Improvement In Symptom Scores Research Articles

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<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<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.

Fractional Flow Reserve and Instantaneous Wave-Free Ratio as Predictors of the Placebo-Controlled Response to Percutaneous Coronary Intervention in Stable Coronary Artery Disease.

The Placebo-controlled Trial of Percutaneous Coronary Intervention for the Relief of Stable Angina (ORBITA-2) provided evidence for the role of percutaneous coronary intervention (PCI) for angina relief in stable coronary artery disease (CAD). Fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are often used to guide PCI, however their ability to predict placebo-controlled angina improvement is unknown. Participants with angina, ischemia, and stable CAD were enrolled and antianginal medications were stopped. Participants reported angina episodes daily for 2 weeks using the ORBITA-app. At the research angiogram, FFR and iFR were measured. After sedation and auditory isolation, participants were randomized to PCI or placebo, before entering a 12-week blinded follow-up phase with daily angina reporting. The ability of FFR and iFR, analyzed as continuous variables, to predict the placebo-controlled effect of PCI, was tested using Bayesian proportional odds modelling. Invasive physiology data were available in 279 patients (140 PCI and 139 placebo). The median (IQR) age was 65 years (59.0 to 70.5) and 223 (79.9%) were male. Median FFR was 0.60 (0.46 to 0.73) and median iFR was 0.76 (0.50 to 0.86). The lower the FFR or iFR, the greater the placebo-controlled improvement with PCI across all endpoints. There was strong evidence that a patient with an FFR at the lower quartile would have a greater placebo-controlled improvement in angina symptom score with PCI than a patient at the upper quartile (FFR 0.46 vs. 0.73: OR 2.01, 95% CrI 1.79 to 2.26, Pr(Interaction)>99.9%). Similarly, there was strong evidence that a patient with an iFR at the lower quartile would have a greater placebo controlled improvement in angina symptom score with PCI than a patient with an iFR at the upper quartile (iFR 0.50 vs. 0.86: OR 2.13, 95% CrI 1.87 to 2.45, Pr(Interaction) >99.9%). The relationship between benefit and physiology was seen in both Rose angina and Rose nonangina. Physiological stenosis severity, as measured by FFR and iFR, predicts placebo-controlled angina relief from PCI. Invasive coronary physiology can be used to target PCI to those patients who are most likely to experience benefit.

Evidence of honey-processed Astragalus polysaccharides improving intestinal immune function in spleen Qi deficiency mice integrated with microbiomics and metabolomics analysis.

Radix Astragali, commonly known as Astragalus, is a traditional medicinal and edible plant valued for its Qi-tonifying properties. The dosage form of Radix Astragali processed with honey, known as honey-processed Astragalus (HPA), shows improved Qi-tonifying efficacy as compared to the raw product. Polysaccharides are the main bioactive ingredients in its aqueous extract. This study used a multiomics approach integrating microbiomics and metabolomics to elucidate the Qi-tonifying mechanisms of honey-processed Astragalus polysaccharides (HAPS). HAPS-treated mice showed improved symptom scores, spleen and thymus indices, serum cytokines (tumor necrosis factor α, interleukin 1β) and intestinal mucosa secretory immunoglobulin A (SIgA) compared to the mice with spleen Qi deficiency. The analysis of gut microbiota indicated that HAPS regulated the relative abundance of Bacteroidetes, Bacteroides, Proteobacteria and Helicobacter, thereby improving intestinal flora dysbiosis in mice with spleen Qi deficiency. Eleven biomarkers in fecal metabolomics analysis were screened and identified, primarily associated with linoleic acid metabolism, sphingolipid metabolism, glycerophospholipid metabolism and biosynthesis of unsaturated fatty acids. Furthermore, comprehensive analyses demonstrated that HAPS regulates palmitic acid and sphingolipid metabolism by modulating the abundance of Bacteroidetes, which in turn increased the levels of intestinal mucosal SIgA and restored intestinal mucosal immune function in mice with spleen Qi deficiency. Our findings revealed that HAPS is an essential active ingredient of HPA, and its Qi-tonifying mechanism is closely related to the improvement of intestinal immune function. These findings lay the foundation for the application of HAPS as an immunomodulatory agent in health and dietary foods. © 2024 Society of Chemical Industry.

