Efficacy and safety of Xinglouchengqi decoction for acute ischemic stroke with constipation: study protocol for a randomized controlled trial

OBJECTIVE: To investigate the efficacy and safety of Xinglouchengqi(XLCQ) decoction in treatment of acute ischemic stroke with constipation.METHODS: In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of(5 ± 2) d and a 1-month follow-up.The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine(TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess.Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.DISCUSSION: The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation.     

Chinese Herbal Medicine for the Treatment of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome‑Associated Diarrhea: A Protocol for the Systematic Review and Meta‑Analysis of Randomized Clinical Trials

Diarrhea can occur at an early or advanced stage of acquired immunodeficiency syndrome (AIDS) as a usual symptom in people with human immunodeficiency virus (HIV) infection. While it is usually not fatal, it can influence patients’ quality of life seriously. It has shown to be efficacious and improves people’simmune statusto a certain extent to treat HIV/AIDS?related diarrhea on the basis ofsyndrome differentiation and treatment or Chinese herbs plus conventional treatment. Therefore, it may have a good application potential. Here, we outline a protocol for the systematic review of this health?care intervention, with the aim to evaluate the beneficial effects and safety of Traditional Chinese Medicine (TCM) for patients who suffer from HIV/AIDS?associated diarrhea. Randomized controlled trials that compare Chinese herbs with placebo or other effective treatments will be searched and included, in spite of publication status or language. The primary outcomes include diarrhea frequency and fecal character. The databases we will search as follows: China Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Wanfang Data, China National Knowledge Infrastructure, PubMed and the CENTRAL in Cochrane Library. Two authors will respectively conduct the screening of trials, data extraction, and use the Cochrane risk of bias tool to assess the methodological quality. We will analyze the data and perform a meta-analysis if possible. We intend to identify potential therapeutic modalities that may be of benefit to inform clinical practice by supplying existing evidence of the helpful effects and safety of TCM to treat patients suffering from HIV/AIDS?associated diarrhea.     

Meta‑analysis of Clinical Efficacy of Traditional Chinese Medicine in the Treatment of Aplastic Anemia

Background: The “Diagnosis and Treatment Guidelines for Chinese Medicine Internal Common Diseases” issued by the Chinese Institute of traditional Chinese medicine (TCM) offers many methods for the treatment of aplastic anemia (AA). However, there is a lack of corresponding evidence. Objective: The study aimed to evaluate the clinical efficacy of TCM in the treatment of AA, and provide evidence for the development of guidelines for the diagnosis and treatment of AA using TCM. Methods: Data of randomized or semi?randomized control trials of AA treatments with TCM were retrieved, and the selected literature was scored using the Jadad scale. The data were extracted, and RevMan 5.2.6 software was used for the meta?analysis. Results: Two studies on the treatment of AA using Liuwei Dihuang pills combined with compound Zaofan pill were included. The results of the meta?analysis showed that there were no statistically significant differences in the efficacy between Liuwei Dihuang pills combined with compound Zaofan pill and androgen in the treatment of AA (P = 0.65). However, there were less adverse reactions, including liver damage and the hirsutism of women, with the former than the latter (P < 0.05). Other studies on the treatment of AA with TCM did not include reports from clinical trials. Conclusion: TCM had a certain curative effect when used to treat AA. However, the quality of the literature is generally low, and the sample size is small, which makes the validation of the results poor. Further high?quality studies are needed to provide high?level evidence.     

