Search

Clinical studies examining the effects of vitamin D on cognition have reported inconsistent results. To date, no comprehensive study has examined this effect on the basis of sample characteristics or intervention model–related factors. This systematic review and meta-analysis of randomized controlled trials investigated the effects of vitamin D supplementation on global cognitive function and specific cognitive domains. This review was preregistered in the PROSPERO database (CRD42021249908) and comprised 24 trials enrolling 7557 participants (mean age: 65.21 years; 78.54% women). The meta-analysis revealed that vitamin D significantly influenced global cognition (Hedges' g = 0.128, p =.008) but not specific cognitive domains. A subgroup analysis indicated that the effect size of vitamin D was stronger for vulnerable populations (Hedges' g = 0.414) and those with baseline vitamin D deficiency (Hedges' g = 0.480). On the basis of subgroup analyses in studies without biological flaws (Hedges' g = 0.549), we suggest that an intervention model should correct baseline vitamin D deficiency. Our results indicate that vitamin D supplementation has a small but significant positive effect on cognition in adults. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to compare the hemodynamic effects of remimazolam- and propofol-based total intravenous anesthesia in patients who underwent transcatheter aortic valve replacement. Methods: This was a single-center, single-blind, randomized controlled trial set at Nara Medical University, Kashihara, Japan. We included 36 patients aged ≥ 20 years scheduled to undergo elective transfemoral transcatheter aortic valve replacement (TAVR) under general anesthesia. The participants were randomly assigned to the remimazolam and propofol groups (n = 18 each). Remimazolam- or propofol-based total intravenous anesthesia was initiated at 12 mg/kg/min or 2.5 mcg/mL via target-controlled infusion, respectively, along with remifentanil. After confirming the loss of consciousness, the administration rate was adjusted using electroencephalographic monitoring. The primary outcome was the rate of arterial hypotension, defined as a mean arterial pressure < 60 mmHg, from anesthesia induction until the beginning of the surgical incision. The total doses of ephedrine and phenylephrine were also assessed. Results: During anesthesia induction, the arterial hypotension rates were 11.9% and 21.6% in the remimazolam and propofol groups, respectively (P = 0.01). The total dose of ephedrine was higher in the propofol group (14.4 mg) than in the remimazolam group (1.6 mg) (P < 0.001); however, the total dose of phenylephrine was not significantly different between the two groups (propofol 0.31 mg vs. remimazolam: 0.17 mg, P = 0.10). Conclusion: Remimazolam-based total intravenous anesthesia resulted in a lower hypotension rate than propofol-based total intravenous anesthesia during induction in patients undergoing TAVR. Remimazolam-based total intravenous anesthesia can be used safely during anesthetic induction in patients with severe aortic stenosis. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the present study was to examine the acute and chronic effects of wild blueberry supplementation on mood, executive function, and serum biomarkers of neuroplasticity, inflammation, and oxidative stress in emerging adults with moderate-to-severe depressive symptoms. Methods: In this double-blind trial, 60 emerging adults (Mage = 20.0 years, 32% male) with self-reported depressive symptoms were randomly assigned to receive a single blueberry drink (acute phase), followed by 6 weeks of daily blueberry supplementation (chronic phase), or a matched placebo drink. The primary outcome was Beck Depression Inventory-II (BDI-II) scores at 6-week follow-up. Further measures included momentary affect (PANAS-X) and accuracy on an executive function task. The data were analyzed using ANCOVAs adjusted for baseline values, sex, and habitual fruit and vegetable intake. Estimated marginal means were calculated to compare the treatment arms. Results: The blueberry drink significantly improved positive affect (p = 0.026) and executive function (p = 0.025) at 2 h post-ingestion, with change scores being positively correlated in the blueberry group (r = 0.424, p = 0.017). However, after six weeks of supplementation the reduction in BDI-II scores was greater in the placebo group by 5.8 points (95% CI: 0.8–10.7, p = 0.023). Generalized anxiety and anhedonia also decreased significantly more in the placebo group. No significant differences were found for any of the biomarkers. Conclusions: Six weeks of wild blueberry supplementation were inferior to placebo in reducing depressive symptoms. Nevertheless, the correlated improvements in positive affect and executive function after a single dose of blueberries point to a beneficial, albeit transient, psychological effect. These contrasting results suggest a biphasic, hormetic-like response that warrants further investigation. Trial registration: NCT04647019, dated 30 November, 2020. [ABSTRACT FROM AUTHOR]

Introduction: This analysis of two Japanese clinical trials evaluated efficacy and safety after galcanezumab (GMB) discontinuation in patients with episodic migraine (EM) and chronic migraine (CM). Methods: Data were from a 6-month, randomized, double-blind, placebo [PBO]-controlled primary trial (patients with EM) and a 12-month open-label extension trial (patients with EM/CM). Patients received 6 months' (primary) or 12/18 months' (extension) treatment with GMB 120 mg (GMB120) plus 240-mg loading dose or 240 mg (GMB240) with 4 months' post-treatment follow-up. Efficacy was assessed as number of monthly migraine headache days during post-treatment. Safety was assessed via post-treatment-emergent adverse events (PTEAEs). Results: The analysis population included 186 patients from the primary trial (PBO N = 93; GMB120 N = 45; GMB240 N = 48), 220 patients with EM from the extension trial (PBO/GMB120 N = 57; PBO/GMB240 N = 55; GMB120/GMB120 N = 55; GMB240/GMB240 N = 53), and 55 patients with CM (GMB120 N = 28; GMB240 N = 27). In patients with EM receiving 6 months' GMB120, mean standard deviation (SD) monthly migraine headache days increased from 5.69 (4.64) at treatment end to 6.24 (4.37) at end of follow-up but did not return to pre-treatment levels (8.80 [2.96]). In the extension trial, mean monthly migraine headache days in patients with EM receiving GMB120 were 4.13 (3.85) after 12 months and 4.45 (3.78) at end of follow-up, and 3.59 (3.48) after 18 months and 3.91 (3.57) at end of follow-up. Monthly migraine headache days in patients with CM (12 months' GMB120) were 10.71 (4.61) at treatment end and 11.17 (5.64) at end of follow-up (pre-treatment 20.15 [4.65]). Similar results were seen for patients receiving GMB240. The most observed PTEAE after GMB discontinuation was nasopharyngitis. Conclusion: Galcanezumab exhibited post-treatment efficacy for up to 4 months in Japanese patients with EM and with CM. No unexpected safety signals were observed. Clinical Trial Registration: ClinicalTrials.gov, NCT02959177 and NCT02959190. [ABSTRACT FROM AUTHOR]

Background: Increasingly, patients, clinicians, and regulators call for more evidence on the impact of innovative medicines on quality of life (QoL). We assessed the effects of disease-modifying therapies (DMTs) on QoL in people with multiple sclerosis (PwMS). Methods: Randomized trials assessing approved DMTs in PwMS with results for at least one outcome referred to as "quality of life" were searched in PubMed and ClinicalTrials.gov. Results: We identified 38 trials published between 1999 and 2023 with a median of 531 participants (interquartile range (IQR) 202 to 941; total 23,225). The evaluated DMTs were mostly interferon-beta (n = 10; 26%), fingolimod (n = 7; 18%), natalizumab (n = 5; 13%), and glatiramer acetate (n = 4; 11%). The 38 trials used 18 different QoL instruments, with up to 11 QoL subscale measures per trial (median 2; IQR 1–3). QoL was never the single primary outcome. We identified quantitative QoL results in 24 trials (63%), and narrative statements in 15 trials (39%). In 16 trials (42%), at least one of the multiple QoL results was statistically significant. The effect sizes of the significant quantitative QoL results were large (median Cohen's d 1.02; IQR 0.3–1.7; median Hedges' g 1.01; IQR 0.3–1.69) and ranged between d 0.14 and 2.91. Conclusions: Certain DMTs have the potential to positively impact QoL of PwMS, and the assessment and reporting of QoL is suboptimal with a multitude of diverse instruments being used. There is an urgent need that design and reporting of clinical trials reflect the critical importance of QoL for PwMS. [ABSTRACT FROM AUTHOR]

Purpose: To investigate fluid absorption and its influencing factors during flexible ureteroscopy with intelligent control of renal pelvic pressure (RPP). Methods: A total of 80 patients with upper urinary tract calculi underwent flexible ureteroscopy with intelligent control of RPP by pressure-measuring ureteral access sheath and were randomly divided into four groups. The RPP of Groups A, B, and C were set at – 5, 0 and 5 mmHg, respectively. Conventional flexible ureteroscopy with uncontrolled pressure served as control Group D. The perfusion flow rate was set at 100 ml/min in the four groups, with 20 patients in each group. The fluid absorption was measured by 1% ethanol every 10 min. Operation time, stone-free rate, and complications were recorded. Result: Seventy-three patients were finally included in the RCT. The general and preoperative data of the patients were comparable between the groups. The fluid absorption of Groups A, B, and C was significantly less than that of Group D (P < 0.01). Fluid absorption and operation time were positively correlated, and the correlation coefficients R were 0.864, 0.896, 0.918, and 0.947, respectively (P < 0.01). The fluid absorption of patients with vomiting, fever and ureteral injury was greater than that of patients without complications in the four groups (P < 0.01). In different groups, fluid absorption was greater in patients with ureteral injury Post-Ureteroscopic Lesion Scale (PULS) 1–3 than in noninjured patients (P < 0.01). Conclusion: Flexible ureteroscopy with intelligent control of RPP effectively reduces the absorption of perfusion fluid. Operation time and ureteral injury are also key factors affecting perfusion fluid absorption. Registration number and date: NCT05201599; August 11, 2021. [ABSTRACT FROM AUTHOR]

