Double-blind Controlled Trial Research Articles

Comparable bleeding and inflammation outcomes between heparin-coated and uncoated minimal invasive extracorporeal circuits in isolated coronary artery bypass surgery - A double-blinded randomized control trial.

Minimally invasive extracorporeal circulation has been shown to be non-inferior or even superior to conventional cardiopulmonary bypass circuits in isolated coronary artery bypass grafting, but there is little evidence whether the addition of a heparin-coated circuit can further reduce the inflammatory response and amount of bleeding in these patients. A single-center randomized control trial enrolled 49 adult patients scheduled to undergo isolated coronary artery bypass grafting with minimally invasive extracorporeal circulation (MiECC) between January 2015 and December 2018. Patients were randomized 1:1 to either the heparin-coated circuit group, or the uncoated (control) circuit group. The primary outcome was chest tube output 18h after weaning from MiECC, and secondary outcomes included inflammatory (TNF-α, IL-6, IL-8, IL-10) and complement (C3a, C4d, C5a, sC5b-9) biomarkers, platelet count and function (D2D, TAT, SDC1, PF4), number of transfused blood products, and 30-day survival. Patients were randomized to undergo myocardial revascularization using heparin-coated circuits (n = 25), and to the uncoated MiECC circuit (n = 24), with comparable baseline demographics. No significant difference was observed in chest tube output and for all secondary outcomes. IL-6 and IL-8 were increased from baseline at 18h after weaning (effect size 0.29 and 0.05, respectively) and sC5b-9 was lower (effect size 0.11) in the heparin-coated than in the uncoated MiECC, although not significantly different. Compared with an uncoated MiECC circuit, heparin-coated MiECC circuit was not associated with a reduction in postoperative bleeding, transfusion, inflammation, complement activation, and platelet biomarkers, following isolated coronary artery bypass grafting.

Efficacy of intra-articular injection of combined platelet-rich-plasma (PRP) and hyaluronic acid (HA) in knee degenerative joint disease: a prospective, randomized, double-blind clinical trial.

Intra-articular injections of hyaluronic acid (HA) and platelet-rich plasma (PRP) represent promising options in the conservative treatment of early stages of knee osteoarthritis (OA). Although the combined use of these two compounds seems to have a synergistic effect in pre-clinical studies, few clinical trials compared the association of PRP and HA with PRP and HA alone. The aim of study is toevaluate the efficacy of combined intra-articular injections of PRP and HA in the treatment of mild to moderate knee OA, compared to PRP and HA alone. One hundred and seventy-four patients were prospectively enrolled and randomized to undergo three intra-articular injections of either HA or PRP or the combination of PRP and HA with a two-week interval period. Patients were evaluated before treatment and after 3, 6, and 12months using Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, Knee Injury and Osteoarthritis Outcome Score, International Knee Documentation Committee subjective score, Visual Analogue Scale and TEGNER Activity Scores. All the treatments proved to be effective in reducing pain and improving joint function. The analysis of covariance did not show statistically significant differences among the three groups for any of the investigated outcome parameters after 6 and 12months (WOMAC: p = 0.45 and p = 0.64, respectively). No significant differences were found in terms of adverse events (p = 0.49) and painkiller use (p = 0.28 and p = 0.56, respectively) among the three groups. This multicenter, prospective, randomized, double-blind controlled trial revealed that intra-articular injections of PRP + HA, PRP, or HA represent a safe and viable treatment with comparable efficacy in terms of pain relief and functional outcomes in mild to moderate knee OA.

