PressureStim

Warning:  Investigational use only, not available for sale.  
 
Safety and Efficacy Not Yet Proven in Randomized, Double Blinded, Placebo Controlled Statistically Significant Controlled Clinical Trials.
 
Data from Early Feasibility Pilot Clinical Studies in China
Bioelectric Treatment High Blood Pressure (Hypertension)
Test Article = Jiajun hypertension depressor
Study Sponsor = Dr. Gao JiaJun – JiaJun Bio-electronics Institute.
Clinical early feasibility un-controlled pilot studies at the provincial capital hospitals in Beijing, Shanghai, Liaoning, Jilin, Hebei and Guangdong show that bioelectric treatment of hypertension is:

  • 98% effective for the first-stage hypertension;
  • 93.5% effective for the second-stage hypertension;
  • 90% effective for the third-stage hypertension;
  • 97% effective for hypertensive headache. 

Clinical Pilot Studies in China Treatment for High Blood Pressure (Hypertension)

Treatment effect observation report of Jiajun Hypertension Depressor

I. Target Observe and evaluate the precise treatment effect of Jiajun hypertension depressor, Including instant blood pressure degrading and the blood pressure status after one month. The evaluation is emphasized in the treatment effect of instant blood pressure degrading of Jiajun hypertension depressor.
II. Solution
1. Observation We arranged two groups for observation. We chose 120 diagnosed hypertension patients from Beijing TianTan Hospital, Beijing No. 4 Hospital, and the Hypertension Administration Committee of ChongWen district Stadium Road Hospital and arranged them to the two groups, 60 persons in each group. One is the observation group, the other is the comparison group. The standard of our choose of the patients are: Volunteers, with SBP >=160mmHg, and/or DBP >=95mmHg, no obvious syndrome of heart, brain, and kidney.
2. Patients to be observed Among the 120 diagnosed hypertensives male are 53 persons, and female 67 persons. The average age is 66.61+-8.64 years old. (M+-SD) The average ill history of hypertension is 17.08+-11.02 years (M+-SD). The general introduction of the observation group and the comparison group see Table 1. The sex and age composition of the two groups are comparable.
Table 1. General introduction of observation group and comparison group
Observation group
Comparison group
Numbers (person)
60
60
Male (%)
27(45.0%)
26(43.3%)
Female (%)
33(55%)
34(56.7%)
Age (year)
65.98+-9.11
67.23+-8.17
Ill history of hypertension (year)
17.82+-11.31
16.35+-10.76
Medication intake in recent two months:
Ever taken medication of BP
57
52
Never taken medication of BP
3
8
3. Training and quality control
Before observation, we trained the 11 observers (already trained in blood pressure measure for many times) in the scheduled observation target, operation and performance of mercury blood pressure meter, and operation and performance of Jiajun hypertension depressor. Of the 11 observers, 3 came from Beijing TianTan Hospital, 5 from Beijing No.4 Hospital, 3 from ChongWen district Stadium Road Hospital. And 5 quality control personals from Beijing Neurosurgery Research Institute carried on the overall quality control during the complete performance.
4. Blood pressure observation
Blood pressure observation took 4 weeks. On every Tuesday or Wednesday we conducted one inspection between 9:00am to 11:00am as scheduled. For the members of observation group it is supposed to take a rest of 5 – 10 minutes in peaceful status before treatment. Their blood pressure is measured twice professionally and noted down afterwards, and then the patients start the treatment with Jiajun hypertension depressor as required. After the treatment the patients are supposed to relax totally and sit calmly for 5 – 10 minutes, and again their blood pressure is measured twice and noted down. The members of comparison group are not required to use Jiajun hypertension depressor for treatment. Their blood pressure is also measured twice after a rest of 5 – 10 minutes. The members of observation group take the device home and do the treatment as required for 3 – 5 times every day. All members of observation group are not supposed to intake blood pressure degrading medication within 6 – 8 hours before treatment in the inspection days.
