Total Symptom Score Research Articles

Efficacy and safety of intranasal medications for allergic rhinitis: Network meta-analysis.

Intranasal antihistamines (INAH), corticosteroids (INCS), and their fixed combinations (INAH+INCS) are one of the cornerstones of the treatment of allergic rhinitis (AR). We performed a systematic review and network-meta-analysis comparing the efficacy and safety of INAH, INCS, and INAH+INCS in patients with AR. We searched four electronic bibliographic databases and three clinical trial databases for randomised controlled trials assessing the use of INAH, INCS, and INAH+INCS in adults with seasonal or perennial AR. We performed a network meta-analysis on the Total Nasal Symptom Score, Total Ocular Symptom Score, Rhinoconjunctivitis Quality-of-Life Questionnaire, development of adverse events, and withdrawals due to adverse events. Certainty of evidence was assessed using GRADE-NMA. We included 167 primary studies, most of which assessed patients with seasonal AR. Among individual medications, azelastine-fluticasone, and fluticasone furoate were the most frequently highest-ranked interventions for efficacy outcomes, being regularly associated with clinically meaningful larger improvements when compared to other active treatments. Considering drug classes, INAH+INCS were the highest-ranked interventions for all outcomes in which they were assessed, followed in most cases by INCS. In 105 out of 184 comparisons in seasonal AR, and 28 out of 97 comparisons in perennial AR, certainty of evidence was considered "high" or "moderate". Intranasal medications for AR display clinically relevant differences in their efficacy, but all show a good safety profile. To our knowledge, this is the first network meta-analysis comparing INAH, INCS, and INAH+INCS in AR, providing relevant evidence for guideline developers and practising physicians on the most efficacious treatments.

Strength profiles in patients with knee osteoarthritis with and without unilateral transfemoral amputation

Background: Individuals with lower limb amputation have increased risk of developing knee osteoarthritis (KOA) in the intact limb, however there is little information regarding strength profiles in individuals with KOA with and without amputation. Objective: To compare lower extremity strength in individuals with KOA with and without unilateral transfemoral (TF) amputation. Study Design: Descriptive laboratory study. Methods: Seven participants with unilateral TF amputation (3F/4M, 58.0 ± 11.0 years, 172.7 ± 12.8 cm, 90.8 ± 19.1 kg, 38.8 ± 14.4 years after amputation) and symptomatic KOA in the intact limb and 9 participants with unilateral KOA (control (CON)) without leg amputation (4F/5M, 66.0 ± 9.9 years, 170.5 ± 10.7 cm, 86.8 ± 18.1 kg) participated in this study. Both groups completed strength testing on the involved limb with KOA and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to meaure subjective function. Strength variables were mass-normalized. Results: There were no significant differences between groups in age, mass, or height. The CON group reported significantly reduced subjective function on the KOOS total score (P = 0.049; d = 1.03) and KOOS symptoms scores (P = 0.047, d = 0.95) compared with the TF amputation group. A lower subjective function score indicates worse function. There were no other significant differences between groups on KOOS subcategories. The TF amputation group had significantly greater average isokinetic quadriceps torque (P = 0.05; d = 1.10), peak isokinetic quadriceps torque (P = 0.02; d = 1.36), and average isokinetic quadriceps power (P = 0.02; d = 1.38) compared with the CON group. There were no differences between groups in isometric knee extensor strength or any differences in knee flexor isokinetic or isometric strength. Conclusions: The TF amputation group demonstrated greater isokinetic knee extensor strength in their intact limb with KOA compared with the CON group osteoarthritic limb; however, there were no differences in isometric strength. Furthermore, the differences in isokinetic strength may suggest that those with a history of leg amputation may require more strength and power in the intact limb to maintain daily activity and, therefore, may require greater thresholds of strength to protect the knee joint from cartilage degradation.

Symptom Screening for Hospitalized Pediatric Patients With Cancer: A Randomized Clinical Trial.

