scholarly journals Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e045961
Author(s):  
Petra Bäumler ◽  
Wenyue Zhang ◽  
Theresa Stübinger ◽  
Dominik Irnich

ObjectiveOverview on risks of acupuncture-related adverse events (AEs).DesignSystematic review and meta-analyses of prospective studies.Data sourcesPubMed, Scopus and Embase from inception date to 15 September 2019.Eligibility criteria for selecting studiesProspective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German.Data extraction and synthesisTwo independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses.Main outcomesOverall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments.ResultsA total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I2 >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely.ConclusionAcupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs.PROSPERO registration numberCRD42020151930.

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e026037 ◽  
Author(s):  
Gillian Sandra Gould ◽  
Laura Twyman ◽  
Leah Stevenson ◽  
Gabrielle R Gribbin ◽  
Billie Bonevski ◽  
...  

BackgroundPregnancy is an opportunity for health providers to support women to stop smoking.ObjectivesIdentify the pooled prevalence for health providers in providing components of smoking cessation care to women who smoke during pregnancy.DesignA systematic review synthesising original articles that reported on (1) prevalence of health providers’ performing the 5As (‘Ask’, ‘Advise’, ‘Assess’, ‘Assist’, ‘Arrange’), prescribing nicotine replacement therapy (NRT) and (2) factors associated with smoking cessation care.Data sourcesMEDLINE, EMBASE, CINAHL and PsycINFO databases searched using ‘smoking’, ‘pregnancy’ and ‘health provider practices’.Eligibility criteria for selecting studiesStudies included any design except interventions (self-report, audit, observed consultations and women’s reports), in English, with no date restriction, up to June 2017.ParticipantsHealth providers of any profession.Data extraction, appraisal and analysisData were extracted, then appraised with the Hawker tool. Meta-analyses pooled percentages for performing each of the 5As and prescribing NRT, using, for example, ‘often/always’ and ‘always/all’. Meta-regressions were performed of 5As for ‘often/always’.ResultsOf 3933 papers, 54 were included (n=29 225 participants): 33 for meta-analysis. Health providers included general practitioners, obstetricians, midwives and others from 10 countries. Pooled percentages of studies reporting practices ‘often/always’ were: ‘Ask’ (n=9) 91.6% (95% CI 88.2% to 95%); ‘Advise’ (n=7) 90% (95% CI 72.5% to 99.3%), ‘Assess’ (n=3) 79.2% (95% CI 76.5% to 81.8%), ‘Assist (cessation support)’ (n=5) 59.1% (95% CI 56% to 62.2%), ‘Arrange (referral)’ (n=6) 33.3% (95% CI 20.4% to 46.2%) and ‘prescribing NRT’ (n=6) 25.4% (95% CI 12.8% to 38%). Heterogeneity (I2) was 95.9%–99.1%. Meta-regressions for ‘Arrange’ were significant for year (p=0.013) and country (p=0.037).ConclusionsHealth providers ‘Ask’, ‘Advise’ and ‘Assess’ most pregnant women about smoking. ‘Assist’, ‘Arrange’ and ‘prescribing NRT’ are reported at lower rates: strategies to improve these should be considered.PROSPERO registration numberCRD42015029989.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017868
Author(s):  
Joey S.W. Kwong ◽  
Sheyu Li ◽  
Wan-Jie Gu ◽  
Hao Chen ◽  
Chao Zhang ◽  
...  

IntroductionEffective selection of coronary lesions for revascularisation is pivotal in the management of symptoms and adverse outcomes in patients with coronary artery disease. Recently, instantaneous ‘wave-free’ ratio (iFR) has been proposed as a new diagnostic index for assessing the severity of coronary stenoses without the need of pharmacological vasodilation. Evidence of the effectiveness of iFR-guided revascularisation is emerging and a systematic review is warranted.Methods and analysisThis is a protocol for a systematic review of randomised controlled trials and controlled observational studies. Electronic sources including MEDLINE via Ovid, Embase, Cochrane databases and ClinicalTrials.gov will be searched for potentially eligible studies investigating the effects of iFR-guided strategy in patients undergoing coronary revascularisation. Studies will be selected against transparent eligibility criteria and data will be extracted using a prestandardised data collection form by two independent authors. Risk of bias in included studies and overall quality of evidence will be assessed using validated methodological tools. Meta-analysis will be performed using the Review Manager software. Our systematic review will be performed according to the guidance from the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.Ethics and disseminationEthics approval is not required. Results of the systematic review will be disseminated as conference proceedings and peer-reviewed journal publication.Trial registration numberThis protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO), registration number CRD42017065460.


