AU2012211420B2

AU2012211420B2 - Treatment of Hypertension

Info

Publication number: AU2012211420B2
Application number: AU2012211420A
Authority: AU
Inventors: Keith Wendell
Original assignee: Thrisoint Pty Ltd
Current assignee: Thrisoint Pty Ltd
Priority date: 2006-12-12
Filing date: 2012-08-08
Publication date: 2013-07-04
Anticipated expiration: 2027-12-12
Also published as: AU2012211420B9; AU2012211420A1

Abstract

- 14 Abstract. A method for treating hypertension comprising delivering a microcurrent to a person suffering from hypertension. The microcurrent may be electric current falling in the range of from 2 milli-amperes to I atto-ampere. The micro-current may be an 5 alternating current having a very low frequency, with the frequency falling in the range of from 0.00065Hz to 0.00085Hz. Treatment of a patient having a disorder of the hypothalamus, for increasing a level of melatonin or serotonin in a patient, for increasing a level of endorphin in a patient and for decreasing a level of cortisol in a patient are also described.

Description

- 1 TREATMENT OF HYPERTENSION FIELD OF THE INVENTION The present invention relates to a method for the treatment of hypertension. BACKGROUND OF THE INVENTION 5 Hypertension affects 20% or more of the adult population in western societies and it is a significant risk factor for stroke, myocardial infarction (heart attack) and congestive heart failure. Together, these ailments account for more than 50% of deaths in the United States. It is estimated that about 50 million Americans have elevated blood pressure, which is defined as systolic blood pressure of 140mm Hz or greater or diastolic blood 10 pressure of 90mm Hg or greater. Despite improvements in prevention, detection and treatment, cardiovascular diseases are the leading causes of death for both men and women in the United States. Over 930,000 American die of cardiovascular disease each year, which amounts to one death every 34 seconds. Over 64 million Americans live with cardiovascular disease. 15 Coronary heart disease is a leading cause for premature permanent disability in the US workforce. Stroke alone accounts for disability among more than one million Americans. In addition, about 90% of middle aged Americans will develop high blood pressure in their lifetime and over 70% of people with high blood pressure do not have it under control. Over six million hospitalisations each year are due to cardiovascular disease. 20 The cost of heart disease and stroke in the United States is projected to be $3768 billion in 2004. Over 80% of those patients who have high blood cholesterol do not have it under control. Evidence for disturbed circadian pacemaker function in hypertension is accumulating. Patients with hypertension show blunted day/night rhythms in sympathetic 25 and parasympathetic heart tone. Patients with coronary heart disease, a major complication of chronic hypertension, show a blunted day/night rhythm in vasodilation and suppressed night time melatonin levels. The endogenous circadian pacemaker, located in the suprachiasmatic nucleus (SCN) imposes 24-hour biological rhythms by endocrine and autonomic mechanisms. It has been demonstrated by previous workers -2 that in comparison with normotensive subjects, the levels of these important supra chiasmatic nucleus (SCN) neurotransmitters are reduced by more than 50% in patients with essential hypertension, corroborating its functional impairment. Buijs & Associates provided anatomical support for a changed SCN output to the sympathetic nervous 5 system and to the hypothalamus, pituitary adrenal axis in patients with hypertension. These findings suggest compromise cardiovascular anticipation to the activity period in patients with hypertension, leading to increased risk for cardiovascular incidents in the early morning. Melatonin secreted from the pineal gland is controlled by the SCN. Melatonin 10 also provides feedback via high-affinity melatonin receptors in the CSN, thus influencing the rhythm of its own production and other circadian rhythms. Night time melatonin amplifies circadian rhythms directly via the central pacemaker and is used to improve disturbed day/night rhythms. Because the SCN influences the autonomic output to the cardiovascular system, restoration of proper functioning of the SCN in the patients with 15 hypertension could improve the autonomic regulation of blood pressure. Australian Patent No. 750177, the entire contents of which are herein incorporated by cross-reference, describe various micro-current electrotherapy methods for treating various ailments selected from pains, lacerations, abrasions, sprains, strains, neuralgia, Parkinson's disease, fatigues, haemorrhoids, wounds, ulcerations, spinal cord injuries, 20 amyotrophic lateral sclerosis, multiple sclerosis, nervous system abnormalities, scar tissue and age lines. This patent describes applying a micro-current under specific conditions such as applying micro-currents ranging from 20 milli-amperes to 1 femto-amperes and applying an alternating current with a frequency in the range of 0.00065Hz to 0.00085Hz. The micro-current may be applied, for example, by using an electrode wrap as described 25 in that patent. Our Australian distributor, ElectroRegenesis Pty Ltd, markets various EPRT (Electro Pressure Regeneration Therapy) devices in the Australasian market. These devices are non-invasive, therapeutic devices that utilise ultra low frequencies for the treatment of pain, wound healing and cellular regeneration. These devices include the 30 G4Z