Traditional Chinese Medicine Syndrome Research Articles

Exploring the relationship between intestinal microbiota and immune checkpoint inhibitors in the treatment of non-small cell lung cancer: insights from the "lung and large intestine stand in exterior-interior relationship" theory.

This study is aim to discern the Traditional Chinese Medicine (TCM) syndrome classifications relevant to immunotherapy sensitive in non-small cell lung cancer (NSCLC) patients, and to delineate intestinal microbiota biomarkers and impact that wield influence over the efficacy of NSCLC immunotherapy, grounded in the TCM theory of "lung and large intestine stand in exterior-interior relationship." The study cohort consisted of patients with advanced NSCLC who received treatment at the Oncology Department of Chengdu Fifth People's Hospital. These patients were categorized into distinct TCM syndrome types and subsequently administered immune checkpoint inhibitors (ICIs), specifically PD-1 inhibitors. Stool specimens were collected from patients both prior to and following treatment. To scrutinize the differences in microbial gene sequences and species of the intestinal microbiota, 16S rRNA amplicon sequencing technology was employed. Additionally, peripheral blood samples were collected, and the analysis encompassed the assessment of T lymphocyte subsets and myeloid suppressor cell subsets via flow cytometry. Subsequently, alterations in the immune microenvironment pre- and post-treatment were thoroughly analyzed. The predominant clinical manifestations of advanced NSCLC patients encompassed spleen-lung Qi deficiency syndrome and Qi-Yin deficiency syndrome. Notably, the latter exhibited enhanced responsiveness to ICIs with a discernible amelioration of the immune microenvironment. Following ICIs treatment, significant variations in microbial abundance were identified among the three strains: Clostridia, Lachnospiraceae, and Lachnospirales, with a mutual dependency relationship. In the subset of patients manifesting positive PD-L1 expression and enduring therapeutic benefits, the study recorded marked increases in the ratios of CD3+%, CD4+%, and CD4+/CD8+ within the T lymphocyte subsets. Conversely, reductions were observed in the ratios of CD8%, Treg/CD4+, M-MDSC/MDSC, and G-MDSC/MDSC. The strains Clostridia, Lachnospiraceae, and Lachnospirales emerge as potential biomarkers denoting the composition of the intestinal microbiota in the NSCLC therapy. The immunotherapy efficacy of ICIs markedly accentuates in patients displaying durable treatment benefits and those expressing positive PD-L1.

Comprehensive effects of traditional Chinese medicine treatment on heart failure and changes in B-type natriuretic peptide levels: A meta-analysis.

Heart failure (HF), a common cardiovascular condition, is characterized by significant morbidity and mortality. While traditional Chinese medicine (TCM) is often used as a complementary approach in HF management, systematic evaluations of its impact on clinical outcomes, TCM syndrome scores, and B-type natriuretic peptide (BNP) levels are lacking. This study fills this gap through a comprehensive analysis of randomized controlled trials (RCTs) focusing on TCM for HF treatment. It encompasses an assessment of methodological quality, a meta-analysis, and an evaluation of evidence quality based on established standards. The results offer crucial insights into the potential advantages and constraints of TCM in HF management. To systematically analyze the effects of TCM on the clinical comprehensive outcomes, TCM syndrome scores, and BNP levels in patients with HF and evaluated the quality of evidence for these trials. RCTs on TCM for HF treatment published since the establishment of the database were searched in four Chinese and English databases, including China National Knowledge Infrastructure, Wanfang, VIP Information Chinese Science and Technology Journal, and PubMed. Methodological quality was assessed for the included studies with the Cochrane risk-of-bias assessment tool, and the meta-analysis and publication bias assessment was performed with the RevMan5.3 software. Finally, the quality of evidence was rated according to the GRADE criteria. A total of 1098 RCTs were initially retrieved. After screening, 16 RCTs were finally included in our study, which were published between 2020 and 2023. These RCTs involved 1660 HF patients, including 832 in the TCM group [TCM combined with conventional Western medicine (CMW) treatment] and 828 in the CWM group (CWM treatment). The course of treatments varied from 1 wk to 3 months. TCM syndrome differentiation was analyzed in 11 of the included RCTs. In all included RCTs, outcome indicators included comprehensive clinical outcomes, TCM syndrome scores, and BNP levels. The meta-analysis results showed significant differences between the TCM and CWM groups in terms of comprehensive clinical outcomes [risk ratio = -0.54; 95% confidence interval (CI) = -0.61, -0.47; P < 0.00001], TCM syndrome scores [weighted mean difference (WMD) = -142.07; 95%CI = -147.56, -136.57; P < 0.00001], and BNP levels (WMD = -142.07; 95%CI = -147.56, -136.57; P < 0.00001). According to the GRADE criteria, RCTs where "TCM improves clinical comprehensive outcomes" were rated as low-quality evidence, and RCTs where "TCM reduces TCM syndrome scores" or "TCM decreases BNP levels" were rated as medium-quality evidence. TCM combined with CWM treatment effectively improves comprehensive clinical outcomes and diminishes TCM syndrome scores and BNP levels in HF patients. Given the low and medium quality of the included RCTs, the application of these results should be cautious.

