Herbal Medicine Maekmundong-Tang on Patients with Nonspecific Chronic Cough: Study Protocol for a Double-Blind, Randomized Controlled Clinical Trial.

As the treatment of nonspecific chronic cough with conventional medications that treat cough according to the cause is limited, Maekmundong-tang (comprising Liriopis seu Ophiopogonis Tuber, Pinelliae Tuber, Oryzae Semen, Zizyphi Fructus, Ginseng Radix, and Glycyrrhizae Radix et Rhizoma) has been used empirically in the clinical setting of East Asian traditional medicine. This study is the first to explore the feasibility, preliminary effect, safety, and cost-effectiveness of Maekmundong-tang for nonspecific chronic cough. This study protocol is that of a double-blind, randomized, active-controlled, parallel-group clinical trial for comparing Maekmundong-tang with Saengmaek-san (comprising Liriopis seu Ophiopogonis Tuber, Ginseng Radix, and Schisandrae Fructus), a Korean national health insurance-covered herbal medicine for cough. A total of 30 nonspecific chronic cough patients will participate and receive the assigned herbal medicine for 6 weeks, and clinical parameters will be assessed at weeks 0 (baseline), 3 (midterm assessment), 6 (primary endpoint), 9, and 24 (follow-up). Study feasibility outcomes, including recruitment, adherence, and completion rates, will be assessed. Preliminary effects on cough severity, frequency, and quality of life will be evaluated using outcome measures, such as the Cough Symptom Score, Cough Visual Analog Scale, and the Leicester Cough Questionnaire. Adverse events and laboratory tests will be monitored for safety evaluation, and exploratory economic evaluations will be conducted. The results will provide evidence of Maekmundong-tang in the treatment of nonspecific chronic cough.

The efficacy and safety of Chinese herbal medicine Guizhi Fuling capsule combined with low dose mifepristone in the treatment of uterine fibroids: a systematic review and meta-analysis of 28 randomized controlled trials.

OBJECTIVE: Guizhi Fuling Capsule (GZFL), a classic traditional Chinese medicine prescription, is often recommended for the treatment of uterine fibroids (UFs). However, the efficacy and safety of GZFL in combination with low-dose mifepristone (MFP) remains controversial. MATERIALS AND METHODS: We searched eight literature databases and two clinical trial registries for randomized controlled trials (RCTs) of the efficacy and safety of GZFL combined with low-dose MFP in the treatment of UFs from database inception to April 24, 2022. Data analysis was performed using the Meta package in RStudio and RevMan 5.4. GRADE pro3.6.1 software was used for the assessment of evidence quality. RESULTS: Twenty-eight RCTs were included in this study, including a total of 2813 patients. The meta-analysis showed that compared with low-dose MFP alone, GZFL combined with low-dose MFP significantly reduced follicle stimulating hormone (p < 0.001), estradiol (p < 0.001), progesterone (p < 0.001), luteinizing hormone (p < 0.001), uterine fibroids volume (p < 0.001), uterine volume (p < 0.001), menstrual flow (p < 0.001) and increased clinical efficiency rate (p < 0.001). Meanwhile, GZFL combined with low-dose MFP did not significantly increase the incidence of adverse drug reactions compared with low-dose MFP alone (p = 0.16). The quality of the evidence for the outcomes ranged from "very low" to "moderate." CONCLUSION: This study suggests that GZFL combined with low-dose MFP is more effective and safe in the treatment of UFs, and it is a potential treatment for UFs. However, due to the poor quality of the included RCTs formulations, we recommend a rigorous, high-quality, large-sample trial to confirm our findings.

[Systematic review and Meta-analysis of efficacy and safety of Tangmaikang Granules in treatment of diabetic peripheral neuropathy].

