How well did the consensus methods apply in the guideline development of traditional Chinese medicine: a web-based survey in China.

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.

[Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine].

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Index-based dietary patterns in relation to gastric cancer risk: a systematic review and meta-analysis.

Dietary indices are widely used in diet quality measurement, and the index-based dietary patterns are related to gastric cancer risk. To evaluate the relationship between different kinds of index-based dietary patterns and gastric cancer risk, we systematically searched four English-language databases and four Chinese-language databases. The quality of studies was assessed by the Newcastle­Ottawa Scale. Meta-analyses were performed to estimate the association between gastric cancer incidence and different types of index-based dietary patterns. The OR and hazard ratios (HR) of gastric cancer incidence were calculated by regression models in case­control studies and prospective cohort studies, respectively. The studies were pooled in the random effects model to calculate the summarised risk estimate of the highest quantile interval of dietary indices, taking the lowest as the referent. The dietary indices included different versions of Mediterranean diet score (MDS) and dietary inflammatory index (DII), healthy eating index, Chinese Food Pagoda score and food index score. The meta-analysis was carried out for studies on MDS and DII. The combined OR of gastric cancer for the highest MDS v. the referent was 0·42 (95 % CI 0·2, 0·86), and the combined HR was 0·89 (95 % CI 0·68, 1·17). The combined OR for DII was 2·11 (95 % CI 1·41, 3·15). Higher Mediterranean dietary pattern consumption might reduce gastric cancer risk, while higher inflammatory diet pattern consumption might increase gastric cancer risk.

Traditional medicines for asthma in children and adults: A systematic review of placebo-controlled studies.

BACKGROUND: Traditional medicines (TMs) adjunctive to conventional medications are widely used for asthma in east-Asia and have gained popularity in western countries. OBJECTIVE: To assess the efficacy and safety of TMs for asthma in children and adults based on placebo-controlled trials in order to inform physicians and assist them in discussions with patients. METHODS: Seventeen electronic databases were searched. Participants had acute or chronic asthma. Interventions included orally administered traditional medicines used in east-Asia. Outcomes included lung function, symptoms, quality of life, exacerbations, medication use and safety. RevMan 5.3 (random effect model) was used for meta-analysis. Baseline values were assessed for balance and asthma severity. Within-group changes were calculated to assess minimal clinically important difference (MCID). RESULTS: Eighteen studies (2080 participants) were included. All combined TMs with conventional medicines. The single study of acute asthma (n = 300) showed an improvement. For chronic asthma, severity at baseline ranged from very mild to severe. When asthma was mild, significant differences in lung function (FEV1%, PEF/R) were not detectable. When participants had moderate and/or severe asthma at baseline improvements were more evident. For measures of lung function, improvements within the TM groups tended to be greater when the asthma was more severe. Some studies showed MCIDs. No serious adverse events or interactions were reported but safety data were incomplete. CONCLUSIONS: The application of certain traditional herbal medicines used in east-Asia as adjuncts to conventional medications improved outcomes in acute and chronic asthma, but most evidence was based on single trials. Therefore, no single TM could be recommended. Effect sizes varied according to asthma severity at baseline. Future studies should consider baseline severity when enrolling participants.

Autoimmune Diseases May Increase Adverse Cardiovascular Events After Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis.

BACKGROUND: Outcomes of patients with autoimmune diseases after percutaneous coronary intervention (PCI), as compared to those without autoimmune disease, remain unclear. METHODS: We searched Medline, EMBASE, and the Cochrane Library from their inception to 1 April 2017. All studies comparing the following outcomes of patients with and without autoimmune diseases after PCI were included: long-term mortality, major adverse cardiovascular events (MACE), repeat revascularisation, myocardial ischaemia or myocardial infarction (MI), restenosis, and in-hospital mortality. The Newcastle-Ottawa Quality Assessment Scale (NOS) and the quality assessment form of the Agency for Healthcare Research and Quality (USA) (AHRQ) were used for assessing the risk of bias, and the certainty of evidence was rated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). RESULTS: A total of 11 studies were included in our analysis. Compared with patients without autoimmune diseases, those with autoimmune diseases carried an increased risk of MACEs (relative risk (RR): 2.24, 95% confidence interval (CI): 1.20-4.16; heterogeneity: p=0.128, I2=56.9%), repeat revascularisation (RR: 1.66, 95% CI 95%: 1.01-2.72; heterogeneity: p=0.057, I2=65.1%), ischaemia or MI (RR: 2.80, 95% CI: 1.38-5.65; heterogeneity: p=0.871, I2=0.0%), and restenosis (RR: 2.06, 95% CI: 1.39-3.07; heterogeneity: p=0.665, I2=0.0%) during the one-year follow-up after PCI, and carried an increased risk of MACEs (RR: 1.10, 95% CI: 1.04-1.17) and death (RR: 1.38, 95% CI: 1.25-1.51) during the 11-year follow-up after PCI. CONCLUSIONS: Evidence of very low quality showed that during the one-year follow-up period, patients with autoimmune diseases after PCI were more likely to experience MACEs, repeat revascularisation, myocardial ischaemia or MI, and restenosis. During the 11-year follow-up period, patients with autoimmune diseases after PCI were more likely to die. It is therefore important to watch for restenosis, repeat ischaemia or MI and other adverse events more carefully in patients with autoimmune diseases after PCI.

