Patient Tolerance Research Articles

Individualized Hyaluronidase-Facilitated Subcutaneous Immunoglobulin 10% Administration in Chronic Inflammatory Demyelinating Polyradiculoneuropathy: The Nurse’s Role

Hyaluronidase-facilitated subcutaneous immunoglobulin (fSCIG) 10% offers potential improvements in patient independence and tolerability versus intravenous immunoglobulin (IVIG) when used for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). fSCIG 10% also requires less frequent infusions and fewer infusion sites than conventional subcutaneous immunoglobulin (subcutaneous immunoglobulin without hyaluronidase). The ADVANCE-CIDP 1 study demonstrated fSCIG 10% efficacy and safety in preventing CIDP relapse and positive responses from patients in terms of satisfaction and treatment preference. Extensive guidance was provided to nurses during the conduct of ADVANCE-CIDP 1, including delivery of a “Train the Trainer” program by clinical trial educators to support study-site nurses. Consequently, ADVANCE-CIDP 1 has generated a valuable source of practical guidance for nurses. This review describes the key role of nursing professionals in facilitating successful transition from IVIG to subcutaneous therapy in patients with CIDP and draws on experience from ADVANCE-CIDP 1 to help equip nursing staff with the knowledge and confidence to support patients with CIDP initiating fSCIG 10% as a maintenance treatment.

Hypertensive women with dyspnea exhibit an unfavorable central blood pressure response to exercise

Abstract Limited exercise tolerance and dyspnea in patients with uncomplicated hypertension may pose a diagnostic challenge, particularly when blood pressure is normal and assessment results do not support a diagnosis of heart failure. The purpose of this study was to assess the differences in central blood pressure (cBP) response to exercise between females with hypertension and good exercise tolerance (non-dyspneic females, nDFs; n = 27) and those with dyspnea on exertion (dyspneic females, DFs; n = 25). We also investigated the relations of cBP and its dynamics with peak oxygen consumption (peak VO2) and peak heart rate (peak HR) assessed by cardiopulmonary exercise test (CPET) and peak cardiac output (peak CO) assessed by impedance cardiography. Fifty-two females (mean age 54.5 ± 8.2 years) underwent applanation tonometry during CPET to assess the augmentation index (AIx), cBP, and central pulse pressure (cPP) before exercise (REST), at minute 3-rd of exercise (Ex), and at minutes: 1-st (R1) and 4-th of post-exercise rest (R2). In comparison with nDFs, DFs showed significantly higher cPP_Ex, AIx_Ex, and AIx_R1. The two subgroups showed no differences in cPP or Alx values either before exercise or at R2. In comparison with nDFs, the DFs had a less pronounced change in AIx values during post-exercise rest. There were negative correlations between peak HR and: AIx_R1, AIx_R2, change in AIx (R1–R2), between peak VO2 and: AIx_R1, AIx_R1–R2; between peak CO and: AIx_R1, AIx_R2, AIx_R1–R2. DFs presented a different cBP response to exercise than nDFs. Assessing cBP via applanation tonometry may prove useful in identifying hemodynamic abnormalities associated with limited exercise tolerance.

Novel Versus Conventional Sequencing of β-Blockers, Sodium/Glucose Cotransportor 2 Inhibitors, Angiotensin Receptor-Neprilysin Inhibitors, and Mineralocorticoid Receptor Antagonists in Stable Patients With Heart Failure With Reduced Ejection Fraction (NovCon Sequencing Study): Protocol for a Randomized Controlled Trial