The Effect of Ginkgo Biloba Extract on Oxidative Stress, Anti-Inflammatory and Antiapoptotic in Vitiligo Treated with Topical Desoxymethasone

Vitiligo is a progressive and multifactorial condition of skin, mucosa, and hair depigmentation. Loss of functional melanocytes leads to the appearance of white macules on the skin, often affecting the lips and genitalia. The impact extends to psychological stress, decreased quality of life, and risk of psychiatric morbidity. Various therapeutic strategies have been designed to inhibit the immune response in vitiligo to reduce melanocyte damage while increasing melanocyte repopulation. There is no standardized method of evaluating treatment outcomes in vitiligo patients. Herbal medicines several studies have shown that GB also has many benefits for health and healing skin diseases, one of which is used in treating vitiligo. Therefore, this study aimed to evaluate the potential of Ginkgo biloba extract as a therapeutic supplement in enhancing the positive effects of desoxymethasone on vitiligo. Using a double-blind randomized control trial clinical trial research design, 26 subjects were divided into treatment and control groups. The control group received standard vitiligo therapy with topical desoxymethasone and placebo, while the treatment group received topical desoxymethasone plus Ginkgo biloba extract. Melanin index, VASI score, MDA, TNF-α, CD8 expression, and caspase 3 were measured before and after treatment. The results showed that the administration of Ginkgo biloba extract had a significant effect in reducing MDA, TNF-α, CD8 expression, and caspase 3 levels, and improving melanin index and erythema in vitiligo patients who received topical desoxymethasone therapy. These findings demonstrate the positive potential of Ginkgo biloba extract as an adjunct to vitiligo therapy, resulting in favorable clinical and molecular impacts in patients undergoing combination treatments.

Antibacterial Efficacy of Benzalkonium Chloride Gel with Tongue Brush on S. Mutans and L. Acidophilus and Tongue Coating – A Randomized Controlled Trial

Introduction: The tongue microbiota, like other parts of the oral cavity, plays a significant role in the development of dental caries. S. mutans and L. acidophilus species, are associated with the initiation and progression of dental caries.  Aim: To assess the efficacy of benzalkonium Chloride gel along with tongue cleaning aids in the reduction of tongue coating and bacterial count on dorsal surface of the tongue.  Materials and Methods: A double blinded randomized control trial was conducted among 17-25 years old college students. A total of 60 participants were randomly divided into 4 groups according to their use of tongue cleaning aids as follows: Group A, Tongue Brush Alone; Group B, Tongue Brush with Chlorhexidine Mouthwash (Clohex ADS); Group C, Tongue Brush with Chlorhexidine Gel (Hexigel); and Group D, Tongue Brush with Benzalkonium Chloride Gel. The Winkel tongue coating index (WTCI) was used to measure the tongue coating at baseline and at 14th day and the participant’s tongue coatings on dorsal surface were sampled using swab method, and the number of S. mutans and L. acidophilus colonies were counted before and after intervention.  Results: Both the Hexigel group and Benzalkonium chloride gel group reduced both the bacterial load and tongue coating at 14th Day compared to the baseline data.  Conclusion: This study suggests that usage of Tongue brush along with Benzalkonium Chloride gel decreased the tongue coating and the number of bacteria on the dorsal tongue surface.

Effects of oral pregabalin on postoperative sleep of patients after video-assisted thoracoscopic surgery: a randomized double-blind controlled trial.

