Visual Analog Scale Symptom Scores Research Articles

Homoeopathic eye drops in the treatment of mild-to-moderate dry eye disease: Randomised, prospective, multicentre, single-masked study.

To compare the efficacy and safety of a homeopathic eye drop medicinal product (Homeoptic®) with 0.9% sodium hydrochloride eye drops (Larmabak®) in patients with mild-to-moderate dry eye disease (DED). Prospective, single-masked, observer-blinded, multicentre study on adult patients. Non-inferiority primary endpoint of the relative change between treatment groups in a composite Visual Analogue Scale (VAS) score covering five symptoms of DED, namely pain, itching, sensation of dry eye, impression of foreign body presence and burning, after 30 days of treatment. Details of all Adverse Events (AEs) were recorded and analysed. Ninety three patients were randomised to each treatment arm. At Day 30, the mean VAS symptom score was 26.0 ± 18.8 in the Homeoptic® group and 32.8 ± 21.2 Larmabak® group. Homeoptic® was demonstrated to be non-inferior to Larmabak®: the mean treatment difference of -7 being below the 10 mm upper limit of the 95% CI ([-12.9; -1.0]) pre-set as significant. The superiority of Homeoptic® over Larmabak® was then established with detection of a significant difference between the two treatment groups (p = 0.022). Significant differences between the treatment groups in favour of Homeoptic® were also detected in isolated VAS scores for the symptoms dry eye sensation (p = 0.009) and burning (p = 0.004). Results of ocular surface staining tests to estimate corneal and conjunctival damage as well as patient satisfaction were also significantly in favour of Homeoptic®. No new safety concerns were identified. Homeoptic® is more effective than Larmabak® at relieving the symptoms of DED and constitutes an effective treatment for mild-to-moderate DED.

Recovery of Breakthrough Asthma Attacks Treated With Oral Steroids While on Monoclonal Antibody Therapy: Protocol for a Prospective Observational Study (BOOST).

Asthma attacks are a common and important problem. Someone experiences an asthma attack in the United Kingdom every 10 seconds. Asthma attacks cause coughing, wheezing, breathlessness, and chest tightness and are highly stressful for patients. They result in reduced quality of life, with days lost from work or school. Asthma attacks are treated with oral corticosteroids (OCSs), but these have many short- and long-term side effects. Asthma monoclonal antibodies (mAbs) have revolutionized the treatment of severe asthma by reducing asthma attacks and OCS burden by over 50%, but some people still experience attacks while on mAbs. The MEX study showed that residual asthma attacks are broadly eosinophilic (high fractional exhaled nitric oxide [FeNO]) or noneosinophilic (low FeNO), but it did not measure response to OCS treatment. There is an evidence gap in understanding the clinical and inflammatory responses that occur when using OCSs to treat residual asthma attacks in patients taking asthma mAbs. The primary objective is to compare the clinical recovery between high-FeNO and low-FeNO attacks after acute treatment with oral prednisolone among people established on long-term asthma mAb treatment. The exploratory objective is to compare the inflammatory response to acute treatment with oral prednisolone between high-FeNO and low-FeNO attacks. BOOST (Breakthrough Asthma Attacks Treated With Oral Steroids) is a single-center, prospective observational study of 60 adults established on long-term asthma mAb treatment who receive acute treatment with oral prednisolone (usual care) for an asthma attack. The primary outcome will be the proportion of treatment failure (the need to start oral prednisolone or antibiotics or an unscheduled health care visit for asthma, following an attack) at day 28. The secondary outcomes will be the change in forced expiratory volume in 1 second and the change in visual analogue scale symptom score between the stable state, attack, day 7, and day 28 visits. The exploratory outcomes include the changes in sputum, nasal, and blood inflammometry between the stable state, attack, day 7, and day 28 visits. The last asthma attack visit is anticipated to occur in December 2023. Data analysis and publication will take place in 2024. We will test the hypothesis that there is a difference in the rate of recovery of clinical and inflammatory measures between high-FeNO and low-FeNO asthma attacks that occur in patients on mAb therapy. The study data will help power a future randomized placebo-controlled trial of prednisolone treatment for nonsevere attacks in patients treated with asthma mAbs and will provide important information on whether corticosteroid treatment should be FeNO-directed. DERR1-10.2196/46741.

Poliprotect vs Omeprazole in the Relief of Heartburn, Epigastric Pain, and Burning in Patients Without Erosive Esophagitis and Gastroduodenal Lesions: A Randomized, Controlled Trial.