This study aimed to explore the efficacy and safety of Tangmaikang Granules in the treatment of diabetic peripheral neuropathy(DPN). PubMed, Cochrane Library, EMbase, SinoMed, CNKI, Wanfang and VIP were retrieved for randomized controlled trial(RCT) of Tangmaikang Granules in the treatment of DPN. Cochrane handbook 5.3 was used to evaluate the quality of the inclu-ded studies, and RevMan 5.4.1 and Stata 15.1 were employed to analyze data and test heterogeneity. GRADEpro was used to assess the quality of each outcome index. Clinical effective rate was the major outcome index, while the improvement in numbness of hands and feet, pain of extremities, sluggishness or regression of sensation, sensory conduction velocity(SCV) and motor conduction velocity(MCV) of median nerve and peroneal nerve, fasting blood glucose(FBG), 2 h postprandial blood glucose(2hPBG), and glycated hemoglobin(HbA1c) and incidence of adverse reactions were considered as the minor outcome indexes. A total of 19 RCTs with 1 602 patients were eventually included. The Meta-analysis showed that the improvements in clinical effective rate(RR=1.45, 95%CI[1.32, 1.61], P<0.000 01), pain of extremities(RR=1.70, 95%CI[1.27, 2.27], P=0.000 3), MCV of peroneal nerve(MD=4.08, 95%CI[3.29, 4.86], P<0.000 01) and HbA1c(SMD=-1.23, 95%CI[-1.80,-0.66], P<0.000 1) of Tangmaikang Granules alone or in combination in the experimental group were better than those in the control group. Compared with the conditions in the control group, numbness of hands and feet(RR=1.42, 95%CI[1.12, 1.80], P=0.003), sluggishness or regression of sensation(RR=1.41, 95%CI[1.05, 1.91], P=0.02), SCV of median nerve(MD=4.59, 95%CI[0.92, 8.27], P=0.01), SCV of peroneal nerve(MD=4.68, 95%CI[3.76, 5.60], P<0.000 01) and MCV of median nerve(MD=5.58, 95%CI[4.05, 7.11], P<0.000 01) of Tangmaikang Granules in combination in the experimental group were improved by subgroup analysis. The levels of FBG(MD=-0.57, 95%CI[-1.27, 0.12], P=0.11) and 2hPBG(MD=-0.69, 95%CI[-1.70, 0.33], P=0.18) in the experimental group were similar to those in the control group after treatment with Tangmaikang Granules alone or in combination. There was no difference in the safety(RR=1.28, 95%CI[0.58, 2.82], P=0.54) of Tangmaikang Granules in the treatment of DPN between the experimental group and the control group. Tangmaikang Granules could significantly increase clinical effective rate and nerve conduction velocity as well as improve symptoms of peripheral nerve and blood glucose level, and no serious adverse reactions were identified yet. Further validation was needed in future in large-sample, multicenter, high-quality RCTs.

[Meta-analysis and GRADE evaluation of Guanxinning Tablets in treatment of angina pectoris of coronary heart disease].

This study aims to evaluate the efficacy and safety of Guanxinning Tablets+conventional western medicine in the treatment of angina pectoris of coronary heart disease, and provide evidence-based references for clinical medication. Retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, randomized controlled trial(RCT) about Guanxinning Tablets for the treatment of angina pectoris of coronary heart disease from the inception to April 2022 were collected. After literature screening and data extraction, the bias risk assessment tool recommended by the Cochrane evaluation manual handbook 5.1.0 was used to evaluate the quality of the included literature, and RevMan 5.3 and Stata 14.0 were used for Meta-analysis. Eighteen RCTs were finally included, involving 2 281 patients. Meta-analysis showed that, compared with conventional western medicine treatment alone, Guanxinning Tablets+conventional western medicine significantly improved angina pectoris efficacy(RR=1.33, 95%CI[1.13, 1.57], P=0.000 8), electrocardiogram efficacy(RR=1.32, 95%CI[1.02, 1.71], P=0.03), and exercise duration(MD=59.53, 95%CI[39.16, 79.90], P<0.000 01) and reduced the incidence of cardiovascular events(MACE)(RR=0.43, 95%CI[0.30, 0.61], P<0.000 01), high sensitivity C-reactive protein(hs-CRP)(MD=-2.75, 95%CI[-3.71,-1.79], P<0.000 01), and endothelin-1(ET-1) levels(MD=-9.34, 95%CI[-11.36,-7.32], P<0.000 01). There was no statistically significant difference in the incidence of adverse reactions between two groups(RR=0.91, 95%CI[0.68, 1.22], P=0.52). Subgroup analysis showed that Guanxinning Tablets may have better short-term efficacy(less than 6 months) in the treatment of heart-blood stasis syndrome. GRADE grading showed that angina pectoris efficacy, electrocardiogram efficacy, MACE, and ET-1 were in the medium grade, hs-CRP and adverse reactions were in the low grade, and exercise duration was in the extremely low grade. In conclusion, the efficacy of Guanxinning Tablets+conventional western medicine is better than conventional western medicine treatment alone, with good safety. Therefore, it is recommended for the short-term treatment of patients with heart-blood stasis syndrome. However, the evidence quality of some results is low, and more rigo-rous RCT is still needed to enhance the reliability of evidence.

Active Ingredient Paeonol of Jijiu Huiyang Decoction Alleviates Isoproterenol-Induced Chronic Heart Failure via the GSK3A/PPARα Pathway.

