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Title:
A METHOD FOR SMOKING CESSATION
Document Type and Number:
WIPO Patent Application WO/2009/062431
Kind Code:
A1
Abstract:
The present invention provides a method for smoking cessation, especially, a kit for smoking cessation and a method for using the same. The kit comprises a scopolamine injection and auricular acupuncture. In the case of using the kit, a superior effect of smoking cessation can be achieved by administrating the scopolamine injection via one single subcutaneous or intramuscular injection with placement of acupuncture staples in Mouth and Lung points outside both ears, and stimulating the acupuncture staples when necessary.

Inventors:
TCHAO, Paul (#2 Lane 1248 Apt 202, Fu-Xing Road, Shanghai 1, 200031, CN)
Application Number:
CN2008/072544
Publication Date:
May 22, 2009
Filing Date:
September 26, 2008
Export Citation:
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Assignee:
TCHAO, Paul (#2 Lane 1248 Apt 202, Fu-Xing Road, Shanghai 1, 200031, CN)
International Classes:
A61K31/46; A61H39/08; A61K31/00; A61K31/137; A61K31/27; A61K31/4168; A61K31/5415; A61K31/5513; A61P25/34
Foreign References:
US20050227998A12005-10-13
CN1875968A2006-12-13
Other References:
FU WEN-RU ET AL.: "Clinical application and mechanism investigation of auriculo- acupuncture for smoking cessation.", JOURNAL OF ANHUI TRADITIONAL CHINESE MEDICAL COLLEGE, vol. 23, no. 2, April 2004 (2004-04-01), pages 30 - 32
DATABASE WPI Derwent World Patents Index; AN 2005-363870, THOMSON AN
Attorney, Agent or Firm:
BEIJING SANYOU INTELLECTUAL PROPERTY AGENCY LTD. (F16 Block A, Corporate Square No.35 Jinrong Street, Beijing 0, 100140, CN)
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Claims:
CLAIMS

1. A kit for smoking cessation comprising: (1) scopolamine injection; and (2) acupuncture staples.

2. The kit for smoking cessation of claim 1, wherein said injection comprises scopolamine in an amount of 0.01 to 0.8 mg.

3. The kit for smoking cessation of claim 1, further comprising at least one adjuvant selected from hydroxyzine, chlorpromazine, atropine, ipratropium, meprobamate, benzodiazepine, clonidine, serotonin (5-hydroxytryptamine) uptake inhibitor and bupropion.

4. The kit for smoking cessation of claim 3, wherein said adjuvant is at least one of hydroxyzine, chlorpromazine and atropine.

5. A method for using the kit for smoking cessation of any one of claims 1 to 4, comprising administrating said scopolamine injection via one single intramuscular subcutaneous injection, and then placing said acupuncture staples in Mouth and Lung points outside both ears.

6. The method of claim 5, wherein at least one adjuvant selected from hydroxyzine, chlorpromazine, atropine, ipratropium, meprobamate, benzodiazepine, clonidine, serotonin (5-hydroxytryptamine) uptake inhibitor and bupropion is administered together with said injection, or is administered simultaneously with said injection, or after the administration of said injection.

7. A use of a combination of scopolamine and acupuncture staples in manufacturing a kit for smoking cessation.

Description:

A METHOD FOR SMOKING CESSATION

Background

Technical Field

The invention relates to a medical kit, in particular, to a kit for smoking cessation and a method for using the same.

Related Art It is known to all that smoking is harmful to the health. The cigarette is found to contain 1400 components. There are more than 40 carcinogens and more than 10 cancer promoters in the cigarette smoke, in which nicotine, carbon monoxide and some metal compounds are the most harmful substances for human. The medical study has shown that cigarette smoking is a behavior type hazard factor which may lead to many diseases such as cardio-cerebrovascular disease, cancer, chronic obstructive pulmonary disease, and it has become the number two killer after hypertension. Currently, almost 5,000,000 persons died of the diseases associated with cigarette smoking every year in the world, and among them, about 1,200,000 smokers are in China.

A smoking addict has a strong craving for tobacco, essentially indicating a dependence on drugs. Nicotine contained in tobacco is bound to nicotine receptors present on cholinergic neurons of central nervous system to change the normal physiological state of human body when smoking, and the number and sensitivity of nicotine receptors are changed over time, thereby developing a dependence on nicotine; once smoking stopped, the smoker has a series of mental, psychological and physiological disorders including craving for smoking, anxiety, dizziness, headache, lack of concentration, strong appetite and decreased heart rate, which are all referred to as nicotine withdrawal symptoms. Another manifestation of nicotine addiction is that

relapse of cigarette smokers is easy to occur after smoking cessation. Nicotine addiction is one of the most difficult addictions to overcome with recidivism equaling that of heroin addiction.

