Traction Therapy for Cervical Radicular Syndrome is Statistically Significant but not Clinically Relevant for Pain Relief. A Systematic Literature Review with Meta-Analysis and Trial Sequential Analysis

Aim: We aimed to investigate the effectiveness of traction therapy in reducing pain by performing a systematic review with meta-analysis. We also explore the best modality for administering traction to patients with cervical radicular syndrome (CRS). Methods: We searched the Medline, Physiotherapy Evidence Database (PEDro), Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) electronic databases. Two reviewers independently selected randomized controlled trials (RCTs) that compared traction in addition to other treatments versus the effectiveness of other treatments alone for pain outcome. We calculated the mean differences (MDs) and 95% confidence intervals (CIs). We used Cochrane’s tool to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to evaluate the quality of evidence and summarize the study conclusions. Results: A total of seven studies (589 patients), one with low risk of bias, were evaluated. An overall estimate of treatment modalities showed low evidence that adding traction to other treatments is statistically significant (MD −5.93 [95% CI, −11.81 to −0.04] P = 0.05 and I2 = 57%) compared to other treatments alone. The subgroup analyses were still statistically significant only for mechanical and continuous modalities. Conclusions: Overall analysis showed that, compared to controls, reduction in pain intensity after traction therapy was achieved in patients with cervical radiculopathy. However, the quality of evidence was generally low and none of these effects were clinically meaningful.

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Ursodeoxycholic Acid: Efficacy and Safety in the Treatment of Nonalcoholic Fatty Liver Disease (Meta-Analysis)

Annals of the Russian academy of medical sciences ◽

10.15690/vramn975 ◽

2018 ◽

Vol 73 (5) ◽

pp. 294-305 ◽

Cited By ~ 1

Author(s):

Сhavdar S. Pavlov ◽

Daria L. Varganova ◽

Marianna C. Semenistaia ◽

Ekatherina A. Kuznetsova ◽

Anna A. Usanova ◽

...

Keyword(s):

Liver Disease ◽

Adverse Events ◽

Ursodeoxycholic Acid ◽

Sequential Analysis ◽

Meta Analysis ◽

Risk Of Bias ◽

Trial Sequential Analysis ◽

Quality Of Evidence ◽

Bias Risk

Вackground: Non-alcoholic liver disease (NAFLD) is a widely spread disease that needs an effective and safe treatment strategy. One of pharmacological treatments for people with NAFLD is ursodeoxycholic acid (UDCA). The use of UDCA is pathogenetically justified because of its cytoprotective, antiapoptotic, antioxidant, and hypoglycemic properties. Aim: Our meta-analysis (M-A) aimed to assess the benefits and harms of UDCA in people with NAFLD. Material and methods: We identified trials through electronic searches in the Cochrane Hepato-Biliary (CHB) Controlled Trials Register, CENTRAL, MEDLINE, Embase, SCI, LILACS, eLibrary (May 2018). We considered for inclusion randomised clinical trials (RCTs) assessing URSO versus placebo/no intervention in adult participants with NAFLD. We allowed co-interventions in the trial groups if they were similar. We followed Cochrane methodology, CHB Group methodology using Review Manager 5 and Trial Sequential Analysis to perform meta-analysis (M-A), assessed bias risk of the trials, quality of evidence using GRADE. Results: Four RCT, at high bias risk, low quality of evidence, provided data for analysis: 254 participants at different stages of NAFLD received oral UDCA (median of 18 months), 256 ― placebo/no intervention; age 18 to 75 years. We found no evidence of effect on mortality (there were no deaths) and on histological parameters such as steatosis (MD -0.13; CI -0.40−0.13; participants 323; trials 3; I2=43%), fibrosis (MD 0.00; CI -0.00−0.22; participants 323; trials 3; I2=0%), and inflammation (MD -0.05; CI -0.20−0.10; participants 325; trials 3; I2=0%). Also we found no evidence for significant influence of UDCA on occurrence of serious adverse events (RR 1.45, 95% CI 0.65−3.21; participants 292; trials 2; I2=0%), adverse events (RR 1.52, 95% CI 0.73−3.16; participants 510; trials 4; I2=36%) neither with traditional M-A (random-effects), nor with TSA SAE (CI 0.56−2.91; participants 292; trials 2; I2=0%, D2=0%), AE (CI 0.77–2.21; participants 510; trials 4; I2=0%, D2=0%). There was no evidence of effect on cytolysis, but beneficial effect of UDCA on cholestasis (GGTP) (data from two trials only) (р0.0001). We found no data on quality of life. All the trials were funded by the industry. Conclusion: Based on the small number of trials at high risk of bias, low quality, despite the safety profile observed with our M-A, we can neither recommend nor reject the use of UDCA for people with NAFLD. Further trials with low risk of bias and high quality are required to assess the benefits and harms of UDCA.