BodiHealth, which delivers currents ranging from 100 nano-amperes to 3 milli amperes and the Jai, which delivers current ranging from 100 atto-amperes (100 x 10-"A) -3 to 1,500 nano-amperes. These devices have been used to treat conditions that include fractured ankles, dysmenorrheal (painful periods), menopausal conditions, shoulder and neck pain, pain of severe osteoarthritis of the hips, respiratory infections, chronic wound ulcers, stress and improving sleep, Achilles tendon injury, acute and chronic pain, 5 increasing circulation to tissues on the verge of necrosis, fibromyalgia, wound management, soft tissue injuries, bone injuries and infections. Discussion of these various treatments is available at www.electroregenesis.com.au. BRIEF DESCRIPTION OF THE INVENTION In a first aspect, the present invention provides a method for treating hypertension 10 comprising delivering a microcurrent to a person suffering from hypertension. The micro-current is suitably an electric current falling in the range of from 20 milli-amperes to I atto-ampere (1 x 1018 amps), or preferably in the range of from 3 milli-amperes to 100 atto-amperes. The micro-current is suitably an alternating current having a very low frequency. 15 For example, the micro-current may comprise an alternating current with a frequency in the range of from 0.00065Hz to 0.00085Hz. A duty cycle of 0.000732Hz or one cycle every 22.77 minutes, has been shown to be useful. In the second aspect, the present invention provides a method for treating a patient having a disorder of the hypothalamus comprising delivering a microcurrent to the 20 person. In another aspect, the present invention provides a method for increasing a level of melatonin or serotonin in a patient by delivering a micro-current to the patient. In a further aspect, the present invention provides a method for increasing a level of endorphin in a patient by delivering a micro-current to the patient. 25 In yet a further aspect, the present invention provides a method for decreasing a level of cortisol in a patient by delivering a micro-current to the patient. The present invention arose serendipitously as part of a study to determine the effectiveness of treating shoulder pain using micro-currents. In this study, 20 shoulders -4 were treated with a placebo machine and 43 shoulders were treated by applying a micro current. A significant finding of this study was that the average overall increase in range of motion with the placebo was 16.9% compared to 37.4% with the treatment using micro-currents. This was an excellent indicator of the efficacy of treating shoulder pain 5 using micro-currents. However, this study also showed that the levels of melatonin, serotonin, endorphins and cortisol in the blood were also affected. This was a surprising outcome. With the inactive placebo device, average melatonin levels rose by 3.4% whereas with the micro-current treatment, the rise in average melatonin levels was 18%. Seratonin levels dropped by 22% with the placebo, but rose by 6% with the micro-current 10 treatment. Endorphin levels rose by 5% with the placebo but dropped by 3% with the micro-current treatment. The significance of these results of raised melatonin and serotonin levels indicate a direct effect on the hypothalamus. The lowered endorphin level indicates that the analgesic effect of the micro-current treatment is such that the body does not have to 15 produce its own endorphins. Lower cortisol shows that stress is lowered. In some embodiments of the present invention, treatment of a patient may comprise applying one or more cycles of a current of 2 milliamps, with each cycle lasting for approximately 23 minutes. Further cycles may be conducted at 300 nanoamps. The electric current may be applied to any part of the body while still obtaining the beneficial 20 outcomes of the present invention. It will be appreciated that applying currents of different values to those specified above still falls within the scope of the present invention. Different cycle lengths may also be used. Examples 25 Example 1 A number of patients were treated in accordance with the present invention by applying a microcurrent to the patient for one more cycles. The melatonin, serotonin, 13-endorphin and cortisol levels of the patients were measured. The raw results are shown in table 1. In one group of patients, the following changes were recorded: -5 melatonin increased -- 50.5% serotonin increase -- 38.9% endorphin increase -- 22.2% cortisol decrease -- 83.3% 5 In a second group of patients, the following results were recorded: melatonin increase -- 42 .9% serotonin increase -- 78.5% endorphin increase -- 57.1% cortisol decrease -- 71.4% 10 The above results are indicative of a decrease in hypertension in the patients. Example 2. 74 year old woman diagnosed with Hypertension, type 2 Diabetes, Peripheral Vascular Disease, Hemi forefoot Amputation. 15 Prior to treatment she was an inpatient in hospital recovering from her hemi forefoot operation. On Admission to hospital her BP was 166/59 and was not on any medication. Postoperatively her BP was on average 155/71 and not responding to increasing doses of medication. She reached a maximum dose of Perindopril 8mg. 20 On the commencement of her treatment in February 2005, her BP stabilized and started to drop. Once discharged from hospital her BP continued to decrease and she reduced and eventually stopped taking the Perindopril. At the present time her average BP over the 25 last 6 weeks is 128/66 (n=12) and she is on no medication.

