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BACKGROUND: Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials (RCTs). Nevertheless, it remains unclear if similar associations exist in RCTs on Chinese herbal medicine (CHM). Further, Chinese medicine-related characteristics have not been explored yet. OBJECTIVE: To investigate trial characteristics related to treatment effect estimates on CHM RCTs. SEARCH STRATEGY: This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021. INCLUSION CRITERIA: An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis. DATA EXTRACTION AND ANALYSIS: Two reviewers independently conducted data extraction on general characteristics of systematic reviews, meta-analyses and included RCTs. They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool. A two-step approach was used for data analyses. The ratio of odds ratios (ROR) and difference in standardized mean differences (dSMD) with 95% confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes, respectively. RESULTS: Ninety-one systematic reviews, comprising 1338 RCTs were identified. For binary outcomes, RCTs incorporated with syndrome differentiation (ROR: 1.23; 95 % CI: [1.07, 1.39]), adopting Chinese medicine formula (ROR: 1.19; 95% CI: [1.03, 1.34]), with low risk of bias on incomplete outcome data (ROR: 1.29; 95% CI: [1.06, 1.52]) and selective outcome reporting (ROR: 1.12; 95% CI: [1.01, 1.24]), as well as a trial size ≥ 100 (ROR: 1.23; 95% CI: [1.04, 1.42]) preferred to show larger effect estimates. As for continuous outcomes, RCTs with Chinese medicine diagnostic criteria (dSMD: 0.23; 95% CI: [0.06, 0.41]), judged as high/unclear risk of bias on allocation concealment (dSMD: -0.70; 95% CI: [-0.99, -0.42]), with low risk of bias on incomplete outcome data (dSMD: 0.30; 95% CI: [0.18, 0.43]), conducted at a single center (dSMD: -0.33; 95% CI: [-0.61, -0.05]), not using intention-to-treat analysis (dSMD: -0.75; 95% CI: [-1.43, -0.07]), and without funding support (dSMD: -0.22; 95% CI: [-0.41, -0.02]) tended to show larger effect estimates. CONCLUSION: This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs. Please cite this article as: Wang BH, Lin YL, Gao YY, Song JL, Qin L, Li LQ, Liu WQ, Zhong CCW, Jiang MY, Mao C, Yang XB, Chung VCH, Wu IXY. Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study. J Integr Med. 2024; 22(3): 223-234.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic , Humans , Drugs, Chinese Herbal/therapeutic use , Epidemiologic Studies , Treatment OutcomeABSTRACT
Objectives: Telemedicine has been widely used during the COVID-19 pandemic. Among other health care professionals, Chinese medicine practitioners (CMPs) face practical challenges in providing telemedicine consultations. This study aims to explore CMPs' experience and perceptions of telemedicine service provision before and during the pandemic. Methods: A territory-wide cross-sectional online survey was conducted in Hong Kong between April and May 2022. A structured questionnaire with open-ended questions was used to investigate the provision of and perception on telemedicine service, as well as usability of telemedicine among CMPs. Results: A total of 195 CMPs participated the survey. Before COVID-19, 42% (81/195) had been providing telemedicine services, and the proportion doubled during COVID-19. CMPs in the private sector are the main providers. Mobile apps including WhatsApp, WeChat, and Zoom were commonly used for consultations (75%, 120/161). Barriers in providing telemedicine included inability of conducting physical examination on patients (69%, 134/195), legal and ethical concerns over medical negligence (61%, 118/195), and patients' incompetence on e-literacy (50%, 98/195). Respondents urged professional and regulatory bodies to provide an explicit clinical guideline that demonstrate best practice in traditional Chinese medicine telemedicine, and to clarify legal and ethical implications of such practice. Conclusions: CMPs demonstrated their competency in telemedicine, and most of them provided telemedicine during COVID-19. Development of appropriate guidelines on the provision of telemedicine would support CMPs to continue provision after the pandemic, whereas a user-friendly and comprehensive telemedicine e-platform would enhance quality of such service. Facilitating patients with lower e-literacy to access telemedicine is key to reduce disparities.
