Mini Rhinoconjunctivitis Quality Of Life Questionnaire Research Articles

SYMPTOM RELIEF AND IMPROVED QUALITY OF LIFE IN ALLERGIC RHINITIS PATIENTS AFTER TRANSDERMAL ALLERGY IMMUNOTHERAPY

Introduction Patients with allergic rhinitis (AR) experience side effects from pharmacotherapies and subcutaneous immunotherapy (SCIT). This prospective, observational study (IRB-approved, informed consent) assessed changes in Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) scores and symptoms from baseline to 3 months for patients with AR using a transdermal allergy immunotherapy (TdIT) formulation. Methods In this observational study, patients 12-64 years old with seasonal/perennial AR who tried/failed SCIT, applied a TdIT with selected allergens compounded in a liposomal base cream over three months. Patients completed a survey at baseline, ∼1.5 months and ∼3 months to assess symptoms, quality of life, and side effects. This interim analysis compares baseline (S1) to 3-month (S3) results. Results Paired data from 43 patients (30 female, 13 male, mean age 43.4±14.6 years) were collected from eight physicians across 6 US states. Mean number of days between S1 and S3 = 93.9±32.8 days. MiniRQLQ scores (scale: 0=not troubled, to 6=extremely troubled during the last week) decreased statistically significantly from 2.51/6 at S1 to 1.94/6 at S3 (P=.004, Wilcoxon test). At S3: side effects of TdIT were reported by 9 patients (none serious: 3 rash/redness, 1 rash/redness just once, 1 slight itching at application, and 4 not specified), 40% had noticed allergy symptom reduction, and 21% had stopped/reduced other allergy medication use. Conclusions TdIT may provide an alternative route of administration for allergy immunotherapy. Interim results demonstrated that patients with AR receiving TdIT had improved quality of life and reduced AR symptoms with minimal or no side effects.

Comparative analysis of the quality of life of patients with some methods of surgical treatment of vasomotor rhinitis

Quality of life (abbr. – QOL) is a category with which it characterizes the essential circumstances of the life of the population, determining the degree of dignity and freedom of the personality of each person and a subjective indicator when evaluating the results of treatment of chronic diseases. To determine the quality of life of patients with cavity problems and SNPs, such as rhinitis and sinusitis, special questionnaires have been created, translated into Russian and adapted. The purpose of this study is to examine in a comparative aspect the indicators of the quality of life of patients with vasomotor rhinitis with various treatment methods. Materials and Methods: The study was conducted in the clinic of the Department of Otorhinolaryngology of the Tashkent institute of postgraduate medical education on 43 patients with vasomotor rhinitis in age from 20 to 46 years, average age 28±1.3 years. All patients with BP included in our study, after collecting complaints and anamnesis, underwent an endoscopic examination of the nasal cavity and nasopharynx, a computerized tomogram of the nose and paranasal sinuses, standard laboratory tests and microscopy of a smear from the nasal cavity on eosinophils. Evaluation of QOL was performed according to a special questionnaire Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ). Results: Studies have shown the highest efficiency of laser coagulation with vasomotor rhinitis. After laser surgery, a rapid improvement in QOL was observed, and there was no adverse effect on the mucous membrane of the nasal cavity. Given the well-tolerated laser coagulation, the lack of the need for observation and care of the nasal cavity in the postoperative period, the possibility of outpatient treatment, allows us to recommend this type of exposure as the method of choice in the surgical treatment of patients with vasomotor rhinitis. However, the need for special equipment and the availability of trained personnel who have access to work with laser systems somewhat limits the widespread use of this method. The simplicity of submucosal vasotomy, the availability of tools for carrying out, the rather rapid restoration of QOL, puts it on a par with the laser effect on efficiency. The need to use nasal tampons after surgery, hospital stay and patient monitoring in the early postoperative period reduces the patients' QL and makes this operation strictly inpatient. In our study, electrocautery demonstrated the lowest rate of improvement in QOL than during laser irradiation and submucous vasotomy. The most slow and incomplete restoration of QOL in this method of treatment emphasizes the disadvantage of this method from the point of view of the patient's QOL. Conclusion: Evaluation of the long-term results of surgical treatment of QL and clinical manifestations of BP makes it possible to recommend laser coagulation as the most optimal method providing a long-lasting effect in treating patients with BP. An alternative is to take a submucous vasotomy of the inferior nasal concha.

