Factors related to acupuncture response in patients with chronic prostatitis/chronic pelvic pain syndrome: secondary analysis of a randomized controlled trial.

PURPOSE: Acupuncture has been recommended as an effective therapy to improve symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We conducted this secondary analysis to explore the factors that may influence the response of patients with CP/CPPS to acupuncture. METHODS: This secondary analysis was based on a randomized controlled trial demonstrating the efficacy of acupuncture among patients with CP/CPPS. Responder is defined as a patient with a decrease of ≥ 6 points in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline at the 32 week. 206 patients who received acupuncture treatment and completed 32-week follow-up were included in this secondary analysis. Descriptive statistics were used to describe the demographic and clinical characteristics of both responders and non-responders in acupuncture group. Logistic regression analysis with bootstrapping was made to identify potential factors that contributed to the effectiveness of acupuncture for treating CP/CPPS. Responders and non-responders were listed as dependent variables. RESULTS: In this study, 130 (63.11%) patients were assessed as responders. The results showed that men with non-sedentariness (OR 4.170 [95%CI 1.837 to 9.463; P = 0.001]), non-smoking habit (OR 2.824 [95%CI 1.453 to 5.487; P = 0.002]), without comorbidity (OR 8.788 [95%CI 1.912 to 40.295; P = 0.005]), and severe NIH-CPSI total score (OR 0.227 [95%CI 0.114 to 0.450; P < 0.0001]) benefited more from acupuncture intervention. CONCLUSION: CP/CPPS patients who are active, non-smokers, without comorbidity, and had severe symptoms may be more likely to respond to acupuncture.

[Regularity of prescriptions for sick sinus syndrome based on latent structure combined with association rules].

This study aims to mine the regularity of traditional Chinese medicine(TCM) prescriptions for sick sinus syndrome(SSS) and provide a reference for clinical syndrome differentiation and treatment. The relevant papers were retrieved from CNKI, Wanfang, VIP, and SinoMed with the time interval from inception to January 31, 2023. The relevant information from qualified papers was extracted to establish a library. Lantern 5.0 and Rstudio were used to analyze the latent structure and association rules of TCMs with the frequency ≥3%, which combined with frequency descriptions, were used to explore the rules of TCM prescriptions for SSS. A total of 192 TCM prescriptions were included, involving 115 TCMs with the cumulative frequency of 1 816. High-frequency TCMs include Aconiti Lateralis Radix Praeparata, Ginseng Radix et Rhizoma, Glycyrrhizae Radix et Rhizoma, Astragali Radix, and Salviae Miltiorrhizae Radix et Rhizoma. The high-frequency medicines mainly had the effects of tonifying, releasing exterior with pungent-warm, and activating blood and resolving stasis. The analysis of the latent structure model yielded 13 hidden variables, 26 hidden classes, 8 comprehensive cluster models, and 21 core prescriptions. Accordingly, the common syndromes of SSS were inferred as heart-Yang Qi deficiency, heart-spleen Yang deficiency, heart-kidney Yang deficiency, Yang deficiency and blood stasis, both Qi and Yin deficiency and blood stasis, and Yin and Yang deficiency. The analysis of association rules predicted 30 strong association rules, among which Ginseng Radix et Rhizoma-Aconiti Lateralis Radix Praeparata had the highest support. SSS is a syndrome with Yang deficiency and Qi deficiency as the root causes and cold, phlegm, and stasis as the manifestations. The clinical treatment of SSS should focus on warming Yang and replenishing Qi, which should be supplemented with the therapies of activating blood and resolving stasis, warming interior and dissipating cold, or regulating Qi movement for resolving phlegm according to the patients' syndromes.

Increased interbrain synchronization and neural efficiency of the frontal cortex to enhance human coordinative behavior: A combined hyper-tES and fNIRS study.

