Multicenter Trial Research Articles

Impact of semaglutide on weight and functional outcomes among obese heart failure patients: a propensity scores matching analysis

Background & objectivesObesity is a common comorbidity in heart failure, yet effective pharmacological options for weight loss in these patients are limited. Semaglutide, a glucagon-like peptide 1 receptor agonist, has shown promise for weight reduction in obese adults. This study aims to evaluate semaglutide’s impact on weight loss, functional status, and clinical outcomes in obese patients with heart failure.MethodsA retrospective analysis was conducted on all consecutive obese (BMI > 30 kg/m²) patients with heart failure at the University Hospital Bonn outpatient clinic from July 2019 to July 2022. Propensity score matching paired patients receiving semaglutide as an add-on therapy (SEMA) with those on medical therapy alone (Control).ResultsAmong 1,942 patients with heart failure screened, 26 matched pairs were identified. At one year, the SEMA group exhibited significant weight loss, with a mean BMI reduction of -2.91 kg/m² (95% CI: -4.27 to -1.55; p < 0.001), while the control group showed a non-significant mean change of -0.41 kg/m² (95% CI: -1.08 to 0.26; p = 0.22). The difference in BMI between the two groups was statistically significant (mean difference: 3.42 kg/m², 95% CI: 1.43 to 5.42; p = 0.001). Improvements by at least one NYHA class were observed in 65% of the SEMA group (p < 0.001) compared to 15% of the control group (p = 0.18). The SEMA group also showed a significant increase in 6-minute walk distance (6MWD), with a mean difference of 75 m between the groups at one year (95% CI: 0.53 to 150.02; p = 0.049). NT-proBNP levels significantly decreased in the SEMA group (p < 0.001) compared to the control group (p = 0.78), with a statistically significant difference in NT-proBNP between the groups (p = 0.048). Both improvements in 6MWD and reductions in NT-proBNP were significantly correlated with BMI percentage reductions.ConclusionsSemaglutide was associated with significant weight reduction in obese patients with heart failure, accompanied by improved NYHA classification and 6-minute walk distance. Larger, multi-center trials and prospective, randomized controlled trials are warranted. These studies should focus on assessing long-term outcomes, optimizing dosage, and exploring the potential cardiovascular benefits beyond weight reduction.

Cellular therapy for traumatic brain injury in adults: a meta-analysis of controlled clinical trials

IntroductionTraumatic brain injury (TBI) has got no effective treatment. Cellular therapy is the transfer of autologous or allogeneic cells or cellular material into patient(s) for treatment, showed better outcomes in TBI in several clinical and preclinical studies. We performed a meta-analysis on published articles on the topic of cellular therapy for the treatment of TBI in adult patients.Material and MethodsThe literature search was done via selected database with no restrictions on publication year. Studies were included based on selection criteria and quality assessment. The following data were extracted from included articles; author names, publication year and place, type of study, number, sex and age of participants, type of cells used, and post-treatment follow up. The required data related to Fugl-Meyer Motor Scale (FMMS), Disability Rating Scale (DRS) and patients. Overall improvement was pooled and analyzed using RevMan (Ver.5.4.1).ResultsFive studies that met the selection criteria and considered as high quality, containing 367 participants, with an average follow up time of (7.58±6.93) months, were included in meta-analysis. The results showed that cellular therapy significantly improves (OR=0.26; 95% CI=0.15 to 0.48; P=0.0001) the overall performance of the patients. Moreover, the improvements in FMMS (MD=3.79; 95% CI= -2.53 to 10.10; P=0.24) and DRS (MD= -0.16; 95% CI= -1.51 to 1.19; P=0.82) were not statically significant, but they are obviously clinically significant.ConclusionsThis meta-analysis suggests that cellular therapy improves the condition of TBI patients in clinic. Larger, multi-central trials are required to further confirm and detail the use of stem cells in TBI.

