Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version) / 中国中药杂志

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Systematic review and Meta-analysis of efficacy and safety of Fengliao Changweikang prescription in treatment of acute gastroenteritis / 中国中药杂志

This study systematically evaluated the clinical efficacy and safety of Fengliao Changweikang prescription for treating acute gastroenteritis(AGE). The databases of CNKI, Wanfang, VIP, SinoMed, Medline, Cochrane Library and two clinical trial registration platforms were retrieved from inception to August 30, 2022, to collect randomized controlled trial(RCT) on Fengliao Changweikang prescription treating AGE. Two researchers independently conducted literature screening, data extraction, and risk of bias assessment according to pre-established inclusion and exclusion criteria. RevMan 5.4.1 was used for data analysis. Finally, 18 RCTs were included, involving 3 489 patients. Meta-analysis showed that compared with conventional western medicine, Fengliao Changweikang prescription improved the relief rate of abdominal pain(RR=1.27, 95%CI[1.17, 1.38],P<0.000 01); Fengliao Changweikang prescription + conventional western medicine increased the cure rate(RR=1.43, 95%CI[1.12, 1.82], P=0.004), shortened the duration of diarrhoea(RR=-1.65, 95%CI[-2.44,-0.86], P<0.000 1), abdominal pain(RR=-1.46, 95%CI[-2.00,-0.92], P<0.000 01), vomiting(RR=-2.16, 95%CI[-2.51,-1.81], P<0.000 01) and fever(RR=-2.61, 95%CI[-4.00,-1.23], P=0.000 2), down-regulated the level of interleukin-8(IL-8)(RR=-1.07, 95%CI[-1.26,-0.88], P<0.000 01), IL-6(RR=-8.24, 95%CI[-8.99,-7.49], P<0.000 01) and hypersensitive C-reactive protein(hs-CRP)(RR=-3.04, 95%CI[-3.40,-2.69], P<0.000 01) and recurrence of AGE(RR=0.20, 95%CI[0.05, 0.90], P<0.04). In conclusion, Fengliao Changweikang prescription was safe in clinical application. It was beneficial to alleviate the clinical symptoms of diarrhea, abdominal pain, vomiting, and fever, and down-regulate the levels of some serum inflammatory factors in AGE patients. However, considering that few high-quality studies have evaluated the efficacy and safety of Fengliao Changweikang prescription in treatment of AGE, further evidence is needed in the future.

Systematic review and Meta-analysis of Biling Weitong Granules in treatment of stomach ache disorder / 中国中药杂志

This study aimed to evaluate the efficacy and safety of Biling Weitong Granules in the treatment of stomach ache disorder. Randomized controlled trial(RCT) of Biling Weitong Granules in the treatment of digestive diseases with stomach ache disorder as the primary symptom was retrieved from Chinese and English electronic databases and trial registration platforms from database inception to June 10, 2022. Two investigators conducted literature screening and data extraction according to the screening criteria. The Cochrane risk-of-bias tool(v 2.0) was used to assess the risk of bias in the included studies. Analyses were performed using RevMan 5.4 and R 4.2.2, with summary estimates measured using fixed or random effects models. The primary outcome indicators were the visual analogue scale(VAS) scores and stomach ache disorder symptom scores. The secondary outcome indicators were clinical recovery rate, Helicobacter pylori(Hp) eradication rate, and adverse reaction/events. Twenty-seven RCTs were included with a sample size of 2 902 cases. Meta-analysis showed that compared with conventional western medicine treatments or placebo, Biling Weitong Granules could improve VAS scores(SMD=-1.90, 95%CI[-2.18,-1.61], P<0.000 01), stomach ache disorder symptom scores(SMD=-1.26, 95%CI[-1.71,-0.82], P<0.000 01), the clinical recovery rate(RR=1.85, 95%CI[1.66, 2.08], P<0.000 01), and Hp eradication rate(RR=1.28, 95%CI[1.20, 1.37], P<0.000 01). Safety evaluation revealed that the main adverse events in the Biling Weitong Granules included nausea and vomiting, rash, diarrhea, loss of appetite, and bitter mouth, and no serious adverse events were reported. Egger's test showed no statistical significance, indicating no publication bias. The results showed that Biling Weitong Granules in the treatment of digestive system diseases with stomach ache disorder as the primary symptom could improve the VAS scores and stomach ache disorder symptom scores of patients, relieve stomach ache disorder, and improve the clinical recovery rate and Hp eradication rate, with good safety and no serious adverse reactions. However, the quality of the original studies was low with certain limitations. Future studies should use unified and standardized detection methods and evaluation criteria of outcome indicators, pay attention to the rigor of study design and implementation, and highlight the clinical safety of the medicine to provide more reliable clinical evidence support for clinical application.