The aim of this study was to explore the effect of oral pregabalin at varying concentrations on postoperative sleep of patients undergoing video-assisted thoracic surgery (VATS), and to identify the optimal dosage. A total of 120 VATS-treated patients admitted from June 2023 to October 2023 were randomly assigned to be orally administered with 75 mg pregabalin, 150 mg pregabalin and starch capsules (control group) at a 1:1:1 ratio. One capsule of pregabalin (75 mg) and one capsule of placebo with the same shape and odor, two capsules of pregabalin (150 mg), and two capsules of placebo with the same shape and odor were administered orally to patients in the three groups on the night of surgery, and in the morning and evening of postoperative days 2 and 3. The primary outcome was the incidence of postoperative sleep disturbance (PSD) on postoperative day 1 (POD1). The secondary outcomes included the St.Mary's Hospital Sleep Questionnaire (SMH), the Pittsburg Sleep Quality Index (PSQI) and pain intensity measured with a Numerical Rating Scale (NRS). Multivariate logistic regression analysis was performed to identify risk factors for PSD in VATS-treated patients. The incidence of PSD on POD1 in the 75 mg pregabalin group and 150 mg pregabalin group was significantly lower than that of the control group (45.0% vs. 42.5% vs. 72.5%; P<0.0167 for two-by-two comparisons of groups A and B with group C, respectively). The SMH scores at night on POD1-3 were significantly higher in the 75 mg pregabalin group and 150 mg pregabalin group than those of the control group (P<0.05). Since there was definitive lower incidence of pain in the experimental groups,the median NRS scores of the incisional pain on POD2-3 were significantly lower in the 75 mg pregabalin group and 150 mg pregabalin group (P<0.05). The incidence of dizziness in the 150 mg pregabalin group was significantly higher than that of the 75 mg pregabalin group and control group (55.0% vs. 25.0% vs. 32.5%; P<0.0167 for two-by-two comparisons of groups A and C with group B, respectively). NRS score on POD1, preoperative PSQI and Self-Rating Depression Scale scores were risk factors for PSD in VATS-treated patients. Oral administration of 75 mg or 150mg pregabalin for consecutive three days after VATS effectively reduces the incidence of PSD and improves the quality of sleep.

Comparison of effects of dexmedetomidine with ketofol and ketofol alone on quality of sedation in pediatric patients undergoing magnetic resonance imaging: A prospective randomized controlled double-blind trial

Background and Aim: Patient movement during magnetic resonance imaging (MRI) is the most frequent cause of artifacts and poor scan quality. Children cannot lie still. Thus, anesthesia is required to keep the child calm and immobile. This randomized double-blinded clinical trial compares the clinical effects of the addition of dexmedetomidine as premedication with ketofol on the quality of sedation. We hypothesized that the addition of dexmedetomidine would improve the quality of sedation. Methods: A total of 132 children aged 6 months to 10 years were randomized into groups DK (dexmedetomidine–ketofol) and K (ketofol). DK received an intravenous bolus of dexmedetomidine (0.5 mcg/kg) as premedication 10 minutes prior. Both the groups were induced with ketofol (0.5 mg/kg), and sedation was maintained with propfol infusion (100 mcg/kg/min). The primary objective was the quality of sedation as assessed by the University of Michigan Sedation Scale. Image quality, requirement of rescue propofol dose, recovery, and adverse events were also studied. Data are given as median [interquartile range (IQR)] or frequency. Results: All 132 children completed MRI scans. The DK group showed significantly better quality of sedation, 71% versus 47% of children, a median difference of 1 (-0.569 to -0.0969), P &lt; .005, a better quality of scan, a reduced number of additional doses of propofol, and a decreased total dose of propofol. Hemodynamic parameters and recovery times for the two groups were similar. There were no significant side effects in both groups. Conclusion: The quality of sedation and the quality of the MRI scan are greatly improved by administering dexmedetomidine (0.5 mcg/kg) 10 minutes before to induction. Additionally, this technique decreases the need of propofol and gives better hemodynamic stability without delaying the recovery time.

Comparative efficacy of THR-β agonists, FGF-21 analogues, GLP-1R agonists, GLP-1-based polyagonists, and Pan-PPAR agonists for MASLD: A systematic review and network meta-analysis

