Note: Descriptions are shown in the official language in which they were submitted.
CA 02529239 2010-01-28
-1-
NON-INVASIVE ACUPUNCTURE DEVICE
FIELD OF THE INVENTION
This invention relates to a therapeutic device usable to provide alternative
medical
treatment, more particularly it relates to an acupuncture device which can
administer
acupuncture treatment in a non-invasive manner without the use of needles.
BACKGROUND OF THE INVENTION
Chronic diseases plague people most. They cause the highest death toll and
high
medical cost for their treatment. Chronic diseases can be attributed to a
variety of origins
that are often unidentifiable and thus resulting in the lack of development of
effective
medicine for their treatment. Most chronic diseases require long-term, often
lifetime,
medical therapy in which the medication may be toxic and can cause harmful
side effects.
For instance, VIOXX(a trade mark) developed by Merck & Co., Inc., for the
treatment of
arthritis, has caused 60 thousand lives worldwide, outnumbering the American
casualty
in the Viet Nam War. Annually, there are about one million people die of
adverse effects
of drugs being consumed. In China alone, about 190 thousands of people die of
adverse
effects of drug treatments annually which is ten times higher than the number
of death
from major infectious diseases.
In an effort to eschew increasing adverse events caused by taking medications,
some non-medication therapies have been widely employed with Complementary and
Alternative Medicines (CAM) for treating diseases even in developed countries.
However,
current CAM procedures have many drawbacks including difficult to implement,
high
cost, less evident of their effectiveness and causing too much pain to the
patient in the
treatment. Therefore, to carry out CAM, new techniques and devices are
required so as to
CA 02529239 2010-01-28
-2-
mitigate the above drawbacks. In recent decade, numerous devices of
rehabilitative CAM
have been developed, outnumbering those intended for diagnosis purposes.
Numerous
active machines have been invented for therapeutic purposes. They provide
therapeutic
treatments by executing operations and/or actions on the human body and the
operations
and/or action are felt and/or sensed physically by the human body during
treatment. Such
active machines provide, for example, radiological therapy, microwave therapy,
radiofrequency therapy, ultrasound therapy, laser therapy, millimeter wave
therapy, and
infrared therapy. Other active devices operate with sound, light, electricity,
magnetic
energy, or mechanical means, and they may even be supplemented with
medication.
Some of these active machines and devices can cause harmful risks to human
body such
as electric shock, unduly high power output, energy distraction, explosion,
fire hazard,
unreliable and abnormal operation, loss of power, mechanical accident,
malpractice by
the operator, bacterial contamination, and interference with other machines.
Heretofore,
passive medical machines and devices which can be used in a non-invasive
manner
without utilizing needle, electricity, electromechanical parts and
radioactivity for
effective treatment of chronic diseases have not been developed. Such passive
machines
and devices could execute therapeutic treatment in a passive manner without
provoking
physical senses of the human body during treatment.
SUMMARY OF THE INVENTION
The passive therapeutic device of the present invention is in the form of a
unique
solid chip or tablet which may be placed at selected meridian locations on the
human
body in a non-invasive manner for effective treatment of chronic diseases. The
main
ingredients of the device include a mixture of polar mineral tourmaline,
infrared radiating
CA 02529239 2010-01-28
-3-
material, pliable magnetic material, photo-catalytic material, composite salt
or oxide of
rare earth, and calcium oxide molded together with adhesive material and
inclusion
compound material. The mixture is first formed into a fine powder through
super tiny
nanometer handle processing prior to the adding of the adhesive material and
inclusion
compound material and then it is subjected to molding and thermal treatment to
form a
solid chip or tablet. The chip or tablet is applicable for rehabilitation
treatment for a wide
variety of chronic diseases in a non-invasive manner. It is safe to human body
and is not
harmful to the natural ecology and environment. It has been proven to provide
more
effective therapeutic treatments than other known alternative medical
treatments such as
acupuncture and moxibustion, massage and scrape therapy; cupping, medicine
paste
electrotherapy, magnetism, infrared, and physical therapy; meditation, Chinese
qigong,
Indian yoga; and Chinese herbal medicine; as well as western medicine.
A plurality of the chip or tablet of the present invention is applicable for
therapeutic treatment by placing a plurality of the chips or tablets at
various selected
acupuncture points for a period of less than 24 hours in each treatment. It is
non-invasive,
safe, not labor intensive and environmentally friendly since no used or waste
material
need to be discarded following the treatment whereas in traditional
acupuncture treatment
used needles must be discarded with extreme care. It can be used to treat
chronic but non-
contagious diseases without the use of needles, medication, electricity,
magnetism and
radiation.
The main ingredients for making the chip or tablet of the present invention
consist
of (by weight): polar mineral tourmaline 20-40%; infrared material 30-50%;
pliable
CA 02529239 2010-01-28
-4-
magnetic material 1-5%; calcium oxide 5-10%; photo-catalytic material 1-5%;
composites salt or oxide of rare-earth 1-5%; calcium oxide 5-10%; adhesive
material 2-5
%; and inclusion compound material 1-5%.
The polar mineral tourmaline is natural jade which possesses a large amount of
electrolytes and may contain mainly of more than ten kinds of silicate ores.
For making
the chip or tablet of the present invention, preferably one kind of tourmaline
or a mixture
of different tourmalines selected from the group consisting of iron
tourmaline,
magnesium tourmaline, iron and magnesium tourmaline, and lithium tourmaline
may be
used.
The infrared material used should permit infrared ray to pass through it with
distinct transmittance, refraction and chromatic dispersion in terms of the
distinct
wavelength of the infrared ray. Preferably, one or a mixture of both of oxide
sapphire
(AL203) and magnesium oxide (MgO) meeting such characteristic properties may
be
used.
The pliable magnetic material may preferably be chosen from the group
consisting of one or both iron oxide (FeO) and iron trioxide (Fe2O3) which may
be
magnetized repeatedly and demagnetized easily under a magnetic field.
The photo-catalytic material (or manometer powder) used may preferably be one
or more types of such material chosen from the group consisting of titanic
oxide (TiO2),
zinc oxide (ZnO), tin oxide (SnO), and tungsten oxide (WO).
CA 02529239 2010-01-28
-5-
The composite salt or oxide of rare-earth is preferably one or a mixture of
such
material chosen from the group consisting of LaPO4, NdPO4, NdPO4, Ce(N03)3,
and
La(N03) which are composite oxide of CeO2, Ce203, La203 and Nd203.
The adhesive material may be one or more of the material preferably chosen
from
the group consisting of stearic acid, polyvinyl chloride, pine resin, flax oil
and castor oil.
The inclusion material may be one or more of the material preferably chosen
from
the group consisting of methyl cellulose, liquid paraffin, colophon, and
polyvinyl
chloride.