Background: Inositol is a potential new therapeutic agent for gestational diabetes mellitus (GDM), but its effectiveness is still controversial. The aim of the report was to evaluate the effectiveness of inositol to preventing or reducing the severity of GDM. Methods: We searched PubMed, EmBase, Web of science, Cochrane library databases, Clinicaltrials.gov, and International Clinical Trials Registry Platform for randomized controlled trials (RCTs) assessing the effectiveness of inositol supplementation to prevent and treat GDM. This meta-analysis was performed using the random-effects model. Results: A total of 7 RCTs (1319 pregnant women at high risk of GDM) were included in the meta-analysis. The meta-analysis found that inositol supplementation resulted in a significantly lower incidence of GDM in the inositol versus the control group (odds ratio [OR] 0.40; 95% confidence interval [CI] 0.24–0.67; P = 0.0005). The inositol group had improved fasting glucose oral glucose tolerance test (FG OGTT; mean difference [MD] = − 3.20; 95% CI − 4.45 to − 1.95; P < 0.00001), 1-h OGTT (MD = − 7.24; 95% CI − 12.23 to − 2.25; P = 0.004), and 2-h OGTT (MD = − 7.15; 95% CI − 12.86 to − 1.44; P = 0.01) results. Inositol also reduced the risk of pregnancy-induced hypertension (OR 0.37; 95% CI 0.18–0.75; P = 0.006) and preterm birth (OR 0.35; 95% CI 0.18–0.69; P = 0.003). A meta-analysis of 4 RCTs including 320 GDM patients showed that the patients' insulin resistance (P < 0.05) and neonatal hypoglycemia risk (OR 0.10, 95% CI 0.01–0.88; P = 0.04) were lower in the inositol than in the control group. Conclusions: Inositol supplementation during pregnancy has the potential to prevent GDM, improve glycemic control, and reduce preterm birth rates. [ABSTRACT FROM AUTHOR]

Purpose: Depressive disorders cause a major burden of disease worldwide and often lead to a loss of social functioning. Patients suffering from depressive disorders report a lower quality of life (QOL) than people without a history of mental health issues. Internet-based interventions (IBIs) based on cognitive behavioral therapy (CBT) are effective in reducing symptom severity but data on their impact on quality of life in clinically depressed patients so far is scarce. Methods: Selfapy is a CBT-based IBI for depressive disorders. 401 participants (332 female, mean age 37 (SD = 11) with a diagnosis of major depressive disorder (MDD) or dysthymia were enrolled in a randomized, parallel, three-arm trial comparing a therapist-guided Selfapy intervention with an unguided Selfapy intervention and a waiting list control. QOL was measured using the WHOQOL-BREF at baseline, post-treatment (12 weeks) and at 24-week follow-up. The effects of the interventions on QOL were calculated using linear mixed effects models. Results: At post-treatment (12 weeks) the guided and unguided intervention groups reported an increase in QOL on physical and psychological health domains compared to controls (significant group*time interaction). The gain in QOL was maintained over the follow-up period only for psychological health. QOL decreased in the social relationships and environment domains over the course of treatment and during the follow-up treatment for all participants. There were no differences between the guided and the unguided intervention. Conclusion: Selfapy proved to positively affect psychological and physical QOL in a sample of participants suffering from depressive disorders and can therefore be considered an effective and highly scalable therapeutic tool. The pattern of results might partly be attributable to effects of the COVID-19 pandemic and public health measures that coincided with the trial. Trial registration: German Clinical Trials Register (DRKS): DRKS00017191. Registered June 14th, 2019, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017191. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to estimate minimal clinically important difference (MCID) values for the World Health Organization Quality of Life Brief version (WHOQOL-BREF) among adults with neurofibromatosis (NF). An MCID is needed to demonstrate clinical meaningfulness of interventions for NF. Methods: We estimated MCID for the WHOQOL-BREF: the quality of life (QoL) measure recommended by the Response Evaluation in Neurofibromatosis and Schwannomatosis International Collaboration. We used data from 228 clinical trial participants with NF type 1, NF type 2-related schwannomatosis, or schwannomatosis (SCHWN) who completed 10 weeks of a virtual group mind–body program targeting resiliency or a time- and attention-matched control. Following established guidelines, we estimated MCIDs using both anchor-based and distribution-based methods for physical, psychological, social relationships, and environmental domains of the WHOQOL-BREF. Results: MCID results varied across method and QoL domain. Three anchor-based methods, average change (AC), change difference (CD), and regression (REG), yielded the most consistent and comparable MCID across QoL domains. Based on these methods, we recommend ranges for each QoL domain: Physical QoL (3.9–7.3), Psychological QoL (4.7–8.1), Social QoL (2.6–5.9), and Environmental QoL (4.1–6.6). Conclusion: Establishing a rigorous MCID for QoL in NF is a critical step toward evaluating meaningful change in response to psychosocial interventions. [ABSTRACT FROM AUTHOR]

Parenting programs have been shown to empower parents and prevent mental health problems in children. However, few programs are designed to promote wellbeing, which led to the development of the Swedish-promotive universal program, "All Children in Focus" (ACF). This study aimed to understand the effects of parents' participation in the ACF program on parents' emotion regulation and parenting practices over a 6-month follow-up and if intervention-produced changes predict child wellbeing (CW). Parental self-efficacy (PSE) was also included to assess the relation with parental outcomes and CW. This is an evaluation of a multicenter randomized waitlisted control trial conducted in Stockholm County, Sweden, with parents of children aged 3 to 12 years (n = 621) in 2012. Parents were randomized 1:1 to enter the program or to a waitlist. Questionnaires were completed by parents at baseline, post-intervention, and 6 months post-baseline. We used generalized mixed modeling to test effects on parental outcomes over time and regression analyses to study the predictive role of parental outcomes on CW. From baseline to the post- and to the 6-month follow-ups, parents in the intervention group reported greater levels of emotion regulation skills, cognitive reappraisal, and positive parenting than did parents in the control group. A decrease in negative and harsh parenting was evident in both groups, although it was greater in the intervention group. An increase in PSE was associated with high negative parenting at baseline in the intervention group. Child gender moderated positive parenting, suggesting that parents of girls in the intervention group had more favorable development of positive strategies. The findings indicate that a change in PSE predicts a change in CW at 6 months. The ACF program can be used to strengthen and develop parenting. This study advances our knowledge about the potential advantages of using a health-promoting approach to strengthen the wellbeing of families in the general population. Clinical trial registration: ISRCTN70202532 Current Controlled Trials [ABSTRACT FROM AUTHOR]

Using a randomized controlled trial, we investigated changes in both sexual harassment (SH) perpetration and victimization of 2104 middle school students in New York City who received divergent saturation and dosage levels of Shifting Boundaries, an SH prevention program, which was represented by the length of the program. We assessed the saturation effect of the program by comparing the outcomes across respondents from 26 schools in which there were varying percentages of students enrolled in the program. The data suggested that, overall, the program was effective in reducing sexual harassment victimization but achieved a null effect against respondents' SH perpetration and that neither the length nor the school-saturation level of the program exerted a significant effect on SH perpetration. Although the data indicated a significant difference in SH victimization between the treatment and control group, when comparing subgroups who received treatment with divergent saturation and dosage levels, no statistically significant difference was identified. Our results suggested that the program effect was not contingent on the portion of students in a school who enrolled in the program, nor was it contingent on the dosage. [ABSTRACT FROM AUTHOR]

The purpose of this study was to systematically evaluate the efficacy of repetitive transcranial magnetic stimulation in children with cerebral palsy and to compare the differences in efficacy of different treatment parameters. Computer searches of PubMed, Embase, Cochrane Library, Scopus, Web of Science, China Knowledge Network, Wanfang Data Knowledge Service Platform, Vipshop and China Biomedical Literature Database were conducted to collect randomized controlled trials (RCTs) of TMS to improve function in children with cerebral palsy. The search period was from the establishment of the database to April 2023. Two researchers independently screened the literature and extracted data information, and the risk of bias was assessed for the included studies using the Cochrane Systematic Evaluation Manual 5.1.0. Statistical analysis was performed using RevMan 5.4 and Stata software. A total of 18 studies containing 1675 patients with cerebral palsy were included, and r-TMS did not differ significantly from other treatments in improving language function [MD = 2.80, 95% CI (-1.51, 7.11), Z = 1.27, P = 0.20] after treatment. The results of the reticulated meta-analysis showed the best probability ranking of the effect of three different frequencies of r-TMS on motor function scores in children with cerebral palsy: combined LF-rTMS + HF-rTMS (49.8%) > LF-rTMS (45.6%) > HF-rTMS (4.6%) > conventional rehabilitation (0%). Publication bias showed no significant asymmetry in the inverted funnel plot, but the possibility of publication bias could not be excluded. The results of this study showed that r-TMS was not statistically significant in improving language function in children with cerebral palsy compared to conventional treatment. r-TMS was almost unanimously significantly effective in motor function in children with cerebral palsy according to current literature data, and the combined high- and low-frequency transcranial magnetic therapy was better than low-frequency transcranial magnetic therapy. [ABSTRACT FROM AUTHOR]

