Effect of Different Method-induced Ankle Dorsiflexion on Ankle Dorsiflexion Function for Stroke Patients / 中国康复理论与实践

Objective:To compare the effect of two kinds of methods inducing ankle dorsiflexion on ankle dorsiflexion function for stroke patients. Methods:From September, 2016 to September, 2018, 60 patients with disorders of ankle active dorsiflexion after stroke were randomly divided into groups A, B and C, who accepted routine rehabilitation, tapping-zone therapy and tapping Qiuxu acupoint (GB40), respectively, for six weeks. They were assessed with three-dimensional gait analysis and surface electromyography before and after treatment. Results:The range of motion of the affected ankle, the peak torque of ankle and integrated electromyography of tibialis anterior muscle increased after treatment (t > 2.318, P < 0.05), and it ranked from best to worst as group C, group B and group A (P < 0.05). Conclusion:Both tapping-zone therapy and tapping Qiuxu may promote the recovery of ankle dorsiflexion in stroke patients, and the latter seems better.

Inspirations of Rome Ⅳ on clinical evaluation of traditional Chinese medicine for functional gastrointestinal disease / 中国中药杂志

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 / 中国中药杂志

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.

Discussion on TCM Treatment for Liver Cirrhosis from DENG Tietao's Ruangan Decoction / 中国中医药信息杂志

DENG Tie-tao is a national TCM doctor and Ruangan Decoction is one of his empirical formulae for liver cirrhosis. It includes functions of tonifying spleen and nourishing liver, reinforcing kidney, enriching blood and invigorating the circulation of blood, manifesting the theory of correlation of five zang, which focuses on entirety but also the sick part.The Ruangan Decoction displays some methods as nourishing,smoothing and regulating the liver, which provides simple and effective methods for TCM treatment of liver cirrhosis.

Controversies on the values for health instruments of Chinese medicine / 中国结合医学杂志

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 / 中国中药杂志

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 / 中国中药杂志

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 / 中国中西医结合杂志

<p><b>OBJECTIVE</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSIONS</b>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.</p>

General integral medicine: the strategic direction for complex health interventions / 中国中西医结合杂志

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 / 中国应用生理学杂志

<p><b>OBJECTIVE</b>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.</p><p><b>METHOD</b>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.</p><p><b>RESULT</b>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.</p><p><b>CONCLUSION</b>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.</p>

Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID / 中国结合医学杂志

<p><b>OBJECTIVE</b>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.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSIONS</b>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.</p>

Literature review and analysis of the development of health outcomes assessment instruments in Chinese medicine / 中西医结合学报

<p><b>OBJECTIVE</b>To evaluate the development of health outcomes assessment instruments in Chinese medicine.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>

Literature review and analysis of the application of health outcome assessment instruments in Chinese medicine / 中西医结合学报

<p><b>OBJECTIVE</b>To evaluate the application of health assessment instruments in Chinese medicine.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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.</p><p><b>CONCLUSION</b>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.</p>

Evaluation of a scale of patient-reported outcomes for the assessment of myasthenia gravis patients in China / 中国结合医学杂志

<p><b>OBJECTIVE</b>To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients (MG-PRO) in China.</p><p><b>METHODS</b>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.</p><p><b>RESULTS</b>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).</p><p><b>CONCLUSIONS</b>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.</p>

Epidemiological investigation of 605 patients with chemical burns in northeastern China / 中华烧伤杂志

