Double-blind Controlled Clinical Trial Research Articles

Influence of an inspiratory muscle fatigue protocol on healthy youths on respiratory muscle strength, vertical jump performance and muscle oxygen saturation: a randomized controlled trial

BackgroundInspiratory muscle fatigue has been shown to have effects on limbs blood flow and physical performance. This study aimed to evaluate the influence of an inspiratory muscle fatigue protocol on respiratory muscle strength, vertical jump performance and muscle oxygen saturation in healthy youths.MethodsA randomized and double-blinded controlled clinical trial, was conducted. Twenty-four participants aged 18–45 years, non-smokers and engaged in sports activity at least three times a week for a minimum of one year were enrolled in this investigation. Participants were randomly assigned to three groups: Inspiratory Muscle Fatigue (IMFG), Activation, and Control. Measurements of vertical jump, diaphragmatic ultrasound, muscle oxygen saturation, and maximum inspiratory pressure were taken at two stages: before the intervention (T1) and immediately after treatment (T2).ResultsThe IMFG showed lower scores in muscle oxygen saturation and cardiorespiratory variables after undergoing the diaphragmatic fatigue intervention compared to the activation and control groups (p < 0.05). For the vertical jump variables, intragroup differences were found (p < 0.01), but no differences were shown between the three groups (p > 0.05).ConclusionsInspiratory muscle fatigue appears to negatively impact vertical jump performance, muscle oxygen saturation and inspiratory muscle strength in healthy youths.Trial registrationClinicalTrials.gov ID: NCT06271876. Date of registration 02/21/2024. https://clinicaltrials.gov/study/NCT06271876.

A randomized double-blind controlled clinical trial demonstrating efficacy of different probiotic strains on serum lipids and glycemic biomarker.

the aim of this randomized placebo-controlled study was to investigate the effect of probiotics mainly on plasma lipids, homocysteine levels, glycemic biomarkers and inflammatory marker in people with hyperlipidemia, compared to a placebo. a randomized, double-blind placebo-controlled study was completed with a total of 51 men and women who have diagnosed with hyperlipidemia. The three study interventions were: 1) probiotic group I asked to take once a day 1 x 106 colony forming unit (CFU) Lactobacillus rhamnosus GG microorganism (n = 18) capsule; 2) probiotic group II asked to take once a day of a combined Lactobacillus acidophilus 1 x 109 CFU and Bifidobacterium animalis subsp.lactis 1 x 109 CFU probiotic capsule (n = 17); and 3) placebo group: emptied capsule (n = 16), plasma lipids, homocysteine, and glycemic biomarkers were were performed at baseline and week 8. Also, hs-CRP levels was assessed as inflammatory parameter. compared to baseline there was a significant decrease in triglyceride and total cholesterol levels of the both intervention groups compared to the placebo group. Regarding the glycemic biomarkers. both intervention groups significantly alter the HOMA-IR values compared to the placebo group (p < 0.05). When homocysteine values were evaluated. a statistically significant decrease was observed only in the group using the combined strain (p < 0.05). Results demonstrated that regular and strain-specific use of probiotics have effective and favorable consequences on plasma lipids and glycemic biomarkers. probiotics containing Lactobacillus or Bifidobacterium could be effective in hypercholesterolemic patients, reducing serum lipids as well as homocysteine and glycaemia.

The effect of intra-articular ozone injection combined with home-based exercise on pain and function in daily living activities of patients with mild to moderate knee osteoarthritis, a randomized double-blinded controlled clinical trial

BackgroundKnee osteoarthritis is the most common arthritis. Various treatments such as analgesics, exercise therapy, and surgery in high-grade OA have been shown to reduce pain and improve patients' function; however, determining the optimal treatment remains a challenge. Ozone therapy is one of the injection techniques used for symptom relief in these patients. Therefore, this study aimed to evaluate the effect of ozone injection in mild to moderate knee osteoarthritis. MethodsThirty-three patients with grade II-III knee osteoarthritis based on the Kellgren-Lawrence classification were involved in the study, by block randomisation. Totally 42 knees were included. All patients received exercise therapy, 500 mg of acetaminophen tablets (up to 2 g per day as needed), and healthy nutrition. In a double-blinded method, the intervention group received Ozone injections, but the control group received placebo injections. Functional tests, including timed-up-and-go and 6-min walk tests, were assessed at baseline and immediately after the 6-week intervention. In addition, the pain was measured by VAS score, and stiffness and activity of daily living (ADL) were evaluated by KOOS questionnaire before and after a 6-week intervention and then one and six months afterwards. FindingsImprovements in pain and KOOS scores were seen in both groups in the 6th week of injections (p < 0.05), with significant differences between groups. However, the effects on pain and KOOS scores disappeared in the 1st and 6th months of follow-ups in the control group. Nevertheless, the effects persisted in the intervention group compared to the baseline and control group, which means that in the mentioned time points intervention group showed significant improvement compared to the control group (p < 0.05). In addition, functional tests showed significant differences between the two groups in the 6th week of injections (p < 0.001). InterpretationOzone injection is a non-surgical treatment for mild to moderate knee osteoarthritis that could decrease pain and improve function and ADL of patients in the short to mid-term (3–6 months), so it seems that adding Ozone injection to the routine exercise therapy in management of patients with knee OA could improve outcomes.

