Traditional Chinese Medicine Symptom Research Articles

Study on blood pressure rhythm in hypertensive patients withdeficiency syndrome and a random forest model for predicting hypertension withdeficiency syndrome.

To investigate blood pressure rhythm (BPR) in Yin deficiency syndrome of hypertension (YDSH) patients and develop a random forest model for predicting YDSH. Our study was consistent with technical processes and specification for developing guidelines of Evidence-based Chinese medicine clinical practice (T/CACM 1032-2017). We enrolled 234 patients who had been diagnosed with primary hypertension without antihypertensive medications prior to the enrollment. All participants were divided into Yin deficiency group (YX, n = 74) and non-Yin deficiency group (NYX, n = 160). Participants were professionally grouped by three experienced chief Traditional Chinese Medicine (TCM) physicians according to four examinations (i.e., inspection, listening and smelling, inquiry and palpation). We collected data on 24 h ambulatory blood pressure monitoring (ABPM) and YDSH rating scale. We divided 24 h of a day into 12 two-hour periods [Chen-Shi (7:00-9:00), Si-Shi (9:00-11:00), Wu-Shi (11:00-13:00), Wei-Shi (13:00-15:00), Shen-Shi (15:00-17:00), You-Shi (17:00-19:00), Xu-Shi (19:00-21:00), Hai-Shi (21:00-23:00), Zi-Shi (23:00-1:00), Chou-Shi (1:00-3:00), Yin-Shi (3:00-5:00), Mao-Shi (5:00-7:00)] according to the theory of "midnight-midday ebb flow". We used random forest to build the diagnostic model of YDSH, with whether it was Yin deficiency syndrome as the outcome. Compared with NYX group, YX group had more female participants with older age, lower waist circumference, body mass index (BMI), diastolic blood pressure (DBP), and smoking and drinking rate (all P ＜ 0.05). The YDSH rating scores of YX group [28.5 (21.0-36.0)] were significantly higher than NYX group [13.0 (8.0-22.0)] (P < 0.001), and the typical symptoms of YX group included vexing heat in the chest, palms and soles, dizziness, dry eyes, string-like and fine pulse, soreness and weakness of lumbus and knees, palpitations, reddened cheeks, and tinnitus (all P < 0.05). The ratio of non-dipper hypertension in YX group was higher than in NYX group (56.9% vs 44.4%, P = 0.004). Compared with NYX group, 24 h DBP standard deviation (SD), nighttime DBP SD, Si-Shi DBP, Si-Shi mean arterial pressure (MAP), Hi-Shi systolic blood pressure (SBP), Hi-Shi DBP, Hi-Shi MAP, Zi-Shi SBP, Zi-Shi DBP, Zi-Shi MAP, Chou-Shi SBP SD, Chou-Shi DBP SD, Chou-Shi SBP coefficient of variation (CV) were lower in YX group (all P ＜ 0.05). Binary Logistic Regression analysis showed that the diagnosis of YDSH was positively correlated with age, heart rate, YDSH rating scores, and four TCM symptoms including vexing heat in the chest, palms and soles, string-like and fine pulse, soreness and weakness of lumbus and knees, and reddened cheeks (all P ＜ 0.05), but was negatively correlated with smoking (P﹥0.05). In addition, the diagnosis of YDSH was positively correlated with daytime SBP SD, nighttime SBP SD, nighttime SBP CV, and Hi-Shi SBP CV, but was negatively correlated with 24 h SBP CV, daytime DBP SD, nighttime DBP SD, and Hi-Shi DBP (all P ＜ 0.05). Hi-Shi SBP CV had independent and positive correlation with the diagnosis of YDSH after adjusting the variables of age, gender, course of hypertension, BMI, waist circumference, SBP, DBP, heart rate, smoking and drinking (P = 0.029). Diagnostic model of YDSH was established and verified based on the random forest. The results showed that the calculation accuracy, specificity and sensitivity were 77.3%, 77.8% and 76.9%, respectively. The BPR was significantly attenuated in YDSH patients, including lower 24 h DBP SD and nighttime DBP SD, and Hi-Shi SBP CV is independently correlated with the diagnosis of YDSH. The prediction accuracy of diagnosis model of YDSH based on the random forest was good, which could be valuable for clinicians to differentiate YDSH and non-Yin deficiency patients for more effective hypertensive treatment of TCM.

Application of Patient-Reported Outcome Measurements in Adult Tumor Clinical Trials in China: Cross-Sectional Study.

