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Sleep Medicine Feb 2021The efficacy and safety of montelukast in children with obstructive sleep apnea (OSA) remain controversial. Therefore, the aims of this systemic review and meta-analysis... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The efficacy and safety of montelukast in children with obstructive sleep apnea (OSA) remain controversial. Therefore, the aims of this systemic review and meta-analysis are to verify this issue and further provide reference for clinical practice.
METHODS
Seven databases were searched for randomized controlled trials (RCTs) up to September 30, 2019. The literature screening and data extraction were performed by two independent researchers. Adverse reactions from trials were also recorded. Meta-analysis was performed and analyzed heterogeneity. Methodological and evidence quality were followed by to evaluate according to Cochrane handbook.
RESULTS
A total of 4 RCTs including 305 children with mild to moderate OSA were involved. Compared with placebo, we found that oral montelukast (OM) significantly improved polysomnography (PSG) monitoring parameters, typical and relevant symptoms including snoring and mouth breathing, and adenoid morphology in children with OSA. When compared with routine drugs, not only PSG monitoring parameters and adenoid morphology, but also sleep-disordered breathing (SDB)-related questionnaire scores were improved in patients with OSA treated by combination of OM and routine drugs. In addition, compared with single nasal spray of mometasone furoate, the present study also showed that OM combined with nasal spray of mometasone furoate significantly improved PSG monitoring parameters, symptoms of snoring and mouth breathing and reduced tonsil morphology in pediatric OSA. In terms of treatment safety, one study reported adverse reactions of OM such as headache, nausea and vomiting, while no adverse events were reported after OM treatment in another study.
CONCLUSION
As a classic leukotriene receptor antagonist, montelukast can be used to treat children with mild to moderate OSA in the short term and improve clinical characteristics. The promotion and application of OM in clinic is considered to be a noninvasive option to avoid surgical treatment.
Topics: Acetates; Adenoids; Child; Cyclopropanes; Humans; Quinolines; Sleep Apnea, Obstructive; Sulfides
PubMed: 33465554
DOI: 10.1016/j.sleep.2020.11.009 -
Paediatric Respiratory Reviews Nov 2019
Topics: Administration, Inhalation; Adolescent; Asthma; Beclomethasone; Body Height; Budesonide; Child; Child Development; Child, Preschool; Fluticasone; Glucocorticoids; Humans; Infant; Mometasone Furoate; Pregnenediones
PubMed: 31732321
DOI: 10.1016/j.prrv.2019.09.007 -
American Journal of Obstetrics and... Jun 2020The purpose of the present systematic review is to evaluate the available medical treatments for vulvar lichen sclerosus, using an arm-based network meta-analysis...
OBJECTIVE
The purpose of the present systematic review is to evaluate the available medical treatments for vulvar lichen sclerosus, using an arm-based network meta-analysis protocol.
DATA SOURCES
We searched Medline (1966-2019), Scopus (2004-2019), Cochrane Central Register of Controlled Trials CENTRAL (1999-2019), Clinicaltrials.gov (2008-2019) databases, and Google Scholar (2004-2019) database along with the reference list of all included studies.
STUDY ELIGIBILITY CRITERIA
All observational, randomized, and single-arm studies that evaluated medical treatments for vulvar lichen sclerosus were considered eligible for inclusion in the present systematic review.
STUDY APPRAISAL
A network meta-analysis was carried out in R 3.4.3 using the pcnetmeta package, which uses a Bayesian hierarchical model (based in Markov chain Monte Carlo convergence simulation).
RESULTS
Sixteen studies were included in this present meta-analysis, which recruited 954 women with vulvar lichen sclerosus. Their quality was evaluated with the JADAD, Cochrane risk of bias, and risk of bias in nonrandomised studies of interventions-I tools. Clobetasol treatment ranked as the best treatment for disease remission after evaluating rank probabilities (40% chance of ranking first compared with tacrolimus [38%]). However, the density plot revealed partial overlapping with tacrolimus. The lowest probability of experiencing a relapse was observed with pimecrolimus (15% [2-48%]); however, the density plot revealed significant overlapping with mometasone furoate, testosterone, and clobetasol.
CONCLUSION
Robust evidence concerning the superiority of potent steroids at least over calcineurin inhibitors is still lacking in the field of vulvar lichen sclerosus. On the other hand, the gross heterogeneity in terms of selected population, duration of treatment, administered regimen, outcome reporting, and selection of outcome measures leaves several fields unanswered.
