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

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.

Effects of acupuncture and nicotine patch on smoking: a multicenter, randomized, controlled, double-blind clinical trial

“…The results showed that acupuncture combined with NRT patch intervention had a significant effect on the tobacco abstinence rate, daily cigarette consumption, expiratory CO, FTND score, and MNWS score. Due to good participant compliance in the pilot test, a 20% loss to follow-up rate was selected to calculate the sample size in the formal test, resulting in a total sample size of 88, which differed from our protocol in the preliminary test ( 21 ).…”

“…The randomization sequence was inserted into sequentially numbered, opaque, sealed envelopes. The acupuncturist treating the patient opened these envelopes ( 21 ).…”

“…Adverse events in this study included needle fainting, stagnation, bending, folding and allergy during the use of the patch ( 21 ), as well as, adverse reactions such as bleeding, hematoma, dizziness, fainting, residual needle sensation, tenderness and infection during the treatment. Adverse events were graded according to the severity of the symptoms/signs using a 3-point scale, 1 = mild (easily tolerated, causing minimal discomfort), 2 = moderate (discomfort significant enough to interfere with daily activities) and 3 = severe (incapacitating and/or requiring therapeutic intervention).…”

“…Baseline characteristics were collected, and the primary outcome was the abstinence rate at the end of treatment, verified by expiratory Carbon Monoxide (CO < 10 ppm) ( 31 ) and/or self/report validation. To reduce/minimize the possible bias, we conducted multiple self-reports over the study, as described ( 21 ). At the meantime, we combined the observation reports of the participants’ families and other medical personnel to obtain more comprehensive information.…”