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.

What Was Tested

This pragmatic clinical trial looks at Therapeutic nicotine (patch, non-peptide).

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.

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.

Who Took Part

By PubMed's age tags, the people studied were young adults and adults, both men and women.

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.

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.

How the Study Was Run

The researchers set it up as a randomized, open-label and pilot study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It is described as a pilot, a small early test of whether a larger Therapeutic nicotine (patch, non-peptide) study would be practical.

The STOP (Stop Tobacco Programme using traditional Korean medicine) study is designed to be a pragmatic, open-label, randomised pilot trial.

What Was Measured

Topics PubMed links to this paper include Acupuncture Therapy, Aromatherapy, Counseling, Pilot Projects, Republic of Korea, Smoking Cessation and Tobacco Use Cessation Devices.

Author keywords: Korean medicine, T&CM, study protocol and tobacco control.

What This Means in Plain Language

The paper is a randomized, open-label and pilot study of Therapeutic nicotine (patch, non-peptide).

The publication is from 2017 (BMJ open), a journal based in England.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.