THE BP CONTROLLER BRACELET'S THERAPEUTIC PRINCIPLE
AND FUNCTION

Modern science knows that electric charges are distributed in every living organism. Bioelectricity is distributed inside and outside every cell and between cells. Dr.Reinhold Voll (1909-1989) of Germany discovered that the paths of electricity on the surface of human bodies coincide nearly exactly with the channels and collaterals by traditional Chinese medicine. It is the acupuncture points by traditional Chinese medicine that serves as the specific points to measure the electricity in human bodies.

A Japanese doctor by the name of Nakafuru Yoshio once used electronic instruments to test wrists and ankles, and showed that the channels, collaterals and acupuncture points are really good conductors and are connected with autonomic nerves in human bodies. Besides, a group of Austrian researchers proved with precision instruments that the acupuncture points by traditional Chinese medicine really have a special capacity to produce energy change. In other words, the so-called channels and collaterals are paths in human bodies that are weak in polarization and strong in conductivity; the so-called acupuncture points are distributive points of the same nature as channels and collaterals exposed on the skin that serve to govern interaction between human bodies and their surroundings.

i In view of the close relation between human bioelectricity on the one hand and channels and collaterals and ! acupuncture points on the other, many researchers are of the opinion that the bioelectricity discovered in modern science is clearly the "qi" (vital energy) by traditional Chinese medicine. The circulation of "qi" through the channels and collaterals is in fact the balance in distribution and circulation of bioelectricity. At present, this bioelectricity is generally thought as bio-energy and the medicine connected with research into I bioenergy is called bioenergetic medicine (some researchers call it quantum medicine).

According to physiology, the bioelectricity in the organs and cells of health human bodies should be kept in balance. Pathological changes first induce changes in cells; before cells change, their bioelectricity would change. When these changes reach a certain point, they are mirrored in the channel and collateral system, causing
corresponding changes in the electric potential at the acupuncture points on the skin. Therefore, it would be of great value to early diagnosis and treatment if we can exactly determine the charges in the cells and their sensitive changes quantitatively. By supplying external energy to regulate the bioelectricity of specified points in human bodies such as one or more acupuncture points, we can directly treat certain diseases or certain types of disease. especially functional disorders such as the disorder of autonomic nervous system and the chronic diseases arising from it.

The BP Controller Bracelet, based on the theory of electric potential of the cells and the theory of channels and ! collaterals, is developed and made with the help of microelectronic technology and new materials. The special I inside structure of dry cell and the "WK" chip form a parallel gradient electric-field of low field-intensity
which, through changing the abnormal electric potential of specified human acupuncture points and their corresponding channel and collateral system, regulates the function of the nervous system and of the human body as a whole, thus fulfilling the purpose of alleviating symptoms of hypertension and hypotension. That is why the BP Controller Bracelet keeps us fit and has some good effects on our health in addition to that of " double- directional" regulation of blood pressure.
 
The BP Controller Bracelet obviously opens up a new avenue for, and provides a new method and a new option in, effectively alleviating symptoms of hypertension and hypotension without incurring side-effects of drugs. It has done this through blending the advances in modern medical research, the latest achievements in the science of materials and the theory and practice of traditional Chinese medicine. It thus .not only stands in the fore-front of applying the bioelectricity theory to clinical practice and of extending knowledges of this, but it also harmonizes with new trends in techniques and medical treatment: "do it yourself". treatment and dispensing with drugs.

CLINICAL OBSERVATIONS OF ANTIHYPERTENSION
EFFECT OF THE BP CONTROLLER BRACELET
March, 1991

by Division of Hypertension, Cardiovascular Institute, Chinese Academy of Medical Science
Xiyuan Hospital, Chinese Research Institute of Traditional Chinese Medicine
Dongzhimen Hospital Affiliated to the Beijing Traditional Chinese Medicine University

The BP Controller 'Bracelet is a new medical apparatus which regulates blood pressure (BP) and makes it in balance state, as well as improves symptoms of hypertensives and reduces BP, based on the guidance of the classical theory of traditional Chinese medical science combining with modem biomedical science. Its principle of treatment is to use the parallel gradient electric field formed by the inside microelectric plate and battery to influence the Neiguan acupuncture point in the wrist or the Sanyinjiao acupuncture point in the inner tibia.
The purpose of this trial is to observe the antihypertension effect, adaptation symptoms and possible side-effect when patients wear the BP Controller Bracelet. The clinical observation was undertaken by the Division of Hypertension of Cardiovascular Institute of Chinese Academy of Medical Science, Xiyuan Hospital of Chinese Research Institute of Traditional Chinese Medicine and Dongzhimen Hospital Affiliated to the Beijing Traditional Chinese Medicine University.

