Traditional Chinese Medicine Symptom Research Articles

The clinical efficacy of Zuqing Xu “Wuduling” powder for snake injury on the swelling of the affected limb bitten by Agkistrodon halys

ABSTRACT To determine the clinical efficacy of Zuqing Xu ‘Wuduling’ powder for snake injury on the swelling of the affected limb bitten by Agkistrodon halys. Sixty-five patients with Agkistrodon halys bite were assigned to a treatment group (n = 35) or control group (n = 30). The treatment group was additionally given ‘Wuduling’ powder dressing locally based on the therapy to the control group with conventional Western medicine. Clinical efficacy and improvement of traditional Chinese medicine symptoms and signs in the two groups were evaluated. The treatment group showed a notably higher cure rate than the control group. After 3 days of therapy, the swelling and pain of the affected limb in the treatment group were greatly alleviated. Additionally, after 7 days of therapy, the swelling and pain of the affected limb in the treatment group were more greatly alleviated, and those in the control group were also alleviated. The comparison of the two groups during the same period showed more obvious alleviation of swelling and pain in the treatment group than that in the other. Moreover, the treatment group experienced notably shorter disappearing time of swelling and pain than the control group. After treatment, the levels of CRP, TBIL, Cr, ALT, AST, BUN, CK, LDH and CK-MB in both groups declined notably, with notably lower levels of them in the treatment group than those in the other. Zuqing Xu ‘Wuduling’ powder for snake injury can substantially alleviate the swelling and local pain of affected limbs bitten by Agkistrodon halys.

Ningxin Tongyu Zishen Tang in Treatment of Premature Ovarian Insufficiency: A Retrospective Control Study

Premature ovarian insufficiency (POI) is a common refractory disease in gynecology, and its etiology and pathogenesis are complex. Psychological stress exerts an impact on women's physical and mental health, and in turn affects the ovarian reserve function, which is one of the important etiologies and pathogenesis of POI. The compound formula Ningxin Tongyu Zishen Tang (NTZT) is composed of Chinese herbal medicines which can nourish heart and tranquilize mind, tonify kidney and supplement essence. By comparing the menstrual symptoms, traditional Chinese medicine (TCM) symptoms and the levels of serum sex hormone before and after treatment, the NTZT is clarified for its curative effect and advantages in patients with POI. The study aimed to observe the effects of NTZT on menstrual symptoms, TCM symptoms and the levels of serum sex hormone in POI patients. 60 POI patients were divided into two groups, namely observation group and control group, with 30 patients each. The patients in both groups were treated by hormone replacement therapy (HRT). The observation and control groups received treatment with NTZT and Liuwei Dihuang Wan (LDW), respectively. Both groups of patients were treated for 3 months continuously. The menstrual symptoms, TCM symptoms and the levels of serum sex hormone of the two groups were investigated before and after treatment. It was found that the menstrual symptoms, TCM symptoms and the levels of serum sex hormone improved dramatically after treatment in the observation group (P < 0.01). By comparison, the menstrual symptoms and the levels of serum sex hormone improved significantly (P < 0.01), but no obvious improvement in TCM symptoms (P > 0.05) in the control group was observed. Compared with the control group, the observation group showed significant improvement in TCM symptoms and the levels of serum sex hormone (P < 0.01), but no significant difference was observed in the menstrual symptoms (P > 0.05). In addition, no any adverse events such as gastrointestinal dysfunction and drug allergy were observed in both groups, indicating the safety of the two TCM formulas. The study found that NTZT could restore menstruation and improve the levels of sex hormone in patients with POI. It was also found that NTZT could eliminate the feelings of vexation, insomnia and dreamfulness, as well as tidal fever and sweating, aching pain of loins, and vaginal dryness significantly. It can be proved that NTZT is effective in treating patients with POI owing to its effects of nourishing heart and tranquilizing mind, tonifying kidney and supplementing essence together, leading to elimination of psychological stress, which further promotes the development of the ovaries.

Clinical Efficacy of Spleen and Yin Prescription in the Treatment of Primary Sjogren Syndrome and Its Impact on Disease Activity

Objective: To study the clinical efficacy of primary Sjogren syndrome and the effect of disease activity. Methods: The 60 patients from January 2021 to January 2022 respectively, and divided into two groups according to random numbers, hydroxychloroquine sulfate, 30 patients, clinical effect combined with hydroxychloroquine sulfate, inflammatory index, complement levels, and immunoglobulins (ESR, RF, CRP, C3, C4, IgG, IgA, IgM), ESSDAI, ESSPRI, and adverse effects. Results: The total response rate of the two groups was 86.67% (26/30) and 73.33% (22/30), respectively, comparing with the treatment group (P &lt;0.05). Comparison between groups found that no differences in CRP, C4, IgA, and IgM were significant (P&gt;0.05). After treatment, peripheral ESR, RF, IgG decreased, complement C3 levels increased (P &lt;0.05), the ESSDAI score and ESSPRI score of the two groups also decreased (P&lt;0.05). On the Traditional Chinese medicine symptom integral, the treatment group had better results in improving dry mouth, dry throat, dry eyes, dry skin, five upset heat, and joint pain(P&lt;0.05), and no adverse reactions were found in either group. Conclusion: The treatment group can effectively improve the clinical efficacy, reduce the level of inflammatory indicators and disease activity, and see no obvious adverse reactions, which can be effectively used in clinical practice.

