| BackgroundWHO global report on trends in prevalence of tobacco use 2000-2025(Fourth Edition)was issued in 2021,and the report mentions that by 2020,there are a total of approximately 1.3 billion global tobacco users,including approximately 38 million smokers among youth aged 13-15 years,and approximately $14 trillion global economic losses due to cigarette smoking.Although the growth rate of tobacco users has shown a downward trend with the continuous promotion of MPOWER measures mediated by WHO,the overall situation is still not optimistic.The "China Smoking Hazards Health Report" shows that smoking has seriously affected the health of the people in China,and the number of smokers in China has exceeded 300 million,and about one million people die from tobacco-related diseases every year.Smoking cessation can reduce the incidence rate and mortality of smoking related diseases,and is also the most fundamental means to improve the prognosis of smoking related diseases.At present,the influence of nicotine abstinence rate(NMR)on the success rate of quitting smoking has been paid more and more attention.Foreign studies show that smokers with higher nicotine metabolism rate have worse withdrawal effect,and need more or more high-frequency withdrawal drugs during treatment.Acupuncture and moxibustion,as a traditional treatment in China,plays an important role in the treatment of smoking cessation.The team and domestic and foreign studies have shown that the abstinence rate of acupuncture smoking cessation is equivalent to that of nicotine patch therapy in nicotine replacement therapy recommended by American clinical smoking cessation guidelines,which proves the effectiveness of acupuncture smoking cessation.This experiment compared the success rate of acupuncture smoking cessation in smokers with different NMR levels,and on this basis,discussed the relationship between NMR and acupuncture frequency,improved the acupuncture smoking cessation scheme,and achieved better acupuncture effect.ObjectiveTo observe the effect of NMR on acupuncture smoking cessation,and on this basis,to explore whether smokers with different NMR levels need acupuncture stimulation with different frequencies,so as to put forward suggestions on the construction of individualized smoking cessation program.MethodThis study is a multicenter clinical randomized controlled study.The source of cases is 220 voluntary smoking cessation subjects who received acupuncture smoking cessation treatment and met the acceptance criteria recruited from acupuncture Hospital of Chinese Academy of traditional Chinese medicine and Wangjing Hospital of Chinese Academy of traditional Chinese medicine from July 2018 to June 2021.All qualified subjects were randomly divided into groups after signing the informed consent form,220 subjects were divided into acupuncture high frequency group and acupuncture low frequency group with a ratio of 1:1 by using the central random system.There were 110 people in each group.In the two groups,they were divided into high NMR and low NMR levels according to the individual nicotine metabolic rate.Before acupuncture treatment,both groups were given smoking cessation counseling.Acupuncture points were selected:Baihui,Lieque,Hegu,Zusanli,Sanyinjiao and Taichong.Except Baihui,other points were taken from both sides.Operation:before operation,75%medical alcohol was used to routinely disinfect the hands of the doctor and the local skin of the patient’s acupoints.Both Baihui and Lieque adopted the flat needling method,and the penetration depth was 15-20mm,Other acupoints adopt the direct needling method,with the penetration depth of 20-30mm.Each acupoint adopts the acupuncture technique of flat tonic and flat diarrhea,taking the sense of Qi at the acupoints as the degree.Electroacupuncture(continuous wave,15Hz)was performed at bilateral column defect and Zusanli.The intensity was based on the patient’s tolerance,and the treatment lasted for 20 minutes.Course of treatment:patients in the high-frequency acupuncture group was treated 5 times a week in the 1st to 4th week and 3 times a week in the 5th to 8th weeks,3 times a week in the 1st to 4th week of acupuncture in the low-frequency acupuncture group,and 2 times a week in the 5th to 8th weeks.Both groups received 8 weeks of treatment and were followed up at week 12.The point abstinence rate,continuous abstinence rate and before and after treatment were compared between the two groups the scores of Fagerstrom test for nicotine dependence(FTND),Heaviness of smoking index(HSI),Minnesota Nicotine Withdrawal Scale(MNWS)and Questionnaire of Smoking Urges(QSU brief questionnaire)were observed and recorded at the time of enrollment and at weeks 1,2,4,8 and 12.Result1.General informationA total of 238 subjects were recruited.In the baseline evaluation stage,10 cases did not comply with the enrolled criteria,8 cases met the exclusion criteria,and a total of 220 subjects were included.220 subjects were randomly divided into acupuncture high-frequency group and acupuncture low-frequency group according to the ratio of 1:1.During the treatment,27 cases fell off in the acupuncture high-frequency group and 18 cases fell off in the acupuncture low-frequency group.During the follow-up,6 cases in the acupuncture high-frequency group and 7 cases in the acupuncture low-frequency group were lost.Analyzed the baseline data of 220 subjects,and the data of subjects’ general data,smoking background and smoking cessation in the two groups were not statistically