Dataset Information

The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.

ABSTRACT: Management of intermittent allergic rhinitis (IAR) is suboptimal in the UK. An Australian community pharmacy-based intervention has been shown to help patients better self-manage their IAR. We conducted a pilot cluster RCT in 12 Scottish community pharmacies to assess transferability of the Australian intervention. Trained staff in intervention pharmacies delivered the intervention to eligible customers (n?=?60). Non-intervention pharmacy participants (n?=?65) received usual care. Outcome measures included effect size of change in the mini-Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) between baseline, 1-week and 6-week follow-up. Trial procedures were well received by pharmacy staff, and customer satisfaction with the intervention was high. The standardised effect size for miniRQLQ total score was -0.46 (95% CI, -1.05, 0.13) for all participants and -0.14 (95% CI,-0.86, 0.57) in the complete case analysis, suggesting a small overall treatment effect in the intervention group. A full-scale RCT is warranted to fully evaluate the effectiveness of this service.

SUBMITTER: Smith S

PROVIDER: S-EPMC7264195 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.

Smith Sarah S Porteous Terry T Bond Christine C Francis Jill J Lee Amanda J AJ Lowrie Richard R Scotland Graham G Sheikh Aziz A Thomas Mike M Wyke Sally S Smith Lorraine L

NPJ primary care respiratory medicine 20200601 1

Management of intermittent allergic rhinitis (IAR) is suboptimal in the UK. An Australian community pharmacy-based intervention has been shown to help patients better self-manage their IAR. We conducted a pilot cluster RCT in 12 Scottish community pharmacies to assess transferability of the Australian intervention. Trained staff in intervention pharmacies delivered the intervention to eligible customers (n = 60). Non-intervention pharmacy participants (n = 65) received usual care. Outcome measur ...[more]

PMID: 32483186

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Project description:BackgroundCommunity pharmacists have a key role to play in the management of allergic rhinitis (AR). Their role is especially important because the majority of medications used to treat AR are available for purchase over-the-counter (OTC), allowing patients to self-select their own medications and bypass the pharmacists. Patients' self-selection often results in suboptimal treatment selection, undertreated AR and poor clinical outcomes. In order for pharmacists to optimise the care for AR patients in the pharmacy, pharmacists need to be able to identify patient cohorts who self-select and are at high risk of mismanagement.ObjectivesThis study aimed to compare the demographics, clinical characteristics and medication selected, between pharmacy customers who choose to self-select and those who speak with a pharmacist when purchasing medication for their AR in a community pharmacy and identify factors associated with AR patients' medication(s) self-selection behaviour.MethodsA cross-sectional observational study was conducted in a convenience sample of community pharmacies from the Sydney metropolitan area. Demographics, pattern of AR symptoms, their impact on quality of life (QOL) and medication(s) selected, were collected. Logistic regressions were used to identify factors associated with participants' medication self-selection behaviour.ResultsOf the 296 recruited participants, 202 were identified with AR; 67.8% were female, 54.5% were >40 years of age, 64.9% had a doctor's diagnosis of AR, and 69.3% self-selected medication(s). Participants with AR who self-select were 4 times more likely to experience moderate-severe wheeze (OR 4.047, 95% CI 1.155-14.188) and almost 0.4 times less likely to experience an impact of AR symptoms on their QOL (OR 0.369, 95% CI 0.188-0.727).ConclusionsThe factors associated with AR patients' self-selecting medication(s) are the presence of wheeze and the absence of impact on their QOL due to AR symptoms. By identifying this cohort of patients, our study highlights an opportunity for pharmacists to engage these patients and encourage discussion about their AR and asthma management.

