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To evaluate the efficacy of a comprehensive TCM regimen on reducing the 2-year recurrence rate of major depressive disorder(MDD). Methods 　This large-scale multi-centered, prospective cohort study was conducted by recruiting MDD patients from 13 sub-centers nationwide from January 2017 to April 2018 with assistance of the Boshi Medical Cloud Data Management Platform . A comprehensive TCM regimen was used in the intervention of MDD patients. Three cohorts(TCM cohort, integrated Chinese and western medicine cohort, and western medicine cohort) were formed to observe the differences in the recurrence rate of MDD. According to the exposure time of the comprehensive TCM regimen intervention, the TCM cohort and the integrated Chinese and western medicine cohort were further divided into three groups with low, medium and high exposure levels respectively, and difference in the recurrence rate among those groups of different exposure levels was observed, so as to evaluate the long-term efficacy of the comprehensive TCM regimen in reducing the recurrence rate of MDD. Results　A total of 4 440 patients with MDD were included in the TCM cohort(1484 patients), western medicine cohort(1412 patients) and integrated Chinese and Western medicine cohort(1544 patients). The two-year recurrence rate was 25.5% in the TCM cohort, 35. 4% in the western medicine cohort, and 19. 3% in the integrated Chinese and western medicine cohort. Compared with the recurrence risk of the low-level exposure group in the Chinese medicine cohort, it was 41. 6% lower in the medium-level exposure group(HR = 0. 584, 95%CI(0.467 ~ 0.731), P <0. 001), and 71.3% lower in the high-level exposure group(HR =0. 287, 95%CI(0.214~0. 384), P<0. 001). Compared with the recurrence risk of the low-level exposure group in the integrated Chinese and western medicine cohort, it was 54. 3% lower in the medium-level exposure group(HR =0. 457, 95%CI(0. 352~0. 692), P<0. 001) and 75. 2% lower in the high-level exposure group(HR = 0. 248, 95%CI(0. 182 ~0. 337), P<0. 001). Conclusion　The comprehensive TCM regimen seems to reduce the 2-year recurrence rate of MDD. There is probably a close correlation between the exposure level of TCM intervention and the recurrence rate, and a longer exposure duration could possibly lead to a lower recurrence rate. [ABSTRACT FROM AUTHOR]

To establish a TCM information database for the prevention and treatment of major depressive disorder(MDD) based on cloud data technology, and to evaluate the clinical efficacy of traditional Chinese medicine(TCM) regimen in the prevention and treatment of suicide risk in MDD. Methods　A total of 4 440 patients with MDD who were inpatients or outpatients in 13 hospitals including TCM hospitals, integrated Chinese and Western medicine hospitals and psychiatric hospitals in 7 cities across the country were recruited, among which 2 513 patients without suicidal ideation were included in this cohort study. The data was collected from January 2017 to April 2018. Three groups of cohorts ( TCM, Western medicine, and integrated Chinese & Western medicine) were naturally formed. The follow-up interval was 3 months. Taking the appearance of suicidal ideation as the end event and the Montgomery-Asberg Depression Rating Scale(MARDS) as the evaluation tool in the follow-up, we assessed the patients′ dynamic status of depression and the occurrence of the end event. Results　A TCM cohort(896 patients), a Western medicine cohort(744 patients), and an integrated Chinese and Western medicine cohort(873 patients) were established with MDD patients without suicidal ideation at baseline, and the overall two-year incidence rates of suicidal ideation in the three groups were 34. 5% (309/896), 46. 9% (349/744), and 23. 0% (201/873) respectively. Compared with the Western medicine cohort, the risk of suicidal ideation was reduced in the TCM cohort by 33. 9% (HR = 0. 671, 95% CI(0. 575-0. 784), P <0. 001), and by 59. 4% (HR = 0. 406, 95%CI (0. 341-0. 483), P < 0. 001) in the integrated Chinese and Western medicine cohort. In the TCM cohort, compared with lowlevel TCM exposure time(TCM-ET), the risk of suicidal ideation was reduced by 47. 2%(HR =0. 528, 95%CI(0. 414-0. 674), P<0. 001), with medium-level TCM-ET, and by 81. 6% (HR =0. 184, 95%CI (0. 127-0. 267), P<0. 001), with high-level TCM-ET. In the integrated Chinese and Western medicine cohort, compared with the low-level TCM-ET time, the risk of suicidal ideation was reduced by 39. 9% (HR =0. 601, 95% CI(0. 438-0. 826), P<0. 001) with medium-level exposure time, and by 65. 9% (HR = 0. 341, 95%CI (0. 235-0. 495), P <0. 001) with high-level exposure time, indicating that a higher level of exposure time could reduce the suicidal risk. Conclusion　TCM, Western medicine, or integrated TCM and western medicine could all improve the depressive symptoms and suicidal ideation in MDD patients, and the application of TCM treatment seems to better reduce the probability of suicidal ideation in MDD patients than Western medicine treatment alone. The application of TCM treatment for over 6 months (medium-level or above TCM-ET) indicates a greater effect on the prevention of suicide in patients with MDD. [ABSTRACT FROM AUTHOR]