Topics: Androgens; Anti-Inflammatory Agents; Calcineurin Inhibitors; Clobetasol; Female; Glucocorticoids; Humans; Mometasone Furoate; Network Meta-Analysis; Practice Guidelines as Topic; Recurrence; Remission Induction; Tacrolimus; Testosterone; Vulvar Lichen Sclerosus
PubMed: 31697910
DOI: 10.1016/j.ajog.2019.10.095 -
Medicine Jul 2019This study aims to systematically explore the efficacy and safety of mometasone furoate (MTF) for patients with nasal polyps (NP).
BACKGROUND
This study aims to systematically explore the efficacy and safety of mometasone furoate (MTF) for patients with nasal polyps (NP).
METHODS
We will search MEDLINE, Cochrane Library, PubMed, Springer, Web of Science, Ovid, Wangfang and Chinese Biomedical Literature Database from their inception to April 30, 2019 without language restrictions. All randomized controlled trials (RCTs) of MTF for the treatment of NP will be considered for inclusion. RevMan 5.3 software will be used for data synthesis, subgroup analysis, sensitivity analysis, as well as the meta-analysis.
RESULTS
Primary outcomes include change in symptom scores (as measured by any symptom scores), and polyp size (as assessed by any Polyp size scores or tools). Secondary outcomes consist of polyp recurrence, change in nasal air flow, quality of life outcomes (as measured by any quality of life scales, such as Short Form Health Survey is a 36-item), and adverse events.
CONCLUSION
This study will provide evidence for judging whether MTF is an effective and safe treatment for NP or not.
PROSPERO REGISTRATION NUMBER
PROSPERO CRD42019134037.
Topics: Administration, Intranasal; Anti-Inflammatory Agents; Humans; Mometasone Furoate; Nasal Polyps; Quality of Life; Randomized Controlled Trials as Topic; Recurrence; Research Design
PubMed: 31348314
DOI: 10.1097/MD.0000000000016632 -
The Cochrane Database of Systematic... Apr 2019Hand eczema is an inflammation of the skin of the hands that tends to run a chronic, relapsing course. This common condition is often associated with itch, social... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Hand eczema is an inflammation of the skin of the hands that tends to run a chronic, relapsing course. This common condition is often associated with itch, social stigma, and impairment in employment. Many different interventions of unknown effectiveness are used to treat hand eczema.
OBJECTIVES
To assess the effects of topical and systemic interventions for hand eczema in adults and children.
SEARCH METHODS
We searched the following up to April 2018: Cochrane Skin Group Specialised Register, CENTRAL, MEDLINE, Embase, AMED, LILACS, GREAT, and four trials registries. We checked the reference lists of included studies for further references to relevant trials.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that compared interventions for hand eczema, regardless of hand eczema type and other affected sites, versus no treatment, placebo, vehicle, or active treatments.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Primary outcomes were participant- and investigator-rated good/excellent control of symptoms, and adverse events.
MAIN RESULTS
We included 60 RCTs, conducted in secondary care (5469 participants with mild to severe chronic hand eczema). Most participants were over 18 years old. The duration of treatment was short, generally up to four months. Only 24 studies included a follow-up period. Clinical heterogeneity in treatments and outcome measures was evident. Few studies performed head-to-head comparisons of different interventions. Risk of bias varied considerably, with only five studies at low risk in all domains. Twenty-two studies were industry-funded.Eighteen trials studied topical corticosteroids or calcineurin inhibitors; 10 studies, phototherapy; three studies, systemic immunosuppressives; and five studies, oral retinoids. Most studies compared an active intervention against no treatment, variants of the same medication, or placebo (or vehicle). Below, we present results from the main comparisons.Corticosteroid creams/ointments: when assessed 15 days after the start of treatment, clobetasol propionate 0.05% foam probably improves participant-rated control of symptoms compared to vehicle (risk ratio (RR) 2.32, 95% confidence interval (CI) 1.38 to 3.91; number needed to treat for an additional beneficial outcome (NNTB) 3, 95% CI 2 to 8; 1 study, 125 participants); the effect of clobetasol compared to vehicle for investigator-rated improvement is less clear (RR 1.43, 95% CI 0.86 to 2.40). More participants had at least one adverse event with clobetasol (11/62 versus 5/63; RR 2.24, 95% CI 0.82 to 6.06), including application site burning/pruritus. This evidence was