In the treatment of upper GI endoscopy-negative patients with heartburn and epigastric pain or burning, antacids, antireflux agents, and mucosal protective agents are widely used, alone or as add-on treatment, to increase response to proton-pump inhibitors, which are not indicated in infancy and pregnancy and account for significant cost expenditure. In this randomized, controlled, double-blind, double-dummy, multicenter trial assessing the efficacy and safety of mucosal protective agent Poliprotect (neoBianacid, Sansepolcro, Italy) vs omeprazole in the relief of heartburn and epigastric pain/burning, 275 endoscopy-negative outpatients were given a 4-week treatment with omeprazole (20 mg q.d.) or Poliprotect (5 times a day for the initial 2 weeks and on demand thereafter), followed by an open-label 4-week treatment period with Poliprotect on-demand. Gut microbiota change was assessed. A 2-week treatment with Poliprotect proved noninferior to omeprazole for symptom relief (between-group difference in the change in visual analog scale symptom score: [mean, 95% confidence interval] -5.4, -9.9 to -0.1; -6.2, -10.8 to -1.6; intention-to-treat and per-protocol populations, respectively). Poliprotect's benefit remained unaltered after shifting to on-demand intake, with no gut microbiota variation. The initial benefit of omeprazole was maintained against significantly higher use of rescue medicine sachets (mean, 95% confidence interval: Poliprotect 3.9, 2.8-5.0; omeprazole 8.2, 4.8-11.6) and associated with an increased abundance of oral cavity genera in the intestinal microbiota. No relevant adverse events were reported in either treatment arm. Poliprotect proved noninferior to standard-dose omeprazole in symptomatic patients with heartburn/epigastric burning without erosive esophagitis and gastroduodenal lesions. Gut microbiota was not affected by Poliprotect treatment. The study is registered in Clinicaltrial.gov (NCT03238534) and the EudraCT database (2015-005216-15).

Effects of auricular acupressure on dysmenorrhea: A systematic review and meta-analysis of randomized controlled trials.

Auricular acupressure (AA) is widely used in treatment of dysmenorrhea, but the safety and efficacy of auricular acupressure on dysmenorrhoea are still lack of evidence-based basis. The purpose of meta-analysis was to evaluate the effects of auricular acupressure on dysmenorrhea. A systematic search was conducted in six electronic databases, including PubMed, Embase, Cochrane Central Register of Controlled Trials (CINAHL), Weipu (CQVIP), China National Knowledge Infrastructure (CNKI), and Wanfang databases, to retrieve studies published from the inception dates to June 10, 2022. Randomized controlled trials (RCTs) that investigated the effectiveness of AA on dysmenorrhea were identified. The data extraction and quality assessment of the included studies were performed by two reviewers independently. Outcomes were abstracted to determine the effect measure by using mean differences (MD), standardized mean differences (SMD), or odds ratio (OR) from a random effects model. Cure rate, total effective rate, and visual analogue scale (VAS) were described as primary outcomes; Short-form Menstrual Distress Questionnaire (MDQs), symptom scores, serum nitric oxide (NO) level, and adverse events were recorded as secondary outcomes. Thirty-five RCTs involving 3960 participants were included in this study. Our findings indicated that, overall, AA was associated with a significant benefit in cured rate (OR = 1.95, 95%CI: [1.34, 2.83], P=0.0004, I2 = 75%), total effective rate (OR = 3.58, 95%CI: [2.92, 4.39], P<0.00001, I2 = 67%), VAS score (MD = -1.45, 95%CI: [-1.73, -1.17], P<0.00001, I2 = 67%), and symptom scores compared to the control group (SMD = -0.85, 95%CI: [-1.28, -0.43], P<0.0001, I2 = 91%). However, no difference in serum NO (SMD = 0.77, 95%CI: [-0.39, 1.92], P = 0.19, I2 = 89%) and MDQs (SMD = -0.58, 95%CI: [-1.26, 0.10], P = 0.10, I2 = 79%) was found between the two groups. Furthermore, subgroup analysis results indicated that AA showed significant superiorities in increasing cured rate and total effective rate, and reducing VAS score and symptom scores when compared to analgesics and non-intervention. Moreover, AA presented the same superiorities when used as an adjunctive strategy to other therapy. However, these benefits were not detected in AA used alone when compared to the therapies, including Chinese herbs, acupuncture, external application of Chineseherbal medicine, moxibustion, auricular needle, and health education. Overall, AA, as a potential safety therapy, is effective for the management of dysmenorrhea, such as increasing cured rate, total effective rate, VAS, and symptom scores. Nevertheless, AA showed no significant improvement in serum NO and MDQs. It is furtherly found that AA used alone is superior to analgesics and non-intervention regarding cured rate, total effective rate, VAS, and symptom scores. Furthermore, the same superiorities are observed when AA serves as an adjunctive strategy to other therapy. However, AA alone has little effect on them compared to other therapies, and there is no definite conclusion on the benefits of AA compared to placebo for patients with dysmenorrhea. Rigorous RCTs with blind method and placebo control are warranted to confirm these findings. https://www.crd.york.ac.uk/prospero/, identifier CRD42022338524.

