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Expert consensus on diagnosis and treatment of septic shock with integrated traditional Chinese and Western medicine

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Abstract

Objective: Septic shock is a pathological stage during the progress of sepsis. The mortality rate is high, and timely, standardized and comprehensive treatment is of great significance in reducing the mortality rate. At present, there are many domestic and international guidelines for the diagnosis and treatment of sepsis and septic shock. On this basis, China Association of Integrative Medicine Emergency Medicine Committee organized experts to collect evidence-based medical evidence and expert experience in the diagnosis and treatment by integrated Chinese and Western medicine, and referred to the Expert consensus on diagnosis and treatment of sepsis with integrated traditional Chinese and Western medicine published by China Association of Integrative Medicine Emergency Medicine Committee in 2013, developed Expert consensus on diagnosis and treatment of septic shock with integrated traditional Chinese and Western medicine. The consensus provided a "China approach" for the resolution of this worldwide problem. In the "China approach", the staging of septic shock is "longitude", and the "four syndromes and four methods" treatment thought is "latitude". Under the framework of interlaced latitude and longitude, we recommend a series of effective integrated Chinese and Western medicine treatment. The method embodies the wisdom of China and has certain guiding significance for the clinical treatment of septic shock.

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... Heparin-binding protein (HBP) belongs to the serine protease family, also known as cationic antibiotic protein 37 (CAP37), is a multifunctional inflammatory mediator present in polymorphonuclear leukocyte (PMN) granules [8]. In the body attacked by sepsis, neutrophils activated by bacteria, toxins, and coagulation factor complexes [9,10] adhere to vascular endothelial cells to release HBP [11]. Subsequently, activation of Ca 2+ and an increase in vascular permeability are induced, causing leakage of macromolecules and tissue injury. ...
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Objective: Heparin-binding protein (HBP) plays an important role in sepsis and is a prognostic biomarker in patients with sepsis, but the role of HBP in the pathogenesis of sepsis-associated acute lung injury (ALI) remains unclear. This study aimed to investigate the role of HBP in sepsis-induced ALI and its underlying molecular mechanisms. Methods: The cecal ligation and puncture (CLP) model was used to induce ALI in mice and randomly divided into 4 groups: control group, CLP (rats treated with cecal ligation and puncture), HBP (rats treated with CLP and HBP injection), and HBP + UFH (rats treated with CLP and injection of HBP and unfractionated heparin). Subsequently, HBP expression in rat serum and lung tissues was detected by qRT-PCR, edema and pathological changes in lung tissue by lung wet-to-dry weight ratio (W/D) and HE staining, myeloperoxidase (MPO) and superoxide dismutase (SOD) activities in lung tissues by detection kits. Additionally, ELISA and western blot were applied for the determination of IL-6, TNF-α, and IL-1β expression in rat bronchoalveolar lavage fluid, and iNOS, Arg-1, Mrc1, NF-κBp65, IKKα, IκBα, and p-IκBα expression in lung tissues. Results: The expression levels of HBP in serum and lung tissues of rats in the HBP group were significantly increased, the lung tissues were severely injured, accompanied by a significant increase in MPO activity but a significant decrease in SOD activity, and the levels of IL-6, TNF-α, and IL-1β in bronchoalveolar lavage fluid were significantly increased. In addition, the expression levels of iNOS, NF-κB p65, IKKα, and p-IκBα in the lung tissues of rats in the HBP group were significantly increased, while the addition of unfractionated heparin reversed the above results. Conclusion: HBP aggravates ALI in septic rats, and its mechanism may be related to the promotion of macrophage M1 polarization and activation of the NF-κB signaling pathway.
... us, it played the role of "Niwan," which means to replenish the righteousness and exorcise evil [15]. Due to the good clinical effect of JDNW, the ACLF treatment guidelines of Integrative Chinese and Western Medicine propose that JDNW is the key method to treat ACLF [16]. However, the underlying scientific reasons for JDNW to alleviate ACLF have not been well studied, limiting our generalization and application of it. ...
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Jieduan-Niwan (JDNW) formula is a traditional Chinese medicine compound created by the famous Chinese medicine expert Professor Qian Ying, and has been used clinically for decades to treat acute-on-chronic liver failure (ACLF) and exhibits remarkable efficacy. However, the exact mechanism remains to be discovered. As an important hepatocyte damage-associated molecular patterns (DAMP) factor, high mobility group box 1 (HMGB1) is a potential therapeutic target as an accelerator of ACLF in the pathogenesis. Therefore, the present study investigated whether JDNW inhibits the overexpression and cytoplasmic translocation of HMGB1 in ACLF liver tissue and alleviates its mediated oxidative stress and apoptosis. In vivo, an immune-induced ACLF rat model was established, and then treated with JDNW for 5, 10, and 15 d. The results showed that a large number of cytoplasmic translocations of HMGB1 occurred in the ACLF group. And there was an increase in the expression of HMGB1 in the M-5 d group. After the intervention of JDNW, the overexpression and translocation of HMGB1 were inhibited. In vitro, D-GaLN caused an increase in the expression and translocation of HMGB1 in L02 cells. Similar to the inhibitor of HMGB1, JDNW serum alleviated this kind of increase. Further tests showed that JDNW attenuated ACLF-related oxidative stress and apoptosis, and the inhibition was associated with the regulation of TLR-4/NF-κB signaling pathway. In conclusion, our present findings suggest that the therapeutic effect of JDNW on ACLF was associated with the inhibition of high expression and cytoplasmic translocation of HMGB1 during the acute injury phase, thus, attenuating oxidative stress injury and apoptosis induced by HMGB1/TLR-4/NF-κB pathway.