rated as moderate certainty.When assessed 36 weeks after the start of treatment, mometasone furoate cream used thrice weekly may slightly improve investigator-rated symptom control compared to twice weekly (RR 1.23, 95% CI 0.94 to 1.61; 1 study, 72 participants) after remission is reached. Participant-rated symptoms were not measured. Some mild atrophy was reported in both groups (RR 1.76, 95% CI 0.45 to 6.83; 5/35 versus 3/37). This evidence was rated as low certainty.Irradiation with ultraviolet (UV) light: local combination ultraviolet light therapy (PUVA) may lead to improvement in investigator-rated symptom control when compared to local narrow-band UVB after 12 weeks of treatment (RR 0.50, 95% CI 0.22 to 1.16; 1 study, 60 participants). However, the 95% CI indicates that PUVA might make little or no difference. Participant-rated symptoms were not measured. Adverse events (mainly erythema) were reported by 9/30 participants in the narrow-band UVB group versus none in the PUVA group. This evidence was rated as moderate certainty.Topical calcineurin inhibitors: tacrolimus 0.1% over two weeks probably improves investigator-rated symptom control measured after three weeks compared to vehicle (14/14 tacrolimus versus 0/14 vehicle; 1 study). Participant-rated symptoms were not measured. Four of 14 people in the tacrolimus group versus zero in the vehicle group had well-tolerated application site burning/itching.A within-participant study in 16 participants compared 0.1% tacrolimus to 0.1% mometasone furoate but did not measure investigator- or participant-rated symptoms. Both treatments were well tolerated when assessed at two weeks during four weeks of treatment.Evidence from these studies was rated as moderate certainty.Oral interventions: oral cyclosporin 3 mg/kg/d probably slightly improves investigator-rated (RR 1.88, 95% CI 0.88 to 3.99; 1 study, 34 participants) or participant-rated (RR 1.25, 95% CI 0.69 to 2.27) control of symptoms compared to topical betamethasone dipropionate 0.05% after six weeks of treatment. The risk of adverse events such as dizziness was similar between groups (up to 36 weeks; RR 1.22, 95% CI 0.80 to 1.86, n = 55; 15/27 betamethasone versus 19/28 cyclosporin). The evidence was rated as moderate certainty.Alitretinoin 10 mg improves investigator-rated symptom control compared with placebo (RR 1.58, 95% CI 1.20 to 2.07; NNTB 11, 95% CI 6.3 to 26.5; 2 studies, n = 781) and alitretinoin 30 mg also improves this outcome compared with placebo (RR 2.75, 95% CI 2.20 to 3.43; NNTB 4, 95% CI 3 to 5; 2 studies, n = 1210). Similar results were found for participant-rated symptom control: alitretinoin 10 mg RR 1.73 (95% CI 1.25 to 2.40) and 30 mg RR 2.75 (95% CI 2.18 to 3.48). Evidence was rated as high certainty. The number of adverse events (including headache) probably did not differ between alitretinoin 10 mg and placebo (RR 1.01, 95% CI 0.66 to 1.55; 1 study, n = 158; moderate-certainty evidence), but the risk of headache increased with alitretinoin 30 mg (RR 3.43, 95% CI 2.45 to 4.81; 2 studies, n = 1210; high-certainty evidence). Outcomes were assessed between 48 and 72 weeks.
AUTHORS' CONCLUSIONS
Most findings were from single studies with low precision, so they should be interpreted with caution. Topical corticosteroids and UV phototherapy were two of the major standard treatments, but evidence is insufficient to support one specific treatment over another. The effect of topical calcineurin inhibitors is not certain. Alitretinoin is more effective than placebo in controlling symptoms, but advantages over other treatments need evaluating.Well-designed and well-reported, long-term (more than three months), head-to-head studies comparing different treatments are needed. Consensus is required regarding the definition of hand eczema and its subtypes, and a standard severity scale should be established.The main limitation was heterogeneity between studies. Small sample size impacted our ability to detect differences between treatments.
Topics: Calcineurin Inhibitors; Eczema; Emollients; Humans; Immunosuppressive Agents; Odds Ratio; Pruritus; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome
PubMed: 31025714
DOI: 10.1002/14651858.CD004055.pub2 -
Otolaryngology--head and Neck Surgery :... Jul 2019Intranasal corticosteroids (INCSs) are widely utilized for the treatment of allergic rhinitis. Epistaxis is a known adverse effect of INCSs, but it is not known if the... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Intranasal corticosteroids (INCSs) are widely utilized for the treatment of allergic rhinitis. Epistaxis is a known adverse effect of INCSs, but it is not known if the risk of epistaxis differs among INCSs.