Coordination is crucial for individuals to achieve common goals; however, the causal relationship between coordination behavior and neural activity has not yet been explored. Interbrain synchronization (IBS) and neural efficiency in cortical areas associated with the mirror neuron system (MNS) are considered two potential brain mechanisms. In the present study, we attempted to clarify how the two mechanisms facilitate coordination using hypertranscranial electrical stimulation (hyper-tES). A total of 124 healthy young adults were randomly divided into three groups (the hyper-tACS, hyper-tDCS and sham groups) and underwent modulation of the right inferior frontal gyrus (IFG) during functional near-infrared spectroscopy (fNIRS). Increased IBS of the PFC or neural efficiency of the right IFG (related to the MNS) was accompanied by greater coordination behavior; IBS had longer-lasting effects on behavior. Our findings highlight the importance of IBS and neural efficiency of the frontal cortex for coordination and suggest potential interventions to improve coordination in different temporal windows.

[Research progress of histone acetylation in prevention and treatment of heart failure and new ideas based on traditional Chinese medicine].

Chronic heart failure(CHF) has become a worldwide public health problem due to its high morbidity and mortality, which seriously endangers people's lifespan and quality of life. In recent years, the treatment strategy of CHF has shifted its emphasis on short-term improvement and transformation of hemodynamics to long-term repair as well as improvement of the biological properties of heart failure. At present, with the continuous deepening of medical research, it has been found that histone acetylation is closely related to the occurrence and development of CHF. Traditional Chinese medicine, via regulating histone acetylation, delays ventricular remodeling, improves energy metabolism, inhibits fibrosis and cardiomyocyte hypertrophy, and intervenes in the development process of heart failure, thus reducing the mortality and the readmission rate and ultimately improving long-term prognosis. Therefore, this study reviewed the mechanism of histone acetylation in the treatment of heart failure as well as its prevention and treatment with traditional Chinese medicine, to provide reference for clinical treatment of CHF.

Effectiveness of electroacupuncture versus prucalopride for women with severe chronic constipation: secondary analysis of a randomized controlled trial.

PURPOSE: Electroacupuncture (EA) is a component alternative therapy for severe chronic constipation (SCC). Women are more vulnerable to SCC and gender might impact the response of patients with functional gastrointestinal disorders to therapy. We performed this secondary analysis to explore the effectiveness and safety of EA compared with prucalopride among women with SCC. METHODS: Based on a multicenter, randomized, noninferiority trial, 446 female patients were randomly assigned to receive 28-session EA (n = 222) over 8 weeks with 24-week follow-up without treatment or to receive prucalopride (n = 224) over 32 consecutive weeks. The primary outcome was the proportion of overall complete spontaneous bowel movements (CSBMs) responders over weeks 1-8, defined as at least three CSBMs per week, and more than an increase of one CSBM from baseline meanwhile for at least 6 weeks during an 8-week treatment period. Secondary outcomes measure sustained CSBM responder, weekly responders, change from baseline in mean weekly CSBMs and SBMs, straining and stool consistency, quality of life, and adverse events (AEs). RESULTS: The proportion of overall responders was 25.23% in the EA group, similar to 25.89% in the prucalopride group, with a between-group difference of - 0.67% (95% CI, - 8.80 to 7.40%; P = 0.872) during an 8-week treatment. In the secondary outcomes, EA and prucalopride groups had no significant difference, except that EA was inferior to prucalopride in improving SBMs. The AEs were less in the EA group than the prucalopride group. CONCLUSION: EA may be a promising and safe treatment for women with SCC; its effect could sustain 24 weeks after treatment stopped.

Acupuncture for Impaired Glucose Tolerance in People With Obesity: A Protocol for a Multicenter Randomized Controlled Trial.

