| ObjectiveTo compare the clinical efficacy and safety of acupuncture combined with auricular point therapy and nicotine patch therapy for moderate and severe tobacco dependence,the trial in order to enrich and optimize the smoking cessation program of acupuncture,and provide objective basis for the clinical promotion of smoking cessation by acupuncture.MethodsIn this study,60 trials with moderate and severe tobacco dependence were randomly divided into treatment group and control group through clinical randomized controlled trial,with 30 cases in each group.The treatment group was treated with acupuncture combined with auricular acupoints,twice a week,4 weeks as a course of treatment,a total of 8 weeks.The control group was given nicotine patch for external use,one patch a day,for continuous use for 24 hours.The dosage was gradually decreased,21 mg was used in the 1st to 4th week,14 mg in the 5th to 6th week and 7mg in the final weeks.Both groups were treated for 8 weeks and follow-up visit for 16 weeks.The main outcome was the success rate of smoking cessation,which was determined by exhaled carbon monoxide(CO)content and no smoking.Outcomes will be evaluated before and after treatment,and at follow-up.Clinical efficacy was evaluated by Fagerstr?m test for nicotine dependence(FTND),Minnesota nicotine withdrawal symptom scale(MNWS)and Pittsburgh Sleep Quality Index(PSQI),and adverse reactions were recorded.Results:1.Intra-group comparison: indicators such as exhaled CO content,smoking amount,FTND,MNWS and PQSI were compared between the two groups before and after treatment and during follow-up.Pared-sample t test was used,and there was a statistically significant difference between the two groups(P<0.05),indicating that the two groups had significant improvement in all aspects of tobacco dependence symptoms after treatment and during follow-up.2.Comparison between groups: the tobacco withdrawal rate of acupuncture combined with auricular point group and nicotine patch group were both 20% at the 8th week,and23.3% and 16.7% at the 16 th week follow-up,respectively.The efficacy of the two groups was similar,and the difference was not statistically significant(P>0.05).There were no statistically significant differences in exhaled CO content,smoking amount and FTND scale score between the two groups after treatment and during follow-up(P>0.05).There were significant differences between the two groups in MNWS and PSQI scales(P<0.05),indicating that acupuncture combined with auricular point group had no significant differences with nicotine patch group in terms of smoking amount and reducing nicotine dependence,but was superior to nicotine patch group in terms of improving withdrawal symptoms and sleep quality.3.Safety evaluation: No adverse events occurred in the acupuncture combined with auricular point group,while 5 cases of adverse reactions occurred in the nicotine patch group.Among them,three patients presented skin allergy,one patient presented fatigue,and one patient presented dizziness,chest tightness and discomfort.Except for one case of severe skin itching caused by allergic reaction,nicotine patch was discontinued and the study was discontinued.The other cases had minor adverse reactions and could be further studied.ConclusionAcupuncture combined with auricular acupoints has a definite effect on the intervention of moderate and severe tobacco dependence patients,which is equivalent to the first-line drug nicotine patch in terms of withdrawal rate,reduction of smoking amount and reduction of nicotine dependence.It is better than nicotine patch in alleviating withdrawal symptoms and improving sleep quality,with higher safety and no adverse events,which is worthy of clinical application. |