Discordance of chronic rhinosinusitis disease control between EPOS guidelines and patient perspectives identifies utility of patient-rated control assessment.

The objective of this study was to determine concordance of patient-reported chronic rhinosinusitis (CRS) disease control with CRS disease control assessed according to European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) criteria. In 421 participants, CRS disease control was determined using EPOS criteria which include the burden of 5 symptoms measured on a binary scale, use of rescue medications in the prior 6 months and presence of diseased mucosa on nasal endoscopy. Symptom severity was also assessed using a visual analogue scale (VAS). Participants rated their CRS disease control as "controlled","partly controlled" or "uncontrolled". Patient-reported and EPOS-based CRS disease control ratings agreed for 49.6% of participants. Amongst cases of disagreement, EPOS guidelines assessed worse CRS disease control relative to 92.9% of patients. Facial pain/pressure and impaired sense of smell distinctly associated with patient agreement with EPOS guidelines on having "uncontrolled" CRS. Higher VAS symptom scores were associated with worse patient-reported CRS disease control (i.e., agreeing with EPOS guidelines). Removal of the nasal endoscopy criterion improved agreement between patients' and EPOS control assessments, and replacement of this criterion with patient-reported control further aligned EPOS guidelines with patient perspectives. EPOS guidelines regularly assess worse CRS control than assessed by patients. The lack of more gradated symptom severity criteria and inclusion of nasal endoscopy may contribute to discordance of EPOS guidelines with patient-reported CRS control. Replacement of nasal endoscopy findings with a measure of patient-reported CRS disease control better aligns EPOS CRS disease control guidelines with patients' perspectives.

Short- and long-term oral steroid therapy in patients with asthma exacerbation.

Steroids are frequently used for symptom control in cases of asthma exacerbation. The aim of this study was to compare the effect of short-term and long-term oral steroid therapy on symptom control in patients with asthma exacerbation. Patients that received short-term (<10 d) and long-term (≥10 d) oral steroid therapy during asthma exacerbation were compared retrospectively. A visual analog scale (VAS) for symptom severity was administered, and the asthma control test (ACT) and pulmonary function tests were performed before and after treatment. The study included 69 patients and the overall mean duration of steroid treatment was 9.57±3.58 d (range: 5-25 d). Mean duration of short-term and long-term steroid treatment was 6.54±0.99 d and 11.63±3.21 d, respectively. Serious side-effects were not observed following oral steroid therapy. Post the short- and long-term oral steroid therapy there were not any significant differences between the 2 groups in terms of ACT, FEV1 (forced expiratory volume 1), or VAS symptom scores. The findings show that in patients with mild asthma exacerbation short-term oral steroid therapy is as effective as long-term steroid therapy and can be safely used for symptom control during periods of mild asthma exacerbation.

Individual symptom visual analogue scale severity scores for determining EPOS guideline-based chronic rhinosinusitis disease control.