Efficacy of combined application of traditional Chinese medicine foot bath and mild moxibustion in the treatment o f limb pain in diabetic peripheral neuropathy patients

Purpose: To determine the efficacy of the combination of traditional Chinese medicine (TCM) foot bath and mild moxibustion in the treatment of limb pain in patients with diabetic peripheral neuropathy (DPN).&#x0D; Methods: A total of 120 patients with symptoms of DPN-induced pain who were hospitalized at the Department of Endocrinology in the 903rd Hospital of PLA, from January 2020 to June 2021, were included in this study. They were randomly assigned to a study group and a control group, with 60 patients in each group. Patients in both groups received conventional treatments and nursing care, while those in study group were additionally treated with a combination of TCM foot bath and mild moxibustion. Treatment efficacy in the patients was evaluated using Short-Form McGill Pain Questionnaire (SF-MPQ), pain rating index (PRI), visual analogue scale (VAS), TCM symptom score (TCMSS), and Toronto Clinical Scoring System (TCSS).&#x0D; Results: Compared with control group, there were significant improvements in pain-related scores, namely, SF-MPQ, (p ˂ 0.05); PRI, (p &lt; 0.01); VAS, (p &lt; 0.05); as well as overall efficacy (p &lt; 0.05). Similar improvements were also observed with regard to TCMSS (p &lt; 0.001) and TCSS (p &lt; 0.001) in the study group. However, there were no significant changes in Adjusted Diabetes Quality of Life (A-DQOL) score and blood glucose control in both groups.&#x0D; Conclusion: Relative to the conventional treatment for DPN, limb pain and disease score of patients are significantly reduced by the combination of TCM foot bath and mild moxibustion treatments. Further clinical trials would be required prior to application in clinical practice.

Clinical research of acupuncture therapy combined with domperidone in treatment of diabetic gastroparesis of liver stagnation and spleen deficiency

To observe the clinical efficacy of shuanggu yitong acupuncture therapy (the therapy for both replenishment and unblocking) combined with domperidone on diabetic gastroparesis (DGP) of liver stagnation and spleen deficiency pattern and explore its effect mechanism. DGP patients differentiated as liver stagnation and spleen deficiency pattern were divided into a control group (n=42) and an observation group (n=42) according to the random number table. The patients in the control group took domperidone tablets orally, 10 mg each time, 3 times a day for 28 days. In the observation group, on the base of the treatment as the control group, shuanggu yitong acupuncture therapy was applied to Baihui (GV20), Shenting (GV24), Zhongwan (CV12), bilateral Zusanli (ST36), Hegu (LI4)and Taichong (LR3), stimulated for 30 min in each treatment. Acupuncture was given once daily, 3 times a weeks for 28 days consecutively. Fasting blood glucose (FBG), 2-hour postprandial blood glucose (2 h PBG) and glycosylated hemoglobin (HbA1c) were detected before and after treatment in the patients of two groups separately. The score of symptom severity index of gastroparesis (GCSI), traditional Chinese medicine (TCM) syndrome score and gastric emptying rate were assessed in the patients of two groups. Using ELISA, radioimmunoassay and colorimentry methods, the contents of motilin in plasma, gastrin, tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), interleukin-1β (IL-1β) and interferon-gamma (INF-γ) in serum, as well as the activity of superoxide dismutase (SOD), reactive oxygen species (ROS) and malondialdehyde (MDA) in the serum were determined in the two groups. The clinical curative effect was evaluated. After treatment, the levels of FBG, 2 h PBG and HbA1c, the scores of GCSI and TCM syndrome, the contents of motilin in plasma, gastrin, TNF-α and MDA, as well as the activity of ROS in serum were all reduced when compared with those before treatment in each group (P<0.05, P<0.01), while gastric emptying rate and SOD activity in the serum were higher than those before treatment (P<0.05, P<0.01). After treatment, the serological content of INF-γ was lower than that before treatment in the control group (P<0.05), and the contents of IL-6 and IL-1β were reduced than those before treatment in the observation group (P<0.05). Compared with the control group, the levels of FBG, 2 h PBG and HbA1c, the scores of GCSI and TCM symptoms, the contents of motilin in plasma, gastrin, TNF-α, MDA, IL-6 and IL-1β, and the activity of ROS in serum in the observation group were all lower significantly (P<0.05, P<0.01), while the SOD activity and gastric emptying rate in the observation group were higher than those in the control group (P<0.05, P<0.01). The total effective rate was 90.5% (38/42) in the observation group, better than the control group (73.8%, 31/42, P<0.05). Shuanggu yitong acupuncture therapy combined with domperidone remarkably relieves the clinical symptoms and improves the gastric emptying rate, effectively reduces motilin and gastrin and regulates oxidative stress and inflammatory responses in the patients with DGP of liver stagnation and spleen deficiency.

