Traditional Chinese Medicine Syndrome Score Research Articles

Individualized Traditional Chinese Medicine treatment antibiotics for recurrent urinary tract infections: a multicenter, randomized controlled study.

To systematically assess the effects of individualized Chinese medicines on recurrent urinary tract infections (rUTIs). This study recruited 230 adult female patients in the remission phase of rUTIs from five hospitals in China. The patients were randomly allocated to two groups: an individualized Chinese medicine group (n = 114) and a control group (n = 116). Patients in the Chinese medicine group received individualized Chinese herbs, which were evaluated for syndrome differentiation. Patients in the control group received antibiotic treatment combined with a Chinese medicine placebo. The duration of treatment was three courses of four weeks each, with a three-month subsequent follow-up. UTI recurrence rate, Traditional Chinese Medicine (TCM) syndrome scores, 36-item Short Form Survey (SF-36) score, and urine secretory immunoglobulin A (SIgA) were measured and analyzed before and after treatment in each group. Patients from the Chinese medicine group exhibited significant decreases in both short- and long-term UTI recurrence rates compared with the control group (P < 0.05). The changes in TCM syndrome scores between the Chinese medicine and control groups were significant (P < 0.05). The changes in the average SF-36 quality-of-life scores in the Chinese medicine group were also significantly higher than those in the control group after treatment (P < 0.05). The Chinese medicine group also demonstrated a significant increase in urine SIgA expression. Taken together, compared to the often-used long-term antimicrobial prophylaxis during the remission stage of rUTIs, treating patients with an individualized Chinese medicine decoction by syndrome differentiation could effectively reduce the recurrence rate, improve the patients' TCM syndrome scores and quality of life, and enhance immunity, which in turn helps to prevent antibiotic resistance.

Efficacy and safety of Piwei Peiyuan Prescription in the treatment of chronic atrophic gastritis: A multicenter, double-blind, double-simulated, randomized, controlled clinical trial.

The incidence of chronic atrophic gastritis (CAG) is on the rise due to the growing pressure in modern social life, increasing bad living habits and emotional disorders (such as anxiety and depression), and the aging of the population. Of note, digestive system diseases are the dominant diseases in the field of traditional Chinese medicine (TCM). Therefore, this study evaluated the efficacy and safety of Piwei Peiyuan Prescription, a TCM prescription, in the treatment of CAG through a multicenter, double-blind, randomized, controlled design. This research was organized by the Second Affiliated Hospital of Anhui University of TCM and simultaneously performed in 6 centers. A total of 120 CAG patients were included and randomized into 2 groups: group A (treatment with Piwei Peiyuan granules plus Weifuchun Simulant) and Group B (treatment with Weifuchun Tablets plus Piwei Peiyuan Simulant). These 2 groups were compared in terms of gastroscopy scores, TCM syndrome scores, and serological indicators at baseline and within 12 weeks after treatment. According to endoscopic biopsy for pathological observation, atrophy (2.56 ± 1.08 vs 3.00 ± 1.00, P = .028) and intestinal epithelial hyperplasia (1.00 ± 1.43 vs 1.69 ± 1.80, P = .043) scores were lower in group A than in group B. For the more, group A had higher effective rates for inflammation, atrophy, and intestinal metaplasia (IM) in various regions of the stomach, especially for atrophy/IM of the gastric angle (64%, P = .034) and atrophy/IM of the lesser curvature of gastric antrum (63%, P = .042) than group B. According to TCM syndrome scores, Piwei Peiyuan Prescription improved the scores of gastric distension (2.30 ± 1.13 vs 2.80 ± 0.99, P = .022), preference for warmth and pressure (1.44 ± 1.06 vs 1.36 ± 1.10, P = .041), and poor appetite and indigestion (0.78 ± 0.66 vs 1.32 ± 0.72, P = .018). GAS, MTL, and PGE2 expression was significantly elevated after treatment with Piwei Peiyuan Prescription (P < .001). Piwei Peiyuan Prescription is effective for CAG treatment with high safety.

