Efficacy of empagliflozin as adjunctive therapy to citalopram in major depressive disorder: a randomized double-blind, placebo-controlled clinical trial.

BACKGROUND: Major depressive disorder is one of the most common psychiatric disorders, which is associated with a high disease burden. Current treatments using antidepressants have limitations, so using medication with neuromodulating and anti-inflammatory properties alongside them could be helpful. In a clinical trial, we studied the effectiveness of empagliflozin, a blood sugar-lowering drug, as an adjunctive therapy to reduce the severity of depression symptoms. METHODS: A number of outpatients with moderate to severe depression (Hamilton Depression Rating Scale (HDRS) > = 17) who were not under related medication or had not taken medication for at least the last two months, had an age range of 18-60 years and had written informed consent to enter the study (N = 90) were randomly divided into two groups receiving placebo or empagliflozin (10 mg daily) combined with citalopram (40 mg daily) based on permuted block randomization method in an 8-week randomized, double-blind, placebo-controlled clinical trial. They were evaluated using the HDRS in weeks 0, 4, and 8. RESULTS: HDRS scores were equal to 28.42(± 3.83), 20.20(± 3.82), and 13.42(± 3.42) in the placebo group during weeks 0,4, and 8, respectively. These scores were 27.36(± 3.77), 13.76(± 1.40), and 7.00(± 1.13), respectively, for the group treated with empagliflozin. Compared to the control group, patients treated with empagliflozin using repeated-measures ANOVA showed greater improvement in reducing the severity of depression symptoms over time (p value = 0.0001). CONCLUSIONS: Considering the promising findings in this clinical trial, further study of empagliflozin as adjunctive therapy in MDD with larger sample sizes and longer follow-ups is recommended.

Utilization of Continuous Positive Airway Pressure (CPAP) by Emergency Medical Services: Updated Systematic Review and Meta-analysis.

BACKGROUND: While new studies are being published on the prehospital continuous positive airway pressure (CPAP) application in patients with respiratory failure with conflicting results, previous meta-analyses are showing the benefits of CPAP in the prehospital transfer of patients with respiratory distress. Before the clinical application of high-level evidence, updated pooled estimates are needed based on the growing literature. This study aimed to compare prehospital CPAP with the usual standard oxygen therapy of respiratory failure patients. MATERIALS AND METHODS: PRISMA guidelines served as the framework for this updated review study. It is an extension of a prior systematic review. We conducted comprehensive searches across several databases, including PubMed, Web of Science, Embase, and Scopus, focusing on randomized trials that juxtaposed pre-hospital CPAP application against standard care. Our primary interest was to assess the in-hospital mortality risks, and we employed random effect models to aggregate risk ratios from the selected studies. RESULTS: Four articles were gathered based on the review of the updated literature (2013 to November 2022) in conjunction with the research incorporated in the preceding meta-analysis with a total number of 747 patients receiving prehospital CPAP with 101 events of in-hospital mortality. In the standard treatment control groups, there were 713 patients and 115 deaths occurred. Pooled mortality risk comparison between the group of prehospital CPAP and standard care patients had no statistically significant difference (P=0.16). There was no heterogenicity. A regression between the year of the studies and the effect size showed increased RR in new studies (P=0.017). CONCLUSION: Still more randomized trials are needed with higher sample sizes to conclude the lifesaving efficacy of the out-of-hospital CPAP.

Nausea control in mild head trauma patients: Effectiveness of metoclopramide and ondansetron in the emergency department in a double-blind study.

Background: Mild head trauma often causes several complications and disabilities including nausea and vomiting in hospitalized people. The aim of the present study was to compare the effectiveness of metoclopramide and ondansetron, and compare it with placebo to control nausea in the patients with mild head trauma admitted to the emergency department. Methods: This is a randomized double-blind placebo-controlled clinical trial conducted on the patients with mild head trauma and normal brain CT scans who were admitted to the emergency department within 24 hours after the injury. The subjects were randomly divided into three groups of ondansetron (n= 41), metoclopramide (n= 44), and placebo (n= 39), and the severity of nausea and vomiting was assessed using the visual analogue scale (VAS). Results: A total of 124 patients with mild head trauma were included in the study. The assessment of the VAS scores during the study showed that over time, the patients in all three groups had reduced nausea (p<0.01). On the other hand, the percentage change of the VAS score indicated that metoclopramide and ondansetron had the greatest changes (46.97% and 66.90%, respectively) within 15 and 30 minutes after the injection, respectively. Conclusion: The results of the present study showed that ondansetron and metoclopramide had similar effects on nausea in the patients with mild head trauma. However, metoclopramide was most effective in 15 minutes and ondansetron in 30 minutes after the injection.

Interleukin-4 can play a role in allergic rhinitis patient during treatment with Zataria multiflora.