Background: The pharmacological mechanism of the traditional Chinese medicine formula-Jijiu Huiyang decoction (JJHYD), which contains several herbal medicines for the treatment of chronic heart failure (CHF), is yet unknown. Method and Materials. The main active components of JJHYD were analyzed by ultrahigh-performance liquid chromatography-mass spectrometry (UHPLC-MS/MS). The target genes of JJHYD and CHF were retrieved through multiple databases, a drug-ingredient-target-disease network was created, and KEGG enrichment and GO analyses were carried out. The binding ability of paeonol and Glycogen Synthase Kinase-3 alpha (GSK3A) was confirmed by molecular docking. CHF animal model and cell model were constructed. The effects of paeonol on cardiac dysfunction, myocardial hypertrophy, cardiac lipid accumulation, and myocardial apoptosis were detected by echocardiography, histopathology, and flow cytometry, respectively. The effects of paeonol on the expression of myocardial hypertrophy index, GSK3A, and genes or proteins related to the PPARα pathway were determined by qRT-PCR or western blot. Result: UHPLC-MS/MS analysis combined with database verification showed a total of 227 chemical components in JJHYD, among which paeonol was the one with heart-protective roles and had the highest content. Paeonol alleviated isoproterenol-induced cardiac lipid accumulation, cardiac hypertrophy, and myocardial dysfunction and inhibited the activation of the PPARα pathway, while overexpression of GSK3A reversed these effects of paeonol. However, the reversal effects of GSK3A overexpression could be offset by siPPARα. Conclusion: As the main active substance of JJHYD, paeonol participates in the protection of CHF by targeting the GSK3A/PPARα signaling pathway to reduce lipid toxicity.

Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial.

BACKGROUND: Numerous pre-clinical studies showed that Qingda granule (QDG) was effective in treating hypertension. This study aims to evaluate the efficacy and safety of QDG in reducing blood pressure among patients with grade 1 hypertension at low-medium risk. METHODS: The study is designed as a randomized, multi-center, double-blinded, non-inferiority clinical trial. Five hundred fifty-two patients with grade 1 hypertension at low-medium risk from 13 hospitals will be recruited and randomly assigned to the QDG group (n = 276, treated with valsartan capsule simulation agent and QDG) or control group (n = 276, treated with valsartan capsule and QDG simulation agent). The treatment period will be 4 weeks and the follow-up period will last 4 weeks after treatment. Primary outcome will be a decreased value of systolic blood pressure and diastolic blood pressure after treatment. And second outcome will include the decreased value of diastolic blood pressure and systolic blood pressure at the end of follow-up, the percentage of participants achieving normal blood pressure at the end of treatment and follow-up, the Hamilton Anxiety Scale and TCM syndrome scores at the end of treatment and follow-up, and levels of hypertensive hormones at end of treatment and follow-up. DISCUSSION: This study will provide initial evidence regarding the clinical efficacy and safety of QDG in treating grade 1 hypertension at low-medium risk. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000033890 . Registered on 15 June 2020.

Efficacy and safety of traditional Chinese medicine for the treatment of epilepsy: A updated meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) in the treatment of epilepsy. METHODS: A comprehensive search of the database in both Chinese and English was performed. Data from the selected studies were extracted and analyzed independently by two authors. RESULTS: 30 randomized controlled trials (RCTs) were included in the meta-analysis with a total of 2471 patients. Among them, 4 trials (n = 235) focused on TCM monotherapy, while the other 26 trials (n = 2236) assessed the benefit of TCM as an add-on therapy to antiseizure medications (ASMs). For the efficacy, the meta-analysis found (1) The effective rate in TCM monotherapy group was higher than that in control group (OR = 4.92, 95 % CI: 2.29-10.57, Z = 4.08, P 0.0001); (2) The add-on of TCM also increased the effective rate (OR = 3.37, 95 % CI: 2.65-4.30, Z = 9.85, P 0.00001) and seizure freedom rate (OR = 1.93, 95 % CI: 1.53-2.44, Z = 5.58, P 0.00001). In terms of safety, the add-on of TCM reduced the rate of total adverse events (OR = 0.46, 95 % CI: 0.31-0.67, Z = 3.96, P 0.0001) as well as adverse events of the gastrointestinal and nervous system. 26 different TCM prescriptions were used in these included RCTs. Among them, the 5 most frequently used herbs were Acorus tatarinowii (19 out of 26), Glycyrrhiza uralensis (13 out of 26), Gastrodia elata (12 out of 26), Pinellia ternata (11 out of 26) and Poria cocos (11 out of 26). CONCLUSION: This study suggested that TCM may be a relatively efficacious and safe clinical strategy for the treatment of epilepsy. Several limitations still exist, such as the risk of bias in the included studies, the diversified composition of TCM prescriptions, and the relatively low quality of study design.

