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Pediatric Allergy and Immunology :... May 2018Chronic spontaneous urticaria (CSU) is not frequent in children. Management guidelines have been developed for adults and randomized controlled trials (RCTs) included... (Review)
Review
BACKGROUND
Chronic spontaneous urticaria (CSU) is not frequent in children. Management guidelines have been developed for adults and randomized controlled trials (RCTs) included teenagers aged 12-18, but data for children under age 12 are limited. We performed a systematic review to assess comorbidities in children <12 years old with CSU and the efficacy and safety of treatments.
METHODS
We searched for original articles of epidemiologic and treatment data in children <12 years old with CSU that were published from 2005 to July 2016 in MEDLINE, EMBASE, CENTRAL, and LILACS. Article selection and data extraction were performed in duplicate.
RESULTS
Our systematic review included 9 reports on epidemiologic data (633 children). Five comorbidities and laboratory anomalies associated with CSU found were atopy (28.1%), positive autologous serum skin test (36.8%), thyroid biologic anomalies (6.4%) and detectable antinuclear antigen (10.4%), seroprevalence for Helicobacter pylori (21.1%), low vitamin D level (69.1%), and psychiatric disorders (70.4%). Only one study allowed for comparison with a control group. Our review included 10 studies (322 children), describing 5 different drug families, mostly H1-antihistamines (n = 297). One randomized controlled study compared single-dose rupatadine with single-dose desloratadine and placebo. Cyclosporine was effective and had no adverse effects in 18 children. Omalizumab, montelukast, and cefuroxime were reported in very small series (5, 1, and 1 patients).
CONCLUSIONS
H1-antihistamines are effective for CSU in children <12 years old, with reassuring safety data at licensed doses. Cyclosporine seems effective, but the level of evidence is low.
Topics: Child; Child, Preschool; Chronic Disease; Comorbidity; Histamine Antagonists; Humans; Immunosuppressive Agents; Prevalence; Urticaria
PubMed: 29392757
DOI: 10.1111/pai.12870 -
The West Indian Medical Journal May 2015To systematically assess the efficacy and safety of montelukast for postinfectious cough (PIC) and to propose a recommendation via a systematic review of all available...
OBJECTIVES
To systematically assess the efficacy and safety of montelukast for postinfectious cough (PIC) and to propose a recommendation via a systematic review of all available randomized controlled trials (RCTs).
METHODS
Electronic databases and relevant journals were searched for RCTs from inception to July 2014. In addition, some unpublished literature was also searched. All studies included in the systematic review met the same inclusion criteria. Methodological quality and evidence quality were examined according to Cochrane handbook. The data were extracted and trial quality was assessed independently by two reviewers.
RESULTS
Fourteen RCTs involving 1372 patients were included in our review. The methodological quality of the included trials was poor because one or more biases were observed in these studies. The quality of evidence was low to moderate levels. All trials reported better effect favouring montelukast treatment. Findings suggested that compared with other Western medication and Chinese medicine, montelukast showed significant effects in shortening cough relief time, increasing the clinic obvious effective rate, decreasing coughing frequency and severity, and improving quality of life. Adverse events were mentioned in six studies, but no serious adverse effects were reported in any of them.
CONCLUSIONS
Montelukast demonstrated potential positive efficacy and safety for PIC; however, we could not come to a firm conclusion on the efficacy and safety of montelukast for PIC. More high quality randomized controlled trials are required to confirm the efficacy and safety of montelukast for PIC.
PubMed: 28358440
DOI: 10.7727/wimj.2014.219 -
The Journal of Allergy and Clinical... Jan 2013Allergic eye diseases are common and cause significant morbidity. Leukotrienes are implicated in the pathogenesis of seasonal and perennial allergic conjunctivitis (AC),... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Allergic eye diseases are common and cause significant morbidity. Leukotrienes are implicated in the pathogenesis of seasonal and perennial allergic conjunctivitis (AC), commonly seen in conjunction with allergic rhinitis, and in vernal keratoconjunctivitis and atopic keratoconjunctivitis.
OBJECTIVES
To assess the available evidence for an effect of leukotriene receptor antagonists (LTRAs) on the ocular symptoms of allergic eye diseases.
METHODS
Selected studies, identified with systematic review search methods, were single/double-blind, randomized, controlled trials that compared LTRAs with other common treatments.
