Double-blind Randomized Clinical Trial Research Articles

Effects of clindamycin and amoxycillin as prophylaxis against early implant failure: double-blinded randomized clinical trial.

The objective of this randomized controlled clinical trial (RCT) was to compare the frequency of early implant failure, postoperative infection, and pain/inflammation and the degree of implant stability between healthy non-penicillin-allergic individuals receiving a single prophylactic dose of 600mg clindamycin versus 2g amoxicillin at 1h before implant surgery. A single-center double-blinded RCT study with parallel groups was undertaken. Eighty-two patients fulfilled study inclusion criteria and were randomly assigned to the amoxicillin (n = 41) or clindamycin (n = 41) group. The primary outcome variable was early implant failure. The presence of infection was evaluated immediately after surgery and on days 7, 14, 30, and 90, and postoperative pain/inflammation was assessed daily on days 1 to 7 post-surgery. Resonance frequency analysis was used to measure primary and secondary implant stability. One early implant failure was observed (1/81), in a patient from the amoxicillin group. No statistically significant between-group differences were observed in early implant failure rate, postoperative infection rate up to 90 days, pain/inflammation scores during the first week post-surgery, or primary or secondary stability values. A single dose of 600mg clindamycin before implant surgery does not increase the risk of early implant failure or infection. These findings suggest that a single dose of 600mg clindamycin at 1h before implant surgery is a safe antibiotic prophylactic approach; however, when a more prolonged antibiotic therapy is required, it appears advisable to prescribe an alternative antibiotic to avoid adverse effects.

Abstract 4134949: Effect of anakinra in patients with ST-elevation myocardial infarction according to the renal function

Introduction: Interleukin(IL)-1 blockade with anakinra dampens the inflammatory response and prevents heart failure (HF) events in patients with ST-elevation myocardial infarction (STEMI). The efficacy of anakinra according to the baseline renal function in STEMI has not been addressed. Hypothesis: The efficacy of anakinra is independent of the baseline renal function. Aim: To determine the effect of anakinra according to the baseline renal function in patients with STEMI. Methods: We pooled patients with STEMI from 3 double-blind randomized clinical trials. Patients with estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2 were excluded. We divided the cohort based on the median baseline eGFR using the modified 2021 CKD-EPI equation (≥ or < 86 mL/min/1.73m2). We analyzed the area-under-the-curve for C-reactive protein (AUC-CRP) at 14 days, and the incidence of the composite outcome of all-cause death or new-onset HF at 1 year using the Log-rank test. We also evaluated the creatinine changes at 48-72 hours after percutaneous coronary intervention (PCI). Results: We analyzed 139 patients, 110 (79%) males, 52 (37%) Black or African-American, with a median age of 56 [49–63] years. The AUC-CRP at 14 days was significantly higher in patients receiving placebo vs. anakinra both in those with eGFR <86 mL/min/1.73m2 (250.5[131.4-512.0] vs. 66.4[42.3-126.5] mg●day/L, p<0.001) and those with eGFR ≥86 mL/min/1.73m2 (214.2[113.6-303.4] vs. 86.4[35.9-194.3] mg●day/L, p<0.01). Anakinra significantly reduced the composite outcome of all-cause death or new-onset HF in patients with baseline eGFR <86 mL/min/1.73m2 (4/41 [9.8%] vs. 9/27 [33.3%], Log-rank p=0.024) as well as in patients with baseline eGFR ≥86 mL/min/1.73m2 (3/43 [6.9%] vs. 7/28 [25%], Log-rank p=0.038)(p=0.97 for interaction)(Figure). No differences in creatinine changes 48-72 hours after PCI were observed (0.01 [-0.10 to 0.15] mg/dL in anakinra vs. 0.01[-0.08 to 0.14] mg/dL in placebo; p=0.80). Conclusion: In a cohort of patients with STEMI and mainly preserved or mildly reduced renal function, IL-1 blockade with anakinra blunts the acute inflammatory response and prevents all-cause death or new-onset HF at 1 year independent of baseline renal function.