In the chip or tablet fabrication process, the polar mineral tourmaline is
transformed into a fine powder in a nanometer processing by either grinding it
with a
high energy ball mill or pulverizing it through an airflow millstone between
48 to 72
hours. In either one of these processes, the tourmaline will transform into
very small
particles with crystalline grain diameter of between 50-1000 nanometers. The
fine
tourmaline particles will then be subjected to a thermal treatment with a
temperature in
the range between 500-1000 C for about 2 to 3 hours. The same processes also
applied to
the infrared material. However, the photo-catalytic material may be subjected
to either
the same processes or only the nanometer process.
The ingredients are placed into a grinding and blending machine for grinding
and
blending them thoroughly for not less than 1 hour. The ground and blended
mixture is
then poured onto a mold plate having a plurality of mold form depressions all
having a
predefined shape and size of the desired chip or tablet. A pressure of 20-50
Mpa is
applied to press the mixture fully into the mold form depressions to form a
plurality of
the chip or tablet. After pressing, the chips or tablets are removed from the
mold plate
CA 02529239 2010-01-28
-6-
and sintered with a thermal treatment at a temperature of between 500-1000 C
for a
period of 2-3 hours. The thermally treated chips or tablets are then cooled at
room
temperature for 48-72 hours to form the final hard solid chips or tablets.
The chips or tablets may be formed in different sizes, shapes and thicknesses.
For
convenient handling during use, the chips or tablets preferably have a
diameter > 25mm
and a thickness ? 3mm.
A plurality of the chips or tablets are placed on acupuncture meridian points
on
the patient's body according to the traditional Chinese medicine and
acupuncture theory.
The meridian points are skin points of the body at which pathological changes
may be
provoked in relevant internal organs. Mountain jade awl may be used for
searching these
sensitive skin points. The mountain jade awl may be obtained from the Liaoning
province
of China and cut and polished into an awl shape. The awl has a base with a
diameter of
0.6 to 0.8 cm, a length of 7 cm, and a dull tip.
A superficial fluid can be applied either to the chips or tablets or to the
selected
skin points prior to placing the chips or tablets at these skin points. The
superficial fluid
may be produced by submerging 1-3 chips or tablets into 100 ml of clean water
for one
hour, and then bottling the treated water for convenient application when it
is needed.
An efficiency enhancing membrane may be placed between the chips or tablets
and the skin points for securing the chips or tablets on the patient's body.
The enhancing
membrane is applied in place for 40-60 minutes. It also enhances the
therapeutic effect of
the chips or tablets. The enhancing membrane may be produced by mixing LLD-PEC
low
density string shaped polythene with corn oil to make a 0.18 mm thick
stretchable
membrane having heat and cold resistance at high temperature not exceeding 115
C and
CA 02529239 2010-01-28
-7-
low temperature not lower than -60 C. It may be rolled and cut into a sheet
form having 5
cm in width. Common bandage or cotton band may be used for keeping the chips
or
tablets in place. However, the bandage or cotton band would not provide the
enhancement of the effectiveness for the therapeutic treatment. A session of
40 to 60
minutes of therapeutic treatment can be carried out in the above manner with
the chips or
tablets of the present invention. The chips or tablets may alternatively be
implanted into
the patient at the selected meridian points or directly in internal organs for
treatment of
some chronic diseases.
After the superficial fluid has been applied between the chip and the skin
point,
the enhancing membrane can be used to secure the chip in place. After 10
minutes of
application, there may be chili, sting, pain and hot sensations and redness on
the point of
application. These sensations will automatically reduce after 40 minutes. The
entire
treatment is to be carried out for a session of one hour. After finishing one
session, the
chips are removed from the body, and the sensations and redness will disappear
in 30
minutes without any damage to the skin. One course of treatment consists of 10
sessions
carried out once daily. The symptom of the diseases will be mitigated and it
is
recommended that a treatment for 1 to 3 courses be administered.
The unique chip or tablet of the present invention may be used for the
rehabilitation treatments of the following chronic diseases:
1. Chronic aches: Headache, Trigeminal pain, Coronary disc disease, Should
pain, Waist
strain, Lumbar pain, Coexistence of Cervical and Lumbar pain, Disc Disease,
Rheumatoid arthritis, Gouty arthritis, Intercostal Neuralgia, Hucklebone nerve
pain,
Osteoporosis, Lumbar bone hyperplasia, Toothache, Vasculitis, Cancer.
CA 02529239 2010-01-28
-8-
2. Neurological and psychiatric diseases: Facial neuritis, Facial muscular
convulsion,
bell's palsy, Parkinson disease, Stroke (hemiplegia), Cerebrovascular
Atherosclerosis,
epilepsy, Dementia, Hysteria, Depression disease, Vertigo (Meniere's disease),
Insomnia.
3. Respiratory diseases: Chronic bronchitis, Bronchus asthma, Bronchus
Expansion
(emptysis), Cold, Emphysema.
4. Digestive diseases: Chronic gastritis, Peptic ulcer, Midriff convulsion,
Enteritis,
Irritable Bowel Syndrome (IBS), Constipation, Chronic hepatitis, Fatty liver,
Chronic
cholecystitis, Gallstone.
5. Circulation system diseases: Hypertension, Hyperlipidemia, Coronary Heart
Disease,
Cardiac Arrhythmias, Cardiovascular Neurosis.
6. Urinary diseases: Chronic prostatitis, Prostate hyperplasia, Chronic
Nephritis.
7. Diseases of orthopedics: Fracture, Dislocation of joint.
8. Disease of gynecology: Dysmenorrhea, Irregular menses, Inflammation of
pelvic
cavity, menopause, Infertility, Galactophore hyperplasia.
9. Diseases of andropathy: Impotence, Nocturnal emission, Prospermia,
Infertility.
10. Diseases of facial features: Allergic rhinitis, Nasal sinusitis, Chronic
Pharyngitis and
tonsillitis, Tinnitus and deafness.
11. Diseases of ophthalmology: Cataract, Myopia, Hyperopia, Poor vision,
Glaucoma,
Dry eye, Trachoma, Eyes fatigue.
12. Endocrine and metabolic diseases: Hypothyroid disease, Diabetes.
13. Diseases of oncology: Anti-immunity tumor, Toxic and adverse effect of
radiation
treatment and chemotherapy.
CA 02529239 2010-01-28
-9-
14. Diseases of dermatology: General acne, Yellow speckle, Hives, Nervous
dermatitis,
Psoriasis disease, Strip anthema, Eczema.
15. Other diseases: idiopathic obesity, Obese breast, Chronic fatigue syndrome
(suboptimal health), Air-conditioning related disease, Quit smoking, EX-Drug.
The chip or tablet of this invention offers a new technology for
rehabilitation of
chronic diseases called surface therapy technology, which can play a versatile
role
replacing acupuncture and moxibustion, massage, manipulation, scraping, fire
cup, herbal
plaster, electricity therapy, magnetic therapy, infrared therapy, far infrared
therapy,
herbal remedies, Chinese Qigong, India Yoga. It can also relieve people from
having to
subject to exhausting long-term chemotherapy.