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Acupuncture for breathlessness in advanced cancer: a protocol for systematic review and meta-analysis with trial sequential analysis

BMJ Open ◽

10.1136/bmjopen-2021-054917 ◽

2021 ◽

Vol 11 (11) ◽

pp. e054917

Author(s):

Zihan Yin ◽

Tao Xu ◽

Mingsheng Sun ◽

Ling Zhao ◽

Fanrong Liang

Keyword(s):

Systematic Review ◽

Advanced Cancer ◽

Sequential Analysis ◽

Meta Analysis ◽

Biomedical Literature ◽

Cochrane Library ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Cochrane Central Register

IntroductionBreathlessness in advanced cancer, a frequent multicomponent and debilitating disorder, severely reduces function and quality of patients’ life. Multiple studies have shown that non-pharmacological therapies can effectively palliate breathlessness in advanced cancer. However, no systematic review has investigated the application of acupuncture, as a non-pharmacological treatment, for breathlessness in advanced cancer. A systematic review will be conducted to summarise evidence supporting the efficacy and safety of acupuncture as a therapeutic option for breathlessness in advanced cancer based on existing randomised controlled trials (RCTs).MethodsRCTs will be retrieved from nine scientific databases, including the MEDLINE via PubMed, Web of Science via the Web of Knowledge, Embase via Ovid, the Cochrane Central Register of Controlled Trials via the Cochrane Library, and Allied and Complementary Medicine Database via EBSCO, China National Knowledge Infrastructure, Wanfang Database, VIP Database, Chinese Biomedical Literature Database; three clinical registry platforms, including the WHO International Clinical Trials Registry Platform, NIH Clinical trials.gov and Chinese Clinical Trial Registry, as well as from other sources. Studies published since inception of these databases to 1 August 2021 will be retrieved. Search terms will include breathlessness, cancer, acupuncture and RCT. Two investigators will independently select and extract data from RCTs and assess the risk of bias. The primary outcome, which is alleviation of breathlessness, will be assessed. Meta-analysis will be performed using RevMan V.5.4 and STATA V.15.0. The TSA 0.9.5.10 β software will be used to conduct trial sequential analysis. Finally, the quality of evidence from RCTs will be assessed using the Grading of Recommendations Assessment, Development and Evaluation System tool.Ethics and disseminationResults will be disseminated through peer-reviewed journals or conference reports. Since this study involves acquisition of secondary data, ethical approval requirements will be waived.PROSPERO registration numberCRD42021240085.

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Efficacy and Safety of Bilastine in the Treatment of Allergic Rhinitis: A Systematic Review and Meta-analysis

Frontiers in Pharmacology ◽

10.3389/fphar.2021.731201 ◽

2022 ◽

Vol 12 ◽

Author(s):

Aranjit Singh Randhawa ◽

Norhayati Mohd Noor ◽

Mohd Khairi Md Daud ◽

Baharudin Abdullah

Keyword(s):

Allergic Rhinitis ◽

Symptom Score ◽

Meta Analysis ◽

Nasal Symptom ◽

Comparable Efficacy ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

Quality Of Evidence

Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.

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Relationship between hormonal contraceptives and sleep among women of reproductive age: a systematic review protocol

BMJ Open ◽

10.1136/bmjopen-2020-045819 ◽

2021 ◽

Vol 11 (10) ◽

pp. e045819

Author(s):

Jinhui Ma ◽

Megan Cheng ◽

Lehana Thabane ◽

Caihong Ma ◽

Ning Zhang ◽

...

