Objective To study the effect of Bi Yuan Shu Liquid on melioration of clinical symptoms and signs of chronic nasal sinusitis or nasal polyp patients after Functional Endosoopic Sinus Surgery (FESS), and discuss the effectiveness of Chinese composite medicine in the overall treatment after FESS. Methods A total of 340 patients were randomly allocated to treatment group (n =170) and control group (n =170) according to simple randomization procedure. Patients in treatment group were administrated with quinolone, steroid, and Bi Yuan Shu Liquid, which were compared with those in control group who were given quinolone and steroid. Results The apparent effect of treatment group and control group were 30.6% and 42.4% of 42.4% of ITT. Results by Wilcoxon signed rank test indicated that there was a statistically significant difference. Conclusions Bi Yuan Shu Liquid may improve the effectiveness of sinus surgery, reduce the time course of antibiotics and hormones, and with out toxicity and side-effect.
Abstract： Objective To analyze the manifestation, treatment，outcome and potentially predisposing risk factors of perioperative thromboembolism after cavo-pulmonary connection, and to assess the effects of our prophylactic antithrombotic strategy. Methods Clinical data of 264 cases of bidirectional Glenn and 224 cases of total cavopulmonary connection （TCPC） operations undertaken from September 2005 to December 2010 in Fu wai hospital were retrospectively analyzed. Perioperative thromboembolic complications occurred in 9 patients. 5 of them were after bidirectional Glenn, 4 were after TCPC. Most of the 9 patients had at least one thrombi-related risk factor. The routine prophylactic antithrombotic therapy after these operations were intravenous infusion of heparin 10 U/（kg·h） initially, followed with oral aspirin 1-3 mg/（kg·d）. Results Thromboembolic events occurred within 7 days after the operation in 6 cases, appeared 2 to 4 weeks after the surgery in 3 cases. All 9 patients received anticoagulation with heparin. One patient also undertook take-down operation. 3 （33%） patients died, accounting for 33% （1/3）, and 18% （2/11） of the early deaths after bidirectional Glenn and TCPC operations. Clinical symptoms improved or disappeared in the remaining 6 patients. Conclusion The mortality of perioperative thromboembolic complications after cavo-pulmonary connection is high, consisting of the important cause of early deaths after these procedures. Our prophylactic anticoagulation strategy proved to be effective, though some thrombi-relatedrisk factors still need to be avoided.
Objective To assess the effectiveness and safety of traditional Chinese medicinal herbs for subfertility. Method Databases used including MEDLINE, EMBASE, CBM and the Cochrane Controlled Trial Register (CCTR). Potentially related trials in reference lists of studies were hand searched. Published RCTs in any languages and length whether they were blind or unblind, were included. Treatments were Chinese medicinal herbs (single or compound), and controls were placebo, standard medical intervention, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2 softeware. Results 7 randomized trials, including 1 042 patients met inclusion criteria. Methodological quality of all trials was poor. Chinese medicinal herbs were effective compared with routine antibiotics [RR 1.49, 95％CI (1.37 to1.62), Plt;0.000 01] and resulted in higher pregnancy rate [RR 1.46, 95%CI (1.09 to,1.96), P=0.01]. There were no adverse events reported in treatment group. Conclusions Some Chinese medicinal herbs may be effective for subfertility. However, the evidence is too weak to draw a conclusion. More strictly designed, randomized, double-blind, placebo-controlled trials are required.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
ObjectiveTo investigate the clinical effect and mechanism of Chinese heat-clearing and phlegm-resolving recipe in the treatment of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). MethodsA randomized controlled trial (RCT) was conducted. A total of sixty in-patients with AECOPD of phlegm heat and phlegm turbidity in lungs were randomly allocated to treatment group and control group with an equal number of patients between October 2009 and March 2010. The treatment duration was 10 days. Symptom scores of traditional Chinese medicine (TCM), pulmonary function, white blood cell count, polymorphonuclear neutrophils, C-reactive protein and the plasma concentration of bactericidal/permeability increasing protein (BPI) and interleukin (IL)-8 and IL-10 were detected. ResultsFor TCM syndrome of phlegm heat and phlegm turbidity, there was a statistical difference between the two groups after treatment (P<0.05). Cough, sputum amount, expectoration and coated tongue were improved obviously in the treatment group (P<0.05). The total explicit efficiency rate and effective rate were 56.0% and 84.0% in the control group and 82.1% and 92.9% in the treatment group respectively. The total explicit efficiency rate was significantly different between the two groups (P<0.05), while the total effective rate was not significantly different (P>0.05). Plasma concentration of IL-8 decreased markedly in the treatment group and IL-10 and BPI increased obviously. There was no significant difference in the change of BPI, IL-8 between the two groups (P>0.05), except for IL-10 (P<0.05). ConclusionChinese heat-clearing and phlegm-resolving recipe can improve signs and symptoms of TCM in the treatment of AECOPD (phlegm heat and phlegm turbidity in lungs), by the potential mechanism of increasing the level of IL-10.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
Diffuse large B-cell lymphoma is highly heterogeneous and is diagnosed according to the 2016 World Health Organization Classification of Tumours of Haematopoietic and Lymphoid Tissues. The decision of treatment should be upon age, International Prognostic Index score and the tolerability of chemotherapy. High-dose chemotherapy and autologous stem cell transplantation is the standard care for relapsed, chemotherapy sensitive patients. Clinical trials are recommended in specific conditions.
