Evaluating health utility score through direct and indirect methods in patients with chronic rhinosinusitis.

INTRODUCTION: EuroQol-5-dimensions-5-levels (EQ-5D-5L), visual analog scale (VAS), time trade-off (TTO), and standard gamble (SG) are used for the assessment of Health Utility Scores (HUS) of chronic rhinosinusitis (CRS). This study aimed to determine the overall HUS of CRS, the factors which influence the HUS, and the preferable method. METHODS: A cross-sectional study was conducted. Patients with primary CRS were recruited. Clinical and socioeconomic data together with HUS were assessed. Four HUS scores determined from the four different methods were compared. RESULTS: A total of 335 patients were enrolled. The overall HUS, as measured by EQ-5D-5L, VAS, TTO, and SG, was 0.88 ± 0.14, 0.79 ± 0.17, 0.89 ± 0.15, and 0.86 ± 0.16, respectively. The multivariable linear regression revealed that each increasing 22-item sinonasal outcome test (SNOT-22) score predicted a reduction of 0.002 to 0.003 in HUS (all methods, p < 0.01). Patients who scheduled for endoscopic sinus surgery had 0.06 to 0.11 HUS lower than other groups in EQ-5D-5L and VAS (all p < 0.05). Higher endoscopy score, age, presence of comorbid airway diseases, and lower education correlated with lower HUS (p < 0.05). Given the HUS results and regression models, the EQ-5D-5L is likely the preferable choice. CONCLUSION: The overall HUS of CRS was approximately 0.79-0.89. High SNOT-22 score and those who failed medications, presence of comorbid AR/asthma, increased age, high endoscopy score, and low education negatively impacted HUS. Our data suggest that EQ-5D-5L is a preferable method for measuring HUS in patients with CRS.

Health Utility Score in Thai Patients with Chronic Rhinosinusitis: Pre- and Postoperative Analyses.

BACKGROUND: Endoscopic sinus surgery (ESS) can increase the health utility score (HUS) of patients with chronic rhinosinusitis (CRS) who require the surgery. HUS varies depending on the geographical or living environment. HUS in CRS has never been evaluated in Thailand. The objective of this study was to evaluate the HUS of Thai patients with CRS before and after ESS through multiple approaches. METHODS: Thai patients (age ≥ 18) with CRS scheduled for ESS were enrolled in this prospective study. The preoperative (baseline) demographics, 22-items sinonasal outcome test, endoscopic score, and CT score were recorded. The HUS was evaluated using four methods: the EuroQoL-5 Dimension-5 level (EQ-5D-5L), Visual Analog Scale (VAS), Standard gamble (SG), and Time trade-off (TTO); at baseline, three months and six months post-operation. RESULTS: Data from 60 patients were analyzed. The mean baseline HUS scores by EQ-5D-5L, VAS, SG, and TTO were 0.75, 0.65, 0.79, and 0.85, respectively. The postoperative HUS significantly improved to 0.96, 0.91, 0.96, 0.97 at three months, and 0.97, 0.92, 0.97, and 0.98 at six months, respectively. ESS raised the HUS by 0.12-0.27 points. Among the four methods, VAS showed the lowest HUS at all time points. CONCLUSION: The preoperative HUS in Thai patients with CRS generally increased to near-perfect values after the ESS. The increase in HUS reflecting the improved general quality of life, was demonstrated at three and up to six months after ESS. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2070-2076, 2024.

Treatments of Epistaxis in Hereditary Hemorrhagic Telangiectasia: Systematic Review and Network Meta-Analysis.

PURPOSE OF REVIEW: To analyze and compare the effects of epistaxis treatments for Hereditary Hemorrhagic Telangiectasia (HHT) patients. RECENT FINDINGS: Of total of 21 randomized controlled trials (RCT), the data from 15 RCTs (697 patients, 7 treatments: timolol, propranolol, bevacizumab, doxycycline, tacrolimus, estriol/estradiol, and tranexamic acid) were pooled for the meta-analyses while the other 6 studies (treatments: electrosurgical plasma coagulation, KTP laser, postoperative packing, tamoxifen, sclerosing agent, and estriol) were reviewed qualitatively. When compared to placebo, propranolol offered the most improved epistaxis severity score, mean difference (MD), -1.68, 95% confidence interval (95%CI) [-2.80, -0.56] followed by timolol, MD -0.40, 95%CI [-0.79, -0.02]. Tranexamic acid significantly reduced the epistaxis frequency, MD -1.93, 95%CI [-3.58, -0.28]. Other treatments had indifferent effects to placebo. Qualitative analysis highlighted the benefits of tamoxifen and estriol. The adverse events of tranexamic acid, tacrolimus, propranolol, and estradiol were significantly reported. Propranolol, timolol, tranexamic acid, tamoxifen, and estriol were effective treatments which offered benefits to HHT patients in epistaxis management. Adverse events of tranexamic acid, tacrolimus, propranolol, and estradiol should be concerned.

