Double-blind 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.

The effect of once-daily vs. twice-daily intermittent theta burst stimulation on suicidal ideation in treatment-resistant depression.

Intermittent theta burst stimulation (iTBS) has demonstrated potential in reducing suicidal ideation (SI) in patients with depression, however, stimulation protocols vary greatly across studies. For this secondary analysis, data from a three-site double-blind, randomized and sham-controlled clinical trial was analyzed to investigate the efficacy of a once-daily versus twice-daily iTBS protocol in the treatment of SI in patients with treatment resistant depression. Secondarily we aimed to explore the associations among SI, anhedonia and quality of life (QOL) measures. The primary outcome for this analysis was SI, which was assessed by computing an average score from four suicidality items on separate depression scales. 158 participants who experienced some degree of SI at baseline were included in the analysis. After 10 days of treatment, 15 (18.3%) participants from the once-daily group and 19 (25%) from the twice-daily group achieved remission from SI which was defined as a SI score of 0. After 30 days of treatment the remission rates were 27 (32.9%) and 30 (39.5%), respectively. There were no significant differences in remission rates between the groups. Moderate correlations between change in SI and change in depressive symptoms were observed. In addition, correlations between change in SI, anhedonia and QOL were observed that remained significant after controlling for change in depressive symptoms. Achieving remission from SI appears to be at least partially correlated to the anti-depressant effect of iTBS. Further studies investigating optimal treatment protocols for the treatment of suicidality with different iTBS schedules are urgently needed. Trial registration Clinicaltrials.gov ID: NCT02729792 ( https://clinicaltrials.gov/ct2/show/NCT02729792 ).

The Efficacy of Botulinum Toxin A Injection in Pelvic Floor Muscles in Chronic Pelvic Pain Patients: A Double-Blinded Randomised Controlled Trial.

To evaluate and compare the efficacy and safety of Botulinum Toxin A (BTA) injections versus placebo injections, combined with pelvic floor muscle therapy (PFMT), in women with chronic pelvic pain (CPP). Randomised, double-blinded clinical trial (January 2020-April 2023). This multicentre study was conducted at four hospitals in the Netherlands. Ninety-four women with CPP and increased pelvic floor muscle tone despite previous PFMT, were enrolled. Participants received either BTA injections (100 units) or placebo injections into the pelvic floor muscle, followed by four PFMT sessions. Primary outcomes included the number of women with at least a 33% reduction in pain and those reporting (very) much improvement of their pain. Secondary outcomes covered quality of life and pelvic floor function. Follow-up visits were scheduled at 4, 8, 12, and 26 weeks post-treatment. Mixed models for repeated measurements were used for analysis. A 33% reduction or more in average pain score was reported by 15 participants (33%) after BTA treatment and 9 participants (20%) after placebo treatment (odd ratio placebo/BTA 1.88; 95% CI 0.72-4.90, p = 0.19). In both groups, 8 women (17%) reported their improvement as (very) much better (odd ratio placebo/BTA 0.947; 95% CI 0.32-2.80, p = 0.92). Pelvic floor resting activity decreased significantly after BTA treatment compared to placebo (p = 0.001). The results from this study do not support the use of BTA injections in the management of CPP in women.

Effects of dietary cellulose on clinical and gut microbiota recovery in dogs with uncomplicated acute diarrhea: a randomized prospective clinical trial.

To assess the impact of dietary fiber supplementation with cellulose on clinical course, fecal consistency, and intestinal microbiota composition in dogs with uncomplicated acute diarrhea (AD). From September 2022 to November 2023, a total of 19 dogs presenting with uncomplicated AD were included in this prospective, randomized, and double-blinded clinical trial. The time to resolution of diarrhea was evaluated via owner surveys and a fecal scoring chart. The client-owned dogs were randomly assigned to a cellulose group (CG) or control group. The intestinal microbiota was analyzed via quantitative PCR. A marginally significant, faster improvement in stool consistency on day 1 was observed in the CG (P = .09). All dogs improved clinically, with a median recovery time of 3.0 days in the CG and 3.2 days in the control group (range, 1 to 6 days in both groups). There was no significant difference regarding the Canine Acute Diarrhea Severity index or composition of the intestinal microbiota during the study. All dogs with uncomplicated AD exhibited rapid clinical improvement and recovery of the core intestinal microbiota within the first few days. Cellulose improved the fecal consistency in a subset of dogs, and intestinal dysbiosis was mild and self-limiting. The administration of dietary cellulose has the potential to accelerate improvements of stool consistency. Mild changes in pathobionts, such as an increased amount of Clostridium perfringens, are self-limiting; thus, antibiotic intervention is not warranted.