5. Operation of Jiajun hypertension depressor
5.1) Head comb: Hold the metal ring at the back of the device with one hand, and apply the three groups of metal pins tightly on the forehead of the patient with proper pressure, and comb in the middle upwards at the even speed of 1 – 2 times per minute and down the back of head. One treatment takes 3 – 5 minutes.
5.2) Hand touch: Hold the metal ring at the back of the device with one hand, and open the other hand naturally. Apply the tops of the three groups of metal pins against the paunch of fingertips tightly and hold for 3 – 5 minutes.
Either of the above two methods can be used, but better not to use them in turn, and the treatment should be taken every day. The observer is responsible to direct the patients to use the device correctly.
Of the 60 patients of the observation group, 35 persons chose the method of head comb, which takes 58.3% of the total members, and 24 chose the method of hand touch, which takes 40.0%. One person chose both methods of head comb and hand touch, which takes 1.7%.
III. Results
1. It is observed the obvious difference of blood pressure levels (P<0.01) of both SBP and DBP measured before and after treatment with Jiajun hypertension depressor, and in the initial measured group, 1st inspection group and the total group. See Table 2.
2. Comparing observation group with comparison group, it is found that there is no obvious difference of both SBP and DBP in different groups except SBP in the first inspection. But the blood pressure degrading of both SBP and DBP of the observation group is more than comparison group, comparing the forth inspection with the initial measured. Details see Table
3. The blood pressure of observation group measured in the last inspection in comparison with those measured initially, SBP degrades 9.83mmHg and DBP degrades 8.41mmHg. For the comparison group the degrading of SBP and DBP is respectively 5.77mmHg and 7.84mmHg.
Table 2. Blood pressure levels of observation group measured before and after treatment
SBP (mmHg) DBP (mmHg)
Before treatment After treatment Before treatment After treatment
Initial measured 170.93+-15.20 164.35+-17.93** 94.13+-8.93 89.77+-8.63**
1st inspect measured 161.42+-18.86 155.27+-19.80** 89.82+-9.36 86.37+-8.92**
2nd inspect measured 169.63+-53.28 154.48+-18.57* 86.92+-13.69 85.68+-9.47
3rd inspect measured 165.68+-48.06 154.95+-18.11 88.17+-10.77 86.43+-9.56
4th inspect measured 161.10+-40.28 153.73+-18.78 85.72+-12.30 84.27+-10.22
Total 165.75+-38.32 156.56+-18.96** 88.95+-11.46 86.50+-9.49**
Note: * P<0.05; ** P<0.01
3. Comparing the BP measured before inspections and after the last treatments, the BPs have certain upgrades, except the SBP measured before 1st inspection and the DBP measured before 4th inspection, but no difference. Details see Table 4.
Table 4. Blood pressure of observation group measured before 1st inspection and after treatment
SBP (mmHg) DBP (mmHg)
BP after initial treatment 164.35+-17.93 89.77+-8.63
BP before 1st inspect 161.42+-18.861 89.82+-9.36
BP after 1st inspect 155.27+-19.89 86.37+-8.92
BP before 2nd inspect 169.63+-53.28 86.92+-13.69
BP after 2nd inspect 154.48+-18.57 85.68+-9.47
BP before 3rd inspect 165.68+-48.06 88.17+-10.77
BP after 3rd inspect 154.95+-18.11 86.43+-9.56
BP before 4th inspect 161.10+-40.28 85.72+-12.30
 
4. Intakes of blood pressure degrading medication
During the observation, majority of the patients were taking blood pressure degrading medication, except 5 persons in observation group and 3 persons in comparison group. There is no obvious difference in both observation group and comparison group among the patients who increased, or made no change, or decreased the medication dosage, or stopped or changed the medication. Details see Table 5 and Table 6
Table 5. Medication intakes of observation group
Dosage
Increased
Person(%)
Dosage
no change
Person(%)
Dosage
Decreased
Person(%)
Medication
Stopped
Person(%)
Medication
changed
Person(%)
Medication
never taken
Person(%)
1st week / 46(76.7%) 4(6.7%) 3(5.0%) 2(3.3%) 5(8.3%)
2nd week 3(5.0%) 46(76.7%) 4(6.7%) / 2(3.3%) 5(8.3%)
3rd week 5(8.3%) 45(75.0%) 2(3.3%) 1(1.7%) 2(3.3%) 5(8.3%)
4th week 3(5.0%) 48(80.0%) 1(1.7%) 1(1.7%) 2(3.3%) 5(8.3%)
 
