[Reflections on supervision strategies of new Tibetan drug registration].

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.

Standard Operating Procedures for Chinese Medicine Data Monitoring Committees of Clinical Studies.

Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.

Does Routine Anti-Osteoporosis Medication Lower the Risk of Fractures in Male Subjects? An Updated Systematic Review With Meta-Analysis of Clinical Trials.

Background: Several epidemiological articles have reported the correlations between anti-osteoporosis medication and the risks of fractures in male and female subjects, but the specific efficacy of anti-osteoporosis medication for male subjects remains largely unexplored. Objective: The aim of this study was to evaluate the correlation between anti-osteoporosis medication and the risk of fracture in relation to low bone mass [including outcomes of osteoporosis, fracture, and bone mineral density (BMD) loss] in male subjects analyzed in studies within the updated literature. Methods: Randomized controlled trials (RCTs) that analyzed the effectiveness of a treating prescription for male subjects with osteoporosis (or low BMD) and that focused on the outcomes of fracture were included. Relevant studies from Embase, Web of Science, PubMed, and Chinese database of CNKI were retrieved from inception to January 30th, 2019. Two staff members carried out the eligibility assessment and data extraction. The discrepancies were settled by consultation with another researcher. We calculated the pooled relative risks (RRs) based on 95% confidence intervals (CIs). Results: Twenty-seven documents (28 studies) with 5,678 subjects were identified. For the category of bisphosphonates, significant results were observed in pooled analyses for decreased risk of the vertebral fracture domain (RR, 0.44 [95% CI, 0.31-0.62]), nonvertebral fracture domain (RR, 0.63 [95% CI, 0.46-0.87]), and clinical fracture domain (RR, 0.59 [95% CI, 0.48-0.72]) compared with those of controls. Participants with bisphosphonates had a 56% (95% CI = 38-69%) lower risk of vertebral fractures, 37% (95% CI = 13-54%) lower risk of nonvertebral fractures, and 41% (95% CI = 28-52%) lower risk of clinical fractures. Furthermore, meta-analyses also demonstrated a decreased risk of the vertebral fracture domain via treatment with risedronate (RR, 0.45 [95% CI, 0.28-0.72]) and alendronate (RR, 0.41 [95% CI, 0.23-0.74]), but not with calcitriol, calcitonin, denosumab, ibandronate, monofluorophosphate, strontium ranelate, teriparatide, or zoledronic acid, compared with that of controls. Conclusions: This systematic review confirms that bisphosphonates were connected with a decreased risk of vertebral fractures, nonvertebral fractures, and clinical fractures for male subjects with osteoporosis. Future research is needed to further elucidate the role of nonbisphosphonates in treating fractures of osteoporosis subjects.

Kai Xin San ameliorates scopolamine-induced cognitive dysfunction.

Kai Xin San (KXS, containing ginseng, hoelen, polygala, and acorus), a traditional Chinese herbal compound, has been found to regulate cognitive dysfunction; however, its mechanism of action is still unclear. In this study, 72 specific-pathogen-free male Kunming mice aged 8 weeks were randomly divided into a vehicle control group, scopolamine group, low-dose KXS group, moderate-dose KXS group, high-dose KXS group, and positive control group. Except for the vehicle control group and scopolamine groups (which received physiological saline), the doses of KXS (0.7, 1.4 and 2.8 g/kg per day) and donepezil (3 mg/kg per day) were gastrointestinally administered once daily for 2 weeks. On day 8 after intragastric treatment, the behavioral tests were carried out. Scopolamine group and intervention groups received scopolamine 3 mg/kg per day through intraperitoneal injection. The effects of KXS on spatial learning and memory, pathological changes of brain tissue, expression of apoptosis factors, oxidative stress injury factors, synapse-associated protein, and cholinergic neurotransmitter were measured. The results confirmed the following. (1) KXS shortened the escape latency and increased residence time in the target quadrant and the number of platform crossings in the Morris water maze. (2) KXS increased the percentage of alternations between the labyrinth arms in the mice of KXS groups in the Y-maze. (3) Nissl and terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling staining revealed that KXS promoted the production of Nissl bodies and inhibited the formation of apoptotic bodies. (4) Western blot assay showed that KXS up-regulated the expression of anti-apoptotic protein Bcl-2 and inhibited the expression of pro-apoptotic protein Bax. KXS up-regulated the expression of postsynaptic density 95, synaptophysin, and brain-derived neurotrophic factor in the cerebral cortex and hippocampus. (5) KXS increased the level and activity of choline acetyltransferase, acetylcholine, superoxide dismutase, and glutathione peroxidase, and reduced the level and activity of acetyl cholinesterase, reactive oxygen species, and malondialdehyde through acting on the cholinergic system and reducing oxidative stress damage. These results indicate that KXS plays a neuroprotective role and improves cognitive function through reducing apoptosis and oxidative stress, and regulating synapse-associated protein and cholinergic neurotransmitters.