Baseline asthma burden, comorbidities, and biomarkers in omalizumab-treated patients in PROSPERO

BackgroundPatients included in clinical trials do not necessarily reflect the real-world population. ObjectiveTo understand the characteristics, including disease and comorbidity burden, of patients with asthma receiving omalizumab in a real-world setting. MethodsThe Prospective Observational Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab (PROSPERO) was a US-based, multicenter, single-arm, and prospective study. Patients (≥12 years of age) with allergic asthma initiating omalizumab treatment based on physician-assessed need were included and followed for 12 months. Exacerbations, health care use, adverse events, and Asthma Control Test (ACT) scores were assessed monthly. Biomarkers (blood eosinophils, fractional exhaled nitric oxide, and periostin) were evaluated and patient-reported outcomes (Asthma Quality of Life Questionnaire for 12 Years and Older [AQLQ+12] and Work Productivity and Activity Impairment: Asthma questionnaire [WPAI:Asthma]) were completed at baseline and months 6 and 12. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) was completed at baseline and 12 months. ResultsMost of the 806 enrollees (91.4%) were adults (mean age 47.3 years, SD 17.4), white (70.3%), and female (63.5%). Allergic comorbidity was frequently reported (84.2%), as were hypertension (35.5%) and depression (22.1%). In the 12 months before study entry, 22.1% of patients reported at least 1 asthma-related hospitalization, 60.7% reported at least 2 exacerbations, and 83.3% reported ACT scores no higher than 19 (uncontrolled asthma). Most patients had low biomarker levels based on prespecified cut-points. Baseline mean patient-reported outcome scores were 4.0 (SD 1.4) for AQLQ+12, 2.7 (SD 1.4) for MiniRQLQ, and 47.7 (SD 28.9) for WPAI:Asthma percentage of activity impairment and 33.5 (SD 28.7) for percentage of overall work impairment. ConclusionThe population initiating omalizumab in PROSPERO reported poorly controlled asthma and a substantial disease burden. Trial RegistrationClinicalTrials.gov Identifier: NCT01922037.

Probiotics (Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and Bifidobacterium longum MM-2) improve rhinoconjunctivitis-specific quality of life in individuals with seasonal allergies: a double-blind, placebo-controlled, randomized trial ,

Background: Rhinoconjunctivitis-specific quality of life is often reduced during seasonal allergies. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (MRQLQ) is a validated tool used to measure quality of life in people experiencing allergies (0 = not troubled to 6 = extremely troubled). Probiotics may improve quality of life during allergy season by increasing the percentage of regulatory T cells (Tregs) and inducing tolerance.Objective: The objective of this study was to determine whether consuming Lactobacillus gasseri KS-13, Bifidobacterium bifidum G9-1, and B. longum MM-2 compared with placebo would result in beneficial effects on MRQLQ scores throughout allergy season in individuals who typically experience seasonal allergies. Secondary outcomes included changes in immune markers as part of a potential mechanism for changes in MRQLQ scores.Design: In this double-blind, placebo-controlled, parallel, randomized clinical trial, 173 participants (mean ± SEM: age 27 ± 1 y) who self-identified as having seasonal allergies received either a probiotic (2 capsules/d, 1.5 billion colony-forming units/capsule) or placebo during spring allergy season for 8 wk. MRQLQ scores were collected weekly throughout the study. Fasting blood samples were taken from a subgroup (placebo, n = 37; probiotic, n = 35) at baseline and week 6 (predicted peak of pollen) to determine serum immunoglobulin (Ig) E concentrations and Treg percentages.Results: The probiotic group reported an improvement in the MRQLQ global score from baseline to pollen peak (-0.68 ± 0.13) when compared with the placebo group (-0.19 ± 0.14; P = 0.0092). Both serum total IgE and the percentage of Tregs increased from baseline to week 6, but changes were not different between groups.Conclusions: This combination probiotic improved rhinoconjunctivitis-specific quality of life during allergy season for healthy individuals with self-reported seasonal allergies; however, the associated mechanism is still unclear. This trial was registered at clinicaltrials.gov as NCT02349711.