An Introduction of EVIDEM Framework and Its Application in Healthcare Decision Making / 中国实验方剂学杂志

Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.

Feasibility Analysis of EVIDEM Framework in Health Technology Assessment of Traditional Chinese Medicine / 中国实验方剂学杂志

Traditional Chinese medicine （TCM） health technology assessment （HTA） provides scientific information and decision-making basis for decision-makers at all levels to choose TCM health technology reasonably. However， it is still in its infancy. In the future， it is necessary to strengthen top-level design， improve cognition and attention， enhance talent training and cooperation， and speed up the development of evaluation criteria in line with the characteristics of TCM， so as to promote the development of HTA in TCM. Therefore， it is imperative to create a method system and tools suitable for TCM HTA. Evidence and value impact on decisionmaking （EVIDEM） framework is developed by EVIDEM collaboration. It combines evidence and value to form a relatively complete decision-making framework system， which can provide methodological support for medical insurance reimbursement， clinical practice decision-making， drug selection and so on. The introduction of EVIDEM framework into the field of TCM has methodological feasibility and practical operability， but it is still necessary to further integrate and optimize the TCM characteristics. On the basis of theoretical research， pilot studies are carried out with Chinese patent medicine as the breakthrough point， forming a preliminary framework and implementation path for the research of TCM HTA， in order to promote healthcare decision-making and achievement transformation.

Efficacy Evaluation of Dingkundan in Treatment of Female Infertility： A Systematic Review Based on Randomized Controlled Trials / 中国实验方剂学杂志

This study systematically evaluated the effectiveness and safety of Dingkundan combined with conventional western medicine in the treatment of female infertility. Four Chinese databases，three English databases， and two clinical trial registration platforms were retrieved from inception to April 2021. Two researchers independently carried out literature screening，data extraction，risk assessment of bias，and grading of evidence quality. RevMan 5.4.1 was used for data analysis. A total of 216 research articles were retrieved and 21 randomized controlled trials （RCTs） were included，involving 2 172 cases. The risks of bias in the included RCTs were high. As unraveled by Meta-analysis results， Dingkundan combined with western medicine for ovulation stimulation was superior to western medicine for ovulation stimulation alone in improving pregnancy rate and progesterone level ［relative risk（RR）pregnancy rate=1.67，95% confidence interval（CI）（1.44，1.93）；standardized mean difference （SMD）progesterone=1.21，95% CI（0.82，1.60）］. Dingkundan combined with western medicine for improving the endometrium was superior to western medicine for improving the endometrium alone in improving the pregnancy rate ［RRpregnancy rate=1.35，95% CI（1.23，1.48）］. Dingkundan combined with clomiphene was more effective than clomiphene alone in regulating endometrial thickness and reducing follicle-stimulating hormone and estradiol levels ［MDendometrial thickness=3.34，95% CI（3.27，3.41）， MDfollicle-stimulating hormone=-0.42，95% CI（-0.65，-0.19）， MDestradiol=-4.33，95% CI （-8.18，-0.48）］. Dingkundan combined with letrozole was superior to letrozole alone in increasing the follicle-stimulating hormone level and reducing the estradiol level ［MD follicle-stimulating hormone=1.14，95% CI（0.49，1.78）， MDestradiol =-33.65，95% CI（-59.13，-8.17）］. The single-study results showed that Dingkundan combined with conventional western medicine had certain advantages in regulating endometrial thickness，reducing follicle-stimulating hormone，luteinizing hormone，and estradiol levels，and increasing progesterone levels. The Grading of Recommendations， Assessment， Development， and Evaluation（GRADE）system was used for the evaluation of outcome indicators. The results showed that the quality of the evidence was graded moderate or low. Based on the existing evidence，Dingkundan combined with western medicine for infertility treatment had certain advantages in increasing the pregnancy rate， improving endometrial thickness， regulating hormone levels， and reducing adverse reactions. However，affected by the quality of the included trials，the results may have limitations，and high-quality RCTs are needed for verification in the future.