Comparative bioavailability study of supplemental oral Sucrosomial® vs. oral conventional vitamin B12 in enhancing circulatory B12 levels in healthy deficient adults: a multicentre, double-blind randomized clinical trial

BackgroundVitamin B12 is essential for neurological function, red blood cell formation, and DNA synthesis. Deficiency can lead to diverse health conditions, including megaloblastic anemia and neurological issues. Oral supplementation is a standard treatment for B12 deficiency. The Sucrosomial® carrier system offers an innovative approach that enhances supplemental nutrient absorption and bioavailability.ObjectivesThis study aimed to compare the effectiveness of oral Sucrosomial® vitamin B12 formulation vs various conventional B12 supplements, randomly selected from local pharmacies, in increasing and maintaining circulatory B12 levels in healthy deficient adults (200–300 pg/mL).MethodsA randomized, double-blind clinical trial was conducted across three centers in Pakistan from April to July 2024. At KEMU, participants received either Sucrosomial® vitamin B12 or Mecogen SL B12; at LRH, Sucrosomial® B12 or B-SUB B12; and at LUMHS, Sucrosomial® B12, Evermin B12, or Neuromax B12. Participants took a daily single dose of 1,000 μg of the assigned B12 formulation for 7 days. Serum B12 levels were measured at baseline (day 0) and on days 1, 3, 5, and 7.ResultsSucrosomial® B12 was significantly more effective than conventional B12 formulations in increasing and maintaining higher serum B12 levels across all time points. At KEMU, it reached a peak concentration of 454 ± 3.9 pg/mL by day 5, compared to 274 ± 11.1 pg/mL with Mecogen SL B12. At LRH, it peaked at 496 ± 34.4 pg/mL by day 5 versus 304 ± 49.4 pg/mL for B-SUB B12. At LUMHS, it reached 592.7 ± 74.3 pg/mL by day 7, compared to 407.24 ± 41.6 pg/mL for Evermin B12 and 263.82 ± 23.8 pg/mL for Neuromax B12. Sucrosomial® B12 was the only formulation to surpass the deficiency-borderline threshold (200–300 pg/mL) within 24 h of the first dose and was well tolerated with no reported side effects.ConclusionSucrosomial® vitamin B12 demonstrated superior efficacy in rapidly and consistently elevating and maintaining higher circulatory B12 levels compared to conventional supplements. Its characteristic absorption mode and proven efficacy suggest it could effectively address B12 deficiency in a broad range of populations, including those with gastrointestinal conditions and pernicious anemia, thereby supporting overall health.Clinical trial registrationclinicaltrials.gov, NCT06376591.

Photobiomodulation Therapy in the Prevention of Chemotherapy Induced Oral Mucositis in Children with Acute Myeloid Leukemia: A Randomized, Double-blind, Clinical trial.

Many preventive modalities have been advocated to reduce the incidence and severity of chemotherapy-induced Oral Mucositis (OM). Photobiomodulation, also known as Low-Level laser. Therapy, has shown promising results. This clinical trial was performed to evaluate the effectiveness of Photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in children with Acute Myeloid Leukemia (AML). A double-blinded randomized clinical trial was performed, including forty-two children diagnosed with Acute Myeloid Leukemia (AML) admitted to receiving chemotherapy (CT) at Children's Cancer Hospital 57357, Cairo, Egypt. Patients were randomly assigned to either the control or test group. Both groups followed the standard preventive protocol for oral mucositis. In the control group I sham therapy, while in the Laser group I had Photobiomodulation sessions for five consecutive days once a day performed by Diode laser (Sirrolaser Blue ™, USA) 660nm, 15watt, 10 s. Laser sessions began on day 1 of chemotherapy and were repeated on days 2,3, 4, and 5. The response to both groups was evaluated according to the development of oral mucositis; graded using the classification criteria of the World Health Organization (WHO) and the National Cancer Institute scale (NCI - Common Terminology Criteria for Adverse Events, version 4.0). Incidence of oral mucositis was evaluated from baseline to 5, 12, 19, and 30 days after treatment. A clinical significant difference between the laser and control group was observed. The laser group showed a higher prevalence of no oral mucositis with decreased incidence of OM, while on day 12, the control group showed a higher prevalence of grades I and II (P-value <0.001, effect size = 0.796). However, the laser group showed higher prevalence of mucosa free of OM; on day 19, the control group showed higher rates of grades II and III, (P-value <0.001, effect size = 0.670). while on day 30 there was higher rates of grades I and II (P-value <0.001, effect size = 0.576) with higher rates of healthy oral mucosa in the laser group. Photobiomodulation effectively reduces the incidence and severity of chemotherapy-induced oral mucositis in pediatric patients diagnosed with AML.