Clinical observation of flupentixol and melitracen combined with specific immunotherapy for treatment of allergic rhinitis patients with anxiety and depression

Objective:To explore the clinical effects of Flupentixol/Melitracencombined with specific immunotherapy in allergic rhinitis patients with anxiety and depression. Method:Totally ninetynine moderate to severe persistent allergic rhinitis patients with anxiety and depression from October 2014 to Sepetember 2015 were randomly divided into two groups: 45 patients in experimental group (Flupentixol/Melitracen 10.5 mg，QD,treatment last 4 months)and 44 patients in control group.All patients were treated with specific immunotherapy for 1 years. The nasal symptoms score, mini Rhinoconjunctivitis Quality of life questionnaire(MiniRQLQ), Medication score, SAS and SDS score and the clinical curative effect were observed before treatment, after 4 months or one year treatment. The drug reactions were also recorded. Result:The VAS scores, MiniRQLQ scores, medication scores, SAS and SDS scores of patients in two groups who were treated after 4 months and 1 year were significantly reduced than that of patients before treatment.The differences were statistically significant(P<0.05).Compared with the control group, nasal symptom scores, MiniRQLQ scores, medication scores, SAS and SDS scores in experimental group were decreased after 4 month or 1 year treatment(P<0.05).After 4 months of treatment, the total effective rate of the experimental group was 84.4%, while the control group was 56.8%.After 1 years of treatment, the experimental group excellence rate was 57.8%, while the control group was 22.7%.The differences were statistically significant(P<0.05). During the course of treatment, there were thirteen cases of mild adverse reactionsin experimental group (17.7%) and control group(11.4%). There was no significant differences(P>0.05). Conclusion:Flupentixol and melitracen combined with specific immunotherapy could sifnificantlly relieve clinical symptom, quality of life and mental depression.is a safe and reliable therapeutic regimen for further improving clinical symptoms,quality of life,mental statusand the clinical efficacy in moderate to severe persistent with anxiety anddepression.

Probiotics and Allergic Rhinitis: A Simon Two-Stage Design to Determine Effectiveness.

Allergic rhinitis (AR) is a chronic upper respiratory disease affecting 10-30% of the population worldwide. It associated with significant economic and medical burden. Probiotics have received attention in recent years as a novel strategy to treat infectious/immune conditions, including AR. However, substantiation of these health claims by regulatory bodies has been rejected due, in part, to inadequate clinical trial design. While randomized controlled trials are considered the gold standard for assessing clinical efficacy, such trials require a priori preclinical data on effect size, which may be a reason for the conflicting results in the probiotic and AR literature. Progressive clinical trial designs, such as the Simon Two-Stage Design, are showing promise within the area of integrative and alternative medicine, particularly in relation to probiotic supplementation, to obtain empirical data for the design of clinical trials that meet regulatory requirements. This Phase II study uses a Simon Two-Stage Design to determine the response rate of patients with AR to a probiotic supplement. Patients will consume a multispecies probiotic twice daily for 8 weeks, and will attend an allergy clinic at the beginning and end of the intervention period for assessment. Symptom improvement following probiotic supplementation will be measured by the mini-Rhinoconjunctivitis Quality of Life Questionnaire. Secondary outcomes include twice-weekly symptom and medication diaries, objective determination of nasal congestion via Nasal Rhinomanometry, and change in frequency of medication usage. This study provides an exemplar of the value of using a progressive study design in the complementary and alternative medicine setting. A Simon Two-Stage Design was adopted to investigate whether a multispecies probiotic supplement, not yet trialed in the context of AR, has promise as a therapeutic intervention and warrants the design of larger placebo-controlled studies.

Impact of surgery and intranasal corticosteroid therapy on quality of life of patients with allergic rhinitis

Introduction: Prevalence of allergic rhinitis (AR) in India ranges from 10% to 15%. AR significantly affects the quality of life (QOL). This study was designed with an objective to assess the impact of surgery and 3 months of intranasal corticosteroids therapy on the QOL of patients with AR. Materials and Methods: A before and after comparison cross-sectional study was conducted between April 2012 and December 2013. A total of fifty consecutive patients in the age group of 19-59 years suffering from moderate-severe AR presenting at KKR ENT Hospital and Research Institute were included in the study after taking their consent. Individuals with contraindications for the surgery or intranasal corticosteroid therapy were excluded from the study. QOL was assessed using the mini rhinoconjunctivitis QOL questionnaire before the surgery and 3 months after starting corticosteroid therapy following the surgery. The study was approved by the Institutional Ethical and Scientific Committee. Absolute eosinophil count (AEC) and QOL scores were used to measure the impact. Descriptive statistics and paired t-tests were used to analyze the data and lend statistical support. Results: Mean AEC reduced from 517.66 (±74.42) to 322.70 (±54.68) after surgery and 3 months of intranasal corticosteroid therapy, and this reduction was statistically significant (P < 0.001). Mean QOL scores reduced from 2.624 (±0.445) to 2.031 (±0.386) after surgery and 3 months of intranasal corticosteroid therapy, and this reduction was statistically significant (P < 0.001). Conclusions: Within 3 months after the surgery and intranasal corticosteroid therapy, the mean AEC as well as the mean QOL scores reduced significantly indicating a reduction in the allergic reaction and an improvement in the QOL of patients suffering from AR.

