Double-blind Clinical Trial Research Articles

The comparison of efficacy of Escitalopram and Bupropion in treatment of depression symptoms in patients with heart failure: randomized clinical trial

Objective: This study aims to compare the effects of two medicines, Escitalopram and Bupropion, on HF patients who have depression symptoms. Methods: This double-blind randomized clinical trial study was conducted on HF patients with depression symptoms at the Heart Failure Clinics affiliated with Babol University of Medical Sciences. In this study, 80 participants were examined for depression based on the Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HDRS). They were randomly allocated into 2 groups of 40 participants treated with Bupropion 75 mg and Escitalopram 5 mg. Following the intervention, the individuals were assessed in terms of their depression score at 4, 8, and 12-week intervals. Finally, the data was analyzed using SPSS version 22.0. Results: In the examination of Beck and Hamilton scores in the two research groups during different follow-ups, a significant decrease was found over time (P<0.001 for both medicines). While the effectiveness of the two medicines was the same at different times (P>0.05 in all cases). Comparing the side effects between the two intervention groups, the orgasm disorder (P=0.018) and sexual dysfunction (P<0.001) were reported significantly more in the Escitalopram group than in the Bupropion group. Conclusions: The findings of this study showed that Escitalopram has the same efficacy as Bupropion in the treatment of depression symptoms in HF patients.

Randomized dose-response trial of n-3 fatty acids in hormone receptor negative breast cancer survivors- impact on breast adipose oxylipin and DNA methylation patterns.

Increasing evidence suggests the unique susceptibility of estrogen receptor and progesterone receptor negative (ERPR-) breast cancer to dietary fat amount and type. Dietary n-3 polyunsaturated fatty acids (PUFAs), such as docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), may modulate breast adipose fatty acid profiles and downstream bioactive metabolites to counteract pro-inflammatory, pro-carcinogenic signaling in the mammary microenvironment. To determine effects of ~1 to 5 g/d EPA+DHA over 12 months on breast adipose fatty acid and oxylipin profiles in women with ERPR(-) breast cancer, a high-risk molecular subtype. We conducted a 12-month randomized controlled, double-blind clinical trial of ~5g/d vs ~1g/d DHA+EPA supplementation in women within 5 years of completing standard therapy for ERPR(-) breast cancer Stages 0-III. Blood and breast adipose tissue specimens were collected every 3 months for biomarker analyses including fatty acids by gas chromatography, oxylipins by LC-MS/MS, and DNA methylation by reduced-representation bisulfite sequencing (RRBS). A total of 51 participants completed the 12-month intervention. Study treatments were generally well-tolerated. While both doses increased n-3 PUFAs from baseline in breast adipose, erythrocytes, and plasma, the 5g/d supplement was more potent (n =51, p <0.001). The 5g/d dose also reduced plasma triglycerides from baseline (p =0.008). Breast adipose oxylipins at 0, 6, and 12 months showed dose-dependent increases in unesterified and esterified DHA and EPA metabolites (n =28). Distinct DNA methylation patterns in adipose tissue after 12 months were identified, with effects unique to the 5g/d dose group (n =17). Over the course of 1 year, EPA+DHA dose-dependently increased concentrations of these fatty acids and their derivative oxylipin metabolites, producing differential DNA methylation profiles of gene promoters involved in metabolism-related pathways critical to ERPR(-) breast cancer development and progression. These data provide evidence of both metabolic and epigenetic effects of n-3 PUFAs in breast adipose tissue, elucidating novel mechanisms of action for high-dose EPA+DHA-mediated prevention of ERPR(-) breast cancer.

A randomized controlled trial of efficacy and safety of Fecal Microbiota Transplant for preventing recurrent Clostridioides difficile infection.