PS-C31-9: A RANDOMISED TRIAL OF THE TRADITIONAL CHINESE MEDICINE (TCM) CONSTITUTION-BASED DIETARY REGIME IN GRADE 1 HYPERTENSIVE PATIENTS: RATIONALE AND DESIGN

Background and Objective: Cardiovascular disease (CVD) represents enormous challenges to population health. Body constitution, from the perspective of traditional Chinese medicine (TCM), differentiates how individuals feel and behave, and ultimately affects how different bodies respond to dietary intake. We hypothesise that the TCM constitution-based dietary intervention would be an effective approach to achieving favourable clinical and TCM-related outcomes when compared to usual care alone among the Chinese grade 1 hypertensive patients. Design and method: This is a parallel-group, randomised trial (registered as ChiCTR2000034749; http://www.chictr.org.cn). Participants consist of 274 primary care adults, aged 35 years or older, with uncomplicated grade 1 hypertension and at low risk of cardiovascular and renal events. Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per computer-generated random numbers. Permuted blocks of random sizes will be used. Subjects in the invention group will receive an on-site constitution assessment based on physical signs, personality, body symptoms, and the susceptibility to environmental changes. This will be conducted by the attending TCM practitioners trained in a prior session to improve the inter-rater reliability. A colour-printed constitution-specific brochure will be provided onsite. Health education materials will be made available to patients by courier service thereafter. All participants receive routine care provided by the ‘family doctor team’ in the context of the national basic public health service delivery. Measurements will be undertaken at three time-points, i.e., at baseline, at 6- and 12-month follow-ups. At each follow-up interview, subjects in the intervention group will be questioned about the constitution types of their own, and a full awareness of the constitution profile will be seen as an adherence to the protocol. Results and outcome evaluation: The primary outcome of the study is the difference between the two arms in the proportion of participants who had optimal control of blood pressure at 12 months. A point estimate of 25% inferiority in effectiveness would be acceptable assuming a gain that is considered to be clinically relevant. The secondary outcome measures include differences in the profile of clinical parameters and TCM symptoms between the two arms. Conclusions: We believe that this study offers new insights for cardiovascular health management through TCM constitution-based strategies in primary care settings to target those who need continuous attention in dietary modifications. The findings may advance our knowledge of the practical contribution of complementary and alternative medicine in the prevention and control of CVD.

Clinical Research of Huatan Quyu Formula on the Treatment of Type 2 Diabetes Mellitus Combined with Non-Alcoholic Fatty Liver Disease

To observe the clinical effect of Huatan Quyu granules on type 2 diabetes mellitus combined with nonalcoholic fatty liver disease. A total of 60 patients who met the inclusion criteria were selected from the Department of Endocrinology in the Southern District of Guang’anmen Hospital from January 2018 to December 2019. Thirty patients in the control group were treated with metformin hydrochloride tablets and thirty patients in the treatment group were additionally treated with Huatan Quyu granules after given by metformin hydrochloride tablets. Patients in both groups were treated for 12 w. The blood sugar (fasting plasma glucose, 2 h post-load plasma glucose, hemoglobin A1C), the blood lipids (triglyceride, low-density lipoprotein, high-density lipoprotein, total cholesterol), homeostatic model assessment of insulin resistance and changes in traditional Chinese medicine symptoms of the two groups were compared and analyzed. The total effective rate of traditional Chinese medicine symptoms was better in the treatment group compared with in the control group (p<0.05); the scores of traditional Chinese medicine symptoms, i.e., fullness in the abdomen and stomach, hidden pain under the hypochondrium, dizziness, drowsiness and tastelessness in the mouth, increased in the treatment group after treatment compared with those before treatment and the control group (p<0.05). The fasting plasma glucose, 2 h post-load plasma glucose, hemoglobin A1C, fasting insulin levels, homeostatic model assessment of insulin resistance, triglyceride, total cholesterol, low-density lipoprotein were lower in the treatment group after treatment compared with those before treatment and the control group (p<0.05). Huatan Quyu granules can reduce the biochemical indexes related to glucose and lipids in patients with type 2 diabetes mellitus combined with non-alcoholic fatty liver disease, alleviate insulin resistance and improve the clinical symptoms of patients. It has a good application prospect.

Efficacy of Fufang E'jiao Jiang in the Treatment of Patients with Qi and Blood Deficiency Syndrome: A Real-World Prospective Multicenter Study with a Patient Registry.

