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OBJECTIVES: Patients receiving chiropractic spinal manipulation (CSM) for low back pain (LBP) are less likely to receive any opioid prescription for subsequent pain management. However, the likelihood of specifically being prescribed tramadol, a less potent opioid, has not been explored. We hypothesised that adults receiving CSM for newly diagnosed radicular LBP would be less likely to receive a tramadol prescription over 1-year follow-up, compared with those receiving usual medical care. DESIGN: Retrospective cohort study. SETTING: US medical records-based dataset including >115 million patients attending academic health centres (TriNetX, Inc), queried 9 November 2023. PARTICIPANTS: Opioid-naive adults aged 18-50 with a new diagnosis of radicular LBP were included. Patients with serious pathology and tramadol use contraindications were excluded. Variables associated with tramadol prescription were controlled via propensity matching. INTERVENTIONS: Patients were divided into two cohorts dependent on treatment received on the index date of radicular LBP diagnosis (CSM or usual medical care). PRIMARY AND SECONDARY OUTCOME MEASURES: Risk ratio (RR) for tramadol prescription (primary); markers of usual medical care utilisation (secondary). RESULTS: After propensity matching, there were 1171 patients per cohort (mean age 35 years). Tramadol prescription was significantly lower in the CSM cohort compared with the usual medical care cohort, with an RR (95% CI) of 0.32 (0.18 to 0.57; p

OBJECTIVES: Radicular low back pain (rLBP) is often treated off-label with gabapentin or by chiropractors using chiropractic spinal manipulative therapy (CSMT). To date, no studies have examined the association between these interventions. We hypothesised that adults under 50 years of age receiving CSMT for newly diagnosed rLBP would have reduced odds of receiving a gabapentin prescription over 1 year-follow-up. DESIGN: Retrospective cohort study. SETTING: US network including linked medical records, medical claims and pharmacy claims of >122 million patients attending large healthcare organisations (TriNetX), queried 15 June 2023, yielding data from 2017 to 2023. PARTICIPANTS: Adults aged 18-49 were included at their first occurrence of rLBP diagnosis. Exclusions were severe pathology, other spinal conditions, on-label gabapentin indications and gabapentin contraindications. Propensity score matching controlled for variables associated with gabapentin use and receipt of prescription medication over the preceding year. INTERVENTIONS: Patients were divided into CSMT or usual medical care cohorts based on the care received on the index date of rLBP diagnosis. PRIMARY AND SECONDARY OUTCOME MEASURES: OR for gabapentin prescription. RESULTS: After propensity matching, there were 1635 patients per cohort (mean age 36.3±8.6 years, 60% women). Gabapentin prescription over 1-year follow-up was significantly lower in the CSMT cohort compared with the usual medical care cohort, with an OR (95% CI) of 0.53 (0.40 to 0.71; p

OBJECTIVES: Chiropractic spinal manipulative therapy (CSMT) and lumbar discectomy are both used for lumbar disc herniation (LDH) and lumbosacral radiculopathy (LSR); however, limited research has examined the relationship between these therapies. We hypothesised that adults receiving CSMT for newly diagnosed LDH or LSR would have reduced odds of lumbar discectomy over 1-year and 2-year follow-up compared with those receiving other care. DESIGN: Retrospective cohort study. SETTING: 101 million patient US health records network (TriNetX), queried on 24 October 2022, yielding data from 2012 query. PARTICIPANTS: Adults age 18-49 with newly diagnosed LDH/LSR (first date of diagnosis) were included. Exclusions were prior lumbar surgery, absolute indications for surgery, trauma, spondylolisthesis and scoliosis. Propensity score matching controlled for variables associated with the likelihood of discectomy (eg, demographics, medications). INTERVENTIONS: Patients were divided into cohorts according to receipt of CSMT. PRIMARY AND SECONDARY OUTCOME MEASURES: ORs for lumbar discectomy; calculated by dividing odds in the CSMT cohort by odds in the cohort receiving other care. RESULTS: After matching, there were 5785 patients per cohort (mean age 36.9±8.2). The ORs (95% CI) for discectomy were significantly reduced in the CSMT cohort compared with the cohort receiving other care over 1-year (0.69 (0.52 to 0.90), p=0.006) and 2-year follow-up (0.77 (0.60 to 0.99), p=0.040). E-value sensitivity analysis estimated the strength in terms of risk ratio an unmeasured confounding variable would need to account for study results, yielding point estimates for each follow-up (1 year: 2.26; 2 years: 1.92), which no variables in the literature reached. CONCLUSIONS: Our findings suggest receiving CSMT compared with other care for newly diagnosed LDH/LSR is associated with significantly reduced odds of discectomy over 2-year follow-up. Given socioeconomic variables were unavailable and an observational design precludes inferring causality, the efficacy of CSMT for LDH/LSR should be examined via randomised controlled trial to eliminate residual confounding.

IntroductionPain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.Methods and analysisWe describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.Ethics and disseminationThe Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.Trial registration numberNCT04095234.

OBJECTIVES: Although chiropractic spinal manipulative therapy (CSMT) and prescription benzodiazepines are common treatments for radicular low back pain (rLBP), no research has examined the relationship between these interventions. We hypothesise that utilisation of CSMT for newly diagnosed rLBP is associated with reduced odds of benzodiazepine prescription through 12 months follow-up. DESIGN: Retrospective cohort study. SETTING: National, multicentre 73-million-patient electronic health records-based network (TriNetX) in the USA, queried on 30 July 2021, yielding data from 2003 to the date of query. PARTICIPANTS: Adults aged 18-49 with an index diagnosis of rLBP were included. Serious aetiologies of low back pain, structural deformities, alternative neurological lesions and absolute benzodiazepine contraindications were excluded. Patients were assigned to cohorts according to CSMT receipt or absence. Propensity score matching was used to control for covariates that could influence the likelihood of benzodiazepine utilisation. OUTCOME MEASURES: The number, percentage and OR of patients receiving a benzodiazepine prescription over 3, 6 and 12 months follow-up prematching and postmatching. RESULTS: After matching, there were 9206 patients (mean (SD) age, 37.6 (8.3) years, 54% male) per cohort. Odds of receiving a benzodiazepine prescription were significantly lower in the CSMT cohort over all follow-up windows prematching and postmatching (p

INTRODUCTION: There are limited available research and guidance regarding the use of spinal manipulative therapy (SMT) in patients with low back-related symptoms following lumbar spine surgery, a condition called persistent spinal pain syndrome type 2 (PSPS-2). This publication outlines a review protocol to identify and synthesise individual participant data (IPD) to examine associations between patient, clinical and surgical variables and SMT application in adults with PSPS-2. METHODS AND ANALYSIS: PubMed, OVID, Web of Science, Scopus, PEDro, Index to Chiropractic Literature and KoreaMed will be searched from inception to 1 January 2022 without language restrictions. Case reports, series, observational studies and cases from grey literature of adults receiving SMT for PSPS-2 will be included. Two investigators will independently screen citations, abstracts and full-text articles. A risk-of-bias assessment will be performed in duplicate to rate cases according to exposure and outcome ascertainment and data completeness. Data extraction will be performed in duplicate and missing IPD will be requested from corresponding authors. Multiple binary logistic regression will be used to identify independent predictors of the use of lumbar-SMT, lumbar-manual-thrust SMT and SMT within 1-year postsurgery. Patient, clinical and surgical variables will be summarised using descriptive statistics, while SMT-related outcomes (lumbar-SMT, lumbar-manual-thrust SMT and 1-year surgery-to-SMT interval) will be described using adjusted ORs with 95% CIs. ETHICS AND DISSEMINATION: This study was deemed not human subjects research by the University Hospitals institutional review board. The results of this review will be disseminated at conferences and/or published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021250039.

IntroductionBack and neck pain are the leading causes of disability worldwide. Doctors of chiropractic (DCs) are trained to manage these common conditions and can provide non-pharmacological treatment aligned with international clinical practice guidelines. Although DCs practice in over 90 countries, chiropractic care is rarely available within integrated healthcare delivery systems. A lack of DCs in private practice, particularly in low-income communities, may also limit access to chiropractic care. Improving collaboration between medical providers and community-based DCs, or embedding DCs in medical settings such as hospitals or community health centres, will improve access to evidence-based care for musculoskeletal conditions.Methods and analysesThis scoping review will map studies of DCs working with or within integrated healthcare delivery systems. We will use the recommended six-step approach for scoping reviews. We will search three electronic data bases including Medline, Embase and Web of Science. Two investigators will independently review all titles and abstracts to identify relevant records, screen the full-text articles of potentially admissible records, and systematically extract data from selected articles. We will include studies published in English from 1998 to 2020 describing medical settings that have established formal relationships with community-based DCs (eg, shared medical record) or where DCs practice in medical settings. Data extraction and reporting will be guided by the Proctor Conceptual Model for Implementation Research, which has three domains: clinical intervention, implementation strategies and outcome measurement. Stakeholders from diverse clinical fields will offer feedback on the implications of our findings via a web-based survey.Ethics and disseminationEthics approval will not be obtained for this review of published and publicly accessible data, but will be obtained for the web-based survey. Our results will be disseminated through conference presentations and a peer-reviewed publication. Our findings will inform implementation strategies that support the adoption of chiropractic care within integrated healthcare delivery systems.