Background: Significant heterogeneity exists regarding patient reported outcome measures (PROMs) used in total hip (THA) and knee (TKA) arthroplasty randomized controlled trials (RCTs). This study investigates the PROMs used as primary and secondary outcomes in contemporary arthroplasty RCTs. Methods: A literature search identified THA and TKA RCTs that were published in top ten impact factor orthopaedic journals from 2017 to 2021. Screening identified 241 trials: 76 THA, 157 TKA, and eight combined. Data were extracted to identify PROMs utilized as either primary or secondary outcomes and the time period of measurement. Results: Visual Analog Scale (VAS) Pain was the most reported primary PROM in THA (9.2%) and TKA (22.9%) trials. This was followed by Numeric Rating Scale (NRS) Pain (7.9%) and the Harris Hip score (6.6%) in THA trials and NRS Pain (4.5%) and the Knee Society score (4.5%) in TKA trials. Many THA (37.0%) and TKA (52.1%) trials did not clearly specify primary outcome time points. Only pain scales were reported at time points less than one week, while various joint-specific functional outcomes were reported at later time points. As secondary outcomes, the Harris Hip score (28.9%) was most common in THA trials and the Knee Society score (26.1%) was most common in TKA trials. Indeterminate primary or secondary outcomes were reported in 18.2% of studies. Conclusions: Contemporary THA and TKA trials exhibit heterogeneity of PROMs as study outcomes after the first postoperative week. Our findings highlight the need for consensus in PROM reporting and better methodological reporting to improve the interpretability of RCT outcomes. PROSPERO registration number: CRD42022337255. [ABSTRACT FROM AUTHOR]

Background: Some Chinese scholars have initially explored the efficacy of electroacupuncture at Baliao acupoint in patients with functional anorectal pain (FAP). However, their studies are performed in a single center, or the sample size is small. Therefore, we aim to further explore the efficacy of electroacupuncture at Baliao acupoint on the treatment of FAP. Methods: In this multicenter randomized controlled trial, 136 eligible FAP patients will be randomly allocated into an electroacupuncture group or sham electroacupuncture group at a 1:1 ratio. This trial will last for 34 weeks, with 2 weeks of baseline, 4 weeks and 8 weeks of treatment, and 1, 3, and 6 months of follow-up. Outcome assessors and statisticians will be blind. The primary outcome will be clinical treatment efficacy, and secondary outcomes will be pain days per month, quality of life, psychological state assessment, anorectal manometry, pelvic floor electromyography, and patient satisfaction. Discussion: Results of this trial will be contributed to further clarify the value of electroacupuncture at Baliao acupoint as a treatment for FAP in the clinic. Trial registration: This trial has been registered in Chinese Clinical Trial Registry https://www.chictr.org.cn/ (ChiCTR2300069757) on March 24, 2023. [ABSTRACT FROM AUTHOR]

Mastectomy serves as the main surgical treatment for both invasive and in situ breast carcinoma and large phyllodes tumors. It is associated with skin necrosis, seroma, and surgical site infection in up to 30% of patients. In the present trial, we compared the complications in patients undergoing skin flap elevation by one of the 4 techniques: thick skin flap raised by scalpel(group1), thin skin flap raised with scalpel (group 2), thick skin flap raised with diathermy (group 3), and thin skin flap raised with diathermy (group 4). A randomized trial with superiority hypothesis and 2 × 2 factorial design was conducted at All India Institute of Medical Sciences New Delhi. Mastectomy skin flap necrosis (MSN) was recorded as the main outcome of interest. MSN was noted in 2.5% in group1, 10% in group 2, 7.5% in group 3, and 30% in group 4. MSN was observed in 5% cases with thick flap compared to 20% cases with a thin skin flap (p = 0.007). Raising the flap with scalpel was associated with MSN in 6.25% compared to 18.75% in the diathermy group (p = 0.029). We conclude that raising a thick flap with scalpel is associated with lowest risk of skin flap necrosis. Trial Registration: Clinical Trial Registry- India CTRI/2014/09/004978 [ABSTRACT FROM AUTHOR]

Objectives: The objective of this single-use, five-treatment, five-period, cross-over randomized controlled trial (RCT) was to compare the efficacy in dental plaque removal of a new Y-shaped automatic electric toothbrush (Y-brush) compared to a U-shaped automatic electric toothbrush (U-brush), a manual toothbrushing procedure (for 45 and 120 s), and no brushing (negative control). Materials and methods: Eligible participants were volunteer students randomized to the treatments in the five periods of the study. The primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing while the secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. Results: After brushing procedures, manual toothbrushing (120 s) showed a statistically significant reduction in FMPS than Y-brush (difference 36.9; 95%CI 29.6 to 44.1, p < 0.0001), U-brush (difference 42.3; 95%CI 35.1 to 49.6, p < 0.0001), manual brushing (45 s) (difference 13.8; 95%CI 6.5 to 21.1, p < 0.0001), and No brushing (difference 46.6; 95%CI 39.3 to 53.9, p < 0.0001). Y-brush was significantly more effective than No brushing (difference 9.8; 95%CI 2.5 to 17.0, p = 0.0030), while there was no significant difference compared to U- brush. Similar results were obtained for the differences in the Clean Mouth VAS. Conclusions: Y-brush was significantly more effective than no brushing (negative control) in removing dental plaque. When compared to manual toothbrushing for both 45 and 120 s, however, Y-brush was less effective in dental plaque removal. Clinical relevance: Modified design of automatic toothbrushing devices could improve plaque reduction, especially in patients with intellectual disabilities or motor difficulties. [ABSTRACT FROM AUTHOR]

Chronic Rhinosinusitis (CRS) affects nearly 10% of the global population, leading to substantial economic and quality-of-life burdens. While patient education has improved outcomes in other chronic conditions, its impact on CRS remains understudied. The study aims to evaluate the effectiveness of a structured patient education program on the psychological well-being and symptom severity of individuals diagnosed with CRS. This was a prospective, randomized controlled trial conducted in a tertiary care centre from January 2021 to December 2022. We enrolled 200 adult patients diagnosed with CRS based on the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines. Participants were randomized into two groups: the control group, receiving conventional CRS medical management, and the intervention group, receiving conventional treatment plus a structured patient education program. By the end of the study, 100 participants from each group completed the 2-year follow-up. The intervention group showed significant improvements in psychological well-being, with HADS scores decreasing from 10 ± 3.5 to 7 ± 3.0. CRS symptom severity, as measured by SNOT-22 scores, also significantly improved in the intervention group, dropping from 45 ± 10 to 35 ± 9. Additionally, the intervention group had fewer acute CRS flare-ups over two years compared to the control group. Adherence to nasal spray usage was higher in the intervention group, and feedback on the educational program was largely positive. A structured patient education program, when added to conventional CRS treatment, enhances psychological well-being, and reduces symptom severity. Given these promising results, there's need to integrate patient education into standard CRS management and explore its long-term benefits. [ABSTRACT FROM AUTHOR]

Purpose: The value of computer navigation in total knee arthroplasty (TKA) for arthritic knees continues to be debated. The purpose of this study was to evaluate the value of navigated TKA associated with updated alignment philosophy. Methods: This prospective randomized controlled trial enrolled 38 consecutive patients (76 knees) and were randomly assigned to both groups. The demographic data and perioperative data were recorded. The coronal plane alignment of the knee (CPAK) classification was used to classify knee alignment phenotypes. Radiographic outcomes were measured and subgroup analysis was further performed. Clinical outcomes were evaluated using patient-reported outcome measures (PROMs). Surgery-related complications were recorded. Results: The distribution of CPAK phenotypes following constitutional aligned TKA was equivalent to the native cohort, whereas the mechanical aligned TKA dramatically altered the phenotype distribution from type I and type II to type V and type IV. Final implant positioning was different between groups, with constitutional aligned TKA having larger cTCA (P =.004), joint line obliquity (P =.006), joint line distance (P =.033) and smaller sFCA (P =.013). Subgroup analysis showed higher actual accuracy of component positioning was achieved in navigated TKA, especially in knees with deformity of > 10° (P <.05). Patients reported higher HSS score at three months postoperatively in constitutional aligned group (P =.002). One patient in navigated group suffered femoral pin site fracture caused by a minor trauma. Conclusion: Computer navigated TKA allows for restoration of constitutional alignment and minimizes soft tissue release, which when compared to mechanical alignment may be associated with superior early outcomes. [ABSTRACT FROM AUTHOR]

We report midline impacts of a community-randomized cash transfer intervention to 1857 vulnerable mothers in 140 rural cocoa-farming communities of Côte d'Ivoire. Compared to mothers in the comparison group who participated in village savings and loan associations (VSLAs), treatment mothers participated in VSLAs and received 8 € each week for up to one year with no conditions attached (the midway point of a two-year program). We find small- to moderate-sized treatment effects on four of six indicators of economic well-being (d = 0.23–0.75), as well as small reductions in maternal stress (d = −0.27). We find no statistically detectable impacts on educational engagement, educational aspirations, or educational expectations for children. Results suggest that cash transfer programs in rural West African communities can improve economic well-being and reduce maternal stress. Implications for children and families and for future cash transfer evaluations are discussed. [ABSTRACT FROM AUTHOR]

