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Background: One anastomosis gastric bypass (OAGB) has been proposed as an effective alternative to the current standard procedure in Switzerland, Roux-en-Y gastric bypass (RYGB). Prospective data comparing both procedures are scarce. Therefore, we performed a non-inferiority randomized controlled trial assessing the effectiveness and safety of these 2 operative techniques. Method: Eighty patients were randomized 1:1. OAGB consisted of a very long gastric pouch with a 200 cm biliopancreatic limb, RYGB of a 150 cm ante-colic alimentary and a 60 cm biliopancreatic limb, respectively. Primary endpoint was the percent excess weight loss (%EWL) at 12 months after surgery. Results: Mean %EWL at 12 months was 87.9% (SD24.4) in the RYGB group and 104.1% (SD24.6) in the OAGB group (p = 0.006). There was no mortality. The rate of marginal ulcers was higher in patients with OAGB compared to those with RYGB (p = 0.011), while the total number of late complications did not statistically differ between the two groups. Except for the remission of GERD, which was higher in the RYGB group compared to OAGB, there was no difference between the groups regarding the remission of comorbidities. OAGB showed improved glucose control compared to the RYGB after 1 year (p = 0.001). Furthermore, glucagon-like peptide-1 increase was significantly higher in OAGB at 6 weeks (p = 0.041) and 1 year after surgery (p = 0.029). Quality of life improved after both surgeries, without differences between the groups. Conclusions: %EWL 1 year after surgery was higher in OAGB than in RYGB. A better glycemic control with a higher increase in GLP-1 was observed after OAGB compared to RYGB. Trial registration: This trial is registered on ClinicalTrials.gov under the identifier NCT02601092. [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]

Objective: To assess the efficacy and safety of Bufei Jiedu (BFJD) ranules as adjuvant therapy for patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB). Methods: A large-scale, multi-center, double-blinded, and randomized controlled trial was conducted in 18 sentinel hospitals in China from December 2012 to December 2016. A total of 312 MDR-PTB patients were randomly assigned to BFJD Granules or placebo groups (1:1) using a stratified randomization method, which both received the long-course chemotherapy regimen for 18 months (6 Am-Lfx-P-Z-Pto, 12 Lfx-P-Z-Pto). Meanwhile, patients in both groups also received BFJD Granules or placebo twice a day for a total of 18 months, respectively. The primary outcome was cure rate. The secondary outcomes included time to sputum-culture conversion, changes in lung cavities and quality of life (QoL) of patients. Adverse reactions were monitored during and after the trial. Results: A total of 216 cases completed the trial, 111 in the BFJD Granules group and 105 in the placebo group. BFJD Granules, as an adjuvant treatment, increased the cure rate by 13.6% at the end of treatment, compared with the placebo (58.4% vs. 44.8%, P=0.02), and accelerated the median time to sputum-culture conversion (5 months vs. 11 months). The cavity closure rate of the BFJD Granules group (50.6%, 43/85) was higher than that of the placebo group (32.1%, 26/81; P=0.02) in patients who completed the treatment. At the end of the intensive treatment, according to the 36-item Short Form, the BFJD Granules significantly improved physical functioning, general health, and vitality of patients relative to the placebo group (all P<0.01). Overall, the death rates in the two groups were not significantly different; 5.1% (8/156) in the BFJD Granules group and 2.6% (4/156) in the placebo group. Conclusions: Supplementing BFJD Granules with the long-course chemotherapy regimen significantly increased the cure rate and cavity closure rates, and rapidly improved QoL of patients with MDR-PTB (Registration No. ChiCTR-TRC-12002850) [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]

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]

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]