Clinical trials were carried out with the chip or tablet of the present
invention with
590 patients suffering from 21 kinds of various chronic diseases in 6 health
clubs of
China Health Way Campaign. Among the 590 patients, 276 were men and 314 were
women. The youngest was 8 years old and the oldest was 85. The longest
therapeutic
course lasted 35 days and the shortest course was in one day. Diseases that
were treated
with the chip involved the following 21 kinds of maladies: headache, chronic
rhinitis,
coronary diseases, hypertension, arteriosclerotic brain disease, premature
beat, slipped
disk, cervical hyperosteogeny, gonitis, scapulohumeral periarthritis, gout,
acute lumbar
sprain, cyclomastopathy, insomnia, infection in upper respiratory tract,
chronic bronchitis,
facial palsy, eczema, acute urinary tract infection, acute gastro-enteritis
and toothache.
Outcomes of the clinical trials were as follows with the chips or tablets
applied at the
acupuncture points indicated: 91 patients suffering from the following
sicknesses were
cured: Headache: 12 patients (Acupuncture Points: Yintang, Fengchi, Yongquan,
Hegu,
CA 02529239 2010-01-28
-10-
Neiguan, TaiYang, Ashixue) ; Infection in upper respiratory tract: 15 patients
(Acupuncture Points: Dazhui, Waiguan, Lieque, Quchi) ; Chronic bronchitis 4
patients
(Acupuncture Points: Yingxiang, Yintang, Hegu, Lieque, Zusanli, Feishu) ;
Gout: 2
patients (Acupuncture Points: SanYinjiao, Taixi, Zusanli, Ganshu, Shenshu,
Ashixue) ;
Toothache: 10 patients (Acupuncture Points: Xiaguan, Jiache, Fengchi, TaiYang,
Ashixue) ; Gonitis: 5 patients (Acupuncture Points: Heding, Dubi, Qiyan,
Yinlingquan,
Zusanli, Weizhong, Ashixue) ; Insomnia: 5 patients (Acupuncture Points:
Dazhui,
Anmian, Fengchi, Neiguan) ; Eczema: I patient (Acupuncture Points: Quchi,
Neiguan,
Xuehai, Fengshi, Zusanli, SanYinjiao) ; Acute gastro-enteritis: 6 patients
(Acupuncture
Points: Shangwan, Zhongwan, Zusanli, 4 Acupuncture Points around navel,
Ashixue) ;
Acute lumbar sprain: 1 patient (Acupuncture Points: Shenshu, Weizhong,
SanYinjiao,
Ashixue) ; Chronic bronchitis: 3 patients (Acupuncture Points: Dazhui, Tiantu,
RenYing, Feishu, Neiguan, Dingchuan, Shanzhong, Zusanli, Chize) ;
Scapulohumeral
periarthritis: 5 patients (Acupuncture Points: Rushu, Jianjing, Jianliao,
Jianyu) ;
Cyclomastopathy: 1 patient (Acupuncture Points: Shanzhong, Rugen, Wuyi,
Ganshu,
Pishu, SanYinjiao) ; Facial palsy: 1 patient (Acupuncture Points: Dazhui,
TaiYang,
Sibai, Shangguan, Xiaguan, Dicang, Jiache, Juliao) ; Ischialgia: 20 patients
(Acupuncture Points: Shenshu, Baihuanshu, Zhibian, Huantiao, Chengfu, Yinmen,
Weizhong, SanYinjiao)
CA 02529239 2010-01-28
-11-
Up to 455 patients showed some certain effect improvement, and 20 patients did
not
remit from their diseases. (Mostly due to the diseases were too severe or the
patients were
unable to persist in the therapy for some unknown reasons).
Another trial that was conducted in the previous two months on 590 patients,
who
were members of six clubs of the Way to Health Campaign. The result showed
that the
cure rate was 16%, effectiveness rate was 77% and total effectiveness rate was
93%.
This rehabilitation chip or tablet has also been used in many hospitals in
China for
trial treatments of chronic diseases. These clinical trials Ito XIII are
described below: (In
all these clinical trials the contact area on the patient's skin was first
moistened with the
superficial fluid prior to the placing of the chips or tablets on the
acupuncture points. The
chips or tablets were secured in place with poromeric adhesive tape. The
treatment was
conducted for one hour in each session for the therapy. Each treatment was
administered
once daily, and ten sessions constituted one therapeutic course. A two-day
pause was
required before the next therapy.)
I. This clinical trial was conducted at Guangdong Shanwei Hospital for
Traditional
Chinese Medicine for treatment of dizziness.
54 patients were treated in this clinical trial in which 24 were outpatients
and 30 were
inpatients and 21 patients were men and 33 patients were women. The youngest
patient
was 17 years old and the oldest was 87. The average age was 50. The shortest
disease
course was 0.5 day and the longest was 21 years. The average time was 2.2
years. 25
patients were suffering brain arteriosclerosis, 10 were suffering
hypertension, 8 were
suffering cervical spondylopathy, 14 were suffering Meniere's syndrome ' 2
were
suffering climacteric syndrome, 3 were suffering hyper viscosity syndrome, 2
were
CA 02529239 2010-01-28
-12-
suffering neurasthenia, 1 was victim of brain trauma residue, 2 were suffering
from
chronic alcoholism. All of the 54 patients had principal symptom of dizziness.
All 54 patients underwent treatment with the rehabilitation chips applied at
primary
acupuncture points of Baihui, TaiYang, Neiguan, Zusanli; and secondary
acupuncture
points were added at Taixi and Shenshu in case of the deficiency in kidney
Yin; and
Geshu and Pishu points were added in case of deficiency in Qi and blood;
Fenglong and
Pishu points were added in case of stagnation of phlegm-dampness; and Taichong
and
Fengchi points were added in case of Excess of Liver Yang.
In the treatment, the chips were applied onto the primary acupuncture points
and with
the added secondary acupuncture points for the different symptoms as indicated
above.
The result of the trials was as follows: Of the 54 patients, 43 were
clinically cured;
namely, the patient's symptom completely disappeared, and the patients were
able to
return to normal life; 38 patients remitted their symptoms (The patient's
symptom was
obviously alleviate); 2 patients showed no effect (symptoms remained the
same). Total
effective rate was 96.2% and the average duration for being cured was 18 days.
In addition to the above, 50 patients suffering a stroke were also treated in
the
same manner with convincing therapeutic effect.
Among the 50 patients in this additional clinical trial, 38 patients were men
and
12 patients were women. The youngest patient was 33 years old and the oldest
was 76. 46
patients had a disease course shorter than 3 months and 4 longer than 3
months. 30 were
suffering sanguineous apoplexy; and 20 patients were suffering from cerebral
embolism.