Phase III study of Phlai capsules in the treatment of allergic rhinitis: A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Preclinical studies demonstrated anti-inflammatory effects of Zingiber montanum (J.König) Link ex Dietr.(Phlai). However, its clinical effect on allergic rhinitis (AR) is not evident. OBJECTIVE: We sought to assess the efficacy and safety of Phlai for treating AR. METHODS: A phase 3, randomized, double-blind, placebo-controlled study was conducted. Patients with AR were randomized into three groups and received Phlai 100 mg or Phlai 200 mg or placebo once a day for four weeks. The primary outcome was a change in the reflective total five symptom score (rT5SS). The secondary outcomes were the change in the instantaneous total five symptom score (iT5SS), the reflective individual symptom scores (rhinorrhea, nasal congestion, sneezing, itchy nose, itchy eyes), Rhinoconjunctivitis Quality of Life-36 Questionnaire (RCQ-36) score, peak nasal inspiratory flow (PNIF), and adverse events. RESULTS: Two hundred and sixty-two patients were enrolled. Compared with placebo, Phlai 100 mg improved rT5SS [adjusted mean difference (aMD) -0.62; 95%CI -1.22, -0.03; p = 0.039], rhinorrhea (aMD -0.19; 95%CI -0.37, 0.002; p = 0.048), itchy nose (aMD -0.24; 95%CI -0.43, -0.05; p = 0.011), and itchy eyes (aMD -0.19; 95%CI -0.36, -0.02; p = 0.033) at week 4. Nasal obstruction, sneezing, iT5SS, overall RCQ-36 score, PNIF did not reach statistical significance. Phlai 200 mg did not bring additional benefits compared to 100 mg. Adverse events were similar among groups. CONCLUSIONS: Phlai was safe. At four weeks, there were small improvements in rT5SS, together with the individual symptoms of rhinorrhea, itchy nose, and itchy eyes.

Aerosol Concentrations During Otolaryngology Procedures in a Negative Pressure Isolation Room.

OBJECTIVE: To evaluate the role of a negative pressure room with a high-efficiency particulate air (HEPA) filtration system on reducing aerosol exposure in common otolaryngology procedures. STUDY DESIGN: Prospective quantification of aerosol generation. SETTINGS: Tertiary care. METHODS: The particle concentrations were measured at various times during tracheostomy tube changes with tracheostomy suctioning, nasal endoscopy with suctioning, and fiberoptic laryngoscopy (FOL), which included 5 times per procedure in a negative pressure isolation room with a HEPA filter and additional 5 times in a nonpressure-controlled room without a HEPA filter. The particle concentrations were measured from the baseline, during the procedure, and continued until 30 minutes after the procedure ended. The particle concentrations were compared to the baseline concentrations. RESULTS: The particle concentration significantly increased from the baseline during tracheostomy tube changes (mean difference [MD] 0.80 × 106 p/m3 , p = .01), tracheostomy suctioning (MD 0.78 × 106 p/m3 , p = .004), at 2 minutes (MD 1.29 × 106 p/m3 , p = .01), and 3 minutes (MD 1.3 × 106 p/m3 , p = .004) after suctioning. There were no significant differences in the mean particle concentrations among various time points during nasal endoscopy with suctioning and FOL neither in isolation nor nonpressure-controlled rooms. CONCLUSION: A negative pressure isolation room with a HEPA filter was revealed to be safe for medical personnel inside and outside the room. Tracheostomy tube change with tracheostomy suctioning required an isolation room because this procedure generated aerosol, while nasal endoscopy with suctioning and FOL did not. Aerosol generated in an isolation room was diminished to the baseline after 4 minutes.