Efficacy of postoperative analgesia with intravenous paracetamol and mannitol injection, combined with thoracic paravertebral nerve block in post video-assisted thoracoscopic surgery pain: a prospective, randomized, double-blind controlled trial

BackgroundAlthough video-assisted thoracoscopic surgery (VATS) has advantages of reduced injury and faster healing, patients still endure moderate and severe postoperative pain. Paracetamol and mannitol injection, the first acetaminophen injection in China, has the advantages of convenient administration, rapid onset of action, and no first-pass effect. This aim of this study was to investigate the efficacy of postoperative analgesia with paracetamol and mannitol injection, combined with thoracic paravertebral nerve block (TPVB) in post VATS pain.MethodsThis study was a single-center, prospective, randomized, double-blind controlled clinical trial. Patients scheduled for VATS were randomly divided into three groups, general anesthesia group (Group C), TPVB group (Group T) and TPVB + paracetamol and mannitol injection group (Group TP). In this study, the primary outcome was determined as visual analog scale (VAS) scores at rest and coughing, the secondary observation outcomes were the first time to use analgesic pump, the total consumption of oxycodone in the analgesic pump, number of effective and total analgesic pump compressions at first 48 h postoperatively, the perioperative consumption of sufentanil, time to extubation, hospital length of stay, urine volume, and the incidence of adverse events.ResultsIn a state of rest and cough, patients in the Group TP showed significantly lower VAS pain scores at 1, 12, 24, and 48 postoperative-hour compared with Group C and Group T. Intraoperative sufentanil and postoperative oxycodone consumption, the first time to press analgesic pump, the times of effective and total compressions of patient- controlled analgesia (PCA) were lower than those of the Group C and Group T. Interestingly, urine output was higher in Group TP. There were no differences between the three groups in terms of extubation time, length of hospital stay and adverse effects, indicating that intravenous paracetamol and mannitol injection is an effective and safe perioperative analgesia method.ConclusionsParacetamol and mannitol injection, combined with TPVB may provide important beneficial effects on acute pain control and reduce the consumption of opioid in patients undergoing VATS.Trial registrationThe trial was registered on Jun 19, 2023 in the Chinese Clinical Trial Registry (https://www.chictr.org.cn/showproj.html?proj=199315), registration number ChiCTR2300072623 (19/06/2023).

Comparing acute normovolumic hemodilution with autologous platelet-rich plasma for blood preservation during aortic surgery : study protocol for a randomized controlled clinical trial

BackgroundBoth acute normovolumic hemodilution (ANH) and autologous platelet-rich plasma (aPRP) have been demonstrated blood-protective effects in cardiac aortic surgery; however, the efficacies of the two methods have not been compared. This study aims to compare the effects of aPRP and ANH prior to aortic surgery on postoperative bleed and other outcomes.Methods and analysisThis is a prospective, single-center, double-blind controlled clinical trial including 160 patients randomized 1:1 to receive aPRP (test group) or autologous whole blood (ANH, control group). The primary objective is to compare the drainage volumes in the two groups at 24, 48, and 72 h postoperatively. Secondary outcomes include input of allogeneic blood and blood products and durations of aortic block, extracorporeal circulation, deep hypothermic arrest of circulation, tracheal extubation, hospital stay, requirement for secondary surgical hemostasis, and application of intra-aortic balloon pump or extracorporeal membrane oxygenation in the two groups. In addition, heart rate, systolic blood pressure, diastolic blood pressure, central venous pressure, and thromboelastography recorded before blood reservation (T1), after blood reservation (T2), before blood transfusion (T3), and after the blood is returned (T4) to the transfusion will be compared between the two groups of patients.DiscussionThis study will demonstrate if the use of aPRP could reduce the risk of bleeding after aortic surgery compared with ANH. The results are expected to have practical clinical applications in terms of more effective blood protection and shorter hospital stay.Trial registrationThis study was registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn/) with the ID ChiCTR 1900023351.Registered on May 23, 2019.Trial statusRecruiting start date: July 1, 2019; expected recruiting end date: July 1, 2024Version number and date: Version 2 of 05-04-2019

A Comparison between Single and Double-Dose Intravenous Ketamine Administration in Bipolar Mood Disorder: A Double-Blind Controlled Clinical Trial.

