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Abstract Objective The fragility index (FI), which is the minimum number of changes in status from “event” to “non-event” resulting in a loss of statistical significance, serves as a significant supplementary indicator for clinical physicians in interpreting clinical trial results and aids in understanding the outcomes of randomized controlled trials (RCTs). In this systematic literature survey, we evaluated the FI for RCTs evaluating Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS), and explored potential associations between study characteristics and the robustness of RCTs. Methods A comprehensive search was conducted in four databases in Chinese and four databases in English from their inception to January 1, 2023. RCTs encompassed 1:1 ratio into two parallel arms and reported at least one binary outcome that demonstrated statistical significance were included. FI was calculated by the iterative reduction of a target outcome event in the treatment group and concomitant subtraction of a non-target event from that group, until positive significance (defined as P

Objective: To evaluate the efficacy and safety of Jiawei Simiao powder (JWSMP) combined with celecoxib for the treatment of acute gouty arthritis by conducting a meta-analysis of randomized controlled trials (RCTs). Methods: The Chinese National Knowledge Infrastructure Databases, Chinese Scientific Journal Database, Wanfang, Cochrane Library, EMBASE, PubMed, and Web of Science databases were searched from inception until December 2023. Continuous variables were analyzed using the mean difference (MD) for analysis, and dichotomous variables were used as risk ratios. Data with similar characteristics were pooled for meta-analysis, and heterogeneity was assessed using I2. The Cochrane Handbook was used to assess the risk of bias and quality. RevMan 5.3 software was used to perform the meta-analysis. Results: Thirteen RCTs involving 1007 patients were included in the study. The quality of the included studies was low (unclear randomization processes and insufficient blinding reporting). The group receiving JWSMP combined with celecoxib showed significantly lower levels of serum uric acid (SUA, MD = −66.32, 95% confidence interval (CI): −80.97 to −51.67, P

Background: The pragmatism levels of randomized controlled trials (RCTs) mean how similar the interventions delivered in the trial setting match those in the setting where the results will be applied. We aimed to investigate the association between the consistency of pragmatism among the characteristics of RCT design and its effect size of results in Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS). Methods: Eight English and Chinese language databases were searched for RCTs on CHM for IBS. Six reviewers independently assessed the pragmatism of trials using the pragmatic-explanatory continuum indicator summary 2 (PRECIS-2) tool. The consistency of pragmatism levels among the characteristics of RCT design was calculated using the coefficient of variation. Linear regression models were adopted to explore influence factors of the pragmatism of RCTs. Results: 78 RCTs were included. The level of consistency in the pragmatism for RCT's design was significantly correlated with the effect size of the results (binary outcome, r = -0.413; P = 0.005; continuous outcome, r = -0.779, P < 0.001). PRECIS-2 score was higher in trials with individualized interventions than fixed interventions (3.29 [0.32] vs 2.90 [0.32]; Cohen's d relative effect size, 0.52; P < 0.001) and in standard or usual-treatment-controlled trials than placebo-controlled (3.05 [0.37] vs 2.83 [0.28]; Cohen's d relative effect size, 0.32; P = 0.048). Conclusion: The consistency of pragmatism level across the 9 domains of the PRECIS-2 tool in CHM IBS RCTs was positively correlated with the effect size of the results.

BackgroundThe duration of sleep plays a crucial role in the development of physiological functions that impact health. However, little is known about the associations between sleep duration and functional disability among older adults in China. ObjectiveThis study aimed to explore the associations between sleep duration and functional disabilities in the older population (aged≥65 years) in China. MethodsThe data for this cross-sectional study were gathered from respondents 65 years and older who participated in the 2018 survey of the China Health and Retirement Longitudinal Study, an ongoing nationwide longitudinal investigation of Chinese adults. The duration of sleep per night was obtained through face-to-face interviews. Functional disability was assessed according to activities of daily living (ADL) and instrumental activities of daily living (IADL) scales. The association between sleep duration and functional disability was assessed by multivariable generalized linear models. A restricted cubic-spline model was used to explore the dose-response relationship between sleep duration and functional disability. ResultsIn total, 5519 participants (n=2471, 44.77% men) were included in this study with a mean age of 73.67 years, including 2800 (50.73%) respondents with a functional disability, 1978 (35.83%) with ADL disability, and 2299 (41.66%) with IADL disability. After adjusting for potential confounders, the older adults reporting shorter (≤4, 5, or 6 hours) or longer (8, 9, or ≥10 hours) sleep durations per night exhibited a notably increased risk of functional disability compared to that of respondents who reported having 7 hours of sleep per night (all P

