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

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 8weeks and then will be followed-up for 8weeks. 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.

Automated summary

This study aims to determine the efficacy and safety of acupuncture and/or nicotine replacement therapy for smoking cessation. A multicenter randomized controlled trial will be conducted, recruiting 96 participants who are willing to quit smoking. The participants will be divided into four groups for different intervention modalities and followed up for assessment.