Objective: As glutamatergic system dysfunction is involved in bipolar depression pathophysiology, the glutamate receptor modulators such as Ketamine have been applied as complementary medication for mood stabilizers. While the treatment is currently just the intravenous injection of a single dose, and there is no robust conclusion on Ketamine effectiveness or its side effects in bipolar patients, this study aimed to consider single- and double-dose intravenous injections of Ketamine in bipolar patients compared to the placebo. Method : In a randomized, double-blind controlled clinical trial, 30 patients diagnosed with bipolar I and II disorders according to DSM-IV-TR (SCID-I) were randomly divided into three groups: the first group received an intravenous injection of Ketamine (0.5 mg/kg) and placebo with a three-day interval, the second group received two doses of Ketamine (0.5 mg/kg) in the same interval, and the third group received two placebo injections. Patients were assessed for depression, anxiety, and mania at various time points, including before the injection, 60 minutes after the injection, on the first, third, fifth, seventh, and 14th day, as well as at the end of the first month using the Hamilton Depression Rating Scale, Beck Anxiety Inventory, and Young Mania Scale, respectively. Data were analyzed using ANOVA and Repeated measure tests. Results: The mean age of patients was 36.8 ± 7.9 years, with 18 females (60%) and 12 (40%) males. Depression and anxiety showed significant differences in both the single- and double-dose Ketamine groups over time (P < 0.01). Moreover, mania displayed significant changes during the study time in the single- and double-dose Ketamine groups, as well as the in the control group. However, during the study time, there were no significant differences observed in depression, anxiety, and mania among the three groups (P = 0.198, P = 0.416, and P = 0.540, respectively). Patients did not indicate any side effects during the study. Conclusion: Intravenous Ketamine administration may relieve depressive manifestations in bipolar patients. The findings suggest that a double dose of Ketamine does not lead to greater improvement than a single dose.

Peri-operative Outcomes of Dexmedetomidine as an Additive to Subtenon Block Compared with Intravenous Dexmedetomidine for Patients Undergoing Vitreoretinal Surgery under General Anesthesia

Background: Several medications such as dexmedetomidine can be used as adjuvants with anesthesia to reduce the stress response during surgery resulting in good post-operative outcomes and safe recovery times. Aims: To compare the peri-operative outcomes of subtenon block with or without dexmedetomidine versus dexmedetomidine infusion as adjuvants to general anesthesia in subjects undertaking retinal operations. Design: A prospective randomized double-blind controlled clinical trial Patients and methods: Through the use of sealed opaque envelopes, 120 participants were randomly divided into three groups. Group SB received subtenon bupivacaine and lidocaine and IV infusion of normal saline. Group SD received subtenon bupivacaine, lidocaine, and dexmedetomidine and IV infusion of normal saline, whereas Group DI received subtenon saline and IV infusion of dexmedetomidine. Peri-operative hemodynamics and intra-ocular pressure were measured and recorded. Intra-operative bleeding, recovery times, post-operative sedation and pain scores, first analgesic times, total analgesic requirements, and the incidence of PONV and OCR were also assessed and documented. Statistical analysis: A prospective analysis of the collected data was performed using the SPSS program for Windows (version 22). Results: The results showed that IV dexmedetomidine has decreased cardiovascular responses to surgery as signified by decreased HR and MAP with a significant drop in IOP measurements before induction and after intubation, in comparison to other groups. Administering dexmedetomidine either or IV in the subtenon block led to a significant reduction in pain scores of the first post-operative six hours, the total pethidine consumption, and the surgical bleeding. Conclusion: When used as a supplement to general anesthesia during retinal surgery, dexmedetomidine is effective at reducing the airway response to tracheal intubation and extubation and maintaining peri-operative hemodynamic stability. Dexmedetomidine is also an efficient method for lowering intraocular pressure, surgical bleeding, and postoperative analgesic consumption with a better recovery profile. It can be administered either through IV infusion or combined with local anesthetics in subtenon block.

Effect of Adding Dexamethasone to Bupivacaine in Ultrasound Guided Adductor Canal Block for Post-operative Analgesia Following Knee Arthroscopy