The comparison of efficacy of Escitalopram and Bupropion in treatment of depression symptoms in patients with heart failure: randomized clinical trial.

This study aims to compare the effects of two medicines, Escitalopram and Bupropion, on HF patients who have depression symptoms. This double-blind randomized clinical trial study was conducted on HF patients with depression symptoms at the Heart Failure Clinics affiliated with Babol University of Medical Sciences. In this study, 80 participants were examined for depression based on the Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HDRS). They were randomly allocated into two groups of 40 participants treated with Bupropion 75mg and Escitalopram 5mg. Following the intervention, the individuals were assessed in terms of their depression score at 4, 8, and 12-week intervals. Finally, the data were analyzed using SPSS version 22.0. In the examination of Beck and Hamilton scores in the two research groups during different follow-ups, a significant decrease was found over time (P<0.001 for both medicines). While the effectiveness of the two medicines was the same at different times (P>0.05 in all cases). Comparing the side effects between the two intervention groups, the orgasm disorder (P=0.018) and sexual dysfunction (P<0.001) were reported significantly more in the Escitalopram group than in the Bupropion group. The findings of this study showed that Escitalopram has the same efficacy as Bupropion in the treatment of depression symptoms in HF patients.

Spinal cord stimulation combined with exercise in patients diagnosed with persistent spinal pain syndrome. Study protocol for a randomized control trial.

Administration of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in PSPS-T2 patients. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study has been registered at Clinicaltrial.gov (NCT06272539). Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.7 (partial η2 = 0.70, α = .05, power = 0.95), resulting in a total of 40 patients. Assuming a 30% dropout rate, 52 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.

Psychometric Properties and Meaningful Change Thresholds of the Vitiligo Area Scoring Index

Defining meaningful improvement using the Total Vitiligo Area Scoring Index (T-VASI) and the Facial VASI (F-VASI) aids interpretation of findings from clinical trials evaluating vitiligo treatments; however, clear and clinically meaningful thresholds have not yet been established. To assess concept validity and measurement performance of the T-VASI and F-VASI in patients with nonsegmental vitiligo and to identify meaningful change thresholds. This mixed-methods study consisted of a secondary analysis of a phase 2 multicenter double-blind dose-ranging randomized clinical trial and embedded qualitative interviews conducted at 35 sites in Canada, France, Japan, and the US. The secondary analysis included the trial's adult patients with nonsegmental vitiligo (T-VASI ≥5 and F-VASI ≥0.5 at baseline). Psychometric performance of the T-VASI and F-VASI and thresholds for meaningful change were evaluated using clinician- and patient-reported information. The trial's embedded interviews were used to qualitatively assess content validity and patient perceptions of meaningful repigmentation. Data analyses were performed from March to July 2023. Participants were randomized to 6-, 11-, or 22-mg/day upadacitinib or placebo for 24 weeks. Psychometric performance of the T-VASI and F-VASI and thresholds for meaningful changed plus content validity and patient perceptions of meaningful repigmentation. Measurement instruments included the T-VASI, F-VASI, Vitiligo Noticeability Scale, Total-Patient Global Vitiligo Assessment, Face-Patient Global Vitiligo Assessment, Total-Physician Global Vitiligo Assessment (PhGVA-T), Face-Physician Global Vitiligo Assessment (PhGVA-F), Patient's Global Impression of Change-Vitiligo, Physician's Global Impression of Change-Vitiligo (PhGIC-V), Vitiligo Quality-of-Life Instrument, Dermatology Life Quality Index, the Hospital Anxiety and Depression Scale, and transcribed verbatim interviews with patients. The psychometric analysis included 164 participants (mean [SD] age, 46 years; 103 [63%] females) and the qualitative analysis included 14 participants (mean [SD] age, 48.8 [12.2] years; 9 females [64%] and 5 males [36%]). Intraclass correlation coefficients were 0.98 for T-VASI and 0.99 for F-VASI in patients with clinically stable vitiligo between baseline and week 4, supporting test-retest reliability. At baseline and week 24, correlations were moderate to strong between T-VASI and PhGVA-T (r = 0.63-0.65) and between F-VASI and PhGVA-F (r = 0.65-0.71). Average baseline and week-24 VASI scores decreased with repigmentation (ie, increasing PhGVA scores). Least-square mean VASI scores increased with greater repigmentation as measured by the PhGIC-V. Least-square mean VASI scores also differed between patients with improved PhGIC-V and those with no change or worsened V-PhGIC scores. Using a multiple anchor approach, improvements of 30% in T-VASI and 50% in F-VASI scores reflected meaningful repigmentation between baseline and week 24. This mixed-methods study found that the T-VASI and F-VASI are reliable, valid, able to differentiate between clinically distinct groups, and responsive in patients with nonsegmental vitiligo. The thresholds for meaningful change were lower than those historically used in clinical trials, suggesting that T-VASI 50 and F-VASI 75 are conservative estimates and reflect improvements that would be meaningful in patients with nonsegmental vitiligo. ClinicalTrials.gov Identifier: NCT04927975.

