| BackgroundSmoking addiction is a chronic disease(ICD-11,6C4A).A large study in Lancet Public Health based on a Chinese population showed that smoking increased the risk of developing 56 diseases and dying from 22 diseases.The risk of disease from regular smoking was significantly higher in the 35～84 age group compared to those who never smoked regularly.With nearly 20%of adult Chinese men and about 3%of women dying from cigarettes,the need to quit is urgent.Studies show that the sooner you quit smoking,the sooner you will reap the health benefits.Although smokers are well aware of the dangers of smoking and show a strong desire to quit,studies show that about 80%of smokers who try to quit on their own do not last a month,and only 3%to 5%of smokers are successful after multiple attempts.quit smoking.In addition to the population’s low awareness of tobacco dependence,the long withdrawal treatment period and low compliance are the main reasons why it is difficult to quit.Therefore,how to adopt effective and cost-effective interventions to reduce the prevalence of smoking in the population is the current focus of attention.Acupuncture has become a new way to quit smoking.Domestic and international studies have shown that acupuncture can effectively reduce smoking,alleviate withdrawal symptoms,and increase the success rate of smoking cessation.However,maintaining acupuncture treatment for 2～3 months has low compliance and increases the burden on each doctor and patient.Therefore,how to perform timely and dynamic self-intervention to improve compliance is the key to successful withdrawal and an important issue to meet the clinical needs of acupuncture for smoking cessation.Transcutaneous electrical acupoint stimulation(TEAS)is widely used and has the advantages of non-invasiveness,higher safety,simplicity of operation,and self-operability.Based on the fact that both auricular acupoint and TEAS therapies have been shown to be effective in smoking cessation,they have more potential to maintain the long-term efficacy of smoking cessation compared with acupuncture and medication,and are important methods to promote self-help acupuncture for smoking cessation.Therefore,this study aims to investigate the clinical efficacy,safety and compliance of auricular acupressure combined with TEAS acupuncture smoking cessation program,and to compare the efficacy with the first-line smoking cessation drug nicotine patch,so as to lay the foundation for the development of a practical and scalable acupuncture smoking cessation program.It also provides clinical data to support the development of clinical treatment protocols for smoking cessation in TCM and the promotion of community-based and home-based programs.ObjectiveTo evaluate the clinical efficacy,safety and compliance of auricular acupressure combined with TEAS therapy for smoking cessation,so as to improve the self-help and practical acupuncture smoking cessation scheme.MethodThis is a prospective clinical randomized controlled study.Subjects were enrolled in the study from February 2022 to January 2023 at the smoking cessation clinic of the Acupuncture and Moxibustion Hospital of the China Academy of Chinese Medical Sciences.After evaluation,122 subjects who met the nadir criteria were enrolled and signed an informed consent form and then randomized into a 1:1 central randomization method into a combination group and a nicotine patch group,with 61 subjects in each group.The subjects in both groups were given basic smoking cessation counseling,with each counseling session lasting at least 15 min,and subjects completed a "quit card" at the end of each day of treatment.At the first,second,fourth,eighth,and twelve weeks after treatment,the subjects were reminded and urged to follow up by telephone or WeChat to comprehensively assess their smoking cessation status.Press each auricular point for at least 1 min,at least 3 times a day,and press both ears at the same time,so that a slight soreness and swelling is appropriate.In the combined group,auricular acupressure combined with TEAS stimulation was applied to the ShenMen,Lung,Stomach,Sympathetic,Subcortical and Endocrine acupoints,with each auricular acupoint pressed for at least 1 min,at least 3 times a day,with simultaneous pressure in both ears,to the extent of slight soreness and swelling,and replaced every 5 d for 8 weeks;transcutaneous electrical stimulation(continuous wave,frequency 20Hz,up and down connection)was performed at LU7 and ST36 for 30 min each time,once a day.In the nicotine patch group,nicotine patch was given.A course of treatment was given for 8 weeks,and the follow-up was conducted at week 12 after the treatment.The primary outcome indicators were the differences in sustained abstinence rate based on urine cotinine verification and point abstinence rate based on exhaled CO content between the two groups at the 8-week treatment and 12-week follow-up;secondary outcome indicators were observed at each visit during the treatment course on the FTND scale、the Daily cigarette consumption、MNWS scale、and QSU-Brief scale;and safety and adherence(dropout rate and treatment completion)were evaluated using intentional statistical analysis.We also stratified the subject population into mild and moderate tobacco dependence groups based on different levels of tobacco dependence(FTND scale),and observed the abstinence rate based on the point of expiratory CO content for different tobacco dependence groups.Observations were recorded at the time of enrollment and at weeks 1,2,4,8,and 12 of treatment.Result1.General informationA total of 122 subjects were included in this study.By the end of 8 