| Background:Sleeping accounts for about 1/3 of one's life, and a good sleeping is an important condition to ensure human health. The previous research shows that generally 10%?15% of adults suffer from chronic insomnia, and 25%?35% of adults suffer from occasional or transient insomnia. In recent years, the epidemiological survey on insomnia shows that the prevalence of insomnia is increasing, and thus it is becoming an intractable problem that puzzles people's life, study, work, health and so on. For the treatment of insomnia, modern medicine mainly undertakes drug and cognitive behavior therapy, but the effect is not so satisfactory, and meanwhile, the side effects of western medicine have become a major obstacle to the treatment of insomnia. However, Traditional Chinese Medicine (TCM) has a long history on the treatment of insomnia, and it has a good therapeutic effect now, and there are fewer side effects and therefore it is attracting more and more patients who suffer from insomnia. However, it is limited in promotion and usage, since there is a lack of strict design of clinical trials about the treatment of insomnia by TCM. Although there are plenty of different types of insomnia, the report about the type of stagnation of liver-qi and Yang deficiency is not so much, and there are a number of patients with insomnia caused by stagnation of liver-qi and Yang deficiency. Due to the lack of acquaintance of this kind of syndrome, this part of the patients can not get the effective treatment by TCM. Therefore, we have carried out the studies through the use of Yang-warming and liver-dispersing decoction to treat insomnia caused by stagnation of liver-qi and Yang deficiency in clinic.Purpose:To study the clinical effect of Yang-warming and liver-dispersing decoction on treating insomnia caused by stagnation of liver-qi and Yang deficiency and evaluate the effectiveness of Yang-warming and liver-dispersing decoction.Methods:By adopting the experiment design of parallel comparison of randomized doubled-blind placebo,32 cases of patients who suffer from insomnia caused by stagnation of liver-qi and Yang deficiency are divided into two groups. After the washout period for one week, the patients in experimental group are given the treatment of Yang-warming and liver-dispersing decoction for two weeks, while the patients in control group are given the treatment of placebo of Yang-warming and liver-dispersing decoction for two weeks. PSQI, GAD-7, PHQ-9 and the TCM syndrome scale assessment are conducted respectively before the treatment and after the treatment for two weeks. The result of PSQI decreasing mark rate is regarded as the main indicator for therapeutic effect and the result of TCM syndrome scale decreasing mark rate, as well as the decreasing mark of GAD-7 and PHQ-9 are regarded as the secondary Indicator for therapeutic effect.Results:1, There are altogether 29 cases of patients who have completed the experiment, wherein 15 cases are in experimental group and 14 cases are in control group.2, Regarding the PSQI decreasing mark rate as the main indicator of therapeutic effect, the overall effective rate of Yang-warming and liver-dispersing decoction group is 80%; compared with the situation in pre-treatment, the decreasing mark rate of PSQI is 5.40±2.72, P<0.001,95%CI is 3.89-6.90, and the therapeutic effects on daytime dysfunction, sleep efficiency and the quality of sleep are the most obvious parts. The overall effective rate of placebo group is 28.57%; the decreasing mark rate of PSQI is 3.00±1.96, P<0.001,95%CI is 1.87?4.13, and the therapeutic effects on daytime dysfunction and sleep efficiency are the most obvious parts. The comparison of therapeutic effects between the two groups:P=0.008<0.05.3, Regarding the TCM syndrome decreasing mark rate as the secondary indicator of therapeutic effect, the overall effective rate of Yang-warming and liver-dispersing decoction group is 86.67%, while the overall effective rate of placebo group is 35.71%. The comparison of therapeutic effect between the two groups:P=0.004<0.05.4, There is another finding:the Yang-warming and liver-dispersing decoction is able to reduce the aggregate score of GAD-7 and PHQ-9, and compared with that in pre-treatment, there is a statistical difference (P<0.05); while placebo can also reduce the aggregate score of GAD-7 and PHQ-9, there is no statistical difference (P>0.05) compared with that in pre-treatment.Conclusion:1, No matter in PSQI evaluation of therapeutic effects or in TCM symptom assessment, the Yang-warming and liver-dispersing decoction has the effective treatment on insomnia caused by stagnation of liver-qi and Yang deficiency and the therapeutic effect is not placebo effect.2, After the scale assessment of GAD-7 and PHQ-9 and the treatment of the Yang-warming and liver-dispersing decoction, the anxiety and depression complicated by insomnia can be relieved to some extent. |
PDF Full Text Request