Health-related quality of life and its contributory factors in allergic rhinitis patients in Nigeria.

To determine the health-related quality of life (HRQoL) in allergic rhinitis patients as well as identify contributory factors to patient's well-being. Cross-sectional study by multistage sampling. Four-month study duration (October 2013 to January 2014). The setting of the study was Kwara State, Nigeria, which has 16 local government areas with 3 senatorial districts, total land mass of 36,825km(2) with a population of 2,591,555. 132 consenting adults; 66 of them have allergic rhinitis (AR) using Score for Allergic Rhinitis (SFAR) instrument and 66 were age- and gender-matched controls (χ(2)=0, d.f.=1, P=1 and χ(2)=1.24, d.f.=2, P=0.54, respectively). Information on HRQoL was obtained using the 14-parameter mini-rhinoconjunctivitis quality of life questionnaire (mini-RQLQ). Socio-demographic variables possibly contributory to patient's well-being were obtained. Kruskal-Wallis and Mann-Whitney U tests were used to compare means. The overall Total Symptom Score (TSS) was 3.37±0.9, while male and female allergic patients and control TSS were 3.61±1.0; 3.16±0.8, and 0.98±0.2; 0.95±0.2, respectively. Effects of gender, marital status, senatorial districts, residential area and duration of symptoms had significant impact on the quality of life. The highest correlation with TSS and components of mini-RQOL questionnaire existed between nasal problems and other symptoms (r=0.866; 0.868). AR had appreciable impact on HRQoL of the participants. Gender, number of dependents, marital status, senatorial districts, residential area and duration of symptoms were major identifiable contributory factors to the patient's well-being.

Isotonic saline nasal irrigation is an effective adjunctive therapy to intranasal corticosteroid spray in allergic rhinitis.

This study was designed to determine if the addition of large-volume, low-positive pressure nasal irrigations delivered with isotonic sodium chloride (hereinafter "saline") added to intranasal corticosteroid therapy improves quality of life and objective measures of nasal breathing in patients with allergic rhinitis when compared with intranasal corticosteroid alone. A prospective, unblinded, single-arm pilot study was performed of patients with allergic rhinitis already on intranasal corticosteroid pharmacotherapy. Patients added large-volume low-pressure saline irrigation twice daily for 8 weeks to their ongoing regiment of nasal corticosteroid. Mini-Rhinoconjunctivitis Quality of life Questionnaire (mRQLQ) assessment and nasal peak inspiratory flow (NPIF) were performed at baseline and at 4 and 8 weeks. A total of 40 patients were enrolled. Twice-daily nasal irrigation with isotonic saline significantly (p < 0.001) reduced mRQLQ scores, from 36.7 ± 20.48 (baseline) to 14.9 ± 11.03 (4 weeks) to 10.10 ± 10.65 (8 weeks). No significant changes were seen in NPIF, pattern use of nasal steroid use, or adverse events. Large-volume, low-positive pressure nasal irrigation with isotonic saline is an effective adjunctive therapy to improve quality of life in patients with allergic rhinitis already on intranasal corticosteroid therapy. This study was a part of the clinical trial NCT01030146 registered at clinicaltrials.gov.