Project description:BackgroundSeasonal-allergic-rhinitis (hay fever) affects approximately 4.6 million (20%) Australians each year. Hay fever manifests as runny/blocked nose and often itchy/sore/swollen eyes, with symptoms greatly impacting the quality of life. Rescue medications such as antihistamines are often needed to restore function, but they may trigger some other unwanted side effects. Probiotics have shown promise to reduce hay fever symptoms.ObjectiveIn this randomized double-blind placebo-controlled 12-week trial, we aimed to assess the tolerability and efficacy of the probiotic formula "NC-Seasonal-Biotic" on symptoms, quality-of-life, and immunological and microbial factors.MethodsAdults, who had previously suffered from hay fever symptoms, were screened for eligibility and randomly allocated to probiotic or placebo trial powder. Treatment effectiveness was assessed by questionnaires, daily total-nasal-symptom-score, and weekly rhinoconjunctivitis quality-of-life questionnaire. Secondary outcome measures included immunological parameters such as T-cell immunity (Th1/Th2 ratio) and the stool-microbiome analysis. Tolerability was assessed weekly by the gastrointestinal symptom scale.ResultsRecruitment and follow-up were challenging around the 2020/2021 hay fever season in Melbourne, Australia, due to the harsh COVID-19 restrictions and extended lockdowns. Out of the 82 adults enrolled in this study, 75% participated (n = 60), and half (n = 40) completed the 10-12-week intervention period. In the intention-to-treat analysis, no significant differences in hay fever symptoms were apparent between the groups, while quality-of-life trended toward greater improvement in the active group. Intention-to-treat analysis was confounded due to a third of all participants not completing the full 10-12-week-intervention period. Subgroup analyses of the participants (n = 40) completing the full 10-12-week study period revealed a significantly greater reduction in symptoms in the active group compared with the placebo group, including runny nose (p = 0.04) and itchy eyes (p = 0.01). Furthermore, the active group reported significant improvements in the quality-of-life, including more functionality during the day (p = 0.05), better sleep (p = 0.005), less fatigue (p = 0.04), less thirst (p = 0.007), and less irritability (p = 0.007). Immunological parameters, measured by T-helper cell ratio (Th1/Th2), improved significantly in the active group compared with the placebo group. Most microbial changes were not statistically different between the groups. The trial powder was generally well tolerated.ConclusionOur study suggests the probiotic formula "NC-Seasonal-Biotic," taken for 10-12 weeks, as effective in reducing hay fever symptoms, such as runny nose and itchy eyes, and improved the quality-of-life and immunological parameters while being well tolerated.Clinical trial registration[www.ClinicalTrials.gov], identifier [ACTRN126200 01078943].

Project description:BackgroundPharmacists and pharmacy assistants can support consumers by identifying minor ailments and providing evidence-based advice about treatment options. In the Netherlands, advice is based on national minor ailment guidelines and structured WWHAM questions (Who, What, How long, Action, Medication).ObjectivesTo study whether pharmacy assistants provide guideline-compliant advice for allergic rhinitis based on WWHAM and condition-specific questions (When and Familiarity) and their association with appropriate self-care advice.MethodsA retrospective study of the assessments of simulated patient (SP) visits regarding one condition- and two symptom-based cases of allergic rhinitis in Dutch community pharmacies. Pharmacies that participated in 2014, 2016 and 2018 were selected. SPs documented their observations of the problem analysis, dispensing and client interaction on a standardized scoresheet. Dispensing of an oral antihistamine according to the guideline recommendation was considered as the correct outcome. Chi-square tests were used to analyze differences in scores for problem analysis of pharmacies with correct and incorrect advice provision in 2014 and 2018. Predictors for correct outcome were identified by univariate and multivariate logistic regression analysis.ResultsData from 673 pharmacies were available for all three years. In 2014 and 2018, problems were presented as a symptom (running nose), and 41.2% and 21.1% of pharmacies dispensed an antihistamine. For the condition-based problem (allergy) in 2016, 96.0% of participating pharmacies dispensed an antihistamine. Both in 2014 and 2018, each additional problem analysis question increased the odds ratio of providing correct advice. Questions asked about 'hay fever symptoms', 'medication', 'when symptoms occurred', and 'familiar symptoms' were significant predictors of correct advice provision.ConclusionsMost pharmacies provided appropriate advice for a condition-based request but less than half of them provided appropriate advice for a symptom-based request. More questions asked was associated with an increased chance of providing correct advice. Addition of condition-specific questions may improve the WWHAM-method.