AimsTo compare the efficacy of thyroid hormone receptor beta (THR-β) agonists, fibroblast growth factor 21 (FGF-21) analogues, glucagon-like peptide-1 receptor agonists (GLP-1RAs), GLP-1-based polyagonists, and pan-peroxisome proliferator-activated receptor (Pan-PPAR) agonists in the treatment of metabolic dysfunction-associated steatotic liver disease (MASLD). MethodsA database search for relevant randomized double-blind controlled trials published until July 11, 2024, was conducted. Primary outcomes were the relative change in hepatic fat fraction (HFF) and liver stiffness assessed non-invasively by magnetic resonance imaging proton density fat fraction and elastography. Secondary outcomes included histology, liver injury index, lipid profile, glucose metabolism, blood pressure, and body weight. ResultsTwenty-seven trials (5357 patients with MASLD) were identified. For HFF reduction, GLP-1-based polyagonists were most potentially effective (mean difference [MD] −51.47; 95 % confidence interval [CI]: −68.25 to −34.68; surface under the cumulative ranking curve [SUCRA] 84.9) vs. placebo, followed by FGF-21 analogues (MD −47.08; 95 % CI: −58.83 to −35.34; SUCRA 75.5), GLP-1R agonists (MD −37.36; 95 % CI: −69.52 to −5.21; SUCRA 52.3) and THR-β agonists (MD −33.20; 95 % CI: −43.90 to −22.51; SUCRA 36.9). For liver stiffness, FGF-21 analogues were most potentially effective (MD −9.65; 95 % CI: −19.28 to −0.01; SUCRA 82.2) vs. placebo, followed by THR-β agonists (MD −5.79; 95 % CI: −9.50 to −2.09; SUCRA 58.2), and GLP-1RAs (MD −5.58; 95 % CI: −15.02 to 3.86; SUCRA 54.7). For fibrosis improvement in histology, GLP-1-based polyagonists were most potentially effective, followed by FGF-21 analogues, THR-β agonists, Pan-PPAR agonists, and GLP-1R agonists; For MASH resolution in histology, GLP-1-based polyagonists were most potentially effective, followed by THR-β agonists, GLP-1R agonists, FGF-21 analogues, and Pan-PPAR agonists. THR-β agonists are well-balanced in liver steatosis and fibrosis, and excel at improving lipid profiles; FGF-21 analogues are effective at improving steatosis and particularly exhibit strong antifibrotic abilities. GLP-1R agonists showed significant benefits in improving liver steatosis, glucose metabolism, and body weight. GLP-1-based polyagonists have demonstrated the most potential efficacy overall in terms of comprehensive curative effect. Pan-PPAR agonists showed distinct advantages in improving liver function and glucose metabolism. ConclusionThese results illustrate the relative superiority of the five classes of therapy in the treatment of MASLD and may serve as guidance for the development of combination therapies.

Use of Tear Substitutes to enhance the Image Quality of the Optic Nerve and Retina by Optical Coherence Tomography

&amp;lt;i&amp;gt;Background &amp; Objectives&amp;lt;/i&amp;gt;: Dry eye disease (DED) has become very prevalent, with the increased usage of internet and video terminals. The present study was carried out to compare the efficacy of tear substitutes in enhancing the signal strength of measurements of optic nerve head, retinal nerve fiber layer and macula by Optical coherence tomography (OCT), and resultant change in image quality. Thus proving the role of artificial tear substitutes in increasing the diagnostic accuracy of Optical coherence tomography (OCT) measurements. &amp;lt;i&amp;gt;Methods&amp;lt;/i&amp;gt;: A double blinded randomized control trial was performed on one hundred and fifty patients needing optical coherence tomography. They were randomly allocated into three groups to receive any one of the three tear substitutes Group 1 –Sodium hyaluronate (Molecular Weight M Wt 799.6g/mol) Group 2 – Poly ethylene glycol (Molecular Weight M Wt 400g/mol), Group -3 Hydroxy Propyl Methyl cellulose (Molecular Weight M Wt 1261.4 g/mol); Measurement of signal strength for optic nerve head, retinal nerve fiber thickness RNFL and sub foveal thickness SFT was done before and after instillation of tear substitutes. Data was analyzed using the Statistical Package for Social Sciences SPSS 22 version software. P value &amp;lt;0.05 was considered statistically significant. &amp;lt;i&amp;gt;Results&amp;lt;/i&amp;gt;: The groups were comparable with respect to mean age and gender distribution. The mean signal strength (SS) of Optic Nerve Head (ONH) evaluation improved in all the groups in both eyes. The increase was the highest in Group II in both eyes. The increase in retinal nerve fiber layer thickness [RNFL] was seen in both eyes in all the groups. Improvement in macular evaluation sub foveal thickness (SFT) was seen in Group II of both eyes and group III in the Left eye. &amp;lt;i&amp;gt;Interpretation and Conclusion&amp;lt;/i&amp;gt;: All tear substitutes improved the quality of the image but the improvement varied with regard to the parameters measured, thus proving artificial tear application is an essential for Optical coherence tomography OCT measurements in persons prone to dry eye This reduces the scope for error due to bad images and thereby the possibility of misdiagnosis of ophthalmic disease.

