Double-blind Randomized Clinical Trial Research Articles

The Effect of Rivaroxaban in the Complementary Therapy of Sudden Sensorineural Hearing Loss

Abstract Background: Due to the importance of sudden sensorineural hearing loss (SSNHL) and the possible role of blood coagulation in its mechanism and the likely therapeutic effect of anticoagulants and also the lack of studies in this field, this study aimed to evaluate the effect of rivaroxaban (RXA) in the treatment of this disease. Materials and Methods: The present double-blind randomized clinical trial study was performed on 34 patients with SSNHL. Patients were randomly divided into two groups. In the first group, in addition to corticosteroid therapy (CST), RXA 10 mg tablets were used daily for 10 days (RXA group), and in the second group, only CST (CST group) treatment was prescribed. Hearing recovery was then assessed and recorded according to the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) criteria. Results: This study showed that the grade of hearing recovery in the RXA group (58.8%) was higher than the CST group (47.1%), but this difference was not significant (P value >0.05). Also, RXA treatment increased the odds of hearing recovery, and this difference was not statistically significant (odd ratio (95% confidence interval)(OR (95% CI): 2.327 (0.180–18.082); P value = 0.518). In contrast, delay to treatment, more increased PTA (pure tone average (PTA)), and having vertigo reduced the odds of hearing recovery by 0.138-, 0.019-, and 0.069-fold, respectively (P value <0.05). Conclusion: According to the results of this study, although the percentage of hearing recovery was higher in the RXA group, in general, the results of the two treatments were not significantly different.

Comparison of adding magnesium sulfate, dexmedetomidine and ondansetron to lidocaine for gargling before laryngoscopy and endotracheal intubation to prevent sore throat: a randomized clinical trial.

Postoperative sore throat is one well-recognized complication, occurring most frequently following tracheal intubation. Effective prevention of postoperative sore throat has been recognized as a top priority, bringing pleasant feelings and satisfaction to patients. This study aimed to assess the efficacy of magnesium sulfate, dexmedetomidine and ondansetron gargle with lidocaine administrated prior to laryngoscopy and tracheal intubation for postoperative sore throat prevention alongside hemodynamic management. This double-blind randomized clinical trial enrolled 105 general anesthesia-administered patients who had undergone laryngoscopy and endotracheal intubation, and they were equally randomized into three groups: magnesium sulfate, dexmedetomidine, and ondansetron groups. No significant intergroup difference was seen in oxygen saturation, non-invasive blood pressure, heart rate, duration of surgery, postoperative complications, analgesic consumption, and incidence of cough and hoarseness. The results showed statistically significant intergroup differences in pain scores and average pain intensity in the dexmedetomidine group was significantly lower than the other groups. Results suggest that dexmedetomidine gargle with lidocaine before general anesthesia induction could be recommended as an option depending on the patient's general condition and the anesthesiologist's discretion.

Evaluation of Antimicrobial Efficacy of 3.8% Silver Diamine Fluoride as a Root Canal Irrigant against Enterococcus Faecalis in Primary Teeth: A Randomised Clinical Trial

Introduction: During a pulpectomy, the infected or inflamed pulp tissues are removed, and the root canal is thoroughly cleaned with mechanical instrumentation and copious irrigation. Various endodontic irrigants are available, such as Sodium Hypochlorite (NaOCl), Chlorhexidine (CHX) gluconate, Ethylene Diamine Tetra Acetic Acid (EDTA), Mixture of doxycycline, citric acid, and a detergent (MTAD), etc. Among these, CHX gluconate is widely used as an endodontic irrigant and medicament due to its antibacterial effect and substantivity. Enterococcus faecalis is the most common bacterial species found in necrotic teeth, with high viability and antibiotic resistance. A 3.8% Silver Diamine Fluoride (SDF) has antimicrobial properties and has been shown to eliminate E. faecalis from the root canals of permanent teeth. However, there are no studies in the literature that have evaluated its efficacy as a root canal irrigant in primary teeth. Aim: To evaluate the antimicrobial efficacy of 3.8% SDF against E. faecalis in primary teeth. Materials and Methods: This was a in-vivo double-blinded randomised clinical trial conducted at Department of Paediatric and Preventive Dentistry, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India in children aged 3-8 years old. The study included 60 primary teeth that required pulpectomy. The teeth were divided into two groups and irrigated: 30 teeth with 3.8% SDF (Group I) and 30 teeth with 2% CHX (Group II). In all cases, two microbiological samples were taken using sterile absorbent paper points: the first after access opening and the second after the final irrigation. All samples were assessed using the agar plate method. The results were analysed statistically using a Student's paired t-test. Results: After analysing the pre- and postirrigation samples, there was a statistically significant reduction in Colony Forming Units (CFU)mL (p<0.05) in both groups. When comparing the two groups, no statistical difference was observed in the percentage reduction of bacterial colonies (p>0.05). Conclusion: The reduction in CFU/mL of E. faecalis was comparable in both groups. Thus, 3.8% SDF can be used as an alternative root canal irrigant to 2% CHX.

