Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial.

BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline. Secondary outcomes included quality of life, adverse events, and maternal and perinatal complications. RESULTS: No significant interaction was detected between the interventions (P = 0.69). Participants receiving acupuncture (mean difference [MD], -0.7 [95% CI, -1.3 to -0.1]), doxylamine-pyridoxine (MD, -1.0 [CI, -1.6 to -0.4]), and the combination of both (MD, -1.6 [CI, -2.2 to -0.9]) had a larger reduction in PUQE score over the treatment course than their respective control groups (sham acupuncture, placebo, and sham acupuncture plus placebo). Compared with placebo, a higher risk for births with children who were small for gestational age was observed with doxylamine-pyridoxine (odds ratio, 3.8 [CI, 1.0 to 14.1]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both acupuncture and doxylamine-pyridoxine alone are efficacious for moderate and severe NVP. However, the clinical importance of this effect is uncertain because of its modest magnitude. The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone. PRIMARY FUNDING SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.

[Status of antibiotic use in hospitalized children with community-acquired pneumonia in multiple regions of China].

OBJECTIVE: To investigate the use of antibiotics in children with community-acquired pneumonia (CAP) in multiple regions of China, and to provide a reference for CAP standard treatment and rational antibiotic use in children. METHODS: The medical data of 1 383 children with CAP who were hospitalized in the department of pediatrics in 10 grade A tertiary hospitals from 9 cities between April 14, 2014 and January 1, 2016 were reviewed, to analyze the status of antibiotic use in hospitalized children in North China, Northeast China, East China, and South China. RESULTS: The overall rate of antibiotic use in children with CAP was 89.08%, with 88.7% in North China, 95.5% in Northeast China, 83.3% in East China, and 86.6% in South China. The main types of antibiotics used were cephalosporins, macrolides, compound preparations of ß-lactam antibiotics, polyphosphoric broad-spectrum antibiotics and other ß-lactam antibiotics. The selection of antibiotics was generally rational, but antibiotics were still used in some patients with viral infection alone or a combined use of ≥2 kinds of antibiotics were noted in some patients with infection caused by one kind of pathogen. Irrational antibiotic use was observed in 131 children (10.63%). CONCLUSIONS: There are high rates of antibiotic use and irrational use of antibiotics among children with CAP. Standard management of antibiotic use in children with CAP should be strengthened.

Chinese herbal medicine for menopausal symptoms.

BACKGROUND: Chinese herbal medicine (CHM) usage is expected to increase as women suffering from menopausal symptoms are seeking alternative therapy due to concerns from the adverse effects (AEs) associated with hormone therapy (HT). Scientific evidence for their effectiveness and safety is needed. OBJECTIVES: To evaluate the effectiveness and safety of CHM in the treatment of menopausal symptoms. SEARCH METHODS: We searched the Gynaecology and Fertility Group's Specialised Register of controlled trials, Cochrane Central Register of Controlled Trials (CENTRAL; 2015, Issue 3), MEDLINE, Embase, CINAHL, AMED, and PsycINFO (from inception to March 2015). Others included Current Control Trials, Citation Indexes, conference abstracts in the ISI Web of Knowledge, LILACS database, PubMed, OpenSIGLE database, and China National Knowledge Infrastructure database (CNKI, 1999 to 2015). Other resources included reference lists of articles as well as direct contact with authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing the effectiveness of CHM with placebo, HT, pharmaceutical drugs, acupuncture, or another CHM formula in women over 18 years of age, and suffering from menopausal symptoms. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed 864 studies for eligibility. Data extractions were performed by them with disagreements resolved through group discussion and clarification of data or direct contact with the study authors. Data analyses were performed in accordance with Cochrane Collaboration guidelines. MAIN RESULTS: We included 22 RCTs (2902 women). Participants were from different ethnic backgrounds with the majority of Chinese origin.When CHM was compared with placebo (eight RCTs), there was little or no evidence of a difference between the groups for the following pooled outcomes: hot flushes per day (MD 0.00, 95% CI -0.88 to 0.89; 2 trials, 199 women; moderate quality evidence); hot flushes per day assessed by an overall hot flush score in which a difference of one point equates to one mild hot flush per day (MD -0.81 points, 95% CI -2.08 to 0.45; 3 RCTs, 263 women; low quality evidence); and overall vasomotor symptoms per month measured by the Menopause-Specific Quality of Life questionnaire (MENQOL, scale 0 to 6) (MD -0.42 points; 95% CI -1.52 to 0.68; 3 RCTs, 256 women; low quality evidence).In addition, results from individual studies suggested there was no evidence of a difference between the groups for daily hot flushes assessed by severity (MD -0.70 points, 95% CI -1.00, -0.40; 1 RCT, 108 women; moderate quality evidence); or overall monthly hot flushes scores (MD -2.80 points, 95% CI -8.93 to 3.33; 1 RCT, 84 women; very low quality evidence); or overall daily night sweats scores (MD 0.07 points, 95% CI -0.19 to 0.33, 1 RCT, 64 women; low quality evidence); or overall monthly night sweats scores (MD 1.30 points, 95% CI -1.76 to 4.36, 1 RCT, 84 women; very low quality evidence). However one study using the Kupperman Index reported that overall monthly vasomotor symptom scores were lower in the CHM group (MD -4.79 points, 95% CI -5.52 to -4.06; 1 RCT, 69 women; low quality evidence).When CHM was compared with hormone therapy (HT) (10 RCTs), only two RCTs reported monthly vasomotor symptoms using MENQOL. It was uncertain whether CHM reduces vasomotor symptoms (MD 0.47 points, 95% CI -0.50 to 1.44; 2 RCTs, 127 women; very low quality evidence).Adverse effects were not fully reported in the included studies. Adverse events reported by women taking CHM included mild diarrhoea, breast tenderness, gastric discomfort and an unpleasant taste. Effects were inconclusive because of imprecise estimates of effects: CHM versus placebo (RR 1.51; 95% CI 0.69 to 3.33; 7 trials, 705 women; I² = 40%); CHM versus HT (RR 0.96; 95% CI 0.66 to 1.39; 2 RCTs, 864 women; I² = 0%); and CHM versus specific conventional medications (such as Fluoxetine and Estazolam) (RR 0.20; 95% CI 0.03 to 1.17; 2 RCTs, 139 women; I² = 61%). AUTHORS' CONCLUSIONS: We found insufficient evidence that Chinese herbal medicines were any more or less effective than placebo or HT for the relief of vasomotor symptoms. Effects on safety were inconclusive. The quality of the evidence ranged from very low to moderate; there is a need for well-designed randomised controlled studies.