Background Chronic heart failure has high morbidity and mortality, with approximately half of the patients dying within 5 years of diagnosis. Recent additions to the armamentarium of anti–heart failure therapies include angiotensin receptor-neprilysin inhibitors (ARNIs) and sodium/glucose cotransporter 2 inhibitors (SGLT2is). Both classes have demonstrated mortality and morbidity benefits. Although these new therapies have morbidity and mortality benefits, it is not known whether rapid initiation is beneficial when compared with the conventional, slower-stepped approach. Many clinicians have been taught that starting with low-dose therapies and gradually increasing the dose is a safe way of intensifying treatment regimens. Pharmacologically, it is rational to use a combination of drugs that target multiple pathological mechanisms, as there is potential synergism and better therapeutic outcomes. Theoretically, the quicker the right combinations are used, the more likely the beneficial effects will be experienced. However, rapid up-titration must be balanced with patient safety and tolerability. Objective This study aims to determine if early addition of ARNIs, SGLT2is, β-blockers, and mineralocorticoid receptor antagonists (within 4 weeks), when compared with the same therapies initiated slower (within 6 months), will reduce all-cause mortality and hospitalizations for heart failure in patients with stable heart failure with reduced ejection fraction. Methods This is a single-center, randomized controlled, double-arm, assessor-blinded, active control, and pragmatic clinical trial. Adults with stable heart failure with reduced ejection fraction and idiopathic dilated cardiomyopathy will be randomized to conventional sequencing (the control arm; over 6 months) of anti–heart failure therapies, and a second arm will receive rapid sequencing (over 4 weeks). Study participants will be followed for 5 years to assess the safety, efficacy, and tolerability of the 2 types of sequencing. Posttrial access and care will be provided to all study participants throughout their lifespan. Results We are currently in the process of obtaining ethical clearance and funding. Conclusions We envisage that this study will help support evidence-based medicine and inform clinical practice guidelines on the optimal rate of sequencing of anti–heart failure therapies. A third placebo arm was considered, but costs would be too much and not providing study participants with therapies with known morbidity and mortality benefits may be unethical, in our opinion. Given the post–COVID-19 economic downturn and posttrial access to interventions, a major challenge will be acquiring funding for this study. International Registered Report Identifier (IRRID) PRR1-10.2196/44027

Effect of binaural beats on pain, anxiety, and procedure tolerance in patients undergoing colonoscopy without sedation: A randomized controlled trial

Objectives: This study aimed to investigate the effect of binaural beats on pain, anxiety,and tolerance during colonoscopy of patients without sedation. Methods: This is a prospective, randomized, controlled, single-blind procedural study that included 92 Turkish patients who underwent colonoscopy. The patients were randomly divided into two groups: the binaural beat music group (n=46) and the control group (n=46). The binaural music group was subjected to music through headphones during the colonoscopy, while the control group was provided headphones without music. The anxiety levels were measured using a Visual Analog Scale for Anxiety (VAS-anxiety), while the pain levels were assessed using a Visual Analog Scale for Pain (VAS-pain). Hemodynamic changes, procedure tolerance, cecal insertion and withdrawal times, polyp detection, and patients’ experiences related to colonoscopy were recorded. Likert scales, indicating procedure satisfaction, were also administered immediately after the colonoscopy. Results: The music group demonstrated significantly lower anxiety scores compared to the control group, along with better tolerance scores, a higher willingness to repeat the procedure, and a significant preference to listen to the same music again for any upcoming unsedated colonoscopy procedures (P<0.05). No significant difference was observed between the groups in terms of pain experienced during the procedure, vital parameters, cecum insertion time, procedure time, and polyp detection rate (P>0.05). Conclusions: For patients undergoing colonoscopy without being sedated, listening to music composed of binaural beats demonstrated a significant decrease in anxiety levels and improved patient tolerance during the procedure, presenting an alternative to sedative medications.

Use quercetin for pulmonary fibrosis: a preclinical systematic review and meta-analysis.