Efficacy of traditional Chinese medicine combined with Silibinin on nonalcoholic fatty liver disease: A meta-analysis and systematic review.

The efficacy and safety of traditional Chinese medicine (TCM) combined with Silibinin in the treatment of nonalcoholic fatty liver disease (NAFLD) are still inconclusive. This meta-analysis intends to evaluation to explore the clinical efficacy and quality assessment of traditional Chinese medicine in combination with Silymarin in the treatment of NAFLD, aiming to aims to provide evidence-based data analysis for researchers and clinical practitioners involved in TCM research for NAFLD, with the hope of facilitating wider adoption and application. In this meta-analysis, we searched PubMed, Embase, Cochrane Library, CNKI, Wanfang, CQVIP and CBM databases from the establishment of the databases to Oct 2023. The study proposed to include studies that reported combination of TCM with Silibinin and Silibinin alone in the treatment of NAFLD, excluding studies for which full text was not available or for which data extraction was not possible; studies using animal studies; reviews and systematic reviews. All data were processed by STATA15.1 statistical software. 16 randomized controlled trials (RCTs) were included in this meta-analysis. The sample size ranged from 48 to 120, with a total of 1335 patients, including 669 in the Combined treatment group and 384 in the Silibinin group. The findings indicated that the total effective rate of combined treatment group was significantly higher than that of Silibinin alone. Levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol (TC), triglycerides (TG), and gamma glutamyl transpeptidase (GGT) of combined treatment group were all significantly lower than that of western medicine alone. Additionally, after treating NAFLD with a combination of TCM and Silibinin, the TCM syndrome score were significantly lower than those observed with Silibinin alone. Traditional Chinese medicine in conjunction with Silibinin capsules has shown significant efficacy in the treatment of NAFLD, improving clinical symptoms, blood lipid levels, and liver function. Furthermore, it is essential to engage in multi-omics research, investigate iron death, and explore the gut microbiota as potential observational indicators for the diagnosis and inclusion criteria. Conducting more high-quality clinical experiments is necessary to further validate these findings.

Evidence map analysis of randomized controlled trial of commonly used Chinese patent medicines in treatment of type 2 diabetes mellitus in recent five years

This study systematically combed the randomized controlled trial(RCT) of Chinese patent medicines in treatment of type 2 diabetes mellitus(T2DM) in recent five years by using the method of evidence map. It understood the distribution and quality of evidence in this field and found the existing Chinese patent medicines in treatment of T2DM and the problems in its research. The study collected the commonly used Chinese patent medicines for the treatment of T2DM from three drug catalogs, retrieved Chinese and English databases to obtain RCT literature related to Chinese patent medicines in recent five years, and extracted information such as sample size, study drug, combination medication, course of treatment, and outcome indicators from the literature. It also conducted quality evaluation based on the Cochrane collaborative network bias risk assessment tool and used charts to display the analysis results. A total of 19 kinds of Chinese patent medicines are collected, of which 13 kinds of Chinese patent medicines are mentioned in 131 articles related to RCT. The literature concerning Shenqi Jiangtang Capsules/Granules, Jinlida Granules, and Xiaoke Pills accounts for a large proportion. Outcome indicators include blood glucose, blood lipids, pancreatic islet cell function, and clinical symptoms. In terms of literature quality, 75 articles have correct random methods, and 1 article performs allocation hiding and blind methods. Therefore, the clinical orientation of Chinese patent medicines for the treatment of T2DM is broad, failing to reflect their own characteristics and lacking safety information. Insufficient attention has been paid to TCM syndrome scores, quality of life, and blood lipid outcome indicators that reflect the characteristics of traditional Chinese medicine(TCM). The number of studies on the treatment of T2DM by Chinese patent medicines varies greatly among varieties, and the quality of the studies is low. It is suggested that the holders of the marketing license of T2DM Chinese patent medicines should carry out a post-marketing re-evaluation of the varieties of traditional Chinese patent medicines for treating T2DM according to the relevant requirements of the State Food and Drug Administration, standardize the clinical positioning, and revise and improve the safety information in the instructions. It is recommended that researchers construct a core indicator dataset for Chinese patent medicine treatment of T2DM, improve the efficacy evaluation system, and develop an experimental plan based on CONSORT before conducting RCT.