Abstract Background Arthroscopic knee surgery refers to a large variety of surgical interventions in the knee, and numerous analgesic regimens have been investigated in order to find the best combination of analgesics for these procedures. The post-operative pain response depends on the type and duration of surgical intervention, and it can be challenging to predict which analgesic regimen will be the most appropriate for each patient until after surgery. Aim of the Work Assessing the effect of adding dexamethasone perineurally to bupivacaine in adductor canal block for post operative analgesia following knee arthroscopy under spinal anaesthesia regarding; duration of postoperative analgesia as a primary objective and one-day postoperative analgesic and opioid consumption as a secondary objective. Patients and Methods The type of study was a randomized prospective double blinded controlled clinical trial at Ain Shams University Hospitals, Cairo, Egypt. Study Period: Six months, Adult patients undergoing Knee Arthroscopy under Spinal Anaesthesia will be randomly assigned into one of the following groups using computer generated codes and opaque sealed envelopes: Group A (study group): The patients received ACB with 20 ml plain bupivacaine (0.25%) + 8 mg dexamethasone (2 ml), Group B (control group): The patients received ACB with 20 ml plain bupivacaine (0.25%) + 2 ml of Normal saline. Results There was a highly statistically significant difference between groups according to analgesic duration (time of first call for analgesics) (min) with p-value (p &amp;lt; 0.001). The highest value was found in group A(study) and group B(control) (241.02±36.15 and 188.49±28.27) respectively, this indicates that that the needs of analgesic in the group B were earlier compared to group A. There was a highly statistically significant difference between groups according to cumulative morphine consumption “mg” with p-value (p &amp;lt; 0.001). The highest value was found in Group B and Group A 4 (3-4) and 2 (1-2) respectively, this indicates much higher needs of analgesic in the Group B than group A. Conclusion We concluded that ACB is a good postoperative analgesic choice for arthroscopic knee surgery under spinal anaesthesia. However, adding (8 mg)dexamethasone to(0.25%) bupivacaine in ACB provided better prolonged postoperative analgesia and less analgesic consumption than bupivacaine alone.

Low dose of liraglutide combined with metformin leads to a significant weight loss in Chinese Han women with polycystic ovary syndrome: a retrospective study

Background Polycystic ovary syndrome (PCOS) is the most common endocrine disorder with complex pathophysiological mechanism. It is reported that even a modest weight loss of 5–10% substantially may improve the reproductive and metabolic profile. This study aims to assess the efficacy of the low dose of liraglutide (0.6 mg QD) combined with metformin (0.85 mg BID) in weight loss in Chinese Han women with PCOS. Methods We included clinical data of 102 obese/overweight (≥18 years, body mass index ≥28 kg/m2 or ≥24 kg/m2) women who were diagnosed with PCOS from October 2016 to March 2018 in Wuhan Union Hospital initially. They were treated with dinae-35, low dose of liraglutide (0.6 mg QD) and metformin (0.85 mg BID) for 12 weeks. The demographic and clinical data were retrieved retrospectively, and weight loss was the main outcome measure. Student’s paired t-test and Wilcoxon rank sum test were used to compare the differences before and after therapy, p < 0.05 was considered statistically significant. Results Participants(n = 102)had lost a mean of 7.20 ± 3.42 kg of body weight (95%CI: 6.55–7.86, p < 0.001), and the mean reduction of BMI was 2.87 ± 1.36 kg/m2 (95%CI: 0.02–0.27, p < 0.001). A total of 88.24% of participants lost more than 5% of their body weight. Conclusion The combination of low dose of liraglutide and metformin was associated with significant reduction of body weight in Chinese Han women with PCOS. Additionally, a larger randomized double-blind multicenter controlled clinical trial is needed to confirm that. Trial registration The study was registered on http://www.chictr.org.cn as ChiCTR1900024384.

Effect of a specially formulated diet on progression of heart enlargement in dogs with subclinical degenerative mitral valve disease.

Previous studies in dogs with degenerative mitral valve disease (DMVD) have identified altered myocardial energy metabolism and oxidation, which might contribute to cardiac hypertrophy. Diets rich in medium chain fatty acids and antioxidants are a potential means of treatment. A previous clinical study found significantly smaller left atrial diameter (LAD) and left atrium-to-aorta diameter ratio (LA : Ao) in dogs with subclinical DMVD fed a specially formulated diet vs control diet for 6 months. A specially formulated diet will slow or arrest left heart enlargement in dogs with subclinical DMVD over 365 days. One hundred twenty-seven dogs with unmedicated subclinical DMVD; 101 dogs in the per protocol cohort. Randomized double-blinded controlled multicenter clinical trial. The study's primary composite outcome measure was the sum of percentage change in LAD and left ventricular internal dimension at end-diastole (LVIDd) at day 365. In the per protocol cohort, the outcome measure increased by 8.0% (95% confidence interval [CI], 2.9%-13.1%) in dogs receiving the test diet vs 8.8% (95% CI, 5.1%-12.5%) in dogs receiving control diet (P = .79). Neither component of the primary outcome measure was significantly different between groups (LAD, P = .65; LVIDd, P = .92). No difference was found in mitral valve E wave velocity (P = .36) or the proportion of dogs withdrawn from the study because of worsening DMVD and heart enlargement (P = .41). Feeding a specially formulated diet for 365 days was not associated with a significantly different rate of change of left heart size in dogs with subclinical DMVD as compared to control.

Effect of promethazine in cleft surgeries among Indian children.