Herbal Medicines for Rhinosinusitis: A Systematic Review and Network Meta-analysis.

PURPOSE OF REVIEW: To analyze and compare the effects of herbal medicines (HMs) for treating different forms of rhinosinusitis. RECENT FINDINGS: Forty-seven randomized controlled trials evaluating 18 HMs in six different rhinosinusitis populations were included in the network meta-analysis. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. For the common cold, Pelargonium sidoides offered the most beneficial effect on symptom improvement (moderate certainty of evidence). For acute post-viral rhinosinusitis, Cineole and Pelargonium sidoides were the most effective treatments for controlling symptoms (moderate certainty), while Spicae aetheroleum was most effective for health-related quality of life (HRQoL) improvement (moderate certainty). For chronic rhinosinusitis without nasal polyps (CRSsNP), Origanum vulgare was the most beneficial treatment for improving symptoms and HRQoL (low certainty). Evidence of HMs for acute bacterial rhinosinusitis, chronic rhinosinusitis with nasal polyps, and unclassified chronic rhinosinusitis was restricted to a limited number of studies. Adverse events should be of concern in some HMs, such as Spicae aetheroleum or Mytorl. Several HMs improved patient-important outcomes, above minimal clinically important differences, in treating common cold, acute post-viral rhinosinusitis, and CRSsNP. Further studies with adequate sample sizes and long-term follow-ups are warranted to support the current evidence. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: PROSPERO ID: CRD42022328265 May 10, 2022.

Overall survival and prognostic factors in diabetic patients with invasive fungal rhinosinusitis.

BACKGROUND: Patients with diabetes mellitus (DM) are susceptible to invasive fungal rhinosinusitis (IFRS). The mortality rate of IFRS varies greatly among the patients with DM. OBJECTIVE: To identify the prognostic factors for the overall survival of patients with DM and IFRS. METHODS: A retrospective study was conducted in four tertiary hospitals in Thailand, Malaysia and Myanmar. Patients diagnosed with IFRS and DM from 2008 to 2019 were identified. The outcome was the overall survival. Variables analyzed for risk factors were age, HbA1C level, ketoacidosis, white blood cell count, hyperglycemia, duration of DM, current use of diabetic medications, serum creatinine level, and the extensions of IFRS to the orbit, the cavernous sinus and intracranial cavity. RESULTS: Sixty-five diabetic patients with IFRS (age 57.9 ± 13.4 years, male 60%) were identified. The mortality rate was 21.5%. The extensions of IFRS to the cavernous sinus (hazard ratio 5.1, 95% CI [1.4-18.2], p = 0.01) and intracranial cavity (hazard ratio 3.4, 95% CI [1.1-11.3, p = 0.05) predicted mortality. Current use of diabetic medications decreased the mortality risk (hazard ratio 0.2, 95% CI [0.1-0.9], p = 0.03). The 6-month overall survival of the patients with and without the cavernous sinus extension were 51.4% and 83.6%, (p = 0.001), with and without intracranial extension 53.3% and 88.9%, (p = 0.001), and with and without current diabetic medications 82.3% and 57.5%, respectively (p = 0.045). CONCLUSIONS: The extensions of IFRS to the cavernous sinus and intracranial cavity increased the risk of death in patients with DM. Survival was primarily related to current use of diabetic medications.

Reshaping the Management of Allergic Rhinitis in Primary Care: Lessons from the COVID-19 Pandemic.

The COVID-19 pandemic presented unique challenges to the delivery of healthcare for patients with allergic rhinitis (AR) following its disruption and impact on the healthcare system with profound implications. Reliance on self-care for AR symptom management was substantial during the pandemic with many patients encouraged to only seek in-person medical care when necessary. The advantage of digital technology becomes apparent when patients and healthcare providers had to change and adapt their method of interaction from the regular physical face-to-face consultation to telehealth and mobile health in the provision of care. Despite the pandemic and the ever-evolving post pandemic situation, optimal management of AR remains paramount for both patients and healthcare professionals. A reshaping of the delivery of care is essential to accomplish this goal. In this paper, we present what we have learned about AR management during the COVID-19 pandemic, the role of digital technology in revolutionizing AR healthcare, screening assessment in the identification and differentiation of common upper respiratory conditions, and a framework to facilitate the management of AR in primary care.