Advances in the study of artemisinin and its derivatives for the treatment of rheumatic skeletal disorders, autoimmune inflammatory diseases, and autoimmune disorders: a comprehensive review.

Artemisinin and its derivatives are widely recognized as first-line treatments for malaria worldwide. Recent studies have demonstrated that artemisinin-based antimalarial drugs, such as artesunate, dihydroartemisinin, and artemether, not only possess excellent antimalarial properties but also exhibit antitumor, antifungal, and immunomodulatory effects. Researchers globally have synthesized artemisinin derivatives like SM735, SM905, and SM934, which offer advantages such as low toxicity, high bioavailability, and potential immunosuppressive properties. These compounds induce immunosuppression by inhibiting the activation of pathogenic T cells, suppressing B cell activation and antibody production, and enhancing the differentiation of regulatory T cells. This review summarized the mechanisms by which artemisinin and its analogs modulate excessive inflammation and immune responses in rheumatic and skeletal diseases, autoimmune inflammatory diseases, and autoimmune disorders, through pathways including TNF, Toll-like receptors, IL-6, RANKL, MAPK, PI3K/AKT/mTOR, JAK/STAT, and NRF2/GPX4. Notably, in the context of the NF-κB pathway, artemisinin not only inhibits NF-κB expression by disrupting upstream cascades and/or directly binding to NF-κB but also downregulates multiple downstream genes controlled by NF-κB, including inflammatory chemokines and their receptors. These downstream targets regulate various immune cell functions, apoptosis, proliferation, signal transduction, and antioxidant responses, ultimately intervening in systemic autoimmune diseases and autoimmune responses in organs such as the kidneys, nervous system, skin, liver, and biliary system by modulating immune dysregulation and inflammatory responses. Ongoing multicenter randomized clinical trials are investigating the effects of these compounds on rheumatic, inflammatory, and autoimmune diseases, with the aim of translating promising preclinical data into clinical applications.

Monocentric experience of venetoclax-based regimen in paediatric refractory and relapsed AML/MDS.

BCL-2 inhibitor venetoclax demonstrates promising efficacy in paediatric relapsed/refractory acute myeloid leukaemia (r/r AML). This retrospective analysis evaluated 12 patients treated with venetoclax-based regimens under compassionate use forr/r myeloid malignancies. The overall response rate (ORR) was 41.6%, with complete response (CR) achieved in 33% of patients. Three patients successfully underwent allogeneic haematopoietic scell transplantation (HSCT) after venetoclax bridging therapy. Venetoclax demonstrated a favourable safety profile with manageable side effects. These findings suggest venetoclax's potential as a valuable therapeutic option for paediatric r/r AML, particularly for heavily pretreated patients. Further investigation in larger multicentre trials is warranted to refine treatment strategy.

Breast and endometrial safety of micronised progesterone versus norethisterone acetate in menopausal hormone therapy (PROBES): study protocol of a double-blind randomised controlled trial

IntroductionData suggest that micronised progesterone (mP) in menopausal hormone therapy is safer for the breast than synthetic progestins, while protection of the endometrium appears to be less effective. However, comparative...