The use of antihistamine therapy in children for the management of upper respiratory tract infections remains a topic of debate. In this study, we focused on evaluating the effectiveness of promethazine (Phenergan), a first-generation H1 receptor antagonist and sedative, in addressing preoperative and intra-operative sequelae in cleft surgeries. A single-centered, parallel, randomized, double-blinded controlled clinical trial was conducted on 128 children aged 2 to 4 years undergoing cleft palate surgery under general anesthesia. The case group received Phenergan syrup orally twice a day for three days, while the control group received a placebo. Primary outcomes measured preoperative anxiety levels using a children's fear scale, while secondary outcomes assessed preoperative sleep quality and cough rate through objective scales. Intraoperative heart rate was monitored using an ECG connected to a monitor. The results demonstrated that the administration of promethazine resulted in a 34% reduction in anxiety levels, a 46% reduction in cold and cough, a 38% improvement in sleep score, and stable heart rates throughout the surgery compared to the control group. Based on these findings, promethazine is considered a safe premedication option for children undergoing cleft palate surgeries; given its benefits outweigh its adverse effects.

Effects of dexmedetomidine at different dosages on perioperative haemodynamics and postoperative recovery quality in elderly patients undergoing hip replacement surgery under general anaesthesia: a randomized controlled trial

BackgroundDexmedetomidine could provide some advantages to prevent postoperative complications in elderly patients undergoing under general anaesthesia. However, dexmedetomidine inhibits haemodynamics to some extent due to its sympathetic inhibition.ObjectiveTo evaluate the effects of different doses of dexmedetomidine on haemodynamics during surgery and recovery after general anaesthesia in elderly patients undergoing hip replacement.MethodsThis was a prospective randomized double-blind controlled clinical trial. Eligible patients were randomly allocated into comparative groups (normal saline (NS) and midazolam (MD), n = 30) and dexmedetomidine groups at different doses (D0.25/D0.5/D0.75, n = 30). In the D0.25/D0.5/D0.75 groups, dexmedetomidine was administered at different initial loading doses (0.25/0.5/0.75 μg/kg for 15 min) following 0.5 μg/kg/h continuous infusion until the end of the operation. In the MD group, patients were administered 0.03 mg/kg midazolam at the beginning of anaesthesia induction.ResultsCompared to the MD and NS groups, there were significant decreases in MAP in the D0.5 and D0.75 groups at many time points, such as skin incision, end of operation, and from extubation until 30 min after extubation (P < 0.05); there were also significant decreases in HR in the D0.5 and D0.75 groups at time points including anaesthesia induction, end of operation, and from extubation to 2 h after operation (P < 0.05). In the D0.25 group, there were few differences in the changes in MAP and HR compared to the MD and NS groups during the entire perioperative period (P > 0.05). Moreover, the percentage of patients whose MAP and HR decreased > 20% of baseline was higher in the D0.75 and D0.5 groups than that in all other groups. Compared to the NS group, from the beginning to the end of the operation, the 95% confidence interval (CI) of RR for MAP below > 20% of baseline in the D0.5 and D0.75 groups was greater than 1. In particular, the CI of the RR in the D0.75 group was greater than 1 until the patient awoke from general anaesthesia (P < 0.05). In addition, the CI of the RR for HR below > 20% of baseline in the D0.5 group was greater than 1 compared to the NS group at the time of induction and extubation (P < 0.05). There was no significant difference in the possibility of developing hypotension or bradycardia in the MD or D0.25 groups compared to the NS group (P > 0.05). The recovery quality of patients during the post-anaesthesia period was also observed. No differences were observed among all the groups in the time to awakening or extubation after general anaesthesia (P > 0.05). According to the Riker Sedation-agitated Scale, dexmedetomidine significantly alleviated emergency agitation or delirium compared to NS (P < 0.05). In addition, the scores in the D0.5 and D0.75 groups were lower than those in the D0.25 group (P < 0.05).ConclusionDexmedetomidine could alleviate the agitation of elderly patients undergoing hip replacement after intravenous general anaesthesia combined with inhaled sevoflurane without delayed recovery. However, it is necessary to be vigilant about the haemodynamic inhibition of the drug at high dosages throughout the perioperative period. Dexmedetomidine 0.25–0.5 μg/kg as the initial loading dose followed by 0.5 μg/kg/h continuous infusion might provide comfortable recovery after general anaesthesia with slight haemodynamic inhibition.Trail registrationClinicalTrial.gov, No. NCT05567523. Registered 05 October 2022, https://clinicaltrials.gov/ct2/show/NCT05567523?term=NCT05567523&draw=2&rank=1.