Pediatric patients with cancer experience severely bothersome symptoms during treatment. It was hypothesized that symptom screening and provision of symptom reports to the health care team would reduce symptom burden in pediatric patients with cancer. To determine if daily symptom screening and provision of symptom reports to the health care team was associated with lower total symptom burden as measured by the Symptom Screening in Pediatrics Tool (SSPedi) compared to usual care among pediatric patients with cancer admitted to a hospital or seen in a clinic daily for at least 5 days. This randomized clinical trial enrolled participants from July 2018 to September 2023 from 8 Canadian tertiary care centers that diagnose and treat pediatric patients with cancer. Patients aged 8 to 18 years with cancer expected to be in a hospital or clinic daily for at least 5 consecutive days were eligible for inclusion. Participants were randomized to intervention (n = 176) vs control (n = 169) groups. Data were analyzed from November 2023 to December 2023. Intervention participants completed the SSPedi once daily for 5 days. Printed symptom reports were provided daily to the health care team, and email alerts were distributed for severely bothersome symptoms. Control participants received usual care. The primary outcome was self-reported total SSPedi score on day 5. Secondary outcomes were individual SSPedi symptoms, pain, quality of life, symptom documentation, and intervention provision. The primary analysis compared the day 5 total SSPedi scores between randomized groups using a multiple linear regression model. For the secondary analysis comparing individual SSPedi symptom scores, the odds ratio for the intervention was estimated using a proportional odds model. Pain and quality of life were analyzed using the same approach as the primary outcome. Fisher exact test was used to compare symptom documentation, any intervention, and symptom-specific intervention between groups. A total of 345 participants were enrolled; median (range) participant age was 13.8 (8.0-18.8) years, and 150 participants (43.5%) were female. Day 5 SSPedi score was significantly better with symptom screening compared to usual care (adjusted mean difference, -2.5; 95% CI, -3.8 to -1.2). Symptom screening reduced the odds of higher individual symptom scores; 8 of 15 symptom reductions were statistically significant. There were no significant differences in pain or quality of life scores between groups. Five symptoms were documented or treated significantly more often with symptom screening than usual care. In this randomized clinical trial, among pediatric patients with cancer admitted to a hospital or seen in a clinic daily for at least 5 days, symptom screening with SSPedi improved total symptom scores compared to usual care. ClinicalTrials.gov Identifier: NCT03593525.

Intranasal acupuncture for allergic rhinitis: A systematic review and meta-analysis.

To evaluate the efficacy of intranasal acupuncture as a treatment for allergic rhinitis (AR) through a comprehensive review. Comprehensive searches were performed in both Chinese (CNKI, VIP, CBM, and Wanfang) and English databases (PubMed, Embase, Cochrane Library, and Web of Science) to gather randomized controlled trials available from the inception of the database until August 2024. The primary outcomes considered were the effectiveness rate, visual analog scale score, total nasal symptom scores, total nonnasal symptom scores, Rhinoconjunctivitis Quality-of-Life Questionnaire score, adverse effects, and follow-up observations. The quality of each study was assessed using the Cochrane Collaboration risk of bias tool, and data analysis was conducted using RevMan 5.4 software. This study incorporated 14 articles involving a total of 1009 patients. The meta-analysis revealed that patients with AR who underwent intranasal acupuncture experienced more significant improvements compared to the control group. Notably, the treatment considerably improved both nasal and nonnasal symptoms, along with the patients' quality of life. Moreover, during the follow-up, it was noted that intranasal acupuncture patients had a lower recurrence rate compared to the control group, indicating better long-term effects in alleviating symptoms like nasal congestion, runny nose, and sneezing. Nonetheless, there was no marked improvement of nasal itching. It's noteworthy that some adverse effects were reported, but all were mild. The findings suggest that intranasal acupuncture serves as an effective intervention for AR, particularly in alleviating both nasal and nonnasal symptoms and enhancing quality of life. However, these positive outcomes should be approached with caution, and further high-quality and extensive studies to substantiate these results are warranted.

Relationship between thyroid-stimulating hormone and blood lipids in patients with first-episode depression

BackgroundPrevious studies demonstrated thyroid stimulating hormone (TSH) plays an important role in regulating lipid metabolism, but the relationship between the two is controversial. Meanwhile, it has not been reported in a population with major depressive disorder (MDD).MethodsWe divided 1718 first-episode and drug naïve patients with MDD into a TSH abnormal group (TSH-AB) and a TSH normal group (TSH-NOR). The participants in the two groups were assessed by the Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA) and the positive subscale of Positive and Negative Syndrome Scale. The patients’ blood was tested for TSH, free T3, free T4, fasting blood glucose, lipid indexes and body mass index was recorded.ResultsThe participants in the TSH-AB group had significantly higher HAMD scores, HAMA scores and total scores of positive symptoms, as well as higher incidence of suicide attempts than those in the TSH-NOR group, accompanied by significantly higher thyroglobulin antibodies, thyroid peroxidase antibodies, fasting blood glucose values, total cholesterol (TC), triglycerides (TG) and low-density lipoprotein cholesterol (LDL-C) levels compared with those of TSH-NOR patients. However, the high-density lipoprotein cholesterol (HDL-C) of TSH-AB patients was lower than those of TSH-NOR patients. TSH values were positively correlated with TC, TG, and LDL-C values, and negatively correlated with HDL-C value.ConclusionTSH was highly correlated with abnormal lipid metabolism in patients with MDD. The specific molecular mechanism of the relationship between TSH, lipid metabolism and the development of depression needs to be further in-depth investigation.