-6 BP n Delta Currents used and frequency of (average) treatment Admission to 166/58 1 No Treatment Hospital Pre Treatment 155/71 42 Post Treatment 146/68 32 9/3 Currents used; I milliampere 23 I" Week minutes, 400 nanoamperes 138 minutes. She received daily treatments. 2 "d Week 129/64 36 26/7 Treatment protocol as above. 3 rd Week 144/67 30 11/4 Treatment protocol as above. Present (Over 128/66 12 27 Treatment protocol as above. She is last 6 weeks) currently not taking any medication Oct - Nov 2007 for Blood Pressure Example 3 70 year old woman diagnosed with Hypertension, Epilepsy, Osteoarthritis, and Rheumatoid Arthritis. BP n Delta Currents used and frequency of (average) treatment Initial BP (Is' 147/84 8 Treatments started in September 2006. 10 days) Currents used: 1 milliampere for 23 Sept 2006 mins, 60 microamperes 23-46 minutes, and 400 nanoamperes 69-138 minutes. She had treatments twice weekly. BP post 138/72 8 9/12 Currents used; 1 milliampere for 23 treatments mins, 60 microamperes 46 minutes, and (taken over 400 nanoamperes 138 minutes. 3.5 weeks) She had treatments twice weekly to Oct 2006 fortnightly 5 -7 Example 4. 77 year old woman diagnosed with Hypertension, Hypercholesterolaemia, Hypothyroidism, type 2 Diabetes. BP n Delta Currents used and frequency of (average) treatment Initial BP (1" 158/81 2 She started having her treatments in 4 days) October 2006 Oct 2006 Currents used; I milliampere for 23 mins, and 400 nanoamperes 138 minutes. She had treatments daily. BP post 125/65 4 33/16 Currents used; 1 milliampere for 23 treatments mins, and 400 nanoamperes 138 (taken over 8 minutes. days) Daily to twice weekly. Oct 2006 5 10 15 -8 Example 5. 67 year old woman diagnosed with Hypertension and Osteoarthritis. BP n Delta Currents used and frequency of (Average) treatment Initial BP (1s 5 157/91 4 She started her treatments in June 2006. weeks) Currents used; 1 milliampere for 23 Jun - Aug minutes, 60 microamperes for 46 2006 minutes and 400 nanoamperes for 69 minutes. She received 1 to 3 treatments per week. BP post 149/86 4 8/5 1 milliampere for 23 minutes, 60 treatment taken microamperes for 46 minutes and 400 (over 3 weeks) nanoamperes for 69 minutes. Aug - Sep She received one treatment per week. 2006 5 10 15 -9 Example 6 68 year old gentleman diagnosed with Hypertension, Hypercholesterolaemia, and type 2 Diabetes. BP n Delta Currents used and frequency of (average) treatment Initial BP (1't 3 202/99 6 He started his treatments in December weeks) 2005 Feb - Mar Currents used; 1 milliampere for 23 2006 minutes, 80 microamperes for 69 minutes and 400 nanoamperes for 69 minutes. He received treatments twice weekly. BP post 155/73 8 47/26 Currents used; 1 milliampere for 23 treatments minutes, 100 microamperes for 46 (taken over 16 minutes, 60 microamperes for 46 days) minutes, and 400 nanoamperes for 69 May 2006 minutes. He received treatments twice to three times per week. 5 10 15 - 10 Example 7 70 year old woman diagnosed with Hypertension, Fibromyalgia, Hepatitis, Hypercholesterolaemia, Tuberculosis, and a Stroke. BP n Delta Currents used and frequency of (average) treatment Initial BP (1"t 8 134/84 4 No BH Treatment days) Jul 2005 BP post 117/73 4 17/11 BodiHealth treatments started at the treatments end of July 2005. (taken over I Currents used; 1 milliampere for 23 month) minutes, and 400 nanoamperes for 138 Aug 2005 minutes. She received one treatment per week. 5 10 15 20 - 11 Example 8 75 year old woman diagnosed with Hypertension and Benign Postural Vertigo. BP n Delta Currents used and frequency of (average) treatment Initial BP 157/86 7 She started treatments in April 2006. (1"4 2 months) Currents used; 1 milliampere for 23 Apr - Jun minutes, 100 microamperes for 46 2006 minutes or 80 microamperes for 46 minutes, and 400 nanoamperes for 69 minutes. She received one treatment per week. BP post 138/76 3 19/10 Currents used; I milliampere for 23 treatments minutes, 100 microamperes for 46 Sep 2006 minutes or 80 microamperes for 46 minutes, and 400 nanoamperes for 138 minutes. She received one treatment per week. 5 Glossary BP - Blood Pressure n - number in the sample group Delta - change in both systolic and diastolic BP from baseline ("Initial BP") 10 Those skilled in the art will appreciate that the present invention may be subject to variations and modifications other than those specifically described. It will be understood that the present invention encompasses all such variations and modifications that fall within its spirit and scope.

