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Evidence-based Evaluation Of Clinical Research On Smoking Cessation Of Traditional Chinese Medicine And Investigation Of Factors Affecting The Success Of Smoking Cessation

Posted on:2019-09-30Degree:DoctorType:Dissertation
Country:ChinaCandidate:J H WangFull Text:PDF
GTID:1364330596971801Subject:Integrative basis
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Purpose: Tobacco use is one of the greatest public health threats the world has faced so far,and it is a major cause of death,disease and poverty.Smoking cessation at any stage has various benefits for human health,society,and economy.But it is difficult to quit smoking.Currently recommended and most common methods to quit smoking include nicotine replacement therapy,psychological support,and antidepressants,etc.With some disadvantages of high cost,limited efficacy and side effects of these,new method is required to be exploited.Because of the features of overall adjustment,traditional Chinese medicine(TCM)therapy has special advantages in smoking cessation.However,its efficacy has not been recognized internationally and domestically.This paper intends to evaluate the clinical evidence of TCM therapies for smoking cessation,explore safety and effective TCM therapy,and explore the factors that affect smoking cessation,in order to provide reference for related personnel or relevant policy makers.Therefore,the purpose of this study is: to summarize the current status and research hotspot of clinical research on traditional Chinese medicine(TCM)for smoking cessation,and to predict future trend of research on TCM for smoking cessation,using bibliometrics;to evaluate the safety and efficacy of transcutaneous acupuncture on smoking cessation;to carry out a cross-sectional investigation on the factors influencing the success of smoking cessation applying internet technology.Method: 1.A bibliometric analysis of clinical study literature of TCM therapies for smoking cessation With two library staff members,we developed the search terms and conducted literature searches,and searched clinical research literature of TCM therapies for smoking cessation systematically from five Chinese(CNKI,VIP,Sino Med,Wanfang,TCM online)and two English(Pub Med,Cochrane Library)language electronic databases from their inception to February,2017.The published language was limited to Chinese and English.All clinical studies and reviews related to TCM on smoking cessation was included.we placed nolimitations on the types of TCM therapies such as acupuncture,acupressure,massage,herbal formulae,and so on.For controlled clinical studies,the control interventions could be no treatment,sham treatment,waiting list,other treatment,and combined therapy.Editorials and letters to the editor were excluded.When the same data was published more than once,we chose those providing more comprehensive information.Those studies that were conducted in order to study the mechanism of efficacy were not eligible.Note Express software was adopted to manage the retrieved documents.Two review authors selected eligible articles by reading full text and extracted data from included studies using a self-developed electronic data extraction form independently.The third author was responsible for resolving differences and contradictions.The extracted variables included publication characteristics,study design,demographic characteristics,intervention details,control treatment details,and clinical outcomes.The extracted data were imported into SPSS(release 22.0,IBM,Armonk,NY,USA)and Microsoft Excel(version 12.3.5,Microsoft,Redmond,WA,USA),which were used for the statistical analysis and to describe the characteristics of the data.Categorical variables were represented by frequencies and percentages,while continuous variables were reported as means and standard deviations.2.Systematic review and meta-analysis of randomized controlled trials on acupuncture for smoking cessation The Chinese and English search terms was developed.A literature search for randomized controlled trials investigating the efficacy of transcutaneous acupuncture for smoking cessation was performed in two English(Pub Med,Cochrane Library)and five Chinese(CNKI,VIP,Sino Med,Wanfang,TCM online)language electronic databases from their inceptions to February,2017.The published language was limited to Chinese and English.Intervention included transdermal acupuncture with or without additional application of electrostimulation or laser therapy,delivered as monotherapy or in combination with other interventions(nicotine replacement therapy(NRT),acupressure,etc).Such intervention could be compared to no intervention/ waiting list,placebo,or other interventions,no matter acupuncture therapy was applied in treatment group or control group.Studies on acupuncture-related therapies without needles inserted into