’s body weight was 68.5 kg, had no symptoms of nosebleed, headache. No swelling of Iymphonodi cervicales and abnormal cranial nerves were observed. Fluoroscopy of chest did not show abnormal heart and lung. Ultrasonic examination did not reveal anything abnormal with the liver, spleen, and gallbladder. Laboratory test showed WBC 4.9×109, RBC 4.5×1012, and Hb 136 g/L. Following confirmed diagnosis, the patient was treated with simple radiotherapy. The treatment was divided into a few periods (with 28 days rest), with a total of 33 visits in 75 days (from August 2 to October 14, 1993). During the time of radiotherapy, the patient had a decreased appetite, had dizziness, and the body weight reduced to 62 kg. Upon finishing the radiotherapy treatment on October 14, 1993, examination of nasopharynx found local swelling on the right protuberance, and residual lesser tubercle. Physical examination did not reveal abnormalities in the heart, lung, liver, spleen, and gallbladder. Physical examination on January 4, 1994 still found the lesser buninoid process on the right protuberance lesser tubercle. The patient had severe dizziness and asthenia. Since the WBC counting was only 3.0×109, no further radiotherapy might be sustained. In April, 1994, the patient started taking “C” Formula and “Y” Formula with the dosage being: “C” Formula, 60 ml B.I.D., and “Y” Formula 30 ml Q.D. In the first week, the patient had diarrhea, but no abdominalgia and rectal tenesmus. The frequency of defecation was once to twice a day, with yellowish watery and pulpy stool. The patient complained with bearable asthenia universalis with no fever and headache. No other treatment was conducted. Another two weeks of administering the two drugs resulted in normalized defecation and recovered physical strength. The frequent dizziness and giddiness complained before the treatment disappeared and the appetite increased. The dosage for “C” Formula was then increased to 60 ml T.I.D. and that of “Y” Formula remained the same. The physical examination on May 10 ,1994 revealed that the lesser tubercle on the right protuberance of nasopharynx had become flattened. The conditions of heart, lung, liver and spleen were all normal. Afterwards, the patient continued taking “C” Formula and “Y” Formula, and came to the hospital for regular physical examination each month. The physical examination on November 8, 1994 found that the tubercle on the right protuberance of the nasopharynx had disappeared, and there were scattered condensed secrete, no swelling on the cervical lymph node. Cranial nerves, heart, lung, liver and spleen were all normal. On March 20, 1995, physical examination showed that the original focus had disappeared, no obvious secrete were seen on the surface. The patient’s self-feeling was good and had been working regularly. Currently, the patient is still taking “C” Formula at 60 ml Q.D. and “Y” Formula at 30 ml Q.D., and has been undergoing a tracing observation.

 

 

Vl. Discussions

 

Of the thirty-nine cases in this group of study, twenty-three were tumor patients, sixteen were secondary immunologic deficiency patients. Among the twenty-three tumor patients, three died of advanced metastatic carcinoma, since they had been already at critical stage when starting the current treatment. There were one case of complete remission, six cases of partial remission, thirteen cases of moderate remission, and stabilized development. The total remission rate was 30.43%. The rate of moderate remission and stabilized development was 56.52%. The death rate was 13.04%. Of the sixteen secondary immunologic deficiency cases, five were notably effective, eight were effective, and three were ineffective.  In addition, there were no toxic side reaction as seen with other Anticancer drugs, such as arrest of bone marrow, digestive tract reaction, reaction of tunica mucosa oris, baldness. On the contrary, with the current treatment, all the patients in the study group had improvements in spirit, appetite, digestive function, physical strength, and immunologic function of the body. The drugs were also shown effective on hepatitis B, rhinallergosis, pulmonary TB and coronary heart disease. Therefore, the drugs are notably better than other antitumor drugs.

The essential ingredients of “C” Formula & “Y” Formula, sheep sorrel, burdock root, schidigera yucca and fennel, etc., have distinct anti-inflammatory, analgesic, peptogenic, and repercussive function. The results of this group of observations showed that the combined use of “C” Formula and “Y” Formula had confirmed therapeutic effect on the treatment and prevention of tumor. They could improve the immunologic function of the body and the overall health of the patient. The drugs had no obvious toxic side reaction.

 


Participants of this study:

YAN Rugui, Chief Physician, The People’s Hospital of Guangdong Province

LAO Qiyun, Deputy Chief Physician, The Second People’s Hospital of Guangzhou City

CHEN Zhu, Researcher, The Institute of Pharmaceutical Research of Guangdong Province

 

 

 

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