The goal of this study was to determine how to translate visual analogue scale (VAS) symptom scores to the binary, descriptive symptom scales used in the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) criteria for chronic rhinosinusitis (CRS) disease control. 309 CRS patients were recruited. All patients rated their burden of 5 symptoms (nasal blockage, rhinorrhea/postnasal drip, facial pain/pressure, smell loss, sleep disturbance or fatigue) using the binary EPOS descriptive symptom scales and a VAS (on a scale of 0 to 10). In addition, participants completed a 22-item Sinonasal Outcome Test (SNOT-22) and rated their overall CRS disease control as "controlled", "partly controlled" or "uncontrolled" Results: Symptom burdens measured by VAS, binary descriptive EPOS scale and SNOT-22 were associated with worsening CRS disease control reported by participants. Each symptom had a distinct VAS score cut-off that strongly predicted the uncontrolled option on the corresponding binary descriptive EPOS symptom scale. However, the predictive ability of VAS for rhinorrhea/ postnasal drip was disparately worse than the other 4 symptoms. When considering all symptom data simultaneously, a VAS score higher than 3.5 strongly predicted the uncontrolled option on the corresponding binary descriptive EPOS symptom scale for all 5 symptoms. A VAS symptom score of higher than 3.5 translates to the uncontrolled option in the binary, descriptive symptom scale of the EPOS control criteria. The rhinorrhea/postnasal drip descriptive symptom scale translates disparately worse to VAS scores and may be considered for revision in future criteria.

Efficacy and toxicities of low-temperature plasma radiofrequency ablation for the treatment of laryngomalacia in neonates and infants: a prospective randomized controlled trial.

BackgroundLaryngomalacia is the most common cause of stridor in neonates and infants, and supraglottoplasty is the mainstay of surgical treatment. Although low-temperature plasma radiofrequency ablation (LTP-RFA) using coblation technology has been used for treating laryngomalacia, it is still lack of high-quality clinical evidence. Therefore, we conduct this prospective randomized study to clearly define the role of LTP-RFA for the treatment of laryngomalacia in neonates and infants.MethodsBetween Jan 2017 and Dec 2019, a total of 89 children with laryngomalacia were included for analysis. All patients were initially stratified according to the severity of laryngomalacia. Patients with severe laryngomalacia were randomly assigned to receive LTP-RFA or traditionally surgical supraglottoplasty, while patients with moderate laryngomalacia were assigned to LTP-RFA or observation. The primary end point was the efficacy and toxicities of LTP-RFA by assessing the changes of clinical score and visual analogue scale (VAS) symptom score. The total score was the combination of clinical score with VAS score.ResultsOf the 89 children, 40 children presented with severe laryngomalacia, and the remaining 49 children were diagnosed as moderate laryngomalacia. The median age was 68 days (range, 19 to 337 days). For children with severe laryngomalacia, our results showed that LTP-RFA treatment significantly reduced the operative time (5.55±1.66 vs. 18.7±5.31 min, P<0.001), length of hospital stay (6.71±1.15 vs. 7.95±1.55 days, P=0.008) and the amount of intraoperative hemorrhage (1.71±1.79 vs. 4.90±1.82, P<0.001) when compared to traditionally surgical supraglottoplasty, while the treatment efficacy was comparable between LTP-RFA and traditionally surgical supraglottoplasty in terms of changed total score (P=0.322), changed clinical score (P=0.135) and changed VAS symptom score (P=0.559). Additionally, for children with moderate laryngomalacia, LTP-RFA treatment significantly improved the symptom evaluated by total score (P<0.001), clinical score (P<0.001) and VAS symptom score (P<0.001) in comparison with the observation group. Post-operative pneumonia was observed in 10 patients. No surgical related death was reported.ConclusionsThe present study indicated that LTP-RFA was an effective treatment option for both severe and moderate laryngomalacia in neonates and infants with a low intraoperative complication. Long-term outcomes of LTP-RFA for laryngomalacia would be reported in further studies.

Differences in self-reported symptoms in patients with chronic odontogenic and non-odontogenic rhinosinusitis.

To evaluate the possible differences in self-reported symptoms between patients with chronic odontogenic rhinosinusitis (CORS) and patients with chronic non-odontogenic rhinosinusitis (CnORS). The study included 64 patients diagnosed with chronic rhinosinusitis according to EPOS guidelines. 32 patients had CORS, and the control group were 32 patients with CnORS. Patients were matched according to gender and age. All the patients underwent a CT scan evaluated by a radiologist, and were evaluated by an oral surgeon and otorhinolaryngologist before being assigned to one of the groups. The severity of the symptoms was assessed through questioners SNOT-22 (sino-nasal outcome test) and VAS (visual analogue scale) symptom score. Kolmogorov-Smirnov's, Fisher's and Mann-Whitney U test were used in the statistical analysis of the data. People with CORS show similar symptomatology on SNOT-22 score to patients with CnORS, with no significant statistical difference between any of the SNOT-22 symptoms. VAS symptom score showed that odontogenic group had a significantly higher score for fever (p = .004) and halitosis (p = .003). Halitosis and fever might be the most important symptoms in differentiating between CORS and CnORS symptomatology. Better diagnostic tools, such as VAS symptom score might help medical professionals to be quicker at recognizing CORS specific symptomatology, and help them treat the disease as early and adequately as possible.

