Double-blind Randomized Clinical Trial Research Articles

The effects of virtual reality training on postural sway and physical function performance on older women with chronic low back pain: A double-blind randomized clinical trial.

Chronic low back pain (CLBP) is known as an important debilitating health condition among older women. This study aimed to evaluate the effects of eight-week virtual reality training (VRT) exercises on postural sway and physical function performance (PFP) among older women suffering from CLBP. Twenty-seven older women presenting with CLBP were randomized into experimental and control groups. The experimental group was instructed to perform 30-minute VRT exercises three times a week for eight weeks. Plantar pressure variables [sway velocity (SV) and anterior-posterior (AP) and medial-lateral (ML) fluctuations of the center of pressure (CoP)], 30-second chair stand test (30CST), and timed up and go (TUG) test were recorded. The VRT group exhibited significant decreases in SV (p= 0.002), AP (p= 0.008), and ML (p= 0.02) fluctuations. Also, the performance of the VRT group in the 30CST and TUG tests significantly improved after the exercises (P< 0.001). According to the results, VRT and the program used in this study should be used to enhance balance and PFP in older women with CLBP who mostly prefer activities that are accessible and feasible in low-risk environments.

Pregnancy outcomes in pregnant women taking oral probiotic undergoing cerclage compared to placebo: two blinded randomized controlled trial

AimThe purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo.MethodsThis study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by “block” randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute).ResultsResults show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn’s weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth.ConclusionOur result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.

Evaluation of the effect of Modafinil in the improvement of the level of consciousness in patients with COVID-19 encephalopathy: A randomized controlled trial.

COVID-19 can lead to encephalopathy and loss of consciousness. This double-blinded randomized clinical trial conducted in Tehran, Iran, aimed to assess the potential effectiveness of modafinil in patients with COVID-19-related encephalopathy. Nineteen non-intubated COVID-19 patients with encephalopathy were randomized into two groups: a treatment group receiving crushed modafinil tablets and a placebo group receiving starch powder. Modafinil was administered at a dose of 100 mg every 2 h, reaching a peak dosage of 400 mg. The level of consciousness was assessed using the Glasgow Coma Score (GCS) at multiple time points on the day of medication administration. The trial was registered under IRCT20170903036041N3 on 23/5/2021. The average age in the modafinil and placebo groups was 75.33 and 70 years, respectively. No significant differences were observed between the two groups in terms of chronic conditions, clinical symptoms, or laboratory data. GCS scores were similar between the groups at baseline (p-value = 0.699). After four doses of modafinil, GCS scores were slightly higher in the treatment group, but this difference was not statistically significant (p-value = 0.581). GCS scores after each round of drug administration didn't significantly differ between the treatment and placebo groups (p-value = 0.908). Modafinil exhibited a slight improvement in the level of consciousness among COVID-19 patients with encephalopathy, although this improvement did not reach statistical significance when compared to the control group. Further research with larger sample sizes and longer treatment durations is recommended to explore modafinil's potential benefits in managing altered consciousness in COVID-19 patients.

Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes

The prevalence of e-cigarette use among US adults, especially young adults, is rising. Many would like to quit vaping nicotine but are unable to do so. Cytisinicline, a plant-based alkaloid, targets nicotinic acetylcholine receptors, reduces nicotine dependence, and helps adults to stop smoking cigarettes. Cytisinicline may also help e-cigarette users to quit vaping. To determine the efficacy and safety of cytisinicline vs placebo to produce abstinence from e-cigarette use in adults seeking to quit vaping nicotine. This double-blind placebo-controlled randomized clinical trial compared 12 weeks of treatment with cytisinicline vs placebo, with follow-up to 16 weeks. It was conducted from July 2022 to February 2023 across 5 US clinical trial sites. A total of 160 adults who vaped nicotine daily, sought to quit, and did not currently smoke cigarettes were enrolled, and 131 (81.9%) completed the trial. Participants were randomized (2:1) to cytisinicline, 3 mg, taken 3 times daily (n = 107) or placebo (n = 53) for 12 weeks. All participants received weekly behavioral support. Biochemically verified continuous e-cigarette abstinence during the last 4 weeks of treatment (weeks 9-12; primary outcome) and through 4 weeks posttreatment (weeks 9-16; secondary outcome). Missing outcomes were counted as nonabstinence. Of 160 randomized participants (mean [SD] age, 33.6 [11.1] years; 83 [51.9%] female), 115 (71.9%) formerly smoked (≥100 lifetime cigarettes). Continuous e-cigarette abstinence in cytisinicline and placebo groups occurred in 34 of 107 participants (31.8%) vs 8 of 53 participants (15.1%) (odds ratio, 2.64; 95% CI, 1.06-7.10; P = .04) at end of treatment (weeks 9-12) and in 25 of 107 participants (23.4%) vs 7 of 53 participants (13.2%) during weeks 9 to 16 (odds ratio, 2.00; 95% CI, 0.82-5.32; P = .15). There was no evidence, based on nonsignificant interactions, that cytisinicline efficacy differed in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence, or smoking history. Cytisinicline was well tolerated, with 4 participants (3.8%) discontinuing cytisinicline due to an adverse event. In this randomized clinical trial, cytisinicline for 12 weeks, with behavioral support, demonstrated efficacy for cessation of e-cigarette use at end of treatment and was well tolerated by adults, offering a potential pharmacotherapy option for treating nicotine e-cigarette use in adults who seek to quit vaping. These results need confirmation in a larger trial with longer follow-up. ClinicalTrials.gov Identifier: NCT05431387.

The Effect of Oral Gabapentin and Pregabalin as a Prodrug in Pain Control after Orthopedic Surgery on the Upper Limb: A Double-Blind Parallel Randomized Clinical Trial Study.

To compare the effects of oral gabapentin (GBP) and pregabalin (PGB) in pain control after orthopedic surgery on the upper limb. In this double-blind randomized clinical trial study, 80 patients who were the candidates for elective orthopedic surgery on one of the parts of the upper limb were divided into two groups using balance-block randomization. For the first group, a 150 mg capsule of PGB (one hour before the surgery) and for the second group, a 300 mg capsule of GBP (two hours before the surgery) were prescribed. Patients were subjected to standard monitoring at the beginning and during surgery. The pain scores were evaluated at before surgery, in PACU (postanesthesia care unit), and 6 and 12 hours after the surgery by VAS (visual analog scale). In this study, 37 subjects were allocated to each group. The participation rate was 92.5%. The mean with 95% confidence interval (CI) of pain scores over 4 times in the PGB group was 4.03 (3.25-4.79), 3.76 (3.02-4.49), 3.65 (3.06-4.23), and 3.41 (2.88-3.93) and in the GBP group was 4.08 (3.33-4.83), 2.78 (2.11-4.45), 2.3 (2.05-2.54), and 2 (1.51-2.50), respectively. The within-group comparisons showed a significant decrease in the pain score over time (P < 0.001). Also, the between-group comparison showed significant differences between the two groups in terms of pain score (P < 0.001). In the end, results showed that there is a significant interaction between time and intervention for pain score (P=0.042). Although two medicines led to a reduction in the pain score, but the rate reduction in the PGB group was significantly more than that in the GBP group. This trial is registered with IRCT20211013052759N1.

The effect of selenium supplementation on oxidative stress, clinical and physiological symptoms in patients with migraine: a double-blinded randomized clinical trial