Keyword(s):

Systematic Review ◽

Meta Analysis ◽

Research Question ◽

Risk Of Bias ◽

Reproductive Age ◽

Hormonal Contraceptives ◽

Controlled Trials ◽

Cochrane Central Register ◽

Women Of Reproductive Age

IntroductionThe aetiology of sleep disruptions is unknown, but hormonal fluctuations during the menstrual cycle, pregnancy and menopause have been shown to potentially affect how well a woman sleeps. The aim of this systematic review was to investigate whether hormonal contraceptives are associated with a decreased quality of sleep and increased sleep duration in women of reproductive age.MethodsThis review will analyse data from randomised controlled trials or non-randomised comparative studies investigating the association between hormonal contraceptives and sleep outcomes among women of reproductive age. Reviews addressing the same research question with similar eligibility criteria will be included. A literature search will be performed using the MEDLINE, Embase and Cochrane Central Register of Controlled Trials databases from inception to 7 March 2021. The Cochrane Collaboration’s Risk of Bias for Randomised Trials V.2.0 and The Risk of Bias for Non-randomised Studies of Interventions tool will be used to assess risk of bias for each outcome in eligible studies. Two reviewers will independently assess eligibility of studies and risk of bias and extract the data. All extracted data will be presented in tables and narrative form. For sleep measures investigated by two or more studies with low heterogeneity, we will conduct random-effects meta-analysis to estimate the magnitude of the overall effect of hormonal contraceptives. If studies included in this systematic review form a connected network, a network meta-analysis will be conducted to estimate the comparative effect of different contraceptives. The Grading of Recommendations, Assessment, Development, and Evaluation approach will be used to summarise the quality of evidence. Our protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols 2015 guidelines.Ethics and disseminationEthics approval is not required as data were sourced from previously reported studies. The findings of this review will be published in a peer-reviewed journal and presented at relevant conferences.PROSPERO registration numberCRD42020199958.

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The Effects of Ascorbic Acid Over Sepsis: Meta-analysis With Trial Sequential Analysis

10.21203/rs.3.rs-95522/v1 ◽

2020 ◽

Author(s):

Ying Wang ◽

Hui-chang Zhuo ◽

Jiandong Lin

Keyword(s):

Odds Ratio ◽

Sequential Analysis ◽

Meta Analysis ◽

Trial Sequential Analysis ◽

Random Errors ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Registration Number ◽

Summary Odds Ratio

Abstract Background: This meta-analysis is performed to evaluate the effects of AA on the mortality over sepsis patients, focusing on the courses and initiation of treatment as well as AA doses.Methods: Randomized controlled trials concerning sepsis patients treated with intravenous AA were included when searching the database. The meta-analysis was performed using the random (M-H heterogeneity) model to produce summary odds ratio with 95% CI. Trial sequential analysis was applied to evaluated the effect of random errors.Results: The included 12 trials enrolled a total of 1232 patients. Intravenously administration of AA could not lower 28-day mortality over sepsis patients (OR = 0.81; 95% CI (0.54-1.23); p = 0.326). Subgroup analysis demonstrated that when administrating AA alone, in a dose ≥ 10 g/d, or within 6 h of admission, the result may turn to positive (OR = 0.36; 95% CI (0.15-0.86); p = 0.020, OR = 0.50; 95% CI (0.27-0.92); p = 0.025, OR = 0.49; 95% CI (0.27-0.89); p = 0.019, relatively). The quality of evidence is moderate.Conclusion: IV AA may have no effects to lower mortality over sepsis patients. However, when administrating AA alone, in a dose ≥ 10 g/d, or within 6 h of admission, the result may turn to positive. Due to a moderate GRADE certainty of evidence, further studies are required to fully elaborate the effectiveness of AA during the management of the sepsis patients.PROSPERO registration number: CRD 42020170825. 24 Feb, 2020 retrospectively registered.

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Ivabradine added to usual care in patients with heart failure: a systematic review with meta-analysis and trial sequential analysis

BMJ evidence-based medicine ◽

10.1136/bmjebm-2021-111724 ◽

2021 ◽

pp. bmjebm-2021-111724

Author(s):

Mathias Maagaard ◽

Emil Eik Nielsen ◽

Naqash Javaid Sethi ◽

Ning Liang ◽

Si-Hong Yang ◽

...