Prolonged polymerization of a universal adhesive in non-carious cervical lesions: 36-month double-blind randomized clinical trial

ObjectiveTo evaluate the effect of prolonged (P) polymerization time of a universal adhesive system applied in etch-and-rinse (ER) or self-etch (SE) strategies on the clinical performance of restorations in non-carious cervical lesions (NCCLs), after 36 months of clinical service. MethodsA total of 140 restorations were randomly placed in 35 subjects according to the polymerization time groups: ER (10 s); ER-P (40 s); SE (10 s); and SE-P (40 s) at 1,200 mW/cm2. Composite resin was placed incrementally. The restorations were evaluated immediately and after 6, 12, 18, and 36 months using the FDI criteria. Data were analyzed using the Kaplan-Meier survival test for retention loss, and the Kruskal-Wallis’ test for secondary outcomes (α = 0.05). ResultsAfter 36 months, 19 restorations were lost: ER 6, ER-P 2, SE 9, SE-P 2. The retention rates were 82.3% for ER; 94.1 % for ER-P; 73.5 % for SE; and 94.1 % for SE-P, with a significant difference between ER vs. ER-P and SE vs. SE-P, as well as ER vs. SE-P and ER-P vs. SE (p < 0.0001). Minor defects were observed in 18 restorations for the marginal staining criteria: ER 5, ER-P 2, SE 8, SE-P 3; and in 33 restorations for the marginal adaptation criteria: ER 11, ER-P 4, SE 12, and SE-P 6 (p > 0.05). No restorations showed recurrence of caries or postoperative sensitivity. ConclusionsA prolonged polymerization time of 40 s improves the clinical performance of the universal adhesive for both adhesive strategies evaluated, even after 36 months. Clinical significanceProlonging the polymerization time of a universal adhesive from 10 to 40 s has been shown to improve its clinical performance when used in NCCLs.

Comparative Evaluation of the Local Anesthetic Action of Tramadol Hydrochloride With Adrenaline Versus Lidocaine Hydrochloride With Adrenaline for Maxillary Exodontia: A Randomized Control Trial

Tramadol hydrochloride (T-HCl) has demonstrated to have a local anesthetic effect similar to lidocaine hydrochloride (L-HCl) when administered locally for minor oral surgical procedures. Our study aimed to compare the anesthetic effect of T-HCl versus L-HCl in maxillary premolar extraction. The study is a split-mouth, double-blind randomized clinical trial at the Faculty of Dental Sciences, Ramaiah University of Applied Sciences, Bengaluru, India. The study sample was composed of patients referred for maxillary bicuspid extraction. Patients were excluded from the sample if, allergic to the study drugs, pregnant or lactating females, and smokers. The variable is an anesthetic drug administered for local anesthesia and it is grouped into 2 categories, T-HCl and L-HCl. A supraperiosteal infiltration of T-HCl with adrenaline on one side and L-HCl with adrenaline on the contralateral side was injected. The primary outcome variable was profound anesthesia of T-HCl, where the patient sensed the loss of sensation of touch, temperature, and pain. Secondary outcomes were onset and duration of anesthesia, intraoperative pain, postoperative analgesia, and adverse reactions, were recorded. Inferential statistics, the χ2 Test, the Mann-Whitney Test, and the Wilcoxon signed-rank test were used to compare the parameters. The level of significance was set at ≤ 0.05. A total of 40 patients were included, and 80 teeth were extracted. Profound anesthesia was achieved in all the cases. The mean subjective duration of anesthesia in the T-HCl and L-HCl groups was 130.80±20.01minutes and 111.40±14.87minutes, respectively, with a P value of .001. The mean Visual Analogue Scale (VAS) score for pain during the procedure in the T-HCl and L-HCl groups was 0.60±0.67 and 1.10±0.71, respectively, with a P value of .002. The mean Visual Analogue Scale score for pain postoperatively in the T-HCl and L-HCl groups was 0.70±0.72 and 1.40±0.67, respectively, with a P value of .001. Six patients in T-HCl required postoperative analgesia when compared to 18 patients in L-HCl (Pvalue < .003). T-HCl provides similar anesthetic outcomes in the extraction of maxillary bicuspids as L-HCl.