Observation of the efficacy of elongated needle therapy in treating patients with ⅢB prostatitis of stagnant dampness-heat syndrome.

To observe the clinical efficacy in patients with ⅢB prostatitis of stagnant dampness-heat syndrome treated with elongated needle therapy. A total of 90 patients with ⅢB prostatitis of stagnant dampness-heat syndrome were selected and randomly divided into a treatment group(45 cases, 2 dropped out) and a control group(45 cases, 1 dropped out) using a random number table method. The control group was treated with oral administration of Qianlie Shutong Capsule, 3 capsules per dose, 3 times a day for a total of 4 weeks. The treatment group received elongated needle therapy at Qihai(CV6), Zhongji(CV3), bilateral Zhibian(BL54) and Shuidao(ST28), with one treatment per day for 4 weeks. Before and after treatment, the traditional Chinese medicine syndrome score, National Institutes of Health Chronic Prostatitis Symptom Index(NIH-CPSI) score were compared between the two groups, and the clinical efficacy was compared after treatment. Compared with that before treatment, the control group showed significant decrease in traditional Chinese medicine syndrome score, testicular pain, urinary frequency, unending remnants of urine, scrotal wetness, yellowish urine, urinary symptoms, and quality of life scores after treatment(P<0.05)；the treatment group showed significant decrease in traditional Chinese medicine syndrome score, and perineal pain, groin pain, pelvic pain, testicular pain, scrotal wetness, yellowish urine scores, NIH-CPSI total score, pain symptoms, urinary symptoms, and quality of life scores after treatment(P<0.05). After treatment, the treatment group showed significantly lower traditional Chinese medicine syndrome score, and perineal pain, groin pain, pelvic pain, testicular pain scores, NIH-CPSI total score, pain symptoms, and quality of life scores than those of the control group(P<0.05). The effective rate in the treatment group (63.64%, 28/43) was significantly higher than that in the control group (88.37%, 38/44, P<0.05). Elongated needle therapy can significantly improve the traditional Chinese medicine syndrome score, NIH-CPSI total score, and pain symptom scores in patients with ⅢB prostatitis of stagnant dampness-heat syndrome. It can significantly improve the cure rate in these patients and is particularly effective in relieving pain.

Pediatric massage therapy for treatment of tic disorders in children: A systematic review and meta-analysis of randomized controlled trials.

Tic disorder is a common neurodevelopmental disorder in childhood, characterized primarily by motor or vocal tics. However, there is no systematic evaluation of pediatric massage therapy for children with Tic disorder. This study aims to evaluate the effectiveness and safety of massage therapy for children with tic disorder through a comprehensive meta-analysis and systematic review. We systematically searched relevant randomized controlled trials from various databases such as CBM, CNKI, VIP, Wanfang database, PubMed, Embase, Web of Science, Cochrane Library, and SINOMED, published up to October 2023. To collect randomized controlled trials on pediatric massage therapy or in combination with other therapies for the treatment of tic disorders in children. The risk of bias in the included articles was assessed using the Cochrane guideline. Meta-analyses were performed using Review Manager 5.4, and publication bias was evaluated by using Begg test and Egger test in Stata SE software. This meta-analysis included 19 randomized controlled trials with 1423 patients. Pediatric massage therapy alone or in combination with conventional medication demonstrated a significant increase in clinical effectiveness rates [risk ratios = 1.15, 95% confidence interval [CI] (1.10, 1.20), Z = 6.54, P < .001], and reduced Yale Global Tie Severity Scale scores [standardized mean difference = -0.85, 95% CI (-1.50, -0.19), Z = 2.54, P = .01] and traditional Chinese medicine syndrome scores [standardized mean difference = -1.35, 95%CI (-2.08, -0.63), Z = 3.66, P = .0002]. In terms of adverse reactions, there was no statistical difference between the experimental and control groups [risk ratios = 0.26, 95% CI (0.14, 0.49), Z = 4.25, P < .001]. The Begg test and Egger test results indicated no publication bias. Evidence suggests that pediatric massage therapy is effective in improving tic disorders in children.