This nationwide, multicenter prospective observational study with a patient registry was designed to evaluate the efficacy of Fufang E'jiao Jiang (FEJ) in Chinese patients with Qi and blood deficiency syndrome (QBDS). QBDS patients were consecutively recruited from 81 investigational sites in China from July, 2019, to December, 2020. Patients who met the eligibility criteria were enrolled in a prospective registry database. Baseline characteristics and changes in scores on the traditional Chinese medicine (TCM) symptom evaluation scale for Qi and blood deficiency, the clinical global impression (CGI) scale, the fatigue scale-14 (FS-14), and the Pittsburgh sleep quality index (PSQI) were analyzed to determine the clinical efficacy of FEJ. A total of 3,203 patients were recruited. The average remission rate (i.e., the sum of the cure rate and improvement rate) of the 20 symptoms of QBDS was 92.49% after 4 weeks of FEJ treatment, which was higher than at baseline; the rate increased to 94.69% at 8 weeks. The CGI scale revealed that the number of total remissions at 4 and 8 weeks was 3,120 (97.41%) and 415 (100%), respectively. The total FS-14 scores decreased by 1.67 ± 4.11 (p < 0.001) at 4 weeks and 1.72 ± 3.09 (p < 0.001) at 8 weeks of treatment. The PSQI scores were 6.6 ± 4.7 and 6.52 ± 3.07 at 4 and 8 weeks, respectively, which were significantly lower than the baseline scores (p < 0.001; p = 0.0033). Both the subhealth fatigue (SF) and iron deficiency anemia (IDA) groups showed significantly improved clinical symptoms of QBDS (p < 0.01). Between-group comparisons revealed significantly greater improvements in FS-14 and PSQI scores in the SF group than in the IDA group (p < 0.05). A multivariate logistic regression analysis showed that disease course, FS-14 score at baseline, and four-week FEJ doses were independent risk factors for the degree of symptom relief in QBDS patients (p < 0.05). In real-world settings, FEJ has a promising effect in treating QBDS and can significantly improve the severity of its symptoms.

Enhancing traditional Chinese medicine diagnostics: Integrating ontological knowledge for multi-label symptom entity classification.

In traditional Chinese medicine (TCM), artificial intelligence (AI)-assisted syndrome differentiation and disease diagnoses primarily confront the challenges of accurate symptom identification and classification. This study introduces a multi-label entity extraction model grounded in TCM symptom ontology, specifically designed to address the limitations of existing entity recognition models characterized by limited label spaces and an insufficient integration of domain knowledge. This model synergizes a knowledge graph with the TCM symptom ontology framework to facilitate a standardized symptom classification system and enrich it with domain-specific knowledge. It innovatively merges the conventional bidirectional encoder representations from transformers (BERT) + bidirectional long short-term memory (Bi-LSTM) + conditional random fields (CRF) entity recognition methodology with a multi-label classification strategy, thereby adeptly navigating the intricate label interdependencies in the textual data. Introducing a multi-associative feature fusion module is a significant advancement, thereby enabling the extraction of pivotal entity features while discerning the interrelations among diverse categorical labels. The experimental outcomes affirm the model's superior performance in multi-label symptom extraction and substantially elevates the efficiency and accuracy. This advancement robustly underpins research in TCM syndrome differentiation and disease diagnoses.

Adjuvant Chinese Medicine for the Treatment of Type 2 Diabetes Mellitus Combined with Mild Cognitive Impairment: A Systematic Review and Meta-Analysis of a Randomised Controlled Trial.

Mild cognitive impairment has a high prevalence in the type 2 diabetic population. Adjuvant therapy with Chinese herbal medicine can effectively improve the clinical symptoms of patients with T2DM combined with MCI. The aim of this study was to systematically evaluate the efficacy and safety of Chinese herbal adjunctive therapy in the treatment of diabetes mellitus combined with cognitive impairment. Information was analysed using the China Knowledge Network, Vip Database, Wanfang Database, China Biomedical Literature Database, PubMed, EMbase, Web of Science, and MedLine Database. The total clinical efficiency, blood glucose, blood lipids, Simple Mental-State Examination Scale (MMSE), Montreal Cognitive Assessment Scale (MoCA), Traditional Chinese Medicine Symptom Score (TCMSS), and incidence of adverse reactions were recorded. The methodological quality of the included studies was evaluated using the application of the Cochrane Collaboration Network Risk Bias Assessment Tool, and meta-analysis was performed using RevMan 5.4 software. Adjuvant treatment with Chinese herbal medicine was effective in improving the clinical outcomes (OR = 5.33, 95% CI (3.62, 7.84), p &lt; 0.00001) and cognitive function by comparing with the control group: MMSE (MD = 1.56, 95% CI (1.29, 1.84), p &lt; 0.00001) and MoCA (MD = 2.77, 95% CI (1.81, 3.73), p &lt; 0.0001); lowered blood glucose: fasting blood glucose (FBG) (MD = -0.27, 95% CI (-0.42, -0.12), p = 0.0006), 2 hPG (MD = -0.28, 95% CI (-0.45, -0.10), p = 0.002), and glycated haemoglobin (HbA1c) (MD = -0.26, 95% CI (-0.39, -0.14), p &lt; 0.001); and improved lipids: total cholesterol (TC) (MD = -0.51, 95% CI (-0.82, -0.21), p = 0.001), triglycerides (TGs) (MD = -0.46, 95% CI -0.46, 95% CI (-0.80, -0.11), p = 0.009), low-density lipoprotein (LDL-C) (MD = -0.28, 95% CI (-0.55, -0.02), p = 0.04), high-density lipoprotein (HDL-C) (MD = 0.17, 95% CI (0.07, 0.28), p = 0.001), reduced TCMSS (MD = -1.84, 95% CI (-2.58, -1.10), p &lt; 0.0001), and incidence of adverse events (OR = 0.46, 95% CI (0.24, 0.88), p = 0.02). In conclusion, through the available evidence, herbal adjuvant therapy for T2DM combined with MCI was observed to be effective and did not significantly increase the adverse effects. Due to the limitation of the number and quality of the included studies, the abovementioned results need to be validated by further high-quality studies.