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.

Therapeutic efficacy and short-term durability of trans-urethral amniotic bladder injections for the treatment of refractory COVID-associated cystitis

Introduction: COVID-19-associated cystitis (CAC) may arise following a COVID-19 infection and is characterized by the development of novel or worsening overactive bladder (OAB). CAC is possibly associated with bladder mucosal damage and the release of pro-inflammatory cytokines, resulting in inflammation and fibrosis of the bladder wall. Amniotic membrane (AM) has been shown to possess anti-inflammatory and anti-fibrotic properties and might potentially be beneficial for CAC. This study investigated the safety and efficacy of bladder injections of AM in CAC patients with resistant OAB symptoms. Methods: Five CAC patients, with an average age of 73 &amp;plusmn; 1.0 years and a median disease duration of 2.4 years, received intra-detrusor injections of 100 mg micronized AM under general anesthesia and were followed for 20 weeks. Key urodynamic measures (involuntary detrusor contraction and maximum cystometric capacity) were determined to evaluate treatment response. Quality of life (QOL) was assessed using the OAB assessment tool, and safety was analyzed. Results: All five patients showed improved urodynamic bladder function and significantly improved QOL improvements. The improvement was evident from 4 weeks post-treatment and sustained until 12 weeks. Symptoms re-surged at 20 weeks. No safety concerns arose during the study. Conclusion: The observed improvements in symptom scores and bladder volume parameters highlighted the promise of AM bladder injections as a viable intervention for CAC patients with refractory OAB symptoms. Comprehensive studies are needed to validate its therapeutic potential, and treatment protocol refinement is warranted to address the observed reduction in efficacy over time.

Non-invasive positive pressure ventilation for acute asthma in children.

Asthma is one of the most common reasons for hospital admission among children, with significant economic burden and impact on quality of life. Non-invasive positive pressure ventilation (NPPV) is increasingly used in the care of children with acute asthma, although the evidence supporting it is weak, and clinical guidelines do not offer any recommendations on its routine use. However, NPPV might be an effective way to improve outcomes for some children with asthma. A previous review did not demonstrate a clear benefit, but was limited by few studies with small sample sizes. This is an update of the previous review. To assess the benefits and harms of NPPV as an add-on therapy to usual care (e.g. bronchodilators and corticosteroids) in children (< 18 years) with acute asthma. We searched the Cochrane Airways Group Specialised Register, CENTRAL, MEDLINE, and Embase. We also conducted a search of ClinicalTrials.gov and the WHO ICTRP. We searched all databases from their inception to March 2023, with no restrictions on language of publication. We included randomised clinical trials (RCTs) assessing NPPV as add-on therapy to usual care versus usual care for children hospitalised for acute asthma exacerbations. We used standard Cochrane methods. We included three RCTs randomising 60 children with acute asthma to NPPV and 60 children to control. All included trials assessed the effects of bilevel positive airway pressure (BiPAP) for acute asthma in a paediatric intensive care unit (PICU) setting. None of the trials used continuous positive airway pressure (CPAP). The controls received standard care. The median age of children ranged from three to six years, and asthma severity ranged from moderate to severe. Our primary outcome measures were all-cause mortality, serious adverse events, and asthma symptom score. Secondary outcomes were non-serious adverse events, health-related quality of life, arterial blood gases and pH, pneumonia, cost, and PICU length of stay. None of the trials reported any deaths or serious adverse events (except one trial that reported intubation rate). Two trials reported asthma symptom score, each demonstrating reductions in asthma symptoms in the BiPAP group. In one trial, the asthma symptom score was (mean difference (MD) -2.50, 95% confidence interval (CI) -4.70 to -0.30, P = 0.03; 19 children) lower in the BiPAP group. In the other trial, a cross-over trial, BiPAP was associated with a lower mean asthma symptom score (MD -3.7; 16 children; very low certainty evidence) before cross-over, but investigators did not report a standard deviation, and it could not be estimated from the first phase of the trial before cross-over. The reduction in both trials was above our predefined minimal important difference. Overall, NPPV with standard care may reduce asthma symptom score compared to standard care alone, but the evidence is very uncertain. The only reported serious adverse event was intubation rate in one trial. The trial had an intubation rate of 40% and showed that BiPAP may result in a large reduction in intubation rate (risk ratio 0.47, 95% CI 0.23 to 0.95; 78 children), but the evidence is very uncertain. Post hoc analysis showed that BiPAP may result in a slight decrease in length of PICU stay (MD -0.87 day, 95% CI -1.52 to -0.22; 100 children), but the evidence is very uncertain. Meta-analysis or Trial Sequential Analysis was not possible because of insufficient reporting and different scoring systems. All three trials had high risk of bias with serious imprecision of results, leading to very low certainty of evidence. The currently available evidence for NNPV is uncertain. NPPV may lead to an improvement in asthma symptom score, decreased intubation rate, and slightly shorter PICU stay; however, the evidence is of very low certainty. Larger RCTs with low risk of bias are warranted.