... From December 2013 to June 2015, 156 patients with chronic obstructive pulmonary disease were selected from relevant departments of the hospital. 3 The patients were 43-85 years old, with an average age of (56.12±4.76) years. ...
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Introduction Chronic obstructive pulmonary disease (COPD) is one of the most common diseases in the lungs. Objective To evaluate the clinical effect of respiratory rehabilitation training combined with Traditional Chinese and western medicine on the clinical treatment of motor function in patients with COPD. Methods 156 patients with chronic obstructive pulmonary disease admitted to a hospital from December 2013 to June 2015 were selected as study subjects and randomly divided into groups for treatment. Results comparing blood gas exchange rates of patients in the four groups, the experimental group, trained using integrated Chinese and Western medicine, was significantly better than the control groups A, B and C, in aspects such as PaCO2, PaO2, SaO2, pH, etc., the difference was statistically significant (p < 0.05). The improvement of lung function in the experimental group was significantly better than in the other three groups, with statistical significance (p < 0.05). Conclusions Applying Chinese and Western Medicine combined with comprehensive respiratory rehabilitation training has a significant clinical effect. It effectively improved patients’ related clinical indicators and should be widely promoted. Level of evidence II; Therapeutic studies - investigation of treatment results. Keywords: Respiratory System; Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome; Effects
... Criteria. Inclusion criteria: people confirmed by head CT or MRI, and in line with the diagnostic criteria for CI in Chinese CI Diagnosis and Treatment Guidelines by Integrated Chinese and Western Medicine (2017) [21]; acute onset; total focal neurological impairment or focal neurological impairment; nonvascular cause; hospitalization after 24 hours of the onset of CI; older than 40 years old; patient's family signed an informed consent form. ...
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To analyze the difference of circulating lncRNA expression profile between the healthy control group and cerebral infarction (CI) patients and to study the epigenetic pathogenesis of CI. Forty patients with acute CI admitted to our hospital from December 2016 to December 2017 were selected as CI group, and 40 healthy people in physical examination center were selected as healthy group. In the CI group, blood samples were taken 5 mL at fasting in the morning (within 72 hours of CI), and the blood samples from healthy group were also taken 5 mL at fasting in the morning. The circulating lncRNA expression profile of serum sample was determined by high-throughput technique, and its difference was analyzed. Bioinformatics technology was used to explore its functional mechanism, and GO, KEGG analysis, and gene expression network were established for lncRNA with significant differences. Next, lnc-ZNF32-1 : 1 and lnc-PCGF5-2 : 1 were selected for further validation of serum lncRNA expression in ACI and NC groups, and ceRNA interaction network analysis, diagnostic specificity, and sensitivity of lnc-ZNF32-1 : 1 and lnc-PCGF5-2 : 1 were conducted. The results showed that compared with the healthy group, there were 512 known lncRNA expressed differentially in the serum of patients with CI, of which 371 were upregulated and 141 were downregulated, and 421 known mRNA expressed differentially, of which 245 were upregulated and 176 downregulated. The differentially expressed mRNA was mainly enriched in 53 gene functions, and the target gene was enriched in the pathways such as HTLV-I infection and pathways in cancer. In addition, the results explored that lnc-ZNF32-1 : 1 and lnc-PCGF5-2 : 1 have potential value for CI diagnosis. In conclusion, the expression profile of lncRNA in CI group was significantly different from that in healthy group, indicating that lncRNA might be closely related to the occurrence, development, and prognosis of CI.
... Based on "Expert consensus on diagnosis and treatment of septic shock with integrated traditional Chinese and Western medicine", [39] intestinal microcirculation disorders in sepsis are classifi ed as syndromes of intestinal dysfunction and obstruction of "Fu-qi" and are often treated by purgation. Therefore, it is recommended that the heat-clearing and purgation prescriptions Dachengqi decoction be used, to promote blood circulation. ...
Article
Background: Intestinal microcirculation dysfunction is an important factor that causes poor prognosis in sepsis patients and is an important pathophysiological basis for the occurrence and development of sepsis. Data resources: PubMed, Web of Science, and China National Knowledge Infrastructure (CNKI) were searched from inception to August 1, 2021. The search was limited to the English language only. Two reviewers independently identified studies related to intestinal microcirculation dysfunction in sepsis. Exclusion criteria were duplicate articles according to multiple search criteria. Results: Fifty articles were included, and most of them were animal studies. These studies reported pathogenesis, including endothelial dysfunction, leukocyte recruitment and adhesion, microthrombus formation, microcirculation hypoperfusion, and redistribution of intestinal wall blood flow. The monitoring methods of intestinal microcirculation were also diverse, including handheld microscopes, intravital microscopy (IVM), laser Doppler blood flow instruments, laser speckle contrast imaging, tissue reflectance spectrophotometry, biochemical markers of intestinal ischemia, and histopathological examination. In view of the related pathogenesis of intestinal microcirculation disorder in sepsis, existing studies also have different opinions on its treatment. Conclusions: Limited by monitoring, there are few clinical studies on intestinal microcirculation dysfunction in sepsis. Related research mainly focuses on basic research, but some progress has also been made. Therefore, this review may provide a reference for future research on intestinal microcirculation dysfunction in sepsis.
