| ObjectiveWe used a randomized controlled trial to study the effects of the treatment group(fire needle group)and the control group(health education group)on the efficacy of smoking cessation,and to observe the effects of different intervention on withdrawal symptoms during smoking cessation.MethodsThis study is a randomized controlled trial.According to the inclusion criteria,60 participants were recruited from the acupuncture department of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine.They were assigned in a 1:1 ratio according to the principle of randomized control.In principle,30 patients in the treatment group were treated with fire needles and 30 patients in the control group were offered health education.The treatment group used fire needled acupuncture at Baihui,Hegu and Lieque.First used Aner iodine disinfection,then applied Wanhua oil,ignited the alcohol lamp,held the fire needle in the right hand,burned the needle lower 1/3 to red,quickly punctured the acup points,the depth was about 0.1mm,Acupunctured each acupoints(Baihui,Hegu and Lieque)at 7 times.After the treatment,the acuppoints were pressed with cotton balls and then coated with Wanhua oil.Each treatment was performed every 3 days,and twice treatments were performed every week for three consecutive weeks.In the control group,only health education was conducted,the participants watched the video about the hazard of smoking and the techniques of smoking cessation.The health education was conducted once every 3 days,2 times a week,20 minutes each time,for three weeks in a row,without any other intervention.All participants filled questionnaires out before the treatment to know their age,gender,education level,smoking habits(including:years of smoking,nicotine dependence level,past smoking cessation records,and reasons to quit smoking),past medical history.The treatment record of the treatment process recorded the number of cigarettes,carbon monoxide levels and withdrawal symptoms.The Hamilton Depression Scale(HAMD)was used to assess the relief of withdrawal symptoms.The follow-up visit was performed at the 3th and the 8th week.The number of cigarettes,carbon monoxide levels,withdrawal symptoms,and the Hamilton Depression Scale(HAMD)were recorded again.After data collection,the effects of age,gender,education level,smoking habits(including:years of smoking,nicotine dependence level,past smoking cessation record,and reasons for quit smoking)was studied on this smoking cessation.This study mainly used the number of cigarettes before and after treatment as the main outcome.The carbon monoxide degree before and after treatment,the carbon monoxide confirmed quit rate,and the withdrawal symptoms such as mood change and sleep quality were secondary outcome.The relief of withdrawal symptoms was assessed by the Hamilton Depression Scale(HAMD).Results1.After 3 weeks,the treatment group was effective after treatment with fire needle,there was 2 people failure,5 people effective,2 people markedly effective,21 people were cured,and the effective rate was 93.3%.In the control group,8 people were invalid after health education,8 people were effective,3 people were markedly effective,11 people were cured,and the effective rate was 73.3%.There was a significant difference between the two groups by chi-square test(P<0.05).After 8 weeks,there were 2 people ineffective,1 people effective,5 people were markedly effective,and 22 people were cured,and the effective rate was 93.3%.In the control group,5 people were invalid,8 people were effective,2 people were markedly effective,and 15 people were cured,and the effective rate was 83.3%.There was a significant difference between the two groups by the chi-square test(P<0.05).It can be seen that the fire needle treatment is better than the health education.2.The 3 weeks self-reported quit rate in the treatment group was 66.7%,in the control group was 36.7%.After chi-square test,there was a significant difference between the two groups(P<0.05).The 8-week self-reported quit rate was 73.3%in the treatment group and 50%in the control group.There was no difference between the two groups by chi-square test(P>0.05).That is to say,the quit rate of fire needle in the short-term is significantly higher than health education.In the long-term,the quit rate of fire needle is higher than health education,but the difference was not significant.3.In the 3th week,the carbon dioxide confirmation quit rate was 53.3%in the treatment group,and 36.7%in the control group.There was no significant difference between the two groups(P>0.05).In the 8th week,the carbon dioxide confirmation quit rate was 73.3%in the treatment group,and 50%in the control group.There was no significant difference between the two groups(P>0.05).Carbon monoxide confirmed quit rate was simi lar as the self-reported quit rate,so the self-reported quit rate was reliable.4.The daily consumption of cigarettes before treatment in the treatment group was 12.5(10,20),and decreased to0(0,2.75)after 3 weeks of treatment,and after 8 weeks,it reduced to 0(0,1).The daily cigarettes consumption of the control group before the health education was 20(10.25,20),and it decreased to 0(5,10)after 3 weeks health education,and decreased to 2(0,8)after 8 weeks health education.After Shapiro-Wilk test P<0.05,so it did not follow the normal distribution.Comparing to the consumption of cigarettes after treatment the amount of cigarettes was significantly lower than before in both fire needle and health education group by Analysis of variance(P<0.01).The consumption of cigarettes in the two groups of smokers after 3 weeks of treatment or health education was significantly lower than before P<0.05,That is to say,there was a significant difference in the amount of cigarettes between the two groups after 3 weeks of treatment or health education.The consumption of cigarettes in the two groups of smokers after 8 weeks of treatment or health education was also significantly lower than before P<0.05.That is to say,there was a significant difference in the amount of cigarettes between the two groups after 8 weeks of treatment or health education.After 3 weeks and 8 weeks treatment or health education,the comparison of the daily cigarettes consumption between the two groups all reduced significantly(P<0.05).It proved that the cigarettes consumption in two groups was significantly lower than before.However,the treatment group was significantly more effective than the health education group.5.The degree of carbon monoxide before treatment in the fire needle group was 14.10±6.16ppm,which was 5(3.25,7)ppm after 3 weeks of treatment,and 3(2,6)ppm after 8 weeks of treatment.The carbon monoxide level before the health education