RESULTS
Eighteen trials, using the LTRA montelukast (in AC only), were identified. Six studies were suitable for meta-analysis, in patients with seasonal AC [treated over a 2-week period, symptoms scored 0 (mild) to 3 (severe)]. These trials were at low risk of bias without significant heterogeneity. Six trials were analyzed and showed that montelukast improved patients' ocular symptoms to a greater extent than placebo, with a difference in mean change-from-baseline score of -0.10 (95% CI, -0.14 to -0.07; P < .00001). Three trials compared montelukast with oral antihistamine. The difference in mean change-from-baseline score was 0.08 (95% CI, 0.02 to 0.14; P = .007), in favor of antihistamines. Two trials compared montelukast and oral antihistamine with placebo. The difference in mean change-from-baseline score was -0.30 (95% CI, -0.38 to -0.21; P < .00001), in favor of combination treatment.
CONCLUSIONS
In seasonal AC LTRAs are more efficacious than placebo but less efficacious than oral antihistamines in adult patients. Clinical trials should be conducted to determine whether combination treatment with LTRA and oral antihistamine has a synergistic effect. Further research is required to clarify the role of LTRAs in other allergic eye diseases.
Topics: Adolescent; Adult; Anti-Asthmatic Agents; Child; Child, Preschool; Conjunctivitis, Allergic; Histamine Antagonists; Humans; Leukotriene Antagonists; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 24229824
DOI: 10.1016/j.jaip.2012.07.001 -
American Journal of Rhinology & Allergy 2015Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) and asthma are strongly associated, and patients suffering from both diseases are often difficult to treat.... (Review)
Review
BACKGROUND
Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) and asthma are strongly associated, and patients suffering from both diseases are often difficult to treat. However, no guidelines about the management of patients with CRS and coexisting asthma exist.
OBJECTIVE
The purpose of this systematic review was to evaluate the management of CRSwNP and coexisting asthma.
METHODS
We systematically searched electronic databases and included clinical trials in which the clinical outcomes after medical or surgical treatment of patients with CRSwNP and asthma were assessed. The strength of the evidence for each outcome was graded on the basis of study quality and consistency in findings.
RESULTS
We included seven trials in which the effect of montelukast, omalizumab, erythromycin, and functional endoscopic sinus surgery (FESS) were studied in 317 adults with CRSwNP and asthma. All the interventions improved the majority of subjective and objective nasal outcomes significantly. However, few studies found significant effects on pulmonary function tests. The strength of the evidence was low overall.
CONCLUSION
Both FESS and medical interventions with systemic anti-inflammatory drugs improved nasal outcomes, although their efficacy in relation to the lower airways remains unclear. A low number of studies met inclusion criteria for this systematic review, which emphasizes the need for high-quality trials to explore the treatment of patients with CRSwNP and coexisting asthma.
Topics: Acetates; Anti-Asthmatic Agents; Asthma; Chronic Disease; Cyclopropanes; Endoscopy; Humans; Leukotriene Antagonists; Nasal Polyps; Omalizumab; Quality of Life; Quinolines; Rhinitis; Sinusitis; Sulfides
PubMed: 25975250
DOI: 10.2500/ajra.2015.29.4178 -
European Journal of Gastroenterology &... Jan 2023Fibrosis impacts long-term outcomes among patients with nonalcoholic fatty liver disease (NAFLD). Due to well-documented flaws associated with liver biopsy, there has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Fibrosis impacts long-term outcomes among patients with nonalcoholic fatty liver disease (NAFLD). Due to well-documented flaws associated with liver biopsy, there has been a recent emphasis on prioritizing noninvasive testing over liver biopsy for the assessment of fibrosis.
METHODS
A comprehensive systematic review and frequentist random effects network meta-analysis was performed among randomized controlled trials reporting pharmacologic intervention in NAFLD. The primary endpoint was the absolute change in liver stiffness measurement (LSM) via elastography. Secondary endpoints included changes in noninvasive serologic tests including APRI, fibrosis-4 index, NAFLD fibrosis score, enhanced liver fibrosis (ELF) and FibroTest (FibroSure in the USA).