Pulmonary fibrosis (PF) is an age-related interstitial lung disease, which lacks effective drug treatment at present. Quercetin has been shown to have favorable anti-inflammatory and anti-fibrotic properties, and preliminary evidence suggests its potential efficacy and tolerability in PF patients. However, a comprehensive systematic review and evaluation of the protective effects and potential mechanisms of quercetin in PF models remains to be completed. Therefore, we conducted this study. The PubMed, Cochrane Library, Embase, and Web of Science databases were searched up to the April 1, 2024. CAMARADES was the methodological quality assessment tool. And statistical analyses were conducted with R and Stata 16.0. Origin was used for a three-dimensional (3D) dosage-intervention duration-efficacy model for quercetin treatment of PF. A total of 20 studies, encompassing 44 independent experiments and involving 1019 animals, were included in the analysis. Meta-analysis revealed that quercetin significantly mitigated lung pathological tissue scores and the expression of lung fibrosis markers in PF animal models. Furthermore, quercetin significantly ameliorated inflammatory responses, oxidative stress, epithelial-mesenchymal transition and myofibroblast activation, cell senescence and apoptosis, and the markers expression of extracellular matrix (ECM) deposition. Quercetin did not show significant hepatic and nephrotoxicity. The 3D dosage-intervention duration-efficacy model indicated that a dosing period over 20days and dosages range of 5-100mg/kg were appropriate modalities. Herein, our study highlights the potential of quercetin in the treatment of PF and the available mechanisms.

Study of stress tolerance in patients with missing teeth on the background of oral xerostomia

The purpose this study was to study stress resistance in elderly and senile patients with missing teeth against the background of oral xerostomia.Material and methods. 80 patients aged 60 to 90 years with missing teeth due to xerostomia were examined and orthopedic treatment with removable plate dentures was carried out. Of these, 32 (40%) patients were male and 48 (60%) were female. Stress tolerance was assessed according to the test of S. Cohen and G. Willanson. Stress resistance was determined based on the data obtained from the test results.Results. Analysis of the obtained data on stress resistance in the studied patients according to the test of S. Cohen and G. Willianson showed that 35% of the subjects showed satisfactory, 57.5% – poor and 7.5% – very poor resistance to stress. In all study groups, the results did not have significant differences. 28 patients (8 men, 20 women) showed satisfactory stress resistance, 46 (18 men and 28 women) patients had poor stress resistance, and 6 male patients had very poor stress resistance.Conclusion. The analysis of the stress resistance data obtained in elderly patients with missing teeth indicates a depressive state of the subjects, especially in male patients, which may directly be the cause of dry mouth or a consequence of this problem.

The Effect of Heart Rate on Quality of Life in Patients with Chronic Heart Failure

Introduction. Chronic heart failure (CHF) leads to a steady deterioration in the quality of life (QOL) and a decrease in exercise tolerance of patients. Numerous studies have confirmed the role of increased heart rate in worsening the prognosis of CHF — heart rate more than 75 bpm needs reduction to optimize the clinical status of patients.The purpose of the study is to analyze the effect of heart rate on QOL and exercise tolerance in patients with CHF with a low left ventricular ejection fraction.Materials and methods. A prospective comparative study was conducted. 80 patients (54 men and 26 women, verage age — (66.3±7.9) years) with postinfarction cardiosclerosis and sinus rhythm, with CHF II–III NYHA functional classes with an ejection fraction less than 40 % were examined.Results. Significantly better QOL indicators were noted in patients with heart rate 60–69 bpm. The lowest indicators of functional activity were noted at 55–59 bpm, and socio-psychological activity at 70–75 bpm. Exercise tolerance is higher in patients with a heart rate of 60–69 bpm, its lowest rates were noted at 70–75 bpm.Discussion. The optimal heart rate range determination in patients with postinfarction cardiosclerosis and CHF allows targeted titration of the β-blocker dosage, achieving an improvement in QOL and the clinical and functional status of patients.Conclusion. In patients with CHF careful selection of β-blockers and ivabradine therapy demonstrates the most optimal indicators of physical activity and QOL with a heart rate of 60–64 bpm and 65–69 bpm.