[Relationship between Life Habits and Constitution Types of Chinese Medicine in the Senile Living at Home in Beijing Downtown].

OBJECTIVE: To investigate the distribution of constitution types of Chinese medicine (CM) in the elderly living at home in Beijing downtown, and to explore its relationship with life habits. METHODS: A total of 3894 senile more than 60 years old were enrolled in this study. Their constitution types of CM were typed using CM constitution questionnaire. Meanwhile, their demographic features, disease condition, diet habits, exercise habits, sleep habits, and so on were investigated. Multivariate Logistic regression analysis was used to evaluate the relationship between life habits and constitution types of CM. RESULTS: The number of mild type constitution senile was 1111 (28.53%) and the number of biased constitutions 2783 (71.47%). Biased constitutions of the top three were qi deficiency constitution (662, 17.00%), yang deficiency constitution (445, 11.43%), and blood stasis constitution (363, 9.32%). Univariate analysis showed that different habits of diet, exercise, and sleep exist among the senile of different constitutions (P < 0.05). By taking mild type constitution, multivariate Logistic regression analysis (except demographic indices and chronic history) showed that significantly positive correlation existed between qi deficiency constitution and favor for hot food (OR = 1.349, P = 0.015), yang deficiency constitution and favor for hot food (OR = 2.448, P < 0.01), phlegm-wetness constitution and favor for barbecue food (OR = 2.144, P = 0.003), wet-heat constitution and favor for sweet food (OR = 1.355, P = 0.032), wet-heat constitution and favor for tea (OR = 1.359, P = 0.047), blood stasis constitution and favor for hot food (OR = 1.422, P = 0.017), and qi depression constitution and favor for hot food (OR = 1.446, P = 0.031). Regular exercise had negative correlation with qi deficiency constitution (OR = 0.397, P < 0.01), yang deficiency constitution (OR = 0.522, P < 0.01) , phlegm-wetness constitution (OR = 0.475, P < 0.01), wet-heat constitution (OR = 0.647, P = 0.015), blood stasis constitution (OR = 0.608, P = 0.001), qi depression constitution (OR = 0.541, P = 0.001), and special diathesis constitution (OR = 0.466, P < 0.01). Early sleep and rise habit had negative with phlegm-wetness constitution (OR = 0.414, P < 0.01), wet-heat constitution (OR = 0.536, P = 0.015), blood stasis constitution (OR = 0.515, P = 0.004), and special diathesis constitution (OR = 0.526, P = 0.039). CONCLUSIONS: Different constitution types of CM might be highly related to specific life habits. Cultivating better life habits can improve biased constitutions of CM.

Performance of ChatGPT on Chinese Master's Degree Entrance Examination in Clinical Medicine.

BACKGROUND: ChatGPT is a large language model designed to generate responses based on a contextual understanding of user queries and requests. This study utilised the entrance examination for the Master of Clinical Medicine in Traditional Chinese Medicine to assesses the reliability and practicality of ChatGPT within the domain of medical education. METHODS: We selected 330 single and multiple-choice questions from the 2021 and 2022 Chinese Master of Clinical Medicine comprehensive examinations, which did not include any images or tables. To ensure the test's accuracy and authenticity, we preserved the original format of the query and alternative test texts, without any modifications or explanations. RESULTS: Both ChatGPT3.5 and GPT-4 attained average scores surpassing the admission threshold. Noteworthy is that ChatGPT achieved the highest score in the Medical Humanities section, boasting a correct rate of 93.75%. However, it is worth noting that ChatGPT3.5 exhibited the lowest accuracy percentage of 37.5% in the Pathology division, while GPT-4 also displayed a relatively lower correctness percentage of 60.23% in the Biochemistry section. An analysis of sub-questions revealed that ChatGPT demonstrates superior performance in handling single-choice questions but performs poorly in multiple-choice questions. CONCLUSION: ChatGPT exhibits a degree of medical knowledge and the capacity to aid in diagnosing and treating diseases. Nevertheless, enhancements are warranted to address its accuracy and reliability limitations. Imperatively, rigorous evaluation and oversight must accompany its utilization, accompanied by proactive measures to surmount prevailing constraints.

