| Depression is a mental disorder which has the character of high prevalence, high recurrence rate and high suicide rates.In2001,World Health Organization published "The World Health Report" that depression has already become the world’s fourth largest disease. Beyond of this, depression is expected to be one of the most severe burden diseases in developing countries in2020.There are diverse therapies for depression which mainly focus on medication and psychological therapy. New antidepressant medicine constantly applied in clinical treatment, while there are still20%-30%of patients are ineffective in drugs.Also some patients cann’t adhere to the treatment for not tolerating with the side effects of drug. Western psychotherapy applied not optimistically in the country for the reason of Chinese traditional culture, the ideology of treatment, cognitive, and cultural levels etc.Beyond of this, psychotherapy usually needs long therapy. At the same time, more Chinese depressive patients prefer to traditional Chinese medical therapy. Depressive patients believe that TCM has better clinical efficacy, fewer side effects, almost no withdrawal syndrome.So it becomes the trend that we search for more effective and safe non-artificial antidepressant and compound herbal at this moment. Xi Le Ning Granule is a traditional Chinese medicine which is created by professor Lu Zhizheng, one of State Medical Masters, according to Chinese medical syndrome differentiation, major clinical syndrome character and clinical experience. Case studies showed that it had a good clinical efficacy for depression.[Objection]1. To observe the clinical efficacy and safety of that Xi Le Ning Granule treats mild and moderate depression of syndrome of liver qi stagnation and spleen deficiency. We want to provide an effective treatment method for the clinical therapy of depression;2. To observe the influence on which Xi Le Ning Granule has to5-HT and NE of the depressive patients’plasma. We expect to explore the mechanism of Xi Le Ning Granule treating depression.[Method]Part I:In clinical research we used a randomized, double-blind, double-dummy, placebo-controlled approach to study the mild and moderate depression patients.120patients were randomly divided into three groups which is Chinese medicine group, Western medicine group and control group. Each group had40patients. Every patient was treated for eight weeks.We observed the Hamilton Depression Rating Scale, Montgomery Depression Scale, Five states Personality Inventory, TCM syndrome score before and after treatment in each group to research the clinical efficacy and safety of that Xi Le Ning Granule treats mild and moderate depression of syndrome of liver qi stagnation and spleen deficiency.Part II:We used a prospective, controlled method in clinical and basic research to observe the influence on which Xi Le Ning Granule has to5-HT and NE of the depressive patients’ plasma and to explore the physiological and pathological mechanism of antidepressant effect of Xi Le Ning Granule.[Results]Part I:Clinical Research1. The total disease effective rate of Chinese medicine group was79.49%. Western medicine group’s total disease effective rate was76.32%. Control group’s total disease effective rate was25.71%.25.71%devoted to the placebo effect. The comparison of disease efficiency among three groups after treatment was significant (P<0.05).There was not a significant difference in diseases efficiency between Chinese medicine group and western medicine group (P>0.05).Also the comparisons of disease efficiency between Chinese medicine group and control group, western medicine group and control group were significant (P<0.05);2. The syndromes effective rate of Chinese medicine group was74.36%. Wester medicine group’s syndromes effective rate was63.16%.The control group’s was28.57%. There was a significant difference in TCM syndromes efficiency among three groups (P<0.05).The comparison of TCM syndromes efficiency between Chinese medicine group and western medicine group was not significant (P>0.05).The syndromes effective rates’ comparison between Chinese medicine group and control group, western medicine group and control group were significant (P<0.05);3. There was a significant difference of HAMD score and MADRS score (P<0.05) among2w,4w,6w,8w in three groups. The HAMD total score and MADRS total score of Chinese medicine group were different with western medicine group (P<0.05) in2w and4w. The change of HAMD total score and MADRS total score was no significantly different (P>0.05) between two groups in6w and8w. There were statistically significant difference(P <0.05) in HAMD total score and MADRS total score between Chinese medicine group and control group, western medicine group and control group.The HAMD score and MADRS total score has significantly decreased after treatment in Chinese medicine group and western medicine group. But the Chinese medicine group had an advantage on the