Effect of lactobacillus reuteri-derived probiotic nano-formulation on recurrent aphthous stomatitis: a double-blinded randomized clinical trial

ObjectivesWe aimed to assess the therapeutic effects of a topical probiotic nano-formulation derived from Lactobacillus reuteri on treating recurrent aphthous stomatitis.Materials and methods60 participants were randomly allocated into two groups (control and probiotic). Probiotic group administered topical probiotic nano-formulation three times a day for seven days. The control group administered a standard analgesic oral rinse. The size of ulcer(s) and pain severity were recorded on days 0, 3, 5, and 7 after intervention.ResultsBefore the intervention, the groups had no significant differences in terms of pain severity (P-value = 0.28) and lesion size (P-value = 0.24). Both groups exhibited significant reductions in pain severity and lesion size over the course of the intervention. After one week, the probiotic group had a notably larger lesion size reduction than the control group (P-value = 0.01). The probiotic group also showed a significantly greater reduction in pain severity than the control group (P-value = 0.04).ConclusionsApplying topical probiotic nano-formulation derived from Lactobacillus reuteri three times a day decreased lesion size and pain severity in RAS patients faster than the local analgesic oral rinse.Clinical relevanceLactobacillus reuteri-derived probiotic nano-formulation might be a promising treatment option for RAS.

Effect of Medicago sativa seed powder (Plus vitamin E vs. vitamin E alone) on semen analysis in men with idiopathic infertility: A double blind randomized clinical trial

Ethnopharmacological relevanceDifferent parts of the alfalfa plant (Medicago sativa L.), especially its seeds, have been introduced as a semen quality enhancer in the folk medicine of different regions of Iran as well as in the traditional Persian medicine (PM) books. The seeds of this plant are also used in many combined medicines to treat male infertility in PM. Aim of the studyThis study was designed to investigate the effect of M. sativa seed powder plus vitamin E vs. vitamin E alone on semen analysis of men with idiopathic infertility. Materials and methodsIn this randomized clinical trial, 60 participants were randomly divided into two groups and then received M. sativa seed powder (6 g daily) or placebo for three months, as add-on to vitamin E (100 U). Results of semen analysis (sperm total count, motility, and morphology as well as semen volume) of these two groups and their changes were compared before and after treatment as the primary outcome. The number of pregnancies after one month and probable side effects were also assessed. ResultsAfter 12 weeks, sperm total count changed from 36.2 ± 21.8 × 106/ml to 48.5 ± 19.1 × 106/ml in M. sativa and from 39.5 ± 23.5 × 106/ml to 41.2 ± 20.9 × 106/ml in placebo, percentage of normal morphology changed from 1.8 ± 0.8% to 2.6 ± 1.2 % in M. sativa and from 2.0 ± 0.9% to 2.6 ± 1.2% in placebo and percentage of motile sperm changed from 36.5 ± 11.8 % to 39.7 ± 12.0% in M. sativa and from 39.3 ± 10.1 % to 38.1 ± 12.1% in placebo. The improvements in M. sativa group are significantly better than placebo group (P = 0.00, 0.01 and 0.04, respectively). However, semen volume decreased in both groups, but its changes were not significant. The number of pregnancies was four in the intervention and zero in placebo group. One case with abdominal bloating and one with respiratory allergy withdrew from the intervention group. No other adverse effect was reported. ConclusionsIn this study, significant improvement was detected in sperm parameters (except semen volume) of men with idiopathic infertility in M. sativa plus vitamin E group in compare to vitamin E alone after 12 weeks. These findings suggest that the M. sativa, as a complementary therapy, may have a beneficial effect on semen quality. More clinical trials with larger sample size are needed.

High-density transcranial direct current stimulation to improve upper limb motor function following stroke: study protocol for a double-blind randomized clinical trial targeting prefrontal and/or cerebellar cognitive contributions to voluntary motion