Background and AimThe present double-blinded randomized clinical trial aimed to investigate the effect of selenium supplementation on oxidative stress, clinical, and physiological symptoms in patients with migraine.MethodsIn total, 72 patients with migraine were randomly assigned to receive either 200 μg/day selenium (n = 36) or placebo (n = 36) for 12 weeks. Clinical traits of migraine (e.g., severity, frequency, and duration of headaches), mental health indices (e.g., depression, anxiety, and distress), quality of life, biomarkers of oxidative stress (e.g., nitric oxide [NO], malondialdehyde [MDA], total antioxidant capacity [TAC], total oxidant status [TOS]), and anthropometric indices were assessed at baseline and at the end of the study.ResultsSelenium supplementation resulted in a significant reduction in NO (−1.24 ± 0.43 vs. 0.16 ± 0.43; p = 0.03) levels and a significant increase in TAC (9.89 ± 2.50 vs. −0.18 ± 2.50; p = 0.01) compared to the placebo group. Moreover, selenium supplementation had a significant protective effect against MDA levels compared to placebo (0.33 ± 0.57 vs. 1.83 ± 0.57; p = 0.03). In addition, selenium intake was associated with a lower headache frequency (−8.15 ± 0.77 vs. −4.12 ± 0.77; p &amp;lt; 0.001) and severity (−2.89 ± 0.42 vs. −1.16 ± 0.42; p = 0.01) as well as a lower Headache Impact Test-6 (HIT-6) score (−9.22 ± 2.00 vs. −2.08 ± 2.00; p = 0.02) compared to the controls. For other outcome variables, we found no significant effect.ConclusionSelenium supplement may be considered a complementary therapy in patients with migraine due to its beneficial effects on oxidative stress and migraine symptoms. Further studies are needed to affirm our findings.Clinical Trial Registration: This study was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir) on 27 May 2023 with code number of IRCT20121216011763N60.

Comparison of the dural puncture epidural and the standard epidural techniques in patients having labor analgesia maintained using programmed epidural boluses: a prospective double-blinded randomized clinical trial

BackgroundThe dural puncture epidural technique has been shown in some studies to improve the onset and quality of the initiation of labor analgesia compared with the standard epidural technique. However,...

Impact of Probiotics on Gastrointestinal Function and Metabolic Status After Roux-en-Y Gastric Bypass: A Double-Blind, Randomized Trial.

Postoperative changes in gut microbiota may occur in patients undergoing Roux-en-Y gastric bypass surgery. In this study, we evaluate the impact of administering probiotic tablets on the gastrointestinal function and metabolic status of these patients. This double-blinded randomized clinical trial was conducted from 2021 to 2022 on 135 Roux-en-Y surgery candidates. The intervention group underwent the surgical procedure and started receiving probiotic supplements (Familact Co.) 1 week after surgery; the control group received a placebo. The laboratory and anthropometric data were measured and analyzed before and 3 and 6 months after the intervention. GIQLI questionnaire was also used at the beginning and 6 months after the intervention to evaluate GI symptoms. We observed significantly reduced BMI in both groups after surgeries (P < 0.001). The levels of FBS and HbA1C were significantly lower in the probiotic group compared to the placebo in 3 months (P = 0.02 and P = 0.001, respectively) and 6months (P < 0.001 for both) after the intervention. The levels of vitamin B12 increased significantly in the probiotic group (P < 0.001), and the values were substantially higher than the placebo group in 3 and 6 months (P < 0.001), respectively. Analysis of the GIQLI questionnaire before and 6 months after interventions also revealed significant improvement in the GIQLI score in both groups (P < 0.001 for probiotics and P = 0.03 for placebo). Probiotic supplement administration following RYGB improves patients' vitamin and metabolic profile, as well as GI function, although it cannot significantly affect weight loss.

The Mexican dataset of a repetitive transcranial magnetic stimulation clinical trial on cocaine use disorder patients: SUDMEX TMS

Cocaine use disorder (CUD) is a global health problem with severe consequences, leading to behavioral, cognitive, and neurobiological disturbances. While consensus on treatments is still ongoing, repetitive transcranial magnetic stimulation (rTMS) has emerged as a promising approach for medication-resistant disorders, including substance use disorders. In this context, here we present the SUDMEX-TMS, a Mexican dataset from an rTMS clinical trial involving CUD patients. This longitudinal dataset comprises 54 CUD patients (including 8 females) with data collected at five time points: baseline (T0), two weeks (T1), three months (T2), six months (T3) follow-up, and twelve months (T4) follow-up. The clinical rTMS treatment followed a double-blinded randomized clinical trial design (n = 24 sham/30 active) for 2 weeks, followed by an open-label phase. The dataset includes demographic, clinical, and cognitive measures, as well as magnetic resonance imaging (MRI) data collected at all time points, encompassing structural (T1-weighted), functional (resting-state fMRI), and multishell diffusion-weighted (DWI-HARDI) sequences. This dataset offers the opportunity to investigate the impact of rTMS on CUD participants, considering clinical, cognitive, and multimodal MRI metrics in a longitudinal framework.

