| Background:Insomnia has become a common and frequent clinical disease,and often accompanied by other diseases and is affected with each other;At present,about 66%worldwide exist sleep disorders,which is expected over 700 million insomnia patients by 2020 in global.In our country,according to a survey in 2002,45.5%people exist sleep problems and 10%have insomnia.Insomnia not only increases the patient's pain and mental burden,seriously,it also affects the physical and mental health,quality of life and work efficiency.According to the epidemiological survey,a variety of factors are closely related with insomnia,including gender,age,genetic quality and other self factors,economic status,education,occupation,marriage,living environment and other external factors,as well as physical and mental illness and drug use.The clinical manifestations of insomnia are:firstly,prolongation of sleep latency:time of falling asleep is more than 30 minutes;secondly,sleep maintenance disorder:nocturnal awakening ? 2 times or early morning wake;thirdly,sleep quality decline:shallow sleep,dreaminess;fourthly,the total sleep time is shortened:usually less than 6 hours;fifthly,daytime residual effect:dizziness,lack of energy,lethargy,fatigue in the next morning.Western medicine considers that the pathogenesis of insomnia is mainly related to sleep-wake mechanism and neurotransmitter mechanism.Chinese medicine considers that the emotional injuries,weakness due to chronic diseases,overwork disorders,eating and drinking without temperance leading to deficiency of Yin that can not induce Yang or vigorous of Yang that can not into Yin,resulting in imbalance of Yin and Yang,disjoint of Yin and Yang,and resulting in the occurrence of insomnia.The current treatment of Western medicine includes non-drug treatment and drug treatment.Non-drug treatment includes cognitive behavioral therapy,sleep hygiene education,and relaxation therapy.It avoids the side effects of drug treatment with a reliable clinical efficacy,the shortcomings are long onset time and slow effect.Drug treatment includes benzodiazepine,non-benzodiazepine,melatonin drugs and antidepressants.However,long-term use of them are easily to induce fatigue,dizziness,drowsiness and other adverse reactions,leading to mental disorders,memory disorders,drug addiction and rebound insomnia after withdrawal.Treatment of insomnia by Chinese medicine mainly includes traditional Chinese medicine,acupuncture,ear acupuncture,massage,foot bath and other methods.At present,traditional Chinese medicine treatment is generally considered to have better clinical efficacy;and Western medicine also has advantages with easy to take and clear efficacy,however,there are a variety of adverse reactions and side effects,with a certain drug dependence.And patients' choices need to be based on efficacy,safety,convenience and other considerations.Ear acupoint cutting therapy is a traditional treatment,the theoretical basis of traditional Chinese medicine is based on the organs meridian theory,Western medicine considers that auricular acupuncture in treating disease is through the vagus nerve impulse conduction to regulate the nervous system and endocrine system.It is currently widely used in clinical departments.In addition,according to more than 60 years of clinical work experience by doctor Wang Fuzhuang in our hospital,especially for the treatment of auricular acupuncture cutting method,which has been used in clinical application for nearly 40 years.He is good at using auricular acupuncture cutting method in treating a variety of medical diseases and dermatology diseases,and has a significant effect,especially on insomnia,depression,high blood pressure,acne and facial chloasma.He has participated in the introduction of experience of acupuncture in North China twice,gave a lecture in the international auricular acupuncture consultation seminar,and won the Beijing Municipal Traditional Chinese Medicine Administration of Science and Technology Achievement Award,has been sent to foreign for acupuncture treatment,who has a certain influence in the field of ear acupuncture.I have followed doctor Wang Fuzhuang in the clinic for many years,combined with my own application of the outpatient diagnosis and treatment of disease,and concluded that the improvement effect ofear acupoint cutting therapy on treatment of patients with insomnia symptoms is particularly significant.However,there is still a lack of clinical studies on different frequency of treatment of auricular acupuncture,and there is also controversy on it.Therefore,we hope that exploratory study of new ideas to investigate the clinical efficacy and safety of ear acupoint cutting therapy of insomnia(Tcm excessive syndrome)through the different frequency of auricular acupuncture treatment of insomnia should be carried out.Objective:To study the clinical effisacy and safety of ear acupoint cutting therapy in the treatment of insomnia(Tcm excessive syndrome)by observing the exploratory study of ear acupoint cutting therapy in the treatment of insomnia(Tcm excessive syndrome);Comparison of therapeutic effects of the different frequency in ear acupoint cutting therapy in the treatment of insomnia(Tcm excessive syndrome).This study provides evidence for enlarge clinical application of ear acupoint cutting therapy,and rovides evidence for clinical expansion.Methods:To collect 60 patitents,during the treatment,2 patitnet was exfoliated case in high frequency group,and 3 patitnets were exfoliated cases in low frequency group,Observation was completed 55 patitents who were in accordance with the inclusion criteria.This patitents were randomly divided into high frequency group(two fractions per week)which had 29 patitents and low frequency group(one fraction every two weeks)which has 28 patitents.heart and subcortex were selected as major acupoints;type of stagnation of liver-Qi combined with liver and gallbladder;type of phlegm-heat attacking internally combined with spleen and stomach.Procedure:The patient sit up,the ear was tuned to sunlight.the ear cavity was disinfected routinely by 75%alcohol dipped in cotton swab.gently cut the skin on the surface of the acupoint with sterile scalpel(Golden Ring,11 blade)for 2 mm length,2-3 drips of blood was on the surface of the acupoint and the depth was appropriate.For each treatment both ears were cut and sterile gauze were covered on the ear cavity,water was avoided for 24h for preventing infection.Treatment was given every 2 days in the high frequency group,two times each week for 4 weeks,and a total of 8 treatments were given.The low frequency group,acupoints selection and disinfection were the same as the high frequency group,treatment