Background: Impaired glucose tolerance (IGT) is associated with being overweight/obesity and is a powerful risk factor for the disease of diabetes. In addition to lifestyle intervention that shows limited clinical application, acupuncture treatment has been a feasible treatment method for IGT in clinical practice. However, the effectiveness of acupuncture treatment has not been proved in evidence-based practice. Therefore, we design a multicenter randomized controlled trial to evaluate the efficacy and safety of acupuncture treatment for IGT in people with overweight/obesity. Methods: The trial will be conducted at hospitals in three different sites in China. A total of 196 participants will be recruited and randomly assigned at a ratio of 1:1 to either to the acupuncture group or the sham acupuncture (SA) group. Both groups will receive 30 sessions of treatment for 12 consecutive weeks and will be provided with lifestyle intervention and a 24-week follow-up. The primary outcome will be change in the baseline value of 2-h blood glucose (2hPG) on the 12th week. Additionally, the expectancy of acupuncture, blinding, and safety will also be assessed. All statistical analyses will be performed by two-sided test, and a p-value of less than 0.05 will be considered statically significant. Discussion: This study aims to provide quantitative clinical evidence of acupuncture effectiveness and safety in treating IGT in people who are overweight/obese. Clinical Trial Registration: [www.ClinicalTrials.gov], identifier [NCT05347030].

Efficacy and Safety of Electro-Thumbtack Needle Therapy for Patients With Chronic Neck Pain: Protocol for a Randomized, Sham-Controlled Trial.

Background: Chronic neck pain is a prevalent condition adversely impacting patients' wellbeing in both life and work experience. Electro-thumbtack needle (ETN) therapy, combining acupuncture with transcutaneous stimulation, might be one of the effective complementary and alternative medicine (CAM) therapies in treating chronic neck pain, although the evidence is scarce. This study aims to estimate the efficacy and safety of ETN therapy for chronic neck pain. Methods and Analysis: This is a sham-controlled, randomized clinical trial. A total of 180 subjects will be randomly allocated to either the ETN group or the sham ETN group. Treatment will be administrated three times a week for four consecutive weeks, with a 6-month follow-up. The primary outcome measure will be the Numerical Rating Scale for neck pain (NRS-NP) over a period of the 4 weeks. Secondary outcome measures include the Northwick Park Neck Pain Questionnaire (NPQ), Neck Disability Index (NDI), Patient Global Impression of Change (PGIC), patient expectation, and preference assessment. The chi-square test or Fisher's exact test will be used for proportions of participants having clinically meaningful improvement. Analysis of covariance or repeated-measures analysis of variance will be applied to examine changes in the outcome measures from baseline. Discussions: This prospective trial will contribute to evaluating the efficacy and safety of ETN in the treatment of chronic neck pain, with an intermediate-term follow-up. This study will provide further evidence for clinical neck pain management. Ethics and Dissemination: This trial has been approved by the Research Ethical Committee of Guang'anmen Hospital (ethical approval number: 2021-039-KY-01). Recruitment began in March 2022 and will continue until December 2023. Dissemination plans include posters, WeChat, websites, and bulletin boards in hospital and communities. Clinical Trial Registration: This trial is registered at ClinicalTrials.gov (identifier: NCT04981171).

Effects of Electroacupuncture on Opioid-Induced Constipation in Patients With Cancer: Study Protocol for a Multicenter Randomized Controlled Trial.

Background: Opioid-induced constipation (OIC) is one of the most prevalent adverse events associated with cancer patients who receive opioid analgesics for moderate to severe pain. Acupuncture may be an effective treatment for OIC. We designed this trial to assess the efficacy and safety of electroacupuncture for OIC in cancer patients. Methods: This is a multicenter, sham-controlled, parallel-group, subject- and assessor-blinded randomized trial. A total of 100 cancer patients with OIC will be randomly assigned to either the electroacupuncture group or the sham electroacupuncture group at a ratio of 1:1. Patients in each group will receive a total of 24-session treatment over 8 weeks, three sessions a week and 30 min each session. Thereafter, patients will be followed up for another 8 weeks. The primary outcome will be the proportion of responders, defined as a patient who has ≥3 spontaneous bowel movements (SBMs)/wk and ≥ increase of 1 SBM from baseline simultaneously for at least 6 out of 8 weeks of the treatment period. The secondary outcomes will include the mean weekly SBMs and complete spontaneous bowel movements, the mean Bristol Stool Form Scale score for stool consistency, the mean score for straining of SBM, the total and subscale scores of Patient Assessment of Constipation-Symptom questionnaires, and the total and subscale scores of Patient Assessment of Constipation-Quality of Life questionnaire. Patients' global assessment of treatment effectiveness, patients' expectation toward the effectiveness of acupuncture and safety of acupuncture will also be assessed. All efficacy analyses will be performed in the intention-to-treat population. Discussion: To improve the adherence to intervention protocols, the majority of the participants will be recruited from an inpatient setting. The results will help to determine the clinical effects and safety of electroacupuncture for the treatment of OIC among patients with cancer. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03797586, registered on 4 January 2019, https://clinicaltrials.gov/ct2/show/NCT03797586.

