Changes In Symptom Scores Research Articles

Genome data based deep learning identified new genes predicting pharmacological treatment response of attention deficit hyperactivity disorder

Although the efficacy of pharmacy in the treatment of attention deficit/hyperactivity disorder (ADHD) has been well established, the lack of predictors of treatment response poses great challenges for personalized treatment. The current study employed a comprehensive approach, combining genome-wide association analyses (GWAS) and deep learning (DL) methods, to elucidate the genetic underpinnings of pharmacological treatment response in ADHD. Based on genotype data of medication-naïve patients with ADHD who received pharmacological treatments for 12 weeks, the current study performed GWAS using the percentage changes in ADHD-RS score as phenotype. Then, DL models were constructed to predict percentage changes in symptom scores using genetic variants selected based on four different genome-wide P thresholds (E-02, E-03, E-04, E-05) as inputs. The current GWAS results identified two significant loci (rs10880574, P = 2.39E-09; rs2000900, P = 3.31E-09) which implicated two genes, TMEM117 and MYO5B, that were primarily associated with both brain- and gut-related disorders. The convolutional neural network (CNN) model, using variants with genome-wide P values less than E-02 (5516 SNPs), demonstrated the best performance with mean squared error (MSE) equals 0.012 (Accuracy = 0.83; Sensitivity = 0.90; Specificity = 0.75) in the validation dataset, 0.081 in an independent test dataset (Acc = 0.61, Sensitivity = 0.81; Specificity = 0.26). Notably, the variant that contributed most to the CNN model was NKAIN2, an ADHD-related gene, which is also associated with metabolic processes. To conclude, the integration of GWAS and DL methods revealed new genes contribute to ADHD pharmacological treatment responses, and underscored the interplay between neural systems and metabolic processes, potentially providing critical insights into precision treatment. Furthermore, our CNN model exhibited good performance in an independent dataset, encouraged future studies and implied potential clinical applications.

Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design.

Selinexor is an investigational, selective oral XPO1 inhibitor that may inhibit myelofibrosis (MF)-relevant JAK/STAT and non-JAK/STAT pathways with potential synergy with ruxolitinib. SENTRY (XPORT-MF-034; NCT04562389) is a Phase 1/3 study evaluating safety and efficacy of selinexor plus ruxolitinib for treatment of patients with JAK inhibitor (JAKi) treatment-naïve MF. The Phase 1 open label portion of the study included a 3 + 3 dose escalation and dose expansion, with no dose limiting toxicities observed. Described here is the Phase 3 randomized, double-blind, placebo-controlled study designed to evaluate selinexor+ruxolitinib versus placebo+ruxolitinib in patients with JAKi treatment-naïve MF. Approximately 350 patients will be enrolled. Primary endpoints will evaluate spleen volume reduction ≥ 35% and absolute mean change in total symptom score from baseline to week 24.Clinical Trial Registration: NCT04562389 (ClinicalTrials.Gov).

Monthly Mental Health Self-Monitoring and Positive Changes in Mental Health Disorder Symptoms Scores Among Royal Canadian Mounted Police Cadets

Monthly Mental Health Self-Monitoring and Positive Changes in Mental Health Disorder Symptoms Scores Among Royal Canadian Mounted Police Cadets

Efficacy and safety of Matricaria chamomilla intervention in managing menopausal symptoms: a triple-blind clinical trial.