Physiotherapists working with pessaries

Pessaries and the physiotherapy profession have evolved over the past 10 years, and pelvic health physiotherapists can now prescribe vaginal pessaries. Pelvic, Obstetric and Gynaecological Physiotherapy (POGP) is developing ways to support members with these skills. Globally, up to 50% of women will suffer from pelvic organ prolapse (POP) (Carroll et al. 2022), and this condition costs the UK National Health Service £45 million every year (PCWHF 2019). The most common symptom is a vaginal bulge. The National Institute for Health and Care Excellence guidelines recommend either doing nothing, or pelvic floor muscle exercises (PFMEs), vaginal pessaries or surgery (NICE 2019). Pessary services are provided in dedicated clinics, usually in general practice or secondary care. There has been an increase in physiotherapists delivering pessary care over the past decade: in 2013, it was reported that 1.4% were part of the pessary workforce compared to 5% in 2020 (Bugge et al. 2013; Brown et al. 2021). Currently, ineffective patient pathways, poor service provision and lack of training are barriers to treatment. Poorly designed patient pathways are frustrating, and women are often required to return to primary or secondary care to get a referral to a pessary clinic. Physiotherapists are well placed to offer a pessary alongside PFMEs since it is part of the range of conservative treatment options. They also build strong a rapport with their patients because of the therapeutic nature of the treatment sessions, and typically, offer longer appointments than postnatal period. A prospective multicentre trial demonstrated the acceptability of and compliance with using a pessary immediately after childbirth irrespective of any pelvic floor dysfunction or mode of delivery (Baessler et al. 2019). The majority of women used the pessary to treat the symptoms of POP. Further work is required to investigate pessary use and the prevention of pelvic floor dysfunction in this cohort of women. The results of the TOPSY [Treatment Of Prolapse with Self-care pessarY] trial (Hagen et al. 2023) highlighted that pessary self-management is cost-effective and reduces complications. This is excellent news because physiotherapists are well placed to teach women pessary self-management because of: generally longer appointments; and the well-established rapport built up over time while teaching PFMEs. Despite women reporting that pessary use during exercise relieves their symptoms, this is an under-researched area. The impact of exercise on POP, and whether there are any protective factors involved that prevent its progression, are not fully understood. There also remains a gap in the evidence with regard to the use of PFMEs and vaginal pessaries. Research proposals are currently in development to address this. A pessary course is being developed by POGP, and this will be launched in 2024 alongside a mentoring programme as part of the pessary accreditation scheme jointly written with the United Kingdom Continence Society. Further governance documents have been created by the Physiotherapists Working with Pessaries subgroup of POGP, including a standard operating procedure, emergency out-of-hours statement, note proformas and template letters (POGP 2024).

A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial

IntroductionRobotic-assisted complete mesorectal excision (RATME) is increasingly being used by colorectal surgeons. Most surgeons consider RATME a safe method, and believe it can facilitate total mesorectal excision (TME) in rectal cancer, and may potentially have advantages over intersphincteric resection (ISR) and anus preservation. Therefore, this trial was designed to investigate whether RATME has technical advantages and can increase the ISR rate compared with laparoscopic-assisted TME (LATME) in patients with middle and low rectal cancer.Methods and analysisThis is a multicenter, superiority, randomized controlled trial designed to compare RATME and LATME in middle and low rectal cancer. The primary endpoint is the ISR rate. The secondary endpoints are coloanal anastomosis (CAA) rate, conversion to open surgery, conversion to transanal TME (TaTME), abdominoperineal resection (APR) rate, postoperative morbidity and mortality within 30 days, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measurements will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.DiscussionThis trial will clarify if RATME improves ISR and promotes anus preservation in patients with mid- and low-rectal cancer. Furthermore, this trial will provide evidence on the optimal treatment strategies for RATME and LATME in patients with mid- and low-rectal cancer regarding improved operational safety.Trial registrationClinicalTrials.gov NCT06105203. Registered on October 27, 2023.

Diabetes Mellitus Is Not a Risk Factor for Difficult Intubation Among Critically Ill Adults: A Secondary Analysis of Multicenter Trials