different(P>0.05).2.Main outcome indicators2.1 Point abstinence rate based on CO content after treatment and follow-upFor smokers with different NMR levels,the comparison of abstinence rates based on expiratory CO content points after 8 weeks of treatment showed that the total abstinence success rate of low NMR group was 48.5%,which was significantly higher than that of high NMR group(33.3%)(P<0.05).The results of urine cotinine test showed that the total abstinence rate of low NMR group was 33.8%,which was 14.3%higher than that of high NMR group,both difference has statistics significance(P<0.05);During the follow-up period,the comparison results of point abstinence rate based on expiratory CO content showed that the total abstinence success rate of low NMR group(48.5%)was higher than that of high NMR group(29.8%),and the difference was statistically significant(P<0.05).The results based on urinary cotinine test showed that the total abstinence success rate of low NMR group(37.5%)was higher than that of high NMR group(20.2%),and the difference was statistically significant(P<0.05).After 8 weeks of treatment,the comparison results of abstinence rate based on expiratory CO content point showed that the total abstinence rate of acupuncture high-frequency group was higher than that of acupuncture low-frequency group,but there was no statistically significant difference between these two groups(P=0.102).The results of urine cotinine test showed that the total abstinence rate of acupuncture high-frequency group was higher than that of acupuncture low-frequency group,and the difference was not statistically significant(P=0.102);At follow-up survey period,the comparison results of point abstinence rate based on expiratory CO content showed that the total abstinence rate of acupuncture high-frequency group was higher than that of acupuncture low-frequency group,and the difference was not statistically significant(P=0.891).The results based on urine cotinine test showed that the total abstinence rate of acupuncture high-frequency group was the same as that of acupuncture low-frequency group,and the difference was not statistically significant(P=1.000).After 8 weeks of treatment,the withdrawal effect of low NMR subjects in the high-frequency acupuncture group was better than that of high NMR subjects(P<0.05).During the follow-up period,the withdrawal effect of low NMR subjects in the low-frequency acupuncture group was better than that of high NMR subjects(P<0.05).After 8 weeks of treatment,the withdrawal effect of low NMR subjects in the high-frequency acupuncture group and low-frequency acupuncture group was better than that of high NMR subjects,and the difference was statistically significant(P<0.05).During the follow-up period,the withdrawal effect of low NMR subjects in the high-frequency acupuncture group was better than that of high NMR subjects,The difference was statistically significant(P<0.05).2.2Sustained abstinence rate based on patients’ self-report after acupuncture treatment and follow-up periodAt the end of the 8-week treatment period and during the follow-up period,there was a trend that the high-frequency acupuncture group had a higher rate of sustained withdrawal than the low-frequency acupuncture group,based on subject self-reported outcomes,with no significant difference(P>0.05).For the subjects with high NMR,the continuous abstinence rate in the high-frequency acupuncture group was higher than that in the low-frequency acupuncture group,and the difference was statistically significant(P<0.05);At the end of treatment,the continuous abstinence rate of low-frequency NMR subjects in the acupuncture low-frequency group was better than that of high NMR subjects;During the follow-up period,the effect of high frequency acupuncture group and low frequency acupuncture group on low NMR subjects was better than that of high NMR subjects,and the difference was statistically significant(P<0.05).3.Secondary outcome indicators3.1 Assessment of tobacco dependenceThe degree of tobacco dependence was evaluated by FTND scale and HSI scale.Comparing the FTND scores before treatment and at each visit point,there were differences in the changes of FTND scores at each time point(P<0.001).The changes of HSI scores at each time point were different(P<0.05).3.2Evaluation of abstinence symptoms and smoking cravingThe abstinence symptoms and smoking craving were evaluated by MNWS score and QSU brief questionnaire.Comparing the MNWS scores of each visit point,the changes of MNWS scores at each time point were different(P<0.05).Comparing the QSU brief scores of each visit point,the changes of QSU brief scores at each time point were different(P<0.001).4.analysis of efficacy related factorsLogistic regression analysis showed that age,daily smoking volume,smoking age,nicotine metabolic rate and FTND scale score before treatment had an impact on the abstinence success rate at the end of treatment(P<0.05).During the follow-up period,age,daily smoking volume,confidence in quitting smoking,nicotine metabolic rate and co exhalation before treatment were the influencing factors of abstinence success.Conclusion1.Acupuncture therapy can be effective in improving smoking cessation rates,and the withdrawal rate of low NMR subjects is higher than that of high NMR subjects.2.In clinical treatment,it is suggested that smokers with high nicotine metabolic rate should take higher frequency acupuncture treatment,and those with low nicotine metabolic rate should take routine frequency(3 times/week)acupuncture. |