International health policies and researchers have emphasized the value of evaluating patient-reported outcomes (PROs) in clinical studies. However, the characteristics of PROs in adult tumor clinical trials in China remain insufficiently elucidated. This study aims to assess the application and characteristics of PRO instruments as primary or secondary outcomes in adult randomized clinical trials related to tumors in China. This cross-sectional study identified tumor-focused randomized clinical trials conducted in China between January 1, 2010, and June 30, 2022. The ClinicalTrials.gov database and the Chinese Clinical Trial Registry were selected as the databases. Trials were classified into four groups based on the use of PRO instruments: (1) trials listing PRO instruments as primary outcomes, (2) trials listing PRO instruments as secondary outcomes, (3) trials listing PRO instruments as coprimary outcomes, and (4) trials without any mention of PRO instruments. Pertinent data, including study phase, settings, geographic regions, centers, participant demographics (age and sex), funding sources, intervention types, target diseases, and the names of PRO instruments, were extracted from these trials. The target diseases involved in the trials were grouped according to the American Joint Committee on Cancer Staging Manual, 8th Edition. Among the 6445 trials examined, 2390 (37.08%) incorporated PRO instruments as part of their outcomes. Within this subset, 26.82% (641/2390) listed PRO instruments as primary outcomes, 52.72% (1260/2390) as secondary outcomes, and 20.46% (489/2390) as coprimary outcomes. Among the 2,155,306 participants included in these trials, PRO instruments were used to collect data from 613,648 (28.47%) patients as primary or secondary outcomes and from 74,287 (3.45%) patients as coprimary outcomes. The most common conditions explicitly using specified PRO instruments included thorax tumors (217/1280, 16.95%), breast tumors (176/1280, 13.75%), and lower gastrointestinal tract tumors (173/1280, 13.52%). Frequently used PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30, the visual analog scale, the numeric rating scale, the Traditional Chinese Medicine Symptom Scale, and the Pittsburgh Sleep Quality Index. Over recent years, the incorporation of PROs has demonstrated an upward trajectory in adult randomized clinical trials on tumors in China. Nonetheless, the infrequent measurement of the patient's voice remains noteworthy. Disease-specific PRO instruments should be more effectively incorporated into various tumor disease categories in clinical trials, and there is room for improvement in the inclusion of PRO instruments as clinical trial end points.

Multi-feature, Chinese-Western medicine-integrated prediction model for diabetic peripheral neuropathy based on machine learning and SHAP.

Clinical studies have shown that diabetic peripheral neuropathy (DPN) has been on the rise, with most patients presenting with severe and progressive symptoms. Currently, most of the available prediction models for DPN are derived from general clinical information and laboratory indicators. Several Traditional Chinese medicine (TCM) indicators have been utilised to construct prediction models. In this study, we established a novel machine learning-based multi-featured Chinese-Western medicine-integrated prediction model for DPN using clinical features of TCM. The clinical data of 1581 patients with Type 2 diabetes mellitus (T2DM) treated at the Department of Endocrinology of the First Affiliated Hospital of Anhui University of Chinese Medicine were collected. The data (including general information, laboratory parameters and TCM features) of 1142 patients with T2DM were selected after data cleaning. After baseline description analysis of the variables, the data were divided into training and validation sets. Four prediction models were established and their performance was evaluated using validation sets. Meanwhile, the accuracy, precision, recall, F1 score and area under the curve (AUC) of ROC were calculated using ten-fold cross-validation to further assess the performance of the models. An explanatory analysis of the results of the DPN prediction model was carried out using the SHAP framework based on machine learning-based prediction models. Of the 1142 patients with T2DM, 681 had a comorbidity of DPN, while 461 did not. There was a significant difference between the two groups in terms of age, cause of disease, systolic pressure, HbA1c, ALT, RBC, Cr, BUN, red blood cells in the urine, glucose in the urine, and protein in the urine (p<0.05). T2DM patients with a comorbidity of DPN exhibited diverse TCM symptoms, including limb numbness, limb pain, hypodynamia, thirst with desire for drinks, dry mouth and throat, blurred vision, gloomy complexion, and unsmooth pulse, with statistically significant differences (p<0.05). Our results showed that the proposed multi-featured Chinese-Western medicine-integrated prediction model was superior to conventional models without characteristic TCM indicators. The model showed the best performance (accuracy=0.8109, precision=0.8029, recall=0.9060, F1 score=0.8511, and AUC=0.9002). SHAP analysis revealed that the dominant risk factors that caused DPN were TCM symptoms (limb numbness, thirst with desire for drinks, blurred vision), age, cause of disease, and glycosylated haemoglobin. These risk factors were exerted positive effects on the DPN prediction models. A multi-feature, Chinese-Western medicine-integrated prediction model for DPN was established and validated. The model improves early-stage identification of high-risk groups for DPN in the diagnosis and treatment of T2DM, while also providing informative support for the intelligent management of chronic conditions such as diabetes.

Dry cupping as an adjuvant treatment of individuals with severe pneumonia: study protocol for a placebo-controlled, randomised study

BackgroundSevere pneumonia (SP) stands as one of the most prevalent critical illnesses encountered in clinical practice, characterised by its rapid onset and progression, numerous complications and elevated mortality rates. While...