RESULTS
Forty-five randomized controlled trials enrolling 6932 patients were identified for this network meta-analysis. Across the primary endpoint, firsocostat, semaglutide, montelukast, cilofexor plus firsocostat, obeticholic acid and diacerein (change in LSM via vibration controlled transient elastography), in addition to lubiprostone and pemafibrate (change in LSM via magnetic resonance elastography) were found to be the most effective and statistically significant treatment interventions. Similarly, the following interventions were determined to be most effective as compared to placebo among secondary endpoints: saroglitazar, lubiprostone, and obeticholic acid (change in APRI); saroglitazar, semaglutide, firsocostat and cilofexor plus firsocostat (change in ELF); obeticholic acid and belapectin [change in FibroTest/FibroSure].
CONCLUSION
This is the first systematic review and network meta-analysis reporting pharmacologic efficacy in the progression of fibrosis based on noninvasive testing among patients with NAFLD. Semaglutide, obeticholic acid, firsocostat, cilofexor plus firsocostat and lubiprostone were found to be the most effective treatments based on their consistent efficacy reproduced across multiple endpoints, both via elastography and noninvasive blood tests.
Topics: Humans; Non-alcoholic Fatty Liver Disease; Lubiprostone; Network Meta-Analysis; Liver Cirrhosis; Randomized Controlled Trials as Topic
PubMed: 36468574
DOI: 10.1097/MEG.0000000000002463 -
Archives of Disease in Childhood May 2010To compare the efficacy of inhaled corticosteroids (ICS) versus montelukast (MONT) in schoolchildren and adolescents with mild-moderate persistent asthma. (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVE
To compare the efficacy of inhaled corticosteroids (ICS) versus montelukast (MONT) in schoolchildren and adolescents with mild-moderate persistent asthma.
METHODS
Randomised, prospective, controlled trials published January 1996 to November 2009 with a minimum of 4 weeks of ICS versus MONT and of ICS versus MONT+ICS were retrieved through Medline, Embase and Central databases. The primary outcome was asthma exacerbations requiring systemic corticosteroids (AEX); secondary outcomes were pulmonary function, withdrawal/hospitalisation due to AEX, change in symptoms score, rescue-medication-free days, albuterol use, adverse effects and adherence.
RESULTS
Of 124 studies identified, 18 studies (n=3757 patients) met criteria for inclusion (13 compared ICS vs MONT, 3 ICS vs MONT+ICS and 2 ICS vs MONT vs ICS+MONT). Patients receiving ICS showed a significantly lower risk for AEX than those with MONT (RR=0.83, 95% CI 0.72 to 0.96, p=0.01); post-hoc analysis suggests this effect was independent of quality, sponsorship and study duration. Children treated with ICS had a significant higher pulmonary function (final FEV1 % predicted, change from baseline FEV1 %, final morning peak expiratory flow (PEF)) and better clinical parameters (albuterol use, symptom score, rescue-medication-free days, withdrawals due to AEX) versus MONT. No significant difference in primary or secondary outcomes was found when MONT was added on to ICS versus ICS alone; however, these analyses were based on only two studies.
CONCLUSIONS
Schoolchildren and adolescents with mild-moderate persistent asthma treated with ICS had less AEX and better lung function and asthma control than with MONT. There are insufficient data to determine whether the addition of MONT to ICS improves outcome.
Topics: Acetates; Adolescent; Anti-Asthmatic Agents; Asthma; Child; Child, Preschool; Cyclopropanes; Drug Therapy, Combination; Forced Expiratory Volume; Glucocorticoids; Humans; Peak Expiratory Flow Rate; Quinolines; Randomized Controlled Trials as Topic; Sulfides; Treatment Outcome
PubMed: 19946008
DOI: 10.1136/adc.2009.169177 -
International Journal of Clinical... Oct 2018Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast...