Effectiveness and Safety of Chinese Herbal Injections Combined with SOX Chemotherapy Regimens for Advanced Gastric Cancer: a Bayesian Network Meta-Analysis.

Background: Randomized controlled trials (RCTs) have demonstrated that combining Chinese herbal injections (CHIs) with oxaliplatin plus tegafur (SOX) chemotherapy regimens improves clinical effectiveness and reduces adverse reactions in patients with advanced gastric cancer (AGC). These RCTs highlight the potential applications of CHIs and their impact on AGC patient prognosis. However, there is insufficient comparative evidence on the clinical effectiveness and safety of different CHIs when combined with SOX. Therefore, we performed a network meta-analysis to rank the clinical effectiveness and safety of different CHIs when combined with SOX chemotherapy regimens. This study aimed to provide evidence for selecting appropriate CHIs in the treatment of patients with AGC. Methods: We searched eight databases from their inception until March 2023. Surface Under the Cumulative Ranking Curve (SUCRA) probability values were used to rank the treatment measures, and the Confidence in Network Meta-Analysis (CINeMA) software assessed the grading of evidence. Results: A total of 51 RCTs involving 3,703 AGC patients were identified. Huachansu injections + SOX demonstrated the highest clinical effectiveness (SUCRA: 78.17%), significantly reducing the incidence of leukopenia (93.35%), thrombocytopenia (80.19%), and nausea and vomiting (95.15%). Shenfu injections + SOX improved Karnofsky's Performance Status (75.59%) and showed a significant reduction in peripheral neurotoxicity incidence (88.26%). Aidi injections + SOX were most effective in reducing the incidence of liver function damage (75.16%). According to CINeMA, most confidence rating results were classified as "low". Conclusion: The combination of CHIs and SOX shows promising effects in the treatment of AGC compared to SOX alone. Huachansu and Shenfu injections offer the greatest overall advantage among the CHIs, while Aidi injections are optimal for reducing the incidence of liver damage. However, further rigorous RCTs with larger sample sizes and additional pharmacological studies are necessary to reinforce these findings.

Development and Validation of an Interpretable Machine Learning Model for Early Prognosis Prediction in ICU Patients with Malignant Tumors and Hyperkalemia.

This study aims to develop and validate a machine learning (ML) predictive model for assessing mortality in patients with malignant tumors and hyperkalemia (MTH). We extracted data on patients with MTH from the Medical Information Mart for Intensive Care-IV, version 2.2 (MIMIC-IV v2.2) database. The dataset was split into a training set (75%) and a validation set (25%). We used the Least Absolute Shrinkage and Selection Operator (LASSO) regression to identify potential predictors, which included clinical laboratory indicators and vital signs. Pearson correlation analysis tested the correlation between predictors. In-hospital death was the prediction target. The Area Under the Curve (AUC) and accuracy of the training and validation sets of 7 ML algorithms were compared, and the optimal 1 was selected to develop the model. The calibration curve was used to evaluate the prediction accuracy of the model further. SHapley Additive exPlanations (SHAP) and Local Interpretable Model-agnostic Explanations (LIME) enhanced model interpretability. 496 patients with MTH in the Intensive Care Unit (ICU) were included. After screening, 17 clinical features were included in the construction of the ML model, and the Pearson correlation coefficient was <0.8, indicating that the correlation between the clinical features was small. eXtreme Gradient Boosting (XGBoost) outperformed other algorithms, achieving perfect scores in the training set (accuracy: 1.000, AUC: 1.000) and high scores in the validation set (accuracy: 0.734, AUC: 0.733). The calibration curves indicated good predictive calibration of the model. SHAP analysis identified the top 8 predictive factors: urine output, mean heart rate, maximum urea nitrogen, minimum oxygen saturation, minimum mean blood pressure, maximum total bilirubin, mean respiratory rate, and minimum pH. In addition, SHAP and LIME performed in-depth individual case analyses. This study demonstrates the effectiveness of ML methods in predicting mortality risk in ICU patients with MTH. It highlights the importance of predictors like urine output and mean heart rate. SHAP and LIME significantly enhanced the model's interpretability.

Herbal medicines for viral myocarditis.