A systematic review of how patients value COPD outcomes.

Our objective was to summarise systematically all research evidence related to how patients value outcomes in chronic obstructive pulmonary disease (COPD).We conducted a systematic review (systematic review registration number CRD42015015206) by searching PubMed, Embase, PsycInfo and CINAHL, and included reports that assessed the relative importance of outcomes from COPD patients' perspective. Two authors independently determined the eligibility of studies, abstracted the eligible studies and assessed risk of bias. We narratively summarised eligible studies, meta-analysed utilities for individual outcomes and assessed the certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations approach.We included 217 quantitative studies. Investigators most commonly used utility measurements of outcomes (n=136), discrete choice exercises (n=13), probability trade-off (n=4) and forced choice techniques (n=46). Patients rated adverse events as important but on average, less so than symptom relief. Exacerbation and hospitalisation due to exacerbation are the outcomes that COPD patients rate as most important. This systematic review provides a comprehensive registry of related studies.

Transfusion of fresher vs older red blood cells in hospitalized patients: a systematic review and meta-analysis.

The impact of transfusing fresher vs older red blood cells (RBCs) on patient-important outcomes remains controversial. Two recently published large trials have provided new evidence. We summarized results of randomized trials evaluating the impact of the age of transfused RBCs. We searched MEDLINE, EMBASE, CINAHL, the Cochrane Database for Systematic Reviews, and Cochrane CENTRAL for randomized controlled trials enrolling patients who were transfused fresher vs older RBCs and reported outcomes of death, adverse events, and infection. Independently and in duplicate, reviewers determined eligibility, risk of bias, and abstracted data. We conducted random effects meta-analyses and rated certainty (quality or confidence) of evidence using the GRADE approach. Of 12 trials that enrolled 5229 participants, 6 compared fresher RBCs with older RBCs and 6 compared fresher RBCs with current standard practice. There was little or no impact of fresher vs older RBCs on mortality (relative risk [RR], 1.04; 95% confidence interval [CI], 0.94-1.14; P = .45; I(2) = 0%, moderate certainty evidence) or on adverse events (RR, 1.02; 95% CI, 0.91-1.14; P = .74; I(2) = 0%, low certainty evidence). Fresher RBCs appeared to increase the risk of nosocomial infection (RR, 1.09; 95% CI, 1.00-1.18; P = .04; I(2) = 0%, risk difference 4.3%, low certainty evidence). Current evidence provides moderate certainty that use of fresher RBCs does not influence mortality, and low certainty that it does not influence adverse events but could possibly increase infection rates. The existing evidence provides no support for changing practices toward fresher RBC transfusion.

Sini decoction as an adjuvant therapy for angina pectoris: a systematic review of randomized controlled trials.

OBJECTIVE: To systematically assess the effects and safety of Sini decoction as an adjuvant therapy for patients with angina pectoris. METHODS: We searched PubMed, Excerpt Medica Database, the Cochrane library, Wanfang Database, China National Knowledge Infrastructure Database, China Science and Technology Journal Database from the date of its inception until August 1, in 2014. Available literatures were selected according to the inclusion criteria. Two reviewers finished data extraction, checked the data and assessed the methodological quality of studies, independently. The Review Manage Software 5.1.0 was used for data analysis. RESULTS: Six trials involving 453 participants were eligible. None of the trials reported the mortality due to angina pectoris. The secondary outcomes showed that Sini decoction, together with nitroglycerin when necessary, may have some effects on reducing the number of angina attacks and the amount of nitroglycerin. But in terms of reducing the duration of angina and improvement of electrocardiogram, there were no statistical differences between Sini decoction group and isosorbide dinitrate group. Only one reported that no adverse events were found. CONCLUSION: Based on this systematic review, Sini decoction can reduce the dosage of nitroglycerin, when compared with isosorbide dinitrate group. And there were no enough evidence in the papers to draw any conclusions for the safety of Sini decoction.