Claims

1. A method for treating hypertension comprising delivering a microcurrent to a person suffering from hypertension. 5

2. A method as claimed in claim 1 wherein the micro-current is an electric current falling in the range of from 20 milli-amperes to 1 atto-ampere.

3. A method as claimed in claim I wherein the micro-current is an electric current falling in the range of from 3 milli-amperes to 100 atto-amperes.

4. A method as claimed in claim 1 wherein the micro-current is an alternating 10 current having a very low frequency, with the frequency falling in the range of from 0.00065Hz to 0.00085Hz.

5. A method as claimed in claim 4 wherein the microcurrent has a frequency of 0.000732Hz, or one cycle every 22.77 minutes.

6. A method for treating a patient having a disorder of the hypothalamus 15 comprising delivering a microcurrent to the person.

7. A method as claimed in claim 6 wherein the micro-current is an electric current falling in the range of from 20 milli-amperes to 1 atto-ampere.

8. A method as claimed in claim 6 wherein the micro-current is an alternating current having a very low frequency, with the frequency falling in the range of from 20 0.00065Hz to 0.00085Hz.

9. A method for increasing a level of melatonin or serotonin in a patient by delivering a micro-current to the patient.

10. A method as claimed in claim 9 wherein the micro-current is an electric current falling in the range of from 20 milli-amperes to 1 atto-ampere. 25

11. A method as claimed in claim 9 wherein the micro-current is an alternating current having a very low frequency, with the frequency falling in the range of from 0.00065Hz to 0.00085Hz. - 13

12. A method for increasing a level of endorphin in a patient by delivering a micro-current to the patient.

13. A method as claimed in claim 12 wherein the micro-current is an electric current falling in the range of from 20 milli-amperes to I atto-ampere. 5

14. A method as claimed in claim 12 wherein the micro-current is an alternating current having a very low frequency, with the frequency falling in the range of from 0.00065Hz to 0.00085Hz.

15. A method for decreasing a level of cortisol in a patient by delivering a micro-current to the patient. 10

16. A method as claimed in claim 15 wherein the micro-current is an electric current falling in the range of from 20 milli-amperes to I atto-ampere.

17. A method as claimed in claim 15 wherein the micro-current is an alternating current having a very low frequency, with the frequency falling in the range of from 0.00065Hz to 0.00085Hz.