The treatment were carried out with the chips or tablets located at the
following
acupuncture points: Primary Acupuncture Points: Shuigou, Neiguan, Laogong,
Quchi,
CA 02529239 2010-01-28
-13-
Weizhong; and also at Secondary Acupuncture Points: Jianyu, Hegu, Waiguan,
Huantiao,
Yanglingquan, Zusanli, Jiexi, Kunlun, Taichong in case of hemiparalysis; or
also at
Secondary Acupuncture Points Dicang or Jiache, Hegu, Neiting, ChengQi,
Yangbai,
Cuanzhu, Kunlun, Yanglao in case of facial hemiparalysis; or also at Secondary
Acupuncture Points Lianquan, Tongli, Yamen, Fengfu, Tiantu, and SanYinjiao in
case of
slurring of speech.
The following terms are used to denote the effectiveness of the treatment in
this
clinical trial:
Cure: means the patient can speak articulately; walk without need of support,
able
to raise hand up to grab an article, lead a normal life without nursing care,
and have
general well feelings.
Obvious effectiveness: means the patient is able to speak relatively
articulately,
walk with need of support, able to grab an article but feel frail in fist,
lead a life with little
nursing care, and limbs occasionally feel discomfort.
Some certain effectiveness: means the patient is unable to speak articulately
but
can communicate, have some improvement in myodynamia of extremities but has
poor
rehabilitation in functions, and requires nursing care to lead a life.
No effect: means symptoms remain after the therapy.
The outcome of the trial was as follows:
17 (34%) patients were cured; 16 (32%) showed obvious effectiveness; 12 (24%)
patients showed some certain effectiveness, 5 (10%) patients showed no effect.
The total effectiveness rate was 90%.
CA 02529239 2010-01-28
-14-
At least one therapeutic course was conducted and the longest was 9
therapeutic
courses. The average was 3.8 therapeutic courses.
The relationship between the disease and the effectiveness of the chip is
tabulated
in table 1 below:
Patients Cure (%) Obvious Some certain No
number effectiveness(%) effectiveness(%) effect(%)
Sanguineous 30 10 (35) 12(40) 6(18.33) 2(6.67)
apoplexy
Cerebral 20 6 (31.5) 4 (20) 7 (33.5) 3 (15)
embolism
The relationship between the disease course and the effectiveness of the chip
is
tabulated in the table below:
Disease Patients Cure Obvious Some certain No effect
course number effectiveness effectiveness
1-3 months 46 15 15 12 4
Longer than 4 1 2 1
3 months
Another clinical trial was conducted with the chip or tablet of the present
invention in the People's Hospital of Shimen County in China for treatment of
constipation-type irritable bowel symptom. The therapeutic effect was
satisfactory. The
detail of the trial is described below:
CA 02529239 2010-01-28
-15-
II. This clinical trial was conducted in the People's Hospital of Shimen
County in
China with the chip or tablet of the present invention for treatment of the
constipation-
type of irritable bowl syndrome.The detail of the trial is described below.
During October 2004-June 2005, 50 patients with irritable bowel syndrome who
attended the digestive sector of the hospital were treated in the trial. All
patients
underwent lab test, barium meal examination and colonoscopy in order to
exclude
presence of organic changes in either intestinal or entire body that can lead
to
constipation. All patients met the criteria set by the 1998 Rome Convention.
18 were men,
32 were women. The oldest was 63 years old, the youngest was 15, and the
average age
was 37. The longest disease course was 20 years and the shortest was half a
year, the
average disease course was 5 years.
The patients were treated by locating the chips or tablets at different
acupuncture
points for the various following symptoms:
There were two types of symptoms, namely stagnation of the liver-Qi and
deficiency in both the heart and the spleen.
Stagnation of the liver-Qi means feces were dry or somewhat dry, difficult
evacuation, infrequent evacuation for less than 3 times each week or even
worse for only
once each week. Abdominal flatulence and pain involved flanks, bitter taste,
dizziness,
and symptoms fluctuated with mood. The tongue texture was pale and the coating
was
thin white. The pulse was fine but weak. Among the 50 patients, 21 had
stagnation of the
liver-Qi, accounting for 42% and 29 had deficiency in both the heart and the
spleen,
accounting for 58%.
CA 02529239 2010-01-28
-16-
All patients underwent psychological counseling to help them to relieve from
anxiety and depression, and dietary adjustment was made to increase their
plant fiber
intake. They were also informed of rational habits of feces evacuation by
having bowel
movement at a certain time, and refraining from smoking or reading during
bowel
movement. All other medications either chemical or herbal were stopped during
the
treatment.
The chips or tablets were applied at the following acupuncture points
according to
the various indicated purposes: Chips were located at primary acupuncture
points
bilateral Dachangshu, Zusanli and Zhongwan. For stagnation of the liver-Qi,
additional
chips were located at secondary acupuncture points bilateral Yanglingquan and
Xiangjian
with a dispelling maneuver (Xiefa). For deficiency in both the heart and the
spleen, chips
were additionally located at bilateral SanYinjiao and Guanyuan.
The therapy was carried out once daily for ten days to constitute one
therapeutic
course. One episode of observation lasted two months.
The following terms were used to denote the effectiveness of the treatment:
Obvious effectiveness: means symptoms disappeared and normal bowl
movement was restored without relapse within two months.
Some certain effectiveness: means symptoms were strikingly alleviated and
relatively normal bowel movement was restored without relapse within two
months.
No effect: means no change in symptom after the therapy and medication therapy
was resumed.
Among the 50 patients with stagnation of the liver-Qi in this clinical trial,
15
patients showed obvious effectiveness, 4 patients showed some certain
effectiveness,.2
CA 02529239 2010-01-28
-17-
patients showed no effect. Among 16 patients with deficiency in both the heart
and the
spleen, 16 showed obvious effectiveness, 9 showed some certain effectiveness,
and 4
showed no effect. Regardless of symptom differentiation, the overall rate of
obvious
effectiveness was 61% (31 patients), the rate of no effect was 12% (6
patients), and the
general effectiveness rate was 88%.
III. This clinical trial was conducted in the No.2 Hospital for Traditional
Chinese
Medicine of changed City in China for treatment of hypertension. 66 patients
were
involved in this clinical trial. Among the 66 patients, 41 were men, 35 were
women. One
patient was younger than 45, 22 were between 45 and 55 years old, and 42 were
older
than 55. The shortest disease course was half year and the longest was 9
years. Criteria
for classifying stage of Ying hypertension were set by the 1978 national
conference on
cardiovascular diseases and WHO. According to such classification, 12 patients
were in
stage I, 47 patients were in stage II and 7 patients were in stage III.
In the treatment, the chips were located at the following acupuncture points:
Dazhui, Neiguan, Jiangyaxue, Taichong, Hegu, Fengchi (all were bilateral),
Ganshu and
Baihui.
Each session of therapy was conducted with 4-5 acupuncture points and
alternates
the acupuncture points. During the therapy, the patient was refrained from
smoking,
alcohol consumption, and fretfulness, while maintaining usual urination and
bowel
movement. All other therapies were terminated.