... Participants will be include who have been diagnosed with sepsis by these criteria: 2001 SCCM/ ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference, [16] Surviving Sepsis Campaign: International guidelines for management of severe sepsis and septic shock: 2008/2012/2016/ 2018. [17][18][19][20] The Third International Consensus Definitions for Sepsis and Septic Shock, [21] Expert consensus on diagnosis and treatment of sepsis formulated by Emergency Medicine Committee of Chinese Society of Integrated Traditional Chinese and Western Medicine in 2013, [22] Definition, diagnostic criteria, main points, and description of TCM syndrome diagnosis of sepsis (draft), [23] guidelines for the treatment of severe sepsis / septic shock in China (2014). [24] There is no restriction on age, sex, or ethnicity of the enrolled subjects. ...
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Introduction: Sepsis is a physiological, pathological, and biochemical syndrome caused by infection. Acupuncture may be useful for sepsis. This systematic review aims to assess the efficacy and safety of acupuncture as a complementary therapy for sepsis. Methods and analysis: We will search PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure (CNKI), Wan Fang Database, Chinese Biomedicine (CBM) database, VIP database, and TCM Literature Analysis and Retrieval Database from inception to October 31, 2019 to identify any eligible study. We include all randomized controlled trials (RCTs) without any limitation of blinding or publication language, exclude cohort studies and case reports. Two reviewers will independently select studies, extract and manage data. The primary outcomes include the mortality at 28 days, acute physiology, and chronic health evaluation II scores. The secondary outcomes include the tumor necrosis factor α (TNF-α) counts, interleukin 6 (IL-6) counts, interleukin 10 (IL-10) counts, procalcitonin (PCT), lactic acid, the level of T cell subsets (CD3+, CD4+, CD8+, CD4+/CD8+), monocytes of human leukocyte antigen DR (HLA-DR), C-reactive protein (CRP), the numeration of leukocyte, intra-abdominal pressure, and adverse events or reactions. Statistical analyses will be performed using the Review Manager V.5.3 and R packages Metafor. We will use the Cochrane risk of bias tool for randomized trials to assess the risk of bias of included studies. Ethics and dissemination: This study will not involve personal information. Ethical approval will not be required. We will publish the results in a peer-reviewed journal. Prospero trial registration number: CRD42019141491.
... Medicine as the diagnostic criteria 32,34,36,37,41 and the final study adopted a consensus published in 2010. 35,42 Both of these tools have been widely recognized in the field of TCM and are more highly regarded than the draft used in Che's study. ...
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Objective: To evaluate the efficacy and safety of Chinese herbal medicine (CHM) for the treatment of functional dyspepsia (FD). Methods: Web of Science, PubMed, EMBASE, Cochrane Library, and four other Chinese electronic databases, including China National Knowledge Infrastructure (CNKI), Chinese Biological Medical Database (CBM), Chinese Scientific Journals Database (VIP), and WanFang Database were used to search (up to Feb, 2016) for randomized, double-blind, placebo-controlled trials recruiting adults with FD treated with CHM. Study selection, data extraction, quality assessment, and data analyses were conducted based on Cochrane standards using Review Manager software. Results: Fourteen publications (1424 patients) were included. Evidence revealed that CHM was more efficacious than the placebo in improving global dyspepsia symptoms (RR, 1.45; 95% CI, 1.31–1.60), Chinese medicine syndrome (CMS) (RR, 1.36; 95% CI, 1.23–1.50), and quality of life (SMD, 0.30; 95% CI, 0.15–0.45) in FD patients. Furthermore, the difference in the incidence of adverse events between CHM and placebo groups had no statistical significance (RR, 1.06; 95% CI, 0.66–1.70). Conclusion: This meta-analysis demonstrates that CHM has a therapeutic potential in treating FD with a certain safety. However, due to the restricted number of trials included, well-planned, long-term studies are necessary to provide credible evidence.