The impact of a whole foods dietary intervention on gastrointestinal symptoms, inflammation, and fecal microbiota in pediatric patients with cystic fibrosis: A pilot study

Gastrointestinal (GI) complications are a significant source of morbidity for people with cystic fibrosis (PwCF). Historically, dietary recommendations in CF have focused on calories, typically emphasizing a high fat diet. The changing landscape of CF highlights the need to update this nutritional strategy. There is little research into how the quality of calories consumed by PwCF influences nutritional outcomes, GI symptoms, or likely contributors: intestinal inflammation and GI microbiology. We assessed the feasibility of a whole foods-based diet (WFD) and avoidance of ultra-processed foods, measuring safety/tolerability, adherence, and GI symptoms, as well as fecal measures of inflammation and microbiota among children with CF (CwCF) with GI symptoms. Single center, 4-week dietary intervention involving CwCF aged 5-14 years who screened positive on GI symptom questionnaire. Assessments included weight, symptom questionnaires and adverse events (AEs). Stool was analyzed for microbiota (16S rRNA) and calprotectin. 108 children were pre-screened, 9 enrolled and 8 initiated and completed the study. There were no significant changes in weight and no AEs. PEDS-QL GI identified overall improvement in symptoms. Certain symptom domains (constipation, diarrhea, gas/bloating, stomach pain and hurt) demonstrated significant improvement on the WFD. Of two participants with abnormal fecal calprotectin at enrollment, both exhibited decreased values on WFD. There was no significant change in microbiota diversity. A WFD diet was feasible and safe in CwCF. There was improvement in GI symptom scores based on both parent and child assessments. Larger studies are needed to further investigate effects on intestinal inflammation and microbiota.

A plant-based diet is feasible in patients with Crohn's disease

BackgroundIncorporating plant-based diets as a supplement to medical treatment may have a beneficial impact on patients with Crohn's disease, however, research with intervention studies is required. ObjectiveTo investigate the feasibility of a plant-based diet intervention. Secondly, the purpose was to investigate whether such diet may reduce disease activity and enhance quality of life. Materials and methodsThis study was designed as a single arm feasibility study. Outpatients with Crohn’s disease in biological therapy were guided over twelve weeks towards a dietary lifestyle change. Outcome measuresFeasibility concerning recruitment, retention rate and compliance. Secondary outcomes were measures of patient reported outcome questionnaires (PROMS). Paired t-tests were used to examine changes in CO2 emissions, anthropology, biomarkers, and patient-reported data. Δ-values were used to investigate difference between dietary intake and requirements. Linear regression analyses examined the association between biomarkers and PROMS. ResultsIn total, 15 participants completed the intervention with easy recruitment and a retention rate at 87.6%. A clinically positive tendency was seen towards improved symptom scores for disease (HBI; p=0.028 and IBDQ; p=0.006) but not for fatigue (IBD-F; p=0.097), although none of these were statistically significant. Adverse effects were decreased protein intake (p=0.69) and slightly reduced muscle mass. It remains unclear to what extent the intervention contributed to the improved self-reported effects although perception of disease activity was improved. ConclusionThis study demonstrates that it is possible to retain patients following a plant-based diet. However, the dietary change required ongoing dietetic support with a focus on anti-inflammatory agents and the still unattainable protein requirements.

