Use of Prophylaxis for Prevention of Venous Thromboembolism in Patients with Isolated Foot or Ankle Surgery: A Systematic Review and Meta-Analysis

AbstractAlthough prophylaxis for venous thromboembolism (VTE) is recommended after many surgeries, evidence base for use of VTE prophylaxis after foot or ankle surgery has been elusive, leading into varying guidelines recommendations and notable practice variations. We conducted a systematic review of the literature to determine if use of VTE prophylaxis decreased the frequency of subsequent VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE), compared with control. We searched PubMed, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov through May 2018, for randomized controlled trials (RCTs) or prospective controlled observational studies of VTE prophylaxis in patients undergoing foot and ankle surgery. Our search retrieved 263 studies, of which 6 were finally included comprising 1,600 patients. Patients receiving VTE prophylaxis had lower risk for subsequent DVT (risk ratio [RR]: 0.72; 95% confidence interval [CI]: 0.55–0.94) and subsequent VTE (RR: 0.72; 95% CI: 0.55–0.94). There was only one case of nonfatal PE, no cases of fatal PE, and no change in all-cause mortality (RR: 3.51; 95% CI: 0.14–84.84). There was no significant difference in the risk for bleeding (RR: 2.12; 95% CI: 0.53–8.56). Very few RCTs exist regarding the efficacy and safety of VTE prophylaxis in foot and ankle surgery. Prophylaxis appears to reduce the risk of subsequent VTE, but the event rates are low and symptomatic events are rare. Future studies should determine the subgroups of patients undergoing foot or ankle surgery in whom prophylaxis may be most useful.

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Blinding integrity in randomized sham-controlled trials of repetitive transcranial magnetic stimulation for major depression: a systematic review and meta-analysis

The International Journal of Neuropsychopharmacology ◽

10.1017/s1461145712001691 ◽

2013 ◽

Vol 16 (5) ◽

pp. 1173-1181 ◽

Cited By ~ 30

Author(s):

Marcelo T. Berlim ◽

Hannah J. Broadbent ◽

Frederique Van den Eynde

Keyword(s):

Systematic Review ◽

Transcranial Magnetic Stimulation ◽

Major Depression ◽

Magnetic Stimulation ◽

Repetitive Transcranial Magnetic Stimulation ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Treatment Allocation ◽

Significant Difference

Abstract Repetitive transcranial magnetic stimulation (rTMS) is a safe and effective treatment for major depression (MD). However, the perceived lack of a suitable sham rTMS condition might have compromised the success of blinding procedures in clinical trials. Thus, we conducted a systematic review and meta-analysis of randomized, double-blind and sham-controlled trials (RCTs) on high frequency (HF-), low frequency (LF-) and bilateral rTMS for MD. We searched the literature from January 1995 to July 2012 using Medline, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials and Scopus. The main outcome measure was participants' ability to correctly guess their treatment allocation at study end. We used a random-effects model and risk difference (RD). Overall, data were obtained from seven and two RCTs on HF- and bilateral rTMS, respectively. No RCT on LF-rTMS reporting on blinding success was found. HF- and bilateral rTMS trials enrolled 396 and 93 depressed subjects and offered an average of approximately 13 sessions. At study end, 52 and 59% of subjects receiving HF-rTMS and sham rTMS were able to correctly guess their treatment allocation, a non-significant difference (RD = −0.04; z = −0.51; p = 0.61). Furthermore, 63.3 and 57.5% of subjects receiving bilateral and sham rTMS were able to correctly guess their treatment allocation, also a non-significant difference (RD = 0.05; z = 0.49; p = 0.62). In addition, the use of angulation and sham coil in HF-rTMS trials produced similar results. In summary, existing sham rTMS interventions appear to result in acceptable levels of blinding regarding treatment allocation.