Status of outcome measures in randomized controlled trials of kidney-tonifying and blood-activating method in treatment of knee osteoarthritis

This study assesses the status of outcome measures in the randomized controlled trial(RCT) involving the kidney-tonif-ying and blood-activating method for treating knee osteoarthritis(KOA), aiming to establish a theoretical foundation for the development of a core set of outcome measures in traditional Chinese medicine(TCM) treatment of KOA. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, in addition to ClinicalTrials.gov and the China Clinical Trial Registration Center, with the time interval from inception to August 2023. The RCT of treating KOA with the kidney-tonifying and blood-activating method was included. Two assessors independently conducted literature screening, data collection, and qualitative analysis to compile the outcome measure results. A total of 350 RCTs were included, involving 165 outcome measures with the total frequency of 1 462. These outcome measures were categorized into six domains: symptom and sign measures(23) with the frequency of 718(49.1%), TCM symptom and syndrome measures(3) with the frequency of 53(3.6%), physical examination measures(130) with the frequency of 506(34.6%), quality of life measures(4) with the frequency of 20(1.3%), long-term efficacy measures(2) with the frequency of 6(0.4%), and safety measures(3) with the frequency of 159(10.9%). Additionally, 53 studies used TCM syndrome and symptom scores as indicators of efficacy, employing eight distinct measurement tools. The RCTs involving the kidney-tonifying and blood-activating method for treating KOA had a variety of problems, such as unclear prio-ritization of outcome measures, diversity in measurement tools, absence of standardized assessment criteria for specific measures, and non-standardized usage. These problems affected the research quality and reliability. Hence, it is advisable to draw upon international expertise, improve research design, and merge TCM efficacy characteristics with clinical research to establish a core set of KOA outcome measures aligned with TCM principles.

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.

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.

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).

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.

Efficacy and Safety of Kuoxin Formula in the Treatment of Dilated Cardiomyopathy-Related Heart Failure: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial.

Dilated cardiomyopathy (DCM) is a severe heterogeneous cardiomyopathy characterized by cardiac enlargement and declining heart function, often leading to refractory heart failure and life-threatening outcomes, particularly prevalent in China. The challenge lies in the scarcity of targeted therapies with substantial efficacy for DCM. Additionally, traditional anti-heart failure drugs are constrained due to hypotension propensity or limited symptom improvement. Kuoxin Formula (KXF), internally endorsed at Longhua Hospital, demonstrates clear biological evidence for enhancing cardiac function and myocardial remodeling. Previous clinical studies suggest its potential to enhance patients' quality of life. This trial aims to further evaluate KXF's safety and efficacy in managing DCM-related heart failure. This prospective, randomized, double-blind, placebo-controlled, multicenter trial aims to recruit 230 DCM patients from five centers. Participants will be randomly assigned to either KXF or placebo for 12 weeks, with careful monitoring of key indicators and adverse events. The primary outcome measures the proportion of patients with NT-proBNP reduction exceeding 30%. Secondary outcomes include New York Heart Association functional classification, Traditional Chinese Medicine syndrome scores, 6-minute walk test, Lee's heart failure score, and Minnesota Heart Failure Quality of Life Scale score. Ventricular remodeling will be assessed using cardiac ultrasound and ELISA. Safety metrics and adverse events will be meticulously recorded. This study will be the first multicentered research conducted in China that utilizes a randomized, double-blind, placebo-controlled design to investigate the use of TCM in the treatment of DCM. It seeks to develop new theoretical frameworks and provide solid clinical data to support the integration of TCM and modern medicine in treating heart failure in DCM patients. China Clinical Trial Registry, ChiCTR2300068937. Registered on March 1, 2023. https://www.chictr.org.cn/bin/project/edit?pid=190926.