The effects of Gualou Qumai Wan combined with Sunitinib on VEGFA, HIF1A, and renal function in advanced clear cell renal cell carcinoma

[Objective:] To study the efficacy of Gualou Qumai Wan (GQW) combined with Sunitinib in the treatment of advanced clear cell renal cell carcinoma (ccRCC) and its effects on vascular endothelial growth factor A (VEGFA), hypoxia inducible factor 1A (HIF1A), and renal function. [Method:] A retrospective analysis was conducted on 20 patients with advanced ccRCC treated with GQW combined with Sunitinib at Shouguang Hospital of Traditional Chinese Medicine from January 2021 to January 2023. Analyze the patient's quality of life, serum VEGFA and HIF1A levels, renal function indicators, T lymphocyte subgroup levels, traditional Chinese medicine (TCM) symptom scores, and clinical efficacy. [Result:] The total effective rate of clinical efficacy in patients after treatment was 70%; The serum levels of VEGFA and HIF1A in patients were lower than before treatment, and the difference was statistically significant (P&lt;0.05); The levels of serum creatinine (Scr), blood urea nitrogen (BUN), and urinary albumin (ALB) in patients were lower than before treatment, and the differences were statistically significant (P&lt;0.05). Before and after treatment, there was no statistically significant difference in the levels of T lymphocyte subgroup among patients (P&gt;0.05). After treatment, the TCM symptom score and EORTC QoL-C30 score of the patients all decreased compared to before treatment, and the difference was statistically significant (P&lt;0.01). [Conclusion:] The combination of GQW and Sunitinib has a significant therapeutic effect on advanced ccRCC, and can effectively improve the levels of VEGFA, HIF1A, and renal function.

Bushen Formula promotes the decrease of HBsAg levels in patients with CHB by regulating Tfh cells and B-cell subsets

Ethnopharmacological relevanceBushen Formula (BSF) is the effective traditional Chinese medicine (TCM) for chronic hepatitis B (CHB) according to our previous researches. However, the special effectiveness of BSF treating CHB patients in different stages and the immunoregulatory mechanisms remain to be explored. Aim of the studyTo compare the therapeutic effects of BSF in both treatment-naive patients and Peg-IFN-α-treated patients, and explore the potential mechanism of immunomodulation. Materials and methodsUltra-high performance liquid chromatography-quadrupole electrostatic field-orbital trap high resolution mass spectrometry and the TCMSP database were used to determine the main components of BSF. Two hundred and sixty-six patients were enrolled in the retrospective study, and they were divided into the treatment group (T-Group, BSF plus Peg-IFN-α) and the control group (C-Group, Peg-IFN-α monotherapy). Within each group, patients were further grouped into subgroups, namely T1/C1 groups (treatment-naive patients, T1 = 34, C1 = 94) and T2/C2 groups (Peg-IFN-α-treated patients, T2 = 56, C2 = 82). Serum HBV markers, serum HBV DNA levels, serum ALT/AST and TCM symptoms were obtained from the record. Bioinformatics analysis was employed to obtain the potential immunoregulatory mechanisms of BSF treating CHB patients. Among patients in T2 and C2 group, peripheral mononuclear cells from 36 patients were used to analyze the characteristics of peripheral follicular helper T (Tfh) cells and B-cell subtypes by flow cytometry. Preparation of BSF-containing serum in rats. In vitro, the co-culture system of CXCR5+ cells and HepG2.2.15 cells was built to investigate the immunoregulatory effects of BSF. ResultsA total of 14 main active compounds were detected in BSF, which were deemed critical for the treatment of CHB. Our findings indicated that the T2-Group exhibited the higher percentage of HBsAg decline ≥ 1-log10 IU/ml and rate of HBeAg seroclearance compared to the C2-Group (35.7% vs. 15.9%, P = 0.033; 33.9% vs. 11.0%, P = 0.002). Additionally, the T2-Group demonstrated the higher percentage of HBsAg decline ≥ 1-log10 IU/ml and rate of HBeAg seroclearance compared to the T1-Group (35.7% vs. 14.7%, P = 0.031; 33.9% vs. 2.9%, P = 0.000). The total effective rate based on TCM clinical syndrome in T1-Group and T2-Group were significantly greater than those in C1-Group and C2-Group (85.3% vs. 61.7%, P = 0.012; 89.1% vs. 63.4%, P = 0.000). Bioinformatics analysis indicated that the immunoregulatory mechanisms of BSF treating CHB patients were mainly linked to the growth and stimulation of B-cell, T-cell differentiation, and the signaling pathway of the B-cell receptor. Furthermore, the frequencies of Tfh cells and its IL-21 level, and the IL-21R expressed by B-cell were all increased after BSF treatment. Additionally, in the co-culture system of CXCR5+ cells and HepG2.2.15 cells, HBsAg and HBeAg levels were decreased after BSF-containing serum treatment，as well as the up-regulating of Tfh cell frequencies and down-regulating of B-cell frequencies. ConclusionsBSF have the higher percentage of HBsAg decline and HBeAg seroclearance in Peg-IFN-α-treated patients compared with treatment-naive patients. The potential immunoregulatory mechanism may correlate with promoting the interaction between Tfh cells and B-cell through IL-21/IL-21R signaling pathway.