Background: Cancer-related fatigue and its associated symptoms of sleep disorder and depression are prevalent in cancer survivors especially among breast, lung, and colorectal cancer survivors. While there is no gold standard for treating cancer-related fatigue currently, studies of mind-body exercises such as Qigong have reported promise in reducing symptoms. This study was designed to evaluate the feasibility and effect of Guolin Qigong on cancer-related fatigue and other symptoms in breast, lung and colorectal cancer survivors while exploring their perceptions and experiences of Guolin Qigong intervention. Methods: This is an open-label randomized controlled trial with 60 participants divided into 2 study groups in a 1:1 ratio. The intervention group will receive 12 weeks of Guolin Qigong intervention with a 4-week follow-up while control will receive usual care under waitlist. The primary outcome will be feasibility measured based on recruitment and retention rates, class attendance, home practice adherence, nature, and quantum of missing data as well as safety. The secondary subjective outcomes of fatigue, sleep quality and depression will be measured at Week-1 (baseline), Week-6 (mid-intervention), Week-12 (post-intervention), and Week-16 (4 weeks post-intervention) while an objective 24-hour urine cortisol will be measured at Week-1 (baseline) and Week-12 (post-intervention). We will conduct a semi-structured interview individually with participants within 3 months after Week-16 (4 weeks post-intervention) to obtain a more comprehensive view of practice adherence. Discussion: This is the first mixed-method study to investigate the feasibility and effect of Guolin Qigong on breast, lung, and colorectal cancer survivors to provide a comprehensive understanding of Guolin Qigong’s intervention impact and participants’ perspectives. The interdisciplinary collaboration between Western Medicine and Chinese Medicine expertise of this study ensures robust study design, enhanced participant care, rigorous data analysis, and meaningful interpretation of results. This innovative research contributes to the field of oncology and may guide future evidence-based mind-body interventions to improve cancer survivorship. Trial registration: This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO: 2022323-11092) and recognized by Western Sydney University Human Research Ethics Committee (RH15124).

Objectives Clinical practice guideline (CPG) developers conduct systematic summaries of research evidence, providing them great capacity and ability to identify research priorities. We systematically analysed the reporting form and content of research priorities in CPGs related to knee osteoarthritis (KOA) to provide a valuable reference for guideline developers and clinicians.Design A methodological literature analysis was done and the characteristics of the reporting form and the content of the research priorities identified in KOA CPGs were summarised.Data sources Six databases (PubMed, Embase, China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang and Chinese Biomedical Literature Database) were searched for CPGs published from 1 January 2017 to 4 December 2022. The official websites of 40 authoritative orthopaedic societies, rheumatology societies and guideline development organisations were additionally searched.Eligibility criteria We included all KOA CPGs published in English or Chinese from 1 January 2017 that included at least one recommendation for KOA. We excluded duplicate publications, older versions of CPGs as well as guidance documents for guideline development.Data extraction and synthesis Reviewers worked in pairs and independently screened and extracted the data. Descriptive statistics were used, and absolute frequencies and proportions of related items were calculated.Results 187 research priorities reported in 41 KOA CPGs were identified. 24 CPGs reported research priorities, of which 17 (41.5%) presented overall research priorities for the entire guideline rather than for specific recommendations. 110 (58.8%) research priorities were put forward due to lack of evidence. Meanwhile, more than 70% of the research priorities reflected the P (population) and I (intervention) structural elements, with 135 (72.2%) and 146 (78.1%), respectively. More than half of the research priorities (118, 63.8%) revolved around evaluating the efficacy of interventions. Research priorities primarily focused on physical activity (32, 17.3%), physical therapy (30, 16.2%), surgical therapy (27, 14.6%) and pharmacological treatment (26, 14.1%).Conclusions Research priorities reported in KOA CPGs mainly focused on evaluating non-pharmacological interventions. There exists considerable room for improvement for a comprehensive and standardised generation and reporting of research priorities in KOA CPGs.