Clostridioides difficile infection (CDI) is the most common cause of healthcare-associated infections in US hospitals with 15%-30% of patients experiencing recurrence. The aim of our randomized, double-blind clinical trial was to assess the efficacy of capsule-delivered fecal microbiota transplantation (FMT) versus placebo in reducing recurrent diarrhea and CDI recurrence. The secondary aim was FMT safety assessment. Between 2018 and 2022, Veterans across the Veterans Health Administration system with recurrent CDI who responded to antibiotic treatment were randomized in a 1:1 ratio to oral FMT or placebo capsules. Randomization was stratified by number of prior CDI recurrences (1 or ≥2). The primary endpoint was clinical recurrence by day 56, defined as >3 unformed stools daily for ≥2 days with or without laboratory confirmation of C. difficile, or death within 56 days. The study was stopped due to futility after meeting pre-specified criteria. Of 153 participants (76 FMT, 77 placebo) with an average age of 66.5 years, 25 participants (32.9%) in the FMT arm and 23 (29.9%) in the placebo arm experienced the primary endpoint of diarrhea and possible or definite CDI recurrence or death within 56 days of capsule administration (absolute difference 3.0%; 95% CI [-11.7%, 17.7%]). Stratification by number of recurrences revealed no statistically significant differences. There were no clinically important differences in adverse events. FMT therapy vs. placebo did not reduce CDI recurrence or death at 56 days. There were no meaningful differences in adverse events between treatment groups.

Assessment of cognitive-motor functions in adults with perceived neuropsychological problems using NIH toolbox after remote biofield energy treatment as non-pharmacological intervention: A randomized double-blind placebo controlled trial.

Non-pharmacological interventions include physical activity, biofield energy therapy, reiki, Tai chi, and therapeutic touch. However, no reports analyzed the effectiveness of biofield therapy on cognition and motor function performance in adult subjects. The study aimed to investigate the impact of remote biofield energy healing therapy on cognition and motor functioning in adults with self-perceived neuropsychological impairments. This was a randomized double-blind clinical trial that involved 114 participants with self-perceived neuropsychological impairments. The participants were divided into three groups (control, sham control, and biofield intervention). Cognitive and motor function scores were assessed using the NIH Toolbox at baseline (day 0), day 90, and day 180. The biofield treatment group showed significant improvements in language function (p < 0.0001), working memory (p < 0.0001), and episodic memory (p < 0.0001) scores. Other cognitive functions also improved, although not statistically significant. The biofield intervention group also demonstrated significant enhancements (p < 0.05 to p < 0.0001) in locomotion, standing balance, dexterity, grip strength, and muscle endurance. No adverse effects were reported. The results suggest that remote biofield energy therapy is a safe, noninvasive intervention that improves cognitive and motor functions in adults. Further research is needed to understand its clinical benefits.

The effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomised control trial

BackgroundWhite spot lesions (WSL) are common side effects of orthodontic treatment with fixed appliances, in which the surface layer of enamel is demineralised. Thus, remineralisation, that is a partial or complete reversal, of these lesions can occur as they affect the surface enamel. Remineralisation with low-dose fluoride, in addition to optimal oral hygiene and diet, has been recommended to manage WSL. The aim of the planned trial is to assess the effectiveness of a fluoride-containing bioactive glass toothpaste (BioMin™) in its ability to remineralise post-orthodontic demineralised WSL.MethodsA single-centre, double-blind randomised clinical trial to assess intervention with Bio-Min toothpaste on WSL forming on the teeth of young people completing orthodontic treatment.DiscussionRemineralisation of WSL can vary depending on the individual and the site of the lesion. There is a range of oral fluoride delivery methods which include toothpastes, oral rinses, and gel preparations, which can aid remineralisation of these lesions. Identifying effective methods of remineralisation to manage this common and unsightly complication of fixed appliance therapy can improve the health and aesthetics of dentition.Trial registrationISRCTN.com International Standard Randomised Controlled Trials Number (ISRCTN) 14479893. Registered on 14 May 2020

A Comparative Study of the Effect of Pericapsular Nerve Block (PENG) and Ultrasound-guided Fascia Iliaca Blocks on Postoperative Pain of Intertrochanteric Fractures