The results of this clinical trial for half a year for the 66 patients were:
47 were
cured with headache and dizziness disappeared, blood pressure returned to
normal level,
CA 02529239 2010-01-28
-18-
and the symptom did not relapse within half a year on follow-up; 18 patients
showed
obvious effectiveness with headache and dizziness disappeared, blood pressure
returned
to normal level, but the symptom relapsed within half a year on follow-up; 6
patients
showed some certain effectiveness with headache and dizziness remitted, but
blood
pressure fluctuated between normal and abnormal levels; 5 patients showed no
effect:
with blood pressure not returning to the normal level or failed to restore to
the normal
range even occasionally. The general effectiveness rate was 92%, and the cure
rate was
71%.
IV. This clinical trial was conducted at the No.l Hospital for Traditional
Chinese
Medicine of Changde City in China for the treatment of coronary disease.
50 patients participated in this trial. Among the 50 patients, 37 were men, 13
were
women. The oldest was 76 years old; the youngest was 23. 8 patients were
between 40-49
years old, 20 were between 50-59, 16 were between 60-69, 3 were between 70-79.
According to criteria set by western medicine, 17 patients were suffering from
angina
pectoris, including 16 with stable angina pectoris, one with unstable angina
pectoris; 15
were suffering from arrhythmia, including 10 patients with ventricular
premature beat, 2
with arterial premature beat, one with sick sinus syndrome, one with arterial
fibrillation,
one with complete right bundle block; 9 were suffering from myocardial
infarct, and 11
were with remote myocardial infarction. According to criteria set by
traditional Chinese
medicine, 13 belonged to blood stasis, 11 belonged to obstruction by phlegm, 8
belonged
to stagnation of Qi, 7 belonged to deficiency in heart-Qi, 11 belonged to
deficiency in
both Qi and Yin, and 5 belonged to deficiency in heart-Yang.
CA 02529239 2010-01-28
-19-
In the treatment, the chips were applied at the following acupuncture points:
acupuncture points were principally from heart and pericardium channel,
matched with
acupuncture points that crisscross of eight channels as well as the Xi-points
that belong to
the heart and the pericardium. The first group of acupuncture points were:
Juque, Xinshu,
Geshu, Neiguan, Gongsun and Yinxi; the second group of acupuncture points
were:
Shanzhong, JueYinshu, SanYinjiao and Ximen. Additional chips were also located
at the
following two secondary locations: at Taiyuan in case of obstruction by
phlegm; and at
Shanzhong or Geshu in case of asthenia cold.
3 therapeutic courses constituted an observation session in this trial.
The 1979 China national Criteria for Evaluating Effectiveness over Treating
Angina Pectoris and Illustrated by ECG were used to determine the
effectiveness of the
treatment of angina pectoris.
The following criteria were used for determining effectiveness over the main
symptoms (choked pain, palpitation and shortness of breath):
Obvious effectiveness: means symptoms disappeared either completely or almost
completely;
Alleviated: means symptoms became obviously alleviated;
No effect: means symptoms remained unchanged after therapy; and
Deteriorated: means symptoms became deteriorated after therapy.
The 1974 Shanghai Panel for Cooperation on study of red sage root compound
was used to determine the effectiveness over index of blood fat.
The result of the treatment for effectiveness over the main symptoms is shown
in
the following table.
CA 02529239 2010-01-28
-20-
Main Number obvious Alleviated No Deteriorated Effectiveness
symptoms of effectiveness effect rate(%)
patient
Chest pain 30 20 6 2 2 86.66
Choked chest 32 12 16 4 0 87.50
Palpitation 23 10 8 5 0 78
Short breath 13 5 7 1 0 92
The result of the treatment for effectiveness over syndrome differentiation of
TCM is shown in the following table.
Main symptoms Number of Obvious Alleviated No effect
patient effectiveness
blood stasis 13 8 4 1
Obstruction by 11 5 5 1
phlegm
Stagnation of Qi 8 2 4 2
Deficiency in 7 3 3 1
heart-Qi
Deficiency in both 6 3 2 1
Qi and Yin
Deficiency in 5 2 2 1
heart Yang.
For the effectiveness over index of blood fat: there were 30 patients who had
high
cholesterol and 23 of them showed effectiveness; and 20 patients had over high
TG and
showed effectiveness.
For the effectiveness over changes on ECG: all disorders on ECG were
alleviated,
including ST-T alterations, V-wave alteration, atria fibrillation, sick sinus
syndrome,
CA 02529239 2010-01-28
-21-
frequent ventricular premature beat, frequent atria premature, and complete
right bundle
block.
For the effectiveness over cardiac function: all disorders in cardiac function
were
alleviated, with LVET elongated, PEP and TICT shortened, and PEP/LVET dropped.
V. The following clinical trial was conducted in Meili and Liu Guang in China
for
treatment of senile dementia.
The clinical trial was conducted with 76 patients among which 46 were men and
30 were women. Their ages were between 59 to 78 and the average age was 73.
Their
disease courses lasted 9 months to 8 years, with an average of two years and
eight months.
The chips were applied at the following acupuncture points: Baihui,
Sishencong,
Dazhui, and Guanyuan.
The usual duration of therapy was 2-3 months. Patients were allowed to use
other
medications during the therapy, including hypertension relieving pills, fat-
reducing
medications, sugar-reducing medications and medications that inhibited
agglomeration of
blood platelet.
In the determination of the effectiveness of the treatment, the following
terms
were used:
Cure: symptoms disappeared so that the patient could lead a normal life
without
nursing care, and would return to normal social activities;
Obvious effectiveness: symptoms alleviated, but still suffering from
retardation in
reaction, intelligence, and was unable to lead a normal life without nursing
care;
CA 02529239 2010-01-28
-22-
No effect: patient's condition remained unchanged in symptoms and signs after
the therapy.
The result of the treatment was as follows: 7 patients were cured, 33 showed
obvious effectiveness; 26 patients showed some certain effectiveness; 10
patients showed
no effect. Of those 19 patients who had disease course shorter than one year,
6 were
cured, 9 showed obvious effectiveness. All patients who showed no effect, and
had a
disease course longer than 3 years. The effectiveness rate was 86%.
VI. The following clinical trial was conducted for treatment of chronic
enteritis.
64 patients participated in the trial, and among the 64 patients, 38 were men,
26
were women. 8 patients were between 30-40 years old, 18 were between 41-50, 26
were
between 51-60, and 12 were older than 61. The shortest disease course was one
year and
the longest was 12 years.
The condition of the patient's chronic enteritis were : (1) History of acute
enteritis
or recurrence of enteritis; (2) Upon onset of enteritis, patients suffered
from diarrhea and
abdominal pain, accompanied by chronic malnutrition and abdominal tenderness.