Menopausal symptoms can significantly impact women's quality of life. Herbal interventions like Matricaria chamomilla (chamomile) have been suggested as potential remedies. However, their efficacy and safety remain underexplored. This triple-blind clinical trial enrolled 80 postmenopausal women meeting specific criteria. Inclusion criteria included participants in early or late perimenopause, defined by a symptom score >15, FSH levels >40, or 2 years since menopause, with no significant comorbidities. Participants were randomly assigned to intervention and placebo groups. In a triple-blind clinical trial with 80 postmenopausal women (aged 47-62) from Babol City Health Center, participants were randomly assigned to receive either chamomile (100 mg capsules with 1.2% apigenin, four times daily) or a placebo over 12 weeks. Symptoms of menopause were assessed using the Australian Menopause Association's Scorecard Symptom Questionnaire. Over 12 weeks, they received either chamomile or placebo capsules, with side effect assessments every 4 weeks. Notable differences were found between the intervention and control groups in the overall scores on the symptom scorecard from baseline to 12 weeks' postintervention (-10.36; 95% confidence interval [CI], -13.84 to -6.92; P < 0.001). Specific subscores also improved in the intervention group: vasomotor (-2.25; 95% CI, -3.09 to -1.42; P < 0.001), psychological (-3.74; 95% CI, -5.29 to -2.20; P < 0.001), locomotor (-2.70; 95% CI, -3.63 to -1.77; P < 0.001), and urological (-1.89; 95% CI, -2.77 to -1.00; P < 0.001). Both groups showed significant changes in total symptom scores over time (P < 0.001). Two participants experienced side effects, including mouth sores, skin spots, and itching, in the chamomile group, which led to their dropping out of the study. Chamomile intervention shows promise in alleviating menopausal symptoms, but its use warrants caution due to associated side effects. Further research is necessary to optimize dosage and mitigate adverse reactions for safer and more effective management of menopausal symptoms.

The efficacy and safety of Fluticasone Furoate/Umeclidinium/vilanterol (FF/UMEC/VI) on cough symptoms in adult patients with asthma, a randomized double-blind, placebo-controlled, parallel group study: Chronic Cough in Asthma (COCOA) study

Background Persistent cough bothers many patients with asthma because it worsens their quality of life; therefore, it must be remedied immediately. The efficacy of triple therapy as a first-line treatment for cough remains unclear. To evaluate the effectiveness and safety of the triple therapy against persistent cough, the clinical effect of regular treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) or placebo in adult patients with asthma was investigated. Methods This randomized, double-blind, placebo-controlled, parallel-group multicenter trial recruited asthma patients with persistent cough from hospitals and primary care clinics between June 2022 and December 2023. Participants were randomly given FF/UMEC/VI 200/62.5/25 µg or placebo for 6 wk. The primary endpoint was the average change in the cough symptom score from baseline to week 6. Secondary outcomes were effectiveness on cough-related disease burdens (asthma control questionnaire [ACQ]-5, Leicester cough questionnaire [LCQ] and nighttime awakening). Furthermore, lung function and adverse events were evaluated. Results The decrease from baseline in the cough symptom score at week 6 was significantly greater in the FF/UMEC/VI group than in the placebo group (p = 0.006). The ACQ-5 scores showed a greater decrease in the FF/UMEC/VI group than in the placebo group. The change from baseline in morning and evening FEV1 increased in the FF/UMEC/VI group as with the results of peak expiratory flow. No significant adverse events associated with FF/UMEC/VI were noted. Conclusions In asthma patients with persistent cough, FF/UMEC/VI showed an early response and a significant effect on cough and lung function for 6 wk of treatment. This study is registered with jRCTs031210412.

Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder

ObjectivesTo evaluate the efficacy and safety of a non-invasive low-frequency tibial nerve stimulator (TNS-01) vs sham control in relieving the symptoms of overactive bladder (OAB) patients.PatientsParticipants who were diagnosed with primary OAB or exhibited at least one OAB symptom. All participants underwent three 30-min intervention sessions weekly.MethodsThe subjects were 1:1randomized (block randomization with a block size of 4) to either active treatment (TNS-01 group) or sham treatment (sham group). Based on the randomization, the subject will be given either an active or sham device system (systems will only differ in the Instructions for Use and electrode size/shape). During the 12-week study period, all participants underwent three 30-min intervention sessions weekly. The primary endpoint was the change in Overactive Bladder Symptom Score (OABSS) at week 12 from the baseline.ResultsOf the 109 recruited OAB patients. In the TNS-01 group, the OABSS change from baseline at week 12 was significantly higher than that in the sham group (2.83 ± 2.53 vs 1.62 ± 2.59, p = 0.02). The absolute and percent changes of average UUI episodes per day from baseline at week 8 in the TNS-01 group were significantly lower from those in the sham group (0.11 ± 1.33 vs 0.68 ± 2.14, p = 0.01; − 27.82% ± 167.33% vs 87.18% ± 25.20%, p = 0.04). One treatment-related adverse event (hematuria) was reported by one patient (1.8%) in the sham group.ConclusionsThe TNS-01 device is effective and safe in relieving OAB symptoms after 12 weeks of stimulation.Trial registration number: NCT04999657.