Background: Previous anesthesia blocks often failed to provide complete pain relief and were associated with weakness in the lower limbs, which hindered the essential mobility of patients undergoing hip surgery. Recently, the pericapsular nerve group block (PENG) has emerged as a promising alternative for managing postoperative pain following hip fracture surgery. Objectives: This study aimed to compare pain reduction between the pericapsular nerve group block (PENG) and the fascia iliaca compartment block (FICB) in patients who underwent intertrochanteric hip surgery. Methods: This randomized, double-blind clinical trial included 41 patients who were randomly assigned to either the pericapsular block group (PENG) or the ultrasound-guided (FICB). The primary outcome was pain relief, assessed using the postoperative Visual Analog Scale (VAS) score. Secondary outcomes included the dose of morphine consumed, the time of first morphine request, patient satisfaction with analgesia, and complications. Results: There was no significant difference between the PENG and FICB groups in terms of pain scores at any of the studied intervals (P-value &gt; 0.05). The dose of morphine consumed and the time to the first morphine request were similar for both methods, with no significant difference (P-value &gt; 0.05). The complication rates were 15% for the PENG group and 8.3% for the FICB group, with no significant difference observed (P-value &gt; 0.05). Conclusions: Both pericapsular and fascia iliaca blocks effectively reduced postoperative pain in patients undergoing intertrochanteric fracture surgery. Additionally, both methods were well tolerated by patients with no significant complications. However, there was no evidence to suggest that PENG is superior to FICB in terms of pain reduction.

Evaluating the Efficacy of Resveratrol-Containing Mouthwash as an Adjunct Treatment for Periodontitis: A Randomized Clinical Trial.

To evaluate the effectiveness of resveratrol mouthwash as an adjunct to nonsurgical periodontal treatment of periodontitis. This study was a randomized, double-blind clinical trial study. The study included 57 participants with periodontitis. Clinical parameters (plaque index [PI], bleeding on probing [BOP], probing pocket depth [PPD], and clinical attachment loss [CAL]) were examined at the baseline visit, after 7 days, and after 30 days of using resveratrol mouthwash as an adjunct to nonsurgical periodontal treatment. The salivary levels of (interleukin [IL]-6) and RANKL (receptor activator of nuclear factor-kappa B ligand) were measured and compared before and after treatment. The participants answered the visual analog scale-based assessment questionnaire at the last visit. A one-way ANOVA (analysis of variance) test was used to compare the means of multiple groups (test, positive control, negative control) at baseline and after treatment. A paired t-test was also used to compare the means of a single group before and after treatment. In addition, Tukey's multiple comparisons test was used to identify specific pairwise differences between the three groups after finding significant differences with ANOVA. The Chi-square test was also used to compare the distribution of categorical variables like sex between the groups. All interventions significantly reduced PI, BOP, PPD, and CAL, but resveratrol and chlorhexidine had a higher significant effect than placebo except for CAL without a significant difference between them. All mouthwashes significantly reduced the salivary concentration of IL-6. However, resveratrol and chlorhexidine had a significantly higher effect than placebo, while the concentration of RANKL was decreased in all groups without a significant difference between them. The participants' responses to the mouthwash questionnaire showed that resveratrol and chlorhexidine had the same feedback without significant differences. Resveratrol-containing mouthwash could be used as an alternative to chlorhexidine as an adjunct to nonsurgical periodontal treatment of periodontitis.

Comparison of Transforaminal Magnesium Sulfate with Steroid Injection in the Management of ‎Radicular Back Pain: A Randomized Double-Blinded Clinical Trial Study

Background: This study compares the effects of transforaminal magnesium sulfate injection versus other methods for managing radicular back pain, highlighting its potential for improved pain relief and functional outcomes. Methods: This randomized, double-blind clinical trial involved 30 patients with radicular back pain who were randomly assigned to receive either transforaminal magnesium sulfate or triamcinolone injection. Primary outcomes were pain intensity and functional disability, assessed using the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI), respectively. These were evaluated at five time points: Before the injection, 2 weeks, 1 month, 3 months, and 6 months after the injection. Secondary outcomes included drug-related adverse events within the six-month follow-up period. Results: Baseline characteristics were not significantly different between the two study groups. Compared to pre-injection measures, post-injection pain intensity and functional disability were significantly reduced in both groups at all time points (P &lt; 0.001). At all postoperative evaluations, pain intensity and functional disability were lower in the magnesium sulfate group compared to the steroid group (P &lt; 0.001). No drug-related side effects were recorded in either group. Conclusions: For patients with radicular back pain, transforaminal magnesium sulfate injection appears to be an effective and safe alternative to transforaminal steroid injection.