516. HELLER MYOTOMY FOR SYMPTOMATIC ACHALASIA: TRADITIONAL LAPAROSCOPY OR ROBOTICS? A SYSTEMATIC REVIEW WITH META-ANALYSIS

Abstract Background Laparoscopic Heller myotomy (LH) has been established as the gold standard for symptomatic achalasia; robotic-assisted laparoscopic myotomy (RH) has shown promising outcomes regarding safety and effectiveness. We aim to meta-analyse data comparing LH and RH surgical outcomes and complications. Methods A systematic search was conducted in February 2024 without restrictions according to PRISMA guidelines in PubMed, Web of Science, Scopus, and Cochrane Register. Studies comparing laparoscopic and robotic approach for Heller myotomy in adults with symptomatic achalasia were included for systematic review. Meta-analysis was performed trough generalized linear mixed model in R 4.3.2. Results 16 observational studies, out of 273, were included; reporting on 15076 patients. No statistically differences in preop characteristics were noted. RH had significantly fewer intraoperative esophageal perforations (OR=7.29, p&amp;lt; 0.0001, 95%), fewer subsequent myotomies and endoscopic treatments for recurrence (OR= 3.64, p=0.01 and OR= 3.38, p=0.03) and better symptom score improvement (OR=0.507, p=0.04). Although not clinically significant, RH had shorter hospital stays (MD=0.45 days, p= 0.005,) and reduced intraoperative blood loss (MD=10.46 ml, p=0.0002). Although not statistically significant, RH had fewer bleeding episodes, lower conversion, reintervention and mortality rates, comparable morbidity and postoperative GERD and higher operative time. Conclusion This updated meta-analysis suggests that RH is associated with lower regarding perforations, recurrence rates and symptom improvement compared to LH, with negligible lengthening of operative times. RH for symptomatic achalasia represents a feasible treatment for symptomatic achalasia, with a satisfying safety and effectiveness profile. RCTs on the topic and about cost-effectiveness evaluations are necessary to support the reported data.

Observation of clinical efficacy of acupuncture combined with bloodletting therapy and Qingwen Xiere decoction in mild to moderate COVID-19 patients.

To evaluate the clinical efficacy and safety of acupuncture combined with bloodletting therapy and Qingwen Xiere decoction in mild to moderate COVID-19 patients. A total of 100 mild to moderate COVID-19 patients collected from December 2022 to February 2023 were randomly divided into control and observation groups, with 50 patients in each group. Patients in the control group received oral Qingwen Xiere decoction for 6 days. The observation group received acupuncture combined with bloodletting therapy in addition to oral Qingwen Xiere decoction, with the acupuncture (at Kongzui ［LU6］, Hegu ［LI4］, Quchi ［LI11］, Feishu ［BL13］, Zhongwan ［CV12］, Qihai ［CV6］, Yinlingquan ［SP9］) administered 30 min each day for 6 days, and bloodletting (at Shaoshang ［LU11］, Shangyang ［LI1］, Dazhui ［GV14］) administered every other day for 3 times. Traditional Chinese medicine syndrome scores and pulmonary CT scores were recorded before and after treatment. Serum contents of C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α) were measured using ELISA. Anxiety and depression degree were assessed using the Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA). Safety of the treatments was evaluated in both groups. Compared with before treatment, after treatment, the control group showed improvement in fever, dry cough, sore throat, and total traditional Chinese medicine syndrome scores (P<0.01), but no significant improvement in muscle pain or fatigue；the observation group showed significant improvement in total traditional Chinese medicine syndrome and individual symptoms scores (P<0.01)；both groups demonstrated reductions in pulmonary CT scores, HAMA score, HAMD score and serum contents of CRP and IL-6 (P<0.01)；serum TNF-α content significantly decreased in the observation group (P<0.01). All outcome measures were superior in the observation group to the control group (P<0.01, P<0.05). No adverse reactions were reported in either group. Acupuncture combined with bloodletting therapy and oral Qingwen Xiere decoction effectively improves clinical symptoms, alleviates pulmonary inflammatory injury, reduces inflammatory cytokine contents, and mitigates anxiety and depression in mild to moderate COVID-19 patients, and without adverse effects.

Oxymetazoline as a predictor of turbinate reduction surgery outcomes: Objective support from a prospective, single-blinded, computational fluid dynamics study.