acupoints were excluded.The primary outcome was abstinence from smoking in short,mid and long-term follow-up.Tworeview authors selected eligible articles by reading full text and extracted data from included studies using a self-developed electronic data extraction form independently.The third author was responsible for resolving differences and contradictions.The extracted variables included study location,sample size,participant characteristics,intervention details,outcome measures,and information of risk of bias.The methodological quality of the included trials was independently analyzed in detail by two authors using the Cochrane Risk of Bias tool in order to assess the strength of the evidence.SPSS 22.0 was used for the statistical description of the characteristics of the data.Meta-analyses were performed when possible using Revman 5.3.0 software.We used random effects model(REM)or fixed effects model(FEM)for pooling data according to the result of heterogeneity test.Statistical heterogeneity was tested using I2(defined as significant if I2 > 50%).Trial sequential analysis(TSA)was applied by TSA 0.9.5.10 Beta software to calculate the sample size of the systematic review and to adjust random errors.3.An online cross-sectional survey on attitudes and promoting and obstructive factors for smoking cessation in China This was a cross-sectional survey carried out in China online.A self-designed Influencing Factors for Smoking Cessation Questionnaire was designed to measure sociodemographic characteristics(such as gender,age,profession,smoking status and so on)and factors related to smoking cessation according to the purpose of the research.The questionnaire inquired about the sociodemographic and tobacco use characteristics,knowledge and attitudes towards smoking and smoking cessation,and a list of factors on smoking cessation.Overall,unstructured anonymous web questionnaires were given to smokers through the We Chat platform.Participants who were current smokers or former smokers in their lifetime were eligible to participate in the study.Respondents could fill in web questionnaire anywhere conveniently,as long as they had a cell phone and network.The respondents with incomplete data from questionnaire were excluded from the study.There was no further inclusion or exclusion criteria.We exported network platform data to create a database,and cleaned up the data.SPSS 22.0 was used for statistical analysis.Results:1.A bibliometric analysis of clinical study literature of TCM therapies for smoking cessation In total,260 publications on TCM therapies for smoking cessation were identified from 1980 to 2016.Annual publications on smoking cessation using TCM therapy are summarized.From 1980 to 2016,the annual number of publications related to smoking cessation using TCM therapy increased slightly in wavy linear,with a peak of 14 in 2006.Then in terms of the quantity of publications,there was a significant decline until 2008.Since 2009 and 2010,there was large increase in publications,peaking in 2013.From 2013 to 2016,the annual number of publications decreased significantly.The long term trend is a gradual increase in the number of publications.178(68.5%)articles were published in Chinese,while 82(31.5%)articles were in English.Of these 260 articles,journal articles(244;93.8%)were the most frequent publication type,followed by dissertations(8;3.1%),and conference full text papers(6;2.3%).Most of the studies were conducted by universities or medical colleges(106;40.8%).Hospitals(96;36.9%)also played a important role in performing the studies related to smoking cessation using TCM therapy,followed by research institutes(30;11.5%)and associations(4;1.9%).Other clinical settings(16;6.2%)in which smoking cessation studies were carried out included clinics,community health centers,nursing homes,companies,and foreign aid medical teams.Seven(2.7%)articles provided no information about the institution.Among 260 articles,205(78.8%)studies did not report whether they had been funded,52(20%)studies received financial support,3(1.2%)did not have any financial aid.The top seven countries,in which studies were carried out,were mainland China(129;49.6%),USA(27;10.4%),the UK(25;9.6%),Korea(9;3.5%),Taiwan(7;2.7%),Australia(5;1.9%),The Republic of Malta(4;1.5%),followed by 27 further countries.Chinese Acupuncture & Moxibustion outranked other journals with 21 publications.Of the top ten active journals,seven were Chinese journals,and three were in English.The data illustrated that the great majority of the literature consisted of case series(110;42.3%),followed by RCTs(52;20.0%),traditional reviews(50;19.2%),individual case reports(18;6.9%),systematic reviews(17;6.5%)and CCTs(7;2.7%).Cross-sectional descriptive epidemiological studies(5;1.9%)accounted for less of the data and cohort studies were the least common(1;0.3%).There were 36,645 