Routine
stool test showed white blood cells and few pyocytes. (3) Being excluded from
other non-
specific enteritis using X-ray barium meal examination and colonoscopy.
In the treatment, the chips were placed at the following acupuncture points:
four
acupuncture points around the navel, Zhongwan, Tianshu, Guanyuan, Zusanli,
Shangjuxu,
Shenshu, Pishu, Dachangshu, Quchi, and SanYinjiao. These acupuncture points
fell into
two groups in which the first group included: four acupuncture points around
the navel,
Zhongwan, Tianshu, Guanyuan, Zusanli, Shangjuxu, Hegu and SanYinjiao, and the
CA 02529239 2010-01-28
-23-
second group included: Pishu, Shenshu, Dachangshu, Zusanli, Shangjuxu, and
Hegu.
These two groups were alternately used during treatment.
The contact area of the skin was first moistened with the superficial fluid.
The
chips were located at the acupuncture points with poromeric adhesive tape. The
chips
were retained at the acupuncture points for one hour in each session of
therapy. 4-5
acupuncture points were used in each session. Ten sessions constituted one
therapeutic
course.
The following terms were used to determine the effectiveness of the treatment:
Cure: stool restored to the normal shape and being evacuated once daily.
Alleviated: stool had restored to the normal shape and being evacuated twice
daily;
No effect: stool condition remained unchanged.
The result of the trial was that among the 64 patients, 31 patients were
cured,
accounting for 48.4%; 28 patients were alleviated, accounting for 43.7%; 5
patients
showed no effect, accounting for 7.9%; The general effectiveness rate was 92.1
%.
VII. The following clinical trial was conducted at the People's Hospital of
Tianjin
City in China for treatment with the chips of the present invention of 68
patients having
chronic prostatitis. All 68 patients were treated in the hospital during June
2004 to June
2005 in this trial. Most of the patients had undergone treatment in using
either chemical
or herbal medications prior to the trial. The youngest patient was 17 years
old and the
oldest was 76; 3 patients were younger than 20; 5 patients were between 21-30
years old;
8 were between 31-40; 17 were between 41-50; and 35 patients were older than
50. The
shortest disease course was half a year and the longest was 20 years. 57
patients were
CA 02529239 2010-01-28
-24-
married, I 1 were single. Main complaints included sore and swelling pain in
back and
bottom, bearing down pain in lower abdomen and perineum, frequent urination,
difficulty
in urination, and dripping urination. 6 patients were complicated with severe
nervosism
and sexual disorder. Examination of the prostatic fluid under microscopy
found: 28
patients showed white blood cells (+) , 21 patients showed white blood cells (
+
+) ' 15 patients showed white blood cells (+ + +) , 4 patients showed white
blood
cells (+ + + +) . 32 patients had prostatomegaly, and 2 patients had calculus
of the
prostate.
In the treatment, the chips were placed at the following primary acupuncture
points: Xiaochangshu, Pangguangshu, Pishu, Ciliao, Guanyuan, and Zhongji and
secondary acupuncture points: Yinlingquan, SanYinjiao, and Taixi. For excess
of viscera,
additional acupuncture points Qugu, and Waigua were used; for deficiency of
viscera,
additional acupuncture points Shenshu, and Zusanli were used.
Each session of therapy used 4-5 acupuncture points and alternates acupuncture
points. The treatment was conducted once daily and ten sessions constituted
one
therapeutic course. A 3-5 days interval was allowed before the next therapy
was
administered. In case both acupuncture points and Mu (collecting) points were
used, the
chips were placed on the patient in the prone position first and then in the
supine position
afterward. More frequently only one position was used for each session.
The following criteria were used for determining the effectiveness of the
treatment:
CA 02529239 2010-01-28
-25-
Cure: self-felt symptoms disappeared, restored to normal examination of the
prostatic fluid under microscopy;
Obvious effectiveness: symptoms disappeared with less than 3 WBCIHP found;
Alleviated: symptoms becomed alleviated obviously, with 4-6 WBC/HP found,
No effect: symptoms and findings under microscopy remained unchanged.
After subjecting to 2-3 therapeutic courses, 18 patients were cured,
accounting
for 26.5%; 21 patients showed obvious effectiveness, accounting for 30.9%; 22
patients
alleviate their symptoms, accounting for 32.3%; 7patients showed no effect,
accounting
for 10.3%. General effectiveness rate was 89.7%. For the effectiveness with
varying with
age, as shown in the table below.
Age Number Cure Obvious Alleviated No effect Effectiveness
(Years) of patient effectiveness rate (%)
17-20 3 1 2 - - -
21-30 5 3 1 1 - -
31-40 8 4 2 2 - -
41-50 17 6 7 3 1 94.1
50-76 35 4 9 16 6 82.9
VIII. The following clinical trial was conducted at No. 1 affiliated Hospital
of Gui
Yang College for Traditional Chinese Medicine in China for treatment of
chronic
nephritis and nephrosis with the chip of the present invention.
52 patients in a first group were treated with the rehabilitation chip of the
present
invention and a second group of 47 patients were treated with medication. CGN
fell into
ordinary type, manifesting slow onset, protracted disease course, having
little or much
CA 02529239 2010-01-28
-26-
proteinuria, hematuria, cylindruria, edema, hypertension, and renal failure;
hypertension
type, besides the preceding findings, this type had also strikingly very high
blood
pressure; type of flare in course of chronic plaguing: manifesting features of
acute
nephritis in course of chronic plaguing. NS was always accompanied by large
amount of
proteinuria (>_3.5g/24h), hypoproteinemia (serum albumin<30g/L), hyperlipemia
and
explicit edema. All patients were classified into certain types according to
the 1985
national conference on diseases of glomerulus (Nanjing). Some underwent renal
biopsy
for pathological classification. The group treated with the rehabilitation
chips included:
20 patients with ordinary type of CGN, 12 patients with type of flare in
course of chronic
plaguing, 5 patients having striking hypertension. The group treated with
medication
included: 18 patients with ordinary type of CGN; 12 patients with type of
flare in course
of chronic plaguing, 4 patients with striking hypertension, and 13 patients
with NS.
For the group treated with the rehabilitation chips, the chips were placed at
the following
acupuncture points: Shenshu, Pangguangshu, Sanjiaoshu, Guanyuan, Qihai,
SanYinjiao,
Shuitong, Shenjue, HuiYin, and Qugu. The treatment was administered for one
hour in
each session of therapy. Each session of therapy used 4-5 acupuncture points.
The
acupuncture points were alternately varied during treatment. The treatment was
conducted once daily and ten sessions constituted one therapeutic course. The
patients in
this group were also administered with routine treatment, of taking inosine
0.2g, three
times daily, Liuweidihuang concoction (add or remove some constituents
according to
need); dihydrochlorothiazide was used to treat edema and to remove retention
of water;
and nifepine and captopril were used to relieve hypertension. The secondl
group only
received the routine treatment.