Table 6. Midication intakes of comparison group
Dosage
Increased
Person(%)
Dosage
no change
Person(%)
Dosage
Decreased
Person(%)
Medication
Stopped
Person(%)
Medication
changed
Person(%)
Medication
never taken
Person(%)
1st week 1(1.7%) 53(88.3%) 3(5.0%) / / 3(5.0%)
2nd week 1(1.7%) 53(88.3%) 1(1.7%) / 2(3.3%) 3(5.0%)
3rd week 1(1.7%) 56(93.3%) / / / 3(5.0%)
4th week 1(1.7%) 53(88.3%) / 3(5.0%) / 3(5.0%)
IV. Summary Our observation demonstrates that Jiajun hypertension depressor has obvious treatment effect of instant blood pressure degrading, and the treatment effect lasts long. Jiajun hypertension depressor, as a no wound, no obvious side effect, assistant blood pressure degrading device, can be promoted in more people.
Medicine Department of Science &
Technology Development Center
Of China Health Ministry
Nov. 1998 
National Cerebrovascular Disease Prevention and Treatment Research Office
Beijing Neurosurgery Research Institute
Nov. 1998
Clinic Report (2)
Observation of 611 treatment cases with Jiajun hypertension depressor
In order to observe the treatment effect of Jiajun hypertension depressor, which is produced under the supervision of China Rural Hygiene Association, we conducted continuous treatment observation to 611 cases of hypertension for a period of 4 weeks. Our summary:
1. Patients to be observed We chose 611 hypertensives according to WHO 1978 hypertension diagnostic standard, among whom 330 are male, 281 female. Stage I hypertensive 333 persons, Stage II hypertensive 228 persons, Stage III hypertensive 33 persons, critical hypertensive 11 persons, and low blood pressure patient 6 persons. The ages are between 20 to 86 years old, and 53 years old in average. See Table 1 and Table 2.
Table 1. Groups in age
Age 20 up 30 up 40 up 50 up 60 up 70 up 80 up
Case 3 47 187 197 139 34 4