The Effect of Deep Respiration and Prone Position on Common Respiratory Symptoms in Patients with COVID-19: A Randomized Clinical Trial

Abstract Background: COVID-19 causes many respiratory problems. The most common clinical manifestation is acute respiratory failure. Respiratory rehabilitation is an important part of treatment, but little is known about it. This study was carried out to determine the effect of deep respiration and prone position on common respiratory symptoms in patients with COVID-19. Materials and Methods: In this clinical trial that was conducted in a hospital in Yasuj city, Iran, in 2021, 96 patients with COVID-19 were selected using a non-random convenience sampling method and were randomly assigned to three groups of deep respiration, prone position, and deep respiration and prone position. Data were collected using the Borg Rating of Perceived Exertion scale, the Visual Analog Scale, pulse oximetry, and a researcher-made checklist of patients’ respiratory rates. The interventions were performed for 1 week (2–8 hours daily) based on patient tolerance. Data were collected before and immediately after the intervention. Results: There was no statistically significant difference (p > 0.05) among the three groups in terms of mean score of shortness of breath, intensity of symptoms, oxygen saturation of blood, and respiration rate before the interventions; however, significant differences were observed after the interventions (p < 0.05) in the three groups. Conclusions: Deep respiration with prone position could improve respiratory symptoms in patients with COVID-19 more than deep respiration or prone position alone. Respiratory exercise should be considered as a part of nursing cares and patients with respiratory symptoms should receive education in this regard.

Transforming Trans-nasal Endoscopy Services: A multicentre service evaluation pilot project.

To assess the impact of pilot Transnasal endoscopy (TNE) services on workforce efficiency, allocated procedure times and patient tolerance of procedures. The aim was to also understand the challenges of setting up a TNE service. Six-month data was collected from ten sites. Data captured included productivity, performance, workforce numbers, facilities and quality metrics. A patient survey was done to capture patient's experience. An eight likert-style and open question survey was designed and used. Pilot sites were visited using a semi-structured interview process. 30% of the pilot sites carried out the TNE service outside of the endoscopy unit. There is an overall 25% improvement in workforce efficiency with TNE. Of those patients that had both a TNE and OGD 78% of patients reported that having the TNE procedure was a better experience. All sites reported that they will continue providing TNE beyond the pilot period. Sites carrying out TNE reported a high satisfaction with the services. Overall satisfaction with the quality of TNE imaging was very high. This multicentre pilot project shows evidence that the integration of TNE services has a positive impact in increasing capacity and patient satisfaction. This should set the scene for scaling this up on a wider capacity. TNE services particularly with an introduction into outpatients will improve service capacity in endoscopy, patients will tolerate the procedures more, national two week wait, and Faster Diagnostic Standard targets will improve, and it is potentially more cost efficient overall.

Quilting Suturing Versus Intranasal Silicone Splinting and Nasal Pack Post-Septoplasty: A Systematic Review and Meta-analysis.

Septoplasty is a common treatment for septal deviation in otolaryngology, and it is the recommended treatment for a deviated septum. However, it can lead to post-operative complications such as septal hematoma, adhesions, and perforation. Trans-septal quilting suture and intranasal silicone splinting effectively prevent complications after septoplasty. This systematic review and meta-analysis aimed to evaluate the effectiveness of intranasal silicone splints compared to quilting sutures in managing post-septoplasty complications and patient tolerance. PubMed, Google Scholar, and CENTRAL databases were used with specific keywords, and the studies were screened using the Rayyan AI system and were selected based on the inclusion and exclusion criteria. Statistical analysis was done by using RevMan version 5.4 to generate forest plots. Regarding quality assessment, the JBI Critical Appraisal Tool for Systematic Reviews was used to evaluate the rigor of the included studies. This systematic review and meta-analysis identified 23 studies and only 18 were eligible. It showed that the three methods effectively prevent post-septoplasty complications; however, quilting sutures reduce post-operative pain and minimize the complications. It is essential to note that quilting sutures and intranasal splints showed a comparable incidence of nasal bleeding postoperatively to nasal packing. It was found that trans-septal quilting sutures had considerable advantages over nasal packing in septoplasty procedures and clearly showed that it is a safe and effective technique. Nasal splints, specifically intranasal silicone splints, are indicated as an alternative to nasal packing to generally improve the patient's comfort, especially by reducing post-operative discomfort. The findings of the study can help medical practitioners make better decisions about the most effective surgical approach, also considering well-tolerated post-septoplasty care. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Designing a sustained-release solid oral formulation for overactive bladder treatment: a quality by design approach