Effect of Self-developed Ye’an Analgetic Decoction/Jiawei Shaoyao Gancao Decoction Combined with Tramadol on TCM Symptom Scores and RLS Severity of patients with Restless Legs Syndrome

Objective: To investigate the effect of self-developed Ye’an Analgetic Decoction/Jiawei Shaoyao Gancao Decoction on Traditional Chinese Medicine (TCM) symptom scores and RLS Severity of patients with restless legs syndrome (RLS).&#x0D; Methods: This was a clinical comparative study. Eighty patients with RLS admitted to Baoding No.1 Central Hospital from January 2022 to December 2022 were randomly divided into observation group and control group(n=40). Patients in the control group were given basic and oral tramadol treatment, while those in the observation group were given self-developed Ye’an Analgetic Decoction/Jiawei Shaoyao Gancao Decoction based on the treatment in the control group. The differences of TCM symptom scores, RLS severity (IRLS), quality of life (QOL-RLS), sleep quality (PSQI) and clinical efficacy between the two groups were compared.&#x0D; Results: Before treatment, no statistically significant differences were observed in the TCM symptom scores, IRLS scores, QOL-RLS scores and PSQI scores between the two groups (p&gt;0.05). After treatment, the above scores decreased significantly in both groups, with a higher degree of decrease in the observation group than in the control group, indicating statistically significant differences (p&lt;0.05). The QOL-RLS scores were significantly higher in the observation group than in the control group, with a statistically significant difference (p&lt;0.05). The overall response rate in the observation group was 95.00%, which was higher than that in the control group (80.00%), with a statistically significant difference (p&lt;0.05).&#x0D; Conclusion: Self-developed Ye’an Analgetic Decoction/Jiawei Shaoyao Gancao Decoction leads to numerous benefits in the treatment of RLS, such as obviously ameliorating patients’ clinical symptoms, reducing RLS severity, and improving their quality of life and sleep quality.&#x0D; doi: https://doi.org/10.12669/pjms.40.5.8400&#x0D; How to cite this: Zhou B, Li W, Li Y, Sun D, Du X. Effect of Self-developed Ye’an Analgetic Decoction/Jiawei Shaoyao Gancao Decoction Combined with Tramadol on TCM Symptom Scores and RLS Severity of patients with Restless Legs Syndrome. Pak J Med Sci. 2024;40(5):---------. doi: https://doi.org/10.12669/pjms.40.5.8400&#x0D; This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Network pharmacology and molecular docking studies on the mechanism of action of moist exposed burn ointment for treatment of diabetic foot ulcer

Purpose: To investigate the bioactive components and mechanism of action of moist exposed burn ointment (MEBO) for treatment of diabetic foot ulcers using network pharmacology (NP) and molecular docking technology &#x0D; Methods: Through pharmacology database of traditional Chinese medicine (TCM) systems (TCMSP), analysis platform and symptom mapping (SymMap) database, the bioactive components of MEBO were screened for and protein binding to bioactive components was predicted. Proteins related to Diabetic foot ulcer (DFU) were collected from GeneCards, OMIM, PharmGkb and TTD disease databases. With R language software, the binding proteins of bioactive components of MEBO intersected with the proteins related to occurrence of DFU. Proteins of DFU linked to treatment with MEBO were subjected to analysis using gene ontology (GO) and KEGG with R language software. AutoDock and PyMOL software were employed to dock active components of MEBO and major proteins of DFU. Targeted binding potential of bioactive compounds in MEBO to core proteins of DFU was analyzed. &#x0D; Results: One hundred and five (105) bioactive ingredients and 246 likely therapeutic proteins were obtained. Proteins were mainly involved in biological processes in wound healing, oxidative stress, and lipopolysaccharide. The enriched signaling pathway focused on lipid metabolism and the process of atherosclerosis which involved PI3K and Akt, advanced glycation end-products (AGE)-receptor (RAGE) and mitogen-activated protein kinase (MAPK). The absolute values of these proteins were screened out with a docking score greater than 5 kcal/mol. &#x0D; Conclusion: The biological effects of MEBO are related to multiple proteins and multiple signaling pathways. Therefore, healing effect of MEBO on DFU occurs via multiple pathways. The biological characteristics of MEBO need to be fully elucidated in further studies.

Analysis of Traditional Chinese Medicine Symptoms in Children with Spastic Cerebral Palsy: A Data Mining Study.