BACKGROUND: Herbal medicines are used as treatment for viral diseases such as viral myocarditis, and numerous clinical trials have been conducted to investigate their efficacy. Despite this wealth of evidence, the role of herbal medicines in the treatment of viral myocarditis has yet to be established. This is an update of a review published in 2012. OBJECTIVES: To assess the benefits and harms of herbal medicines on clinical (e.g. mortality, incidence of complications) and indirect outcomes (e.g. cardiac function, biochemical response) in patients with viral myocarditis, irrespective of the patients' age, gender or type (including acute and chronic viral myocarditis). SEARCH METHODS: We searched CENTRAL (2013, Issue 1) on The Cochrane Library, MEDLINE (Ovid, 1946 to January Week 4 2013), EMBASE (Ovid, 1980 to 2013 Week 04) and LILACS (Bireme) on 1 February 2013. We previously searched The Chinese Biomedical Database (1979 to 2011), China National Knowledge Infrastructure (1979 to 2011), Chinese VIP Information (1989 to 2011), Chinese Academic Conference Papers Database and Chinese Dissertation Database (1980 to 2011), AMED (June 2011) and the Cochrane Complementary Medicine Field Trials Register (June 2011). We handsearched Chinese journals and conference proceedings. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of herbal medicines (with a minimum duration of seven days of treatment) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus a conventional drug versus the drug alone were also included. We included only trials that reported an adequate description of allocation sequence generation. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and evaluated trial quality. Information on adverse effects was collected from the trial reports. MAIN RESULTS: We did not identify any new trials with the updated search in February 2013. The 2011 update of this review included twenty randomised controlled trials involving 2177 people. All the trials were conducted and published in China. The controls included anti-arrhythmic drugs, corticosteroids, and antiviral therapies such as ribavirin or interferon. Combining the risk of bias for random sequence generation, allocation concealment, selective reporting, and incomplete outcome data, we assessed the included trials as being at a high risk of bias. Thirteen different herbal medicines were tested in the included trials. One of the trials reported outcomes on mortality. The trials reported electrocardiogram results, levels of myocardial enzymes, cardiac function, and adverse effects.Compared with supportive therapy, Astragalus membranaceus injection did not show a significant reduction in the number of patients that died of cardiac failure.A meta-analysis showed a significant effect ofAstragalus membranaceus injection plus supportive therapy on the number of participants with an abnormal electrocardiogram (RR 0.28, 95% CI 0.13 to 0.61), ST-T changes (RR 0.72, 95% CI 0.54 to 0.95), creatine phosphate kinase (CPK) levels (MD -21.54, 95% CI -33.80 to -9.28), and lactate dehydrogenase (LDH) levels (MD -30.33, 95% CI -46.78 to -13.88).Shengmai injection plus supportive therapy showed a significant effect on the number of patients with an abnormal electrocardiogram (RR 0.11, 95% CI 0.01 to 0.86), CPK levels (MD -103.90, 95% CI -114.97 to -92.83), LDH levels (MD -34.60, 95% CI -51.25 to -17.95), and on myocardial enzyme CK-MB levels (MD -10.87, 95% CI -14.50 to -7.24). Shengmai decoction plus supportive therapy showed a significant effect on improving quality of life measured by the SF-36 (MD 40.20, 95% CI 18.13 to 62.27) compared to supportive therapy. Data on adverse events were only available from six of the included trials and no serious adverse effects were reported. AUTHORS' CONCLUSIONS: Since no new trials were identified in the updated search in 2013, the conclusions remain the same as they were in 2012. There is no evidence of benefit of herbal medicine on all cause mortality. Some herbal medicines may lead to improvement of ventricular premature beat, electrocardiogram, levels of myocardial enzymes, and cardiac function in viral myocarditis. However, these findings should be interpreted with care, due to the risk of bias of the included studies, small sample size, and limited number of trials on individual herbs. Further robust trials are needed to explore the use of herbal medicines for viral myocarditis.

Chinese herbal medicines for hypertriglyceridaemia.

BACKGROUND: Hypertriglyceridaemia is associated with many diseases including atherosclerosis, diabetes, hypertension and chylomicronaemia. Chinese herbal medicines have been used for a long time as lipid-lowering agents. OBJECTIVES: To assess the effects and safety of Chinese herbal medicines for hypertriglyceridaemia. SEARCH METHODS: We searched a number of databases including The Cochrane Library, MEDLINE, EMBASE and several Chinese databases (all until May 2012). SELECTION CRITERIA: Randomised controlled trials in participants with hypertriglyceridaemia comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. Any disagreement was resolved by discussion and a decision was achieved based on consensus. We assessed trials for risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias. MAIN RESULTS: We included three randomised trials with 170 participants. Ninety participants were randomised to the Chinese herbal medicines groups and 80 to the comparator groups with numbers ranging from 50 to 60 participants per trial. The duration of treatment varied from four to six weeks. All the included trials were conducted in China and published in Chinese. Overall, the risk of bias of included trials was unclear. There were no outcome data in any of the trials on death from any cause, cardiovascular or cerebrovascular events, health-related quality of life, or costs.Three different herbal medicines, including Zhusuan Huoxue decoction, Huoxue Huayu Tongluo decoction, and Chushi Huayu decoction were evaluated. All three trials investigating Chinese herbal medicines treatment alone (two studies) or in combination with gemfibrozil (one study) reported results on serum triglyceride (TG) in favour of the herbal treatment. We did not perform a meta-analysis due to significant clinical heterogeneity between the studies.No relevant differences in adverse effects occurred and no serious adverse events were noted. AUTHORS' CONCLUSIONS: The present systematic review suggests that Chinese herbal medicines may have positive effects on hypertriglyceridaemia. The trials did not report serious adverse effects following Chinese herbal medicines treatment. However, based on an unclear risk of bias in included studies and lack of patient-important long-term outcomes, no definite conclusion could be reached.

Herbal medicines for fatty liver diseases.

