A CLINICAL STUDY
CONCENTRATED NUTRITIONAL ORAL LIQUID
IN SUPPORTING HEALTHY ENERGY AND LOWERING TOXIC
EFFECTS OF RADIATION AND CHEMOTHERAPY ON CANCER PATIENTS
------------------------------------------------
This clinical study was a joint effort of six hospitals and one medical school in
China. It studies the benefits of nutritional supplementation for cancer patients
receiving chemotherapy and radiotherapy treatments in these hospitals. The study
included 318 cancer patients. Of the 318 patients, 239 received chemotherapy and
101 received radiation therapy.
The purpose of this clinical research was to determine if superior nutrition would
improve the healthy energy and reduce the toxic effects of radiation and chemotherapy
treatments on cancer patients. The study was performed between April and October
1992. Haelan 851 nutritional oral liquids were given to the test groups of patients
and a control group of patients was given ‘Zhen-Qi”, a standard water soluble oral
medical preparation.
Method of observation and general information:
1. Case Selection:
Cases were selected in accordance with the criteria established in the “Specifications
of diagnosis and treatment of common carcinomas in China”, which was established
and adopted by the Anti-carcinoma Association of China as a result of cooperative
efforts by its members. Patients were medically diagnosed for cancer and their condition
was confirmed by operation, pathology, cytology or CT scanning. Patients with and
without surgical operations were all chosen as observative objects.
2. Method of Nutritional Supplementation;
Three test groups were established. Two of the three test groups received Haelan
851 nutritional supplementation with basically the same oral nutritional product
but with differences in the product preparation. The two nutritional product test
groups were designated Groups A and B respectively, (the Haelan 851 Platinum and
Golden Formula Groups). The third group was the control group (Group C). Dosage
and administration. Test group: Haelan 851 Platinum Formula or Golden Formula nutritional
oral liquid supplementation, 80 ml each, three times daily on an empty stomach.
Child patients were given Haelan 851 Platinum Formula or Golden Formula nutritional
oral liquid supplementation, 10 ml each three times daily. The Control group: I
pack of Z.Q.S.P. each, mixed with boiled water, orally twice per day. During radiation
or chemotherapy treatments both groups were treated simultaneously. All traditional
and western medicines, including health supporting and toxicity lowering remedies
were ceased to be taken by these patients during the nutritional testing period.
3. Grouping according to analyzing and differentiating pathological conditions based
on traditional Chinese medical science (TCMS) and evaluation criteria for curative
effects:
(1) Grouping according to analyzing and differentiating pathological conditions:
Deficiency of Qi (vital energy), deficiency of blood, deficiency of Yin (body fluid
with irritability, thirst constipation, etc. as symptoms) and deficiency of Yang.
Each group might be met with each other (for details, see Appendix I on page 2).
energy by Traditional Chinese Medical Science (TCMS) in oncology
|
Group of
Symptoms |
Visual Observations: | Before After | |
| Qi Deficiency |
Cardinal Symptoms: Tongue Condition: |
1) Fatigue in vitality and energy 2) Deficiency of Qi or lazy to talk 3) Spontaneous sweating 4) Corpulent or indented tongue 5) Feeble pulse (weak, soft) |
|
| Blood Deficiency |
Cardinal
Symptoms: Tongue Condition: |
1) Pale looking 2) Amaurosis and vertigo when standing 3) Pallid tongue and lips 4) Thready pulse |
|
| Yin Deficiency |
Cardinal Symptoms: Subordinated Symptoms: Tongue Condition: |
1)Burning sensation of five centers 2) Dryness of mouth and pharynx 3) Elevated "fire" in the afternoon 4) Constipation, short and reddish urine 5) Light sweat 6) Red tongue, little or no fur 7) Rapid and thready pulse |
|
| Yang Deficiency |
Cardinal
Symptoms: Subordinated Symptoms: Tongue Condition: |
1) Systemic or topical chill or cold estremities 2) Puffiness of face and feet 3) Urinate frequently during the night 4) Unformed stool, long and clear urine 5) Pallid, corpulent tongue, moist fur. 6) Deep, slow, scarcely perceptible pulse |
1 Inquiring by order, mark the positive number and fill in the column “Before or
After
2. Standards:
4. Index of objective detection:
5. Method of observation:
A complete examination was given all of the observative objects before treatment,
a case history was recorded by category classification, and nutritional profile
testing procedures were performed and indexed on the monitoring procedures each
week or before and after the nutritional supplementation. A complete reexamination
and evaluation was carried out after the nutritional supplementation was completed.