Objectives: Mental health problems are highly prevalent in people with Alzheimer's disease (AD) and their family caregivers. Therefore, this study aimed to examine the effects of the Mindfulness-Based Health Care Program (MBHC) on the psychological distress of family caregivers of people with AD and, indirectly, on the behavioral and psychological symptoms of dementia (BPSD) in people with AD. Method: A sample of 66 caregivers of people with AD was randomly assigned to either 8 weeks of MBHC or treatment as usual (TAU) groups. The psychological distress in family caregivers, measured by the Hospital Anxiety and Depression Scale (HADS), and BPSD in patients, measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q), were evaluated and compared at baseline, post-intervention, and 3-month follow-up. Results: A total of 50 participants (75.6%) completed the MBHC post-intervention and 30 (50%) at the 3-month follow-up. At post-intervention, compared to TAU, MBHC was associated with significantly greater decreases in psychological distress (β = − 3.86; 95%CI, − 7.67, − 0.04; p = 0.047), specifically in anxiety symptoms (β = − 2.84; 95%CI, − 5.38, − 0.30; p = 0.029), but no significant changes were observed in depressive symptoms. MBHC did not produce a significant change in psychological distress at 3-month follow-up. MBHC did not yield a significant reduction in BPSD in people with AD, neither at post-intervention nor at 3-month follow-up. Conclusions: The results suggest that 8-week mindfulness training can effectively reduce psychological distress and anxiety symptoms in caregivers of people with Alzheimer's disease. Preregistration: This study was preregistered on ClinicalTrials.gov (identifier NCT03858283) on 26 February 2019. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Surgical removal of the mandibular third molar requires reflection of the mucoperiosteal flap. Several studies have suggested different varieties and innovative designs for flap reflection. We have designed a randomized controlled trial (RCT) to check the feasibility of two flap designs: lingual-based triangular flap (LBTF) and buccal-based triangular flap (BBTF) by calculating the duration of surgery and evaluating postoperative complications such as pain, swelling, and trismus. Materials and Method: It was a non-inferiority parallel-group RCT. The trial was registered in the Control Trial Register of India (CTRI/2021/10/037182) and was performed according to Consolidated Standards of Registered Trial (CONSORT) guidelines. Intraoperative surgery time and postoperative pain, swelling, and trismus were measured and analyzed by a two-sample t test. The Chi-square test was used to measure gender distribution in the study. Result: Of the total of 88 required subjects, gender distribution and performed surgical time were statistically insignificant with a p-value of 0.76 and 0.48, respectively. The pain was significantly higher in the LBTF group in the 5th and 7th postoperative days with a p-value of 0.02 and 0.028. The swelling was statistically higher during all the follow-ups except for the 28th day in the LBTF group with values of 0.006, 0.002 and 0.003, respectively. There was no significant difference in inter-incisional distance (IID) between the groups during postoperative check-ups. Conclusion: LBTF shows no edge over BBTF during mandibular third molar disimpaction. [ABSTRACT FROM AUTHOR]

Copyright of Zeitschrift für Erziehungswissenschaft is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objectives: This randomized controlled trial (RCT) assessed the effectiveness of a community-infused problem-oriented policing (CPOP) intervention on reducing property/violent crime. Methods: In two mid-Atlantic cities, a total of 102 crime hot spots were randomly assigned to receive CPOP or standard patrol. Analyses examine changes in crime the year before, during, and one year after the intervention. We used hierarchical Poisson regression models. Results: We found no main effects for the CPOP intervention on property and violent crimes in either site. In site B, the violent crime count in low treatment hot spots was 200% higher than controls post-intervention but this likely reflected officers paying less attention to treatment locations with lower levels of crime. Conclusions: Our results suggest that CPOP was not effective in the unusual context of the COVID-19 pandemic and post-George Floyd killing. Given the challenges of implementing CPOP during this unique time, caution is needed in interpreting these findings. [ABSTRACT FROM AUTHOR]

