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ABSTRACT: To evaluate the clinical adverse drug reactions (ADR) of Shuxuetong Injection (SXTI) comprehensively for its proper use and post-marketing reevaluation.
Electronic searching of the online Chinese and English medical databases were carried out from their inception to Feb. 2012, studies were screened and data were extracted according to inclusion and exclusion criteria; total number of ADR were calculated by study type respectively, ADR incidence rate was calculated by number of ADRs in experimental arm of clinical trials with control groups divided by total number of experimental groups.
Eighty and eight papers published concerning ADRs report of SXTI were included, including 65 clinical trials, 20 case reports, and 3 ADRs surveillance or analysis report. 174 ADRs were reported, mainly in circulation system, nervous system, the digestive system, skin and appendages. Adverse reaction type is mainly rash (44.3%) and the digestive system response (23.0%). The incidence rate calculated by data extracted from 65 clinical trials was 4.3%.
Allergic reaction is the most common ADR type of SXTI. Incidence rate of different studies varies, so a rigorously designed prospectively ADR surveillance study is needed to reevaluate its incidence rate, and analyze reasons of the heterogeneity. Information concerning ADR in literatures is always absent, the quality of reporting is relative poor, thus it is suggested that active, standardized, and systematic ADR reporting should be focused on in clinical trials.
Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica 09/2012; 37(18):2782-5.
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ABSTRACT: 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.
Database searches of Chinese Biomedical Literature Database, China Academic Journal Network Publishing Database and Chinese Scientific Journals Database were undertaken to identify published studies with the purpose of developing instruments in assessing the effectiveness of TCM, including papers regarding the construction of conceptual framework of instrument, item generation and selection and the evaluation of measurement properties.
A total of 60 pieces of literature involving 36 instruments were included. The first article on the development of each of the instruments was published between 2005 and 2011 and the instruments were used in many kinds of medical conditions, including cardiocerebrovascular, respiratory, digestive and infectious diseases. The number of items ranged from 10 to 52. Of the 36 instruments, 13 (36.1%) defined the hypothesized concepts measured by the instrument, 30 (83.3%) reported the domains of the questionnaires before measurement property testing and all of them were multidomain. Of 32 studies regarding item selection and the instrument's property evaluation, 14 (43.8%) articles reported the administration mode, 24 (75%) reported response option types, and 10 (31.5%) provided scoring algorithm for the scale, but none of these 32 studies specified the recall period. In 29 studies aiming at testing instrument's measurement property, 28 articles tested the Cronbach's α coefficient of the full scale and/or subscales, and retest reliability was also detected in 15 studies. Twenty-seven studies evaluated the construct validity by exploratory factor analysis and among them there were two studies applying confirmatory factor analysis. Content validity, responsiveness and feasibility of instruments were assessed in 11, 16 and 16 studies, respectively.
This study shows that in recent years many instruments have been developed in an attempt to evaluate the therapeutic effects of TCM, but some problems still exist in their practical implementation, including negligence in outlining the hypothesized concepts of the TCM instruments and in the reporting of instrument's content validity such as administration mode, scoring and recall period. Some instrument attributes and testing methods were misunderstood and/or misused. Revision of instruments is rarely carried out, though the development of an instrument is an iterative process. Researchers should have a thorough understanding of the general procedure and steps before starting to develop an instrument.
Journal of Chinese Integrative Medicine 07/2012; 10(7):726-37.
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Ze-huai Wen
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui, Zhongguo Zhong yi yan jiu yuan zhu ban 04/2011; 31(4):452-4.
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2011 IEEE International Conference on Bioinformatics and Biomedicine Workshops (BIBMW), Atlanta, GA, USA, November 12-15, 2011; 01/2011
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ABSTRACT: To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians.
Field investigation and direct inquiry were performed in the study. Two physicians from the same department judged tongue manifestation and pulse condition independently. The consistency among observers was assessed by means of Kappa statistics.
A total of 55 patients were included in the study. There were 13 inconsistent cases (23.6%) in tongue body observation and 7 cases (12.7%) in form of the tongue observation. The observation consistency of tongue body (Kappa=0.649) and form of the tongue (Kappa=0.752) were good. There were 24 inconsistent cases (43.6%) in tongue fur observation, the consistency of which was moderate (Kappa=0.525). There were 22 inconsistent cases (40%) in pulse condition diagnosis, the diagnosis consistency of which was also moderate (Kappa=0.562).
Observation and diagnosis consistency of tongue manifestation and pulse condition were moderately the same between different clinicians. By analyzing the reasons of inconsistency, it is necessary to improve the consistency in three aspects, such as the detailed-oriented criterion, the attitude of researchers and better training of researchers.
Journal of Chinese Integrative Medicine 12/2010; 8(12):1153-8.
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ABSTRACT: To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).
A cross-sectional investigation was carried out among 28 hospital staff members by using 151 scale descriptors. This investigation involved all the descriptors from the initial version of HSTCM. Each response scale had five ordinal descriptors, including two anchors at extreme levels and three intermediates. The participants were invited to determine the two anchors of extreme levels, and then to place each descriptor on a 10-centimeter (0 to 10 cm) line according to where they considered the descriptor lay in relation to the two anchors.
The selection of scale descriptors was based on comprehensive considerations regarding the median, average score and standard deviation of each descriptor. The main rule of selection was to choose the descriptor of extreme level anchor with a median value closer to 0 or 10, and the same for the selection of descriptors of the intermediates, which should possess a median value closer to 2.5 or 5 or 7.5. If two descriptors had similar median values, we compare the average score and/or the standard deviation of these descriptors and prefer to keep the one containing either an average score closer to anchor point or a less value of standard deviation. Furthermore, the codes of Chinese language were also considered. Four kinds of response scales including capacity, frequency, evaluation, and intensity with a total of 85 scale descriptors were selected. For HSTCM, a total of 8.24% (7/85) descriptors for 14.9% (7/47) items were revised based on the study results.