Can Dietary Intake of Vitamin C-Oriented Foods Reduce the Risk of Osteoporosis, Fracture, and BMD Loss? Systematic Review With Meta-Analyses of Recent Studies.

Background: Several epidemiological studies have been performed to evaluate the association of dietary intake of vitamin C-oriented foods (DIVCF) with risk of fracture and bone mineral density (BMD) loss, but the results remain controversial. Therefore, we conducted a systematic meta-analysis to assess this correlation. Methods: We searched EmBase, PubMed, Web of Science, and the Chinese database CNKI for relevant articles published up to August 2019. Pooled relative risks (RRs) with 95% confidence intervals (CIs) were calculated using the random- or fixed-effects model. Discrepancies were resolved by consultation with a third expert. Results: A total of 13 eligible articles (including 17 studies) with 19,484 subjects were identified for the present meta-analysis. The pooled RR of hip fracture for the highest vs. lowest category was 0.66 (95% CI, 0.47-0.94) for DIVCF, i.e., people with a greater frequency of Vitamin C uptake had a 34% (95% CI, 6%-53%) lower prevalence of hip fracture. In subgroup analyses stratified by study design, gender, and age, the negative associations were statistically significant. Furthermore, the statistical analysis of the association between DIVCF and risk of osteoporosis (RR, 0.66; 95% CI, 0.48-0.92), BMD at the lumbar spine (pooled r, 0.15; 95% CI, 0.09-0.23), and BMD at the femoral neck (pooled r, 0.20; 95% CI, 0.11-0.34) showed beneficial effects of DIVCF. Conclusion: Our meta-analysis indicates that DIVCF is negatively associated with the risk of hip fracture, osteoporosis, and BMD loss, suggesting that DIVCF decreases the risk of hip fracture, osteoporosis, and BMD loss.

Role of Xingnaojing combined with naloxone in treating intracerebral haemorrhage: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Xingnaojing injection (XNJ) sharpen the mind and induce consciousness and are widely used in acute phases of intracerebral hemorrhage (ICH). Naloxone hydrochloride injection (NX) performs equally well and replace the effects of morphine-like substances to promote conscious awareness. The applications of XNJ combined with NX for ICH show some advantages compared with NX applied individually. The aim of this systematic review is to evaluate the effectiveness and safety of XNJ combined with NX for ICH. METHODS: Comprehensive searches were conducted in 8 medical databases (PubMed, Cochrane Library, Web of Science, Embase, CNKI, VIP, CBM and Wanfang database) from inceptions to October 2017 for randomized controlled trials (RCTs) that compared the applications of XNJ and NX with NX applied individually in ICH. Literature screening, assessing risk of bias and data extraction were conducted by 2 reviewers independently. According to the Cochrane Collaboration's RevMan5.3 software to perform the data analysis. RESULTS: 32 RCTs (3068 cases) were selected and the quality of studies were low. All trials compared XNJ and NX with NX applied individually. The overall meta-analysis results showed that XNJ combined with NX have significant effect on clinical efficacy (OR 3.78, 95% CI: 3.03-4.73; P < .00001), GCS score (MD 3.86, 95% CI: 3.46-4.25; P < .00001), coma duration (MD -5.59, 95% CI: -6.96 to -4.22; P < .00001), NIHSS score (MD -6.24, 95% CI: -8.05 to -4.42; P < .00001), Barthel Index score (MD 14.12, 95% CI: 6.7-21.54; P < .0002), cerebral hematoma volume (MD -6.05, 95% CI: -6.85 to -5.24; P < .00001) than NX applied individually. Adverse events reported in 4 studies and included mild discomfort symptoms. CONCLUSION: The effectiveness and safety of XNJ combined with NX for ICH cannot be determined due to the low quality of literature, publication bias and heterogeneity. More rigorous RCTs are necessary to verify the role of XNJ combined with NX in the treatment of ICH.

