Acupoint Injection Combined With Acupuncture For Insomnia With Cardiacsplenic Asthenia:a Research Protocol For Clinical Trial

BackgroundInsomnia is a kind of disease that people can not sleep normally. The light have trouble falling asleep, or are easy to wake up after sleep. The weigh can not sleep all night. According to the clinical, the common forms are:(1)sleep incubation elongation:falling sleep for more than30min.(2) sleep disorder:awakening for more than2times in the nighttime, or early awakening before dawn.(3)the decline of sleep quality:light sleep and dreaminess.(4)sleep time shorten:less than6h usually.(5)diurnal residual effects between13:feeling dizzy、languid、lethargic、hypodynamic, etc.Foreign epidemiological investigation showed that about33%of people have sleep disorders. The survey for the grassroots patient in the15region of14countries finded that about27%of people have sleep problems, according to the World Health Organization. And tha materials provided by the Chinese Medical Association also showed that there are300million people who had sleep disorders such as insomnia and sleep too much in China.A survey of insomnia in6major cities in China in2006finded that the rate of adult insomnia is as high ai57%. Insomnia is mostly related to psychological factors, including psychological stress, anxiety, depression and bad emotional reactions caused by life events, or disease. Some research has shown that neural insomnia and psychogenic insomnia is the most cause of insomnia, accounted for about58.7%.At present insomnia has become the second big disease after headache in a neurologist clinic, while not life threatening, but seriously affects people’s quality of life.Drug is one of the important methods for the treatment of insomnia. The surcey about global insomnia in2002displayed that in the past year43.4%of people have experienced varying degree of insomnia, of which about20%has choosen sedative hypnotic drugs to solve insomnia. The hypnotic drugs used commonly are benzodiazepine and what type of non-benzodiazepine. The diagnostic and statistical manual of mental diasorders fourth edition(DSM—Ⅳ) mentions zolpidem which one of what type of non-benzodiazepine can be used as a drug of choice for primary insomnia.As is well-known, when you get some hypnotic drugs, especially the half-life of drugs, there is a certain degree adverse reactions, for example the hangover phenomenon, drug dependence, withdrawal symptoms and ambivalent reaction and so on. In addition, the long-term use of hypnotics can make memory loss, fall the ability of reaction and reduce the efficiency.Acupuncture is considered to be harmless and effective treatment for insomnia. In modern literature about acupuncture for treating insomnia indicates its efficient is all above80%. Acupuncture treatment for insomnia has lots of advantages, including multi-link adjustment on the whooe, no side effect, expedience, saving money, small pain and convenience for popularization and application and so on. And the study design about acupuncture treatment for insomnia has been improved and more practical and scientific than the previous.But acupuncture treatment for insomnia still has some problems in clinical such as tolerance easily caused by repeated acupuncture on the local point, late-onset reaction or timeliness. Therefore, modern acupunvture trends to use combination therapy for the treatment of insomnia.Acupoint injection combines acupoint effect and drug efficacy, not only makes the overalltreatment effect better than intravenous injection, intramuscular injection and simple acupuncture, but also has the pharmacodynamics pharmacodynamics of original features of drugs and relative specificity.At the same time to the small dose of acupoints, acupuncture injection enhances the efficacy of small dose of drug guided by meridian theory, and unites the two to create synergy effect. Anmian and Zusanli are chosen for acupuncture injection, because Anmian has peculiar efficacy for insomnia caused by a variety of reasons as one of extra nerve points,and Zusanli can tone the spleen and stomach, tonify middle-Jiao and Qi, activate collaterals, dispel wind and resolve dampness, and strengthen the body resistance to eliminate pathogenic factors,as the he point of Yangming Stomach Meridian of Foot and the LowerSea point of the stomach. The root of red-rooted salvia is chosen for acupuncture injection, which is as a top grade in Sheng Nong’s herbal clssic, and stated that "bowel faint heart evil, such as water. Not accumulate, broken Dian in addition to any, full stop, yiqi". Supplementary Records of Famous Physicians states that salvia miltiorrhiza could nourish blood, treat heart disease and gas, strong waist ridge, remedy feet certification, in addition to the wind hot. And it is benefit for the people that take it for a long time. There are179prescription that contain salvia miltiorrhiza(8or less taste) in Prescriptions of traditional Chinese medicine dictionary before the founding of the formulas se formula. Through the accounting certification and comparative induction, the effect of salvia miltiorrhiza is summaried seven effect, including itching anti, regulating menstruation and arresting leucorrhoea, fetus and removing stasis; sedating, protecting the stomach and relieving the pain, stringing waist and removing certification;heat from the blast, and complementing qi and tonic. In addition, acupoint injection, which offsets the deficiency of pure acupuncture, is more simple and efficient to seek the treatment of traditional Chinese medicine for insomnia. So ti’s necessary to carry out the study about acupoint injection combined with acupuncture to to treat insomnia with cardiacsplenic asthenia.Object iveAiming ai the limitation and deficiency of the treatment of insomnia, in order to futher improve curative effect, according to the understanding of the etiology and pathogenesis about cardiaplenic asthenia from traditional Chinese medicine, we use acupoint injection combined with acupuncture to treat insomnia with cardiacsplenic asthenia and discuss its dff icacy and safety, also evaluate the effect of the treatment from the improvement of clinical symptoms, which is the purpose of this research.MethodsIn the study, we choose70patients met the criteria for the study, a computer randomly assigned to set the treatment group of35cases and a control group of35patients, both groups were given acupuncture method, with acupoint injection for the treatment group. Three times treatment each week,4weeks over, both groups continuous treatment of12.. We assessed the difference of the treatment effect between the two groups by SPSS soft ware statistics. RusltsCompared the general information of the two groups, Prompted that the two proups in sex, age, duration, before treatment in degree of tinnitus were found no Significant difference(P>0.05). The two groups in scores on insomnia, the result after six times has no significant difference(P=0.062, P>0.05), while the result after twelve times has significant difference(P=0.019, P<0.05), and the result about one month after twelve times has significant difference (P=0.017, P<0.05);the result between before treatment and after six times of treament (P=0.000, P<0.05), and the result between after six times and after twelve times(P=0.000, P<0.05), all is significant. Comparison of the clinical efficacy after six times of treatment, the result between treatment group and control group is found no significance(P=0.463, P>0.05), while after twelve times of treatment, the result between treatment group and control group is found significance(P=0.036, P<0.05).ConclusionClinical studies have shown that the therapy acupoint injetion on Anmian and Zusanli with Salvia injection has a synergism on the improvement of insomnia with cardiacsplenic asthenia, acupoint injetion on Anmian and Zusanli with Salvia injection is combined with acupuncture phase for simple acupuncture treatment of insomnia with cardiacsplenic asthenia has the better efficacy. It is simple, cheap and efficient, worthy of clinical application.