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Objectives To compare the efficacy and safety of seven Chinese patent medicines (CPMs) combined with conventional triple/quadruple therapy (T/Q) for Helicobacter pylori -positive peptic ulcers. Design A systematic review and network meta-analysis. Data sources China National Knowledge Infrastructure, VIP database, Wanfang database, ScienceDirect, EBSCO, EMBASE, Web of Science, Cochrane Library and PubMed were searched through 1 June 2022. Eligibility criteria Randomised controlled trials (RCTs) testing CPMs combined with T/Q for H. pylori -positive peptic ulcers were included. The CPMs included Anweiyang capsule, Jianweiyuyang tablets/capsule/granule, Jinghuaweikang capsule, Kangfuxin liquid, Puyuanhewei capsule, Weifuchun tablets/capsule and Weisu granule. At least one of the following outcome indicators was recorded: complete ulcer healing rate (CUHR), effective rate (ER), H. pylori eradication rate ( HP ER), rate of peptic ulcer recurrence (RPUR) and incidence of adverse reactions (IAR). Data extraction and synthesis Two researchers independently conducted the study selection and extracted data for included studies. The risk of bias was assessed using the Cochrane risk of bias tool. A pairwise meta-analysis was performed using RevMan V.5.3. Network meta-analysis was performed using STATA/MP V.15.0. Confidence in the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation. Results A total of 36 RCTs involving 3620 patients were included. Compared with T/Q alone, Weisu+T/Q, Weifuchun+T/Q and Puyuanhewei+T/Q had the highest CUHR, ER and HP ER, respectively. Weisu+T/Q and Jianweiyuyang+T/Q had the lowest RPUR and IAR, respectively. The cluster analysis results showed Jianweiyuyang+T/Q might be the best choice concerning efficacy and safety simultaneously, followed by Kangfuxin+T/Q. Conclusion Among the combination therapies with the CPMs, Jianweiyuyang+T/Q might be the most favourable option for H. pylori -positive peptic ulcers, followed by Kangfuxin+T/Q. Considering the limited quantity and quality of the included RCTs, the results should be interpreted with caution. PROSPERO registration number CRD42022327687.
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Background Acute-on-chronic liver failure (ACLF) is a refractory disease with high mortality, which is characterized by a pathophysiological process of inflammation-related dysfunction of energy metabolism. Jieduan-Niwan formula (JDNWF) is a eutherapeutic Chinese medicine formula for ACLF. However, the intrinsic mechanism of its anti-ACLF effect still need to be studied systematically. Purpose This study aimed to investigate the mechanism of JDNWF against ACLF based on altered substance metabolic profile in ACLF the expression levels of related molecules. Materials and methods The chemical characteristics of JDNWF were characterized using ultra performance liquid chromatography (UPLC) coupled with triple quadrupole mass spectrometry. Wistar rats subjected to a long-term CCL 4 stimulation followed by a combination of an acute attack with LPS/D-GalN were used to establish the ACLF model. Liver metabolites were analyzed by LC–MS/MS and multivariate analysis. Liver function, coagulation function, histopathology, mitochondrial metabolic enzyme activity and mitochondrial damage markers were evaluated. The protein expression of mitochondrial quality control (MQC) was investigated by western blot. Results Liver function, coagulation function, inflammation, oxidative stress and mitochondrial enzyme activity were significantly improved by JDNWF. 108 metabolites are considered as biomarkers of JDNWF in treating ACLF, which were closely related to TCA cycle. It was further suggested that JDNWF alleviated mitochondrial damage and MQC may be potential mechanism of JDNWF improving mitochondrial function. Conclusions Metabolomics revealed that TCA cycle was impaired in ACLF rats, and JDNWF had a regulatory effect on it. The potential mechanism may be improving the mitochondrial function through MQC pathway, thus restoring energy metabolism.
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Objective Functional constipation (FC) is a common intestinal disease worldwide. Despite the presence of criteria such as Roman IV, there is no standardized diagnosis and treatment algorithm in Hong Kong that combines both Western and Chinese medicine approaches. This study integrates current effective and safe diagnosis and treatment methods for FC and provides a clear and scientific pathway for clinical professionals and patients. Methods A systematic search of the PubMed, Cochrane Library, and China National Knowledge Infrastructure databases was performed from their inception to June 30th, 2022, collecting the current evidence about the efficacious integrative management for FC. We organized a meeting of professionals in fields relevant to treatment and management of FC to develop a consensus agreement on clinical pathway process. Results We developed a clinical pathway for the treatment of FC based on the most recent published guidelines and consultation with experts. This pathway includes a hierarchy of recommendations for every step of the clinical process, including clinical intake, diagnostic examination, recommended labs, diagnostic flowchart, and guidance for the selection of therapeutic drugs. Conclusion This pathway establishes clinical standards for the diagnosis and treatment of FC using Chinese medicine and Western medicine; it will help to provide high-quality medical services in Hong Kong for patients with FC.
