Quality of Life and Chinese Medicine──The Development of Health Status Measures for Chinese Medicine

Quality of Life (QOL) is a multiphase conception, including physical, mental and social factors, and can overall reflect health status of the human. At present, QOL has become a relevant measure of efficacy of treatment in clinical trials. Its use is spreading, and its importance is growing as a valid indicator of whether or not a medical treatment is

Quality Marker Concept Inspires the Quality Research of Traditional Chinese Medicines

Traditional Chinese medicines （TCMs） have been used in China for thousands of years for the treatment of various diseases, highly treated as the Chinese cultural heritage. It has played the pivotal role in maintaining the health of Chinese people and even the entire globe.

Assessing the Quality of the First Batch of Evidence-Based Clinical Practice Guidelines in Traditional Chinese Medicine

Objective: To assess the quality of the first batch of Chinese evidence-based clinical practice guidelines (CPGs) in Traditional Chinese Medicine (TCM) using the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. Methods: Evidence-based CPGs in TCM supported by the World Health Organization Western Pacific Regional Office (WHO/WPRO) and whose development was organized by the China Academy of Chinese Medical Sciences were identified and manually retrieved. CPGs were assessed using the AGREE instrument, and the data in each CPG were analyzed in terms of the six domains in the AGREE instrument: scope and purpose, stakeholder involvement, rigor of development, clarity and presentation, applicability, and editorial independence. Results: Twenty-eight CPGs were identified, of which 26 were included in the study. The AGREE instrument rated the 26 CPGs in terms of the six domains. The assessment results showed the following average scores: for editorial independence, 84.16%; for rigor of development, 80.95%; for scope and purpose, 79.96%; for clarity and presentation, 70.88%; for stakeholder involvement, 61.28%; for applicability, the average score was only 27.09%. In summary, nine CPGs were rated as "strongly recommended", six as "recommended with provision or alternation", and 11 as "unsure". Conclusion: Most of the first batch of Chinese evidence-based CPGs in TCM had significant shortcomings in applicability. It is suggested that special attention be paid to enhancing the quality of applicability when developing evidence-based CPGs in TCM.

Quality Assessment of Clinical Research on Liver Cancer Treated by Intra-Arterial Infusion of Chinese Medicine

Objective：To assess the methodological quality of clinical research on Chinese medicine（CM）applied by infra-arterial infusion in treating primary liver cancer（PLC）.Methods：Cochrane Central Register of Controlled Trials（CENTRAL）,PubMed,and three Chinese databases,including Chinese BioMedical Database（CBM）,China National Knowledge Infrastructure（CNKI）and China Academic Journal（VIP）were searched.Chinese articles were also searched manually in 16 journals.Two reviewers independently selected studies,the quality of literatures were assessed according to the Cochrane Collaboration method of quality assessment.Results：A total of 14 articles met the inclusion criteria for this review.Only three of these articles described the randomization method used.None of the studies was blinded.All of the articles didn＇t report the calculation of the sample size.Only six studies mentioned adverse reactions.All of the studies were of grade C according to the Cochrane Collaboration method.Six studies reported results of survival,and only two of these reported better efficacy in the treatment groups.Conclusions：The quality of studies concerned intra-arterial infusion of CM in treating with PLC was poor and the exact effect of these medicines still need evaluation.Well designed RCTs with large sample sizes,adequate follow-up data and reliable methods of assessment are needed to better appraise the real effect of CMs in the treatment of PLC patients.

Clinical and Psychometric Validation of the Quality of Life Assessment System for Advanced Gastric Cancer Based on Traditional Chinese Medicine

Objective： To establish questionnaire scaling and reliability and examine the clinical and psychometric validity of the quality of life assessment based on Traditional Chinese Medicine for advanced gastric cancer（QLASTCM-Ga）. Methods： The QLASTCM-Ga was developed based on programmed decision procedures with multiple nominal and focus group discussions, in-depth interview, pretesting and quantitative statistical procedures. The questionnaire was administered to 240 patients diagnosed with advanced gastric cancer before and after treatment. Structured group methods were employed to establish a general and a specific module respectively. The psychometric properties of the scale were evaluated with respect to validity, reliability and responsiveness. Results： The three identified scales of the QLASTCM-Ga and the total score demonstrated good psychometric properties. Test-retest reliability of the total scale and all domains ranged from 0.90 to 0.94, and internal consistency ranged from 0.86 to 0.93. Correlation and factor analysis demonstrated good construct validity. Significant difference in the subscales and the total score were found among groups differing in traditional Chinese medicine syndrome, supporting the clinical sensitivity of the QLASTCM-Ga. Statistically significant changes were found for each scale and the total score. Responsiveness was also good. Conclusions： The QLASTCM-Ga demonstrates good psychometric and clinical validity to assess quality of life in patients with advanced gastric cancer undergoing traditional Chinese medicine therapy. This study is an important first step for future research in this area.

Health related quality of life:is it another comprehensive evaluation indicator of Chinese medicine on acquired immune deficiency syndrome treatment?

Health related quality of life(HRQOL) can better reflect changes in acquired immune deficiency syndrome(AIDS) patients and inform economic evaluation of AIDS treatment services,and the assessment of HRQOL can help us to detect problems that may influence the progression of the disease,hence HRQOL has become a particularly important assessment indictor for HIV comprehensive interventions.Being a multi-angle,multi-level,and diversified complex intervention,roles of Chinese medicine(CM) in AIDS treatment have been recognized and accepted by more and more patients,and HRQOL has been widely used to evaluate the comprehensive management effects of CM on AIDS.In this article,the authors analyze the definition and measurement of HRQOL,measurement of HRQOL of HIV/AIDS patients and effects of CM on AIDS,and give some reasonable advices for the usage of the scale of HRQOL.The authors hold that some new HRQOL instruments specific for CM treatment of AIDS should be developed and further prospective studies should be carried out to demonstrate the practicality,reliability and validity of HRQOL as an evaluation indictor for CM treatment of AIDS.

Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.

QUALITY CONTROL OF TRADITIONAL CHINESE MEDICINES: INVESTIGATION ON CHEMICAL MARKERS

Traditional Chinese medicines(TCMs)have played an important role in the treatment of diseases for thousands of years.With the rise of the combination therapy for multi-gene diseases,TCMs attracted more attentions gradually.However,TCMs is a complex system which could contain tens,or even hundreds of compounds.Selection of chemical markers is thus a key to the

State Key Laboratory of Quality Research in Chinese Medicine(Macao University of Science and Technology)

The State Key Laboratory of Quality Research in Chinese Medicine （Macao University of Science and Technology） was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of China. It is so far the only State Key Laboratory （SKL） specifically in the field of Traditional Chinese Medicine （TCM） over the country. It is also the jothed-laboratory partner of the State Key Laboratory of Natural and Biomimetic Drugs at the Peking University.

State Key Laboratory of Quality Research in Chinese Medicine(Macao University of Science and Technology)

The State Key Laboratory of Quality Research in Chinese Medicine （Macao University of Science and Technology） was formally established on January 25, 2011 upon approval from the Ministry of Science and Technology of China. It is so far the only State Key Laboratory （SKL） specifically in the field of Traditional Chinese Medicine （TCM） over the country. It is also the joined-laboratory partner of the State Key Laboratory of Natural and Bimnimetic Drugs at the Peking University.

MHC-2D LC STRATEGY FOR THE HOLISTIC QUALITY CONTROL OF NOTOGINSENG-CONTAINING CHINESE PATENT MEDICINES

Current China Pharmacopoeia(ChP)standards employ diversified and case-dependent assay methods to evaluate the quality of different Chinese patent medicines(CPM)that contain Panax notoginseng as the monarch drug.These conventional HPLC-based approaches utilizing complex sample preparation procedure can easily result in low analytical efficiency and possible component loss.We thereby propose a'monomethodheterotrait matrix'(MHM)

A Systematic Review of RCTs and quasi-RCTs on Traditional Chinese Patent Medicines for Treatment of Chronic Hepatitis B

Traditional Chinese patent medicines (TCPMs) are widely used for treatment of chronic hepatitis B (CHB) in China. To estimate the overall effectiveness of TCPMs for CHB, we performed a systematic review of clinical reports designed as randomized controlled trials (RCTs). One hundred and thirty-eight available RCTs and quasi-RCTs on 62 TCPMs, involving 16,393 patients, were included. The methodological quality of these trials was generally "poor". Few trials (6.52%) reported the methods of randomization correctly. Another common problem was the lack of allocation concealment, proper blinding, and the reporting of lost cases and dropouts. Forty-two trials (30.43%) on 27 TCPMs reported some anti-viral effect of TCPMs. Others reported beneficial aspects, including improvements of liver function (79.71% of the studies), liver fibrosis (29.99%), and CHB symptoms (92.75%). Forty-one articles (29.71%) reported mild adverse events with TCPMs but these occurred infrequently. In summary, the outcome of the report on currently registered TCPMs may be biased due to poor methodology. The data from these trials, therefore, is too weak to use in forming a recommendation for treatment of CHB. Nevertheless, five drugs (Dan Shen agents, Da Huang Zhe Chong pill/capsule, Shuang Hu Qing Gan granule, Fu Zheng Hua Yu granule and Cao Xian Yi Gan capsule) appear to be more effective than the other TCPMs.

Effect of Health Education Based on Integrative Therapy of Chinese and Western Medicine for Adult Patients with Type 2 Diabetes Mellitus： A Randomized Controlled Study

Objective： To investigate the effects of health education based on integrative therapy of Chinese and Western medicine for type 2 diabetes mellitus（T2DM） from the aspects of knowledge, attitude and practice（KAP）, health-related quality of life（HRQo L）, body mass index（BMI） and glucose control. Methods： Patients were individually randomized into intervention group（receiving integrative education, n=120） and control group（receiving usual education, n=120）. The primary outcome was the changes in glycosylated hemoglobin A1c（HbA1c） levels after 3, 6, 9 and 12 months from baseline. Hierarchical linear models（HLMs） were used to assess within-group changes in outcomes over time and between-group differences in patterns of change. Secondary outcomes were KAP scores, HRQo L scores and BMI after 6 and 12 months, paired-sample t test was used to assess within-group changes in outcomes in 6 and 12 months, independent-sample t test was used to assess between-group differences in patterns of change. Results： HbA1c decreased statistically from baseline to 3 months, from 3 to 6 months, from 6 to 9 months and from 9 to 12 months in the intervention group（all P〈0.01）; and decreased significantly from baseline to 3 months, and from 3 to 6 months in the control group（P〈0.01）. There were significant between-group differences from baseline to 3 months（P=0.044）, from 6 to 9 months（P〈0.01） and from 9 to 12 months（P〈0.01）. Significant improvements in the intervention group along with significant between-group differences were found in KAP and HRQo L scores respectively（all P〈0.05）. The number in the intervention group of normal weight increased from 56 at baseline to 81（6 months）, 94（12 months）, the number in the control group were 63（baseline）, 69（6 months）, 70（12 months）, the χ~2 of hierarchical analysis of BMI were 6.93（P=0.075）, 10.31（P=0.016）, 15.53（P〈0.01）, respectively. Conclusion： Health education based on integrative therapy of Chinese and Western medicine is beneficial to the control of T2DM and should be recommended for T2DM.