CA 02529239 2010-01-28
-27-
The tests for observing the effectiveness of the treatment included: routine
urine
test, quantitative measurement of protein in 24h urine, 0213-MG, urine 32 -MG,
blood
routine test, blood creatinine, blood urea nitrogen, complement, Ig and
renogram.
The effectiveness of the treatment was determined based on the observation of
the
following findings after the therapy: observational measurement of urinary
protein was
negative, quantitative measurement of protein in 24h urine was <150mg, normal
renal
function, and normal immunity test. Lowering of blood pressure, decreasing of
urine
protein and improvement of renal function were not discussed in determining
the
effectiveness.
After subjecting to 1-3 therapeutic courses using the rehabilitation chip,
protein
disappeared in urine of 39(75%) patients. 17 out of 20 patients with ordinary
type CGN
showed effectiveness, 9 out of 12 patients with type of flare in course of
chronic plaguing
showed effectiveness, one out of 5 patients with striking hypertension showed
effectiveness, 12 out of 15 patients with NS showed effectiveness. While in
the other
group treated with medication, protein disappeared in urine of 16 (34%)
patients. 4 out of
18 patients with ordinary type CGN showed effectiveness, 4 out of 12 patients
with type
of flare in course of chronic plaguing showed effectiveness, none of 4
patients with
striking hypertension showed effectiveness, 8 out of 13 patients with NS
showed
effectiveness. Biopsy of patients treated with the chip showed mostly minute
lesions,
mild proliferation of mesenteric tissue, and membranate nephrosis. All
patients showed
effectiveness had normal value of Cr, Bun, C3 and renogram showed favorable
profile.
Effectiveness rate between the two groups differed significantly with u>2.58,
P<0.05 which indicated that the group treated with the chip plus medication,
the result
CA 02529239 2010-01-28
-28-
was superior to the group of patients treated with only medication. Due to the
scarcity of
patients having biopsy, it was unable to obtain the relationship between
pathological type
and effectiveness. However, aftermath of protein in urine was related to
pathological
classification.
IX. This clinical trial was conducted at the Linli Hospital for Traditional
Chinese
Medicine in China for treatment of 56 patients having trigeminal neuralgia.
56 patients with trigeminal neuralgia were treated, in which 20 were men, 36
were
women. The oldest was 78 years old; the youngest was 35.5 patients suffered
pain in first
branch, 15 in second branches and 16 in third branches. 20 were compounded.
The
shortest disease course was one month and the longest was 10 years. 48
patients were
primary and 8 were secondary. 3 suffered cholesteatoma, 5 suffered eye-branch
residual
pain due to infection of herpes zoster virus.
For the patients in the first branch the chips were located at primary
acupuncture
points Yuyao and Xiaguan, matched with Yangbai, Shangxing, Hegu, and Neiting.
For
the second and third branches the chips were located at Sibai, Xiaguan,
Dicang,
Jiachengjiang, Hegu, and Neiting. For lesion on head and face, acupuncture
points
located on the side feeling the pain were used, and Hegu and Neiting were used
alternately. The treatment was stopped for 3-5 days between two therapeutic
courses.
The following criteria were used to denote the result of the treatment:
Cured: pain in the face completely disappeared.
Obvious effectiveness: pain in the face became dramatically infrequent.
Alleviated: pain in the face became alleviated and infrequent.
CA 02529239 2010-01-28
-29-
No effect: pain in the face remained unchanged in severity and frequency after
the
therapy.
In the treatment, 38 patients originally orally taking carbamazepine and
stopped
taking it for poor effect. They were stopped from taking carbamazepine during
the
therapeutic course with the chip. 18 patients who had not been taking
carbamazepine
were administered carbamazepine 0.1 g bid during their therapeutic course with
the chip.
The numbers of least sessions for using the chip were 6 times and the most
numbers were
20 times. 42 patients were clinically cured, accounting for 75%; 9 patients
showed
obvious effectiveness, accounting for 16.1 %; 5 patients alleviated,
accounting for 8.9%;
all of the chip-treated patients showed effectiveness from the treatment; and
the general
effectiveness rate was 100%. 42 patients did not relapse within half a year
following the
treatment, 11 patients relapsed within 3-4 months, but only with mild
symptoms, and the
symptoms disappeared for another 5-10 sessions of therapy with the chip. 3
patients with
cholesteatoma were referred to other hospital for operation with no available
follow-up
result.
X. The following clinical trial was conducted at the 302 Hospital of anshun in
China for treatment of 120 patients suffering from headache.
Of the 120 patients, 39 were men and 81 were women. The youngest patient was
20 years old and the oldest was 70. The shortest disease course was 5 hours
and the
longest was 20 years.
In the treatment the chips were located at the primary acupuncture points
Fengchi,
and Baihui, matched with other acupuncture points according to various
different
syndrome. The patients were clinically classified as: (1) Affection due to
external wind in
CA 02529239 2010-01-28
-30-
which headache occurred upon encountering wind and the pain was striking. They
were
treated with the chips located at Fengfu, Lieque, Waiguan, and Heger (2) Liver-
Yang
with pain on one side of the head and which may be at the top of the head.
They were
treated with the chips located at Sishencong, Taichong and Shuiquan. (3)
Stasis of blood
with refractory and pricking pain. They were located with the chips located at
SanYinjiao
and Ashixue.
The following criteria were used to denote the effectiveness of the treatment:
Cure: pain disappeared completely and did not relapse within half a year,
Obvious effectiveness: pain was obviously alleviated and became less frequent;
Some certain effectiveness: pain was alleviated and became less frequent; and
No effect: pain remained unchanged.
The result of the trial therapy showed that among the 120 patients, 96
patients
were cured, accounting for 80%; 18 patients showed obvious effectiveness,
accounting
for 15%; 6 patients showed some certain effectiveness, accounting for 5%. The
effectiveness rate was 100%.
XI. This clinical trial was conducted at the No.l Hospital for Traditional
Chinese
Medicine of Changde City in China for the treatment of 80 patients suffering
from gastric
or duodenal ulcer.
All 80 patients met the criteria as having gastric or duodenal ulcer. They
were
randomly separated into two groups. The first group consisted of 50 patients
in which 35
were men and 15 were women, and the ages ranged between 24-62, with an average
age
CA 02529239 2010-01-28
-31-
of 35.5 11.3. The disease courses varied between 0.5-20 years with an average
of
6.4 2.8. 19 patients were suffering from gastric ulcer, 26 patients were
suffering from
duodenal ulcer, 5 patients were suffering from compound ulcer, 44 patients had
negative
occult blood in stool, 4 patients had weak positive result and 2 had positive
result. The
second group consisted of 30 patients in which 18 were men and 12 were women.