Effects of Spirulina platensis Supplementation on COVID-19 Severity in Critically Ill Patients: A Randomized Clinical Trial

Background: Spirulina is a functional food with antioxidant and anti-inflammatory properties. Its anti-inflammatory, antioxidant, antiviral, and immunomodulatory potential may improve certain clinical conditions in patients with coronavirus disease 2019 (COVID-19) in the intensive care unit (ICU). Objectives: This study aimed to investigate the effects of Spirulina supplementation on clinical conditions in critically ill patients with COVID-19. Methods: A double-blind clinical trial randomized patients admitted to an ICU to receive either Spirulina platensis supplementation (5g/day, n = 97) or to a control group (n = 95). The severity of COVID-19 was assessed using the Acute Physiology and Chronic Health Evaluation (APACHE), National Early Warning Score (NEWS) 2, and Sequential Organ Failure Assessment Score (SOFA). The study also evaluated the length of stay in the hospital and ICU, respiratory support at discharge, and 28-day mortality. In the survival analysis, 126 participants were evaluated (58 in the control group and 68 in the Spirulina group). Results: There was no significant difference between the groups in 28-day mortality (HR = 1.07, 95% CI 0.57 - 1.97) or NEWS2 (P = 0.76). However, the SOFA score significantly decreased in the Spirulina group compared to the control group (P = 0.03). The Spirulina group had a shorter ICU length of stay (7.43 ± 3.98 days) compared to the control group (10.00 ± 4.69 days, P = 0.007). The hospital length of stay was also shorter in the Spirulina group compared to the control group (P = 0.001). Conclusions: Spirulina supplementation reduced disease severity (as measured by the SOFA score) and shortened hospital and ICU length of stay in critically ill COVID-19 patients, but it did not reduce mortality.

SPIDOL study protocol for the assessment of intrathecal ziconotide antalgic efficacy for severe refractory neuropathic pain due to spinal cord lesions

RationaleCentral neuropathic pain resulting from spinal cord injury is notoriously debilitating and difficult to treat with few currently available treatments. A novel molecule with intrathecal administration: Ziconotide has been approved for treatment of refractory neuropathic pain in general. It acts as a presynaptic calcium channel blocker. A pilot study has shown its potential in SCI neuropathic pain patients.ObjectiveThe aim of this study is to determine the long-term (6 months) efficacy of chronic intrathecal ziconotide for the treatment of neuropathic SCI pain.Study designMulticenter, Randomized, Comparative, Placebo controlled, Double blind clinical trial, with a crossover of random alternated periods of 6 months (placebo or ITZ) for a total of 15 months including a total of 44 patients.Study population• Patients with SCI of various etiologies exhibiting neuropathic pain refractory to non-invasive treatments.• > 18 years.InterventionIntrathecal administration of ziconotide via an implanted pump.Study outcomesPrimary study outcomeDifference in pain intensity for all patients between effective treatment and placebo periods.Secondary study outcomes1. Continuous evaluation of pain intensity.2. Percentage of patients with at least 30% of pain reduction.3. Satisfaction level of the patient pain relief.4. Declarations of serious adverse events.5. Duration and intensity of spontaneous and provoked pain.6. Quality of life.7. Patient global impression of change.8. Quantification of daily dosages of analgesic drug intake.9. Long term memory and neurocognitive effects.10. Assessment of the patient’s physical and emotional distress.Nature and extent of the burden and risks associated with participation, benefit, and group relatednessParticipation in this study is in accordance with current treatment protocols for SCI neuropathic pain in France therefore it proposes a treatment that would currently be considered regular practice even though no RCT evidence is yet available. The study gives patients the advantage of directly testing versus placebo a treatment that otherwise entails significant constraints.A Data Safety Monitoring board (DSMB) will be created for continuous safety analysis. Furthermore, patients will be followed in specialized pain centers offering the possibility of continuing their treatment after the study period.

Comparative efficacy and safety of ciprofol, propofol, and propofol and etomidate mixture, and ciprofol and etomidate mixture in patients undergoing painless gastroscopy: A randomized, double-blind controlled clinical trial.