Cerebral palsy (CP) ranks as a major cause of motor disabilities in children, with spastic CP making up roughly 70-80% of all CP cases. The primary objective of our study is to identify characteristics of Traditional Chinese Medicine(TCM) symptom of spastic CP, thereby establishing correlations between the TCM symptom and the disease, providing a more scientific theoretical foundation for TCM treatments on spastic CP, enabling a deeper comprehension of clinical interventions, ultimately, improving rehabilitation outcomes in TCM treatment for spastic CP. We conducted a data mining study on TCM symptom of spastic CP children aged 4-14 years old treated at Xi'an Encephalopathy Hospital Affiliated to Shaanxi University of Chinese Medicine, from October 2021 to March 2023. The medical records of all eligible and complete spastic CP patients were extracted, processed for data cleansing, transformed, and subsequently analyzed to discern distinctive TCM symptom. K-Means Clustering Analysis and Association Rule Analysis were used for data mining. Core symptoms identified for spastic CP encompassed "Motor Dysfunction", "Impaired Speech", "Delayed Development", "Limb Stiffness", "Rigidity in the limbs", "Intellectual Impairment", "Timidity and susceptibility to startle responses", "Muscle Wasting", and "Pale or Dull Complexion". Among the top-ranking associations of symptom, patterns emerge wherein "Motor dysfunction" intertwine with "Impaired speech", "Motor dysfunction" coexist with "Delayed development", and "Impaired speech" are accompanied by "Delayed development". This study identified the core symptom of spastic CP and tentatively suggests that the clinical manifestations of spastic CP are essentially consistent with the TCM pattern "liver exuberance and spleen weakness". This finding has facilitated the preliminary establishment of correlations between TCM pattern differentiation and the disease in medicine. It is anticipated that this correlation will bring tangible benefits to a larger number of children with spastic CP.

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.

Efficacy and safety of Pien Tze Huang capsules in patients with herpes zoster: A multicenter, randomized, double-blinded, and placebo-controlled trial

BackgroundHerpes zoster (HZ) is a common medical condition accompanied by several distressing symptoms, including acute pain. Pien Tze Huang (PZH) is a well-known traditional Chinese medicine (TCM) with numerous pharmacological effects, including antiviral properties, neuroprotection, and immunity regulation. PurposeTo investigate the efficacy and safety of PZH capsules in patients with HZ. Study designA multicenter, double-blinded, randomized, and placebo-controlled trial from 8 hospitals in 5 cities of China. MethodsEligible participants were randomly assigned to the PZH capsule and placebo group at a 1:1 ratio. Treatment was conducted for 14 days with a window period of no more than 2 days. For the first 7 days, participants received antiviral drugs combined with PZH capsules (0.6 g/time, 3 times a day) or placebos. For the remaining 7 days, they were only treated with PZH capsules (0.6 g/time, 3 times a day) or placebos. ResultsWe included 222 patients in the full analysis set (FAS), and 187 patients in the per protocol set (PPS). The change of numeric rating scale pain scores from baseline to the seventh day (±1 day) after treatment in the PZH capsule group was statistically superior to the placebo group (FAS: 2.33 vs. 1.71, 97.5%CI: 0.03 ∼ 1.19; PPS: 2.29 vs. 1.51, 97.5%CI: 0.18 ∼ 1.38). In the PPS, there was a significant difference in the time (days) of pain relief between the placebo group and the PZH capsule group (Mean (SD): 5.71 (3.76) vs. 4.69 (3.57), p = 0.046). On the seventh day (±1 day) after treatment, the level of CD8+ cells in the PZH capsule group were higher than those of the placebo group (FAS: Mean (SD): 24.08 (6.81) vs. 21.93 (8.19), p = 0.007; PPS: Mean (SD): 24.26 (6.93) vs. 22.15 (8.51), p = 0.012). The level of cytotoxic lymphocyte cells found similar results on the seventh day (±1 day) (FAS: Mean (SD): 12.17 (4.65) vs. 10.55 (4.15), p = 0.018; PPS: Mean (SD): 12.25 (4.65) vs. 10.11 (3.93), p = 0.002). No serious adverse events were noted and PZH capsules were well tolerated. ConclusionPZH capsules confer therapeutic effects on HZ with the TCM symptom of stagnated heat of liver channel by substantially reducing the pain intensity, shortening the time of pain relief as well as regulating the immune function. On the basis of the efficacy and safety profiles, PZH capsules may be a promising complementary therapy for the treatment of HZ.

A conformal regressor for predicting negative conversion time of Omicron patients.

In light of the situation and the characteristics of Omicron, the country has continuously optimized the rules for the prevention and control of COVID-19. The global epidemic is still spreading, and new cases of infection continue to emerge in China. To facilitate the infected person to estimate the course of virus infection, a prediction model for predicting negative conversion time is proposed in this article. The clinical features of Omicron-infected patients in Shandong Province in the first half of 2022 are retrospectively studied. These features are grouped by disease diagnosis result, clinical sign, traditional Chinese medicine symptoms, and drug use. These features are input to the eXtreme Gradient Boosting (XGBoost) model, and the output is the predicted number of negative conversion days. At the same time, XGBoost is used as the underlying algorithm of the conformal prediction (CP) framework, which can realize the probability interval estimation with a controllable error rate. The results show that the proposed model has a mean absolute error of 3.54days and has the shortest interval prediction result. This shows that the method in this paper can carry more decision-making information and help people better understand the disease and self-estimate the course of the disease to a certain extent.