Research and development strategy of new traditional Chinese medicine drugs for syndromes based on human use experience

Chinese drug registration laws and regulations have always reserved a place for the new traditional Chinese medicine(TCM) drugs for syndromes, but so far no such new drugs have been approved for registration. This paper expounded on the relevant policies, regulations, and technologies of new TCM drugs for syndromes in China and pointed out that the application of the animal model of TCM syndromes to carry out pharmacodynamics research and clinical efficacy evaluation criteria of TCM syndromes were the main technical difficulties in the research and development of new TCM drugs for syndromes. Not all syndromes are suitable for developing new drugs, and the indications for new TCM drugs should be constant syndromes. Among the three research and development models of simple syndrome, syndrome-unified disease, and combined disease and syndrome, the research and development model of combined disease and syndrome is recommended. Clinical positioning is the key to new TCM drugs for syndromes. It is encouraged to conduct high-quality human use experience studies to determine the clinical positioning of new TCM drugs for syndromes, as well as the target population, dose, course of treatment, and initial therapeutic and safety, and apply for exemption from non-clinical effectiveness studies. Clinical trials of new TCM drugs for syndromes should take the target symptoms or signs as the main efficacy index and the efficacy of TCM syndromes as the secondary efficacy index. Clinical research program design should implement the &quot;patient-centered&quot; concept and introduce clinical outcome evaluation indicators. In the clinical safety evaluation, special conditions such as characteristic syndromes and changes should be considered. With the construction of the human use experience technology system and the promotion of the TCM registration and evaluation evidence system featuring the &quot;combination of TCM theory, human use experience, and clinical trials&quot;, it is believed that many high-quality new TCM drugs for syndromes will be developed in the future.

Clinical research and the rules of acupoint selection on acupuncture treatment of psoriasis in the past 20 years

To sum up clinical researches and the rule of acupoint selection on the treatment of psoriasis by acupuncture and moxibustion in the past 20 years, so as to provide new ideas and reference for improving the clinical effect of acupuncture for psoriasis. Research papers, published from January 1, 2002 to December 31, 2022 in both Chinese and English, were searched from databases of China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (WanFang), and Chinese Science and Technology Journal (CSTJ), PubMed, Embase and Web of Science by using key words of psoriasis, psoriases, psoriasis vulgaris, acupuncture, needle, acupoint and moxibustion. Then, Microsoft Excel 2021 was used for data entry, extraction and sorting of the included literature, data extraction mainly includes diagnostic criteria, treatment methods, treatment frequency, total course of treatment, selection of acupoints, efficacy evaluation and outcomes. SPSS Modeler 18.1 software was used to make analysis on the association rules of acupoints. A total of 26 papers were included, and the diagnostic criteria of clinical studies on acupuncture treatment of psoriasis are constantly updated. Of the 26 clinical studies, 23 had both treatment group and control group, 21 were randomized controlled trials. The main methods for treatment of psoriasis included fire needle, acupuncture, electroacupuncture, acupuncture combined with moxibustion or fire needle, fire needle plus western medicines, etc. with the acupuncture combined with moxibustion, and fire needle combined with western medicines being most frequently used. The observation index and clinical efficacy evaluation were effective rate, psoriasis area and severity index, dermatology life quality index, Traditional Chinese Medicine syndrome score, etc., with the effective rate being about 40% to 100%. Comparison of clinical efficacy of acupuncture in treating psoriasis showed that the simple fire needle, simple acupuncture, acupuncture combined with moxibustion, fire needle or acupuncture combined with western medicines were superior to simple western medicines, etc. In regard to acupoint selection, a total of 35 acupoints were found in the 26 studies included, among which the top 5 frequently used were Ashi points (skin lesion region), Geshu (BL17), Feishu (BL13), Ganshu (BL18) and Quchi (LI11), and there were strong association rules among BL17, BL13, BL18 and Shenshu (BL23). Acupuncture is safe and effective in the treatment of psoriasis, and acupuncture combined with moxibustion and fire acupuncture needle combined with western medicines are recommended as the main intervention method, with Ashi-point, BL13, BL17, BL18 and BL23 as the main acupoints.

Clinical Effect of Modified Shengyang Yiwei Decoction in the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome due to Spleen and Stomach Weakness