1. Method
1.1 Sample Selection: male or female, age between 30 -60, primary hypertension at stage I or ll, SBP ;> 160mmHg or DBP ;> 95mmHg or both in conformity with the above criteria, at least one week without
medicine before being selected. The patients who suffer from the following diseases were excluded from the "'! trial: accompanying with other cardiovascular or cerebrovascular diseases; severe diseases in liver or kidney; ::' diabetes; diseases in the blood-creating system; malignant tumour; keeping taking hormone; or the women in
the nurse period.

1.2 Observation Method:
The study was a double-blind, randomized control trial. The sealed envelope system was used for the purpose of randomization. 'During the running period (one week), the patients took one placebo pill per day and BP was, measured twice a day (sitting and standing). 116 patients with average SBP ;> 160mmHg and/or DBP ;> 95mmHg were allocated according to the sealed envelope number to the BP Controller Bracelet GB) group and '. control (captopril) group. After that the following examinations were done: electro-cardiogram (12 leads), chest
X-ray, fundus, haematological indexes (Hb. WBC), routine urinalysis (protein, sugar, sediment examined by mirror) and serum biochemistry (cholesterol, creatinine, blood glucose, SGPT & TTT). After four-week treatment, the above indexes were repeated except the fundus.
Meanwhile, the JB group took the captopril placebo pills and wore JB; the captopril group took captopril and wore the relief watches without microelectronic device inside while the outside design completely the same as that of the BP Controller Bracelet. The patients wore the BP Controller Bracelet or relief watch on the right Neiguan acupuncture point, once from 8:30 to 10:00 am, and another time from 3:30 to 5:00 pm,20 minutes for each time, accompanying with taking 1 pill of medicine for each of the two times per day. BP was measured (sitting and standing) twice a week. The observation lasted for 4 weeks. If BP at the end of the first, second and third week was still higher than 160/95~Hg, nq, change for the wearing time, the dosage could be increased from 25mg (on 1 capsules), 50mg (2 capsules) to 75mg (3 capsules) per day. In addition to BP, heart rate, rhythm, drug compliance and adverse effects were also, recorded. Clinical characteristics for the two groups are shown in table I.

1.3 Evaluation of Effect:
The average blood pressure during the running period was regarded as the baseline BP, while that at the fourth week was regarded as the BP after treatment. The two kinds of average BP was compared with each other and the two groups were also compared with each other.

2. Results.
2.1 Antihypertensive Effect.
The trends in blood pressure (BP) for the two groups are shown in the table 2. The sitting and standing BP reduced respectively from 167.8 :I: 18.7/99.4 :I: 10.9mmHg to 151.5 :I: 15.9/91.4 :I: 9.5mmHg (p < 0.001) and from 169.2 :I: 21.8/102.3 t 12.1mmHg to 152.0 :I: 16:0/92.9+9.2mmHg (p<0.001) for JB group. The sitting and standin§ BP of tire captopril group decreased respectively from 164.1 ± 16.8/99.2 :I: 7.7mmHg to 149.2 :I: 17.3/91.1 :I: ~.7mmHg (p<0.001) and from 166.4 :I: 18.7/103.5 :I: 8.6 to 149.4 :I: 15.2/93.1 :I: 7.9. (p<0.001) The difference between the baseline BP and the BP after treatment of the two groups was statistically significant. 34 cases (58.6%)in JB group became return to normal level. 36 cases (62.1%) in captopril group declined to normal range. Comparing the two groups, the difference was not found out statistically significant.

2.2 Heart Rate (HR) Effect
In JB group, the average HR for baseline was 78.0 :I: 10.7 beats/min, after treatment it was 80.7 :I: 9.7 beats/min (p > 0.05). In captopril group, it was 77.8 :I: 10.1 beats/min for baseline, and after treatment 79.1 :I: 9.4 beats/min (p > 0.05)

2.3 Lab Examination Effect(table 3)
In JB group, except one case's SGPT before and after treatment was higher than normal level, other biochemistry items before and after treatment remained in normal range. The electrocardiogram, size of hean through the chest fluoroscopy and the blood as well routine urinalysis before and after treatment in the two groups had no obvious change.