Comparison of patient-reported symptoms with multi-item patient-reported outcome measures of fatigue, anxiety, and depression in the clinical care of women undergoing chemotherapy for early breast cancer.

As patient-reported symptoms are increasingly incorporated into routine clinical practice and captured in electronic medical records these data can be used to conduct health-related quality of life research studies. This study compares symptom reports from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and its precursor patient reported symptom monitoring (PRSM) (hereafter PRSM/PRO-CTCAE) with multi-item patient-reported outcome (PRO) scales for fatigue (Functional Assessment of Chronic Illness Therapy/FACIT-Fatigue) and depression and anxiety (Mental Health Index/MHI). This is a secondary analysis of data collected from women with early breast cancer (Stage I-III) scheduled for chemotherapy who completed PRSM/PRO-CTCAE, FACIT-Fatigue, and MHI scales pre- and post-chemotherapy. Spearman correlation coefficients estimated the magnitude and direction of correlations between measures (convergent validity). For each symptom, patients were then categorized based on who improved, stayed the same, or worsened on the composite PRSM/PRO-CTCAE score, and changes in scores on the PRO scales were compared. In a sample of 374 women, mean age was 57years (SD 12.6) with 76% White. PRSM/PRO-CTCAE fatigue measures were strongly correlated with FACIT-Fatigue total scale and had mixed moderate to strong correlation for individual items within the FACIT-Fatigue scale. PRSM/PRO-CTCAE Sad and Anxiety measures were strongly correlated with MHI-Depression and MHI-Anxiety total scales, respectively, and had mixed moderate to strong correlation with individual items within the MHI subscales. PRSM/PRO-CTCAE pre-post changes in symptom scores mirrored pre-post changes in FACIT-Fatigue and MHI subscales.

A Concussion Management Policy Change Promoted Earlier Initiation of Rehabilitation Services and Improved Clinical Recovery Outcomes in Concussion.

In line with emerging research, an interprofessional specialty concussion clinic instituted a policy change permitting earlier physiotherapy-based treatment entry. Our objective was to determine the effect of this policy change on concussion recovery outcomes. Secondary analysis of prospectively collected clinical data. 600 youth with concussion were included. Active rehabilitation was initiated ≥4 weeks (prepolicy) or ≥2 weeks (postpolicy) postconcussion based on institutional policy. Cox proportional hazard models, linear mixed models, and chi-square analyses were conducted. The postpolicy group (median = 22 d [interquartile range: 17-27]) started treatment earlier than the prepolicy group (median = 26d [interquartile range: 24-30], P < .001). Length of episode of care (χ2(1) = 11.55, P < .001, odds ratios = 1.49; 95% confidence interval, 1.19-1.88); rehabilitation (χ2(1) = 9.47, P = .002, odds ratios = 1.73, 95% confidence interval, 1.22-2.45]); and total recovery (χ2(1) = 11.53, P < .001, odds ratios = 1.49; 95% confidence interval, 1.18-1.88) were reduced in patients postpolicy change. A significant interaction effect was found for total postinjury symptom (F2,320 = 3.59, P = .03) and symptom change scores (F2,315 = 5.17, P = .006), with the postpolicy group having faster symptom resolution over time. No group differences were observed for persisting symptoms. Earlier rehabilitation initiation occurred as intended following an institutional policy change, which had small, but significant, effects on recovery outcomes in youth with concussion. Health care providers should adopt policies to encourage early active rehabilitation services after concussion.

Ultrasound-guided Transperineal Prostate Thermal Ablation (TPTA) for Benign Prostatic Hyperplasia: Feasibility of an Outpatient Procedure using Radiofrequency Ablation.