Subject(s)
COVID-19 , Medicine, Chinese Traditional , SARS-CoV-2 , Telemedicine , Humans , COVID-19/epidemiology , Cross-Sectional Studies , Hong Kong , Telemedicine/organization & administration , Male , Female , Adult , Middle Aged , Attitude of Health Personnel , Pandemics , Surveys and QuestionnairesABSTRACT
OBJECTIVES: To evaluate the association between healthy lifestyle behaviours and the incidence of irritable bowel syndrome (IBS). DESIGN: Population-based prospective cohort study. SETTING: The UK Biobank. PARTICIPANTS: 64 268 adults aged 37 to 73 years who had no IBS diagnosis at baseline were enrolled between 2006 and 2010 and followed up to 2022. MAIN EXPOSURE: The five healthy lifestyle behaviours studied were never smoking, optimal sleep, high level of vigorous physical activity, high dietary quality and moderate alcohol intake. MAIN OUTCOME MEASURE: The incidence of IBS. RESULTS: During a mean follow-up of 12.6 years, 961 (1.5%) incident IBS cases were recorded. Among the 64 268 participants (mean age 55.9 years, 35 342 (55.0%) female, 7604 (11.8%) reported none of the five healthy lifestyle behaviours, 20 662 (32.1%) reported 1 behaviour, 21 901 (34.1%) reported 2 behaviours and 14 101 (21.9%) reported 3 to 5 behaviours at baseline. The multivariable adjusted hazard ratios associated with having 1, 2 and 3 to 5 behaviours for IBS incidence were 0.79 (95% confidence intervals 0.65 to 0.96), 0.64 (0.53 to 0.78) and 0.58 (0.46 to 0.72), respectively (P for trend <0.001). Never smoking (0.86, 0.76 to 0.98, P=0.02), high level of vigorous physical activity (0.83, 0.73 to 0.95, P=0.006) and optimal sleep (0.73, 0.60 to 0.88, P=0.001) demonstrated significant independent inverse associations with IBS incidence. No significant interactions were observed between these associations and age, sex, employment status, geographic location, gastrointestinal infection, endometriosis, family history of IBS or lifestyle behaviours. CONCLUSIONS: Adhering to a higher number of healthy lifestyle behaviours is significantly associated with a lower incidence of IBS in the general population. Our findings suggest the potential of lifestyle modifications as a primary prevention strategy for IBS.
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BACKGROUND: Proton pump inhibitors (PPIs) are widely prescribed for gastroesophageal reflux disease and peptic ulcer disease. However, the association between the regular PPIs use and the risk of cardiovascular disease (CVD) outcomes remains unclear. We aimed to determine whether regular proton pump inhibitors (PPIs) use is associated with an altered incidence of cardiovascular disease (CVD) in the general population. METHODS: This prospective cohort study included 459,207 participants (mean [SD] age, 56.2 [8.1] years) from the UK Biobank study without prevalent CVD who enrolled between 2006 and 2010 and were followed until 2018. Hazard ratios (HRs) and 95% confidence intervals (CIs) for incident CVD and its components (coronary heart disease [CHD], stroke, heart failure, atrial fibrillation, and venous thromboembolism) were obtained using Cox proportional hazards models with adjustment for potential confounding factors, including demographic factors, lifestyle behaviors, prevalent comorbidities, and clinical indicators for PPIs use. RESULTS: During the follow-up period, we recorded 26,346 incident CVD events (including 13,749 CHD events, 4144 stroke events, 5812 atrial fibrillation events, 1159 heart failure events, and 4206 venous thromboembolism events). The fully adjusted HRs (and 95% CIs) associated with PPIs users compared to nonusers were 1.44 (95% CI 1.39-1.50) for incident CVD, 1.65 (95% CI 1.57-1.74) for CHD, 1.21 (95% CI 1.09-1.33) for stroke, 1.17 (95% CI 1.08-1.28) for atrial fibrillation, 1.61 (95% CI 1.37-1.89) for heart failure, and 1.36 (95% CI 1.24-1.50) for venous thromboembolism. CONCLUSIONS: Regular PPIs use was associated with higher risk of CVD outcomes. Clinicians should therefore exercise caution when prescribing PPIs.
Subject(s)
Atrial Fibrillation , Cardiovascular Diseases , Coronary Disease , Heart Failure , Stroke , Venous Thromboembolism , Humans , Child , Cardiovascular Diseases/diagnosis , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/complications , Proton Pump Inhibitors/adverse effects , Risk Factors , Prospective Studies , Atrial Fibrillation/complications , Venous Thromboembolism/complications , Coronary Disease/epidemiology , Stroke/epidemiology , Stroke/complications , Heart Failure/complications , IncidenceABSTRACT
BACKGROUND: Integrative oncology (IO) appears to be beneficial to patients with cancer, but its implementation remains a challenge. Guided by the Theoretical Domains Framework (TDF) and the Capability-Opportunity-Motivation-Behaviour (COM-B) model, this systematic review identified the barriers to and facilitators of IO implementation in conventional cancer care settings. METHODS: We searched eight electronic databases from their inception until February 2022 for qualitative, quantitative or mixed-methods empirical studies reporting the implementation outcomes for IO services. Critical appraisal approach was tailored according to study types. The identified implementation barriers and facilitators were mapped onto TDF domains and the COM-B model, and subsequently onto the behavioural change wheel (BCW) for formulating behavioural change interventions. RESULTS: We included 28 studies (11 qualitative, 6 quantitative, 9 mixed-methods and 2 Delphi studies) of satisfied methodological quality. The main implementation barriers were the lack of IO knowledge, the absence of funding and healthcare professionals' low level of IO receptiveness. The key implementation facilitators were the dissemination of evidence on IO clinical benefits, the equipping of professionals with IO service delivery skills and the provision of a supportive organisational climate. CONCLUSION: Multifaceted implementation strategies are needed to address the determinants influencing IO service delivery. Based on our BCW-based analysis of the included studies, the key behavioural change techniques are: (1) educating healthcare professionals about the value and application of traditional and complementary medicine; (2) ensuring access to actionable clinical evidence on IO effectiveness and safety and (3) designing guidelines on communicating traditional and complementary medicine interventions with patients and caregivers for biomedically trained doctors and nurses.