INTRODUCTION: Medical pluralism, or concurrent utilisation of multiple therapeutic modalities, is common in various international contexts, and has been characterised as a factor contributing to poor health outcomes in low-resource settings. Traditional healers are ubiquitous providers in most regions, including the study site of southwestern Uganda. Where both informal and formal healthcare services are both available, patients do not engage with both options equally. It is not well understood why patients choose to engage with one healthcare modality over the other. The goal of this study was to explain therapeutic itineraries and create a conceptual framework of pluralistic health behaviour. METHODS: In-depth interviews were conducted from September 2017 to February 2018 with patients seeking care at traditional healers (n=30) and at an outpatient medicine clinic (n=30) in Mbarara, Uganda; the study is nested within a longitudinal project examining HIV testing engagement among traditional healer-using communities. Inclusion criteria included age ≥18 years, and ability to provide informed consent. Participants were recruited from practices representing the range of healer specialties. Following an inductive approach, interview transcripts were reviewed and coded to identify conceptual categories explaining healthcare utilisation. RESULTS: We identified three broad categories relevant to healthcare utilisation: (1) traditional healers treat patients with care; (2) biomedicine uses modern technologies and (3) peer testimony influences healthcare engagement. These categories describe variables at the healthcare provider, healthcare system and peer levels that interrelate to motivate individual engagement in pluralistic health resources. CONCLUSIONS: Patients perceive clear advantages and disadvantages to biomedical and traditional care in medically pluralistic settings. We identified factors at the healthcare provider, healthcare system and peer levels which influence patients therapeutic itineraries. Our findings provide a basis to improve health outcomes in medically pluralistic settings, and underscore the importance of recognising traditional healers as important stakeholders in community health.

Objective: We evaluate change in low back pain (LBP) intensity and interference as the mechanism by which chiropractic care affects other biopsychosocial factors in US active-duty military members., Design: We conducted secondary, exploratory mediation analysis of pragmatic, multisite, clinical trial (NCT01692275) post results using natural effect modeling. Mediators were the 6-week values of Patient-Reported Outcomes Measurement Information System (PROMIS)-29 pain interference and intensity. Outcomes were 12-week values of other PROMIS-29 biopsychosocial subdomains. Models evaluated overall and individual factor contribution and were adjusted for baseline age, sex, LBP duration, LBP intensity and mediator and outcome values., Setting: Three US military treatment facilities., Participants: 750 US active-duty military members with LBP., Interventions: Trial participants received 6 weeks of treatment with chiropractic care plus usual medical care or usual medical care alone., Results: In multiple mediator models, pain interference and pain intensity explained much of the effect of chiropractic care on physical function (proportion mediated=0.77, 95% CI 0.43 to 2.0), fatigue (0.62, 95% CI 0.30 to 1.0), sleep disturbance (0.49, 95% CI 0.31 to 1.5) and social roles (0.81, 95% CI 0.50 to 2.0). Mental health was not evaluable due to the low prevalence of symptoms reported. The combined models of pain interference and pain intensity did not have a higher proportion mediated than the individual pain intensity models except for fatigue outcome models., Conclusion: Pain intensity appeared to be the mechanism by which much of the change in biopsychosocial factors occurred and should be considered a key clinical indicator for improvement in biopsychosocial health when chiropractic care is added to usual medical care for US active-duty military members., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Tandem Spinal Stenosis (TSS) is a disease characterised by the narrowing of the spinal canal in two or more non-adjacent areas of the spine, often affecting both the cervical and lumbar vertebrae. Doctors and patients increasingly favour non-surgical treatments that have the function of relieving symptoms and improving outcomes. This systematic review aims to evaluate the effectiveness and safety of non-surgical therapies for TSS and comprehensively summarise existing evidence., Methods and Analysis: We will conduct comprehensive searches, both manual and electronic, of literature published up to 30 September 2024; database searches will commence after the publication of this agreement, with an estimated commencement date of 1 December 2024, and the end date is 31 May 2025, without language restrictions. Key databases such as MEDLINE, PubMed, EMBASE, Web of Science, Cochrane Library, WHO International Clinical Trial Registration Platform, China National Knowledge Infrastructure, China Biomedical Literature Database, China Scientific Journal Database and Wan-Fang Database will be explored. In addition, we will include resources such as library journals and conference abstracts. Following the identification and screening of all randomised controlled trials focusing on non-surgical treatments for TSS, two investigators will perform a meta-analysis of the included studies. The findings will be summarised as the risk ratio for binary data and the standardised or weighted mean difference for continuous data., Ethics and Dissemination: Ethical approval is not required, as the review does not involve individual patient data. The review's findings will provide clinicians with evidence on using non-surgical treatments for TSS, disseminated through peer-reviewed publications or conferences., Prospero Registration Number: CRD42024496634., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic liver disease in the world and carries an increased risk of liver-related events, but no approved medicine. Electroacupuncture has been used to treat non-alcoholic fatty liver disease, but its effect was uncertain because of the poor quality of prior studies. We designed this trial to evaluate the efficacy and safety of electroacupuncture for MAFLD., Methods/design: This is a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial. Participants will take part in a total of 20 weeks of study, containing three phases: a 4-week run-in period, 12-week treatment (36 sessions of acupuncture) and 4-week follow-up. A total of 144 eligible patients diagnosed with MAFLD will be randomly allocated to the electroacupuncture or sham acupuncture groups. The primary outcome is the percentage of relative liver fat reduction on the MRI proton density fat fraction from baseline to 12 weeks. Secondary outcomes include magnetic resonance elastography, liver and metabolic biomarkers, anthropometry parameters, blinding assessment, credibility and expectancy, and adverse events. All patients who receive randomisation will be included in the intent-to-treat analysis., Discussion: The finding of this trial will provide evidence of the efficacy and safety of electroacupuncture for the treatment of MAFLD. The results of this study will be published in peer-reviewed journals., Trial Registration Number: www.chictr.org.cn, ChiCTR2200060353. It was registered on 29 May 2022., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related fatigue (CRF) is one of the most common and painful symptoms in patients with prostate cancer (PCa). Moreover, PCa patients who receive the androgen deprivation therapy (ADT) are more likely to develop CRF. Baduanjin exercise has been shown to improve CRF in some cancers. However, such effects have not been verified in patients with PCa treated with the ADT. So, this study was designed as a randomised controlled trial (RCT) to explore the effects of Baduanjin exercise on CRF in PCa patients treated with the ADT., Methods and Analysis: This study will be a single-centre, assessor and statistician blinded, RCT consisting of a 12 week intervention and 12 week follow-up. Patients with PCa who meet the inclusion criteria will be recruited from Shanghai Hudong Hospital. Participants will be randomly assigned to Baduanjin exercise group (n=42) and the control group (n=42), performing 12 weeks of Baduanjin exercise or reeiving the standard care. The primary outcome will be the clinical effect of Baduanjin exercise on CRF in PCa patients, which will be measured using the Piper Fatigue Self-Assessment (PFS) scale, a multidimensional measure of CRF using three different dimensions: somatic, emotional and cognitive. The secondary outcome will be the clinical effect of the Baduanjin exercise on the patient's level of fatigue, sleep, depression and life quality at the time, which will be assessed by the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P)., Ethics and Dissemination: This study has been approved by Shanghai Hudong Hospital Ethics Committee, Shanghai province (2022 SHHDKY08). The trial results will be submitted to conferences and peer-reviewed journals., Trail Registration Number: ChiCTR2300074293., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Increasing evidence has emerged for traditional, complementary and integrative medicine (TCIM) to treat COVID-19 which requires systematic summaries of the net benefits of interventions against standard care and one another. The study aims to conduct a systematic review and network meta-analysis (NMA) regarding TCIM therapies for treating mild/moderate acute COVID-19, potentially informing the WHO guideline development and clinical decision-making., Methods and Analysis: We will search Embase, MEDLINE, Virtual Health Library on Traditional Complementary and Integrative Medicine, Cochrane Central Register of Controlled Trials, WHO's International Clinical Trials Registry Platform with additional searches of Chinese and Korean literature sources for randomised controlled trials comparing TCIM with placebo, standard care, no treatment or with an alternate type of TCIM to treat COVID-19. We will limit the search dates from 2020 to 28 March 2024. Reviewers will, in duplicate, screen eligible articles, extract data and evaluate the risk of bias. We will conduct frequentist network meta-analyses for network comparisons and each outcome. We will assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach and classify interventions from most to least effective or harmful., Ethics and Dissemination: This NMA is based on the existing trials and data which is not subject to ethical approval. We will publish the NMA in a peer-reviewed journal. This may provide methodological reference and clinical evidence for TCIM on future epidemic-prone diseases., Prospero Registration Number: CRD42024517321., Competing Interests: Competing interests: We would like to disclose that Dr. Guyatt Gordon and Dr. Thabane Lehana are listed as members of the Editorial Board of BMJ Open, as noted on their website (https://bmjopen.bmj.com/pages/editorial-board). This association has been declared in accordance with the journal’s submission policies. All other authors have no potential conflicts of interest