An exploration of the role of a fish-oriented diet in cognitive decline: a systematic review of the literature.

Epidemiological studies have presented inconsistent evidence of the correlation between a fish-oriented dietary intake (FDI) and the risk of cognitive decline. To address these controversies, we performed this systematic review of prospective studies published in December 2016 and earlier using PubMed, Embase, and Web of Science. Two independent researchers conducted the eligibility assessment and data extraction; all discrepancies were solved by discussion with a third researcher. The pooled relative risks (RRs) focused on the incidence of events were estimated with 95% confidence intervals (CIs). Overall, nine studies containing 28,754 subjects were analyzed. When the highest and lowest categories of fish consumption were compared, the summary RR for dementia of Alzheimer type (DAT) was 0.80 (95%CI = 0.65-0.97); i.e., people with a higher intake of fish had a 20% (95%CI = 3-35%) decreased risk of DAT. Additionally, the dose-response synthesized data indicated that a 100-g/week increase in fish intake reduced the risk of DAT by an additional 12% (RR = 0.88, 95%CI = 0.79-0.99). Non-significant results were observed for the risk of dementia of all causes (DAC) and mild cognitive impairment (MCI). Limited evidence involving heterogeneity was found within subgroups or across studies. In conclusion, this review confirmed that a higher intake of fish could be correlated with a reduced risk of DAT. Further research, especially prospective studies that specifically quantify FDI, will help find a more accurate assessment of the different levels of dietary intake.

Role of Medicinal Plants for Liver-Qi Regulation Adjuvant Therapy in Post-stroke Depression: A Systematic Review of Literature.

Current evidence demonstrated certain beneficial effects of medicinal herbs as an adjuvant therapy for post-stroke depression (PSD) in China; Chai-hu (Chinese Thorowax Root, Radix Bupleuri) is an example of a medicinal plant for Liver-Qi regulation (MPLR) in the treatment of PSD. Despite several narrative reports on the antidepressant properties of MPLR, it appears that there are no systematic reviews to summarize its outcome effects. Therefore, the aim of this review was to assess the effectiveness and safety of MPLR adjuvant therapy in patients with PSD. Seven databases were extensively searched from January 2000 until July 2016. Randomized control trials (RCTs) involving patients with PSD that compared treatment with and without MPLR were taken into account. The pooled effect estimates were calculated based on Cochrane Collaboration's software RevMan 5.3. Finally, 42 eligible studies with 3612 participants were included. Overall, MPLR adjuvant therapy showed a significantly higher effective rate (RR = 1.23; 95% CI = 1.19, 1.27; p < 0.00001) compared to those without. Moreover, the administration of MPLR was superior to abstainers regarding Hamilton Depression Scale (HAMD) score changes after 3 weeks (WMD = -4.83; 95% CI = -6.82, -2.83; p < 0.00001), 4 weeks (WMD = -3.25; 95% CI = -4.10, -2.40; p < 0.00001), 6 weeks (WMD = -4.04; 95% CI = -5.24, -2.84; p < 0.00001), 8 weeks (WMD = -4.72; 95% CI = -5.57, -3.87; p < 0.00001), and 12 weeks (WMD = -3.07; 95% CI = -4.05, -2.09; p < 0.00001). In addition, there were additive benefits in terms of response changes for the National Institutes of Health Stroke Scale (NIHSS) and other self-rating scores. No frequently occurring or serious adverse events were reported. We concluded that there is supporting evidence that adjuvant therapy with MPLR is effective in reducing the depressive symptoms and enhancing quality of life for patients with PSD. More well-designed RCTs are necessary to explore the role of MPLR in the treatment of PSD. Copyright © 2016 John Wiley & Sons, Ltd.