To compare the efficacy and safety of ciprofol, propofol, propofol and etomidate mixture or ciprofol and etomidate mixture in patients undergoing painless gastroscopic anesthesia, and to explore the optimal plan to relieve the patient's discomfort. A total of 120 patients scheduled for painless gastroscopy were randomly assigned to 4 groups: propofol (Group P), ciprofol (Group C), propofol-etomidate mixture (Group P-E), and ciprofol-etomidate mixture (Group C-E). The success rate of gastroscopy examination, patient satisfaction, incidence of injection pain, hemodynamic parameters, induction time, procedure time, the consumption of drugs, awakening time, and incidence of adverse events were evaluated. All patients in the study successfully completed the gastroscopy. The satisfaction of patients in Group C-E was significantly higher than that in Group P (P < .05), but there was no statistical significance in the patient satisfaction among the other groups. Compared with Group P, the incidence of injection pain in Groups C and C-E significantly decreased (P < .05). There were no significant differences in the SBP, diastolic blood pressure, HR, and SpO2 among the 4 groups (P > .05). The awakening time of Group C was significantly longer than that of Groups P and P-E (P < .05), but there was no statistically significant difference in the awakening time of other groups. Ciprofol demonstrated efficacy in inducing sedation or anesthesia during painless gastroscopy that was similar to propofol, while exhibiting a comparable safety profile. Moreover, the combination of propofol and etomidate, as well as the combination of ciprofol and etomidate, were both shown to be equally safe and effective for this clinical application. These findings suggest that ciprofol can be considered as a safe and effective alternative for painless gastroscopy, and the ciprofol-etomidate mixture may be a better choice.

Comparing the effects of intrathecal and intra-articular magnesium sulfate and fentanyl on pain after knee arthroscopy; double-blind clinical trial

Abstract Objectives: The aim of this study was to compare the effects of intrathecal and intra-articular magnesium sulfate (IA-Mg) and fentanyl on pain after knee arthroscopy (KA). Materials and Methods: This double-blind clinical trial was conducted in 2022–2023. One hundred and forty candidates for KA were randomly allocated to four groups, namely intrathecal magnesium sulfate, IA-Mg, intrathecal fentanyl (IT-F), and intra-articular fentanyl. A medical intern used a 0–10 visual analog scale to assess participants’ post-KA pain at recovery and 1, 4, 6, 12, and 24 h after KA. Participants with a pain score of more than 4 were provided with intravenous pethidine 25 mg. Data were analyzed at a significance level of &lt; 0.05 and using the SPSS software (version 22.0). Results: No significant difference was found among the groups respecting participants’ arterial oxygen saturation, heart rate, blood pressure, and KA duration (P &gt; 0.05). The mean score of pain significantly increased in all study groups (P &lt; 0.05) and the mean score of pain in the IA-Mg group was significantly less than the other groups (P = 0.001). Respecting postoperative complications, only six cases from the IT-F group experienced pruritus (P = 0.001). Conclusion: IA-Mg can significantly reduce post-KA pain and the need for postoperative analgesics. Therefore, it may be a safe and effective adjacent therapy for post-KA pain management.

Proprioceptive neuromuscular facilitation stretching exercises for treatment of temporomandibular dysfunction in patients with forward head posture: A double-blinded, randomized, controlled trial.

Proprioceptive neuromuscular facilitation (PNF) stretching exercises have been widely advocated for the management of patients with different musculoskeletal conditions. However, its effect on the treatment of temporomandibular dysfunction (TMD) in patients with forward head posture (FHP) has not been fully investigated. To investigate the effect of PNF stretching exercises on the treatment of TMD in patients with FHP. A prospective, randomized, double-blinded clinical trial. Twenty-four patients with TMD and FHP aged from 18-40 years were randomly assigned to PNF or control group. The PNF group composed of 12 patients received PNF stretching exercises of masticatory muscles in addition to routine physical therapy treatment (FHP correction exercises and ultrasound for the temporomandibular joint); the control group composed of 12 patients received routine physical therapy treatment only. Interventions were conducted twice a week for six weeks. Craniovertebral angle, pain threshold, pain intensity, temporomandibular joint ROM, and temporomandibular joint function were assessed for all participants before and after the intervention. The outcomes were analyzed using Two-way mixed MANOVA. For further multiple comparisons, post-hoc tests with the Bonferroni correction were performed. There was no significant difference between both groups pre-treatment (p> 0.05). Comparison between groups post-treatment revealed statistically significant differences in all outcome measures (p< 0.05) in favor of the PNF group. Adding PNF stretching exercises of masticatory muscles to routine physical therapy programs is an effective method for management of TMD in patients with FHP more than routine physical therapy programs alone.