To evaluate the feasibility, safety, and short-term (3-month) results of transperineal prostate thermal ablation (TPTA) as a minimally invasive outpatient treatment for benign prostatic hyperplasia (BPH). A prospective nonrandomized study of 25 patients with lower urinary tract symptoms secondary to BPH seeking care at 2 interventional radiology centers between March and July 2024. TPTA was performed using a 17G radiofrequency needle with a 10-mm active tip under unconscious sedation combined with bilateral perineal and periprostatic nerve blocks. The primary outcome measure was technical success, defined as successful bilateral ablation of the prostate transition zone. Secondary outcome measures included changes of international prostate symptom score (IPSS), quality of life (QoL), prostate volume, intravesical prostatic protrusion (IPP), prostate-specific antigen (PSA), post-void residual volume (PVR), maximum urinary flow rate (Qmax), and need for BPH medical therapy at 3months relative to baseline. All procedures were technically successful (100%). The median patient age was 69.4years (IQR 54-74), and all were discharged within 3h of the end of the procedure. Sixteen patients (64.0%) were discharged without a urinary catheter, and 6 patients (24.0%) reported mild complications. At 3-month follow-up, there were significant reductions in IPSS (79.1%), QoL score (70.3%), prostate volume (36.9%), IPP (70.8%), PSA (54.7%), and PVR (51.1%), whereas Qmax increased significantly (102.3%). Twenty-four patients (96.0%) reported discontinuation of medical therapy after TPTA. Ultrasound-guided TPTA using radiofrequency ablation is feasible and safe in the outpatient setting, with significant clinical improvements after 3months of the procedure. Level 3 [non-randomized prospective cohort study].

Chronic Rhinitis Surgery: Association Between Preoperative Severity and Response Rate.

The success rate of chronic rhinitis surgery varies depending on the patients' factor and surgical method. While outcomes for nasal obstruction differ, the association between preoperative severity of other rhinitis symptoms, such as rhinorrhea, sneezing, and nasal itching, measured via the reflective total nasal symptom score (rTNSS) remains unevaluated. To evaluate the association between the response rate to surgical treatment of chronic rhinitis and preoperative severity. A retrospective cohort study was conducted among adult patients with chronic rhinitis symptoms refractory to medication and nasal spray for over 6 months and received radiofrequency ablation of inferior turbinates with posterior nasal nerve neurolysis. The primary endpoint was the change from baseline in 24-h rTNSS and nasal obstruction symptom evaluation (NOSE) scores. Postoperative surgery response rate, rTNSS score change, and score improvement ratios were also evaluated. A total of 183 patients (110 males, 60.1%) were included in this study. After 3-month follow-up, the preoperative rTNSS was 6.51 ± 2.74 change to 1.70 ± 1.43, and the NOSE score was 56.48 ± 19.90 change to 4.56 ± 7.74. Both scores and all sub-scores showed significant differences when comparing preoperative, 1-month, and 3-month results (P < 0.05-0.001). The response rate by rTNSS for whole cohort was 78.14 ± 41.44% and 93.99 ± 23.83% at 1- and 3-month follow-up. Subgroup analyses were performed according to individual rTNSS scores and 2 in 1 score groups (ie, 1-2, 3-4, etc) and their relationship to the surgery outcomes. Both preoperative individual score and score groups were significantly associated with all post-operation outcomes (P = 0.022 to <0.001) in linear regression analysis. Patients with more severe preoperative rhinitis symptoms are associated with better response rate, post-operation symptom score changes, and score improvement ratio.

Turbinate Injection of Botulinum Toxin in the Treatment of the Chronic Rhinitis.

This systemic review with meta-analysis evaluated the effect of intranasal BTX-A turbinate injection on chronic rhinitis-related symptoms. PubMed, SCOPUS, Embase, Web of Science, and Cochrane databases. We reviewed studies retrieved from databases up to Aug 2024. The studies evaluating the degree of change of rhinitis-related symptom scores and quality of life before and after BTX-A injection were analyzed. Standard mean differences were used to calculate effect sizes. A total of 269 patients from 7 studies were analyzed. BTX-A injection showed a significant improvement in rhinitis-related symptoms (congestion: 2.5416, 95% CI 1.0927-3.9905, I2 = 94.4%, itching: 1.2553, 95% CI 0.6660-1.8446; I2 = 70.8%, rhinorrhea: 1.8451, 95% CI 1.0468-2.6435, I2 = 89.7%, and sneezing: 1.3580, 95% CI 0.5194-2.1967; I2 = 90.7%), total nasal symptom score (2.4020, 95% CI 1.4161-3.3879, I2 = 86.1%), and quality of life (1.5256, 95% CI 1.0760-1.9752; I2 = 0.0%) throughout the follow-up period (4 months). However, 3 months after injection, although symptom improvement remained, there was no statistical significance. Allergic rhinitis (AR) patients showed a significant improvement in rhinitis-related symptoms compared with nonallergic rhinitis (NAR) patients. Nasal symptoms and quality of life scores related to rhinitis were decreased after BTX-A injection. In particular, this treatment showed better efficacy in AR and could be more beneficial for the symptoms of nasal congestion and rhinorrhea at the early periods of treatment. However, the effects lasted for a relatively short period of only 2-3 months. Laryngoscope, 2024.