Efficacy and Mechanism of Buyang Huanwu Decoction in Patients With Ischemic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Trial Combined With Proteomic Analysis.

Objective: Buyang Huanwu Decoction (BYHW), a famous herbal prescription in traditional Chinese medicine (TCM), has been used for 200 years for treating ischemic heart failure (IHF). This study aims to assess the efficacy and safety of BYHW combined with guideline-guided pharmacotherapy in patients with IHF and explore the biological mechanism by which BYHW exerts its efficacy. Methods: In the multicenter, double-blind, randomized controlled trial, a total of 80 patients with IHF were randomized to receive BYHW or placebo for 3 months. The primary efficacy endpoints were New York Heart Association (NYHA) classification, TCM syndrome scores, N-terminal pro-B-type natriuretic peptide (NT-ProBNP), whereas the mechanism exploration endpoints included energy metabolism parameters and coagulation function parameters. In addition, we performed the proteomic study of the serum of patients after treatment by label-free quantification technology to verify the candidate target proteins and pathways. Results: After 3 months of treatment, the NYHA classification, TCM syndrome scores, and the percentage of subjects with at least 30% reduction in NT-ProBNP were significantly improved in the BYHW group, compared with the control group (p < 0.05); BYHW treatment also significantly regulated blood glucose, blood lipid levels, ameliorated energy metabolism and improved coagulation function parameters. There were no significant differences in safety endpoints between the two groups. In addition, we obtained 56 differentially expressed proteins by proteomics, including 20 upregulated proteins and 36 downregulated proteins. Bioinformatic analysis revealed the mechanism of BYHW treatment was significantly related to complement and coagulation cascades, cholesterol metabolism, NF-kappa B signaling pathway, PI3K-Akt signaling pathway, and metabolic pathways. Among these differentially regulated proteins, fibrinogen gamma (FGG), fibrinogen beta (FGB), Carboxypeptidase B2 (CPB2), Coagulation factor XIII A (F13A1), Intercellular adhesion molecule1 (ICAM1), Apolipoprotein C-II(APOC2), Apolipoprotein C-I(APOC1), and CD44 were found to be signature proteins associated with the efficacy of BYHW against IHF. Conclusion: BYHW treatment can further improve cardiac dysfunction and clinical symptoms in IHF based on standard therapy without apparent adverse effects. Additionally, BYHW may play a therapeutic role in IHF by improving energy metabolism and regulating coagulation function through multiple targets and pathways.

Effect of Acupuncture for Mixed Urinary Incontinence in Women: A Systematic Review.