Efficacy and safety of Tripterygium glycosides as an add-on treatment in adults with chronic urticaria: a systematic review and meta-analysis.

CONTEXT: Tripterygium glycosides (TG), a traditional Chinese medicine, has been used to treat chronic urticaria (CU) in China, and the evidence of TG for CU needs to be updated thoroughly. OBJECTIVE: To systematically evaluate the efficacy and safety of TG combined with H1-antihistamine (H1-AH) in adults with CU. METHODS: Eligible randomized controlled trials were searched in eight databases until May 31, 2022, including CNKI, WanFang, VIP, SinoMed, PubMed, Cochrane Library, Embase, and Web of Science. The search terms included urticaria, Tripterygium, Lei Gong Teng, and Leigongteng. Rev Man 5.3 and Stata 12.0 were used for statistical analysis. RESULTS: A total of 27 studies with 2788 patients were included. The pooled results showed that TG plus H1-AH was superior to H1-AH alone in cure rate (RR = 1.37, 95% CI = 1.15 to 1.63, p = 0.0003), total efficacy rate (RR = 1.40, 95% CI = 1.30 to 1.50, p < 0.00001), pruritus (MD = -0.32, 95% CI = -0.54 to -0.11, p = 0.003), wheal number (MD = -0.31, 95% CI = -0.55 to -0.07, p = 0.01), wheal size (MD = -0.32, 95% CI = -0.46 to -0.19, p < 0.00001), and the serum level of immunoglobulin E (SMD = -1.39, 95% CI = -2.42 to -0.36, p = 0.008). Moreover, adverse events between two groups were mild, and their incidences were not significantly different. CONCLUSIONS: The combination of TG and H1-AH is a promising and safe treatment for adults with refractory CU. Further high-quality studies are needed to confirm the evidence.

Efficacy and Safety of Shenfu Injection on Acute Heart Failure: A Systematic Review and Meta-Analysis.

BACKGROUND: The adjunctive efficacy and safety of Shenfu Injection (SFI) for acute heart failure (AHF) still remains ambiguous even though previous studies made initial conclusions. OBJECTIVE: To comprehensively evaluate the adjunctive efficacy and safety of SFI in the treatment of AHF. STUDY DESIGN: This was a meta-analysis and systematic review. METHODS: 8 databases were searched for qualified randomized controlled trials (RCTs) from May 1990 to May 2022. The primary results included total clinical effective rate (TCER) and left ventricular ejection fraction (LVEF). The secondary results included left ventricular end diastolic dimension (LVEDD), heart rate (HR), N-terminal pro-B-type natriuretic peptide (NT-proBNP), brain natriuretic peptide (BNP) and adverse events (AE). The quality evaluation, meta-analysis, sensitivity analysis, subgroup analysis and publication bias were conducted by RevMan5.3 software. Meta-regression analysis was conducted using Stata software 15.0, and trial sequential analyses (TSA) was performed by TSA program. Finally, the GRADE (Grading of Recommendation, Assessment, Development, and Evaluation) system was applied for evaluating the quality of evidence. RESULTS: 61 RCTs containing 5505 AHF patients were included. The meta results demonstrated SFI combined with conventional western treatment (CWT) for AHF was superior to CWT alone in improving the TCER (RR = 1.21; 95% CI (1.18, 1.24); p < 0.001), improving LVEF (SMD = 0.85; 95% CI (0.77,0.92); p < 0.001) and reducing HR (SMD = -0.67; 95% CI (0.80, -0.54) p < 0.001). It had a lower AE rate in the SFI+CWT group (27/753, 3.59%) than the CWT group (68/739, 9.20%) (RR = 0.40; 95% CI (0.26, 0.61); p < 0.001). The outcomes' evidentiary quality of TCER, HR, LVEF and AE were assessed as moderate. CONCLUSION: Adjunctive use of SFI was safer to improve TCER and heart function of AHF, but the results should be interpreted with cautious for clinical practice until high quality-designed RCTs were require for further confirmation due to poor quality of part of the included studies.

The role of traditional herbal medicine for ischemic stroke: from bench to clinic-A critical review.