Effects of focal vibration on changes in sports performance in amateur athletes: A randomized clinical trial.

The aim of this study was to evaluate the effectiveness of a focal vibration protocol added to an activation protocol with active muscle contractions and to see what repercussions it has on sprint, countermovement jump (CMJ), and lower limb isometric strength. A double-blind randomized clinical trial was conducted in the Functional Anatomy Laboratory and the sample consisted of 70 athletes. The main outcome measures were knee extension force, CMJ, sprint, and surface electromyography. Repeated-measures analysis of variance revealed significant improvements. They were found in the within-group analysis for the Experimental Group in the isometric extension force (p < 0.001; η2 = 0.368), CMJ (p < 0.001; η2 = 0.301) and 30 m sprint (p < 0.001; η2 = 0.376). In the electromyography, there are changes in the Sham Group in all muscles, in CMJ and Sprint tests, and no differences in the Experimental Group, except for the RF muscle. In the between-group analysis, statistically significant differences were found only in favor of the Experimental Group in CMJ (p = 0.017; η2 = 0.81) and 30 m sprint (p < 0.001; η2 = 0.152). These results confirm a significant improvement in the sprint, CMJ performance, and quadriceps strength, after a focal vibration protocol, added to a muscle active contraction, compared to a focal vibration sham protocol. Therefore, our results suggest that the focal vibration can be a very useful tool in sports involving high-powered actions.

The Effect of Depth of Anesthesia on Postoperative Pain in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial

BackgroundPatients with obesity are more sensitive to pain and more likely to have acute postoperative pain (APP). Studies have shown that the depth of anesthesia may affect the incidence of APP. The purpose of the study was to look into the connection between APP and depth of anesthesia in patients with obesity undergoing laparoscopic sleeve gastrectomy.MethodsThis is a prospective, double-blinded randomized clinical trial, 90 patients undergoing laparoscopic sleeve gastrectomy were randomly divided into two groups: the light anesthesia group (Bispectral Index of 50, BIS 50) and the deep anesthesia group (BIS 35). The degree of pain was evaluated by the visual analogue scale (VAS) at 0, 12, 24, 48, and 72 h after surgery. The use of analgesics, grade of postoperative nausea and vomiting (PONV), and the Quality of Recovery-15 (QoR-15) score were recorded.ResultsThe VAS scores at rest or coughing at 0, 12, and 24 h after surgery in the BIS 35 group were lower than those in the BIS 50 group (P < 0.05). Fewer patients in the deep anesthesia group needed analgesia during the recovery period, and patient satisfaction was higher on the 3rd day after surgery (P < 0.015, P < 0.032, respectively).ConclusionsFor patients with obesity, maintaining a deeper depth of anesthesia during surgery is beneficial to reduce APP causes less need for additional analgesic drugs, and improves patient satisfaction.Graphical

The effect of curcumin and high-content eicosapentaenoic acid supplementations in type 2 diabetes mellitus patients: a double-blinded randomized clinical trial.