Abstract Background and objective Consensus methods are crucial in developing clinical guidelines. Different methods, such as the Delphi and nominal group techniques, are commonly used, but there is a lack of detailed instructions on how to implement them effectively. The survey aims to explore the opinions and attitudes of the chair, panel and working group on the critical elements of the consensus methods during guideline development. Methods We used a cross-sectional design to conduct this study and sent a structured questionnaire to stakeholders, including the chair, panel members, and working group participants, through the popular mobile phone application WeChat.We selected participants using a combination of purposive and snowball sampling. The questionnaire gathered information on demographics, experiences, opinions, and concerns regarding consensus methods and guideline development. Results The sample comprised 290 participants representing 31 provinces or municipalities. Among them, the most significant number of respondents (n = 107, 36.9%) were from Beijing. Most participants, specifically 211 (72.76%), held senior professional titles, while 186 (64.14%) adhered to ongoing guidelines. The Delphi method was the most commonly used consensus method (n = 132, 42.31%), but the respondents had only a preliminary understanding of it (n = 147, 47.12%). The consensus process also revealed the insufficiency of involving pharmacoeconomists, patients, and nurses. Conclusions Consensus methods have to be standardised and used consistently in the guideline development process. The findings of this study offer insights into diverse roles and more effective ways to apply the consensus process during guideline development.

ObjectivesTo compared the presentation of research priorities in the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) clinical practice guidelines (CPGs) developed under the guidance of the GRADE working group or its two co-chair, and the Chinese CPGs.MethodsThis was a methodological empirical analysis. We searched PubMed, Embase, and four Chinese databases (Wanfang, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure and Chinese Biomedical Literature Database) and retrieved nine Chinese guideline databases or Society websites as well as GRADE Pro websites. We included all eligible GRADE CPGs and a random sample of double number of Chinese CPGs, published 2018 to 2022. The reviewers independently screened and extracted the data, and we summarized and analyzed the reporting on the research priorities in the CPGs.ResultsOf the 135 eligible CPGs (45 GRADE CPGs and 90 Chinese CPGs), 668, 138 research priorities were identified respectively. More than 70% of the research priorities in GRADE CPGs and Chinese CPGs had population and intervention (PI) structure. 99 (14.8%) of GRADE CPG research priorities had PIC structures, compared with only 4(2.9%) in Chinese. And 28.4% (190) GRADE CPG research priorities reflected comparisons between PICO elements, approximately double those in Chinese. The types of research priorities among GRADE CPGs and Chinese CPGs were mostly focused on the efficacy of interventions, and the type of comparative effectiveness in the GRADE research priorities was double those in Chinese.ConclusionsThere was still considerable room for improvement in the developing and reporting of research priorities in Chinese CPGs. Key PICO elements were inadequately presented, with more attention on intervention efficacy and insufficient consideration given to values, preferences, health equity, and feasibility. Identifying and reporting of research priorities deserves greater effort in the future.