BACKGROUND: Ischemic stroke (IS) is a leading cause of death and severe long-term disability worldwide. Over the past few decades, considerable progress has been made in anti-ischemic therapies. However, IS remains a tremendous challenge, with favourable clinical outcomes being generally difficult to achieve from candidate drugs in preclinical phase testing. Traditional herbal medicine (THM) has been used to treat stroke for over 2,000 years in China. In modern times, THM as an alternative and complementary therapy have been prescribed in other Asian countries and have gained increasing attention for their therapeutic effects. These millennia of clinical experience allow THM to be a promising avenue for improving clinical efficacy and accelerating drug discovery. PURPOSE: To summarise the clinical evidence and potential mechanisms of THMs in IS. METHODS: A comprehensive literature search was conducted in seven electronic databases, including PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, the Chinese National Knowledge Infrastructure, the VIP Information Database, the Chinese Biomedical Literature Database, and the Wanfang Database, from inception to 17 June 2022 to examine the efficacy and safety of THM for IS, and to investigate experimental studies regarding potential mechanisms. RESULTS: THM is widely prescribed for IS alone or as adjuvant therapy. In clinical trials, THM is generally administered within 72 h of stroke onset and are continuously prescribed for over 3 months. Compared with Western medicine (WM), THM combined with routine WM can significantly improve neurological function defect scores, promote clinical total effective rate, and accelerate the recovery time of stroke with fewer adverse effects (AEs). These effects can be attributed to multiple mechanisms, mainly anti-inflammation, antioxidative stress, anti-apoptosis, brain blood barrier (BBB) modulation, inhibition of platelet activation and thrombus formation, and promotion of neurogenesis and angiogenesis. CONCLUSIONS: THM may be a promising candidate for IS management to guide clinical applications and as a reference for drug development.

Efficacy and Safety of East Asian Herbal Medicine for Brain Metastases in Non-small Cell Lung Cancer: A Systematic Review and Meta-analysis Protocol to Identify Specific Herbs.

INTRODUCTION: Brain metastasis (BM) is a significant risk factor for survival and prognosis in non-small cell lung cancer (NSCLC). While surgical resection and radiotherapy are the primary treatment modalities, the overall prognosis in NSCLC patients with BM remains poor, and all therapies lead to adverse events. East Asian herbal medicine (EAHM) has broad prospects as an adjuvant treatment, but its efficacy and safety remain controversial. We propose to conduct a systematic review and meta-analysis to summarize the clinical efficacy and safety of EAHM for the treatment of NSCLC with BMs and to identify specific herbs that can improve the prognosis. METHODS: The PubMed, EMBASE, CENTRAL, Web of Science, CBM, CNKI, Wanfang, VIP, Evidence Reports on Kampo Treatment, ICHUSHI, and Oriental Medicine Advanced Searching Integrated System databases will be searched from their inception to October 2022. Randomized controlled trials will be included. Two authors will evaluate the eligibility and quality of the included trials. The methodological quality will be assessed using the RoB 2 tool, and Stata 16 will be used for data synthesis. Publication bias will be assessed using funnel plots and Egger tests. The GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system will evaluate the quality of the synthesized evidence. Further sensitivity analyses will be performed to determine the efficacies of specific herbs in EAHM. DISCUSSION: Given there are currently no systematic reviews and meta-analyses of the efficacy of EAHM as a treatment for NSCLC with BMs, a compilation and analysis of the available high-quality clinical research evidence are essential. The results will help establish guidelines for the application of specific herbs as a complementary alternative therapy for BMs in NSCLC. The findings will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022300527.

Exploration of potential mechanism of Rougan formula against hepatic fibrosis by network analysis and experimental assessment.

ETHNOPHARMACOLOGICAL RELEVANCE: Rougan Formula (RG) has long been clinically applied to treat hepatic fibrosis in patients with different chronic liver diseases. However, the core active substances and the potential pharmacological mechanisms of RG remain unclear. AIM OF THE STUDY: The purpose of this study is to explore bioactive components, key targets, and potential mechanisms of RG by performing network pharmacological analyses and experimental model validation. MATERIALS AND METHODS: All chemical components in RG extract were identified using ultraperformance liquid chromatography-quadrupole/time-of-flight tandem mass technology. The candidate components and drug targets of RG, as well as disease-related genes, were extracted from TCMSP and GeneCards databases. The potential pathways related to genes were predicted by Gene Ontology and Kyoto Encyclopedia of Genes and Genomes pathway enrichment analyses. The core bioactive components, key targets, and signaling pathways were ultimately obtained by analyzing protein-protein interaction (PPI) and component-target-pathway (C-T-P) networks. Subsequently, the efficacy and underlying mechanisms of RG on hepatic fibrosis were experimentally validated in transforming growth factor-beta 1 (TGF-ß1)-induced hepatic stellate cell activation model and CCL4-induced hepatic fibrosis mouse model. RESULTS: A total of 52 components in RG extract were obtained, and 22 of them were selected as the core bioactive components. Five hundred and thirty-nine overlapped targets were determined by matching drug targets with disease-related targets. The results of PPI and C-T-P network analyses revealed 100 key targets and 19 signaling pathways associated with RG efficacy. In vitro and in vivo studies further verified that RG exerted a significant anti-hepatic fibrotic effect by suppressing the activation of hepatic stellate cells by downregulating the TGF-ß1/Smads signaling pathway. CONCLUSIONS: These results may provide some evidence for further clinical research and development of RG formula as an effective and safe drug for hepatic fibrosis treatment.