The effect of prebiotic supplementation on serum levels of tryptophan and kynurenine in obese women with major depressive disorder: a double-blinded placebo-controlled randomized clinical trial

ObjectiveThe objective of the present study was to examine the effect of calorie restricted diet (CRD) plus inulin supplementation on serum levels of tryptophan (Trp), kynurenine (Kyn) and Trp/Kyn ratio in obese women with major depressive disorder (MDD).ResultsIn this double-blind placebo-controlled randomized clinical trial, 51 obese women (BMI = 30–40 kg/m2) with mild MDD were assessed for depression level using Hamilton depression rating scale (HDRS). The patients were randomly allocated into either “Prebiotic group” (received 10 g/day inulin) or “Placebo group” (received 10 g/day maltodextrin). All participants also received individualized CRD. Fasting serum levels of Trp, Kyn, and Trp/Kyn ratio were assessed at baseline and after 8 weeks. Results showed slightly greater increases in serum levels of Trp and Trp/Kyn ratio as well as reductions in serum level of Kyn and HDRS score in prebiotic group than placebo group. However, between group differences in these parameters as well as HDRS score were not statistically significant after adjusting for baseline variables at the end of the trial. Results indicates that CRD accompanied by inulin supplementation (10 g/day) did not influence serum levels of Trp, Kyn and Trp/Kyn ratio as well as HDRS score after 8 weeks.Trial registration: The trial was registered in the Iranian registry of clinical trials at 2018-08-02 (https://www.irct.ir/; registration number: IRCT20100209003320N15).

The Effect of Adding Agomelatine to Escitalopram in the Treatment of Major Depressive Disorder

Major Depressive Disorder (MDD) is a psychiatric illness that imposes a high cost on the patient and the community. Over the past few decades, a variety of treatments have been used to treat depression. One of the most common treatments for depression is medication. Today, specific serotonin reuptake inhibitors are the first line of treatment for major depression. Another drug that has been considered in the treatment of depression is agomelatine.Objective of this study was to evaluate the effect of adding agomelatine to Escitalopram in treatment of major depressive disorder.Materials and methods. This study was a double-blind randomized clinical trial with before and after designs (b and a). In this study, 70 patients with MDD referred to psychiatric clinics affiliated with Yazd University of Medical Sciences were studied. Patients were randomly divided into two groups of 35 patients (agomelatine + Escitalopram and Escitalopram + placebo) and were treated for 12 weeks. Depression Scale was the Hamilton Depression Inventory and was assessed before treatment, 1, 2, and 3 months after treatment. Variables such as gender, age, marital status, level of education, occupation, and duration of illness were also collected. The data were entered into SPSS version 18 software and analyzed using statistical tests.Results. Of the 70 patients studied, 31 (44.3%) were male and 39 (55.7%) were female. There was not significant difference between gender distribution (p=0.810), marital status(p=0.789), job (p=0.651) and educational level (p=0.794). Also, no significant difference was found between the mean variables: age (p=0.563) and duration of depression (p=0.958). There was a statistically significant difference between the mean score of depression 2 months after treatment (p=0.10) and 3 months after treatment (p=0.023) in the two groups. Also the mean depression score after treatment compared to before, was significantly lower in both groups (p=0.000). Also, no significant difference was found between the frequency of drug side effects in the two groups (p=0.970).Conclusion. Adding agomelatine to Escitalopram is more effective than mood-boosting depression as a result of depression or depressive disorder alone.Future researchers in the field of MDD treatment could consider investigating the long-term effects and comparative efficacy of combining agomelatine with other antidepressants beyond Escitalopram to further enhance treatment outcomes for patients with MDD.

The Macular Choroidal Thickness in Danish Children with Myopia After Two-Year Low-Dose Atropine and One-Year Wash-Out: A Placebo-Controlled, Randomized Clinical Trial.

