| [Background]Depression is a common affective disorder which caused by various reasons. The main clinical manifestations are as follows:a significant and lasting low mood, reducing interest,retardation of thinking, pessimism and hopeless, lack of initiative, remorse since sin, loss of appetite, sleep disturbances, suspicious and worry too much,and it often accompanied by a variety of body discomforts of multiple system which are not consistent with the objective examination, severe cases may have suicidal thoughts and behavior. In the Chinese ancient literature,there is no record of the name of depression disease, but the understanding has a long history and a variety of related terms are found such as "depression syndrome","lily disease" and so on.Depression is a common mental disease,16%of people will be influenced by it at some point in their life. The incidence rate of depression is about5.3%in china, approximately69million. Depression is associated with a trend of spread along with the accelerating rhythm of modern life. It was reported that depression was ranked as the fourth leading cause of burden among all diseases according to a research of WHO.It should be the disease Second only to coronary heart disease by2020, Currently, 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.It was reported that more than half of the patients with depression are associated with a certain degree of anxiety according to some clinical researches, however, it should bring more acute adverse events when depression with anxiety was treated by western medicine. Furthermore,the foreign scholars also got a conclusion that antidepressant medicine could have a substantial effect on more severe depressions, but there was no evidence showed that they can produce specific pharmacological benefit for the majority of patients with mild to moderate depressions.Traditional Chinese Medicine (TCM) has long history of prevention and treatment of depression up to two thousand years.TCM,such as JiaWeiXiaoYao (JWXY) power,etc,can bring a reliable clinical curative effect compared with west medicine,and the price is much cheaper following with less side-effects. Because of lack of rigorous clinical research, it seriously prevented the unique advantage of TCM for its popularization and application at home and abroad.Depression diagnosis is symptom-based diagnostic, the diagnosis criteria is based on the a series of symptoms that significantly impair the function of human body for a long period,which often overlap with other conditions such as anxiety disorders. TCM diagnosis is also based on individual symptom of patients. TCM treatment is based on symptoms differentiation, so according to different type of symptoms different herbs are used. JWXY capsule can smooth the liver and clear heat, strength spleen and nourish blood. It is an effective Chinese medicine commonly used on depression with syndrome of qi stagnation transforming into fire in China.3advantages of JWXY capsule for depression disease are as below:1. JWXY capsule is orient from the formula JWXY powder, which has been used for hundreds and thousands years in our country, so it is relatively safe and effective for people.2. JWXY capsule is originated from natural vegetation, and it is more easily accepted by patients.3. JWXY capsule is relatively cheap, which cause much lower economic load for patients and society than conventional antidepressant.The randomized, double-blind, positive controlled trial is the gold standard for testing treatment efficacy, but till now as we know there were few strict designed studies of JWXY capsule in treating depression. Syndrome of qi stagnation transforming into fire is one of common syndromes of depressive patients. So on the basis of previous research, we carried out a multicenter, randomized, double-blind, double-dummy, positive controlled study among mild to moderate depressive patients with syndrome of qi stagnation transforming into fire, in order to study the effectiveness and safety of JWXY capsule in treating mild to moderate depressive patients with syndrome of qi stagnation transforming into fire,to confirm JWXY capsule worthy of extending as a kind of TCM in treating depression,and to provide evidence-based medical evidence of TCM in the treatment of depression.[Objective]1. To study the effectiveness and safety of JWXY 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.[Methods]1. Research designMulticenter, randomized, double-blind, double-dummy and positive controlled clinical study was carried out.2. Research objectBetween October2011to March2013,127mild to moderate depression outpatients with syndrome of qi stagnation transforming into fire were recruited, which from3hospitals in Beijing:Guanganmen hospital of china academy of Chinese medical sciences, Dongfang hospital of Beijing university of Chinese medicine and Anding hospital of capital medical university. The patients were randomly divided into Chinese medicine group and western medicine group according to the time sequence,65in Chinese medicine group and62in western medicine group.3. Therapeutic methodChinese medicine group:JWXY capsule and Sertraline placebo, Western medicine group:Sertraline and JWXY capsule placebo. Either of them got different treatment for8weeks.4. Observation data and observation pointDemographic data were surveyed before the treatment. Hamilton Depressive Scale (HAMD) and TCM symptoms assessed the effects on depression at the0,2nd,4th and8thweek. Curative effect evaluated at the2nd,4th and8th week. Treatment Emergent Symptom Scale (TESS) were filled in the2nd,4th,8thweek. Blood and urine regular,liver and renal function and electrocardiogram were test at0week and8th week. Adverse events were recorded.