Efficacy and safety of Yaobitong capsule for acute lumbar disc herniation: A protocol for a multi-center randomized controlled trial.

BACKGROUND: There are few effective conservative therapies for acute lumbar disc herniation (LDH), and the choice of nonsteroidal anti-inflammatory drugs is not recommended for all patients. The purpose of this study was to compare the effect of Yaobitong capsule with celecoxib capsule, and to further confirm the safety and efficacy of Yaobitong capsule. METHODS: This study is a large sample multicenter randomized controlled trial. Eight hospitals served as sub centers to recruit patients. A total of 258 patients are divided into Yaobitong group and celecoxib group according to the ratio of 1:1. Celecoxib or Yaobitong capsule was taken orally for 14 days. Patients will complete the trial after 3 months of follow-up, and independent statisticians who are blinded to random assignment will analyze the data using SAS 9.3 software. The primary outcome was the visual analogue scale (VAS) score after 14 days of treatment, and Japanese Orthopaedic Association (JOA), Oswestry Disability Index (ODI), and SF-12 will be regarded as secondary outcomes. Safety indexes will be recorded before and after treatment, and adverse events (AEs) will be recorded throughout this trial. DISCUSSION: This study will evaluate the efficacy and safety of Yaobitong capsule in treating LDH. The experimental results will provide evidence support to treat LDH with Yaobitong capsule.

[Systematic review and Meta-analysis of efficacy and safety of Ganshuang Granules in treatment of liver injury].

This study systematically evaluated the efficacy and safety of Ganshuang Granules in the treatment of liver injury, so as to provide a new choice for patients with liver injury. CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed, EMbase, and Web of Science were systematically searched for the randomized controlled trial(RCT) of Ganshuang Granules in the treatment of liver injury. RevMan 5.4 was employed to perform the Meta-analysis of the included RCT according to the Cochrane Handbook 5.1. A total of 3 005 patients were included in 38 RCTs, including 1 536 patients in the observation group and 1 469 in the control group. The results of Meta-analysis showed that Ganshuang Granules combined with conventional therapy was superior to the therapy in the control group in reducing alanine aminotransferase(ALT)(MD=-24.12, 95%CI[-32.17,-16.07], P<0.000 01), aspartate aminotransferase(AST)(MD=-23.24, 95%CI[-29.70,-16.78], P<0.000 01), total bilirubin(TBiL)(MD=-12.42, 95%CI[-14.62,-10.22], P<0.000 01), and gamma-glutamyl transpeptidase(GGT)(MD=-21.32, 95%CI[-33.61,-9.03], P=0.000 7). Compared with the control group, the observation group had witnessed a significant increase in albumin(ALB)(MD=4.94, 95%CI[4.44, 5.45], P<0.000 01). No significant adverse reactions were observed. According to the available data, Ganshuang Granules combined with conventional therapy can effectively recover the levels of ALT, AST, TBiL, GGT, and ALB in patients with liver injury. Nevertheless, high-quality RCT is still needed to further verify the findings of this study.

Efficiency and Safety of Baofei Granules in Chronic Obstructive Pulmonary Disease (Lung and Spleen Qi Deficiency Syndrome): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial.