Optimal Device and Regimen of Nasal Saline Treatment for Sinonasal Diseases: Systematic Review.

Objective: This review aimed to systematically determine the optimal nasal saline regimen for different types of sinonasal diseases. Data Sources: PubMed, Embase, SCOPUS, Cochrane Library, Web of Science, ClinicalTrials.gov. The last search was on December 6, 2021. Review Methods: Study selection was done by 2 independent authors. Randomized controlled trials and meta-analyses were included. The effects of nasal saline treatment through various devices, saline tonicities, and buffer statuses were evaluated in patients with allergic and nonallergic rhinitis, acute and chronic rhinosinusitis (CRS), CRS with cystic fibrosis, and postoperative care, including septoplasty/turbinoplasty and endoscopic sinus surgery. Results: Sixty-nine studies were included: 10 meta-analyses and 59 randomized controlled trials. For allergic rhinitis, large-volume devices (≥60 mL) were effective for treating adults, while low-volume devices (5-59 mL) were effective for children. Isotonic saline was preferred over hypertonic saline due to fewer adverse events. For acute rhinosinusitis, saline irrigation was beneficial in children, but it was an option for adults. Large-volume devices were more effective, especially in the common cold subgroup. For CRS, large-volume devices were effective for adults, but saline drop was the only regimen that had available data in children. Buffered isotonic saline was more tolerable than nonbuffered or hypertonic saline. The data for CRS with cystic fibrosis and nonallergic rhinitis were limited. For postoperative care, buffered isotonic saline delivered by large-volume devices was effective. Conclusion: Nasal saline treatment is recommended for treating most sinonasal diseases. Optimal delivery methods for each condition should be considered to achieve therapeutic effects of saline treatment.

Combined medical therapy in the treatment of allergic rhinitis: Systematic review and meta-analyses.

BACKGROUND: Antihistamines (ATH) and intranasal corticosteroids (INCS) are primary treatments for patients with allergic rhinitis (AR). When monotherapy of either primary treatment fails to control symptoms, combined medical therapy is an option. In this meta-analysis we assessed the additional effects of different medical combinations compared with primary treatments. METHODS: Systematic searches on PubMed and EMBASE were updated on November 4, 2021. Randomized, controlled trials comparing the effects of combinations with monotherapy were included. There were 7 comparisons: (1) ATH-decongestant vs ATH; (2) ATH-leukotriene receptor antagonist (LTRA) vs ATH; (3) INCS-ATH vs INCS; (4) INCS-LTRA vs INCS; (5) INCS-decongestion vs INCS; (6) INCS-saline irrigation vs INCS; and (7) ATH-saline irrigation vs ATH. Data were pooled for meta-analysis. Outcomes were composite nasal symptom score, composite ocular symptom score, quality of life (QoL), and adverse events. RESULTS: Fifty-three studies were included. Compared with ATH alone, the ATH-decongestant combination improved composite nasal symptoms; ATH-LTRA improved nasal symptoms in patients with perennial AR; and ATH-nasal saline improved both symptoms and QoL. Compared with INCS alone, the INCS-intranasal ATH combination improved nasal symptoms, ocular symptoms, and QoL; INCS-LTRA improved ocular symptoms but not nasal symptoms; and INCS-nasal saline improved QoL but not symptoms. There were no additional effects observed from adding oral ATH or topical decongestant to INCS. CONCLUSION: After ATH monotherapy fails to control symptoms, addition of decongestant, saline, or LTRA can improve the outcomes. When INCS monotherapy is ineffective, addition of intranasal ATH can improve nasal symptoms; LTRA can improve ocular symptoms, and saline irrigation can improve QoL.

Empty Nose Syndrome Pathophysiology: A Systematic Review.

