Fexofenadine: review of safety, efficacy and unmet needs in children with allergic rhinitis
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ABSTRACT: Supplementary Information
The online version contains supplementary material available at 10.1186/s13223-021-00614-6.
SUBMITTER: Meltzer E
PROVIDER: S-EPMC8561980 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:In recent decades, seasonal allergic rhinitis (SAR) prevalence has increased and recent studies have shown that air pollutants, such as diesel exhaust particles (DEP), can increase inflammatory and allergic biomarkers. The aim of this study was to investigate the effects of DEP on SAR symptoms induced by ragweed and to evaluate the efficacy and safety of fexofenadine HCl 180 mg versus placebo. This phase 3, single-centre, sequential, parallel-group, double-blind, randomised study (NCT03664882) was conducted in an environmental exposure unit (EEU) during sequential exposures: Period 1 (ragweed pollen alone), Period 2 (ragweed pollen+DEP), and Period 3 (ragweed pollen+DEP+single-dose fexofenadine HCl 180 mg or placebo). Efficacy and safety were evaluated in Period 3. Primary endpoints were the area under the curve (AUC) of total nasal symptom score (TNSS) from baseline to hour 12 (AUC0-12) during Period 1 and Period 2; and the AUC of the TNSS from hour 2 to 12 (AUC2-12) during Period 3. 251 out of 257 evaluable subjects were included in the modified intent-to-treat population. Least squares mean difference (95% CI) for TNSS Log AUC0-12 in Period 2 versus Period 1 was 0.13 (0.081-0.182; p<0.0001). Least squares mean difference in TNSS Log AUC2-12 for fexofenadine HCl versus placebo during Period 3 was -0.24 (-0.425--0.047; p=0.0148). One fexofenadine HCl-related adverse event was observed. SAR symptoms evoked by ragweed were aggravated by DEP. Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.
| S-EPMC8021806 | biostudies-literature
Project description:In this study, we aim to evaluate the efficacy and safety of Guizhi Decoction associated formulas for the treatment of allergic rhinitis. A total of seven online databases were searched to collect studies published up to Feb 23rd, 2020. Study quality of each included article was evaluated by the Cochrane Collaboration risk of bias tool. Systematic reviews were conducted based on the Cochrane systematic review method by using RevMan 5.3 Software. Among the included trials, Guizhi Decoction associated formulas alone (or plus Western medicine, or acupoint-based therapy) were main therapies in experimental groups. Interventions in control groups include Western medicine, Guizhi Decoction associated formulas alone, Chinese patent medicine, and placebo control. Primary outcomes in this study include recovery rate, accumulative marked effective rate, accumulative effective rate, and recurrence rate. Finally, 23 trials involving 2281 participants were included. Results of systematic reviews show that Guizhi Decoction and associated formulas alone, plus Western medicine or plus acupoint-based therapies, were significantly better compared with using Western medicine alone in terms of efficacy. In addition, the formulas plus nasal TCM fumigation therapy could improve effective rate for AR treatment compared to using the formulas alone. More types and cases of adverse events were reported in the control groups (Western medicine alone), but events of included trials were all mild and did not need specific medical intervention. More RCTs of high quality, and large sample size, with appropriate blinding methods or nonblinded pragmatic trials of Guizhi Decoction and associated formulas for AR are needed.
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Project description:BackgroundIntralymphatic immunotherapy (ILIT) is a potential treatment option for allergic rhinitis (AR). We aimed to determine the efficacy (primary outcomes) and safety (secondary outcomes) of ILIT in treating patients with AR.MethodsAn electronic literature search was performed using MEDLINE and Cochrane Central Register of Controlled Trials CENTRAL (from their inception to December 2020). A random-effects model was used to estimate the pooled prevalence with 95% confidence intervals. This study is registered with PROSPERO (CRD42019126271).ResultsWe retrieved a total of 285 articles, of which 11 satisfied our inclusion criteria. There were 452 participants with age ranged from 15 to 58 years old. Intralymphatic immunotherapy was given in three doses with intervals of four weeks between doses in 10 trials. One trial gave three and six doses with an interval of two weeks. Both primary and secondary outcomes showed no difference between ILIT and placebo for all trials. There was no difference in the combined symptoms and medication score (SMD -0.51, 95% CI -1.31 to 0.28), symptoms score (SMD -0.27, 95% CI -0.91 to 0.38), medication score (SMD -6.56, 95% CI -21.48 to 8.37), rescue medication (RR 12.32, 95% CI 0.72-211.79) and the overall improvement score (MD -0.07, 95% CI -2.28 to 2.14) between ILIT and placebo. No major adverse events noted.ConclusionsIntralymphatic immunotherapy possibly has a role in the treatment of AR patients. This review found it is safe but not effective, which could be contributed by the high variation amongst the trials. Future trials should involve larger numbers of participants and report standardized administration of ILIT and outcome measures.