Efficacy of Xinbao pill on chronic heart failure: Study protocol of a multicenter, randomized, double-blind, placebo-controlled trial.

Introduction: Chronic heart failure (CHF) is a common cardiovascular disease. In China, Xinbao pill (XBP) is widely used as an adjuvant therapy for CHF. However, there is still a lack of high-quality clinical evidence. We designed this multicenter, randomized, double-blind, placebo-controlled trial to critically evaluate the efficacy and safety of XBP as an adjuvant treatment for patients with CHF. Methods and analysis: We will recruit 284 patients with a clinical diagnosis of "heart-kidney yang deficiency syndrome" CHF receiving treatment in six hospitals in China. Patients will be randomly assigned, in a 1:1 ratio, to the treatment or control group using a central randomization system. All patients will receive conventional drug therapy for heart failure combined XBP (Guangdong Xinbao Pharmaceutical Co., Ltd., Guangdong, China) or a placebo. Study physicians, subjects, outcome assessors, and statisticians will be blinded to the group assignment. The primary outcome will be the change in the proportion of patients who show a decrease in serum NT-proBNP of more than 30% after treatment. Secondary outcomes are NYHA class, 6-minute walk distance test, Minnesota Quality of Life Scale score, endpoint events, serum NT-proBNP, echocardiographic parameters, and traditional Chinese medicine (TCM) symptom score. Adverse events will be monitored throughout the trial. Data will be analyzed according to a predetermined statistical analysis plan. Discussion: The results of this study will provide solid evidence of the safety and efficacy of XBP as an alternative and complementary treatment measure for patients with CHF. Clinical Trial Registration: Chinese Clinical Trial Registration Center (ChiCTR2000038492).

Chuan Huang Fang combining reduced glutathione in treating acute kidney injury (grades 1-2) on chronic kidney disease (stages 2-4): A multicenter randomized controlled clinical trial.

Lack of effective drugs for acute kidney injury (AKI) grades 1–2 is a crucial challenge in clinic. Our previously single-center clinical studies indicated Chuan Huang Fang (CHF) might have nephroprotection in AKI on chronic kidney disease (CKD) (A on C) patients by preventing oxidant damage and inhibiting inflammation. Reduced glutathione (RG) has recently been shown to increase the clinical effectiveness of high-flux hemodialysis among patients with severe AKI. In this multicenter randomized controlled clinical study, we designed a new protocol to assess the efficacy and safety of CHF combining RG in patients with A on C. We also explored therapeutic mechanisms from renal fibrosis biomarkers. 98 participants were randomly and equally divided into the RG and RG + CHF subgroups. The RG and RG + CHF groups received general treatments with RG and a combination of RG and CHF, respectively. The therapy lasted for 2 weeks. In this study, the primary assessment result was a difference in the slope of serum creatinine (Scr) over the course of 2 weeks. The secondary evaluation outcomes were alterations in blood urea nitrogen (BUN), uric acid (UA), estimated glomerular filtration rate (eGFR), urinary AKI biomarkers, renal fibrosis biomarkers (transforming growth factor-β 1 (TGF-β 1), connective tissue growth factor (CTGF)), and traditional Chinese medicine (TCM) symptoms. Furthermore, vital signs and adverse events (AEs) were observed. Both groups had a slower renal function decline after treatment than before treatment. Compared with RG group, more reductions of Scr, BUN, UA, and better improvement of eGFR were observed in RG + CHF group (p < 0.05). Additionally, the levels of urinary AKI biomarkers, renal fibrosis biomarkers, and TCM syndromes were decreased in RG + CHF group versus RG group (p < 0.05). No significant between-group differences were observed of AEs. We thus concluded this novel therapy of CHF combining RG might be a useful method for treating A on C patients.