Ivacaftor for Chronic Obstructive Pulmonary Disease - Results from a Phase 2, Randomized Controlled Trial.

Patients with chronic obstructive pulmonary disease (COPD) exhibit acquired cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction. CFTR modulators may improve outcomes in patients with COPD, although recent data regarding magnitude of benefit have been inconclusive and effects on mucociliary clearance are unknown. We conducted a phase 2, randomized, double blind placebo control trial to determine safety and tolerability, and explore the potential mechanism of ivacaftor for the treatment of COPD. We randomized 40 patients with moderate to severe COPD and symptoms of chronic bronchitis to ivacaftor (N=30) or placebo (N=10) 150mg BID for 12 weeks. Primary endpoints included evaluation of safety of ivacaftor and pharmacokinetics (PK). Secondary endpoints included measures of CFTR activity and clinical outcomes. Ivacaftor was safe and tolerable with similar rates of adverse events rates between groups. Most common adverse event was diarrhea in the ivacaftor group and acute COPD exacerbation in the placebo group. PK analysis found the mean area under the curve over 12 hours (AUC12) to be 72% of the previously reported AUC12 in cystic fibrosis (CF). Treatment with ivacaftor did not improve sweat chloride, whole lung mucociliary clearance, lung function or respiratory symptoms. Ivacaftor was safe and well tolerated, but did not improve measures of CFTR activity or mucus clearance. As serum concentrations achieved were lower than observed in CF at the same dose, and modulation of wild type CFTR differs from G551D, further dose determination studies are needed to better understand treatment efficacy of CFTR potentiators in COPD. Clinical trial registration available at www. gov, ID: NCT03085485.

Effect of sublingual fast-dissolving piroxicam premedication on postoperative pain experience in mandibular molars with non-vital pulp: a randomized double-blind controlled trial

BackgroundThe aim of this trial was to evaluate the effect of a preoperative, single dose sublingual fast-dissolving piroxicam (20 mg) compared to placebo on postoperative pain at rest (POP), on biting (POPB) and on percussion (POPer) after single-visit endodontic treatment of asymptomatic mandibular molars with non-vital pulp.MethodsSeventy patients randomly received either piroxicam or placebo 1 h before treatment (n = 35). Patients recorded their pain (POP and POPB) level 6 h, 12 h, 24 h, 48 h, 72 h and 7 days postoperatively using an 11-point numerical rating scale; POPer was assessed after 7 days. Resuce-analgesic intake (RAI) and flare-up incidence (FUI) were recorded. Data were statistically analyzed.ResultsBoth groups had similar baseline characteristics (P > 0.05). Piroxicam showed less POP intensity and incidence than placebo at 6, 12 and 24 h, less POPB intensity and incidence at all timepoints, less POPer intensity and incidence and less RAI (p > 0.05), but similar FUI (P > 0.05). A significant rise in pain compared to baseline occurred with placebo from 6 to 72 h for POP and to 7 days with POPB (p > 0.05); such rise was not detected with piroxicam. POPB showed higher pain intensity than POP at all time points (p < 0.05). No swelling or adverse effects occured.ConclusionsA preoperative single dose of sublingual fast-dissolving piroxicam can be effective in reducing spontaneous pain up to 24 h, stimulated pain up to 7 days, and RAI incidence in asymptomatic mandibular molars with non-vital pulp; it can prevent rise in POP and POPB postoperatively. Stimulated postoperative pain can be more severe and longer lasting than spontaneous pain.Trial registrationClinicaltrials.gov ID: NCT03998826 (2019).