BACKGROUND: Fatty liver disease is potentially a reversible condition that may lead to end-stage liver disease. Since herbal medicines such as Crataegus pinnatifida and Salvia miltiorrhiza have increasingly been used in the management of fatty liver disease, a systematic review on herbal medicine for fatty liver disease is needed. OBJECTIVES: To assess the beneficial and harmful effects of herbal medicines for people with alcoholic or non-alcoholic fatty liver disease. SEARCH METHODS: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 3, 2012), MEDLINE, EMBASE, and Science Citation Index Expanded to 1 March 2012. We also searched the Chinese BioMedical Database, Traditional Chinese Medical Literature Analysis and Retrieval System, China National Knowledge Infrastructure, Chinese VIP Information, Chinese Academic Conference Papers Database and Chinese Dissertation Database, and the Allied and Complementary Medicine Database to 2 March 2012. SELECTION CRITERIA: We included randomised clinical trials comparing herbal medicines with placebo, no treatment, a pharmacological intervention, or a non-pharmacological intervention such as diet or lifestyle, or Western interventions in participants with fatty liver disease. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently. We used the 'risk of bias' tool to assess the risk of bias of the included trials. We assessed the following domains: random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias. We presented the effects estimates as risk ratios (RR) with 95% confidence intervals (CI) or as mean differences (MD) with 95% CI, depending on the variables of the outcome measures. MAIN RESULTS: We included 77 randomised clinical trials, which included 6753 participants with fatty liver disease. The risks of bias (overestimation of benefits and underestimation of harms) was high in all trials. The mean sample size was 88 participants (ranging from 40 to 200 participants) per trial. Seventy-five different herbal medicine products were tested. Herbal medicines tested in the randomised trials included single-herb products (Gynostemma pentaphyllum, Panax notoginseng, and Prunus armeniaca), proprietary herbal medicines commercially available, and combination formulas prescribed by practitioners. The most commonly used herbs were Crataegus pinnatifida,Salvia miltiorrhiza,Alisma orientalis,Bupleurum Chinense,Cassia obtusifolia, Astragalus membranaceous, and Rheum palmatum. None of the trials reported death, hepatic-related morbidity, quality of life, or costs. A large number of trials reported positive effects on putative surrogate outcomes such as serum aspartate aminotransferase, alanine aminotransferase, glutamyltransferase, alkaline phosphatases, ultrasound, and computed tomography scan. Twenty-seven trials reported adverse effects and found no significant difference between herbal medicines versus control. However, the risk of bias of the included trials was high.The outcomes were ultrasound findings in 22 trials, liver computed tomography findings in eight trials, aspartate aminotransferase levels in 64 trials, alanine aminotransferase activity in 77 trials, and glutamyltransferase activities in 44 trials. Six herbal medicines showed statistically significant beneficial effects on ultrasound, four on liver computed tomography, 42 on aspartate aminotransferase activity, 49 on alanine aminotransferase activity, three on alkaline phosphatases activity, and 32 on glutamyltransferase activity compared with control interventions. AUTHORS' CONCLUSIONS: Some herbal medicines seemed to have positive effects on aspartate aminotransferase, alanine aminotransferase, ultrasound, and computed tomography. We found no significant difference on adverse effects between herbal medicine and control groups. The findings are not conclusive due to the high risk of bias of the included trials and the limited number of trials testing individual herbal medicines. Accordingly, there is also high risk of random errors.

A cross-sectional study of the clinical characteristics of hospitalized children with community-acquired pneumonia in eight eastern cities in China.

BACKGROUND: Community-acquired pneumonia in children is common in China. To understand current clinical characteristics and practice, we conducted a cross-sectional study to analyze quality of care on childhood pneumonia in eight eastern cities in China. METHODS: Consecutive hospital records between January 1, 2010 and December 31, 2010 were collected from 13 traditional Chinese medicine (TCM) and western medicine (WM) hospitals in February, May, August, and November (25 cases per season, 100 cases over the year), respectively. A predesigned case report form was used to extract data from the hospital medical records. RESULTS: A total of 1298 cases were collected and analyzed. Symptoms and signs upon admission at TCM and WM hospitals were cough (99.3% vs. 98.6%), rales (84.8% vs. 75.0%), phlegm (83.3% vs. 49.1%), and fever (74.9% vs. 84.0%) in frequency. Patients admitted to WM hospitals had symptoms and signs for a longer period prior to admission than patients admitted to TCM hospitals. Testing to identify etiologic agents was performed in 1140 cases (88.4%). Intravenous antibiotics were administered in 99.3% (595/598) of cases in TCM hospitals and in 98.6% (699/700) of cases in WM hospitals. Besides, Chinese herbal extract injection was used more frequently in TCM hospitals (491 cases, 82.1%) than in WM hospitals (212 cases, 30.3%) (p < 0.01). At discharge, 818 cases (63.0%) were clinically cured, with a significant difference between the cure rates in TCM (87.6%) and WM hospitals (42.0%) (OR = 9.8, 95% confidence interval (CI): 7.3 ~ 12.9, p < 0.01). Pathogen and previous medical history were more likely associated with the disappearance of rales (OR = 7.2, 95% CI: 4.8 ~ 10.9). Adverse effects were not reported from the medical records. CONCLUSIONS: Intravenous use of antibiotics is highly prevalent in children with community-acquired pneumonia regardless of aetiology. There was difference between TCM and WM hospitals with regard to symptom profile and the use of antibiotics. Intravenous use of herbal injection was higher in TCM hospitals than in WM hospitals. Most of the cases were diagnosed based on clinical signs and symptoms without sufficient confirmation of aetiology. Audit of current practice is urgently needed to improve care.