Chinese medicine practitioners’ consensus on traditional Chinese medicine diagnostic patterns, symptoms, and herbal formulas for COVID-19 survivors: A Delphi study

IntroductionIn April 2022, the “Guidance and recommendations on Chinese Medicine Rehabilitation during COVID-19 recovery stage (pilot version)” (the CM Rehabilitation Guidance) was formulated for Hong Kong COVID-19 survivors. However, no consensus regarding traditional Chinese medicine (TCM) diagnostic patterns, symptoms, and herbal formulas in the Guidance has been reached among Hong Kong Chinese medicine practitioners (CMPs). Thus, this study aimed to establish a consensus among them as a guidance for practice. MethodsA modified Delphi method was conducted from July 28 to September 14, 2022. Each survey gathered feedback by using a five-point Likert scale and open-ended questions. Descriptive statistics for quantitative data and thematic analysis for qualitative data were used. The consensus was defined as ≥80 % level of agreement with interquartile range (IQR) ≤1. ResultsA total of 13 CMPs with clinical experience in managing COVID-19 survivors participated in the three-round Delphi survey. A final consensus was reached regarding the following: (1) the diagnostic pattern qi deficiency of the lung and spleen (median = 4; IQR = 0; level of agreement = 92.31 %) with six new suggested symptom items; (2) the diagnostic pattern dual deficiency of qi and yin (median = 4; IQR = 0.5; level of agreement = 100 %) with three new suggested symptom items; and (3) the suggested herbal formulas for these two diagnostic patterns after modification. ConclusionsThrough the three-round Delphi survey, we established a modified CM Rehabilitation Guidance for Hong Kong COVID-19 survivors. The modified Guidance based on the views of Hong Kong CMPs with frontline clinical experience in COVID-19 should be more applicable to current COVID-19 survivors.

The efficacy and safety of acupoint catgut embedding therapy for depression: a protocol for systematic review and meta-analysis.

Depression is a common public health problem, characterized by persistent low mood, lack of pleasure and exhaustion. Conventional treatments such as antidepressants and psychotherapy have some limitations, including variable efficacy, adverse side effects and high costs. Acupoint catgut embedding (ACE) therapy, as a subtype of acupuncture, has gained increasing clinical application due to its long-term effects, higher patient compliance, and cost-effectiveness. This study aims to conduct a meta-analysis to evaluate the efficacy and safety of ACE for depression. Electronic searches will be conducted in 12 databases (both in English and Chinese databases), encompassing from inception to April 2022, without language restrictions. Randomized controlled trials (RCTs) that involve ACE for treating depression will be included. The primary outcome measures will include the response rate, Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI), and Traditional Chinese Medicine Symptom Scale (TCMSSS). The secondary outcome measure will include Quality of Life scale score (QoL) and the incidence of adverse events. Results will be presented as risk ratios for dichotomous data and mean differences for continuous data. Two reviewers will independently conduct study selection, data extraction, and quality assessment. The methodological quality of eligible studies will be evaluated according to the criteria specified by the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Meta-analysis will be performed by RevMan 5.3 software. Due to the limitations, a safer, high-efficacy and non-pharmacological intervention with minimal side effects is required for treating depression. ACE has the advantages of longer-lasting effects, improved patient compliance, and reduced treatment costs. This protocol represents a meta-analysis and systematic review, aiming to present the current evidence regarding the efficacy and safety of ACE for depression. It seeks to provide clinicians with a theoretical basis and valuable references for complementary and alternative medicine therapies in their treatment approaches. https://www.crd.york.ac.uk/PROSPERO/#recordDetails, Identifier CRD42022325966.

Efficacy and safety of the modified Zhiwang decoction combined with methotrexate in early rheumatoid arthritis: study protocol for a randomised controlled trial

IntroductionRheumatoid arthritis (RA) is a progressive inflammatory autoimmune disease characterised by chronic systemic inflammation, which can cause swelling, stiffening and destruction of articular cartilage and bone. Early diagnosis and treatment...