Objective: The objective of our study was to integrate the efficacy results of post-nephrectomy adjuvant therapies in renal cell carcinoma (RCC) patients with risk of recurrence, and attempt to determine the optimal intervention choice. Methods: We performed standard meta-analysis procedures in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The PubMed, Embase, and Cochrane Library databases were searched from inception to 22 September 2022. Randomized controlled trials reporting overall survival (OS) or disease-free survival (DFS) of adjuvant therapies, including immune checkpoint inhibitors (ICIs) and targeted therapies, in adult post-nephrectomy RCC patients were eligible for inclusion. Results: Seven studies involving 7548 participants were included in our analyses. In contrast with placebo, DFS benefit with ICIs was only observed in female RCC patients and RCC patients with high programmed death-ligand 1 (PD-L1) expression (≥ 1%), sarcomatoid features, and M0 intermediate–high risk. Network meta-analyses demonstrated that pembrolizumab exhibited both DFS and OS benefit compared with placebo, sunitinib, sorafenib, and girentuximab, and only DFS benefit compared with atezolizumab and nivolumab plus ipilimumab. Conclusions: Our results suggest that post-nephrectomy RCC patients with sarcomatoid differentiation and high PD-L1 expression were more responsive to ICIs. Furthermore, pembrolizumab monotherapy exhibited superior DFS and OS results over other adjuvant therapies. [ABSTRACT FROM AUTHOR]

Neuromuscular electrical stimulation (NMES) is a novel treatment method that stimulates patients' swallowing functions. This systemic review was designed to evaluate the impact of NMES on dysphagia in stroke patients. Databases including PubMed, Embase, Web of Science, and Cochrane Library were searched from the date of establishment to January 28th, 2022. Two investigators identified all included studies and compared the swallowing function after NMES treatment with traditional therapy (TT). The Cochrane risk bias assessment tool was utilized to analyze the quality of included studies. Research outcomes included Swallowing Quality of Life (SWAL-QoL), Penetration–Aspiration Scale (PAS), Functional Oral Intake Scale (FOIS), Dysphagia Outcomes and Severity Scale (DOSS), the Repeat Salivary Swallowing Test (RSST), and Water Swallowing Test (WST). We extracted the mean and standard deviation of specific outcomes at the baseline level and after the treatment in both NMES and TT groups for subsequent meta-analysis. 9 randomized controlled trials (RCTs) and quasi-RCTs were included, and remarkable differences were found between patients treated with or without NMES in respect of FOIS scores (SMD = 0.48; 95% CI 0.26–0.70, P < 0.0001), PAS scores (SMD = − 0.56; 95% CI 1.01–0.10, P = 0.02), and SWAL-QoL scores (SMD = 0.57; 95% CI 0.00–1.14, P = 0.05). No significant difference was manifested in WST, RSST, and DOSS (SMD: − 0.02; 95% CI 0.38–0.35, P = 0.93). Evidence suggests that NMES is more effective for post-stroke dysphagia patients than treatment without NMES. [ABSTRACT FROM AUTHOR]

One-third of cancer pain patients do not experience adequate pain relief using analgesic ladder by the World Health Organization. Interventional procedures, such as epidural morphine, have been considered. This study aimed to review the literature comparing the effects of epidural administration of morphine with the oral route. This systematic review included randomized controlled trials (RCTs) conducted with patients with gastrointestinal neoplasm. A search was conducted on PubMed, EMBASE, Web of Science, Scopus, Cochrane Library, and CINAHL databases to identify studies published up to May 2023. The retrieved study was evaluated using the Risk of Bias 2 (RoB 2) tool and qualitatively synthesized. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach (Prospero: CRD42021264728). Only one RCT, a crossover trial, was included in this systematic review. The study was conducted with ten participants (one withdrawal) and reported a statistically significant difference between both subcutaneous and epidural morphine solutions and oral morphine. The adverse events were not described. The included study presents some concerns of bias and low certainty of evidence on the effectiveness and security of epidural morphine administration. The available literature does not suffice to elucidate whether morphine administration via the epidural route is more effective than other routes. Further RCTs are necessary to improve the level of evidence on the effectiveness and risk-benefit of epidural morphine in the management of cancer pain in gastrointestinal neoplasm patients. [ABSTRACT FROM AUTHOR]