Objectives To describe how systematic reviews with network meta-analyses (NMAs) that used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) NMA approach addressed intransitivity when assessing certainty of evidence.Design Systematic survey.Data sources Medline, Embase and Cochrane Database of Systematic Reviews from September 2014 to October 2022.Eligibility criteria Systematic reviews of randomised controlled trials with aggregate data NMAs that used the GRADE NMA approach for assessing certainty of evidence.Data extraction and synthesis We documented how reviewers described methods for addressing intransitivity when assessing certainty of evidence, how often they rated down for intransitivity and their explanations for rating down.Results Of the 268 eligible systematic reviews, 44.8% (120/268) mentioned intransitivity when describing methods for assessing the certainty of evidence. Of these, 28.3% (34/120) considered effect modifiers and from this subset, 67.6% (23/34) specified the effect modifiers; however, no systematic review noted how they chose the effect modifiers. 15.0% (18/120) mentioned looking for differences between the direct comparisons that inform the indirect estimate. No review specified a threshold for difference in effect modifiers between the direct comparisons that would lead to rating down for intransitivity. Reviewers noted rating down indirect evidence for intransitivity in 33.1% of systematic reviews, and noted intransitivity for network estimates in 23.0% of reviews. Authors provided an explanation for rating down for intransitivity in 59.6% (31/52) of the cases in which they rated down. Of the 31 in which they provided an explanation, 74.2% (23/31) noted they detected differences in effect modifiers and 67.7% (21/31) specified in what effect modifiers they detected differences.Conclusions A third of systematic reviews with NMAs using the GRADE approach rated down for intransitivity. Limitations in reporting of methods to address intransitivity proved considerable. Whether the problem is that reviewers neglected to address rating down for transitivity at all, or whether they did consider but not report, is not clear. At minimum systematic reviews with NMAs need to improve their reporting practices regarding intransitivity; it may well be that they need to improve their practice in transitivity assessment. How to best address intransitivity may remain unclear for many reviewers thus additional GRADE guidance providing practical instructions for addressing intransitivity may be desirable.

Introduction Chronic obstructive pulmonary disease (COPD) represents one of the leading causes of death worldwide. Published clinical trials suggest that the Chinese patent herbal medicine Shufeng Jiedu capsule (SFJD) is safe and may be effective for treating acute exacerbations of COPD (AECOPD). However, these effects have been reported with low or very low certainty evidence. This trial aims to evaluate the effectiveness and safety of SFJD for AECOPD.Methods and analysis This study is designed as a multicentre, randomised, double-blind, placebo-controlled trial. Three hundred patients with moderate or severe hospitalised AECOPD will be recruited in Beijing, Shanghai and Hefei. Participants will be randomly assigned to SFJD and usual care or placebo and usual care at a ratio of 1:1. SFJD and placebo will be administered orally four capsules three times daily for 7 consecutive days followed by an 8-week follow-up period. The primary outcome will be COPD symptom severity as measured by the EXAcerbation of Chronic Pulmonary Disease Tool score. Secondary outcomes include clinical symptoms, quality of life, length of hospital stay, a total dose of antibiotics, the frequency of recurrence of AECOPD, haematological biomarkers, death and adverse events. This study will answer the question of whether SFJD was safe to use and will improve symptoms in people with AECOPD, and will therefore reduce the necessity for antibiotics, the risk and duration of admission to hospital, and the risk of recurrence.Ethics and dissemination The ethics committee of the first affiliated hospital of Anhui Medical University, Beijing University of Chinese Medicine affiliated Dongzhimen hospital and fifth people’s hospital of Shanghai Fudan University approved the study protocol. Informed written consent will be obtained from all the participants. The results of this trial will be disseminated at academic conferences and in peer-reviewed publications.Trial registration number ISRCTN99049821.