participants in the 188 clinical studies excluding the 67 reviews and 5 descriptive epidemiological studies.The largest sample size was 8803(a case seriesconducted in Guangxi China with a reported rate of smoking cessation of 95.0%),while the smallest study had an N of 1(case report).21990(60.0%)were male and 14655(40.0%)were female.Of the 188 clinical studies,only 11 studies reported a detailed ethnic distribution of participants.The analysis of extracted data indicated that the youngest participant was 12 years and the oldest 86.The duration of regular active or passive smoking of all participants varied from 3 months to 70 years.There was a wide variation in the number of cigarettes consumed daily(3-100).The most commonly used TCM interventions were auricular acupressure,body acupuncture,body acupuncture plus auricular acupressure.The TCM therapy effectiveness was reported comprehensively in 111(59.0%)studies,smoking cessation rate was reported in 77(41.0%)studies,smoking craving in 24(12.8%)studies,nicotine dependence scale in 19(10.1%)studies,changes in withdrawal symptoms in 33(17.6%)studies,decrease in daily cigarette consumption in 47(25.0%)studies,change of the taste of cigarettes in 25(13.3%)studies,laboratory parameters in 33(17.6%)studies.Five(2.7%)studies included assessment of quality of life.Forty-one(21.8%)studies focused on the safety of the therapy,including adverse events and/or adverse drug reactions.Two studies(1.1%)reported health economic data.2.Systematic review and meta-analysis of randomized controlled trials on acupuncture for smoking cessation Twenty-four clinical studies involving 3984 patients were finally included in this review.The overall quality of evidence was low depending on the poor methodological quality,according to the high or unclear risk of bias.Pooled results comparing acupuncture to sham acupuncture were not significant for smoking abstinence(in short term [3 trials,RR 1.78,95% CI 0.96 to 3.27,I2=25%,FEM],mid term [1 trial,RR 1.38,95% CI 0.43 to 4.45],long term [2 trials,RR 0.80,95% CI 0.23 to 2.85,I2=0%,FEM]),Nicotine withdrawal symptoms(NWS)(in short term [2 trials,MD-0.72,95% CI-1.72 to 0.28,I2=0%,FEM]),Beck Depression Inventory(BDI)(in short term [1 trial,MD 0.90,95% CI-1.56 to 3.36]),Beck Anxiety Inventory(BAI)(in short term [1 trial,MD-0.40,95% CI-2.28 to 1.48]),appetite for cigarette(in short term [1 trial,MD 1.60,95% CI 0.87 to 2.94]),and were significant for Exhaled CO level(in short term [1 trial,MD-0.60,95% CI-0.93 to-0.27]),Serum cotinine(in short term [1 trial,MD-86.00,95% CI-107.79 to-64.21],long term [1 trial,MD-80.00,95% CI-100.03 to-59.97]),Daily cigarette consumption(in short term [1 trial,MD-5.10,95% CI-6.99 to-3.21],long term [1 trial,MD-3.20,95% CI-5.05 to-1.35]).No significant differences of effects were observed in results of acupuncture compared to nicotine replacement therapy(NRT)for smoking abstinence(in short term [1 trial,RR 1.04,95% CI 0.95 to 1.15],long term [1 trial,RR 1.05,95% CI 0.98 to 1.11]),Nicotine withdrawal symptoms(NWS)(in short term [1 trial,MD-2.30,95% CI-20.29 to 15.69]),Fagerstrom test for nicotine dependence(FTND)(in short term [1 trial,MD 0.48,95% CI-0.31 to 1.27],mid term [1 trial,MD 0.10,95% CI-0.71 to 0.91]),Exhaled CO level(in short term [1 trial,MD-0.49,95% CI-2.64 to 1.66],mid term [1 trial,MD 0.36,95% CI-2.11 to 2.83]),Urine cotinine(in short term [1 trial,MD-0.18,95% CI-1.14 to 0.78],mid term [1 trial,MD-0.34,95% CI-1.11 to 0.43]),Heaviness of smoking index(HSI)(in short term [1 trial,MD 0.28,95% CI-0.28 to 0.84],mid term [1 trial,MD 0.11,95% CI-0.50 to 0.72]).Meta-analysis showed acupuncture was more effective compared to no intervention/ waiting list refer to smoking abstinence(in short term [1 trial,RR 2.37,95% CI 1.41 to 3.97],long term [2 trials,RR 2.66,95% CI 1.50 to 4.70,I2=0%,FEM]).Compared to single acupuncture/ auricular acupressure,acupuncture plus auricular acupressure showed more benefit in terms of smoking abstinence [3 trials,RR 1.52,95% CI 1.03 to 2.25,I2=0%,FEM].Acupuncture plus auricular acupressure showed more effective compared to sham acupuncture plus sham auricular acupressure involving in smoking abstinence(in short term [3 trials,RR 2.50,95% CI 1.44 to 4.33,I2=55%,REM],mid term [2 trials,RR 3.61,95% CI 1.37 to 9.48,I2=0%,FEM]).Acupuncture plus auricular acupressure and nicotine replacement therapy(NRT)showed similar benefit in smoking abstinence(in short term [2 trials,RR 0.61,95% CI 0.28 to 1.36,I2=58%,REM],mid term [1 trial,RR 1.28,95% CI 0.44 to 3.76]).Acupuncture plus counselling/educational smoking cessation program/moxibustion had more benefit compared to acupuncture in terms of smoking abstinence in short term [3 trials,RR 0.75,95% CI 0.63 to 0.91,I2=67%,REM] and long term [2 trials,RR 0.77,95% CI 0.56 to 1.05,I2=0%,FEM]),whereas comparisons were not significant in mid term [2 trials,RR 