Purpose : Patients hospitalized with COVID-19 may develop a hyperinflammatory, dysregulated cytokine "storm" that rapidly progresses to acute respiratory distress syndrome, multiple organ dysfunction, and even death. Remote ischaemic conditioning (RIC) has elicited anti-inflammatory and cytoprotective benefits by reducing cytokines following sepsis in animal studies. Therefore, we investigated whether RIC would mitigate the inflammatory cytokine cascade induced by COVID-19. Methods: We conducted a prospective, multicentre, randomized, sham-controlled, single-blind trial in Brazil and South Africa. Non-critically ill adult patients with COVID-19 pneumonia were randomly allocated (1:1) to receive either RIC (intermittent ischaemia/reperfusion applied through four 5-min cycles of inflation (20 mmHg above systolic blood pressure) and deflation of an automated blood-pressure cuff) or sham for approximately 15 days. Serum was collected following RIC/sham administration and analyzed for inflammatory cytokines using flow cytometry. The endpoint was the change in serum cytokine concentrations. Participants were followed for 30 days. Results: Eighty randomized participants (40 RIC and 40 sham) completed the trial. Baseline characteristics according to trial intervention were overall balanced. Despite downward trajectories of all cytokines across hospitalization, we observed no substantial changes in cytokine concentrations after successive days of RIC. Time to clinical improvement was similar in both groups (HR 1.66; 95% CI, 0.938–2.948, p 0.08). Overall RIC did not demonstrate a significant impact on the composite outcome of all-cause death or clinical deterioration (HR 1.19; 95% CI, 0.616–2.295, p = 0.61). Conclusion: RIC did not reduce the hypercytokinaemia induced by COVID-19 or prevent clinical deterioration to critical care. Trial Registration: ClinicalTrials.gov Identifier: NCT04699227. [ABSTRACT FROM AUTHOR]

Objective: To assess the use of evidence-based research (EBR) approach in randomized controlled trials (RCTs) of acupuncture-related therapies for primary dysmenorrhea (PD). Methods: PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Database, and China Science and Technology Journal Database were searched from January 2013 to December 2022 for RCTs of acupuncture on PD. The full text and references of each RCT were read to assess whether systematic reviews (SRs) or other types of studies with similar research questions and end-users' perspectives were cited to justify and design the trial. In addition, the discussion section were analyzed to evaluate whether trials placed the new result in the existing SRs to draw a conclusion. Multivariable logistic regression was used to find variables that associated with 3 aspects of EBR approach: (1) citing clinical studies for justification, (2) citing relevant studies that obtain the perspectives of end users, and (3) citing clinical studies for results discussion. Results: Of 473 RCTs included, 45.67% (216) of the trials cited relevant similar studies, 21.56% (102) referenced to the studies that collected end-users' perspectives, and 10.99% (52) placed result in the context of the previous research. Few RCTs appropriately applied EBR approach. Among all the included studies, 3.17% (15) of the trials used SRs to inform study questions but none of them used updated SRs with acceptable quality; 1.05% (5) of the trials cited SRs of end-user's perspectives in the justification and design of the study, and only 1 trial added results in existing SR to draw a conclusion. Year of publication, language, funding, registration, ethical approval and number of sites were significantly associated with 1 of the 3 aspects of EBR approach. Conclusions: Few RCTs in acupuncture-related therapies for PD used the EBR approach to minimize research redundancy. Researchers, research institutes, funding agencies, ethics committees, journals and peer reviewers in acupuncture should make efforts to use and promote the EBR approach to ensure the value of new trials. [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]