The present study investigated the effect of curcumin and eicosapentaenoic acid, as one the main components of omega-3 polyunsaturated fatty acids, on anthropometric, glucose homeostasis, and gene expression markers of cardio-metabolic risk in patients with type 2 diabetes mellitus. This clinical trial was conducted at the Endocrinology Clinic of Imam Reza Hospital in Tabriz. It aimed to determine the impact of Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), and curcumin supplements on various health indicators in patients with Type 2 Diabetes Mellitus (DM2) from 2021.02.01 to 2022.02.01. The study was a randomized double-blinded clinical trial and conducted over 12 weeks with 100 participants randomly divided into four groups. Stratified randomization was used to assign participants to two months of supplementation based on sex and Body Mass Index (BMI). The study comprised four groups: Group 1 received 2 capsules of 500 mg EPA and 200 mg DHA, along with 1 nano-curcumin placebo; Group 2 received 1 capsule of 80 mg nano-curcumin and 2 omega 3 Fatty Acids placebos; Group 3 received 2 capsules of 500 mg EPA and 200 mg DHA, and 1 capsule of 80 mg nano-curcumin; Group 4, the control, received 2 omega 3 Fatty Acids placebos and 1 nano-curcumin placebo. After twelve weeks of taking EPA + Nano-curcumin supplements, the patients experienced a statistically significant reduction in insulin levels in their blood [MD: -1.44 (-2.70, -0.17)]. This decrease was significantly greater than the changes observed in the placebo group [MD: -0.63 (-1.97, 0.69)]. The EPA + Nano-curcumin group also showed a significant decrease in High-Sensitivity C-Reactive Protein (hs-CRP) levels compared to the placebo group (p < 0.05). Additionally, the EPA + Nano-curcumin group had a significant increase in Total Antioxidant Capacity (TAC) levels compared to the placebo group (p < 0.01). However, there were no significant differences in Fasting Blood Sugar (FBS), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, Quantitative Insulin Sensitivity Check Index (QUICKI), or Hemoglobin A1c (HbA1C) levels between the four groups (all p > 0.05). There were significant differences between the Nano-curcumin and EPA groups [MD: -17.02 (-32.99, -1.05)], and between the Nano-curcumin and control groups [MD: -20.76 (-36.73, -4.79)] in terms of lowering the serum cholesterol level. The difference in Triglycerides (TG) serum levels between the EPA + Nano-curcumin and placebo groups were not statistically significant (p = 0.093). The Nano-curcumin group showed significant decreases in Low-Density Lipoprotein (LDL) levels compared to the EPA group [MD: -20.12 (-36.90, -3.34)] and the control group [MD: -20.79 (-37.57, -4.01)]. There was a near-to-significant difference in High-Density Lipoprotein (HDL) serum levels between the EPA + Nano-curcumin and EPA groups (p = 0.056). Finally, there were significant differences in the decrease of serum Vascular Endothelial Growth Factor (VEGF) levels between the EPA and Nano-curcumin groups [MD: -127.50 (-247.91, -7.09)], the EPA and placebo groups [MD: 126.25 (5.83, 246.66)], the EPA + Nano-curcumin and Nano-curcumin groups [MD: -122.76 (-243.17, -2.35)], and the EPA + Nano- curcumin and placebo groups [MD: 121.50 (1.09, 241.92)]. The findings of the present study suggest that 12-week supplementation with EPA and Nano-curcumin may positively impact inflammation, oxidative stress, and metabolic parameters in patients with diabetes. The supplementation of EPA and Nano-curcumin may be a potential intervention to manage diabetes and reduce the risk of complications associated with diabetes. However, further research is needed to validate the study's findings and establish the long-term effects of EPA and Nano-curcumin supplementation in patients with diabetes.

Clinical trial of tolerability, safety and immunogenicity of influenza inactivated split-vaccine Flu-M in children aged 6 to 17 years

Purpose. To evaluate the tolerability, safety and immunogenicity of influenza inactivated split flu vaccine Flu-M during single immunization of children aged 6 to 17 years.Materials and methods. A multicentre double-blind comparative randomised clinical trial of influenza inactivated split vaccine Flu-M for immunisation of children aged 6 to 17 years (the reference agent – Ultrix vaccine) was conducted. Children aged 12 to 17 years inclusive (300 children) were studied at stage I, and children aged 6 to 12 years (300 children) at stage II. Volunteers of each age category were randomised 1:1 into 2 groups comparable in sex and age, one was vaccinated with Flu-M vaccine and the other with Ultrix vaccine. The follow-up, including various laboratory and clinical tests, lasted for 28 days from the time of vaccination.Results. Both vaccines were well tolerated by children aged 12 to 17 years and by children aged 6 to 12 years. There were no severe or serious adverse events. By all criteria of immunogenicity evaluation, vaccine Flu-M was not inferior to the comparison vaccine Ultrix.Conclusion. Influenza inactivated split Flu-M vaccine produced by SPbNIIVS is approved for use for specific prophylaxis of influenza in children aged 6 to 17 years in the Russian Federation, the Republic of Belarus, Latin America and the Caribbean.The trial is registered at ClinicalTrials. gov (NCT 05317767).