Introduction: Frozen shoulder is a very common musculoskeletal condition and the evidence related to the additional effects of extracorporeal shockwave therapy (ESWT) with intra-articular (IA) lidocaine injection in individuals with frozen shoulder is rare. Therefore, this study aims to compare and investigate the additional effects of extracorporeal shockwave therapy (ESWT) with intra-articular (IA) lidocaine injection in a frozen shoulder. Methods: Sixty eligible participants with frozen shoulder were included and the active group (n = 30, age 52.12 ± 5.2 years) received a lidocaine injection (1% lidocaine (Xylocaine) and 2cc (80 mg) methylprednisolone acetate) with active ESWT (3.5 bar air pressure and 2000 pulses with an energy flux density (EFD) ¼ 0.16 mJ/mm2) three sessions a week for 4 weeks. The placebo group (n = 30, age 53.56 ± 5.5 years) received lidocaine injection with placebo treatment (a special head that blocked the shock waves) three sessions a week for 4 weeks. Both groups received progressive resistance exercises (PRE) to the shoulder muscles. The primary outcome was pain intensity, measured with the visual analogue scale. The other outcome measures were the thickness of the coracohumeral ligament (CHL) measured by magnetic resonance imaging (MRI), abduction, and lateral rotation range of motion (ROM), functional disability, kinesiophobia, depression status, and quality of life. Participants were assessed at baseline, after 4 weeks, 8 weeks, and at 6-month follow-up. Results: The post-intervention at 4 weeks showed an improvement of 2.0 (CI 95% 1.71–2.28) in the active group compared to the placebo group. Similar effects were noted after 8 weeks (2.2) (CI 95% 1.91–2.48) and at the 6-month (1.9) (CI 95% 1.61–2.18) follow-up. Similar improvements were also found in the thickness of the CHL ligament (0.6) (CI 95% 0.46–0.73), abduction and lateral rotation (ROM) (– 23.6) (CI 95% – 27.47 to -19.72), (- 18.10) (CI 95% – 19.72 to – 16.47), functional disability (16.2) (CI 95% 14.85–17.54), kinesiophobia (11.0 (CI 95% 10.21–11.98), depression status (4.4) (CI 95% 4.03–4.76) and quality of life (0.9) (CI 95% 0.79–1.00) (p = 0.001) at the 6-month follow-up period, where mean estimates and their confidence intervals all included worthwhile effects. There were no adverse reactions or side effects noted in either the active or placebo groups during and after the treatment. Conclusions: The study concluded that the addition of extracorporeal shockwave therapy after intra-articular lidocaine injection improves pain, functional disability, range of motion, kinesiophobia, depression status, and quality of life in people with frozen shoulder. Trial Registration: https://ctri.nic.in, identifier; CTRI/2020/04/024834 prospectively registered on 24/04/2020. [ABSTRACT FROM AUTHOR]

Background: Depression often leads to clinical admission. Stimulating positive memory bias through repeated retrieval can counteract a ruminative depressotypic processing style. Cognitive Bias Modification (CBM)-Memory is a psychological intervention, which was evaluated as possible adjunct treatment for depressed inpatients. Methods: A randomized controlled pilot study with a one-week follow-up was implemented to compare the effect of a four-session positive CBM-Memory intervention to a neutral CBM-Memory version. Training-congruent retrieval (as manipulation check), and transfer to rumination (as mechanistic target) and depressive symptoms (self-rated and clinician-rated; indication of clinical relevance) were assessed. Results: In the intention-to-treat sample (N = 81, Mage=35.6/SD = 11.9, 60% female), condition-congruent memory retrieval of previously presented target words was found after the training and at follow-up (large effect-sizes). Positive CBM-Memory intervention resulted in sustained recall bias and largest rumination reduction with a small-medium effect size. Additionally, the conditions did not differ significantly on the reduction in depressive symptoms. Conclusions: Positive CBM-Memory intervention yielded positive recall bias, which was still present one week later. Additionally, the positive condition did yield more decrease in trait (but not state) rumination, providing some support for rumination as mechanistic target of positive CBM-Memory. However, there was no evidence for transfer of the training effect to depressive symptoms, indicating no superiority on clinical recovery of the positive over the neutral condition. Future research should examine a higher dosage, integration of CBM in the treatment provision, and its long-term effects in a well-powered trial. [ABSTRACT FROM AUTHOR]

The meta-analysis aims to explore the effect of cognitive behavioral therapy for insomnia (CBT-I) in the perinatal period. Randomized controlled trials (RCTs) assessed the effects of CBT-I in perinatal women with insomnia, published in English, were eligible. Electronic searches were performed using PubMed, Embase (Elsevier), PsycINFO (Ebsco), and Web of Science (Clarivate Analytics). Insomnia Severity Index (ISI) as the primary outcome was used to estimate the pooled effects and durable efficacy of CBT-I. The secondary outcome measures were Edinburgh Postnatal Depression Scale (EPDS) and Pittsburgh Sleep Quality Index (PSQI). Of 46 studies reviewed, seven studies met the inclusion criteria. The meta-analysis indicated significant improvement in insomnia as measured with the ISI (standardized mean difference (SMD) = − 0.62, 95% confidence intervals (CI) − 0.77, − 0.47, I2 = 28%). At the follow-up time point, the meta-analysis indicated the durable efficacy of CBT-I (SMD = − 0.47, 95% CI − 0.90, − 0.03, I2 = 73%). Definite improvement of CBT-I on EPDS (SMD = -0.31, 95% CI − 0.55, − 0.06, I2 = 33%) and PSQI (SMD = − 0.82, 95% CI − 1.27, − 0.38, I2 = 68%) score change post-intervention were found. In sub-analyses, CBT-I had similar effect sizes, independent of possible modifiers (study population, comparison group, delivery format, etc.). This meta-analysis demonstrates that CBT-I is effective in alleviating insomnia, depression, and sleep quality among perinatal women. It is equally important to find that CBT-I has a durable efficacy on insomnia in the perinatal period. However, it is necessary to include larger samples and conduct rigorous RCTs to further explore this issue. [ABSTRACT FROM AUTHOR]

The indications for collagenase ointment (CO) and its efficacy are not clearly established in the treatment of second-degree burn wounds. To evaluate the efficacy of CO versus silver sulfadiazine ointment (SSD) in the treatment of second-degree burn wounds. A total of 170 eligible patients with deep second-degree burns, aged 18–65 years, with injuries occurring within 48–96 h, and having a total wound area of less than 30% of the total body surface area were included from 5 centers in China. The primary outcome was the wound healing time, and the secondary outcomes were the clearance time of wound necrotic tissues, wound healing rate, and wound inflammation. The study included 85 patients in SSD group and 84 in CO group in the modified intention-to-treat (mITT) population. The median time of wound healing was comparable in both groups (10 days vs. 10.5 days P = 0.16). The time for wound necrotic tissue removal was significantly shortened by CO compared with SSD (5 vs. 10 days P < 0.01). Wound inflammation, pain, wound healing rate, and scar were compared with SSD (all P-values > 0.05). No adverse events, such as infection or allergic reactions to the drugs and materials used, were reported. Both CO and SSD could heal the burn wounds at 10 days of treatment. However, CO significantly shortened the time of wound necrotic tissue removal by 5 days. Trial Registration: ChiCTR2100046971. [ABSTRACT FROM AUTHOR]

Acne scarring results from a common inflammatory condition present in many people. These scars can have an impact on quality of life by influencing self-esteem and social acceptance. Current acne scarring treatments, such as chemical peels and laser treatments, often have limited success due to their time-consuming nature and the variability of acne scar types. The subcision technique has shown promise for the treatment of rolling acne scars. There are few studies to date that examine the effects of multiple subcision treatments on rolling acne scars. We evaluated whether the use of multiple subcision treatments improved the appearance of rolling acne scars compared to no treatment. Five patients with rolling acne scars on both sides of their face who met inclusion and exclusion criteria were enrolled in the study. One side of the face was randomized to receive treatment, while the contralateral side of the face received no treatment. Subjects underwent five sequential subcision treatments, spaced 4 weeks apart, with two follow-up visits at weeks 20 and 36 from the 1st treatment. Photographs were taken before and after the initial treatment visit and at each subsequent visit. Acne scar appearance was evaluated by the subject, a blinded live rater, and two double-blinded dermatologist raters. Evaluations of treatment outcomes involved overall acne scar appearance on a 5-point scale, acne scar improvement on a percentage scale, a modified quantitative global scarring grading system, and potential treatment side effects. There was a greater decrease in global scarring scores in the multiple subcision side compared to the control side. There was a greater difference in the average acne scar appearance scores between the Week 36 follow-up visit and baseline for the multiple subcision side compared to that of the control side. 50% of patients reported being more satisfied with the treatment side compared to the control side in regard to overall improvement. The study results suggest that multiple subcision treatments may improve the appearance of rolling acne scars compared to no treatment. [ABSTRACT FROM AUTHOR]

Background: Fibromyalgia syndrome is a widespread chronic pain condition identified by body-wide pain, fatigue, cognitive fogginess, and sleep issues. In the past decade, repetitive transcranial magnetic stimulation has emerged as a potential management tool.. In the present study, we enquired whether repetitive transcranial magnetic stimulation could modify pain, corticomotor excitability, cognition, and sleep. Methods: Study is a randomized, sham-controlled, double-blind, clinical trial; wherein after randomizing thirty-four fibromyalgia patients into active or sham therapy (n = 17 each), each participant received repetitive transcranial magnetic stimulation therapy. In active therapy was given at 1 Hz for 20 sessions were delivered on dorsolateral prefrontal cortex (1200 pulses, 150 pulses per train for 8 trains); while in sham therapy coil was placed at right angle to the scalp with same frequency. Functional magnetic resonance imaging was used to identify the therapeutic site. Pain intensity, corticomotor excitability, cognition, and sleep were examined before and after therapy. Results: Baseline demographic and clinical parameters for both active and sham groups were comparable. In comparison to sham, active repetitive transcranial magnetic stimulation showed significant difference in pain intensity (P < 0.001, effect size = 0.29, large effect) after intervention. Other parameters of pain perception, cognition, and sleep quality also showed a significant improvement after the therapy in active therapy group only, as compared to sham. Conclusions: Findings suggest that repetitive transcranial magnetic stimulation intervention is effective in managing pain alongside cognition and sleep disturbances in patients of fibromyalgia. It may prove to be an important tool in relieving fibromyalgia-associated morbidity. [ABSTRACT FROM AUTHOR]