Comparative effectiveness and safety of Chinese medicine belly button application for childhood diarrhea: a Bayesian network meta-analysis of randomized controlled trials.

Background: Chinese medicine belly button application (CMBBA) has been used to treat childhood diarrhea (CD) in several randomized controlled trials (RCTs), but its effectiveness and combination strategy still need to be clarified. Therefore, we aimed to evaluate the effectiveness, safety, and the optimal combination strategy of CMBBA in treating CD. Methods: Up until January 2023, we searched for studies that met our inclusion criteria in six databases, including PubMed, the Cochrane Library, Chinese SinoMed, CNKI, VIP, and Wanfang. Heterogeneity was quantified using I2 statistics. A methodological evaluation was performed using the Cochrane Risk Bias Tool 2.0. The Confidence in Network Meta-Analysis online software was employed to evaluate evidence grading. A minimally contextualized framework was used to provide a comprehensive conclusion for the network meta-analysis. This study protocol was registered with PROSPERO. Results: We analyzed data from 33 RCTs that included 4,490 children with diarrhea. In terms of clinical effectiveness, CMBBA plus montmorillonite powder plus anti-infectives may be the most effective treatment option for children with diarrhea and concurrent infection according to a minimally contextualized framework. Either exclusive use of CMBBA or CMBBA in combination with modern medicine was beneficial in reducing the time to diarrhea disappearance (MD = -1.33 days, 95% CI: -1.59 to -1.08, Z = -10.103, p < 0.001) compared to modern medicine exclusively, and the difference was statistically significant. The combined usage of CMBBA could shorten the recovery time of dehydration by an average of 0.74 days (MD = -0.74 days, 95% CI: -1.10 to -0.37, Z = -3.931.103, p < 0.001). While some studies have reported mild allergic reactions and mild abdominal pain after CMBBA use, these symptoms can be cured in a relatively short period of time. Conclusions: The combination of CMBBA, montmorillonite powder, and anti-infectives may provide superior clinical effectiveness for children with diarrhea and concurrent infection. To treat CD, CMBBA can be used effectively and safely. However, the findings must be interpreted with cautiously due to the limited number of clinical trials and the low quality of the studies. In addition, the choice of treatment plan should also be based on the specific conditions of each patient. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier: CRD42022380694.

Chinese herbal injections in combination with radiotherapy for advanced pancreatic cancer: A systematic review and network meta-analysis.

Background: Advanced pancreatic cancer (APC) is a fatal disease with limited treatment options. This study aims to evaluate the effectiveness and safety of different Chinese herbal injections (CHIs) as adjuvants for radiotherapy (RT) in APC and compare their treatment potentials using network meta-analysis. Methods: We systematically searched three English and four Chinese databases for randomized controlled trials (RCTs) from inception to July 25, 2023. The primary outcome was the objective response rate (ORR). Secondary outcomes included Karnofsky performance status (KPS) score, overall survival (OS), and adverse events (AEs). The treatment potentials of different CHIs were ranked using the surface under the cumulative ranking curve (SUCRA). The Cochrane RoB 2 tool and CINeMA were used for quality assessment and evidence grading. Results: Eighteen RCTs involving 1199 patients were included. Five CHIs were evaluated. Compound Kushen injection (CKI) combined with RT significantly improved ORR compared to RT alone (RR 1.49, 95 % CrI 1.21-1.86). Kanglaite (KLT) plus RT (RR 1.58, 95 % CrI 1.20-2.16) and CKI plus RT (RR 1.49, 95 % CrI 1.16-1.95) were associated with improved KPS score compared to radiation monotherapy, with KLT+RT being the highest rank (SUCRA 72.28 %). Regarding AEs, CKI plus RT was the most favorable in reducing the incidence of leukopenia (SUCRA 90.37 %) and nausea/vomiting (SUCRA 85.79 %). Conclusions: CKI may be the optimal choice of CHIs to combine with RT for APC as it may improve clinical response, quality of life, and reduce AEs. High-quality trials are necessary to establish a robust body of evidence. Protocol registration: PROSPERO, CRD42023396828.

Herbal medicines for viral myocarditis.