The expression of CD22 and CD72 on B cells negatively correlate with IgE level in eosinophilic chronic rhinosinusitis with nasal polyps

Abstract Background CD22 and CD72 have been demonstrated to act as B cell inhibitory receptors, which suppress B cells activation. However, the roles of CD22 and CD72 on B cells in nasal polyps (NPs) are largely unknown. Objective To explore the expression of CD22 and CD72 on B cells and the association with immunoglobulins (Igs) in NPs. Methods The expression levels of CD22 and CD72 was measured by RT-PCR, immunohistochemistry, immunofluorescence and flow cytometry. Igs levels in NPs were quantified by Bio-Plex assay or the UniCAP system. Computed tomography scan and symptom severity were graded. Results The mRNA expression of CD22 and CD72 were elevated in eosinophilic chronic rhinosinusitis with nasal polyps (Eos CRSwNP) patients compared with non-eosinophilic chronic rhinosinusitis with nasal polyps (non-Eos CRSwNP) and controls. CD22 and CD72 were mainly expressed on CD19+ B cells. The numbers of CD22+ and CD72+ B cells and the percentage of CD22+ B cells and CD72+ B cells in B cells were increased in Eos CRSwNP compared with non-Eos CRSwNP and controls. IgA, IgG and IgM were elevated in both Eos CRSwNP and non-Eos CRSwNP, while IgD and IgE were increased in Eos CRSwNP. CD22 mRNA and CD72 mRNA expression level were negatively correlated with IgE, but not IgA, IgG, IgM and IgD in Eos CRSwNP. The percentage of CD22+ B cells and CD72+ B cells in B cells negatively correlate with the total visual analog scale symptom scores and total endoscope scores. Conclusion CD22 and CD72 were significantly increased in Eos CRSwNP patients and negatively correlated with IgE level, indicating the down-regulation role of CD22 and CD72 in B cell activation and a suppressive role in the synthesis of IgE in Eos CRSwNP.

Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial

Patients with eosinophilic nasal polyposis frequently require surgery, and recurrence rates are high. We sought to assess the efficacy and safety of mepolizumab versus placebo for severe bilateral nasal polyposis. This randomized, double-blind, placebo-controlled trial recruited patients aged 18 to 70years with recurrent nasal polyposis requiring surgery. Patients received 750mg of intravenous mepolizumab or placebo every 4weeks for a total of 6 doses in addition to daily topical corticosteroid treatment. The primary end point was the number of patients no longer requiring surgery at Week 25 based on a composite end point of endoscopic nasal polyp score and nasal polyposis severity visual analog scale (VAS) score. Secondary end points included change in nasal polyposis severity VAS score, endoscopic nasal polyp score, improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes, and safety. One hundred five patients received mepolizumab (n=54) or placebo (n=51). Asignificantly greater proportion of patients in the mepolizumab group compared with the placebo group no longer required surgery at Week 25 (16 [30%] vs 5 [10%], respectively; P=.006). There was a significant improvement in nasal polyposis severity VAS score, endoscopic nasal polyp score, all individual VAS symptom scores, and Sino-Nasal Outcome Test patient-reported outcome score in the mepolizumab compared with placebo groups. Mepolizumab's safety profile was comparable with that of placebo. In patients with recurrent nasal polyposis receiving topical corticosteroids who required surgery, mepolizumab treatment led to a greater reduction in the need for surgery and a greater improvement in symptoms than placebo.

Analysis of surgical outcomes of functional endoscopic sinus surgery and radical sinus surgery for refractory rhinosinusitis