| S-EPMC8369948 | biostudies-literature
Project description:BackgroundProbiotics have proven beneficial in a number of immune-mediated and allergic diseases. Several human studies have evaluated the efficacy and safety of probiotics in allergic rhinitis; however, evidence for their use has yet to be firmly established.ObjectiveWe undertook a systematic review and meta-analysis aiming to address the effect and safety of probiotics on allergic rhinitis.MethodsWe systematically searched databases [MEDLINE (PubMed), Embase, and the Cochrane Central Register of Controlled Trials] from inception until June 1, 2021. Qualified literature was selected according to inclusion and exclusion criteria, the data were extracted, and a systematic review and meta-analysis was conducted.ResultsTwenty-eight studies were included. The results showed that probiotics significantly relieved allergic rhinitis symptoms (standardized mean difference [SMD], -0.29, 95% confidence interval (CI) [-0.44, -0.13]; p = 0.0003, I 2 = 89%), decreased Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores compared with the control group (SMD, -0.64, 95% CI [-0.79, -0.49], p < 0.00001, I 2 = 97%), and increased T helper cell 1(Th1)/Th2 ratio (mean difference [MD], -2.47, 95% CI [-3.27, -1.68], p < 0.00001, I 2 = 72%). There was no significant change in overall or specific IgE levels between probiotic-treated and placebo-treated subjects (SMD, 0.09, 95% CI [-0.16, 0.34], I 2 = 0%, and SMD, -0.03, 95% CI [-0.18, 0.13], p = 0.72, I 2 = 0%, respectively).ConclusionsTo sum up, probiotic supplement seems to be effective in ameliorating allergic rhinitis symptoms and improving the quality of life, but there is high heterogeneity in some results after subgroup analysis and clinicians should be cautious when recommending probiotics in treating allergic rhinitis.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/, PROSPERO (CRD42021242645).
| S-EPMC9161695 | biostudies-literature
Project description:Childhood asthma is one condition within a family of allergic diseases, which includes allergic rhinitis, atopic dermatitis, and food allergy, among others. Omalizumab is an anti-IgE antibody therapy that was approved in Japan for children with asthma and added to the Japanese pediatric asthma guidelines in 2017. This review highlights the Japanese clinical perspectives in pediatric allergic asthma, and consideration for allergic comorbidities, and reflects on omalizumab clinical trials in progress to present comprehensive future opportunities.
| S-EPMC6365659 | biostudies-literature
Project description:Nasya/Prevalin is a natural, drug-free nasal spray for treatment and prevention of allergic rhinitis. Because of its thixotropic property, it forms a barrier on the nasal mucosa, preventing allergen contact. This study assesses the clinical efficacy and safety of Nasya/Prevalin in a nasal provocation test with house dust mite allergens.In this randomised, double-blind, placebo-controlled trial, 20 subjects suffering from allergic rhinitis because of house dust mite allergens received a single dose of Nasya/Prevalin or saline spray before allergen challenge. Total nasal symptom score and total ocular symptom score were assessed 15, 30, 60, 75, 90, 120 and 240?min after challenge. Further, the appearance of the mucosa was examined by rhinoscopy.A single treatment with Nasya/Prevalin led to a significant reduction of TNSS at 60, 75 and 90?min after dust mite allergen challenge as compared with placebo (pVCAS ?=?0.021, pVCAS ?=?0.035, pVCAS ?=?0.036, respectively). Mucosa changes assessed by the rhinoscopic score (on swelling, secretion and colour) were significantly worse in the placebo group compared with the Nasya/Prevalin group (P?=?0.033). Nasya/Prevalin was well tolerated, and the safety was comparable with placebo.Treatment with Nasya/Prevalin was effective in preventing allergic reactions induced by dust mite allergen challenge.