Purpose: Regarding the importance of obesity concerns and trying to help obese individuals, we planned to develop an effective probiotic formula for weight control. So, this double-blind randomized clinical trial study investigated the impact of probiotics supplementation on anthropometric and biochemical parameters in obese adults. Methods: In this study, 66 obese patients with BMI in the range of 30–40 kg/m2, were enrolled and randomly assigned to either the probiotic or placebo group. They all received advice to maintain a reduction in daily caloric intake and for 3 months received two unlabeled placebo or probiotic (Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus casei and Bifidobacterium langum) capsules per day. For each participant demographic and medical history questionnaire, semi-quantitative food frequency questionnaire (FFQ), and modifiable activity questionnaire (MAQ) were completed at the beginning of the study and anthropometric and biochemical measurements were done before and after intervention. Results: At the end of the trial 25 subjects in the probiotic group and 26 subjects in the placebo group were analyzed. After the intervention, in the probiotic group, the level of fasting insulin was reduced significantly (P < 0.05). Weight, body mass index, waist circumference, and hip circumference decreased within both groups. This reduction amount's mean was higher in the probiotic group. Also, total cholesterol, triglycerides, and LDL levels were decreased, but not statistically significant. Conclusion: This study may suggest the potential of this combined probiotic supplement for treating obesity and related metabolic disorders. However, further researches are warranted for a definitive determination of its properties. [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: 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]

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]

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]

Objectives: Repetitive negative thinking (RNT) is a problematic thinking style that is related to multiple mental disorders. Detached mindfulness is a technique of metacognitive therapy that aims to reduce RNT. Our study set out to investigate the immediate effects of detached mindfulness in daily life. Methods: Participants with elevated trait RNT (n = 50) were prompted to engage in detached mindfulness exercises three times a day for 5 consecutive days. Immediate effects on RNT and affect were assessed 15 and 30 min after each exercise using experience sampling methodology. We compared the effects of this exercise phase to (1) a 5-day non-exercise baseline phase and (2) a different group of participants that engaged in an active control exercise (n = 50). Results: Results of Bayesian multilevel models showed that, across groups, improvements in RNT, negative affect, and positive affect were stronger during the exercise phase than during the non-exercise baseline phase (RNT after 15 min: b = -0.26, 95% CI = [-0.38, -0.14]). However, the two exercise groups did not differ in these improvements (RNT after 15 min: b = 0.02, 95% CI = [-0.22, 0.27]). Thus, the detached mindfulness and the active control exercises resulted in similar effects on RNT and affect in daily life. Conclusions: Results of this study imply that there was no additional benefit of having participants observe their thoughts detached and non-judgmentally, compared to excluding these assumed mechanisms of action as done for the active control group. We discuss possible reasons for the non-difference between the groups. Preregistration: This study was preregistered at https://osf.io/rze64. [ABSTRACT FROM AUTHOR]

Background: Aesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin. Methods: A randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane® DefyneTM (HADEF), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HADEF or delayed-treatment controls, and those in the HADEF group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up). Results: HADEF was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HADEF group). All subjects reported satisfaction with results at 6 months after treatment with HADEF and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile. Conclusions: These results demonstrated HADEF to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population. Level of Evidence I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266. [ABSTRACT FROM AUTHOR]