Prevalence of Ocular Symptoms in Patients with Allergic Rhinitis: Korean Multicenter Study

Allergic rhinitis (AR) is often accompanied by multiple ocular symptoms. This study aimed to evaluate the prevalence of ocular symptoms and the impact of ocular symptoms on the quality of life in patients with AR. One thousand one hundred seventy-four patients with AR were enrolled from 24 centers in Korea. They were classified into four groups according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) guideline and also classified into perennial AR (PAR) and seasonal AR groups. All patients were asked to complete the questionnaire regarding the presence of ocular symptoms, such as eye itching, watery eyes, and red eyes. The correlation between ocular symptoms and the rest of the quality-of-life areas in the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) was also asked. Seven hundred nineteen (61.2%) of 1174 patients had ocular symptoms. In detail, the numbers of patients with eye itching, watery eyes, red eyes, and other ocular symptoms were 605 (51.5%), 313 (26.7%), 207 (17.6%), and 66 (5.6%), respectively. Female patients (72.5%) complained of ocular symptoms more commonly than male patients (55.1%). The patients with moderate-severe persistent AR showed the highest prevalence of ocular symptoms. The correlation coefficients between ocular symptoms and the rest of the quality-of-life areas in the Mini-RQLQ were statistically significant (p < 0.05). Sixty-one percent of Korean AR patients experienced ocular symptoms. The patients who were women and had PAR and more severe AR showed higher prevalence of ocular symptoms. The ocular symptoms might have a significant impact on the quality of life in patients with AR.

Clinical study on the acupuncture of "zhibi 3" in the treatment of non-allergic rhinitis

Objective To observe the Clinical study on the acupuncture ot zhibi 3 in the treatment of non-allergic rhinitis.Methods 20 individuals over 15 years old with non-allgergic rhinitis were prospectively recruited from rhinology clinic and ward of Beijing TongRen Hospital from December 2008 to August 2009.Acupuncture points of treat nasal 3 and the compatibility of Fengchi,Hegu were performed by once a week for 7 weeks.The changes of the total nasal symptom score (TNSS) and the Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire (Mini-RQLQ) were observed at baseline and recertification every week.Results After 7 weeks treatment,we found the fourth week of score in fatigue (0.5±0.2; 2.6±1.2,respectively),embarrassed (1.0±0.3; 3.7-0.3,respectively),sleep (0.8±0.1; 4.1±0.9,respectively)、the quality of life (1.0±0.4; 3.8±0.7,respectively),congestion (0.6±0.4; 2.6± 1.0,respectively),rhinorrhea (1.2±0.5; 4.4±0.7,respectively),sneezing (1.6±0.5; 5.0±0.6,respectively),nasal itching (1.7±0.6; 4.4±0.9,respectively) were significantly improved over 75％ (15/20) compared with the baseline (P＜0.05).However,at the sixth week,congestion,rhinorrhea,sneezing were recurring,especially rhinorrhea,but the benefit effects of acupuncture were more than 55％ comparing with baseline.Contusion Acupuncture of zhibi 3,and Fengchi,Hegu may have the effective effects on non-allergic rhinitis. Key words: Non-allergic rhinitis; Acupuncture ofzhibi 3; TNSS; Mini-RQLQ

‘Help for Hay Fever’, a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial

BackgroundDespite the availability of evidence-based guidelines for managing allergic rhinitis in primary care, management of the condition in the United Kingdom (UK) remains sub-optimal. Its high prevalence and negative effects on quality of life, school performance, productivity and co-morbid respiratory conditions (in particular, asthma), and high health and societal costs, make this a priority for developing novel models of care. Recent Australian research demonstrated the potential of a community pharmacy-based ‘goal-focused’ intervention to help people with intermittent allergic rhinitis to self-manage their condition better, reduce symptom severity and improve quality of life. In this pilot study we will assess the transferability of the goal-focused intervention to a UK context, the suitability of the intervention materials, procedures and outcome measures and collect data to inform a future definitive UK randomized controlled trial (RCT).Methods/DesignA pilot cluster RCT with associated preliminary economic analysis and embedded qualitative evaluation. The pilot trial will take place in two Scottish Health Board areas: Grampian and Greater Glasgow & Clyde. Twelve community pharmacies will be randomly assigned to intervention or usual care group. Each will recruit 12 customers seeking advice or treatment for intermittent allergic rhinitis. Pharmacy staff in intervention pharmacies will support recruited customers in developing strategies for setting and achieving goals that aim to avoid/minimize triggers for, and eliminate/minimize symptoms of allergic rhinitis. Customers recruited in non-intervention pharmacies will receive usual care. The co-primary outcome measures, selected to inform a sample size calculation for a future RCT, are: community pharmacy and customer recruitment and completion rates; and effect size of change in the validated mini-Rhinoconjunctivitis Quality of Life Questionnaire between baseline, one-week and six-weeks post-intervention. Secondary outcome measures relate to changes in symptom severity, productivity, medication adherence and self-efficacy. Quantitative data about accrual, retention and economic measures, and qualitative data about participants’ experiences during the trial will be collected to inform the future RCT.DiscussionThis work will lay the foundations for a definitive RCT of a community pharmacy-based ‘goal-focused’ self-management intervention for people with intermittent allergic rhinitis. Results of the pilot trial are expected to be available in April 2013.Trial registrationCurrent Controlled Trials ISRCTN43606442