Outcome and Prognostic Factors for Partial and Full Pulpotomy in the Management of Spontaneous Symptomatic Pulpitis in Carious Mature Permanent Teeth: A Randomized Clinical Trial

IntroductionThe aim of this study was to compare the outcome and prognostic factors for partial and full pulpotomy in the management of mature teeth with spontaneous symptomatic pulpitis. MethodsThe study was a parallel double-blind randomized clinical trial; 200 carious mature permanent teeth with spontaneous symptomatic pulpitis were randomized using a block randomization technique to either partial pulpotomy (n = 99) or full pulpotomy (n = 101). Intraoperative assessment of the pulp under magnification was performed, hemostasis was achieved with a 2.5% sodium hypochlorite moist pellet, and NeoPUTTY (Avalon Biomed, Bradenton, FL) was the pulpotomy material. Preoperative pain levels were recorded and re-evaluated after 1 week. Clinical and radiographic evaluation was performed after 6 and 12 months. Data were analyzed using the chi-square test, the Wilcoxon rank test, and regression analysis. ResultsAt 1 week, immediate failure occurred in 4 cases in partial pulpotomy, and 196 of 200 subjects reported pain relief and were satisfied with the treatment with no significant difference. At 6 months, 6 teeth failed in the partial pulpotomy group and 1 tooth in the full pulpotomy group, with a higher success rate for full pulpotomy (98.96 vs 89.69, P = .003). At 12 months, the recall rate was 98% (96/200). Full pulpotomy was more successful than partial pulpotomy (98.98% [98/99] vs 84.53% [82/97], P < .001). Multivariate analysis revealed that the odds of success for full pulpotomy were 13.6 times higher than partial pulpotomy. Increased age and higher time to hemostasis were significantly associated with decreased odds of success. ConclusionsFull pulpotomy has a higher success rate than partial pulpotomy in the management of spontaneous symptomatic pulpitis. Hemostasis within 4 minutes in partial pulpotomy can be set as the cutoff point beyond which further tissue removal is indicated.

Effectiveness of Combined Treatment of Transcranial Direct Current Stimulation and Treatment as Usual on Depression, Anxiety and Anger in Adolescents with Bipolar Disorder

Objectives: Bipolar disorder (BD) is a prevalent psychological disorder associated with depressive symptoms. Transcranial direct current stimulation (tDCS) is a portable and non-invasive technique for brain stimulation. The present study was conducted to determine the effectiveness of the combined treatment of tDCS and routine medication on the symptoms of depression, anxiety, and anger in BD adolescents. Methods: In this double-blind randomized clinical trial study, forty adolescents with BD referred to the outpatient clinic of child and psychiatry of Golestan Ahvaz Teaching Hospital were included. Eligible patients aged 12 - 18 years were randomly divided into 2 groups receiving routine medications plus active tDCS (intervention group) or routine medications plus sham tDCS (control group). Transcranial direct current stimulation intervention with an intensity of 2 mA was applied to the dorsolateral prefrontal cortex in two sessions for 20 minutes each day, for 5 consecutive days. Data were collected at baseline, one week, and one month after the start of the intervention using the Hamilton Depression Rating Scale (HDRS-21), Hamilton Anxiety Rating Scale (HDRS), and State-Trait Anger Expression Inventory. Results: Based on our findings, age and gender were not considerably different between the two groups (P = 0.592, P = 0.1, respectively). In both groups, scores of depression (control: 12.25 ± 3.97, intervention: 0.75 ± 1.44, mean [SD]), anxiety (13.55 ± 2.58, 25.0 ± 0.55), and anger (52.65 ± 8.27, 47.25 ± 4.86) improved significantly one month after treatment (P &lt; 0.0001). After one month of treatment, the severity of bipolar symptoms in the intervention group (slightly: 10%, moderately: 50%, and markedly: 40%) improved significantly compared to the control group (slightly: 15%, moderately: 10%, and markedly: 0%) (P &lt; 0.0001). The improvement rate of HDRS in the intervention group was 81.29% and 95.24% at one week and one month after treatment, while these values were 8.41% and 23.04% in the control group, respectively (P &lt; 0.0001). All patients tolerated the treatment well without serious side effects. There was no significant difference between the side effects observed in both groups (P = 0.185). Conclusions: The combination of tDCS with routine medications can reduce depressive symptoms and improve bipolar symptoms. Therefore, tDCS add-on could be an effective, safe, and tolerable intervention for bipolar depression.