OBJECTIVE: The pathophysiology of empty nose syndrome (ENS) remains unclear despite significant research. The pathophysiologic mechanism of ENS was systematically reviewed. DATA SOURCES: MEDLINE and Embase. REVIEW METHODS: Data were systematically reviewed for studies that provided original data on pathophysiology. RESULTS: A total of 2476 studies were screened, and 19 met the inclusion criteria: 13 case-control and 6 cross-sectional. Nine pathophysiologic themes were identified.• Demographics: ENS symptoms had no relationship with climatic factors.• Symptomatology: ENS patients demonstrated high symptom severity.• Mental health: Anxiety and depression including hyperventilation were reported in >50% of ENS patients and correlated with ENS symptom severity.• Anatomic features: Structural changes in response to turbinate surgery were similar between ENS and non-ENS patients.• Airflow analysis: Airflow parameters were similar between ENS and non-ENS patients after turbinate surgery. On computational fluid dynamic analysis, differences were found on multiple outcomes.• Diagnostic testing: The menthol detection test was impaired in ENS, and cotton placement in the airway improved ENS symptoms.• Cognitive function: Functional magnetic resonance imaging showed activation in emotional processing area during breathing.• Olfactory function: Subjective impairment was reported in ENS, but quantitative measures were similar to non-ENS patients.• Mucosal physiology/innate immunity: Turbinate histopathology in ENS showed a tissue-remodeling pattern. Nasal nitric oxide level was lower in ENS patients. CONCLUSION: There is evidence of high comorbid mental health disorders in ENS patients. An abnormal trigeminal-thermoreceptor response may be present in some patients. The influence of altered airflow and the evidence of surgery as the cause for ENS are unclear.

Self-reported olfactory and gustatory dysfunction and psychophysical testing in screening for COVID-19: A systematic review and meta-analysis.

BACKGROUND: A substantial proportion of coronavirus disease-2019 (COVID-19) patients demonstrate olfactory and gustatory dysfunction (OGD). Self-reporting for OGD is widely used as a predictor of COVID-19. Although psychophysical assessment is currently under investigation in this role, the sensitivity of these screening tests for COVID-19 remains unclear. In this systematic review we assess the sensitivity of self-reporting and psychophysical tests for OGD. METHODS: A systematic search was performed on PubMed, EMBASE, and ClinicalTrials.gov from inception until February 16, 2021. Studies of suspected COVID-19 patients with reported smell or taste alterations were included. Data were pooled for meta-analysis. Sensitivity, specificity, and diagnostic odds ratio (DOR) were reported in the outcomes. RESULTS: In the 50 included studies (42,902 patients), self-reported olfactory dysfunction showed a sensitivity of 43.9% (95% confidence interval [CI], 37.8%-50.2%), a specificity of 91.8% (95% CI, 89.0%-93.9%), and a DOR of 8.74 (95% CI, 6.67-11.46) for predicting COVID-19 infection. Self-reported gustatory dysfunction yielded a sensitivity of 44.9% (95% CI, 36.4%-53.8%), a specificity of 91.5% (95% CI, 87.7%-94.3%), and a DOR of 8.83 (95% CI, 6.48-12.01). Olfactory psychophysical tests analysis revealed a sensitivity of 52.8% (95% CI, 25.5%-78.6%), a specificity of 88.0% (95% CI, 53.7%-97.9%), and a DOR of 8.18 (95% CI, 3.65-18.36). One study used an identification test for gustatory sensations assessment. CONCLUSION: Although demonstrating high specificity and DOR values, neither self-reported OGD nor unvalidated and limited psychophysical tests were sufficiently sensitive in screening for COVID-19. They were not suitable adjuncts in ruling out the disease.

Benefits of nasal saline treatment in acute rhinosinusitis: Systematic review and meta-analysis.

BACKGROUND: Although nasal saline treatments are widely used in treating acute rhinosinusitis (ARS), the evidence in adult patients is inconclusive. Our objective was to assess the add-on benefits of saline treatment in adults with ARS. METHODS: Literature searches were performed (updated May 9, 2021). Randomized, controlled trials studying the effects of nasal saline treatment in adults with ARS were included. Data were pooled for meta-analysis. Outcomes were composite symptoms score (CSS), disease-specific quality-of-life (DS-QoL) score, individual symptom score, endoscopy score, saccharin transit time, cure rate, days to resolution, and adverse events. RESULTS: Eleven studies (718 patients) were included in our investigation. Nasal discharge was the only symptom improved (standardized mean difference [SMD], -0.36; 95% confidence interval [CI], -0.66 to -0.05]. Saline as an add-on treatment brought no benefit to CSS and DS-QoL score at both time-points (3-10 days and at the end of the study). Other outcomes also showed no benefits with use of saline, including endoscopy score, saccharin transit time, cure rate, days to resolution, and adverse events. Subgroup analyses showed improvement in viral ARS patients for CSS (SMD, -0.60; 95% CI, -1.12 to -0.08) and DS-QoL score (mean difference, -15.90; 95% CI, -31.78 to -0.02), and also in patients using high-volume saline (SMD, -0.42; 95% CI, -0.78 to -0.06). CONCLUSION: Nasal saline as an add-on treatment improved rhinorrhea. There was no improvement in CSS and DS-QoL, except among the subgroup of viral ARS patients using high-volume saline. There were no differences in adverse events between the saline and non-saline treatments.