Low-dose interleukin-2 in birch pollen allergy: a phase-2 randomized double-blind placebo-controlled trial

Regulatory T cells (Tregs) are pivotal in immune tolerance to allergens. Low-dose IL-2 (IL-2LD) activates Tregs. To assess IL-2LD efficacy for controlling clinical responses to allergen exposures. RHINIL-2 was a phase-2a, randomised, double-blind, placebo-controlled trial. Patients with allergic rhinitis to birch pollen (BP) were included, 66% having concomitant asthma. All had a total nasal symptom score (TNSS) ≥5 following nasal exposure to BP in an environmental-exposure-chamber (EEC). Patients received 1 MUI/day of IL-2 (n=12) or Placebo (n=12) for 5 days, followed by weekly injections for 4 weeks. Clinical responses to subsequent BP exposures in the EEC were evaluated using TNSS, the rhinitis visual analogue scale (VAS) and spirometry. The primary efficacy endpoint was the difference in TNSS area under the curve between inclusion and day 40 (TNSSΔAUC). IL-2LD treatment induced a significant expansion of Tregs. The TNSSΔAUC in the IL-2 and Placebo groups was non significantly different. TNSS and VAS AUCs were significantly reduced from baseline to day 40 in the IL-2LD group only (p=0.04 and p=0.01, respectively). The ratio of forced expiratory volume in 1 second/forced vital capacity (FEV1P) and the forced mid-expiratory flow (FEF25-75%) showed improvement in the IL-2LD vs Placebo groups at day 40 (p=0.04 and 0.04, respectively). However, the short treatment duration used in this study cannot have effects on specific IgE or IgG4 levels given their half-life. There was no severe treatment-related adverse events. IL-2LD is well-tolerated in allergic patients, even with asthma, clearing the path for further therapeutic development. Our work suggests that Treg can safely attenuate an ongoing allergic response. It paves the way for larger studies with longer treatment periods, which are needed to properly evaluate the therapeutic potential of IL-2 in allergy.

Analyzing Phenotypes Post-Exposure in Allergic Rhinitis (APPEAR) in the Environmental Exposure Unit (EEU).

Previous studies have defined clinical phenotypes of allergic rhinitis (AR) after allergen exposure using the time course of the total nasal symptom score (TNSS). We aimed to validate previously proposed AR phenotypes across different allergens (birch, grass, ragweed, house dust mite) following exposure in the Environmental Exposure Unit (EEU). The Analyzing Phenotypes Post-Exposure in Allergic Rhinitis (APPEAR) database comprises 153 participants from EEU studies conducted between 2010-2021 by Kingston Allergy Research. TNSS, nasal congestion symptom scores, and percent change in peak nasal inspiratory flow from baseline (%ΔPB) were recorded for each participant. Participants were phenotyped using previously described criteria RESULTS: 65 participants (42.5%) were classified as Early-phase Responders (EPR), 58 (37.9%) as Protracted Early-phase Responders (pEPR), 13 (8.5%) as Dual Responders (DR), and 17 (11.1%) as Low Responders (LoR). Significant negative correlations exist between TNSS and %ΔPB (r = -0.99, p<0.0001), and nasal congestion symptom score and %ΔPB (r = -0.99, p<0.0001). At the beginning of the late-phase AR response (6 to 7 hours), pEPRs had significantly higher TNSS compared to EPRs, DRs, and LoRs (p<0.0001). By the end of the study (up to 12 hours), DRs and pEPRs had significantly higher TNSS compared to EPRs and LoRs (p<0.0001). Visible and statistical validity between the phenotypes were also confirmed by assessing participants' mean TNSS and mean %ΔPB over time when grouping by phenotype. This study confirms distinct phenotypes exist in the late-phase AR response amongst different allergens and in a greater sample size than described previously, which could provide clinical benefit.

Efficacy and safety of azelastine hydrochloride and fluticasone propionate nasal spray in treating allergic rhinitis: a randomized controlled trial

Background: MP-AzeFlu (Dymista; Meda Pharma GmbH &amp; Co., KG), a formulation combining azelastine hydrochloride and fluticasone propionate in a single spray, is superior to fluticasone propionate alone in relieving symptoms and improving the quality of life of patients with allergic rhinitis. Objectives: In this study, we evaluated whether the effect of AzeFlu, a generic drug manufactured from China, is equivalent to that of MP-AzeFlu. Methods: In total, 679 patients were recruited for a multicentre, randomized, double-blind, original drug-controlled, and parallel-group clinical trial. Overall, 339 and 340 patients were administered with AzeFlu and MP-AzeFlu, respectively. Efficacy was assessed by changes in the reflective total nasal symptom score, the area under the curve of reflective total nasal symptom score changes over time, changes from baseline in individual nasal symptom scores, and the Rhinoconjunctivitis Quality of Life Questionnaire. In addition, a safety evaluation was simultaneously performed. Results: AzeFlu and MP-AzeFlu reduced the reflective total nasal symptom score from baseline (AzeFlu −6.7 [standard deviation, 2.59]; MP-AzeFlu −6.7 [standard deviation, 2.76]; P = 0.905) and improved nasal symptoms and quality of life (AzeFlu −62.3 [standard deviation, 33.59]; MP-AzeFlu −64.7 [standard deviation, 33.73]; P = 0.394) in patients with allergic rhinitis. Significant differences were not observed between groups. Conclusion: AzeFlu showed effects equivalent to those of MP-AzeFlu in this clinical trial and may benefit Chinese patients with allergic rhinitis. Registration number: CTR20190189 (chinadrugtrials.org.cn/index.html)