Since more and more people realize the harmfulness of smoking but smoking cessation is highly difficult, it has become a subject attracting increasing concerns to seek for a method for smoking cessation which is simple, safe and effective without discomfort to the quitting smokers.

Scopolamine is an alkaloid extracted from the dry flower (Flos Datura) of Datura metel L. which belongs to the family of Solanaceae, and has been widely used for clinical application as one M-choline receptor blocker.

Scopolamine has a stronger spasmolytic effect for smooth muscle than atropine, and it can selectively remit spasm of smooth muscles in gastrointestinal tract, biliary tract and urinary tract and inhibit peristalsis of these smooth muscles, or may be used for relieving spasm of vascular smooth muscle and improving microcirculation. Scopolamine has excitatory effect on the respiratory center; and has a stronger effect of anti-vertigo and anti-paralysis agitans than atropine. Moreover, scopolamine has a significant sedation effect on the central nervous system, which can produce hypnosis effect upon application in a high dosage. Currently, scopolamine is mainly used for the preoperative preparation of fibrogastroscopy, duodenum endoscopy and colonoscopy; endoscopic retrograde cholangiopancreatography; and the preoperative preparation of pneumobarim hypotenic radiography of stomach, duodenum and colon or abdomen CT scanning in clinical practice, since scopolamine can reduce or inhibit gastrointestinal peristalsis. In addition, scopolamine is further used for remitting gastrointestinal spasm, biliary colic, renal colic or gastrointestinal hypermotility caused by various etiologies.

Glick, et al. found that scopolamine decreased tobacco dependence in monkeys in 1970 (Glick S. D, Jarvick M. E, Nakamura NK Inhibition by

Drugs of Smoking Behavior in Monkeys, Nature, 227:969:71(1970)). Subsequently, Bachynsky demonstrated a significant improvement in smoking cessation rates by using an injection of atropine, scopolamine and chlorpromazine, and was granted the U.S. Pat. No. 4,555,397. U.S. Pat. No. 4,555,397 disclosed a method which can alleviate nicotine withdrawal symptoms of a quitting smoker by subcutaneously injecting the site behind each ear of the quitting smoker with a solution containing both atropine and scopolamine, and promoting, with chlorpromazine, the inhibition of an excessive acetylcholine stimulation caused by cessation. As a result of the two month follow-up evaluation, it was found that the smoking cessation rate was attained to an average of 66.2% by using only the injection containing both atropine and scopolamine without chlorpromazine, whereas the smoking cessation rate was attained to an average of 86.8% by using the above solution simultaneously with chlorpromazine. This method proved that a satisfactory cessation rate could be attained only by using an injection simultaneously containing atropine, scopolamine and chlorpromazine. However, the simultaneous use of scopolamine and chlorpromazine may cause serious side effects on some quitting smokers.

U.S. Pat. No. US20050226920 to Voelker disclosed a method which can decrease nicotine withdrawal symptoms of a quitting smoker by injecting the quitting smoker with an injection containing scopolamine, hyoscyamine(or atropine) and chlorpromazine(or hydroxyzine). In this method, after injecting a quitting smoker with said injection, anticholinergic medications such as scopolamine or hydroxyzine were orally continuously administered for 14 days, until the physiological effect of nicotine withdrawal was minimized. This method was directed to the physiological aspect of nicotine withdrawal, and meantime quitting smokers needed to conquer the psychological addiction of smoking, so as to succeed in smoking cessation. However, this patent did not mention the effect of smoking cessation which could be

attained.

Another U.S. Pat. No. US20050227998 to Voelker disclosed a method which can alleviate nicotine withdrawal symptoms of quitting smokers by administrating a pharmaceutical composition containing scopolamine and hydroxyzine. In this method, after intramuscularly injecting a quitting smoker with an injection containing scopolamine and hydroxyzine, anticholinergic medications such as scopolamine or hydroxyzine were orally continuously administered for 14 days. A smoking cessation rate of 80% could be attained by this method in one month after administration. In addition, the Chinese Patent Application Publication No. CNl 875968 filed by Ping ZHENG disclosed a method of smoking cessation by continuously injecting anisodamine injection for 10 to 14 days in combination with acupuncture staples or Chinese traditional medicine differentiating symptoms. For this method, 61% had remained non-smokers following a period of treatment of 10 to 14 days, and 73% had remained non-smokers following two periods of the treatment.

However, the above methods for helping smokers quit smoking have disadvantages of inconvenience, unsafety, and a low complete success rate of smoking cessation when implemented.

Summary

Therefore, the invention provides a method for smoking cessation which is simple, safe and effective.