| S-EPMC4235399 | biostudies-literature
Project description:Bilastine is a non-sedating second generation H1 oral antihistamine (OAH) for treating allergic rhinitis (AR) patients. The effect of bilastine has not previously been evaluated in a meta-analysis. The aim of this review was to determine the efficacy and safety of bilastine in treating AR. An electronic literature search was performed using Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Science Direct and Google Scholar up to March 2021. Randomized controlled trials comparing bilastine with placebo and standard pharmacotherapy were included. The included studies must have diagnosis of AR established by clinicians and the outcomes must have a minimum of 2 weeks of follow-up period. The primary outcomes assessed were total symptom score (TSS), nasal symptom score (NSS) and non-nasal symptom score (NNSS). The secondary outcomes were discomfort due to rhinitis, quality of life (QOL) and adverse events. The risk of bias and quality of evidence for all studies were appraised. The meta-analysis was done using Review Manager 5.3 software based on the random-effects model. The search identified 135 records after removal of duplicates. Following screening and review of the records, fifteen full-text articles were assessed for eligibility. Five trials involving 3,329 patients met the inclusion criteria. Bilastine was superior to placebo in improving TSS, NSS, NNSS, rhinitis discomfort score and QOL but has comparable efficacy with other OAHs in TSS, NSS, NNS, rhinitis discomfort score and QOL. There was no difference in adverse effects when bilastine was compared against placebo and other OAHs except for somnolence. Bilastine has fewer incidence of somnolence compared to cetirizine. The overall quality of evidence ranged from moderate to high quality. Bilastine is effective and safe in treating the overall symptoms of AR with comparable efficacy and safety with other OAHs except somnolence. Whilst bilastine has similar efficacy to cetirizine, somnolence is notably less in bilastine.
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Project description:IntroductionAllergic rhinitis is a chronic inflammatory disease which affects 1 out of 6 individuals. Perennial allergic rhinitis accounts for 40% of AR cases. Ciclesonide is one of the relatively new intranasal steroid for allergic rhinitis.ObjectiveThe purpose of this study was to evaluate the efficacy and safety of ciclesonide in the treatment of perennial allergic rhinitis.MethodsWe searched Pubmed, Scientific Citation Index, Embase, Clinical Trial Registries for randomized controlled trials and Cochrane Central Register of Controlled Trials to find out the randomized controlled Trial comparing ciclesonide with placebo for PAR.ResultsEight studies were included. In comparison with placebo groups, ciclesonide groups significantly decreased Reflective Total Nasal Symptom Score (MD=-0.56; 95% CI -0.72 to 0.39, p<0.00001) with heterogeneity (p=0.19, I2=24%), Instantaneous Total Nasal Symptom Score (MD=-0.57; 95% CI -0.75 to -0.39, p<0.00001) with heterogeneity (p=0.34, I2=11%). A significant effect for Reflective Nasal Symptom Score Subtotal (MD=-0.15; 95% CI -0.18 to -0.13, p<0.00001) with heterogeneity (p=0.12, I2=24%) was also demonstrated. Rhinoconjunctivitis quality of life questionnaire score (RQLQs) (MD=-0.27; 95% CI -0.39 to -0.15, p<0.00001) with heterogeneity (p=0.58, I2=0%) in the treatment of ciclesonide was also significantly reduced. In addition, the difference in Treatment-Emergent Adverse Events between the two groups was not significant.ConclusionCiclesonide can improve perennial allergic rhinitis without increasing adverse events. Ciclesonide may be another valuable choice for perennial allergic rhinitis in the future.