Objective: To explore the therapeutic effect of Shengyang Yiwei Decoction in patients with diarrhea-predominant irritable bowel syndrome (IBS) due to spleen and stomach weakness. Methods: 40 patients with diarrhea-predominant IBS who were treated from April 2018 to April 2020 were taken as samples. TCM (traditional Chinese medicine) syndrome differentiation found that they were all due to spleen and stomach weakness. They were randomly divided into two groups. Group A was treated with modified prescriptions of Shengyang Yiwei Decoction, while Group B was treated with Western medicine. The therapeutic effects in the two groups were compared. Results: The treatment efficacy in Group A was higher than that in Group B (P &lt; 0.05); the symptom scores of Group A such as loose stools, chills, physical weakness, poor appetite, and abdominal distension after meals were all lower than those in Group B (P&lt; 0.05); the SF-36 (36-Item Short Form Health Survey) scores of patients with diarrhea-predominant IBS in Group A were higher than those in Group B (P &lt; 0.05); the treatment satisfaction of Group A was higher than that of Group B (P&lt; 0.05). Conclusion: Treatment of diarrhea-predominant IBS patients with spleen and stomach weakness by Shengyang Yiwei Decoction can promote the disappearance of gastrointestinal discomfort symptoms, improve the quality of life, and enhance treatment efficacy. Hence, it is an efficient and feasible treatment for diarrhea-predominant IBS due to spleen and stomach weakness.

Exploration of biomarkers for efficacy evaluation of traditional Chinese medicine syndromes of acute exacerbation of chronic obstructive pulmonary disease based on metabolomics.

Background: Traditional Chinese medicine (TCM) is effective for the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD); however, there is no objective index for the evaluation of TCM syndrome efficacy. This study aimed to screen biomarkers related to the efficacy of TCM syndrome using metabolomics. Methods: We recruited AECOPD patients with phlegm-heat congesting lung (PH)/phlegm-damp amassing lung (PD) syndrome and treated them with Chinese herbal medicine (Qingre Huatan or Zaoshi Huatan granules) in addition to conventional medicine for 7days. Data on clinical symptoms and sign scores, modified British Medical Research Council (mMRC), COPD assessment test (CAT), and inflammation indicators, including white blood cell (WBC) count, percentage of neutrophil count (NEU%), and C-reactive protein (CRP), were collected before and after treatment to evaluate the therapeutic effect. Serum samples were collected before and after treatment for metabolomic analysis to screen differential metabolites. Results: A total of 69 patients with AECOPD were enrolled, including 41 and 28 patients in the PH and PD groups, respectively. The clinical symptoms and sign scores, CAT, mMRC, NEU%, and CRP levels after treatment were lower than those before treatment in both groups (p < 0.05). Serum metabolomics analysis showed that there were 13 differential metabolites in the PH group and 16 differential metabolites in the PD group before and after treatment (p < 0.05, variable importance projection (VIP) ≥ 1.00). In the PH group, lysophosphatidylcholine (LPC) (16:0), LPC (17:1), LPC (18:3), LPC (18:2), and LPC (17:0) negatively correlated with clinical symptoms and sign scores (p < 0.05); LPC (16:0), LPC (17:1), LPC (16:1), and LPC (17:0) negatively correlated with WBC (p < 0.05) and NEU% (p < 0.05); and LPC (16:0) negatively correlated with CRP levels. In the PD group, L-phenylalanine positively correlated with CRP levels (p < 0.05), and 2-methylbutyroylcarnitine positively correlated with clinical symptoms and sign (p < 0.05) and CAT scores (p < 0.05). DL-carnitine positively correlated with clinical symptoms and sign scores (p < 0.05). Conclusion: Serum metabolites may be potential indicators to objectively evaluate the efficacy of TCM syndromes; however, further large controlled trials are required to verify these findings.

Conducting and reporting the Delphi method in traditional Chinese medicine syndrome diagnosis research: A cross-sectional analysis

BackgroundThe Delphi method has been extensively used to reach a consensus in traditional Chinese medicine (TCM) syndrome diagnosis research when subjective judgment is not uniform and objective evidence is lacking. The conduct and reporting of the Delphi method in TCM syndrome diagnosis research have never been critiqued. Our study aims to explore the consistency of using this technique and assess the reporting quality. MethodsA cross-sectional study was employed to scope articles reporting the conduct of the Delphi method in TCM syndrome diagnosis research. We searched the PubMed, Web of Science, CNKI, VIP, Wanfang and SinoMed databases with the restriction of Chinese and English language from their inception to March 25, 2023. A standardized extraction form was designed to collect demographics and methodological processes reflecting the rigor and transparency in TCM syndrome diagnosis research. ResultsA total of 1832 studies were screened, and 50 were included. The median number of panels was 30 (IQR 20–34.5) and only 12 (24.0 %) studies were with a heterogeneous sample of panels. Two rounds was most common (37/50; 74.0 %), followed by three (7/50; 14.0 %), and only 13 (26.0 %) studies determined the number of rounds a priori. The reporting quality varied, with 18.0 % (9/50) reporting anonymity, 30.0 % (15/50) describing the controlled feedback, 20.0 % (10/50) reporting the procedure duration (7.14 ± 3.29 months) and 26.0 % (13/50) predefining the consensus. ConclusionThe Delphi method is inconsistently conducted and nontransparently reported in TCM syndrome diagnosis research. Standardized criteria are urgently needed for best practices in future research.