Effects of large volume, isotonic nasal saline irrigation for acute rhinosinusitis: a randomized controlled study.

BACKGROUND: The purpose of this study was to compare the effects of nasal saline irrigation (large volume, positive pressure isotonic saline) in addition to standard treatment in patients with acute rhinosinusitis (ARS). METHODS: This parallel, randomized controlled trial was conducted at a tertiary hospital. The adult patients with ARS (age ≥18 years) were randomly assigned to two groups. The irrigation group received 0.9% saline irrigation twice daily, using a 250-ml squeeze bottle, in addition to standard treatment. The no-irrigation group received standard treatment only. Patients were evaluated at baseline, 1 week, and 2 weeks. The quality of life, rhinologic subscore, symptom score, endoscopy score, and cure rate were compared. RESULTS: Sixty-one patients (30: irrigation, 31: no-irrigation) were enrolled. There were 17 males and 44 females. The mean age was 41.06 years. Although both groups showed improvements, the improvement of each outcome was not different between the groups. Subgroup analysis by ARS subtype showed benefits of irrigation in the common cold subgroup; the improvements that were greater than control included: rhinologic subscore, intergroup mean difference -4.15 [95% confidence interval (CI), -7.49, -0.80] at 1 week and -5.23 [95% CI, -9.69, -0.78] at 2 weeks; combined symptom score -5.35 [95% CI, -10.55, -0.14] at 1 week and -8.02 [95%CI, -14.36, -1.70] at 2 weeks. CONCLUSION: The add-on isotonic nasal saline irrigation using a large volume, positive pressure device did not add benefits equally for all ARS patients. The benefits of irrigation on quality of life and nasal symptoms were only observed in the common cold patient subgroup.

Botulinum toxin for chronic rhinitis: A systematic review and meta-analysis.

BACKGROUND: Botulinum toxin type A (BTX-A) is a potential treatment for chronic rhinitis. This study aimed to assess the effectiveness and safety of BTX-A in treating patients with chronic rhinitis. METHODS: Systematic searches of MEDLINE, Scopus, and EMBASE databases were performed. Randomized controlled trials (RCTs) that assessed the efficacy of BTX-A in allergic rhinitis and/or nonallergic rhinitis patients, compared with either placebo or active treatment, were included. The outcomes were total nasal symptom (TNSS), disease-specific quality of life (QOL), and adverse events. RESULTS: Nine RCTs (340 patients) met the eligibility criteria. Compared with placebo, the ≤ 12-week effects favored BTX-A injection on TNSS (standardized mean difference [SMD] -2.22, 95% confidence interval [CI] -3.27 to -1.17, p < 0.01, four RCTs). Beneficial effects > 12 weeks over placebo (MD -9.69, 95% CI -11.29 to -8.09, p < 0.01, one RCT) were demonstrated up to 24 weeks. However, the benefits were not shown on nasal congestion and individual nasal symptoms. Compared with active comparators (triamcinolone injection, ipratropium bromide, and cetirizine), there was no difference in the < 12-week effect between groups on TNSS. There was no difference between BTX-A and cetirizine on QOL (one RCT). The > 12-week effects on TNSS and individual nasal symptoms favored BTX-A over triamcinolone injection (one RCT). The risk ratio of adverse events favored BTX-A over cetirizine (one RCT). CONCLUSIONS: BTX-A improved TNSS and QOL in patients with chronic rhinitis. These effects were demonstrated up to 24 weeks post treatment. BTX-A was safe, well tolerated, and may be considered in patients who are refractory to current standard-of-care therapies.

Biologics for chronic rhinosinusitis.