| S-EPMC9442893 | biostudies-literature
Project description:Background: Allergic rhinitis is prevalent among children and can cause nasal itching, fatigue, and even hinder growth and development. The main discomfort symptom of allergic rhinitis is nasal itching. Clinical reports suggest that Chinese herbal medicine (CHM) is effective in allergy rhinitis treatment. Therefore, we evaluate the clinical efficacy of Chinese herbal medicine in treating nasal itching caused by allergic rhinitis in children. Methods: Nine databases, including PubMed, Embase, The Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wan Fang Data, CQVIP, Chinese Biological Medicine, and ClinicalTrials.gov, were systematically searched from their inception until March 2023. Randomized controlled trials (RCTs) comparing the efficacy of Chinese herbal medicine, either alone or in combination with Western medicine, to Western medicine treatment or placebo intervention for treating allergic rhinitis in children were eligible for inclusion. The effectiveness of Chinese herbal medicines for nasal itching was mainly evaluated. The Risk of Bias tool 2.0 assessed the risk of bias. Statistical analysis using RevMan 5.3 and Stata/SE 12. The quality of evidence was evaluated by GRADEpro 3.6. Risk ratios (RR) with corresponding 95% confidence intervals (CI) were utilized to evaluate and present dichotomous data, while mean difference (MD) and standardized mean difference (SMD) were employed for continuous data. A fixed-effects model was applied in cases where the data exhibited homogeneity (p > 0.1, I2 < 50%), whereas a random-effects model was utilized for heterogeneous data. Statistical significance was determined by a p-value <0.05. This study was conducted by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and its review protocol was registered on the International Platform for Registered Systematic Reviews and Meta-Analysis Programs (INPLASY202340076). Results: The review incorporated 23 studies. The meta-analysis indicated that herbal medicine was significantly related to the reduction of nasal itching (MD = -0.59, 95%CI: -0.94-0.24) and the increase of interleukin 10 level (SMD = 1.47, 95% CI: 0.90-2.05). Compared to Western medicine, the combining herbs and Western medicine showed better efficacy in relieving nasal itching, inhibiting immunoglobulin E, interleukin 4 and 33, enhancing interleukin 10, improving therapeutic efficiency, and reducing recurrent. Oral herbal medicine was more effective in treating nasal itching (MD = -0.45, 95% CI: -0.62-0.29). Combining oral and external herbal medicines was more efficient in treating nasal itching (MD = -0.44, 95% CI: -0.54-0.33), inhibiting immunoglobulin E, interleukin 4 (SMD = -0.87, 95% CI: -1.24-0.50) and 33 (SMD = -1.16, 95% CI: -1.54-0.77), and improving therapeutic efficiency. External herbal medicine did not show differences compared to Western medicines. Regarding safety, herbal medicine alone exhibited fewer adverse events than Western medicine; combining herbal and Western medicine showed no significant variation in adverse event incidence. Conclusion: Chinese herbal medicine (CHM) holds great potential in alleviating symptoms, modulating immune factors levels, and reducing relapse in pediatric rhinitis. Meanwhile, CHM is relatively safe. However, the efficacy and safety of CHM in treating pediatric rhinitis still need to be confirmed due to the inclusion of studies with low methodological quality, small sample sizes, and potential heterogeneity. More high-quality research is necessary to provide reliable evidence for the clinical application of CHM. Systematic Review Registration: INPLASY.com, identifier INPLASY202340076.
| S-EPMC10482051 | biostudies-literature
Project description:BACKGROUND:Non-compliance to, or drop-out from treatment for childhood ADHD, result in suboptimal outcome. Non-compliance and drop-out may be due to mismatches between patients' care needs and treatments provided. This study investigated unmet care needs in ADHD patients. Unmet needs were assessed in two different treatment settings (general outpatient setting versus youth-ACT). Youth-ACT treatment is an intensive outreach-oriented treatment for patients with severe psychiatric and psychosocial problems. Comparison of a general outpatient sample with a youth-ACT sample enabled us to assess the influence of severity of psychiatric and psychosocial problems on perceived care needs. METHODS:Self-reported unmet care needs were assessed among 105 ADHD patients between 6 and 17 years of age in a general outpatient (n = 52) and a youth-ACT setting (n = 53). RESULTS:ADHD patients most frequently reported unmet needs regarding mental health problems, information on diagnosis/treatment, and future prospects. Outpatients differed from youth-ACT patients with respect to 30% of the unmet care needs that were investigated. Outpatients perceived more unmet needs regarding information on diagnosis/treatment (p = 0.014). Youth-ACT patients perceived more unmet needs concerning medication side effects (p = 0.038), quality and/or quantity of food (p = 0.016), self-care abilities (p = 0.016), regular/suitable school or other daytime activities (p = 0.013), making and/or keeping friends (p = 0.049), and future prospects (p = 0.045). CONCLUSIONS:Focusing treatment of ADHD patients on unmet needs may reduce non-compliance and drop-out. In clinical practice, systematic assessment of unmet care needs in all ADHD patients may be warranted, e.g. using the CANSAS questionnaire during the screening/intake phase.
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