Qiming granule in treating type 2 diabetic kidney disease patients:study protocol for a randomized controlled trial

Background:Diabetic kidney disease(DKD)is a chronic renal microvascular complication associated with abnormal glucose metabolism.According to traditional Chinese medicine(TCM)theory,Qi and Yin deficiency with blood stasis(the name of TCM symptoms,its main clinical features are fatigue,dry mouth,red or pale tongue,weak pulse,etc.)is the primary TCM syndrome of DKD,and Qiming granule(QMG)is suitable for the treatment of Qi and Yin deficiency with blood stasis syndrome.In view of this,we designed a randomized controlled trial to assess whether QMG is efficacious and safe in treating DKD patients.Methods:This protocol is for a randomized,double-blind,placebo-controlled,parallel group,six-centre clinical trial.A total of 180 participants will be randomized into the QMG group or placebo group,with a 1:1 ratio.The study will last for 50 weeks,including a 2-week run-in period,24 weeks of intervention,and 24 weeks of follow-up.The experimental intervention will be QMG,and the control intervention will be a placebo.The primary outcome will be the 24h urinary albumin excretion ratio and the change in the albumin-to-creatinine ratio.The secondary outcome will be evaluation of renal function,fundus changes,management of blood lipids,TCM symptom improvement and safety assessments.Adverse events will be recorded during the trial.Discussion:This study is a randomized controlled trial to test the effectiveness and safety of QMG for DKD patients.The findings of this study will help to provide evidence-based recommendations in treating DKD patients.Trial registration:Chinese Clinical Trial Registry,ChiCTR-TRC-12002953.Registered 23 December 2012.     

Traditional Chinese medicine for acute mountain sickness prevention:A systematic review and meta-analysis of randomized controlled trialsOA

Objective: To evaluate the efficacy of traditional Chinese medicine(TCM) for preventing acute mountain sickness(AMS).Methods: We included randomized controlled trials(RCTs) which evalueded the effect of TCM for preventing AMS, compared with a placebo, no treatment or acetazolamide. The literature was searched in 6major databases. RevMan 5.4 software was used for the meta-analysis. The relative risk for discrete variables and the mean difference for continuous variables with 95% confidence interv...     

Pharmacodynamic advantages and characteristics of traditional Chinese medicine in prevention and treatment of ischemic strokeOA

Ischemic stroke(IS) is a severe cerebrovascular disease with a high incidence, mortality, and disability rate. The first-line treatment for IS is the use of recombinant tissue plasminogen activator(r-t PA).Regrettably, numerous patients encounter delays in treatment due to the narrow therapeutic window and the associated risk of hemorrhage. Traditional Chinese medicine(TCM) has exhibited distinct advantages in preventing and treating IS. TCM enhances cerebral microcirculation, alleviates neurolo...     

Close Correlations Between Carotid Arterial Mean Blood Flow Velocity,Body Mass Index,and Temperature in Normal Individuals

Objective: Assessing carotid and radial pulses is an essential sphygmology method in traditional Chinese medicine(TCM). It is believed in TCM and by doctors that pulse force is markedly linked with the physiological state of a human, including body mass index(BMI) and temperature. However, comprehensive analysis elucidating these potential correlations remains undetermined. Therefore, this investigation aimed to assess the association of pulse strength with human metabolism. Materials and Method...     

A systematic review of randomized controlled trials examining the effectiveness of saffron(Crocus sativus L.) on psychological and behavioral outcomes