Table 2. History of illness

Year Less than 2 3-5 6-10 11-15 Over 15
Case 110 227 136 57 81
2. Observation
Patients use Jiajun hypertension depressor twice a day, 2 – 3 minutes each time. When using the device, patients must grasp the metal ring with fingers at the back of the device, and the optimum frequency of combing is 1 (one) time in a minute, moving from forehead upwards and down at the back. The metal pins should not be pressed hard against the skin to avoid hurting. In case the patient is helped by somebody, the helper should take the patient’s hand in one hand, and do the performance as mentioned above with the other hand. On Monday, Wednesday and Friday, in the morning and in the afternoon, before treatment and at the peaceful status, the patients’ blood pressure is measured twice and the average value is taken. Again 3 – 5 minutes after the treatment the patients’ blood pressure is measured twice and the average value is taken. The treatment effect is observed in this way and the performance is done by specially assigned people.
3. Judgment of treatment effect
3.1) The treatment effect after first week see Table 3 and Table 4.
Table 3. SBP treatment effect
Patients’ status
of Hypertension
Stage I Stage II Stage III Critical Total
2 45 31 7 83
Blood
3-5 87 52 7 1 147
Pressure 6-10 105 73 10 188
Degrade 11-15 44 28 3 1 76
16-20 11 10 2 23
mmHg 21-30 5 3 3 11
Total 297 197 32 2 528 cases
Altogether 528 patients have got their blood pressure degraded after using the device, among whom Stage I patient are 297 persons, Stage II 197 persons, Stage III 32 persons, and critical 2 persons. The degrade of SBP takes 88.44%, the degrade range from 1 – 10mmHg takes 79.2%, the degrade range over 11mmHg takes 20.8%.
3.2) Table 4. DBP treatment effect
Patients’ status
of Hypertension
Stage I Stage II Stage III Critical Total
1 – 2 80 57 8 145
Blood
3 – 5 119 81 7 2 209
Pressure 6 – 10 74 47 11 132
Degrade 11 – 15 9 7 16
(mmHg) 16 – up 1 1 2
Total 283 192 27 2 504 cases
Altogether 504 cases of DBP degrade are observed after using the device, and it takes 84.4%. Among the 504 cases degrade range from 1 – 10mmHg takes 96.4%, and degrade range from 11 – 22 up mmHg takes 3.6%.
The treatment effect after forth week see Table 5 and Table 6.
3.3) Table 5. SBP treatment effect
Patients’ status
of Hypertension
Stage I Stage II Stage III Critical Total
Blood
2 38 22 5 65
Pressure 3-5 105 59 4 1 159
Degrade 6-10 69 76 13 1 16 9
11-15 37 19 3 1 60
mmHg 16-20 4 7 11
21-up 2 2
Total 253 185 25 3 466 cases
3.4) Table 6. DBP treatment effect
Patients’ status
of Hypertension
Stage I Stage II Stage III Critical Total
Blood
2 61 57 7 1 126
Pressure 3-5 119 69 8 1 197
Degrade 6-10 58 37 7 102
11-15 1 1 1 3
mmHg
Total 239 164 23 2 428 cases
It is observed:
In the forth week SBP keeping going down are 466 persons, among whom Stage I are 253 persons, Stage II are 185 persons, Stage III are 25 persons, critical are 3 persons. The blood pressure degrade rate takes 88.1%, among whom SBP degrade from 1 – 10mmHg takes 84.3%, from 11 – 20mmHg takes 5.2%, down from 20mmHg takes 0.5%.
In the forth week DBP keeping going down are 428 persons, among whom Stage I are 239 persons, Stage II are 164 persons, Stage III are 23 persons, Critical are 2 persons. The blood pressure degrade rate takes 80.91%, among whom DBP degrade from 1 – 10mmHg takes 99.3%, down from 10mm Hg takes 0.7%.
3.5) Table 7.
The blood pressure measured before and after the first treatment with the device, and measured before and after the last treatment with the device after 4 weeks, are averaged as below:
Time Before treatment After treatment
First week
BP average
(mmHg)
Difference to
standard
BP average
(mmHg)
Difference to
standard
SBP 152.70 17.49 146.41 17.55
DBP 95.10 10.60 91.43 10.58
Last week SBP 145.29 14.46 140.19 14.16
DBP 90.33 8.60 87.38 8.38
3.6) Among the 611 cases 605 are high blood pressure patients, and 6 are low blood pressure patients. After treatment with the device, the SBP and DBP of the low blood pressure patients all rise to certain extent, among whom 2 patients got their SBP rising 10mmHg, and 2 patients rising 8 mmHg, the other 2 patients got no obvious change in SBP. Meanwhile all 6 patients got their DBP rising, ranging from 2 – 10 mmHg.
4. Summary
The data obtained in 4 weeks demonstrates that:
4.1) Using Jiajun hypertension depressor can bring down high blood pressure in 3 – 5 minutes, and the degrading of BP is smooth. That is in average SBP degrades 7.3mmHg, and DBP degrades 7.4mmHg.
4.2) The blood pressure average value before the first treatment and after the last treatment indicates degrade of 12.51mmHg in SBP, and 7.72mmHg in DBP.
4.3) After 4 weeks, BP degrade can still be observed. In terms of the whole observation period (over 4 weeks), the BP average taken after the last treatment also indicates degrade in comparison with the BP average taken before the first treatment. That is 7.41mmHg in SBP, and 4.77mmHg in DBP.
4.4) Jiajun hypertension depressor also has good treatment effect to low blood pressure patients.
4.5) This product has its value to be used and promoted in the people of hypertension for prevention and treatment of high blood pressure.
 
Beijing Cerebrovascular Disease Prevention and Treatment Office