QIN Yuning, HE Liyun, YAN Shiyan, LIU Yanjiao, WANG Songling, GUO Rongjuan, WANG Ping, AI Yanke, LV Xiaoying, LUO Lin, ZHANG Yanhong, LI Xinlong, LI Lingxiang, BAI Hetian, LIU Baoyan
To summarize the research phases of the efficacy evaluation of stepwise progressive evidence-based treatment, and to verify the efficacy and safety of the core prescriptions of evidence-based treatment of insomnia by individual practitioners, the scientific problems and solution strategies in the three stages of "description-exploration-validation" were compared and analyzed in this paper. Based on the observational study of the evidence-based treatment efficacy by famous TCM practitioners, the further validation of the efficacy was carried out through a multicenter blinded randomized controlled trial design. 133 insomnia patients with TCM classification of phlegm-heat-disturbing-the-mind were used as the study population. The patients were randomly divided into three treatment groups, namely Qing Tan Ning Shen Fang, Xiang Fu Wen Dan Tang and Huang Lian Wen Dan Tang; all of them were prepared as Chinese medicine compound granules and taken for 28 days. The differences in total sleep time (TST) and sleep latency (SL) were observed before and after treatment; the Pittsburgh Sleep Quality Index (PSQI) scores, Insomnia Severity Index (ISI) scores before and after treatment were compared between the groups. After 4 weeks of treatment, sleep efficiency (SE) and clinical efficiency were calculated. After 4 weeks of treatment, the decrease of PSQI score was 4.64, 4.91, and 5.43 in the three groups, respectively; the total sleep time was prolonged by 1.22, 1.14, and 1.62 hours, and the sleep latency was shortened by 43.81, 55.44, and 53.37 minutes on average, the decrease of ISI score was 6.79, 7.98, and 7.43 in the three groups, and the SE was improved by 15.18% and 10.26%, respectively. The overall effective rates were 73.81%, 73.33%, and 76.09%, with no statistically significant differences between groups (P>0.05). Compared with the results of the observational study, the efficacy was reduced. The effective core prescriptions of the famous TCM discriminative treatment are effective, safe and reliable for patients with phlegm-heat disturbed insomnia, and the stepwise progressive discriminative treatment efficacy evaluation research method can gradually increase the level of evidence of TCM clinical research and finally obtain objective and scientific research conclusions.