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Difluprednate versus Prednisolone Acetate after Cataract Surgery: a Systematic Review and Meta-Analysis

BMJ Open ◽

10.1136/bmjopen-2018-026752 ◽

2019 ◽

Vol 9 (11) ◽

pp. e026752

Author(s):

Mahmoud Tawfik KhalafAllah ◽

Ahmed Basiony ◽

Ahmed Salama

Keyword(s):

Systematic Review ◽

Cataract Surgery ◽

Meta Analysis ◽

Prednisolone Acetate ◽

Controlled Trials ◽

Topical Steroids ◽

Cochrane Central Register ◽

Small Incision Cataract Surgery ◽

Significant Difference ◽

Evidence Quality

ObjectiveTopical steroids are the cornerstone in controlling the inflammation after cataract surgery. Prednisolone acetate and difluprednate are the two main products for this purpose. However, it is unclear which one should be used in terms of effectiveness and safety.DesignSystematic review and meta-analysis.Data sourcesMedline via PubMed, Cochrane Central Register of Controlled Trials, Web of science and clinicaltrials.gov were searched through 10 January 2018, and updated on 20 July 2019, in addition to researching the references’ lists of the relevant articles.Eligibility criteriaRandomised-controlled trials (RCTs) comparing difluprednate and prednisolone acetate regardless of the dosing regimen used.Data extraction and synthesisTwo independent authors assessed the included RCTs regarding the risk of bias using the Cochrane tool. Relevant data were extracted, and meta-analysis was conducted using a random-effects model. The Grading of Recommendations Assessment, Development, and Evaluation approach was used to appraise the evidence quality.ResultsWe included six RCTs with 883 patients: 441 received difluprednate and 442 received prednisolone acetate. The evidence quality was graded as moderate for corneal oedema and intraocular pressure and low for anterior chamber (AC) clearance. After small incision cataract surgery, difluprednate was superior in clearing AC cells at 1 week (OR=2.5, p>0.00001) and at 2 weeks (OR=2.5, p=0.04), as well as clearing the AC flare at 2 weeks (OR=6.7, p=0.04). After phacoemulsification, difluprednate was superior in terms of corneal clarity at 1 day (OR=2.6, p=0.02) and 1 week after surgery (OR=1.96, p=0.0007). No statistically significant difference was detected between both agents at 1 month in effectiveness. Also, both agents were safe, evaluated by the ocular hypertension (OR=1.23, p=0.8).ConclusionWith low-to-moderate certainty, difluprednate and prednisolone acetate are safe agents for controlling the inflammation after cataract surgery. Difluprednate showed significant superiority in terms of AC cells and AC flare at 2 weeks postoperatively.

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Impact of levothyroxine in women with positive thyroid antibodies on pregnancy outcomes: a systematic review and meta-analysis of randomised controlled trials

BMJ Open ◽

10.1136/bmjopen-2020-043751 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043751

Author(s):

Lorraine Lau ◽

Jamie L Benham ◽

Patricia Lemieux ◽

Jennifer Yamamoto ◽

Lois E Donovan

Keyword(s):

Systematic Review ◽

Preterm Delivery ◽

Pregnancy Outcomes ◽

Randomised Controlled Trials ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Significant Difference ◽

Randomised Controlled

ObjectiveTo evaluate the effect of levothyroxine therapy on pregnancy outcomes compared with placebo or no treatment in women without overt hypothyroidism with presence of thyroid peroxidase antibodies (TPOAb) and/or thyroglobulin antibodies (TgAb).DesignSystematic review and meta-analysis of randomised controlled trialsStudy eligibility criteriaPrespecified criteria for inclusion were: randomised trials of levothyroxine versus control (placebo or no treatment) among women with positive TPOAb or TgAb who were pregnant or considering conception.Data sourcesOvid MEDLINE, EMBASE, CINAHL, Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials were searched from 1980 to 5 November 2020.Outcome measuresPrespecified data elements were extracted and where appropriate, meta-analyses were conducted. Main outcomes include pregnancy achieved, miscarriage, preterm delivery and live birth.Risk of bias assessmentCochrane Risk of Bias Tool for Quality Assessment of Randomised Controlled Trials.ResultsFrom 3023 citations, 79 citations were identified for full-text review. Of these, six trials (total of 2263 women) were included for qualitative and quantitative analyses. Risk of bias was deemed low for only one trial. There was no significant difference in the relative risk (RR) of pregnancy achieved (RR 1.03; 95% CI 0.93 to 1.13), miscarriage (RR 0.93; 95% CI 0.76 to 1.14), preterm delivery (RR 0.66; 95% CI 0.39 to 1.10) or live births (RR 1.01; 95% CI 0.89 to 1.16) in thyroid autoimmune women treated with levothyroxine compared with controls. Sensitivity analyses of preterm birth identified study quality and timing of levothyroxine initiation as sources of heterogeneity.ConclusionsAmong pregnant women or women planning conception, with thyroid autoimmunity, there is a lack of evidence of benefit for levothyroxine use (moderate to high Grading of Recommendations, Assessment, Development and Evaluations). Recommendations to use levothyroxine in this setting need to be reconsidered.PROSPERO registration numberCRD42019130459.