in the control group was 17.20±7.56ppm,which was 9(3.25,15)ppm after 3 weeks health education,and 3(7,15)ppm after 8 weeks of health education.The carbon monoxide levels in two groups were significantly lower than before(P<0.01).However,the degree of carbon monoxide decrease in the treatment group was greater than that in the control group(P<0.01).6.The nicotine dependence level before fire needle treatment in the treatment group was 4.53±2.39 points,3(2,4)points after 3 weeks treatment with fire needles,2.5(2,3)points after 8 weeks treatment.Before the health education in the control group,the degree of nicotine dependence was 5.23±2.47,and drop to 4.5(3,6)after 3 weeks health education,and decreased to 3(3,4.75)after 8 weeks.After ANOVA test,the degree of nicotine dependence level decreased significantly after fire needle treatment in both 3 weeks and 8 weeks(P<0.05).After 3 weeks health education,the degree of nicotine dependence was not significantly decreased(P>0.05),but it decreased significantly at 8 weeks(P<0.05).Fire needle treatment has a significant effect on the short-term reduction of nicotine dependence level.The health education was not significantly reduced the dependence of nicotine level in the short term.Fire needle treatment and health education have a significant effect on the long-term reduction of nicotine dependence level,but fire needle treatment is better than health education in reducing long-term nicotine dependence level.It can be seen that the effect of fire needle treatment on reducing the dependence of nicotine in short-term and long-term is better than the health education.7.After 3 weeks of fire needle treatment,the effective relief rate of withdrawal symptoms in the fire needle group was 96.7%,and the effective relief rate of the withdrawal symptoms in the health education group was 86.7%.After the chi-square test,P<0.05,that is to say,the withdrawal symptoms in two groups were significantly relief,and the fire needle treatment group was better than the health education group.After 8 weeks’ treatment,the effective relief rate of withdrawal symptoms in the fire needle group was 90.0%,and the effective relief rate of withdrawal symptoms in the health education group was 80.0%.After the chi-square test,P>0.05,that is to say,the effect of the relief withdrawal symptoms in the fire needle group was not significant different from that of the health education group in 8 weeks.8.After ANOVA test,there were no significant changes in the total score of the Hamilton Depression Scale score after 3 weeks treatment in both fire needle group and health education group(P>0.05).However,there were significant differences in the total score of the Hamilton Depression Scale score after 8 weeks treatment in both fire needle group and health education group(P>0.05).The total score in treatment group was significant lower than control group after 8 weeks treatment.It can be seen that fire needle treatment improve the long term total score of the Hamilton Depression Scale better than the control group.So the fire needle treatment relief the long term withdraw symptom better than health education.There were significant differences in the Hamilton Depression Scale sleep disorder factor scores between the two groups of smokers who were treated with fire needle or had health education for 3 weeks and 8 weeks.The Hamiltonian Depression Scale of the fire needle group was significantly lower than the health education group(P<0.05).The score of the sleep disorder factor of the Hamilton Depression Scale in the treatment group was significantly lower than the health education group after 3 weeks ’ and 8 weeks treatment,which proved that the quality of sleep after fire needle treatment was significantly improved.There were significant differences in the Hamilton Depression Scale sleep disorder factor scores between the two groups of smokers who were treated or had health education for 3 weeks and 8 weeks.The Hamiltonian Depression Scale of the Fire Needle Group was significantly lower than the health education group The anxiety or somatization of the factor score,the cognitive impairment and the average score of the block were not significant decreased compare with those before treatment.(P>0.05).The fire needle treatment is effective in relieving withdrawal symptoms especially sleep disorders in during smoking cessation.The health education did not significantly relieve the effects of withdrawal symptoms during smoking cessation.9.In this study,we found there was no significant association between the demographic factors(such as:gender,age,education level)and quit rate(P>0.05).10.We studied the smoking habits of the participants,the history of smoking cessation,and the mentality of this smoking cessation.The number of cigarette smoked each day,years of smoking,initial nicotine dependence level,initial carbon monoxide degree,number of times of smoking cessation,previous smoking cessation methods(nicotine replacement therapy or self-control smoking cessation),reasons for quit smoking failure(mind addiction,hand addiction,friends,colleagues,relatives smoked,unbearable withdrawal symptoms),the reasons for this smoking cessation(self-health,family health,family advice),the reasons for choosing fire needles to quit smoking(promotional introduction,try new methods and have confidence in fire needles),the importance of this cessation,ready to quit smoke,the confidence in this smoking cessation are all not the factors affect successful quit smoking(P>0.05).11.The average score of the Hamilton Depression Scale score was 10.43±3.84.It indicated that some people may suffer from depression or anxiety.In the analysis of the Hamilton Depression Scale total score and various factor scores,such as:anxiety or somatization,cognitive impairment,block,sleep disorders,these factors have no effect on smoking cessation(P>0.05)·It can be seen that the baseline data of this study was balanced.The effect of fire needle on smoking cessation was significant,and other factors have no obvious intervention on smoking cessation.The carbon monoxide confirmation quit rate is consistent with the self-reported quit rate,so the participants’self-reported results were reliable.ConclusionThe results of this study suggest that using fire needles to stop smoking is better.After the treatment,the number of cigarettes was significantly reduced,the degree of carbon monoxide and the nicotine dependence level were significantly decreased,and the sleep disorder during smoking cession was significantly improved.In the future,the use of fire needles in smoking cessation can be considered,and this method as a Chinese medicine therapy to stop smoking which provide a new mindset. |