Local and systemic photobiomodulation using a 650nm LED on skin temperature and hyperalgesia in cellulite: a randomized, placebo-controlled and double-blinded clinical trial.

Cellulite is a skin condition that significantly affects women, characterized by "holes" or depressions in the skin, affecting approximately 95% of women at some point in their lives. Cellulite often presents inflammatory symptoms such as increased skin temperature and hyperalgesia. Photobiomodulation, whether applied locally or systemically, has demonstrated important anti-inflammatory effects in various conditions. This study investigates the effects of local and systemic photobiomodulation on hip culottes temperature increases and hyperalgesia in patients with grades 2 to 4 cellulite. Cellulite assessment was carried out using detailed anamnesis, photographic records, algometry, and infrared thermography. Participants received randomized bilateral treatment with or without systemic irradiation using LED photobiomodulation on the hip culottes for four weeks, three times a week. This study aimed to evaluate the effect of photobiomodulation, especially locally applied, together or not with systemic irradiation, on cellulite hyperalgesia and skin temperature among 25 female participants. The group that received only LED treatment showed an increase in pain threshold of 8% and 20% on the right and left sides, respectively, while the group treated with LED + ILIB showed an increase in pain threshold of 32% on both sides. Local photobiomodulation produced a skin temperature decrease of 0.4°C, while the combination of local and systemic irradiation produced an average skin temperature decrease of 1.2°C. Our results clearly demonstrate a significantly beneficial effect of LED therapy for cellulite treatment, especially when administered in combination with mILIB, leading to a significant reduction of pain hypersensitivity and skin temperature, indicating a regional subcutaneous improvement of the inflammatory status.

Modulation of neural networks and symptom correlated in fibromyalgia: A randomized double-blind multi-group explanatory clinical trial of home-based transcranial direct current stimulation.

Transcranial direct current stimulation (tDCS) might modulate neural activity and promote neural plasticity in patients with fibromyalgia (FM). This multi-group randomized clinical trial compared home-based active tDCS (HB-a-tDCS) on the left dorsolateral prefrontal cortex (l-DLPFC) or home-based sham tDCS (HB-s-tDCS), and HB-a-tDCS or HB-s-tDCS on the primary motor cortex (M1) in the connectivity analyses in eight regions of interest (ROIs) across eight resting-state electroencephalography (EEG) frequencies. We included 48 women with FM, aged 30 to 65, randomly assigned to 2:1:2:1 to receive 20 sessions during 20 minutes of HB-a-tDCS 2mA or HB-s-tDCS, over l-DLPFC or M1, respectively. EEG recordings were obtained before and after treatment with eyes open (EO) and eyes closed (EC). In the EC condition, comparing pre to post-treatment, the HB-a-tDCS on l-DLPFC decreased the lagged coherence connectivity in the delta frequency band between the right insula and left anterior cingulate cortex (ACC) (t = -3.542, p = .048). The l-DLPFC HB-a-tDCS compared to HB-s-tDCS decreased the lagged coherence connectivity in the delta frequency band between the right insula and left ACC (t = -4.000, p = .017). In the EO condition, the l-DLPFC HB-a-tDCS compared to M1 HB-s-tDCS increased the lagged coherence connectivity between the l-DLPFC and left ACC in the theta band (t = -4.059, p = .048). Regression analysis demonstrated that the HB-a-tDCS effect on the l-DLPFC was positively correlated with sleep quality. On the other hand, the HB-a-tDCS on l-DLPFC and HB-s-tDCS on M1 were positively correlated with pain catastrophizing. These results show that HB-a-tDCS affects the neural connectivity between parts of the brain that control pain's emotional and attentional aspects, which are most noticeable at lower EEG frequencies in a rest state. This effect on neural oscillations could serve as a neural marker associated with its efficacy in alleviating fibromyalgia symptoms. identifier [NCT03843203].

Ciprofol versus propofol for anesthesia induction in cardiac surgery: a randomized double-blind controlled clinical trial.