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Oropharyngeal Colostrum for Preterm Infants: A Systematic Review and Meta-Analysis

Advances in Nutrition ◽

10.1093/advances/nmz033 ◽

2019 ◽

Vol 10 (6) ◽

pp. 1152-1162 ◽

Cited By ~ 5

Author(s):

Harshad Panchal ◽

Gayatri Athalye-Jape ◽

Sanjay Patole

Keyword(s):

Systematic Review ◽

Preterm Infants ◽

Late Onset ◽

Meta Analysis ◽

Oral Microbiome ◽

Secretory Iga ◽

Controlled Trials ◽

Cochrane Central Register ◽

Assessment Development ◽

Significant Difference

ABSTRACT Administration of oropharyngeal colostrum (OPC) is safe, feasible, and potentially beneficial in preterm infants. We aimed to assess the effects of OPC in preterm infants. A systematic review of randomized controlled trials (RCTs) and non-RCTs of OPC administration in preterm infants was conducted. We searched MEDLINE via PubMed and Ovid, EMBASE, the Cochrane Central Register of Controlled Trials, Emcare databases, abstracts of Pediatric Academic Societies meetings, and gray literature in April 2018. Six RCTs (n = 269) and 4 non-RCTs (n = 737) were included. One RCT (n = 40) focused on enteral bovine colostrum and hence was excluded from our review. Five of the 6 RCTs had unclear risk of bias in many domains of assessment. Meta-analysis (random effects model) of RCT data showed no significant difference in ≥stage 2 necrotizing enterocolitis (RR: 0.83; 95% CI: 0.39, 1.75; P = 0.62), late-onset sepsis (RR: 0.78; 95% CI: 0.50, 1.22; P = 0.28), all-cause mortality (RR: 0.74; 95% CI: 0.27, 2.06; P = 0.56); duration of hospital stay (mean difference [MD]: −1.65 d; 95% CI: −10.09, 6.80; P = 0.70), and time to full feeds (MD: −2.86 d; 95% CI: −6.49, 0.77; P = 0.12). Meta-analysis of data from non-RCTs also showed no benefit for any of these outcomes. OPC increased secretory IgA and lactoferrin concentrations (4 RCTs), and had only a transient effect on the oral microbiome (1 RCT). There were no adverse effects (e.g., aspiration) of OPC. The overall quality of evidence (Grades of Recommendation, Assessment, Development, and Evaluation analysis) was very low. Adequately powered RCTs are needed to confirm the nutritional and immunomodulatory benefits of OPC in preterm infants.

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Drug-Coated Balloon vs. Stent for de novo Non-small Coronary Artery Disease: A Systematic Review and Meta-Analysis

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.700235 ◽

2021 ◽

Vol 8 ◽

Author(s):

Kaiwen Sun ◽

Zhenzhu Liu ◽

Hongyan Wang

Keyword(s):

Systematic Review ◽

Coronary Artery Disease ◽

Coronary Artery ◽

De Novo ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Significant Difference ◽