Clinical Observation of Fuzheng Xiaoji Granule in the Treatment of Stage IIIC Colorectal Cancer.

Objective This study aimed to evaluate the effectiveness and safety of Fuzheng Xiaoji granule in patients with stage IIIC colorectal cancer. Methods A total of 150 patients with stage IIIC colorectal cancer treated in Shanghai Ruijin Hospital from January 2019 to January 2022 were selected. They were divided into treatment and control groups according to a 2 : 1 random number table. There were 100 cases in the treatment group and 50 cases in the control group. The treatment group was administered Fuzheng Xiaoji (FZXJ) granule, and the control group was administered the placebo orally. The primary endpoint was disease-free survival (DFS). In addition, after 6 months, the changes in Traditional Chinese Medicine (TCM) symptom score (fatigue, emotional depression, chest tightness, insomnia, anorexia, abdominal distension, abdominal pain, soreness and weakness in the waist and legs, chills, and dysphoria in the chest, palm, and soles) were compared. Results The DFS was 34.37 ± 2.91 months in the control group and 37.0 ± 1.08 months in the treatment group (p < 0.05). Compared with the control group, the treatment group showed less fatigue, abdominal distension, and soreness and weakness in the waist and legs (p < 0.05), significantly. The scores of emotional depression and anorexia decreased obviously, with a significant difference between the control and treatment groups (p < 0.01). There were no significant differences between the control and treatment groups in the incidence of chest tightness, insomnia, abdominal pain, chills, and dysphoria in the chest, palm, and soles (p > 0.05). Conclusion Fuzheng Xiaoji granule can improve patients' symptoms and prolong the DFS.

Systematic evaluation and meta-analysis of Chinese medicine in the treatment of centrally mediated abdominal pain syndrome.

Background:This study aimed to evaluate the clinical efficacy of Chinese medicine for the treatment of centrally mediated abdominal pain syndrome (CAPS) using a meta-analysis system.Methods:Six databases, including China National Knowledge Infrastructure, Vendor Information Pages, Chinese Biomedical Database, Wanfang, PubMed, and Embase were searched for randomized controlled trials related to the treatment of CAPS with traditional Chinese medicine. The bias risk assessment tool and RevMan5.3 software (Copenhagen, The Nordic Cochrane Centre, The Cochrane Collaboration) were used to conduct quality assessment and meta-analysis, and the GRADE grading system was used to evaluate the quality of evidence for outcome indicators.Results:Fifteen articles were included in this study. Meta-analysis results showed that the treatment group was more effective in terms of the total effective rate (relative risk = 1.27; 95% confidence interval [CI], 1.19–1.34; P < .00001), Behavioral Rating Scale-6 pain score (mean difference [MD] = −0.79; 95% CI, −0.99 to −0.59; P < .00001), and traditional Chinese medicine (TCM) symptom score (MD = −1.74; 95% CI, −2.23 to −1.26; P < .00001) than the control group (P < .05). However, in terms of numerical rating scale pain score (MD = 0.79; 95% CI, −1.70 to 0.12; P = .09), the efficacy was comparable between the 2 groups, and the difference was not statistically significant (P > .05). In terms of verbal rating scale pain, depression, and anxiety scores, the data could not be combined due to inconsistent scoring criteria, and only descriptive analysis was performed. The results showed that the treatment group was slightly better than the control group in terms of relieving verbal rating scale pain and improving anxiety and depression (P < .05).Conclusion:Chinese medicine can effectively improve the pain and TCM clinical symptoms of patients with CAPS and relieve patients’ anxiety and depression with fewer adverse effects, which has certain therapeutic advantages. However, because of the low methodological quality assessment of the included literature, the quality of GRADE evidence for outcome indicators is of mostly low and very low quality, the strength of recommendation is weak, and the credibility of the conclusion is average. More rigorous, larger sample, and higher-quality clinical trials are required to provide a higher level of evidence-based medicine for the development of TCM treatment standards for CAPS.

Efficacy and safety of tailin formulation combined with continuous low-dose antibiotic therapy in patients with recurrent urinary tract infection: A multicenter, randomized, controlled clinical trial