Zhuifeng Tougu capsules in the treatment of knee osteoarthritis (cold dampness obstruction syndrome): a randomized, double blind, multicenter clinical study

BackgroundIn Traditional Chinese Medicine (TCM) theory, cold dampness obstruction is one of the common syndromes of osteoarthritis. Therefore, in clinical practice, the main treatment methods are to dispel wind, remove dampness, and dissipate cold, used to treat knee osteoarthritis (KOA). This report describes a mulitercenter clinical study to assess Zhuifeng Tougu Capsule’s efficacy and safety in the treatment of patients who are cold dampness obstruction syndrome in KOA, and to provide evidence-based medical for the rational use of Zhuifeng Tougu Capsules in clinical practice.MethodsThis randomized, parallel group controlled, double-blind, double dummy trial will include a total of 215 KOA patients who meet the study criteria. 215 patients underwent 1:1 randomisation, with 107 cases assigned the experimental group (Zhuifeng Tougu Capsules + Glucosamine Sulfate Capsules Simulator) and 108 assigned the control group (Glucosamine Sulfate Capsules + Zhuifeng Tougu Capsules Simulator). After enrolment, patients received 12 weeks of treatment. The main efficacy measure is the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score. Visual analogue scale (VAS) pain score, Self-condition assessment VAS score, WOMAC KOA score, TCM syndrome score and TCM syndrome efficacy, ESR level, CRP level, suprapatellar bursa effusion depth, use of rescue drugs, and safety indicators are secondary efficacy indicators.ResultsCompared with before treatment, WOMAC pain score, VAS pain score, Self-condition assessment VAS score, WOMAC KOA score, and TCM syndrome score decreased significantly in both groups (P < 0.01). Also, the experimental group showed significant differences in the above indicators compared to control (P < 0.01). However, after treatment, no significant differences were showed in the ESR level, CRP level, and suprapatellar bursa effusion depth between the two groups (P > 0.05). No any serious adverse effects showed in the experimental group and control group.ConclusionsZhuifeng Tougu Capsules can effectively improve knee joint function and significantly alleviate the pain of KOA.Trial registration: Clinical trial registration was completed with the China Clinical Trial Registration Center for this research protocol (No. ChiCTR2000028750) on January 2, 2020.

THE USE OF REFLEXOLOGY ACCORDING TO THE “BALANCING HEXAGRAMS” TECHNIQUE IN THE COMPLEX REHABILITATION OF ARTHROPATHIES

Abstract. Traditional Chinese medicine is half syndromes, not diseases. This is the identification of a wider range of problems than just individual nosologies: usually, this is a comorbidity, with regular involvement of other tissues, other systems. For example, the syndrome of traditional Chinese medicine "Congestion of the liver" includes the facilitated formation of various pain syndromes in a person, often their combination, and not just a liver disease such as hepatitis. Similarly, Bi syndrome includes more than just "pain in the knee" or osteoarthritis of the knee joint. The article describes the concept of Bi syndrome in traditional Chinese medicine, its classification. The article also presents the main theoretical principles of the "balancing hexagrams" method and its practical implementation. Also given is a clinical case: treatment of a patient with subacute postinfectious arthropathy of the right sphenoid and ankle joints. Purpose. To consider the peculiarities of the use of reflexotherapy by the method of "balancing hexagrams" in the complex rehabilitation of arthropathies. Scientific novelty. For the first time in our country, the technique of compiling acupuncture prescriptions and acupuncture using the method of "balancing hexagrams" was used in the complex rehabilitation of arthropathies. Methods. We consider one clinical case of the use of reflexology using the method of "balancing hexagrams" in complex rehabilitation of arthropathies. The methods of clinical objective neurological examination, the method of syndromic diagnosis of traditional Chinese medicine, the pulse diagnosis method, and the tongue diagnosis method were used. We consider one clinical case of the use of reflexotherapy using the method of "balancing hexagrams" in complex rehabilitation of arthropathies. The methods of clinical objective neurological examination, the method of syndromic diagnosis of traditional Chinese medicine, the pulse diagnosis method, and the tongue diagnosis method were used. Results. As a result of treatment using the method of "balancing hexagrams", the patient's condition improved: it was possible to balance him and achieve a pain-free period. Conclusions. 1. Patients with arthropathies are found in the practice of a reflexologist. 2. The use of the acupuncture method "balancing hexagrams" can be effective in the complex of treatment measures for arthropathies.

Chinese herbal medicine Shenqi compound for early intervention in patients at high cardiovascular risk of type 2 diabetes mellitus: the protocol of a multicenter, randomized, double-blind, placebo-controlled trial.