Article
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Article
[Abstract] Objective This study focused on the application regularity of medicinal and dietary substances (MDS) of traditional Chinese medicine (TCM) diet therapy during rehabilitation, in order to help patients with Corona Virus Disease 2019 (COVID-19) reduce sequelae and improve their life quality. Methods The official websites of the national and provincial health committees, the website of the National Administration of Traditional Chinese Medicine, the China BioMedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), and Wanfang Database were used to search the keywords, such as “coronavirus” “novel coronavirus pneumonia” “COVID-19” “protocol” “guideline” “consensus” and “rehabilitation period”. The search time was from the establishment of databases to July 31, 2022. The prevention and control protocols of various provinces and cities were manually supplemented and screened out. The information on the frequency, property, flavor, meridian tropism, and efficacy of MDS was collected for association rule analysis through the Apriori algorithm. Hierarchical cluster analysis was performed using the Euclidean distance and longest distance. Results A total of 18 protocols were screened out, including 56 lists of TCM diet therapy, and 47 kinds of MDS with a frequency of 132 times during the rehabilitation of COVID-19. Among them, six lists of diet therapy were collected from national websites, 26 from local government websites, and 24 from social and academic institution websites. The intended population can be divided into seven categories including normal recovery, lung-spleen Qi deficiency, deficiency of both Qi and Yin, spleen-stomach weakness, deficiency of Yang Qi, kidney Qi deficiency, and blood deficiency. Shanyao (Dioscoreae Rhizoma) and Lianzi (Nelumbinis Semen), followed by Dazao (Jujubae Fructus) were used most commonly in MDS, with mainly flat property, sweet flavor, and spleen and lung meridians in meridian tropism. Besides, deficiency-tonifying drugs were commonly used in MDS. Through association rule analysis, 12 groups of association MDS pairs were obtained. The pair of Yiyiren (Coicis Semen) and Chenpi (Citri Reticulatae Pericarpium) had the highest Lift value, and Yiyiren (Coicis Semen) was used most frequently in the MDS category for eliminating pathogenic factors. The results of complex network analysis showed that the core MDS were Yiyiren (Coicis Semen), Shanyao (Dioscoreae Rhizoma), Huangqi (Astragali Radix), Fuling (Poria), and Dazao (Jujubae Fructus). Three core categories were classified by cluster analysis, including the category of strengthening spleen, nourishing kidney, and grasping Qi, the category of removing phlegm, abating panting, and regulating Qi, and the category of strengthening the middle-energizer and reinforcing Qi. Conclusion Based on the TCM theory, most patients during the rehabilitation of COVID-19 are in a state of lingering pathogens due to deficient vital Qi. TCM diet therapy is based on the principle of “giving both reinforcing and reducing treatment”, and the MDS combinations focus on both reinforcing the health Qi and eliminating pathogenic factors. The diet therapy mainly uses the MDS with flat property and sweet flavor, which belongs to deficiency-tonifying drugs, adding suitable MDS of pathogen-eliminating drugs according to different situations. The ultimate goal is to promote lung inflammation absorption, improve pulmonary fibrosis, increase immunity, reduce the occurrence of sequelae, and improve life quality.
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Aims In recent years, we have developed the concept of ‘clinical pathway based on integrated traditional Chinese and western medicine for the management of Chronic heart failure (CHF)’. The purpose of this study was to assess the implementation effects of multifaceted optimization management of chronic heart failure. Methods A total of nine physicians in optimization group from nine research sites received multifaceted intervention (a 1‐day training session on how to implement the optimization programme, a written optimization programme for CHF management, supervision from daily quality coordinator, and 1‐monthly monitoring and feedback of performance measure) with respect to the management of CHF, comparing to nine physicians in control group who did not receive the aforementioned multifaceted intervention and diagnosed and treated CHF patients with conventional programme (usual care). After that, a total of 256 patients with CHF were enrolled and randomly assigned to receive optimization programme [integration of usual care and traditional Chinese medicine (TCM) treatment] or conventional programme (usual care) for the treatment of CHF. The primary outcome was the change in New York Heart Association (NYHA) functional classification during 24 weeks of treatment. Results When compared with usual care, multifaceted optimization management resulted in superior improvements in NYHA functional classification at the 12‐week visit (P = 0.023), the 16‐week, 20‐week, and 24‐week visits (P < 0.001). It also demonstrated superior performance in comparison with the conventional programme with respect to readmission rate for major adverse cardiovascular events (MACEs), readmission rate for worsening heart failure, plasma N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) level, left ventricular ejection fraction (LVEF), patient TCM syndrome scores, quality of life, and patients with heart failure with reduced ejection fraction (HFrEF) in optimization group more likely received beta‐blockers and ACE inhibitors or ARBs than those in control group (P = 0.038 and P = 0.013, respectively). Conclusions It is likely that the multifaceted optimization programme used in this study is feasible would benefit patients with CHF in NYHA functional classification, readmission for worsening heart failure, plasma NT‐proBNP level, LVEF, patient TCM syndrome scores, and quality of life. Additionally, it would improve hospital personnel adherence to evidence‐based performance measures for HFrEF.
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Chronic prostatitis (CP)/chronic pelvic-pain syndrome (CPPS) is a common urinary-system disease with a high incidence in young and middle-aged men, seriously affecting patients’ ability to work and their quality of life (QoL). Western medicine (WM) has some limitations in treating CP/CPPS. Acupuncture is an ancient Chinese medical method that is commonly used to treat this condition and has a relatively good effect on it. Many randomized controlled trials (RCTs) on this subject have been published. For this study, we searched the China National Knowledge Infrastructure (CNKI), Chinese Science and Technology Periodical (VIP), Wanfang, SinoMed, and PubMed databases for RCTs on acupuncture treatment of CP/CPPS in the last 5 years (2016/01/01–2021/12/01). In addition, we conducted analysis and research, aiming to summarize acupuncture treatment in CP/CPPS RCTs and the clinical efficacy, with the goal of providing clinical reference. A total of 132 related documents were retrieved in the search, and 85 articles were retained after screening. We obtained RCT information on acupuncture treatment of CP/CPPS. The results showed that several relevant clinical studies have been performed over the last 5 years and that acupuncture and moxibustion have better curative effect on CP/CPPS than WM. Due to the small number of included studies, more experimental evidence is needed to verify the clinical efficacy of acupuncture.