BACKGROUND: Herbal medicines are being used as a treatment for viral diseases such as viral myocarditis and numerous clinical trials have been conducted to investigate their efficacy. Despite this wealth of evidence, the role of herbal medicines in the treatment of viral myocarditis is yet to be established. This is an update of the review published in 2010. OBJECTIVES: To assess the effects of herbal medicines on clinical (for example mortality, incidence of complications) and indirect outcomes (for example cardiac function, biochemical response) in patients with viral myocarditis. SEARCH METHODS: We searched CENTRAL (The Cochrane Library 2011, Issue 2), MEDLINE (January 1966 to June 2011), EMBASE (January 1998 to June 2011), Chinese Biomedical Database (1979 to 2011), China National Knowledge Infrastructure (1979 to 2011), Chinese VIP Information (1989 to 2011), Chinese Academic Conference Papers Database and Chinese Dissertation Database (1980 to 2011), AMED (June 2011), LILACS (June 2011), and the Cochrane Complementary Medicine Field Trials Register. We handsearched Chinese journals and conference proceedings. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials of herbal medicines (with a minimum of seven days treatment duration) compared with placebo, no intervention, or conventional interventions were included. Trials of herbal medicine plus conventional drug versus drug alone were also included. Only trials that reported an adequate description of allocation sequence generation were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and evaluated trial quality. Adverse effects information was collected from the trials. MAIN RESULTS: Twenty randomised controlled trials involving 2177 people were included. All trials were conducted and published in China. The controls included anti-arrhythmic drugs, corticosteroids, and antiviral therapies such as ribavirin or interferon. Combining the risk of bias on random sequence generation, allocation concealment, selective reporting, and incomplete outcome data, the included trials were assessed to be at high risk of bias. Thirteen different herbal medicines were tested in the included trials. None of the trials reported outcomes on mortality. The trials reported electrocardiogram results, level of myocardial enzymes, cardiac function, and adverse effects.A meta-analysis showed a significant effect of Astragalus membranaceus injection plus supportive therapy on the number of patients with an abnormal electrocardiogram (RR 0.28, 95% CI 0.13 to 0.61), ST-T changes (RR 0.72, 95% CI 0.54 to 0.95), creatine phosphate kinase (CPK) levels (MD -21.54, 95% CI -33.80 to -9.28), and lactate dehydrogenase (LDH) levels (MD -30.33, 95% CI -46.78 to -13.88).Shengmai injection plus supportive therapy showed a significant effect on the number of patients with an abnormal electrocardiogram (RR 0.11, 95% CI 0.01 to 0.86), CPK levels (MD -103.90, 95% CI -114.97 to -92.83), LDH levels (MD -34.60, 95% CI -51.25 to -17.95), and on myocardial enzyme CK-MB levels (MD -10.87, 95% CI -14.50 to -7.24). Shengmai decoction plus supportive therapy showed a significant effect on improving quality of life measured by the SF-36 (MD 40.20, 95% CI 18.13 to 62.27) compared to supportive therapy. Data on adverse events were only available from six of the included trials and no serious adverse effects were reported. AUTHORS' CONCLUSIONS: Some herbal medicines may lead to improvement of ventricular premature beat, electrocardiogram, level of myocardial enzymes, and cardiac function in viral myocarditis. However, these findings should be interpreted with care due to the high risk of bias of the included studies, small sample size, and limited number of trials on individual herbs. Further robust trials are needed to explore the use of herbal medicines in viral myocarditis.

[Using nested case-control study to appraise the effectiveness of Chinese medicines in the treatment of diabetic nephropathy].

OBJECTIVE: A nested case-control study was carried out to assess the effectiveness of Chinese medicines in the treatment of diabetic nephropathy, so as to explore the feasibility of using nested case-control study on effect assessment of Chinese medicine. METHODS: Nested case-control study was applied and the participants were enrolled from the subjects recruited in a cohort study. The cases and the controls were matched by 1 to 4 in age, gender, nationality and the stage of diabetic nephropathy when recruited in the cohort study. The EpiData 3.1 software was used for inputting data and SAS system was used for data analysis. Conditional logistic regress was applied to analyze the relationship between treatment and the progression of diabetic nephropathy. The study power was estimated and the sample sizes for case-control study and cohort study were recalculated based on the data from the cohort study. RESULTS: Eight cases and 32 controls were recruited in this study. The education level, ratio of drug withdrawal, change of therapy, syndrome differentiation and treatment were not significantly different in case and control groups. The progression of diabetic nephropathy was not significantly related with the treatment and the odds ratio (OR) value was 0.725 with a 95% confidence interval from 0.174 to 3.030. The statistical power of the study was 5%. To achieve the statistical power of 80%, 1 350 (270:1 080) participants were needed for 1:4 matched case-control study, 880 (440:440) for 1:1 paired case-control study, and 1 020 (510:510) for 1:1 control study. CONCLUSION: The treatment method is not significantly related with the progress of diabetic nephropathy. The nested case-control study is applicable in the therapeutic effect evaluation of Chinese medicine. Basic studies such as cross-sectional studies should be carried out to supply fundamental information for other types of studies including case-control study, cohort study and randomized clinical trials. Large sample size studies were needed to appraise the effect of Chinese medicine.