Background: Mirabegron, a first-in-class β3-adrenergic agonist used for managing overactive bladder (OAB), is well-documented in the literature. However, its low oral permeability results in poor bioavailability, limiting patient compliance and tolerability. To address this, the present study focuses on developing a sustained-release (SR) tablet of mirabegron with enhanced oral effectiveness. In this research, mirabegron was combined with polyethylene oxide to improve permeability and formulated as an HPC-loaded SR tablet, promising improved bioavailability and anti-OAB efficacy. Methods: Tablet design and optimization were carried out using the Box-Behnken Design (Design Expert® 12 software) to refine formulation parameters. The study aimed to create a commercially viable SR tablet with improved intestinal permeability, bioavailability, and clinical acceptance. Results: The optimized formulation showed a 34.8% increase in bioavailability compared to the marketed tablet. In vivo pharmacokinetic studies demonstrated a 31.77% increase in plasma concentration over the marketed formulation. Conclusion: The developed formulation is safe and effective, offering improved therapeutic potential for treating overactive bladder. This work represents a significant advancement in OAB management and highlights the commercial viability of the emerging mirabegron SR tablet in meeting current therapeutic needs.

177Lu-DOTATATE in Combination with PARP Inhibitor Olaparib Is Feasible in Patients with Somatostatin-Positive Tumors: Results from the LuPARP Phase I Trial.

This phase I trial aimed to assess the feasibility and toxicity of combining the poly(adenosine diphosphate-ribose) polymerase inhibitor olaparib with 177Lu-DOTATATE in patients with somatostatin receptor-positive tumors, with the goal of enhancing treatment efficacy through the inhibition of tumor cell DNA repair mechanisms. Methods: Eighteen patients were enrolled, mostly with pancreatic or small intestinal neuroendocrine tumors or atypical lung carcinoids. Patients received a standard dose of 177Lu-DOTATATE (7,400 MBq) for up to 4 cycles, combined with escalating doses of olaparib (50-300 mg twice a day [BID]). The primary objective was to evaluate toxicity using National Cancer Institute Common Toxicity Criteria version 5.0. Secondary objectives included time to progression, overall survival, response rate, and dosimetry variables. Results: The combination of olaparib and 177Lu-DOTATATE was generally well tolerated. Five patients did not complete the 4 cycles because of progression, noncompliance, and carcinoid crisis after the first 177Lu-DOTATATE infusion. Among the remaining patients, thrombocytopenia was the primary dose-limiting toxicity, observed in 3 patients at the 300-mg dose level. Other toxicities were mild, predominantly low-grade bone marrow suppression, nausea, and fatigue. Conclusion: This study demonstrates that combining olaparib with 177Lu-DOTATATE is feasible, with toxicity primarily related to thrombocytopenia. On the basis of the findings, we recommend a starting dose of 200 mg BID for future studies, with the potential to escalate to 300 mg BID depending on patient tolerance. Further investigation in larger, randomized trials is warranted to assess the clinical efficacy of this combination and optimize dosing strategies.

An update and overview of the various health-related benefits of probiotics: A focus on clinical trials demonstrating efficacy, tolerability and use in patients with impaired glucose tolerance and type 2 diabetes.

Recently, probiotics have been investigated as potential therapeutic agents for various diseases. Clinical studies using probiotics have been conducted in humans with impaired glucose tolerance and type 2 diabetes mellitus. Chronic inflammation plays a pivotal role in initiating insulin resistance in the pathogenesis of type 2 diabetes, leading to cardiovascular diseases. Intestinal dysfunction and inflammation have been postulated to trigger systemic chronic inflammation, and it is assumed that the suppression of inflammation in the intestine is the point of activity of probiotics. Therefore, in this review, among the randomised controlled trials that evaluated the effects of probiotics in patients with impaired glucose tolerance and type 2 diabetes, we selected trials that evaluated the indices of glycaemic control and inflammation-related markers. Some trials have shown that the probiotics administration improved glycaemic indices, such as HbA1c levels, and reduced C-reactive protein levels and proinflammatory cytokines, such as IL-6, in the blood, suggesting the suppression of inflammation. Two trials showed improvements in glycaemic indices, implying that they were mediated by IL-10, an anti-inflammatory cytokine. Although a correlation between the suppression of inflammation by probiotics and improvement in glycaemic control has not been documented, one trial revealed that glycaemic control worsened, accompanied by a decrease in anti-inflammatory cytokine levels, after probiotics were discontinued. Other studies have shown that probiotics can reduce blood endotoxin levels and increase intestinal mucin production. These findings suggest that probiotic administration has enormous potential to suppress chronic inflammation in metabolic disorders, leading to improved glycaemic control. Suppression of chronic inflammation has been speculated to prevent vascular diseases in type 2 diabetes.