Short-Course Adjuvant Vaginal Cuff Brachytherapy in Early Endometrial Cancer Compared with Standard of Care (SAVE): A Randomized Clinical Trial

PURPOSE Vaginal cuff brachytherapy (VCB) is widely used for adjuvant treatment of endometrial cancer, yet limited randomized data examine the optimal dose/fractionation. We aimed to study short-course VCB using patient-reported outcomes. METHODS We conducted a prospective, randomized, multicenter trial examining short-course adjuvant VCB (11 Gy × two fractions at the surface) compared with standard regimens (7 Gy × three fractions at 0.5 cm depth, 6 Gy × five fractions at the vaginal surface, or 5-5.5 Gy × four fractions at 0.5 cm depth). Eligible patients underwent hysterectomy and had pathologically confirmed endometrioid adenocarcinoma, serous sarcoma, clear cell sarcoma, or carcinosarcoma. Patients with stage I and II cancers were included, with lymphovascular invasion required for stage IAG1. The primary outcome was Global Health Status measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core Module (QLQ-C30) with a prespecified noninferiority margin of 15 points. Secondary outcomes included patient-reported outcomes, toxicities, and recurrences. RESULTS Fifty-four patients enrolled in each arm. The QLQ-C30 for the experimental arm was within the predefined boundary, and thus two fractions were noninferior to standard of care at 1 month ( P = .000005) and 12 months ( P = .0005). Using EORTC Quality of Life Questionnaire - Endometrial Cancer Module for patient-reported vaginal/sexual, urologic, and GI symptoms, the change in mean patient-reported symptom score from baseline to 1 and 12 months was not significantly different between arms. Using Common Terminology Criteria for Adverse Events v5 20 patients (37%) in the experimental arm and 31 patients (57%) in the control arm experienced short-term adverse events related to study treatment ( P = .053). At 28-month median follow-up, the vaginal control rate was 96% in both arms. The isolated vaginal control rate in the experimental arm was 100%. CONCLUSION Short-course VCB has noninferior short-term quality of life compared with standard regimens with acceptable short-term acute toxicity and cancer control outcomes.

Efficacy and Safety of Zihua Wenfei Zhisou Granule in Treatment of Postinfectious Cough: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial.

To evaluate the efficacy and safety of Chinese medicine (CM) Zihua Wenfei Zhisou Granule (ZWZG) in postinfectious cough (PIC) patients with CM syndrome of wind-cold invading Fei (Lung, WCIF). This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase II clinical trial. PIC patients with WCIF syndrome were recruited from the Respiratory Departments in 6 hospitals across China between March 2019 and December 2020. Eligible patients were randomly assigned to group A (ZWZG-matched placebo 15 g), group B (active ZWZG 15 g), and group C (active ZWZG 10 g plus ZWZG-matched placebo 5 g) in a 1:1:1 ratio. All medications were taken orally 3 times daily for 14 consecutive days. The primary outcomes were cough relief rate and cough disappearance rate. The secondary outcomes included time to cough relief, time to cough disappearance, and changes in cough symptom score (CSS), cough Visual Analog Scale (VAS) value, Cough-Specific Quality of Life Questionnaire (CQLQ) score, and CM syndrome score from baseline (day 0) to post-treatment (day 14). Adverse events (AEs) in each group were recorded. A total of 198 patients were included in the full analysis set (FAS) and safety analysis set (SS), while 183 were enrolled in the per-protocol analysis set (PPS). In the FAS population, the cough relief rate was 47.76%, 90.77% and 84.85% in groups A, B, and C, respectively; while the cough disappearance rate was 31.34%, 72.31% and 68.18%, respectively. The cough relief rates and cough disappearance rates in groups B and C were significantly higher than group A (P<0.0001). Both the median time to cough relief and cough disappearance in groups B and C were shorter than group A (P<0.0001). Compared with group A, groups B and C showed significantly greater improvements from baseline to post-treatment in CSS during daytime and nighttime as well as VAS (P<0.05). There were no significant differences in changes from baseline to post-treatment in CQLQ and CM syndrome scores among 3 groups (P>0.05). Results in the PPS population were consistent with those in the FAS population. Groups B and C showed lower incidence in AEs than group A (P<0.05), while there was no significant difference between groups B and C (P>0.05). No drug-related severe AEs were reported. ZWZG can increase cough disappearance rate and cough relief rate; and it is beneficial in shortening cough duration and reducing cough severity and frequency in patients suffering from PIC. It is safe and generally well tolerated. (Registration No. ChiCTR1900022078).