Background Atopic dermatitis (AD) is the most common form of eczema. As leukotriene mediators are involved in the inflammatory phase of atopic dermatitis, montelukast has been suggested as a possible therapy. Aim of the review To evaluate the safety and efficacy of montelukast off-label use for the treatment atopic dermatitis. Method A search was performed from database inception until March 2018 in six electronic databases for randomized-controlled-trials examining the use of montelukast for AD. Results Among 301 articles screened, 11 studies met the inclusion criteria and were included in the review. The study populations consist of paediatric and adult subjects with moderate-to-severe AD. Montelukast use was shown to improve symptoms such as pruritus in four studies. Another 2 studies reported that montelukast could improve symptoms similar to the standard regimen of topical steroid and oral antihistamine. However, five studies reported that montelukast had no effects in symptoms alleviation. The use of montelukast was associated with a similar safety profile to placebo and well-tolerated with minimal adverse effects. Conclusion There is limited evidence to suggest that the off-label use of montelukast is effective in treating moderate-to-severe AD. Further research with larger study populations employing standardized endpoint measuring instrument is warranted to further investigate the off-label use of montelukast in AD treatment. Until then, the use of conventional treatments including optimal daily skin hydration should remain the mainstay in the management of atopic dermatitis. In fact, for moderate-to-severe condition, steroid sparing immune-suppressants should still be used clinically until more effective and safer alternative is discovered.
Topics: Acetates; Cyclopropanes; Dermatitis, Atopic; Humans; Immunosuppressive Agents; Leukotriene Antagonists; Off-Label Use; Quinolines; Randomized Controlled Trials as Topic; Sulfides
PubMed: 29777328
DOI: 10.1007/s11096-018-0655-3 -
The Journal of Allergy and Clinical... Feb 2014Many patients with moderate-to-severe atopic dermatitis (AD) require systemic immunomodulating treatment to achieve adequate disease control. (Review)
Review
BACKGROUND
Many patients with moderate-to-severe atopic dermatitis (AD) require systemic immunomodulating treatment to achieve adequate disease control.
OBJECTIVE
We sought to systematically evaluate the efficacy and safety of systemic treatments for moderate-to-severe AD.
METHODS
A systematic literature search was performed in MEDLINE, EMBASE, and CENTRAL (until June 2012). Randomized controlled trials (RCTs) evaluating systemic immunomodulating treatments for moderate-to-severe AD were included. Selection, data extraction, quality assessment, and generation of treatment recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach were performed independently by 2 reviewers. Efficacy outcomes were clinical signs, symptoms, quality of life, and the course of AD. Safety data were compared by calculating the weekly incidence rates (as percentages) for adverse events.
RESULTS
Thirty-four RCTs with 12 different systemic treatments and totaling 1653 patients were included. Fourteen trials consistently indicate that cyclosporin A efficaciously improves clinical signs of AD. Cyclosporin A is recommended as first-line treatment for short-term use. A second-line treatment option is azathioprine, but efficacy is lower, and evidence is weaker. Methotrexate can be considered a third-line treatment option. Recommendations are impossible for mycophenolate, montelukast, intravenous immunoglobulins, and systemic glucocorticosteroids because of limited evidence. A meta-analysis was not performed because of a lack of standardization in outcome measures.
CONCLUSION
Although 12 different interventions for moderate-to-severe AD have been studied in 34 RCTs, strong recommendations are only possible for the short-term use of cyclosporin A. Methodological limitations in the majority of trials prevent evidence-based conclusions. Large head-to-head trials evaluating long-term treatments are required.
Topics: Azathioprine; Cyclosporine; Dermatitis, Atopic; Glucocorticoids; Humans; Immunosuppressive Agents; Interferon-gamma; Methotrexate; Mycophenolic Acid
PubMed: 24269258
DOI: 10.1016/j.jaci.2013.07.049 -
Thorax May 2008To systematically review the evidence for the medium to long term benefits and risks of montelukast as add-on therapy to inhaled corticosteroids (ICS) in comparison with... (Comparative Study)
Comparative Study Review
OBJECTIVE
To systematically review the evidence for the medium to long term benefits and risks of montelukast as add-on therapy to inhaled corticosteroids (ICS) in comparison with placebo and active controls in mild to moderate asthma.
DATA SOURCES
Medline, Embase, Cochrane Register of Controlled Trials, reference lists of retrieved articles, clinical trial registries and study results databases.
REVIEW METHODS
Systematic review of randomised controlled trials (duration > or = 12 weeks) in adolescents and adults comparing montelukast/ICS versus ICS monotherapy or montelukast/ICS versus active control/ICS. Meta-analyses were conducted where feasible. The main focus was on clinical outcomes (eg, exacerbations). Adverse events were also assessed.