Reducing multiple cardiovascular risk factors is a key link and a challenging clinical problem to reduce the risk of cardiovascular complications and death in patients with diabetes. Currently, there is a lack of clinical studies on patients with diabetes combined with multiple risk factors. Traditional Chinese medicine is believed to have therapeutic effects that contribute to the comprehensive control of multiple cardiovascular factors. This study aims to provide evidence for the efficacy and safety of Shenqi compound (SQC) for early intervention in diabetic patients at high cardiovascular risk. This study is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 120 diabetic patients with high cardiovascular risk were enrolled in five research centers. After a 2-week run-in period, the intervention group received basic treatment and SQC granules, and the control group received basic treatment and placebo granules for a total of 24 weeks, with a 24-week follow-up. The endpoint outcomes are major adverse cardiovascular events and renal-related and peripheral vascular disease events. The primary efficacy outcome is carotid intima-media thickness, and the secondary efficacy outcomes are carotid shear stress, indicators of glucose and lipid metabolism, pancreatic islets function, hemorheology, traditional Chinese medicine syndrome score, and quality of life scale. Safety indicators and adverse events were used to assess the safety of SQC. This study comprehensively evaluated the efficacy and safety of SQC for early intervention in diabetic patients at high cardiovascular risk from the aspects of overall metabolic level, structure, and function of blood vessels, quality of life, and long-term follow-up of endpoint events, providing evidence-based evidence for the short-term efficacy and long-term benefits of early treatment to reduce the risk of diabetic cardiovascular complications.Trial Registration: This trial is registered in the Chinese Clinical Trial Registry on March 9, 2023, https://www.chictr.org.cn/showproj.html?proj=192803 (No. ChiCTR2300069219).

Differential clinical characteristics across traditional Chinese medicine (TCM) Syndromes in patients with sickle cell disease.

Pain is a common, debilitating, and poorly understood complication of sickle cell disease (SCD). The need for clinical pain management of SCD is largely unmet and relies on opioids as the main therapeutic option, which leads to a decreased quality of life (QoL). According to the literature, acupuncture has shown certain therapeutic effects for pain management in SCD. However, these clinical studies lack the guidance of Traditional Chinese Medicine (TCM) Syndrome Differentiation principles for treatment. To characterize differences in clinical presentation amongst TCM diagnosed Syndromes in SCD patients. Fifty-two patients with SCD and 28 age- and sex-matched healthy controls (HCs) were enrolled in an ongoing trial of acupuncture. Each participant completed a series of questionnaires on pain, physical function, fatigue, sleep, anxiety, depression and QoL and underwent cold- and pressure-based quantitative sensory testing at baseline. Data on prescription opioid use over the 12 months prior to study enrollment was used to calculate mean daily morphine milligram equivalents (MME). Differences among the three TCM Syndromes were analyzed by one-way ANOVA followed by Tukey post hoc testing. Two-sample t-tests were used to compare SCD and HC groups. TCM diagnosis criteria classified SCD patients into one of three TCM Syndromes: (a) Equal; (b) Deficiency; and (c) Stagnation. The Stagnation group exhibited higher pain interference, physical dysfunction, nociplastic pain, fatigue, anxiety, depression, MME consumption and lower sleep quality and QoL compared to the Equal group. Few differences were observed between HCs and the Equal SCD group across outcomes. Deficiency and Stagnation groups were differentiated with observed- and patient-reported clinical manifestations. These findings suggest that TCM diagnosed Syndromes in SCD can be differentially characterized using validated objective and patient-reported outcomes. Because characteristics of pain and co-morbidities in each SCD patient are unique, targeting specific TCM "Syndromes" may facilitate treatment effectiveness with a Syndrome-based personalized treatment plan that conforms to TCM principles. These findings lay the foundation for the development of tailored acupuncture interventions based on TCM Syndromes for managing pain in SCD. Larger samples are required to further refine and validate TCM diagnostic criteria for SCD.

Study on the Characteristics of Traditional Chinese Medicine Syndromes in Patients with Erosive Gastritis Based on Metabolomics.

According to traditional Chinese medicine theory, tongue coatings reflect changes in the body. The goal of this study was to identify a metabolite or a set of metabolites capable of classifying characteristics of traditional Chinese medicine syndromes in erosive gastritis. In this study, we collected tongue coatings of patients with erosive gastritis with damp-heat syndrome (DHS), liver depression and qi stagnation syndrome (LDQSS), and healthy volunteers. Then, we analyzed the differences in metabolic characteristics between the two groups based on metabolomics. We identified 14 potential biomarkers related to the DHS group, and six metabolic pathways were enriched. The differential pathways included pyrimidine metabolism, pantothenate and CoA biosynthesis, citrate cycle (TCA cycle), pyruvate metabolism, glycolysis/gluconeogenesis, and purine metabolism. Similarly, in the LDQSS group, we identified 25 potential biomarkers and 18 metabolic pathways were enriched. The top five pathways were the TCA cycle, sphingolipid metabolism, fatty acid biosynthesis, pantothenate and CoA biosynthesis, and the pentose phosphate pathway. In conclusion, the DHS group and the LDQSS group have different characteristics.