In order to achieve the object of the invention, the invention provides a kit for smoking cessation comprising: (1) scopolamine injection; and (2) acupuncture staples.

The invention also provides a method for using said kit, which comprises administrating said scopolamine injection via one single intramuscular injection, and then placing said acupuncture staples in Mouth and Lung points

outside both ears and stimulating them when necessary, and moreover administrating an adjuvant if necessary.

In addition, the invention proposes a use of a combination of scopolamine and acupuncture staples in reducing nicotine withdrawal symptoms of quitting smokers.

Through this method, the cessation rate in quitting smokers can be attained to 88.97% by one single injection treatment followed by an auxiliary therapy of auricular acupunctures and, if necessary, psychological consultation or assistance.

Detailed description

The kit for smoking cessation of the invention comprises (1) scopolamine injection; and (2) acupuncture staples.

The scopolamine injection used in the invention is not particularly limited, and the conventional scopolamine injection used in clinic may be used.

The amount of scopolamine can be adjusted according to the conditions such as body weight of the quitting smoker, and the dosage of conventional scopolamine injection used in clinic may be used. Generally, said injection contains scopolamine in an amount ranging from 0.01 mg to 0.8 mg. Moreover, the injection of the invention is preferably a subcutaneous or intramuscular injection.

The following adjuvant can be administered substantially together with, or simultaneously with the injection containing scopolamine of the invention, or after the administration of said injection. Said adjuvant is at least one selected from hydroxyzine, chlorpromazine, atropine, ipratropium, meprobamate, benzodiazepines, clonidine, serotonin (5-hydroxytryptamine) uptake inhibitors and bupropion. The dosage of said adjuvant is a conventional dosage currently used in clinic. Said adjuvant is preferably at

least one of hydroxyzine, chlorpromazine and atropine.

When using the kit of the invention, said injection is administered via one single intramuscular injection followed by placing said acupuncture staples in Mouth and Lung points outside both ears of quitting smokers, and stimulating the acupuncture staples when there are urges to smoke, which helps further decrease nicotine withdrawal symptoms of the quitting smokers.

There is no particular limitation to acupuncture staples which is used, and in view of convenience, disposable acupuncture seed can be used. The operation method thereof comprises disinfecting the local auricle, sticking said acupuncture staples onto auricular points and properly pressing to produce feeling of hot and distending pain at the auricle. The sticking of acupuncture staples is maintained for 1 to 2 weeks.

In clinical study, 1000 voluntary quitters used the kit of the invention to receive the treatment of smoking cessation after the physical examination, and the results showed that of 1000 quitters 88.97% had remained non-smokers for one month after the treatment; 78.67% had remained non-smokers for three months after the treatment; 67.65% had remained non-smokers for six months after the treatment; and 53.45% had remained non-smokers for twelve months after the treatment. Among the 1000 voluntary quitters, 93 percent of them were only subjected to a treatment of one single scopolamine injection in combination with auricular acupunctures; and 7 percent of them were only subjected to a treatment of one single injection containing both scopolamine and hydroxyzine in combination with auricular acupunctures. Therefore, the method for smoking cessation of the invention is not only more convenient and safer for most of quitters, but also has significant short-term effect and long-term effect on smoking cessation.

After the treatment using the above mentioned kit, 5 percent of quitters started to show symptoms of tension and dysphoria. For these quitters, a subsequent treatment can be carried out to continuously decrease the

physiological effect of nicotine withdrawal according to respective conditions after a physical examination of them. The subsequent treatment includes that the individual compounds comprising scopolamine (patches or tablets), hydroxyzine, chlorpromazine, atropine, ipratropium (vasodilator, inhalant), meprobamate (tranquilizer, tablets), benzodiazepines (being used when tensioned), clonidine, serotonin uptake inhibitors (vasoconstrictor) and bupropion were administered either singly or in an optional combination thereof for 14 to 21 days in the dosages and forms which are conventionally used in clinic. In addition, the method of the invention can succeed in smoking cessation after a treatment of one single injection in combination with auricular acupunctures without a subsequent treatment, but many quitting smokers are required to overcome the psychological addiction of smoking. To address this psychological addiction, numerous methods can be used, for example, before or after the administration of the kit, means such as individual or group counseling, watching video, CD, DVD and follow-up video, listening to the recording, telephone counseling, internet discussion, internet chatting, group telephone discussion and group meetings can be used to implement behavioral modification of psychological addiction, thereby helping reduce the psychological dependence on nicotine and improve success rate of smoking cessation.

The success rate of the method for smoking cessation of the invention is higher than that of the methods reported in current literatures, and the method of the invention is more convenient and safer than them.