Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Phytotherapy ; Randomized Controlled Trials as Topic ; standards ; Treatment Outcome

In this paper, the concepts of surrogate outcomes and intermediary outcomes, their correlation with the primary outcome, how to select surrogate outcomes and intermediary outcomes and the particular requirements for using surrogate outcomes in assessing TCM clinical efficacy were discussed and described. It is difficult to evaluate clinical efficacy objectively and thoroughly by means of a single surrogate outcome for reason of the global characteristics of TCM, therefore, to rationally select such intermediary outcomes as important clinical symptoms, combination of several syndromes, patients' subject feeling, patients' satisfaction for treatment and quality of life, should be beneficial for objectively evaluating the efficacy of TCM intervention approaches.
Drugs, Chinese Herbal ; therapeutic use ; Health Status Indicators ; Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; methods ; Phytotherapy ; Treatment Outcome

This paper briefly introduced the general principles for causality in scientific researches and clinical studies, addressed the importance of population-based approaches in it, and also reviewed the developing course and presented the elementary requirements of randomized controlled trials (RCTs). The author identified with views that as compared with the research design of other types, RCTs is the most authentic one in the aspect of causality of efficacy and intervention. It is stressed that a causal inference for the efficacy assessment of traditional Chinese medicine (TCM) must meet the nomothetic criteria. The author emphasized that the scientific merits of RCTs are not only for assessing the efficacy of conventional treatments, but also for TCM intervention owing to RCTs yield stronger inferences about therapeutic intervention than other study designs, which are wildly accepted by academic communities.
Evidence-Based Medicine ; Humans ; Medicine, Chinese Traditional ; Randomized Controlled Trials as Topic ; Research Design ; Treatment Outcome

Evaluation Studies as Topic ; Humans ; Medicine, Chinese Traditional ; Publishing ; standards ; Quality Control ; Randomized Controlled Trials as Topic ; standards

HPS1-D, an active polysaccharide,was isolated and purified from Hedysarum polybotrys. HPS1-D was obtained after treated with Savage method and H2O2, and purified with DEAE-cellulose 52 and Sephadex G-100 gel filtration chromatography. Then physicochemical property analysis, GC, methylation, partial acid hydrolysis, and NMR method were used to study chemical structural of HPS1-D. The conformation was primarily analyzed with GPC-MALLS method and Congo red reaction. The anti-complementary activity of HPS1-D was evaluated with the hemolysis assay. HPS1-D was a heteropolysaccharide and consisted of D-glucose, L-arabinose, (7.2:1.3). HPS1-D proved to be a neutral sugar, with 1, 4-and 1, 4, 6-alpha-D-glucopyranosyl residues in backbone ,and 1, 5-and 1, 3, 5-alpha-L-arabinofuranosyl residues in branches. HPS1-D has a random coil state conformation with monodisperse mass distribution in 0.9% NaCl solution. And HPS1-D had triple-helix conformation in concentrate of NaOH solution. Anti-complementary activity of HPS1-D was closed to its positive control heparin.
Animals ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; Hemolysis ; drug effects ; Mice ; Plant Extracts ; chemistry ; pharmacology ; Polysaccharides ; chemistry ; pharmacology

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.
Diagnosis, Differential ; Humans ; Medicine, Chinese Traditional ; standards ; Syndrome ; Yang Deficiency ; diagnosis ; Yin Deficiency ; diagnosis

Viewing from some TCM concepts and basic characteristics of health, assimilating the operationalization concerning thinking and procedure of modern scientific research, the pilot form of Health Scale of TCM--initial health scale of TCM (iHSTCM) based upon TCM theory was developed. From November 2002 to January 2003, the domain, facets and items of HSTCM were finally established by analyzing the data from a survey of 652 persons in Guangzhou City using iHSTCM. In conclusion, the HSTCM has its theoretical ratio-nality and is applicable. It could be further applied in TCM clinical practice.
Adolescent ; Adult ; Aged ; Diagnosis, Differential ; Female ; Health ; Health Promotion ; methods ; standards ; Health Status Indicators ; Humans ; Male ; Medicine, Chinese Traditional ; methods ; standards ; Middle Aged ; Surveys and Questionnaires

Viewing from the concept of health and several basic characteristics of health outlook of traditional Chinese medicine (TCM), assimilating the thinking and procedure of modern scientific research concerning operationalization, in this paper, the TCM concept of health and its measurement operationalization as well as their relevant things were expounded. And the frame, related domain, indexes and items of health assessment scale based upon TCM theory were tried to be established using opertionalization method.
Health ; Health Status Indicators ; Humans ; Medicine, Chinese Traditional

OBJECTIVETo observe the effect of Bushen Yizhi Recipe (BSYZR) on neurotransmitter release in A beta segment neurotoxin induced NG108-15 cellular model of Alzheimer disease (AD).

METHODSThe levels of choline acetyltransferase (ChAT) activity, synapsin and functional synapse formation rate in the cellular model treated with BSYZR containing serum were determined by Western blot analysis, immunoradiometric assay and electrophysiologic technique.

RESULTSBSYZR containing serum treatment could cause increase of ChAT activity and synapsin level in model cells, as compared with those in normal control model cells treated with non-drug containing serum, it also could regulate the release capacity of transmitter and raise the functional synapse formation.

CONCLUSIONBSYZR could reduce the reaction of cell to A beta neurotoxin, indicating that it could be antagonistic to the pathological development of AD by means of raising the neurotransmitter release capacity.

Alzheimer Disease ; metabolism ; pathology ; Amyloid beta-Peptides ; metabolism ; Animals ; Cell Line ; Choline O-Acetyltransferase ; metabolism ; Drugs, Chinese Herbal ; pharmacology ; Neurotoxins ; pharmacology ; Neurotransmitter Agents ; metabolism ; Random Allocation ; Rats ; Rats, Wistar ; Synapsins ; metabolism

This paper discussed the concept, categorizations, methods and basic principles for establishing of soft index survey tools (SIST) in clinical medicinal field, pointed out the relation between the connatural theoretical and practical mode of TCM and the establishment of SIST having TCM characteristics, and elaborated several key points which should be paid attention to in the establishment of SIST. It was pointed out that there was broad space for application of SIST in TCM study.
Diagnosis, Differential ; Health Status Indicators ; Humans ; Medicine, Chinese Traditional ; methods ; Quality of Life ; Research Design ; Surveys and Questionnaires