The effective evaluation of scientific and technological achievements in traditional Chinese medicine (TCM) is of great significance in promoting the innovative development of TCM. Previous evaluations of scientific and technological achievements in TCM often used a generalized evaluation method, leading to problems such as inappropriate indicators and limited dimensions, which is not conducive to reflecting the multiple values of achievements in a scientific and comprehensive way. Consequently, there is an urgent need to establish categorized and multi-dimensional evaluation index system for the evaluation of scientific and technological achievements in TCM in the new period.
To establish a scientific, categorized, reliable and comprehensive evaluation index system that reflects the principles of TCM and highlights its unique advantages aiming at the scientific and technological achievements in TCM, in accordance with the contemporary requirements for scientific and technological evaluation in China.
This study began in November 2022 and was completed in May 2023. A preliminary index framework was developed through literature review and focus group discussions. Delphi expert consultation was then conducted over two rounds to determine the evaluation indexes and points. The hierarchical analysis method was used to calculate the weight of each index.
The final evaluation index system of scientific and technological achievements in TCM clinical research comprised 10 threshold indicators, 4 primary indicators, 17 secondary indicators, and 17 evaluation points. After testing, the positive coefficient of experts in both rounds of Delphi method implementation was 100%, the authority coefficient was 0.94 and 0.93, respectively. The Kendall's W consistency test for each level of indicators yielded two-tailed significance (P<0.05), indicated high levels of expert positivity and authority, strong consistency of expert opinion, and reliable consulting results.
This study constructs a scientific, reasonable, reliable and easy-to-operate evaluation index system for scientific and technological achievements in TCM clinical research. The indexes cover a wide range with highly differentiated weights and TCM characteristics, which is conducive to highlighting the core strengths while comprehensively considering the multiple value of the results. Additionally, the associated evaluation points, enhancing the operationalization of the index system, may potentially serve as a valuable reference for related evaluation activities.
Polycystic ovary syndrome with insulin resistance (PCOS-IR) is recognized as one of the most challenging subtypes of PCOS to treat due to its intricate pathogenesis and significant individual variability. Although Metformin, as a first-line medication, can ameliorate blood glucose levels and enhance insulin sensitivity, its efficacy in regulating hormonal imbalances and improving ovarian function is limited. Additionally, its gastrointestinal side effects often hinder patient adherence.
To evaluate the efficacy and safety of Yishen Quzhuo Formula compared to metformin in the treatment of PCOS-IR.
A prospective study enrolled 102 PCOS-IR patients from June 2022 to October 2023 at the Department of Gynecology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University. Patients were randomly assigned in a 2∶1 ratio to the experimental group (n=68) treated with Yishen Quzhuo Formula or the control group (n=34) treated with metformin. The comparison was made between the two groups in terms of ovulation rate, pregnancy rate, sex hormones [follicle-stimulating hormone (FSH), luteinizing hormone (LH), LH/FSH ratio, testosterone (T), anti-Müllerian hormone (AMH) ], glucose and lipid metabolism indicators, BMI, waist-hip ratio (WHR), and incidence of adverse reactions.
After treatment, the basal body temperature (BBT) ovulation rate in the experimental group increased compared to before treatment (P<0.05). Among patients with a desire for fertility in the experimental group, 13 cases resulted in pregnancy, while in the control group, with 5 such cases, only 1 resulted in pregnancy. The comparison of pregnancy rates between the two groups after treatment showed no statistically significant difference (χ2=1.154, P>0.05). After treatment, both groups showed a decrease in LH/FSH compared to before treatment (P<0.05). Following treatment, both groups showed a decrease in fasting plasma glucose (FPG), fasting insulin (FINS), homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), and triglycerides (TG) compared to before treatment (P<0.05). Following treatment, there was no statistically significant difference in high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) between the two groups compared to before treatment (P>0.05). After treatment, the waist circumference of the control group was lower than that of the experimental group (P<0.05). After treatment, the BMI, waist circumference, hip circumference, and waist hip ratio of both groups of patients decreased compared to before treatment (P<0.05). After treatment, alanine aminotransferase (ALT) and uric acid (UA) in the experimental group decreased compared to before treatment, while UA in the control group increased compared to before treatment (P<0.05). After treatment, there was no statistically significant difference in other indicators between the two groups compared to before treatment (P>0.05). During treatment, adverse reactions such as hypoglycemia, fatigue, epigastric discomfort, and diarrhea occurred in patients, with a lower incidence of adverse reactions in the experimental group (5/68, 7.35%) than in the control group (15/31, 48.39%) (χ2=20.404, P<0.001) .
Yishen Quzhuo Formula regulates hormone imbalance, improves glucose and lipid metabolism abnormalities, and is as effective as metformin in treating PCOS-IR. It exerts protective effects on liver and kidney function and exhibits superior tolerance over metformin in reducing adverse reactions. Given metformin's gastrointestinal side effects, patients demonstrate better tolerance and acceptance of Yishen Quzhuo Formula, thus warranting its clinical promotion and application.
Traditional Chinese medicine (TCM) is effective in the treatment of sepsis-induced acute lung injury (ALI) /acute respiratory distress syndrome (ARDS). However, the lack of standard and uniform outcome indicators in the design of most published clinical trials makes it difficult to combine and compare the results of similar studies, causing the impossibility of generating high-quality evidence to guide clinical decision-making.
To analyze the use of outcome indicators in randomized controlled trials on TCM for sepsis-induced ALI/ARDS from 2017 to 2022.
CNKI, Wanfang Data, SinoMed, PubMed, Embase, Web of Science and Cochrane Library were searched for RCTs on sepsis-induced ALI/ARDS, with the intervention group treated with TCM combined with other drugs or conventional treatment, and no restrictions in the control group. The ROB.2 tool of the Cochrane Review Group was used to assess the quality of literature and the classification of outcome indicators was summarized.
39 papers were included after screening, including 1 (2.56%) with low risk of bias, 3 (7.69%) with high risk of bias and 35 (89.74%) with concerns of bias. The outcome indicators in 5 RCTs were reported with a quality score of ≥5, indicating the complete reporting of outcome indicators. A total of 106 outcome indicators were reported and used for 443 times, including physicochemical testing outcome (55 types, 51.89%), TCM syndrome/sign outcome (2 types, 1.89%), symptom and syndrome outcome (13 types, 12.26%), long-term prognosis outcome (19 types, 17.92%), quality of life outcome (7 types, 6.60%), safety event outcome (8 types, 7.55%) and economic evaluation outcome (2 types, 1.89%). There were four outcome indicators with utilization rate>50%, including oxygenation index (82.05%), Acute Physiology and Chronic Health Evaluation Scoring System (58.97%), mechanical ventilation duration (51.28%) and interleukin-6 (51.28%). The composite outcome indicators of effective rate or TCM syndrome efficacy were used in 21 papers, involving a total of 12 times of effective rate, TCM syndrome score of 8 times and TCM symptom efficacy of 6 times. The total 106 outcome indicators were summarized and categorized sequentially including overall evaluation indicators (36 types, 33.96%), common indicators (36 types, 33.96%) and different focus indicators (34 types, 32.08%) .
At present, the selection of outcome indicators in RCTs on TCM for sepsis-induced ALI/ARDS is still nonstandard, mainly manifests in unclear differentiation between primary and secondary outcome indicators, trivialization of endpoint indicators, lack of follow-up data and characteristic indicators of TCM. A core outcome set of TCM outcome indicators for septic induced ALI/ARDS should be constructed to promote the high-quality development of TCM in the future.