Persistent inflammation associated with recurrent urinary tract infection (rUTI) is a crucial inducement of inflammation-driven renal fibrosis (IDRF). Although continuous low-dose antibiotic therapy (CLAT) is the common treatment for rUTI, its clinical efficacy remains unsatisfactory. Tailin formulation (TLF), a Chinese herbal formulation prescribed for treating rUTI, is effective in alleviating symptoms and reducing recurrence. This study was to evaluate the efficacy and safety of TLF combined with CLAT compared with CLAT used alone in patients with rUTI. In this multicenter, randomized, controlled clinical trial, patients were assigned (1:1) to receive either TLF + CLAT or CLAT for 12 weeks. The primary outcome was the effective rate at week 12 of the treatment. The secondary outcomes were the recurrent rate at week 4 and week 12 post treatment; the post-treatment changes in renal tubular injury markers (urinary N-acetyl-β-d-glucosaminidase (NAG) and β2-microglobulin (β2-MG)), profibrotic factors (urinary monocyte chemoattractant protein-1 (MCP-1) and transforming growth factor beta1 (TGF-β1)), and traditional Chinese medicine (TCM) symptoms, and vital signs indicators and serious adverse events (SAEs) were also monitored throughout the trial. A total of 195 patients were included in the final analysis. The TLF + CLAT group had a higher effective rate and a lower recurrence rate than the CLAT group (p < 0.01). Significant decrease of urinary NAG and β2-MG was observed in the TLF + CLAT group vs. CLAT group (p < 0.01), and similar changes were observed in profibrotic factors (urinary MCP-1 and TGF-β1) (p < 0.05), which indicated that TLF might have potential renal tubular protection and anti-fibrosis effects. Additionally, a positive correlation within a certain range was shown in the correlation analysis of medical history (months) of rUTI patients with urinary MCP-1 (r = 0.50, p < 0.05) and TGF-β1 (r = 0.78, p < 0.01). A significant difference was also observed in TCM symptoms (p < 0.01). There were no obvious adverse reactions that occurred during this study. We conclude that TLF combined with CLAT was superior to CLAT used alone in reducing rUTI recurrence, alleviating the non-infection-related physical symptoms and protecting renal tubular and anti-fibrosis, which suggests this novel therapy might be an available treatment with great promise in treating rUTI.

TCM Constitution Analysis Method Based on Parallel FP-Growth Algorithm in Hadoop Framework.

This work is devoted to establishing a comparatively accurate classification model between symptoms, constitutions, and regimens for traditional Chinese medicine (TCM) constitution analysis to provide preliminary screening and decision support for clinical diagnosis. However, for the analysis of massive distributed medical data in a cloud platform, the traditional data mining methods have the problems of low mining efficiency and large memory consumption, and long tuning time, an association rules method for TCM constitution analysis (ARA-TCM) is proposed that based on FP-growth algorithm and the open-source distributed file system in Hadoop framework (HDFS) to make full use of its powerful parallel processing capability. Firstly, the proposed method was used to explore the association rules between the 9 kinds of TCM constitutions and symptoms, as well as the regimen treatment plans, so as to discover the rules of typical clinical symptoms and treatment rules of different constitutions and to conduct an evidence-based medical evaluation of TCM effects in constitution-related chronic disease health management. Secondly, experiments were applied on a self-built TCM clinical records database with a total of 30,071 entries and it is found that the top three constitutions are mid constitution (42.3%), hot and humid constitution (31.3%), and inherited special constitution (26.2%), respectively. What is more, there are obvious promotions in the precision and recall rate compared with the Apriori algorithm, which indicates that the proposed method is suitable for the classification of TCM constitutions. This work is mainly focused on uncovering the rules of “disease symptoms constitution regimen” in TCM medical records, but tongue image and pulse signal are also very important to TCM constitution analysis. Therefore, this additional information should be considered into further studies to be more in line with the actual clinical needs.

CPMCP: a database of Chinese patent medicine and compound prescription.

Although several traditional Chinese medicine (TCM)-related databases have emerged, they focus on researching single medicinal materials, which is far from sufficient for clinical research and application. In comparison, compound prescriptions are more informative and meaningful in TCM, for they embody the information on the compatibility of TCM besides the relatively isolated information about single medicinal materials. The compatibility information is essential in TCM because it conveys not only what components are involved to treat special diseases but also how to combine these single medical materials. We established a database of Chinese patent medicine and compound prescription (CPMCP). It demonstrates the prescription information of Chinese patent medicines (CPMs) and ancient Chinese medicine prescriptions (CMPs). CPMCP reports their comprehensive and standardized information such as the components, indications and contraindications. It is worth mentioning that we organized relevant experts and spent lots of time manually mapping the functions of compound prescriptions in ancient Chinese to the standardized TCM symptom vocabularies, obtaining a total of 71 414 associations between compound prescriptions and TCM symptoms. In this way, CPMCP established the associations between TCM and modern medicine (MM) according to the associations between TCM symptoms and MM symptoms. In addition, to further exhibit the compatibility mechanism of compound prescriptions, CPMCP summarizes a set of common drug combination principles by analyzing the existing prescriptions. We believe that CPMCP can promote the modernization of TCM and make greater contributions to MM. Database URL http://cpmcp.top

Clinical effectiveness of a combination of oxiracetam and traditional Chinese medicine rehabilitation program in the treatment of early stroke patients with hemiplegia