Conventional versus high-voltage, long-term pulse Radiofrequency of ganglion impar in perineal pain with advanced rectal cancer: a Randomized, double-blind controlled trial

Study objectiveAdvanced rectal cancer is a common cause of perineal pain and research on the use of radiofrequency therapy for the treatment of this pain is limited. In the present study, we aimed to compare the effectiveness and safety of conventional radiofrequency (CRF) and high-voltage long-term pulsed radiofrequency (H-PRF) of radiofrequency therapy in the management of perineal pain in advanced rectal cancer.DesignRandomized, Double-Blind Controlled Trial.SettingSichuan Cancer Hospital & Institute and Yanjiang District People’s Hospital in Sichuan, China.ParticipantsA total of 72 patients with advanced rectal cancer experiencing perineal pain who were accepted for radiofrequency treatment.InterventionsPatients were assigned randomly (1:1) assigned to either the group CRF or H-PRF in a double-blind trial.Measurements and main resultsThe primary focus was on assessing perineal pain using numeric rating scales (NRS) scores at various time points. Secondary outcomes included the duration of maintaining a sitting position, depression scores, sleep quality, consumption of Oral Morphine Equivalent and Pregabalin, and the incidence of perineal numbness. A total of 57 patients (28 patients in the group CRF and 29 patients in the group H-PRF) were investigated. At all observation time points postoperatively, both groups of patients exhibited significant reductions in pain, enhancements in depression, improvements in sleep quality, and increased duration of sitting compared to their baseline measurements (P<0.05). During the 3 months and 6 months follow-up period, the group CRF exhibited significant reduction in pain, improvement in depression, sleep quality, and increased the time of keeping a sitting position compared with the group H-PRF (P<0.05). The consumption of oral morphine equivalent and Pregabalin as well as the incidence of perineal numbness were not significantly different between groups (P > 0.05).ConclusionOur results demonstrate that application of CRF and H-PRF in ganglion impar to reduce perineal pain and improve the quality of life of patients with advanced rectal cancer is safe and effective. However, the long-term effect of CRF is better compared with that of H-PRF.Trial registrationhttps://www.chictr.org.cn/ (ChiCTR2200061800) on 02/07/2022. This study adheres to CONSORT guidelines.

Community-Based Exercise Programs Post Spinal Cord Injury Hospitalization: A Pilot Study for a Randomized, Multicenter, Double-Blind Controlled Setting.

This study explores the effectiveness of community-based exercise programs for individuals with spinal cord injury (SCI) following hospital discharge. Given the rising incidence of SCI, particularly in South Korea, and the associated long-term disabilities, the necessity for comprehensive post-discharge rehabilitation is paramount. The study focuses on a pilot randomized multicenter double-blind controlled trial, targeting SCI patients who have completed inpatient rehabilitation and are living in the community. The primary aim is to evaluate the impact of structured exercise programs on physical fitness, functional capacity, and overall recovery. The research introduces the SpinalFit program, a community-based intervention designed to enhance muscle strength, cardiopulmonary endurance, and mobility through a combination of aerobic and resistance training. This program addresses the critical need for safe and effective rehabilitation options outside the hospital setting, utilizing circuit training with resistance bands and body-weight exercises tailored to each participant's capacity. The study also investigates barriers to physical activity in the community for SCI patients and the potential role of community exercise centers in bridging this gap. Preliminary findings from this pilot trial are expected to provide valuable insights into optimizing exercise regimens for SCI patients, informing future large-scale studies and contributing to improved post-discharge rehabilitation strategies.

