CA2180762A1 - Potable germicide to kill helicobacter pylori bacteria - Google Patents

Abstract

It has recently been discovered that gastritis is caused by an infection of the stomach by a germ, namely Helicobacter Pylori. This infection can, over time, lead to ulcers and cancer. Physicians can cure the infection with a combination of up to four patented antibiotics, albeit with risk of side effects and at substantial expense. It is estimated by medical authorities that 50% of the world population has the problem. An appropriately concentrated solution of ethanol ingested under the right conditions can also cure the infection at minimal cost and without burden to clinical resources.

Description

C . Specif ication To explain how this invention of an ethanol solution for treating gastritis in a permanent manner is effective it is well to present an overview of what the current medical knowledge about Helicobacter Pylori infection is and how it is currently being treated. For the examiners' convenience photocopies of scientific articles on the subject are included although these are not meant to be a part of this formal petition for a patent. On the basis of this new knowledge about gastritis the petitioner has experimented upon himself and established dosage and concentration.
Scores of others have participated and all no longer have any gastric distress.

Gastritis is an inflammation of the stomach which causes much su~fering. Usually, a few hours after a meal, a searing pain begins in the pit of the stomach as gastric acid builds up. The discomfort is a sure sign that there is inflammation of the stomach wall, clinically called gastritis. The problem may manifest itself as "heartburn", caused by an upward flow of acid into the oesophagus which is also quite unpleasant. In time, this hyperacidity does damage to the stomach walls and the lining of the oesophagus. These surfaces are normally protected by a mucous lining but they become infected with a certain bacteria which causes localized irritation. This results in increased acid production. When the acid builds up in quantity and strength to the point that the lining is damaged then the stomach wall tissue is attacked and it develops sores or lesions, often becoming ulcerated. Ulcers can lead to perforations of blood vessels, leading to bleeding or they can lead to cancer.

Various treatments have been used over the years, the most common approach being to neutralize the acid by ingesting hydroxides, or carbonates. In recent years drugs have been developed such as cimetidine, as well as various blockers to decrease the production of excess acid.
While all these different products give welcome relief to the chronic sufferer they are usually temporary and need to be used on a continuous basis, often for a lifetime. An irritated stomach seems to become its own worst enemy by secreting even more acid than usual. For this reason ulcers can sometimes be healed by taking the antacid material before the acid level is able to reach destructive concentrations. In that event, the ulcers get an opportunity to heal if about ten or more days elapse without the acid level being allowed to build up and undo the healing and reopen the sore(s). Then by avoiding foods that seem to add to irritation and hence increased acid production and he can sometimes get by with minimal problems for a considerable time.

An article in 'The New Scientist', points out that it is estimated that three quarters of the world's population goes through life with a chronic inflammation of the stomach. It is now realized that a bacteria, Hel icobacter Pyl ori, infects the stomach and is very destructive. Over decades of being infected, a person may have no symptoms, yet over time, the germs can effect erosion of the lining of the stomach and cause ulcers and even stomach cancer. In the now over ten years since the germ was discovered H. Pyl ori has been implicated in other disorders such as causing the blood to clot more readily, leading to heart 2 1 ~Q~J76~

disease and strokes. Others who have been infected have the symptoms of hyperacidity, such as "heartburn", duodenal and peptic ulcers, "indigestion", dyspepsia, and some get diagnosed as having hiatal hernia.

There has been much debate as to how serious an effort should be made to combat this disease. The National Institute of Health in the U.S. has agreed that the bacteria can cause peptic ulcers and which can lead to cancer. In the case of ulcers they advised doctors to stop trying to heal the ulcer by means of conventional acid suppressing drugs, including cimetidine, "H2receptor blockers" such as ranitidine, made by Glaxo and "proton pump inhibitors" such as omeprazole made by Astra. These drugs do fairly well in healing the ulcers but ulcers treated with them often come back. People then can end up having to take "maintenance doses" for years. Probably annual sales by now of these drugs would amount to well over 10 billion dollars. Only in the case of ulcers does NIH recommend that they should use antibiotics for a week or two to get rid of H. Pyl ori .
One doctor states: "If the bug is gone, the ulcers heal and don't come back."

HELI COBACTER PYLORI

In the early eighties two doctors, J. Robert Warren and his assistant, Barry J. Marshall, working at the Royal Perth Hospital, discovered a bacteria which takes up residence in 21 ~0762 and behind the mucous lining of the stomach. They noted that everyone with gastritis, or stomach inflammation was host to this bacteria. Because of its shape and because it infected the pylorum region at the lower end of the stomach it came to be named Helicobacter pylori. But was it the cause of the gastritis?