Iloprost and Organ Dysfunction in Adults With Septic Shock and Endotheliopathy

Soluble thrombomodulin is a marker of endotheliopathy, and iloprost may improve endothelial function. In patients with septic shock, high plasma levels of soluble thrombomodulin (>10 ng/mL) have been associated with worse organ dysfunction and mortality. To assess the effects of treatment with iloprost vs placebo on the severity of organ failure in patients with septic shock and plasma levels of soluble thrombomodulin higher than 10 ng/mL. This investigator-initiated, adaptive, parallel group, stratified, double-blind randomized clinical trial was conducted between November 1, 2019, and July 5, 2022, at 6 hospitals in Denmark. The trial had a maximum sample size of 380, with an interim analysis for futility only at 200 patients with 90 days of follow-up. In total, 279 adults in the intensive care unit (ICU) with septic shock and endotheliopathy were included. Patients were randomized 1:1 to masked intravenous infusion of iloprost, 1 ng/kg/min (n = 142), or placebo (n = 137) for 72 hours. The primary outcome was mean daily Sequential Organ Failure Assessment (SOFA) score in the ICU adjusted for trial site and baseline SOFA score for the per-protocol population. SOFA scores for each of the 5 organ systems ranged from 0 to 4, with higher scores indicating more severe dysfunction (maximum score, 20). The secondary outcomes included serious adverse reactions and serious adverse events at 7 days and mortality at 90 days. Of 279 randomized patients, data from 278 were analyzed (median [IQR] age, 69 [58-77] years; 171 (62%) male), 142 in the iloprost group and 136 in the placebo group. The trial was stopped for futility at the planned interim analysis. The mean [IQR] daily SOFA score was 10.6 (6.4-14.8) in the iloprost group and 10.5 (5.9-15.5) in the placebo group (adjusted mean difference, 0.2 [95% CI, -0.8 to 1.2]; P = .70). Mortality at 90 days in the iloprost group was 57% (81 of 142) vs 51% (70 of 136) in the placebo group (adjusted relative risk, 1.12 [95% CI, 0.91-1.40]; P = .33). Serious adverse events occurred in 26 of 142 patients (18%) for the iloprost group vs 20 of 136 patients (15%) for the placebo group (adjusted relative risk, 1.25 [95% CI, 0.73-2.15]; P = .52). Only 1 serious adverse reaction was observed. In this randomized clinical trial of adults in the ICU with septic shock and severe endotheliopathy, infusion of iloprost, 1 ng/kg/min, for 72 hours did not reduce mean daily SOFA scores compared with placebo. In a clinical context, administration of iloprost will be unlikely to improve outcome in these patients. ClinicalTrials.gov Identifier: NCT04123444.

"The protective effect of nano curcumin supplementation on doxorubicin induced cardiotoxicity in breast cancer patients; a randomized, double-blind clinical trial".

Anthracycline drugs play a fundamental role in breast cancer treatment; however, the cardiotoxicity side effects obscure the advantages of treatment. Curcumin has antioxidant and anti-inflammatory effects. In this study, we investigated the effect of nanocurcumin supplementation on Doxorubicin induced Cardiotoxicity. In this randomized clinical trial, a week before starting the doxorubicin regimen for breast cancer patients, the control group received placebo and curcumin group received 80 mg daily dosage of nano curcumin capsules for six months. Echocardiography parameter changes before chemotherapy and after six months were evaluated. 46 patients were included. Left ventricle (LV) ejection fraction significantly decreased and LV end diastolic volume significantly increased in control group but no significant changes were observed in the curcumin group (LVEF: 2.62 ± 59.35 to 4.23 ± 56.85, p-value: 0.014 vs 59.55 ± 1.91 to 58.46 ± 3.41, p-value:0.135; LVEDV: 77.09 ± 15.33 to 80.65 ± 14.54, p-value:0.023 vs 72.41 ± 15.34 74.00 ± 14.25, p-value: 0.294). Additionally, LVEF, LV end systolic diameter (LVESD), and end diastolic diameter (LVEDD) insignificantly more decreased in control group versus curcumin group (LVEF: 4.13 ± 2.50- vs 3.36 ± 1.08-, p-value: 0.223; LVESD: 0.27 ± 0.06-vs 0.120.45 ±, p-value:0.110; LVEDD: -0.44 ± 0.33 vs 0.070.33 ±, p-value:0.269). Furthermore, symptomatic cardiomyopathy and ejection fraction ratio less than 53% were not observed. The LVEF reduction >15% was observed was also high in the control group, (p-value = 0.020). This study shows the possible effect of nanocurcumin capsules to reduce the cardiotoxicity of anthracycline chemotherapy medications.