Effect of Dapagliflozin on health-related quality of life in patients with heart failure: a meta-analysis of Randomized Controlled Trials

Abstract Introduction Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces the risk of cardiovascular mortality and hospitalization for heart failure among individuals with chronic heart failure with reduced (HFrEF) or preserved ejection fraction (HFpEF). The effect of dapagliflozin on symptoms, physical capacity and quality of life is still unclear in this population. Purpose To investigate the effects of dapagliflozin on symptoms and health-related quality of life improvement in patients with chronic heart failure. Methods We systematically searched PubMed, Embase and Cochrane Central databases for randomized controlled trials (RCTs) comparing dapagliflozin to placebo in patients with chronic heart failure. We pooled mean differences (MD) and 95% confidence intervals (CI) with a random-effects model for continuous outcomes. Subgroup analyses were performed by reduced or preserved ejection fraction (EF). The outcomes analyzed were change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score and six-minute walk test (6MWT). Results Five RCTs with 6,238 patients were included. Of these, 5,410 (86.7%) presented a reduced EF and 2,724 (43.65%) had diabetes. There was a statistical significant improvement in total symptoms score (KCCQ-TSS) (MD=3.08; 95% CI 2.14-4.02; p&amp;lt;0.00001; I2=0%; Fig.1A) and in physical limitation score (KCCQ-PLS) (MD=3.91; 95% CI 1.66-6.17; p=0.0007; I2=0%; Fig1B) when dapagliflozin was compared to placebo. Subgroup analyses showed that the KCCQ-TSS score were significant higher in patients treated with dapagliflozin when compared to placebo in HFrEF (MD= 2.98; 95% CI 1.96-.99; p&amp;lt;0.00001; I2=0%; Fig1A) and HFpEF group (MD=3.73; 95% CI 1.16-6.30; p=0.004; I2=0%; Fig1A). The KCCQ-PLS score had a significant increase after dapagliflozin treatment when compared to placebo in participants with HFrEF (MD=4.36; 95% CI 0.72-8.00; p=0.02; I2=0%; Fig1B) and HFpEF (MD=3.64; 95% CI 0.76-6.51; p=0.01; I2=0%; Fig1B). There was no significant difference in 6MWT in dapagliflozin versus placebo group (MD=5.78; 95% CI -0.48-12.03; p=0.07; I2=0%; Fig.2). Conclusions Dapagliflozin improves health-related quality of life by reducing symptoms and physical limitation in patients with HFrEF and HFpEF.

Quality of Life and Symptoms of Hospitalized Hematological Cancer Patients

Patients with hematological malignancies undergo intensive treatment and prolonged hospitalization, thus having a variety of physical and psychosocial symptoms and worse quality of life (QOL). This study aimed to assess the QOL and investigate the symptoms of hospitalized hematological cancer patients. A cross-sectional study was conducted in the hematology clinics and day units of two general hospitals of Heraklion, Crete. Adult patients with hematological malignancy and an adequate understanding of the Greek language participated. A demographic questionnaire, the European Organization for Research and Treatment for Cancer quality assessment questionnaire (EORTC QLQ-C30), and the MD Anderson Symptom Inventory (MDASI) were used. The sample consisted of 120 patients—42.5% were women, with a mean age of 65.6 years. The mean time from diagnosis was 33 months. The global health status of QoL had an average value of 47.1. The highest levels of QOL were found in the subscale of cognitive function (72.8) and the lowest in the role function (46.1). For the EORTC QLQ-C30 symptoms scale, the lowest score was found in nausea-vomiting (11.0) and the highest in fatigue (59.1). In the MDASI, in part I (core symptoms), higher levels but also medium intensities were reported at fatigue (78.3%, mean 3.5), drowsiness (65.0, mean 3.3), and distress (65.8%, mean 2.8). In part II, enjoyment of life (85.8%, mean 5.1) had the highest, and relation with other people (67.5%, mean 3.7) had the lowest scores. The increase in the severity of the core symptoms (part I) was related to females (rho = 0.193, p &lt;0.05) and comorbidities (rho = 0.220, p &lt; 0.05). It was also associated with a significant decrease in all functional domains and increased fatigue (rho = 0.571, p &lt; 0.05) in the EORTC QLQ-C30 questionnaire. The increased global health status was related to males (rho = −0.185, p &lt; 0.05) and physical functioning with younger age (rho = −0.331, p &lt; 0.05), higher education (rho = 0.239, p &lt; 0.05), fewer months from diagnosis (rho = −0.199, p &lt; 0.05), and low comorbidity (rho = −0.209, p &lt; 0.05). Finally, multiple linear regression analysis revealed that the total average symptom score of the MDASI was the most significant factor influencing the global health status of the EORTC QLQ-C30 (β = −4.91, p &lt; 0.001). The increased global health status of the EORTC QLQ C30 was not significantly related (p &gt; 0.05) to the social characteristics of the patients, such as education or employment, which requires further validation. The QoL of hematological cancer patients significantly decreases during treatments due to a considerable number of symptoms that must be taken into consideration for high-quality, individualized care.