Clinical Study on Self-Made Lixin Granules Combined with Natriuretic Peptide in the Treatment of Refractory Heart Failure

Objective: To analyze the clinical effects of the combined application of self-made Lixin Granule and natriuretic peptide in treating refractory heart failure. Methods: From January 2022 to June 2023, 40 patients with refractory heart failure were randomly divided into groups using the envelope method. A reference group (n = 20) received conventional Western medicine treatment, while an observation group (n = 20) received self-made Lixin Granules and natriuretic peptide. Clinical efficacy, heart failure scores, traditional Chinese medicine (TCM syndrome scores, inspection indicators, and adverse reactions of the two groups were compared. Results: The effective treatment rate in the observation group was significantly higher than that in the reference group (P &lt; 0.05). There were no significant differences in heart failure scores and traditional Chinese medicine (TCM) syndrome scores between the two groups before treatment (P &gt; 0.05). However, both scores in the observation group were lower than those in the reference group after treatment (P &lt; 0.05). Before treatment, there were no significant differences in the inspection indicators between the two groups (P &gt; 0.05). After treatment, the left ventricular ejection fraction (LVEF) of the observation group was higher than that of the reference group, while the N-terminal pro b-type natriuretic peptide (NT-proBNP) level and fractional shortening (FS) of the observation group were lower than those of the reference group (P &lt; 0.05). There were no apparent adverse reactions in either group during treatment. Conclusion: The combined application of self-made Lixin Granules and natriuretic peptide in treating refractory heart failure improved clinical efficacy, alleviation of clinical symptoms, and enhanced cardiac function. This approach is deemed safe and holds high application value.

Laparoscopic Surgery and Modified Xiaoyan Lidan Decoction: An Effective Combination for Treating Cholecystitis with Cholelithiasis

Objective: To assess the clinical effects of combining laparoscopic surgery with Modified Xiaoyan Lidan Decoction in patients diagnosed with cholecystitis and cholelithiasis. Methods: Following the guidelines of the double-blind method, 86 cases of cholecystitis with cholelithiasis were randomly divided into two groups, each comprising 43 cases. Both groups underwent laparoscopic surgery, with the observation group additionally receiving Modified Xiaoyan Lidan Decoction. A comparative analysis was conducted on clinical treatment effectiveness, general observation indicators, Traditional Chinese Medicine (TCM) syndrome scores, and the occurrence of adverse reactions between the two groups. Results: The observation group demonstrated a significantly higher overall clinical treatment effectiveness compared to the control group (P &lt; 0.05). The clinical symptom improvement time and hospitalization time were shorter in the observation group, and the pain score and TCM syndrome score after treatment were lower than those in the control group (P &lt; 0.05). No statistically significant difference was observed in the total reaction values (P &gt; 0.05). Conclusion: The combined application of laparoscopic surgery and Modified Xiaoyan Lidan Decoction can enhance clinical treatment efficiency for patients with cholecystitis and cholelithiasis. It facilitates a quicker improvement in clinical symptoms without causing serious adverse reactions, suggesting its potential for widespread adoption.

Clinical effect of Shenfu injection combined with glucocorticoid on patients with acute left heart failure complicated with bronchospasm