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Background Poria cocos (Schw.) Wolf (PC), a fungus, has been used for more than 2000 years as a food and medicine in China. It has a very good therapeutic effect for functional dyspepsia (FD). However, the material basis and mechanism of PC on FD were not reported. Purpose To investigate the function and potential mechanisms of PC including its three extracts (triterpenoid, PCT; water-soluble polysaccharide, PCWP; acidic polysaccharide, PCAP) on FD. Study Design The study explored the therapeutic effect of PC and its three extracts on FD in rats for the first time and discussed its mechanisms based on brain-gut peptides, immunity and repair of the gastrointestinal mucosa. Methods The chemical components of PC extracts were analyzed and quantified using ultra high performance liquid chromatography coupled with quadrupole time of flight mass spectrometry (UPLC-Q-TOF-MS) and gel permeation chromatography coupled with size exclusion chromatography (GPC/SEC). The FD rat models were established using weight-loaded forced swimming and alternate-day fasting for 42 days. After 14 days of treatment, the effect and mechanisms were investigated using ELISA, histopathology, immunohistochemistry as well as Western blot. Results Seventy-seven triterpenoids in PCT were identified. PCWP was primarily composed of component A (Mw: 3.831 × 10⁷ Da), component B (Mw: 5.650 × 10⁶ Da) and component C (Mw: 113117 Da). PCAP was a homogeneous composition with an average Mw of 74320 Da. PCT, PCWP and PCAP alleviated the symptoms of FD. These extracts promoted the repair of gastrointestinal mucosa and regulated the balance between the T helper cell (Th)1/Th2 axis and the Th17/Treg axis. PCT and PCWP regulated brain-gut peptides more effectively, PCWP and PCAP enhanced immunity more effectively. Further study demonstrated that these extracts may have enhanced immunity via the Toll-like receptor (TLR) and c-Jun N-terminal kinase (JNK) signaling pathways. Conclusions PC extracts showed therapeutic effects on FD rats, and the mechanism of action involved multiple pathways. PCAP, which is often discarded in traditional applications, was effective. Our study provides new ideas for the application and development of PC extracts.
Chapter
Two small randomized controlled trials (RCTs) dealing with as many “alternative medicine” topics were identified during the recent update of previous international “democracy-based” consensus conferences aimed at identifying all nonsurgical strategies which have been shown by sufficiently strong randomized evidence to affect mortality in the perioperative and critical care setting. Although these topics were excluded during the consensus building process, the number of RCTs reporting a significant survival benefit with the use of Traditional Chinese Medicine (TCM), particularly herbal remedies, in critically ill patients has increased in the last few years, and now also includes two relatively large investigations published in a top-rating international journal. Since Traditional Medicine is still used as an adjunct to standard therapy in the intensive care units of East Asian countries and considering the international scope of the consensus conference whose findings are the subject of the book, this chapter briefly summarizes the main evidences about the potential role of “alternative medicine” in reducing mortality among critically ill patients although the implications for clinical practice in Western countries are currently virtually absent.
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The aim of this study is to systematically evaluate existing evidence of the Chinese herbal formula, Zuogui pill (ZGP), for the treatment of osteoporosis. A systematic literature search was performed in six electronic databases. The authors independently extracted data in pairs and evaluated the risk of bias. A total of 221 articles were identified initially, of which 12 relevant studies were enrolled. The primary outcome was fracture incidence and bone mineral density (BMD) at different sites. Bone metabolism markers, clinical symptoms, quality of life, and adverse events or adverse drug reactions (ADRs) were secondary outcomes. The results showed that ZGP, combined with anti‐osteoporosis drugs, significantly increased BMD at the lumbar spine, Ward's area, and total hip. In terms of markers for improved bone metabolism, ZGP plus conventional drugs dramatically improved the levels of alkaline phosphatase, bone Gla protein, bone alkaline phosphatase, and tartrate‐resistant acid phosphatase. Gastrointestinal discomfort, dizziness, and fatigue were found in the combined therapy group. Although the results indicate that ZGP is a potential candidate for osteoporosis, evidence remains insufficient. Further rigorously designed and high‐quality trials with a larger sample size are warranted to verify the current conclusions.