2.4 Compliance
Compliance was satisfactory in this study. Ninety per cent cases lasted the scheduled appointment and claimed
to be fully compliant with wearing JB and drug regimen. Only one case in JB group withdrew due to non-compliance.

2.5 The Effect on Symptoms: (Table 4)
JB group improved the dizziness and headache. That is comparable with captopril.

2.6 Side Effect
One case in JB group experienced slight itching after the second day of wearing JB (no taking other drug), two
days later, the itching naturally disappeared and the treatment still went on. This case had allergic physique, so
the itching was uncertainly caused by JB. In captopril group, there was one case with nausea and vomitting, one
had cough, and other three had itching and rash. But the symptoms were not strong, all of them still continued
the regimen.

3. Summary
The JB could reduce SBP and DBP in both sitting and standing positions. The BP for fifty eight per cent cases returned to normal level. The side-effect was mild. JB is indicated for treatment of mild and moderate "- hypertension.

THERAPEUTIC EFFECT OF THE BP CONTROLLER BRACELET ON RENAL HYPERTENSIVE PATIENTS AND ITS POSSIBLE MECHANISM -A DOUBLE-BLIND PROSPECTIVE STUDY
March,1996

Division of Nephrology, Huashan Hospital, Shanghai Medical University

The BP Controller Bracelet, a health care product with watch-like appearance, has regulatory effect on blood pressure..
This study was carried out for clarification of this effect in renal hypertensive patients and its possible mechanism.

Materials and Methods
20 hospitalized patients with renal hypertension aged 20-60, which diastolic blood pressure (DBP) was 90-105 mmHg and systolic blood pressure (SBP) 150-170 mmHg, were randomly divided into two groups: one group was the BP Controller Bracelet treatment group (n= 11), another group was hypertension control group (n-9) that worn the placebo watch with same appearance. All patients had been stopped taking any antihypertensive drugs for at least one week before experiment. Another 21 normal volunteers without family history of hypertension aged 20-60 were also selected and randomly divided into two groups: one group was normal BP Controller Bracelet treatment group (n-9), another group was normal control group (n-lZ) that worn. the placebo watch. all these watches was tightly attached to the Neiguan acupuncture point of right forearm, while a placebo watch with same appearance was applied as placebo control. The watch was worn three times a day at 8AM, 12AM and 8PM with each time lasting 30 min. The experiment lasted 7 days. Blood pressure and heart rate were measured each time after wearing by a particularly assigned doctor. Each measurement was performed three times with the mean value being recorded. 
Activities of autonomic nervous system was detected by analyzing heart rate variance with the SMUP heart rate variance spectrum analytic system. The ratio of low and high frequency component (LF /HF) was used as the parameter for evaluation of autonomic nervous function. Electrocardiac R-R interval spectrum was determined before and after the 7-day experiment in patients and volunteers. 
This experiment was designed as a prospective, randomized, double-blind, self-controlled clinical study with placebo control. Data were presented as mean :t: SD. Paired Students' t-test between values of pre- and post- treatment was used for statistic analysis. P < 0.05 was set as the criterion for statistic significance. 

1. Effect of the BP Controller Bracelet on blood pressure '. SBP was significantly decreased in patient with the BP Controller Bracelet treatment group (p < 0.05). DBP was also decreased but did not reach the statistic significance (P > 0.05). Blood pressure in other three groups had no remarkable change. (Tab 1)