Is adjunctive treatment with medication of liver-soothing-oriented method beneficial for depression after cerebrovascular accident?: A PRISMA-compliant meta-analysis.

BACKGROUND: Adjunctive treatment with medication of liver-soothing-oriented method (MLSM) is one of the most commonly used approaches for subjects with depression after cerebrovascular accident (DCVA) in China. The purpose of this meta-analysis was to evaluate the outcome of MLSM treatment in subjects with DCVA using relevant published literature. METHODS: The PubMed, Cochrane Library, Embase, Chinese databases of China National Knowledge Infrastructure, WanFang, Sinomed, and VIP were used to collect all publications until March 2016. Randomized controlled trials comparing treatments with and without MLSM for subjects with DCVA were included. The quality of each publication was assessed based on the recent Handbook (5.1 version) for Cochrane Reviewers. Cochrane Collaboration's software RevMan 5.3 software was applied for data analysis. RESULTS: Thirty studies, including 2599 cases, were identified and collected. Adjunctive treatment with MLSM noticeably enhanced total effective rates (odds ratio 3.76; 95% confidence interval [CI] 2.92-4.85, I = 0%, P = 0.96) in comparison to non-MLSM conventional pharmacotherapy. Compared to non-MLSM treatment, the changes of Hamilton Depression Scale in adjunctive treatment with MLSM, respectively, decreased and showed beneficial effects after 3 weeks (weighted mean difference [WMD] -4.83; 95% CI -6.82 to -2.83; I = 86%, P < 0.001), 4 weeks (WMD -4.20; 95% CI -5.06 to -3.33; I = 78%, P < 0.001), 6 weeks (WMD -3.36; 95% CI -4.05 to -2.68; I = 54%, P = 0.02), 8 weeks (WMD -4.83; 95% CI -5.62 to -4.04; I = 73%, P < 0.001), and 12 weeks (WMD -2.88; 95% CI -4.09 to -1.67; I = 58%, P = 0.09). As for changes in inflammatory cytokine levels, adjunctive treatment with MLSM was associated with a significant decrease in tumor necrosis factor-α, IL-6, and interleukin-1ß levels in comparison to non-MLSM treatment. Moreover, there were positive effects on score changes for National Institute of Health Stroke Scale, activities of daily living, Hamilton Anxiety Scale, Modified Edinburgh Scandinavian Stroke Scale, and Self-Rating Anxiety Scale. No serious adverse events were reported. CONCLUSION: MLSM appears to improve symptoms of depressive disorders, enhance immediate responses, and the quality of life in subjects with DCVA. The positive action of MLSM might be potentially connected with its immunoregulating effects. More prospective trials with strict design and larger sample sizes are warranted to clarify its effectiveness and safety.

[Acute Stanford B aortic intramural hematoma: early and midterm follow-ups and morphological changes of computed tomography].

OBJECTIVE: To summarize the clinical performances and analyze the morphological characters of acute Stanford B aortic intramural hematoma (IMH) on computed tomography (CT). METHODS: From January 2010 to June 2012, a total of 28 IMH patients at General Hospital of People's Liberation Army were retrospectively reviewed. Among them, 18 patients were followed up with CT. The data of vessel wall maximum thickness (MT), aortic maximum outside diameter (OD) and aortic inner diameter (ID) at onset and 1 week, 1, 3, 6, 12 months post-onset. Statistical analysis was performed with paired t-test. RESULTS: No mortality occurred. Two patients received endovascular repair. According to the follow-ups of 18 IMH patients, MT was (12.1 ± 2.6) mm on CT. Hematoma disappeared in 44.4% patients at 6 months post-onset. Hematoma disappeared more in the patients with MT ≤ 10 mm than those with > 10 mm (85.7% vs 18.2%, P < 0.01). Hematoma disappeared in 13/15 patients (86.7%) at 12 months post-onset. OD decreased (7.3 ± 2.4) mm per year and (6.7 ± 3.5) and (0.6 ± 1.7) mm within the first 6 months and 6 months later respectively. OD increased (0.9 ± 0.5) mm after the disappearance of hematoma. ID increased (6.1 ± 2.3) mm per year and (4.7 ± 1.8) and (1.2 ± 1.0) mm within the first 6 months and 6 months later respectively. CONCLUSION: The early and midterm outcomes of IHM are satisfactory most of hematoma disappear 12 months after onset. Hematoma disappears more rapidly in the patients with MT ≤ 10 mm than those with > 10 mm. OD reduces and ID increases before the disappearance of hematoma, and both increase afterward. Aortic cavity has a trend of dilating continually.