BACKGROUND: Allergic rhinitis is a widespread disorder across the globe. The Shirazi thyme (Zataria multiflora) has been shown to have considerable antioxidant and anti-inflammatory properties. This study assessed the effect of this herbal product on alterations in inflammatory/anti-inflammatory cytokines. METHOD: This study was conducted on the bank sample before and after the intervention to measure interleukin-4, interleukin-5, and interferon -γ levels with the ELISA test method in a supernatant taken from the PBMC cell culture from 30 allergic rhinitis patients. RESULTS: The IL-4 level had no significant difference between the two groups before the treatment. However, it had a significant increase in the case group after the treatment. The IL-5 level was significantly higher in the case group before the treatment. Nevertheless, there were no significant differences between the case and control groups after the treatment. Similarly, no significant differences were observed between the two groups considering IFN-γ before and after the treatment. CONCLUSION: Consuming thyme with an increase in anti-inflammatory cytokine IL-4 and a decrease in IL-5 cytokine control inflammation and improvement in allergic rhinitis symptoms. Clinical trial details This clinical trial study was recorded at 22.5.2014 in the Iran Registry of Clinical Trials code: (IRCT2016121823235N6) https://www.irct.ir/trial/19852.

Shirazi thyme (Zataria multiflora) extract can alleviate allergic rhinitis: a randomized clinical trial.

INTRODUCTION: Atopic diseases are global concerns in the today's industrialized world. Allergic rhinitis is the most common allergic condition affecting 20% of individuals. This disorder is associated with remarkable morbidity and rising healthcare expenditure. AIM: Considering the anti-inflammatory properties of a plant Zataria multiflora (ZM) with the common name of Shirazi thyme, a randomized clinical trial was designed to evaluate the alleviation of the symptoms of allergic rhinitis. MATERIAL AND METHODS: A total of 30 allergic rhinitis patients were randomly and equally assigned to experimental and control groups. Afterwards, the case group was treated with an extract of ZM and the control group with placebo for 2 months. Finally, the clinical signs and symptoms before and after the treatment according to the SNOT22 questionnaire were analysed. RESULTS: Comparing the symptoms of allergic rhinitis and an average score of SNOT22 questionnaire between the two groups before the intervention provided some difference, which was significantly greater after the treatment. Based on this questionnaire, our patients in the ZM syrup group had lower grades than before the treatment and experienced amelioration. CONCLUSIONS: Regarding the significant effect of the ZM syrup in reducing symptoms of allergic rhinitis, its use is highly recommended. Since allergic rhinitis is a multifactorial condition, the use of herbal antioxidants along with conventional treatment would result in a more effective improvement of the disease.

Oral Administration of Zataria multiflora Extract Decreases IL-17 Expression in Perennial Allergic Rhinitis.

BACKGROUND: Rhinitis, which occurs most commonly as allergic rhinitis and affects 20% of the world's population, is a major health care burden causing significant morbidity. Considering the high prevalence of allergic rhinitis and anti-inflammatory effects of thyme, a favorite condiment, we performed a randomized clinical trial to determine whether thyme can relieve allergic rhinitis symptoms and affect the expression of TH17- and T-regulatory cell- (Treg) related cytokines IL-17, TGF-ß, FOXP3, and IL-10. METHODS: Thirty patients with allergic rhinitis symptoms and positive skin prick test for common aero allergens were randomly assigned to experimental or control groups. The experimental group received thyme or Zataria multiflora (ZM) extracts and the control group received placebo for two months. Expression of IL-17, TGF-ß, FOXP3, and IL-10 was evaluated in all subjects by real-time PCR before and after intervention. RESULTS: After treatment IL-17 expression was significantly less in the ZM group than in controls (p<0.05), while TGF-ß, FOXP3, and IL-10, expression were not significantly changed. CONCLUSION: Given the significant effect of thyme in reducing symptoms of allergic rhinitis and decrease IL-17 gene expression and because allergic rhinitis is a multifactorial disease, the administration of thyme extract along with conventional treatments may benefit allergic rhinitis sufferers.

A Promising Modified Procedure for Upper Eyelid Retraction-Associated Graves' Ophthalmopathy: Transconjunctival Lateral Levator Aponeurectomy.

Upper eyelid retraction is a characteristic feature of thyroid eye disease, including Graves' orbitopathy. In this study, a new surgical technique for correction of lid retraction secondary to Graves' orbitopathy is described. Sixteen eyelids of patients older than 18 years old underwent surgical correction for moderate to severe lid retraction secondary to Graves' orbitopathy. In this procedure, levator aponeurectomy was performed via a transconjunctival approach. Upper marginal reflex distance (MRD1) was measured before the surgery and at 1 week, 3 months, and 6 months after the surgery. MRD1 was reduced significantly from preoperatively (mean: 7.84 mm) to 1 week after the surgery (mean: 3.59 mm) (P < 0.001). Three and six months after surgery, mean MRD1 was 5.09 mm and 5.10 mm, respectively, showing that lid retraction was improved significantly (P < 0.001). Lateral levator aponeurectomy via the transconjunctival approach is a simple, scar-less, quick procedure that has optimal stable outcome.