Objective:To study the surgical outcomes of functional endoscopic sinus surgery and radical sinus surgery for refractory rhinosinusitis.Method:A retrospective analysis of 56 cases with refractory rhinosinusitis was performed, who were enrolled in Beijing Tongren hospital from January 2011 to April 2013. According to different surgical methods, all patients were classified into functional endoscopic surgery group (FESS group) and radical sinus surgery group (RSS group). All patients were followed up for more than one year after surgery. Symptom visual analog scale (VAS), peripheral blood eosinophil percentage, serum total IgE, skin prick test (SPT), olfactory function, Lund-Kennedy score and Lund-Mackay score were all examined and analyzed in two groups before and after surgery. SPSS 17.0 was used to do data statistic analysis.Result:There was no significant difference between two groups in age, gender, complicated with allergic rhinitis and asthma (P> 0.05). However, there was significant difference between two groups in the number of patients with previous surgery (P< 0.05). Pre-operative VAS symptom score, Lund-Kennedy score and Lund-Mackay score were higher in RSS group than in FESS group. All patients were followed up for at least one year. VAS symptom score, Lund-Kennedy score and Lund-Mackay score in two groups were compared before and after surgery respectively. VAS symptom score (P< 0.01; P< 0.01), Lund-Kennedy score (P< 0.01; P< 0.01), Lund-Mackay score (P< 0.01; P< 0.01) were significantly lower after surgery. There was no significant difference in VAS symptom scores between two groups postoperatively (P> 0.05). However, Lund-Kennedy score (P< 0.01) and Lund-Mackay score (P< 0.01) were lower in RSS group postoperatively. Among patients with surgery history, Lund-Kennedy score (P< 0.01) and Lund-Mackay score (P< 0.01) were also lower in RSS group at one year follow-up. Conclusion:Radical sinus surgery was more effective in relieving symptoms and reducing inflammation of sinus, compared with functional sinus surgery, especially in refractory sinusitis patients with previous surgery.

The guiding role of preoperative visual analog scale symptom scores in patients with chronic rhinosinusitis during perioperative period

Objective:To assess the guiding role of preoperative visual analog scale(VAS) symptom scores in patients with chronic rhinosinusitis(CRS) during perioperative period.Method:The patients with CRS undergoing endoscopic sinus surgery were divided into experimental group and control group according to doctor group.Preoperative VAS symptom scores which including the overall symptom score and every single symptom scores were assessed. Patients with symptom(nasal congestion, nasal discharge, dizziness or headache, hypoamia or anosmia, rhinocnesmus, sneeze) scores more than 5 points were taken corresponding appropriate strategies in experimental group, but conventional empirical measures in control group during perioperative period.Nasal endoscopic surgeries were performed under local or general anesthesia after preoperative preparation. Postoperative followup were performed in six months and one year for the overall symptom and each symptom scores in both groups. SPSS17.0 was used for statistical analysis.Result:There was no statistical difference in general condition, overall symptom score and every symptom scores before operation between experimental group(120 cases) and control group(82 cases) (P >0.05). At the three time points (preoperative, six months, one year after operation), significant differences were found in the two groups about VAS overall symptom score (P <0.05). Except hypoamia, VAS for the other symptoms in different postoperative time showed statistical significance (P <0.05).Conclusion:Preoperative VAS symptom score can be used not only in the evaluation of severity and treatment effect,but also in the guiding of perioperative treatment for CRS, which is worthy of using widely in clinic.

Semi-depot house-dust mite allergen extract for Chinese with allergic rhinitis and asthma.

Real-world data of the subcutaneous immunotherapy (SCIT) with semi-depot house-dust mite (HDM) allergen extract (a HDM allergen extract that contains a 50%-50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farina) for allergic rhinitis and asthma was unavailable in China until recently. To investigate the effectiveness and safety of a HDM-SCIT for allergic rhinitis and asthma in Chinese patients. A multicenter, single-arm, open-label, self-controlled study. Chinese patients with allergic rhinitis or allergic asthma and with a history of symptoms from HDM exposure were included and received allergen-specific immunotherapy for 1 year by subcutaneous injection of HDM-SCIT. The primary outcome measure was the percentage of patients with an improvement in symptom severity assessed at 12 months after initiation of the treatment. The occurrence of adverse events and compliance of treatment were also evaluated. A total of 272 outpatients were included for effectiveness analysis. The subject-evaluated improvement rate in the visual analog scale (VAS) was 76.1% and 71.3% at 6 and 12 months, respectively; corresponding values for investigator-evaluated VAS were 77.9% and 71.7%, respectively (p < 0.0001). Symptom score changes were -2.43 and -3.79 at 6 and 12 months, respectively (both p < 0.0001); the VAS improvement rate and symptom score change did not differ significantly between children and adolescents and/or adults. Good injection schedule adherence was found in 98.8% of the patients. No study drug-related serious adverse events or serious systemic allergic reactions occurred. HDM-SCIT was safe and effective in the treatment of allergic rhinitis and asthma in a Chinese population, with good compliance.