This meta-analysis was to investigate the efficacy of transcranial direct current stimulation (tDCS) for general cognitive function in Alzheimer's disease (AD) and to investigate the potential influential factors. A systematic literature retrieval until August 2023 was performed by searching the PubMed, Embase, Web of Science, and Cochrane Library. Therapeutic effects of tDCS were evaluated using standardized mean difference (SMD) and 95% confidence interval (CI). Pooled effects of tDCS on AD patients were calculated immediately after treatment and at follow-up periods. Subgroup analyses were conducted to identify the potential prognostic factors. Eleven studies with 12 trials including 451 cases were included in our systemic review, in which 9 studies with 10 trials using Mini-Mental State Examination (MMSE) scales were included in the meta-analysis. tDCS significantly improved global cognition in AD immediately after the treatment (SMD, 0.46; 95% CI, 0.25–0.66; P<0.0001), but not at the shorter or longer follow-up period. Subgroup analyses suggested significant global cognitive improvement in patients receiving stimulation on temporal lobes instead of left dorsolateral prefrontal cortex, and in cases receiving tDCS with current density ≥ 0.08 mA/cm2 rather than <0.08 mA/cm2. Compared with tDCS plus cognitive training (CT), tDCS without CT produced obvious cognitive enhancement. In addition, patients with lower education were more likely to benefit from tDCS. tDCS was effective in improving general cognition in AD after treatment. However, further randomized trials are warranted to validate its longer-term effects as well as our subgroup analyses results. [ABSTRACT FROM AUTHOR]

Objectives: Root-end filling is important for the clinical outcome of endodontic microsurgery. Our previous study showed that combined application of iRoot BP Plus Root Repair Material (BP-RRM) and iRoot SP Injectable Root Canal Sealer (SP-RCS) in root-end filling exhibited better apical sealing as compared to the application of BP-RRM alone. The aim of this randomized controlled clinical trial was to evaluate the effect of the combined use of BP-RRM and SP-RCS on the prognosis of teeth with refractory periapical diseases after endodontic microsurgery. Materials and methods: 240 teeth with refractory periapical diseases scheduled for endodontic microsurgery were randomly divided into BP-RRM/SP-RCS group (n = 120) and BP-RRM group (n = 120). The patients were followed up at 3 months, 6 months, and 12 months after endodontic microsurgery. Pre- and post-operative clinical and radiographic examinations were performed to evaluate the treatment outcome. The 1-year success rate of endodontic microsurgery in BP-RRM/SP-RCS and BP-RRM groups was compared by Chi-square test. Factors that might impact the prognosis were further analyzed using Chi-square test or Fisher's exact test. Results: A total of 221 teeth completed the 12-month follow-up. The 1-year success rates of the BP-RRM/SP-RCS and BP-RRM groups were 94.5% (104/110) and 92.8% (103/111), respectively. The combined use of BP-RRM and SP-RCS achieved a clinical outcome comparable to BP-RRM alone (P = 0.784). Tooth type (P = 0.002), through-and-through/apico-marginal lesion (P = 0.049), periodontal status (P < 0.0001), and Kim’s lesion classification (P < 0.0001) were critical factors associated with the 1-year success of endodontic microsurgery. Conclusions: The combined use of BP-RRM and SP-RCS is a practicable method for root-end filling in endodontic microsurgery with a satisfactory 1-year clinical outcome. Clinical relevance: The combined application of BP-RRM and SP-RCS in EMS is an effective root-end filling method with a satisfactory 1-year clinical outcome. Trial registration: This study was registered in the Chinese Clinical Trial Registry (ChiCTR2100052174). [ABSTRACT FROM AUTHOR]

Children in out-of-home care persistently show poorer educational and developmental outcomes than their peers. This study investigates the effect of the comprehensive educational intervention, "LUKoP," in a randomized controlled trial, compared to treatment-as-usual (TAU). Outcome measures included reading and math abilities, IQ and executive function, learning skills, and psychosocial functioning. One hundred foster children (66% female) aged 6–14 (M = 10.5, SD = 2.1) from 80 regular schools participated in the study. We applied a fixed-effects regression analysis. Regardless of group allocation, the children demonstrated significant progress in cognitive development, including IQ (ES = 0.40, p <.001), verbal comprehension (ES = 0.29, p =.02), and perceptual reasoning (ES = 0.60, p <.001) over time. The children who received the LUKoP intervention also had a significant increase in word-reading speed (ES = 0.21, p =.02) and a significant additional gain in IQ (ES = 0.34, p =.02) and verbal comprehension (ES = 0.41, p =.03), compared to TAU. No significant effect was found on the other outcome measures for either the TAU group (ES range = − 0.13 to 0.47, p >.05) or the LUKoP group (ES range = − 0.15 to 0.42, p >.05). We found no compelling evidence that the LUKoP intervention gives overall benefit to academic achievement; however, LUKoP demonstrated a greater effect on cognitive abilities than TAU. The findings and future directions for educational interventions for children in out-of-home care are discussed. [ABSTRACT FROM AUTHOR]

Purpose: Virtual reality (VR) training effectiveness in improving hip arthroplasty surgical skills requires further evaluation. We hypothesised VR training could improve accuracy and the time taken by medical students compared to a control group with only video teaching. Methods: This single-centre randomized controlled clinical trial collected data from March to June 2023. Surgically naïve volunteer undergraduate medical students performed three sessions on a VR training platform, either cup (VR-Cup=Control-Stem) or stem (VR-Stem=Control-Cup) implantation. The primary outcome was the mean difference between predefined cup inclination (60°) and stem anteversion (20°) compared to the actual implanted values in sawbones between VR and control groups. Secondary outcomes were task completion time and mistake number between the groups. Results: A total of 101 students participated (VR-Cup 47, VR-Stem 54). Groups did not significantly differ concerning age (p = 0.879), gender (p = 0.408), study year (p = 0.938), previous VR use (p = 0.269) and baseline medical and procedural knowledge. The VR-Cup implanted the cup closer to the intended target (p < 0.001) and faster than the Control-Cup group (p = 0.113). The VR-Stem implanted the stem closer to the intended target (p = 0.008) but not faster than the Control-Cup group (p = 0.661). Stem retroversion was commoner in the Control-Stem than in the VR-Stem group (p = 0.016). Conclusions: VR training resulted in higher rates of accurate procedure completion, reduced time and fewer errors compared to video teaching. VR training is an effective method for improving skill acquisition in THA. Trial registration: ClinicalTrials.gov Identifier: NCT05807828 [ABSTRACT FROM AUTHOR]

Purpose: To compare the clinical outcomes and radiographic outcomes of cortical bone trajectory (CBT) and traditional trajectory (TT) pedicle screw fixation in patients treated with single-level transforaminal lumbar interbody fusion (TLIF). Methods: This trial included a total of 224 patients with lumbar spine disease who required single-level TLIF surgery. Patients were randomly assigned to the CBT and TT groups at a 1:1 ratio. Demographics and clinical and radiographic data were collected to evaluate the efficacy and safety of CBT and TT screw fixation in TLIF. Results: The baseline characteristic data were similar between the CBT and TT groups. Back and leg pain for both the CBT and TT groups improved significantly from baseline to 24 months postoperatively. The CBT group experienced less pain than the TT group at one week postoperatively. The postoperative radiographic results showed that the accuracy of screw placement was significantly increased in the CBT group compared with the TT group (P < 0.05). The CBT group had a significantly lower rate of FJV than the TT group (P < 0.05). In addition, the rate of fusion and the rate of screw loosening were similar between the CBT and TT groups according to screw loosening criteria. Conclusion: This prospective, randomized controlled analysis suggests that clinical outcomes and radiographic characteristics, including fusion rates and caudal screw loosening rates, were comparable between CBT and TT screw fixation. Compared with the TT group, the CBT group showed advantages in the accuracy of screw placement and the FJV rate. Clinical Trials Registration: This trial has been registered at the US National Institutes of Health Clinical Trials Registry: NCT03105167. [ABSTRACT FROM AUTHOR]

Introduction and hypothesis: Safety concerns with the use of mesh in vaginal surgery have been ongoing. Autologous fascial slings (AFS) avoid foreign body complications. We compared the long-term (17-year) outcomes of two AFS repair methods—the standard sling and short sling (sling-on-string), and assessed durability and patient satisfaction of these for the treatment of stress urinary incontinence (SUI). Methods: A total of 107 patients from three urogynaecology units who had participated in a randomised controlled trial assessing standard (n = 52) and short (n = 55) slings were followed up for a median period of 17 years. Primary outcomes were Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory (UDI-6) scores to assess the impact on the quality of life and symptom distress. Logistic quantile regression was employed to compare the two methods. Secondary outcomes included long-term complications and patient satisfaction. Results: Mean scores showed no statistically significant difference between the standard and short slings at the 17-year follow-up relating to IIQ and UDI scores, leakage or urgency (p > 0.05). Improved bladder function was observed at 17 years compared with baseline (standard sling—IIQ scores mean difference [MD] 1.22 [CI: 0.69, 1.74], UDI scores MD 0.83 [CI: 0.70, 0.97]; short sling—IIQ score MD 1.14 [CI: 0.73, 1.54], UDI scores MD 0.54 [CI: 0.40, 0.67]) with age-related deterioration over time. Re-operation rates were low and patient satisfaction rates were high (67.2%) at follow-up. Conclusions: Autologous fascial slings are an effective and durable option for management of SUI and the short sling procedure can be recommended owing to plausible surgical advantages. [ABSTRACT FROM AUTHOR]