Background: Baofei Granules (BFGs) have been extensively applied in the clinical treatment of chronic obstructive pulmonary disease (COPD) and significantly have affected COPD patients with lung and spleen qi deficiency syndrome. However, the data from previous small-sample clinical trials are limited. This trial aimed to estimate the efficiency and safety of BFGs in COPD with lung and spleen qi deficiency syndrome. Methods: It is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. The 216 stable COPD patients will be divided randomly in a ratio of 1:1. The whole trial period consists of a 4-week introductory period, a 52-week treatment period and a 48-week follow-up. Study visits occur every 4 weeks during the treatment period and every 12 weeks during the follow-up. All the subjects will receive 10g BFGs or placebo three times per day for 56 weeks and be followed up for 48 weeks. The primary efficiency evaluation outcome will be the frequency and duration of AECOPD, and the secondary efficiency evaluation outcome will be pulmonary function tests (PFTs), modified Medical Research Council (mMRC) dyspnoea scale, six-minute walking test (6MWT), COPD assessment test (CAT) score, traditional Chinese medicine (TCM) syndrome score, the frequency of emergency medication, BODE index, and the time to first Clinically important deterioration (CID). The safety evaluation outcomes will be adverse events (AEs), vital signs, physical examination, twelve-lead electrocardiogram (ECG), and laboratory examinations. All the data will be analyzed by SAS9.4. Discussion: This is the first and largest clinical trial that evaluates the efficiency and safety of BFGs for COPD with lung and spleen qi deficiency syndrome. It will provide valuable clinical evidence for recommendations on COPD management by the integrated TCM and western medicine. Trial Registration: CTR20211280. Date: June 09, 2021. http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml?id=383a370ecd9f43d7af6f1c8585779e1a.

Effectiveness and safety of Tiaogan formula in the treatment of coronary heart disease: A protocol for systematic review and meta-analysis.

BACKGROUND: The morbidity and mortality of coronary heart disease (CHD) has remained high, which greatly increases people's economic burden. Several studies have showed that Tiaogan formula (TGF), as a kind of Chinese herbal medicine, was of benefit to relieving angina pectoris symptoms and improving the quality of life for CHD patients. However, the intensity of evidence has been poor, limiting the further clinical application of TGF to CHD. This systematic review and meta-analysis will assess the effectiveness and safety of studies of TGF in CHD patients. METHODS: A systematic search for literature up to December 2022 will be conducted in following public electronic databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database Database, and Wanfang Database. Inclusion criteria are randomized controlled trials of Tiaogan formula in the treatment of coronary heart disease. The primary outcome measures will be mortality, acute cardiovascular events, total efficacy rate, and improvement of angina symptoms. The secondary outcome measures will be electrocardiogram, levels of blood lipid, and adverse events. RevMan 5.4 software Cochrane Collaboration (London, United Kingdom) will be applied for data synthesis, sensitivity analysis, subgroup analysis, and risk of bias assessment. A funnel plot will be developed to evaluate reporting bias and Egger tests will be used to assess funnel plot symmetries. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence. RESULTS: This study will provide a systematic review of Tiaogan formula in the treatment of CHD. CONCLUSION: This study will provide a high-quality synthesis of the effects and safety of Tiaogan formula in the treatment of CHD patients.

Efficacy and safety of anti-obesity herbal medicine focused on pattern identification: A systematic review and meta-analysis.

BACKGROUND: Herbal medicine based on pattern identification (PI) is used widely in Traditional Chinese Medicine. Proper herbal medicine based on PI has been suggested for effective weight reduction and decreasing the adverse events. This systematic review examined the effectiveness and safety of herbal medicine, focusing on PI in treating obesity. METHODS: Eight electric databases were used for searching randomized controlled trials (RCT) (to August 31, 2021). RCTs which prescribed herbal medicine to obese patients based on PI were included. Body weight (BW) and body mass index (BMI) were the primary outcomes. The risk of bias was assessed using Cochrane risk of bias tool, and the meta-analysis was conducted. Grading the evidence was conducted by using GRADEpro. RESULTS: Sixteen RCTs (1052 patients) were included: 2 studies compared herbal medicine to placebo (128 patients); 2 studies compared them to western medication (161 patients); 12 studies compared them with usual care (763 patients). The meta-analysis showed that the herbal formulas reduced the BW and BMI without significant Adverse events compared to the control group (BW: mean difference  = -4.10, 95% confidence interval: -5.14 to -3.06, I2 = 2% and BMI: mean difference = -1.53, 95% confidence interval: -1.88 to -1.19, I2 = 25%). Moderate-quality evidence on the primary outcomes was found. CONCLUSIONS: Herbal medicine - has good clinical efficacy and safety in treating obesity. This study has limitations that some literatures with high risk of bias in blinding or without using a standardized diagnosis of PI were included. However, the current evidence suggests the possibility of precision medicine using PI.

Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial.