ObjectiveTo systematically analyze the distribution of research evidence on diabetes in current clinical practice guidelines of Chinese medicine (CM). MethodsThe PubMed, Embase, Cochrane Library, CBM, WanFang Data, CNKI, VIP databases and related guideline websites were electronically searched to collect clinical practice guidelines for CM in diabetes published before December 2023. We systematically reviewed the distribution of evidence in these guidelines. ResultsThe 27 CM guidelines on diabetes mainly covered syndrome differentiation and treatment, specific disease-specific drugs, diet, external therapies, and traditional exercises. The included guidelines used three different levels of evidence grading, with most of the evidence falling into the low-to-moderate level (67.3%). However, guidelines on diabetes-related osteoporosis, diabetic cardiomyopathy, prediabetes, and diabetic peripheral neuropathy had a relatively low proportion of high-level evidence, accounting for only 7.2%, 7.6%, 13.2%, and 13.3% respectively. Only guidelines on diabetic nephropathy provided evidence on the toxicity of Chinese herbal medicine, while other guidelines did not cover this aspect. Acupuncture, Tai Chi, Baduanjin, and other characteristics therapies had varying levels of evidence for different types of complications. Low-level evidence mainly focused on syndrome differentiation and treatment, symptom-based treatment, sign-based treatment, indicator-based treatment, Chinese patent medicine, specific disease-specific formulas, etc., for diabetes and related complications. ConclusionCurrently, topics supported by low/no evidence, new themes, inconsistent content between guidelines, evidence sources for overlapping targets, classical formulas, toxicity of Chinese herbal medicine, and characteristic CM therapies can provide directions for future research on CM in diabetes. We advocate addressing important issues related to diabetes specifically, to improve research value, eliminate unnecessary duplication of studies and resource waste, and promote the healthy development of CM research in the field of diabetes.
ObjectiveTo systematically review the prevalence of osteoarthritis in Chinese aged 40 and above from January 2000 to December 2019.MethodsPubMed, ScienceDirect, Wiley Online Library, The Cochrane Library, CBM, VIP, CNKI and WanFang Data databases were electronically searched to collect cross-sectional studies on osteoarthritis in Chinese aged 40 and above from January 1st, 2000 to December 31st, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using R 3.5.2 software.ResultsA total of 29 cross-sectional studies with a total sample of 60 711 cases and 19 707 patients were included. The results of meta-analysis showed that, the crude prevalence of osteoarthritis in Chinese aged 40 and over was 38.46% (95%CI 24.31% to 46.22%). Subgroup analysis results showed that the prevalence of lumbar osteoarthritis was the highest (24.79%, 95%CI 13.28% to 27.37%), followed by knee osteoarthritis prevalence (20.50%, 95%CI 14.51% to 27.23%) which increased with age. The prevalence of knee osteoarthritis in females (25.14%, 95%CI 19.54% to 31.19%) was higher than that in males (18.99%, 95%CI 13.86% to 24.71%). The prevalence of knee and lumbar osteoarthritis in rural areas was higher than that in urban areas. The prevalence of knee osteoarthritis in western China (23.59%, 95%CI 18.34% to 30.35%) was higher than that in eastern China (18.36%, 95%CI 12.43% to 27.92%) and central China (15.54%, 95%CI 11.22% to 21.53%). The prevalence of lumbar osteoarthritis in western China (31.17%, 95%CI 19.21% to 50.60%) was higher than that in eastern China (24.38%, 95%CI 16.26% to 36.54%). The incidence of cervical osteoarthritis in the eastern China (20.49%, 95%CI 13.90% to 30.21%) was higher than that in the western China (12.32% 95%CI 8.09% to 18.75%). The prevalence of hand osteoarthritis in western China (6.85%, 95%CI 2.71% to 8.13%) was higher than that in eastern China (2.7%, 95%CI 1.33% to 5.48%).ConclusionsCurrent evidence shows that the prevalence of osteoarthritis in Chinese aged 40 and above is high, and the prevalence of lumbar osteoarthritis is the highest, and the prevalence in western China is higher than that in eastern and central China, followed by knee osteoarthritis, in which the prevalence in females, rural areas, and western China is high. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.