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BACKGROUND: High 30-day readmission rates increase hospital costs and negatively impact patient outcomes in many healthcare systems, including Hong Kong. Evidence-based and local adaptable nurse-led interventions have not been established for reducing 30-day hospital readmissions among general medical patients in Hong Kong's public healthcare system. AIMS: The aim of this study was to select and refine evidence-based nurse-led interventions for reducing 30-day hospital readmissions among general medical patients in Hong Kong's public healthcare system using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Evidence to Decision (EtD) framework. METHODS: Eighteen local healthcare stakeholders were recruited to carry out a two-step process. In step 1, stakeholders were invited to prioritize nurse-led interventions which were supported by existing evidence and suggest important combinations of different interventions. For all interventions prioritized in step 1, step 2 involved stakeholders performing a two-round Delphi questionnaire aiming to generate consensus-based interventions appropriate to the local context. GRADE EtD framework was applied to guide the decision-making process, taking into account certainty of evidence, benefits and harms, resource use, equity, acceptability, and feasibility. RESULTS: Four out of eight nurse-led interventions reached a positive consensus with percentage agreement ranging from 70.6% to 82.4%. GRADE EtD criteria ratings showed that over 70% of stakeholders agreed these four interventions were probably acceptable and feasible, though the certainty of evidence was low or moderate. Half of stakeholders believed their desirable effects compared to undesirable effects were large. However, the resources required and how these nurse-led interventions might affect health inequities when implemented were uncertain. Preliminary implementation issues included high complexity of delivering multiple nurse-led intervention components, and challenges of coordinating different involved parties in delivering the interventions. Appropriate resource allocation and training should be provided to address these potential problems, as suggested by stakeholders. LINKING EVIDENCE TO ACTION: Using the GRADE EtD framework, four nurse-led interventions were recommended by healthcare stakeholders as possible strategies for reducing 30-day hospital readmissions among general medical patients in Hong Kong. To address preliminary implementation issues, nurses' role as care coordinators should also be strengthened to ensure smooth delivery of nurse-led intervention components, and to facilitate multidisciplinary collaboration during service delivery.
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Nurse's Role , Patient Readmission , Humans , Delphi Technique , Hospitals , ConsensusABSTRACT
OBJECTIVE: To systematically review the effectiveness of hypertonic dextrose prolotherapy (DPT) in plantar fasciopathy (PF) compared with other non-surgical treatments. DATA SOURCES: PubMed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Allied and Complementary Medicine Database, Global Health, Ovid Nursing Database, Dimensions, and WHO ICTRP were searched from inception to April 30th, 2022. STUDY SELECTION: Two independent reviewers selected randomized controlled trials (RCTs) that evaluated the effectiveness of DPT in PF compared with non-surgical treatments. Outcomes included pain intensity, foot and ankle function, and plantar fascia thickness. DATA EXTRACTION: Two independent reviewers conducted data extraction. Risk of bias (RoB) assessment was conducted using the Cochrane Risk of Bias 2 (RoB 2) tool, and certainty of evidence was assessed with Grading of Recommendation Assessment, Development, and Evaluation (GRADE). DATA SYNTHESIS: Eight RCTs (n=469) met the inclusion criteria. Pooled results favored the use of DPT versus normal saline (NS) injections in reducing pain (weighted mean difference [WMD] -41.72; 95% confidence interval [CI] -62.36 to -21.08; P<.01; low certainty evidence) and improving function [WMD -39.04; 95% CI -55.24 to -22.85; P<.01; low certainty evidence] in the medium term. Pooled results also showed corticosteroid (CS) injections was superior to DPT in reducing pain in the short term [standardized mean difference 0.77; 95% CI 0.40 to 1.14; P<.01; moderate certainty evidence]. Overall RoB varied from "some concerns" to "high". The overall certainty of evidence presented ranges from very low to moderate based on the assessment with the GRADE approach. CONCLUSION: Low certainty evidence demonstrated that DPT was superior to NS injections in reducing pain and improving function in the medium term, but moderate certainty evidence showed that it was inferior to CS in reducing pain in the short term. Further high-quality RCTs with standard protocol, longer-term follow-up, and adequate sample size are needed to confirm its role in clinical practice.