Acupuncture for the prevention of episodic migraine.

BACKGROUND: Acupuncture is often used for migraine prevention but its effectiveness is still controversial. We present an update of our Cochrane review from 2009. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than sham (placebo) acupuncture; and c) as effective as prophylactic treatment with drugs in reducing headache frequency in adults with episodic migraine. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL: 2016, issue 1); MEDLINE (via Ovid, 2008 to January 2016); Ovid EMBASE (2008 to January 2016); and Ovid AMED (1985 to January 2016). We checked PubMed for recent publications to April 2016. We searched the World Health Organization (WHO) Clinical Trials Registry Platform to February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomized trials at least eight weeks in duration that compared an acupuncture intervention with a no-acupuncture control (no prophylactic treatment or routine care only), a sham-acupuncture intervention, or prophylactic drug in participants with episodic migraine. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on participants, interventions, methods and results, and assessed risk of bias and quality of the acupuncture intervention. The primary outcome was migraine frequency (preferably migraine days, attacks or headache days if migraine days not measured/reported) after treatment and at follow-up. The secondary outcome was response (at least 50% frequency reduction). Safety outcomes were number of participants dropping out due to adverse effects and number of participants reporting at least one adverse effect. We calculated pooled effect size estimates using a fixed-effect model. We assessed the evidence using GRADE and created 'Summary of findings' tables. MAIN RESULTS: Twenty-two trials including 4985 participants in total (median 71, range 30 to 1715) met our updated selection criteria. We excluded five previously included trials from this update because they included people who had had migraine for less than 12 months, and included five new trials. Five trials had a no-acupuncture control group (either treatment of attacks only or non-regulated routine care), 15 a sham-acupuncture control group, and five a comparator group receiving prophylactic drug treatment. In comparisons with no-acupuncture control groups and groups receiving prophylactic drug treatment, there was risk of performance and detection bias as blinding was not possible. Overall the quality of the evidence was moderate. Comparison with no acupunctureAcupuncture was associated with a moderate reduction of headache frequency over no acupuncture after treatment (four trials, 2199 participants; standardised mean difference (SMD) -0.56; 95% CI -0.65 to -0.48); findings were statistically heterogeneous (I² = 57%; moderate quality evidence). After treatment headache frequency at least halved in 41% of participants receiving acupuncture and 17% receiving no acupuncture (pooled risk ratio (RR) 2.40; 95% CI 2.08 to 2.76; 4 studies, 2519 participants) with a corresponding number needed to treat for an additional beneficial outcome (NNTB) of 4 (95% CI 3 to 6); there was no indication of statistical heterogeneity (I² = 7%; moderate quality evidence). The only trial with post-treatment follow-up found a small but significant benefit 12 months after randomisation (RR 2.16; 95% CI 1.35 to 3.45; NNT 7; 95% 4 to 25; 377 participants, low quality evidence). Comparison with sham acupunctureBoth after treatment (12 trials, 1646 participants) and at follow-up (10 trials, 1534 participants), acupuncture was associated with a small but statistically significant frequency reduction over sham (moderate quality evidence). The SMD was -0.18 (95% CI -0.28 to -0.08; I² = 47%) after treatment and -0.19 (95% CI -0.30 to -0.09; I² = 59%) at follow-up. After treatment headache frequency at least halved in 50% of participants receiving true acupuncture and 41% receiving sham acupuncture (pooled RR 1.23, 95% CI 1.11 to 1.36; I² = 48%; 14 trials, 1825 participants) and at follow-up in 53% and 42%, respectively (pooled RR 1.25, 95% CI 1.13 to 1.39; I² = 61%; 11 trials, 1683 participants; moderate quality evidence). The corresponding NNTBs are 11 (95% CI 7.00 to 20.00) and 10 (95% CI 6.00 to 18.00), respectively. The number of participants dropping out due to adverse effects (odds ratio (OR) 2.84; 95% CI 0.43 to 18.71; 7 trials, 931 participants; low quality evidence) and the number of participants reporting adverse effects (OR 1.15; 95% CI 0.85 to 1.56; 4 trials, 1414 participants; moderate quality evidence) did not differ significantly between acupuncture and sham groups. Comparison with prophylactic drug treatmentAcupuncture reduced migraine frequency significantly more than drug prophylaxis after treatment ( SMD -0.25; 95% CI -0.39 to -0.10; 3 trials, 739 participants), but the significance was not maintained at follow-up (SMD -0.13; 95% CI -0.28 to 0.01; 3 trials, 744 participants; moderate quality evidence). After three months headache frequency at least halved in 57% of participants receiving acupuncture and 46% receiving prophylactic drugs (pooled RR 1.24; 95% CI 1.08 to 1.44) and after six months in 59% and 54%, respectively (pooled RR 1.11; 95% CI 0.97 to 1.26; moderate quality evidence). Findings were consistent among trials with I² being 0% in all analyses. Trial participants receiving acupuncture were less likely to drop out due to adverse effects (OR 0.27; 95% CI 0.08 to 0.86; 4 trials, 451 participants) and to report adverse effects (OR 0.25; 95% CI 0.10 to 0.62; 5 trials 931 participants) than participants receiving prophylactic drugs (moderate quality evidence). AUTHORS' CONCLUSIONS: The available evidence suggests that adding acupuncture to symptomatic treatment of attacks reduces the frequency of headaches. Contrary to the previous findings, the updated evidence also suggests that there is an effect over sham, but this effect is small. The available trials also suggest that acupuncture may be at least similarly effective as treatment with prophylactic drugs. Acupuncture can be considered a treatment option for patients willing to undergo this treatment. As for other migraine treatments, long-term studies, more than one year in duration, are lacking.