Keyword(s):

Heart Failure ◽

Adverse Events ◽

Usual Care ◽

Sequential Analysis ◽

Meta Analysis ◽

Risk Of Bias ◽

Trial Sequential Analysis ◽

Serious Adverse Events ◽

All Cause Mortality

ObjectivesTo assess the beneficial and harmful effects of adding ivabradine to usual care in participants with heart failure.DesignA systematic review with meta-analysis and trial sequential analysis.Eligibility criteriaRandomised clinical trials comparing ivabradine and usual care with usual care (with or without) placebo in participants with heart failure.Information sourcesMedline, Embase, CENTRAL, LILACS, CNKI, VIP and other databases and trial registries up until 31 May 2021.Data extractionPrimary outcomes were all-cause mortality, serious adverse events and quality of life. Secondary outcomes were cardiovascular mortality, myocardial infarction and non-serious adverse events. We performed meta-analysis of all outcomes. We used trial sequential analysis to control risks of random errors, the Cochrane risk of bias tool to assess the risks of systematic errors and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to assess the certainty of the evidence.ResultsWe included 109 randomised clinical trials with 26 567 participants. Two trials were at low risk of bias, although both trials were sponsored by the company that developed ivabradine. All other trials were at high risk of bias. Meta-analyses and trial sequential analyses showed that we could reject that ivabradine versus control reduced all-cause mortality (risk ratio (RR)=0.94; 95% CI 0.88 to 1.01; p=0.09; high certainty of evidence). Meta-analysis and trial sequential analysis showed that ivabradine seemed to reduce the risk of serious adverse events (RR=0.90; 95% CI 0.87 to 0.94; p<0.00001; number needed to treat (NNT)=26.2; low certainty of evidence). This was primarily due to a decrease in the risk of ‘cardiac failure’ (RR=0.83; 95% CI 0.71 to 0.97; p=0.02; NNT=43.9), ‘hospitalisations’ (RR=0.89; 95% CI 0.85 to 0.94; p<0.0001; NNT=36.4) and ‘ventricular tachycardia’ (RR=0.59; 95% CI 0.43 to 0.82; p=0.001; NNT=212.8). However, the trials did not describe how these outcomes were defined and assessed during follow-up. Meta-analyses showed that ivabradine increased the risk of atrial fibrillation (RR=1.19; 95% CI 1.04 to 1.35; p=0.008; number needed to harm (NNH)=116.3) and bradycardia (RR=3.95; 95% CI 1.88 to 8.29; p=0.0003; NNH=303). Ivabradine seemed to increase quality of life on the Kansas City Cardiomyopathy Questionnaire (KCCQ) (mean difference (MD)=2.92; 95% CI 1.34 to 4.50; p=0.0003; low certainty of evidence), but the effect size was small and possibly without relevance to patients, and on the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) (MD=−5.28; 95% CI −6.60 to −3.96; p<0.00001; very low certainty of evidence), but the effects were uncertain. Meta-analysis showed no evidence of a difference between ivabradine and control when assessing cardiovascular mortality and myocardial infarction. Ivabradine seemed to increase the risk of non-serious adverse events.Conclusion and relevanceHigh certainty evidence shows that ivabradine does not seem to affect the risks of all-cause mortality and cardiovascular mortality. The effects on quality of life were small and possibly without relevance to patients on the KCCQ and were very uncertain for the MLWHFQ. The effects on serious adverse events, myocardial infarction and hospitalisation are uncertain. Ivabradine seems to increase the risk of atrial fibrillation, bradycardia and non-serious adverse events.PROSPERO registration number: CRD42018112082.

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Were Traditional Chinese Medicine Injections Efficacious for Angina Pectoris? A Frequentist Network Meta-Analysis of Randomized Controlled Trials

10.21203/rs.3.rs-137394/v1 ◽

2020 ◽

Author(s):

Guoying Gao ◽

Siu-wai Leung ◽

Yongliang Jia

Keyword(s):

Chinese Medicine ◽

Angina Pectoris ◽

Traditional Chinese Medicine ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Quality Of Evidence ◽