Integrating artificial intelligence into a real-world clinical pathway to facilitate clinician treatment optimisation in patients with HFrEF on suboptimal medical therapy

Abstract Background Despite evidence-based pharmacological recommendations, many patients with HFrEF remain undertreated. (1) These patients remain at risk of decompensation and might benefit treatment optimisation. Many patients may also have been diagnosed with HFrEF prior to the use of sacubitril/valsartan or SGLT2 inhibitors. Identification of patients with historical HF diagnosis is time-consuming. Artificial intelligence approaches using deep learning might allow rapid identification of such patients. Aim To develop an artificial intelligence deep-learning algorithm for rapid identification of HF from electronic health records (EHRs) and to determine the potential benefit of our AI-driven algorithm for the detection of undertreated HFrEF patients in the community. Methodology In this study data was collected from EHRs of 1,200 patients who underwent transthoracic echocardiography. The records were screened to identify HF diagnosis through an AI deep-learning algorithm using a Convolutional Neural Network (CNN). Medication status of patients identified as having HFrEF was assessed to determine whether they were on optimal guideline-directed medical therapy. Accuracy of the AI algorithm was assessed by a manual clinician review in a subset of 150 patients. Eligible patients not on optimal medical therapy where no further optimisation was planned (judged to be "stable" at last visit) were invited for a clinical evaluation including NT-proBNP and Kansas City Cardiomyopathy Questionnaire (KCCQ) and offered a treatment optimization that could include either uptitration or initiation of a new medication if symptomatic. NT-proBNP and KCCQ were repeated at 12 week, pre- and post-optimization results were compared to evaluate patient outcomes. Results The deep-learning algorithm accurately identified HFrEF patients (99%) and use of RAAS inhibitors (97%) and beta-blockers (92%). 73 patients attended for initial clinical assessment (mean age 70 years, 77% male) and demonstrated a moderate level of HF-symptom burden (median NT-proBNP was 679 pg/mL, interquartile range was from 220 to 1300) and mean KCCQ overall summary score was 70, indicating a moderate level of HF symptom burden. 27 patients agreed to treatment optimisation. After 12 weeks there was a significant 22% reduction in NT-proBNP (from 1991 pg/mL (SD+/- 1796) to 1630 pg/mL (SD +/- 1588),p=0.049) and improvements in KCCQ (total symptom score 79 (+/-22) to 85 (+/-20), p=0.005; clinical summary score 78 (+/-23) to 82 (+/-20); overall summary score from 75 (+/- 24) to 80 (+/-22), both p=0.04). 23 patients (85%) and 18 patients (67%) out of 27 had an improvement in NT-proBNP and KCCQ overall summary scores respectively. Conclusion In our study we demonstrated the feasibility and potential benefits incorporating AI into a clinical workflow, allowing optimising treatment of patients with HF, with improvements in biomarkers and quality of life that could translate to long-term patient benefits.Changes in NT-proBNP after treatmentChanges in KCCQ after treatment

Efficacy of Capsaicin for Non-allergic Rhinitis: An Updated Systematic Review and Meta-analysis.