BACKGROUND:Throughout the past three decades,increased scientifi c attention has been given to examining saffron’s(Crocus sativus L.)use as a potential therapeutic or preventive agent for a number of health conditions,including cancer,cardiovascular disease,and depression.OBJECTIVE:The purpose of this systematic review is to examine and categorize the current state of scientifi c evidence from randomized controlled trials(RCTs)regarding the effi cacy of saffron on psychological/behavioral outcomes.SEARCH STRATEGY:Electronic and non-electronic systematic searches were conducted to identify all relevant human clinical research on saffron.The search strategy was extensive and was designed according to the"Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)."Reference lists of articles that met the inclusion criteria were searched.Only English language studies were reviewed.INCLUSION CRITERIA:Saffron trials in combination with other substances and saffron safety studies were considered,in accordance with the PRISMA statement.Included studies must have a control group.Included studies must measure a physiological and/or a behavioral outcome.DATA EXTRACTION AND ANALYSIS:The methodological quality of all included studies was independently evaluated by two reviewers using the Jadad score.Mean scores and P-values of measures were compared both inter-and intra-study for each parameter(i.e.,depression).RESULTS:Twelve studies met our inclusion criteria.These studies examined the effects of saffron on psychological/behavioral outcomes of:major depressive disorder(n=6),premenstrual syndrome(n=1),sexual dysfunction and infertility(n=4),and weight loss/snacking behaviors(n=1).The data from these studies support the effi cacy of saffron as compared to placebo in improving the following conditions:depressive symptoms(compared to anti-depressants and placebo),premenstrual symptoms,and sexual dysfunction.In addition,saffron use was also effective in reducing excessive snacking behavior.CONCLUSION:Findings from initial clinical trials suggest that saffron may improve the symptoms and the effects of depression,premenstrual syndrome,sexual dysfunction and infertility,and excessive snacking behaviors.Larger multi-site clinical trials are needed to extend these preliminary fi ndings.     

Efficacy of Traditional Chinese Medicine in the Treatment of Rash Caused by Epidermal Growth Factor Receptor Inhibitors: A Frequency Statistics and Meta‑Analysis

Objective: The aim of this study is to evaluate the efficacy of Traditional Chinese Medicine (TCM) in the treatment of rash caused by epidermal growth factor receptor inhibitors (EGFRIs). Materials and Methods: Foreign language database (such as PubMed, Web of Science, Cochrane Library, EMBASE) and Chinese language database (such as China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals [VIP], Wangfang, CBM disc) were searched for all trials of TCM in the treatment of rash caused by EGFRIs until January of 2019. We also looked through the references of relevant studies to supplement additional trials. The SPSS 25.0 was used for statistics of TCM with high frequency, and Review Manager 5.3 was used for meta-analysis. Results: A total of 22 studies were included in the study. We selected TCM whose frequency were >3.0%. They were Lonicera japonica（金银花）, Licorice Roots Northwest Origin（生甘草）, Cortex Dictamni（白鲜皮）, Radix Sophorae Flavescentis（苦参）, Schizonepeta（荆芥）, Saposhnikovia Divaricate（防风）. The meta?analysis revealed that the efficacy of TCM in treating EGFRIs?related rash was better than that of Western medicine or none. Conclusions: TCM could significantly relieve rash caused by EGFRIs, which is worth popularizing. Moreover, the mechanism deserves to be further explored.     

Physical and mental health conditions of young college students with different Traditional Chinese Medicine constitutions in Zhejiang Province of China

OBJECTIVE: To investigate Traditional Chinese Medicine(TCM) constitutions of youths in colleges,and their physical and mental health conditions of different TCM constitutions, so as to provide a theoretical basis for the TCM way to improve young people's physical and mental health.METHODS: The Standard TCM Constitutions' Classification and Determination Questionnaire was used to measure the body health condition, and the Symptom Checklist 90 Questionnaire and the Questionnaire of the National Student Physical Health Standards were used to determine mental and physical health conditions respectively in 1421 young participants validly answering the questionnaires in Zhejiang Province.RESULTS: The participants had a mean age of 19.96years(SD = 0.95 years) with the majority of females(55.10%). One fourth of the 1421 participants were the Ping-he constitution and others were the tendency constitutions. Participants with Ping-he module(which has characteristics of moderate posture,rosy, energetic and is a healthy condition in TCM)were healthier than those with tendency constitutions in physical and mental health, with 65.81 ±7.83(men) and 77.99 ± 7.24(women) scores in the physical test and around 1.25 scores in the mental health test. College students with combined biased constitutions were more likely suffer force, sensitive, depression and anxiety.CONCLUSION: Most of college students have a tendency or biased constitution which could be more likely to suffer suboptimal health status and diseases. Youths in college themselves and health providers should pay more attention to their potential health issues and make proper healthcare plan according to their own TCM constitution.     