Author(s):  
Alejandro Piscoya ◽  
Luis Fernando Ng-Sueng ◽  
Angela Parra del Riego ◽  
Renato Cerna-Viacava ◽  
Vinay Pasupuleti ◽  
...  

AbstractBackgroundWe evaluated the efficacy and safety of remdesivir for the treatment of COVID-19.MethodsSystematic review in five engines, pre-print webpages and RCT registries until May 22, 2020 for randomized controlled trials (RCTs) and observational studies evaluating remdesivir on confirmed, COVID-19 adults with pneumonia and/or respiratory insufficiency. Primary outcomes were all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAE). Secondary outcomes included length of hospital stay, progression of pneumonia, and adverse events (AE). Inverse variance random effects meta-analyses were performed.ResultsTwo placebo-controlled RCTs (n=1300) and two case series (n=88) were included. All studies used remdesivir 200mg IV the first day and 100mg IV for 9 more days, and followed up until 28 days. Wang et al. RCT was stopped early due to AEs; ACTT-1 was preliminary reported at 15-day follow up. Time to clinical improvement was not decreased in Wang et al. RCT, but median time to recovery was decreased by 4 days in ACTT-1. Remdesivir did not decrease all-cause mortality (RR 0.71, 95%CI 0.39 to 1.28) and need for invasive ventilation at 14 days (RR 0.57, 95%CI 0.23 to 1.42), but had fewer SAEs (RR 0.77, 95%CI 0.63 to 0.94). AEs were similar between remdesivir and placebo arms. Risk of bias ranged from some concerns to high risk in RCTs.InterpretationThere is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in adult, hospitalized COVID-19 patients. Remdesivir should not be recommended for the treatment of severe COVID-19.


2021 ◽  
Vol 7 (3) ◽  
pp. e001144
Author(s):  
Zackary William Nichols ◽  
Daniel O'Brien ◽  
Steven Gordon White

ObjectiveTo identify, critique and synthesise the research findings that evaluate the use of resistance training (RT) programmes on return to sport outcome measures for people following ACL repair (ACLR).Design and data sourcesThis systematic review included a comprehensive search of electronic databases (EBSCO health databases (CINAHL, MEDLINE, SPORTDiscus), Scopus and Pedro) performed in June 2020 and was guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Studies were appraised using the Downs and Black checklist.Eligibility criteriaRandomised and non-randomised controlled trials, longitudinal cohort studies and case series were considered for inclusion where an adequate description of the RT intervention was provided as a part of the study’s ACLR rehabilitation protocol. Articles that did not include outcome measures related to return to sport criteria were excluded.ResultsEleven articles met the inclusion criteria and were subjected to appraisal and data extraction. Study quality ranged from poor to excellent. RT intensity varied considerably among studies (between 5% and >80% of one repetition maximum). Only one identified study specifically investigated the effect of a low-intensity versus high-intensity RT protocol. The majority of studies reported participant outcomes that would not meet commonly used return to sport criteria.ConclusionThere appears to be considerable variation in the intensity of RT prescribed in research for people following ACLR. Furthermore, in most of the identified studies, RT protocols promoted muscle endurance and hypertrophy without progressing to strength or power-based RT. The findings of this review provide insight into potential factors limiting returning to sport and contributing to reinjury for people following ACLR.


2020 ◽  
Vol 12 (6) ◽  
pp. 521-527
Author(s):  
Timothy R. Jelsema ◽  
Anthony C. Tam ◽  
James L. Moeller

Context: The use of injectable medications to help athletes quickly return to the field of play after injury is common. Understanding the effects and risks of these medications will help providers make informed decisions regarding their use in this patient population. Objective: To evaluate the utilization, efficacy, and adverse effects of injectable ketorolac and corticosteroids in athletes. Data Sources: This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A systematic search of the literature was performed using multiple databases (PubMed, Embase, Cochrane, Web of Science, and ClinicalTrials.gov). Secondary references were appraised for relevant articles. No randomized controlled trials or other prospective studies were identified. Articles included retrospective database reviews and physician survey studies. Study Selection: A total of 6 studies met the inclusion and exclusion criteria and were reviewed by 2 independent reviewers with a third consulted in the case of disagreement, which was not needed. Study Design: Systematic review. Level of Evidence: Level 5. Data Extraction: Two reviewers recorded rate of use, effectiveness of treatment, and reported side effect data. Results: Most studies centered around the football athlete, either professional or collegiate. Professional football game day use of intramuscular ketorolac declined from 93.3% (28/30) in 2002 to 48% in 2016. Collegiate football game day use of intramuscular ketorolac declined from 62% in 2008 to 26% in 2016. Game day corticosteroid injection was far lower than ketorolac usage. Both medications were reported to be effective with few adverse events. Conclusion: Use of injectable ketorolac is common but declining in professional and college football. Pain control efficacy is good, and risk of adverse events is low. The incidence of injectable corticosteroid use in athletes is unknown. Use of injectable corticosteroids in athletes allows for early return to sport activities with no reported complications.


BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e015411 ◽  
Author(s):  
Abigail Hucker ◽  
Frances Bunn ◽  
Lewis Carpenter ◽  
Christopher Lawrence ◽  
Ken Farrington ◽  
...  

IntroductionAdherence to immunosuppressant medication is essential for renal transplant recipients. This review aims to summarise what is known about non-adherence, with a view to providing comprehensive evidence to inform strategies aimed at advancing adherent behaviour.Methods and analysisA systematic review of quantitative studies that report adherence to immunosuppressants in adult (over 18 years) renal transplant recipients. The review will follow the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines; study quality will be assessed using the Downs and Black checklist. Systematic searches will be completed across relevant databases. Two reviewers will independently extract data using a predefined data extraction form. We will summarise the operationalisation of adherence across studies and use narrative synthesis to identify factors associated with non-adherence. A meta-analysis will be conducted if there is sufficient homogeneity, and available data, across studies to estimate the prevalence of non-adherence in renal transplant recipients. Heterogeneity will be assessed using the I2test. Survival analysis will be conducted to estimate hazard ratios to explore the impact of non-adherence on graft survival, graft failure and patient survival.Ethics and disseminationFindings will be published in a peer-reviewed journal and disseminated at conferences for professionals and researchers. Review outcomes will help support clinical practice by highlighting the extent of non-adherence among adults, and in doing so, signpost the need for suitable intervention.Trial registration numberPROSPERO registration number (CRD42016038751).


Author(s):  
Prateek Kumar Panda ◽  
Indar Kumar Sharawat ◽  
Lesa Dawman ◽  
Pragnya Panda ◽  
Ananthanarayanan Kasinathan ◽  
...  

Abstract Purpose Lennox–Gastaut syndrome (LGS) is one of the most difficult to treat childhood-onset epileptic encephalopathies. There is growing evidence that lacosamide is safe and efficacious in patients and adults with refractory epilepsy. However, the evidence regarding the efficacy of lacosamide in LGS is controversial so far. We aimed to evaluate the efficacy and tolerability of lacosamide in patients with LGS. Methods We conducted a systematic review on MEDLINE, EMBASE, COCHRANE CENTRAL, Google Scholar, and Web of Science, collating all available literature till July 31, 2020. The qualitative review included case reports, case series, and both controlled/uncontrolled trials as well as retrospective studies, but for determining pooled estimates, we only included studies with a sample size of 5 or more. The primary outcome was the efficacy of lacosamide in patients with LGS. Clinical variables related to efficacy and adverse events attributed to lacosamide were extracted from each publication. The pooled estimate of variables related to these parameters was performed using a random-effect model. Results Of the 68 items identified by the search, 14 were reviewed as full-text. Eleven articles including two prospective and six retrospective studies fulfilled eligibility criteria and described outcomes in 81 patients (42 adults, 39 children, 60% male, range—1.4–61 years). On average, 35.2%, 27.9%, 7.3%, and 29.4% patients had > 50% reduction, < 50% reduction, no change, and worsening of seizure frequency, respectively. Although 36% of patients had adverse events like somnolence, behavioral abnormalities including irritability, aggressiveness, nausea, tremor, memory problems, dizziness, gastrointestinal discomfort, vomiting, and weight loss, no serious adverse events were noted. Conclusion The evidence available in the current literature is not sufficient to support or refute the use of lacosamide in patients with LGS. Although it is one of the possible therapeutic options worth exploring in patients with LGS, caution is still necessary, as there are reports of worsening of seizure frequency in some patients.


BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031193 ◽  
Author(s):  
Eric Jauniaux ◽  
Lene Grønbeck ◽  
Catey Bunce ◽  
Jens Langhoff-Roos ◽  
Sally L Collins

ObjectiveTo estimate the prevalence and incidence of placenta previa complicated by placenta accreta spectrum (PAS) and to examine the different criteria being used for the diagnosis.DesignSystematic review and meta-analysis.Data sourcesPubMed, Google Scholar, ClinicalTrials.gov and MEDLINE were searched between August 1982 and September 2018.Eligibility criteriaStudies reporting on placenta previa complicated by PAS diagnosed in a defined obstetric population.Data extraction and synthesisTwo independent reviewers performed the data extraction using a predefined protocol and assessed the risk of bias using the Newcastle-Ottawa scale for observational studies, with difference agreed by consensus. The primary outcomes were overall prevalence of placenta previa, incidence of PAS according to the type of placenta previa and the reported clinical outcomes, including the number of peripartum hysterectomies and direct maternal mortality. The secondary outcomes included the criteria used for the prenatal ultrasound diagnosis of placenta previa and the criteria used to diagnose and grade PAS at birth.ResultsA total of 258 articles were reviewed and 13 retrospective and 7 prospective studies were included in the analysis, which reported on 587 women with placenta previa and PAS. The meta-analysis indicated a significant (p<0.001) heterogeneity between study estimates for the prevalence of placenta previa, the prevalence of placenta previa with PAS and the incidence of PAS in the placenta previa cohort. The median prevalence of placenta previa was 0.56% (IQR 0.39–1.24) whereas the median prevalence of placenta previa with PAS was 0.07% (IQR 0.05–0.16). The incidence of PAS in women with a placenta previa was 11.10% (IQR 7.65–17.35).ConclusionsThe high heterogeneity in qualitative and diagnostic data between studies emphasises the need to implement standardised protocols for the diagnoses of both placenta previa and PAS, including the type of placenta previa and grade of villous invasiveness.PROSPERO registration numberCRD42017068589


BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024562 ◽  
Author(s):  
Marija Barbateskovic ◽  
Sara Russo Krauss ◽  
Marie Oxenboell Collet ◽  
Laura Krone Larsen ◽  
Janus Christian Jakobsen ◽  
...  

ObjectivesWe assessed the evidence from reviews and meta-analyses of randomised clinical trials on the effects of pharmacological prevention and management of delirium in intensive care unit (ICU) patients.MethodsWe searched for reviews in July 2017 in: Cochrane Library, MEDLINE, Embase, Science Citation Index, BIOSIS Previews, CINAHL and LILACS. We assessed whether reviews were systematic according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and assessed the methodological quality using ROBIS.Outcome measuresPrimary outcomes: all-cause mortality, serious adverse events, prevention of delirium and management of delirium. Secondary outcomes: quality of life; non-serious adverse events and cognitive function.ResultsWe included 378 reviews: 369 narrative reviews, eight semisystematic reviews which failed on a maximum of two arbitrary PRISMA criteria and one systematic review fulfilling all 27 PRISMA criteria. For the prevention of delirium, we identified the one systematic review and eight semisystematic reviews all assessing the effects of alpha-2-agonists. None found evidence of a reduction of mortality (systematic review RR 0.99, 95% CI 0.79 to 1.24). The systematic review and three semisystematic reviews found no evidence of an effect for the prevention of delirium (systematic review RR 0.85, 0.63 to 1.14). Conversely, four semisystematic reviews found a beneficial effect. Serious adverse events, quality of life, non-serious adverse events and cognitive function were not assessed. We did not identify any systematic or semisystematic reviews addressing other pharmacological interventions for the prevention of delirium. For the management of manifest delirium, we did not identify any systematic or semisystematic review assessing any pharmacological agents.ConclusionBased on systematic reviews, the evidence for the use of pharmacological interventions for prevention or management of delirium is poor or sparse. A systematic review with low risk of bias assessing the effects of pharmacological prevention of delirium and management of manifest delirium in ICU patients is urgently needed.PROSPERO registration numberCRD42016046628.


Author(s):  
Alejandro Prieto-Ayuso ◽  
Juan Carlos Pastor-Vicedo ◽  
Sixto González-Víllora ◽  
Javier Fernández-Río

Objectives: The goal of this study was to shed light on the existent knowledge, internationally published over the last decade (2009–2019), on how to deal with talented children in physical education (PE). Methods: A mixed systematic review (SR) was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and registered in the International Prospective Register of Systematic Reviews (PROSPERO), registration number: CRD42019117211. Study eligibility criteria: The articles included were selected using the following criteria: (a) studies published in peer-reviewed international journals; (b) studies published from 2009 to 2019 (both inclusive); (c) studies that included quantitative and/or qualitative methods and findings; (d) research conducted within school contexts; (e) articles that focused on both talent/gift and PE, and (f) studies published in English or Spanish. Results: A total of 11 articles were identified. Results showed a gradual change in both methods and instruments used for talent identification (TI) in PE, focused currently on children’s health and involvement in sports. Second, there is consensus on the lack of clarity in schools’ policies and guidelines on how to deal with talented children in PE. Conclusions: Finally, there are alternative programs to elite athlete models that better fit in PE to deal with talented children and to avoid child disengagement in PE and sports.


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