Background: Mixed urinary incontinence increasingly undermines women's quality of life. Previous studies showed some effects of acupuncture for MUI, but no systematic review has been done to evaluate the efficacy and safety of acupuncture for MUI in women. Objective: To systematically review the efficacy and safety of acupuncture for women with MUI. Methods: Ten databases (i.e., PubMed, Web of Science, Embase, ClinicalTrials.gov, the Cochrane Library, CBM, Scoups, CNKI, VIP and WANFANG DATA) were searched up to July 19th, 2021, using tailored search strategies with keywords not limited to "female," "mixed urinary incontinence," "acupuncture," and "randomized controlled trial," etc. RCTs and quasi-RCTs were included if investigating effect of any type of acupuncture for female patients with MUI. Data were extracted from eligible studies, and risks of bias were assessed according to the Cochrane Handbook from seven aspects using the RevMan 5.4 software. Results: A total of three randomized studies with 591 women were included. The risk of bias among the studies varied, with major concerns on blinding of participants and outcome assessor. Liu's study (497) mainly showed that electroacupuncture's effect on reduction of numbers of incontinence, urgency, nocturia episodes, and amount of urine leakage etc. was not inferior to that of PFMT-Solifenacin group at 12, 24, and 36 weeks. Zhan's study (60) showed that electroacupuncture reduced significantly more amount of urine leakage than Tolterodine at 8 weeks, with no data on incontinence episodes frequency. All 3 studies reported that acupuncture significantly increased the quality of life assessed by ICIQ score. In addition, incidence of acupuncture-related adverse events was rare, while antimuscarinic agents related adverse events were common in two studies. Conclusion: Although acupuncture showed some benefit for women with MUI, more evidences were required to draw a solid conclusion of effectiveness and safety of acupuncture for women with MUI. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO, identifier: CRD42021224600.

Non-pharmacological therapies for treating chronic pelvic pain in women: A review.

Chronic pelvic pain (CPP) is an intricate condition with multiple etiologies that lead to indefinite pain mechanisms. Physicians and researchers are challenged in its treatment, and the combined therapy of pharmacologic and non-pharmacologic treatment has been recognized as a multidisciplinary approach cited by guidelines and adopted in clinical practice. As an alternative therapy for CPP, non-pharmacologic therapies benefit patients and deserve further study. This study reviews the literature published from January 1991 to April 2022 on non-pharmacologic therapies for CPP in adult women. Based on a survey, this review found that the most commonly used non-pharmacological therapies for CPP include pelvic floor physical therapy, psychotherapy, acupuncture, neuromodulation, and dietary therapy. By evaluating the efficacy and safety of each therapy, this study concluded that non-pharmacological therapies should be included in the initial treatment plan because of their high degree of safety and low rate of side effects. To fill the lack of data on non-pharmacologic therapies for CPP, this study provides evidence that may guide treatment and pain management.

Ginger and 6-gingerol prevent lipopolysaccharide-induced intestinal barrier damage and liver injury in mice.

BACKGROUND: Inflammation-related diseases present a significant public health problem. Ginger is a flavoring spice and medicinal herb with anti-inflammatory activity. This study investigated the preventive effects of ginger extract (GE) and its main bioactive component, 6-gingerol (6G), on lipopolysaccharide (LPS)-induced intestinal barrier dysfunction and liver injury in mice. RESULTS: GE and 6G were orally administered to mice for seven consecutive days before LPS administration. After 24 h, the mice were sacrificed. GE and 6G were found to significantly reverse LPS-induced inflammation in the mouse ileum by modifying the NF-κB pathway. They also alleviated apoptosis in the ileum by downregulating Bax and cytochrome c gene expression and by inhibiting the caspase-3 pathway. Through the aforementioned mechanisms, GE and 6G restored the intestinal barrier by increasing ZO-1 and claudin-1 protein expressions. Gut-derived LPS induced inflammation and apoptosis in the liver; these effects were markedly reversed through GE and 6G treatment. 6G was the most abundant component in GE, as evidenced through liquid chromatography-mass spectrometry, and accounted for >50% of total gingerols and shogaols in GE. CONCLUSION: The current results support the use of GE and 6G as dietary supplements to protect against gut-derived endotoxemia-associated inflammatory response and disorders. © 2021 Society of Chemical Industry.

Efficacy and Safety of Shexiang Baoxin Pill for Coronary Heart Disease after Percutaneous Coronary Intervention: A Systematic Review and Meta-analysis.