Effects of Bushen Huayu Decoction combined with entecavir on liver function and hepatic fibrosis in patients with compensated cirrhosis.

To analyze the effect of Bushen Huayu Decoction combined with entecavir on alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBil) and albumin (Alb) in patients with hepatitis cirrhosis. A retrospective study was conducted on 102 patients with compensated hepatitis cirrhosis treated at the No. 2 Hospital of Baoding from February 2020 to April 2023. These patients were divided into two groups based on different treatment modalities: a control group treated with entecavir (n=51) and an observation group treated with Bushen Huayu decoction plus entecavir (n=51). The Traditional Chinese Medicine (TCM) syndrome scores, level of liver function indicators, and liver fibrosis symptoms were compared between the two groups before treatment and after 2 weeks and 4 weeks of treatment. Before treatment, the two groups differed insignificantly in liver fibrosis indicators (HA, IV-C, and PCIII), liver function indices (ALT, AST, TBil, and Alb) and TCM syndrome scores (all P>0.05). After 2 weeks and 4 weeks of treatment, HA, IV-C, and PCIII in both groups decreased. Those in the observation group were significantly lower than those in the control group (P<0.05). The levels ALT, AST, and TBil decreased significantly in both groups. The level of Alb increased significantly, and the alterations in the observation group was more prominent compared with those in the control group (all P<0.05). The scores of TCM syndromes across various aspects all decreased significantly. The scores in the observation group were significantly lower than those of control group (P<0.05). The combined treatment of Bushen Huayu Decoction and entecavir is helpful to improve the TCM symptoms, reduce the levels of ALT, AST, and TBil, increase the level of Alb, improve the state of liver fibrosis, and promote the recovery of liver function in patients with compensatory hepatitis cirrhosis.

Network medicine analysis for dissecting the therapeutic mechanism of consensus TCM formulae in treating hepatocellular carcinoma with different TCM syndromes.

Hepatocellular carcinoma (HCC) is a major cause of cancer-related mortality worldwide. Traditional Chinese Medicine (TCM) is widely utilized as an adjunct therapy, improving patient survival and quality of life. TCM categorizes HCC into five distinct syndromes, each treated with specific herbal formulae. However, the molecular mechanisms underlying these treatments remain unclear. We employed a network medicine approach to explore the therapeutic mechanisms of TCM in HCC. By constructing a protein-protein interaction (PPI) network, we integrated genes associated with TCM syndromes and their corresponding herbal formulae. This allowed for a quantitative analysis of the topological and functional relationships between TCM syndromes, HCC, and the specific formulae used for treatment. Our findings revealed that genes related to the five TCM syndromes were closely associated with HCC-related genes within the PPI network. The gene sets corresponding to the five TCM formulae exhibited significant proximity to HCC and its related syndromes, suggesting the efficacy of TCM syndrome differentiation and treatment. Additionally, through a random walk algorithm applied to a heterogeneous network, we prioritized active herbal ingredients, with results confirmed by literature. The identification of these key compounds underscores the potential of network medicine to unravel the complex pharmacological actions of TCM. This study provides a molecular basis for TCM's therapeutic strategies in HCC and highlights specific herbal ingredients as potential leads for drug development and precision medicine.

Clinical Study of Shenhong Tongluo Recipe in Treating Carotid Atherosclerosis

Abstract To observe the clinical effect of Shenhong Tongluo Recipe on carotid atherosclerosis. Method: 72 patients were randomly divided into a control group (36 cases) and an experimental group (36 cases). The control group received atorvastatin calcium, while the experimental group received the Shenhong Tongluo formula. The treatment program consisted of 24 weeks. Observe the thickness of the intima media and plaque area of the carotid artery; Hs CRP, MLR (mononuclear C/lymphoid C), NLR (neutrophil C/lymphoid C); Clinical efficacy of traditional Chinese medicine and TCM syndrome score; Measurement of blood lipid levels (TG, TC, HDL, LDL); Homocysteine and uric acid; Changes in safety indicators. The total effective rate of the experimental group was higher than that of the control group (P&lt;0.05). After treatment, the carotid intima-media thickness and plaque area in the experimental group; Hs CRP, MLR (mononuclear C/lymphoid C), NLR (neutrophil C/lymphoid C); Clinical efficacy of traditional Chinese medicine and TCM syndrome score; Blood lipid levels (TG, TC, LDL); Homocysteine and uric acid levels decreased (P&lt;0.05), and the traditional Chinese medicine syndrome score was lower than that of the control group (P&lt;0.05). No significant adverse reactions were observed in the experimental group’s control group. Conclusion Shenhong Tongluo Recipe can safely and effectively regulate the level of inflammation in the circulation of patients with carotid atherosclerosis, improve lipid metabolism disorder, reduce inflammatory reaction, alleviate and stabilize plaque and resist atherosclerosis.