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Objective. This study aimed to investigate the methodological quality of clinical guidelines (CGs) for integrated Chinese and Western medicine (ICWM) to inform clinical practice and guideline development. Methods. We searched PubMed, EMBASE, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang Data, VIP, five guideline databases, and four online book malls to identify ICWM CGs published up to January 11, 2019. Four independent appraisers assessed the quality of CGs using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument and evaluated six specific concerns for ICWM. The standardized scores were calculated for the individual AGREE II domains. Results. Sixty-two ICWM CGs were included. The median standardized scores in the six domains of AGREE II were 65% in scope and purpose, 46% in clarity of presentation, 26% in applicability, 24% in stakeholder involvement, 15% in rigor of development, and 0% in editorial independence. The quality of ICWM CGs was significantly associated with the publication year (higher quality for CGs published after 2014) and the development method (higher quality for evidence-based CGs). Only one ICWM CG obtained a direct recommendation for use, and 14 could be recommended for use after modifications. The intra-appraiser consistency of the AGREE II appraisal was good (mean intraclass correlation coefficient range, 0.813–0.998). ICWM CGs also lacked a systematic search of ancient traditional Chinese medicine (TCM) classics (40.3%), conversion of TCM recommendations from ancient Chinese to the vernacular (14.5%), a discussion of interactions between TCM and Western medicine (27.4%), and rankings of different ICWM choices (0%). Conclusions. Although an improvement after 2014 occurred, the current 64 ICWM CGs are generally of poor methodological quality. Only 15 ICWM CGs can be recommended for use directly or with modifications. As the key distinctions from Western/Chinese medicine CGs, the ICWM-specific recommendations are also insufficient for the ICWM CGs, especially for interactions between TCM and Western medicine and rankings of different ICWM choices. Study Registration. This study has been registered at PROSPERO (no. CRD42018095767). 1. Introduction Although Western medicine has become the mainstay of the health care system in China, traditional Chinese medicine (TCM), an ancient medical approach with 3000 years of history, is still widely practiced [1, 2]. Integrated Chinese and Western medicine (ICWM) has proven to be more effective than either treatment style alone for many conditions, especially some chronic refractory conditions such as osteoarthritis and functional gastrointestinal disorders, as well as side effects from chemotherapy [3, 4]. In China, more than 90% of Western medicine practitioners and almost all TCM practitioners are simultaneously prescribing Chinese and Western medicine [5]. Moreover, ICWM has received specific support from the Chinese government as a basic health development strategy [6]. ICWM practice, however, is difficult. TCM is fundamentally different from Western medicine in both theory and practice. Western medicine is based on modern scientific methods and evidence, whereas TCM uses philosophical perspectives to explain physiological and pathological changes in the human body, as manifested in its unique diagnostic method of syndrome differentiation and use of Chinese herbs and acupuncture to treat diseases [7]. Due to the limitation of professional education, few healthcare practitioners master both Western medicine and TCM, and this is associated with ineffective application of ICWM and may increase costs and safety concerns [8]. In fact, most Western medicine practitioners do not understand TCM theory, such as syndrome differentiation, and the properties, compatibility, and contraindications of Chinese herbs [5]. Indeed, 21% of adverse events caused by TCM were associated with inappropriate combinations of Chinese and Western medicine [9]. TCM practitioners also lack evidence-based concepts and knowledge to make clinical decisions in Western medicine practice. They may be afraid that Western medicine is not sufficiently effective or safe and thus abandon this treatment approach, which also creates a risk of delaying treatment and missing the optimal time to treat a condition. An essential approach to improving ICWM practice is to develop and utilize clinical guidelines (CGs), which are recommendation documents systematically developed to standardize clinical decisions in specific clinical settings [10]. To date, dozens of ICWM CGs have been released and have influenced decision-making and patient outcomes. The actual efficacy of ICWM CGs is, of course, closely related to their quality. Many efforts have been made by methodologists to improve the quality of CGs. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument, developed in 2009, is a representative achievement of these efforts to assess the quality of CGs [11]. Owing to its advantages in structure and feasibility, AGREE II has a myriad of uses worldwide [12]. Overall, AGREE II is applicable to ICWM CGs, but many issues regarding the particular characteristics of ICWM, such as the vernacularization of ancient Chinese in TCM recommendations and the interactions between Chinese and Western medicine, should be further considered [13]. A previous study explored the quality of ICWM CGs published before 2014 [14]. However, this assessment was out of date and did not consider ICWM-specific concerns. With the publication of an increasing number of ICWM CGs since that previous study, we aimed to conduct an updated survey to inform clinical practice and guideline development by thoroughly investigating the methodological quality and ICWM-specific concerns of ICWM CGs. 2. Methods 2.1. Study Design This is a survey of currently available ICWM CGs published before January 11, 2019, using the AGREE II instrument. The study protocol is registered at PROSPERO (no. CRD42018095767). We report this study following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) criteria where applicable [15]. 2.2. Searches We searched PubMed, EMBASE, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang Data, VIP, five guideline databases (the National Guideline Clearinghouse, the Guidelines International Network, the National Institute for Health and Clinical Excellence, the Scottish Intercollegiate Guidelines Network, and MedLive), and four online book malls (http://www.amazon.com, http://www.jd.com, http://www.amazon.cn, and http://www.dangdang.com). The keywords used for the search included “integrated Chinese and Western,” “guideline,” “consensus,” and “recommendation,” among others (see details in Table S1 in the supplementary file). 