Top

Published in:

Open Access 01-12-2022 | Acupuncture | Study protocol

The efficacy and safety of acupuncture and nicotine replacement therapy for smoking cessation: study protocol for a randomized controlled trial

Authors: Qingsheng Wang, Runjing Dai, Hailiang Zhang, Xiaomei Jiang, Xiaojing Ma, Xiangrong Zhang, Shisan Bao, Dong Ren, Jingchun Fan

Published in: Trials | Issue 1/2022

Abstract

Introduction

Tobacco hazard is one of the most serious public health problems, accounting for up to 6 million deaths worldwide p.a. We aim to determine the efficacy and safety of acupuncture and/or nicotine replacement therapy on smoking cessation.

Methods

We will recruit 96 participants who are willing to quit smoking by acupuncture and/or nicotine replacement therapy in Chengguan, Xigu and Heping Districts, Lanzhou city, for multicenter randomized, double-blind, double-dummy controlled clinical trial. Following obtained the informed consent forms, all eligible participants will be randomly divided into 4 groups: (1) acupuncture combined with nicotine patch, (2) acupuncture combined with sham nicotine patch, (3) sham acupuncture combined with nicotine patch, and (4) sham acupuncture combined with sham nicotine patch. These participants will be treated with different intervention modalities for 8 weeks and then will be followed-up for 8 weeks. The SPSS 26.0 software will be applied to analyze the clinical effects and adverse reactions of different intervention measures for smoking cessation.

Discussion

This trial is a prospective, pragmatic, randomized, multicenter trial study protocol. The outcomes will illustrate the efficacy and safety of acupuncture and/or nicotine patches for smoking cessation. Provide smokers with a superior smoking cessation program.

Trial registration

Chinese Clinical Trial Registry ChiCTR2100042912. Registered on January 31, 2021.

Available only for authorised users

World Health Organization. The ICD-10 Classification of Mental and Behavioural Disorders: diagnostic criteria for research. Clinical Descriptions & Diagnostic Guidelines Geneva. 1993. https://www.mendeley.com/catalogue/19782f27-db9a-3f14-a2af-10aa58fb500b/

Botvin GJ. The Health Consequences of Smoking-50 Years of Progress: A Report of the Surgeon General. U.S. National Library of Medicine; 2014. https://stacks.cdc.gov/view/cdc/21569.

Qin YB, Qu NN, Zheng X, et al. Clinical observation of Chinese herbal quit smoking Babu Patch combining acupuncture treating tobacco dependence with phlegm and blood stasis syndrome. Chin J Tradit Chin Med and Pharm. 2020;35(11):542–6.

Bloom EL, Minami H, Brown RA, et al. Quality of life after quitting smoking and initiating aerobic exercise. Psychol Health Med. 2017;22(9):1127–35. https://doi.org/10.1080/13548506.2017.1282159.CrossRefPubMedPubMedCentral

Toll BA, Rojewski AM, Duncan LR, et al. “Quitting smoking will benefit your health”: the evolution of clinician messaging to encourage tobacco cessation. Clin Cancer Res. 2014;20(2):301–9. https://doi.org/10.1158/1078-0432.CCR-13-2261.CrossRefPubMedPubMedCentral

D'Argenzio A, D'Argenio P, Ferrante G, et al. 40% of smokers try to stop smoking, only 8% succeed in. Epidemiol Prev. 2011;35(5-6):362.PubMed

Jang S, Lee JA, Jang BH, et al. Clinical effectiveness of traditional and complementary medicine interventions in combination with nicotine replacement therapy on smoking cessation: a randomized controlled pilot trial. J Altern Complement Med. 2019;25(5):526–34. https://doi.org/10.1089/acm.2019.0009.CrossRefPubMed

Hartmann-Boyce J, Chepkin SC, Ye W, et al. Nicotine replacement therapy versus control for smoking cessation. Cochrane Database Syst Rev. 2018;5(5):Cd000146. https://doi.org/10.1002/14651858.CD000146.pub5.CrossRefPubMed

Hajek P, West R, Foulds J, et al. Randomized comparative trial of nicotine Polacrilex, a transdermal patch, nasal spray, and an inhaler. Arch Intern Med. 1999;159(17):2033–8. https://doi.org/10.1001/archinte.159.17.2033.CrossRefPubMed

10.