A double blinded randomized prospective trial of comparison between control and study group, nefopam versus tramadol on shivering scores after spinal anesthesia in patients undergoing Transurethral resection of prostate

IntroductionShivering is a common and distressing complication that can occur after subarachnoid block (SAB) in patients, particularly those undergoing transurethral resection of the prostate (TURP) due to the use of irrigating fluid and older age group. This study aims to compare the effectiveness of nefopam and tramadol in reducing intraoperative shivering compared to a control group, in Indian patients. MethodologyThis study is a double-blinded randomized control trial with a total of 99 patients undergoing elective TURP under SAB were enrolled. The patients were randomly divided into three groups (GT, GN, and GC): GT received tramadol (0.5 mg kg-1) and GN received nefopam (0.15 mg kg-1). Both tramadol and nefopam were premixed into 100 ml of normal saline (NS) and GC received 100 ml NS, given over 15 min just before SAB. The induction protocol was the same for all groups, and shivering score, hemodynamic parameters, and body temperature (BT) were recorded. ResultsThe overall incidence of shivering was 29.67 % (27/91), with the lowest incidence being in GN (16.67 %, 5/30), followed by GT (22.58 %, 7/31) and GC (50 %, 15/30). Both nefopam and tramadol resulted in a significant (p < 0.05) decrease in the incidence of shivering compared to control. Among the hemodynamic parameters and BT, no significant difference was seen between GT, GN, and GC (p > 0.05). ConclusionBoth nefopam and tramadol were effective in reducing the incidence but the severity was controlled better with nefopam during TURP under SAB.

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.

Probiotics and magnesium orotate for the treatment of major depressive disorder: a randomised double blind controlled trial

Following on from our pilot studies, this study aimed to test the efficacy of a combination of probiotics (Lactobacillus acidophilus, Bifidobacterium bifidum, Streptococcus thermophilus), magnesium orotate and coenzyme 10 for the treatment of major depressive disorder (MDD) through a double-blind placebo controlled clinical trial. The participants were 120 adults diagnosed with MDD randomised to daily oral administration, over 8 weeks, of either the intervention or placebo, with a 16-week follow-up period. Intent-to-treat analysis found a significantly lower frequency of the presence of a major depressive episode in the intervention group compared with placebo at the end of the 8-week treatment phase, with no difference between the two conditions at 8-week follow-up. Both the categorical and continuous measure of depressive symptoms showed a significant difference between the two conditions at 4 weeks, but not 8 and 16 weeks. The secondary end-point was demonstrated with an overall reduction in self-rated symptoms of anxiety and stress in the active treatment group compared with placebo. These findings suggest that the combination of probiotics, magnesium orotate and coenzyme 10 may be an effective treatment of MDD over an 8-week period.

The Effectiveness of Centella asiatica Extract and Aerobic Exercise on Plasma Levels of Amyloid Beta-42 and Phosphorylated Tau in Older Women with Dementia

Urgency: Effect of Centella asiatica (CA) and aerobic exercise on Amyloid beta-42 (Aβ42) and phosphorylated tau (p-tau) as biomarkers of dementia is not yet known. Objectives: This study aimed to analyze the effect of CA, aerobic exercise, and their combination on Aβ42 and p-tau in older women with dementia. Design: It was a 24-week randomized, double-blind controlled trial. Partisipants: Subjects were divided into four groups: the Centella asiatica group (CA, 1x500 mg/day, n = 16), the aerobic exercise group (AE, 3x60 minutes/week, n = 16), the CA-AE combination group (1x500 mg/day and exercise, n = 15), and the placebo group (n = 15). Instruments: The dementia screening test used the Mini Mental State Examination (Intraclass correlation coefficients : ranging from 0.60 to 0.93, sensitivity of 88.3%) and Clinical Dementia Rating questionnaires (sensitivity 93.6% and specificity 100%). The Wilcoxon, Kruskal-Wallis, and Mann-Whitney tests were used to analyze the data. Results: Plasma amyloid beta-42 showed an increase in all groups: CA (p