Effects of cortico-cortical paired associative stimulation based on multisensory integration to brain network connectivity in stroke patients: study protocol for a randomized doubled blind clinical trial

Introduction: Brain has a spontaneous recovery after stroke, reflecting the plasticity of the brain. Currently, TMS is used for studies of single-target brain region modulation, which lacks consideration of brain networks and functional connectivity. Cortico-cortical paired associative stimulation (ccPAS) promotes recovery of motor function. Multisensory effects in primary visual cortex(V1) directly influence behavior and perception, which facilitate motor functional recovery in stroke patients. Therefore, in this study, dual-targeted precise stimulation of V1 and primary motor cortex(M1) on the affected hemisphere of stroke patients will be used for cortical visuomotor multisensory integration to improve motor function.MethodThis study is a randomized, double-blind controlled clinical trial over a 14-week period. 69 stroke subjects will be enrolled and divided into sham stimulation group, ccPAS low frequency group, and ccPAS high frequency group. All groups will receive conventional rehabilitation. The intervention lasted for two weeks, five times a week. Assessments will be performed before the intervention, at the end of the intervention, and followed up at 6 and 14 weeks. The primary assessment indicator is the ‘Fugl-Meyer Assessment of the Upper Extremity ’, secondary outcomes were ‘The line bisection test’, ‘Modified Taylor Complex Figure’, ‘NIHSS’ and neuroimaging assessments. All adverse events will be recorded.DiscussionCurrently, ccPAS is used for the modulation of neural circuits. Based on spike-timing dependent plasticity theory, we can precisely intervene in the connections between different cortices to promote the recovery of functional connectivity on damaged brain networks after stroke. We hope to achieve the modulation of cortical visuomotor interaction by combining ccPAS with the concept of multisensory integration. We will further analyze the correlation between analyzing visual and motor circuits and explore the alteration of neuroplasticity by the interactions between different brain networks. This study will provide us with a new clinical treatment strategy to achieve precise rehabilitation for patient with motor dysfunction after stroke.Trial registrationThis trial was registered in the Chinese Clinical Trial Registry with code ChiCTR2300067422 and was approved on January 16, 2023.

SATELLITE IMAGE-DERIVED NEIGHBORHOOD CHARACTERICS EXPLAIN REGIONAL VARIATION IN CARDIOMETABOLIC DISEASE

We are aware of no study indicating the effects of synbiotic food consumption on metabolic profiles, inflammation and oxidative stress among diabetic patients. The aim of the current study was to investigate the effects of synbiotic food consumption on metabolic profiles, hs-CRP and biomarkers of oxidative stress in diabetic patients.This randomized double-blinded cross-over controlled clinical trial was performed among 62 diabetic patients aged 35–70 y. After a 2-wk run-in period, subjects were randomly assigned to consume either a synbiotic (n = 62) or control food (n = 62) for 6 weeks. A 3-week washout period was applied following which subjects were crossed over to the alternate treatment arm for an additional 6 weeks. The synbiotic food consisted of a probiotic viable and heat-resistant Lactobacillus sporogenes (1 × 107 CFU), 0.04 g inulin (HPX) as prebiotic with 0.38 g isomalt, 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food (the same substance without probiotic bacteria and prebiotic inulin) was packed in identical 9-gram packages. Patients were asked to consume the synbiotic and control foods three times a day. Fasting blood samples were taken at baseline and after a 6-wk intervention to measure metabolic profiles, hs-CRP and biomarkers of oxidative stress.Consumption of a synbiotic food, compared to the control, resulted in a significant decrease in serum insulin levels (changes from baseline: −1.75 ± 0.60 vs. +0.95 ± 1.09 μIU/mL, P = 0.03). Although we failed to find a significant effect of synbiotic food consumption on total- and LDL-cholesterol levels and HOMA-IR, the effects on FPG (22.3 vs. 4.2 mg/dL, P = 0.09), serum triglycerides (45.9 vs. 20.6 mg/dL, P = 0.08) and HDL-cholesterol levels (3.1 vs. −2 mg/dL, P = 0.06) tended to be significant. A significant reduction in serum hs-CRP levels (−1057.86 ± 283.74 vs. 95.40 ± 385.38 ng/mL, P = 0.01) was found following the consumption of synbiotic food compared with the control group. Supplementation with the synbiotic food led to a significant increase in plasma total GSH (319.98 vs. 19.73 μmol/L, P < 0.001) and serum uric acid levels (+0.7 vs. −0.1 mg/dL, P = 0.04) compared to the control food. No significant effect of the synbiotic food was observed on plasma TAC levels.In conclusion, consumption of a synbiotic food for 6 weeks among diabetic patients had significant effects on serum insulin, hs-CRP, uric acid and plasma total GSH levels.Clinical trial registration number: www.irct.ir: IRCT201201195623N1.