Acupuncture for the prevention of tension-type headache.

BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.

Corticosteroid Therapy for Patients Hospitalized With Community-Acquired Pneumonia: A Systematic Review and Meta-analysis.

BACKGROUND: Community-acquired pneumonia (CAP) is common and often severe. PURPOSE: To examine the effect of adjunctive corticosteroid therapy on mortality, morbidity, and duration of hospitalization in patients with CAP. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through 24 May 2015. STUDY SELECTION: Randomized trials of systemic corticosteroids in hospitalized adults with CAP. DATA EXTRACTION: Two reviewers independently extracted study data and assessed risk of bias. Quality of evidence was assessed with the Grading of Recommendations Assessment, Development, and Evaluation system by consensus among the authors. DATA SYNTHESIS: The median age was typically in the 60s, and approximately 60% of patients were male. Adjunctive corticosteroids were associated with possible reductions in all-cause mortality (12 trials; 1974 patients; risk ratio [RR], 0.67 [95% CI, 0.45 to 1.01]; risk difference [RD], 2.8%; moderate certainty), need for mechanical ventilation (5 trials; 1060 patients; RR, 0.45 [CI, 0.26 to 0.79]; RD, 5.0%; moderate certainty), and the acute respiratory distress syndrome (4 trials; 945 patients; RR, 0.24 [CI, 0.10 to 0.56]; RD, 6.2%; moderate certainty). They also decreased time to clinical stability (5 trials; 1180 patients; mean difference, -1.22 days [CI, -2.08 to -0.35 days]; high certainty) and duration of hospitalization (6 trials; 1499 patients; mean difference, -1.00 day [CI, -1.79 to -0.21 days]; high certainty). Adjunctive corticosteroids increased frequency of hyperglycemia requiring treatment (6 trials; 1534 patients; RR, 1.49 [CI, 1.01 to 2.19]; RD, 3.5%; high certainty) but did not increase frequency of gastrointestinal hemorrhage. LIMITATIONS: There were few events and trials for many outcomes. Trials often excluded patients at high risk for adverse events. CONCLUSION: For hospitalized adults with CAP, systemic corticosteroid therapy may reduce mortality by approximately 3%, need for mechanical ventilation by approximately 5%, and hospital stay by approximately 1 day. PRIMARY FUNDING SOURCE: None.

Sleep Duration and Functional Disability Among Chinese Older Adults: Cross-Sectional Study.