The purpose is to explore the analgesic effect of a single Nd:YAG laser dose after mandibular third molar extraction. This was a prospective randomized controlled clinical trial. Subjects were enrolled according to the inclusion and exclusion criteria and randomly divided into the experimental and control groups. In the experimental group, the wound was irradiated with the Nd:YAG laser (wavelength, 1064 nm; output power, 1.5 W; energy density, 45 J/cm2; and power density, 1.5/cm2, pulsed mode) immediately after mandibular third molar extraction for 120 s (30 s at each site). In the control group, the laser working tip was placed near the extraction site but not activated. The primary outcome was the visual analog scale (VAS) pain scores in both groups at 2, 4, 12, 24, 48, and 72 h and 7 days after surgery. Secondary outcomes included wound healing scores and adverse reactions. The VAS score was significantly lower in the experimental group than in the control group at 2 and 4 h after surgery, while there was no significant difference in the VAS score between the two groups at 12, 24, or 48 h or 7 days after surgery. There were no significant differences in the wound healing scores between the two groups on postoperative day 7. No adverse reactions were observed in any of the laser-irradiated areas. A single Nd:YAG laser dose was effective in reducing pain at 2 and 4 h after mandibular third molar extraction. China Clinical Trial Registry: ChiCTR2000033870 (Registration Date: 2020–6-15). [ABSTRACT FROM AUTHOR]

Background: Premature ejaculation is one of the most common male sexual dysfunction, affecting approximately 30% of men. The aim of this study is to evaluate the efficacy and at the same time the safety of the cranial electrotherapy stimulation (CES) device in treatment of premature ejaculation disorder. Methods: Based on a randomized clinical trial, two groups were included in the study, so that the first group was treated with sertraline along with an ATANG (AT-9 model) CES, and the second group with sertraline and inactive the CES device (as the placebo group). The state of premature ejaculation after treatment (using the Premature Ejaculation Diagnostic Tool (PEDT) questionnaire) was evaluated and compared for both groups. Results: In the intervention and placebo groups, the average score of the PEDT questionnaire before the intervention did not differ significantly between the two groups (p-value equal to 0.93). However, the average score of the PEDT questionnaire after the intervention for CES group and placebo group was 10.28 ± 1.93 and 13.23 ± 3.05, respectively, which demonstrated a significant decrease in the intervention group (p-value equal to 0.01). Conclusion: The use of CES device as a complementary treatment along with routine drug treatment (sertraline) is associated with a significant improvement in the condition of premature ejaculation of patients. Trial registration: Name of the registry: IRCT Iranian Registry of Clinical Trials. Trial registration number: IRCT20210621051657N1. Date of registration: December 11, 2022. URL of trial registry record: https://en.irct.ir/trial/57201. [ABSTRACT FROM AUTHOR]

Purpose: Breast cancer survivors face dual challenges: long-term sequelae of treatment and the risk of recurrent disease. Furthermore, obesity and a sedentary lifestyle can complicate both challenges. We aimed to assess the effect of a 12-week exercise-based weight-management program in overweight/obese breast cancer survivors. Methods: A two-arm, single-blinded, randomized controlled trial was conducted among 60 overweight/obese, stage 0–III breast cancer survivors. During the 12-week program, the intervention group received weekly information support, fortnightly exercise prescriptions, including aerobic and resistance exercises to perform at home, and one dietary instruction. The control group received information support about weight management and exercise. Weight, body composition, and physical fitness data were collected at baseline, postintervention, and the 3-month follow-up. Results: The intervention group showed significant improvements in body weight and all adiposity indices, including body mass index, waist circumference, and %body fat, in comparison with baseline (P < 0.001) and the control group (P < 0.05). Both groups showed no significant changes in fat-free mass during the 6-month period (P > 0.05). International Physical Activity Questionnaire scores and left grip strength increased significantly in the intervention group in comparison with the baseline (P < 0.01) and the control group (P < 0.05). Right grip strength, lower-body strength, and aerobic endurance showed no significant intergroup differences (P > 0.05). Conclusions: A combination of exercise prescription and weight-loss interventions yielded clinically meaningful weight loss in overweight/obese breast cancer survivors. These findings may facilitate the incorporation of home-based exercise and weight management into breast cancer treatment and survivorship care. [ABSTRACT FROM AUTHOR]

We examined whether a housing voucher intervention influenced adolescent risky sexual behavior (RSB) across 15 years in the Moving to Opportunity Study. Low-income families in public housing that resided in 5 cities were randomized to one of three treatment groups: a housing voucher to move to low-poverty neighborhoods (i.e., < 10% poverty rate), a Sect. 8 voucher but no housing relocation counseling, or a control group that could remain in public housing. Youth and their caregivers completed baseline surveys, as well as two uniform follow-ups: interim (2001–2002; 4–7 years after baseline) and final (2008–2010; 10–15 years after baseline). Approximately 4,600 adolescents (50.5% female) aged 13–20 years participated at the final timepoint. Adolescents reported on their RSB, including condom use, other contraceptive use, early sexual initiation (< 15 years old), and 2+ sexual partners in the past year. We modeled each indicator separately and as part of a composite index. We tested baseline health vulnerabilities as potential effect modifiers. The low-poverty voucher group and the Sect. 8 voucher group were combined due to homogeneity of their effects. Applying intent-to-treat (ITT) regression analyses, we found no significant main effects of voucher receipt (vs. control) on any RSB. However, we found protective effects of voucher receipt on RSB among youth with health problems that limited activity, and youth < 7 at baseline but adverse effects among females, youth > 7 at baseline, and youth who were suspended/expelled from school. Results highlight the importance of understanding how housing interventions differentially influence adolescent health and behaviors. [ABSTRACT FROM AUTHOR]

Background: Although the risk of gastric cancer can be stratified according to Helicobacter pylori (H. pylori) IgG antibody titer and pepsinogen levels (ABC classification), a population-based gastric cancer screening system combining serological tests and endoscopy has not been introduced. This study aimed to compare the total testing cost per participant between the ABC classification method and the existing protocol. Methods: Using the minimization method with sex and age as allocation factors, 1206 participants were randomly assigned to the following two methods for a 5-year intervention: barium photofluorography as primary examination followed by detailed examination with upper gastrointestinal endoscopy (Ba-Endo) and risk-based upper gastrointestinal endoscopy by ABC classification (ABC-Endo). The primary endpoint was the total testing cost per participant over a 5-year period. The secondary endpoint was the expense required to detect one gastric cancer. Results: The total testing cost per participant was 39,711 yen in Ba-Endo (604 participants) and 45,227 yen in ABC-Endo (602 participants), with the latter being significantly higher (p < 0.001). During the intervention period, gastric cancer was found in 11 and eight participants in Ba–Endo and ABC-Endo, respectively. The expenses required to detect one gastric cancer were 2,240,931 yen in Ba-Endo and 3,486,662 yen in ABC-Endo. Conclusions: The testing cost per participant turned out to be higher in the ABC-Endo group than in the Ba-Endo group. This superiority trial, based on the hypothesis that the cost of testing is lower for ABC-Endo than for Ba-Endo, was rejected. [ABSTRACT FROM AUTHOR]

Introduction: This study assessed the safety, tolerability, and PK/PD of HSK7653 tablets in Chinese patients with type 2 diabetes mellitus (T2DM). Methods: This was a Phase IIa, multicenter, randomized, double-blind, placebo-controlled, and dose-increasing study with 48 Chinese diabetes patients. Subjects were randomly assigned to placebo and 10/25/50 mg dose groups, and they received oral administration once every two weeks for a total of six times. Safety and tolerability were assessed throughout this study, and PK/PD parameters were analyzed using non-compartment model with WinNonlin. Results: The three doses of HSK7653 were well tolerated, and the incidence of TEAE and ADR was not significantly increased compared with the placebo group. Cmax increased linearly with the increasing dose, and the mean t1/2 was 64.0–87.0 h. The first dose and last dose PK parameters were similar. After oral administration of 10–50 mg HSK7653 every two weeks, the average Rac_Cmax and Rac_AUC were 0.9–1.0 and 1.0–1.1 respectively; therefore, HSK7653 was not accumulated in vivo. All three doses significantly inhibited DPP-4 activity and increased plasma GLP-1 level and serum insulin levels. When the plasma concentration of HSK7653 was ≥ 20.0 ng/mL, the DPP-4 inhibition rate in all subjects was maintained at > 80.0%. In 10 and 25 mg dose groups, the HbA1c levels maintained a downward trend compared with the placebo group. Discussion: HSK7653 showed desirable pharmacokinetic and pharmacodynamic properties with good safety and tolerability in Chinese T2DM patients. DPP-4 inhibition rate and plasma GLP-1 levels were higher in each dose group than in placebo group. Trial Registration Number: CTR20182505 (Drug Clinical Trial Registration and Information Disclosure Platform, www.chinadrugtrials.org.cn). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the clinical relevance of using the XP-endo Finisher as a supplementary tool to improve the success of root canal treatment of posterior teeth with apical periodontitis, as assessed by 1-year follow-up. Methods: A randomized clinical trial was conducted with 92 posterior teeth with apical periodontitis. Root canal treatment was performed using a single reciprocating file, with or without the supplementary use of the XP-endo Finisher. The status of apical periodontitis was assessed using the periapical index (PAI) at baseline and 1 year follow-up. Changes on PAI indicated that the lesions were healed, healing, or not healed. Successful treatments were defined as healed or healing lesions without clinical symptoms. Chi-square analysis and logistic regression were used for data analysis (α = 0.05). Results: There was no significant difference in the distribution of healing status between the XP-endo Finisher group and the control group (p = 0.690). The success rates were also similar, with 81% in the XP-endo Finisher group and 78% in the control group. However, gender had a significant impact on success rates, with higher rates observed in females. Conclusions: The use of the XP-endo Finisher file as a supplementary tool did not affect the success rate of root canal treatment in posterior teeth with apical periodontitis. The findings indicate that the XP-endo Finisher file has limited clinical relevance in improving treatment outcomes for root canal treatment in posterior teeth with apical periodontitis. Clinical trial registration: The study protocol was registered in the Brazilian Clinical Trials Registry under identification number RBR-76w7cj (June 19, 2018). [ABSTRACT FROM AUTHOR]