Our aim in this work was to investigate the macular choroidal thickness (ChT) changes in 6-12-year-old Danish children with myopia during 2years of low-dose atropine treatment and 1-year wash-out vs. placebo in an investigator-initiated, placebo-controlled, double-blind randomized clinical trial. Ninety-seven participants wererandomized to either 0.01% for 2years, 0.1% loading dose for 6months followed by 0.01% for 18months, or placebo, then a 1-year wash-out. The primary outcome was ChT in the sub-foveal and inner and outer superior, nasal, inferior, and temporal sectors. The secondary outcome was axial length (AL). Outcomes were measured at baseline and 6, 12, 24, and 36 months. One-way analysis of variance was used to detect baseline ChT differences between AL-stratified groups (< 24mm, 24-25mm, or > 25mm). To determine the longitudinal changes in ChT and its effect on AL, all eyes were included in linear mixed modeling with individual eyes nested in the study ID as a random effect. Longer eyes had significantly thinner ChT in all choroidal sectors (adj-P < 0.01) at baseline. There was no statistically significant change in any ChT sector after 3years in the placebo group. Sub-foveal and nasal ChT in the 0.1% loading dose and 0.01% group were not significantly different from placebo after 2-year treatment. In the placebo group, a 1-mm increase in AL was significantly associated with a 47-µmthinner nasal ChT after 3years (95% confidence interval (CI): -55; -38, adj-P < 0.001). A 10-µmthicker nasal choroid at baseline was associated with 0.13 mm (95% CI: 0.009; 0.017, adj-P < 0.001) less 3-year axial elongation. The ChT in Danish children with myopia remained stable over the 3-year follow-up. A thinner choroid at myopia onset might predispose to increased axial elongation. Treatment with 0.01% atropine did not change the ChT. We speculate that low-dose atropine does not primarily reduce myopia progression via a choroidal mechanism. ClinicalTrials.gov identifier, NCT03911271.

The Effect of Magnesium Sulfate plus Ketorolac versus Morphine plus Ketorolac on Pain Relief in Patients with Renal Colic: A Double-blind Randomized Clinical Trial

Abstract Background: It seems that magnesium sulfate (MgSO4) can be useful in reducing acute pain caused by stone passing through the ureter by reducing ureteral smooth muscle contractions. Aim: This study aimed to evaluate the effect of MgSO4 plus ketorolac versus morphine plus ketorolac on pain relief in renal colic. Methods: The present double-blind randomized clinical trial was performed on 70 patients with renal colic divided into two groups. Patients in the first group received 30 mg intravenous ketorolac plus 5 mg intravenous morphine while patients in the second group received 30 mg/kg MgSO4 plus 30 mg intravenous ketorolac. Then, patients’ hemodynamic parameters and pain scores were evaluated before and 20, 40, and 60 min after the intervention. Results: Within 60 min of administration, systolic blood pressure was significantly reduced in the morphine plus ketorolac group (P &lt; 0.001) while there was no significant change in the MgSO4 plus ketorolac group in this regard (P = 0.576). In addition, the patients’ mean pain scores were not significantly different between the two groups in any of the studied times (P &gt; 0.05). Conclusion: Given that the addition of MgSO4 to ketorolac, as compared with the addition of morphine (as a drug) to ketorolac, has been associated with fewer complications and greater stability of hemodynamic parameters, it can be stated that the use of MgSO4 as an adjunct can be a good choice for further pain relief in patients with contraindications for drug administrations.

Comparison of 75 mg versus 150 mg aspirin for the prevention of preterm preeclampsia in high-risk women at a tertiary level hospital: study protocol for a randomized double-blind clinical trial