BACKGROUND: The 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. OBJECTIVE: This study aimed to explore the associations between sleep duration and functional disabilities in the older population (aged≥65 years) in China. METHODS: The 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. RESULTS: In 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<.05), which revealed a U-shaped association between sleep duration and dysfunction. When the sleep duration fell below 7 hours, increased sleep duration was associated with a significantly lower risk of functional disability (odds ratio [OR] 0.85, 95% CI 0.79-0.91; P<.001). When the sleep duration exceeded 7 hours, the risk of functional disability associated with a prolonged sleep duration increased (OR 1.16, 95% CI 1.05-1.29; P<.001). CONCLUSIONS: Sleep durations shorter and longer than 7 hours were associated with a higher risk of functional disability among Chinese adults 65 years and older. Future studies are needed to explore intervention strategies for improving sleep duration with a particular focus on functional disability.

Global trends of acupuncture clinical research on analgesia from 2010 to 2023: a bibliometric and visualization analysis.

Objective: Acupuncture, acknowledged as a potent non-pharmacological therapy, is frequently employed to alleviate pain. Despite its widespread use, there has been a lack of overarching bibliometric analysis of clinical research on acupuncture analgesia. We aimed to summarize current patterns, hotspots, and development trends in this field through bibliometric analysis. Methods: This study evaluates academic publications retrieved from the Web of Science database (2010.01-2023.09) concerning acupuncture analgesia in clinical settings. All primary and secondary studies on humans were included. To track global developmental trends, we employed several software for analyzing annual publication volumes, countries/regions, institutions, authors, cited authors, journals, cited journals, references, and keywords and to draw collaborative networks and reference co-citation network maps. Results: The final search encompassed 7,190 relevant studies, including 1,263 randomized controlled trials (RCTs) and 1,293 systematic reviews and meta-analyses. The results indicated a gradual increase in the number of annual publications on acupuncture analgesia in clinical practice. Among countries and institutions, China (2,139) and Chengdu University of Traditional Chinese Medicine (258) ranked first. Liang FR (89 articles) was the most prolific author, while MacPherson H (604) was the most cited author. MEDICINE (455) was the most productive journal, and Pain (2,473/0.20) ranked first in both the frequency and centrality of cited journals. Notably, the most frequently cited reference was a systematic review of individual patient data on acupuncture carried out for chronic pain that was published by Vickers Andrew J in 2012 (156). Burst analysis identified frontier research areas for 2010-2020, encompassing network meta-analysis, case reports, dry needling, lumbar disc herniation, cancer, post-herpetic neuralgia, insomnia, and bibliometric analysis. Conclusion: This study outlines current trends and potential future research hotspots in clinical acupuncture analgesia over the past decade. Findings emphasize the necessity for enhanced international collaboration to improve research output and translation.

Reporting form and content of research priorities identified in knee osteoarthritis clinical practice guidelines: a methodological literature analysis.

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.

Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol.

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).

Comprehensive consideration of multiple determinants from evidence to recommendations in guidelines for most traditional Chinese medicine was suboptimal: a systematic review.

BACKGROUND: The overall comprehensive consideration of the factors influencing the recommendations in the traditional Chinese medicine (TCM) guidelines remains poorly studied. This study systematically evaluate the factors influencing recommendations formation in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) clinical practice guidelines (CPGs) and TCM CPGs. METHODS: This was a methodological review in which we searched six databases and multiple related websites. The GRADE CPGs were identified as the guidelines developed by the GRADE Working Group or the two Co-Chairs. For the TCM CPGs, we randomly selected guidelines that were published by the TCM or integrative medicine academic societies from China mainland (published by the TCM or integrative medicine academic societies of China mainland). Two reviewers independently screened and extracted data. We included CPGs published in 2018-2022. We extracted information on the influencing factors of evidence to recommendation and conducted the analyses using descriptive statistics and calculated the proportion of relevant items by IBM SPSS Statistics and Microsoft Excel to compare the differences between the GRADE CPGs and the TCM CPGs. RESULTS: Forty-five GRADE CPGs (including 912 recommendations) and 88 TCM CPGs (including 2452 recommendations) were included. TCM recommendations mainly considered the four key determinants of desirable anticipated effects, undesirable anticipated effects, balance between desirable and undesirable effects, certainty of evidence, with less than 20% of other dimensions. And TCM CPGs presented more strong recommendations (for or against) and inappropriate discordant recommendations than GRADE CPGs. GRADE CPGs were more comprehensive considered about the factors affecting the recommendations, and considered more than 70% of all factors in the evidence to recommendation. CONCLUSIONS: The TCM CPGs lack a comprehensive consideration of multiple influencing determinants from evidence to recommendations. In the future, the correct application of the GRADE approaches should be emphasized.