Background: Patients with colon cancer who receive chemotherapy usually experience various gastrointestinal adverse reactions, including nausea, vomiting, and diarrhea, which make it challenging for them to adhere to treatment. As an effective traditional Chinese medicine, the Jianpi Bushen formula has been widely used to alleviate the side effects of chemotherapy. Objective: To evaluate the efficacy and safety of Jianpi Bushen formulae for patients who undergo chemotherapy. This statistical analysis plan (SAP) is intended to enhance the transparency and research quality of our randomized controlled trial. Methods: Our study is a multicenter, double-blind, randomized controlled clinical trial. This trial aimed to compare the completion rate of chemotherapy in colon cancer patients who are using and not using Jianpi Bushen formula. To attenuate possible selection bias in the final report, we declared the overall trial design, outcome measures, subgroup analyses, and safety measures. Also, we described the data management and statistical analysis methods in detail. Conclusion: The SAP provides more detailed information than the trial protocol for data management and statistical analysis methods. Further post-hoc analyses can be performed by referring to the SAP, and possible selection bias can be attenuated.

Objective: To explore the effects and dose–response relationship of Tai Chi for type 2 diabetes mellitus (T2DM) and to evaluate the methodological quality of the included trials and evidence quality of the outcomes. Methods: Nine major English and Chinese databases were searched for randomized controlled trials of Tai Chi for T2DM from inception to December 2021. The effects and dose–response relationships were assessed with a meta-analysis and meta-regression using Stata.16. The methodological quality of the included studies was assessed using the risk of bias tool. The evidence quality of the outcomes was assessed using the GRADE tool. Results: A total of 24 studies with 1314 patients were included. Compared with the usual care, Tai Chi improved HbA1c (MD = −0.80%, 95% CI [−1.05, −0.54], P

ObjectiveStudies of sleep duration in relation to the risk of sensory impairments other than dementia are scarce. Little is known about the associations between sleep duration and sensory impairments in China. This study aims to explore the associations between sleep duration and single or dual sensory impairments (visual and/or hearing).MethodsThis cross-sectional study used the data from 17,668 respondents were drawn from the 2018 survey of the China Health and Retirement Longitudinal Study (CHARLS), an ongoing national longitudinal study of Chinese adults aged 45 years and above. The duration of sleep per night was obtained from face-to-face interviews. The presence of sensory impairments was measured by self-reported visual and hearing functions. Multivariable generalized linear models (GLM) with binomial family and log link to assess the associations between sleep duration and sensory impairments.ResultsOf the 17,668 respondents, 8,396 (47.5%) were men. The mean (SD) age was 62.5 (10.0) years old. Respondents with short (≤ 4, 5 h per night) sleep duration had a significantly higher risk of visual, hearing and dual sensory impairments than those who slept for 7 h per night after adjusting for covariates (P < 0.05). Meanwhile, respondents who slept for 6 h per night had a higher risk of hearing impairment (P = 0.005). Further analysis suggested a U-shaped association between sleep duration and sensory impairments. When sleep duration fell below 8 h, increased sleep duration was associated with a significantly lower risk of visual (OR, 0.93; 95%CI, 0.88–0.98; P = 0.006), hearing (OR, 0.89; 95% CI, 0.86–0.93; P < 0.001), and dual (OR, 0.90; 95% CI, 0.87–0.94; P < 0.001) impairments. When sleep duration exceeded 8 h, the risk of visual (OR, 1.09; 95% CI, 1.00–1.19; P = 0.048), hearing (OR, 1.04; 95% CI, 0.97–1.11; P = 0.269), and dual (OR, 1.07; 95% CI, 1.00–1.14; P = 0.044) impairments would increase facing prolonged sleep duration. Women and the elderly aged over 60 years old were more sensitive to short sleep duration and experienced a higher risk of sensory impairments.ConclusionIn this study, short sleep duration was associated with a higher risk of visual and hearing impairments. Future studies are needed to examine the mechanisms of the associations between sleep duration and sensory impairments.

