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【 Objective:】 To understand subjects’ experiences and opinions on clinical trials of traditional Chinese medicine (TCM) and the process of informed consent during the process of participating in TCM clinical trials, and to provide reference for obtaining high-quality informed consent in TCM clinical trials. 【Methods:】 Using qualitative research methods, semi-structured individual in-depth interviews were conducted on 6 participants who had previously participated in TCM clinical trials. 【Results:】 Through data analysis, five major themes and several sub-themes were obtained, including the reasons why participants are willing to participate in TCM clinical trials, the concerns about unwillingness to participate, the information that they hope to be informed during the informed consent process, the specific content that they want to know in TCM clinical trials, and the evaluation of understanding and satisfaction with informed consent. 【Conclusion:】 In the process of informed consent in TCM clinical trials, attention should be paid to the explanation of adverse drug reactions of TCM, the reasonable arrangement and clear notification of the time for participants to participate in the trial, emotional humanistic care in the process of informed consent communication, and the value embodiment of subjects and their expectations for acquiring special knowledge of TCM.
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The grading of evidence is an important factor in clinical decision-making. The current evidence grading system based on western medicine is limited in the clinical practice of traditional Chinese medicine （TCM）， therefore we propose the solutions to the development of grading system for TCM interventional evidence， following the international evidence grading standards， taking into considerations of the unique characteristics of TCM practice， based on the Grades of recommendation， assessment， development and evaluation （GARDE） evaluation system， and integrating with grading system regarding TCM classical literature and empirical evidence from modern famous doctors. The evidence from classical literature is suggested to be evaluated from three aspects including source of ancient medical records， comprehensive of treatment details， and the inheritance. The qualification of famous doctors， content integrity， and inheritance of experiences will be used to evaluate the evidence from famous doctors' experience. The multi-sourced evidence such as TCM classical literature， experience of modern famous doctors， and modern researches is mainly integrated in a qualitative way， and the overall level of evidence of TCM interventions will be graded consistently with the GRADE system based on modern research. The evidence from classical literature and modern famous doctors' experience will be assessed and considered as supplementary evidence， which will make the evaluation of clinical evidence more objectively and comprehensively， thereby guiding clinical practice further.
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Data acquisition is one of the key links that influencing the quality of clinical research.Electronic data capture system (EDC) embodies the advantages of saving time,manpower and material resources and improving efficiency and reliability by data acquisition.CDISC has established worldwide industry standards to support the electronic acquisition,exchange,submission and archiving of clinical research data.The application of CDISC standards to EDC system is favorable in ensuring the validity and standardization of clinical data.This paper takes the Oracle's OC/ RDC (Oracle Clinical / Oracle Remote Data Capture) system as an example to discuss the application of CDISC standard to EDC system from the two aspects:direct application and indirect application.We suggest that data collection should be taken into account during the design phase of a clinical trial,and the CDISC standard be applied at the CRF design stage.A design for eCRF takes time and effort by the combination of EDC system and CDISC standard,while thoughtless design may collect the wrong data.Therefore,it is suggested that a specialized personnel should be put in charge of eCRF design and maintenance during the operation of EDC system,and a set of standardized eCRFs based on CDISC standard and standard operating procedures should be built in one organization.
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Objective To evaluate the efficacy and safety ofGuipi Decoction vs. antidepressants for depression. Methods Articles about the randomized controlled trials (RCTs) ofGuipi Decoction for depression were searched in the databases of CNKI, VIP, Wanfang Data, CMB, Embase, PubMed, and Cochrane Library. Two researchers independently screened the articles, extracted the data, and evaluated the methodological quality. Meta-analyses were performed by using RevMan 5.2 software.Results A total of 9 RCTs articles involving 893 cases were included. Meta-analysis results suggested that as compared with antidepressants only,Guipi Decoction together with antidepressants was associated with a significantly greater reduction in HAMD scores (MD=-4.63, 95%CI [-5.95, -3.32];P<0.001). There was no significant difference in HAMD scores betweenGuipi Decoction used alone and antidepressants (MD=-0.30, 95%CI [-4.22, 3.62];P=0.88). As compared with antidepressants,Guipi Decoction together with antidepressants increased in the rates of total effective events (RR=1.26, 95%CI [1.14, 1.38];P<0.001). No serious adverse reactions were reported. Meta-analysis results suggested that the incidence of adverse reactions of Guipi Decoction(RR=0.48, 95%CI [0.40, 0.58];P<0.001) andGuipi Decoction together with antidepressants (RR=0.51, 95%CI [0.30, 0.85];P=0.010) were lower than that of antidepressants alone.Conclusion The present evidence suggests thatGuipi Decoction is effective and relatively safe for patients with depression. However, because the quality of included research was low, more large-scale RCTs with multicenter and high quality are needed for further verification.
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Due to the differences between Chinese and Western cultures, Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine (TCM). Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM. This study aims to understand the current situation of research in the development of evaluation instrument in TCM.
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To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians.
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To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).