[A review of research on the development of instruments for therapeutic efficacy evaluation of traditional Chinese medicine].

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

[Problems to pay attention to in taking patient-reported outcomes as clinical outcomes assessment].

Patient-reported outcomes (PROs) provide clinical researchers with a good means to assess patient-based outcomes. Yet there are still some problems to pay attention to while using PROs as an effectiveness assessment index, including the selection of an appropriate scale of PRO, quality control in PRO data collection, and the interpretations and application ranges of the PRO results.

Principles of ethics review on traditional medicine and the practice of institute review board in China.

As one of the significant parts of medical science research in China, the research on Chinese medicine (CM) reflects the essence of healthcare tradition in the country both theoretically and clinically, and embodies the values of Chinese culture. Therefore, in the practice of ethics review on CM research protocols, besides abiding by the contemporary prevalent international principles and guidelines on bioethics, which emphasizes the scientific and bioethical value of the study, we should also stress the CM theoretical background and relevant clinical experience in the framework of Chinese culture and values. In this paper, we went over the traits of CM clinical research and the experience from the practice of ethics review by the institution review board for bioethics, and then attempted to summarize the key points for the bioethics review to CM researches in China, so as to serve as reference for the bioethics review to traditional and alternative medicine researches.

[Randomized controlled clinical trials for acupuncture treatment of spastic cerebral palsy children by bilateral horizontal puncturing from Yuzhen (BL 9) to Tianzhu (BL 10)].

OBJECTIVE: To observe the effect of acupuncture of the body surface projection region of the pyramidal decussationes on spastic cerebral palsy (CP) so as to explore an effective therapy for it. METHODS: A total of 120 CP infant patients were randomized into control group (treated with modern rehabilitation training, n = 60) and acupuncture group (treated with acupuncture combined with modern rehabilitation training, n = 60). Four acupuncture needles were penetrated subcutaneously through the region between Yuzhen (BL 9) and Tianzhu (BL 10)equidistantly (the superficial projection region of the pyramidal decussationes), once daily for 3 months. The modified Ashworth rating, gross motor function measure (GMFM)-88 scores and synthetic function scale were adopted to assess the therapeutic effect after the treatment. RESULTS: After the treatment, of the 59 and 58 CP children in the control and acupuncture groups, 17 (28.81%) and 26 (44.83%) experienced marked improvement in their symptoms, 33 (55.84%) and 27 (46.55%) had an improvement, 9 (15.25%) and 5 (8.62%) failed in the treatment, with the total effective rates being 84.75% and 91.38%, respectively. The effective rate of the acupuncture group was significantly superior to that of the control group (P < 0.05). The scores of modified Ashworth rating and GMFM-88 of the control group were significantly lower than those of the acupuncture group after the treatment (P < 0.05). CONCLUSION: Acupuncture combined with modern rehabilitation training is effective in the treatment of CP children patients.

[Influence of acupoint-catgut-implantation on blood pressure and cardiac function in chronic congestive heart failure rats].