BACKGROUND: This living systematic review is one of several Cochrane Reviews evaluating the medical management of patients with chronic rhinosinusitis. Chronic rhinosinusitis is common. It is characterised by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps.   'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, already evaluated in other inflammatory conditions (e.g. asthma and atopic dermatitis). OBJECTIVES: To assess the effects of biologics for the treatment of chronic rhinosinusitis. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2020, Issue 9); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished studies. The date of the search was 28 September 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) with at least three months follow-up comparing biologics (monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were disease-specific health-related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by endoscopic or computerised tomography (CT) score), generic HRQL and adverse effects (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included 10 studies. Of 1262 adult participants, 1260 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All of the studies were sponsored or supported by industry. For this update (2021) we have included two new studies, including 265 participants, which reported data relating to omalizumab. Anti-IL-4Rα mAb (dupilumab) versus placebo/no treatment (all receiving intranasal steroids) Three studies (784 participants) evaluated dupilumab. Disease-specific HRQL was measured with the SNOT-22 (a 22-item questionnaire, with a score range of 0 to 110; minimal clinically important difference (MCID) 8.9 points). At 24 weeks, dupilumab results in a large reduction (improvement) in the SNOT-22 score (mean difference (MD) -19.61, 95% confidence interval (CI) -22.54 to -16.69; 3 studies; 784 participants; high certainty). At between 16 and 52 weeks of follow-up, dupilumab probably results in a large reduction in disease severity, as measured by a 0- to 10-point visual analogue scale (VAS) (MD -3.00, 95% CI -3.47 to -2.53; 3 studies; 784 participants; moderate certainty). This is a global symptom score, including all aspects of chronic rhinosinusitis symptoms. At between 16 and 52 weeks of follow-up, dupilumab may result in a reduction in serious adverse events compared to placebo (5.9% versus 12.5%, risk ratio (RR) 0.47, 95% CI 0.29 to 0.76; 3 studies, 782 participants; low certainty). Anti-IL-5 mAb (mepolizumab) versus placebo/no treatment (all receiving intranasal steroids) Two studies (137 participants) evaluated mepolizumab. Disease-specific HRQL was measured with the SNOT-22. At 25 weeks, the SNOT-22 score may be reduced (improved) in participants receiving mepolizumab (MD -13.26 points, 95% CI -22.08 to -4.44; 1 study; 105 participants; low certainty; MCID 8.9).  It is very uncertain whether there is a difference in disease severity at 25 weeks: on a 0- to 10-point VAS, disease severity was -2.03 lower in those receiving mepolizumab (95% CI -3.65 to -0.41; 1 study; 72 participants; very low certainty). It is very uncertain if there is a difference in the number of serious adverse events at between 25 and 40 weeks (1.4% versus 0%; RR 1.57, 95% CI 0.07 to 35.46; 2 studies; 135 participants, very low certainty). Anti-IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids) Five studies (329 participants) evaluated omalizumab. Disease-specific HRQL was measured with the SNOT-22. At 24 weeks omalizumab probably results in a large reduction in SNOT-22 score (MD -15.62, 95% CI -19.79 to -11.45; 2 studies; 265 participants; moderate certainty; MCID 8.9). We did not identify any evidence for overall disease severity. It is very uncertain whether omalizumab affects the number of serious adverse events, with follow-up between 20 and 26 weeks (0.8% versus 2.5%, RR 0.32, 95% CI 0.05 to 2.00; 5 studies; 329 participants; very low certainty). AUTHORS' CONCLUSIONS: Almost all of the participants in the included studies had nasal polyps (99.8%) and all were using topical nasal steroids for their chronic rhinosinusitis symptoms. In these patients, dupilumab improves disease-specific HRQL compared to placebo. It probably also results in a reduction in disease severity, and may result in a reduction in the number of serious adverse events. Mepolizumab may improve disease-specific HRQL. It is very uncertain if there is a difference in disease severity or the number of serious adverse events. Omalizumab probably improves disease-specific HRQL compared to placebo. It is very uncertain if there is a difference in the number of serious adverse events. There was no evidence regarding the effect of omalizumab on disease severity (using global scores that address all symptoms of chronic rhinosinusitis).

Herbal Medicines for Allergic Rhinitis: a Systematic Review and Meta-analysis.