BackgroundFocal brain lesions following a stroke of the middle cerebral artery induce large-scale network disarray with a potential to impact multiple cognitive and behavioral domains. Over the last 20 years, non-invasive brain neuromodulation via electrical (tCS) stimulation has shown promise to modulate motor deficits and contribute to recovery. However, weak, inconsistent, or at times heterogeneous outcomes using these techniques have also highlighted the need for novel strategies and the assessment of their efficacy in ad hoc controlled clinical trials.MethodsWe here present a double-blind, sham-controlled, single-center, randomized pilot clinical trial involving participants having suffered a unilateral middle cerebral artery (MCA) stroke resulting in motor paralysis of the contralateral upper limb. Patients will undergo a 10-day regime (5 days a week for 2 consecutive weeks) of a newly designed high-definition transcranial direct current stimulation (HD-tDCS) protocol. Clinical evaluations (e.g., Fugl Meyer, NIHSS), computer-based cognitive assessments (visuo-motor adaptation and AX-CPT attention tasks), and electroencephalography (resting-state and task-evoked EEG) will be carried out at 3 time points: (I) Baseline, (II) Post-tDCS, and (III) Follow-up. The study consists of a four-arm trial comparing the impact on motor recovery of three active anodal tDCS conditions: ipsilesional DLPFC tDCS, contralesional cerebellar tDCS or combined DLPFC + contralesional cerebellar tDCS, and a sham tDCS intervention. The Fugl-Meyer Assessment for the upper extremity (FMA-UE) is selected as the primary outcome measure to quantify motor recovery. In every stimulation session, participants will receive 20 min of high-density tDCS stimulation (HD-tDCS) (up to 0.63 mA/cm2\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\\mathrm{cm}}^{2}$$\\end{document}) with πcm2\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$${\\mathrm{\\pi cm}}^{2}$$\\end{document} electrodes. Electrode scalp positioning relative to the cortical surface (anodes and cathodes) and intensities are based on a biophysical optimization model of current distribution ensuring a 0.25 V/m impact at each of the chosen targets.DiscussionOur trial will gauge the therapeutic potential of accumulative sessions of HD-tDCS to improve upper limb motor and cognitive dysfunctions presented by middle cerebral artery stroke patients. In parallel, we aim at characterizing changes in electroencephalographic (EEG) activity as biomarkers of clinical effects and at identifying potential interactions between tDCS impact and motor performance outcomes. Our work will enrich our mechanistic understanding on prefrontal and cerebellar contributions to motor function and its rehabilitation following brain damage.Trial registrationClinicalTrials.gov NCT05329818. April 15, 2022.

Photobiomodulation Therapy to Treat Snakebites Caused by Bothrops atrox

Bothrops venom acts almost immediately at the bite site and causes tissue damage. To investigate the feasibility and explore the safety and efficacy of low-level laser therapy (LLLT) in reducing the local manifestations of B atrox envenomations. This was a double-blind randomized clinical trial conducted at Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, in Manaus, Brazil. A total of 60 adult participants were included from November 2020 to March 2022, with 30 in each group. Baseline characteristics on admission were similarly distributed between groups. Data analysis was performed from August to December 2022. The intervention group received LLLT combined with regular antivenom treatment. The laser used was a gallium arsenide laser with 4 infrared laser emitters and 4 red laser emitters, 4 J/cm2 for 40 seconds at each application point. Feasibility was assessed by eligibility, recruitment, and retention rates; protocol fidelity; and patients' acceptability. The primary efficacy outcome of this study was myolysis estimated by the value of creatine kinase (U/L) on the third day of follow-up. Secondary efficacy outcomes were (1) pain intensity, (2) circumference measurement ratio, (3) extent of edema, (4) difference between the bite site temperature and that of the contralateral limb, (5) need for the use of analgesics, (6) frequency of secondary infections, and (7) necrosis. These outcomes were measured 48 hours after admission. Disability assessment was carried out from 4 to 6 months after patients' discharge. P values for outcomes were adjusted with Bonferroni correction. A total of 60 patients (mean [SD] age, 43.2 [15.3] years; 8 female individuals [13%] and 52 male individuals [87%]) were included. The study was feasible, and patient retention and acceptability were high. Creatine kinase was significantly lower in the LLLT group (mean [SD], 163.7 [160.0] U/L) 48 hours after admission in relation to the comparator (412.4 [441.3] U/L) (P = .03). Mean (SD) pain intensity (2.9 [2.7] vs 5.0 [2.4]; P = .004), circumference measurement ratio (6.6% [6.6%] vs 17.1% [11.6%]; P < .001), and edema extent (25.8 [15.0] vs 40.1 [22.7] cm; P = .002) were significantly lower in the LLLT group in relation to the comparator. No difference was observed between the groups regarding the mean difference between the bite site temperature and the contralateral limb. Secondary infections, necrosis, disability outcomes, and the frequency of need for analgesics were similar in both groups. No adverse event was observed. The data from this randomized clinical trial suggest that the use of LLLT was feasible and safe in a hospital setting and effective in reducing muscle damage and the local inflammatory process caused by B atrox envenomations. Brazilian Registry of Clinical Trials Identifier: RBR-4qw4vf.