Five-Flavor Sophora flavescens Enteric-Coated Capsules for Ulcerative Colitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

BACKGROUND: Ulcerative colitis (UC), a chronic inflammatory bowel disease, is characterized by abdominal pain, diarrhea, and mucopurulent bloody stool. In recent years, the incidence and prevalence of UC have been increasing consistently. Five-flavor Sophora falvescens enteric-coated capsule (FSEC), a licensed Chinese patent medicine, was specifically used to treat UC. This review was aimed to assess the effectiveness and safety of FSEC for the treatment of UC. METHODS: Six electronic databases were searched from inception to March 2021. Randomized clinical trials (RCTs) comparing FSEC or FSEC plus conventional Western medicine with conventional Western medicine in participants with UC were included. Two authors screened all references, assessed the risk of bias, and extracted data independently. Binary data were presented as risk ratios (RRs) with 95% confidence intervals (CIs) and metric data as mean difference (MD) with 95% CI. The overall certainty of the evidence was assessed by GRADE. RESULTS: We included 15 RCTs (1194 participants, 763 in the FSEC group and 431 in the control group). The treatment duration ranged from 42 to 64 days. Twelve trials compared FSEC with conventional Western medicine, and two trials compared FSEC plus conventional medicine with conventional medicine. Another trial compared FSEC plus mesalazine with compound glutamine enteric capsules plus mesalazine. FSEC showed a higher clinical effective rate (improved clinical symptoms, colonoscopy results, and stools) (RR 1.12, 95% CI 1.05 to 1.20; 729 participants; 8 trials; low-quality evidence) as well as the effective rate of traditional Chinese medicine (TCM) syndromes (RR 1.10, 95% CI 1.01 to 1.20; 452 participants; 5 trials; low-quality evidence) compared to mesalazine. There was no significant difference in the adverse events between FSEC and control groups. CONCLUSIONS: FSEC may show effectiveness in UC treatment compared to conventional medicine, and the use of FSEC may not increase the risk of adverse events. Due to the limited number of clinical trials and low methodological quality of the included trials, our findings must be interpreted with discretion.

Chinese herbal injections versus intrapleural cisplatin for lung cancer patients with malignant pleural effusion: A Bayesian network meta-analysis of randomized controlled trials.

Background: Malignant pleural effusion (MPE) is a common complication in patients with advanced lung cancer that can severely compromise the quality of life and limit life expectancy. Randomized controlled trials (RCTs) have shown that Chinese herbal injections (CHIs) may be beneficial in improving quality of life. This network meta-analysis (NMA) aims to explore several CHIs used for lung cancer patients with MPE. Methods: Seven databases were systematically searched for eligible RCTs from inception to November 2021. The primary outcome was the clinical effective rate. Secondary outcomes were the improvement rate of Karnofsky performance status (KPS) score and incidence of adverse events (AEs). The Cochrane risk of bias 2 tool was used to assess the quality of included studies. Data analysis was performed using STATA 16.0 and R software 4.1.0. Both pairwise meta-analysis and Bayesian NMA were conducted. Competing interventions were ranked using the surface under the cumulative ranking (SUCRA) probabilities. Evidence grading was evaluated using the Confidence in Network Meta-Analysis online software (https://cinema.ispm.unibe.ch/). Results: A total of 44 studies involving 2,573 patients were included. The combined Huachansu injection (HCS) with intrapleural cisplatin (cis-diamminedichloro-platinum, DDP) had the highest probability of improving the clinical effective rate (SUCRA, 84.33%). The Kangai injection (KA) combined with DDP had the most improvement rate of KPS score (SUCRA, 80.82%), while the Fufangkushen injection (FFKS) alone was more likely to reduce AEs including gastrointestinal reactions (SUCRA, 89.92%), leukopenia (SUCRA, 91.85%), and chest pain (SUCRA, 98.17%). FFKS combined with DDP ranked the best in reducing the incidence of fever (SUCRA, 75.45%). Conclusions: Our NMA showed that CHIs alone or combined with DDP could improve clinical effectiveness and quality of life and reduce AEs, compared to DDP alone. HSC and KA, combined with DDP, may be the most effective considering clinical effective rate and improvement of KPS score, respectively. FFKS, either used alone or in combination therapy with DDP, may be the best in reducing AEs. However, high-quality RCTs with larger sample sizes are needed to further support the evidence. Systematic review registration: PROSPERO https://www.crd.york.ac.uk/prospero/, identifier CRD42021285275.

Chinese herbal medicines for hypercholesterolemia.

BACKGROUND: Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents. OBJECTIVES: To assess the effects of Chinese herbal medicines on hypercholesterolemia. SEARCH STRATEGY: We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010 ), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010). SELECTION CRITERIA: We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias. MAIN RESULTS: We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 ± 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional medicine in six comparisons (20 trials), or placebo (two trials). There were no outcome data in any of the trials on cardiovascular events and death from any cause. One trial each reported well-being (no significant differences) and economic costs. No serious adverse events were observed. Xuezhikang was the most commonly used herbal formula investigated. A significant effect on total cholesterol (two trial, 254 participants) was shown in favor of Xuezhikang when compared with inositol nicotinate (mean difference (MD) -0.90 mmol/L, 95% confidence interval (CI) -1.13 to -0.68) . AUTHORS' CONCLUSIONS: Some herbal medicines may have cholesterol-lowering effects. Our findings have to be interpreted with caution due to high or unclear risk of bias of the included trials.

[Introduction of dynamic balancing randomization method and its application].

Following the development of clinical trials, the methodology of clinical trials has developed a great deal, including randomization method and blinding method, etc. The method of randomization includes simple randomization, stratification randomization, etc. Dynamic randomization is also considered as a method of randomization. Two dynamic randomization methods are introduced in this paper, including a method considering the balance of numbers in each group and a method considering prognostic factors. This paper also demonstrates the procedure of dynamic randomization of the above two methods by simulations and actual examples.