To investigate the clinical effect of Shenfu injection combined with glucocorticoid in the treatment of acute left heart failure complicated with bronchospasm. A prospective study was conducted.Ninety patients with acute left heart failure complicated with bronchospasm admitted to Huai'an Second People's Hospital from January 2021 to July 2022 were selected and divided into conventional treatment group, hormone therapy group and combined treatment group according to random number table method, with 30 cases in each group. All patients in the 3 groups received basic Western medicine treatment. On this basis, the conventional treatment group was given 0.25-0.50 g aminophylline injection plus 5% glucose injection or 0.9% sodium chloride injection (diabetes patients) 100 mL slow intravenous infusion, 1-2 times a day. In the hormone treatment group, 1 mg of budesonide suspension for inhalation was diluted to 2 mL by 0.9% sodium chloride injection, twice a day, and applied until 48 hours after the pulmonary wheezing disappeared. The combined treatment group was given glucocorticoid combined with Shenfu injection 80 mL plus 5% glucose injection or 0.9% sodium chloride injection (diabetes patients) 250 mL intravenously, once a day. All treated for 1 week. The general data, traditional Chinese medicine (TCM) syndrome score, TCM syndrone efficacy index, acute left heart failure efficacy, bronchospasm efficacy, systolic blood pressure (SBP), mean arterial pressure (MAP), serum N-terminal pro-brain natriuretic peptide (NT-proBNP) level and safety of the 3 groups were compared. The patients were followed up for 6 months, and the mortality and re-hospitalization rate of the 3 groups were recorded. Among the 90 patients, a total of 83 patients completed the study, excluding the cases dropped due to death and other reasons. There were 29 cases in the combined treatment group, 25 cases in the hormone therapy group and 29 cases in the conventional treatment group. There were no significant differences in age, gender, course of disease, and previous history (history of diabetes, history of hypertension, history of hyperlipidemia) among the 3 groups. Therefore, they were comparable. The difference of TCM syndrome score before and after treatment, TCM syndrome efficacy index of combined treatment group and hormone therapy group were higher than those of conventional treatment group [difference of TCM syndrome score: 15.14±5.74, 13.24±5.75 vs. 10.62±5.87, TCM syndrome efficacy index: (67.84±14.31)%, (59.94±14.26)% vs. (48.92±16.74)%, all P < 0.05], and the difference of TCM syndrome score and TCM syndrome efficacy index of combined treatment group were higher than those of hormone treatment group (both P < 0.05). The total effective rate of acute left heart failure and bronchospasm in the combined treatment group was significantly higher than that in the conventional treatment group (total effective rate of acute left heart failure: 96.55% vs. 75.86%, total effective rate of bronchospasm: 93.10% vs. 65.52%, both P < 0.05). The difference of serum NT-proBNP before and after treatment in combination therapy group and hormone therapy group was significantly higher than that in conventional treatment group (ng/L: 7 922.86±5 220.31, 7 314.92±4 450.28 vs. 4 644.79±3 388.23, all P < 0.05), and the difference of serum NT-proBNP before and after treatment in the combined treatment group was significantly higher than that in the hormone treatment group (P < 0.05). There were no significant differences in SBP difference, MAP difference, mortality and re-hospitalization rate among the 3 groups. No adverse reactions occurred in the 3 groups during treatment. Shenfu injection combined with glucocorticoid is effective in the treatment of patients with acute left heart failure complicated with bronchospasm. It is superior to glucocorticoid and aminophylline in relieving bronchospasm, reducing NT-proBNP level and improving total effective rate, and has good prognosis and safety.

Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Coronary Heart Disease Complicating Chronic Heart Failure (Syndrome of Qi Deficiency with Blood Stasis): Study Protocol for a Randomized, Placebo-Controlled, Double-Blind and Multi-Centre Phase II Clinical Trial.

Heart failure (HF) is a serious and terminal stage of various cardiac diseases and the most common complication of coronary heart disease (CHD). Previous clinical studies have shown that Qishen Yiqi dropping pills (QSYQ) have the effect of treating chronic heart failure. This study aims to evaluate the clinical efficacy, safety and optimal effective dose of QSYQ in treating CHD complicating chronic HF with reduced ejection fraction (HFrEF). We will conduct a randomized, double-blind, placebo controlled, multicenter clinical trial. A total of 228 individuals from 16 hospitals in China will be randomly assigned to the low-dose, high-dose, and placebo groups in a ratio of 1:1:1. The trial consists of a screening period (standard medical treatment for at least 2 weeks) and a 12-week treatment period. After randomization, follow-up will be conducted at the 4th, 8th and 12th week. The primary outcomes will be the 6-Minute Walk Test (6MWT) at Week 12. Secondary outcomes will include 6MWT distance at Week 4 and 8, New York Heart Association (NYHA) functional classification, Traditional Chinese Medicine (TCM) Syndrome score, echocardiography indices, N-terminal pro-B-type natriuretic peptide (NT-proBNP), oxyhemoglobin saturation, Minnesota living with heart failure questionnaire (MLHFQ) score, grasp strength body mass index test and cardiovascular adverse events (AE). This trial has been approved by the Research Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine, China (approval number: ZYYEC [2021]005). Written informed consent will be obtained from all participants. The results of this trial will be publicly shared through academic conferences and peer-reviewed journals. Clinical Trials Registry (NCT04983043, Date: 07/08/2021, https://clinicaltrials.gov/ct2/show/NCT04983043).