Early warning model for stroke recurrence in acute ischemic stroke patients based on traditional Chinese medicine syndrome theory.

This study aimed to establish an early warning model for stroke recurrence in acute ischemic stroke patients based on Traditional Chinese Medicine (TCM) syndrome theory. This retrospective study collected the data of 1741 patients with ischemic stroke from 7 clinical centers between July 2016 and November 2019. Distance correlation coefficient, mutual information entropy, and statistical correlation test were used for univariate analysis. Cox proportional hazards regression model was applied to construct and validate the stroke recurrence warning model at different time. The area under the ROC curve (AUC) was used to evaluate the early warning ability of the model. We successfully constructed the early warning model. The median follow-up time was 1.42 years (95% CI [1.37, 1.47]). Recurrence events occurred in 175 patients, with a cumulative recurrence rate of 10.05% (95% CI [8.64, 11.47]). The AUC of the model was 0.64±0.02 in the training set and 0.70±0.03 in the validation set. The TCM syndrome model can give an early warning for the recurrence of stroke and provide reference for the secondary prevention of ischemic stroke.

New approach to heart failure: Integrated traditional Chinese with Western medicine

AbstractHeart failure (HF) is a major global healthcare problem leading to substantial deterioration of prognosis. The current clinical guidelines in HF have begun to emphasize the importance of traditional Chinese medicine (TCM). TCM has been utilized in clinical practice for over 2000 years and is capable of treating a variety of HF pathogenic issues. This review summarizes the classification, pathophysiology, and treatment of HF from three perspectives: Western medicine, TCM, and integrated traditional Chinese and Western medicine (ITCWM). Emphasizing the most recent evidence, this review consolidates knowledge on ITCWM treatments for HF pertaining to different TCM syndromes, including TCM decoctions, oral patent Chinese medicine, TCM injections, as well as therapies like acupuncture and moxibustion. Additionally, this review explores TCM approaches to HF prevention, such as tai chi, Baduanjin exercise, and Sanfu acupoint herbal patching. The findings of this study suggest that ITCWM holds promise for the treatment and rehabilitation of HF. However, further research is warranted to elucidate the underlying mechanisms.

Combination of traditional Chinese medicine and standard biomedical treatment for rosacea: a systematic review and a meta-analysis.

A combination of standard biomedical treatment and traditional Chinese medicine (TCM) has been suggested as a therapeutic approach for rosacea that may significantly lower the recurrence rate and clinical symptom scores. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the impact of this combination treatment on clinical symptom and TCM syndrome scores, as well as on the scores of the Dermatology Life Quality Index (DLQI), erythema index (EI), and interleukin 37 (IL-37) levels in patients with rosacea. The PROSPERO registration number for the study is CRD42023472737. We systematically searched the PubMed, Embase, Web of Science, China National Knowledge Infrastructure Wanfang Database, China Biomedical Medicine database (CBM), and the VIP information resource integration service platform (cqvip) databases for RCTs (published from the beginning to September 2023, regardless of the language used) that compared the traditional Chinese medicine and standard biomedical treatment combination treatment to conventional anti-rosacea treatments. Our primary outcomes comprised the clinical symptom and TCM syndrome scores, and the scores of Dermatology Life Quality Index, erythema index, and IL-37 levels. We used a random-effects model to evaluate the pooled data. We identified 260 studies. Of these, 13 eligible studies were employed for analysis (N = 1,348 participants). Compared with other anti-rosacea treatments, the TCM and standard biomedical treatment combination treatment yielded an improved mean reduction in the clinical symptom score -2.24% [95% CI (-3.02 to -1.46), p < 0.00001], TCM syndrome score -4.42 [95% CI (-5.33 to -3.50), p < 0.00001], and the score of DLQI of -2.55 [95% CI (-3.73 to -1.36), p < 0.00001], EI of -151.97 [95% CI (-276.59 to -27.36), p < 0.00001], and IL-37 level -4.23 [95% CI (-4.95 to -3.51), p = 0.854], as well as in the overall effective rate risk ratio (RR) = 1.25 [95%CI (1.18, 1.32), p = 0.994] and the recurrence rate = 0.27 [95%CI (0.15, 0.46), p = 0.297]. The TCM and standard biomedical treatment combination treatment can provide a better outcome, including a reduction in the TCM syndrome and clinical symptom scores, and in the scores of DLQI, EI, and IL-37. Hence, this combination is a viable and more effective therapeutic approach for rosacea. However, these results should be considered cautiously because of uncertain evidence and the low quality of the study reports considered in this meta-analysis. website, identifier CRD42023472737.