1.Integrated evidence chain (Eff-iEC) based effectiveness evaluation of a multifunctional traditional Chinese medicine formula: Taking Xiaoyao San as an example
Caiping HE ; Ye LUO ; Zhiqi LI ; Haocheng YANG ; Lu LIU ; Yingjie XU ; Xiaoyan CHEN ; Siqi HUANG ; Jincai WEN ; Xiaoyan ZHAN ; Zhaofang BAI ; Xu ZHAO ; Xiaohe XIAO
Science of Traditional Chinese Medicine 2026;4(1):96-103
The study focuses on the concept of multifunctional traditional Chinese medicine (TCM) formulas and aims to evaluate the efficacy of the classical formula Xiaoyao San (逍遥散). Study employs the integrated evidence chain (Eff-iEC) method to organize, integrate, and evaluate its therapeutic efficacy in treating different diseases with the same therapy, and to investigate the feasibility of using Eff-iEC to evaluate the multifunctionality of TCM formulas. The evaluation covered Xiaoyao San's therapeutic effects on depression, premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Concurrently, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used for evaluation, and authoritative medical documents were incorporated to corroborate the recognition of Xiaoyao San within the medical community. Depression and menopausal syndrome received higher ratings than other conditions in the Eff-iEC, GRADE, and Medical Community Recognition assessments. The Eff-iEC evidence grade for Xiaoyao San was rated as "High" or above for chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Premenstrual syndrome received a "Moderate +" rating. The GRADE evidence level was "Low-〇〇⨁⨁" for depression, premenstrual syndrome, and chronic hepatitis; "Moderate-〇⨁⨁⨁" for dyspepsia and menopausal syndrome; and "Very Low-〇〇〇⨁" for irritable bowel syndrome. Depression and menopausal syndrome had the highest inclusion frequency, appearing in all 4 categories. Premenstrual syndrome, chronic hepatitis, and dyspepsia are not recommended in Western medical guidelines, but they are included in TCM guidelines, the China National Basic Medical Insurance Drug List, and the China National Essential Drug List. Irritable bowel syndrome appears only in the China National Basic Medical Insurance Drug List and China National Essential Drug List. The evaluation results obtained using the Eff-iEC method align with Medical Community Recognition, providing an objective and comprehensive assessment of Xiaoyao San's efficacy. The findings suggest that Xiaoyao San has strong evidence for treating depression and menopausal syndrome. However, further experimental and clinical trials are needed to assess its efficacy in treating premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, and dyspepsia. These results support the clinical efficacy and rational use of Xiaoyao San, expand the application scope of the Eff-iEC method, and offer valuable insights and methodological references for the comparative evaluation of multifunctional TCM formulas.
2.Integrated evidence chain-based effectiveness evaluation of traditional Chinese medicines (Eff-iEC): A demonstration study.
Ye LUO ; Xu ZHAO ; Ruilin WANG ; Xiaoyan ZHAN ; Tianyi ZHANG ; Tingting HE ; Jing JING ; Jianyu LI ; Fengyi LI ; Ping ZHANG ; Junling CAO ; Jinfa TANG ; Zhijie MA ; Tingming SHEN ; Shuanglin QIN ; Ming YANG ; Jun ZHAO ; Zhaofang BAI ; Jiabo WANG ; Aiguo DAI ; Xiangmei CHEN ; Xiaohe XIAO
Acta Pharmaceutica Sinica B 2025;15(2):909-918
Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.
3.Self-care activities and their influencing factors among young and middle-aged patients with type 2 diabetes mellitus
Yawei HE ; Huaying GE ; Xiuying LI ; Zhaofang YE ; Liping KONG
Journal of Preventive Medicine 2022;34(3):258-262
Objective:
To investigate the self-care activities and their influencing factors among young and middle-aged patients with type 2 diabetes mellitus ( T2DM ), so as to provide the basis for the care management of T2DM.
Methods:
T2DM patients at ages of 18 to 59 years that were admitted to Department of Endocrinology, Hangzhou First People's Hospital Affiliated to Medical School of Zhejiang University were selected using the convenient sampling method from January to August 2021, and the demographic data were collected using questionnaires, including gender, age and educational levels. The self-care level was measured using the Summary of Diabetes Self-Care Activities ( SDSCA ) was used to assess self-management behaviors, and the social support level was evaluated using the Social Support Rating Scale ( SSRS ), while the coping modes were assessed using the Medical Coping Modes Questionnaire ( MCMQ ). Factors affecting the self-care activities were identified among young and middle-aged patients with T2DM using multivariable linear regression analysis.
Results:
The 342 respondents included 185 men ( 54.07% ) and 157 women (45.93% ), and had a mean age of ( 43.76±3.82 ) years. The total score of self-care activities was ( 94.22±18.74 ), and the overall scoring rate was 72.48%, including 63 cases with high scores ( 18.42% ), 208 cases with moderate scores ( 60.82% ) and 71 cases with low scores ( 20.76% ). Multivariable linear regression analysis identified gender ( women, β'=0.213 ), educational level ( high school/technical secondary school, β'=0.187; diploma and above, β'=0.411 ), household monthly income per capita (5 000 Yuan and higher, β'=0.390), course of disease ( >5 years, β'=0.340 ), history of receiving health education targeting diabetes ( β'=0.411 ), coping mode ( avoidance, β'=0.195; confronce, β'=0.367 ) and social support level ( general, β'=0.206; high, β'=0.383 ) as factors affecting self-care activities among young and middle-aged patients with T2DM.
Conclusions
The overall self-care activities at a moderate level among young and middle-aged patients with T2DM, which are associated with gender, educational level, economic income, course of disease, health education targeting diabetes, coping mode and social support level.
4.Guidance for the clinical evaluation of traditional Chinese medicine-induced liver injuryIssued by China Food and Drug Administration.
Xiaohe XIAO ; Jianyuan TANG ; Yimin MAO ; Xiuhui LI ; Jiabo WANG ; Chenghai LIU ; Kewei SUN ; Yong'an YE ; Zhengsheng ZOU ; Cheng PENG ; Ling YANG ; Yuming GUO ; Zhaofang BAI ; Tingting HE ; Jing JING ; Fengyi LI ; Na AN
Acta Pharmaceutica Sinica B 2019;9(3):648-658


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