Analysis on the therapeutic effect of Cangfu Daotan Decoction combined with drospirenone and ethinylestradiol tablets (II) on patients with polycystic ovary syndrome

ObjectiveThis study was designed to investigate the therapeutic effect of Cangfu Daotan Decoction (CDD) combined with drospirenone and ethinylestradiol tablets (II) on patients with polycystic ovary syndrome (PCOS). MethodsPatients with PCOS were gathered from September 2020 to September 2022 and divided into the experimental group (n=36), treated with CDD combined with drospirenone and ethinylestradiol tablets (II), and the control group (n=41), received only drospirenone and ethinylestradiol tablets (II). Levels of sex hormone, obesity, blood glucose, blood lipid were detected and compared between the two groups pre- and post-treatment. The treatment efficacy, Traditional Chinese Medicine (TCM) syndrome score, adverse drug reactions, and pregnancy rate were compared as well. ResultsAfter treatment, the experimental group had a higher treatment efficacy (94.44% vs 73.17%, P<0.05) and a higher pregnancy rate (44.44% vs 21.95%, P<0.05) than the control group, but the difference in the incidence of adverse drug reactions was not statistically significant (P>0.05). Compared with control group, TCM syndrome score and levels of fasting blood glucose, fasting insulin, homeostasis model assessment of insulin resistance (HOMA-IR), and waist circumference of the experimental group after treatment displayed remarkable reduction (P<0.05), while the levels of estradiol (E2) and high-density lipoprotein cholesterol (HDL-C) showed a remarkable increase (P<0.05). ConclusionCDD in combination with drospirenone and ethinylestradiol tablets (II) may be effective in treating PCOS by improving obesity, glucose metabolism and lipid metabolism with no serious adverse events, making it a feasible clinical practice option.

Electroacupuncture for hot flashes in early postmenopause: A study protocol for a randomized sham-controlled trial

IntroductionMany early postmenopausal women experience hot flashes (HFs). Electroacupuncture (EA) is a safe and effective therapy for menopause-related symptoms. However, there are few rigorous clinical trials on this topic. This randomized controlled trial is designed to explore the feasibility and efficacy of EA in the treatment of early postmenopausal HF. MethodsThis study is a randomized, controlled trial involving 72 early postmenopausal patients. Patients will be randomized 1:1 to the EA or sham acupuncture (SA) group. The acupuncture points that will be used are Hegu (LI4), Fuliu (KI7), Taixi (KI3), Shenshu (BL23), Guanyuan (CV4), and Sanyinjiao (SP6). Participants in each group will receive 18 acupuncture sessions over 6 weeks (three times per week). The primary outcome is the hot-flash score at the end of the 6 week of intervention. Secondary outcome measures are the Pittsburgh Sleep Quality Index, Menopause-Specific Quality of Life, Menopause Rating Scale, Traditional Chinese Medicine Syndrome Score Scale, and estradiol, follicle-stimulating hormone, luteinizing hormone, and anti-Mullerian hormone levels. Safety will be assessed at every visit. ConclusionThis prospective trial will evaluate the efficacy of EA in the treatment of HFs among early postmenopausal women. Our results will provide additional knowledge for clinicians in the treatment of HFs.