weeks of treatment,there were 13 cases of detachment,including 5 cases in the combination group and 8 cases in the nicotine patch group;at the end of follow-up,26 cases were discharged,10 cases in the combination group(3 cases due to quarantine of the new crown epidemic,4 cases due to work travel or busy schedule,3 cases lost)and 16 cases in the nicotine patch group(5 cases due to quarantine of the new crown epidemic,2 cases due to distant residential address,4 cases due to work and follow-up conflict,1 case moved,4 cases lost),no adverse events occurred in both groups.The baseline data including general information,smoking data and smoking cessation data of the two groups were comparable(P>0.05).2.Main outcome2.1 Continuous abstinence rate and point abstinence rateAt the end of 8 weeks of treatment,the sustained abstinence rate in the combination group was 24.6%(15/61),compared with 27.9%(17/61)in the nicotine patch group,and the difference was not statistically significant(P=0.606,P>0.05);at the end of the follow-up at week 12,the abstinence rate in the combination group was 31.3%(19/61),compared with 29.0%(18/61)in the nicotine patch group.The difference was not statistically significant(P=0.844,P>0.05).At the end of 8 weeks of treatment,the point withdrawal rate in the combination group was 32.8%(20/61),compared with 29.5%(18/61)in the nicotine patch group,a statistically insignificant difference(P=0.696,P>0.05);at the end of the follow-up at week 12,the withdrawal rate in the combination group was 36.1%(22/61),compared with 29.5%(18/61)in the nicotine patch group,a statistically insignificant difference(P=0.696,P>0.05).The difference was not statistically significant(P=0.440,P>0.05).3.Secondary outcome3.1 Assessment of the degree of tobacco dependenceWhen comparing FTND scores at each visit point,FTND scores at 1,2,4,8 weeks and 12 weeks follow-up periods were different between the two groups compared to FTND scores before treatment(P<0.01),but the difference in FTND scores at each visit point between groups was not statistically significant(P>0.05).When comparing the Daily cigarette consumption at each visit point,the Daily cigarette consumption in both groups were lower than before treatment at 1,2,4,8 weeks and 12 weeks follow-up(P<0.01),and at 8 weeks of treatment,the combined group was significantly less than the nicotine patch group(Z=-4.065,P<0.01);at the 12th week of follow-up,the combined group was significantly less than the nicotine patch group(Z=-6.483,P<0.01),with a statistically significant difference in smoking between groups(P<0.01).3.2 Assessment of tobacco withdrawal symptoms and smoking craving levelWhen comparing the MNWS scores at each visit point,the MNWS scores decreased in both groups at 2,4,8 and 12 weeks of follow-up compared to the initial evaluation(P<0.01),with no statistically significant difference between the groups(P>0.05).When comparing the QSU-Brief scores at each treatment visit,the QSU-Brief scores decreased in both groups at 2,4,8 and 12 weeks of treatment compared to the initial evaluation(P<0.01).At 8 weeks of treatment,the decrease in smoking craving was higher in the combined group than in the nicotine group(Z=-2.077,P=0.038);at the 12-week follow-up,the decrease in smoking craving was higher in the combined group than in the nicotine patch group(Z=-2.116,P=0.034).4.Adherence and safety evaluationAt both the 8 week treatment and 12th week follow-up,the rate of shedding was lower in the combination group than in the nicotine patch group,but the difference was not statistically significant(P=0.379,P>0.05),and in terms of treatment completion,the number of completed 8-week treatments(≥45 days)was higher in the combination group than in the nicotine patch group,but the difference was not statistically significant(P=0.241,P>0.05).No serious adverse events occurred in subjects in either group.5.CO point abstinence rates for different levels of tobacco dependence at each visit pointBy comparing the point abstinence rates based on exhaled CO content at different visit points for the two groups with different degrees of tobacco dependence,the study found that(1)mild tobacco dependence:at 8 weeks of treatment,the point abstinence rate in the combined group was 100%(6/6)compared with 88.8%(8/9)in the nicotine patch group(P=0.876,P>0.05);12th week follow-up,the point abstinence rate in the combined group was 100%(6/6)compared with 100%(9/9)in the nicotine patch group(P=1.000,P>0.05).(2)Subjects with moderate to severe tobacco dependence:at 8 weeks of treatment,the point abstinence rate in the combined group was 25.4%(14/55)compared with 19.2%(10/52)in the nicotine patch group(P=0.539,P>0.05);at week 12 follow-up,the point abstinence rate in the combined group of subjects with moderate to severe tobacco dependence was 29.0%(16/55)compared with 17.3%(9/52)in the nicotine patch group(P=0.085,P>0.05).Conclusion(1)Auricular acupressure combined with TEAS has comparable efficacy to nicotine patch for smoking cessation,and can effectively relieve tobacco withdrawal symptoms and increase the abstinence rate.(2)Auricular acupressure combined with TEAS is better to nicotine patch therapy in relieving smoking cravings and reducing daily cigarette consumption.(3)The degree of tobacco dependence can be used as one of the bases for choosing the course of acupuncture cessation therapy,and auricular acupressure combined with TEAS therapy may have more advantageous long-term efficacy and higher safety and compliance for smokers with moderate to severe tobacco dependence,which is worthy of clinical promotion. |
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