Effects of Tegoprazan, Potassium-Competitive Acid Blocker, on the Gastric Emptying and Postprandial Symptoms in Healthy Humans.

Proton pump inhibitors are potent gastric acid inhibitors. However, they may worsen symptoms such as postprandial fullness and early satiation by reducing gastric emptying (GE). This study aims to evaluate the effects of tegoprazan, a new potassium-competitive acid blocker, on GE and dyspeptic symptoms. A randomized, double-blind, placebo-controlled design was adopted for this study. Participants underwent GE tests and responded to a questionnaire regarding gastrointestinal symptoms before and after administration of tegoprazan 50mg. GE was assessed using scintigraphy over 4h with a standardized solid meal. Thirty participants were recruited (19 men, mean age 28.2 ± 7.3years). After medication, no significant differences were observed in gastric half emptying time (T1/2) and gastric retention at 4h (GE 4h) between the tegoprazan and the control group (114.2 ± 48.9min vs. 93.7 ± 34.7min, P = 0.20; 10.1 ± 12.0% vs. 4.3 ± 5.4%, P = 0.11, respectively). Furthermore, there were no statistically significant differences detected in the changes within each group between two groups (T1/2, 9.9 ± 52.7min vs. -4.7 ± 30.5min, P = 0.36; GE 4h, 5.2 ± 13.9% vs. -1.3 ± 6.5%, P = 0.12). The changes in dyspeptic symptom scores after tegoprazan administration did not significantly differ from those in the control group with no correlation between symptoms and GE parameters. In healthy adults, the administration of tegoprazan did not show a significant impact on GE and dyspeptic symptoms, especially postprandial fullness or early satiation.

Anxiety and depression among a community-recruited cohort of people who use methamphetamine: A longitudinal analysis.

This study (1) estimated changes in anxiety and depression throughout 3 years in a community-recruited cohort who use methamphetamine and (2) modelled whether these changes were associated with patterns of methamphetamine use or other time-varying or fixed covariates. We used a longitudinal analysis using data derived from surveys conducted between August 2016 and March 2020, set in metropolitan and rural locations in Victoria, Australia. Participants comprised a total of 849 adults with regular methamphetamine use history at baseline, recruited for the prospective VMAX study via snowball and respondent-driven sampling. Anxiety and depression symptoms were measured using the Generalized Anxiety Disorder (GAD)-7 and the Patient Health Questionnaire (PHQ)-9 instruments. Frequency of methamphetamine use was measured by self-reported number of days per week participants used any form of methamphetamine in the past month. Changes in anxiety and depression symptom scores were associated with change in route of administration from non-injecting to injecting [adjusted coefficient (adj. coeff.) = 1.44, 95% confidence intervals (CI) = 0.39, 2.48, adj. coeff. = 1.49, 95% CI = 0.39, 2.58], change in severity of dependence for methamphetamine (adj. coeff. = 0.29, 95% CI = 0.21, 0.37, adj. coeff. = 0.34, 95% CI = 0.26, 0.42), starting treatment for drugs other than methamphetamine (adj. coeff. = -2.21, 95% CI = -3.70, -0.73, adj. coeff. = -2.09, 95% CI = -3.60, -0.58) and other covariates. Among regular methamphetamine users in Australia, changes in anxiety or depression scores are associated with changes in route of administration, dependence severity and starting treatment for other drugs, but do not appear to be associated with frequency of methamphetamine use.