"Life Satisfaction & Distress Tolerance in Oral Cancer Patients Undergoing Chemotherapy at a Chennai Tertiary Care Hospital"

Oral cancer significantly impacts patients' psychosocial well-being, particularly during chemotherapy. This descriptive study assessed life satisfaction and distress tolerance among oral cancer patients at Rajiv Gandhi Government General Hospital, Chennai. Sixty patients were selected using nonprobability consecutive sampling and assessed using the Satisfaction with Life Scale (SWLS) and Distress Tolerance Scale (DTS). Results revealed that 100% of patients experienced dissatisfaction with life, with 83.33% reporting strong dissatisfaction. High distress levels were found in 86.67% of patients, and only 13.33% exhibited moderate tolerance. A significant negative correlation (-0.37, p=0.05) was observed between life satisfaction and distress tolerance. Demographic factors like age, gender, and residence significantly influenced these outcomes.

Randomized crossover comparison of two teriparatide self-injection regimens for primary osteoporosis: Interim report (end of 52-week treatment) of the Japanese Osteoporosis Intervention Trial 06 (JOINT-06).

Patient satisfaction with two teriparatide (TPTD) self-injection regimens [once-daily (1/D)-TPTD and twice-weekly (2/W)-TPTD] was compared in a randomized crossover study involving patients with osteoporosis at high fracture risk. Questionnaires evaluated overall satisfaction, satisfaction with treatment effectiveness, satisfaction with utility of the self-injection device, and preference for a particular injection regimen after crossover. Quality of life (QOL), visual analogue scale pain scores, and bone mineral density (BMD) were also analyzed. Safety was evaluated based on the incidence and severity of adverse events (AEs). The 1/D-TPTD and 2/W-TPTD groups comprised 180 (mean age: 75.9 ± 7.3years) and 178 (75.4 ± 6.9years) patients, respectively. After 26weeks of treatment, the injection regimens were switched and treatment continued for another 26weeks. Significantly higher persistence was observed in the 1/D-TPTD to 2/W-TPTD group (p = 0.032). No significant between-group differences in overall satisfaction scores or satisfaction with treatment were observed. Satisfaction with the utility of the injection device was significantly higher with the 2/W-TPTD regimen (p < 0.05); this regimen was preferred by 69.4% of patients after crossover (p < 0.001). A significant increase in BMD from baseline was observed at the lumbar vertebrae in both groups and at the hip area in the 1/D-TPTD to 2/W-TPTD group at 52weeks (p < 0.05). Significant improvement in the QOL score was observed in both groups (p < 0.05). No serious AEs were reported. Continuation of this study will further clarify patient satisfaction, treatment effects, and tolerability.

Non-Invasive Ventilatory Support as a Tool to Improve Exercise Tolerance in Patients With Heart Failure: A Systematic Review With Meta-Analysis.