RESULTS
13 studies meeting all of the inclusion criteria were identified: 7 studies, including constant or tapered doses of ICS, compared montelukast/ICS with ICS monotherapy. Six studies compared add-on montelukast with an add-on active control (salmeterol). Overall, the data indicated that montelukast/ICS was clinically more effective than ICS monotherapy. The ICS sparing potential of montelukast was clearly demonstrated in one study. Montelukast/ICS and ICS monotherapy showed similar safety profiles. In the active controlled studies, montelukast/ICS was clinically less effective than salmeterol/ICS in the 12 week trials (pooled proportion of patients with > or = 1 exacerbation: p = 0.006). However, separate analysis of active controlled 48 week trials showed comparable proportions for patients with > or = 1 exacerbation in both groups.
CONCLUSIONS
Montelukast as add-on therapy to ICS improves control of mild to moderate asthma compared with ICS monotherapy. Although the addition of salmeterol to ICS is clinically as effective as or even more effective than the addition of montelukast, montelukast may have a better long term safety profile and offer a treatment alternative for asthma patients.
Topics: Acetates; Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adrenergic beta-Agonists; Adult; Albuterol; Anti-Asthmatic Agents; Asthma; Cyclopropanes; Drug Therapy, Combination; Female; Humans; Male; Quinolines; Randomized Controlled Trials as Topic; Salmeterol Xinafoate; Sulfides
PubMed: 18443162
DOI: 10.1136/thx.2007.081596 -
Frontiers in Pediatrics 2022The global prevalence of allergic diseases has led to a negative and extensive impact on the health and lives of a large population of children. This study investigates...
OBJECTIVE
The global prevalence of allergic diseases has led to a negative and extensive impact on the health and lives of a large population of children. This study investigates the efficacy, acceptability, and safety of cetirizine (CTZ) for treating allergic diseases in children and provides evidence-based assertions for decision-making.
METHODS
PubMed, Embase, the Cochrane Library, World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov, and the European Union Clinical Trials Register were systematically searched from inception to April 21, 2022. Randomized controlled trials (RCTs) or quasi-RCTs of children with allergic diseases receiving CTZ compared with those receiving placebo or other drugs were included without language limitations. Two investigators independently identified articles, extracted data, conducted meta-analyses, assessed the Cochrane risk of bias of individual studies, and evaluated the evidence certainty using the Grading of Recommendations Assessment, Development, and Evaluation approach; any discrepancies were resolved by consulting with a third investigator. Primary outcomes included scales that evaluated the recovery of allergic conditions in AR, such as the total symptom score (TSS). Secondary outcomes included laboratory test changes, safety (adverse events, AEs), and quality of life (QOL). Data were pooled using the Cochrane Review Manager 5.4, and a fixed-effects model was used if heterogeneity was evaluated as low ( < 50%); otherwise, a random-effects model was adopted.
RESULTS
A total of 22 studies (5,867 patients) were ultimately included [eight with perennial AR, six with seasonal AR, four with atopic dermatitis (AD), and four with other allergic diseases], most of which had a low or unclear risk of bias. Moderate certainty evidence showed that CTZ was found to benefit allergic symptom control [mean difference (MD) of TSS at 1 week: MD, -0.32 (-0.52, -0.12); at 2 weeks: MD, -0.25 (-0.35, -0.14); at 4 weeks: MD, -4.07 (-4.71, -3.43); at 8 weeks: MD, -4.22 (-4.73, -3.72); at 12 weeks: MD, -5.63 (-6.14, -5.13); all -values were less than 0.05] and QOL [at 12 weeks: MD, -23.16 (-26.92, -19.39); < 0.00001] in children with AR. It had similar efficacy compared with other antihistamines (AHs) or montelukast, without showing better control of AD severity in children. Moderate-to-low certainty evidence demonstrated that CTZ was well tolerated and did not increase the risk of severe and overall AEs, cardiotoxicity, damage to the central nervous and digestive systems, or other systems in children, except for the risk of somnolence [risk ratio, 1.62 (1.02, 2.57); = 0.04, compared with placebo].
CONCLUSION
Moderate-to-low certainty evidence revealed that CTZ could improve clinical improvement and QOL in children with AR and have comparable efficacy with other AHs. CTZ is well tolerated in the pediatric population, except for an increased risk of somnolence.
SYSTEMATIC REVIEW REGISTRATION
[https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42021262767].
PubMed: 36090559
DOI: 10.3389/fped.2022.940213