Wavefront aberration and contrast sensitivity after implantation of foldable and rigid iris claw phakic intraocular lenses: Artiflex versus artisan.

AIM OF STUDY: The aim of this study is to assess wavefront aberration and contrast sensitivity (CS) after implantation of foldable iris claw - artiflex- and rigid iris claw - artisan- phakic intraocular lenses (pIOLs). MATERIALS AND METHODS: A nonrandomized prospective comparative case study was performed on 57 eyes; of which, 54 were myopia and 3 were hyperopia. Twenty-four patients had artisan pIOL implantation and 33 had artiflex pIOL implantation. Higher-order aberration (HOA) and CS were obtained 1 year after surgery. RESULTS: Total HOA in artisan group was greater than artiflex group (P = 0.044) with a mean HOA of 0.44 ± 0.15 root mean square (RMS) for artisan and 0.35 ± 0.15 RMS for artiflex. Although, there were no significant differences in the vertical trefoil, vertical coma, horizontal trefoil, horizontal coma, secondary astigmatism, quatrefoil, and fourth order spherical aberration in two groups. CS in mesopic conditions was better in artiflex-treated eyes at three spatial frequencies of 6, 12, and 18 cycles per degree (cpd) (P = 0.003, P = 0.007, and P = 0.00, respectively), and no significant difference was seen between two lenses at 3 cpd. CONCLUSION: Although the components of HOA were not significantly different between two groups, total HOA was higher in artisan group, which may be due to the slight differences in each component, increasing the HOA as a total. CS was significantly better in artiflex group.

In vitro evaluation of human endometrial stem cell-derived osteoblast-like cells' behavior on gelatin/collagen/bioglass nanofibers' scaffolds.

New biomimetic nanocomposite scaffold was prepared by the combination of nanofibrilar bioglass containing copper ion as the inorganic phase and gelatin/collagen as the organic phase of bone tissue. In this study for fabrication of the scaffold, freeze drying and electrospinning methods were used, and genipin was used as the cross-linking agent for increasing the mechanical properties of the scaffold. The growth and viability of human endometrial stem cell-derived osteoblast-like cells were investigated on this biomimetic scaffold. Cellular biocompatibility assays illustrated that this scaffold has more viabilities and osteoblast growths in comparison with two-dimensional culture. Copper ion increased growth of the osteoblasts on nanocomposite scaffold containing nanofibrous bioglass. Thus, the results obtained from this study indicate that the prepared scaffold is suitable for osteoblast growth and attachment; thus, potentially, this nanocomposite scaffold is an appropriate scaffold for bone tissue engineering. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 2210-2219, 2016.

New aspects in laparoscopic cholecystectomy.

BACKGROUND: Laparoscopic cholecystectomy is the gold standard access. The aim of this study was to increase the safety of the procedure by using four new aspects. METHODS: In this prospective study on 200 cases, four important points were used as a new technique to increase the safety of the operation, including: (1) Choosing the place of trocars, based on the ergonomic rule, which specifies a 120-degree angle between the two trocars in the surgeon's hands from outside and the trocar related to the telescope, and a 7-10-cm distance between each trocar and the position of the telescope and at least a 15-20-cm distance between the position of the telescope and the gallbladder, which is individualized in each case; (2) Starting with dissection from the Hartman's pouch at first and after encircling the Hartman's pouch, continuing to the cystic duct and artery to decrease the unavoidable risk of iatrogenic trauma to these structures (extensive dissection); (3) Ligating the cystic duct and artery by intracorporeal suturing to decrease the risk of bile leakage, ductal trauma, cystic artery bleeding, or inversion of clips into the duct; and (4) Removing the gallbladder through the umbilical trocar site to limit the number of trocars to three 5-mm trocars and one 10-mm trocar and also improving the cosmetic result. RESULTS: All of the cases were chosen without any selection, but only 200 cases were analyzed because of the lack of data in the remaining 30 cases. In 20 of 200 cases, this technique was not practical in one or more of the above-mentioned aspects. Using ergonomic rules to select the sites of trocars made the operation easy and more convenient for the surgeon. One case of major bile duct trauma was reported in this study, compared to up to 4% of the classic form, confirms the importance of an extensive dissection in the Hartman's pouch. Ligation by suturing had not any leaking or bleeding, postoperatively, compared to up to 2.5% in the classic method. The cosmetic result was superior because of the deletion of subxiphoid trocar and our changing of one 10-mm trocar to a 5-mm trocar. CONCLUSIONS: Using the above-mentioned new aspects is effective in decreasing the risk of ductal trauma or bile leak. Greater convenience for the surgeon as well as superior cosmetic results were evident, although this procedure requires great expertise during the operation.