BackgroundHypertensive disorders of pregnancy (HDP) pose significant risks to maternal and fetal health, with substantial mortality and morbidity rates globally, particularly in developing countries. Pre-eclampsia (PE) accounts for a notable portion of maternal morbidity and mortality, with varied prevalence across regions within countries like India. Despite advancements, disparities in healthcare access persist, influencing outcomes. PE not only affects maternal health during pregnancy but also predisposes women to long-term cardiovascular complications, emphasizing the need for early screening and preventive measures.MethodsThis prospective randomized double-blind clinical trial aims to compare the efficacy and safety of 75 mg versus 150 mg aspirin for preventing preterm pre-eclampsia in high-risk women. Screen-positive women aged 18–45 years with singleton pregnancies between 12 and 16 weeks of gestational age will be enrolled. They will be randomized in a 1:1 ratio to receive either 75 mg or 150 mg of aspirin nightly until 37 weeks of pregnancy or earlier if preterm pre-eclampsia develops. Feto-maternal outcomes, including preterm pre-eclampsia incidence and neonatal and maternal complications, will be assessed. The sample size calculation based on expected proportions of preterm pre-eclampsia in both groups indicates a total of 370 participants (185 per group) accounting for 20% attrition.DiscussionThis prospective randomized double-blind clinical trial aims to compare the effectiveness and safety of two doses of aspirin (75 mg vs 150 mg) in preventing preterm pre-eclampsia in high-risk women. The potential implications of this study are significant, including the optimization of aspirin prophylaxis, the development of evidence-based guidelines, and comprehensive assessment of maternal and fetal outcomes. In conclusion, the results of this study have the potential to significantly impact clinical practice by enhancing maternal and perinatal health outcomes and contributing to evidence-based obstetric care.Trial registrationClinical Trials Registry-India CTRI/2023/12/060983. Trial was registered prospectively on 29 December 2023. Acknowledgement Number REF/2023/12/076358. https://acrobat.adobe.com/id/urn:aaid:sc:AP:15870322-f1f4-4460-900c-6e056ab83a44.

Advice to People with Parkinson's in My Clinic: Probiotics and Prebiotics.

There is increasing evidence that microbial-based therapies can be useful in people with Parkinson's disease (PD). In this viewpoint, we provide a state-of-the-art review of the clinical and pre-clinical evidence for probiotics and prebiotics in PD. Currently, short-term clinical studies, including double-blind placebo-controlled randomized clinical trials, have demonstrated safety, and efficacy primarily in improving constipation-related symptoms. Pre-clinical studies consistently reported improvements in a range of biological markers and outcomes, including evidence for attenuation of gut dysfunction and neuroprotection. Bacteria from the genus Lactobacillus and Bifidobacterium have been the most frequently studied both in clinical and pre-clinical probiotics studies, while research into prebiotics is still limited and primarily involved resistant starch and fructooligosaccharides. We provide practical suggestions for clinicians on how to advise patients in the clinic regarding these popular treatments, and important caveats to be aware of. Finally, areas for further advancements are highlighted. It is envisaged that in the future, microbial-based therapies may benefit from personalization based on an enhanced understanding of a whole range of host factors and host-microbiome interactions.

Projection of visual material on postoperative delirium in patients undergoing cardiac surgery: A double blind randomized clinical trial.

Postoperative delirium is a neurobehavioral disorder that can appear after surgery. It is characterized by an altered level of consciousness and impaired cognitive function. The aim of this study was to evaluate the impact of visual projection of images of relatives or loved ones in patients undergoing cardiac surgery in the immediate postoperative period, and its influence on the incidence and development of postoperative delirium. A randomized, double-blind clinical trial was designed in the immediate postoperative period of adult patients undergoing cardiac surgery. Consolidated Statement of Reporting Trials guidelines were followed. A control group (CG) and an intervention group (IG) were established. In the IG, the patients underwent a visual projection, while the usual unit treatment was carried out with the CG. Sociodemographic, anthropometric, anesthetic, and surgical variables were also recorded. The postoperative delirium assessment scale used was the confusion assessment method for diagnosing delirium in intensive care unit patients. Information was collected from 104 patients undergoing cardiac surgery. Most of the patients included in the study were men (66.35%) and the most performed surgical intervention was aortic valve replacement (34.62%). In the CG, positive patients in postoperative delirium increased from 19.23% to 25%, while in the IG they decreased from 5.77% to 1.92%. The logistic regression analysis presents a prediction model where the variables that influence the model are gender and group membership, meaning that being female and belonging to the IG significantly reduce the presence of delirium. The projection of visual material reduced the incidence of postoperative delirium in patients undergoing cardiac surgery, although it cannot be established that it is effective as a treatment once the pathology is already established.

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.

