Smoking Cessation
Conditions
Keywords
smoking cessation, tobacco control, acupuncture, Korean Medicine, Traditional & Complementary Medicine
Brief summary
Background: As smoking regulatory policies, including the WHO FCTC (Framework Convention on Tobacco Control), are enforcing, demand for smoking cessation treatment is being increased. According the trend, development and evaluation of the medical guideline, Induced participation of medical personnel and available in Korean medical clinic, is needed. Purpose: To evaluate the satisfaction and effect of traditional & complementary medicine (T&CM) tobacco control program Methods: Recruited subjects were divided into control and test groups. They treated two times a week during the first three weeks and once a week during the last week. Program participation rates and drop rates, satisfaction, amount of smoking before and after programs , smoking-related key variables, nicotine dependence test (Fagerstrom test), Expired CO amounts, urinary cotinine amount, withdrawal symptoms, the change in quality of life(EQ-5D) are measured.
Detailed description
Subjects in control group are treated NRT and counselling. Nicotine Replacement Therapy is provided 7 patches and 30 gums once a week for 4 weeks. Using amounts are depend on each subject's cravings. (Investigator will check how much they used.) Doctor consults about 10-15 minutes per visit. Subjects in intervention group are treated NRT, counselling and traditional & complementary medicine treatment (Body acupuncture, Ear acupuncture and aromatic therapy). Body acupoints are HT7, LI4, ST36, LU7, LU6 on both sides. Ear acupoints are Shenmen, Lung, Pharynx, Trachea, Endocrine. Subjects are treated with acupuncture for 20 minutes per visit and put ear acupuncture like sticker for 1-2 days. Mixture oil of Lavender, peppermint, rosemary are used to massage behind the ears. It is used 2 times a day and they can adjust frequency depending on their cravings.(Investigator will check how much they used.)
Interventions
OTHERTraditional & Complementary Medicine treatment
Body acupuncture, Ear acupuncture and aromatic therapy
OTHERNRT, counselling
Nicotine Replacement Therapy, counselling
Sponsors
Daejeon University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\) having willing to stop smoking 2) currently smoking and applying one of the following
Exclusion criteria
* 1\) suffering in the last 2 weeks cardiovascular disease or Severe arrhythmias, unstable angina 2) suffering from severe arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Abstinence Rate | 4 week | endpoint of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Abstinence Rate | 3,6 month | follow-up measure |
| Program participation rate | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | each treatment and follow-up |
| Amount of smoking | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | each treatment and follow-up |
| Tobacco craving | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | each treatment and follow-up |
| 7-day Point Prevalence Abstinence | 6,8,12,16,24 week | follow-up measure |
| Quality of life | 0,4 week | beginning and endpoint of treatment |
| Nicotine dependence test (Fagerstrom test) | 10, 17 day, 4week | — |
| Withdrawal symptoms | 1,2,3,4 week | — |
| Exhaled Carbon monoxide monoxide | 0,7,10,14,17 day, 3,4,6,8,12,16,24 week | each treatment and follow-up |
Countries
South Korea
Outcome results
None listed