Background: Lumbar facet joint pain (LFJP) is one of the main causes of chronic low back pain (LBP) and can be treated using radiofrequency (RF) sensory denervation. The aim of this work is to analyze the efficacy of RF in LFJP through a systematic review and meta-analysis of randomized controlled trials (RCTs) with placebo control. Materials and methods: A systematic search was conducted in the Medline (PubMed), Scopus, Web of Science databases, and the Cochrane Central Register of Controlled Trials (CENTRAL). The variables of interest were pain, functional status, quality of life (QoL), and global perceived effect (GPE) measured at different time intervals: short (< 3 months), medium (> 3 and < 12 months), and long term (> 12 months). Results: Eight RCTs with placebo control were included. RF showed significant benefits over placebo in pain relief in the short (MD − 1.01; 95% CI − 1.98 to -0.04; p = 0.04), medium (MD − 1.42; 95% CI − 2.41 to − 0.43; p = 0.005), and long term (MD − 1.12; 95% CI − 1.57 to − 0.68; p < 0.001), as well as improvement in functional disability in the short (SMD − 0.94; 95% CI − 1.73 to − 0.14; p = 0.02) and long term (SMD − 0.74; 95% CI − 1.09 to − 0.39; p < 0.001). No statistically significant differences were observed in QoL or quantitative GPE, but benefits for RF were observed in dichotomous GPE in the medium (OR 0.19; 95% CI 0.07–0.52; p = 0.001) and long term (OR 0.22; 95% CI 0.06–0.78; p = 0.02). Subgroup analyses showed more benefits for RF in LBP < 1 year in the short term and in RCTs that did not require performing an MRI for patient selection. Conclusions: RF demonstrated significant improvement in pain and functionality, but the benefits in terms of QoL and GPE are inconclusive. Future clinical trials should investigate the long-term effects of RF, its impact on quality of life, and define appropriate criteria for patient selection. [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]

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]

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]

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]

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]

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]

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]

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]

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]

Objectives: Test anxiety has a negative impact on college students' academic performance and mental health. This study evaluated the effects of a group program integrating Compassionate Mind Training (CMT) with Cognitive Behavioral Therapy (CBT) on test anxiety and a range of secondary outcomes. It was hypothesized that a 6-week program would reduce test anxiety and improve a range of mental health outcomes, compared to a wait-list condition. Method: A total of 64 college students (M = 20.26, SD = 1.63 years) with test anxiety (Test Anxiety Index greater than 49) were randomly assigned to either a 6-week intervention or wait-list control group. Participants completed a series of self-reports questionnaires before the intervention, after the intervention, and at a 4-month post-intervention follow-up. Results: The intervention significantly reduced test anxiety and improved self-compassion, the perceived ability to manage negative emotions, and general anxiety levels, with these effects persisting at the follow-up assessment. Moreover, the intervention group of participants experienced a further significant reduction in test anxiety and a significant improvement in subjective well-being 4 months after intervention. Conclusions: This study provides preliminary evidence supporting the efficacy of an integrated CMT with CBT group program for alleviating test anxiety. Preregistration: This study is not preregistered. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Journal of Acupuncture & Tuina Science is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The inappropriate use, especially overuse, of fertilizers aggravates greenhouse gas emissions and non-point source pollution. China is the largest fertilizer user worldwide, and information provision is a determinant of farmers' fertilizer use. Using survey data of 1002 rice farmers from Hubei, Jiangsu and Jiangxi provinces in China, this study aims to analyze the heterogeneity in farmers' fertilizer use and evaluate the heterogeneous effects of various modes of information provision on fertilizer use among different groups of farmers. A group of extended difference-in-differences models are developed and estimated based on a two-year randomized controlled trial. Results show that while farmers as a whole overuse fertilizers, there is copresence of overusers, consistent users and underusers. Information provision induces a sizeable fertilizer reduction among the overusers and a moderate increase among the underusers. Moreover, the reduction is small among top overusers. Information provision by public agricultural extension agents exerts larger reduction effects among the overusers than that by fertilizer firms, while that by fertilizer firms exerts larger incremental effects among the underusers. These findings illustrate that information provision is effective in rationalizing farmers' fertilizer use in China and underscores the importance of reinforcing such a mechanism. This study provides fresh evidence for the copresence of fertilizer overuse and underuse in China and might be the first to investigate the heterogeneous effects of various modes of information provision on fertilizer use among the overusers, consistent users and underusers of fertilizers, which has crucial policy implications for rationalizing fertilizer use in China. [ABSTRACT FROM AUTHOR]