Artery Disease ◽

Drug Coated Balloon

Introduction: Drug-coated balloon (DCB) has been an attractive option in de novo vessels. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB vs. stent for treating de novo lesions in non-small vessels.Methods: Studies in PubMed, Embase, the Cochrane Central Register of Controlled Trials, and Web of Science were searched (from their commencement to March 2021). This meta-analysis was performed by Review Manager 5.3.Results: A total of 3 random controlled trials (RCTs) with 255 patients and 2 observational studies (OS) with 265 patients were included in this meta-analysis following our inclusion criteria. It could be observed that DCB presented no significant difference in cardiac death (CD) (RR 0.33, 95% CI [0.01, 8.29], p = 0.50 in OS), myocardial infarction (MI) (RR 0.49, 95% CI [0.09, 2.50], p = 0.39 in RCT), target lesion revascularization (TLR) (RR 0.64, 95% CI [0.19, 2.18], p = 0.47 in RCT) (RR 1.72, 95% CI [0.56, 5.26], p = 0.34 in OS), and late lumen loss (LLL) (SMD −0.48, 95% CI [−1.32, 0.36], p = 0.26 in RCT) for de novo non-small coronary artery disease (CAD) compared with stents, whereas minimal lumen diameter (MLD) including MLD1 (SMD −0.67, 95% CI [−0.92 −0.42], p < 0.00001 in RCT) and MLD2 (SMD −0.36, 95% CI [−0.61 −0.11], p = 0.004 in RCT) was smaller in DCB group.Conclusion: This systematic review showed that DCB might provide a promising way on de novo non-small coronary artery disease compared with stents. However, more RCTs are still needed to further prove the benefits of the DCB strategy.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/#recordDetails.

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Soap versus sanitiser for preventing the transmission of acute respiratory infections in the community: a systematic review with meta-analysis and dose–response analysis

BMJ Open ◽

10.1136/bmjopen-2020-046175 ◽

2021 ◽

Vol 11 (8) ◽

pp. e046175

Author(s):

Tammy Hoffmann ◽

Mina Bakhit ◽

Natalia Krzyzaniak ◽

Chris Del Mar ◽

Anna Mae Scott ◽

...

Keyword(s):

Systematic Review ◽

Hand Hygiene ◽

Dose Response ◽

Respiratory Infections ◽

Meta Analysis ◽

Response Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Acute Respiratory Infections ◽

Significant Difference

ObjectiveTo compare the effectiveness of hand hygiene using alcohol-based hand sanitiser to soap and water for preventing the transmission of acute respiratory infections (ARIs) and to assess the relationship between the dose of hand hygiene and the number of ARI, influenza-like illness (ILI) or influenza events.DesignSystematic review and meta-analysis.Data sourcesCochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, Cumulative Index of Nursing and Allied Health Literature (CINAHL) and trial registries were searched in April 2020.Inclusion criteriaWe included randomised controlled trials that compared a community-based hand hygiene intervention (soap and water, or sanitiser) with a control, or trials that compared sanitiser with soap and water, and measured outcomes of ARI, ILI or laboratory-confirmed influenza or related consequences.Data extraction and analysisTwo review authors independently screened the titles and abstracts for inclusion and extracted data.ResultsEighteen trials were included. When meta-analysed, three trials of soap and water versus control found a non-significant increase in ARI events (risk ratio (RR) 1.23, 95% CI 0.78 to 1.93); six trials of sanitiser versus control found a significant reduction in ARI events (RR 0.80, 95% CI 0.71 to 0.89). When hand hygiene dose was plotted against ARI relative risk, no clear dose–response relationship was observable. Four trials were head-to-head comparisons of sanitiser and soap and water but too heterogeneous to pool: two found a significantly greater reduction in the sanitiser group compared with the soap group and two found no significant difference between the intervention arms.ConclusionsAdequately performed hand hygiene, with either soap or sanitiser, reduces the risk of ARI virus transmission; however, direct and indirect evidence suggest sanitiser might be more effective in practice.

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The Effect of Probiotics, Prebiotics, and Synbiotics on CD4 Counts in HIV-Infected Patients: A Systematic Review and Meta-Analysis

BioMed Research International ◽

10.1155/2020/7947342 ◽

2020 ◽

Vol 2020 ◽

pp. 1-11

Author(s):

Yuan-Sheng Fu ◽

Qin-Shu Chu ◽

Akililu Alemu Ashuro ◽

Dong-Sheng Di ◽

Qi Zhang ◽

...