Heart failure (HF) is a complex syndrome that impacts persons' daily activities and adherence to exercise programs. Non-Invasive ventilation (NIV) reduces respiratory load and improves cardiac function, potentially serving as an important adjunct in its treatment. These effects can be enhanced with a cardiac rehabilitation program, improving dyspnea and functionality. This study aimed to evaluate the effects of NIV during exercise on functional performance outcomes, dyspnea, QL, hemodynamics, and respiratory function. A systematic review followed by meta-analysis was conducted. Searches were performed in PubMed, CENTRAL, Embase, LILACS, SciELO, and CINAHL. Randomized clinical trials of patients over 18years of age with HF, compared to a control group, were included with the objective of improving exercise tolerance. The studies were categorized as short-term effects of NIV and those implementing an exercise program. Seven studies were included in the qualitative review and five in the meta-analysis. Only two studies presented a low risk of bias. The analyzed outcomes were the 6-min walk test (6MWT), dyspnea, SpO2, heart rate (HR), systolic, and diastolic arterial pressure (SAP and DAP, respectively), maximal inspiratory and expiratory muscle strength (MIP and MEP, respectively), forced expiratory volume in one second (FEV1), and quality of life (QL). There was a significant difference in favor of the NIV group compared to the control group in both modalities in relation to the 6MWT, with a mean difference (MD) 41.72 (CI 95% 2.15, 81.29) meters in the exercise program and MD 68.61 (CI 95% 5.69, 131.54) meters in short-term effect studies. There were also favorable results in the outcomes of dyspnea and FEV1 in the NIV group (p<0.01). There were no statistically significant differences in the outcomes peripheral oxygen saturation (p=0.11), systolic (p=0.76) and diastolic blood pressure (p=0.93), heart rate (p=0.19), MIP (p=0.49), MEP (p=0.22) and QL (p=0.13). PROSPERO CRD42022367746.

Hypertensive heart disease in older patients: considerations for clinical practice.

Hypertensive heart disease in older patients: considerations for clinical practice.

A prospective, single-blinded, non-inferiority, randomized controlled study comparing the effectiveness and safety of oral lactulose combined with carbohydrate-containing clear liquids versus 3-L polyethylene glycol electrolyte for colonoscopy bowel preparation

BackgroundPolyethylene glycol electrolyte solution (PEG-ELS) is the standard for bowel preparation but often suffers from poor patient compliance and tolerability due to its high-volume requirement. This prospective, single-blinded, non-inferiority, randomized control trial aims to investigate the efficacy and safety of a lactulose-based regimen as an alternative for bowel preparation.MethodsTwo hundred nine patients were randomly allocated to receive either a combination regimen consisting of 133.4 g lactulose in 200 mL, 800 mL carbohydrate-containing clear liquid, 2L additional water, and 5 g simethicone (n = 104) or 3L PEG-ELS with 5 g simethicone (n = 105), both administered in a split-dose format. The primary outcome was the rate of adequate bowel preparation, measured by the Boston bowel preparation score (BBPS). Adequate bowel preparation was defined as a BBPS score of 2 or 3 in all colon segments. Secondary outcomes included the percentage of high-quality bowel preparation (defining as a total BBPS score of 8 or 9), polyp detection rate (defining as the percentage of procedures where at least one polyp was detected), willingness to repeat the bowel preparation, adverse events, and changes in blood glucose and electrolyte levels.ResultsThe rate of adequate bowel preparation (96.2% vs. 97.1%, p = 0.691), the percentage of high-quality preparation (62.5% vs. 66.7%, p = 0.529), average total BBPS scores (p = 0.607), polyp detection rates (66.3% vs. 77.1%, p = 0.083), and tolerability and acceptability outcomes, including satisfaction (p = 0.729) and willingness to repeat preparation (p = 0.744), were not statistically different between the two arms. Adverse events and changes in blood glucose and electrolytes showed no significant differences (all p > 0.05).ConclusionThe combination of oral lactulose and carbohydrate-containing clear fluids was non-inferior to 3L PEG-ELS for bowel preparation adequacy and polyp detection, without statistically significant differences in terms of tolerability and safety.

Comparative efficacy of tropicamide 1% and cyclopentolate 1% for cycloplegic refraction: A systematic review and meta-analysis of randomized controlled trials.