In 1985 Dr. Marshall who was healthy announced that he had purposely ingested H. Pylori. And sure enough, he developed a full blown case of severe gastritis. Although the painful inflammation reportedly disappeared without treatment it looked like the bacteria was the cause.
Subsequent tests on other volunteers bore this out and that when the bacteria was killed, typically with two different antibiotics and with "Pepto-Bismol", the gastritis would be cured. Subsequently, it has been found that the success rate is about 90% on the first attempt with this antibiotic treatment. When using only one antibiotic the success rate is much lower. One problem is that there are a number of different strains of this bacteria with different levels of resistance to specific antibiotics and the other is that the antibiotics themselves are vulnerable to the high acid levels in the stomach.

When presented with the irrefutable evidence, the medical world came to accept the fact that what had been treated symptomatically since the dawn of medical practice could now be truly cured by the simple treatment of an infection. As reported by health writer, Hans Larsen, the 21 3fJ762 current standard treatment for Helicobacter pylori consists of a two week therapy with 500 milligrams of tetracycline (or amoxycillin) four times daily, 400 mg.
metronidazole three times daily, plus 120 mg. bismuth subcitrate four times daily. He reports that Dutch physicians recommend omeprazole as an added component of the standard treatment. The new treatment takes only a week to complete and reportedly eradicates the bacteria in 98.1 % of the cases. HIS SOURCE: Harris, Adam and Misiewicz, J.J.
Hitting H. pylori for four. The Lancet, Vol.345, April, 1995, pp.806-07. By now millions have been cured and they stay cured, as long as the H. Pylori was thoroughly eliminated and as long as the patient does not get reinfected. There is only about a 1% per year chance of this happening.

There is the problem though, that millions of people who need treatment would not have access to medical facilities or could not afford them if they were available.
Too, sometimes the antibiotics are not well tolerated by patients. A lady writes in to Dr. Paul Donahue, publisher of the syndicated column, YOUR GOOD HEALTH OF August 21, 1995. She writes: "I have a bleeding ulcer and infection of the stomach. The doctor put me on two antibiotics for ten days. I could not tolerate the pills. I tried three times. I get such pains and nervousness and nausea. The doctor says the only cure is to take the pills. Is there anything else that I can do to heal my stomach?" Mrs. G.N.

~ 1 ~0762 Dr. ~onahue replies: "Return to your doctor pronto.

"So newer readers will know whereof we speak here, let me explain Mrs. N's ulcer situation. A relatively new view of ulcers focuses on a germ, Helicobacter. That connection was made when many ulcer patients were found to be harbouring the germ. That is why Mrs. N's doctor is prescribing the pair of antibiotics, to assure elimination of the culprit germ, permitting ulcer healing to proceed.

"Now there is more than one combination of drugs from which to select. For example, one potent Helicobacter weapon is PeptoBismol in conjunction with the antibiotics tetracycline and metronidazole. Another combination is composed of omeprazole - which stops stomach acid production - and the antibiotics metronidazole amoxicillin. I am sure that your doctor can find some drug combination you can tolerate."

Several things shine through from this column. First, the ulcer can be cured by killing the bacteria. Also, the antibiotics can be a problem because of side effects. The question also comes to mind: Why was Mrs. N not treated for the infection earlier but was allowed to suffer till her gastritis became ulcerous? It could have even become cancerous. What a boon it is to have a safe and effective medicine that is cheap and could become readily available' 21 8û762 It is not clear how H. pyl ori is transmitted from person to person or where it comes from. It has been noted that the rate of infection is highest in developing countries where sanitation standards are not as high as in the developed world.

A NON-TOXIC GERMICIDE TO KILL HELICOBACTER PYLORI

It has become necessary as a result of the medical research breakthrough that we have learned about, to have a different mindset now that we know the cause of the problem of gastritis or hyperacidity or heartburn. It is not caused by stress, or spicy foods or an inherited predisposition.
IT IS A BACTERIAL INFECTION. So we will need to use an antibacterial agent. Such a commonly available and highly effective one is ethanol or plain grain alcohol. It is the main ingredient in many disinfectants.