Purpose: To evaluate the efficacy of a combination of oxiracetam and traditional Chinese medicine rehabilitation program on early stroke patients with hemiplegia.&#x0D; Methods: 120 patients with early stroke hemiplegia admitted to Wuhu Fifth People's Hospital from March 2019 to July 2020 were recruited. They were equally and randomly assigned to either a control group or a study group, using the random number table method. The control group received oxiracetam, while the study group received oxiracetam plus a traditional Chinese medicine (TCM) rehabilitation program. Outcome measures included treatment effectiveness, motor function, neurological function, TCM symptom scores, and patient satisfaction.&#x0D; Results: There was significantly higher treatment effectiveness in the study group versus the control group (p &lt; 0.05). The Fugl-Meyer score of the control group was lower than that of the study group (52.49 ± 4.73 vs 74.73 ± 5.92; p &lt; 0.001). After treatment, patients in the study group showed lower neurological function and TCM scores than those in the control group (p &lt; 0.05). Furthermore, the study group showed higher satisfaction than the control group (p &lt; 0.05). Conclusion: The combination of oxiracetam and TCM rehabilitation program produce good treatment effectiveness in early stroke hemiplegia patients, and also boosts motor and neurological functions when compared to the use of oxiracetam alone. However, the combination treatment should be subjected to further clinical trials prior to application in clinical practice.&#x0D; Keywords: Chinese medicine rehabilitation program; Early stroke hemiplegia; Oxiracetam; Motor function; Nerve function

The efficacy and safety of the Xuesaitong soft capsule in the treatment of patients with ischemic stroke: systematic review and meta-analysis.

Ischaemic stroke is a common neurological disease and a leading cause of severe disability and death in developed countries. In most cases, stroke is thought to be a multifactorial disorder or complex trait for which classic patterns of inheritance cannot be shown. Xuesaitong is one of the most commonly used medicines for treating ischemic stroke in China. However, compared to the conventional therapy, the effectiveness and safety of Xuesaitong for ischemic stroke needs to be further systematically reviewed and determined. Relevant randomized controlled trials (RCTs) examining the use of the Xuesaitong soft capsule in the treatment of patients with ischemic stroke were identified from databases, including the China National Knowledge Infrastructure, Wanfang, PubMed, Embase, and Web of Science databases. Next, 2 researchers independently extracted information from the included studies, analyzed the data using STATA 15.0 software, and evaluated the quality of the included studies using RevMan 5.3. A total of 17 RCTs (comprising 1,942 patients with ischemic stroke) were included in the meta-analysis. The meta-analysis results showed that the Xuesaitong soft capsule treatment increased patients' total effective rate compared to conventional or other drug treatments, and improved patients' Clinical Severity Score (CSS scores) or Barthel index (BI) score. A further subgroup analysis stratified by different treatment times showed that Xuesaitong soft capsule treatment at 4 and 8 weeks improved CSS scores more than treatment at 2 weeks in patients with ischemic stroke. Additionally, the Xuesaitong soft capsule also significantly improved plasma viscosity, whole-blood viscosity at high and low shear rates, fibrinogen, hematocrit, and the effect on traditional Chinese medicine (TCM) single symptoms or signs in patients with ischemic stroke. In summary, compared to conventional or other drug treatments, the Xuesaitong soft capsule treatment was beneficial in improving patients' TCM symptoms (e.g., crooked mouth and tongue, and dizziness) and various indicators. Further, Xuesaitong soft capsule may be a safe and effective drug for the treatment of ischemic stroke. And large-scale randomized clinical trials are needed to further confirm our findings.

Effects of Chinese Herbal Formula on Immune Function and Nutritional Status of Breast Cancer Patients.

Background Chinese herbal formulas have certain effects on patients with breast cancer (BC). This article discussed the effect of Buqi Yangxue decoction on the immune function and nutritional status of BC patients and provided an evidence for traditional Chinese medicine (TCM) to improve the quality of life and curative effect of BC patients. Methods 66 cases of BC patients were divided into control group (n =33) and Chinese herbal formula group (n =33). The control group was received with TE chemotherapy, and the Chinese herbal formula group was received with Buqi Yangxue decoction combined with TE chemotherapy. Nutritional status, immune function, TCM symptom quantitative score, and adverse reactions were compared between the two groups. Results There was no difference in all indexes between the two groups before intervention. After 4 weeks, the nutritional indexes ALB, PA, TRF, and TP in Chinese herbal formula group were higher than those in control group, except HGb. CD3+, CD4+, and CD4+/CD8+ in both groups were sharply higher than before treatment, while CD8+ was dramatically lower, and the changes in Chinese herbal formula group were more obvious than those in control group. In Chinese herbal formula group, the levels of IgG, IgA, and IgM were sharply increased compared with control group. The TCM syndrome scores in both groups were decreased significantly after treatment, especially in Chinese herbal formula group. In addition, nausea and vomiting, inappetence, liver function impairment, leukopenia, and thrombocytopenia occurred in both groups. There was no clear difference in the incidence of adverse reactions between Chinese herbal formula group and control group. Conclusion Buqi Yangxue decoction can effectively improve the nutritional status and immune function of BC patients, which has important clinical significance for the later comprehensive treatment.