2.3. Inclusion Criteria We defined ICWM CGs as CGs that simultaneously focused on TCM and Western medicine for diagnosis or treatment. We used the World Health Organization’s definition of CGs, i.e., systematic recommendations developed to assist any healthcare provider in making optimal clinical decisions [10]. The CGs were further divided into two types: (1) evidence-based CGs developed according to systematic searches and a summary of research evidence and (2) consensus-based guidelines developed according to scant research evidence or only expert opinions and consensus [16]. If a guideline had multiple versions, the final version was included. There were no restrictions regarding language. 2.4. Exclusion Criteria The following CGs were excluded: (1) CGs developed for TCM or Western medicine alone; (2) no full text available; (3) translations; (4) CGs developed by a single author; (5) guideline-like textbooks; and (6) systematic reviews, narrative reviews, clinical pathways, and clinician training manuals. 2.5. Study Screening and Data Extraction Two appraisers, independently and in duplicate, screened the bibliographies to identify potentially eligible CGs and then read the full text to determine the final eligibility. Discrepancies were resolved by discussion. The following information was extracted from the CGs included using a standardized, pilot-tested form: authors, publication year, publication form, type of CG (evidence-based or consensus-based), type of developer, scope, condition, numbers of pages and references, consensus method, evidence grading system, composition of development team, and funding sources. 2.6. Appraisal of Guidelines We used the AGREE II instrument to assess the quality of ICWM CGs across the following six domains: scope and purpose (3 items), stakeholder involvement (3 items), rigor of development (8 items), clarity of presentation (3 items), applicability (4 items), and editorial independence (2 items). The items in AGREE II are scored from strongly disagree (1 point) to strongly agree (7 points). A standardized score for each domain was calculated using the following formula: ((actual score − minimum score)/(maximum score − minimum score)) × 100%. Finally, we performed an overall assessment of “whether you recommend this guideline for use” with the following standards proposed by previous studies [17, 18]: (1) recommend, all domains scored ≥60%; (2) recommend with modifications, less than three domains scored <30% but one or more domains scored <60%; and (3) not recommend: three or more domains scored <30%. Four appraisers who had experience in the development and appraisal of CGs independently assessed the quality of each CG. To enhance the consistency between the appraisers, they were trained in both English and Chinese versions of the AGREE II user’s manual [19, 20], a paper of detailed explanations of the AGREE II assessment for the CGs of Chinese medicine [21], and an online AGREE II training tutorial (https://www.agreetrust.org/resource-centre/agree-ii/agree-ii-training-tools/). Before the formal appraisal, the appraisers performed a pilot exercise for two ICWM guidelines with different methodological qualities and discussed and addressed discrepancies. The formal appraisal was performed using an official online platform “My AGREE PLUS (https://http://www.agreetrust.org/my-agree/),” which is widely used in AGREE II appraisals and may enhance consistency between appraisers [22, 23]. To assess whether the CGs appropriately specified key concerns for ICWM, we consulted five clinicians each in Western medicine and Chinese medicine to collect the information they were most interested in and the gaps they most frequently faced when using ICWM guidelines. We determined the following six ICWM-specific concerns by a consensus meeting: (1) whether the CG included evidence from ancient TCM classics; (2) whether ancient Chinese in the TCM recommendations had been converted to the vernacular for the comprehension of non-TCM practitioners; (3) whether the CG provided the principles of the addition and subtraction of TCM interventions based on syndrome differentiation; (4) whether the CG specified the interactions between TCM and Western medicine; (5) whether the CG ranked the efficacy and safety of different ICWM interventions; and (6) whether the CG provided monitoring criteria for both diseases (Western medicine concept) and syndromes (TCM concept). All these items received an answer of “yes” or “no.” The assessment was also performed by four appraisers, and they achieved consistency through discussion. 2.7. Statistical Analysis We calculated the mean, standard deviation, median, interquartile range (IQR), range, or proportion to describe the characteristics of the CGs, standardized AGREE II scores, and additional items. We performed stratified comparisons of CGs with different characteristics using the Mann–Whitney U test or the Kruskal–Wallis H test, and the difference was significant if the value was less than 0.05. The intraclass correlation coefficient (ICC) and 95% confidence interval (CI) were calculated to assess consistency among the appraisers using a two-way mixed model; an ICC <0.50, 0.50–0.74, 0.75–0.89, and 0.90–1.00 indicated poor, fair, good, and excellent consistency, respectively [24]. 3. Results 3.1. Epidemiological Characteristics As shown in Figure 1, the search yielded 5,571 results, and 62 ICWM CGs [25–86] were included in the quality appraisal after screening. The number of ICWM CGs was low between 2003 and 2015 but increased rapidly since 2016 (Figure 2). Most CGs were published as journal articles, except for one published as a conference paper. Two CGs were published in English, and the others were published in Chinese. There were 15 evidence-based and 47 consensus-based CGs. Most (87.1%) of the developers were academic associations, two (3.2%) were government departments, and six (9.7%) were nonofficial organizations. Recommendations for diagnosis and treatment were included in 47 CGs (75.8%), for only treatment in 13 (21.0%), and for only diagnosis in two (3.2%). Seventeen CGs (27.4%) focused on digestive diseases, 12 (19.4%) on cardiovascular diseases, 8 (12.9%) on skin diseases, 8 (12.9%) on urogenital diseases, 7 (11.3%) on respiratory diseases, and 10 (16.1%) on other diseases (e.g., bone, kidney, and nerve). The average number of pages and references in the included CGs was 6.2 and 32.3, respectively. Only five CGs were longer than 10 pages, and 13 had no references. The detailed characteristics of the included ICWM CGs are presented in Table S2 in the supplementary file.
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