A patient's subjective response to topical nasal decongestant is often used to screen for turbinate reduction surgery suitability. However, this anecdotal strategy has not been objectively and quantitatively evaluated. Prospective, longitudinal, and single-blinded cohort study employing computational fluid dynamic modeling based on computed tomography scans at baseline, 30min postoxymetazoline, and 2 months postsurgery on 11 patients with chronic turbinate hypertrophy. Nasal obstruction symptom evaluation (NOSE) and visual analogue scale (VAS) obstruction scores significantly improved from baseline to postoxymetazoline and again to postsurgery (NOSE: 71.82±14.19 to 42.27±25.26 to 22.27±21.04; VAS: 6.09±2.41 to 4.14±2.20 to 2.08±1.56; each interaction p<0.05), with significant correlation between the latter two states (r∼0.37-0.69, p<0.05). Oxymetazoline had a broader anatomical impact throughout inferior and middle turbinates than surgery (many p<0.05); however, the improvement in regional airflow is similar (most p>0.05) and predominantly surrounding the inferior turbinate. Strong postoxymetazoline to postsurgery correlations were observed in decreased nasal resistance (r=0.79, p<0.05), increased regional airflow rates (r=-0.47 to -0.55, p<0.05) and regional air/mucosa shear force and heat flux (r=0.43 to 0.58, p<0.05); however, only increasing peak heat flux significantly correlated to symptom score improvement (NOSE: r=0.48, p<0.05). We present the first objective evidence that the "topical decongestant test" can help predict turbinate reduction surgery outcomes. The predictive effect is driven by similar improvementin regional airflow that leading to improved air/mucosa stimulations (peak heat flux) rather than through reduced nasal resistance.

Anti-IL-4Rα monoclonal antibody (CM310) in patients with chronic rhinosinusitis with nasal polyps (CROWNS-2): Rationale and design of a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous disease that affects a large proportion of the global population. The treatment of CRSwNP, especially eosinophilic CRSwNP (ECRSwNP), has always been of great obstacle. Our previous phase 2 trial showed that CM310, a monoclonal antibody that targets interleukin-4 receptor alpha, was both safe and effective in reducing the size of nasal polyps, improving symptom scores, and increasing the quality of life for those with severe ECRSwNP. This phase 3 trial aims to evaluate the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of CM310 in participants with CRSwNP. The CROWNS-2 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 trial. The study consisted of a screening/run-in period (up to 4 weeks), a treatment period (24-week double-blind treatment period plus 28-week maintenance period), and a safety follow-up period (8 weeks). The study planned to enroll 180 participants with CRSwNP (at least 60% of ECRSwNP) to receive CM310 300 mg/placebo every 2 weeks (Q2W) subcutaneously for a total of 12 doses in double-blind treatment period and 300 mg CM310 Q2W subcutaneously for a total of 14 doses in maintenance period. Enrolled participants continued to use mometasone furoate nasal spray throughout the study. The primary endpoints are a change from baseline in nasal polyp score and nasal congestion score at week 24 between CM310 and placebo in both ECRSwNP and CRSwNP. The CROWNS-2 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical study to evaluate the efficacy and safety of CM310 in patients with CRSwNP. NCT05436275.

Predictors of Patient-Reported Outcomes After Hyaluronic Acid Injections: Effect of Expectations and Psychological Stress.