Burden of illness and quality of life in patients being treated for seasonal allergic rhinitis: a cohort survey

BackgroundAllergic Rhinitis is an inflammatory disease which is characterised by burdensome nasal and/or ocular symptoms. This study aimed to assess the impact of symptoms (number of symptom-free days (SFD) and Quality of Life (QoL)) in patients with Seasonal Allergic Rhinitis (SAR) being treated with fluticasone furoate (FF), mometasone furoate (MF) or fluticasone propionate (FP).MethodsIn a cross-sectional, non-interventional, cohort analysis, primary care physicians and allergy specialists in France, Germany, and Spain were recruited via telephone interviews. Each physician prospectively recruited 4 SAR patients - 2 receiving FF, 1 receiving MF and 1 receiving FP - during June 2009. Patients answered questions on symptoms and completed questionnaires on QoL (mini-rhinoconjunctivitis Quality of Life Questionnaire, RQLQ) and burden of illness (Pittsburgh Sleep Quality Index).ResultsA total of 540 patients were recruited during June 2009. 88 patients were subsequently found to be ineligible and excluded from the analyses. In the 4 weeks prior to assessment, patients reported a mean of 14.58 (±8.42) SFD. Patients receiving FF had more SFD (mean 15.45 ±8.29) than patients receiving MF (adjusted mean difference -1.22, 95% Confidence Interval (CI) [-3.16 to 0.72], p=0.434) or FP (adjusted mean difference -1.95, 95% CI [-3.87 to -0.03], p=0.092), although statistical significance was not achieved. The mean RQLQ score was 1.54 (±1.06). Patients receiving FF had a better quality of life in the previous week (mini-RQLQ score: mean 1.42, ±1.04) than patients receiving MF (adjusted mean difference 0.28, 95% CI [0.03 to 0.52], p=0.052) or FP (adjusted mean difference 0.18, 95% CI [-0.05 to 0.41], p=0.244). Again, none of these results achieved statistical significance.ConclusionsAt the height of the allergy season, patients with SAR suffer symptoms approximately 50% of the time, and report an impact on their QoL. No significant differences were observed between FF, FP and MF related to SFD or QoL.Trial registrationClinicalTrials.gov identifier: NCT01199757

Clinical effect of pricking blood at neiyingxiang (ExHN 9) on non-allergic rhinopathy: study protocol for a randomized controlled trial

BackgroundNon-allergic rhinopathy (NAR), formerly known as vasomotor rhinitis, is a non-allergic and non-infectious chronic disease that is accompanied by nasal hyperemia, rhinorrhea, and no increase in the number of eosinophils. Although the medications for NAR, including intranasal corticosteroids and intranasal antihistamine, have been used in clinical practice, given the relative paucity of effective therapy with available medications, alternative non-pharmacologic treatments could play an important role in treating NAR. Acupuncture treatment is representative potential alternative therapy for the treatment of various diseases, including rhinitis. Therefore, the objective of this study was to evaluate the efficacy of pricking blood at Neiyingxiang (ExHN 9) relative to acupuncture treatment at Waiyingxiang (LI 20) in patients with NAR.Methods/DesignA randomized, parallel-group, controlled, assessor single-blinded, trial will be conducted. Fifty participants with NAR will be randomized into one of two groups: either the control group with acpuncture treatment at LI 20 or the experimental group with pricking blood at ExHN 9. After randomization, a total of three sessions of treatment will be performed once a week in both groups. The total nasal symptom score (TNSS) and the Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire (MiniRQLQ) at baseline and the end of the trial will be used to evaluate the efficacy of each treatment.DiscussionThis study will be the first randomized trial to evaluate the efficacy of pricking blood for the treatment of NAR. The results of this study will help establish an alternative approach for treating patients with NAR that do not respond to Western medication.Trial registrationThe trial was registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0000195.