onset time than western medicine group and control group.4. The comparison of three groups’Chinese syndromes scores among each observation point was statistically significant different (P<0.05).The Chinese syndrome scores minus were different between Chinese medicine group and western medicine group (P<0.05) in2w or4w. But the minus scores were no significant different in6w or8w (P>0.05).The Chinese syndrome scores’comparison had significant difference between Chinese medicine group and control group, western medicine group and control group in2w,4w,6w, or8w(P<0.05).The Chinese syndrome scores of Chinese medicine group and western medicine group had decreased in8weeks.But control group had not such an apparent tendency. The Chinese medicine group had a faster onset than western medicine group or control group.There was a difference in comparison of main symptoms score in each observation point of three groups (P<0.05).The main symptoms included depression, chest fullness, sighing. The Chinese medicine group and western medicine group had the same efficacy in improving main symptoms (P>0.05).The comparison was statistically significant (P<0.05) between Chinese medicine group and control group, western medicine group and control group in main symptoms score.The main symptoms scores of Chinese medicine group or western medicine group descended more than control group. The total score of secondary symptoms which included insomnia, forgetfulness, fatigue, weakness etc.of three groups was basically the same in4weeks (P>0.05). But they were different after6weeks or8weeks (P<0.05).The reduction of secondary symptoms score of Chinese medicine group and western medicine group were the same in each observation point (P>0.05).There was a difference in comparison of secondary symptoms score in each observation point of three groups (P<0.05).5. Shaoyang and taiyin scores of three groups were different with normal Chinese before treatment (P<0.05).The Shaoyang score of patients with depression was lower than normal Chinese. But taiyin score was higher than normal Chinese. Shaoyang and taiyin scores were different (P<0.05) among three groups except for others (P>0.05) after8weeks therapy. Each factor score of Five State TCM Personality Scale was consistent between Chinese medicine group and western medicine group (P>0.05).Taiyang, yin and yang peace, shaoyin scores were no significant difference (P>0.05) between Chinese medicine group and control group, western medicine group and the control group. But shaoyang, taiyin scores were different (P<0.05). Chinese medicine group and western medicine group had the same score level with normal Chinese after treatment (P>0.05).Shaoyang and taiyin scores of control group were different with normal Chinese (P<0.05).Shaoyang score increased and taiyin score decreased of Chinese medicine group and western medicine group after treatment. While shaoyang score was still lower and taiyin score was higher than normal Chinese.6. Xi Le Ning Granule had one case of mild adverse events which may be not related to the treatment in clinical application. There were6patients in venlafaxine group who had mild adverse reactions that may be caused by medicine.The control group had one case of light may not interfere with the treatment. This study shown that Xi Le Ning Granule was safer than venlafaxine.Part II:Basic Research1. The plasma5-HT and NE levels of depressive patients were different with normal healthy people (P<0.05) before treatment. The plasma5-HT, NE levels of depression were lower than healthy ones. Although the plasma5-HT and NE levels of depression were still lower than healthy control. The plasma5-HT and NE levels between depression and healthy controls were statistically significant difference (P<0.05) after12weeks’ treatment.2. The plasma5-HT levels and HAMD score were different before and after Xi Le Ning Granule treating (P<0.05). But NE levels of plasma basically unchanged before and after the treatment (P>0.05). The5-HT levels of plasma elevated and NE levels did not significantly change after12weeks of treatment.3. The correlation analysis of plasma5-HT levels and HAMD of patients with depression found that R=-0.134, P<0.05. Plasma5-HT levels of depression were negatively correlated with HAMD scores.[Conclusion]1. Xi Le Ning Granule could reduce the HAMD, MADRS scores and effectively improve the clinical symptoms of depression patients. Xi Le Ning Granule and Venlafaxine had the same efficacy of treating mild and moderate depression. But Xi Le Ning Granule had advantage on onset time. It had shorter onset time than venlafaxine;2. Xi Le Ning Granule maybe impact on Shaoyang,and Taiyin score by improving clinical symptomsof depression;3. Xi Le Ning Granule maybe play a therapeutic role through the mechanism of increasing5-HT of depressive patients;4. Xi Le Ning Granule had better security in clinical application. |
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