Non-allergic rhinitis (NAR) is a prevalent condition with limited effective treatments. Capsaicin, an agonist of the transient receptor potential vanilloid subfamily 1 (TRPV1) receptor, has emerged as a potential therapeutic option for NAR by targeting heightened nasal reactivity. This systematic review and meta-analysis, conducted in accordance with PRISMA guidelines and registered on PROSPERO, evaluated the efficacy of capsaicin for NAR treatment. Nine studies with placebo-controlled group were included, with primary outcomes assessed as total nasal symptom scores (TNSS), visual analog scale (VAS) scores, and the proportion of therapeutic responders. Meta-analysis revealed significant improvements in TNSS and VAS scores, along with a higher proportion of therapeutic responders in patients receiving capsaicin treatment compared to placebo. While some studies demonstrated reductions in substance P levels and TRPV1 expression after capsaicin treatment, further investigation is warranted. This meta-analysis provides preliminary evidence suggesting that capsaicin treatment holds promise for alleviating symptoms in patients with NAR. However, the limited number of studies and methodological heterogeneity necessitate larger and more rigorously designed clinical trials with standardized methodologies and advanced diagnostic techniques to establish their definitive roles in clinical practice.

Effect of mite-specific subcutaneous immunotherapy on patients with allergic rhinitis

This study analyzed the effect of mite-specific subcutaneous immunotherapy (SCIT) on patients with allergic rhinitis (AR). We enrolled 98 AR patients visiting our hospital from April 2017 to April 2019 and grouped them in a random number table. The control group (n=49) received conventional treatment for three years. The SCIT used a standardized mite allergen injection for the experimental group (n=49) for three years. The study compared total nasal symptom score (TNSS), daily medication score (DMS), total combined score (TCS), visual analog scale (VAS) score, mini-rhinitis quality of life questionnaire (MiniRQLQ) score, and serum immunoglobulin E (sIgE) level before and after treatment. The overall response rate was higher in the experimental group than in the control group (59.18% vs. 30.61%, p&lt;0.05). After treatment, the experimental group had lower values for TCS and VAS score (p&lt;0.05); motion score; practical problems; nasal, ocular, and other symptoms (p&lt;0.05); and sIgE, Dermatophagoides pteronyssinus (Dp)-sIgE, and Dermatophagoides farinae (Df)-sIgE levels (p&lt;0.05) than the control group. The sIgE, Dp-sIgE, and Df-sIgE levels were lower in the effective group than in the ineffective group (p&lt;0.05). The areas under the ROC curves of IgE, Dp-sIgE, and Df-sIgE and their combination for predicting the therapeutic effect of mite-specific SCIT on AR were 0.839, 0.779, 0.814, and 0.903, respectively. Mite-specific SCIT relieved clinical symptoms and improved the quality of life of AR patients, probably by decreasing the IgE expression level.

Short-term influence of Immufen™ on mild allergic rhinitis: a randomized, double-blind, placebo-controlled study.

Allergic rhinitis (AR) is an IgE-mediated reaction to inhaled allergens, and is a prominent health concern affecting approximately 400 million people worldwide. A comprehensive understanding of AR's pathophysiology is imperative for developing novel therapies, especially considering its frequent co-morbidity with asthma and conjunctivitis. The escalating prevalence of AR is correlated with increased urbanization and environmental pollutants, recognized as prominent contributing factors. Dysregulation in immune networks, Th1/Th2 cytokine imbalance, activation of mast cells and eosinophils are implicated in AR progression. Classic AR symptoms include nasal congestion, nasal itching, rhinorrhea, and sneezing which significantly impact the quality of life, social interactions, and workplace productivity. This randomized, double-blind, placebo-controlled, three-arm, three-sequence study was aimed to assess the efficacy of supplementation of a co-delivery form of turmeric extract with ashwagandha extract (CQAB) in comparison with a bioavailable curcumin (CGM) and placebo in alleviating AR symptoms and enhancing the quality of life in individuals with mild AR. Participants received either placebo, CGM, or CQAB twice/day for 28 days, and subjective measures were recorded at the baseline and at the end of study. CQAB supplementation demonstrated a significant (P < 0.05) improvement in Total Nasal Symptom Score (TNSS) compared to placebo and CGM. Furthermore, CQAB administration resulted in enhanced sleep quality (P < 0.05) as evaluated by the BIS questionnaire, heightened energy levels, and decreased fatigue and overall mood disturbance (POMS-SF) compared to both placebo and CGM. The results suggests that CQAB has the potential to be used as a dietary supplement in alleviating AR discomforts. https://ctri.nic.in/Clinicaltrials/login.php; Identifier CTRI/2021/01/030355.

Associations of diagnostic awareness with psychosocial symptoms and survival time in patients with advanced lung cancer.