Postoperative effects of bilateral sphenopalatine ganglion blockade in septorhinoplasty operations; double-blind randomized clinical trial

ObjectiveWe aimed to investigate the effect of bilateral sphenopalatine ganglion blockade (SPGB) on the main postoperative complications in septorhinoplasty operations. MethodsIn this randomized, controlled, prospective study, 80 cases planned for Septorhinoplasty operations under general anesthesia were included in the study. The cases were divided into two groups; SPGB was performed with 2 mL of 0.25% bupivacaine bilaterally 15 min before the end of the operation in the SPGB group (Group S, n = 40). In the control group (Group C, n = 40), 2 mL of 0.9% NaCl solution was applied into both SPG areas. In the recovery unit after the operation; the pain and analgesic needs of the patients at 0, 2, 6 and 24 h were evaluated. ResultsThere was no statistically significant difference between the groups in terms of hemodynamic parameters (ASA, MBP, HR) (p > 0.05) All VAS values were statistically lower in Group S than in Group C (p < 0.05). In Group S, the need for analgesic medication was found in 5 cases between 0–2 h, whereas in Group C, this rate was found in 17 cases, and it was statistically significant (p < 0.05). ConclusionBilateral SPGB application was determined to provide better analgesia in the early postoperative period compared to the control group, it was concluded that further studies are needed to say that there are significant effects on laryngospasm and nausea-vomiting. Level of evidence2, degree of recommendation B.

Allogeneic mesenchymal stem cell therapy for dry eye disease in patients with Sjögren's syndrome: A randomized clinical trial

PurposeThis double-blinded randomized clinical trial aimed to evaluate the efficacy of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) for the treatment of dry eye disease (DED) secondary to Sjögren's syndrome (SS). MethodsFifty-four participants with severe DED secondary to SS were included and allocated to either ASCs (n = 20), vehicle (n = 20), or a non-randomized observation group (n = 14). The intervention groups received a single injection of either ASCs or an active comparator (vehicle, Cryostor® CS10) into the LG in one eye, while the observation group received lubricating eye drops only. The primary outcome measure was changes in Ocular Surface Disease Index (OSDI) score and secondary outcome measures were non-invasive tear break-up time, tear meniscus height, Schirmer's test, and Oxford score within a 12-month follow-up. ResultsA significant reduction in OSDI score was observed in the ASCs and vehicle groups compared to the observation group. In addition, the ASCs group demonstrated a significant increase in non-invasive tear break-up time compared to the vehicle group at the 4-week follow-up and to the observation group at the 12-month follow-up. A significant improvement in ocular surface staining, tear osmolarity, and Schirmer test score from baseline was also observed in the ASCs group; however, these changes were not significant compared to the other groups. ConclusionImprovement of subjective and objective signs and symptoms of DED was observed in both intervention groups following injection into the LG compared to the observation group. Future studies should investigate the mode-of-action of both injection treatments.

Comparison of the effect of vaginal misoprostol alone and in combination with evening primrose capsules on the course of labor in pregnant women candidates for termination of pregnancy

Background: Induction of labor at any time before the spontaneous onset of labor is indicated when the benefits of termination of pregnancy for the mother and fetus outweigh the benefits of continued pregnancy. The aim of this study was to compare the effect of vaginal misoprostol alone and in combination with evening primrose capsule on the course of labor in pregnant women candidates for termination of pregnancy. Methods: In this double-blind randomized clinical trial, 30 pregnant women were candidates for termination of pregnancy. At the time of referral, the examination was performed to calculate the bishop score (primary outcome) and the partograph was recorded and plotted once every hour until the end of labor. Length of active phase of labor (from dilatation 3-6 cm to birth), type of labor, Apgar score of the first and fifth minute of the baby and volume of postpartum hemorrhage and pain intensity every 30 minutes was recorded in two groups for up to 2 hours using a ruler. Results: The mean length of the latent labor phase in the misoprostol and evening primrose groups was 9.07±0.96 and in the misoprostol group was 10.13±0.83 hours and this difference was significant. There was no significant difference in bishop score between the two groups at the beginning of the study but after the intervention was significant. Conclusions: Our study showed that using evening primrose oil capsule instead of misoprostol is effective in induction of labor.

Comparing the effects of injecting bupivacaine, tramadol, and bupivacaine-tramadol combination at the surgical incision site on pain intensity and postoperative complications in patients undergoing elective cesarean section: A randomized controlled trial

Backgroundcesarean sections (C-sections) are the most popular surgical procedure for women of reproductive age. In the majority of procedures, effective postoperative pain management is crucial for postoperative care in order to lower morbidity and mortality while also making patients feel comfortable. The current study aims to compare the effects of injecting bupivacaine, tramadol, and bupivacaine-tramadol combination at the surgical incision site in patients undergoing elective cesarean section. MethodThe current study is a double-blind randomized clinical trial that included patients September of pregnant women referred to Obstetrics and Gynecology Clinic between 2021 June and 2022 September. ResultsThis study included 180 patients (60 in each group). The average age of the patients was 31.33 years, and the difference in vas 6, vas 12, and vas 24 scores between groups was significant (P > 0.001). The group that used drugs in combination experienced significantly less pain and there was no significant difference in analgesic drug consumption. Discussion and conclusionresults of the current study revealed there was a significant difference in vas 6, vas 12, and vas 24 scores between the groups, with the group of bupivacaine-tramadol combination providing a greater analgesic effect. However, there is no statistically significant difference in the frequency of post-operative side effects.