<p><b>OBJECTIVE</b>To investigate the pathogenic and clinical characteristics of chemical burns in recent years, so as to provide reference for its prevention and treatment.</p><p><b>METHODS</b>Medical records of patients with chemical burns out of 6299 burn patients admitted to our unit from January 1992 to December 2011 were screened and retrospectively analyzed, including gender, age, onset time of the injury, pre-hospital management, injury cause, injury-causing chemicals, body site of wound, burn area and depth, complications, treatment and follow-up results. The data of age distribution and incidence of complications were processed with chi-square test.</p><p><b>RESULTS</b>Investigation showed that 605 out of 6299 burn patients (accounting for 9.60%) were chemically injured. (1) Among the patients with chemical burns, the ratio of male to female was 5.11:1.00, with the mean age of 37.6 years, and the highest incidence occurred in patients aged from 20 to 29 years (29.42%, 178/605). The difference in the numbers of patients among different age groups was statistically significant (χ(2) = 207.298, P < 0.01). (2) Chemical burns mainly occurred in summer (28.43%, 172/605) and autumn (38.35%, 232/605). About 72.07% (436/605) of patients received irrigation before admission. (3) In 453 (74.88%) patients, injury occurred during industrial production. The main injury-causing chemicals were acid (46.61%, 282/605) and alkali (20.66%, 125/605), and among them the sulfuric acid accounted for the highest ratio (18.18%, 110/605). (4) The main wound positions of chemical burns were the limbs (289 patients) and the head, face, and neck region (263 patients). The mean burn area was 5.98% TBSA. The depth ranged from superficial partial-thickness to full-thickness. (5) Three hundred and forty-eight patients with chemical burns suffered common complications, including inhalation injury (154, 44.25%), ocular burns (113, 32.47%), and poisoning (81, 23.28%). There was statistically significant difference in the incidence of the three complications (χ(2) = 23.086, P < 0.01). (6) Five hundred and twenty-one patients were cured, with the cure rate of 86.12%, and 76.20% out of them healed with scars (397/521). Three patients died of poisoning, with a mortality of 0.50%.</p><p><b>CONCLUSIONS</b>The patients with chemical burns accounted for a high proportion of the burn patients admitted to our unit in the same period. The chemical burns mainly involved young males with the relatively close time of onset, and acid and alkali were the main causative factors in the process of industrial production. Most patients had the clinical features of deep wound, high incidence of complications, and liability of scar formation after wound healing.</p>

Parallel subgroup design of a randomized controlled clinical trial-comparing the approaches of Chinese medicine and Western medicine / 中国结合医学杂志

A new method for the comparison of the treatment efficacy for specific diseases or conditions between Chinese medicine and Western medicine, which serve the same medical aim but are based on substantially different theoretical systems, was identified. Abiding by the principle of parallel subgroup design of a randomized controlled trial (PSD-RCT), participants were recruited following identical inclusion and exclusion criteria and were randomly allocated into two groups to receive treatment using the respective approaches of Chinese medicine and Western medicine. The Chinese medicine group was divided into subgroups according to the theory of Chinese medicine and the Western medicine group was also divided into subgroups according to the theory of Western medicine. The treatment for each subgroup was well defined in the protocol, including major formulae and principles for individualized modifications. The primary outcome measure was ascertained to be directly related to the patients' status but independent from both theories of Chinese medicine and Western medicine, while the secondary outcomes were represented by the patient-reported outcomes and some laboratory tests commonly accepted by Chinese medicine and Western medicine. Then, taking functional dyspepsia as an example, the authors explain the framework of the PSD-RCT for efficacy comparisons between Chinese medicine and Western medicine, and recommend that the PSD-RCT can be used to compare treatment efficacy for a specific disease or condition between Chinese medicine and Western medicine, and the comparison among subgroups can provide valuable clues for further studies.