Clinical Observation on Combination of Acupuncture and Medication in Treating Breast Hyperplasia简

Objective： To observe the clinical efficacy of acupuncture combined with medication in treating breast hyperplasia. Methods： One hundred patients with breast hyperplasia who met the inclusion criteria were randomly divided into an acupuncture combined with traditional Chinese medicine（A＆TCM） group and a traditional Chinese medicine（TCM） group, 50 cases in each group. The A＆TCM group received acupuncture combined with oral TCM; the TCM group only received oral TCM. After two courses of treatment, the efficacy was observed. Results： During the two treatment courses, the recovery rates had been increasing in both groups. The recovery rate of the A＆TCM group was 40.0% and the total effective rate was 98.0%. While the recovery rate of the TCM group was 18.0% and the total effective rate was 80.0%. According to statistical analysis, the differences of recovery rate and total effective rate between the two groups were statistically significant（P〈0.01）. Conclusion： Combination of acupuncture and TCM is more effective than simple oral TCM.     

Effect of herb-partitioned moxibustion on pain and quality of life in women with endometriosis: a protocol for a randomized clinical trial

OBJECTIVE: To investigate the effect of herb-partitioned moxibustion(HPM) on pain and quality of life in women with endometriosis.METHODS: Thirty-six patients will be randomly assigned to a treatment group or a wait-list control group. The treatment group will receive 12 sessions of HPM in the lower abdomen and lumbosacral region for 3 months. Wait-list participants will not receive any specific treatments until the trial is completed.RESULTS: The primary outcome measure is pain intensity assess...     

DEVELOPMENT OF A QUESTIONNAIRE TO FACILITATE CHINESE MEDICINE PATTERN DIFFERENTIATION OF LATERAL ELBOW PAIN(TENNIS ELBOW):RESULTS FROM A DELPHI PROCESS

Background: Acupuncture is a possible alternative treatment method for lateral elbow pain(LEP).Individualized acupuncture treatment has been practiced for pain therapy; however, studies on the underlying rational for individualized acupuncture treatment are limited.Objective: To develop a questionnaire using the Delphi process that can assist acupuncturists to assess the underlying traditional Chinese medicine(TCM) pattern of LEP.Methods: First, a multi-disciplinary research team was formed to conduct the Delphi survey.A provisional version of the questionnaire was developed by(1) comprehensive literature search on acupuncture for LEP as well as symptoms and TCM patterns associated with LEP;(2) extensive literature review from text books on TCM patterns;(3) meetings of a representative of the research team with specialized acupuncturists to consult expert opinion.Panelists of the Delphi survey consisted of experts with substantial clinical and research experience in acupuncture for LEP.A total of 33 international and national experts were invited by e-mail.The Delphi survey was terminated after two rounds.In each round consensus was defined by content validity index(CVI) of ≥ 0.51(representing a 51% level of consensus).Results: Consensus was found on 72 of the 74 symptoms that could be indicative for a specific TCM pattern of LEP.Consensus was achieved from all 25 panelists who responded to the second round on all four TCM patterns that could underlie LEP, namely, Invasion of Wind-Cold Dampness, Retention of Damp-Heat, Deficiency of Qi and Blood and Stagnation of Qi and Blood.A list of symptoms that indicate one of the four TCM patterns and a list of preferred treatment modalities for each pattern were also generated via CVI of ≥ 0.51 during the Delphi process.Conclusion: The current version of the Delphi-based questionnaire appeared to have considerable face and content validities.The reliability and validity are currently being tested.     

Investigation of the Test–Retest Reliability and Inter-Rater Agreement of Traditional Chinese Medicine-Based Pulse Practitioners

Objective: The objective of this study was to assess the test–retest reliability and inter-rater agreement between the traditional Chinese medicine(TCM) pulse diagnosis between two Indian TCM practitioners. Methods: A total of 300 participants were evaluated for their bilateral pulse based on TCM independently by two investigators with similar years of experience but who graduated from different medical schools.The investigators who were blinded diagnosed the participants as per TCM based on the...     