OBJECTIVE: Shexiang Baoxin Pill (SBP) is a licensed Chinese herbal pharmaceutical that has been widely accustomed to treat coronary heart disease (CHD) after percutaneous coronary intervention (PCI). This study points to systematically assess the efficacy and security of the combination of SBP with conventional western medicine in the treatment of CHD after PCI. METHODS: Databases including PubMed, the Cochrane Library, Web of Science, Embase, CNKI, Wanfang, VIP, and SINOMED were searched to collect RCTs on SBP in CHD after PCI before July 2021. Review Manager 5.3 was used to analyze the data. The Cochrane Collaboration Bias Risk Tool is used to assess the quality of methods. RESULTS: A total of 19 eligible trials of 2022 patients with CHD after PCI were finally included. The results of the aggregate evidence showed that, compared with routine western medicine treatment alone, the combination of SBP with conventional treatment trial groups could significantly reduce the incidence of major adverse cardiac events (MACE) of the patients (RR = 0.38, 95% CI (0.29, 0.51), P < 0.00001). SBP also significantly enhanced left ventricular ejection fraction (LVEF) (MD = 4.00, 95% CI (3.42, 4.58), P < 0.00001) and lessened N-terminal pro-B-type natriuretic peptide (NT-pro-BNP) levels (MD = -167.18, 95% CI (-174.80, -159.57), P < 0.00001). In addition, the inflammatory mediators and blood lipid index in the experimental group after the combined therapy were also mediated (P < 0.05). Moreover, SBP did not increase the incidence of adverse reactions during treatment. The results of subgroup analysis illustrated that the length of the intervention course might be the source of the heterogeneity of NT-pro-BNP and hs-CRP. CONCLUSION: SBP could demonstrate a beneficial role in patients with CHD after PCI of reducing the incidence of MACE and improving LVEF, NT-pro-BNP, inflammatory mediators, and blood lipid index. However, limited by the quantity and quality of eligible studies, the above conclusions required more standardized, rigorous, high-quality clinical trials to verify further.

Comparison of efficacy and safety of His-Purkinje system pacing versus cardiac resynchronisation therapy in patients with pacing-induced cardiomyopathy: protocol for a randomised controlled trial.

INTRODUCTION: Recent studies have shown that the His-Purkinje system pacing (HPSP) can achieve electrocardiomechanical synchronisation, and thus improve cardiac function. For patients with pacing-induced cardiomyopathy (PICM) who should be treated with pacemaker upgrade, the HPSP is a viable alternative to cardiac resynchronisation therapy (CRT). However, no randomised controlled trial has been performed to evaluate the efficacy and safety of HPSP in patients with PICM. The present study compared the efficacy and safety of HPSP with that of traditional CRT in the treatment of patients with PICM. METHODS AND ANALYSIS: This study is a single-centre, randomised controlled non-inferiority trial. This trial was carried out at the cardiac centre of Beijing Anzhen Hospital. A total of 46 patients with PICM who needed pacemaker upgrade treatment between January 2022 and December 2023 will be enrolled in this study. Patients will be randomised into an investigational group (HPSP) and a control group (CRT) at a 1:1 ratio. The primary outcome is the duration of QRS complex (QRS width), and the secondary outcomes are NT-proBNP (N terminal pro B type natriuretic peptide), C reactive protein, the number of antibiotics used, left ventricular ejection fraction, end systolic volume, end diastolic volume, the hospitalisation duration, the incidence of postoperative infection, pacemaker parameters (threshold, sensing and impedance), the 6-minute walking test, and quality of life (36-Item Short Form Survey scale), all-cause mortality, cardiovascular death, heart failure-related rehospitalisation rate, other rehospitalisation rates, major complication rates and procedure costs. ETHICS AND DISSEMINATION: This study has been approved by the Beijing Anzhen Hospital Medical Ethics Committee (No. 2020043X). TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry (ChiCTR2000034265).

Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial.

BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.

[Key points of post-marketing evaluation of classic traditional Chinese medicine prescriptions based on combination of disease and syndrome].