Vogeler T, McClain C, Evoy KE. Combination bupropion SR and varenicline for smoking cessation: a systematic review. Am J Drug Alcohol Abuse. 2016;42(2):129–39. https://doi.org/10.3109/00952990.2015.1117480.CrossRefPubMed

11.

Guo ST, Lin H, Chi JF. Recent advances in the methods for smoking cessation. Chin Gen Pract. 2017;30:117–21.

12.

Chai X, Yang JS, Liu Z, et al. Effect of the different smoking cessation regimens with acupuncture on smoking withdrawal and their influence factors: a multi-center randomized controlled trial. Zhongguo Zhen Jiu. 2019;39(12):1255–61. https://doi.org/10.13703/j.0255-2930.2019.12.001.CrossRefPubMed

13.

Wang YY, Liu Z, Wu Y, et al. Efficacy of acupuncture is noninferior to nicotine replacement therapy for tobacco cessation: results of a prospective, randomized, active-controlled open-label trial. Chest. 2018;153(3):680–8. https://doi.org/10.1016/j.chest.2017.11.015.CrossRefPubMed

14.

Hyun S, Huh H, Kang NG. Effectiveness of auricular acupuncture combined with nicotine replacement therapy for smoking cessation. Tob Induc Dis. 2018;16(40). https://doi.org/10.18332/tid/94328.

15.

Lhommeau N, Huchet A, Castera P. Acupuncture and smoking cessation, a review of the literature. Rev Mal Respir. 2020;37(6):474–8. https://doi.org/10.1016/j.rmr.2020.02.016.CrossRefPubMed

16.

Dai R, Cao Y, Zhang H, et al. Comparison between acupuncture and nicotine replacement therapies for smoking cessation based on randomized controlled trials: a systematic review and bayesian network meta-analysis. Evid Based Complement Alternat Med. 2021;2021:9997516. https://doi.org/10.1155/2021/9997516.CrossRefPubMedPubMedCentral

17.

Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. https://doi.org/10.1136/bmj.e7586.CrossRefPubMedPubMedCentral

18.

Wang YY, Liu Z, Wu Y, et al. A randomized controlled trial on smoking cessation by acupuncture. J Beijing Univ Tradit Chin Med. 2018;v.41(07):79–84.

19.

Wang M, Luo X, Xu S, et al. Trends in smoking prevalence and implication for chronic diseases in China: serial national cross-sectional surveys from 2003 to 2013. Lancet Respir Med. 2019;7(1):35–45. https://doi.org/10.1016/S2213-2600(18)30432-6.CrossRefPubMed

20.

Parker L, Mok MS. The use of acupuncture for smoking withdrawal. Am J Acupunct. 1977;5(4):363–6.

21.

Sammito S, Claus A, Rose DM. Smoking prevalence in the area of responsibility of the German Ministry of Defense - results of the employee survey in the context of occupational health management. Mil Med Res. 2020;7(1):5.PubMedPubMedCentral

22.

World Health Organization. International classification of diseases, 10th revision, online versions. 2016.

23.

Neo HY. From Bolam-Bolitho to modified-montgomery - a paradigm shift in the legal standard of determining medical negligence in Singapore. Ann Acad Med Singapore. 2017;46(9):347–50.CrossRef

Title: The efficacy and safety of acupuncture and nicotine replacement therapy for smoking cessation: study protocol for a randomized controlled trial
Authors: Qingsheng Wang
Runjing Dai
Hailiang Zhang
Xiaomei Jiang
Xiaojing Ma
Xiangrong Zhang
Shisan Bao
Dong Ren
Jingchun Fan
Publication date: 01-12-2022
Publisher: BioMed Central
Keyword: Acupuncture
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06384-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

The efficacy and safety of acupuncture and nicotine replacement therapy for smoking cessation: study protocol for a randomized controlled trial

Abstract

Introduction

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

Pediatric specific challenges of the single institutional review board mandate

Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study

Efficacy and safety of Dengyinnaotong Capsule in patients with Cognitive impairment caused by cerebral Small Vessel Disease: study protocol of a multicenter, randomized, open-label, controlled trial (De-CSVD trial)

Correction: Acipimox in Mitochondrial Myopathy (AIMM): study protocol for a randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in adult patients with mitochondrial myopathy

Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial

Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerised anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial