Adverse events related to electroacupuncture: a systematic review of single case studies and case series

2020 ◽  
Vol 38 (6) ◽  
pp. 407-416 ◽  
Author(s):  
Jeong Hwan Park ◽  
Jun-Hwan Lee ◽  
Sanghun Lee ◽  
Jae-Young Shin ◽  
Tae-Hun Kim
Keyword(s):  
Systematic Review ◽  
Electrical Stimulation ◽  
Clinical Practice ◽  
Adverse Events ◽  
Case Studies ◽  
Single Case ◽  
Skin Pigmentation ◽  
Case Series ◽  
Organ Injury ◽  
Partial Recovery

Objective Electroacupuncture (EA) is used in the treatment of various diseases through the use of electrical stimulation. Reports of adverse events (AEs) associated with acupuncture are relatively consistent, but the safety of EA has been less well reported. In this systematic review, we provide a summary of the types of AEs related to EA in clinical practice. Methods Twelve electronic databases, including those in English (PubMed, Ovid-EMBASE, CENTRAL), Korean (KMbase, KISS, NDSL, KISTI, OASIS), Chinese (CNKI, Wanfang, Weipu) and Japanese (J-STAGE), were systematically searched for single case studies and case series through April 2018. There were no language restrictions. We included clinical studies in which EA was used as a key intervention and in which AEs that may have been causally related to EA were reported. Results Thirty-seven studies, including 27 single case studies and 10 case series, were evaluated. The most frequently reported AEs were pallor (eight cases), skin pigmentation (eight cases), vertigo (seven cases), chest tightness (six cases), vomiting (six cases) and unconsciousness (five cases). Thirty-one cases (62%) achieved full recovery and three cases (6%) achieved partial recovery. There were also three cases of death (6%). Conclusion AEs related to EA included acupuncture-related AEs and serious AEs induced by electrical stimulation. Currently, specific stimulation conditions associated with EA-specific AEs are not identifiable due to inappropriate reporting. However, skin pigmentation, syncope or spasm, implantable cardioverter-defibrillator shock, cardiac emergencies, electrical burns, and potential internal organ injury are potential EA-specific AEs regarding which physicians should be cautious in clinical practice.

scholarly journals Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline

2018 ◽  
Vol 36 (17) ◽  
pp. 1714-1768 ◽  
Author(s):  
Julie R. Brahmer ◽  
Christina Lacchetti ◽  
Bryan J. Schneider ◽  
Michael B. Atkins ◽  
Kelly J. Brassil ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Adverse Events ◽  
Clinical Practice Guideline ◽  
Practice Guideline ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitor ◽  
Checkpoint Inhibitor ◽  
Case Series ◽  
Organ System

Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, trialist, and advocacy was convened to develop the clinical practice guideline. Guideline development involved a systematic review of the literature and an informal consensus process. The systematic review focused on guidelines, systematic reviews and meta-analyses, randomized controlled trials, and case series published from 2000 through 2017. Results The systematic review identified 204 eligible publications. Much of the evidence consisted of systematic reviews of observational data, consensus guidelines, case series, and case reports. Due to the paucity of high-quality evidence on management of immune-related adverse events, recommendations are based on expert consensus. Recommendations Recommendations for specific organ system–based toxicity diagnosis and management are presented. While management varies according to organ system affected, in general, ICPi therapy should be continued with close monitoring for grade 1 toxicities, with the exception of some neurologic, hematologic, and cardiac toxicities. ICPi therapy may be suspended for most grade 2 toxicities, with consideration of resuming when symptoms revert to grade 1 or less. Corticosteroids may be administered. Grade 3 toxicities generally warrant suspension of ICPis and the initiation of high-dose corticosteroids (prednisone 1 to 2 mg/kg/d or methylprednisolone 1 to 2 mg/kg/d). Corticosteroids should be tapered over the course of at least 4 to 6 weeks. Some refractory cases may require infliximab or other immunosuppressive therapy. In general, permanent discontinuation of ICPis is recommended with grade 4 toxicities, with the exception of endocrinopathies that have been controlled by hormone replacement. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

scholarly journals Effectiveness of surgical fixation for lateral compression type one (LC-1) fragility fractures of the pelvis: a systematic review

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e024737
Author(s):  
Alison Booth ◽  
Helen Margaret Ann Ingoe ◽  
Matthew Northgraves ◽  
Elizabeth Coleman ◽  
Melissa Harden ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Case Series ◽  
Fragility Fractures ◽  
Hospital Length Of Stay ◽  
Cochrane Central Register ◽  
Lateral Compression ◽  
Post Surgery ◽  
Surgical Fixation ◽  
And Function

ObjectivesTo undertake a systematic review of the evidence base for the effectiveness of surgical fixation of lateral compression (LC-1) fragility fractures of the pelvis compared with non-surgical approaches.SearchesMEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and two international trials registers were searched up to January 2017 (MEDLINE to February 2019) for studies of internal or external fixation of fragility fractures of the pelvis.ParticipantsPatients with lateral compression pelvic fractures, sustained as the result of a low-energy mechanism, defined as a fall from standing height or less.InterventionsSurgery using either external or internal fixation devices. Conservative non-surgical treatment was the defined comparator.Outcome measuresOutcomes of interest were patient mobility and function, pain, quality of life, fracture union, mortality, hospital length of stay and complications (additional operative procedures, number and type of adverse events and serious adverse events).Quality assessment and synthesisThe Joanna Briggs Institute Checklist for Case Series was used to assess the included studies. Results were presented in a narrative synthesis.ResultsOf 3421 records identified, four retrospective case series met the inclusion criteria. Fixation types were not consistent between studies or within studies and most patients had more than one type of pelvic fixation. Where reported, mobility and function improved post-surgery, and a reduction in pain was recorded. Length of hospital stay ranged from 4 days to 54 days for surgical fixation of any type. Reported complications and adverse outcomes included: infections, implant loosening, pneumonia and thrombosis. Use of analgesia was not reported.ConclusionsThere is insufficient evidence to support guidance on the most effective treatment for patients who fail to mobilise after sustaining an LC-1 fragility fracture.Trial registration numberCRD42017055872.

scholarly journals Category-selective deficits are the exception and not the rule: Evidence from a case-series of 64 patients with ventral occipito-temporal cortex damage

2020 ◽  
Author(s):  
Grace E Rice ◽  
Sheila J Kerry ◽  
Ro Julia Robotham ◽  
Alex Leff ◽  
Matt Lambon Ralph ◽  
...  
Keyword(s):  
Face Recognition ◽  
Case Studies ◽  
Cerebral Artery ◽  
Posterior Cerebral Artery ◽  
Single Case ◽  
Full Range ◽  
Temporal Cortex ◽  
Case Series ◽  
Single Subject ◽  
Stroke Patients

The organisational principles of the visual ventral stream are still highly debated, specifically the relative association/dissociation between word and face recognition. Reports of dissociations between word and face recognition stem from reports of category-selective impairments in single case-studies, and more recently neuroimaging investigations of healthy participants. Despite the historical reliance on single case-studies, more recent group studies have highlighted a greater commonality between word and face recognition. Studying individual patients with rare selective deficits misses (a) important variability between patients, (b) associations between task performance, and (c) patients with mild, severe and/or non-selective impairments; meaning that the full spectrum of deficits is unknown. The Back of the Brain project assessed the range and specificity of visual perceptual impairment in 64 patients with posterior cerebral artery stroke. Patients were recruited based on lesion localization and not behavioral performance. Group-level data-driven and single-subject case-series analyses revealed the full range of visual perceptual deficits. In both analyses, the general organisational principle was of associations between words and faces. Category-selective deficits were the exception and not the rule. This large-scale investigation of posterior cerebral artery stroke patients highlights the bilateral representation of visual perceptual function.

scholarly journals Direct Oral Anticoagulants in Sickle Cell Disease, Where We Stand and Where We Are Heading: A Systematic Review

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4188-4188
Author(s):  
Waail Rozi Kashgary ◽  
Elrazi Awadelkarim Awadelkarim Hamid Ali ◽  
Alaa Rahhal ◽  
Abdulrahman F Al-Mashdali ◽  
Yousef Hailan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Practice ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Observational Studies ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Case Series ◽  
Cell Disease ◽  
Bleeding Events

Abstract Introduction: Sickle Cell Disease (SCD) is a hemolytic disorder with an increased risk of venous thromboembolism (VTE). By the age of 40 years around 11-12% of sickle cell disease patients will have at least one episode of VTE. VTE among patients with SCD is associated with a two to four times increase in mortality compared to SCD patients without VTE. Nevertheless, the evidence guiding VTE management in SCD, specifically in terms of anticoagulant choice, is scarce. Therefore, we conducted a systematic review that evaluates the effectiveness and safety of direct oral anticoagulants (DOACs) in SCD with VTE. Methods: We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched the English literature (PubMed, SCOPUS, and Google Scholar) for randomized controlled trials, observational studies, reviews, case series, and case reports for patients with SCD treated with DOAC for thromboembolic disease. We used the terms in combination: "Sickle cell disease" or "Sickle cell anemia", and "DOAC", "rivaroxaban", "apixaban", "dabigatran" "edoxaban". The search included all articles published up to 20th April 2021. Quality and risk of bias assessment were done by two independent authors for each included study. Results: A total of 7 articles were included; four observational studies, and three case series addressing this matter. Patel A et al. found that the use of DOACs, including rivaroxaban, dabigatran, and apixaban in comparison to vitamin K antagonists (VKAs) and low molecular weight heparin (LMWH) for the treatment of VTE in SCD among adults was associated with similar VTE recurrence rate and a better safety profile in terms of a significant reduction in major bleeding events. Similarly, Roberts MZ et al. reported that the use of DOACs for VTE treatment in SCD compared to VKAs resulted in similar effectiveness in terms of VTE recurrence, but the use of DOACs was associated with a similar safety in comparison to VKAs in contrary to the results reported by Patel A et al. in their retrospective study. With regards to the risk of major hemorrhagic events associated with the use of non-VKAs, Gupta VK et al. showed that among 55 patients with SCD treated with VKAs, DOACs, or injectable anticoagulants, only patients treated with VKAs had major bleeding events. Discussion: The current data demonstrated that the use of DOACs for VTE in SCD has similar effectiveness in the prevention of VTE recurrence in comparison to other anticoagulants, including VKAs and injectable anticoagulants with a better safety profile. However, given the absence of clinical practice guidelines for the treatment of VTE among patients with SCD, the clinical practice guidelines recommendations for VTE treatment can be applied to patients with SCD. According to the latest CHEST guidelines (2016) for the treatment of VTE, the use of DOACs is recommended in patients with VTE over VKAs. Similarly, the latest American Society of Hematology (2020) guidelines for VTE suggest the use of DOACs over VKAs, except among patients with renal insufficiency (creatinine clearance less than 30 mL/min), moderate to severe liver disease, or those with antiphospholipid syndrome. Conclusion: In view of the current evidence and based on the results observed; using DOACs was associated with lesser bleeding incidence and fewer complications comparing to VKAs. We think it is rational to use DOACs for VTE treatment among patients with SCD rather than use VKAs. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

scholarly journals Efficacy and harms of remdesivir for the treatment of COVID-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Alejandro Piscoya ◽  
Luis Fernando Ng-Sueng ◽  
Angela Parra del Riego ◽  
Renato Cerna-Viacava ◽  
Vinay Pasupuleti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Meta Analysis ◽  
Case Series ◽  
Length Of Hospital Stay ◽  
Invasive Ventilation ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Meta Analyses

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.

scholarly journals Is adjunctive perampanel beneficial for lafora disease?

2020 ◽  
Vol 77 (5) ◽  
pp. 539-544
Author(s):  
Galina Stevanovic ◽  
Nebojsa Jovic ◽  
Miljana Kecmanovic
Keyword(s):  
Case Studies ◽  
Functional Disability ◽  
Single Case ◽  
Case Series ◽  
Lafora Disease ◽  
Open Label ◽  
Progressive Myoclonus Epilepsy ◽  
Case Series Study ◽  
Myoclonus Epilepsy ◽  
Psychiatric Side Effects

Backgrund/Aim. Lafora disease (LD) is progressive myoclonus epilepsy, characterized by intractable myoclonus and seizures, inevitable neurological deterioration, brutal cognitive decline and poor prognosis. The treatment still remains purely symptomatic. Recently, two single-case studies and one case series study reported the favourable effects of perampanel in LD. Our study aimed to test the benefits reported in three separate case studies. Methods. We performed an open label, prospective study of 4 patients aged between 22 and 34 years with mutation in NHLRC1 (EPM2B) gene, treated with perampanel (6?8 mg/day) as add-on therapy. Follow-up period comprised 14?26 months. Seizure frequency, myoclonus, functional disability and cognitive performance were analysed. Results. In 3 patients, both, seizures and myoclonus, showed remarkable improvement after the drug introduction (> 50% reduction). No significant effect was seen in one case. The functional and cognitive impairment maintained at the same level, though all patients were at the later stage of the disease. Psychiatric side effects were dose related. Conclusion. Our study supports the rare, previously reported observations that perampanel is beneficial in treating LD patients.

scholarly journals Repurposing of drugs for Covid-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Pinky Kotecha ◽  
Alexander Light ◽  
Enrico Checcucci ◽  
Daniele Amparore ◽  
Cristian Fiori ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Cochrane Library ◽  
Control Group ◽  
Significant Difference

AbstractObjectiveThe aim of this systematic review is to evaluate the data currently available regarding the repurposing of different drugs for Covid-19 treatment. Participants with suspected or diagnosed Covid-19 will be included. The interventions being considered are drugs being repurposed, and comparators will include standard of care treatment or placebo.MethodsWe searched Ovid-MEDLINE, EMBASE, Cochrane library, clinical trial registration site in the UK(NIHR), Europe (clinicaltrialsregister.eu), US (ClinicalTrials.gov) and internationally (isrctn.com), and reviewed the reference lists of articles for eligible articles published up to April 22, 2020. All studies in English that evaluated the efficacy of the listed drugs were included. Cochrane RoB 2.0 and ROBINS-I tool were used to assess study quality. This systematic review adheres to the PRISMA guidelines. The protocol is available at PROSPERO (CRD42020180915).ResultsFrom 708 identified studies or clinical trials, 16 studies and 16 case reports met our eligibility criteria. Of these, 6 were randomized controlled trials (763 patients), 7 cohort studies (321 patients) and 3 case series (191 patients). Chloroquine (CQ) had a 100% discharge rate compared to 50% with lopinavir-ritonavir at day 14, however a trial has recommended against a high dosage due to cardiotoxic events. Hydroxychloroquine (HCQ) has shown no significant improvement in negative seroconversion rate which is also seen in our meta-analysis (p=0.68). Adverse events with HCQ have a significant difference compared to the control group (p=0.001). Lopinavir-ritonavir has shown no improvement in time to clinical improvement which is seen in our meta-analyses (p=0.1). Remdesivir has shown no significant improvement in time to clinical improvement but this trial had insufficient power.DiscussionDue to the paucity in evidence, it is difficult to establish the efficacy of these drugs in the treatment of Covid-19 as currently there is no significant clinical effectiveness of the repurposed drugs. Further large clinical trials are required to achieve more reliable findings. A risk-benefit analysis is required on an individual basis to weigh out the potential improvement in clinical outcome and viral load reduction compared to the risks of the adverse events. (1-16)

Bed rest: outdated following traumatic solid organ injury?

2020 ◽  
pp. bmjmilitary-2019-001374
Author(s):  
James Ashcroft ◽  
M Khan
Keyword(s):  
Systematic Review ◽  
Case Series ◽  
Bed Rest ◽  
Healthcare Services ◽  
Organ Injury ◽  
Cochrane Library ◽  
Low Grade ◽  
Solid Organ ◽  
Solid Organ Injury ◽  
Early Ambulation

IntroductionThis systematic review aimed to evaluate early ambulation protocols implemented for traumatic solid organ injury.MethodsThe electronic databases PubMed, Medline (Ovid), Embase and Cochrane Library were searched without time constraint to identify prospective and retrospective analyses, randomised controlled trials, cohort studies, and case series that investigated early ambulation in solid organ trauma.ResultsSix studies met the predefined inclusion criteria and were reviewed. Three studies investigated early ambulation protocols in direct comparison with bed rest. The remaining three studies were early ambulation case series. In all studies there was no convincing evidence to suggest differences in clinical outcomes between early ambulation and bed rest protocols. In all studies early ambulation resulted in a reduced length of hospitalisation and decreased cost to national healthcare services.ConclusionsThis systematic review has found preliminary evidence that suggests bed rest has no clinical benefit in those with low-grade to mid-grade (grades 1–2) solid organ injury. Further studies are required to inform guidance to improve trauma patient outcomes.

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