Efficacy and safety of activating blood circulation and removing blood stasis of Traditional Chinese Medicine for managing renal fibrosis in patients with chronic kidney disease: a systematic review and Meta-analysis

OBJECTIVE: To evaluate the efficacy and safety of activating blood circulation and removing blood stasis in terms of Traditional Chinese Medicine(TCM) for managing renal fibrosis(RF) in patients with chronic kidney disease(CKD). METHODS: We searched randomized controlled trials(RCTs) from eight databases. RESULTS: Sixteen eligible studies with 1,356 participants were included in this study. Compared to treatment with Western Medicine(WM) alone, the combined treatment with activating blood circul...     

Common traditional Chinese medicine therapies for diarrhea-predominant irritable bowel syndrome: An overview of systematic reviewsOA

Objective: To critically evaluate and summarize the methodological quality of systematic reviews(SRs)and present objective and important outcomes on the effectiveness of traditional Chinese medicine(TCM) therapies, including Chinese herbal medicine(CHM), acupuncture, and moxibustion, for diarrheapredominant irritable bowel syndrome(IBS-D).Methods: We conducted a comprehensive literature search for SRs in 7 databases until April 16, 2022.Two reviewers independently extracted data and assessed the...     

Effect of traditional Chinese medicine on anthracycline-induced cardiotoxicity in animal models:A systematic review and metaanalysis

Objective:To evaluate the effect of traditional Chinese medicine(TCM)on anthracycline-induced cardiotoxicity(AIC)in animal models.Methods:Separate systematic searches for preclinical studies were performed in the PubMed,EMBASE,Web of Science,Chinese National Knowledge Infrastructure,Chinese Biomedical Database,Chinese Scientific Journal Database,and Wanfang Data from inception to August 2019.The primary outcomes were echocardiography,serum assays for myocardial enzymograms,histological assessments,and electrocardiograms.The secondary outcomes mainly included body weight and safety evaluations.The protocol is registered on PROSPERO(CRD42019145819).RevMan(V.5.3)was used for meta-analysis.Results:We identified 10 studies from 9 international scientific publications describing the efficacy of TCM on AIC animal models.All the included studies reported that,compared with animal model without any intervention,TCM significantly improved ventricular function,cardiac biomarkers,electrocardiograph results,and cardiac fibrosis.Improved survival rates and body mass indices were also observed with TCM.We further pooled the available data from four studies(63 animals)for the meta-analysis and the results showed that,compared with models without any intervention,TCM significantly increased the ejection fraction by 14.13%(95%CI,9.96e18.29)and fraction shortening by 8.66%(95%CI,6.05 e11.26).Creatine kinase-MB(SMD=2.49,95%CI:-3.12 to-1.85)and lactate dehydrogenase(SMD=-2.78,95%CI:-3.45 to-2.12)were also significantly decreased by TCM.Conclusions:TCM is effective in improving AIC in animal models and has tremendous potential to be translated to treat AIC in clinical practice.Additionally,the systematic review and meta-analysis of animal experiments may be valuable in enhancing and guiding animal experiments and promoting the transformation of the results.     

Characteristics of Xiao Chai Hu decoction based on randomized controlled trials: A bibliometric analysisOA

Objective: To explore the characteristics of Xiao Chai Hu(XCH) decoction in randomized controlled trials(RCTs) using a bibliometric method.Methods: Seven databases including PubMed, Web of Science, Embase, Cochrane library, China National Knowledge Infrastructure(CNKI), Chinese Scientific Journal Database(VIP) and Wanfang database were retrieved from inception to May 27, 2022. In the study, XCH decoction(or modified) used alone or combined with conventional Western medicine as an intervention me...