The scale descriptors selected are suitable for HSTCM and the results can be referenced in developing similar health profile assessment.
Journal of Chinese Integrative Medicine 09/2009; 7(8):717-23.
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ABSTRACT: To select the items from the Chinese menopause rating scale (CMRS) through pre-testing those people with menopausal syndromes.
293 people were surveyed in Guangzhou in 2005, among which 196 people with menopausal syndromes and others without. Psychometrics methods were employed to develop the scale. The item pools were all round. Methods used would include: focus group discussion and interviews, subjective evaluation method and Delphi method, to preliminarily screen the items. Data on scales measured from 196 cases with and 97 subjects without menopausal syndromes during the menopausal period, were collected. Again, seven statistical methods were employed to select the items.
The 40-items scale for menopausal syndrome was formed to include: a) three domains: somatic (18-items), psychological (14-items) and social (5-items); b) one general appraisal item; c) two lie-test items.
The Chinese menopausal syndrome scale we used seemed to possess good content validity, feasibility and intra-class reliability.
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi 11/2008; 29(10):985-8.
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ABSTRACT: To evaluate the feasibility, reliability, validity and responsiveness of a Chinese Menopause Rating Scale (CMRS).
Cross-sectional survey and convenience sampling were adopted. Participants: women with menopause syndrome and those in menopause but without menopause syndrome were recruited. All participants were asked to complete the CMRS, Kupperman Index, WHOQOL-BREF and MENQOL. The Self-control observation design was adopted when the responsiveness was evaluated. Patients were treated with TCM for weeks. MRSTCM was evaluated before and after the treatment.
(1) Feasibility: 3343 participants including 2320 patients and 1023 menopause women, were surveyed in 8 different settings. The recovery rate of CMRS was 100%, with a response rate as 99.7%. The completion of the CMRS took 10.30 minutes on average. (2)Reliability: Cronbach's alpha of CMRS, soma dimension, psychology dimension and community dimension of CMRS were 0.93, 0.87, 0.89 and 0.73 respectively, with the correlation coefficient of split half of the CMRS. Soma dimension, psychology dimension and community dimension were 0.92, 0.89, 0.86 and 0.73 respectively and the test-retest correlation coefficient of MRSTCM, the soma dimension, psychology dimension and community dimension were as 0.88, 0.91, 0.85 and 0.77 respectively. (3) Validity: CMRS was established on the basis of connotation of menopause syndrome, and a series of steps were adopted to modify the scale. CMRS was applicable for patients with menopause syndrome. CMRS seemed to have had good content-related validity. The result of exploratory factor analysis was accorded with the theory frame of CMRS by and large. The correlations between CMRS and KI, CMRS and WHOQOL-BREF, CMRS and MENQOL seemed good. The CMRS was able to discriminate between groups of people with or without menopausal syndrome and had good discriminative validity. (4) Responsibility: The CMRS was measured based on 174 patients with menopausal syndrome before and after the TCM therapy. Our result showed that the CMRS having the ability to measure the clinically important differences.
CMRS was suitable for outcome assessment of menopausal syndrome. This primary research proved that the CMRS had good feasibility, reliability, validity as well as responsiveness.
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi 10/2008; 29(9):882-6.
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ABSTRACT: To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires.
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.
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).
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.
Journal of Chinese Integrative Medicine 08/2008; 6(7):682-9.
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ABSTRACT: Starting from the thinking characteristics of TCM in the holistic approach of syndrome and process of syndrome differentiation, the problems in the criteria of syndrome diagnosis was analyzed, combining with the outcome of investigation on macrocosmic diagnosis of syndrome carried on twice by expert group nationwide in China, a concept for designing basic framework of standard for macrocosmic diagnosis of syndrome was advocated in this study. In order to recognize and master fully the standard, the following items would be the contents of the framework: give a standardized term of each syndrome; the basic clinical features of a syndrome; the qualitative parameters which could be used to distinguish the nature of a syndrome, and indexes to be used to judge the affected location of a syndrome during identifying process for a syndrome; the order of pertinent indexes with their given score, and the threshold for quantitative diagnosis. It is considered that the above framework defined the sufficient criteria which is constructed on the bases of the approaches with integrated qualitative and quantitative methods. It may enable the syndrome differentiation to access the real world of a patient to be used appropriately this framework.
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui, Zhongguo Zhong yi yan jiu yuan zhu ban 07/2005; 25(6):552-5.
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ABSTRACT: To introduce Menopause-Specific Quality of Life (MENQOL) into China, and to evaluate the quality of its Chinese Version.
MENQOL was translated into Chinese language and the reverse translation was done by several specialists. After retest study on 30 cases, validity, reliability and responsiveness were implemented in 409 cases with menopause syndrome in the multicenter study.
7 components were extracted in factor analysis, and the total cumulative contribution was 59.476%. By correlation analysis, 7 components were divided into four domains: vasomotor, psychosocial, physical and sexual items, same as in the English Version. The test-retest reliability of four domains were 0.806, 0.804, 0.941, 0.940 respectively. Cronbach alpha of four domains were 0.7258, 0.8234, 0.8475, 0.8641 respectively. There had been significant changes after treatment noticed.
The measurement properties of MENQOL-Chinese Version including effectueness, reliability were met with satisfaction and seemed to be adaptable to Chinese menopause women.
Zhonghua liu xing bing xue za zhi = Zhonghua liuxingbingxue zazhi 02/2005; 26(1):47-50.
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Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui, Zhongguo Zhong yi yan jiu yuan zhu ban 12/2004; 24(11):1022-5.