The value of "diaphragmatic relaxing incision" for the durability of the crural repair in patients with paraesophageal hernia: a double blind randomized clinical trial.

Surgical repair of paraesophageal hernias (PEHs) is burdened with high recurrence rates, and hitherto various techniques explored to enforce the traditional crural repair have not been successful. The hiatal reconstruction in PEH is exposed to significant tension, which may be minimized by adding a diaphragmatic relaxing incision to enhance the durability of the crural repair. All individuals undergoing elective laparoscopic repair of a large PEH, irrespective of age, were considered eligible. PEHs were classified into types II-IV. The preoperative work-up program included multidetector computed tomography and symptom assessment questionnaires, which will be repeated during the postoperative follow-up. Patients were randomly divided into a control group with crural repair alone and an intervention group with the addition of a left-sided diaphragmatic relaxing incision at the edge of the upper pole of the spleen. The diaphragmatic defect was then covered by a synthetic mesh. The primary endpoint of this trial was the rate of anatomical PEH recurrence at 1 year. Secondary endpoints included symptomatic gastroesophageal reflux disease, dysphagia, odynophagia, gas bloat, regurgitation, chest pain, abdominal pain, nausea, vomiting, postprandial pain, cardiovascular and pulmonary symptoms, and patient satisfaction in the immediate postoperative course (3 months) and at 1 year. Postoperative complications, morbidity, and disease burden were recorded for each patient. This was a double-blind study, meaning that the operation report was filed in a locked archive to keep the patient, staff, and clinical assessors blinded to the study group allocation. Blinding must not be broken during the follow-up unless required by any emergencies in the clinical management of the patient. Likewise, the patients must not be informed about the details of the operation. ClinicalTrials.gov, identification number NCT04179578.

Photobiomodulation, Transmucosal Laser Irradiation of Blood, or B complex as alternatives to treat Covid-19 Related Long-Term Taste Impairment: double-blind randomized clinical trial.

COVID-19 Related Long-Term Taste Impairment (CRLTTI) is a condition that can be expressed after COVID-19 contagion, lasting for months or even years, affecting the routine and quality of life of individuals. Participants expressing CRLTTI, with a minimum of 2months, attested by PCR-RT test were assessed for taste and smell, and underwent experimental treatments in 6 distinct groups: Photobiomodulation (PBM) in tongue dorsum and lateral (660nm, 808nm, association of 660 and 808nm), Transmucosal Laser Irradiation of Blood (TLIB)-ventral surface of tongue (660nm), B complex supplementation, and Sham laser. No intergroup statistical differences were observed at the final evaluation, despite the tendencies of better results with PBM and TLIB observed. PBM, TLIB, and B complex might be treatment options in the management of CRLTTI, despite the lack of total remission of taste and smell perception after 8 sessions (PBM and TLIB) or 30days of B complex supplementation.

Evaluation of the separate and combined effects of anodal tDCS over the M1 and F3 regions on pain relief in patients with type-2 diabetes suffering from neuropathic pain

BackgroundNeuropathic pain (NP) is a common complication of chronic diabetes that negatively affects the routine functioning and sleep of patients. The present study aimed to investigate the separate and combined effects of anodal transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) and left dorsolateral prefrontal cortex (F3) regions on pain relief in patients with type-2 diabetes suffering from NP. MethodsThe statistical population of this double-blind randomized clinical trial consisted of all the members of the Bonab Diabetes Association in 2022 aged 45 to 65 years who were diagnosed with NP by a specialist. A total of 48 patients who met the inclusion criteria were selected as the sample through purposive sampling. The participants were then randomly assigned into 4 groups, each attending 12 sessions of a special intervention (three times a week). The Short Form-McGill Pain Questionnaire-2 (SF-MPQ-2) was used for data collection. Data were statistically analyzed using SPANOVA, analysis of covariance, and the Bonferroni test. ResultsThe results showed that tDCS had the potential to induce pain relief in patients with type-2 diabetes suffering from NP (F = 11.48, P < 0.001). The mean perceived pain intensity in the posttest was lower in the M1 stimulation group than in the F3 stimulation group. Nevertheless, there was no significant difference between the two groups in terms of perceived pain intensity in the one-month and two-month follow-up stages. ConclusionsThe tDCS approach (over both M1 and F3) showed promising effects for pain management in patients with type-2 diabetes suffering from NP and may be an effective add-on treatment. However, more trials with larger sample sizes are necessary to define clinically relevant effects.