Ciprofol, a novel intravenous general anesthetic with a chemical structure similar to propofol, exhibits significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and has comparable effects on heart rate and blood pressure to propofol. However, clinical data on its use for anesthesia induction in cardiac surgery remain limited. Seventy-eight patients undergoing coronary artery bypass grafting or valve replacement surgery were randomly assigned to receive either ciprofol (N = 40) or propofol (N = 38) for anesthesia induction. Variables recorded included changes in mean arterial pressure and heart rate during anesthesia, alterations in the oxygenation index and lactic acid concentration before and 10min after anesthesia induction, and the incidence of adverse events such as bradycardia, hypotension, and injection pain. The incidence of anesthesia-induced injection pain was significantly lower in the ciprofol group compared to the propofol group (3% vs. 18%, P < 0.05). The incidence of other adverse events was similar between the groups. No significant differences in hemodynamics or oxygenation index were observed during anesthesia induction between ciprofol and propofol. Ciprofol demonstrated a significantly lower incidence of injection pain compared to propofol, potentially improving patient comfort during anesthesia induction. Additionally, ciprofol showed comparable circulatory stability to propofol during anesthesia induction in cardiac surgery, suggesting it may be a suitable alternative to propofol for this application. The trial was registered at the ClinicalTrials.gov on 03/10/2024 (NCT06312345).

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) &lt;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 &lt; 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 &lt;86 mL/min/1.73m2 (250.5[131.4-512.0] vs. 66.4[42.3-126.5] mg●day/L, p&lt;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&lt;0.01). Anakinra significantly reduced the composite outcome of all-cause death or new-onset HF in patients with baseline eGFR &lt;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.

Probiotics' supplementation alleviates disease severity and improves postural balance by repairing intestinal leak in patients suffering from osteoarthritis: A double-blinded clinical trial.

Increased intestinal leakiness and associated systemic inflammation are potential contributors to osteoarthritis (OA) and postural imbalance in the geriatric population. To-date, no successful treatment to correct postural imbalance in OA is known. We aimed to explore the effects of a multistrain probiotic upon postural imbalance in OA-affected patients. In this randomized, double-blind trial with a placebo group, 147 patients suffering from knee OA (age-span = 64-75 years) were divided into placebo (n=75) and probiotics (n=72) study groups. Vivomix 112 billion, multistrain probiotic was given once a day for 12 weeks. The outcomes of study variables were determined first at baseline and later after 12 weeks of intervention. These were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), knee flexion range-of-movement (ROM), pain intensity by visual analogue scale (VAS), handgrip strength (HGS), gait speed, and balance control assessed in standing, semi-tandem, and tandem stances. We determined plasma zonulin, to determine intestinal leak along with c-reactive protein (CRP) and 8-isoprostanes levels. A total of 136 OA patients taking placebo (n=71) and probiotics (n=65) were analyzed. The probiotics group exhibited a reduction in pain intensity, disease severity, and WOMAC scores along with improvement in balance scores, HGS, and walking speed (p<0.05 for all), no change in ROM, resting pain, and 8-isoprostanes levels. The correlation analysis revealed a robust association of balance scores with plasma markers of intestinal leakiness and inflammation in probiotics but not in the placebo group. Probiotics reduce postural imbalance in OA patients partly due to a reduction in intestinal leakiness.

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.

Comparison of Analgesic and Anti-Inflammatory Effects of Kale Extract Versus Ibuprofen After Impacted Mandibular Third Molar Surgery: A Randomized, Double-Blind Split-Mouth Clinical Trial

Comparison of Analgesic and Anti-Inflammatory Effects of Kale Extract Versus Ibuprofen After Impacted Mandibular Third Molar Surgery: A Randomized, Double-Blind Split-Mouth Clinical Trial

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.

Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.

Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke. This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days. There were 57 and 60 patients in the ANP and placebo groups finally included respectively for modified intention-to-treat analysis. The median age was 66 years, and the median NIHSS score at baseline was 12. The changes in cerebral infarct volume at day 14 were 0.3mL and 0.4mL in the ANP and placebo groups, respectively (median difference: -7.1mL; interquartile range [IQR]: -18.3 to 2.3 mL, P=0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4mL and 4.0mL, respectively (median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P=0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups (P=0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P=0.03). ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis. Clinicaltrials.gov, No. NCT04475328.

Comparison of the Effects of Mucosa Tissue Healing with Chlorhexidine Digluconate and Choline Salicylate in Patients Wearing a Removable Prosthetic Restoration—A RCT