Hyaluronic acid (HA) injections are a common nonsurgical treatment of knee osteoarthritis (OA). Patient expectations and psychological stress are believed to affect outcomes after orthopaedic procedures. This was a prospective cohort study seeking to identify factors predictive of greater patient-reported outcomes after HA injections, particularly expectations and psychological stress. 250 patients receiving a series of HA injections for knee OA were enrolled, with 196 being included for analysis. Demographics, surgical history, and preoperative Kellgren-Lawrence severity scores were collected, and patients completed the Knee Osteoarthritis Outcome Score (KOOS) questionnaire, a modified KOOS questionnaire assessing their 6-month postinjection expectations, and the Perceived Stress Scale before the first injection. Outcomes were assessed at 3 weeks and 3 and 6 months after the final injection. KOOS scores improved from preinjection to 6-month follow-up but did not meet patients' expectations or minimal clinically important difference. Expectations correlated with 6-month KOOS pain, activities of daily living, sport, and quality of life subscales (ρ = 0.19 to 0.34), but not the symptom subscale (P = 0.10). Expectations (ρ = 0.31 to 0.37), younger age (ρ = -0.17 to -0.18), and greater perceived stress (ρ = 0.23) correlated with greater improvement from baseline KOOSs. Lower body mass index (ρ = -0.19 to -0.22), male sex (ρ = -0.17), and greater preinjection function (ρ = 0.37 to 0.46) correlated with greater 6-month outcomes. Stress measured on the Perceived Stress Scale did not correlate with 6-month KOOSs (P ≥ 0.27). Lower Kellgren-Lawrence severity score was weakly associated with greater 6-month KOOS activities of daily living and sport scores (ρ = -0.15 to -0.16) and greater improvement in the KOOS symptom score (ρ = -0.15). This study identified that higher expectations, lower body mass index, younger age, male sex, lower radiographic severity, greater preinjection function, and greater perceived stress are associated with greater patient outcomes after HA injection. Physicians should consider these factors when counseling patients with knee OA about viscosupplementation. Prospective Cohort Study (Level of Evidence II).

The clinical application and experience of acupuncture in the treatment of asthma assisted by intelligent technology

Asthma, a prevalent chronic respiratory disease, impacts patients' quality of life. Traditional acupuncture therapy is effective but lacks personalization. This paper introduces AI technology into acupuncture treatment, proposing an intelligent assistance system. The system uses patients' physiological and imaging data to construct an intelligent diagnostic model, accurately identifying conditions and symptom types. Through reinforcement learning optimization algorithms, personalized acupuncture plans are tailored for each patient. Clinical trials show that AI-assisted acupuncture significantly improves symptom scores, lung function, and reduces attack frequency, enhancing clinical efficacy and serving as a valuable tool for traditional Chinese medicine acupuncture training.

Evaluating the Efficacy of Transcranial Magnetic Stimulation in Symptom Relief and Cognitive Function in Obsessive–Compulsive Disorder, Substance Use Disorder, and Depression: An Insight from a Naturalistic Observational Study

The utilization of non-invasive neurostimulation techniques, such as transcranial magnetic stimulation (TMS), is increasingly prevalent in psychiatry due to their efficacy and safety. Although the precise therapeutic mechanisms remain partially unclear, repetitive TMS, particularly high-frequency stimulation, may enhance cognitive functions, contributing to therapeutic benefits. This within-subjects study examined the impact of TMS on cognitive and symptomatic outcomes in patients with obsessive–compulsive disorder (OCD), substance use disorder (SUD), and major depressive disorder (MDD). A total of 44 patients underwent cognitive tests and symptom assessments before and after an intensive four-week TMS treatment phase, followed by a four-week maintenance phase. Cognitive assessments included Raven’s matrices, verbal fluency, and digit span tests, while symptom severity was measured using the Italian version of the SCL-90-R. Decision-making performance was also evaluated by administering a delay discounting (DD) test. Principal component analysis was used to generate a dimensional characterization of subjects along cognitive and symptom-related axes before and after treatment. The results indicated that TMS significantly improved symptom scores, but no significant cognitive enhancement was observed. Statistical analysis based on linear mixed-effects models confirmed these findings, showing a significant fixed effect of TMS treatment on symptoms but not on cognitive performance. DD metrics remained unchanged. These findings suggest that while TMS effectively alleviates clinical symptoms, it does not produce consistent or appreciable enhancement of cognitive functions in these protocols. This study highlights the need for more personalized and combined therapeutic approaches to maximize the benefits of TMS, potentially incorporating cognitive enhancement strategies. Future studies will be useful to explore whether the results we obtained are valid for other pathologies, cognitive tests, and stimulation protocols.