Comparative efficacy of probing with or without intubation, and/or inferior turbinate fracture in simple congenital nasolacrimal duct obstruction: a randomized clinical trial

To compare the success rates of probing with or without monocanalicular intubation, and/or inferior turbinate fracture in resolving simple congenital nasolacrimal duct obstruction (CNLDO). A randomized, double-blind clinical trial was conducted on children aged 12–36 months exhibiting symptoms of epiphora and/or mucous discharge along with a positive fluorescein dye disappearance test (DDT). Patients were randomly assigned to one of the following interventions: (1) probing; (2) probing and monocanalicular intubation; (3) probing and inferior turbinate fracture; (4) probing, inferior turbinate fracture, and monocanalicular intubation. Participants were categorized into two age groups (12–24 months and 24–36 months) and assessed for resolution of CNLDO three months post-surgery. Success was defined as the absence of epiphora or mucopurulent discharge and a negative DDT. Among the 201 participants, 51 underwent probing alone, 53 underwent probing with intubation, 47 underwent probing with turbinate fracture, and 50 underwent probing with turbinate fracture and intubation. No significant differences were observed in age, gender, or laterality of the disease between the groups (Ps > 0.05). While there was no significant difference in success rates among interventions in both age groups (Ps > 0.05), patients aged 24–36 months who underwent interventions involving intubation exhibited a significantly higher success rate compared to those without intubation (93.0% vs. 76.2%; P = 0.018). However, this difference was not observed in patients aged 12–24 months (95.7% vs. 92.9%; P = 0.551). Incorporating interventions such as intubation and/or turbinate fracture alongside conventional probing does not significantly alter the success rate of simple CNLDO resolution in children aged 12–24 months. However, older patients (24–36 months) may derive greater benefits from interventions involving intubation.

Pulmonary Vein Isolation vs Sham Intervention in Symptomatic Atrial Fibrillation

There are concerns that pulmonary vein isolation for atrial fibrillation may have a profound placebo effect, but no double-blind randomized clinical trials have been conducted. To determine whether pulmonary vein isolation is more effective than a sham procedure for improving outcomes in atrial fibrillation. Double-blind randomized clinical trial conducted at 2 tertiary centers in the UK between January 2020 and March 2024 among patients with symptomatic paroxysmal or persistent atrial fibrillation. Major exclusion criteria included long-standing persistent atrial fibrillation, prior left atrium ablation, other arrhythmias requiring ablative therapy, a left atrium of 5.5 cm or larger, and ejection fraction of less than 35%. Participants were randomly assigned to receive pulmonary vein isolation with cryoablation (n = 64) or a sham procedure with phrenic nerve pacing (n = 62). The primary end point was atrial fibrillation burden at 6 months, excluding a 3-month blanking period. Secondary outcomes included quality-of-life measures, time to events, and safety. Atrial fibrillation burden was measured by an implantable loop recorder. A total of 126 participants were randomized (mean age, 66.8 years; 89 men [70.63%]; 20.63% with paroxysmal atrial fibrillation). The absolute mean atrial fibrillation burden change from baseline to 6 months was 60.31% in the ablation group and 35.0% in the sham group (geometric mean difference, 0.25; 95% CI, 0.15-0.42; P < .001). The estimated difference in the overall Atrial Fibrillation Effect on Quality of Life score at 6 months, favoring catheter ablation, was 18.39 points (95% CI, 11.48-25.30 points). The Short Form 36 general health score also improved substantially more with ablation, with an estimated difference of 9.27 points at 6 months (95% CI, 3.78-14.76 points). Pulmonary vein isolation resulted in a statistically significant and clinically important decrease in atrial fibrillation burden at 6 months, with substantial improvements in symptoms and quality of life, compared with a sham procedure. ClinicalTrials.gov Identifier: NCT04272762.

The effect of fiber supplementation with agave fructans or psyllium plantago in symptoms of constipation and its relation with whole and regional transit time and pH.