PURPOSE OF REVIEW: To assess the effects of herbal medicine (HM) therapy in various durations and analyze the effects of HM separately by mechanism of action in the treatment of allergic rhinitis (AR). RECENT FINDINGS: Thirty-two studies were included (2,697 patients, mean age 34.6 years). For the ≤ 4 weeks of treatment duration, HM brought greater benefits over placebo in reduction of total nasal symptoms score (standardized mean difference (SMD) -0.68; 95% confidence interval (CI) -0.98, -0.38; p <0.01) and improvement in Rhinoconjunctivitis Quality of Life Questionnaire score (SMD -0.53; 95% CI -0.81, -0.25; p <0.01). For the 4-12 weeks duration, total nasal symptoms score (SMD -0.22; 95%CI -0.4, -0.05; p =0.01) and Rhinoconjunctivitis Quality of Life Questionnaire score (SMD -0.48; 95% CI -0.89, -0.06; p =0.03) favored the HM. However, HM therapy for longer than 12 weeks was related to tachyphylaxis and showed no benefit over placebo in any outcomes. There was no difference between the HM and standard treatment on symptoms improvement. Anti-allergic effect, anti-inflammatory effect, anti-leukotriene effect, and anti-histaminic effect of HM were revealed. HM was safe and their adverse effects were comparable placebo. HM therapy is safe and provides better results than placebo in improving nasal symptoms and disease-specific quality of life in patients with AR. Its beneficial effects are demonstrated only in less than 12 weeks of treatment. TRIAL REGISTRATION: PROSPERO ID: CRD42020168367.

Risk factors of orbital complications in outpatients presenting with severe rhinosinusitis: A case-control study.

OBJECTIVES: We assessed associations of potential factors with orbital complications in acute rhinosinusitis (ARS) patients. DESIGN: An unmatched case-control study. SETTING: A tertiary referral hospital in Thailand. PARTICIPANTS: Consecutive outpatients of any age with severe ARS (visual analog scale ≥ 7) with and without orbital complications. MAIN OUTCOME MEASURES: Patients were enrolled from January 2013 to December 2018. Forty-three ARS patients (55.8% female, median age 45.6, (range 2.0-93.0) years) were included, with 19 patients in the complicated group and 24 in the uncomplicated group. Patient characteristics (gender, age, diabetes, immune status), symptoms and signs, site of infection and type of pathogenic bacteria were recorded and assessed their associations with orbital complications by univariable and multivariable logistic regression analyses. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: The most common orbital complication was subperiosteal abscess (42.1%), followed by orbital cellulitis (15.8%) and cavernous sinus thrombosis (10.5%). Multivariable logistic regression analysis demonstrated a positive association with orbital complications (pseudo R2 0.4) for ethmoid sinusitis (OR 31.1, 95% CI [2.3-430.6]) and a short duration of symptoms (OR 0.9, 95% CI [0.8-0.9]). CONCLUSIONS: Orbital complications were associated with ethmoid sinusitis with a short duration of ARS symptoms.

Predictive factors for invasive fungal rhinosinusitis in diabetic patients: Systematic review and data re-analysis.

This systematic review aims to identify prognostic factors for the overall survival of invasive fungal rhinosinusitis (IFRS) in patients with diabetes using original data from the existing published articles. Systematic searches of Medline, EMBASE, and Cochrane Library databases were performed to include articles from 1988 to 2019 using the terms: "fung*" AND "rhinosinusitis" AND "invasive" AND "diabetes OR ketoacidosis". Data from 258 diabetic patients with IFRS (mean age 55.9 years, 55.6% male, 124 studies) were extracted for data analysis. The mortality rate was 31.8%. Seven variables: plasma glucose level, HbA1C, ketoacidosis, leukopenia, serum creatinine level, duration of diabetes, and the cavernous sinus extension were assessed. Univariate analysis was done for each variable and revealed that the cavernous sinus extension was a significant risk factor. Multivariable logistic regression analysis confirmed that the cavernous sinus extension independently predicted mortality in patients with diabetes (hazard ratio (HR) 2.6, 95% confidence interval (CI) 1.2 to 5.4, p = 0.01). Kaplan Meier curve and Log-rank test were used for analyzing survival outcomes. The twelve-month overall survival rate of the patients with the cavernous sinus extension was 43.9% compared to 73.9% for the patients without the cavernous sinus extension (p = 0.01). Appropriate treatment of this condition could enhance the survival outcomes.