| [Background]The main clinical manifestations of depression is depressed mood, severe person can appear Dutch act or aggressive behavior,which seriously hurts people’s health and safety. In recent years, along with the rapid development of society and the fast pace of life, people’s psychological pressure increases, the incidence of depression is rising rapidly.Depression is treated by modern medicine with western medicine such as Sertraline, but western medicine treatment cycle is long, the price is expensive along with large side-effects, so it greatly influences the patient’s compliance and clinical curative effect.Traditional Chinese Medicine (TCM) has long history of prevention and treatment of depression up to two thousand years. It has a variety of advantages such as different means, the reliable curative effect, lower price and less side effects, all these promote the development of traditional Chinese medicine in the treatment of depression. But there is no unified standard in Traditional Chinese Medicine with the etiology and pathogenesis, syndrome differentiation typing and therapy of depression. The existing experimental studies more come from personal experience,which goes against the development of the theory and clinical application of depression in traditional Chinese medicine, so more rigorous and scientific study is in need to make improvement and innovation of the system theory of traditional Chinese medicine in the treatment of depression.Depression of Syndromeof qi stagnation transforming into fire is one of the most common clinical syndromes. Currently, there is no rigorous experiment on clinical study of JiaWeiXiaoYao capsule in the treatment of depression. As a part of the research that is directed by china academy of chinese medical sciences, we use rigorous scientific experiment in order to evaluate the effect and safety of JiaWeiXiaoYao capsule in treatment of mild to moderate depressive patients with syndrome of qi stagnation transforming into fire, and provide basis for further study of traditional Chinese medicine in treating depression.[Objective]1. To study the effectiveness and safety of JiaWeiXiaoYao Capsule in treating mild to moderate depressive patients with syndrome of qi stagnation transforming into fire.2. To explore the superiority of TCM in the treatment of mild to moderate depressive patients with syndrome of qi stagnation transforming into fire compared to antidepressant western medicine.3. To provide a basis for further study of TCM in the treatment of depressive patients.[Methods]1. Research designRandomized, double-blind, double-dummy and positive controlled clinical study was carried out.2. Research objectBetween October2012to August2013,65mild to moderate depression outpatients with syndrome of qi stagnation transforming into fire were recruited, which from Dongfang hospital of Beijing university of Chinese medicine. The patients were randomly divided into Chinese medicine group and western medicine group according to the time sequence,34in Chinese medicine group and31in western medicine group.3. Therapeutic methodChinese medicine group:JiaWeiXiaoYao Capsule and Sertraline placebo, Western medicine group:Sertraline and JiaWeiXiaoYao Capsule placebo. Either of them got different treatment for8weeks.4. Observation data and observation pointCurative effect evaluated at the2nd,4th and8th week, all patients were followed up after4weeks. Hamilton Depressive Scale (HAMD) and Hamilton Anxiety Scale (HAMA) and TCM symptoms assessed the effects on depression at the0,2nd,4th and8th week, all patients were followed up after4weeks. Blood and urine regular, liver and renal function and were test at0week and8th week.[Results]1.The Baseline DataA total of62cases with33in Chinese medicine group and29in western medicine group were actually recruited in our study. There were no significant statistical differences (P>0.05) between the two groups in the demographic data as gender, height, weight, systolic blood pressure, diastolic blood pressure and heart rate by T test. 2. Comparison of HAMD depression scale curative effect evaluationThere were no significant differences (P=0.694>0.05) of HAMD scale curative effect evaluation between the two groups at each observing point, effective and markedly effective cases have the highest share in both groups.3. Comparison of HAMD depression scale total scoreBy paired t test, there were statistically significant differences (P<0.05) of HAMD scale total score at each observing point compared with the baseline of the Chinese medicine group and western medicine group, indicating that both groups have good therapeutic effect.By group sample t test, there were no statistically significant difference (P>0.05) of HAMD scale comparison between Chinese medicine group and western medicine group on each observing point. In the improvement of somatic anxiety symptoms, gastrointestinal symptoms and sleep disorder symptoms, Jiawei Xiaoyao capsule has obvious advantages than sertraline.4Comparison of HAMA anxiety scale total scoreA total of62cases were actually recruited in our study, of which56patients had Somatic anxiety symptoms (90.32%). By paired t test, there were statistically significant differences (P<0.05) of HAMA anxiety scale total score at each observing point compared with the baseline of the Chinese medicine group and western medicine group,indicating that both groups have good therapeutic effect. By group sample t test, there was no statistically significant difference (P>0.05) of HAMA anxiety scale total score comparison between Chinese medicine group and western medicine group on each observing point, indicating that there is no significant difference between Chinese medicine group and western medicine group. In the improvement of somatic anxiety symptoms, gastrointestinal symptoms and sleep disorder symptoms, Jiawei Xiaoyao capsule has obvious advantages than sertraline.5.Comparison of TCM scale total scoreBy paired t test, there were statistically significant differences (P<0.05) of TCM scale total score at each observing point compared with the baseline of the Chinese medicine group and western medicine group, indicating that both groups have good therapeutic effect. By group sample t test, there was no statistically significant difference (P>0.05) of TCM scale comparison between Chinese medicine group and western medicine group on each observing point, indicating that there is no significant difference between Chinese medicine group and western medicine group. After treatment, every TCM symptom of Chinese medicine group and Western medicine group was all reduced.6.Therapeutic safetyDuring the study, at2nd, two patients in the western medicine group suffered side effect such as dry mouth, nausea and dry eyes. Only one patients suffered side effect such as dry mouth and headache. The severe symptom of adverse reactions disappeared after drug withdrawal. There was no other adverse reaction in the course of treatment. Before treatment and8th week later, there was no significant abnormity of blood and urine regular,liver and renal function and electrocardiogram among all patients of two groups. There were no other adverse events and serious adverse events of two groups in the course of treatment.[Conclusions]1.For treating mild to moderate depression with syndrome of qi stagnation transforming into fire, JiaWeiXiaoYao Capsule has similar good therapeutic effect to western medicine sertraline.2. For treating mild to moderate depression with syndrome of qi stagnation transforming into fire, both JiaWeiXiaoYao Capsule and sertraline can significantly improve patients with symptoms of TCM.3. Compared with sertraline, JiaWeiXiaoYao Capsule has obvious advantages of improving some symptoms of mild to moderate depressive patients with syndrome of qi stagnation transforming into fire,such as somatic anxiety symptoms, gastrointestinal symptoms and sleep disorder symptoms.4. For the treatment of mild to moderate depression with anxiety disorder, Jiawei Xiaoyao capsule has similar good therapeutic effect to western medicine sertraline. |
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