to declare related to this submission., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related insomnia (CRI), a significant concurrent symptom of cancer, profoundly impacts patients. Non-pharmacological interventions include cognitive behavioural therapy, mindfulness-based stress reduction programmes, bright light, acupuncture, exercise and music therapies and tai chi. These approaches, unlike pharmacological treatments, exhibit minimal adverse effects, without drug-drug interactions. They are a promising treatment strategy for CRI patients. However, a comprehensive comparative study evaluating the efficacy and safety of all non-pharmacological interventions for CRI is lacking. Accordingly, we aim to conduct a relatively comprehensive systematic review and network meta-analysis., Methods and Analysis: We will conduct an extensive search across various databases, including Pubmed, Web of Science, Cochrane Library, Embase, Google Scholar, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), Wanfang and Vip databases (VIP). The search will focus on non-pharmacological therapeutic interventions related to CRI in randomised controlled trials published from the inception of these databases until 15 May 2024. The primary outcomes of this study will encompass the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI), while the secondary outcomes will evaluate sleep parameters, fatigue levels, anxiety-depressive mood, quality of life and any potential adverse effects. Paired meta-analyses and network meta-analyses will be conducted utilising ADDIS V.1.16.8, Stata V.14.2 and V.R4.1.2. Bias risk will be independently assessed using the Cochrane Risk of Bias tool (ROB V.2.0), and the evidence quality will be evaluated according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) standards., Ethics and Dissemination: There are no ethical issues as this study did not conduct any experiments, surveys, or human trials. We will ensure that the findings are shared through pertinent channels., Prospero Registration Number: CRD42023427752., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Pisa syndrome (PS) is a postural abnormality that frequently manifests in various neurological disorders. In recent years, the dangers associated with Parkinson's disease (PD) and PS have been increasingly acknowledged, leading to heightened research efforts directed toward the treatment of PS. Nevertheless, the underlying causes of PS remain complex, and no clinically effective treatments have been established. While several studies have demonstrated the significant effects of Qigong in treating PD, there is currently no evidence to support the efficacy of Qigong in the treatment of PS., Objective: To assess the immediate and long-term effects of Zhan Zhuang Qigong on PS in participants with PD using a rigorous randomised, parallel-control design with assignment concealment and evaluator-blinding methodologies., Methods: 60 PD participants meeting the inclusion criteria will be recruited and randomly assigned to one of two groups: conventional treatment (n=30) or Zhan Zhuang Qigong (n=30). The conventional treatment group will receive standard medications and physical therapy. The Zhan Zhuang Qigong group will receive conventional medicine plus 30 min of Zhan Zhuang Qigong practiced five times per week. The long-term effects of Qigong on PS will be evaluated after 6 months and 1 year of follow-up. Assessment tools will include the NeuroPostureApp, the B-PHY(A model of a balance testing system) balance check training system, the Unified Parkinson's Disease Rating Scale and the Parkinson's Disease Quality of Life Questionnaire, which will measure total camptocormia, upper hump degree, Pisa angles, plantar pressure distribution, motor function and quality of life in participants with PD., Ethics and Dissemination: The local ethics committee approved this study (approval number: 2023-K068). The committee will oversee the study throughout its duration and will be notified of any protocol modifications. The results of the study will be disseminated through publication in an international journal or presentation at a conference., Trial Registration Number: ChiCTR2400079696., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To evaluate the minimal clinically important difference (MCID) value for acupuncture treatment in chronic spontaneous urticaria (CSU), providing guidance for its application in CSU management., Design: Secondary analysis of data from a multicentre randomised controlled trial., Setting: Three tertiary hospitals across three cities in China., Participants: 103 CSU patients (78.7% female) with an average age of 39.97 years., Interventions: Participants received acupuncture treatment for 4 weeks in the original study., Outcome Measures: MCID and minimal detectable change (MDC) for the Urticaria Activity Score over 7 days (UAS7) in acupuncture treatment of CSU. Convergent validity assessed by intraclass correlation coefficient (ICC). Responsiveness evaluated through Spearman correlation between UAS7 improvements and anchor tools (physician's and patient's assessments). MDC calculated using SE of measurement of changes in UAS7 scores. MCID estimated using distribution-based and anchor-based methods., Results: The ICC for UAS7 was 0.86. Improvements in UAS7 scores were significantly correlated with patient (r=0.44, p<0.01) and physician (r=0.85, p<0.01) assessments of CSU activity shifts. The MDC for UAS7 was 5.08. The MCID for acupuncture treatment in CSU was 8.3., Conclusions: This study provides the first MCID value for acupuncture treatment in CSU. These findings contribute to the understanding of acupuncture's effects in treating CSU and may inform future research and clinical practice in the management of this condition., Trial Registration Number: ChiCTR1900022994., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Axial symptoms (AS) represent one of the primary complications after cervical spondylotic myelopathy (CSM) surgery. Traditional Chinese Medicine (TCM), as a complementary and alternative therapy, is widely used in the treatment of postoperative AS in CSM. However, it lacks standardised treatment protocols, uniform therapeutic criteria, assessment methods and a sufficiently in-depth understanding of its mechanisms of action. These shortcomings impact the credibility of TCM treatment in clinical practice., Methods and Analysis: We will conduct comprehensive searches, both manual and electronic, on literature published up to 31 July 2024, and database searches will commence after the publication of this agreement, with an estimated commencement date of 1 October 2024 and the end date of 31 March 2025, without language restrictions. Key databases such as MEDLINE, PubMed, Embase, Web of Science, Cochrane Library, WHO International Clinical Trial Registration Platform, China National Knowledge Network, China Biomedical Literature Database, China Scientific Journal Database and Wanfang Database will be explored. In addition, we will include resources such as library journals and conference abstracts. After identifying and screening all randomised controlled trials focused on TCM for postoperative AS of CSM, the two investigators will conduct a meta-analysis of the included studies. The results will be summarised as the risk ratio for binary data and the standardised or weighted average difference for continuous data., Ethics and Dissemination: Ethical approval is not required since this review does not involve individual patient data. The review's findings will provide clinicians with evidence on using TCM treatment for AS post-CSM surgery, disseminated through peer-reviewed publications or conferences., Prospero Registration Number: CRD42024505160., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Comfort is a primary goal of healthcare. Theory-informed interventions and measurement are essential for comfort enhancement., Objectives: To categorise and synthesise the international literature on the application of Kolcaba's Comfort Theory in research and practice aiming to promote adults' comfort., Eligibility Criteria: Papers reporting the application of Kolcaba's Comfort Theory on adult participants published in English and Chinese., Sources of Evidence: MEDLINE, CINAHL, APA PsycInfo, Embase, AMED, Web of Science, Scopus, The Cochrane Library, JBI EBP Database, CNKI, Wan Fang; grey literature of Google Scholar, Baidu Scholar and The Comfort Line were searched from January 1991 to January 2024., Chart Methods: Following the Joanna Briggs Institute guidance and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist, two reviewers selected papers and extracted data independently using a standardised chart embedded in NVivo software. A thematic synthesis and a descriptive analysis were provided., Results: The review included 359 papers. Approximately two-thirds (n=216, 60.2%) had been published since 2017. The majority of papers (n=316, 88.0%) originated from China, the USA, Turkey, Brazil and Portugal. The use of Kolcaba's Comfort Theory was dominated in a range of hospital settings (n=263) and with participants suffering neoplasms (n=55). Seven categories of theory application were identified: (I) interventions underpinned by Comfort Theory as the theoretical framework, (II) interventions evaluated by instruments derived from Comfort Theory, (III) descriptive or observational studies of services or practices underpinned by Comfort Theory, (IV) surveys using questionnaires derived from Comfort Theory, (V) questionnaires development or adaption based on Comfort Theory, (VI) qualitative studies interpreted by Comfort Theory and (VII) literature reviews and discussion about Comfort Theory use. The most commonly evaluated interventions included music therapy (n=31), position intervention (n=20) and massage (n=19), and the most commonly used questionnaire was General Comfort Questionnaire (n=109)., Conclusions: Kolcaba's Comfort Theory has been largely used in interventions and assessments across a wide range of contexts, providing a set of options for practitioners. However, quantifying evidence is needed through further systematic reviews, and continuous development of Comfort Theory is warranted based on the categorisation by this review., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: In areas with limited and unaffordable biomedical mental health services, such as sub-Saharan Africa (SSA), traditional healers are an incredibly well-used source of mental healthcare. This systematic review synthesises the available evidence on traditional healing practices, factors to access it and its effectiveness in improving people's mental health in SSA., Design: Systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses approach., Data Sources: PubMed, MEDLINE, CINAHL and Scopus studies published before 1 December 2022., Eligibility Criteria: Qualitative and quantitative studies reported traditional healing practices to treat mental health problems in SSA countries published in English before 1 December 2022., Data Extraction and Synthesis: Data were extracted using Covidence software, thematically analysed and reported using tables and narrative reports. The methodological quality of the included papers was evaluated using Joanna Briggs Institute quality appraisal tools., Results: In total, 51 studies were included for analysis. Traditional healing practices included faith-based (spiritual or religious) healing, diviner healing practices and herbal therapies as complementary to other traditional healing types. Objectively measured studies stated that people's mental health improved through collaborative care of traditional healing and biomedical care services. In addition, other subjectively measured studies revealed the effect of traditional healing in improving the mental health status of people. Human rights abuses occur as a result of some traditional practices, including physical abuse, chaining of the patient and restriction of food or fasting or starving patients. Individual, social, traditional healers, biomedical healthcare providers and health system-related factors were identified to accessing traditional healing services., Conclusion: Although there is no conclusive, high-level evidence to support the effectiveness of traditional healing alone in improving mental health status. Moreover, the included studies in this review indicated that traditional healing and biomedical services collaborative care improve people's mental health., Prospero Registration Number: CRD42023392905., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Several systematic reviews and meta-analyses (SRs/MAs) of clinical trials showed the efficacy of acupuncture for post-stroke motor impairment. To systematically estimate and synthesise these results, we aimed to conduct an overview of SRs/MAs to summarise the evidence and evaluate the methodological quality regarding the effectiveness and safety of acupuncture for post-stroke motor impairment., Methods and Analysis: This is a protocol for an overview of SRs/MAs. A literature search will be conducted in PubMed, Embase, Web of Science and Cochrane Central Registry of Controlled Trials from the construction of the database to March 2024. SRs/MAs evaluating the efficacy of acupuncture in post-stroke motor impairment patients will be included. Two independent investigators will screen and evaluate related SRs/MAs back-to-back. We will extract data into a predefined form designed to summarise the key characteristics of each study. The evaluation of methodological quality of the included SRs/MAs will be assessed using AMSTAR-2, the PRISMA 2020 checklist and the GRADE grading system., Ethics and Dissemination: Ethics approval is not required for this overview as we will only analyse published literature. The results will be published in a peer-reviewed journal., Prospero Registration Number: CRD42024502006., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Acupuncture is widely used for metabolic-associated fatty liver disease (MAFLD) treatment; however, the clinical efficacy has not been confirmed due to the lack of high-level evidence-based clinical practice. The purpose of this study is to design a research protocol that will be used to determine the efficacy of acupuncture versus sham acupuncture (SHA) for MAFLD treatment., Methods and Analysis: This will be a multicentre, randomised and sham-controlled trial. Ninety-eight participants with MAFLD will be enrolled in this trial. Participants will be randomly assigned in a 1:1 ratio to receive acupuncture or SHA for 12 weeks. The primary outcome is the rate of patients with a 30% relative decline in liver fat after 12 weeks of treatment in MRI-proton density fat fraction (MRI-PDFF), which will be obtained by quantitative chemical shift imaging such as the multipoint Dixon method at 0, 12 and 24 weeks. Secondary outcomes include the changes in the relative liver fat content measured by MRI-PDFF, magnetic resonance elastography, liver function, lipid metabolism, homeostatic model assessment for insulin resistance (HOMA-IR) and serum high sensitivity C reactive protein, which will be obtained at 0, 6, 12 and 24 weeks. Body measurement indicators (body mass index, waist circumference, hip circumference and waist-to-hip ratio) will be obtained at 0, 3, 6, 9, 12 and 24 weeks. The alteration in the gut microbiota composition and its metabolism will be assessed by 16S ribosomal RNA sequencing and liquid chromatography-mass spectrometry at 0 and 12 weeks., Ethics and Dissemination: This study protocol has been approved by the ethics committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine (2023-1347-114-01). The results of this study will be published in a peer-reviewed journal and presented at academic conferences., Trial Registration Number: ChiCTR2300075701., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Overactive bladder (OAB) affects approximately 500 million people worldwide, with a higher prevalence in women than in men, significantly impacting the quality of life of female patients. Treatment options for OAB are currently limited. Previous research has proposed that electroacupuncture could be a viable treatment for OAB in women, but there is a lack of high-quality clinical evidence. This study aims to evaluate the effectiveness of electroacupuncture as a safe and efficient non-pharmacological treatment for female OAB by comparing it with solifenacin succinate., Methods and Analysis: This study is a multicentre, single-blind, double-dummy randomised controlled non-inferiority clinical trial involving 204 eligible female participants with OAB. Participants will be randomly assigned in a 1:1 ratio to either the electroacupuncture group (receiving electroacupuncture and placebo) or the solifenacin succinate group (receiving sham electroacupuncture and solifenacin succinate). Each participant will undergo 12 sessions of electroacupuncture (or sham electroacupuncture) treatment and solifenacin succinate (or placebo) treatment over a 4-week period. The primary outcome measure will be the percentage change in the number of micturition episodes every 24 hours at week 4 compared with baseline. Secondary outcomes will include a percentage reduction in the number of micturition episodes every 24 hours at 2th, 8th and 16th weeks of the trial, Overactive Bladder Symptom Score, number of urinary incontinence and urgency episodes every 24 hours based on a 3-day voiding diary, OAB Questionnaire, Generalised Anxiety Disorder Scale-7, King's Health Questionnaire and Participant Self-evaluation of Therapeutic Effects. Adverse events will be monitored throughout the study. Efficacy analyses will be conducted on both the intention-to-treat population and the per-protocol set population., Ethics and Dissemination: Ethical approval has been obtained from the Medical Ethics Committee of Longhua Hospital Shanghai University of Traditional Chinese Medicine (approval number: 2022LCSY097). Each participant will sign a written informed consent before randomisation. The results of this study will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER : NCT05798403., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

OBJECTIVE: To examine patterns of, and decision-making processes, informing referrals for inpatient access to integrative medicine (IM) services at a large, acute care hospital. DESIGN: Retrospective electronic health record review and structured qualitative interviews. SETTING: A 630-bed tertiary care hospital with an IM service available to inpatients. PARTICIPANTS: IM referrals of all inpatients aged ≥18 years between July 2012 and December 2014 were identified using the hospitals electronic health record. Fifteen physicians, 15 nurses and 7 administrators were interviewed to better understand roles and perspectives in referring patients for IM services. RESULTS: In the study hospital, primary sources of referrals for IM services were the orthopaedic and neuroscience/spine service lines. While the largest absolute number of IM referrals was made for patients with lengths of stay of 3 days or fewer, a disproportionate number of total IM referrals was made for patients with long lengths of stay (≥10 days), compared with a smaller percentage of patients in the hospital with lengths of stay ≥10 days. Physicians and nurses were more likely to refer patients who displayed strong symptoms (eg, pain and anxiety) and/or did not respond to conventional therapies. IM referrals were predominantly nurse-initiated. A built-in delay in the time from referral initiation to service delivery discouraged referrals of some patients. CONCLUSIONS: Conventional providers refer patients for IM services when these services are available in a tertiary hospital. Referral patterns are influenced by patient characteristics, operational features and provider perspectives. Nurses play a key role in the referral process. Overcoming cultural and knowledge differences between conventional and IM providers is likely to be a continuing challenge to providing IM in inpatient settings.

Introduction: Osteoporotic vertebral compression fracture (OVCF) is a common complication in elderly patients with osteoporosis. Despite undergoing percutaneous kyphoplasty (PKP) treatment, a significant percentage of OVCF patients (1.8% to 31.9%) continue to experience residual low back pain. While acupuncture has shown promise in relieving this pain, there is currently no systematic review on its efficacy specifically for residual low back pain after PKP in OVCF patients. This project aims to evaluate the effectiveness and safety of acupuncture as a treatment for this condition., Methods and Analysis: A comprehensive search will be conducted, including manual and electronic searches of literature published. Various databases such as MEDLINE, PubMed, EMBASE, Web of Science, Cochrane Library, International Clinical Trial Registration Platform, China National Knowledge Network, China Biomedical Literature Database, China Scientific Journal Database and Wan-fang Database will be explored. Additional sources like bibliographies and meeting minutes will also be searched. All randomised controlled clinical trials related to acupuncture for treating residual low back pain after PKP in OVCF patients will be included. Two researchers will independently perform study selection, data extraction and quality assessment. The primary outcome measure will be pain relief assessed using a visual analogue scale (VAS) or other validated scales. Secondary outcomes include effectiveness, Oswestry dysfunction index (ODI), quality of life questionnaire (QUALEFFO-41), follow-up relapse rate and adverse events. If feasible, a meta-analysis using RevMan V.5.3 software will be conducted. Otherwise, descriptive or subgroup analyses will be performed. Database searches will commence after the publication of this agreement, with an estimated commencement date of 1 August 2024., Ethics and Dissemination: Ethical approval is not required since this review does not involve individual patient data. The findings will be disseminated through peer-reviewed journals or relevant conferences., Prospero Registration Number: CRD42023478838., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Obesity is a major public health issue in China and around the world. While acupuncture is often used in clinical practice, there is a lack of conclusive evidence for its weight-loss effect. Thus we will conduct a parallel, randomised, sham-controlled trial to evaluate the efficacy and safety of acupuncture for treating obesity., Methods and Analysis: A total of 160 eligible participants with obesity will be randomly assigned to the verum acupuncture group or sham acupuncture group at a ratio of 1:1. All participants will be treated three times a week for a duration of 12 weeks, and followed up for another 16 weeks. The primary outcome is the percentage change in body weight from baseline to Week 12. The secondary outcomes include body mass index (BMI), waist circumference (WC), body fat percentage (BF%), blood pressure, fasting blood glucose, insulin, glycosylated haemoglobin A1c, blood lipids, and physical functioning score on the Short Form 36 Health Survey. Other secondary outcomes including psychological and social functions will also be evaluated using the body image scale, psychological function scale, and social function scale of the BODY-Q, Rosenberg Self-Esteem Scale, Patient Health Questionnaire-9, and Dutch Eating Behaviour Questionnaire. BMI, WC, BF% and blood pressure will be evaluated at Week 0, 4, 8, 12 and 28. Other secondary outcomes will be measured at Week 0, 12 and 28, respectively. Adverse events will be recorded in detail during the trial., Ethics and Dissemination: Ethical approval of this trial was granted by the Ethics Committee of Chengdu Sport University (2023-102). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals., Trial Registration Number: Chinese Clinical Trial Registry (ChiCTR2200062092)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The therapeutic needs of women with diminished ovarian reserve (DOR), coupled with the increasing application of acupuncture in improving ovarian function, have highlighted the need to verify the efficacy and safety of acupuncture for DOR. This study aims to provide high-quality evidence by evaluating both ovarian reserve and in vitro fertilisation (IVF) outcomes., Methods and Analysis: A large-scale, multicentre, randomised controlled trial will be carried out across seven hospitals in China. 400 women with DOR will be randomised in a 1:1 ratio to an acupuncture group or a sham acupuncture group. Acupuncture or sham acupuncture will consist of 36 sessions per participant over 12 weeks. The primary outcome will be the change in antral follicle count (AFC) at week 12 from baseline. Secondary outcomes are AFC at week 24, the serum levels of basal follicle-stimulating hormone and anti-Mullerian hormone at weeks 12 and 24, the scores of the Self-Rating Anxiety Scale at weeks 12 and 24, clinical pregnancy rate, and IVF embryo transfer related outcomes. Any adverse events during treatment will be documented., Ethics and Dissemination: The study protocol has been approved by all the participating institutions. Written informed consent will be obtained prior to participant enrolment. The results of this study will be published in peer-reviewed publications., Trial Registration Number: ChiCTR2200062295 PROTOCOL VERSION: V2.0-20220317., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Febrile convulsion (FC) among children is a common emergency concern received in hospitals and clinics. However, in Ghana, FC is commonly perceived as a non-hospital disease and usually managed at home. There is limited research on the home management of FC. This study, therefore, explored the home management of FC., Methods: The study design was a descriptive and interpretive phenomenology. Data sources were triangulated among 42 participants across 5 communities within 2 km distance from regional hospitals in the Cape Coast Metropolis. Participants were purposively selected and interviewed face to face in their homes and treatment centres using semistructured interview guides. Interviews were transcribed and thematically analysed with QSR NVivo V.14., Results: Three themes were identified from the inductive analysis. These themes were treatment, prevention and case referral. Subthemes on treatment were tepid sponging with lukewarm water, the use of herbal medicine and spiritual approaches. FC was referred to as 'asram suro'. The 'asram' literally means the moon, and 'suro' connotes the skies, indicating possibly that the condition emanates from a god of the moon. Caregivers prevented FC through behavioural approaches, herbal medicine, and mystical approaches including making scarification and tying amulets and beads particularly on the child's face and wrists respectively. FC cases were referred for clinical attention after home care resulted in undesirable treatment outcomes. A conceptual framework depicting the decision-making and practices towards FC management is presented., Conclusion: FC is commonly managed at home independent of orthodox care availability. Caregivers employed herbal and ad hoc treatment regimens, usually unwarranted, visually frightening and spiritual approaches which were not the best home management approaches. These findings call for the need to educate caregivers about the best home management of FC., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: The presence of perioperative insomnia is common but yet often overlooked among cancer survivors. Non-pharmaceutical therapies have shown promise in treating cancer-related insomnia during the perioperative period; however, the existing evidence from various studies remains inconsistent. Therefore, this study aims to systematically review and assess the effectiveness of a wide range of non-pharmaceutical interventions during perioperative period for cancer-related insomnia. Findings from this study will help to make evidence-based treatment decisions., Methods and Analysis: A comprehensive electronic search will be conducted to identify relevant articles from multiple databases, including PubMed, MEDLINE, Embase, Web of Science, Cochrane Central Register of Controlled Trials and Chinese literature databases such as CNKI, VIP, Wanfang from inception to 1 December 2023. Language restrictions will not be imposed to ensure inclusivity. The change of the Pittsburgh Sleep Quality Index or the Insomnia Severity Index from baseline will be used as the primary outcome of the study. Studies using these as secondary outcomes are also acceptable. Pairwise meta-analysis and network meta-analysis will be conducted using Stata V.15.0 software. The Cochrane collaboration tool for assessing the Risk of Bias and Risk of Bias in Non-randomised Studies of Interventions will be used for risk and bias assessment. Additionally, the Grading of Recommendations, Assessment, Development and Evaluation scale will be employed to evaluate the quality of the evidence., Ethics and Dissemination: Ethical approval is not required for this study since it involves the analysis of existing studies. The anticipated results will be disseminated through publication in a peer-reviewed journal., Prospero Registration Number: CRD42023437356., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Fatigue is a common symptom observed in post-cancer treatment, yet its underlying mechanisms remain poorly understood. Acupuncture has been employed to alleviate cancer-related fatigue (CRF); however, its effectiveness in addressing associated comorbidities that may influence fatigue is also poorly understood. This study represents the first investigation to use acupuncture as an intervention for fatigue in breast cancer survivors within a Norwegian cohort. The study will employ questionnaires to evaluate various facets of fatigue. As a pragmatic trial, it statistically assesses its clinical relevance, documents adverse events and evaluates the cost-effectiveness of the acupuncture treatment., Methods and Analysis: This assessor-blinded, pragmatic, randomised, mixed method, controlled trial with two parallel arms aims to evaluate the effectiveness, safety and cost-effectiveness of acupuncture. It will recruit 250 participants presented with CRF for 6 months or longer. Patients will be randomly allocated either to acupuncture and usual care (n=125) or to usual care alone (n=125). Acupuncture treatments (12 in total) are to be given within 12 weeks. The statistician who will analyse the data will be blinded to group allocation. The primary outcome will be changes in CRF measured by the Chalder fatigue scale. Measurements will be taken 12 weeks and 6 months after randomisation. The secondary outcomes include patient-reported outcomes of pain, anxiety, depression, hot flashes, insomnia and sleepiness. Health-related quality of life and economic evaluation will also be conducted 12 weeks and 6 months after randomisation. Nested within this randomised controlled trial are two qualitative studies and one sub-study measuring biomarkers (C-reactive protein, interleukin (IL)-1, IL-6, tumour necrosis factor alpha (TNF-α) and aPL in addition to the current genotype genes TNF-308 and IL-6-174) from blood samples (n=80). Such biomarkers can potentially address changes in CRF., Ethics and Dissemination: Ethical approval of this study has been granted by the Regional Committees for Medical and Health Research Ethics (REC southeast ID number: 112285). Written informed consent will be obtained from all participants. The outcomes of the trial will be disseminated through peer-reviewed publications., Trial Registration Number: NCT04418115., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Stiff neck is a condition mainly characterised by persistent pain and limited neck movement, which can substantially impact patients' daily lives during acute episodes. Accordingly, rapid pain relief and restoration of normal activities are the main needs of patients during doctor visits. This study aims to assess the immediate efficacy of acupuncture combined with active exercises in rapidly relieving pain and improving movement disorders within 10 min in patients with acute stiff neck (ASN)., Methods and Analysis: This randomised controlled clinical trial is being conducted at a single centre in China. 120 participants diagnosed with ASN will randomly be assigned in a 1:1:1 ratio to one of three groups: the acupuncture combined with active exercise group (group A), sham acupuncture combined with active exercise group (group B) and active exercise only group (group C). Each participant will undergo a single 10 min session. The primary outcome is the effective rate at 10 min of treatment. Secondary outcomes include the effective rate at other time points (0-1, 2, 4, 6 and 8 min), Visual Analogue Scale score and cervical range of motion. The intention-to-treat analysis will include all randomised participants., Ethics and Dissemination: Ethics approval was obtained from the Ethics Committee of the Second Affiliated Hospital of Yunnan University of Chinese Medicine (2022-009). Written informed consent will be obtained from all participants before randomisation. The findings of this study will be disseminated through publication in a peer-reviewed journal and presentation at conferences., Trial Registration Number: ChiCTR2200066997., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Postoperative ileus (POI) is a postoperative complication that can cause lingering recovery after colorectal resection and a heavy healthcare system burden. Acupuncture aims to prevent postoperative complications, reduce the duration of POI, help recovery and shorten hospital stays. We hypothesise that preoperative electroacupuncture (EA) can promote POI recovery under the enhanced recovery after surgery protocol after laparoscopic surgery in patients with POI., Methods and Analysis: This is a multicentre, randomised, sham-controlled trial. A total of 80 patients will be enrolled and randomly assigned to the EA or sham electroacupuncture (SA) group. The eligible patients will receive EA or SA for one session per day with treatment frequency starting on preoperative day 1 for four consecutive days. The primary outcome is the time to first defecation. The secondary outcomes include the time to first flatus, length of postoperative hospital stay, time to tolerability of semiliquid and solid food, postoperative nausea, vomiting, pain and extent of abdominal distention, time to first ambulation, preoperative anxiety, 30-day readmission rate, the usage of anaesthetics and analgesics during operation, length of postanaesthesia care unit stay. A mechanistic study by single-cell RNA sequencing in which postintervention normal intestinal tissue samples will be collected. The results of this study will provide evidence of the effects of acupuncture on POI and promote good clinical decision to millions of patients globally every year., Ethics and Dissemination: This study has been approved by the ethical application of Beijing University of Chinese Medicine (2022BZYLL0401), Beijing Friendship Hospital Affiliated to Capital Medical University(2022-P2-368-02), Cancer Hospital Chinese Academy of Medical Science (23/175-3917), Huanxing Cancer Hospital (2023-002-02). The results will be published in a medical journal. In addition, we plan to present them at scientific conferences., Trial Registration Number: ChiCTR2300077633., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Upper limb problems have a significant impact on the global population leading to pain and restricted joint mobility, ultimately impacting their quality of life. Traditional treatments, such as non-steroidal anti-inflammatory drugs and corticosteroids, often come with undesirable side effects, prompting patients to seek alternative therapies. In this trial, we hypothesise that soothing cream gel (SCG) will improve range of motion and chronic pain in the shoulder and elbow. The objective of this trial is to evaluate the efficacy of SCG in improving the range of motion and chronic pain in the shoulder and elbow., Methods and Analysis: A double-blinded, randomised, placebo-controlled trial is conducted to compare the effects of SCG and placebo gel. SCG contains Vitis vinifera essence, Melaleuca viridiflora essential oil, etc, and is manufactured according to Good Manufacturing Practice standards. The placebo gel will be processed with similar appearance, texture and scent but will lack active ingredients. 70 participants with upper limb problems will be recruited from four study sites, including clinical centres and a sport department at the Chinese University of Hong Kong (CUHK). Participants will be randomly assigned to either treatment group or placebo group for 2 weeks. Primary outcome will be the range of motion in the upper limb, assessed by a goniometer, to measure active flexion and abduction for the shoulder, and active flexion and extension for the elbow. The primary efficacy analyses will be based on the full analysis set following the intention-to-treat principle., Ethics and Dissemination: The trial has obtained approval from the joint CUHK-New Territories East Cluster (CRE-2023.142), and the patient enrolment commenced in July 2023. Written informed consent will be obtained from all participants prior to participation. Study results will be disseminated through publication in peer-reviewed journals and presentations at conference., Trial Registration Number: NCT05799391., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Obesity has become a worldwide public health problem and is directly linked to loss of quality of life, complications and comorbidities. One of them is chronic pain, especially in the knees, which increases significantly and proportionally with weight gain. In patients with severe obesity, with indication for bariatric surgery, the presence of chronic pain disables and often prevents their participation in a pre-surgical rehabilitation programme. As an analgesic therapy, photobiomodulation (PBM) has been studied with safety, efficacy, well-tolerated used and low costs. Thus, this study aims to evaluate the use of PBM for the treatment of chronic knee pain in obese patients undergoing a pre-surgical rehabilitation programme for bariatric surgery., Methods and Analyses: This is a double-blinded, randomised, placebo-controlled clinical, superiority, trial protocol. The PBM will be applied in bilateral knees and lumbar paraspinal points levels referring to the roots of innervation of the knee. The outcomes evaluated will be pain intensity, functionality, quality of life and clinical signs of neurological sensitization of chronic knee pain pathways., Ethics and Dissemination: This protocol has already been approved by the Comitê de Ética em Pesquisa do Hospital das Clínicas da Universidade Federal de Goiás/EBSERH-Ethics Committee and it is following SPIRIT guidelines. The results will be statistically analysed and subsequently published in peer-reviewed journals., Trial Registration Number: Clinical Trials Platform (https://clinicaltrials.gov/) with the number NCT05816798., Competing Interests: Competing interests: The authors declare no competing interests, (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Indigenous people experience a unique set of health inequalities and social determinants that can negatively affect their physical health, mental health and wellness. This critical state of affairs is compounded by the limited availability of culturally appropriate care services and treatments for the different groups. In response, increasing numbers of studies are turning their focus to art-based interventions and how these might benefit Indigenous lives. The proposed scoping review aims to map this growing field of research., Methods and Analysis: This scoping review is based on the Arksey and O'Malley methodological framework and the subsequent enhancements proposed by Levac et al . Academic databases and grey literature sources will be searched to identify appropriate studies for inclusion. The search strategies of all databases were tested on 25 April 2024. This will be followed by a two-step screening process to be conducted by two researchers and consisting of (1) a title and abstract review and (2) a full-text review. Data from the selected studies will be extracted, collated and charted to summarise all relevant interventions, their outcomes and key findings. An Indigenous research partner will be hired as a consultant, and the research will be further informed by other stakeholders., Ethics and Dissemination: This study is the first step in a research programme involving working with Indigenous artists to codesign a pilot art-based intervention aimed at improving mental health and wellness among Indigenous people. The scoping review will identify the specific components in documented art-based interventions that have proven beneficial to this group. Since it will draw exclusively on data from published and public sources, no ethics approval is required. The results will be disseminated through knowledge translation activities with Indigenous organisations and art therapy groups; a summary of the results will also be distributed through Indigenous networks., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The aim of this study was to investigate the prevalence of indigenous herbal medicine use and its associated factors among pregnant women attending antenatal care (ANC) at public health facilities in Dire Dawa, Ethiopia., Design: A facility-based cross-sectional study design., Setting: The study was conducted in seven public health facilities (one referral hospital, three urban and three rural health centres) in Dire Dawa, Ethiopia, from October to November 2022., Participants: 628 pregnant women of any gestational age who had been on ANC follow-up at selected public health facilities were included., Main Outcome Measures: Prevalence of indigenous herbal medicine (users vs non-users) and associated factors., Results: The study revealed that 47.8% (95% CI 43.8% to 51.6%) of pregnant women used herbal medicines. Lack of formal education (adjusted OR, AOR 5.47, 95% CI 2.40 to 12.46), primary level (AOR 4.74, 95% CI 2.15 to 10.44), housewives (AOR 4.15, 95% CI 1.83 to 9.37), number of ANC visits (AOR 2.58, 95% CI 1.27 to 5.25), insufficient knowledge (AOR 4.58, 95% CI 3.02 to 6.77) and favourable perception (AOR 2.54, 95% CI 1.71 to 3.77) were factors significantly associated with herbal medicine use. The most commonly used herbs were garden cress ( Lepidium sativum ) (32%), bitter leaf ( Vernonia amygdalina ) (25.2%), moringa ( Moringa oleifera ) (24. 5 %). Common indications were related to gastrointestinal problems, blood pressure and sugar., Conclusion: The prevalence of herbal medicine use is high (one in two pregnant women) and significantly associated with education level, occupation, ANC visits, knowledge and perceptions. The study's findings are helpful in advancing comprehension of herbal medicines using status, types and enforcing factors. It is essential that health facilities provide herbal counselling during ANC visits, and health regulatory bodies ought to raise awareness and implement interventions to lower the risks from over-the-counter herbal medicine use by pregnant women., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

IntroductionInfant colic, or excessive crying of unknown cause in infants less than 3 months old, is common and burdensome. Its aetiology is undetermined, and consensus on its management is still lacking. Recent studies suggest a possible link between infant colic and gut microbiota, indicating probiotics to be a promising treatment. However, only a few strains have been tested, and results from randomised controlled trials are conflicting. It is important to clarify whether probiotics are effective for treating infant colic in general, and to identify whether certain subgroups of infants with colic would benefit from particular strains of probiotics.Methods and analysisThrough an individual participant data meta-analysis (IPDMA), we aim to identify whether the probiotic Lactobacillus reuteri DSM 17938 is effective in the management of infant colic, and to clarify whether its effects differ according to feeding method (breast vs formula vs combined), proton pump inhibitor exposure, and antibiotic exposure. The primary outcomes are infant crying duration and treatment success (at least 50% reduction in crying time from baseline) at 21 days postintervention. Individual participant data from all studies will be modelled simultaneously in multilevel generalised linear mixed-effects regression models to account for the nesting of participants within studies. Subgroup analyses of participant-level and intervention-level characteristics will be undertaken on the primary outcomes to assess if the intervention effect differs between certain groups of infants.Ethics and disseminationApproved by the Royal Children's Hospital Human Research Ethics Committee (HREC 34081). Results will be reported in a peer-reviewed journal in 2015.Trial registration numberPROSPERO CRD42014013210.

Background: Randomised controlled trials (RCTs) are the predominant type in acupuncture clinical research, and the publications have increased rapidly in recent years, but there is a prevalence of the high risk of bias and poor methodological design in acupuncture RCTs. Clinical trial registration can improve the transparency and credibility of studies by disclosing key information in advance. However, the registration in acupuncture RCTs is not satisfactory, as there is widespread of the under-registration, inconsistency with published studies and insufficient disclosure of key methodological information. Whether registration can reduce the risk of bias in acupuncture RCTs and improve data transparency has not been fully explored. Therefore, we constructed this study to investigate the association between registration and risk of bias and data sharing level in acupuncture RCTs., Methods: Seven databases including MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP databases will be systematically searched between 1 January 2014 and 31 March 2024, for acupuncture RCTs. Two reviewers will independently extract data using a predefined standardised format and perform secondary validation. The characteristics and data sharing level of the included studies will be summarised. The risk of bias of included RCTs will be assessed by the revised Cochrane risk-of-bias tool for randomised trials. The risk of bias and registration in acupuncture RCTs will be analysed by logistic or quantile regression analyses (depending on the number of minimum events). The data sharing level and registration will be analysed by quantile regression analyses., Ethics and Dissemination: As the systematic review aims to consolidate info from published sources, ethical approval is not necessary for this study. The study's findings will be submitted to a peer-reviewed academic journal and disseminated via conference presentations. This protocol has been registered in Open Science Framework Registries., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Severe pneumonia (SP) stands as one of the most prevalent critical illnesses encountered in clinical practice, characterised by its rapid onset and progression, numerous complications and elevated mortality rates. While modern medical interventions primarily focus on symptomatic management such as anti-infective therapy and mechanical ventilation, challenges including high drug resistance and suboptimal therapeutic outcomes for certain patients persist. Dry cupping as an ancient practice with over a millennium of clinical use in China is renowned for its convenience and perceived clinical efficacy in various illnesses. Nevertheless, the lack of well-designed studies assessing its effects remains a notable gap in the literature. This protocol describes a placebo-controlled, randomised, single-blind study to evaluate the efficacy and safety of dry cupping as an adjuvant treatment for SP., Methods and Analysis: 66 patients diagnosed with SP, aged 18-80 years, will be randomly divided into two groups: intervention group, receiving 10 times of dry cupping treatment; control group, receiving placebo dry cupping therapy. Both applications are used in bilateral Fei Shu (BL13), Pi Shu (BL21) and Shen Shu (BL22) cupping. The application will be conducted once a day for 10 days. Participants will be assessed before treatment (D0), after the first intervention (D1), after the fifth intervention (D5) and after treatment ended (D10). The assessments include blood oxygen saturation, respiratory rate, traditional Chinese medicine symptom score, inflammatory response, mechanical ventilation time and oxygen condition., Ethics and Dissemination: This protocol has been approved by the Ethics Committee of Shanghai Seventh People's Hospital (2023-7th-HIBR-070). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings., Trial Registration Number: ChiCTR2300076958., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To compare the efficacy and safety of seven Chinese patent medicines (CPMs) combined with conventional triple/quadruple therapy (T/Q) for Helicobacter pylori -positive peptic ulcers., Design: A systematic review and network meta-analysis., Data Sources: China National Knowledge Infrastructure, VIP database, Wanfang database, ScienceDirect, EBSCO, EMBASE, Web of Science, Cochrane Library and PubMed were searched through 1 June 2022., Eligibility Criteria: Randomised controlled trials (RCTs) testing CPMs combined with T/Q for H. pylori -positive peptic ulcers were included. The CPMs included Anweiyang capsule, Jianweiyuyang tablets/capsule/granule, Jinghuaweikang capsule, Kangfuxin liquid, Puyuanhewei capsule, Weifuchun tablets/capsule and Weisu granule. At least one of the following outcome indicators was recorded: complete ulcer healing rate (CUHR), effective rate (ER), H. pylori eradication rate ( HP ER), rate of peptic ulcer recurrence (RPUR) and incidence of adverse reactions (IAR)., Data Extraction and Synthesis: Two researchers independently conducted the study selection and extracted data for included studies. The risk of bias was assessed using the Cochrane risk of bias tool. A pairwise meta-analysis was performed using RevMan V.5.3. Network meta-analysis was performed using STATA/MP V.15.0. Confidence in the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluation., Results: A total of 36 RCTs involving 3620 patients were included. Compared with T/Q alone, Weisu+T/Q, Weifuchun+T/Q and Puyuanhewei+T/Q had the highest CUHR, ER and HP ER, respectively. Weisu+T/Q and Jianweiyuyang+T/Q had the lowest RPUR and IAR, respectively. The cluster analysis results showed Jianweiyuyang+T/Q might be the best choice concerning efficacy and safety simultaneously, followed by Kangfuxin+T/Q., Conclusion: Among the combination therapies with the CPMs, Jianweiyuyang+T/Q might be the most favourable option for H. pylori -positive peptic ulcers, followed by Kangfuxin+T/Q. Considering the limited quantity and quality of the included RCTs, the results should be interpreted with caution., Prospero Registration Number: CRD42022327687., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Perimenopause is a critical transitional period in reproductive ageing. A set of physiological and psychological changes can affect perimenopausal women's quality of life and further threaten their older adult health conditions. In China, less than one-third of midlife women with menopausal symptoms have actively sought professional healthcare. Regarding the public health significance of comprehensive menopause management, the current study aims to investigate the effects of a therapeutic lifestyle modification (TLM) intervention on cardiometabolic health, sexual functioning and health-related quality of life among perimenopausal Chinese women., Method and Analysis: A randomised controlled trial with two parallel arms will be conducted at the gynaecology outpatient department of Yunnan Provincial Hospital of Traditional Chinese Medicine in China. 94 eligible perimenopausal women aged between 40 and 55 years will be recruited for the study. The TLM intervention consists of four elements: menopause-related health education, dietary guidance, pelvic floor muscle training and Bafa Wubu Tai Chi exercise. Participants will be randomly assigned (1:1) to receive either the 12-week TLM intervention or routine care via stratified blocked randomisation. The primary outcome is quality of life; secondary outcomes of interest include sexual functioning and cardiometabolic health. The outcome measures will be assessed at baseline and post-intervention. To explore the effects of the intervention, linear mixed models will be applied to test the changes between the two groups over time in each outcome based on an intention-to-treat analysis., Ethics and Dissemination: The Research Ethics Review Committee of Chulalongkorn University (COA No 178/66) and the Medical Ethics Committee of Yunnan Provincial Hospital of Traditional Chinese Medicine (IRB-AF-027-2022/02-02) approved the study protocol. Written informed consent will be obtained from all participants. Results will be published in peer-reviewed journals and disseminated through conferences., Trial Registration Number: ChiCTR2300070648., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Specific treatment for diabetic peripheral neuropathy (DPN) is still lacking, and acupuncture may relieve the symptoms. We intend to investigate the efficacy and safety of electro-acupuncture (EA) in alleviating symptoms associated with DPN in diabetes., Methods and Analysis: This multicentre, three-armed, participant- and assessor-blind, randomised, sham-controlled trial will recruit 240 eligible participants from four hospitals in China and will randomly assign (1:1:1) them to EA, sham acupuncture (SA) or usual care (UC) group. Participants in the EA and SA groups willl receive either 24-session EA or SA treatment over 8 weeks, followed by an 8-week follow-up period, while participants in the UC group will be followed up for 16 weeks. The primary outcome of this trial is the change in DPN symptoms from baseline to week 8, as rated by using the Total Symptom Score. The scale assesses four symptoms: pain, burning, paraesthesia and numbness, by evaluating the frequency and severity of each. All results will be analysed with the intention-to-treat population., Ethics and Dissemination: The protocol has been approved by the Ethics Committee of the Beijing University of Chinese Medicine (Identifier: 2022BZYLL0509). Every participant will be informed of detailed information about the study before signing informed consent. The results of this trial will be published in a peer-reviewed journal., Trial Registration Number: ChiCTR2200061408., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Parkinson's disease (PD) has a significant impact on a substantial number of individuals in China. Notably, 31% of patients with PD also grapple with the additional burden of anxiety. This dual challenge of managing both PD and anxiety underscores the complexity of the condition and the diverse range of symptoms patients may experience. Considering the circumstances, the cost and potential drawbacks associated with traditional antiparkinsonian drugs become increasingly relevant. Acupuncture emerges as a significant non-pharmacological adjunct therapy. Offering a potentially safer and more cost-effective option, acupuncture addresses the pressing need for holistic and complementary treatments that may alleviate both the motor symptoms of PD and the accompanying anxiety., Methods and Analysis: This is a multicentre, randomised controlled and assessor-blind trial. A total of 210 eligible patients with PD will be randomly assigned (1:1) to Jin's three-needle (JTN) acupuncture group or waitlist (WL) group. Patients in the JTN group will receive acupuncture therapy three times per week for 4 weeks. Patients in the WL group will maintain their original dosage of antiparkinsonian drugs and receive acupuncture therapy after the observation period. The primary outcome measure will be the Unified Parkinson's Disease Rating Scale score. The secondary outcome measures will be the scores of the Hoehn-Yahr Rating Scale, Unified Dyskinesia Rating Scale, Non-Motor Symptoms Scale, 39-item Parkinson's Disease Questionnaire, Parkinson Anxiety Scale, Hamilton Anxiety Scale, Hamilton Depression Scale, Zarit burden interview and the level of cortisol and adrenocorticotropic hormone. The evaluation will be executed at baseline, the end of the treatment and a follow-up period., Ethics and Dissemination: The study was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine (K[2023]014). All patients have to provide written, informed consent. The study will be disseminated through presentations in peer-reviewed international journals and at national and international conferences., Trial Registration Number: Chinese Clinical Trial Registry; ChiCTR2300074675., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Non-pharmacological interventions play a crucial role in the management of non-specific chronic low back pain (NSCLBP). One prime example is Tuina, a traditional Chinese manual therapy that incorporates pressing, kneading and rubbing techniques to alleviate physical discomfort and enhance overall well-being. It serves as a widely used technique in China and other East Asian countries. However, the effectiveness and safety of Tuina for managing NSCLBP have not been substantiated through rigorous clinical research. We sought to carry out a randomised controlled trial with an open-label design, blinded assessors and parallel arms to assess the effectiveness and safety of Tuina as a treatment for NSCLBP. The trial aims to provide high-quality evidence regarding the efficacy and safety of Tuina in improving outcomes for patients with NSCLBP., Methods and Analysis: A total of 150 patients aged 18-60 years with NSCLBP will be recruited. Participants will be randomly assigned to one of the two groups. Both groups will receive standard health education. In addition, the treatment group will receive Tuina therapy, while the control group will participate in core stability exercises. Each group will undergo a total of 18 interventions over 6 weeks, with the interventions administered three times per week. The primary outcome measure is the patient's pain intensity, assessed using the Numerical Rating Scale, at week 6 following randomisation. Secondary outcomes encompass disability (measured by the Roland-Morris Disability Questionnaire), quality of life (assessed using the EuroQoL-5 dimensions questionnaire), adverse emotions (evaluated with the Pain Catastrophizing Scale, Tampa Scale of Kinesiophobia and Depression Anxiety Stress Scale), biomechanical outcomes, socioeconomic indicators (medication use, healthcare utilisation and absenteeism), patient satisfaction, treatment adherence and other relevant factors.The statistical analysis will follow the intention-to-treat principle. Two-way repeated measures analysis of variance will be used to compare the clinical data across different time points within both groups., Ethics and Dissemination: The study protocol has received approval from the Ethics Committee of Shuguang Hospital, Shanghai University of Traditional Chinese Medicine (2023-1366-133-01). All study participants will be required to give written informed consent. The findings of the study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences. Additionally, the participants will receive copies of the results., Trial Registration Number: ChiCTR2300076257., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed 'prehabilitation') may mitigate these side effects and improve quality of life.During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that 'packaged' care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme., Methods and Analysis: This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20-30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them., Ethics and Dissemination: The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences., Trial Registration Number: ACTRN12622000584730., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Ulcerative colitis (UC) is a global chronic inflammatory bowel disease, and the poor efficacy of currently available pharmacological regimens makes the management of UC a great challenge. Moxibustion has shown great potential in the management of UC. However, its effectiveness and safety are still controversial. The purpose of this study is to synthesise the latest evidence regarding the clinical efficacy and safety of moxibustion for UC., Methods and Analysis: The Cochrane Library, PubMed, EMBASE, CNKI, Wanfang, VIP and SinoMed databases will be searched from inception to July 2023, to identify all randomised controlled trials with moxibustion for UC. The primary outcome will be clinical efficacy, as measured by validated scales. The serum inflammatory factor, colonoscopy results, quality of life, recurrence rate and adverse events will be the secondary outcomes. The Cochrane Risk of Bias 2.0 tool will be used to assess the methodological quality of each included trial. All data extraction will be carried out independently by two investigators. RevMan V.5.4 software will be used for data analysis and Cochran's Q statistic and I 2 test will be used to assess heterogeneity between studies. In addition, we will perform subgroup analyses, sensitivity analyses and publication bias if the available data are sufficient. The strength of evidence will be graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system., Ethics and Dissemination: Ethics approval is not required for this review. Our findings will be published in a peer-reviewed journal., Prospero Registration Number: CRD42023425481., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Knee osteoarthritis (KOA) is still a challenging degenerative joint disease with high morbidity and disease burden. Early-stage KOA, the focus of this study, could present a Window of Opportunity to arrest the disease process and reduce the disease burden. Yijinjing exercise is an important part of physical and psychological therapies in Traditional Chinese Exercise and may be an effective treatment. However, there is no clinical efficacy assessment of Yijinjing exercise for patients with early-stage KOA. Therefore, we designed a randomised controlled trial to evaluate the effectiveness of Yijinjing exercise on patients with early-stage KOA., Methods and Analysis: This is a parallel-design, two-arm, analyst assessor-blinded, randomised controlled trial. In total, 60 patients with early-stage KOA will be recruited and randomly assigned to the Yijinjing exercise group (n=30) and health education group (n=30) at a ratio of 1:1, receiving 12 weeks of Yijinjing exercise or health education accordingly. The primary outcome will be measured with the Western Ontario and McMaster Universities Osteoarthritis Index, and the secondary outcomes will include the Visual Analogue Scale, Short-Form 36 Item Health Survey Questionnaire, Beck Depression Inventory, Perceived Stress Scale, Berg Balance Scale, and Gait Analysis for a comprehensive assessment. Outcome measures are collected at baseline, at 12 week ending intervention and at the 12 week, 24 week and 48 week ending follow-up. The primay time point will be 12 weeks postintervention. Adverse events will be recorded for safety assessment., Ethics and Dissemination: This study has been approved by the ethical application of the Shanghai Municipal Hospital of Traditional Chinese Medicine Ethics Committee (2021SHL-KY-78)., Trial Registration Number: ChiCTR2200065178., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: In critically ill children, pain management is complex owing to cognitive development and the nature of hospitalisation in paediatric intensive therapy units. Although there are many protocols and guidelines for pain control via pharmacological interventions, non-pharmacological practices should also be explored and disseminated for their potential benefit., Methods and Analysis: A systematic literature search will be performed using the following databases: Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Excerpta Medica Database, Virtual Health Library, Medical Literature Analysis and Retrieval System Online, ScienceDirect, Scopus, Web of Science Core Collection, Theses from Coordenação de Aperfeiçoamento de Pessoal de Nível Superior , Dart Europe, Open Access Theses and Dissertations and grey literature from Google Scholar. The research will consider quantitative and qualitative studies, mixed-method studies, systematic reviews, text articles, opinion articles, letters to editors and editorials in any language and from any database. The following will be eligible for inclusion: (1) newborns, infants, children and adolescents; and (2) non-pharmacological therapies used for pain in paediatric intensive care., Ethics and Dissemination: This study does not require ethical approval. The results of this research will be disseminated through social media channels and podcasts about pain in children., Trial Registration Number: This protocol has been registered with the Open Science Framework (DOI 10.17605/OSF.IO/DZHKT)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Neck pain is a common problem that severely affects physical and mental health. While musculoskeletal manipulations are recommended as the first-line treatment for adults with neck pain, the comparative effectiveness of different musculoskeletal manipulations remains unclear. This systematic review and network meta-analysis of randomised controlled trials (RCTs) will compare the effectiveness of different types of musculoskeletal manipulations, with the overarching aim of guiding clinical practice., Methods and Analysis: Two independent reviewers will search four English electronic databases (Web of Science, Cochrane Library, EMBASE, PubMed) and three Chinese electronic databases (China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang) for relevant RCTs published from 1 January 2013 to 30 April 2023. The Clinical Trials Registry (ClinicalTrials.gov) will be searched for completed but unpublished RCTs. English and Chinese will be used to search English databases and Chinese databases, respectively. RCTs of musculoskeletal manipulations for adults (aged ≥18 years) with neck pain will be considered eligible for inclusion. A pairwise meta-analysis and network meta-analysis will be performed, and pooled risk ratios, standardised mean differences and 95% CIs will be determined., Ethics and Dissemination: Ethics approval is not required as this study is a literature review. The results of this review will be published in peer-reviewed journals or disseminated at conferences., Prospero Registration Number: CRD42023420775., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patient-reported outcomes (PROs) are health reports that come directly from the patients themselves and represented the experience and insights of the patient's perspective on the impact of the intervention. PROs were increasingly emphasised in acupuncture randomised controlled trials (RCTs). However, the reporting quality of PROs in acupuncture RCTs has not been investigated to date. Therefore, we constructed this study to reveal the basic characteristics and reporting quality of PROs in acupuncture RCTs, and explore the relationship between concealment, blinding and RROs. We hope our findings can provide guidance for the reporting standards and future development of PROs in acupuncture RCTs in reverse., Methods and Analysis: RCTs using acupuncture treatment as the intervention and PROs as primary outcomes or secondary outcomes will be systematically searched through seven databases MEDLINE, EMBASE, CENTRAL, CBM, CNKI, Wanfang and VIP between 1 January 2012 and 15 October 2022. The basic characteristics, concealment, blinding design and the characteristics of PROs in included RCTs will be summarised. The reporting quality of PROs will be assessed based on the CONSORT PRO extension. Logistic analysis will be performed to identify the association between concealment, blinding and RROs., Ethics and Dissemination: Ethical approval is not required for this study. This protocol has been registered in Open Science Framework (OSF) Registries. The findings of this study will be submitted to a peer-reviewed academic journal., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study was aimed at assessing the prevalence of herbal drug use among pregnant women with access to modern medicine and associated factors in public health facilities in the west Shewa zone, Oromia regional state, Ethiopia., Design: A sequential mixed-method study approach was carried out among pregnant women and other stakeholders., Setting: This study was conducted at public health facilities, including 3 public hospitals and 20 health centres, in the west Shewa zone of Ethiopia., Participants: A systematically selected sample of 411 pregnant women was participated in the quantitative study. For the qualitative method, focus group discussions and in-depth interviews were conducted among pregnant women attending antenatal care and key informants using an interview guide until data saturation was achieved., Primary Outcome: For outcome variables, the respondents were asked if they used any herbal medicine during their current pregnancy. It was then recorded as 0=no and 1=yes., Results: The prevalence of herbal medicines was found to be 19.7%. The most commonly used herbal medicines were Zingiber officinale , Ocimum gratissimum , Eucalyptus globules , Allium sativum and Rutacha lepensis . Herbal medicine use during pregnancy was significantly associated with older maternal age (adjusted OR (AOR) 2.4, 95% CI 1.2 to 5.1), urban residence (AOR 2.3, 95% CI 1.3 to 3.7) and second trimester of pregnancy (AOR 2.3, 95% CI 1.3 to 4.5)., Conclusions: In this study, one in five pregnant women uses herbal medicine, which is relatively low. Sociodemographic factors and the duration of pregnancy affected the utilisation of herbal drugs during pregnancy. The most common herbals used by pregnant women were intended to treat minor disorders of pregnancy and medical disorders such as hypertension., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)