Classic prescriptions, hospital preparations and famous traditional Chinese medicine(TCM) experience prescriptions are the main sources of new drug development and innovation. The multi-components and multi-targets treatment characteristics of TCM are advantages, but at the same time, broad indications, unclear clinical positioning and lack of evidence-based evidence support are the key problems affecting the play of TCM efficacy and restricting its promotion and application. The hot in recent research was to how to break through the bottleneck, precise clinical positioning, highlight the advantages of the classic TCM prescriptions, and complete the transformation from clinical practice, clinical research to clinical evidence, but at the same time, it is also the difficulty. The clinical research model of the combination of disease and syndrome can fully reflect the ancient medical case evidence of classic TCM prescriptions, the historical experience of human used and the characteristics of syndrome differentiation and treatment, and highlight the advantages of Chinese medicine. At the same time, under the modern disease classification system and research mode, is conducive to established the standardized clinical evidence report and evaluation system, is conducive to promote the integration of clinical research evidence, and avoids excessive attenuation of information. Based on the previous work of our team, the intention of this study was to make a comment about the key points of the post-marketing evaluation of the classic TCM prescriptions under the combination of disease and syndrome and includes key points:(1)With the syndrome as the carrier, connected with the classical prescription and clinical diseases, focused on the clinical positioning on macroscopically.(2)The combination of syndrome visualization, standardization and pharmacological molecular basis, focus on clinical precise positioning in microscopic.(3)Innovating therapeutic effect evaluation methods, reflecting the curative effect characteristics based on syndrome differentiation.(4)The combination of "randomized controlled evidence-based studies" and "real world evidence-based evaluation", focusing on clinical advantages, fully evidence-based evidence.(5)Make full use of clinical registration studies and pay attention to safety.

Protective Effects of Shenfuyixin Granule on H2O2-Induced Apoptosis in Neonatal Rat Cardiomyocytes.

Shenfuyixin granule (SFYXG, i.e., Xinshuaikang granule) is a prescription, commonly used in the clinical experience, which plays a significant role in the treatment of heart failure. The purpose of this present research was to investigate the protective effect of SFYXG, and the mechanism about anti-H2O2-induced oxidative stress and apoptosis in the neonatal rat cardiomyocytes. Myocardial cells, as is well known, were divided into 4 groups: normal, model, SFYXG, and coenzyme Q10 group, respectively. Cells viability was determined by MTT assay. Flow cytometry and AO/EB staining were implemented to test the apoptosis rate and intracellular reactive oxygen species (ROS) level. Mitochondrion membrane potential (MMP) was evaluated by JC-1 fluorescence probe method. The myocardial ultrastructure of mitochondrion was measured by electron microscope. The related mRNA expression levels of Bax, Bcl-2, Caspase-3, caspase-8, and caspase-9 were detected by real-time polymerase chain reaction (PCR). Also, the expression levels of Bax and Bcl-2 protein were detected by Western blot, and the expression levels of caspase-3, caspase-8, and caspase-9 protein were tested by caspase-Glo®3 Assay, caspase-Glo®8 Assay, and caspase-Glo®9 Assay, respectively. GAPDH was used as the internal reference gene/protein. The results revealed that SFYXG (0.5 mg/ml) raised the viability of myocardial cell, weakened the apoptosis rate and ROS level, corrected the mitochondrion membrane potential stability, and improved cell morphology and ultrastructure of myocardial mitochondrion. Furthermore, SFYXG upregulated the antiapoptosis gene of Bcl-2, but downregulated the proapoptosis genes of Bax, caspase-3, and caspase-9. In conclusion, SFYXG could appear to attenuate myocardial injury by its antioxidative and antiapoptosis effect.

Zero-fluoroscopy transseptal puncture guided by right atrial electroanatomical mapping combined with intracardiac echocardiography: A single-center experience.