The effects of atomoxetine and trazodone combination on obstructive sleep apnea and sleep microstructure: A double-blind randomized clinical trial study

Study objectiveswe aimed to compare the effects of atomoxetine and trazodone (A-T) in combination with placebo in patients with obstructive sleep apnea (OSA). MethodsThis randomized, placebo-controlled, double-blind, crossover trial study was conducted in adults with OSA referred to a Sleep Clinic. Participants with eligibility criteria were recruited. Patients were studied on two separate nights with one-week intervals, once treated with trazodone (50 mg) and atomoxetine (80 mg) combination and then with a placebo and the following polysomnography tests. ResultsA total of 18 patients with OSA completed the study protocol, 9(50%) were male, the mean age was 47.5 years (SD = 9.8) and the mean Body mass index of participants was 28.4 kg/m2 (SD = 3.4). Compared with the placebo, the A-T combination resulted in significant differences in AHI (28.3(A-T) vs. 42.7 (placebo), p = 0.025), duration of the REM stage (1.3%TST (A-T) vs. 13.1%TST (placebo), p = 0.001), and the number of REM cycles (0.8 (A-T) vs. 4.7 (placebo), p = 0.001), number of apneas (38.3 (A-T) vs. 79.3 (placebo), p = 0.011), number of obstructive apneas (37.2 (A-T) vs. 75.2 (placebo), p = 0.011), oxygen desaturation index (29.5 (A-T) vs. 42.3 (placebo), p = 0.022) and number of respiratory arousals (43.2 (A-T) vs. 68.5 (placebo), p = 0.048). This decrement effect did not change among those with a low-arousal phenotype of OSA. ConclusionsThe A-T combination significantly improved respiratory events’ indices compared with placebo in patients with OSA. This combination is recommended to be assessed in a large trial. It could be an alternative for those who do not adhere to the standard available treatments for OSA.

Effect of a Social Care Intervention on Health Care Experiences of Caregivers of Hospitalized Children

Health-related social risks (HRSRs), like food and housing insecurity, are stigmatized conditions that, when addressed in clinical settings, could inadvertently compromise health care experiences. To test the noninferiority hypothesis that a low-intensity, high-scale social care intervention does not promote experiences of discrimination or diminish satisfaction with care compared to usual care. This was a double-blind randomized clinical trial conducted from November 2020 to June 2022 with 12-month follow-up analyzing data obtained 1 week after baseline intervention at a 155-bed academic urban children's hospital with 5300 annual admissions. Participants were recruited from their children's hospital rooms during their children's inpatient hospital stays. Inclusion criteria were identifying as the primary caregiver of a child younger than 18 years who was hospitalized in the general, intensive care, or transplant units; living in 1 of 42 target zip codes; and consenting to receive text messages. Caregivers of healthy newborns and caregivers of children expected to be hospitalized for less than 24 hours or greater than 30 days were excluded. A total of 637 eligible parents and caregivers were enrolled. Participants were randomized to usual care or usual care plus CommunityRx, a low-intensity, universally delivered, electronic medical record-integrated social care assistance intervention providing personalized information about local resources alongside education about HRSRs and how to access additional support. Usual care included an admission brochure about hospital-based free food options and nonsystematic provision of resource information. Experiences of discrimination, measured using the Discrimination in Medical Settings Scale (range 7-35; higher scores indicate more frequent discrimination) and satisfaction with hospital discharge 1 week postdischarge using Child HCAHPS (range 0-100; higher scores indicate higher satisfaction). The a priori noninferiority margins (control minus intervention) were -0.9 (discrimination) and 1.6 (satisfaction). Of 637 eligible caregiver participants, most identified as female (n = 600 [94.3%]), Black (n = 505 [79.4%]), and had household income less than $50 000 per year (n = 488 [78.5%]). One-third were experiencing food insecurity (n = 223). Half of participants reported discrimination experiences during the pediatric hospitalization (n = 259). Discrimination experiences among the intervention group were noninferior to those among the control group (mean [SD] score: control, 10.3 [4.7] vs intervention, 10.0 [4.6]; difference, 0.2; 90% CI, -0.5 to 0.9). Mean (SD) satisfaction with discharge was high (control, 84.2 [23.8] vs intervention, 81.9 [24.8]), but evidence was insufficient to support intervention noninferiority for this end point (difference, 2.3; 90% CI, -1.2 to 5.8). Food security status did not moderate the relationship between intervention and either outcome. The findings suggest that a universally delivered social care assistance intervention did not promote caregiver experiences of discrimination during a child's hospitalization but were inconclusive regarding satisfaction. ClinicalTrials.gov Identifier: NCT04171999.