Keyword(s):

Systematic Review ◽

Publication Bias ◽

Weighted Mean Difference ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Cd4 Counts ◽

Cell Counts ◽

Significant Difference

Background. Probiotics as a potential adjuvant therapy may improve the restoration of the intestinal CD4+ T-cell population in HIV-infected patients, whereas findings from clinical trials are inconsistent. This systematic review and meta-analysis of randomized controlled trials (RCTs) was performed to quantify the effects of probiotic, prebiotic, and synbiotic supplementation on CD4 counts in HIV-infected patients. Methods. We searched PubMed, Embase, Web of Science, Scopus, and the Cochrane Central Register of Controlled Trials for relevant articles published up to March 20, 2020. Two authors independently performed the study selection, data extraction, and risk of bias assessment. Data were pooled by using the random effects model, and weighted mean difference (WMD) was considered the summary effect size. Publication bias was evaluated by a funnel plot and Egger’s test. Results. The search strategy identified 1712 citations. After screening, a total of 16 RCTs with 19 trials were included in the meta-analysis. Pooling of the extracted data indicated no significant difference between the probiotics/prebiotics/synbiotics and placebo groups on CD4 counts ( WMD = 3.86 , 95% confidence interval (CI) -24.72 to 32.45, P = 0.791 ). In subgroup analysis, a significant increase in CD4 counts was found in the study with high risk of bias ( WMD = 188 , 95% CI 108.74 to 227.26, P ≤ 0.001 ). Egger’s test showed no evidence of significant publication bias ( P = 0.936 ). Conclusions. In summary, the evidence for the efficacy of probiotics, prebiotics, and synbiotics in improving HIV-infected patients’ CD4 counts as presented in currently published RCTs is insufficient. Therefore, further comprehensive studies are needed to reveal the exact effect of probiotics, prebiotics, and synbiotics on CD4+ cell counts.

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Rivaroxaban for cancer-associated venous thromboembolism

Science Progress ◽

10.1177/00368504211012160 ◽

2021 ◽

Vol 104 (2) ◽

pp. 003685042110121

Author(s):

Bo Liang ◽

Yi Liang ◽

Li-Zhi Zhao ◽

Yu-Xiu Zhao ◽

Ning Gu

Keyword(s):

Venous Thromboembolism ◽

Major Bleeding ◽

Meta Analysis ◽

Controlled Trials ◽

Cochrane Central Register ◽

Efficacy And Safety ◽

China National Knowledge Infrastructure ◽

Bleeding Events ◽

Significant Difference ◽

Major Bleeding Events

All cancers can increase the risk of developing venous thromboembolism (VTE), and anticoagulants should be considered as an optimal treatment for patients suffering from cancer-associated VTE. However, there is still a debate about whether the new oral anticoagulant, rivaroxaban, can bring better efficacy and safety outcomes globally. Thus, this systematic review and meta-analysis was conducted to evaluate the efficacy and safety of rivaroxaban. We searched PubMed, Cochrane Central Register of Controlled Trials, Web of Science, and China National Knowledge Infrastructure for relevant published papers before 1 September 2019, with no language restrictions. The primary outcomes are defined as the recurrence of VTE. The secondary outcomes are defined as clinically relevant non-major bleeding, adverse major bleeding events, and all-cause of death. The data were analyzed by Stata with risk ratio (RR) and 95% confidence interval (CI). Four trials encompassing 1996 patients were included. Rivaroxaban reduced recurrent VTE with no significant difference (RR = 0.68, 95% CI = 0.43–1.07). Similarly, there were no significant differences in adverse major bleeding events (RR = 0.86, 95% CI = 0.37–2.00), clinically relevant non-major bleeding (RR = 1.24, 95% CI = 0.73–2.12) and all-cause mortality (RR = 0.76, 95% CI = 0.40–1.44). In a selected study population of cancer patients with VTE, rivaroxaban is as good as other anticoagulants. Further, carefully designed randomized controlled trials should be performed to confirm these results.

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Hydroxychloroquine for Treatment of COVID‐19 Patients: a Systematic Review and Meta-Analysis of Randomized Controlled Trials

10.21203/rs.3.rs-603673/v1 ◽

2021 ◽

Author(s):

Vinícius Y Moraes ◽

Alexandre R Marra ◽

Leandro L Matos ◽

Ary Serpa Neto ◽

Luiz Vicente Rizzo ◽

...