The
ages were in the range of between 20-68 with an average age of 34.4 12.4. The
disease
courses were between 4 months to 18 years with the average length of 6.5 3.0
years. 10
patients were suffering from gastric ulcer, 13 patients were suffering
fromduodenal ulcer,
7 patients were suffering from compound ulcer, 25 patients had negative occult
blood in
stool, 3 patients had weak positive result and 2 had positive result. The
differences
between the two groups were non-significant according to X2 (P>0.05, were
comparable
to one another.
The first group was treated with the chips located at Zusanli, Neiguan, and
Gongsun; and the second group was treated with the chips located at Zhongwan,
Pishu,
and Weishu. The location LiangQiu was added in case of stomach pain; and the
locations
at the upper and lower Zhongwan were added in case of cold in stomach; the
location
Tianshu was added in case of flatulence; the location Taichong was added in
case of acid
regurgitation; the location Zhigou was added in case of constipation; the
location
Shenmen was added in case of insomnia; the location Qihai was added in case of
fatigue.
The two groups of acupuncture points were applied alternately once daily. The
treatment
administered for 2 months.
CA 02529239 2010-01-28
-32-
For the second group, the acupuncture points were same as those of the first
group
except for additionally using supplementing or dispelling maneuver. For mild
bleeding
ulcers (mild), some medications could additionally be used.
The parameters for observation included ulcer lesion observed in gastroscopy,
and
some physical symptoms of abdominal pain, and acid regurgitation.
The Standard for Determining Effectiveness over Diseases Treated with
Traditional Chinese Medicine issued in 1994 by State Administration of
Traditional
Chinese Medicine of PR China was used to determine the following criteria of
effectiveness of the treatment:
Clinically cured: ulcer lesion heals found by gastroscopy, symptoms
disappeared;
Obvious effectiveness: ulcer lesion shrank or less found by gastroscopy,
symptoms disappear or become alleviated;
Alleviated: lesion did not shrink, but congestion and edema in membrane of
stomach became alleviated, and symptoms became alleviated;
No effect: ulcer remained unchanged i.e. lesion and symptoms remained
unchanged.
The results are tabulated in the following two tables.
Table 1 Comparison between the two groups in effectiveness
main Number Cure Obvious Alleviated No General
symptoms of patient effectiveness effect effectiveness
rate (%)
Treatment 50 14 11 21 4 92.01
group
Control 30 6 6 13 5 83.3
group
CA 02529239 2010-01-28
-33-
Table 2 Comparison between the two groups for the length of treatment time
required to
show effectiveness
Group Number of patient Therapeutic course
6 7 8 9
Treatment 14 2 5 5 2
group
Control 6 0 0 2 4
group
XII. The following clinical trial was conducted at the Hospital of Jinshi
county in
China for the treatment of vascular headache.
120 patients participated in the trial in which 35 were men and 85 were women.
The youngest was 18 years old and the oldest was 76. The longest therapeutic
course
lasted 10 years and the shortest course was one day.
The acupuncture points used in the treatment were classified into four groups.
The
first group included Yintang, Yongquan, and Hegu; the second group included
Yintang,
Fengchi, and Zhongwan; the third group included Neiguan, Yifeng, and TaiYang.
For
headache in the entire head, acupuncture points along hairline were added. The
fourth
group included Fengchi, Neiguan, TaiYang, and Shuaigu.
The therapeutic effect was evaluated after every two therapeutic courses.
The following criteria were used in determining the effectiveness of the
treatment:
Clinically cured: pain disappeared and normal life was restored, and pain did
not
relapse within half a year afterward;
CA 02529239 2010-01-28
-34-
Obvious effectiveness: pain disappeared and normal life was restored, but
relapses occurred within half a year afterward;
Some certain effectiveness: pain was alleviated, but became deteriorated with
tiredness and fretfulness, and relapses sometimes occurred;
No effect: pain remained unchanged.
The result of the therapy was that 120 patients were cured; 20 patients showed
obvious effectiveness; 20 patients showed some certain effectiveness; 12
patients showed
no effect. The general effectiveness rate was as high as 97.5%.
XIII. This clinical trial was conducted in Duan Changjiu in China with 48
patients
suffering from bronchial asthma.
Among the 48 patients, 20 were men and 28 were women. The youngest was 6
years old and the oldest was 65. The longest therapeutic course lasted 27
years and the
shortest course was 6 months. 36 patients had phlegm-hot, 12 were had wind-
cold.
This disease was mostly due to wax of evil and wane of genuine according to
traditional
Chinese medicine, with excess of viscera at the onset, displaying either cold
or hot
feature. Symptoms can be short breath and choked chest, wheeze, loud speaking
and
powerful pulse. For those who displayed cold features, their sputum was cold
and thin
and was complicated by coldness signs; for those who displayed hot features,
they had
more expiration and less inspiration, exacerbated by motion, short breath,
fatigue,
gloomy complexion and weak pulse. Protracted period of such disease course
could hurt
spleen and kidney and could be complicated with deficiency in the functions of
both the
spleen and kidney.
CA 02529239 2010-01-28
-35-
In the treatment, the chips were located at acupuncture points Neiguan,
Tiantu,
Dingchuan, Shanzhong, Feishu, Chize, Zusanli, Yuji, Yezui, and Lieque. 4 to 5
of these
acupuncture points were used alternately in the treatment.
The following criteria were used to denote the effectiveness of the treatment:
Obvious effectiveness: symptoms were removed without relapse within half a
year, or occasionally relapse very slightly, and could survive without anti-
asthma
medications.
Alleviated: symptoms were obviously alleviated, and could return to normal
life
although the symptoms could still occur occasionally, and anti-asthma
medications was
reduced dramatically.
No effect: symptoms remained unchanged after three therapeutic courses.
The result of the treatment was that 15 patients showed obvious effectiveness,
accounting for 315; 30 patients showed some certain effectiveness, accounting
for 63%; 3
patients showed no effect, accounting for 6%; general effectiveness rate was
94%.
The following table shows the effectiveness of the types of asthma treated
with
acupuncture
Main Number Obvious Alleviated No General
symptoms of patient effectiveness effect effectiveness
rate (0/u)
Treatment 36 12(33) 23(64) 1(3) 97
group
Control 12 3(25) 7(58) 2(17) 83
group
CA 02529239 2010-01-28
-36-
Comparing to other procedures of CAM (Complementary and alternative
medicines), the chip of the present invention is more effective in providing
treatment of
various diseases and additionally it can provide the following advantages:
1. Without using needle and medications, and it is thus free from any side or
toxic
effect. It is superior to invasive procedures, and meets the requirements for
non-
deleteriousness and environment-friendliness.
2. Without using electricity and mechanic parts, and it is thus free from
damage
and requirement of maintenance. It is therefore better than electromechanical
devices.
3. It can be used easily and is very accessible for self administering and
household
use. It does not require a special practitioner to operate, and thus is not
subject to poor
effect due to inappropriate practice.
4. It is economical and cheap to use since the chip can be used personally and
it
can endure repeated uses as many as tens of thousand of times, with the cost
of only
several cents for each session of therapy.
20