The effect of atomoxetine efficacy on freezing of gait in patient with Parkinson’s disease: a double-blinded randomized clinical trial

Introduction: Freezing of gait (FOG) is a debilitating symptom experienced by many individuals with Parkinson’s disease, characterized by an abrupt and transient inability to initiate or continue locomotion. Despite extensive research, effective pharmacological interventions targeting FOG remain elusive. Atomoxetine, a selective norepinephrine reuptake inhibitor, has shown promise in alleviating FOG in small-scale studies. However, the efficacy of atomoxetine in larger cohorts remains underexplored. Objectives: This study aims to assess the impact of atomoxetine on Parkinson’s disease-related FOG in a larger study population than currently reported in the literature. Patients and Methods: This randomized clinical trial was performed in Golestan Hospital, Ahvaz, Iran, in 2022. The participants were divided into group A comprising 16 patients subjected to atomoxetine treatment, and group B consisting of 16 patients administered a placebo. Three scheduled visits were conducted. Freezing of Gait Questionnaire (FOGQ) scores was documented during each visit. Results: The mean age of all participants was 62.4 ± 8.3 years, with no significant intergroup age disparity and no statistically significant gender-based distinctions between the two groups. The average disease duration in the atomoxetine group was 8.2 ± 3.1 years, while in the placebo group, it was 7.2 ± 3.4 years, with no significant divergence between the two groups. The study findings indicated no significant distinction in FOGQ scores between the treatment and placebo groups. Conclusion: Though atomoxetine did not significantly improve improvement in freezing of the gait of studied patients with Parkinson’s disease, it may cause a modest improvement in the gait freezing of some patients. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20211008052695N1; https://irct.behdasht.gov.ir/trial/59643, ethical code; #IR.AJUMS.HGOLESTAN. REC.1400.026).

The effects of selenium administration on mean platelet volume, neutrophil-to-lymphocyte ratio, and red cell distribution width in critically ill older adults: A double-blinded randomized clinical trial

BackgroundLow serum Selenium (Se) levels in critical patients have been associated with poor clinical outcomes and higher mortality rates. The purpose of this study was to investigate the effect of Se administration on mean platelet volume (MPV), neutrophil-to-lymphocyte ratio (N/L), and red cell distribution width (RDW) in older adults admitted to the intensive care unit (ICU). MethodThis study was a double-blinded randomized clinical trial. Critically ill patients were randomly divided into two groups of Se and placebo. The Se group (N=30) initially received 3000 mg of Se at once within 3 hours, followed by a dose of 1500 mg daily for 10 days as a one-hour infusion. The control group (N=30) received normal saline for 10 days. A venous blood sample was collected on the first and 10th day. Statistical analysis was performed using SPSS.26 statistical software. To analyze quantitative data in two groups, based on the estimated normality, an independent t-test was used. P value less than 0.05 was considered statistically significant. ResultsOn day 10, the MPV value in the Se group was significantly lower compared to the placebo group (9.32 ± 1.78 and 10.43 ± 2.06, respectively, p = 0.03). Within the Se group, contrary to the controls, the MPV value decreased significantly from day 1 to day 10 (p<0.001). Further, the RDW value in the Se group was significantly lower compared to the placebo group (13.77 ± 1.57 and 15.32 ± 2.42, respectively, p = 0.005). The N/L ratio remained similar between the two groups before and after the intervention. ConclusionOur findings suggest that Se can affect the MPV and RDW parameters in older adults hospitalized in the ICU. However, further studies with a larger population are necessary to support these findings. Clinical Relevancy StatementThe effects of selenium administration on hematological parameters in older adults admitted to the ICU are not well-established. There is limited direct evidence linking serum selenium levels to erythrocyte and hemoglobin stability in humans. The current clinical trial promotes the current literature and shows that selenium holds potential in management of the older ICU patients.

The impact of oral melatonin on pain and anxiety reduction during venipuncture in pediatric patients: a double-blind randomized clinical trial