The effect of Brazilian Green Propolis extract on inflammation in patients with chronic kidney disease on peritoneal dialysis: A randomised double-blind controlled clinical trial

BackgroundChronic kidney disease (CKD) patients on dialysis display a low-grade systemic inflammatory burden. Nutritional interventions designed to activate the cytoprotective nuclear factor erythroid-2-related factor 2 (Nrf2) and inhibit nuclear factor-kB (NF-κB) have been proposed to mitigate this burden. Several bioactive compounds have been investigated to achieve this, including propolis, a resin produced by Apis mellifera bees. Considering the safety and efficacy of propolis, it could be a strategy to benefit these patients. Still, there are no studies using propolis in patients with CKD on peritoneal dialysis (DP), and clinical studies to support this application are lacking. Hypothesis/PurposeThe objective and novelty of the present study are to evaluate the effects of propolis supplementation on inflammatory markers in patients with CKD on PD. Study designA longitudinal, double-blind, placebo-controlled trial with CKD patients on PD. MethodsThe patients were randomised into two groups: propolis that received four capsules of 100 mg (400 mg/day), containing concentrated and standardised dry EPP-AF® Brazilian green propolis extract) or placebo, four capsules of 100 mg (400 mg/day), of magnesium stearate, silicon dioxide, and microcrystalline cellulose, for two months. Plasma levels of inflammatory cytokines, including tumour necrosis factor (TNF-α) and interleukin-6 (IL-6), were evaluated by ELISA. Quantitative real-time PCR analyses were performed to evaluate the transcriptional expression levels of Nrf2 and NF-κB in peripheral blood mononuclear cells (PBMCs). Plasma malondialdehyde (MDA) levels, a lipid peroxidation marker, was measured as thiobarbituric acid reactive substances (TBARS). Routine biochemical markers, including C-reactive protein (CRP), were analysed using commercial kits. Carotid Intima-Media Thickness (CIMT) was measured with a doppler ultrasonography device. The study was registered on ClinicalTrials.gov under the number NCT04411758. ResultsA total of 19 patients completed the study, ten patients in the propolis group (54 ± 1.0 years, five men, 7.2 (5.1) months on PD) and 9 in the placebo group (47.5 ± 15.2 years, three men, 10.8 (24.3) months on PD). The plasma levels of TNF-α reduced significantly (p = 0.02), and expression of Nrf2 showed a trend to increase (p = 0.07) after propolis supplementation. ConclusionEPP-AF® Green Propolis extract (400 mg/day) supplementation for two months appears as a potential strategy to mitigate inflammation, reducing TNF-α plasma levels in CKD patients on PD.

Efficacy of Oral Dextrose versus Acetaminophen versus Placebo on Pain Relief during Retinopathy of Prematurity Eye Examinations: A Randomized, Double-Blind Controlled Clinical Trial.

To assess the effect of oral dextrose versus acetaminophen versus placebo in pain relief in retinopathy of prematurity (ROP) examination. In this prospective randomized, double-blind controlled clinical trial study performed in the ophthalmology clinic of Shafa Hospital (referral hospital for eye disease), Kerman, Iran, 105 premature neonates with birth weight ≤2000 g and gestational age between 28 and 34 weeks were studied. Pain score measurement with Premature Infant Pain Profile-Revised (PIPP-R) during ROP examination in three intervention groups, acetaminophen group (15 mg/kg oral acetaminophen), dextrose group (one cc of oral dextrose 50%), and placebo group (one cc of distilled water), was done. Out of 105 infants, 33 infants received acetaminophen drops, 35 infants received dextrose drops, and 37 infants received placebo. The mean pain score of the group receiving acetaminophen was 11.39, dextrose 12.17, and placebo 11.54. The acetaminophen group had a lower average PIPP-R score. This difference was not significant between the three groups (P = 0.38). Acetaminophen and dextrose in comparison with distilled water did not show a significant difference in reducing neonatal pain during ROP examinations. However, the PIPP-R score in the acetaminophen group was lower compared to the other groups.

Effects of propolis on inflammation markers in patients undergoing hemodialysis: A randomized, double-blind controlled clinical trial

Background and aimsSeveral studies have been performed in vitro and in animals showing that propolis (a resin made by bees) has excellent anti-inflammatory properties, but no study has been performed in patients with chronic kidney disease (CKD) on hemodialysis (HD). The present study aimed to evaluate the effects of propolis supplementation on inflammatory markers in patients with CKD on HD. MethodsThis is a longitudinal, double-blind, placebo-controlled trial with patients randomized into two groups: propolis (4 capsules of 100 mg/day containing concentrated and standardized dry EPP-AF® green propolis extract) or placebo (4 capsules of 100 mg/day containing microcrystalline cellulose, magnesium stearate and colloidal silicon dioxide) for two months. Routine parameters were analyzed using commercial kits. The plasma levels of inflammatory cytokines were evaluated by flow luminometry. ResultsForty-one patients completed the follow-up, 21 patients in the propolis group (45 ± 12 years, 13 women, BMI, 22.8 ± 3.7 kg/m2) and 20 in the placebo group (45.5 ± 14 years, 13 women, BMI, 24.8 ± 6.8 kg/m2). The obtained data revealed that the intervention with propolis significantly reduced the serum levels of tumour necrosis factor α (TNFα) (p = 0.009) as well as had the tendency to reduce the levels of macrophage inflammatory protein-1β (MIP-1β) (p = 0.07). There were no significant differences in the placebo group. ConclusionShort-term EPP-AF® propolis dry extract 400 mg/day supplementation seems to mitigate inflammation, reducing the plasma levels of TNFα and MIP-1β in patients with CKD on HD. This study was registered at clinicaltrials.gov (NCT04411758).