Treatment Outcomes With Licensed and Unlicensed Stimulant Doses for Adults With Attention-Deficit/Hyperactivity Disorder

Stimulants (methylphenidate and amphetamines) are often prescribed at unlicensed doses for adults with attention-deficit/hyperactivity disorder (ADHD). Whether dose escalation beyond US Food and Drug Administration recommendations is associated with positive risk benefits is unclear. To investigate the impact, based on averages, of stimulant doses on treatment outcomes in adults with ADHD and to determine, based on averages, whether unlicensed doses are associated with positive risk benefits compared with licensed doses. Twelve databases, including published (PubMed, Cochrane Library, Embase, Web of Sciences) and unpublished (ClinicalTrials.gov) literature, up to February 22, 2023, without language restrictions. Two researchers independently screened records to identify double-blinded randomized clinical trials of stimulants against placebo in adults (18 years and older) with ADHD. Aggregate data were extracted and synthesized in random-effects dose-response meta-analyses and network meta-analyses. Change in ADHD symptoms and discontinuations due to adverse events. A total of 47 randomized clinical trials (7714 participants; mean age, 35 (SD, 11) years; 4204 male [56%]) were included. For methylphenidate, dose-response curves indicated additional reductions of symptoms with increments in doses, but the gains were progressively smaller and accompanied by continued additional risk of adverse events dropouts. Network meta-analyses showed that unlicensed doses were associated with greater reductions of symptoms compared with licensed doses (standardized mean difference [SMD], -0.23; 95% CI, -0.44 to -0.02; very low certainty of evidence), but the additional gain was small and accompanied by increased risk of adverse event dropouts (odds ratio, 2.02; 95% CI, 1.19-3.43; moderate certainty of evidence). For amphetamines, the dose-response curve approached a plateau and increments in doses did not indicate additional reductions of symptoms, but there were continued increments in the risk of adverse event dropouts. Network meta-analysis did not identify differences between unlicensed and licensed doses for reductions of symptoms (SMD, -0.08; 95% CI, -0.24 to 0.08; very low certainty of evidence). Based on group averages, unlicensed doses of stimulants may not have positive risk benefits compared with licensed doses for adults with ADHD. In general, practitioners should consider unlicensed doses cautiously. Practitioners may trial unlicensed doses if needed and tolerated but should be aware that there may not be large gains in the response to the medication with those further increments in dose. However, the findings are averages and will not generalize to every patient.

Acute effects of a chewable beetroot-based supplement on cognitive performance: a double-blind randomized placebo-controlled crossover clinical trial

BackgroundDietary nitrate (NO3−) has been shown to be useful as an ergogenic aid with potential applications in health and disease (e.g., blood pressure control). However, there is no consensus about the effects of dietary NO3− or beetroot (BR) juice supplementation on cognitive function.ObjectiveThe aim of this study was to evaluate the effects of a single dose of a chewable BR-based supplement on cognitive performance.MethodsA double-blind randomized placebo-controlled two-period crossover clinical trial was carried out based on the extension of the CONSORT guidelines for randomized crossover trials. A total of 44 participants (24 F; 20 M; 32.7 [12.5] years; 66.3 [9.0] kg; 170 [9.2] cm; 22.8 [1.4] kg/m2) were randomly allocated to receive first either four BR-based chewable tablets (BR-CT) containing 3 g of a Beta vulgaris extract (RedNite®) or four tablets of a placebo (maltodextrin). A 4-day washout period was used before crossover. Ninety minutes after ingestion of the treatments, a neuropsychological testing battery was administered in each period. The trial was registered at clinicaltrials.gov NCT05509075.ResultsSignificant improvements with moderate effect size were found on memory consolidation at the short and long term only after BR-CT supplementation via the Rey Auditory Verbal Learning Test immediate (+ 20.69%) and delayed (+ 12.34%) recalls. Likewise, enhancement on both frontal lobe functions (+ 2.57%) and cognitive flexibility (+ 11.16%) were detected after BR-CT. There was no significant change (p < 0.05) on verbal memory of short-term digits, working memory and information processing speed. Mixed results were found on mood and anxiety through the Beck Depression Inventory-II (BDI-II) and the State-Trait Anxiety Inventory (STAI-Y1 and STAI-Y2); however, sequence and period effects were seen on STAI-Y2.ConclusionsThe acute administration of a chewable BR-based supplement improves certain aspects of cognitive function in healthy females and males, particularly memory capacity and frontal skills.