Randomized Controlled ◽

Grade Approach

Abstract Background: The efficacy of traditional Chinese medicine injections (TCMIs) for angina pectoris has never been well investigated for lacking quality assessment of evidence. This study aimed to conduct a comprehensive and rigorous network meta-analysis and assess the quality of evidence according to the Grading of Recommendations and Assessment, Development, and Evaluation (GRADE) approach to compare the efficacy of all TCMIs in treating angina pectoris.Methods: Following the protocol (reference: CRD42018117720), randomized controlled trials (RCTs) which compared one TCMI with another TCMI or conventional treatments on anginal outcome measures (i.e. symptomatic improvement, electrocardiography improvement, symptomatic recovery, and electrocardiography recovery) were included. The risk of bias among included RCTs was assessed with the revised Cochrane’s risk of bias tool 2. Frequentist statistical analyses including subgroup analysis, sensitivity analysis, meta-regression and publication bias analysis were performed. The certainty of evidence was assessed with the GRADE approach.Results: Totally, 475 RCTs including all 24 TCMIs were identified, while the quality of all but two included RCTs was poor. According to the network meta-analysis, Honghua (Safflower) injection were preferable both in improving symptoms and electrocardiography. However, significant inconsistency showed the intransitivity among indirect comparisons, results in network meta-analysis seemed thus not trustworthy. The quality of evidence was assessed as low or very low.Conclusions: The low-quality evidence reduced the confidence in the efficacious results. Current evidence hardly supports the beneficial effects of TCMIs in treating angina pectoris.

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Effect of Extracorporeal Blood Purification on Mortality in Sepsis: A Meta-Analysis and Trial Sequential Analysis

Blood Purification ◽

10.1159/000510982 ◽

2020 ◽

pp. 1-11

Author(s):

Timothy A.C. Snow ◽

Shona Littlewood ◽

Carlos Corredor ◽

Mervyn Singer ◽

Nishkantha Arulkumaran

Keyword(s):

Sequential Analysis ◽

Meta Analysis ◽

Blood Purification ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Mortality Benefit ◽

Nonspecific Adsorption ◽

Extracorporeal Blood ◽

Extracorporeal Blood Purification

Objective: The objective of this study was to conduct a meta-analysis and trial sequential analysis (TSA) of published randomized controlled trials (RCTs) to determine whether mortality benefit exists for extracorporeal blood purification techniques in sepsis. Data Sources: A systematic search on MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials for RCTs was performed. Study Selection: RCTs investigating the effect of extracorporeal blood purification device use on mortality among critically ill septic patients were selected. Data Extraction: Mortality was assessed using Mantel-Haenszel models, and I2 was used for heterogeneity. Data are presented as odds ratios (OR); 95% confidence intervals (CIs); p values; I2. Using the control event mortality proportion, we performed a TSA and calculated the required information size using an anticipated intervention effect of a 14% relative reduction in mortality. Data Synthesis: Thirty-nine RCTs were identified, with 2,729 patients. Fourteen studies used hemofiltration (n = 789), 17 used endotoxin adsorption devices (n = 1,363), 3 used nonspecific adsorption (n = 110), 2 were cytokine removal devices (n = 117), 2 used coupled plasma filtration adsorption (CPFA) (n = 207), 2 combined hemofiltration and perfusion (n = 40), and 1 used plasma exchange (n = 106). On conventional meta-analysis, hemofiltration (OR 0.56 [0.40–0.79]; p < 0.001; I2 = 0%), endotoxin removal devices (OR 0.40 [0.23–0.67], p < 0.001; I2 = 71%), and nonspecific adsorption devices (OR 0.32 [0.13–0.82]; p = 0.02; I2 = 23%) were associated with mortality benefit, but not cytokine removal (OR 0.99 [0.07–13.42], p = 0.99; I2 = 64%), CPFA (OR 0.50 [0.10–2.47]; p = 0.40; I2 = 64%), or combined hemofiltration and adsorption (OR 0.71 [0.13–3.79]; p = 0.69; I2 = 0%). TSA however revealed that based on the number of existing patients recruited for RCTs, neither hemofiltration (TSA-adjusted CI 0.29–1.10), endotoxin removal devices (CI 0.05–3.40), nor nonspecific adsorption devices (CI 0.01–14.31) were associated with mortality benefit. Conclusion: There are inadequate data at present to conclude that the use of extracorporeal blood purification techniques in sepsis is beneficial. Further adequately powered RCTs are required to confirm any potential mortality benefit, which may be most evident in patients at greatest risk of death.

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Ganglioside-monosialic acid (GM1) for prevention of chemotherapy-induced peripheral neuropathy: a meta-analysis with trial sequential analysis

10.21203/rs.3.rs-431559/v1 ◽

2021 ◽

Author(s):

Shaoyong Wu ◽

Xiaohui Bai ◽

Caixia Guo ◽

Zhimei Huang ◽

Handong Ouyang ◽

...