Cyclopentolate 1% is considered the drug of choice for effective cycloplegic refraction in clinical population, although tropicamide 1% is also reported to have similar effects with better tolerability. The objective of this meta-analysis was to evaluate the efficacies of tropicamide 1% and cyclopentolate 1% for cycloplegic refraction. MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials were systematically searched for articles published until March 20, 2024. Randomized controlled trials that compared tropicamide 1% with cyclopentolate 1% in terms of differences in spherical equivalent refractive errors were included. The meta-analysis included only nonstrabismic participants with no restriction to age. The included studies were appraised using the Cochrane Risk of Bias Tool-2. The meta-analysis was conducted using the random-effects model with restricted maximum likelihood estimation method. Of 17 full-text reviews from 2555 identified studies, 4 randomized controlled trials were included in quantitative synthesis. The meta-analysis included 171 eyes of 171 participants (age range, 4 months to 50 years), in each group, with all types of refractive errors. The results showed no statistically significant differences in mean spherical equivalent refractive error values between the two groups (mean difference, -0.05; standard error, 0.16; p=0.774). There was no heterogeneity observed between the studies (I2 = 0.00%, p=0.93). The outcome did not change when only children were included in the meta-analysis (age range, 4 months to 16 years; mean difference, -0.14; standard error, 0.21; p=0.508). In the risk-of-bias assessment, generally all studies were judged to have low risk of bias, but only one was judged to have low risk of bias across all seven domains. Tropicamide 1% and cyclopentolate 1% showed similar efficacies for cycloplegic refraction in nonstrabismic children and adults. Considering patient tolerability and drug safety, it may be practical to use tropicamide 1% in routine cycloplegic refractions.

Safety and feasibility of concomitant scalp cooling and limb cryocompression to prevent paclitaxel-induced alopecia and neuropathy

IntroductionScalp cooling is standard-of-care for prevention of chemotherapy-induced alopecia (CIA), with proven safety and efficacy. Limb cryotherapy has shown promise in preventing chemotherapy-induced peripheral neuropathy (CIPN). The safe application of concomitant scalp and limb cryotherapies during chemotherapy is crucial due to concerns about potential interactions, including central hypothermia, yet limited data exist on their safe delivery in this context. Here we report a prospective, single-arm study assessing feasibility, safety, and tolerability of concomitant scalp cooling and limb cryocompression in healthy volunteers, and in cancer patients undergoing chemotherapy.MethodsSafety and tolerability of concomitant scalp cooling and limb cryocompression were evaluated in healthy volunteers and then in cancer patients receiving weekly paclitaxel chemotherapy. Limb cryocompression was administered starting at 11 °C, with thermoregulation allowed up to 25 °C to accommodate patient tolerance. Core body temperature changes, adverse events (CTCAE v4.0), and tolerance to cryotherapy were documented. EORTC Quality of Life Questionnaire-CIPN20 scores were evaluated before the start of chemotherapy (QoLpre), after the last cycle of chemotherapy (QoLpost), and 3 months after the last cycle of chemotherapy (QoL3m). Physician grading of CIA was documented using CTCAE v4.0, and results at baseline and at completion of weekly paclitaxel were compared.ResultsConcomitant scalp and limb cryocompression at 11 °C was safe and tolerable in healthy volunteers (n = 3). Fifteen patients enrolled in the study and 13 completed the entire treatment, with negligible core body temperature changes (− 0.18 °C ± 0.37). Eight patients completed all 12 cycles of cryocompression at 11 °C while some required thermoregulation (range 14 °C to 18 °C). One patient completed all cryotherapy cycles at 25 °C and another withdrew due to intolerance to 25 °C. There were no occurrences of ≥ Grade 2 neuropathy. QoL was preserved and scores remained stable at QoL3m (18 (18–21); median (IQR)) compared to QoLpre (18 (18–19)). Patients who underwent cryocompression at lower temperatures showed better preservation of QoL scores (QoL3m 18 (18–20)) than the others (QoL3m 26 (22–31)). 11/13 patients (85%) demonstrated preservation or improvement of CIA.ConclusionDelivery of concomitant scalp cooling and limb cryocompression is feasible, safe, and tolerable. Larger studies are needed, and currently ongoing, to investigate the efficacy of limb cryocompression for CIPN prevention.