Systematic Evaluation of Pushen Capsule in the Treatment of Hyperlipidemia： A Meta-analysis / 中国实验方剂学杂志

The present study systematically evaluated the efficacy and safety of Pushen capsule （PC） in the treatment of hyperlipidemia （HPL） to provide the basis for its clinical application in the future. The randomized controlled trials （RCTs） of PC in treating HPL were comprehensively retrieved from four Chinese databases and three English databases. The included RCTs were evaluated using the Cochrane risk-of-bias tool， followed by the Meta-analysis by RevMan 5.3. Twenty-four RCTs were included， with 2 634 patients involved. The patients in the experimental group were treated with PC， PC combined with conventional therapy，or PC combined with other Chinese patent medicine. The cases in the control group were treated conventionally or by other Chinese patent medicine. Meta-analysis results showed that PC alone or in combination was superior to the treatment in the control group in improving total cholesterol （TC），triglyceride （TG），high-density lipoprotein cholesterol （HDL-C），low-density lipoprotein cholesterol （LDL-C），and total response rate. Fourteen trials reported adverse reactions， including seven reporting specific results. The adverse reactions were dominated by epigastric discomfort， but the difference was not statistically significant. However， affected by the quality of the included trials，the evidence strength of the conclusion of this study is graded low. More high-quality RCTs reported in detail are needed for further confirmation.

Analysis on disease burden and direct medical cost of Xueshuan Xinmaining Tablets in patients with cerebral infarction and coronary heart disease / 中国中药杂志

The increasing burden of cardiovascular disease in China has become a major public health problem, and the prevention and treatment of cardiovascular disease is in urgent need. For the reality of integrated Chinese and Western medicine in the Chinese health care system, we can consider the service ability of traditional Chinese medicine. Xueshuan Xinmaining Tablet is a kind of Chinese patent medicine commonly used in the treatment of recovery stage of ischemic stroke and angina pectoris of coronary heart disease. Based on the data of hospitalized patients covered by national urban basic medical insurance of China Medical Insurance Research Association in 2013, this study evaluated the treatment cost and detailed composition of the cost for the patients with cerebral infarction and coronary heart disease treated by Xueshuan Xinmaining Tablets. At the same time, the differences in disease burden and direct medical expenses among Xueshuan Xinmaining Tablets group, Western medicine group and another commonly used Chinese patent medicine group were analyzed. Among the three groups of patients with cerebral infarction and coronary heart disease, the hospitalization rates caused by various causes(44.4% and 29.6%) and diseases(20.8% and 5.2%) in Xueshuan Xinmaining Tablets group were the lowest(all P<0.01), and the number of hospitalization times in half a year was highest in the common Chinese patent medicine group(all P<0.01). In patients with cerebral infarction, the median annual total outpatient expenses were 7 476.8, 7 601.8, 15 650.1 yuan respectively in Western medicine group, Xueshuan Xinmaining Tablets group and the common Chinese patent medicine group(P<0.01), and the median hospitalization expenses were 11 620.2, 14 988.9, 13 325.6 yuan respectively(P=0.058). In patients with coronary heart disease, the total outpatient expenses of the three groups were 6 831.4, 10 228.6, 13 132.4 yuan respectively(P<0.01), and the total hospitalization expenses were 13 354.7, 14 911.5, 15 725.3 yuan respectively(P=0.134). The results showed that in patients with cerebral infarction and coronary heart disease, the hospitalization rate was lowest in Xueshuan Xinmaining Tablets group, beneficial to the turnover of hospital beds and full use of hospital medical resources. The total annual outpatient cost of Xueshuan Xinmaining Tablets group was lower than that of common Chinese patent medicine group, beneficial to reduce the burden of disease.