DATA SOURCES
Systematic review of primary studies identified through Medline, Embase, Web of Science, PubMed Central, and Cochrane databases.
REVIEW METHODS
Systematic review was conducted according to the PRISMA standard. English-language studies were queried through February 1, 2018. The search identified randomized controlled trials of INCSs for treatment of allergic rhinitis that reported incidence of epistaxis. An itemized assessment of the risk of bias was conducted for each included study, and meta-analysis was performed of the relative risk of epistaxis for each INCS.
RESULTS
Of 949 identified studies, 72 met the criteria for analysis. Meta-analysis demonstrated an overall relative risk of epistaxis of 1.48 (95% CI, 1.32-1.67) for all INCSs. The INCSs associated with the highest risk of epistaxis were beclomethasone hydrofluoroalkane, fluticasone furoate, mometasone furoate, and fluticasone propionate. Beclomethasone aqueous, ciclesonide hydrofluoroalkane, and ciclesonide aqueous were associated with the lowest risk of epistaxis. Conclusions about epistaxis with use of budesonide, triamcinolone, and flunisolide are limited due to the low number of studies and high heterogeneity.
CONCLUSIONS
While a differential effect on epistaxis among INCS agents is not clearly demonstrated, this meta-analysis does confirm an increased risk of epistaxis for patients using INCSs as compared with placebo for treatment of allergic rhinitis.
Topics: Administration, Intranasal; Adrenal Cortex Hormones; Epistaxis; Humans; Nasal Sprays; Rhinitis, Allergic; Risk
PubMed: 30779679
DOI: 10.1177/0194599819832277 -
Recenti Progressi in Medicina Apr 2017Inhaled glucocorticoids are anti-inflammatory drugs used in combination with long acting bronchodilators beta2-agonists for the treatment of stable chronic obstructive... (Review)
Review
Inhaled glucocorticoids are anti-inflammatory drugs used in combination with long acting bronchodilators beta2-agonists for the treatment of stable chronic obstructive pulmonary disease (COPD), to improve lung function and symptoms and to reduce the future risk COPD exacerbations. However, has been also associated to an increased risk of pneumonia. The objective of this systematic review was therefore to analyze all randomized controlled trials to identify the risk of pneumonia during the regular treatment with long-term inhaled glucocorticosteroids compared to treatment with placebo in patients with stable COPD. From a literature search on PubMed, 19 randomized, placebo-controlled, long term (at least 52-week) studies have been identified. The inhaled glucocorticoids administered were: budesonide (6 studies), mometasone furoate (3 studies), beclomethasone dipropionate (1 study), triamcinolone acetonide (1 study), fluticasone propionate (7 studies) and fluticasone furoate (1 study). Only 7 of the 19 trials identified in our systematic review reported data on pneumonia and only one study required radiological evidence for diagnosis. The incidence of pneumonia was slightly increased in patients treated with glucocorticoid inhaled compared to placebo in most studies, regardless of the type of glucocorticoid inhalation used, suggesting a class effect. Older age, low body mass index, low FEV1, being a smoker are all factors variously associated with increased risk of pneumonia.
Topics: Administration, Inhalation; Age Factors; Anti-Inflammatory Agents; Bronchodilator Agents; Drug Therapy, Combination; Glucocorticoids; Humans; Pneumonia; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Risk Factors; Smoking
PubMed: 28492586
DOI: 10.1701/2681.27453 -
Allergy and Asthma Proceedings Nov 2016Maintenance therapy with oral corticosteroid (OCS) is used, although not based on evidence, for patients with severe asthma, but OCS is associated with serious adverse... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Maintenance therapy with oral corticosteroid (OCS) is used, although not based on evidence, for patients with severe asthma, but OCS is associated with serious adverse effects; therefore, management strategies aimed at steroid sparing are important.
OBJECTIVE
To provide an update on the evidence for OCS-sparing strategies in adults with severe asthma.