Clinical observation of kidney-tonifying and mind-calming acupuncture therapy in the treatment of perimenopausal insomnia

Abstract Objective To observe the effects of kidney-tonifying and mind-calming acupuncture therapy on sleep, mood, sex hormone levels, and traditional Chinese medicine (TCM) symptoms in patients with perimenopausal insomnia (PMI). Methods A total of 90 patients with PMI were randomly divided into a treatment group and a control group, with 45 cases in each group. Patients in the treatment group were treated with acupuncture at Shenshu (BL23), Taixi (KI3), Baihui (GV20), and Anmian (Extra). The control group was treated with sham acupuncture. Both groups were treated 3 times a week for 4 weeks. Pittsburgh sleep quality index (PSQI) and insomnia severity index (ISI) were used to evaluate the sleep quality of the subjects before treatment, after treatment, and 1 month after treatment (follow-up). Beck depression inventory (BDI) and Beck anxiety inventory (BAI) were used to evaluate the depression and anxiety of the subjects before treatment, after treatment, and at 1-month follow-up. The TCM symptom scale was used to evaluate the TCM symptoms of the subjects before treatment, after treatment, and 1 month after treatment. Serum levels of estradiol (E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured before and after treatment. Results During the study, 2 cases dropped out of the treatment group, and no cases dropped out of the control group. The PSQI scores of the treatment group were significantly lower after treatment and at 1-month follow-up compared with those before treatment (P&lt;0.05), and the difference was statistically significant compared with that of the control group (P&lt;0.05). In the control group, the PSQI score was significantly lower after treatment compared with before treatment (P&lt;0.05), and the difference was not statistically significant at 1-month follow-up compared with before treatment (P&gt;0.05). Compared with the pre-treatment, the ISI, BDI, BAI, and TCM symptom scale scores of the treatment group were lower after treatment and at 1-month follow-up (P&lt;0.05), and the differences with the control group at the same time point were statistically significant (P&lt;0.05). The differences in ISI, BDI, BAI, and TCM symptom scale scores of the control group before treatment, after treatment, and at 1-month follow-up were not statistically significant (P&gt;0.05). After treatment, the serum E2 level in the treatment group was significantly higher than that before treatment (P&lt;0.05), and the difference with the control group was statistically significant (P&lt;0.05). The difference in the serum E2 level before and after treatment in the control group was not statistically significant (P&gt;0.05). The differences in the serum FSH and LH levels between before and after treatment were not statistically significant in either group of subjects (P&gt;0.05). Conclusion Kidney-tonifying and mind-calming acupuncture therapy can improve sleep quality, relieve anxiety and depression, delay the decrease of serum E2 level, and improve related TCM symptoms in patients with PMI.

Efficacy of TCM Fumigation Using Dampness-and-cold-dispelling Formula Combined with Methotrexate and Leflunomide Treating Rheumatoid Arthritis with Cold-dampness Bi Syndrome

BackgroundRheumatoid arthritis (RA), a chronic autoimmune disease, has a high incidence and disability rate, causing patients significant discomfort. Although several medicines can be effective, they are also associated with significant adverse effects. In contrast, fumigation as one of the most often used traditional Chinese medicine (TCM) external therapy has shown both efficacy and safety with less side effect. In light of this, we complement western medicine treatment with TCM fumigation therapy to improve patients' clinical efficacy, alleviate symptoms, and improve prognosis. ObjectiveTo investigate the therapeutic effect of TCM fumigation and modern medicine combined therapy in treating RA patients with cold-dampness Bi syndrome. MethodsA single-center, randomized, controlled study was designed. From January 2022 to December 2022, a total of 60 RA patients with cold-dampness Bi syndrome were enrolled in the study. The control group (30 cases) received conventional modern medicine treatment with methotrexate for 4 weeks, while the observation group (30 cases) for 4 weeks received a combination of TCM fumigation treatment and conventional modern medicine. The effects of the two groups were comprehensively compared, including the changes in TCM symptom scores and laboratory indicators, as well as the use of visual analogue scale (VAS) and health status rating scale (HAQ) before and after treatment. ResultsThe total effective rate of the observation group was 93.3%, which was significantly higher than that of the control group, which is 70% (P < 0.05). Before treatment, there were no significant differences in joint functional activity, pain visual analogue scale (VAS), health assessment questionnaire (HAQ-DI) and laboratory indexes between the two groups (P > 0.05). After treatment, each group compared to their initial condition, respectively, showed major improvement of joint functional activity and significantly decreased VAS, HAQ-DI, and RA-related biomarkers (P < 0.05); inter-group comparison of these indicators showed significanty further enhanced effect of TCM fumigation combined therapy on the RA-related biomarkers and joint functional activity of patients (P < 0.05), yet the control group receiving only modern medicine showed better results of the VAS and HAQ-DI . ConclusionThe TCM fumigation combined therapy is effective to treat RA patients with cold-dampness Bi syndrome, and to enhance their life quality, improving the joint function, and reducing inflammation.

Mechanism of Weiwei granules in the treatment of chronic active Helicobacter pylori gastritis with atrophy based on the TLR4/NF-κB/COX-2 inflammatory signaling pathway.