Emphasis should be placed on identifying and reporting research priorities to increase research value: An empirical analysis.

OBJECTIVES: To 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. METHODS: This 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. RESULTS: Of 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. CONCLUSIONS: There 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.

Acupuncture as Add-on Therapy to SSRIs Can Improve Outcomes of Treatment for Anxious Depression: Subgroup Analysis of the AcuSDep Trial.

Purpose: Anxious depression (AD) is a common, distinct depression subtype. This exploratory subgroup analysis aimed to explore the effects of acupuncture as an add-on therapy of selective serotonin reuptake inhibitors (SSRIs) for patients with AD or non-anxious depression (NAD). Patients and Methods: Four hundred and sixty-five patients with moderate-to-severe depression from the AcuSDep pragmatic trial were included in analysis. Patients were randomly assigned to receive MA+SSRIs, EA+SSRIs, or SSRIs alone (1:1:1) for six weeks. AD was defined by using dimensional criteria. The measurement instruments included 17-items Hamilton Depression Scale (HAMD-17), Self-Rating Depression Scale (SDS), Clinical Global Impression (CGI), Rating Scale for Side Effects (SERS), and WHO Quality of Life-BREF (WHOQOL-BREF). Comparison between AD and NAD subgroups and comparisons between groups within either AD or NAD subgroups were conducted. Results: Eighty percent of the patients met the criteria for AD. The AD subgroup had poorer clinical manifestations and treatment outcomes compared to those of the NAD subgroup. For AD patients, the HAMD response rate, remission rate, early onset rate, and the score changes on each scale at most measurement points on the two acupuncture groups were significantly better than the SSRIs group. For NAD patients, the HAMD early onset rates of the two acupuncture groups were significantly better than the SSRIs group. Conclusion: For AD subtype patients, either MA or EA add-on SSRIs showed comprehensive improvements, with small-to-medium effect sizes. For NAD subtype patients, both the add-on acupuncture could accelerate the response to SSRIs treatment. The study contributed to the existing literature by providing insights into the potential benefits of acupuncture in combination with SSRIs, especially for patients with AD subtypes. Due to its limited nature as a post hoc subgroup analysis, prospectively designed, high-quality trials are warranted. Clinical Trials Registration: ChiCTR-TRC-08000297.

[Auxiliary treatment of HBV correlated hepatic failure by Chinese herbs: a systematic review of randomized controlled trials].

OBJECTIVE: To evaluate the effectiveness and safety of Chinese herbs as an adjuvant treatment for hepatitis virus B (HBV)-related hepatic failure. METHODS: Data were retrieved through the Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, PubMed, CNKI, VIP, Wanfang Database, and ChiCTR by key words or free words such as hepatic failure, severe hepatitis, HBV, Chinese medicine, randomization, and control. Appendix references of related papers were taken as supplementary indices. According to requirement for Cochrane systematic evaluation, randomized clinical trials on assessing the effectiveness and safety of Chinese herbs as main or adjuvant treatment in treating HBV-related hepatic failure were methodologically assessed, data extracted and analyzed. RESULTS: Totally 21 trials on Chinese herbal medicine therapy versus standard medical therapy (involving 1 881 patients) were included. Most trials had unclear risk bias. In 5 studies on the mortality, 3 trials showed that the mortality was lower in the test group than in the control group [RR 0.40, 95% CI (0.20, 0.79), P = 0.0002]. In 6 randomized control trials, totally 20 papers reported the control of complications. Eight results showed Chinese herbal medicine therapy had better effect in controlling complications. The recurrence rate and assessment of the survival quality were reported. Considering secondary indicators, four trials showed Chinese herbal medicine therapy had better effect in lowering the ineffective rate, decreasing total bilirubin (TBIL), and elevating prothrombin activity (PTA). Other prescriptive analyses found that the overall effect on secondary indicators was better in the test group than in the control group, but not all the indicators were statistically different. Adverse reactions were only reported in two papers, showing no severe adverse reaction. CONCLUSION: According to present evidence, till now, we could not judge whether Chinese herbs, as an adjuvant treatment, could do any favor for lowering the incidence and recurrence of hepatic failure patients, and improving their survival qualities.