METHODS
A systematic literature review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
A total of 21 studies (which comprised 3060 subjects) were included. Of the nonbiologic oral steroidsparing strategies (n = 5), the following lowered the OCS dose: Internet-based tapering strategy (44% reduction in OCS dose), inhaled corticosteroids (mometasone furoate [mean daily OCS dose reduction of 39% and 31% in patients treated with 800 mcg/day and 1600 mcg/day, respectively] and ciclesonide [OCS dose reduction of 47% and 63% in patients treated with 640 mcg/day and 1.280 mcg/day, respectively]), and methotrexate (OCS dose reduction of 55%). Of the biologic oral steroidtapering strategies (16 studies) the following agents lowered the OCS dose: cyclosporin A (62% reduction in OCS dose), masitinib (78% reduction in OCS dose), mepolizumab (50%83% reduction in OCS dose), and omalizumab (30%64% of enrolled patients achieved a reduction in OCS dose, and one study reported a dose reduction of 45%).
CONCLUSIONS
In adults with severe asthma, several corticosteroid-sparing interventions were shown to be effective in reducing systemic steroid exposure, not least in studies of add-on biologic therapy. However, based on the available studies, ciclesonide, based on the low potential for systemic effect, especially seems to be a good candidate for reducing steroid exposure in these patients before possible initiation of biologic therapy.
Topics: Administration, Inhalation; Administration, Oral; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Antibodies, Monoclonal; Asthma; Biomarkers; Humans; Immunosuppressive Agents; Severity of Illness Index; Treatment Outcome
PubMed: 27931289
DOI: 10.2500/aap.2016.37.4004 -
American Journal of Clinical Dermatology Apr 2017Facial seborrheic dermatitis (SD), a chronic inflammatory skin condition, can impact quality of life, and relapses can be frequent. Three broad categories of agents are... (Review)
Review
BACKGROUND
Facial seborrheic dermatitis (SD), a chronic inflammatory skin condition, can impact quality of life, and relapses can be frequent. Three broad categories of agents are used to treat SD: antifungal agents, keratolytics, and corticosteroids. Topical therapies are the first line of defense in treating this condition.
OBJECTIVE
Our objective was to critically review the published literature on topical treatments for facial SD.
METHODS
We searched PubMed, Scopus, Clinicaltrials.gov, MEDLINE, Embase, and Cochrane library databases for original clinical studies evaluating topical treatments for SD. We then conducted both a critical analysis of the selected studies by grading the evidence and a qualitative comparison of results among and within studies.
RESULTS
A total of 32 studies were eligible for inclusion, encompassing 18 topical treatments for facial SD. Pimecrolimus, the focus of seven of the 32 eligible studies, was the most commonly studied topical treatment.
CONCLUSION
Promiseb, desonide, mometasone furoate, and pimecrolimus were found to be effective topical treatments for facial SD, as they had the lowest recurrence rate, highest clearance rate, and the lowest severity scores (e.g., erythema, scaling, and pruritus), respectively. Ciclopirox olamine, ketoconazole, lithium (gluconate and succinate), and tacrolimus are also strongly recommended (level A recommendations) topical treatments for facial SD, as they are consistently effective across high-quality trials (randomized controlled trials).
Topics: Administration, Cutaneous; Anti-Inflammatory Agents; Antifungal Agents; Calcineurin Inhibitors; Ciclopirox; Dermatitis, Seborrheic; Dermatologic Agents; Desonide; Facial Dermatoses; Humans; Ketoconazole; Malassezia; Mometasone Furoate; Plant Preparations; Practice Guidelines as Topic; Pyridones; Quality of Life; Randomized Controlled Trials as Topic; Tacrolimus; Treatment Outcome; Vitamins
PubMed: 27804089
DOI: 10.1007/s40257-016-0232-2 -
The Cochrane Database of Systematic... Sep 2016Vilanterol (VI) is a long-acting beta-agonist (LABA) that binds to the beta-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is... (Review)
Review
BACKGROUND
Vilanterol (VI) is a long-acting beta-agonist (LABA) that binds to the beta-adrenoceptor on the airway smooth muscle, producing bronchodilation. LABA therapy, which is well established in adults as part of the British Thoracic Society (BTS) Guidelines for the Management of Asthma, leads to improvement in symptoms and lung function and reduction in exacerbations. At present, the commonly used LABAs licensed for use in asthma management (formoterol and salmeterol) require twice-daily administration, whereas VI is a once-daily therapy.Fluticasone furoate (FF) is an inhaled corticosteroid (ICS), and ICS therapy is recommended by the BTS asthma guidelines. ICSs, the mainstay of asthma treatment, lead to a reduction in both airway inflammation and airway hyper-responsiveness. Regular use leads to improvement in symptoms and lung function. ICSs are currently recommended as 'preventer' therapy for patients who use a 'reliever' medication (e.g. short-acting beta agonist (SABA), salbutamol) three or more times per week. Most of the commonly used ICS treatments are twice-daily medications, although two once-daily products are currently licensed (ciclesonide and mometasone).At the present time, only one once-daily ICS/LABA combination (FF/VI) is available, and several other combination inhalers are recommended for twice-daily administration.