OBJECTIVE: To observe the effect of acupoint-catgut-implantation on blood pressure and cardiac function in chronic heart failure (CHF) rats. METHODS: A total of 60 SD female rats were randomly divided into sham-operation group (sham), CHF model group, catgut-implantation group, Captopril group. CHF model was established by suprarenal abdominal artery constriction. Surgical catgut (No. 3-0, 2-3 mm length piece) was implanted into bilateral "Neiguan" (PC 6), "Xinshu" (BL 15) and "Zusanli" (ST 36) twice for 7 weeks. Rats of the Captopril group were treated with intragastric infusion of Captopril from the 50= day on after the operation, once daily for 7 weeks. Blood pressure (BP) including the systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MBP), heart rate (HR) and the left ventricular ejection fraction (LVEF) were detected respectively by cardiac sonography. RESULTS: On the 14th week after modeling, in comparison with the sham group, the SBP, DBP, MBP and HR in rats of the model group were increased significantly (P<0. 01, P<0. 05), while LVEF of the model group was decreased considerably (P<0. 01). Compared with the model group, the SBP, DBP, MBP and HR after 7 weeks' treatment in rats of the catgut-implantation and Captopril groups were decreased considerably (P<0. 01), while the LVEF of the catgut-implantation group was increased evidently (P<0. 05). No significant differences were found between the catgut-implantation and Captopril groups in the SBP, DBP, MBP and HR levels, and between the model and Captopril groups in LVEF values (P>0. 05). CONCLUSION: Acupoint-catgut-implantation can down-regulate BP and HR, and increase LVEF in chronic congestive heart failure rats, which may contribute to its effect in ameliorating the cardiac function.

[Evaluation of consistency of tongue and pulse signs observed by traditional Chinese medicine clinicians].

OBJECTIVE: To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

[Synthetic evaluation of the clinical effect of the Shengmai capsule for treatment of chronic congestive heart failure using analytic hierarchy process].

OBJECTIVE: To explore the approaches and techniques for synthetic evaluation of the clinical therapeutic effect of new Chinese herbal medicine in clinical trials. METHODS: In a double-blind, randomized, and placebo-controlled clinical trail, analytic hierarchy process (AHP) was applied to evaluate the clinical therapeutic effect of Shengmai capsule in the treatment of chronic congestive heart failure. RESULTS: Shengmai capsule produced positive therapeutic effect on chronic congestive heart failure. CONCLUSION: A feasible method is established for evaluating and grading the clinical therapeutic effect of Chinese herbal medicine.

[A prospective comparative study of three treatment options in patients with malignant gastric outlet obstruction].

OBJECTIVE: To evaluate outcomes after different treatment options including endoscopic stent placement, surgical bypass, and percutaneous gastrostomy for malignant gastric outlet obstruction (GOO). METHODS: Thirty-nine patients with GOO secondary to unresectable primary or metastatic cancer were treated with endoscopic stent placement (group 1, n=13), surgical bypass (group 2, n=21), or percutaneous gastrostomy (group 3, n=5). QLQ-STO22 form was used to assess quality of life (QOL) at baseline, 1 month, and 3 months following intervention. RESULTS: Overall median survival time was 68 days. Median survival time in group 1 and group 2 was 85 and 72 days respectively, longer than that in group 3 (48 days, P<0.05). Fourteen patients (7 cases in group 1 and 7 cases in group 2) completed all three QOL surveys. All the patients in group 1 had significant improvement in dysphagia, dietary restrictions, dry mouth, and reflux (P<0.05). In group 2, dysphagia and dietary restrictions were significantly improved (P<0.05), while there were no significant improvements in dry mouth, reflux and pain (all P>0.05). CONCLUSION: Although the prognosis of malignant GOO is poor, endoscopic stent placement and surgical bypass may improve QOL of patients and therefore are reasonable alternatives for palliation.

[A study of scale response for Health Scale of Traditional Chinese Medicine].

OBJECTIVE: To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM). METHODS: 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. RESULTS: 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. CONCLUSION: The scale descriptors selected are suitable for HSTCM and the results can be referenced in developing similar health profile assessment.

[Comparison of pragmatic clinical trials and explanatory clinical trials].

Clinical trials are often designed as either pragmatic or explanatory. The pragmatic clinical trials are generally used for measuring the effectiveness of a treatment in common clinical practice, while the explanatory trial for measuring the efficacy of a treatment under ideal conditions. Since the methods concerning pragmatic clinical trials are less introduced in China, its archetypal features, advantages and limitations were introduced in this paper. And a current study of pragmatic clinical trials on using acpuncture for treatment of low back pain carried out in German was taken as an example to illustrate the practical methods concretely. The key steps of the design were presented in detail, and reasonable suggestions about the problems often encountered in the trial, as well as how to balance the internal and external validity, outcome measurement, etc., were offered.