Keyword(s):

Systematic Review ◽

Adverse Effects ◽

Risk Ratio ◽

Meta Analysis ◽

Standard Of Care ◽

Control Group ◽

Controlled Trials ◽

Cochrane Central Register ◽

Random Effects Models ◽

Significant Difference

Abstract Background: We performed a systematic review of the literature and meta-analysis on the efficacy and safety of hydroxychloroquine to treat coronavirus disease 2019 (COVID-19) patients. Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and LILACS (2019 to March 2021) for patients aged 18 years or older, who had COVID-19 and were treated with hydroxychloroquine versus placebo or standard of care. We also searched the WHO Clinical Trials Registry for ongoing and recently completed studies, and the reference lists of selected articles and reviews for possible relevant studies, with no restrictions regarding language or publication status. Random-effects models were used to obtain pooled mean differences of treatment effect on mortality, and serious adverse effects between hydroxychloroquine (HCQ) and the control group (standard of care or placebo); heterogeneity was assessed using the I2 and the Cochran´s Q statistic. Results: Nine studies met the inclusion criteria and were included in the meta-analysis. There was no significant difference in mortality rate between patients treated with HCQ compared to standard of care or placebo (16.7% vs. 18.5%; pooled risk ratio 1.09; 95%CI: 0.99-1.19). Also, therate of serious adverse effects was similar between both groups, HCQ and control (3.7% vs. 2.9%; pooled risk ratio 1.22; 95%CI: 0.76-1.96). Conclusion: Hydroxychloroquine is not efficacious in reducing mortality of COVID-19 patients.Systematic review registration: Prospero database, registration number: CRD42020197070.

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ICS-formoterol reliever versus ICS and SABA reliever in asthma: a systematic review and meta-analysis

ERJ Open Research ◽

10.1183/23120541.00701-2020 ◽

2020 ◽

pp. 00701-2020

Author(s):

Lee Hatter ◽

Pepa Bruce ◽

Irene Braithwaite ◽

Mark Holliday ◽

James Fingleton ◽

...

Keyword(s):

Systematic Review ◽

Meta Analysis ◽

Symptom Control ◽

Treatment Algorithm ◽

Mean Difference ◽

Controlled Trials ◽

Severe Exacerbation ◽

Cochrane Central Register ◽

Serious Adverse Events ◽

Significant Difference

BackgroundThe Global Initiative for Asthma recommends as-needed inhaled corticosteroid (ICS)-formoterol as an alternative to maintenance ICS plus short-acting beta2-agonist (SABA) reliever at Step 2 of their stepwise treatment algorithm. Our aim was to assess the efficacy and safety of these two treatment regimens, with a focus on severe exacerbation prevention.MethodsWe performed a systematic review and meta-analysis of all randomised controlled trials (RCTs) comparing as-needed ICS-formoterol with maintenance ICS plus SABA. MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from database inception to 12 December 2019. The primary outcome was time to first severe exacerbation. RCTs were excluded if they used as-needed budesonide-formoterol as part of a maintenance and reliever regimen, or did not report on severe exacerbations. The review is registered with PROSPERO (CRD42020154680).ResultsFour RCTs (n=8065 participants) were included in the analysis. As-needed ICS-formoterol was associated with a prolonged time to first severe exacerbation (hazard ratio 0.85, 95%CI 0.73 to 1.00; p=0.048) and reduced daily ICS dose (mean difference −177.3 mcg, 95%CI −182.2 to −172.4). Asthma symptom control was worse in the as-needed group (ACQ-5 mean difference 0.12, 95%CI 0.09 to 0.14), though did not meet the minimal clinically important difference of 0.50 units. There was no significant difference in serious adverse events (odds ratio 1.07 95%CI 0.84 to 1.36).ConclusionAs-needed ICS-formoterol offers a therapeutic alternative to maintenance low-dose ICS plus SABA in asthma and may be the preferred option if severe exacerbation prevention is the primary aim of treatment.

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