2. Effect of the BP Controller Bracelet on heart rate 
   Heart rate was not significantly changed in all four groups.

3. Effect of the BP Controller Bracelet on autonomic nervous system (Tab 2) 
   Discussion and Conclusion
   It has been clarified that the BP Controller Bracelet has antihypertensive effect in essential hypertension (stage I-II), but whether this effect also exists for renal hypertension remains unknown. Our stUdy demonstrated that the BP Controller Bracelet could decrease SBP significantly in renal hypertensive patients. DBP was also mildly decreased by the BP Controller Bracelet, however which did not reach the statistic significance. This might be because of the small number of cases as well as the short duration for treatment. 
   The BP Controller Bracelet had no obvious effect on blood pressure in normal volunteers. Heart rate both in renal hypertensive patients and normal persons was not affected by the BP Controller Bracelet, which indicates that application of the BP Controller Bracelet for renal hypertension treatment is quite safe without side-effects as hypotension, palpitation and bradycardia. 
   It is widely established that hypertension is related to hypervolemia and disturbance of renin-angiotensin- aldosterone system (RAAS). Renal perfusion of patients with renal diseases is commonly reduced, resulting in renal ischemia and increment of renin secretion from juXtaglomerular apparatus. High activity of renin- angiotensin system causes constriction of peripheral arteries, increase in total peripheral vascular resistance, and consequently hypertension develops. The sodium retention hormone aldosterone is simultaneously elevated, which could induce hypervolemia and hypertension. Also activation of sympathetic nervous system plays a role in renal hypertension. It could induce hypertension through direct increase of cardiac output and total peripheral vascular resistance, meanwhile activate RAAS via 13 -adrenergic pathway thus Cause elevation of blood pressure. In addition, angiotensin II could enhance the effect of central and peripheral sympathetic nervous system and stimulate catecholamine releasing, both of which could induce hypertension. Heart rate variance analysis is an advanced, sensitive and non-invasive method to examine the activity of autonomic nervous system. High LF/HF indicates the relative hypertonicity of central sympathetic nerve and hypotonicity of central parasympathetic nerve, and vice versa. Our experiment showed that the BP Controller 
   , Bracelet could decrease LF/HF in renal hypertensive. patient while there was no effect in normal individual. The possible mechanism might lie in the change of electronic field alld localization of specified points and their related channels, which could result in the adjustment of nervous system, especially decrease the intensified sympathetic nerves, finally exert its therapeutic effect 011 hypertension.

In conclusion, we have found:

• The BP Controller Bracelet has antihypertensive effect on renal hypertension. 

• The BP Controller Bracelet would not affect the heart rate and blood pressure in normal individuals. 

• The antihypertensive effect of the BP Controller Bracelet might be through alleviation of over-intensified sympathetic nervous system.

REPORT ON THE THREE-YEAR OBSERVATION OF THE BP CONTROLLER BRACELETS' EFFECTS ON HYPERTENSION 
June, 1994

by Dongzhimen Hospital affiliated to the Beijing Traditional Chinese Medicine University.

From December, 1990 to January, 1991 we have made a one-month observation of the blood-pressure-lowering effect of the BP Controller Bracelet. We are convinced that it has the effect of lowering the blood pressure of primary hypertensives at stage I and 11, with the total effectiveness rate being 72.4%, and without any side-effect. In order to find out the tong-term effect of the BP Controller Bracelet, a continuous three-year observation on 40 primary hypertensives was carried out from April, 1991 to April, 1994. We came to the following conclusion: 

1. Clinical Data and Observation Method. 
1.1 Objects of Observation. 
According to the WHO 1978 diagnosis criterion of hypertensive, 40 primary hypertensives were selected, 12 being male, 28 female; and 30 at stage I , 10 at stage 11. The age range was from 35 to 83, average 50.7 :t: 40.3.

1.2 Method of Observation 
The BP Controller Bracelet were worn twice each day and 20 minutes each time. The central hole of the bracelet was put right on the Neiguan acupuncture point. Sitting and standing blood pressure were measured twice each week. The blood pressure was always taken after 10 -20 minutes' rest between 8 and 10 o'clock in the 
morning. 

1.3 Criterion for Assessment of Effects 
According to the nationwide epidemiological criterion for the prevention and treatment of coronary heart disease and hypertension in 1979: 

a. Good to Excellent: BP records below 160/95mmHg for 3/4 of a year.
b. Fair: BP records below 160/95mmHg for 1/2 of a year. 
c. Poor: BP records above 160/95mmHg for 1/2 of a year. 

2. Outcome 
2.1 Effects 

2.3 Changes in Medication 
Before wearing the bracelet, 30 people had been taken antihypertensive drugs continuously for a long time, 10 occasionally. During the first year they were wearing the bracelet, the drug-stopping rate is 40%, the drug- reducing rate is 52.5°/,,; During the second year, the drug-stopping rate is 40%, and the drug-reducing rate is 95%; During the third year, the drug-stopping rate is 52.5%, and the drug-reducing rate is 97.5%. 