Therapeutic effects of Naohuan Dan combined with idebenone in treating mild cognitive impairment with kidney deficiency and phlegm stasis: A retrospective study

Abstract Background Naohuan Dan is a prescription used to treat dementia. This study aims to assess the effectiveness and safety of Naohuan Dan combined with idebenone in treating mild cognitive impairment (MCI) with kidney deficiency and phlegm stasis. Materials and methods This retrospective, observational clinical trial enrolled 64 MCI patients treated in the Sun Yat-sen Memorial Hospital, Zhongshan University, from May 1, 2019, to April 30, 2022. The 32 patients in the treatment group received Naohuan Dan combined with idebenone, whereas the 32 patients in the control group were treated with idebenone alone. The observation lasted for 12 weeks. The primary outcomes were the Mini-Mental State Examination (MMSE) score and clinical efficacy, whereas secondary outcomes included the Montreal Cognitive Assessment (MCS) score, the activities of daily living (ADL) score, the Geriatric Depression Scale (GDS) score, the traditional Chinese medicine (TCM) syndrome score, and changes in serum markers. Neuron-specific enolase (NSE), interleukin 8 (IL-8), and tumor necrosis factor α (TNF-α) were taken as the serological indicators for evaluating cognitive function. Adverse events in both groups were recorded during the treatment period. Results The treatment group demonstrated higher MMSE scores and clinical efficacy than the control group, specifically in the scores of spatial orientation, attention and calculation, and language proficiency in the MMSE scale. The treatment group outperformed the control group in MCS, ADLs, GDS, and TCM syndrome scores. Furthermore, the treatment group was superior to the control group in recovering the levels of NSE, IL-8, and TNF-α. In addition, the treatment group had lower incidence of adverse reactions such as nausea and poor appetite than the control group. Conclusions The 12-week treatment with Naohuan Dan combined with idebenone significantly improved the cognitive function and daily life abilities, lowered the depression levels, and reduced the occurrence of adverse events among patients with MCI. These findings offer valuable insights into the efficacy of integrating TCM with Western medicine in the clinical management of MCI. (ClinicalTrials.gov ID: NCT05931029; https://clinicaltrials.gov/study/NCT05931029?cond=Naohuan%20Dan&amp;rank=1)

Electroacupuncture for ulcerative colitis patients: A meta-analysis and acupoints selection study

ObjectiveTo evaluate the efficacy and safety of electroacupuncture (EA) on ulcerative colitis (UC) and explore the influence of EA parameters and acupoint compatibility to optimize the clinical treatment plan. MethodsAfter searching eight databases, data were extracted and analyzed to determine the quality and bias of the study's methodological design, and randomized controlled trial (RCT) datas were meta-analyzed. ResultsTwelve studies that meet the criteria were included. The results of meta-analysis indicated that, compared with the control group, experimental group had better clinical efficacy [RR = 1.27, 95%CI = (1.19, 1.36), P < 0.01], Other indicators such as cure rate [RR = 1.73, 95%CI = (1.43, 2.09), P < 0.01], effective rate of mucosal lesions under enteroscopy [RR = 1.24, 95%CI = (1.11, 1.38), P < 0.01], serum inflammatory factor TNF-α [MD = −41.11, 95%CI = (−46.01, 36.22), P < 0.01] were significantly better than those in the control group. Sixteen acupoints on the Ren, Bladder, Stomach, Spleen, and Liver meridians were used 74 times. RN4-ST25 is the most compatible acupoints. ConclusionThe clinical efficacy of EA in treating UC is superior than the control group's, and it has curative effects in terms of cure rate, efficacy of mucosal lesions under colonoscopy, serum inflammatory factors, and Traditional Chinese Medicine (TCM) syndrome scores. Combining acupoints of the Bladder, Stomach, and Ren meridians and using dense wave for 30 min each time for more than 6 weeks may be optimal for UC patients.