Abstract Background This is the second part of a large spectrum systematic review which aims to identify and assess the evidence for the efficacy of non-pharmacological acupuncture techniques in the treatment of chronic obstructive pulmonary disease (COPD). The results of all techniques except for filiform needle are described in this publication. Methods Eleven different databases were screened for randomised controlled trials up to June 2019. Authors in pairs extracted the data and assessed the risk of bias independently. RevMan 5.3 software was used for the meta-analysis. Results Thirty-three trials met the inclusion criteria, which involved the follow techniques: AcuTENS (7 trials), moxibustion (11 trials), acupressure (7 trials), ear acupuncture (6 trials), acupressure and ear acupuncture combined (1 trial) and cupping (1 trial). Due to the great heterogeneity, only 7 meta-analysis could be performed (AcuTENS vs sham on quality of life and exercise capacity, acupressure vs no acupressure on quality of life and anxiety and ear acupuncture vs sham on FEV1 and FEV1/FVC) with only acupressure showing statistical differences for quality of life (SMD: -0.63 95%CI: − 0.88, − 0.39 I2 = 0%) and anxiety (HAM-A scale MD:-4.83 95%CI: − 5.71, − 3.94 I2 = 0%). Conclusions Overall, strong evidence in favour of any technique was not found. Acupressure could be beneficial for dyspnoea, quality of life and anxiety, but this is based on low quality trials. Further large well-designed randomised control trials are needed to elucidate the possible role of acupuncture techniques in the treatment of COPD. Trial registration PROSPERO (identifier: CRD42014015074 ).

Background: The completeness of reporting of acupuncture interventions is critical to ensure the applicability and reproducibility of acupuncture clinical trials. In the past, different publications have evaluated the completeness of reporting of acupuncture interventions for different clinical situations, such as knee osteoarthritis, neurological diseases or cancer. However, this has not been done for acupuncture trials for chronic obstructive pulmonary disease (COPD). Objective: To assess the completeness of reporting of acupuncture interventions in trials for COPD. Methods: A total of 11 English and Chinese databases were screened up until May 2019 for randomised or quasi-randomised control trials of acupuncture for COPD. The STRICTA checklist was used to determine the quality of the reporting of acupuncture interventions. Results: A total of 28 trials were included in our review. Out of the 16 STRICTA checklist subitems analysed, only 4 were considered appropriately reported in more than 70% of the trials, while 7 were correctly reported in less than 30%. Conclusion: The adherence to STRICTA guidelines of acupuncture trials for COPD is suboptimal, and future efforts need to be addressed to improve the completeness of reporting.

Background: Diarrhea is a ubiquitous digestive system disease, leading to loss of fluid and electrolytes, and may be life-threatening, especially in children and adults who are immunosuppressed or malnourished. Berberine has a broad-spectrum antibiotic activity and is very widely used to treat diarrhea in China. No systematic review has been carried out to evaluate the evidence presented in clinical trials. The aim of this study was to assess the effectiveness and safety of berberine in diarrhea treatment among children and adults. Methods: Seven databases and two clinical trial registries were searched on 1 September 2019. Randomized controlled trials were included, where participants were diagnosed (first diagnosed) as having diarrhea according to clear diagnostic criteria. Berberine alone or in combination with Western medication as intervention were included. Subgroup analyses were conducted based on children or adults, acute or persistent diarrhea, infectious or noninfectious and treatment courses. Primary outcomes were clinical cure rate and duration of diarrhea. The GRADE tool was used to assess the quality of evidence. Results: A total of 38 randomized controlled trials were included involving 3948 participants (including 27 trials on 2702 children) were included. Compared with antibiotics, berberine plus antibiotics showed better results in both adults and in children in general, especially when given for 7 days or 3 days in acute infectious diarrhea of children. Compared with the control groups, using berberine alone or in combination with montmorillonite, probiotics, and vitamin B increased the clinical cure rate of diarrhea. The use of berberine alone or berberine combined with montmorillonite reduced the duration of hospitalization. Using berberine had significantly better laboratory indicators (isoenzyme, inflammatory factors, myocardial enzyme, and fecal trait) and fewer systemic symptoms than the no berberine groups. Overall, 22 of 27 trials on children used berberine as an enema. No deaths and serious adverse events were reported. The quality of evidence of included trials was moderate to low or very low. The impact of different dosages, frequencies and treatment durations on the outcomes was not evaluated due to insufficient number of trials. Conclusion: This review demonstrated that berberine was generally effective in improving clinical cure rates and shortening the duration of diarrhea compared with control groups. No severe adverse event was reported. However, there is still a lack of high-quality evidence for evaluating the efficacy and safety of berberine. Trial registration: PROSPERO CRD42020151001 (available from http://www.crd.york.ac.uk/PROSPERO/ ).