Comparison of the effects of preoperative celecoxib and gabapentin on pain, functional recovery, and quality of life after total knee arthroplasty: A randomized controlled clinical trial.

Acute pain is one of the main complaints of patients after total knee arthroplasty (TKA), which causes delayed mobility, increased morphine consumption, and subsequently increased costs. Therefore, the present study was performed to evaluate the preventive effect of preoperative celecoxib and gabapentin on reducing patient pain as a primary outcome after TKA surgery. This randomized, double-blind controlled clinical trial was performed on 270 patients with osteoarthritis that were candidates for TKA surgery allocated into three groups. In the first group, 900 mg of gabapentin was administered orally on a daily basis for 3 days before surgery. In the second group, 200 mg of oral celecoxib was administered twice daily for 3 days before surgery. In the third group, oral placebo was administered twice daily for 3 days before the surgery. The patients' pain score and knee and its functional score were recoded. The mean of reduction pain in gabapentin and celecoxib groups was significantly lower than that of the control group at 12, 24, and 48 h after surgery (P < 0.001); however, two groups were not significantly different from each other (P > 0.05). Furthermore, the two medication groups were not significantly different in this regard (P > 0.05). In addition, the knee score in the gabapentin group with the means of 85.40 ± 5.47 and the celecoxib group with the means of 87.03 ± 3.97 were significantly higher than those of the control group with the means of 78.90 ± 4.39 in the 1st month after the surgery (P < 0.001). According to the results of the present study, the preventive administration of gabapentin and celecoxib showed a significant and similar effectiveness on reducing patient pain after TKA surgery and on improving the KSS and quality of life scores.

Prophylaxis Effect of Metronidazole Vaginal Gel in Decreasing the Risk of Surgical Site Infections after Elective Hysterectomy.

Infections are an important cause of morbidity and mortality after hysterectomy. Here, we aimed to investigate and evaluate the beneficial effects of metronidazole vaginal gel on the rate of surgical site infections in women undergoing elective abdominal hysterectomy. This is a randomized prospective, double-blind controlled clinical trial performed in 2020 in Isfahan on 108 candidates for elective hysterectomy. At the beginning of the study, we completed a checklist of the patient's characteristics (patient age, body mass index [BMI], and history of medical conditions such as diabetes, hypertension, anemia, and immune deficiency) and the cause of hysterectomy. All patients were randomized into two groups. The first group received a lubricant vaginal gel single dosage, and the second group received a 0.75% metronidazole vaginal gel single dosage the night before surgery. Patients were visited up to 6 weeks after surgery, and the frequency of infection at the surgical site was determined. The rates of infection were lower in patients who received metronidazole vaginal gel (5.8%) compared to the control group (11.6%) (P = 0.03). Patients with an estimated blood loss volume of more than 500 mL had higher rates of infection (13.46%) compared to patients with a bleeding volume of fewer than 500 mL (1.9%) (P = 0.001). We also found that patients with diabetes (13.5%) and patients with BMI more than 30 kg/m2(13.5%) had higher rates of infection compared to patients without diabetes (5.8%) and patients with BMI <30 kg/m2 (11.5%) (P = 0.001 for both). Patients with higher hospitalization duration had higher infection rates (P = 0.009). Administration of a single dosage of metronidazole vaginal gel before abdominal hysterectomy may reduce surgical site infection and have clinical values.

Examination of the Topical Effect of the Combination of Plantago ovata and Vinegar on the Improvement of Rural Cutaneous Leishmaniasis Lesions.

The present study aimed at investigating the topical effect of the combination of Plantago ovata and vinegar on the improvement of rural cutaneous leishmaniasis lesions. The present randomized double-blind controlled clinical trial was performed on 42 patients with rural skin leishmaniasis. In the case group, in addition to injecting glucantime into the lesion according to the latest national instructions, a combination of P. ovata and vinegar was applied topically twice a day for 8 weeks. In the control group, only glucantime injection into the lesion was performed for 8 weeks according to the latest national guidelines. At the end of the 1st, 2nd, 3rd, 4th, 8th, and 12th weeks after the intervention, the lesion area and improvement were evaluated and recorded. The results of the present study indicated the lesion area in the case group with the mean of 0.35 ± 0.39 cm and 0.18 ± 0.27 cm in the 8th and 12th weeks, respectively was significantly less than that of the control group with the mean of 0.64 ± 0.78 cm and 0.56 ± 0.44, respectively (P < 0.05). Twelve weeks after the intervention, 84.1% of the lesions in the case group and 65.9% of the lesions in the control group were completely improved (P < 0.05). According to the results of the present study, the improvement of leishmaniasis lesion with the topical application of the combination of P. ovata and vinegar was significantly more than that of the control group in the 8th and 12th weeks after the intervention.