Objective: To investigate the immediate effects of electro-acupuncture (EA) on endometrial blood flow among recurrent implantation failure (RIF) patients. Methods: Eighty RIF patients, enrolled from March 2022 to December 2022, were randomly allocated into either the EA group (40 cases) or the waiting-list (WL) group (40 cases) by using a random number table. The EA group underwent acupuncture at points of Shenting (GV 24), Baihui (GV 4), Benshen (GB 13), bilateral Zigong (EX-CA 1), Huangshu (KI 16), Sanyinjiao (SP 6) and Xuehai (SP10), and electric acupuncture apparatus was connected to EX-CA 1, KI 16, SP 6, and SP 10 with disperse-dense waves at 4/20 Hz frequencies for 30 min after transvaginal ultrasound, while the WL group received no intervention. The primary outcome measured was the endometrial volume blood flow. The secondary outcomes included the bilateral uterine artery index, endometrial volume, endometrial blood flow type, vascular distribution index (VIMV) for endometrial and ovary, clinical pregnancy rate, and embryo implantation rate. Results: In the EA group, there was a notable decrease in the bilateral pulsatility index and a significant improvement in the endometrial blood flow type post-EA (P<0.05). Both the endometrial blood flow type and VIMV for the endometrium and right ovary were markedly higher in the EA group compared to the WL group post-treatment (P<0.05). Conversely, no significant disparities were observed in vascular index, flow index, vascular blood flow index, uterine arterial blood flow indices, endometrial volume, clinical pregnancy rate and embryo implantation rate between the two groups after treatment (P>0.05). Besides, no adverse events related to EA were observed. Conclusions: EA can promptly ameliorate VIMV for the endometrial and right ovary, and endometrial blood flow type. Future randomized controlled trials are warranted to investigate the long-term effects of EA on blood flow of RIF patients and its implications for pregnancy outcomes. (Trial registration No. ChiCTR2200057377) [ABSTRACT FROM AUTHOR]

Key summary points: Aim: We investigated the effectiveness of a self-monitoring intervention to promote step count and reduce sedentary behavior in older people covered by the long-term care insurance system (LTCI) in Japan. Findings: Results from a randomized controlled trial of a self-monitoring intervention using accelerometers with a 5-week follow-up: improvement in a number of steps, light physical activity, and sedentary behavior in the intervention group compared to the control group. Message: Self-monitoring with an accelerometer may be effective in increasing the number of steps taken and amount of light physical activity per day and in reducing sedentary behavior in older people with LTCI. Purpose: This study aimed to investigate the effects of a self-monitoring intervention to promote an increase in physical activity, as measured by step count, and reduce sedentary behavior in older people covered by the long-term care insurance system (LTCI) in Japan. Methods: This was a randomized controlled trial conducted at a daycare center from October 2022 to January 2023. Fifty-two older adults with LTCI who were able to walk with or without aids were assigned to an intervention (n = 26) group and control (n = 26) group. During the 5-week follow-up period, the intervention group received education on physical activity and self-monitoring such as goal setting, self-management and feedback. The primary outcome was step count, and the secondary outcome was sedentary behavior. Results: Participants who completed the study to the end of the 5-week follow-up and drop-out participants for whom outcome data were available were included in the final analysis of 57 participants, n = 24 (79.8 ± 8.8 years, male 25.5%) in the intervention group and n = 23 (82.5 ± 8.5 years, male 39.1%) in the control group. Comparisons between the two groups at baseline showed no significant differences. In the results of a two-way mixed analysis of variance (ANOVA) including 2 (group: control, intervention) × 2 (term: baseline, 5-week follow-up) factors, an interaction was observed in the number of steps, sedentary behavior, and light physical activity (p < 0.05). Conclusion: Self-monitoring of physical activity using an accelerometer may be effective in increasing the number of steps and light physical activity and in reducing sedentary behavior in older people with LTCI. Clinical trial registration: UMIN000052044, registered on 2023/08/29. [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]

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]