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)

Predictive Value of Physiological Values and Symptom Scores for Exacerbations in Bronchiectasis and Chronic Obstructive Pulmonary Disease With Frequent Exacerbations: Longitudinal Observational Cohort Study.

COPD (chronic obstructive pulmonary disease) and bronchiectasis are common, and exacerbations contribute to their morbidity and mortality. Predictive factors for the frequency of future exacerbations include previous exacerbation frequency and airway colonization. Earlier treatment of exacerbations is likely to reduce severity. This study tested the hypothesis that, in a population with bronchiectasis, COPD, or both who have frequent exacerbations and airway colonization, changes in symptom scores or physiological variables within 10 days prior to an exacerbation would allow the prediction of the event. We performed a 6-month, longitudinal, observational, cohort study among 30 participants with bronchiectasis, COPD, or both; at least 2 exacerbations per year; and colonization with Pseudomonas aeruginosa or Haemophilus influenzae. Daily symptom and physiological data were collected, comprising pulse rate, blood pressure, oxygen saturation, peak flow rate, step count, weight, and temperature. Exacerbations (defined as the onset of new antibiotic use for respiratory symptoms) were collected, and predictive values for abnormal values in the 10 days prior to an exacerbation were calculated. A total of 30 participants were recruited, collecting a total of 39,534 physiological and 25,334 symptom data points across 5358 participant-days; these included 78 exacerbations across 27 participants, with the remaining 3 participants not having exacerbations within the 6-month observation period. Peak flow rate, oxygen saturation, and weight were significantly different at the point of exacerbation (all P<.001), but no significant trends around exacerbation were noted and no clinically beneficial predictive value was found in the overall or individually adjusted model. Symptom scores tended to worsen for 10 days on either side of an exacerbation but were of insufficient magnitude for prediction, with area under the receiver operating characteristic curve values of ranging from 0.4 to 0.6. Within this small cohort with bronchiectasis, COPD, or both and airway colonization, physiological and symptom variables did not show sufficient predictive value for exacerbations to be of clinical utility. The self-management education provided as standard of care may be superior to either of these approaches, but benefit in another or larger cohort cannot be excluded. RR2-10.2196/resprot.6636.

The effect of yoga on dyspnea, sleep, and quality of life in patients with bronchiectasis: A randomized controlled trial

Background and purposeBronchiectasis is characterized by chronic cough, acute exacerbations, and excessive sputum production, along with symptoms such as shortness of breath and fatigue, which impair respiratory functions and quality of life. This study aims to investigate the effects of yoga on dyspnea, sleep quality, and overall quality of life in patients with bronchiectasis. Materials and methodsForty-eight participants with bronchiectasis were included in the study. The patients were randomly divided into two groups, the yoga group (n = 24) or control group (no placebo or sham intervention) (n = 24). The yoga group participated in a total of 24 sessions over 8 weeks, with three sessions per week. No intervention was performed on the patients in the control group. The Modified Medical Research Council (mMRC) questionnaire was used to assess patients' dyspnea level, and the Pittsburgh Sleep Quality Index (PSQI) and St. George's Respiratory Questionnaire (SGRQ) were used to assess sleep quality and health-related quality of life, respectively. ResultsIt was observed that the yoga intervention affected the intergroup change in dyspnea severity score over time (p < 0.05) (x̄yoga = 2.64-1.50 = 1.14; x̄control2.24-1.95 = 0.29). The decrease in the mean PSQI score of the yoga practice group (16.41-13.18 = 3.23) was significantly higher compared with the control group (14.90-14.57 = 0.33). Post-practice SGRQ activity scores were significantly different from pre-practice SGRQ activity scores. Similar to the change in SGRQ activity and symptom scores, the impact score also changed significantly over time (x̄yoga12.55-9.09 = 3.46; x̄control12–11.52 = 0.48). ConclusionThe results indicate that yoga may have a positive effect on dyspnea, sleep, and quality of life in patients with bronchiectasis.