3. Summary 
The result of the observation shows that the BP Controller Bracelet has good long term effects on hypertension. Its excellent rate of effects by the end of third year reaches 62.5%, with a total effectiveness rate 77.5%. To most of the cases, the BP Controller Bracelet could be used to replace antihypertensive drugs, or reduce the dosage of such drugs. Therefore, it could minimize side-effect of the drugs. The drug-stopping rate is 52.5%, while the drug- reducing rate is 97.5%. Only 2.5% of the patients are still taking antihypertensive drugs. There is also being a great deal of improvement to the symptoms of dizziness, vertigo, palpitation, insomnia, and tinnitus, etc. "

THE INFLUENCE OF THE BP CONTROLLER BRACELET ON THE CARDIOVASCULAR BLOOD FLOW PARAMETER 
June, 1993

by the Immunology Research Center of the Naval General Hospital Beijing. China. 

The BP Controller Bracelet has been widely used in the clinical treatment of hypertensive and hypotensive diseases. It has been proved that it can be used to replace medicine entirely or partly. In order to find out the principle of how the BP Controller Bracelet regulates blood pressure, we tried to make it clear by measuring the cardiovascular blood flow parameter in human body. TP-CBS, a kind of pocket-sized, non-damage instrument, is used for measuring cardiovascular blood flow parameter. It has many advantages: safe and reliable, quick and convenient, economic and practical, and the good function of using over and again, etc. This apparatus has been proved to be satisfactory by scientists of an authoritative medical research institute and some hospitals. Meanwhile, electromagnetic flow meter, cardiotube, two-dimension Doppler supersonic cardiography, and other conventional apparatuses were used synchronously for the examination of the blood flow parameter. A large amount of data demonstrated that there are close relationships between TP-CBS and the conventional apparatuses (the relative coefficient R is between 0,9-0.96), and the examination and measurement of the blood flow parameter in human body with TP-CBS are accurate and reliable and had also imporant value in the clinical application. W e appointed a specialist to operate TP-CBS and 60 patients were examined in total, by taking of the pulse condition picture of the left radial artery, measuring the sitting blood pressure in the right arm together with the body height and weight. By this method, we have avoided the operative errors, to keep the parameter accurately. 
1. Materials and Methods 1.1 Cases selection 
The patients must be corresponded with the following conditions,: a. hypertension of I or II stage; 
b. SBP > 140mmHg, DBP > 90mmHg; 
c. Antihypertensive drugs, vasodilator or other methods of reducing blood pressure should not be taken in a 
week. 
In the test the number of patients was 53 male and 7 femal. Their age was 33-75, and the average was 58.

1.2 Apparatuses: a TP-CBS, watch A (unreal the BP Controller Bracelet, the outside is completely the same as that of real one, but inside there is only WK plate) 3 pieces, watch B (the BP Controller Bracelet) 3 pieces, a table blood pressure monitor, and an apparatus to measure body height and weight.

1.3 The procedure of examination: 

1.3.1 First we measured the patients' body height and weight (only once no need to measure again for the other two tests), then measured the sitting blood pressure twice continuously after the patients' 15 minutes' rest we took the average data. TP-CBS was put °.n the patients' left radial artery, the patients were told to take the sitting gesture and not to talk or move, the tie was fastened comfortably. The data of body height, weight and blood pressure were transmitted into TP-CBS. After testing the picture of pulse condition we typewrote the 14 results.

1.3.2 We examinated the 14 data of TP-CBS after a rest. When the patients wearing watch A 20 minutes later, sitting blood pressure were measured, we transmitted the new measured data into TP-CBS computer and examinated 14 parameters.

1.3.3 When the second test was ended, the patients wore watch B for 20 minutes. Immediately, we took quick measurements for sitting blood pressure and repeated the above operation to finish the examination. Each patient received three times' TP-CBS test. During the examination, watches were worn on the left Neiguan acupuncture point. The 14 results were: Ps SBP (mmHg) , Pd DBP (mmHg) , DP(mmHg) , MAP(mmHg) , HR(times/min), SV(ml/min), CO(l/min), BSA, 51, CI, TPR, AC(ml/mmHg), K, V.

2. The analysis of the examination result The patients were selected strictly according to the above conditions, avoiding the influences caused by the antihypertensive drug or other methods of treatment. From the beginning to the end, only one appointed specialist operated TP-CBS and measured the blood pressure, in order to reduce the ope,ration errors. The data before and after wearing watch A, watch B were compared to find out the notable changes in some data. These are shown as follows: