Berberine Enhances Intestinal Mucosal Barrier Function by Promoting Vitamin D Receptor Activity.

OBJECTIVE: To evaluate if berberine can act on vitamin D receptors (VDR) and thereby regulate the expression of tight junction proteins (TJPs) in irritable bowel syndrame-diarrhea-predominant (IBS-D) rats. METHODS: The newborn rats were induced into IBS-D rat model via neonatal maternal separation combined with acetic acid chemical stimulation. After modeling, the model was evaluated and rats were divided into the control group and berberine treatment groups (0.85, 1.7 and 3.4 mg/kg, once a day for 2 weeks). The distal colon was obtained and colonic epithelial cells (CECs) were isolated and cultured after IBS-D model evaluation. The vitamin D receptor response element (VDRE) reporter gene was determined in the CECs of IBS-D rats to analyze the effect of berberine on the VDRE promoter. VDR overexpression or silencing technology was used to analyze whether VDR plays a role in promoting intestinal barrier repair, and to determine which region of VDR plays a role in berberine-regulated intestinal TJPs. RESULTS: The IBS-D rat model was successfully constructed and the symptoms were improved by berberine in a dose-dependent manner (P<0.05). The activity of VDRE promoter was also effectively promoted by berberine (P<0.05). Berberine increased the expression of TJPs in IBS-D CECs (P<0.05). VDR expression was significantly increased after transfection of different domains of VDR when compared to normal control and basic plasmid groups (all P<0.05). RT-qPCR and Western blot results showed that compared with the blank group, expressions of occludin and zonula occludens-1 were significantly higher in VDR containing groups (all P<0.05). Berberine plus pCMV-Myc-VDR-N group exerted the highest expression levels of occludin and zonula occludens-1 (P<0.05). CONCLUSION: Berberine enhances intestinal mucosal barrier function of IBS-D rats by promoting VDR activity, and the main site of action is the N-terminal region of VDR.

Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial.

BACKGROUND: Irritable bowel syndrome (IBS) is one kind of common functional bowel disease with obscure pathogenesis, and exploration about whole transcriptome profiling in IBS-D is still negligible. Conventional medications have limited effects, which makes focus shifted to traditional Chinese medicine (TCM). Tong-Xie-Yao-Fang, as a classic herbal formula in TCM, is pretty effective and safe for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), but the underlying therapeutic mechanism remains unknown. We aim to verify the efficacy and safety of TXYF granule (the formula particles mixed together) in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXYF granule based on whole transcriptome analysis. METHODS/DESIGN: This is a randomized, double-blind, and placebo-controlled clinical trial consisting of 2 weeks of run-in period, 12 weeks of treatment period, and 8 weeks of follow-up period. We will enroll 120 participants with IBS-D, who will be randomly assigned to the TXYF granule group and the placebo group, and recruit additional 10 healthy individuals as controls for mechanistic outcome. The two groups respectively take TXYF granule or placebo orally for treatment. The primary outcome is the response rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes include adequate relief (AR), IBS-Quality of Life Questionnaire (IBS-QOL), and long-term efficacy. Mechanistic outcome is the whole transcriptome profiling of the intestinal mucosae from IBS participants before and after the treatment and healthy individuals. DISCUSSION: This trial will prove the effectiveness and safety of TXYF granule with high-quality evidence and provide a penetrating and comprehensive perspective on the molecular mechanism of IBS-D by whole transcriptome analysis, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXYF. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-IOR-1900021785 . Registered on 9 March 2019.

Reviews and Thoughts on the Relevance between Qualitative Chinese Medicinal Properties and Quantitative Material Components.

OBJECTIVE: Chinese Medicinal Properties (CMP) play a vital role in theoretical research and clinical practice. However, the traditional CMP system is subjective, qualitative, fixed, inconsistent, and obscured. Nowadays, quantifying CMP research achieved a notable progress. This study aims to review and reflect the relevance between qualitative CMP and quantitative material components. METHODS: A raw literature search was performed firstly in CNKI and Pubmed database to get a rough idea on the general advances in measuring CMP. Then, a strict literature search and data extraction from two dependent research studies were performed to analyze the relevance and discrimination between CMP and material components. RESULTS: The quantitative CMP research mainly focused on the microelements and chemical compositions. The largest microelements research listed 747 Chinese Materia Medica (CMM) (6780 flavors) and 120,000 element data. The measurement of chemical composition of CMM has risen rapidly in the 1990s and continues till the present. Thirty-seven articles were finally identified for the relevance analysis of CMP and material components. Of these, 18 and 19 articles correspondingly focused on the chemical compositions and microelements, and 26 and 11 articles correspondingly focused on their correlation and discrimination relationship. The most commonly used method for correlation analysis is intuitive analysis. The support vector machine maybe highly efficient and would act as the preferred method in discriminant analysis. Twelve (67%) and 5 (26%) articles' data came from the literature search in chemical compositions and microelement research studies. Four studies indicated that the research objects are the basic substances and material basis of CMP, 15 articles claimed that the chemical compositions were significantly related to CMP, 12 research studies concluded that the regularity and causality were identified between the research objects and CMP, and 9 research studies successfully established discriminant models for CMP basing on the detected substances. CONCLUSIONS: The relevance research between qualitative CMP and quantitative material components achieved a positive progress, though it is weak and defective. Standardizing the qualitative CMP system, establishing series comprehensive databases for the material components, innovating statistical and data mining methods, and integrating doctors' experiences are important and feasible for future research.

Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials.

BACKGROUND: Modified Sijunzi decoction (SJZD) has been used to treat ulcerative colitis (UC) in remission. However, more rigorous clinical trials are necessary to evaluate its effectiveness. Therefore, a series of single-case randomised controlled trials (N-of-1 trials) is proposed to compare the efficacy of modified SJZD with mesalazine for treating UC in remission. METHODS: This is a single-site, hospital-based, double-blind N-of-1 trial for 10 single subjects. Three cycles of N-of-1 trials are planned. There are two treatment periods in each cycle. Modified SJZD combined with mesalazine placebo or mesalazine combined with modified SJZD placebo will be randomised during each 8-week treatment period. There is no washout period in the study. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria. DISCUSSION: Paired t tests and mixed-effect models will be used to analyse the visual analogue scale (VAS) for clinical symptoms and the quality of life questionnaire responses. The findings will be interpreted with caution. We anticipate that the results will show that modified SJZD is effective for patients with UC in remission. TRIAL REGISTRATION: Chinese Clinical Trial Register, ID: ChiCTR1900024086. Registered on 24 June 2019.

Efficacy of traditional Chinese Medicine for gastric precancerous lesion: A meta-analysis of randomized controlled trials.

OBJECTIVE: To evaluate efficacy of traditional Chinese medicine (TCM) for gastric precancerous lesion (GPL). METHOD: Literature retrieval was conducted in seven databases from their inception through Dec. 24th, 2018. The Cochrane collaboration, Review Manager (RevMan5.3) and GRADE profiler software were conducted for this meta-analysis. RESULTS: In primary outcomes, results of meta-analysis showed that TCM had superior to current routine pharmacotherapy (RP) in clinical efficacy, Helicobacter pylori (Hp) eradication rate, efficacy under endoscopy, and TCM syndrome efficacy. Meanwhile, no potential publication bias was detected by Begg's and Egger's tests. In secondary outcomes, compared with control groups, experimental groups were more positive effects on improvement of stomach distention, stomachache, and heartburn. CONCLUSION: Our findings indicated that TCM could have positive effects on GPL. However, further standardized RCTs of rigorous design should be required to obtain more forceful evidence.

Development of a Traditional Chinese Medicine Syndrome-Specific Scale for Ulcerative Colitis: The Large Intestine Dampness-Heat Syndrome Questionnaire.

The aim of this study was to develop and validate the large intestine dampness-heat syndrome questionnaire (LIDHSQ) for patients with ulcerative colitis (UC). The domains and items of the LIDHSQ were developed according to standard procedures, namely, construct definition, item generation, language testing, content validity, pilot study, and validation study. At first, a total of 20 items in 3 domains were generated based on literature review and expert consultation. After the item selection, the LIDHSQ contains 11 items in three domains: disease-related domain (diarrhoea, abdominal pain, bloody purulent stool, and mucus stool), heat domain (fever, dry mouth, red tongue, yellow fur, and anal burning), and dampness domain (greasy fur and defecation disorder). The Cronbach's alphas of all domains were greater than 0.6. All of the intraclass correlation coefficients were greater than 0.8. The LIDHSQ and domain scores of the patients with LIDHS were higher than those of the patients with other syndromes (P < 0.001). The area under the receiver operating characteristic curve of the LIDHSQ was 0.900, with a 95% confidence interval of 0.872-0.928. When the cut-off value of the LIDHSQ was ≥ 7, the sensitivity and specificity were 0.867 and 0.854, respectively. The LIDHSQ is valid and reliable for measuring LIDHS in UC patients with good diagnostic efficacy. We recommend the use of the LIDHSQ in Chinese UC patients.

[Inspirations of Rome â £ on clinical evaluation of traditional Chinese medicine for functional gastrointestinal disease].

The Rome Foundation released the Rome Ⅳ for functional gastrointestinal diseases (FGIDs) in 2016, which fully presented the latest advances and views on the disease origin, definition, diagnosis, classification, pathology, mechanism, clinical features, influential factors, interventions, clinical evaluation, clinical research design and so on, showing high positive effects on global researches. Traditional Chinese medicines (TCM) have cognitive advantages and well-recognized and-demonstrated efficacy in the prevention and treatment for FGIDs. However, the monotonous presentation ways and weak interpretation on clinical evaluation have also hindered the inherent advantages explanation, characteristics quantization, evidence and communication accumulation. This study first analyzed the background and key points on clinical evaluation of Rome Ⅳ and corresponding inspirations, believed that its concept and viewpoints were assimilated with systematic medicine, and emphasized the important influence of subjective factors such as mental psychology and social culture on the disease and its importance in clinical evaluation. Its views on several aspects such as the theoretical model, internal and external causes, and transfer process were highly consistent with TCM. Therefore, TCM researchers should devote more dedication and courage on the innovation and collaboration with global researches to advance related studies. Then, based on 59 TCM clinical researches for FGIDs funded by national projects upon searching in CNKI with strict search strategy, the clinical evaluation methods and indexes and their correlations were summarized and analyzed, and it was found that more attention was paid to the disease symptoms and impact, symptom/syndrome score, patient report outcome, et al. However, many limitations were also founded, such as disordered relationships among different indexes, ambiguous explanation of research results, and extremely few domestic evaluation instruments in Chinese culture. Therefore, it is suggested that future research should regress and highlight the subjective features of patients and diseases, standardize the elemental structure and management mode of clinical evaluation, enhance the values and status of reported outcomes. It is highly recommended that the domestic disease-specific instruments developed in Chinese culture should be adopted as primary outcome for clinical evaluation, assisted with symptoms/signs assessment tools and doctors reporting outcome scale, et al. The common used TCM syndrome scores in current researches are not recommended as the primary outcome. However, there are some limitations in the above suggestions. We hope that more relevant researches will explore and establish a unified outcome assessment system for FGIDs and improve the quality of TCM clinical research.

[Clinical experience and academic thoughts of Professor LIU Feng-bin on case series of gastroesophageal reflux disease based on data mining].

To analyze and summarize Professor LIU Feng-bin's clinical experience and academic thoughts on gastroesophageal reflux disease (GERD), the study group adopted the retrospective study for case series and expert interview, extracted the retrospective data, including the herbs, diseases, syndrome type, medical expense and quantity of herbs of GERD patients attended the First Affiliated Hospital of Guangzhou University of Chinese Medicine. Statistical description and binary Logistic regression were used for the identification and modification of syndrome type and initial core herbs. After expert interviews were performed for the syndrome type and herbs, the final scheme were formed. A total of 112 GERD patients ages（48.97±13.13）y; male: 35 (31.3%), female: 77(68.7%) were enrolled. The numbers of patients with liver and stomach incoordination syndrome, heat stagnation of liver and stomach syndrome, syndrome of dual deficiency of Qi and Yin, syndrome of spleen deficiency and dampness-heat, spleen-stomach disharmony syndrome were 40, 26, 19, 17 and 10, respectively. The patients used totally 80 herbs, and 26 of them had significant differences among different syndrome groups. According to the logistic regression analysis on the 23 herbs used by 112 patients, the herbs scheme was modified for the second time. After the expert interviews and modification, the final consensus was reached. The main causes for GERD were dietary irregularities, moodiness, and weak constitution. The basic mechanism of GERD was spleen deficiency with Qi adverseness. The spleen-stomach disharmony syndrome was deleted by expert interviews. The 10 core herbs for GERD treatment were Taizishen(Pseudostellariae Radix), Fuling(Poria), Baizhu(Atractylodismacrocephalae Rhizoma), Gancao(Glycyrrhizae Radix Et Rhizoma), Zhebeimu(Fritillariae Thunbergii Bulbus), Haipiaoxiao(Sepiae Endoconcha), Zhiqiao(Aurantii Fructus), Chenxiang(Alosewood), Pugongying(Taraxaci Herba), Zhizitan(Cape Jasmine Fruit). The modification and psychological and diet interventions were also identified. This study summarized Professor LIU Feng-bin's clinical experience and academic thoughts of chronic atrophic gastritis based on data mining of case series and expert interviews. The quality of methodologies and report were both well. The results provide a foundation and ideas for further study on the complex intervention for GERD, and can be directly applied in clinical practice.

Anti-inflammatory effect of Chang-An-Shuan on TNBS-induced experimental colitis in rats.

BACKGROUND: Inflammatory bowel disease (IBD), denominated by Crohn's disease and ulcerative colitis, is often associated with abdominal pain, diarrhea and bloody stool. The standard protocols for treating colitis conditions are not satisfactory; thus, complementary and alternative medicines have been increasingly accepted by IBD sufferers worldwide. In this study, we aimed to elucidate the anti-inflammatory effect of Chang-An-Shuan (CAS), a 6-herb Chinese medicinal formula, on 2, 4, 6-trinitrobenzenesulfonic acid (TNBS)-induced colitis in rats and the underlying mechanisms. METHODS: Sprague-Dawley rats were administered with rectal gavage of 2.5% TNBS in 50% ethanol for the induction of experimental colitis which is considered as a model for Crohn's disease. Upon the TNBS induction, rats were given CAS at 0.5 g/kg/day or 5 g/kg/day for 10 days. The application of salicylazosulfapyridine (0.5 g/kg/day) was served as a positive reference drug for the colitis condition. The efficacy and mechanistic action of CAS were evaluated by means of histopathological and biochemical approaches such as histological staining, real-time polymerase chain reaction, Western blotting analysis and enzyme-linked immunosorbent assay. RESULTS: Oral administration of CAS at 5 g/kg/day, but not 0.5 g/kg/day, significantly ameliorated the severity of TNBS-induced colitis as evidenced by the reduced loss of body weight, alleviated diarrhea and decreased bloody stool. While lowering the disease activity index, the administration of CAS lessened mucosal lesions thus mucosal integrity of the colitis rats was notably improved. Further, the CAS treatment also significantly suppressed the mRNA and protein levels of pro-inflammatory cytokines, namely interleukin-1ß and tumor necrosis factor-α while enhancing the level of anti-inflammatory cytokine IL-10 in the TNBS-treated rats. Importantly, the ameliorative effect of CAS was related to an inhibition of the nuclear factor-κB (NF-κB) signaling pathway by downregulating the expression levels of NF-κBp-65, p-38 and p-AKT. CONCLUSIONS: We suggest that CAS is a potential alternative remedial approach for treating IBD conditions, and the anti-inflammatory effect of CAS is associated with the down-regulation of the NF-κB signaling pathway and the balanced production of pro- and anti-inflammatory cytokines.

Controversies on the values for health instruments of Chinese medicine.

Currently, there are increasing debates on the necessity of health instruments in Chinese medicine (CM) emerging in China. This study aims to reevaluate its status and values. Analyzing the causes, limits, advantages, and properties characters of health instruments in CM, it is found that weak fundamental research, incomplete self-awareness, and complicated social factors are the primary causes of debates. A comprehensive analysis showed health instruments in CM have health evaluation benefits to people from a dominant Chinese culture, meet the requirements of cultural background, and bring long-term value to Chinese instrument researches. However, its values and status should be treated differently depending on various subtypes. Although little theoretical and practical evidences proved that patients-reported health instruments in CM should be proposed independently, the doctors- and nurses-reported questionnaires are necessary. With this in mind, the study group proposes the 'Chinese cultural instruments (CCIs)' and 'health-related CCIs'. The latter one aims to evaluate the health status of people in a dominant Chinese culture. The CCIs theory represents Chinese instrument researches on a larger regional and higher level, and resolves the debates on instruments between CM and Western medicine in China. Health instruments in CM bring more scientific and social benefits for Chinese instrument researches. However, it does not include cultural demands, and lacks scientific significance. CCIs have all its virtues, and add solutions to the latter's theory bottleneck and scientific debates, thus bringing increased benefits to clinical assessment in complementary and alternative medicine researches.

[Traditional Chinese medicine syndrome distribution and neuroendocrine mechanisms of irritable bowel syndrome: cross-sectional study].

In order to clarify the traditional Chinese medicine(TCM) syndrome distribution and pathogenesis of irritable bowel syndrome(IBS), the patients in the first affiliated hospital of Guangzhou university of Chinese medicine were enrolled for the cross-sectional study. The data of 12 sociological variables, 13 risk factors, 84 symptoms and signs variables(in 9 aspects), and 19 neuroendocrine indices were extracted for group-between analysis with one-way ANOVA, chi-square test and nonparametric test, and the relationship analysis between clinical symptoms and diseases sub-types was done with binary Logistic regression. In addition, the patterns of TCM syndromes were divided by several syndrome factors to analyze the difference in neuroendocrine indices between various patterns and syndrome factors. A total of 383 IBS patients were enrolled, including 353(92.2%) cases of diarrhea, 14(3.7%) cases of constipation and 16(4.1%) cases of mixed types. In IBS-diarrhea patients, there were 291(76.0%), 18(4.7%), 48(12.5%) and 26(6.8%)cases of syndrome of liver depression and spleen deficiency (sLDSD), syndrome of liver depression and qi stagnation (sLDQS), syndrome of dampness-heat in the spleen and stomach (sDHSS), and syndrome of spleen deficiency with dampness encumbrance (sSDDE) respectively. There was significant differences in blood groups between IBS-diarrhea patients, IBS-constipation patients and IBS-mixed types patients; their disease classification was significantly correlated with the allergies, drinking, irregular meals habits, no or less vacations, and other causes of morbidity (P<0.05, f<0.3). A total of 15 symptoms and signs variables (e.g., chills, facial abnormalities, epigastric fullness, etc.) had significant differences between different groups (P<0.05), and 5, 8, 5 variables were respective independent factors for IBS-diarrhea, constipation and mixed type. There was no significant difference in neuroendocrine indices between various groups. The sLDSD, sLDQS, sDHSS, sSDDE patients had significant differences in genders, living conditions and occupations, and the TCM syndrome type was significantly correlated with the drinking, smoking, no or less breakfast, less than 8 sleeping hours(P<0.05, f<0.3). Meanwhile, a total of 14 symptoms and signs variables (e.g., dysphoria heat, fatigue, stretching, etc.) had significant differences between various groups(P<0.05) and 3, 4, 6, 3 variables were respective independent factors for sLDSD, sLDQS, sDHSS, and sSDDE. There were significant differences in acetylcholine(Ach) and angiotensin Ⅱ(AT-Ⅱ) between the sLDSD group and sSDDE group. There were significant difference in Ach, AT-Ⅱ, adrenotrophin(ACTH) and estradiol (E2) in comparison between several pattern factors. This study preliminary identified the sociological characters, risk factors, syndromes distribution, diseases and subgroup mechanisms of this disease. More samples and multi-centers are required for future study to improve the scientificity and representativeness.

[Mining analysis and experience summary for chronic atrophic gastritis cases treated by Professor LIU Feng-bin].

To summarize Professor LIU Feng-bin's clinical experience and theoretical thoughts on chronic atrophic gastritis (CAG), the study group designed a retrospective study on his case series and expert interview. First of all, the data of CAG patients treated in the First Affiliated Hospital of Guangzhou University of Chinese Medicine between 2009 and 2013, e. g. herbs, diseases, syndrome type, prescription amount and number of herbs, was collected and processed. The statistical description and binary logistic regression were used to determined the syndrome type, initial basic remedy and modification. During the statistics, a complete and sub-group analysis was performed simultaneously. After the expert interview, the syndrome type and medication were finalized. As a result, a total of 228 CAG patients aged at (50.30 ± 10.18) were collected, including 151 males (66.23%). Of them, the TCM diagnosis and syndrome type were extracted from the information of 157 patients, including 115 cases with gastric stuffiness, 23 cases with gastric pain, 19 missing cases, 2 cases with spleen-stomach weakness syndrome, 57 cases with spleen deficiency and dampness-heat syndrome, 18 cases with spleen-stomach disharmony syndrome, 23 cases with syndrome of liver depression syndrome, 21 cases with liver qi invading stomach syndrome and 26 qi and yin deficiency syndrome, respectively. All of the 228 patients used totally 104 herbs, while the subgroups with 157 patients used 94 herbs. The most frequently used 15 herbs used in each groups were analyzed to determine the initial basic remedy and modification. Subsequently, based on the information of the sub-groups with 157 patients, with the syndrome type as the dependent variable, the logistic regression analysis was made on the most frequently used 32 herbs, in order to determined the modification in herbs for different syndrome types. After experts reviewed and modified, they believed the main causes of CAG were dietary irregularities, moodiness and weak constitution; the pathogenesis of CAG was spleen deficiency with qi stagnation, heat depression and blood stasis in the stomach meridian. The above six syndrome types and 12 herbs were determined, including Pseudostellariae Radix, Poria, Atractylodismacrocephalae Rhizoma, Glycyrrhizae Radix et Rhizoma, Fritillariae Thunbergii Bulbus, Sepiae Endoconcha, Arecae Pericarpium, Aurantii Fructus, Perillae Caulis, Herba Hedyotis Diffusae, Scutellariae Barbatae Herba, Curcumae Rhizoma. This study summarized Professor LIU Feng-bin's clinical experience and theoretical thoughts of chronic atrophic gastritis based on clinical practice data and expert interview, with a rigorous design and good scientificity and practicability.

[Development and Evaluation of GS-SF for Gastric Stuffiness (Wei PI) Patients Based on Item Response Theory, Computerized Adaptive Testing, and Data Simiuation].

OBJECTIVE: To develop and evaluate the short version of patient reported outcomes (PROs) questionnaire for gastric stuffiness (Wei Pi) patients with modern test theory and technologies, hoping to provide testing tools for related clinical practice and scientific researches with higher quality and less administrative and response burdens. METHODS: Using descriptive study design, clinical data were collected with sociological questionnaire and previous developed full items version of PROs instrument for gastric stuffiness (Wei Pi) patients via field and online surveys between Sep 2011 and Mar 2012. The statistical analysis group identified the termination parameters firstly, and then selected items with discrimination, fitting residual, item information curve (IIC) , item characteristic curve (ICC), and the rank of computerized adaptive testing (CAT) select proportion, etc. After assumption evaluation of item response theory (IRT), IIC, ICC, difficulty coefficient distribution, items-response relation and thresholds, etc. were used for psychometric evaluation of instrument. RESULTS: A total of 331 patients [Ages: 31.99 +/- 10.29 yrs; Male: 186 (56.3%)] were enrolled in statistical analysis. The test termination criterion was Max SE = 0.2 or Max items number =16. After items selection, a 15-item short version of instrument, which contains symptoms facet (8 items) and impact facet (7 items) was generated. With good unidimensionality, local independence, and monotonicity, the IC and ICC in IRT analysis showed good working capability of the questionnaire. The difficulty coefficient distribution and items-response relation were also rational, as well as response thresholds. CONCLUSIONS: The short version of PROs instrument for adult gastric stuffiness (Wei Pi) patients was successfully developed and assessed. The instrument with good methodological and reporting quality could be used in clinical and scientific evaluating their symptoms and impact.

[General integral medicine: the strategic direction for complex health interventions].

Nowadays, the simple combination of Western medicine (WM) and complementary and alternative medicine (CAM) cannot resolve all the health problems and various requirements. This article proposed the general integral medicine (GIM) theoretical model, which declares the disease causes analysis, clinical intervention and outcomes assessment should be recognized, managed and evaluated both from physiological, psychological, and spiritual status, and all the four dimensions: orthodox medicine (WM, Chinese medicine, etc.), individual inherent characteristics (emotion, attitude, psychology, etc.), cultural influences (doctors, caregivers, groups care, etc.), and natural environment and social systems (economic status, social security system, environmental pollution, etc). As for health outcomes assessment, a more comprehensive system including biological, doctors, patients, health intimate, social and environmental evaluations were required. The GIM model has individualized, dynamic, standardized, objective, systematic inherent characteristics, and opening and compatible external characteristics. It aims to provide the new theoretical guidance and strategic development direction for complex health interventions, and solve various medical related psychological and social problems.

[The initial study on mechanism in postpone skeletal muscle aging process of D-galactose rats by movement training and soy polypeptide supplement].

OBJECTIVE: To observe the effect of the postpone in skeletal muscle aging process of D-galactose rats by weight training and soy polypeptide supplement in 6 weeks, and discuss the initial mechanism. METHOD: Sixty male SD rats (three month old)were randomly assigned: 6 week control (C6,) and 6 week model (M6) 6 for each group, 12 week model (M12), big load (B12), small load (S12), peptide (P12), peptide + big load (PB12) and peptide + small load group (PS12) 8 for each group, eight fourteen month rats were taken in the natural aging group. The rats were killed by the end of 6th week and 12th week, tested the indicators. RESULT: Compare with group C6, the indicators in group M6 showed aging in different levels; Compare with group M12, weight training or soy polypeptide supplement in all intervention groups could increase the content of skeletal muscle superoxide dismutase (SOD), SOD/MDA, the serum growth hormone(GH), insulin-like growth factor-1 (IGF-I)and skeletal muscle IGF-I mRNA, decreased the malondialdehyde (MDA) content of skeletal muscle, and they had notable interaction. CONCLUSION: Rat skeletal muscle aging model can be copied successfully by D-galactose hypodermic, and go on with 6-week weight training or soy polypeptide supplement, they can postpone the skeletal muscle aging process of D-galactose rats, and the two interference way united can have more obvious effect. Its preliminary mechanism may be related to the reduction of skeletal muscle oxidative stress and lipid peroxidation, the correction of hormones and related factors metabolic disorders, the elevation of skeletal muscle IGF-I mRNA expression and so on.

Literature review and analysis of the application of health outcome assessment instruments in Chinese medicine.

OBJECTIVE: To evaluate the application of health assessment instruments in Chinese medicine. METHODS: According to a pre-defined search strategy, a comprehensive literature search for all articles published in China National Knowledge Infrastructure databases was conducted. The resulting articles that met the defined inclusion and exclusion criteria were used for analysis. RESULTS: A total of 97 instruments for health outcome assessment in Chinese medicine have been used in fundamental and theoretical research, and 14 of these were also used in 29 clinical trials that were randomized controlled trials, or descriptive or cross-sectional studies. In 2 152 Chinese medicine-based studies that used instruments in their methodology, more than 150 questionnaires were identified. Among the identified questionnaires, 51 were used in more than 10 articles (0.5%). Most of these instruments were developed in Western countries and few studies (4%) used the instrument as the primary evidence for their conclusions. CONCLUSION: Usage of instruments for health outcome assessment in Chinese medicine is increasing rapidly; however, current limitations include selection rationale, result interpretation and standardization, which must be addressed accordingly.

Literature review and analysis of the development of health outcomes assessment instruments in Chinese medicine.

OBJECTIVE: To evaluate the development of health outcomes assessment instruments in Chinese medicine. METHODS: A comprehensive literature search for all published articles in China National Knowledge Infrastructure Database, Chongqing VIP Database and WANFANG Data was conducted. The studies that met the inclusion and exclusion criteria were used to extract information according to a predesigned assessment instrument. RESULTS: A total of 97 instruments for health outcome assessment in Chinese medicine were identified. Of these questionnaires, 7 were generic, 12 were condition-specific and 78 were disease-specific. All instruments were suitable for adults, children, and both men and women. These instruments aimed to evaluate the health-related quality of life, signs and symptoms as well as patient satisfaction and doctor-reported outcome. However, the descriptions were poorly constructed for some of the most basic parameters, such as the domains and items, administrative mode, response options, memory recall periods, burden evaluation, format, copyright, content validity, and other properties. CONCLUSION: The instrument development for health outcomes assessment in Chinese medicine is increasing rapidly; however, there are many limitations in current methodologies and standards, and further studies are needed.

Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID.

OBJECTIVE: The reporting of patient-reported outcomes (PRO) instrument development is vital for both researchers and clinicians to determine its validity, thus, we propose the Preferred Reporting Items for PRO Instrument Development (PRIPROID) to improve the quality of reports. METHODS: Abiding by the guidance published by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network, we had performed 6 steps for items development: identified the need for a guideline, performed a literature review, obtained funding for the guideline initiative, identified participants, conducted a Delphi exercise and generated a list of PRIPROID items for consideration at the face-to-face meeting. RESULTS: Twenty three items subheadings under 7 topics were included: title and structured abstract, rationale, objectives, intention, eligibility criteria, conceptual framework, items generation, response options, scoring, times, administrative modes, burden assessment, properties assessment, statistical methods, participants, main results, and additional analysis, summary of evidence, limitations, clinical attentions, and conclusions, item pools or final form, and funding. CONCLUSIONS: The PRIPROID contains many elements of the PRO research, and this assists researchers to report their results more accurately and to a certain degree use this instrument to evaluate the quality of the research methods.

Evaluation of a scale of patient-reported outcomes for the assessment of myasthenia gravis patients in China.

OBJECTIVE: To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients (MG-PRO) in China. METHODS: A total of 100 MG patients were interviewed for the field testing. Another 56 MG patients were selected and assessed with the MG-PRO scale before treatment and at 1, 2 and 4 weeks after treatment. The classical test theory and item response theory (IRT) were used to assess the psychometric characteristics of the MG-PRO scale. RESULTS: The MG-PRO scale included 4 dimensions: physical, psychological, social environment, and treatment. Confirmatory factor analysis showed that each dimension was consistent with the theoretical construct. The scores of the physical and psychological dimensions increased significantly at 1 week after treatment (P<0.05). All the dimension scores and the MG-PRO score increased significantly at 2 and 4 weeks after treatment (P<0.05). IRT showed that person separation indices were greater than 0.8, most of the item fit residual statistics were within ± 2.5, and no item had uniform or non-uniform differential item functioning (DIF) between gender and age (<40, [Symbol: see text]40). CONCLUSIONS: The MG-PRO scale is valid for measuring the quality of life (QOL) of MG patients, with good reliability, validity, responsiveness, and good psychometric characteristics from IRT. It can be applied to evaluate the QOL of MG patients and to assess treatment effects in clinical trials.

[On the necessity of developing quality of life instruments in traditional Chinese medicine].

The development of health-related quality of life (HRQL) instrument in traditional Chinese medicine (TCM) is increasing rapidly in China, but few studies focus on their necessity. This study explores the necessity of the development of TCM instruments from both theoretical and practice perspectives, and aims to explain whether the adoption of the cross-medical style is valid. Through theoretical analysis, both TCM and Western medicine instruments show the same objectives, whereas TCM instruments are more suitable for the Chinese social behavior, customs and expectations. In practical analysis, 47 TCM instruments were identified, among which 17 had 18 corresponding Western medical instruments. In the domains layer, except for physiological, psychological and social factors, TCM instruments focus more on the harmony between body and spirit, humanity and nature or human and society and the constitution, etc. In the facts layer, TCM instruments focus on the emotions, initiative social intercourse, TCM symptoms, diet, sleep, taste, feces and urine, etc. In addition, significant differences existed in the methods of information selection. There is no need to modify cross-medical style research except when TCM characteristic terms exist, but attention must be paid to the influence of culture in different areas. Therefore, the TCM instruments can resolve the limitations of the application of Western medical instruments to the Chinese setting, while also having remarkable abilities of information coverage and detection. Both forms of instruments have the capacity and requirement to inter-communicate with each other in order to serve the whole Chinese cultural system. Generally speaking, there is no need to modify the instruments in cross-medical style research. But this point requires further demonstration in the rigorous designed clinical trials.