[Results]1. The Baseline DataA total of127cases with65in Chinese medicine group and62in western medicine group were actually recruited in our study, which including32males (25.20%) and95females (74.80%).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,heart rate and the baseline data as HAMD depression scale entry, TCM symptoms by Z test.2. Comparison of HAMD depression scale total score and curative effect evaluation By 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 Rank sum test or 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. There were no significant differences (P>0.05) of HAMD scale curative effect evaluation between the two groups at each observing point.3. Comparison of HAMD depression scale factors3.1At8th week, the Somatic anxiety symptoms of the two groups were compared by Z test, there was a significant difference (P<0.05) between the two groups,Chinese medicine group was superior to western medicine group.3.2At8th week,there was a significant difference (P<0.05) between the Gastro-intestinal symptoms of the two groups by Z test, Chinese medicine group was superior to western medicine group.3.3At4th and8th week, there was a significant difference (P<0.05) between the Paranoid symptoms of the two groups by Z test,Chinese medicine group was superior to western medicine group.The paranoid symptoms of Chinese medicine group were relieved at2nd week, and disappeared at4th week among most patients without repeating later.Although the paranoid symptoms of Western medicine group relieved at2nd week, they gradually increased after that time.3.4At2nd,4th, and8th week, there was a significant difference (P<0.05) between the obsessive-compulsive symptoms of the two groups by Z test,Chinese medicine group was superior to western medicine group.The obsessive-compulsive symptoms of Chinese medicine group were relieved at2nd week, and disappeared at4th week among most patients without repeating later. The obsessive-compulsive symptoms of Western medicine group not only didn’t relieved at2nd week, but also got an increasing period.3.5After treatment, every symptom of HAMD scale could be relieved gradually among the patients of both Chinese medicine group and Western medicine group. Other symptoms of HAMD depression scale at each observing point were compared by Z test, and there was no significant difference (P>0.05)between the two groups. 4. Comparison of TCM scale total score and symptomsBy 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 Rank sum test or 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.After treatment, every TCM symptom of Chinese medicine group and Western medicine group was all reduced; At2nd,4th and8th week, there was no significant difference (P>0.05) between the symptoms of two groups compared by Z test.5. Therapeutic safetyBefore 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. Two groups were no drug combination. At2nd, adverse reactions and pains caused by traditional Chinese medicine group were significantly lower than the Western medicine group,there was a significant difference (P<0.05) between the adverse reactions of two groups compared by Z test, and the severe symptom of adverse reactions disappeared after drug withdrawal. At4th and8th week, only a few patients of two groups had mild adverse reactions, they all could alleviate by themselves, and there was no significant difference (P>0.05) between the adverse reactions of two groups compared by Z test. There were no other adverse events and serious adverse events of two groups in the course of treatment.6. Falling off and eliminating casesIn the therapeutic process,5cases felled off in Chinese medicine group and10cases in western medicine group, higher rate felled off Western medicine group than that in Chinese medicine group. The expulsion rate was11.81%,and it was inferior to15%. All the cases of two groups were in line with the research needs,and there were no eliminated cases.[Conclusions]l.For treating mild to moderate depression with syndrome of qi stagnation transforming into fire, JWXY 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 JWXY capsule and sertraline can significantly improve patients with symptoms of TCM.3.Compared with sertraline, JWXY 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, gastrointestinal symptoms, paranoia and forced symptoms.4.1n the course of treating mild to moderate depressive patients with syndrome of qi stagnation transforming into fire,JWXY capsule has smaller side-effects compared with sertraline,both the safety and patient compliance are good.5.JWXY capsule has certain advantages of treating depression accompany with symptom of anxiety by contrast sertraline.[Innovations]1.Multicenter clinical study was firstly used to test the effectiveness and safety of JWXY capsule in treating mild to moderate depression with syndrome of qi stagnation transforming into fire,and to explore a new method for treatment of depression.2.Randomized, double-blind, double-dummy and positive controlled clinical study was firstly to test the clinical curative effect of JWXY capsule in treating mild to moderate depression with syndrome of qi stagnation transforming into fire.3.The top-level design based on the GCP requirements and reasonable statistical methods were firstly used for strict clinical trial evaluation of JWXY capsule in the treatment of mild to moderate depression with syndrome of qi stagnation transforming into fire. |
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