Consistency of Spleen and Symptom Reduction Regardless of Cytopenia in Patients With Myelofibrosis Treated With Pacritinib

BackgroundPacritinib is a JAK2/IRAK1/ACVR1 inhibitor that is approved in the United States for the treatment of patients with myelofibrosis who have a platelet count < 50 × 109/L. Phase 3 clinical studies of pacritinib included patients across a wide range of baseline platelet and hemoglobin levels. Patients and MethodsIn order to assess the impact of baseline blood counts on pacritinib efficacy, an analysis of efficacy outcomes by baseline platelet and hemoglobin levels was performed using data pooled from 2 Phase 3 studies of pacritinib in patients with MF (PERSIST-1 and PERSIST-2). ResultsOf 276 patients evaluable for spleen response, spleen volume reduction occurred consistently across platelet subgroups (< 100 × 109/L or ≥ 100 × 109/L) and hemoglobin subgroups (< 8 g/dL, ≥ 8 to < 10 g/dL, or > 10 g/dL), with no diminution in treatment effect in patients with severe thrombocytopenia or anemia. Among 159 patients evaluable for symptoms response, improvement in total symptom score (TTS) was similar across platelet subgroups. A ≥ 50% improvement of TSS occurred more frequently in patients with baseline hemoglobin < 8 g/dL compared with those with baseline hemoglobin ≥ 8 to < 10 g/dL or > 10 g/dL. Patients with baseline hemoglobin < 8 g/dL also experienced improved hemoglobin sustained over 24 weeks, whereas subgroups with less severe anemia had stable hemoglobin levels over time. Symptom improvement as assessed using the Patient Global Impression of Change instrument was generally consistent across platelet and hemoglobin subgroups. ConclusionPacritinib demonstrates consistent efficacy in patients with MF regardless of baseline platelet and hemoglobin counts.

Glans cap-preserving dorsal inlay-free graft augmentation technique for reconstruction of meatal stenosis and fossa navicularis strictures: Analysis of short-term functional outcomes.

Meatal stenosis and fossa navicularis strictures (FNSs) are commonly caused by lichen sclerosus and instrumentation. We present the technique and short-term functional outcomes of glans cap-preserving dorsal inlay-free graft augmentation for the reconstruction of meatal stenosis and FNS. This retrospective study analyzed patients with meatal stenosis and FNS who underwent glans cap-preserving dorsal inlay-free graft augmentation at our institute since 2019. The surgical technique included a ventral subcoronal approach, preservation and mobilization of the glans cap, a ventral midline urethrotomy incision over the stricture, and a dorsal midline meatotomy incision extending to the proximal normal urethral mucosa at the fossa navicularis, followed by dorsal inlay graft augmentation. During the follow-up, patients were periodically assessed for symptom scores, urinary flow rates (UFRs), and patient-reported outcomes. A total of 26 patients with a mean age of 45 ± 15 years were assessed. The predominant cause of stricture was lichen sclerosus (n = 15; 58%). The mean stricture length was 3.8 ± 0.5 cm, 73% had a circumcised phallus, and an oral mucosa graft augmentation was performed in 22 (85%) patients. Notable postoperative complications included intractable meatal hemorrhage (n = 1) and glans suture granuloma (n = 1), which required intervention. At a mean follow-up of 40 months, there were four failures, of which one patient required redo-urethroplasty. The remaining patients (n = 22; 85%) showed improved symptom scores (P < 0.05), UFRs (P < 0.05), and satisfactory patient-reported outcomes. Glans cap-preserving dorsal inlay-free graft augmentation is a safe and feasible technique with satisfactory short-term functional outcomes for the management of meatal stenosis and FNS in carefully selected patients.

Treatment of oral graft-versus-host disease with intraoral nbUVB phototherapy.

There are limited treatment options available for hematopoietic stem-cell transplant patients (HSCT) with oral graft-versus-host disease (GVHD). Intraoral phototherapy is a novel, yet promising therapeutic regimen. To assess the safety and effectiveness of intraoral narrowband UVB (nbUVB) phototherapy in the treatment of oral GVHD. This case series evaluated 10 patients with refractory oral GVHD, who were treated at Northwestern Memorial Hospital with nbUVB between July 2019 and October 2023. Primary outcomes were to evaluate the safety and efficacy of phototherapy. Efficacy was measured by objective improvement in symptom scores and subjective improvement in patient reported symptoms. Safety was determined by the withdrawal due to adverse events. Total nbUVB exposure, number of treatments, and change in systemic immunosuppressive medications were also examined. The study cohort comprised 10 patients who developed oral GVHD at a median of 9.5months after HSCT. The total median dose of nbUVB was 36J/cm2, and the median number of sessions was 55. All 10 patients demonstrated some degree of improvement in symptoms. Notably, there was a reduction in the number of patients who reported symptoms of oral pain (83%), bleeding (67%), xerostomia (50%), and oral sensitivity (78%) after initiating phototherapy. There was also a statistically significant decrease in the levels of pain, erythema, and edema (p ≤ 0.001, < 0.001, 0.01, respectively). Most patients tolerated phototherapy well, but 1 patient withdrew from treatment due to adverse effects. Seventy-five percent of patients who were on immunosuppressive medications were able to decrease or stop these medications. This case series suggests that nbUVB phototherapy is well tolerated and efficacious in patients with oral GVHD.