Differences in the Sino-Nasal Outcome Test 22 and visual analog scale symptom scores in chronic rhinosinusitis with and without nasal polyps.

Chronic rhinosinusitis (CRS) with and without polyps has a high impact on health-related quality of life (HRQL), but the difference in HRQL and symptom presentation between two clinical phenotypes of CRS has not been specifically evaluated before now. To evaluate patterns of symptoms and HRQL disease-specific domains affected in patients with CRS by comparing differences between two clinical phenotypes, adjusted for demographics, major risk factors, comorbidities, current medical treatment, and previous surgery. A group of 251 patients with CRS completed the visual analog scale (VAS) symptom severity score and the Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire. Data sets were analyzed by using principal component analysis (PCA) to identify a set of symptom components, together with the items excluded from PCA, which were then analyzed for differences between patients with CRS with nasal polyps (CRSwNP) and patients with CRS without nasal polyps (CRSsNP). PCA of SNOT-22 items identified six components, three referred to CRS-specific symptoms termed "nasal"; "extranasal, rhinologic"; and "olfactory/cough"; and three referred to HRQL impairment termed "sleep disturbance," "functional disturbance," and "emotional disturbance." Nasal obstruction, ear pain, ear fullness, and fatigue were excluded from PCA and treated as separate outcomes. Patients with CRSwNP had significantly worse nasal symptoms, olfactory/cough symptoms, and nasal obstruction. Patients with CRSsNP scored significantly worse with regard to fatigue and to sleep and functional disturbances. The PCA results for VAS scores identified three symptom components: pain, nasal symptoms, and pharyngeal symptoms. Patients with CRSwNP had significantly worse VAS nasal symptoms but less pronounced VAS pain symptoms than patients with CRSsNP. The total SNOT-22 score between the groups was not significantly different. With controlling of covariates that may influence the severity of the disease, this study showed significant differences in symptom patterns and different aspects of HRQL impairment between patients with CRSwNP and patients with CRSsNP, however, with no difference in the total HRQL score.

Relationship between nasal septal deformity, symptoms and disease severity in chronic rhinosinusitis.

The objective of this study was to evaluate the interaction of nasal septal deformity (NSD), including the contribution of septal spurs, with the severity of subjective symptoms, impairment of health-related quality of life (HRQoL) and sinus mucosal hyperplasia in patients with chronic rhinosinusitis (CRS). One hundred seventeen patients with CRS were assigned to three groups with mild, moderate or severe NSD, according to the measured nasal septal angle, including the presence of contact septal spurs. All CRS patients completed the visual analog scale (VAS) symptom severity score and the Sino-Nasal Outcome Test (SNOT-22) questionnaire. Symptoms scores, SNOT-22 and Lund-Mackay (LM) scores among the three NSD groups were compared. Related anatomy from the study group was compared with 100 control patients. VAS score for postnasal discharge in CRS patients was significantly higher in patients with mild NSD. There was a significantly higher LM score in CRS patients with severe NSD, compared to those with mild (P = 0.001) or moderate NSD (P = 0.005). CRS patients with a contact spur demonstrated a significantly higher LM score (P = 0.006) compared to those without a contact spur, and no differences in VAS symptom scores or HRQoL scores. There was a similar prevalence of septal deformities in CRS patients and in the non-ENT population. Our results support the conclusion that in patients with CRS, associated NSD or contact septal spur do not contribute significantly to CRS symptom severity or HRQoL impairment, but may have an impact on sinus mucosal hyperplasia.

Prospective trial of intense pulsed light for the treatment of meibomian gland dysfunction.

To evaluate the effect of intense pulsed light (IPL) applied to the periocular area for meibomian gland dysfunction (MGD) in a prospective, double-masked, placebo-controlled, paired-eye study. Twenty-eight participants underwent IPL treatment, with homogeneously sequenced light pulses delivered to one eye and placebo treatment to the partner control eye at 1, 15, and 45 days following baseline (BL) evaluation. Lipid layer grade (LLG), noninvasive tear break-up time (NIBUT), tear evaporation rate (TER), tear meniscus height (TMH), and subjective symptom score using visual analogue scales (VAS) were compared with BL and control values at each visit. Lipid layer grade improved significantly from BL to Day (D) 45 in the treated eye (P < 0.001), but not the control eye (P = 0.714), with 82% of treated eyes improving by at least one LLG. Noninvasive tear break-up time also improved significantly from BL to D45 in the treated (P < 0.001) but not in the control eye (P = 0.056) and was significantly longer than in the treated eye at D45 (14.1 ± 9.8 seconds versus 8.6 ± 8.2 seconds, P < 0.001). The tear evaporation rate was not different in the treated eye compared with the control eye at any visit. Tear meniscus height did not change from BL in either eye (P > 0.05). Visual analog scale symptom scores improved from BL in the treated (P = 0.015), but not the control eye (P = 0.245), with 86% of participants noting reduced symptoms in the treated eye by D45. Intense pulsed light with multiple sculpted pulses shows therapeutic potential for MGD, improving tear film quality and reducing symptoms of dry eye. ( https://www.anzctr.org.au number, ACTRN12614000162617.).