Project description:IntroductionAlthough recent studies have shown that the human microbiome is involved in the pathogenesis of allergic diseases, the impact of microbiota on allergic rhinitis (AR) and non-allergic rhinitis (nAR) has not been elucidated. The aim of this study was to investigate the differences in the composition of the nasal flora in patients with AR and nAR and their role in the pathogenesis.MethodFrom February to September 2022, 35 AR patients and 35 nAR patients admitted to Harbin Medical University's Second Affiliated Hospital, as well as 20 healthy subjects who underwent physical examination during the same period, were subjected to 16SrDNA and metagenomic sequencing of nasal flora.ResultsThe microbiota composition of the three groups of study subjects differs significantly. The relative abundance of Vibrio vulnificus and Acinetobacter baumanni in the nasal cavity of AR patients was significantly higher when compared to nAR patients, while the relative abundance of Lactobacillus murinus, Lactobacillus iners, Proteobacteria, Pseudomonadales, and Escherichia coli was lower. In addition, Lactobacillus murinus and Lacttobacillus kunkeei were also negatively correlated with IgE, while Lacttobacillus kunkeei was positively correlated with age. The relative distribution of Faecalibacterium was higher in moderate than in severe AR patients. According to KEGG functional enrichment annotation, ICMT(protein-S-isoprenylcysteine O-methyltransferase,ICMT) is an AR microbiota-specific enzyme that plays a role, while glycan biosynthesis and metabolism are more active in AR microbiota. For AR, the model containing Parabacteroides goldstemii, Sutterella-SP-6FBBBBH3, Pseudoalteromonas luteoviolacea, Lachnospiraceae bacterium-615, and Bacteroides coprocola had the highest the area under the curve (AUC), which was 0.9733(95%CI:0.926-1.000) in the constructed random forest prediction model. The largest AUC for nAR is 0.984(95%CI:0.949-1.000) for the model containing Pseudomonas-SP-LTJR-52, Lachnospiraceae bacterium-615, Prevotella corporis, Anaerococcus vaginalis, and Roseburia inulinivorans.ConclusionIn conclusion, patients with AR and nAR had significantly different microbiota profiles compared to healthy controls. The results suggest that the nasal microbiota may play a key role in the pathogenesis and symptoms of AR and nAR, providing us with new ideas for the treatment of AR and nAR.

Project description:BackgroundTopical probiotics have been suggested as a treatment option for allergic rhinitis, as they may skew the immune response towards a beneficial type-1 non-allergic profile. So far observations in man have exclusively involved oral intake. The aim of this study was to examine whether a topical/nasal administration of a probiotic assemblage (PA) affects quality of life, symptoms and signs of allergic rhinitis in a nasal allergen challenge (NAC) model.MethodsIn a placebo-controlled and crossover design, 24 patients with seasonal allergic rhinitis were randomised to topical/nasal administration with a PA of Lactobacillus rhamnosus SP1, Lactobacillus paracasei 101/37 and Lactococcus lactis L1A or placebo for 3 weeks. Participants and investigators were blind to treatment allocation. The last week of each treatment period was combined with a NAC series. Efficacy variables were "Mini-Rhinoconjunctivitis Quality of Life Questionnaire" (Mini-RQLQ), "Total Nasal Symptom Score" (TNSS), "Peak Nasal Inspiratory Flow" (PNIF) and "Fractional Exhaled Nitric Oxide" (FeNO). In addition, to assess whether or not the PA produced any pro-inflammatory effect per se, soluble analytes were monitored in nasal lavage fluids. Finally, bacterial cultures, sampled using swabs from the middle nasal meatus, were assessed for the presence of the PA by MALDI-TOF analysis.ResultsAdministration of the PA did not produce any nasal symptoms (cf. placebo). An innate immune response was discerned within the PA run (cf. baseline), but no change in nasal lavage fluid levels of cytokines/mediators was observed cf. placebo except for IL-17/IL-17A (a minor increase in the PA run). Administration of the PA did neither affect Mini-RQLQ, TNSS, PNIF nor FeNO. No evidence of persistent colonization was observed.ConclusionsTopical/nasal administration of a PA comprising Lactobacillus rhamnosus SP1, Lactobacillus paracasei 101/37 and Lactococcus lactis L1A, while likely evoking a minor innate immune response yet being safe, does not affect quality of life, symptoms or signs of allergic rhinitis.Trial registrationnot registered.

Dataset Information

The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.

Publications

The Help for Hay Fever community pharmacy-based pilot randomised controlled trial for intermittent allergic rhinitis.

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