Disclosing the diagnosis of lung cancer to patients is an issue, especially in the Middle East where cultural factors may prohibit disclosure from being done. The psychosocial consequences of diagnostic awareness and its impact on life expectancy of disclosure are an important issue that may influence this decision. The present study evaluated the effects of diagnostic awareness on psychosocial symptomatology and survival time in advanced lung cancer patients in Turkey. This prospective cohort study included 126 advanced lung cancer patients admitted to the oncology department between February 2021 and August 2021. A face-to-face survey included questions on age, gender, marital/employment statuses, comorbidities, and psychological symptoms (SCL-90-R). Diagnostic awareness was assessed by asking patients whether they knew their diagnosis. The correlation of diagnostic awareness with 2-year survival time was analyzed using Cox regression analysis. Of the 126 patients, 86 died at the time of follow-up. Survival time and scores on SCL-90-R symptom subscales were compared between diagnosis-aware (79.4%) and diagnosis-unaware groups (20.6%). Somatization (P = 0.04), depression (P = 0.01), hostility (P = 0.03), scores on additional symptom scales (P = 0.01), and Positive Symptom Total scores (P = 0.01) were significantly higher in the diagnosis-unaware group. No significant difference was found between diagnostic awareness and survival time (P = 0.24). Advanced lung cancer patients aware of their diagnosis experienced less psychosocial burden. However, no significant difference was found in survival time between diagnosis-aware and diagnosis-unaware patients. These findings suggest that the diagnosis should be disclosed to lung cancer patients after confirmation of diagnosis.

A case study on the management of Prathishyaya (Chronic Allergic Rhinitis) using Bharangi Arka Nasal Spray

The omnipresence of Prathishyaya among school-aged groups is overlooked until the complications like kasa, swasa and rajayakshma come into being. Pratishyaya if taken heed of in the initial stage, helps to frustrate the looming effects of its complications. Bharangi Arka is cited as an effectual remedy for Prathishyaya in the Arka Prakasha of Ravana. Prescribing medications for children is usually challenging as they often resist taking them and so, Ayurveda formulations when transmuted into more palatable forms can have salutary impacts on children than classical forms. This case study was carried out on an 8 ½ years old male child with sneezing, runny nose and chronic symptoms including nasal itching and obstruction in particular. Prathishyaya was diagnosed after a proper clinical evaluation. Bharangi Arka in the form of nasal spray was opted as the sole drug in the treatment. Assessment of symptoms was done using Total Nasal Symptom score on the 7th, 14th, 21st and 28th days of the first month of the treatment and at the end of the following two months. Subsidence of all the symptoms was observed in the patient almost in the 4th week. This corroborates the stupendous action of Bharangi Arka nasal spray on Pratishyaya and it could usher in a way for further research to be carried out on the potency of nasal sprays in Ayurveda.

The relationship between COMT, proline, and negative symptoms in clinical high risk and recent psychosis onset

Individuals at clinical high-risk (CHR) of developing psychosis, as well as patients with recent psychosis onset (RO), experience significant negative symptoms that detrimentally impact daily-life functioning and are associated with poor outcomes, even in those who do not convert to psychosis. Targeting negative symptoms may thus hold promise for the treatment of CHR and RO patients. Building from previous findings we examined whether the catechol-O-methyltransferase (COMT) Val158Met functional polymorphism and fasting peripheral proline concentration predicts the severity of negative symptoms experienced by adolescents and young adults at CHR or those with RO. As hypothesized, the interaction between fasting plasma proline and COMT predicted negative symptoms, as measured via the Scale for the Assessment of Negative Symptoms (SANS) total (n = 50, β = 0.066, adjusted p = 0.007) and global severity scores (n = 50, coefficient = 0.026, adjusted p = 0.003): Higher proline was beneficial for Val/Val subjects, but detrimental to those with the Met allele. In a secondary analysis, the COMT x proline interaction also predicted symptoms measured via the Clinical Assessment Interview for Negative Symptoms (CAINS) total scores (n = 50, β-coefficient = 0.035, adjusted p = 0.044), although this result did not reach the Benjamini-Hochberg’s threshold for significance. Further, there was a trend towards significance for an association with social and interpersonal function (Global Functioning-Social, coefficient = −0.005, adjusted p = 0.055). Negative symptoms are intractable and largely unaddressed by current medications. This study further supports a relationship between peripheral proline and COMT influencing negative symptoms such as anhedonia, in young CHR individuals and those with RO. That higher proline has converse effects on symptoms by COMT may have implications for the development of therapeutics to intervene early and specifically target the interaction pathway.