OBJECTIVES
To compare effects of VI and FF in combination versus placebo, or versus other ICSs and/or LABAs, on acute exacerbations and on health-related quality of life (HRQoL) in adults and children with chronic asthma.
SEARCH METHODS
We searched the Cochrane Airways Group Register of trials, clinical trial registries, manufacturers' websites and reference lists of included studies up to June 2016.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of adults and children with a diagnosis of asthma. Included studies compared VI and FF combined versus placebo, or versus other ICSs and/or LABAs. Our primary outcomes were health-related quality of life, severe asthma exacerbation, as defined by hospital admissions or treatment with a course of oral corticosteroids, and serious adverse events.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and analysed outcomes using a fixed-effect model. We used standard Cochrane methods.
MAIN RESULTS
We identified 14 studies that met our inclusion criteria, with a total of 6641 randomised participants, of whom 5638 completed the study. All studies lasted between two and 78 weeks and showed good methodological quality overall.We included 10 comparisons in this review, seven for which the dose of VI and FF was 100/25 mcg (VI/FF 100/25 mcg vs placebo; VI/FF 100/25 mcg vs same dose of FF; VI/FF 100/25 mcg vs same dose of VI; VI/FF 100/25 mcg vs fluticasone propionate (FP) 500 mcg twice-daily; VI/FF 100/25 mcg vs fluticasone propionate/salmeterol (FP/SAL) 250/50 mcg twice-daily; VI/FF 100/25 mcg vs FP/SAL 250/25 mcg twice-daily; FF/VI 100/25 vs FP/SAL500/50) and three for which the dose of VI and FF was 200/25 mcg (VI/FF 200/25 mcg vs placebo; VI/FF 200/25 mcg vs FP 500 mcg; VI/FF 200/25 mcg vs same dose of FF).We found very few opportunities to combine results from the 14 included studies in meta-analyses. We tabulated the data for our pre-specified primary outcomes. In particular, we found insufficient information to assess whether once-daily VI/FF was better or worse than twice-daily FP/SAL in terms of efficacy or safety.Only one of the 14 studies looked at health-related quality of life when comparing VI and FF 100/25 mcg versus placebo and identified a significant advantage of VI/FF 100/25 mcg (mean difference (MD) 0.30, 95% confidence interval (CI) 0.14 to 0.46; 329 participants); we recognised this as moderate-quality evidence. Only two studies compared VI/FF 100/25 mcg versus placebo with respect to exacerbations; both studies reported no exacerbations in either treatment arm. Five studies (VI/FF 100/25 mcg vs placebo) sought information on serious adverse events; all five studies reported no serious adverse events in the VI/FF 100/25 mcg or placebo arms. We found no comparison relevant to our primary outcomes for VI/FF at a higher dose (200/25 mcg) versus placebo.The small number of studies contributing to each comparison precludes the opportunity to draw robust conclusions for clinical practice. These studies were not of sufficient duration to allow conclusions about long-term side effects.
AUTHORS' CONCLUSIONS
Some evidence suggests clear advantages for VI/FF, in combination, compared with placebo, particularly for forced expiratory volume in one second (FEV) and peak expiratory flow; however, the variety of questions addressed in the included studies did not allow review authors to draw firm conclusions. Information was insufficient for assessment of whether once-daily VI/FF was better or worse than twice-daily FP/SAL in terms of efficacy or safety. It is clear that more research is required to reduce the uncertainties that surround interpretation of these studies. It will be necessary for these findings to be replicated in other work before more robust conclusions are revealed. Only five of the 13 included studies provided data on health-related quality of life, and only six recorded asthma exacerbations. Only one study focused on paediatric patients, so no conclusions can be drawn for the paediatric population. More research is needed, particularly in the primary outcome areas selected for this review, so that we can draw firmer conclusions in the next update of this review.
PubMed: 27582089
DOI: 10.1002/14651858.CD010758.pub2