Subject(s)
Fasciitis, Plantar , Prolotherapy , Humans , Fasciitis, Plantar/drug therapy , Randomized Controlled Trials as Topic , Adrenal Cortex Hormones , Pain , Glucose/therapeutic useABSTRACT
BACKGROUND: Carefully conducted systematic reviews (SRs) can provide reliable evidence on the effectiveness of treatment strategies for Alzheimer's disease (AD). Nevertheless, the reliability of SR results can be limited by methodological flaws. This cross-sectional study aimed to examine the methodological quality of SRs on AD treatments, along with potentially relevant factors. METHODS: To identify eligible SRs on AD treatments, four databases including the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, and PsycINFO were searched. The Assessing the Methodological Quality of Systematic Reviews 2 instrument was used for quality appraisal of SRs. Multivariable regression analyses were used to examine factors related to methodological quality. RESULTS: A total of 102 SRs were appraised. Four (3.90%) SRs were considered as high quality; 14 (13.7%), 48 (47.1%), and 36 (35.3%) were as moderate, low, and critically low quality, respectively. The following significant methodological limitations were identified: only 22.5% of SRs registered protocols a priori, 6.9% discussed the rationales of chosen study designs, 21.6% gave a list of excluded studies with reasons, and 23.5% documented funding sources of primary studies. Cochrane SRs (adjusted odds ratio (AOR): 31.9, 95% confidence interval (CI): 3.81-266.9) and SRs of pharmacological treatments (AOR: 3.96, 95%CI: 1.27-12.3) were related to the higher overall methodological quality of SRs. CONCLUSION: Methodological quality of SRs on AD treatments is unsatisfactory, especially among non-Cochrane SRs and SRs of non-pharmacological interventions. Improvement in the following methodological domains requires particular attention due to poor performance: registering and publishing protocols a priori, justifying study design selection, providing a list of excluded studies, and reporting funding sources of primary studies.
Subject(s)
Alzheimer Disease , Humans , Cross-Sectional Studies , Reproducibility of Results , Alzheimer Disease/therapy , Systematic Reviews as Topic , Research DesignABSTRACT
INTRODUCTION: Functional dyspepsia (FD) is diagnosed based on self-reported symptoms and negative upper gastrointestinal endoscopic findings. The Rome criteria were not adopted as a diagnostic instrument in clinical guidelines due to their complexity. Different guidelines used relatively simple symptom assessment schemes with contents that vary significantly. A previously evaluated short Reference Standard may serve as a more standardised tool for guidelines. We evaluated its diagnostic accuracy against the Rome IV criteria in a cross-sectional study in Hong Kong. METHODS: A total of 220 dyspeptic patients sampled consecutively from a tertiary hospital and the community completed the Rome IV diagnostic questionnaire, which was translated into Cantonese-Chinese, and the Reference Standard. Sensitivity, specificity, positive and negative likelihood ratios (LRs), and area under the receiver operating characteristics curve (AUC), with 95% confidence intervals (CIs), were calculated. RESULTS: Among the participants, 160 (72.7%) fulfilled the Reference Standard with negative upper gastrointestinal endoscopic results. The Reference Standard identified patients with Rome IV-defined FD with 91.1% (95% CI 82.6%-96.4%) sensitivity and 37.6% (95% CI 29.6%-46.1%) specificity. The positive and negative LRs were 1.46 (95% CI 1.26-1.69) and 0.24 (95% CI 0.11-0.49), respectively. The AUC value was 0.64 (95% CI 0.59-0.69). CONCLUSIONS: The Reference Standard can rule out patients without Rome IV-defined FD. It may be used as an initial screening tool for FD in settings where the use of the Rome IV criteria is impractical. It may also provide a uniform definition and diagnostic rule for future updates of clinical guidelines.
Subject(s)
Dyspepsia , China , Cross-Sectional Studies , Dyspepsia/diagnosis , Endoscopy, Gastrointestinal , Humans , Reference Standards , Rome , Surveys and QuestionnairesABSTRACT
BACKGROUND: Traditional Chinese Medicine (TCM) treatment strategies are guided by pattern differentiation, as documented in the eleventh edition of the International Classification of Diseases (ICD). However, no standards for pattern differentiation are proposed to ensure inter-rater agreement. Without standardisation, research on associations between TCM diagnostic patterns, clinical features, and geographical characteristics is also not feasible. This diagnostic cross-sectional study aimed to (i) establish the pattern differentiation rules of functional dyspepsia (FD) using latent tree analysis (LTA); (ii) compare the prevalence of diagnostic patterns in Hong Kong and Hunan; (iii) discover the co-existence of diagnostic patterns; and (iv) reveal the associations between diagnostic patterns and FD common comorbidities. METHODS: A total of 250 and 150 participants with FD consecutively sampled in Hong Kong and Hunan, respectively, completed a questionnaire on TCM clinical features. LTA was performed to reveal TCM diagnostic patterns of FD and derive relevant pattern differentiation rules. Multivariate regression analyses were performed to quantify correlations between different diagnostic patterns and between diagnostic patterns and clinical and geographical variables. RESULTS: At least one TCM diagnostic pattern was differentiated in 70.7%, 73.6%, and 64.0% of the participants in the overall (n = 400), Hong Kong (n = 250), and Hunan (n = 150) samples, respectively, using the eight pattern differentiation rules derived. 52.7% to 59.6% of the participants were diagnosed with two or more diagnostic patterns. Cold-heat complex (59.8%) and spleen-stomach dampness-heat (77.1%) were the most prevalent diagnostic patterns in Hong Kong and Hunan, respectively. Spleen-stomach deficiency cold was highly likely to co-exist with spleen-stomach qi deficiency (adjusted odds ratio (AOR): 53.23; 95% confidence interval (CI): 21.77 to 130.16). Participants with severe anxiety tended to have liver qi invading the stomach (AOR: 1.20; 95% CI: 1.08 to 1.33). CONCLUSIONS: Future updates of the ICD, textbooks, and guidelines should emphasise the importance of clinical and geographical variations in TCM diagnosis. Location-specific pattern differentiation rules should be derived from local data using LTA. In future, patients' pattern differentiation results, local prevalence of TCM diagnostic patterns, and corresponding TCM treatment choices should be accessible to practitioners on online clinical decision support systems to streamline service delivery.
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BACKGROUND: Systematic reviews (SRs) synthesise the best evidence of effectiveness and safety on Chinese herbal medicine (CHM). Decision-making should be supported by the high-quality evidence of prudently conducted SRs, but the trustworthiness of conclusions may be limited by poor methodological rigour. METHODS: This survey aimed to examine the methodological quality of a representative sample of SRs on CHM published during January 2018 to March 2020. We conducted literature search in Cochrane Database of Systematic Reviews, MEDLINE via Ovid, and EMBASE via Ovid. Eligible SRs must be in Chinese or English with at least one meta-analysis on the treatment effect of any CHM documented in the 2015 Chinese Pharmacopoeia. Two reviewers extracted the bibliographical characteristics of SRs and appraised their methodological quality using AMSTAR 2 (Assessing the Methodological Quality of Systematic Reviews 2). The associations between bibliographical characteristics and methodological quality were investigated using Kruskal-Wallis tests and Spearman's rank correlation coefficients. RESULTS: We sampled and appraised one hundred forty-eight SRs. Overall, one (0.7%) was of high methodological quality; zero (0%), four (2.7%), and one-hundred forty-three (96.6%) SRs were of moderate, low, and critically-low quality. Only thirteen SRs (8.8%) provided a pre-defined protocol; none (0%) provided justifications for including particular primary study designs; six (4.1%) conducted a comprehensive literature search; two (1.4%) provided a list of excluded studies; nine (6.1%) undertook meta-analysis with appropriate methods; and seven (4.7%) reported funding sources of included primary studies. Cochrane reviews had higher overall quality than non-Cochrane reviews (P < 0.001). SRs with European funding support were less likely to have critically-low quality when compared with their counterparts (P = 0.020). SRs conducted by more authors (rs = 0.23; P = 0.006) and published in higher impact factor journals (rs = 0.20; P = 0.044) were associated with higher methodological quality. CONCLUSIONS: Our results indicated that the methodological quality of SRs on CHM is low. Future authors should enhance the methodological quality through registering a priori protocols, justifying selection of study designs, conducting comprehensive literature search, providing a list of excluded studies with rationales, using appropriate method for meta-analyses, and reporting funding sources among primary studies.
Subject(s)
Drugs, Chinese Herbal , Databases, Factual , Drugs, Chinese Herbal/therapeutic use , Research Design , Surveys and Questionnaires , Systematic Reviews as TopicABSTRACT
BACKGROUND: An overview of systematic reviews(SRs) and network meta-analysis(NMA) were conducted to evaluate the comparative effectiveness of peri-discharge complex interventions for reducing 30-day readmissions among chronic obstructive pulmonary disease(COPD) patients. METHODS: Five databases were searched for SRs of randomized controlled trials(RCTs). An additional search was conducted for updated RCTs from database inception until Jun 2020. Pooled effect of peri-discharge complex interventions was assessed using random-effect pairwise meta-analyses. Comparative effectiveness across different peri-discharge complex interventions was evaluated using NMA. RESULTS: Nine SRs and 11 eligible RCTs(n = 1,422) assessing eight different peri-discharge complex interventions were included. For reducing 30-day all-cause readmissions, pairwise meta-analysis showed no significant difference between peri-discharge complex interventions and usual care, while NMA indicated no significant differences among different peri-discharge complex interventions as well as usual care. For reducing 30-day COPD-related readmissions, peri-discharge complex interventions were significantly more effective than usual care (pooled RR = 0.45, 95% CI:0.24-0.84). CONCLUSIONS: Peri-discharge complex interventions may not differ from usual care in reducing 30-day all-cause readmissions among COPD patients but some are more effective for lowering 30-day COPD-related readmission. Thus, complex intervention comprising core components of patient education, self-management, patient-centred discharge instructions, and telephone follow up may be considered for implementation, but further evaluation is warranted.
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BACKGROUND: Non-specific effect of acupuncture constitutes part of the overall effect generated via clinical encounter beyond needle insertion and stimulation. It is unclear how responders and non-responders of acupuncture experience non-specific effects differently. We aimed to compare their experiences in a nested qualitative study embedded in an acupuncture randomized trial on functional dyspepsia. METHODS: Purposive sampling was used to capture experience of responders (n=15) and non-responders (n=15) to acupuncture via individual in-depth interviews. Design and analysis followed a framework analysis approach, with reference to an existing model on acupuncture non-specific effects. Themes emerging outside of this model were purposefully explored. RESULTS: Responders had a more trusting relationship with acupuncturist in response to their expression of empathy. In turn they were more actively engaged in lifestyle modifications and dietary advice offered by acupuncturists. Non-responders were not satisfied with the level of reassurance regarding acupuncture safety. They were also expecting more peer support from fellow participants, regarded that as an empowerment process for initiating and sustaining lifestyle changes. CONCLUSIONS: Our results highlighted key differences in acupuncture non-specific effect components experienced by responders and non-responders. Positive non-specific effects contributing to overall benefits could be enhanced by emphasizing on empathy expression from acupuncturists, trust-building, offering appropriate explanations on safety, and organizing patient support groups. Further research on the relative importance of each component is warranted.
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Background: Hypertension is a leading contributor to the global burden of disease and to mortality. The combined effects of sleep factors on the risk of hypertension are unclear. We aimed to evaluate the effect of combined sleep factors on the risk of hypertension and to explore whether this association is independent of genetic risk. Methods: This population-based prospective cohort study included 170,378 participants from the UK Biobank study. We conducted a healthy sleep score based on a combination of major five sleep factors and a genetic risk score based on 118 risk variants. Cox proportional hazard regression models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Results: A total of 170,378 participants were included. Compared to participants with a healthy sleep score of 0-1, those with healthy sleep scores of 2 (HR, 0.90; 95% CI, 0.83-0.98), 3 (HR, 0.81; 95% CI, 0.75-0.88), 4 (HR, 0.74; 95% CI, 0.68-0.81), or 5 (HR, 0.67; 95% CI, 0.59-0.77) had increasingly lower risks of hypertension (P for trend <0.001). Participants with high genetic risk and an unfavorable sleep pattern had a 1.80-fold greater risk of hypertension than participants with low genetic risk and a favorable sleep pattern. The association between sleep patterns and hypertension persisted in subgroup analysis, stratified by the genetic risk. Nearly 18.2% of hypertension events in this cohort could be attributed to unfavorable sleep pattern. Conclusions: Favorable sleep pattern was associated with a low risk of hypertension, regardless of genetic risk. These findings highlight the potential of sleep interventions to reduce risk of hypertension across entire populations.
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BACKGROUND: Prokinetic is the first-line conventional treatment for functional dyspepsia (FD) in Asia despite potential adverse events. Chinese herbal medicine (CHM) may be an effective and safe substitution. This network meta-analysis (NMA) aimed to evaluate the comparative effectiveness of different CHM formulae for FD against prokinetics. METHODS: Seven international and Chinese databases were searched from their inception to July 2020 for randomised controlled trials (RCTs) on CHM versus prokinetics. Data from each RCT were first pooled using random-effect pairwise meta-analyses and illustrated as risk difference (RD) or standardised mean difference (SMD) with 95% confidence interval (CI). Random-effect NMAs were then performed to evaluate the comparative effectiveness of CHM formulae and displayed as RD with 95% CI or SMD with 95% credible interval (CrI). The GRADE partially contextualised framework was applied for NMA result interpretation. RESULTS: Twenty-six unique CHM formulae were identified from twenty-eight RCTs of mediocre quality. Pairwise meta-analyses indicated that CHM was superior to prokinetics in alleviating global symptoms at 4-week follow-up (pooled RD: 0.14; 95% CI: 0.10-0.19), even after trim and fill adjustment for publication bias. NMAs demonstrated that Modified Zhi Zhu Decoction may have a moderate beneficial effect on alleviating global symptoms at 4-week follow-up (RD: 0.28; 95% CI: - 0.03 to 0.75). Xiao Pi Kuan Wei Decoction may have a large beneficial effect on alleviating postprandial fullness (SMD: - 2.14; 95% CI: - 2.76 to 0.70), early satiety (SMD: - 3.90; 95% CI: - 0.68 to - 0.42), and epigastric pain (SMD: - 1.23; 95% CI: - 1.66 to - 0.29). No serious adverse events were reported. CONCLUSION: Modified Zhi Zhu Decoction and Xiao Pi Kuan Wei Decoction may be considered as an alternative for patients unresponsive to prokinetics. Confirmatory head-to-head trials should be conducted to investigate their comparative effectiveness against prokinetics.
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BACKGROUND: While well-conducted systematic reviews (SRs) can provide the best evidence on the potential effectiveness of acupuncture, limitations on the methodological rigour of SRs may impact the trustworthiness of their conclusions. This cross-sectional study aimed to evaluate the methodological quality of a representative sample of SRs on acupuncture effectiveness. METHODS: Cochrane Database of Systematic Reviews, MEDLINE, and EMBASE were searched for SRs focusing on the treatment effect of manual acupuncture or electro-acupuncture published during January 2018 and March 2020. Eligible SRs must contain at least one meta-analysis and be published in English language. Two independent reviewers extracted the bibliographical characteristics of the included SRs with a pre-designed questionnaire and appraised the methodological quality of the studies with the validated AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews 2). The associations between bibliographical characteristics and methodological quality ratings were explored using Kruskal-Wallis rank tests and Spearman's rank correlation coefficients. RESULTS: A total of 106 SRs were appraised. Only one (0.9%) SR was of high overall methodological quality, zero (0%) was of moderate-quality, six (5.7%) and 99 (93.4%) were of low-quality and critically low-quality respectively. Among appraised SRs, only ten (9.4%) provided an a priori protocol, four (3.8%) conducted a comprehensive literature search, five (4.7%) provided a list of excluded studies, and six (5.7%) performed meta-analysis appropriately. Cochrane SRs, updated SRs, and SRs that did not search non-English databases had relatively higher overall quality. CONCLUSIONS: Methodological quality of SRs on acupuncture is unsatisfactory. Future reviewers should improve critical methodological aspects of publishing protocols, performing comprehensive search, providing a list of excluded studies with justifications for exclusion, and conducting appropriate meta-analyses. These recommendations can be implemented via enhancing the technical competency of reviewers in SR methodology through established education approaches as well as quality gatekeeping by journal editors and reviewers. Finally, for evidence users, skills in SR critical appraisal remain to be essential as relevant evidence may not be available in pre-appraised formats.
Subject(s)
Acupuncture Therapy , Systematic Reviews as Topic , Cross-Sectional Studies , Humans , Meta-Analysis as Topic , Research Report , Surveys and QuestionnairesABSTRACT
OBJECTIVE: To examine the association of incident type 2 diabetes (T2D) risk with sleep factors, genetic risk, and their combination effects. DESIGN: Large prospective population-based cohort study. METHODS: This population-based prospective cohort study included 360 403 (mean (s.d.) age: 56.6 (8.0) years) participants without T2D at baseline from the UK Biobank. Genetic risk was categorised as high (highest quintile), intermediate (quintiles: 2-4), and low (lowest quintile) based on a polygenic risk score for T2D. Sleep scores, including long or short sleep duration, insomnia, snoring, late chronotype, and excessive daytime sleepiness, were categorized as an unfavourable, intermediate, or favourable sleep and circadian pattern. RESULTS: During a median follow-up of 9.0 years, 13 120 incident T2D cases were recorded. Among the participants with an unfavourable sleep and circadian pattern, 6.96% (95% CI: 6.68-7.24%) developed T2D vs 2.37% (95% CI: 2.28-2.46%) of participants with a favourable sleep and circadian pattern (adjusted hazard ratio (HR): 1.53, 95% CI: 1.45-1.62). Of participants with a high genetic risk, 5.53% (95% CI: 5.36-5.69%) developed T2D vs 2.01% (95% CI: 1.91-2.11%) of participants with a low genetic risk (adjusted HR: 2.89, 95% CI: 2.72-3.07). The association with sleep and circadian patterns was independent of genetic risk strata. Participants in the lowest quintile with an unfavourable sleep and circadian pattern were 3.97-fold more likely to develop T2D than those in the lowest quintile with a favourable sleep and circadian pattern. CONCLUSIONS: Sleep and circadian patterns and genetic risk were independently associated with incident T2D. These results indicate the benefits of adhering to a healthy sleep and circadian pattern in entire populations, independent of genetic risk.