Background and Objectives: A randomized, double-blind clinical trial was conducted based on the CONSORT study protocol for randomized clinical trials (NCT06531720) to compare the effectiveness of oral mucosa healing properties of 0.2% chlorhexidine digluconate (CHX) and 8.7% choline salicylate (CHS), as well as a control group (CON) with no intervention, in patients with delivered partial removable dentures (PRDs). Materials and Methods: Patients (n = 27) who were enrolled in the study were healthy subjects according to the inclusion/exclusion criteria, and they received new PRDs to complement Kennedy’s class III and IV deficiencies. During the process of adaptation to new prosthetic restorations, OMLs were formed and treated with one of two selected preparations, either CHX = 0.2% or CHS = 8.7%, in relation to the control group (CON). The wound surface area (WSA) (mm2) was measured on repeatable intraoral images taken in accordance with the examination protocol on the first control visit on day 1, day 3, day 7, day 10, and day 14 with the assistance of computer software. Results: There were no statistically significant differences between groups. The fastest effect of WSA complete reduction was observed in the CHX group after 7 days (WAS = 0.78, SD = 1.18) in comparison to CHS = 10 days (WAS = 0.44, SD = 0.90) and CON = 14 days (WAS = 0.22, SD = 0.67). The decrease in the WSA after 7 days of observation was 85.1% in the CHX group, 70.1% in the CHS group, and 59.2% in the CON group. Conclusions: The WSA decreased most rapidly after 7 days of treatment with 0.2% chlorhexidine digluconate (CHX), slightly more slowly after 10 days of treatment with 8.7% choline salicylate (CHS), and relatively most slowly in the CON group, who were not treated with any topical medication after 14 days. Oral mucosa lesions (OMLs) therapy during the process of adaptation to new removable prosthetic restorations is a very important element supporting the whole process. Topical medications containing 0.2% chlorhexidine digluconate are indicated as adjunctive therapy in the process of the supportive treatment and disinfection of oral mucosa lesions. However, this does not release the dentist from liability for the careful adjustment of the removable prosthetic restoration.

The Administration of Resveratrol and Vitamin C Reduces Oxidative Stress in Postmenopausal Women-A Pilot Randomized Clinical Trial.

In postmenopausal women, due to endocrine changes, there is an increase in oxidative stress (OS) that predisposes them to cardiovascular and metabolic alterations. Sixty-one percent of women in this stage require a primary therapeutic strategy to decrease OS. This study aimed to evaluate the effect of resveratrol and vitamin C on OS in postmenopausal women. A randomized, double-blind clinical trial was carried out. Forty-six postmenopausal women with insulin resistance (HOMA-IR > 2.5) were included and divided into three treatment groups: group A: resveratrol, n = 13; group B: resveratrol + vitamin C, n = 15; and group C: vitamin C, n = 14. Between before and after the antioxidants, group B showed a decrease of 33% in lipohydroperoxides (p = 0.02), and malondialdehyde (MDA) decreased by 26% (p = 0.0007), 32% (p = 0.0001), and 38% (p = 0.0001) in groups A-C, respectively. For protein damage, group B is the most representative, with a decrease of 39% (p = 0.0001). For total antioxidant capacity (TAC), there were significant increases of 30% and 28% in groups B and C, respectively. For HOMA-IR, there were no significant differences among the study groups. Supplementation with this combination of antioxidants significantly decreases markers of OS in postmenopausal women. In addition, it increases TAC by up to 30%.

Assessment of the Impact of Gabapentin on Postoperative Pain Following Shoulder Open Rotator Cuff Repair: A Double-Blind Clinical Trial

BackgroundGabapentin is an anticonvulsant used for managing neuropathic pain. Its effectiveness and dosing strategies for postoperative pain, particularly in open shoulder rotator cuff repair, are still debated. This study assesses gabapentin ‘s impact on postoperative pain intensity in open rotator cuff repair. MethodsSixty eligible patients were randomly distributed into two groups: placebo and gabapentin. The gabapentin group received a daily dose of 600 mg, administered in two divided increments, beginning three days before the surgery and continuing for one week postoperatively. Pain intensity, assessed via the Visual Analog Scale (VAS), was the primary endpoint during the first postoperative week. Secondary aims conducted on both groups included quantifying opioid consumption, evaluation of side effects attributed to gabapentin and opioids, assessment of sleep quality, and patients’ satisfaction levels with the employed approach. ResultPostoperative pain in the gabapentin group significantly decreased from the first twenty-four hours until the fourth day post-surgery (p<0.002), accompanied by reduced opioid consumption (P=0.02). Following discharge, the prevalence of nocturnal sleep disruptions and oxycodone consumption in the gabapentin group notably decreased compared to the placebo group, alongside a significant improvement in sleep quality and duration until the fifth day, as well as overall satisfaction with the pain management approach seen within the gabapentin group (P=0.003). ConclusionAdministering gabapentin perioperatively at 600 mg daily and divided over a minimum duration of four days postoperatively may significantly reduce postoperative pain intensity and opioid consumption in open shoulder rotator cuff repair surgery patients.

