A Systematic Review And Meta-analysis Of TCM Smoking Cessation And Qualitative Interviews On Factors Influencing Successful Implementation Of Smoking Cessation

BackgroundThe harm of tobacco is one of the most serious public health problems in the world.Every year,the global death toll caused by tobacco is as high as 6 million,among which China is the largest tobacco producer and consumer in the world.The China's Health Hazards of Smoking Report clearly states that quitting smoking is the most effective and cost-effective intervention to improve health and save lives.Tobacco dependence is not just a disease,it is also a sociological behavior.In view of this characteristic,this study will start from external factors(smoking cessation intervention)and internal factors(smokers' psychology),to study how to improve the success rate of smoking cessation.At present,there are too many ways to quit smoking,including nicotine replacement therapy,medication therapy,behavioral therapy and psychological therapy,Chinese medicine therapy,etc.Traditional Chinese medicine(TCM),as a complex intervention guided by a holistic view,has its unique advantages in the field of smoking cessation,but its efficacy needs further study.As smoking been an addictive behavior,smokers' cognition,experience,attitude and belief in quitting smoking are also important factors affecting the success rate of smoking cessation.Understandng the psychological factors of smokers can better promote the use of smoking cessation interventions and improve the success rate of smoking cessation.PurposeThis study will combine quantitative and qualitative methods to evaluate the efficacy and safety of smoking cessation by TCM,explore the factors affecting the success rate of smoking cessation,and provide research ideas for the participation of TCM in smoking cessation in the future.Study 1:To systematically summarize and analyze the clinical research characteristics of published randomized controlled trials(RCT)of TCM on smoking cessation,assess the methodological quality of included studies,and evaluate the effectiveness and safety of TCM intervention on smoking cessation.Study2:Semi-structured,one-to-one qualitative interviews were conducted for healthy smokers or ex-smokers to summarize and analyze their cognition,attitudes and beliefs about quitting smoking,and to explore the facilitating and hindering factors affecting smokers'success rate of quitting smoking,so as to provide a research basis for future smoking cessation implementation research.MethodStudy 1:Randomized controlled trials of smoking smoking with TCM as the main intervention were systematically retrieved from CNKI,WANFANG,CQVIP,SINOMED,PubMed,and Cochrane Library.The publication language was limited to Chinese and English,and the retrieval time is from the establishment of each database to November 7,2020.The basic information and clinical study characteristics of the included studies were extracted.The main outcome indicators were point prevalence and continuous abstinence rate,and the secondary outcome indicators were nicotine withdrawal symptoms(NWS),nicotine dependence score(FTND)and relapse rate,the safety outcome was adverse events due to the trial intervention.According to the intervention measures of the control group,the included trials were divided into the conventional medication group(nicotine patch,Varenicline or bupropion hydrochloride),the placebo group,the blank control group,and other non-pharmaceutical intervention groups(Psychological intervention,behavioral therapy,publicity and education or consultation).The studies comparing the intervention methods of TCM with TCM were not included in the meta-analysis.The Cochrane Risk of Bias Assessment Tool was used for evaluation and analysis,and the extracted data were statistically analyzed using RevMan 5.4 software.Subgroup analysis was performed if data were qualified,heterogeneity test was performed at 75%of I2,and publication bias analysis was performed when more than 10 studies were included in Meta analysis.Study2:The method of convenient sampling is adopted to select healthy smokers of different ages and occupations who have smoked for more than half a year as the interviewees.According to the dynamic sampling principle and information saturation principle,interviewees with different demographic characteristics were selected,and the information provided by the last interviewee was regarded as information saturation when there was no difference between the previous interviewee and the last interviewee.The researcher raised questions in accordance with the interview outline prepared in advance,and adjusted the order of questions at any time according to the interviewees' answer ideas until all the questions on the interview outline were completed.The interview was conducted online due to the influence of COVID-19.After obtaining the consent of interviewees,the interview content was recorded,and the recording file was transcribed into text.Nvivo12 software was used to encode the transcribed text and form the basic theme.We used frame-topic analysis method to conclude the codes and basic themes into Behavior,Motivation,Ability and Material Opportunity for analysis based on the Behavior Change Wheel theory.ResultsStudy 1:Sixty-six RCTs involved 9977 participants were included.The number of RCTs for smoking cessation in TCM is increasing year by year,and China was the country with the largest number of researches(39 studies,59.1%).Fifty-four(80.6%)of them included healthy adult smokers as research objects,and TCM intervention measures were mainly acupoint stimulation(57,85.1%).Twenty-eight(41.8%)studies used placebo control.Internal administration of traditional Chinese medicine compound,acupoint stimulation,external use of Chinese herbal medicine patch combined with nicotine patch are common intervention methods of integrated TCM and western medicine.Twenty six(38.8%)studies did not distinguish between the two indicators,only reported general abstinence rate as outcome.The overall methodological quality of included studies was low,and random sequence generation,allocation concealment,blinding of outcome assessment,selective reporting were not fully reported.Twenty-eight(41.79%)studies reported blinding method used,and 39(58.2%)studies had a high