ObjectivesTo explore doctors’ knowledge, willingness, concerns and the countermeasures to the most stringent antimicrobial stewardship regulations of China which implemented in August 2012.DesignCross-sectional survey. A pretested 32-point structured questionnaire was distributed to doctors by sending a web link via the mobile phone application WeChat through snowball sampling methods and email groups of medical academic societies.SettingChina.ParticipantsDoctors.Primary and secondary outcome measuresThe questionnaire inquired about the doctors’ experiences, knowledge, willingness, concerns and the countermeasures to the stewardship policies.ResultsTotal of persons in the groups was 19 791, among them 1194 submitted the answers, within them, 807 were doctors. Doctors had a mean age of 39.0 years. The majority (78.9% in 2012, 89.1% in 2016) reported that they were willing or very willing to accept the regulations. Almost all respondents (93.2%) felt the stewardship regulations had the potential to adversely affect the prognosis of patients who would have been prescribed antimicrobials before they were implemented, and >65% (65.7% in 2012, 66.9% in 2016) of doctors were often or always concerned about the prognosis of these patients. In 2012, 32% of doctors prescribed restricted antimicrobials or suggested patient self-medication with restricted antimicrobials to address doctors’ concerns, and this number decreased to 22.6% in 2016. Although compulsory antimicrobial stewardship training was frequent, less than half of respondents (46.8%) responded correctly to all three knowledge questions.ConclusionAntimicrobial stewardship regulations had some positive effect on rational antimicrobial use. Willingness and practice of doctors towards the regulations improved from 2012 to 2016. Knowledge about rational antimicrobial use was still lacking. Doctors found ways of accessing restricted antibiotics to address their concerns about the prognosis of patients, which undermined the implementation of the stewardship regulations.

OBJECTIVES:To investigate the consistency of adverse events (AEs) and adverse drug reactions (ADRs) reported in the literature, monitoring and social media data. METHODS:Using one Chinese patent medicine-Cordyceps sinensis extracts (CSE) as an example, we obtained safety data from the national monitoring system (July 2002 to February 2016), literature (up to November 2016) and social media (May 2019). For literature data, we searched the Chinese National Knowledge Infrastructure Database (CNKI), WanFang database, Chinese Science and Technology Periodical Database (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Embase and the Cochrane Library. Social media data was from the Baidu post bar and Sina micro-blog. Two authors independently screened the literature and extracted data by PRISMA Harms checklist was followed. AEs and ADRs were coded using the World Health Organization Adverse Reaction Terminology (WHO-ART). AEs and ADRs were grouped into thirty-one organ-system classes for comparisons. Frequencies, relative frequencies and rank were used as metrics. Radar chart was used to manifest the features of the distributions and proportions. RESULTS:610 AEs reported in CFDA monitoring data were associated with CSE, of which 537 (88.03%) were suspected ADRs (10.49% certain). 5568 AEs were identified from 172 papers (63% RCTs, 37% other types of studies including case series, case reports, ADR monitoring reports and reviews), in which 86 (1.54%) were ADRs (1.54% certain). 15 AEs (0 certain ADR) were identified from social media. AEs, ADRs and their affected system-organ classes, looked largely similar, but different in every aspect when looking at details. Data from RCTs demonstrated the most disparity. CONCLUSIONS:In our study, the most prevalent AEs and ADRs, mainly gastro-intestinal system disorders including nausea, diarrhea and vomiting, in monitoring system were largely similar with those in literature and social media. But data from different sources varied if looked at details. Multiple data sources (the monitoring system, literature and social media) should be integrated to collect safety information of interventions. The distributions of AEs and ADRs from RCTs were least similar with the data from other sources. Our empirical proof is consistent with other similar studies.

