Efficacy and safety of acupuncture combined with auricular acupressure for smoking cessation: A study protocol of a multicentre, randomized, controlled clinical trial

Jinchun Zeng; Yizu Liao; Xiaojing Wei; Guangxian Chen; Zibin Cai; Min Chen; Yanhua Gou; Guohua Lin

doi:10.3389/fneur.2022.921054

Efficacy and safety of acupuncture combined with auricular acupressure for smoking cessation: A study protocol of a multicentre, randomized, controlled clinical trial

Front Neurol. 2022 Jul 27:13:921054. doi: 10.3389/fneur.2022.921054. eCollection 2022.

Authors

Jinchun Zeng¹, Yizu Liao², Xiaojing Wei³, Guangxian Chen¹, Zibin Cai², Min Chen⁴, Yanhua Gou⁵, Guohua Lin^{1

6}

Affiliations

¹ Department of Rehabilitation, The First Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.
² The First Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, China.
³ Clinical Research and Data Center, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.
⁴ Department of Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.
⁵ Department of Acupuncture and Moxibustion, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China.
⁶ Shenzhen Nanshan Hospital of Traditional Chinese Medicine, Shenzhen, China.

Abstract

Background: Nicotine dependence is an addictive behavioral disease facilitated by habitually smoking cigarettes. In many countries, acupuncture and auricular acupressure have attracted growing attention as complementary or alternative treatments for smoking cessation; however, there is a lack of rigorous randomized, controlled studies evaluating the combination of these two interventions specifically for smoking cessation. The aim of this study is to evaluate the efficacy and safety of using acupuncture combined with auricular acupressure (A&AA) to increase the rates of smoking cessation and ultimately reduce the rates of relapse.

Methods: This is a multicentre, prospective, parallel, randomized, controlled trial. A total of 360 patients with severe nicotine dependence will be randomized into test (A&AA) or control (nicotine replacement therapy, NRT) groups. The test group will be treated with A&AA twice weekly, while the control group will use an NRT patch daily. All treatments will be administered for 8 weeks, with a follow-up period of 4 months. The primary outcome will be the smoking abstinence rate at week 24, with a combined safety assessment. The secondary outcomes will be smoking cessation rates at other timepoints, saliva cortisone test results, and scores on the Fagerstrom Test for Nicotine Dependence, the Autonomy over Tobacco Scale, the Hamilton Anxiety Rating Scale, the Self-rating Anxiety Scale, and the Pittsburgh Sleep Quality Index. The cost of treatment will also be used to evaluate the economic effects of different smoking cessation interventions. Statistical analysis on the data collected from both the intention-to-treat (all randomly assigned patients) and per-protocol (patients who complete the trial without any protocol deviations) patients, will be performed using the statistical software package, IBM SPSS 27.0.

Discussion: This study will provide rigorous clinical evidence evaluating the efficacy and safety of using A&AA as a smoking cessation therapy.

Trial registration: Chinese Clinical Trial Registry (Registration number: ChiCTR1900028371).

Keywords: acupuncture combined with auricular acupressure (A&AA); acupuncture therapy; auricular acupressure therapy; nicotine dependence; smoking cessation.