Supplementation with the Agave tequilana Weber blue variety fructans is a feasible treatment option for functional constipation (FC). However, its effects on colonic function have not yet been studied. This study assessed whole gut transit time (WGTT) and regional transit time using a wireless motility capsule (WMC) before and after supplementation with different fiber treatments in patients with FC. A secondary analysis was performed on data collected from a randomized, double-blind clinical trial comparing agave fructans with psyllium plantago. WGTT, regional transit time, contractility, and pH were measured using WMC before and after fiber supplementation. Comparisons were performed using nonparametric tests. Twenty patients with FC were evaluated, with a median age of 39 (25-54 years), and 18 (90%) were women. Five patients were included in each intervention group. There were no changes in WGTT or regional transit times between the groups (p > 0.05). Similarly, there were no differences in the changes experienced by regional or general contractility among the groups (p > 0.05). The cecal pH profile did not differ between the groups before and after fiber supplementation (p > 0.05). The percentages of clinical responses and consistency of bowel movements between the groups were similar. FC presents a clinical response to a fiber challenge, regardless of the administered intervention. However, this response was not associated with improvement in contractility or regional transit time. We speculate that there are other mechanisms by which fiber consumption may improve FC.

Potential therapeutic effects of topical recombinant human erythropoietin on burn wound healing: A preliminary randomized double-blind controlled clinical trial

BackgroundBurn injuries can cause significant mortality and morbidity. This study aimed to evaluate the efficiency of topical recombinant human erythropoietin (rhEPO) on enhancing burn wound healing. MethodsIn this randomized double-blind controlled clinical trial, we enrolled 40 participants aged 18 years and older who were referred to a burn center during the first 24 h of burning. The participants with no concurrent comorbidities had superficial and deep second-degree burns, no respiratory burns, no face and perineum burns, no keloid formation, or a healed, fully epithelialized, hypertrophic burn scar. Topical rhEPO or nitrofurazone/Vitamin A was administered every other day, and the patients were scheduled for follow-up visits to receive wound cleansing, debridement, and dressing changes. Burn wound healing response to treatment was measured as the study main outcome. ResultsAt the second follow-up visit, all parameters were significantly lower in the rhEPO group compared with the control group except for itchiness. The results of the next two follow-up sessions were also the same. The total value of the modified Vancouver Scar Scale (VSS) at days 5, 7, and 14 was significantly lower in the rhEPO group compared with the routine of care group.Trial Registry Date: 2022–03-02, Trial Registry number: IRCT20190810044500N23 ConclusionsThe results of the present study suggested that topical rhEPO is a potential option in burn wounds and patient satisfaction, without causing intolerable side effects.

Comparing the sedative and analgesic effects of ketorolac and diclofenac eye drops among patients with cataract surgery: A double-blind randomized clinical trial

Abstract: AIM: The aim of this study was to compare the sedative and analgesic effects of ketorolac and diclofenac eye drops among patients with cataract surgery (CS) who received tetracaine. METHODS: This double-blind randomized clinical trial was conducted in 2022. Participants were the candidates for CS consecutively selected from Amirkabir hospital, Arak, Iran, and were assigned to an artificial tear group, a ketorolac group, and a diclofenac group through block randomization. Pain, sedation status, heart rate, blood pressure, and arterial oxygen saturation were assessed during and after surgery. Complications prevalence and intraoperative propofol use were also documented. Data were analyzed using the SPSS software (v. 20.0) at a significance level of &lt;0.05. RESULTS: There were no significant differences among the study groups respecting participants’ age, gender, body mass index, blood pressure, heart rate, arterial oxygen saturation, CS duration, and Aldrete score (P &gt; 0.05). From 5 min after CS onward, the mean score of pain in the ketorolac group was significantly less than the other groups (P &lt; 0.05). The mean score of sedation from recovery to 1 h after surgery in the artificial tear group was significantly more than the other groups, whereas the mean score of sedation 2 and 4 h after CS in the ketorolac group was significantly more than the other groups (P &lt; 0.05). Propofol use in the artificial tear group was significantly more than in other groups (P = 0.001) and patient and surgeon satisfaction in this group was significantly less than in other groups (P &lt; 0.05). The ketorolac and the diclofenac groups did not significantly differ from each other respecting surgeon and patient satisfaction and the prevalence of complications (P &gt; 0.05). CONCLUSION: Ketorolac eye drops are more effective than diclofenac eye drops in significantly reducing intraoperative pain among the candidates for CS with topical anesthesia. Therefore, ketorolac eye drops can be used with tetracaine eye drops in CS with topical anesthesia to produce greater perioperative analgesia and sedation.