The International Study of Kidney Disease in Children (ISKDC), begun in 1966, conducted the first international collaborative randomized blinded controlled trial in pediatric nephrology and one of the first in either pediatrics or nephrology. For this trial, the ISKDC developed the criteria, such as those for response and relapse, used today to describe the clinical course of the nephrotic syndrome, and the trial generated the nephropathologic terminology and criteria which largely remain the current standards. Over an approximately 20-year span, the ISKDC followed the natural history and evaluated the therapeutic effectiveness of therapies in over 500 children with the nephrotic syndrome from three continents. It published 14 peer-reviewed studies and several reports and commentaries, many of which helped create current standards of practice for therapy of childhood nephrotic syndrome and consequently remain highly cited today. The ISKDC continues to be an important model for subsequent collaborative studies and was the impetus for the development of regional and national pediatric nephrology societies leading to the recognition and growth of pediatric nephrology as a separate subspecialty. [ABSTRACT FROM AUTHOR]

Introduction: Chronic low back pain often comprises mixed pain types and involves multiple factors. Therefore, we hypothesized that the systemic transdermal formulation of diclofenac sodium (DF systemic patch), which is effective for nociceptive pain, and an α2δ Ca2+ channel ligand, which is effective for neuropathic pain, would have additive effects in the treatment of chronic low back pain. Methods: From among participants in a randomized, double-blind, placebo-controlled study of DF systemic patch (75 or 150 mg) applied once daily for 2 weeks in patients with chronic low back pain, we performed a subpopulation analysis of those who were concomitantly treated with an α2δ Ca2+ channel ligand during the study period. The efficacy endpoint was pain intensity score on a visual analog scale (VAS). Results: The difference (95% confidence interval) in the least square mean pain VAS score between patients in the 150-mg combination group, who were treated with 150-mg DF systemic patch and an α2δ Ca2+ channel ligand (n = 11), and those in the non-combination group, who were treated with placebo patch and α2δ Ca2+ channel ligand (n = 22), was − 15.09 mm (− 26.45, − 3.73). Because the upper limit of the 95% confidence interval was less than zero, this result indicates that the pain VAS score improved more in the 150-mg combination group than in the non-combination group (placebo group). Conclusions: The combination of the DF systemic patch and an α2δ Ca2+ channel ligand may be more effective than α2δ Ca2+ channel ligand monotherapy for controlling chronic low back pain. Trial registration numbers: JPRN-JapicCTI-205134 and jRCT2080225040. [ABSTRACT FROM AUTHOR]

Introduction: The efficacy and safety of galcanezumab as a preventive treatment in Japanese patients with episodic migraine was demonstrated in a phase 2, randomized, placebo-controlled trial (conducted December 2016–January 2019). This post hoc analysis assessed the consistency of galcanezumab efficacy through the monthly dosing interval. Methods: Patients with 4–14 migraine headache days/month were randomized (2:1:1, stratified by baseline migraine frequency) to subcutaneous placebo (n = 230), 120-mg galcanezumab (with 240-mg loading dose; n = 115) or 240-mg galcanezumab (n = 114) once monthly for 6 months. Outcomes included change from baseline in weekly migraine headache days, proportion of patients with migraine headache on each day, and proportion of patients with worsening migraine headache days during each month ([average of weeks 3–4] − [average of weeks 1–2] > 0). Results: In the 120-mg (approved dose) galcanezumab group, mean change from baseline in weekly migraine headache days was consistent and significantly greater (p < 0.05) than placebo for weeks 1–4; efficacy was consistent when averaged across months 1–6 and in most individual months. Averaged across months 1–6, the proportion of patients with migraine headache was significantly lower with galcanezumab than placebo on every day in both dose groups and was not significantly different between days 2 and 28 with 120-mg galcanezumab (p = 0.161). Within each month, the proportion of patients with migraine headache was generally consistent from days 2–28. The proportion of patients with worsening during the dosing interval did not significantly exceed 50% in any group during any month. Conclusions: This post hoc analysis supports the consistency of efficacy of galcanezumab across 6 months of treatment and suggests that wearing-off within the dosing interval does not occur on a population level in Japanese patients with episodic migraine. Trial Registration: ClinicalTrials.gov identifier, NCT02959177. [ABSTRACT FROM AUTHOR]

Depression in early childhood increases risk of psychopathology and impairment across the lifespan. Parent–Child Interaction Therapy-Emotion Development (PCIT-ED) effectively treats depression and improves functioning in preschoolers. Parental depression has been associated with inconsistent parenting, depression onset and maintenance in offspring, and decreased treatment efficacy for youth. Given the intensity of parent involvement in PCIT-ED, this secondary data analysis aimed to evaluate parental depression severity (i.e., Beck Depression Inventory-II Total Score; BDI-II) as a moderator and predictor of child, parenting, and engagement outcomes, within the context of a randomized trial. Children (N = 229; ages 3–6.11) with early childhood depression and a consenting caregiver were randomly assigned to receive PCIT-ED or Waitlist (WL). Moderation results supported the superiority of PCIT-ED over WL on child and parenting outcomes, independent of parent-reported BDI-II at baseline (p ≥ 0.684 and p ≥ 0.476, respectively). BDI-II did not significantly predict child (p ≥ 0.836), parenting (p ≥ 0.114) or engagement (p ≥ 0.114) outcomes. Finally, BDI-II did not surpass chance in predicting whether children would maintain a depression diagnosis after PCIT-ED (AUC = 0.530) or prematurely terminate treatment (AUC = 0.545). Our results suggest that PCIT-ED is not contraindicated by minimal-to-moderate symptoms of depression in parents. Taken together with previous reports, PCIT-ED may indeed be a particularly beneficial treatment choice for this population. Further research in samples with more severe parental depression is needed. ClinicalTrials.gov identifier: NCT02076425. [ABSTRACT FROM AUTHOR]

Tension between doctors and patients as a social problem has existed for a long time; thus far, there is no good solution. From the perspective of trust between doctors and patients, this research studies the relieving effect of perspective-taking interventions on the tension between doctors and patients. This study used a randomized, single-blind online experiment. 133 participants were randomly divided into an intervention group (n = 67) and control group (n = 66). Participants were asked to complete writing tasks from the doctor's perspective. Patients' trust in doctors was measured at 3 time points: before intervention, immediately after intervention, and 10 days after the intervention. Findings showed a significant interaction effect between time measurement and group. In the intervention group, a pairwise comparison of time measurements showed a significant difference between T1 and T2. Perspective-taking interventions can improve patients' trust in doctors, but this effect diminishes over time. [ABSTRACT FROM AUTHOR]

Aims: Evaluate patient-reported liver symptoms during treatment for chronic hepatitis B viral (HBV) infection and associations between changes in symptoms and levels of alanine aminotransferase (ALT) and viral markers. Methods: Data from 200 participants in the Hepatitis B Research Network Immune Active Trial who completed symptom assessments were analyzed. Patients were treated with tenofovir, with or without peginterferon (TDF + PegIFN vs. TDF alone) for 192 weeks. Participants completed a Symptom Checklist at baseline and every 4–12 weeks. A total symptom score was created, ranging from 0 (none) to 40 (severe). The SF-36 was completed every 48 weeks. Associations of symptom scores with ALT and viral markers were evaluated at baseline and end of treatment. Results: Participants were 65% male, 83% Asian, with a mean age of 42. Baseline symptoms were mild (median = 2, range 0–25) and associated with baseline ALT, HBV DNA levels and HBeAg + status. Patients on TDF alone experienced a more rapid and greater improvement in symptoms, but by week 192, symptom improvement was similar in both groups (54% vs 36%). Symptom improvements correlated with ALT and HBV DNA, most markedly among those with symptoms at baseline. Most patients (4 out of 6) who achieved HBsAg loss experienced symptom improvements. Overall, SF-36 scores did not change with treatment. Conclusions: Reduction in ALT and HBV DNA levels with therapy are associated with significant improvement in liver symptoms such as fatigue and pain over the liver, especially among those with higher ALT, HBV DNA, symptoms and HBeAg + status prior to treatment. [ABSTRACT FROM AUTHOR]

