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

2022 ◽  
Vol 12 ◽  
Author(s):  
Aranjit Singh Randhawa ◽  
Norhayati Mohd Noor ◽  
Mohd Khairi Md Daud ◽  
Baharudin Abdullah

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.

2020 ◽  
Vol 9 (11) ◽  
pp. 3389
Author(s):  
Claudio Colombo ◽  
Stefano Salvioli ◽  
Silvia Gianola ◽  
Greta Castellini ◽  
Marco Testa

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.


2021 ◽  
Author(s):  
Cita Rosita Sigit Prakoeswa ◽  
Sylvia Anggraeni ◽  
Damayanti Damayanti ◽  
Menul Ayu Umborowati ◽  
Cintya Dipta Riswanto ◽  
...  

Abstract Background: Specific immunotherapy with standardized aeroallergens can reduce symptoms and increase the quality of life for related allergy patients. This therapy is still controversial for atopic dermatitis (AD). Hence, a meta-analysis to assess efficacy and safety of specific immunotherapy with aeroallergens on patients with AD could provide a clear oversight on advantages and limitations of such treatment.Methods: We systematically searched PubMed, DOAJ, and Cochrane Central Register of Controlled Trials databases for relevant studies published Randomized controlled trials (RCTs) up to October 2020. Studies involving all ages and gender with AD who treated with specific immunotherapy employing aeroallergens compared with placebo/control.Results: Seven studies RCTs were identified with 832 participants. Significantly decreased of SCORAD values favoring immunotherapy were observed (MD: -5.42; 95% CI - 10.31, -0.52; p=0.03). VAS score was significantly decrease (MD: -1.21; 95% CI -2.10, -0.31; p=0.008). However, immunotherapy showed no significant local and systemic adverse events ((RR 1.77; 95% CI 0.98, 3.19, p=0.06); (RR 0.69; 95% CI 0.16, 3.01, p=0.62)) and IgG4 Dermatophagoides farinae (MD: 92.36, 95% CI -89.14,273.87; p=0.32). Conclusion: Our five years meta-analysis included small number studies, indicated moderate-level evidence for immunotherapy with standardized extract of aeroallergens is effective and safe for AD patients.


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044357
Author(s):  
Caio Chaves Guimaraes ◽  
Luciane Cruz Lopes ◽  
Cristiane de Cássia Bergamaschi ◽  
Juliana Cama Ramacciato ◽  
Marcus Tolentino Silva ◽  
...  

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).


2019 ◽  
Vol 48 (4) ◽  
pp. 1000-1013 ◽  
Author(s):  
Alberto Grassi ◽  
Kristian Samuelsson ◽  
Pieter D’Hooghe ◽  
Matteo Romagnoli ◽  
Massimiliano Mosca ◽  
...  

Background: Several devices for obtaining dynamic fixation of the syndesmosis have been introduced in recent years, but their efficacy has been tested in only a few randomized controlled trials (RCTs), without demonstrating any clear benefit over the traditional static fixation with screws. Purpose: To perform a level 1 meta-analysis of RCTs to investigate the complications, subjective outcomes, and functional results after dynamic or static fixation of acute syndesmotic injuries. Study Design: Meta-analysis of RCTs. Methods: A systematic literature search was performed of the Medline/PubMed, Cochrane Central Register of Controlled Trials, and Embase electronic databases, as well as ClinicalTrials.gov for unpublished studies. Eligible studies were RCTs comparing dynamic fixation and static fixation of acute syndesmosis injuries. A meta-analysis was performed, while bias and quality of evidence were rated according to the Cochrane Database questionnaire and the Grading of Recommendations Assessment, Development and Evaluation guidelines. Results: Dynamic fixation had a significantly reduced relative risk (RR = 0.55, P = .003) of complications—in particular, the presence of inadequate reduction at the final follow-up (RR = 0.36, P = .0008) and the clinical diagnosis of recurrent diastasis or instability (RR = 0.10, P = .03). The effect was more evident when compared with permanent screws (RR = 0.10, P = .0001). The reoperation rate was similar between the groups (RR = 0.64, P = .07); however, the overall risk was reduced after dynamic fixation as compared with static fixation with permanent screws (RR = 0.24, P = .007). The American Orthopaedic Foot & Ankle Society score was significantly higher among patients treated with dynamic fixation—6.06 points higher ( P = .005) at 3 months, 5.21 points ( P = .03) at 12 months, and 8.60 points ( P < .00001) at 24 months—while the Olerud-Molander score was similar. The visual analog scale for pain score was reduced at 6 months (–0.73 points, P = .003) and 12 months (–0.52 points, P = .005), and ankle range of motion increased by 4.36° ( P = .03) with dynamic fixation. The overall quality of evidence ranged from “moderate” to “very low,” owing to a substantial risk of bias, heterogeneity, indirectness of outcome reporting, and evaluation of a limited number of patients. Conclusion: The dynamic fixation of syndesmotic injuries was able to reduce the number of complications and improve clinical outcomes as compared with static screw fixation—especially malreduction and clinical instability or diastasis—at a follow-up of 2 years. A lower risk of reoperation was found with dynamic fixation as compared with static fixation with permanent screws. However, the lack of patients or personnel blinding, treatment heterogeneity, small samples, and short follow-up limit the overall quality of this evidence.


BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e040906
Author(s):  
Xinyu Zhao ◽  
Lihui Meng ◽  
Youxin Chen

ObjectiveTo give a comprehensive efficacy and safety ranking of different therapeutic regimens of ranibizumab for neovascular age-related macular degeneration (nAMD).DesignA systematic review and network meta-analysis.MethodsThe PubMed, Embase, Cochrane Central Register of Controlled Trials, and other clinical trial registries were searched up to 1 October 2019 to identify related randomised controlled trials (RCT) of different regimens of ranibizumab for nAMD. The primary efficacy outcome was the changes of best-corrected visual acuity (BCVA) at 1 year, the primary safety outcome was the incidence of severe ocular adverse events. Secondary outcomes such as changes of central retinal thickness (CRT) were evaluated. We estimated the standardised mean difference (SMD), ORs, 95% CIs, the surface under the cumulative ranking curves and the mean ranks for each outcome using network meta-analyses with random effects by Stata 14.0.ResultsWe identified 26 RCTs involving 10 821 patients with nAMD randomly assigned to 21 different therapeutic regimens of ranibizumab or sham treatment. Ranibizumab 0.5 mg (treat and extend, T&E) is most effective in terms of changes of BCVA (letters, SMD=21.41, 95% CI 19.86 to 22.95) and three or more lines of BCVA improvement (OR=2.83, 95% CI 1.27 to 4.38). However, it could not significantly reduce retreatment times compared with monthly injection (SMD=−0.94, 95% CI −2.26 to 0.39). Ranibizumab 0.5 mg (3+pro re nata)+non-steroidal anti-inflammatory drugs (NSAIDs) is most effective in reducing CRT and port delivery system of ranibizumab (100 mg/mL) could reduce the number of retreatment most significantly. All regimes have no more risk of severe ocular complications (including vitreous haemorrhage, rhegmatogenous retinal detachment, endophthalmitis, retinal tear and retinal pigment epithelium tear) or cardiocerebral vascular complications.ConclusionsRanibizumab 0.5 mg (T&E) is most effective in improving the visual outcome. The administration of topical NSAIDs could achieve additional efficacy in CRT reduction and visual improvement. Both interventions had acceptable risks of adverse events.


BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e045819
Author(s):  
Jinhui Ma ◽  
Megan Cheng ◽  
Lehana Thabane ◽  
Caihong Ma ◽  
Ning Zhang ◽  
...  

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.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041184
Author(s):  
Dan Wang ◽  
Jin Li ◽  
Feilong Zhu ◽  
Qianqin Hong ◽  
Ming Zhang ◽  
...  

IntroductionBoth physical and mental disorders may be exacerbated in patients with COVID-19 due to the experience of receiving intensive care; undergoing prolonged mechanical ventilation, sedation, proning and paralysis. Pulmonary rehabilitation is aimed to improve dyspnoea, relieve anxiety and depression, reduce the incidence of related complications, as well as prevent and improve dysfunction. However, the impact of respiratory rehabilitation on discharged patients with COVID-19 is currently unclear, especially on patients who have been mechanically ventilated over 24 hours. Therefore, we aim to investigate the efficacy of respiratory rehabilitation programmes, initiated after discharge from the intensive care unit, on the physical and mental health and health-related quality of life in critical patients with COVID-19.Methods and analysisWe have registered the protocol on PROSPERO and in the process of drafting it, we strictly followed the checklist of Preferred Reporting Items for Systematic Review and Meta-Analysis Potocols. We will search the PubMed, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, WanFang, VIP information databases and Chinese Biomedical Literature Database. Additionally, ongoing trials in the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov and ISRCTN registry will be searched as well. Studies in English or Chinese and from any country will be accepted regardless of study design. Two review authors will independently extract data and assess the quality of included studies. Continuous data are described as standard mean differences (SMDs) with 95% CIs. Dichotomous data from randomised controlled trials are described as risk ratio(RR) with 95% CIs; otherwise, it is described as odds ratio(OR) with 95% CIs. I2 and the Cochrane’s Q statistic will be used to conduct heterogeneity assessment. The quality of evidence of main outcomes will be evaluated according to the Grading of Recommendations, Assessment, Development and Evaluation(GRADE) criteria. When included studies are sufficient, we will conduct subgroup analysis and sensitivity analysis; the publication bias will be statistically analysed using a funnel plot analysis and Egger’s test.Ethics and disseminationOur review, planning to include published studies, does not need the request to the ethical committee. The final results of this review will be published in a peer-reviewed journal after completion.Patient and public involvementNo patient involved.PROSPERO registration numberCRD42020186791.