Theta Burst Stimulation Protocols for Schizophrenia

To date, several theta burst stimulation (TBS) protocols, such as intermittent TBS (iTBS), have been proposed; however, previous systematic reviews have revealed inconsistent efficacy findings in individual TBS studies for schizophrenia. To examine which TBS protocols are associated with the most favorable and acceptable outcomes in adults with schizophrenia. The Cochrane Library, PubMed, and Embase databases were searched for studies published before May 22, 2024. The inclusion criteria were as follows: (1) published and unpublished randomized clinical trials (RCTs) of any TBS treatment and (2) RCTs including individuals with schizophrenia spectrum disorders, other psychotic disorders, or both. This study followed the Cochrane standards for data extraction and data quality assessment and used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guideline for reporting. The risk of bias of individual studies was assessed using the second version of the Cochrane risk of bias tool, and the Confidence in Network Meta-Analysis application was used to rate the certainty of evidence for meta-analysis results. At least 2 authors double-checked the literature search, data transfer accuracy, and calculations. The primary outcome of this study was improvement in scores related to negative symptoms. Our frequentist network meta-analysis used a random-effects model. The standardized mean difference (SMD) or odds ratio for continuous or dichotomous variables, respectively, was calculated with 95% CIs. A total of 30 RCTs of 9 TBS protocols, with 1424 participants, were included. Only iTBS over the left dorsolateral prefrontal cortex (L-DLPFC) was associated with reduced negative symptom scores (SMD, -0.89; 95% CI, -1.24 to -0.55), overall symptom scores (SMD, -0.81; 95% CI, -1.15 to -0.48), Positive and Negative Syndrome Scale general subscale scores (SMD, -0.57; 95% CI, -0.89 to -0.25), depressive symptom scores (SMD, -0.70; 95% CI, -1.04 to -0.37), and anxiety symptom scores (SMD, -0.58; 95% CI, -0.92 to -0.24) and improved overall cognitive impairment scores (SMD, -0.52; 95% CI, -0.89 to -0.15) compared with a sham. However, positive symptom score changes, all-cause discontinuation rate, discontinuation rate due to adverse events, headache incidence, and dizziness incidence did not significantly differ between any TBS protocols and sham. In this network meta-analysis, iTBS over the L-DLPFC was associated with improved scores for negative, depressive, anxiety, and cognitive symptoms in individuals with schizophrenia and was well tolerated by the participants. Other forms of TBS were not associated with benefit. Further research is needed to assess the potential role of TBS in the treatment of schizophrenia.

Single simple question in axonal polyneuropathy.

The single simple question (SSQ), "What percentage of normal (0%-100%) do you feel regarding your disease?" has proven feasible and valid in assessing myasthenia gravis and a heterogeneous spectrum of neuropathies. This study explores the utility of the SSQ in axonal polyneuropathies (PNPs), encompassing diabetic neuropathy, and evaluates its responsiveness to scale changes. A retrospective chart review of 150 patients with axonal PNP responding to the SSQ was performed. Patients underwent clinical and electrophysiological evaluations, and were evaluated by clinical and disability scales, including the Medical Research Council sum score, modified Toronto Clinical Neuropathy score (mTCNS), Overall Neuropathy Limitation Scale, and Rasch-built Overall Disability Scale (RODS). The SSQ total scores correlated moderately with both the RODS score (r = .59, p < .001) and the mTCNS symptom score (r = -.43, p < .001), maintaining significance after adjustment for multiple comparisons. Longitudinally, after adjusting for multiple comparisons, the change in mTCNS symptom score retained statistical significance (adjusted p = .048). The SSQ did not show any association with electrophysiological parameters or sensory symptoms, other than a lower score in those with pain (100% with SSQ <40%, 85% with SSQ 40%-70%, and 34% with SSQ >70%). The SSQ is a feasible, valid scale that may be utilized to assess and follow patients with length-dependent axonal PNPs. Given that the SSQ is not strongly associated with clinical and disability scales or electrophysiological findings, additional investigations are required for a comprehensive assessment of PNP.