Effect of hypnosis on anxiety and blood pressure of pregnant women with preeclampsia: A double-blind controlled clinical trial study

Effect of hypnosis on anxiety and blood pressure of pregnant women with preeclampsia: A double-blind controlled clinical trial study

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 24hours 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-ups sessions were also the same. The total number of modified 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.

Double-blind, Randomized, Placebo-Controlled study evaluating the Efficacy of an early treatment using Herbal Supplement in the Prevention of Post-Traumatic Stress Disorder in the emergency department (PHYTéS Study)

IntroductionThe purpose of this study was to evaluate the efficacy and safety of a herbal supplement in preventing the occurrence of PTSD MethodsIt is a randomized double blind controlled trial including patients exposed to a traumatic event meeting DSM-V Criterion A and having a Peri-traumatic Distress Inventory score and/or Peri-traumatic Dissociative Experience Questionnaire (PDEQ) and/or immediate stress score (L.Crocq score) higher than the thresholds between day 1 and day 3. Patients were randomly assigned into two groups: Patients included in the herbal supplement Group received Aleozen® for 10 days while patients in the Placebo Group received a placebo. The main outcome was to assess the efficacy through the evaluation of CAPS-5 after 03 months of follow-up. The secondary outcome was to evaluate the safety of this supplement and to assess PTSD after one year. Resultstwo hundred patients were enrolled among 03 months and then randomly assigned to receive the herbal treatment or the placebo; 100 in each group. The two groups have similar characteristics at baseline. At day 10 after inclusion, the two groups had comparable CAPS-5 scores (p=0.591).After day 90 of follow-up, 85 patients (42.5%) had PTSD, according to the CAPS-5 Scale. Developing PTSD was lower in the intervention group compared to the placebo group (38.8% versus 61.2%, respectively; p<0.001). No adverse events were noted during the study. ConclusionAn early administration of a herbal supplement may prevent the occurrence of PTSD in patients exposed to trauma and having a high risk to develop it. Clinical registration NumberIt was recorded in the ClinicalTrials.gov register ( NCT03724448) in June 26 th 2018

Jujube Oxymel for the Treatment of Chronic Spontaneous Urticaria: Efficacy and Safety

Background: Chronic spontaneous urticaria (CSU) is a challenging disorder that severely impacts the quality of life. The current study objective was to evaluate the efficacy and safety of jujube oxymel (JO) for treating CSU. Materials and Methods: In this randomized double-blind controlled trial, 92 patients (aged 12–65) with CSU were randomly allocated to JO or placebo groups. They received 30cc of each syrup three times daily with 10 mg cetirizine for 28 days, subsequently taking 10 mg cetirizine alone for the next 4 weeks. Outcomes were evaluated using the weekly urticaria activity score (UAS-7) and Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL). Results: After four weeks, the UAS-7 score mean and standard deviation in the JO group significantly decreased to 10.89 ± 4.87 compared to the placebo group at 15.06 ± 7.55 (P: 0.002). In the follow-up period, JO group participants achieved a score of 10.28 (4.67), while a significant increase occurred in the control group (18.33 ± 6.29) (P = 0.001). On day 28, there was a notable improvement in the quality of life within the JO group (P &lt; 0.05). By the eighth week, both groups experienced an increase in CU-Q2oL score, but the changes in the control group were statistically significant (18.09 (5.96) vs 41.31 (10.34) (P: 0.001). Conclusion: JO, as part of integrated therapy, exhibited potentially longer-lasting efficacy than cetirizine alone, contributing to enhanced quality of life and increased patient satisfaction due to minimal side effects.