BACKGROUND: Sanfu herbal patch (SHP) is widely used in the prevention and treatment of bronchial asthma in China, but its efficacy and mechanism of action are not completely clear. This trial aims to determine the efficacy of SHP and the underlying mechanism. METHODS/DESIGN: We will conduct a multi-centre parallel randomised controlled trial consisting of 72 participants with bronchial asthma recruited and randomly allocated at a ratio of 1:1 into two groups. The patients in one group will receive three courses of SHP treatment, and the patients in the other group will receive placebo treatment, with 24 weeks of follow-up evaluation for both groups. The primary outcome, i.e. forced expiratory volume in the first second (FEV1), which refers to the change in FEV1 from the beginning of the baseline to the end of 3 treatment sessions (TSs), will be assessed and compared via Student's t test or the Mann-Whitney U test. Other outcomes will include questionnaire surveys and laboratory indicators. Detailed and complete statistical analyses in a double-blinded fashion will be provided for evaluating this trial. DISCUSSION: The data we obtain will be examined based on the above statistical analysis, which will help to reduce the risk of external reporting bias and data-driven results. TRIAL REGISTRATION: Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), ChiCTR1900024616. Registered on 19 July 2019.

Effectiveness of Lianhua Qingwen Capsule in Treatment of Asymptomatic COVID-19 Patients: A Randomized, Controlled Multicenter Trial.

Background: Asymptomatic patients are unneglected sources in propagating transmission chain due to their high viral loads. However, treatments available based on symptoms seem not applicable to asymptomatic patients. In this study, the authors want to estimate the effectiveness of Lianhua Qingwen (LH) capsule on asymptomatic coronavirus disease 2019 (COVID-19) patients. Methods: A randomized controlled trial (RCT) was performed to explore the effectiveness and safety of LH capsule in treating asymptomatic COVID-19 patients. Patients were randomized to control group (isolated observation) and treatment group (LH, 4 capsules, thrice daily) for 14 days. The primary endpoints were the rate and time of nucleic acid turning negative during the isolation observation. Results: A total of 120 participants were included in the full analysis set (60 each in the control and treatment groups). Data showed that the rate of nucleic acid turning negative during the isolation observation in the treatment group was higher than that in the control group (rate difference: 21.66%, 95% confidence interval [CI]: 4.34 to 37.27, p = 0.0142). Patients in the treatment group have a shorter time of nucleic acid turning negative (7.5 vs. 14.5 days, p = 0.018). Moreover, the rate of clinical symptoms appearance in the treatment group was lower compared with that in the control group (rate difference: -31.67, 95% CI: -46.83 to -13.82, p = 0.0005). The proportion of confirmed mild and common cases in the treatment group was also lower (35.00% vs. 66.67%, p = 0.0005). No serious adverse events were documented. Conclusions: In this study, the authors illustrated that LH capsule is beneficial to asymptomatic COVID-19 patients. Considering the lack of interventions for treating asymptomatic COVID-19 patients at this stage, LH capsule could be considered as a choice. Chinese Clinical Trial Registry: ChiCTR2100042066.

Efficacy and safety of Chinese herbal medicine Buzhong Yiqi decoction for postmenopausal women with osteoporosis: A protocol for systematic review and meta-analysis.

BACKGROUND: Postmenopausal osteoporosis (PMOP) is a disorder of bone metabolism caused by estrogen deficiency in women after menopause, which manifests clinically as pain, spinal deformities, and even fragility fractures, affecting the quality of life of patients and possibly shortening their life span. Traditional Chinese medicine prescription Buzhong Yiqi Decoction (BZYQD) has been widely used in clinical practice and achieved good results. But there is no high-level evidence to support this result. The aim of this study is to evaluate BZYQD's efficacy and safety in the management of PMOP. METHODS: We will search articles in 7 electronic databases including Chinese National Knowledge Infrastructure, Wanfang Data, Chinese Scientific Journals Database, Chinese databases SinoMed, PubMed, Embase, and Cochrane Library databases. All the publications, with no time restrictions, will be searched without any restriction on language and status, the time from the establishment of the database to September 2022. Two reviewers will independently assess the quality of the selected studies, NoteExpress and Excel software will be used to extract data, and the content will be stored in an electronic chart. Different researchers will separately screen the titles and abstracts of records acquired potential eligibility which comes from the electronic databases. Full-text screening and data extraction will be conducted afterward independently. Statistical analysis will be conducted using RevMan 5.4 software. RESULTS: This study will evaluate the efficacy and safety of BZYQD in the treatment of PMOP, to provide high-quality, evidence-based clinical recommendations. CONCLUSION: The study provides a trustable clinical foundation for BZYQD in the treatment of PMOP.