Rupatadine improves quality of life in mastocytosis: a randomized, double‐blind, placebo‐controlled trial

Mastocytosis is frequently associated with mast cell-mediated symptoms which require relieving medication. While second generation antihistamines (sgAHs) are the first line therapeutic strategy to treat mast cell mediator-related symptoms, controlled clinical trials on how they improve quality of life have not been performed. This randomized, double-blind, placebo-controlled, cross-over trial assessed rupatadine 20 mg daily in the treatment of mastocytosis symptoms in 30 adult patients. Symptoms were assessed by a visual analogue scale (VAS) and symptom specific quality of life questionnaire (ItchyQoL). The mean ItchyQoL total score and VAS symptom score were significantly improved in the rupatadine treatment phase compared with placebo. There were also significant reductions from placebo in the severity of itch, wheal and flare, flushing, tachycardia and headache but not gastrointestinal symptoms. In this first comprehensive trial of a sgAH in mastocytosis, rupatadine 20 mg daily for 4 weeks significantly controlled symptoms and improved patients' quality of life.

Epicutaneous allergen-specific immunotherapy ameliorates grass pollen–induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study

Epicutaneous allergen administration using a patch may be an alternative to subcutaneous or sublingual immunotherapy. To optimize treatment dose and to demonstrate the efficacy and safety of epicutaneous immunotherapy. This monocentric, placebo-controlled, double-blind trial included 132 patients with grass pollen-induced rhinoconjunctivitis. In February 2008, patients were randomly allocated to receive placebo or 3 different doses of allergen. Before and during the pollen season 2008, patients received 6 weekly patches. Efficacy was assessed 4 to 5 months later (n = 110) and during the pollen season of the treatment-free follow-up year in 2009 (n = 93). The primary outcome was patient-reported changes in hay fever symptoms assessed by a visual analog scale. Secondary outcome measures were weekly visual analog scale symptom scores during pollen season, use of rescue medication, changes in conjunctival and skin reactivity, as well as safety. Hay fever symptoms during the pollen season were reduced by more than 30% in 2008 and by 24% in 2009 in the high-dose group as compared with that in the placebo group, and the alleviation of symptoms in the follow-up year was dependent on the treatment dose. Higher allergen doses were associated with drug-related adverse events (AEs), predominantly manifested by pruritus, erythema, wheal, or eczema. Eleven systemic AEs of grades 1 to 2 required treatment and led to study exclusion. The dropout rate due to AEs was 8.3%. No drug-related serious AE was recorded. Epicutaneous immunotherapy is safe and efficacious in a dose-dependent manner after 6 patches only.

Transoral Incisionless Fundoplication: Initial Experience in Patients Referred to an Integrated Academic Institution

Transoral incisionless fundoplication is a new treatment for patients with gastroesophageal reflux disease. We present our initial experience with 10 patients undergoing this procedure with varying past surgical histories. All procedures were performed under general nasotracheal anesthesia. RAND-36 and Visual Analog Scale symptom scores were collected at pre and postoperative appointments for a mean of 9.2 months. The mean procedure time was 68 minutes. There were no intraoperative or postoperative complications. Patients with prior pancreaticoduodenectomy had observed reduced working space due to prior distal gastrectomy and required additional insufflation due to no pyloric resistance to insufflation of the small bowel. The patient with prior fundoplication required additional time and force for fastener penetration of the resultant scar from the partially disrupted fundoplication. All patients were discharged within 23 hours of the procedure. Throughout the follow-up period, patients reported gradual changes in medication requirements and symptom scores. There were no late complications. Transoral incisionless fundoplication is technically safe in well-selected patients including those with prior esophageal and gastric surgery.