BACKGROUND: Right atrial electroanatomical mapping may be combined with SoundStar 3D diagnostic ultrasound catheter (EAM-ICE) as a zero-fluoroscopy procedure for radiofrequency catheter ablation (RFCA). We aimed to evaluate the efficiency and safety of zero-fluoroscopy transseptal puncture guided by EAM-ICE and fluoroscopy combined with intracardiac echocardiography (F-ICE) in patients with paroxysmal atrial fibrillation (PAF). HYPOTHESIS: Zero-fluoroscopy transseptal puncture is an effective and safe procedure. METHODS: This study had a prospective design. A total of 57 patients with PAF were enrolled and assigned to two groups. Twenty-seven patients were enrolled in the EAM-ICE group, and 30 patients were enrolled in the F-ICE group. RESULTS: There were no statistically significant differences in baseline patient characteristics between groups. Transseptal puncture was successful in all patients (57/57, 100%). Total procedure time and duration of transseptal puncture were lower in the F-ICE group (199.4 ± 26.0 minutes vs 150.7 ± 22.1 minutes, P = 0.000; 118.4 ± 19.7 vs 70.5 ± 13.5 minutes, P = 0.000). There was no use of fluoroscopy in the EAM-ICE group (0 mGy vs 70.5 ± 13.5 mGy); the duration of fluoroscopy in the EAM-ICE group was negligible (0 minutes vs 5.4 ± 1.9 minutes). No procedural complication occurred in either group. CONCLUSIONS: EAM-ICE guided zero-fluoroscopy transseptal puncture is an effective and safe procedure.

Tongmai Yangxin intervening in myocardial remodeling after PCI for coronary heart disease: study protocol for a double-blind, randomized controlled trial.

BACKGROUND: Coronary heart disease (CHD) has become a common cardiovascular disease that seriously threatens the health of people. As reperfusion in the early phase and drug therapy, especially percutaneous coronary intervention (PCI), have become widely used in the clinic, the mortality of acute myocardial infarction in the short term has been reduced significantly. In addition, in 40%-56% of patients who experience myocardial infarction, cardiac dysfunction occurs and about 25%-33% develop heart failure. METHODS: This study was designed as a multicenter, double-blind, randomized, placebo-controlled, parallel-group, superiority trial. Participants were randomly assigned in a 1:1 ratio through a centrally controlled, computer-generated, simple randomization schedule. The primary outcome was left ventricular end-diastolic volume index = left ventricular end-diastolic volume/body surface area. The combined secondary outcomes include traditional Chinese medicine syndrome score, echocardiogram results, 6-minute walk test results, Seattle Angina Questionnaire score, cardiac magnetic resonance imaging results, biological indicators, dynamic electrocardiogram results, and experiment event rate. Assessments will be performed at baseline and at 4, 8, and 12 weeks after randomization. DISCUSSION: This trial will demonstrate that the addition of a Tongmai Yangxin pill (TMYX) to conventional treatment will intervene in the development of cardiac remodeling and cardiac dysfunction. TRIAL REGISTRATION: This study was registered in the Chinese Clinical Trial Registry on 7 May 2019. The registration number is ChiCRT1900023023 (http://www.chictr.org.cn/showproj.aspx?proj=12370).

Profiling of organosulfur compounds and amino acids in garlic from different regions of China.

The quality of garlic is mainly attributed to organosulfur compounds that are the secondary metabolites of certain amino acids. Herein, a sensitive and rapid method for the simultaneous determination of 7 organosulfur compounds and 21 amino acids using ultra-high-performance liquid chromatography coupled with tandem mass spectrometry (UHPLC-MS/MS) was developed. Then the levels of these 28 compounds and allicin in garlic among 242 samples from 6 provinces in China were profiled with multivariate data analysis. The results showed that garlic was rich in organosulfur compounds and could be a good supplement for amino acids. Contents of 29 compounds varied greatly among the provinces. The multivariate data analysis demonstrated two major groups for all samples, indicating that the location has a significant influence on the metabolism of garlic. Besides, the compositional differences of garlic from 6 provinces and correlations for growing conditions and contents of components were also analyzed.