Role of Rhinitis in Laryngitis: Another Dimension of the Unified Airway

We evaluated the prevalence of dysphonia and secondary laryngeal symptoms among patients with allergic rhinitis (AR), nonallergic rhinitis (NAR), and no rhinitis symptoms (controls). Patients with rhinitis symptoms with positive and negative allergy tests were recruited from allergy clinics, and patients without rhinitis symptoms were recruited from an orthopedic clinic. All groups completed the Voice-Related Quality of Life survey (VRQOL),the mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ), and the Reflux Symptom Index (RSI). Completing the study were 134 patients with AR, 54 patients with NAR, and 62 controls. Both AR and NAR patients had an increased prevalence of dysphonia compared to controls (32.8% and 26.9% versus 8.1%, respectively; p = 0.001). When we controlled for confounding variables such as asthma, inhaled steroid use, and gastroesophageal reflux, patients with either AR or NAR had higher odds of dysphonia (odds ratio, 4.22; 95% confidence interval, 1.03 to 17.32). Patients with worse mini-RQLQ scores had lower VRQOL scores and higher RSI scores (Spearman correlation of -0.47 and p < 0.001 and Spearman correlation of 0.6 and p <0.001, respectively). Patients with rhinitis (AR or NAR) had a higher prevalence of dysphonia than did controls. Patients with worse rhinitis symptoms had worse voice-related quality of life and more severe chronic laryngeal symptoms.

Efficacy and Safety of Sterols/Sterolins in Allergic Rhinitis: A Randomised Double Blind placebo-controlled Clinical Trial

Objective: Sterols/sterolins (Moducare®) have demonstrated immunomodulation and anti-inflammatory effects in preclinical studies, but no clinical trial of patients with allergic rhinitis has yet been published. Thus, our aim was to investigate the safety and efficacy of sterols/sterolins in patients with allergic rhinitis. Methods: The framework was a pilot double-blind randomized controlled clinical trial. Forty patients were randomized to receive Moducare® capsules or placebos for 12 weeks. Patients were evaluated at weeks 4, 8 and 12 with symptom severity questionnaires and immunological assays, including: serum total immunoglobulin E (IgE), eosinophil, and eosinophil cationic protein (ECP). The primary efficacy endpoint indicated the mean change of the allergic rhinitis symptoms score in the therapeutic period at week 12; the secondary efficacy endpoints represented the changes of the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) monthly score and the immunological assays of IgE, eosinophil and ECP at week 12. Results: A total of 28 patients (70%) completed the 12-week study, with eight patients dropping out of the Moducare® group and four patients dropping out of the placebo group. The results showed no significant adverse events of sterols/sterolins in this 12-week study. The results of the allergic rhinitis symptoms score, Mini-RQLQ, total IgE, eosinophil count and ECP value had no statistically significant changes in either group. Conclusions: While sterols/sterolins were well tolerated and safe in patients with allergic rhinitis, no significant clinical and immunological benefits were demonstrated in this 12-week pilot study.

Quality of life outcomes with sublingual immunotherapy

Purpose Immunotherapy is the titrated exposure of allergens to induce immunologic tolerance and offers long-term immune modification. Traditional subcutaneous immunotherapy (SCIT) has resulted in several deaths and raised safety concerns. Sublingual immunotherapy (SLIT) is an alternative administration route for allergen-specific immunotherapy. Compared to SCIT, SLIT has a shorter escalation phase, equal or greater efficacy for rhinitis, and an improved safety profile. The purpose of this study was to evaluate quality of life measures in a preliminary patient sample initiating SLIT at our institution. Materials and methods Patients with appropriate allergen reactivity were given the option to pursue immunotherapy by traditional SCIT or by SLIT techniques. Patients choosing SLIT completed the mini-Rhinoconjunctivitis Quality of Life Questionnaire (m-RQLQ), a 14-item Likert-type questionnaire, at baseline and during maintenance therapy. Patients typically reached maintenance dosing in less than 5 weeks. Results Paired m-RQLQ data were available for 15 patients after antigen titration. Initial m-RQLQ results indicate statistically significant ( P < .05) improvement on 12 of 14 domains, including impact on regular and recreational activities, sleep, nose rubbing and nose blowing, stuffy nose and runny nose, itchy eyes, sore eyes, watery eyes, thirst, and tiredness. In addition, total m-RQLQ score showed statistically significant improvement ( P = .001). No serious adverse events occurred with the initiation of SLIT. Conclusion These results indicate that SLIT is effective in controlling allergic symptoms and is safe in an introductory patient sample. Double-blind placebo-controlled trials are needed to confirm our preliminary results.