Reduction of Surgical Bleeding During Lumbar Laminectomy with Pedicular Screw Using Oral Clonidine as a Premedication: A Randomized Comparative Study

Background: Spinal fusion surgeries are often associated with major blood loss. The aim of this study was to investigate the effect of oral clonidine as premedication on the amount of blood loss and the need for blood transfusion during lumbar laminectomy spine surgery with pedicle screw insertion, achieved by controlled hypotension. Methods: In this double-blind randomized clinical trial, 100 patients scheduled for lumbar spine laminectomy with pedicle screw insertion (as a fusion procedure) were included. Patients were classified into two groups: the intervention group received a 0.2 mg clonidine tablet one hour before entering the operating room, and the control group received a placebo. The patients were compared with respect to hemodynamic variables, quality of the surgical field, duration of the surgery, estimated amount of blood loss, and any blood transfusion. Results: Oral clonidine was found to be significantly better in terms of maintaining stable dynamics and having a lower amount of blood loss, thereby requiring fewer blood transfusions compared to the control group. Conclusions: Premedication with 0.2 mg oral clonidine in patients undergoing lumbar spine laminectomy with pedicle screw insertion results in improved perioperative hemodynamic stability and a reduction in the amount of intraoperative blood loss, thereby reducing the need for blood transfusion.

Effect of vitamin E supplementation on bilirubin levels in infants with hyperbilirubinemia: a double-blind randomized clinical trial.

The effect of vitamin E supplementation on bilirubin levels in infants was previously explored, but the results were inconclusive. To examine the effect of vitamin E supplementation on bilirubin levels in term infants in the neonatal intensive care unit (NICU). This interventional double-blind randomized clinical trial was conducted in the Sanandaj Besat Hospital NICU. Enrolled newborns were between 37 and 42 weeks and 6 days of gestation and required phototherapy according to American Academy of Pediatrics clinical guidelines. A total of 138 infants were randomly assigned to vitamin E (n=68) or placebo (n=70) groups. In addition to phototherapy, the vitamin E group received 0.5 mL (5 IU) of supplemental vitamin E daily, whereas the placebo group received 0.5 mL of oral dextrose daily. STATA 17 was used for the data analysis. Changes in bilirubin levels at 24 hours postintervention did not differ significantly from baseline in either group. Vitamin E supplementation did not significantly reduce total bilirubin levels at 24 hours postintervention (mean difference [MD], -0.18; P=0.204; 95% confidence interval [CI], -1.39 to 1.02). However, the vitamin E group exhibited lower total bilirubin levels than the placebo group at 48 hours postintervention (MD, 0.18; P=0.365; 95% CI, -0.89 to 1.27) and 72 hours (MD, 0.36; P=0.356; 95% CI, -2.34 to 1.61), although the differences were not statistically significant. A subgroup analysis revealed that female infants experienced a greater reduction in total bilirubin levels than male infants. Infants administered vitamin E versus placebo demonstrated similar reductions in bilirubin levels and hospital stays. Although the average bilirubin changes did not differ significantly between groups, the vitamin E group showed a more noticeable reduction over time, indicating a positive effect of vitamin E supplementation on serum bilirubin reduction. Trial registration: IRCT20220806055625N2 (registered December 26, 2022; http://irct.ir/trial/67135).