0.56,95% CI 0.38 to 0.82,I2=0%,FEM].Acupuncture showed similar benefit compared to wrist-ankle acupuncture in smoking abstinence in short term [1 trial,RR 0.64,95% CI 0.41 to0.99].Acupuncture plus counselling/gum was not shown to be more effective than sham acupuncture plus counselling/gum about smoking abstinence in short term [2 trials,RR 1.03,95% CI 0.87 to 1.21,I2=0%,FEM],mid term [1 trials,RR 0.99,95% CI 0.74 to 1.34],and long term [2 trials,RR 1.06,95% CI 0.78 to 1.44,I2=0%,FEM].TSA illustrated that the cumulative Z-curve of acupuncture VS acupuncture plus counselling/ educational smoking cessation program/ moxibustion in long term gone across the traditional boundary of 5% significance and the monitoring boundaries.No serious adverse events occurred.3.An online cross-sectional survey on attitudes and promoting and obstructive factors for smoking cessation in China Study subjects were recruited in a three-month period from 6 August to 20 November 2017.Of the 656 respondents who submitted the web questionnaires,638 completed fully the study questionnaires(97.3% qualified rate).Of the 638 qualified respondents,520 experienced smoking cessation once or more which included 155 quitted smoking successfully and 365 failed in smoking cessation.Respondents who came from 30 provinces(Table 1)in China with 70 different occupations had an average age of 37.3 ± 11.7 years(range,13–79 years),and 92.3 % were male.The reported cause which promoted them to smoke included habits(207,32.4%),relieving fatigue(124,19.4%),boring(117,18.3%),relieving anxiety(61,9.6%),and so on.Of the 638 respondents who participated in the study,635(99.5%)were aware of the adverse health effects of smoking directly,while 552(86.5%)were aware of the adverse health effects of exposure to secondhand smoke from cigarettes to other people when they smoked.Regarding the attitude towards smoking cessation,596(93.4%)respondents held the will to quit smoking(past,223,35.0%;now,140,21.9%;future,71,11.1%;always,162,25.4%).336(64.6%)wanted to give up smoking because they had perception of general and specific health effects of smoking,39(7.5%)due to preparing for pregnancy,38(7.3%)becesuse of persuade from relative or friends,31(6.0%)due to no craving for smoking,28(5.4%)becesuse of lack of money,10(1.9%)due to feeling unwell,9(1.7%)becesuse of wanting to give a try just,6(1.2%)due to working environment.The reasons of 8 respondents were betting,saving money,academic,decreasing health effect onothers,smoke smell,afraid of delay to find a spouse,boring,unhygienic,respectively.The majority of people had different degrees of improvement in their health status after quitting smoking,except for a few people with mild withdrawal symptoms.But 32(20.6%)respondents encountered a weight gain after they quitted smoke.The key factors leading to relapse included lack of determination,surrounding environmental impact,stress from work or life,mood swings,social needs,access to tobacco everywhere,and lack of coercive measures.Conclusion: The annual number of published articles on TCM for smoking cessation shown an increasing trend with wave.China was the country with the largest number of studies on TCM for smoking cessation.Of all types of the applied research design,randomized controlled trials that were considered as the gold standard for efficacy evaluation accounted for relatively few.There were many kinds of TCM therapies applied to the field of smoking cessation.Among them,the most widely used and most promising methods of smoking cessation therapy were acupoint stimulation.The methodology quality of clinical research design was quit low generally.The present study has suggested that acupuncture was safer to quit smoking.Overall,methodology quality of included studies were poor.Acupuncture combined with counselling/ educational smoking cessation program/ moxibustion showed better efficacy than acupuncture alone in long term,based on the present evidence.However,other comparisons or subgroup analyzes were difficult to obtain conclusively valid conclusions.The current study of smoking cessation mostly focuses on the boycott of nicotine dependence.However,our study found that many factors,including lack of determination to quit smoking of smokers,the surrounding environmental influences,stress from work or life,mood swings,social needs,availability of tobacco,lack of coercive measures and psychological dependence were all key factors that led to failure of smoking cessation or relapse.It is suggested that in the future,comprehensive study on smoking cessation should be carried out with individualized and stage interventions,and finally a complete package of smoking cessation interventions will be formed.
Keywords/Search Tags:smoking cessation, traditional Chinese medicine, evidence-based evaluation, acupunture, factors
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