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OBJECTIVE: To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires. METHODS: A cross-sectional survey was conducted at Liwan Community of Guangzhou, Old People's Home in Guangzhou and Outpatient Department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 652 Chinese individuals (over 18 years old) were assessed with the 88-item version of HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF), which were randomly delivered to them. Some socioeconomic characteristics were registered. RESULTS: A test-retest reliability (15-day interval) was found among the 76 persons who completed the questionnaires by themselves. Intra-class correlation coefficient (ICC) was 0.93. Associated 95% confidence interval (CI) was 0.89-0.96. Split-half reliability was 0.79. Inter-investigator reliability (0.93) was also good, and the ICC of HSTCM was 0.90 (95%CI 0.67-0.97). The correlation between HSTCM and WHOQOL-BREF was -0.66. The correlations of HSTCM and questionnaire deliver order, investigator, interview date and interview time were 0.06, -0.12, -0.17 and 0.20 respectively. The correlation between HSTCM and self-rated health (0.46) was greater than that between HSTCM and chronic illness (0.28). Divided by individuals with or without chronic illness, area under the ROC (receiver operator characteristic) curve for HSTCM was 0.67 (95%CI 0.63-0.71). CONCLUSION: It indicates that the HSTCM is conceptually valid with satisfactory psychometric properties and forms a basis for further applications in clinical research of traditional or integrative medicine.
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Objective To obtain an accurate prevalence of dementia and Alzheimer's disease (AD) in large sample of ≥75 year old elderly living in Guangzhou city. Methods From August 1994 to December 1995, the study was conducted in Liwan District of Guangzhou, China. A two stage cluster sampling design was used to obtain a large sample. ‘Jiedao’ (resident unit in China) was the primary sampling units (PSU),‘Jumin Xiaozu’ (resident group) was the secondary sampling units (SSU). Systematic sampling and simple random sampling procedures were used for the first and second stages, respectively. The study was divided into two phases: a door to door survey of the entire sample aged ≥75 years (4 735 persons), followed by a clinical examination of suspected cases for positive and differential diagnosis. In the first phase, mini mental status examination (MMSE) was used as screening method for dementia. In the second phase, dementia and AD were clinically diagnosed according to the criteria of Diagnostic and Statistical Manual for Mental Disorders (DSM III R) , National Institute of Neurological and Communicative Disorders (NINCDS) and Stroke Alzheimer's Disease and Related Disorders Association (ADRDA). Results The sensitivity and specificity of MMSE were 0 7451 and 0 7496 respectively while the positive predictive value was 0 2251. The prevalence of dementia in individuals aged 75 years and over was 8 90%, in which male and female were found to be 2 91% and 13 11%, and that of AD was 7 49%, male and female found to be 2 01% and 11 36% respectively. The prevalence of vascular dementia (VD) was 1 16%. Of the subjects with dementia, 84 24% was diagnosed Alzheimer's disease, 13% VD, and 2 76% dementia with other causes. The proportion of AD increased obviously by every 5 years. Conclusions The prevalence of dementia in ≥ 75 year persons was lower in Guangzhou than that in Shanghai, but was higher than that in other regional studies within China. In ≥75 year male and/or poorly educated female were more easily suffered from AD. The proportion of AD in dementia was higher in this study than that in others. These figures indicated that as a screening tool for dementia MMSE need improving and should be combined with ADL and POD together.
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Objective To study the anticoagulant and fibrinolytic mechanism of vascular endothelial cells in rabbit model of blood stasis syndrome (BSS). Methods BS S rabbit model was induced by injection of noradrenaline and bovine serum albumin . The aortic endothelial cells from the normal rabbits (Group A)and BSS rabbits (Group B)were cultured primarily and subcultured. The activities of antithrombin Ⅲ (AT_Ⅲ), tis sue_type plasminogen activator (t_PA) and plasminogen activator inhibitor (PAI) in the plasma of rabbits and cultured supernatant were measured. Results The activities of t_PA and AT_Ⅲ were obviously decreased and PAI activity incre ased in the plasma of BSS model rabbits as compared with those of the normal rabbits (P 0.05 ). Conclusion Anticoagulant and fibrinolytic dysfunction p lays an imp ortant role in the occurrence and development of BSS.
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Objective To explore the molecular mechanism of blood_stasis syndrome (BSS) by studying the changes of gene expression of endothelin (ET) and constit utive nitric oxide synthase (cNOS) in vascular endothelial cells (VEC) cultured w ith BSS rabbit serum. Methods ET_1 mRNA expression and cNOS mRNA expression were analyzed by semi_quantitative reverse transcription and polymerase chain re action method. Results ET_1 mRNA expression level was increased and cNOS mRN A expression level was decreased in VEC cultured with BSS rabbit serum (Group A) as compared with VEC cultured with normal rabbit serum (Group B) or without rab bit serum (Group C) (P
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Objective To observe the protective effect of Xuefu Zhuyu Decoction (XZD) on vascular endothelial cells (VEC) injured by the serum of blood_stasis_syndrome ( BSS) rabbits. Methods The morphological features of VEC cultured with norma l rabbit serum (Group A), BSS rabbit serum(Group B), the serum of normal rabbit medicated with XZD(Group C) and the serum of BSS rabbit medicated with XZD(Group D) were observed respectively under light microscope and electron microscope. Results Under light microscope, VEC was shrinked, intercellular space widene d and cytoplasm contained dark granules in Group B. The change of intercellular space was not obvious in Group D. Under electron microscope, pinocytotic vesicle s increased, rough endoplasmic reticulum (RER) decreased and dilated, mitochondr ia became smaller and indistinct and only a small amount of microvilli appeared on cell membrane with top expanded and merged in VEC of Group B as compared with Group A and Group C. Less RER but no dilatation and fewer microvilli without to p merged were found in VEC of Group B. Conclusion The serum of BSS rabbits c an injury normal VEC cultured in vitro and XZD exerts a certain protective effe ct on VEC injured by the serum of BSS rabbits.