6. General Information: (See Table I on Page 8)
As seen in Table 1, there were 239 total cases receiving chemotherapy treatments
and 79 cases receiving radiation treatments. Of the chemotherapy group, 177 of the
patients were given nutritional supplementation with Haelan 851 concentrated nutritional
oral liquids, which produced a beneficial results effect in 61 cases. The control
group had 79 cases, of which 62 of these cases received chemotherapy treatments
and the other 17 cases received radiation treatments. The Haelan 851 nutritional
supplementation formulas administered consisted of two type, Platinum (Group A)
and Golden (Group B) formulas. Both of these fermented soybean protein beverages
are essentially the same except for differences in the preparation. The Platinum
formula was used for nutritional supplementation with 119 cases and the Golden formula
was used in 120 cases.
The distribution of cancer in this group of patients is as much as 23 kinds. Commonly,
they are:
Stomach
esophagus
lung
nasopharynx
intestinal
acute lymphemia
acute granulocytaemia
According to TCMS the group of deficiency of Qi and deficiency of both Qi and Blood
are mostly seen, they are 43.9% and 26.73% respectively. Special observation has
been given to the Platinum Formula Nutritionally supplemented group and the Control
Group (Group C).
In child leukemia cases, as both groups were randomly distributed, their comparison
is realistic. The variable factors in other groups are also reduced to a minimum.
Beneficial Effects
1. Relation between Traditional Chinese Medical Science (TCMS) groups and classifications
for supporting healthy energy with lowering toxicity. (See Table 2 below)
Table 2- Relationship between TCMS groups and supporting
healthy energy with lowering toxicity
|
Significant Effect
|
Effect
|
Void
|
|
| Groups: |
A
|
A
|
A
|
| Deficiency: | |||
| Qi |
18
|
26
|
3
|
| Blood |
2
|
13
|
0
|
| Yin |
14
|
7
|
0
|
| Yang |
1
|
3
|
0
|
| Qi & Yin |
0
|
1
|
1
|
| Qi & Blood |
20
|
10
|
0
|
|
Total
|
55
|
60
|
4
|
Table 2 shows the beneficial effects of Haelan 851 oral liquid nutritional supplementation
on the patients in the various groups by TCMS as having “deficiency of healthy energy”.
The total effective rates of Group A, B and C are 96.68%, 92.49% and 31.64% respectively.
The significant effective rates are 46.21%, 34.16% and 1.2% respectively. In TCMS
all types except the cases of types Yang deficiency and both Qi and Ying deficiency
are too few, the other 4 types are carried on ridgid analysis. It points out that
groups A, B, and C in types Qi deficiency, Blood deficiency, Ying deficiency and
both Qi and Blood deficiency have very significant differences (all P values C 0.01),
of which group A is the best, group C is the worst, and groups A and B are similar
to each other.
2. Haelan 851 concentrated nutritional oral liquid improves the patient’s living
quality during radiation and chemotherapy. (see Table 3 on Page 9 %r statistical
data).
As shown in Table 7 on Page 13, during the course of radiation and chemotherapy
treatments, the most frequent symptoms described by patients are as follows:
1. Decrease in appetite (57.98%)
2. Nausea and vomiting.( 34.45%)
3. Hemorrhage
4. Diarrhea
5. Constipation
6. Stomatitis
After nutritional supplementation with Haelan 851 oral liquids the primary symptoms,
such as the decrease of appetite nausea and vomiting & etc., in Groups A and
B are all subsided obviously. By rigid analysis, the primary symptoms of “decrease
in appetite” and “nausea and vomiting”, are improved significantly for those receiving
the Haelan 851 nutritional supplementation. As to alopecia and stomatitis, there
was no improvement. “nausea” and “vomiting” symptoms, before and after treatment,
in Group C are aggravated significantly ( P C 0.05). This analysis points out that
Haelan 851 nutritionally supplemented Groups A and B had better relief of some symptoms
during radiation and chemotherapy therapy than that experienced in the Control Group
(Group C).