Keyword(s):

Peripheral Neuropathy ◽

Adverse Events ◽

Sequential Analysis ◽

Meta Analysis ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Random Errors ◽

Clinical Issue ◽

Response To Chemotherapy

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a dose-limiting side effect that largely remains an unresolved clinical issue, leading to long-term morbidity. This meta-analysis aimed to evaluate the efficacy and safety of Ganglioside-monosialic acid (GM1) in preventing CIPN.Methods: Systematic literature searches of Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were performed to identify randomized controlled trials and cohort studies that evaluated the efficacy of GM1 for preventing CIPN. Ameta-analysis was conducted to calculate odds ratios (ORs) and 95% confidential intervals (CIs) using a random-effects model. Trial sequential analyses (TSA) also were conducted to control for random errors. Results: A total of five studies involving 868 participants were included. The results showed that GM1 did not reduce the overall incidence of grade ≥2 CIPN when the common terminology criteria for adverse events (CTCAE) was used (OR 0.34, 95% CI 0.34-1.11). Subgroup analyses showed that GM1 could not reduce the risk of CTCAE grade ≥2 CIPN (OR 0.63, 95% CI 0.35-1.13) and neurotoxicity criteria of Debiopharm (DEB-NTC) grade ≥2 CIPN (OR 0.25, 95% CI 0.01-7.10) in oxaliplatin-treated patients, although GM1 might reduce the risk of CTCAE grade≥2 CIPN in the taxane subgroup in one study (OR 0.003, 95% CI 0.00-0.05). Besides, TSA suggested that the results in the taxane subgroup were robust, while that of the oxaliplatin subgroup were inconclusive. Furthermore, GM1 did not influence the rate of response to chemotherapy and CTCAE grade ≥2 adverse events such as fatigue, nausea, diarrhea, and rash.Conclusions: GM1 was not associated with a lower risk of oxaliplatin-induced peripheral neuropathy nor could improve the response or safety to chemotherapy; however, it might be able to prevent taxane-induced peripheral neuropathy. Higher-quality trials are required to clarify the preventive effect of GM1 in oxaliplatin-treated patients.

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Local anaesthetics combined with vasoconstrictors in patients with cardiovascular disease undergoing dental procedures: systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-044357 ◽

2021 ◽

Vol 11 (7) ◽

pp. e044357

Author(s):

Caio Chaves Guimaraes ◽

Luciane Cruz Lopes ◽

Cristiane de Cássia Bergamaschi ◽

Juliana Cama Ramacciato ◽

Marcus Tolentino Silva ◽

...

Keyword(s):

Systematic Review ◽

Meta Analysis ◽

Intervention Group ◽

Local Anaesthetics ◽

Control Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Quality Of Evidence ◽

Dental Procedures

ObjectivesThere is a lack of evidence about the use of local anaesthetics (LAs) in patients with cardiovascular diseases (CVD) in dental procedures. Thus, this study evaluated the safety of using LA with vasoconstrictor to determine the risk of cardiovascular events in patients with CVD.DesignSystematic review and meta-analysis.MethodsWe have searched in Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid), EMBASE (via Ovid), Healthstar (via Ovid), CINAHL, Web of Science and ClinicalTrials.gov for randomised controlled trials (RCTs) up to January 2020. We have included RCTs involving adults with CVD within two groups: intervention group with LA with vasoconstrictor and control group with LA without vasoconstrictor. The primary outcomes assessed were death, mortality by a specific cause, stroke, acute myocardial infarction, hospitalisation, pain, bleeding and arrhythmias. The secondary outcomes were ST segment depression, anxiety, adverse effects and changes in haemodynamic parameters. The data were pooled using random effects meta-analyses and the confidence in the estimates was verified using the Grading of Recommendations Assessment, Development and Evaluation (GRADE).ResultsTen RCTs (n=478 participants) were included. Most of them had a high risk of bias. There were more cases of pain and bleeding in groups without vasoconstrictor. Meta-analysis demonstrated a decrease in the systolic blood pressure with the use of LA with vasoconstrictor (standard mean difference −0.95, 95% CI −1.35 to −0.55) after procedure. Overall, for the other outcomes assessed there was no statistical difference. The quality of evidence was considered low according to the GRADE profile.ConclusionsThe results suggest that the use of LA with vasoconstrictors (epinephrine in low doses) is safe in patients with some types of CVD. However, the low quality of evidence demonstrated that literature needs further studies in order to confirm these results.Protocol registrationPROSPERO (CRD42016045421).

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