Zinc supplementation to improve prognosis in patients with compensated advanced chronic liver disease: a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Zinc homeostasis could play a role in compensated advanced chronic liver disease, and its supplementation has been linked to improvement in liver function, a decrease of hepatic complications, and reduction in HCC incidence. Compensated advanced chronic liver disease encompasses a heterogeneous group of patients with variable risks of clinically significant portal hypertension and clinical events. The ANTICIPATE model is a validated model for stratifying these risks. Our aim is to demonstrate that zinc administration can reduce the rate and risk of presenting clinical events (first decompensation, HCC, death, and liver transplantation). This study protocol describes an ongoing phase III, national, multicenter, randomized, double-blind clinical trial that will enroll 300 patients to receive either the trial treatment (zinc acexamate) or placebo. An inclusion period of 42 months is planned, with a minimum follow-up of 2 years. Our principal hypothesis is that zinc could modify the natural history of patients with compensated advanced chronic liver disease, with an overall improvement in prognosis.

Efficacy and Safety of Yangxinshi versus Trimetazidine on Exercise Tolerance in Patients with Coronary Heart Disease after Percutaneous Coronary Intervention: Multicenter, Double-Blind Clinical Trial

BackgroundOptimizing medication to improve exercise tolerance in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI) is limited. Yangxinshi tablets, an herbal-based oral medicine, relieve symptoms of angina might be that they can improve energy metabolism of the ischemic myocardium. We conducted a randomized trial to assess the efficacy and safety of Yangxinshi vs. trimetazidine in improving exercise tolerance in patients with CHD after PCI. MethodsThis prospective, randomized, double-blind, double-dummy, multicenter, non-inferiority study enrolled patients aged 18–75 years with CHD who underwent their first PCI within 2 months of diagnosis. Patients were randomized to Yangxinshi plus trimetazidine-placebo or trimetazidine plus Yangxinshi-placebo for 24 weeks. The primary endpoint was the change in metabolic equivalents (METs) assessed by cardiopulmonary exercise test (CPET) between 0 and 24 weeks. Secondary endpoints were comprehensive variables of the CPET, health status and adverse events. This study has been registered at ClinicalTrials. gov (NCT03809273). ResultsBetween August 1, 2019, and March 31, 2022, a total of 681 patients were randomized to Yangxinshi (n=341) or trimetazidine (n=340). After 24 weeks, the exercise tolerance of patients increased by 0.77±1.25 METs in the Yangxinshi group and 0.76±1.00 METs in the trimetazidine group (difference, 0.01; 95% confidence interval [CI], −0.17 to 0.19), meeting the predefined non-inferiority threshold. Better outcomes were observed in the Yangxinshi group compared with the trimetazidine group for patient-reported depression (PHQ-9; −1.88±3.32 vs. −0.93±3.68; P < 0.001) and anxiety (GAD-7; −1.70±3.26 vs. −0.39±3.29; P < 0.001). Adverse events were similar in both groups. ConclusionsIn patients with CHD after PCI, Yangxinshi was non-inferior to trimetazidine in improving exercise tolerance during the 24-week treatment period. Notably, patients in the Yangxinshi group showed a better mental health profile compared with trimetazidine recipients.

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.

The effect of a subclinical dose of esketamine on depression and pain after cesarean section: A prospective, randomized, double-blinded controlled trial.

The aim of this randomized, double-blind placebo-controlled clinical trial was to study the effects of subclinical doses of esketamine on postpartum depression and pain following elective cesarean sections. This randomized, double-blind placebo-controlled trial included 150 pregnant women undergoing elective cesarean sections. After umbilical cord clamping, participants received either subclinical doses of esketamine (0.25 mg/kg, diluted in 10 mL of 0.9% saline) or a placebo (10 mL of 0.9% saline). The primary outcome measures were the incidence of postpartum depression (PPD) and postoperative pain. The Edinburgh Postnatal Depression Scale was used to evaluate PPD on days 3, 7, and 14 postpartum, with an Edinburgh Postnatal Depression Scale score ≥ 10 indicating PPD. Postoperative pain was assessed using the Visual Analog Scale (VAS) at 4, 24, and 48 hours post-surgery. Secondary outcomes included adverse reactions and Ramsay sedation scores at 5 and 15 minutes post-administration. There were no significant differences in the incidence of PPD between the 2 groups on days 3, 7, and 14 postpartum (P > .05). The VAS scores showed significant differences between the 2 groups at 4 and 24 hours postoperatively (P < .05), but not at 48 hours (P > .05). The experimental group had significantly higher adverse reactions and Ramsay sedation scores 5 minutes post-administration compared to the control group (P < .05), but no significant differences were observed upon leaving the operating room (P > .05). Subclinical doses of esketamine did not reduce the incidence of PPD at 14 days postpartum but did significantly lower VAS scores at 24 hours post-surgery. The experimental group experienced temporary increases in adverse reactions and Ramsay sedation scores shortly after administration.