Table 7 on Page 13 reflects the positive beneficial effects of Groups A and B receiving
Haelan 851 nutritional supplementation for those undergoing radiation and chemotherapy
treatments.
In the group that received nutritional supplementation with Haelan 851 Platinum
Formula all 119 cases successfully completed the scheduled course of radiation and
chemotherapy. In the
group that received nutritional supplementation with Haelan 851 Golden Formula only
one out of the 120 cases were transferred to surgical service for an operation.
In the Control Group (Group C) 4 of 97 cases discontinued the scheduled radiation
and chemotherapy. The discontinuation rate was 5.06%.
As a result of observation, except fur a few patients having stomach discomfort,
there were no other side effects observed from nutritional supplementation with
Haelan 851 oral liquids.
Discussion
I. An investigation into the use of nutritional supplementation to improve and support
the healthy energy and reduction of toxicity caused by chemotherapy and radiation
therapy given to cancer patients is an important theme in the prevention and healing
of carcinomas. Haelan 851 is a soybean protein nutritional oral liquid that contains
vitamins minerals and amino acids that are essential to the body. Pharmacodynaniic
experiments have shown that it is possible to strengthen the body’s vitality and
increase the immune system functions with superior nutrition. Through clinical observation
of 239 cases (178 chemotherapy and 61 radiotherapy cases), the cancerous patients
were nutritionally supplemented with two types of Haelan 851 oral liquids (Groups
A & B) and with Z.Q.S.P (Control Group C). The results show that the gross effective
rates of group A, B, and C are 96.63%, 92.4% and 31.64% respectively. Significantly
effective rates are 46.21%, 34.16% and 126% respectively. According to the energy
deficiency types, as classified by traditional Chinese Medicine science (TCMS) when
we contrast the beneficial effects of nutritional supplementation given groups A,
B and C, by rigid analysis, it indicates that the types of Qi deficiency. Blood
deficiency, Yin deficiency and deficiency of both Qi and Yin, Group A has the best
nutritional profile and Group C is the worst, with Group B being similar to Group
A. Thus it illustrates that Haelan 851 Nutritional Supplementation possesses the
ability to strengthen the spleen, nourishing the kidney, tonifying the Qi, enriching
the blood, nourishing the Yin and moisten the dryness.
2. Effect of Haelan 851 on supporting healthy energy.
(1) Increasing the living quality of radiation and chemotherapy patients:
Clinical observations show, regardless lithe patients took radiation or chemotherapy,
if those patients received Haelan 851 nutritional supplementation, they all experience
increases in their quality of life, and both Haelan 851 types of nutritional supplementation
are better than the control group (P < 0.05-0.01).
(2) Improving the immune function of radiation and chemotherapy patients;
Results of clinical tests show that the Haelan 851 nutritionally supplemented Group
(A) experienced partial increase in the contents of IgG and IgA for both radiation
and chemotherapy patients, and most of them were within the normal range. 1gM was
only increased in child leukemia (P <005). Haelan 851 Platinum Formula (Group
A) experienced elevated lymphocyte transformation rates, while the Haelan 851 Golden
(Group B) and the Control Group (Group C) do not have these effects, the difference
is remarkable (P <0.01).
(3) Effect of Haelan 851 nutritional supplementation in reducing toxicity.
1. Slowing the fall tendency of WBC and neutrogranulocytes during radiation and chemotherapy.
The nutritional profiles of the Haelan 851 nutritionally supplemented groups (Groups
A and B) are much better than the Control Group (Group C.).
2. Effect on increasing Hg and Pt in radiation and chemotherapy patients.
The Haelan 851 Platinum Formula nutritionally supplemented group (Group A) is the
best of all groups but there is no obvious change in both types of radiotherapeutic
patients. Hg and Pt was also increased in the Control Group (Group C), which is
primarily related to blood transfusions in some of the patients in this Control
Group.
3. Lessening clinical symptoms of radiation and chemotherapy.
Especially the symptoms of “loss of appetite” & and “nausea and vomiting” are
improved obviously. In the Control Group (Group C) the symptoms were not improved
but on the other side were aggravated significantly (P> 005).