Our paper aimed to elucidate the mechanism of Weiwei granules in the treatment of Helicobacter pylori (Hp)-positive chronic atrophic gastritis (CAG) based on the TLR4/NF-κB/COX-2 inflammatory signaling pathway. Hp-positive CAG patients were randomized into the control group (treated with quadruple therapy) or the observation group (treated with Weiwei granules based on the control group). The clinical efficacy, Hp clearance rate, and efficacy of traditional Chinese medicine (TCM) symptoms were compared between the two groups after six months of treatment. The scores of various histopathology variables, serum levels of inflammatory factors (interleukin-6 [IL-6], interleukin-8 [IL-8], and tumor necrosis factor-alpha [TNF-α]), gastrin-17 (G-17) and motilin (MTL), pepsinogen (PG) I and PG II, as well as serum levels of gastrointestinal hormone endothelin (ET), epidermal growth factor (EGF), and calcitonin gene-related peptide (CGRP), were compared between the two groups before and after treatment. TLR4, NF-κB, and COX-2 mRNA levels were compared in gastric mucosal tissues before and after treatment in the two groups. After treatment, the clinical efficacy, Hp clearance rate, and efficacy of TCM symptoms of patients in the observation group were higher than those in the control group. After treatment, the scores of various histopathology variables, serum levels of inflammatory factors (IL-6, IL-8, and TNF-α), gastrointestinal hormones (ET and EGF), and the expression levels of TLR4, NF-κB, and COX-2 mRNA in the gastric mucosal tissues were lower and G-17, MTL, CGRP, and PG I levels were higher in the observation group than in the control group. Weiwei granules can effectively improve Hp-positive CAG patients and reduce the expression levels of TLR4, NF-κB, and COX-2.

The Effects of Prescription for Restoring Kidney Function on Chronic Kidney Failure (Renal Deficiency with Blood Stasis and Turbidity) and Its Impact on Renal Function

Objective: To analyze the clinical effects of Prescription for restoring kidney function in the treatment of chronic kidney failure with renal deficiency, blood stasis, and turbidity, and its influence on renal function recovery. Methods: A comparative treatment study was conducted on 72 patients with chronic kidney failure due to renal deficiency with blood stasis and turbidity, seen at the Yongchuan District Chinese Medicine Hospital in Chongqing (study period: February 2023 to October 2023). The patients were randomly divided into two groups: the control group (36 cases) received standard treatment, and the study group (36 cases) received combined treatment with Prescription for restoring kidney function. Statistical analysis was performed on changes in traditional Chinese medicine symptom scores, renal function indicators, and treatment effectiveness between the two groups before and after treatment. Results: (1) After treatment, the study group exhibited significantly lower scores for symptoms such as lumbar and knee soreness, shortness of breath, poor appetite, nausea, vomiting, and limb heaviness, as well as lower levels of blood Scr, BUN, and UA compared to the control group. The differences were statistically significant (P&lt;0.05). (2) Compared to the control group, the study group showed an increased clinical treatment effectiveness rate (94.44%), with a statistically significant difference (P&lt;0.05). Conclusion: Prescription for restoring kidney function provides precise clinical effectiveness in the treatment of chronic kidney failure with renal deficiency, blood stasis, and turbidity. It not only addresses symptom presentations according to traditional Chinese medicine but also corrects the metabolic function of the kidneys, optimizing clinical treatment outcomes.

Efficacy of Chinese Herbal Medicine Formula in the Treatment of Mild to Moderate Erectile Dysfunction: Study Protocol for a Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

Erectile dysfunction (ED) is a prevalent condition in urology, primarily managed with PDE5 inhibitors (PDE5Is). However, approximately 20% of patients do not experience improvement in overall sexual satisfaction (OS) after taking PDE5Is. Among these, traditional Chinese medicine (TCM) has emerged as a complementary approach, with formulas like Hongjing I granules (HJIG) showing promise in preliminary studies. This study aims to rigorously evaluate the effectiveness and safety of HJIG in mild to moderate ED cases, assessing improvement in both sexual function and TCM pattern alignment. This study is a randomized, double-blind, placebo-controlled multicentre trial. Recruitment will be conducted from patients who have a strong willingness to try using only traditional Chinese medicine treatment (This is very common in traditional Chinese medicine hospitals.). A total of 100 patients diagnosed with mild to moderate ED caused by qi deficiency and blood stasis will be recruited and randomly assigned to receive one of two treatments: HJIG (N = 50) or placebo (N = 50). Patients will receive 8 weeks of treatment and a 16-week follow-up starting from the fourth week of treatment. Outcome measures, including the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, Sexual Encounter Profile (SEP), and Traditional Chinese Medicine symptom score, will be evaluated. The expected outcome of this trial is that the use of the herbal formula HIJG alone can improve overall sexual satisfaction (OS) in patients with mild to moderate ED, while also improving their traditional Chinese medicine symptom scores. This will provide evidence-based support for the use of Chinese medicine in the treatment of ED in China. Chinese Clinical Trial Registry, ChiCTR2000041127, Registered on 19 December 2020, https://www.chictr.org.cn/showproj.html?proj=46469. Recruitment began in March 2021, therefore 80 patients have been recruited. It is expected to finish recruiting in December 2023.