Rationale: Inadequate responses to current schizophrenia treatments have accelerated research into novel therapeutic approaches. Objectives: This study investigated the efficacy and tolerability of adjunctive L-theanine, an ingredient with neuroimmunomodulatory and neuroprotective properties, for chronic schizophrenia. Methods: Eighty chronic schizophrenia inpatients were equally assigned to receive risperidone (6 mg/day) plus either L-theanine (400 mg/day) or matched placebo in this 8-week, randomized, parallel-group, double-blind, placebo-controlled trial. The participants were assessed using the Positive and Negative Syndrome Scale (PANSS) by recording the results of subscales at baseline and weeks 4 and 8 to measure treatment efficacy. Additionally, the participants were assessed for the Hamilton Depression Rating Scale (HDRS) and adverse events, including the Extrapyramidal Symptom Rating Scale (ESRS). Results: Sixty patients, 30 in each group, were included in the analyses. All baseline demographic and clinical characteristics were comparable between the groups (p-values > 0.05). The reduction rates from baseline to endpoint in negative, general psychopathology, and total scores of PANSS were greater in the L-theanine group (p-values = 0.03, 0.01, and 0.04, respectively). Regarding general psychopathology scores, the reduction in the L-theanine group was also greater until week 4 (p-value < 0.01). The time × treatment interaction effect was significant on negative (p-value = 0.03), general psychopathology (p-value < 0.01), and total (p-value = 0.04) scores of PANSS, indicating additional improvements in the L-theanine group. The HDRS and side effects were comparable between the groups (p-values > 0.05). Conclusions: L-Theanine adjunct to risperidone safely and tolerably outperformed adjunctive placebo for schizophrenia, and promising evidence indicated its effects on primary negative symptoms, which need to be scrutinized in further studies. Trial registration: The study protocol was registered and published prospectively in the Iranian Registry of Clinical Trials (http://www.irct.ir; registration number: IRCT20090117001556N133) on 2020–12-12. [ABSTRACT FROM AUTHOR]

Purpose: Dysphagia is common after radiotherapy for head and neck cancer (HNC) and can affect health-related quality of life (HRQL). This randomized controlled trial aimed to evaluate the effect of the head-lift exercise (HLE) over 12 months in HNC patients with radiation-induced dysphagia. Methods: Sixty-one patients with dysphagia were randomized to intervention group (n = 30) and control group (n = 31) at 6–36 months after completion of radiotherapy for HNC. Dysphagia-specific HRQL was measured with the MD Anderson Dysphagia Inventory (MDADI); general and HNC-specific HRQL was measured with the European Organization for Research and Treatment of Cancer Quality of Life questionnaire Core 30 (EORTC QLQ-C30) and QLQ-H&N35. Measurements were made at baseline, and at 8 weeks and 12 months after start of intervention. Results: Adherence to the intervention was good throughout the year. When comparing change from baseline reports to each follow-up no statistically significant differences between the groups were found in any of the HRQL instruments. There were some statistically significant changes within groups compared to baseline. The intervention group improved self-rated swallowing function on the MDADI at 8 weeks (emotional domain, p = 0.03; functional domain, p = 0.007; total score, p = 0.01) and the control at twelve months (emotional domain, p = 0.03; functional domain, p = 0.02; physical domain, p = 0.004; total score, p = 0.002). Conclusion: In this randomized control study, no effect was observed short term or at 12 months on HRQL after use of the HLE as rehabilitation for radiation-induced dysphagia. [ABSTRACT FROM AUTHOR]

Purpose: This was a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the efficacy and safety of intratympanic OTO-313 in patients with subjective unilateral tinnitus. Methods: Patients with moderate to severe unilateral tinnitus of 2–12 months duration were enrolled. A single intratympanic injection of OTO-313 or placebo was administered to the affected ear and patients were evaluated during a 16-weeks follow-up period. Efficacy was assessed using the Tinnitus Functional Index (TFI), daily ratings of tinnitus loudness and annoyance, and Patient Global Impression of Change (PGIC). Results: Intratympanic administration of OTO-313 and placebo produced reductions in tinnitus with a similar percentage of TFI responders at Weeks 4, 8, 12, and 16. Reductions in daily ratings of tinnitus loudness and annoyance, and PGIC scores were also similar between OTO-313 and placebo groups. No significant differences in mean TFI scores between OTO-313 and placebo were observed for pre-specified strata regarding tinnitus duration (≥ 2 to ≤ 6 months and > 6 to ≤ 12 months) and TFI baseline scores (≥ 32 to ≤ 53 points and ≥ 54 to 100 points), although the results numerically favored OTO-313 in patients in the ≥ 2 to ≤ 6 months strata. These results also demonstrated an unexpectedly high placebo response particularly amongst patients with chronic tinnitus, despite training implemented to mitigate placebo response. OTO-313 was well-tolerated with a similar incidence of adverse events compared to placebo. Conclusions: OTO-313 did not demonstrate a significant treatment benefit relative to placebo due in part to a high placebo response. OTO-313 was safe and well-tolerated. [ABSTRACT FROM AUTHOR]

The purpose was to do a study to compare infectious complications in patients operated for MiniPerc or Minimally invasive Percutaneous Nephrolithotomy (MPCNL) using MIP and MPCNL with suction using Shah Superperc sheath for medium-sized renal stones less than 3 cm in size. The primary objective of this study is to compare the infectious complications and the secondary objectives are to compare stone-free rates, complication rates and operative times. A prospective randomized controlled trial with patients having proximal ureteral and renal stones of 10–30 mm size and planned for MPCNL done at a single institute. A total of 80 consecutively admitted patients with written informed consent were included for randomization with 40 patients in each arm of MPCNL and suction MPCNL. The median age in MPCNL and suction MPCNL arms were 48 and 49 years, the median stone size of 15.45 and 16.7 cm, the Median stone volume of 1576.2 vs 1752 mm3, and the median stone density of 1258 and 1250 Hu, the median hospital stay of 3 days in both arms were comparable. Infectious complications were comparable in both arms. Operative time was significantly less in the suction MPCNL group (26.5 min–IQR 17–34.8) than in the MPCNL group (34.8 min–IQR 20–45), p = 0.021 and stone-free rates (SFR), were more in Suction MPCNL arm 97.5% than in MPCNL 87.5%, p = 0.04. Overall, the complication rates were comparable in both arms. Suction MPCNL procedure resulted in shorter operating times and more SFR than conventional MPCNL with comparable complication rates. [ABSTRACT FROM AUTHOR]

Background: Trauma patients frequently receive supplemental oxygen, but its hemodynamic effects in blood loss are poorly understood. We studied the effects of oxygen on the hemodynamic response and tolerance to simulated blood loss in healthy volunteers. Methods: Fifteen healthy volunteers were exposed to simulated blood loss by lower body negative pressure (LBNP) on two separate visits at least 24 h apart. They were randomized to inhale 100% oxygen or medical air on visit 1, while inhaling the other on visit 2. To simulate progressive blood loss LBNP was increased every 3 min in levels of 10 mmHg from 0 to 80 mmHg or until hemodynamic decompensation. Oxygen and air were delivered on a reservoired face mask at 15 L/min. The effect of oxygen compared to air on the changes in cardiac output, stroke volume and middle cerebral artery blood velocity (MCAV) was examined with mixed regression to account for repeated measurements within subjects. The effect of oxygen compared to air on the tolerance to blood loss was measured as the time to hemodynamic decompensation in a shared frailty model. Cardiac output was the primary outcome variable. Results: Oxygen had no statistically significant effect on the changes in cardiac output (0.031 L/min/LBNP level, 95% confidence interval (CI): − 0.015 to 0.077, P = 0.188), stroke volume (0.39 mL/LBNP level, 95% CI: − 0.39 to 1.2, P = 0.383), or MCAV (0.25 cm/s/LBNP level, 95% CI: − 0.11 to 0.61, P = 0.176). Four subjects exhibited hemodynamic decompensation when inhaling oxygen compared to 10 when inhaling air (proportional hazard ratio 0.24, 95% CI: 0.065 to 0.85, P = 0.027). Conclusions: We found no effect of oxygen compared to air on the changes in cardiac output, stroke volume or MCAV during simulated blood loss in healthy volunteers. However, oxygen had a favorable effect on the tolerance to simulated blood loss with fewer hemodynamic decompensations. Our findings suggest that supplemental oxygen does not adversely affect the hemodynamic response to simulated blood loss. Trial registration This trial was registered in ClinicalTrials.gov (NCT05150418) December 9, 2021 [ABSTRACT FROM AUTHOR]

Objective: Mirtazapine and SSRIs are widely prescribed as first-line agents for late-life depression. However, evidence for these drugs is mostly based on non-elderly patients. Therefore, we reanalyzed a randomized controlled trial of mirtazapine versus SSRIs for depression in a sub-population of late-life patients. Methods: A randomized controlled trial was conducted with 141 patients, of whom 41 were elderly, and 100 were non-elderly. This study compared SSRIs and mirtazapine in late-life depression, examined late-onset and early adult-onset separately and compared elderly and non-elderly patients for each drug. Treatment effects and adverse events were assessed using the Hamilton Depression Rating Scale and the Udvalg for Kliniske Undersøgelser Side Effect Rating Scale, respectively. Results: In late-life depression, mirtazapine showed faster HAM-D total score improvement (3.3 points difference, p = 0.021) and higher improvement in insomnia (1.7 points difference, p = 0.001) and appetite (1.2 points difference, p = 0.020). Similar findings were observed for late-onset depression with the HAM-D total score (4.3 points difference, p = 0.007) and appetite (0.9 points difference, p = 0.004), favoring mirtazapine. Depressive symptoms were generally less improved in late-life depression than in non-late-life depression. Regarding the effect of mirtazapine on appetite, late-life depression showed greater improvement (0.7 points difference, p = 0.008). Nausea and micturition disturbances were more common with SSRIs in late-life depression than in non-late-life depression. In contrast, somnolence was less common in late-life depression with mirtazapine. Conclusion: The potential usefulness of mirtazapine in elderly patients was demonstrated. The results also showed differences in the treatment response to SSRIs and mirtazapine between elderly and non-elderly patients. [ABSTRACT FROM AUTHOR]