4. Increasing the completion rate of scheduled radiation and chemotherapy treatments:
Clinical results show that Haelan 851 nutritional supplementation has the effect
of supporting the healthy energy and lowering toxicity. Thus, it provides the foundation
to insure the completion of radiation and chemotherapy treatment courses successfully.
Of 119 cases receiving Haelan 851 Platinum Formula nutritional supplementation,
all completed their scheduled courses of treatments. Among 120 cases receiving the
Haelan 851 Golden Formula nutritional supplementation, only one case was transferred
to surg3cal service for operation. The discontinuation rate was 0.83%. While in
the control group (Group C) there are 4 cases that had to be discontinued. The control
Groups (Group C) discontinuation rate was 5.06%.
As mentioned above, Haelan 851 nutritional supplementation has the function of strengthening
the spleen, tonifying Qi, nourishing Yin and enriching Blood. It has the functions
of increasing the patient’s living quality, improving the condition of vital energy
deficiency, strengthening the immune function, slowing the fail tendency of white
blood cells and neutrogranulocytes increasing Jig and Pt, improving appetite, alleviating
the gastrointestinal reaction, increasing the completion of scheduled radiation
and chemotherapy treatment courses by means of supporting healthy energy and lowering
toxicity. This it alters the routine treatment in the past administration with blood
plasma, albumin, interferon etc. during the course of radiation and chemotherapy.
Therefore, to extend the clinical use of Haelan 851 nutritional supplementation
has both distinct economic and social benefits.
Results of typical Cases
Case 1. Ma Shi Qiang, boy, 8 years of age, was admitted on March 10, 1992
(Hospital No. 108668) on account of repeated fever, pale looking accompanied with
osteoarticular pain for more than I month. I Clear consciousness, anemic appearance,
scattered petachiae over the skin, the superficial lymph-nodes were enlarged as
broad beam, slight tenderness over sternum, heart and lung (-),liver was 3 cm below
right costal margin, spleen was felt 2 cm below left coastal margin, NS (-). Laboratory
findings: Rb 60g/L, WBC 25x10’/L, segmented neutrophils 2%, lymphocytes 88%, juveniles
10%, thrombocytes 20,dO%. Bone marrow showed acute lymphemia, belongs to the type
of deficiency of both Qi and Blood. Apply plan DOAP for treatment, appetite was
towered obviously with nausea and vomiting, Motilium was given orally and Paspertin
intramuscularly, however both were useless, the first course of chemotherapy had
to be discontinued on the sixth day, and could not go on to the schedule second
course. Alter giving die patient Haelan 851 nutritional supplementation the nausea
and vomiting was greatly improved (grade 11 to Ito 0), chemotherapy was continued
successfully. One month later, lymph-node (-), liver spleen (-), patient’s condition
improved, up and out of bed. Living quality improved 50 to 60 points, body weight
was 1kg heavier, fib 6610 77g/L, WBC 2.0 to 3.8xI0 neutrogranulocytes 4 to 35%,
thrombocytes 45 to 90x10’/L, IgO 2.8 to l.92gfL, IgA 0,2 to 0. 1gM 3.63 to 4.5gTh.
The following course of chemotherapy was administered after the sick child asked
for Haelan 851 nutritional supplementation to go along with his treatment.
Case 2. Hong xx, male, 29 years old, (Hospital No. 155552), loss of strength
in extremities, ptosis for last 5 months, patient was transferred from a district
hospital on Match 4, 1992. Chest film and EEC normal, CT showed thymoma. Operation
was performed on March 13, 1992. Pathological diagnosis after operation was lipothymoma.
Patient was discharged in March 31st. EKO: liver and kidney function normal. Radiotherapy
was started from May 48th, body weight before treatment was 60 kg, appetite poor
(Grade I), Hb 14.9, WRC 4037, N 61%, BPC 0.178 million, IgG 10.2,1122, gA 2.60,1gM
reticuloerthrocytes 0.3% CO’° radiation for 24 days. 300 roentgen each, stayed in
hostel. Haelan 851 nutritional supplementation was administered orally, 80 ml three
times daily. There was no radiation reaction after a course of radiotherapy. Hunger
feeling after administration, took 6 meals per day, body weight increased form 60
kg to 65 kg. Blood for routine was normal, repeat examinations oldie functions of
heart, kidney, liver were normal, IgO 14.2, IgA 2.92,1gM 1.53 were elevated obviously
before and after the therapy in contrast. No medications were administered during
the radiotherapy.