Objective: To systematically evaluate the effectiveness and safety of Chinese herbal medicine (CHM) plus nucleotide analogues (NAs) for treating compensated HBV-related cirrhosis, the early stage of cirrhosis. Methods: PubMed, Cochrane library, China Network Knowledge Infrastructure Database (CNKI), Chinese Scientific Journals Database (VIP), Wan Fang Database and Sino-Med Database were searched. Randomized controlled trials (RCTs) and quasi-RCTs comparing NAs and NAs plus CHM therapy on patients with compensated HBV-related cirrhosis were included. Two reviewers independently extracted information and assessed the methodological quality of the trials. Different CHM herbal formulas used in the trials were considered. Primary meta-analysis was conducted when there were at least two trials comparing the same CHM formula. Results: Forty-five trials comprising 3497 participants were included. The quality of most of the trials was moderate or low. Twenty-six herbal formulations were identified. A meta-analysis was conducted for compound Biejia Ruangan (FFBJ), Dahuang Zhechong (DHZC), and Fuzheng Huayu (FZHY). The results of the subgroup analysis showed a beneficial effect of FFBJ plus entecavir (ETV), and DHZC plus adefovir dipivoxil (ADV) on hyaluronic acid (HA); FFBJ plus ADV on laminin (LN); and FZHY plus ADV on HA, LN, and precollagen type III (PC-III). The results from other studies suggested significant benefits of CHM plus NAs compared with NAs alone, except those on albumin (ALB). None of the trials evaluated the quality of life or reported severe adverse events. Conclusions: A positive effect was found for FFBJ plus ETV, DHZC plus ADV, and FZHY plus ADV on HA; FZHY plus ADV and FFBJ plus ADV on LN; and FZHY plus ADV on PCIII compared with the effects of NAs used alone.

Background: The quality of reporting of acupuncture interventions is critical to ensure the applicability and reproducibility of acupuncture clinical trials. In the past, different publications have evaluated the quality of reporting of acupuncture interventions for different clinical situations, such as knee osteoarthritis, neurological diseases or cancer. However, this has not been done for acupuncture trials for chronic obstructive pulmonary disease (COPD). Objective: To assess the quality of reporting of acupuncture interventions in trials for COPD. Methods: A total of 11 English and Chinese databases were screened up until May 2019 for randomised or quasi-randomised control trials of acupuncture for COPD. The STRICTA checklist was used to determine the quality of the reporting of acupuncture interventions. Results: A total of 28 trials were included in our review. Out of the 16 STRICTA checklist subitems analysed, only 3 were considered appropriately reported in more than 70% of the trials, while 7 were correctly reported in less than 40%. Conclusion: The adherence to STRICTA guidelines of acupuncture trials for COPD is suboptimal, and future efforts need to be addressed to improve the quality of reporting.

Background: The quality of reporting of acupuncture interventions is critical to ensure the applicability and reproducibility of acupuncture clinical trials. In the past, different publications have evaluated the quality of reporting of acupuncture interventions for different clinical situations, such as knee osteoarthritis, neurological diseases or cancer. However, this has not been done for acupuncture trials for chronic obstructive pulmonary disease (COPD). Objective: To assess the quality of reporting of acupuncture interventions in trials for COPD. Methods: A total of 11 English and Chinese databases were screened up until May 2019 for randomised or quasi-randomised control trials of acupuncture for COPD. The STRICTA checklist was used to determine the quality of the reporting of acupuncture interventions. Results: A total of 28 trials were included in our review. Out of the 16 STRICTA checklist subitems analysed, only 3 were considered appropriately reported in more than 70% of the trials, while 7 were correctly reported in less than 40%. Conclusion: The adherence to STRICTA guidelines of acupuncture trials for COPD is suboptimal, and future efforts need to be addressed to improve the quality of reporting.