Subject(s)
Circadian Rhythm/physiology , Diabetes Mellitus, Type 2/epidemiology , Genetic Predisposition to Disease/epidemiology , Population Surveillance , Sleep Wake Disorders/epidemiology , Sleep/physiology , Aged , Cohort Studies , Diabetes Mellitus, Type 2/genetics , Diabetes Mellitus, Type 2/physiopathology , Female , Follow-Up Studies , Genetic Predisposition to Disease/genetics , Humans , Male , Middle Aged , Prospective Studies , Sleep Wake Disorders/genetics , Sleep Wake Disorders/physiopathologyABSTRACT
BACKGROUND: Chinese medicine (CM) modalities, including acupuncture and Chinese herbal medicine (CHM), are popular palliative interventions among patients with cancer, but further clinical research is required to assess their effectiveness and safety. OBJECTIVE: To prioritize top ten important CM clinical research questions from patients with cancer, cancer survivors and caregivers' perspectives via a face-to-face prioritization workshop in Hong Kong. METHODS: A list of 25 CM clinical research questions for cancer palliative care, which were identified from existing systematic reviews (SRs) and overview of SRs, was presented to 17 participants (patients with cancer [n = 5], cancer survivors [n = 6] and caregivers [n = 6]). The participants were then invited to establish consensus on prioritizing top ten research questions. RESULTS: Among the top ten priorities, five (50%) focused on acupuncture and related therapies, while five (50%) were on CHM. The three most important research priorities were (i) manual acupuncture plus opioids for relieving pain; (ii) CHM for improving quality of life among patients receiving chemotherapy; and (iii) concurrent use of CHM plus loperamide for reducing stomatitis. CONCLUSION: The top ten participant-endorsed CM clinical research priorities for cancer palliative care can guide local researchers on future direction. They can also inform local research funders on patient-centred allocation of limited funding. Under limited research funding, the most important co-prioritized research question from professional and patient perspectives may be addressed first. PATIENT OR PUBLIC CONTRIBUTION: Patients with cancer, cancer survivors and caregivers participated in conduct of the study to prioritize CM clinical research questions.
Subject(s)
Caregivers , Neoplasms , Humans , Medicine, Chinese Traditional , Neoplasms/drug therapy , Palliative Care , Quality of LifeABSTRACT
BACKGROUND: The World Health Organization advocates integration of traditional and complementary medicine (T&CM) into the conventional health services delivery system. Integrating quality services in a patient-centred manner faces substantial challenges when T&CM is delivered within a health system dominated by conventional medicine. This review has synthesized international experiences of integration strategies across different contexts. SOURCES OF DATA: Publications describing international experiences of delivering T&CM service in conventional healthcare settings were searched. Backward and forward citation chasing was also conducted. AREAS OF AGREEMENT: Capable leaders are crucial in seeking endorsement from stakeholders within the conventional medicine hierarchy and regulatory bodies. However, patient demands for integrative care can be successful as demonstrated by cases included in this review, as can the promotion of the use of T&CM for filling effectiveness gaps in conventional medicine. Safeguarding quality and safety of the services is a priority. AREAS OF CONTROVERSY: Different referral mechanisms between conventional and T&CM practitioners suit different contexts, but at a minimum, general guideline on responsibilities across the two professionals is required. Evidence-based condition-specific referral protocols with detailed integrative treatment planning are gaining in popularity. GROWING POINTS: Interprofessional education is critical to establishing mutual trust and understanding between conventional clinicians and T&CM practitioners. Interprofessional communication is key to a successful collaboration, which can be strengthened by patient chart sharing, instant information exchange, and dedicated time for face-to-face interactions. AREAS TIMELY FOR DEVELOPING RESEARCH: Research is needed on the optimal methods for financing integrated care to ensure equitable access, as well as in remuneration of T&CM practitioners working in integrative healthcare.
Subject(s)
Complementary Therapies , Communication , Delivery of Health Care , HumansABSTRACT
BACKGROUND: With increasing burden of chronic non-communicable diseases (NCD), ageing becomes a global public health concern, and the World Health Organization Western Pacific Region has no exception. To address the NCD challenge, priority should be given to promote healthy ageing across the life-course. As traditional and complementary medicine (T&CM) is popular within the Region, it is of policy interest to explore possibilities of applying T&CM for promoting healthy ageing. METHODS: We first summarized sources of clinical evidence supporting the use of T&CM. We then searched publications through MEDLINE from its inception to April 2020 to identify studies focusing on the perception of T&CM among older people. Finally, taking current evidence base and patient choice into account, we generated policy recommendations for of integrating T&CM into health systems. RESULT: Experiences from countries with different income levels suggested that promoting evidence-based T&CM as self-care modalities would be the most efficient way of maximizing impact among the older population, especially via a train the trainer approach. Meanwhile, popularity of natural products in the Region mandates policy makers to implement appropriate regulation and quality assurance, and to establish pharmacovigilance to detect potential harm. The role of pharmacists in advising patients on self-medication using natural products needs to be strengthened. CONCLUSION: Policy-makers will benefit from continued global dialogue and sharing of experience in T&CM policy development and implementation. Harmonizing regulatory frameworks for natural products at regional and global levels, including mutual recognition of regulatory approval, to improve standards and protect patients could be a priority.