was given every two weeks for consecutive 4 weeks,and a total of 2 treatments were given.Pittsburgh sleep quality index scale(PSQI)and TCM syndrome self-rating scale were used for evaluating the clinical effect in patients of both groups before the treatment(0 week),after the first treatment,after treatment(4th week),first follow-up period(8th week)and second follow-up period(12th week).Adverse effects such as local infection and the pain after cutting were observed after ear acupoint therapy to evaluate the safety of this method.Spss20.0 statistical software was used for statistical analysis of the collected data.Result:1.There were no significant differences in gender,age,disease course,PQSI scores and total score before inclusion in both groups with different treatment frequencies,and the baseline characteristics of both groups had no statistically differences(P>0.05),which suggested the comparability in both groups.2.Effects were observed immediately,PQSI score after the first treatment showed that 7 evaluation indexes before treatments,including sleep quality,time for falling asleep,sleep time,sleep efficiency,sleep disorders,daytime dysfunction and PQSI total score were decreased in both groups after treatments,the differences were statistically significant(P<0.05).PQSI total score,sleep quality,time for falling asleep,sleep efficiency and daytime dysfunction in high frequency group before treatments were significantly lower than those after treatment(P<0.01);sleep time and sleep disorders scores before treatments were lower than those after treatment(P<0.05).Comparing the follow-up period and after the treatment in high frequency group,there were no statistically differences in PQSI total score,sleep quality,time for falling asleep,sleep efficiency,sleep disorders and daytime dysfunction between the first and second follow-up period(P>0.05);sleep time score in the first follow-up period was decreased compared with that after the treatment(P<0.05),there was no statistically difference in sleep time score between the second follow-up period and after the treatment(P>0.05);there was no statistically difference in hypnotic score between the first follow-up period and after the treatment(P>0.05),which was increased during the second follow-up period(P<0.05).Time for falling asleep and daytime dysfunction scores after treatments were significantly decreased compared with those before treatments in low frequency group(P<0.01);sleep disorders scores were decreased(P<0.05);there were no statistically differences in PQSI total score,sleep quality,time of falling asleep and sleep efficiency before and after treatments(P>0.05).There were no statistically differences in PQSI total score,sleep quality,time for falling asleep,sleep time,sleep efficiency,sleep disorders and daytime dysfunction between the first and second follow-up period in low frequency group(P>0.05);hypnotic score during the first follow-up period was increased compared with that after treatments(P<0.05),and was significantly increased during the second follow-up period(P<0.01).After treatments,differences of PQSI total score,sleep quality,sleep time and sleep efficiency before and after treatments in both groups showed that the difference before and after treatment in high frequency group was higher than those of low frequency group(P<0.01);differences of time for falling asleep,sleep disorders,hypnotic and daytime dysfunction before and after treatments in both groups showed no statistically differences(P>0.05).During the follow-up,differences of PQSI score,sleep quality,sleep time and sleep efficiency before and after treatments in high frequency group were higher than those of low frequency group(P<0.01);during the first follow-up period,the difference of hypnotic score before and after treatment in high frequency group was lower than that of the low frequency group(P<0.05),and it was also lower during the second follow-up period(P<0.01);there were no significant differences in time for falling asleep and sleep disorder in the follow-up period compared with those before treatments(P>0.05);there was no significant difference in daytime dysfunction score in the first follow-up period compared with those before treatments(P>0.05),the difference of daytime dysfunction score between the second follow-up period and before treatments in high frequency group was higher than that of the low frequency group(P<0.05).3.In the aspect of overall TCM effect,total effective rate was 92.9%in high frequency group,among them,4 cases were recovered,17 were markedly effective,5 were effective,2 were without effective;total effective rate was 51.9%in low frequency group,among them,0 cases were recovered,5 were markedly effective,9 were effective,13 were without effective.The total effective rate of the two groups was statistically significant(P<0.01),which indicated that different frequencies of TCM ear acupuncture therapy all had relative effect on treating excess syndrome of insomnia,and the overall TCM effect in high frequency group was better than that of the low frequency group.In the comparison of TCM syndromes,total effective rate was 92.9%in high frequency group,among them,0 cases were recovered,16 were markedly effective,8 were effective,2 were without effective;total effective rate was 55.6%in low frequency group,among them,0 cases were recovered,1 were markedly effective,14 were effective,12 were without effective.The total effective rate of the two groups was statistically significant(P<0.01),which indicated that different frequencies of ear acupoint therapy all could improve the TCM syndromes,and the overall TCM effect in high frequency group was better than that of the low frequency group.4.Safety evaluation:Among 57 observed cases in this study,2 had adverse effects,however,no sequelae appeared and it did not affect the subsequent treatment.Conclusion:1.Through this clinical observation,it suggested that ear acupoint cutting therapy for insomnia(Tcm excessive syndrome)had a certain clinical efficacy.2.Different frequency of ear acupoint cutting for insomnia(Tcm excessive syndrome)improvement was different,Compared with low frequency treatment,high frequency treatment has better clinical efficacy,can better improve sleep efficiency,improve sleep disorder and sleep quality,prolong sleep time;the same time,to improve sleep efficiency,improve sleep disorder,shorten sleep time,Reduce the use of hypnotic drugs,there is a certain follow-up effect.3.Although there have some risks in ear acupoint cutting therapy,as long as the procedure is normalized and nursing is appropriate,this method is still safe and effective. |
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