Case3. LiuXX, male, age;47wasadmittedoniuly 1,1992.
Patient was admitted 6 months after an operation for stomach cancer, and required
a second course of chemotherapy. Patient had received a radical gastrectomy on January
27, 1992, the cut was healed finely. The pathological diagnosis: ulcerous cancer
of stomach. Classification of type according to TCMS was a deficiency of Yin. After
admission to the hospital, the patient was administered to with 5-Eu, MMC twice,
poor appetite tired and loss of strength dryness of mouth was apparent. Examination:
GPT>200,, 6 chemotherapy treatments were administered to the patient again and
no adverse reactions could be seen from the chemotherapy treatments and the chemotherapy
treatments were completed successfully. Conclusion of the value of Haelan 851 supplemental
nutritional benefits: Remarkable results.
Table 1 - General Information
|
|
|
Radiotherapy
|
Total
|
Chemotherapy
|
Total
|
|||||||
|
|
|
Child leukemia
|
Adult carcinoma
|
|||||||||
|
|
Groups:
|
A
|
B
|
C
|
|
A
|
B
|
C
|
A
|
B
|
C
|
|
|
|
No. of Case
|
34
|
27
|
17
|
79
|
15
|
26
|
15
|
70
|
67
|
47
|
239
|
|
Sex
|
Male
|
29
|
20
|
8
|
57
|
9
|
19
|
8
|
45
|
47
|
32
|
160
|
|
Female
|
5
|
8
|
9
|
22
|
6
|
7
|
7
|
25
|
20
|
14
|
79
|
|
|
|
Age
|
48.10 + or - 14.46
|
47.63 + or - 15.96
|
45.47 + or - 14.57
|
|
7.60
+ or - 2.87 |
8.46
+ or - 2.73 |
7.93
+ or - 2.96 |
59.95 + or - 14.23
|
55.19 + or - 11.55
|
54.89 + or - 11.36
|
|
|
Ca
Distrib- ution |
Type Dose
|
C
|
|
|
|
B
|
|
|
A
|
|||
|
Head & Face
|
11
|
|
|
|
16
|
|
|
18
|
||||
|
Neck
|
1
|
|
|
|
4
|
|
|
2
|
||||
|
Chest
|
19
|
|
|
|
18
|
|
|
29
|
||||
|
Abdomen
|
27
|
|
|
|
54
|
|
|
48
|
||||
|
Others
|
21
|
|
|
|
28
|
|
|
22
|
||||
|
Opera-
tion |
No
|
28
|
20
|
9
|
57
|
15
|
26
|
15
|
27
|
25
|
17
|
125
|
|
Yes
|
6
|
8
|
8
|
22
|
0
|
0
|
0
|
43
|
42
|
29
|
114
|
|
|
Course
(Week) |
Less than 4
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
13
|
1
|
14
|
|
4 or more
|
8
|
16
|
17
|
41
|
15
|
26
|
15
|
18
|
11
|
18
|
103
|
|
|
6 or more
|
14
|
11
|
0
|
25
|
0
|
0
|
0
|
6
|
7
|
2
|
15
|
|
|
8 or more
|
12
|
0
|
0
|
12
|
0
|
0
|
0
|
46
|
36
|
25
|
107
|
|
|
Group-
ing
accord- to TCMS |
Qi-
deficiency |
21
|
13
|
5
|
39
|
0
|
0
|
0
|
26
|
27
|
19
|
72
|
|
Blood-deficiency
|
3
|
12
|
2
|
17
|
0
|
0
|
0
|
12
|
11
|
13
|
36
|
|
|
Yin-deficiency
|
6
|
2
|
9
|
17
|
0
|
0
|
0
|
15
|
13
|
6
|
22
|
|
|
Yang-deficiency
|
0
|
0
|
1
|
1
|
1
|
5
|
3
|
3
|
0
|
0
|
12
|
|
|
Deficiency of Qi & Yin
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
3
|
0
|
5
|
|
|
Deficiency of Qi & Blood
|
4
|
0
|
0
|
4
|
14
|
21
|
12
|
|||||