Investigation of the probiotic supplement’s effect on obese adults demonstrated a reduction in fasting insulin levels: a double-blind randomized clinical trial

Investigation of the probiotic supplement’s effect on obese adults demonstrated a reduction in fasting insulin levels: a double-blind randomized clinical trial

UPDATE ON THE RELATIONSHIP BETWEEN VITAMIN D AND DEPRESSION: SYSTEMATIC REVIEW

Introduction: Depression remains a significant global health challenge, affecting approximately one in ten individuals, and its multifaceted nature requires prolonged therapeutic interventions. Recent studies have explored the potential link between vitamin D deficiency and depression, highlighting the role of vitamin D in neurobiology and its plausible association with depressive symptoms. However, the exact nature of this relationship and its implications for depression management require further investigation, as outlined in the systematic review "Association of Vitamin D and Depression: An Update Systematic Review," aiming to provide clarity on the role of vitamin D in depression etiology and guide future research and clinical interventions.  Method: The researchers in this study followed the 2020 Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines to ensure that their work met the required standards. This was done to ensure the precision and reliability of the conclusions derived from the research. Result: Our search produced 13 results. After looking at the titles and summaries, we found 10  papers that fit our criteria. At first, we excluded several articles because they were written in review style and case reports. But after reading the full papers carefully, we included five papers in our final analysis. These papers included experimental study, observational study  a randomized, double-blind, placebo controlled clinical trial, a cross-sectional analysis, and  double-blind randomized clinical trial. Conclusion: Some studies indicate improvements in mood, reductions in corticosterone levels, and prevention of serum vitamin D decreases with vitamin D and SSRI antidepressant combination. Another study in obese women with depression showed positive effects on mood, BDNF levels, inflammation, and SIRT1 with vitamin D and magnesium supplementation. However, no significant associations were found between baseline vitamin D levels and depression symptoms, and vitamin D supplementation did not improve depression symptoms in deficient but otherwise healthy individuals, suggesting caution in using it for depression management. Further research, especially in diverse populations, is needed to clarify the role of vitamin D in depression.

The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health status in patients with migraine: a study protocol for a double-blinded randomized clinical trial

BackgroundDespite a number of recommended strategies, effective treatment of migraine remains elusive. Given the role of oxidative stress in the pathogenesis of migraine, selenium, as an antioxidant nutrient, may have a beneficial effect on migraine outcomes. However, no study has explored the effects of selenium supplementation on migraine symptoms, oxidative stress biomarkers, and mental health. Therefore, this randomized, double-blinded, placebo-controlled clinical trial aims to examine the effects of selenium supplementation among migraine patients.MethodsSeventy-two migraine patients will receive either 200 µg/day selenium supplement (n = 36) or placebo (n = 36) for 12 weeks in a randomized, double-blinded, placebo-controlled study. The severity, frequency, and duration of headaches, mental health indices including depression, anxiety, and distress, and quality of life, as well as biomarkers of oxidative stress such as nitric oxide (NO), malondialdehyde (MDA), total antioxidant capacity (TAC), and total oxidant status (TOS), will be measured at the baseline and end of the study. The intention-to-treat (ITT) approach will be used to estimate missing values. One-way analysis of covariance (ANCOVA) will be performed to detect the effect of selenium supplementation on outcome variables.DiscussionOxidative stress is recognized as a key contributor to migraine pathogenesis. Selenium is an essential trace element with antioxidant properties, capable of crossing the blood–brain barrier (BBB), holding promise to alleviate the oxidative stress and neurotoxicity. Thus, selenium may beneficially affect clinical symptoms and oxidative stress as well as the quality of life in migraine patients.Trial registrationThis trial was registered in the Iranian Registry of Clinical Trials (https://www.irct.ir/) on 27 May 2023 with the code number IRCT20121216011763N60.