risk of bias in blinding of participants and personnel.The included studies were divided into two subgroups of acupoint stimulation and herbal medicine according to TCM intervention measures.The results of 6 meta-analyses showed that there were no statistically significant difference between the effect of TCM intervention and that of conventional medication intervention in terms of the point prevalence at 7-day,1-month,2-month,5-month and 6-month time points.There were no statistically significant difference between TCM and conventional medication intervention(RR=0.33,95%CI[0.01,7.87],1 trial)or placebo(RR=3.00,95%CI[0.13,70.16],1 trial)in continuous abstinence rate after 7 days and below.There was no statistical difference between TCM intervention and conventional medication intervention(RR=0.33,95%CI[0.04,3.03],1 trial)in continuous abstinence rate from 7 days to 1 month.However,the effect of TCM combined with conventional medication compared with conventional medication(RR=0.75,95%CI[0.62,0.90],1 trial)was better than that of conventional medication,and the effect of TCM compared with placebo(RR=1.47,95%CI[1.05,2.07],7 trials)was better.In terms of continuous abstinence rate from 1 month to 6 months,TCM intervention(RR=0.81,95%CI[0.69,0.95],9 trials)and TCM combined with conventional medication intervention(RR=1.32,95%CI[1.14,1.55],2 trials)were better than conventional medication intervention.There was no statistically significant difference between TCM and other non-pharmacy interventions(RR=1.05,95%CI[0.36,3.05],4 trials),placebo(RR=2.01,95%CI[0.93,4.34],5 trials),and blank control(RR=1.93,95%CI[0.70,5.29],1 trial).In terms of continuous abstinence rate from 6 months to 1 year,TCM intervention(RR=0.52,95%CI[0.39,0.70],2 trials)and TCM combined with Western medicine intervention(RR=1.45,95%CI[1.23,1.70],1 trial)were superior to conventional medication intervention.In addition,TCM intervention was also better than placebo(RR=1.85,95%CI[1.29,2.67],3 trials)and blank control(RR=2.27,95%CI[1,12,4.58],1 trial).When compared with other non-drug therapies(RR=1.74,95%CI[0.95,3.18],3 trials),there was no statistically significant difference.The results of five trials showed that there was no statistical difference in the efficacy of acupoint stimulation(acupuncture,auricular acupoint pressing)compared with nicotine patches in alleviating the NWS.With the extension of intervention time,the effect of TCM intervention on the alleviation of NWS gradually decreased.The results of 9 trials showed that there was no statistical difference in the effect of acupoint stimulation(acupuncture,ear acupoint sticking)compared with nicotine patches in alleviating nicotine dependence,and the extension of intervention time at any time did not reflect the possible advantages of traditional Chinese medicine.The results of the four experiments showed that there was no significant difference in the relapse rate of TCM,and the effect of TCM combined with western medicine was better than that of western medicine,and the effect of Chinese medicine intervention was better than that of placebo.There were no serious adverse events caused by TCM intervention.Study2:This study included 30 interviewees from 5 different cities,involving 25 males and 5 females.The age of the interviewees ranged from 13 to 63.The average age of smoking was 18.15 years.The interview time ranged from 20 to 40 minutes.Through the information saturation test,the interview information reached saturation.The interview text were concluded into 9 themes:behavior(smoking and quitting),motivation(smoking and quitting),ability(smoking and quitting),material opportunity(smoking and quitting)and advice to prevent youth from smoking.The results suggest that there are two ways to improve your chances of quitting:On the one hand,we need to ease and weaken smokers' smoking motivation(curiosity,pressure,boredom,etc.),change their cognition(smoking is not a disease,smoking has various benefits,smoking is a social tool),and weaken the negative impact of material opportunities(people around them offer cigarettes,family connivance,ineffective propaganda of quitting).On the other hand,we need to constantly strengthen quitters quitting motivation(healthy,for families and children),give people who wants to stop smoking the ability of positive significance(willpower,determination,quitting smoking cessation methods,quit smoking knowledge,etc.),create better quit smoking material opportunities(get away from the smoking environment,understanding and support of people around,families and partner support and supervision).ConclusionsThe TCM smoking cessation RCT is increasing year by year,and they mainly chose healthy adult smokers as study subjects,and most TCM intervention measures were acupoint stimulation.There were nearly half of studies using placebo control,and the most concerned outcome indicator was abstinence rate,but the distinction between point of effectiveness and continuous effectiveness on abstinence rate is inadequate and unclear.At present,the quality of published studies is generally low,and the generation and concealment of randomization,registration of trial protocol,funding and conflict of interest need to be fully reported.And there is still room for improvement in blinding design.In terms of the abstinence efficacy,the withdrawal effect of the intervention method combining Chinese and conventional medicine is better than that of conventional medication alone.In terms of the long-term abstinence rate,the intervention of Chinese medicine may be more advantageous than other interventions.In terms of relieving nicotine withdrawal symptoms,the short-term effect of TCM intervention with acupoint stimulation may be better,while the long-term effect of herbal medicine may be better,and the effect of TCM intervention on reducing nicotine dependence is equivalent to other interventions.For smokers,smoking behavior is closely related to the smokers around them.At the same time,smoking and quitting behaviors are greatly affected by emotions.In the future,more studies are needed to focus on integrated TCM and conventional medication for smoking cessation,long-term efficacy of TCM for smoking cessation,internal treatment of TCM for smoking cessation,TCM for alleviating symptoms of smoking cessation anxiety.