Efficacy and safety of Xiangsha liujunzi decoction for functional dyspepsia: a systematic review and meta-analysis.

Functional dyspepsia is a highly prevalent digestive disorder. The limited effectiveness of current pharmaceutical interventions necessitates the exploration of alternative therapeutic options for functional dyspepsia. Xiangsha liujunzi decoction, a well-known traditional Chinese medicine formulation, has been widely employed in the treatment of functional dyspepsia in China. Nevertheless, the effectiveness of Xiangsha liujunzi decoction in the treatment of functional dyspepsia remains uncertain. To examine the effectiveness and safety of Xiangsha liujunzi decoction for treating functional dyspepsia. We retrieved seven databases containing randomized controlled trials on functional dyspepsia published up until 31 July 2023. The quality of these studies was evaluated using the Cochrane Risk of Bias assessment tool. The analysis of data was performed using the software RevMan 5.4. The total clinical effectiveness rate was evaluated as the primary outcome. In addition, gastric emptying rate, symptom score and safety evaluation were evaluated as the secondary outcomes. The meta-analysis included 23 studies, involving 2,101 individuals. Xiangsha liujunzi decoction demonstrated a significantly higher clinical effectiveness rate compared to the control group (RR 1.27; 95% CI 1.21, 1.33; p < 0.00001). Moreover, it exhibited superior gastric emptying rate and symptom score improvement compared to the control group. Nevertheless, no remarkable differences were detected in safety between Xiangsha liujunzi decoction and the control group (RR 0.67; 95% CI 0.16, 2.76; p = 0.58). The findings of this study suggest that Xiangsha liujunzi decoction exhibits effectiveness and no significant adverse events observed. However, because of the low quality of the enrolled studies, more high-quality and strict design randomized controlled trials are required in the future.

Comparing the effectiveness of oral montelukast versus cetirizine in the management of allergic rhino-conjunctivitis and its effect on quality of life among children: A randomized, double-blind clinical trial

Background: Allergic rhino-conjunctivitis (AR) is a common disorder in children, which causes significant morbidity and impact on learning and day-to-day activities. Objectives: To compare effectiveness of montelukast versus cetirizine in AR and its effect on the quality of life (QoL) among children aged 6-12 years, attending Asthma Clinic, Faculty of Medicine, University of Ruhuna, Sri Lanka. Method: This was a randomized, double-blind, parallel-group trial; 'Group A' was given montelukast with a cetirizine dummy; 'Group B' was given cetirizine with a montelukast dummy. Primary endpoint was to compare improvement of nasal, eye and night symptom scores. Secondary endpoint was to compare the QoL between the groups. Total symptoms were assessed at baseline, one month, two months and three months. Results: There were 176 children (62.5% boys) with a mean age of 8.82 ± 1.79 years. Fifteen children were lost to follow-up, 7 from the montelukast and 8 from the cetirizine group. There was a significant reduction in all symptoms (p&lt;0.05) every month in both treatment groups. Whilst montelukast group had more improved day and night symptom scores than cetirizine group, statistically significant improvement was seen only in the 3rd month (t-4.10 p &lt;0.001). Mean QoL score showed no significant difference between the two groups at onset (montelukast 9.01±9.4 and cetirizine 15.9 ± 10.4; t-0.369; p=0.712). Both groups showed a statistically significant improvement in all domains of QoL by completion of treatment (p&lt;0.05). Upon completion, the montelukast group showed a significantly better QoL than the cetirizine group. Conclusions: Both cetirizine and montelukast showed remarkable improvement in the symptoms and better QoL in children. Study outcomes in all clinical domains and QoL were more significantly improved in montelukast group than in cetirizine group when treatment was continued for 3 months.