Responsiveness of the Chinese Quality of Life Instrument in patients with congestive heart failure / 中国结合医学杂志

<p><b>OBJECTIVE</b>The Chinese Quality of Life Instrument (ChQOL) was developed as a valid generic health status instrument based on the well-established theory of health in Chinese medicine. Psychometric properties of the ChQOL were good. In the present study, the responsiveness of the ChQOL in patients with congestive heart failure (CHF) were investigated and compared with two generic questionnaires, the Medical Outcomes Study Short Form 36-item Health Survey (SF-36) and World Health Organization Quality of Life Assessment (WHOQOL-BREF), as well as one disease-specific questionnaire, the Minnesota Living with Heart Failure Questionnaire (MLHF).</p><p><b>METHODS</b>Thirty-nine in-patients with CHF who had undergone treatment with integrative medicine were recruited. The health status measurements were performed at enrolment and after a 4-week treatment. The following responsiveness indices were used: the effect size (ES) and standardized response mean (SRM). All patients were classified into those groups with stable measures and those groups with changes after a 4-week treatment, based upon both the doctor's global rating of changes in heart function tests, and the patient's global rating of changes in overall quality of life.</p><p><b>RESULTS</b>All domains of the ChQOL showed significant improvement. In the comparison of the responsiveness indices, the ChQOL was regarded as more responsive than the WHOQOL-BREF or SF-36 utility, but it was less responsive than the MLHF.</p><p><b>CONCLUSIONS</b>The ChQOL was better in sensitivity and responsiveness for assessing congestive heart failure as a generic measure than the SF-36 and WHOQOL-BREF. The ChQOL is considered suitable as an outcome measure for clinical trials in patients with congestive heart failure.</p>

Application and prospect of scale measurement and appraisal in the assessment in TCM therapeutic efficacy evaluation / 中国中西医结合杂志

The assessing contents of the health related quality of life (HRQOL) and the patient reported outcomes (PRO) are identical with the inquiry of traditional Chinese medicine (TCM), which are uniformly soft indicators which could be evaluated with the scales for instruments. The assessing method for the soft indicator in the HRQOL and PRO was gradually accepted by TCM practitioners and applied in evaluating the curative effect of TCM. The applying scale in the assessment of curative effect of TCM and the developing scale with the TCM features just started in the TCM field. There was much inadequacy in the scale study, such as no penetrating understanding of the theory and connotation of the scale in the HRQOL and PRO, on scale system for TCM, no direction in selecting scale, not standardizing in the design of the study with scale in the practice. So, it is necessary that the international guideline of developing scale applied for worldwide should be carried out in the study for developing scale. Meanwhile, it must also be under the guidance of TCM theory in the whole course. It will promote the normalization development of applying scale in the assessment of curative effect in the TCM practice.

Application of Quality of Life to Evaluate the Effect of Traditional Chinese Medicinein on Parkinson's Disease / 中国康复理论与实践

@#This article summarized the application of Quality of Life in Parkinson's disease such as in therapy or nurse assessment, and discussed how it can be used to assess the effect of Traditional Chinese Medicine on Parkinson's disease, which suggest that a Sinicized Patient Reported Outcome (PRO) measure should be advanced.

Psychometric properties of the chinese quality of life instrument in patients with chronic heart failure / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To assess the reliability, validity and responsiveness of the Chinese Quality of Life Instrument (ChQOL) in patients with chronic heart failure (CHF).</p><p><b>METHODS</b>Assessment on quality of life (QOL) of 39 CHF patients was performed in synchronous step adopting three generally used questionnaires the World Health Organization Quality of Life Assessment (WHOQOL-BREF), the Medical Outcomes Study Short Form 36-items Health Survey (SF-36), and the Minnesota Living with Heart Failure Questionnaire (MLHF), as well as the ChQOL respectively.</p><p><b>RESULTS</b>ChQOL showed good internal consistency (Cronbach's alpha > 0.7), with its theoretical structural model consistent with the three factors produced from factor analysis, and showed better criterion validity than that of WHOQOL-BREF, SF-36 and MLHF. The 4 weeks' follow-up visiting completed in 32 patients showed that according to patients' self-evaluation and the cardiac functional assessment by the doctors, the responsiveness of the ChQOL was better than that of the WHOQOL-BREF and SF-36, but slightly inferior to that of the MLHF.</p><p><b>CONCLUSION</b>ChQOL showed good reliability, validity and responsiveness in assessing QOL of CHF patients.</p>