Killing H. pylori is a very suitable application for using alcohol as the antibacterial. Alcohol put into the stomach gets absorbed through the stomach walls into the bloodstream very rapidly and so will transit through the mucous layer and come in contact with the underlying H.
Pylori. If the alcohol is strong enough the bacteria perish. However, if the stomach has a lot of liquid already in it when the alcoholic drink is ingested it will get diluted to the point that it will not kill the bacteria.
That is why people can be regular users of alcohol and still have gastritis.

21 8~762 The alcohol gets into their stomachs and gets absorbed through the stomach wall but because of dilution by stomach contents, soda water etc. or water, as in the case of beer, the alcoholic concentration is too weak to hurt the bacteria.
Alcohol at strength is a potent germicide. That is why it is standard medical practice to swab the skin with alcohol before using a hypodermic needle. Alcohol kills germs very quickly. The H. Pylori germs do not circulate in the blood stream but colonize the mucous lining and the cells underneath it. (Antibodies can be detected in the blood stream.) Hence it is sufficient to topically subject the germs to a lethal concentration of a suitable germicidal agent.
The invention for destroying Helicobacter Pylori, for which a patent is hereby being applied, consists of a strong solution of ethanol, to which suitable non-toxic acid neutralizing chemicals or drugs to inhibit acid production and flavouring agents may or may not be added.
Instructions to the user will advise that the dose of about 60 ml. needs be taken after a fast of at least 12 hours and then to abstain from food or drink for at least 20 minutes. After that normal eating and drinking can be resumed.
Putting 40~ or even stronger alcohol into the stomach in a moderate amount is safe. It even feels therapeutic.
There is a procedure, well known in medical circles, called Endoscopic Ethanol Injection where they use an instrument that is equipped with a television system and a remotely operated hypodermic needle.

2 1 ~0762 With the patient under anaesthesia, they insert the device down the gullet into the stomach. The surgeon sees the bleeding sites in the stomach and injects 99% alcohol (ethanol) into the tissue and the bleeding stops. Four doctors have published a case history paper where they report performing this procedure very successfully on three young children. This scientific paper can be looked up in a medical library and is cited at the end of this application.
It shows how this procedure works as well on children as it does on adults. Certainly about a 40% solution is not going to be a problem.

Alcohol, in the small quantities and moderate strength we are talking about, is well tolerated. In fact, people report a soothing warm feeling after drinking it on an empty stomach like this remedy requires. Many experience a very noticeable improvement of their symptoms on the first day and in two or three days do not need to use any antacid medications and can digest food without any difficulties.
With the antibiotic treatment there is the problem that some bacteria have an inherent resistance to the particular antibiotics being used, and if some of them survive the course of treatment, they are then able to reinfect with a large population of their antibiotic resistant progeny.
That means that another combination of antibiotics must be used in an attempt to, hopefully, eliminate them all. It is unlikely, though, that any of the strains of the bacteria can survive the antiseptic properties of strong alcohol.

21 ~37~2 The only possibility for that to happen is if the alcohol is diluted by stomach contents to the point that it is of insufficient strength. Hence the need to ensure that it is strong to begin with and is taken upon an empty stomach. Then sufficient time for the alcohol to be absorbed through the mucous lining must be allowed before any food or drink is taken. As the alcohol transits through the mucous lining and the epithelial cells underneath, it contacts the bacteria, destroying them.
In view of the fact that this remedy is completely harmless with no unpleasant or harmful side effects it is worth taking the course of treatment, even if symptoms appear minimal. It is reported that many infected persons can be symptom free and after some time come down with ulcers or even cancer. Helicobacter Pylori is suspected by some physicians as being a factor in some heart disease because it may be the root cause of changes in the clotting characteristics of the blood. Also, under certain conditions, the bacteria can get through into the rest of the digestive system and do more damage. This easily cured infection imposes a great stress upon the worlds medical resources at present and much suffering to literally billions of persons.
Patent protection would ensure that an affordable medicine and the publicity and knowledge as to how to use it could be brought to the world wide mass of people in great need of such a cure.

Claims (2)

1. Claim 1 An alcohol solution of sufficient strength to act as a germicide against Helicobacter Pylori is an improvement over antibiotic medications for this purpose. It works more rapidly and effectively and is inexpensive. I hereby claim the exclusive right to the discovery of this substance as a medication to eradicate the said antigen in infected persons and claim the exclusive rights to such an alcohol solution formulated for this purpose.
2. Claim 2 An alcohol solution as defined in Claim 1 but with any adjuncts such as flavouring, antacid material, colouring agents, antibiotic agents, extracts, drugs, emollients, gelling material, minerals, vitamins, and or food supplements added.