Patient Reported Burden of Indolent Systemic Mastocytosis in a Managed Care Organization

Indolent systemic mastocytosis (ISM), the most frequent subtype of SM, requires better understanding. To better understand the diagnostic journey, symptom severity, impact on quality of life and work/activities, and healthcare utilization of ISM. Survey data were collected from 40 adults with documented ISM meeting WHO 2016 criteria, including validated questionnaires [ISM Symptom Assessment Form (ISM-SAF©), Short Form Quality of Life Survey (SF-12v1)]. Spearman correlation coefficients determined the associations between the ISM-SAF© total symptom score (TSS) and SF-12v1 scores. ISM burden was compared based on moderate/severe compared to mild TSS scores using Kruskal-Wallis and Fisher's Exact tests. Patients were aged 56.0±13.0 years, 65.0% female, 62.5% White and 22.5% Hispanic patients. ISM diagnosis took >2 years in 40%, required ≥6 visits in 47.5%, and was considered moderately/extremely difficult in 50% of patients. Nearly half experienced symptoms daily and rated severity somewhat/ significantly worsened since diagnosis. The overall TSS was 27.4±16.2 (mean±SD). SF-12 Physical Component Summary (PCS) (46.7±11.4) and Mental Component Summary (MCS) (47.6±10.2) scores were lower than the general population score of 50. Moderate correlations (P<.001) were found between TSS and the PCS (ρ = -0.6406; p<.001) and MCS (ρ = -0.5104; p<.001). Compared to patients with mild severity (TSS<28; n=21), patients with moderate/severe severity (TSS≥28; n=19) evidenced significantly higher skin and gastrointestinal symptom scores (both, P≤.001). ISM's impact on ability to work for pay was associated with TSS (P=.004). Symptom-directed treatment had limited effect. ISM was self-reported as a burdensome condition in half the patients which markedly affected daily living.

Sensitization of Visually Induced Motion Sickness by Prior Provocative Physical Motion

INTRODUCTION: Habituation to motion has therapeutic applications for motion sickness desensitization and rehabilitation of patients with vestibular disease. Less attention has been devoted to the opposite process: sensitization. METHODS: Subjects (N = 50) were randomly allocated to four sequences: Baseline visual stimulus; then 15 min of time gap; cross-coupled motion (C-C) or a Control condition; then a time gap of 15 min or 2 h; then a retest visual stimulus. Motion exposures were for 10 min or until moderate nausea, whichever was sooner. The visual stimulus was a scene rotating in yaw at 0.2 Hz with superimposed "wobble". C-C was whole-body rotation on a turntable with eight 45° head tilts during each 30-s period. Control was head tilt without rotation. Rotational velocity was incremented in staircase steps of 3° · s−1 every 30 s. RESULTS: Groups were equivalent for Total Motion Sickness Symptom scores elicited by the first visual stimulus (combined: mean ± SD 10.8 ± 8.4). C-C produced greater Total Symptoms (20.3 ± 6.8) than Control (3.1 ± 3.7). Subjects recovered subjectively from C-C before retest of visual stimulus. For the retest visual stimulus, Total Symptoms were higher following C-C (15.1 ± 9.0) than following Control (8.3 ± 7.1) for both the 15 min and 2 h retests. Sickness ratings (SR) mirrored these effects of C-C. DISCUSSION: C-C motion sensitized subsequent responses to visual stimulation up to 2 h later. Sensitization of visual stimulation crossed modalities and appeared subconscious since it occurred despite subjective recovery from C-C. For some individuals, a previously relatively innocuous visual stimulus became nauseogenic on retest. The results have implications for the use of visual technologies within hours of exposure to provocative motion. Golding JF, Alund D, Gresty MA, Flynn MB. Sensitization of visually induced motion sickness by prior provocative physical motion. Aerosp Med Hum Perform. 2024; 95(10):741–748.

Comparison of the Efficacy and Safety of Bilastine 20mg versus Fexofenadine 180mg for Treatment of Perennial Allergic Rhinitis: Randomized Controlled Study.

Antihistamines has always remained the mainstay drug treatment for Allergic Rhinitis (AR). Bilastine is a novel, non-sedative antihistamine with a super-selective H1 receptor antagonist property. Both bilastine and fexofenadine are second generation antihistamine drugs commonly used to manage AR and Chronic Urticaria (CU). Autologous Skin Serum Test (ASST) is a practical test for histamine release in CU. These tests have been studied in AR patients with limited data studies. 114 patients diagnosed with perennial AR were recruited and divided into two groups of 57 each. One group was started Bilastine 20mg once a day and other group, fexofenadine 180mg once a day. Total Nasal Symptom Score (TNSS) was calculated at presentation and two weeks of antihistamine therapy. ASST was hypothesized to be the test for AR and performed at the time of presentation and at two weeks follow-up. Intergroup and Intragroup assessment of TNSS, ASST and its variables were done using unpaired and paired t test respectively. Patients showed reduction in symptoms of AR with both antihistamines. A significant improvement of sneezing and rhinorrhoea was seen in Fexofenadine group as compared to Bilastine group. TNSS showed statistically significant improvement in both the groups. ASST had statistically significant reduction in both the groups. Both Bilastine and fexofenadine were found to be effective in reduction of symptoms of allergic rhinitis. Bilastine was found to be more effective in overall as well as sneezing and rhinorrhoea noted two weeks after therapy. The online version contains supplementary material available at 10.1007/s12070-024-04770-0.