Positive Health Online

Abstract

JANG and COLLEAGUES, 1. Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea; 2. KM Fundamental Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea.

3. Department of Preventive Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea; 4. Department of Korean Internal Medicine, Daejeon University Korean Medicine Hospital, Daejeon, Republic of Korea; 5. Internal Medicine College of Korean Medicine, Semyung University, Jecheon, Republic of Korea conducted a pilot study to investigate the effectiveness of traditional and complementary medicine (T&CM) interventions upon smoking cessation.

Background

Nicotine dependence is a disease, and tobacco use is related to 6 million deaths annually worldwide. Recently, in many countries, there has been growing interest in the use of traditional and complementary medicine (T&CM) methods, especially acupuncture, as therapeutic interventions for smoking cessation. The aim of this pilot study is to investigate the effectiveness of T&CM interventions on smoking cessation.

Methodology

The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial. This trial will evaluate whether adding T&CM methods (i.e., ear and body acupuncture, aromatherapy) to conventional cessation methods (i.e., nicotine replacement therapy (NRT), counselling) increases smoking cessation rates. Forty participants over 19 years old who are capable of communicating in Korean will be recruited. They will be current smokers who meet one of the following criteria: (1) smoke more than 10 cigarettes a day, (2) smoke less than 10 cigarettes a day and previously failed to cease smoking, or (3) smoke fewer than 10 cigarettes a day and have a nicotine dependence score (Fagerstrom Test for Nicotine Dependence) of 4 points or more. The trial will consist of 4 weeks of treatment and a 20 week follow-up period. A statistician will perform the statistical analyses for both the intention-to-treat (all randomly assigned participants) and per-protocol (participants who completed the trial without any protocol deviations) data using SAS 9.1.3. Ethics and Dissemination: This study has been approved by the Institutional Review Board (IRB) of the Dunsan Korean Medicine Hospital of Daejeon University (IRB reference no: DJDSKH-15-BM-11-1, Protocol No. version 4.1.).The protocol will be reapproved by IRB if it requires amendment. The trial will be conducted according to the Declaration of Helsinki, 7th version (2013). This study is designed to minimize the risk to participants, and the investigators will explain the study to the participants in detail. As an ethical clinical trial, the control group will also be given conventional cessation treatments, including NRT and counselling. Participants will be screened and provided with a registration number to protect their personal information. Informed consent will be obtained from the participants prior to enrolling them in the trial. Participants will be allowed to withdraw at any time without penalty. Trial Registration Number: ClinicalTrials.gov (NCT02768025); pre-results.

Results

Conclusion

References

Jang S1,2, Park S3, Jang BH1, Park YL1, Lee JA2, Cho CS4, Go HY5, Shin YC1, Ko SG1. Study protocol of a pragmatic, randomised controlled pilot trial: clinical effectiveness on smoking cessation of traditional and complementary medicine interventions, including acupuncture and aromatherapy, in combination with nicotine replacement therapy. BMJ Open. 7(5):e014574. doi: 10.1136/bmjopen-2016-014574. Jun 2 2017.