Mometasone furoate nasal spray reduces symptoms and improves quality of life in Chinese patients with moderate to severe allergic rhinitis: a multicenter open-label study

Conclusion: mometasone furoate nasal spray (MFNS) can reduce the symptoms and improve quality of life in Chinese patients with moderate to severe allergic rhinitis (AR). Objective: To evaluate the effects of MF on symptoms and quality of life in Chinese patients with moderate to severe AR. Patients and methods: In a multicenter and open-label study, 500 patients with moderate to severe AR were enrolled and received MFNS 200 µg once daily. We visited the patients four times (at baseline, and week 1, 2, and 4) to record symptom scores and the influence of AR on daytime activities and quality of sleep. The Mini Rhinoconjunctivitis Quality of Life Questionnaire (Mini-RQLQ) and the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ) were used in this study. Results: Compared with the baseline, MFNS significantly reduced the total and individual symptom scores and nocturnal sleep and daytime activities scores at week 1, 2, and 4 according to the Mini-RQLQ and NRQLQ.

Comparative safety and efficacy of 2 formulations of fluticasone aqueous nasal spray in persistent allergic rhinitis

There are few data on the clinical equivalence of different nasal corticosteroids in persistent allergic rhinitis (AR). Studies measuring plasma concentrations after a single dose may not predict relative systemic bioactivity at steady state. To compare a test formulation of fluticasone propionate with the innovator using a noninferiority design. Twenty-three patients with persistent AR were randomized to completion in a double-blind, placebo-controlled, crossover manner to receive the formulations at 200 microg/d for 4 weeks, with baselines measured after 2-week run-in and washout periods. The primary outcome measure was the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) score. Both formulations produced significant improvements in MiniRQLQ scores as change from baseline (P < .001), with a nonsignificant mean difference (test vs innovator) of -0.06 U (95% confidence interval [CI], -0.41 to 0.52 U) and the lower bound of the 95% CI being above the predefined noninferiority limit of -0.7 U. Both formulations produced significant improvements in peak nasal inspiratory flow rates as change from baseline (P < .01), with a nonsignificant mean difference of 0.5 L x min(-1) (95% CI, 9.8 to 10.8 L x min(-1)). There were also significant reductions in total nasal symptom scores (P < .01), with a nonsignificant mean difference of 0.4 U (95% CI, 0.3 to 1.1 U). No significant suppression of the 10-hour overnight urinary cortisol to creatinine ratio was seen with either formulation. The test formulation was noninferior to the innovator for the primary outcome of MiniRQLQ score. The secondary efficacy and safety end points also support the interchangeability of the 2 formulations.

Health‐related quality of life in allergic rhinitis: comparing the short form ESPRINT‐15 and MiniRQLQ questionnaires

We compared the psychometric properties of the ESPRINT-15, the short form of a new Spanish instrument to measure health-related quality of life in allergic rhinitis (AR) patients, with those of the Mini-Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ). The questionnaires were compared in Spanish patients with intermittent allergic rhinitis (IAR) or persistent AR in a prospective, observational study. Floor and ceiling effects, internal consistency (Cronbach's alpha), test-retest reliability (intraclass correlation coefficient; ICC), convergent and known groups validity, and sensitivity to change (standardized response means; SRMs) were compared. In terms of content, while the MiniRQLQ has a dimension covering practical problems and places more emphasis on symptoms, the ESPRINT-15 has two dimensions (Sleep and Psychological impact) which are not included in the MiniRQLQ. In the validation study, 400 patients were included and 59% of the sample had persistent AR. There were no significant floor or ceiling effects on any dimension on either questionnaire. Cronbach's alpha values for the ESPRINT-15 and MiniRQLQ overall scores were 0.92 and 0.90, respectively. In 48 clinically stable patients, ICCs were 0.80 and 0.77, respectively. Both instruments discriminated between patients with IAR and persistent AR. Correlations with symptom scores and generic measures were moderate to strong. SRMs for overall scores and individual dimensions on the two questionnaires in the 197 patients reporting a change in health status ranged from 0.7 to 1.3. Both questionnaires performed well in psychometric terms. The ESPRINT-15 is particularly recommended for use in Spanish-speaking populations.