2019 ◽  
Vol 8 (1) ◽  
Author(s):  
James D. Millard ◽  
Elizabeth A. Mackay ◽  
Laura J. Bonnett ◽  
Geraint R. Davies

Abstract Background Pyrazinamide (PZA) is a key component of current and future regimens for tuberculosis (TB). Inclusion of PZA at higher doses and for longer durations may improve efficacy outcomes but must be balanced against the potential for worse safety outcomes. Methods We will search for randomised and quasi-randomised clinical trials in adult participants with and without the inclusion of PZA in TB treatment regimens in the Cochrane infectious diseases group’s trials register, Cochrane central register of controlled trials (CENTRAL), MEDLINE, EMBASE, LILACS, the metaRegister of Controlled Trials (mRCT) and the World Health Organization (WHO) international clinical trials registry platform. One author will screen abstracts and remove ineligible studies (10% of which will be double-screened by a second author). Two authors will review full texts for inclusion. Safety and efficacy data will be extracted to pre-piloted forms by one author (10% of which will be double-extracted by a second author). The Cochrane risk of bias tool will be used to assess study quality. The study has three objectives: the association of (1) inclusion, (2) dose and (3) duration of PZA with efficacy and safety outcomes. Risk ratios as relative measures of effect for direct comparisons within trials (all objectives) and proportions as absolute measures of effect for indirect comparisons across trials (for objectives 2 and 3) will be calculated. If there is insufficient data for direct comparisons within trials for objective 1, indirect comparisons between trials will be performed. Measures of effect will be pooled, with corresponding 95% confidence intervals and p values. Meta-analysis will be performed using the generalised inverse variance method for fixed effects models (FEM) or the DerSimonian-Laird method for random effects models (REM). For indirect comparisons, meta-regression for absolute measures against dose and duration data will be performed. Heterogeneity will be quantified through the I2-statistic for direct comparisons and the τ2 statistic for indirect comparisons using meta-regression. Discussion The current use of PZA for TB is based on over 60 years of clinical trial data, but this has never been synthesised to guide rationale use in future regimens and clinical trials. Systematic review registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42019138735


BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e040962
Author(s):  
Mathilda Björk ◽  
Björn Gerdle ◽  
Gunilla Liedberg ◽  
Frida Svanholm ◽  
Marco Solmi ◽  
...  

IntroductionWork absenteeism due to chronic non-malignant pain (CNMP) is a major societal and individual cause of concern that requires effective treatments.ObjectiveWe present a protocol for a systematic review and network meta-analysis (NMA) aiming to compare available interventions for return to work (RTW) in adults with CNMP.Methods and analysisPubMed, Embase, PsycINFO, Web of Knowledge and Cochrane Central Register of Controlled Trials databases will be searched till 31 August 2020 for randomised controlled trials (RCTs) examining interventions for RTW outcomes among patients with CNMP. Two independent investigators will search the databases, perform data extraction and assess the methodological quality of the selected RCTs. The primary outcome will be RTW, if possible, full-time or part-time after work absence due to chronic pain from baseline to the last available follow-up. Secondary outcomes will include self-reported workability or work capacity, or self-reported physical functioning and quality of life as measured by any validated scale. Pairwise meta-analysis and NMA will be conducted for each outcome using a random-effects model. For the primary outcomes, we will also obtain the ranking of all competing interventions within each NMA using surface under the cumulative ranking curve. The assumption of coherence (ie, that direct and indirect evidence are in statistical agreement) will be examined using both a local and a global approach. We will also conduct subgroup and meta-regression analyses, whenever feasible, to investigate the unexplained variation in effect size. The comparison-adjusted funnel plot will be used to evaluate small-study effects. The overall quality of evidence will be rated with the Confidence in Network Meta-Analysis tool. Data analysis will be conducted using Stata V.16.0.Ethics and disseminationThis systematic review does not require ethical approval since it will not disseminate any private patient data. The results of this study will be disseminated through peer-reviewed publication.PROSPERO registration numberCRD42020171429.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e030713 ◽  
Author(s):  
Dacheng Li ◽  
Li Zhu ◽  
Daming Liu

IntroductionRefractory gastro-oesophageal reflux disease (rGORD) is a common disease, affecting patients’ quality of life. Since conventional medicines have limitations, like low effective rates and adverse events, acupuncture may be a promising therapy for rGORD. While no related systematic review has been published, the present study is designed to evaluate the efficacy and safety of acupuncture for rGORD.Methods and analysisPubMed, the Cochrane Central Register of Controlled Trials and Chinese electronic databases, including China National Knowledge Infrastructure, Wan Fang database, VIP, SinoMed and the Chinese Clinical Trial Registry, will be searched from establishment of the database to 31 August 2019. There will be no limitations on language, and all articles will be screened and collected by two reviewers independently. RevMan V.5.3.5 software will be used for meta-analysis, and the conduction of study will refer to the Cochrane Handbook for Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines. The efficacy and safety of acupuncture for rGORD will be evaluated based on outcomes, including global symptom improvement, oesophageal sphincter function test measured by high-resolution manometry, quality of life, recurrence rate and adverse events.Ethics and disseminationThere is no necessity for this study to acquire an ethical approval, and this review will be disseminated in a peer-reviewed journal or conference presentation.Trial registration numberCRD42018111912.


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