Background: Pain resulting from therapeutic procedures and injections is a prevalent source of stress for children. Immediate side effects of pain in infants include syncope, irritability, sleep disturbances, and nutritional issues. This study aimed to investigate the effects of oral melatonin on alleviating pain and anxiety in pediatric patients undergoing venipuncture. Methods: This double-blind, randomized controlled trial was conducted in the pediatric emergency ward. Patients were randomly assigned to one of two groups; the intervention group received 0.5 mg/kg of oral melatonin (maximum 5 mg) 30 min before venipuncture, while the placebo group received an equivalent amount of a placebo 30 min before the procedure. Using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, postcanulation fear, pain severity, compliance, and potential side effects were evaluated. Results: In total, 202 patients (113 male and 89 female) in the intervention and control groups were included in the analysis. The mean pain score during venipuncture was 1.52±3.04 in the intervention group and 2.04±6.57 in the control group (P&lt;0.001). In the intervention group, only 19 (18.8%) patients reported pain during venipuncture, whereas 79 (78.2%) patients in the control group reported pain (P&lt;0.001). Less than half (44.6%) of the patients in the intervention group experienced anxiety during venipuncture, while the majority (94.1%) of the patients in the control group exhibited anxiety (P&lt;0.001). The venipuncture success rate was 60.4% in the intervention group and 51.5% in the control group (P=0.257). Conclusion: Administering 0.5 mg/kg of oral Melatonin 30 min before venipuncture reduces procedure-related pain and anxiety in pediatric patients and may be associated with higher venipuncture success rates.

Effectiveness of 0.2% Hyaluronic Acid on Clinical, Biomolecular and Microbiological Parameters in Type 2 Diabetes Mellitus Patients with Periodontitis.

This double-blind randomized clinical trial assessed the effectiveness of 0.2% hyaluronic acid (HA) gel as an adjunct to scaling and root planning (SRP) in patients with periodontitis and type 2 diabetes mellitus (DM), focusing on changes in clinical periodontal parameters, the expression of inflammatory mediators, and oral pathogens. The randomized clinical trial involved 36 participants, 18 DM patients, and 18 healthy patients. The participants in each group were randomly assigned to receive placebo or HA gel after SRP. Gingival crevicular fluid and subgingival plaque samples were taken before treatment and at 4-week follow-up. Clinical parameters, interleukin-1β (IL-1β) and IL-10 levels, and proportions of Porphyromonas gingivalis (Pg) and Fusobacterium nucleatum (Fn) were evaluated at baseline and follow-up. Paired t-test (parametric data) or Wilcoxon signed-rank test (nonparametric data) was used for intragroup comparison between baseline and follow-up, and comparisons between groups one-way analysis of variance test (parametric data) or Kruskal-Wallis test (nonparametric data). At 4 weeks, most of the groups showed statistically significant decreases (p ≤ 0.05) in various clinical and biomolecular parameters. However, there were exceptions: the pocket probing depth (PPD) and clinical attachment loss (CAL) parameter did not significantly decrease for the placebo (p > 0.05) non-DM group, and the IL-10 parameter in the DM HA gel group (p = 0.108). Regarding bacterial proportions, the non-DM and DM placebo group exhibited significant test results for Pg after 4 weeks (p ≤ 0.05). In the case of Fn bacteria proportions, they decreased in all groups, but these results were not statistically significant (p ≥ 0.05). An intergroup analysis revealed no significant differences (p ≤ 0.05) for bleeding on probing (BOP), PPD, and both proinflammatory and anti-inflammatory cytokines. Only clinical attachment loss (CAL) exhibited a statistically significant intergroup difference 0.042. The use of 0.2% HA gel into periodontal pockets alongside SRP, for both diabetic and healthy individuals, showed no statistically significant variances in clinical, biomolecular, and microbiological measures.

Effects of intravenous tranexamic acid on bleeding during burn surgery: A double-blinded randomized clinical trial

Blood loss during burn surgery significantly contributes to morbidity and mortality. Tranexamic acid (TXA), an antifibrinolytic agent, is hypothesized to reduce intraoperative bleeding. This double-blinded, randomized clinical trial aimed to assess the efficacy of systemic TXA in severe burn patients (total body surface area [TBSA] > 20 %) undergoing surgery. The study evaluated the impact of TXA on surgical bleeding, operating room (OR) time, intravenous (IV) fluid requirements, length of hospital stay (LOS), and overall patient outcomes. A total of 94 patients, with equal distribution in age, sex, and TBSA, were randomly assigned into two groups (47 each). We administered TXA as a 10 mg/kg loading dose followed by a 1 mg/kg/h infusion during surgery. Results demonstrated significant reductions in blood loss (P = 0.043), total IV fluid volume (P = 0.021), OR time (P = 0.002), LOS (P = 0.0001), and transfusions (P = 0.024) in the TXA group. Notably, women and patients without inhalation injuries exhibited better responses to TXA treatment, and graft survival was lower in the TXA group. The study concludes that IV TXA administration during burn surgery can reduce bleeding, minimize IV fluid and blood transfusion needs, and shorten surgery duration, enhancing overall surgical outcomes.