Objectives: Diabetes mellitus has been associated with greater difficulty of tracheal intubation in the operating room. This relationship has not been examined for tracheal intubation of critically ill adults. We examined whether diabetes mellitus was independently associated with the time from induction of anesthesia to intubation of the trachea among critically ill adults. Design: A secondary analysis of data from five randomized trials completed by the Pragmatic Critical Care Research Group (PCCRG). Setting: Emergency departments (EDs) or ICUs at 11 centers across the United States that enrolled in randomized trials of a pre-intubation checklist, fluid bolus administration, bag-mask ventilation between induction and laryngoscopy, and intubation using a bougie vs. stylet. Patients: Critically ill adults undergoing tracheal intubation with a laryngoscope in an ED or an ICU. Interventions: None. Measurements and Main Results: A total of 2654 patients were included in this analysis, of whom 638 (24.0%) had diabetes mellitus. The mean time from induction of anesthesia to intubation of the trachea was 169 seconds (sd, 137s). Complications occurred during intubation in 1007 patients (37.9%). Diabetes mellitus was not associated with the time from induction of anesthesia to intubation of the trachea (–4.4 s compared with nondiabetes; 95% CI, –17.2 to 8.3 s; p = 0.50). Use of a video vs. direct laryngoscope did not modify the association between diabetes mellitus and the time from induction to intubation (p for interaction = 0.064). Diabetes mellitus was not associated with the probability of successful intubation on the first attempt (85.6% vs. 84.3%; p = 0.46) or complications during intubation (39.8% vs. 37.4%; p = 0.52). Conclusions: Among 2654 critically ill patients undergoing tracheal intubation in an ED or an ICU, diabetes mellitus was not independently associated with the time from induction to intubation, the probability of successful intubation on the first attempt, or the rate of complications during intubation.

Early minimally invasive image-guided endoscopic evacuation of intracerebral hemorrhage (EMINENT-ICH): a randomized controlled trial

BackgroundSpontaneous supratentorial intracerebral hemorrhage is the deadliest form of stroke with mortality rates over 50%. Currently, no sufficiently effective treatment to improve both mortality and functional outcome rates exists. However, it seems that minimally invasive surgery, especially endoscopic surgery, might be beneficial in improving survival and functional outcome rates, yet large confirmatory studies thereof are lacking. The aim of this trial is to compare whether early minimally invasive endoscopic surgery leads to improved functional outcome rates compared to the best medical treatment.MethodsThis is a prospective, parallel-arm, outcome assessor blinded multicenter trial across Switzerland. Endoscopic surgery will be compared to the best medical treatment in a 1:1 randomization over a total time of 12 months. The primary outcome is defined as improved functional outcome (mRS < 3) after 6 months; secondary outcomes include mortality and morbidity rates as well as patient reported outcomes and the temporal evolution of serum biomarkers for brain damage.DiscussionCurrently, large, randomized trials assessing the role and potential effect of early endoscopic surgery in intracerebral hemorrhage are lacking. Potential practical and methodological issues faced in this trial are patient enrollment, adherence to the hematoma evacuation technique used, potential patient cross-over, and the adaptive Bayesian statistical design. Nonetheless, this trial would be among the first to research the effects of early minimally invasive endoscopic surgery for SSICH and can provide class I evidence for future treatment options in intracerebral hemorrhage.Trial registrationClinicalTrials.gov NCT05681988. Registered on January 3, 2023.

Brain Stimulation in Alzheimer's Disease Trials.

Alzheimer's disease (AD) continues to lack definitive curative therapies, necessitating an urgent exploration of innovative approaches. This review provides a comprehensive analysis of recent clinical trials focusing on invasive and non-invasive brain stimulation techniques as potential interventions for AD. Deep brain stimulation (DBS), repetitive transcranial magnetic stimulation (rTMS), transcranial direct current stimulation (tDCS), and transcranial alternating current stimulation (tACS) are evaluated for their therapeutic efficacy, safety, and applicability. DBS, though invasive, has shown promising results in mitigating cognitive decline, but concerns over surgical risks and long-term effects persist. On the other hand, non-invasive methods like rTMS, tDCS, and tACS have demonstrated potential in enhancing cognitive performance and delaying disease progression, with minimal side effects, but with varied consistency. The evidence hints towards an individualized, patient-centric approach to brain stimulation, considering factors such as disease stage, genetic traits, and stimulation parameters. The review also highlights emerging technologies and potential future directions, emphasizing the need for larger, multi-center trials to confirm preliminary findings and establish robust clinical guidelines. In conclusion, while brain stimulation techniques present a promising avenue in AD therapy, further research is imperative for more comprehensive understanding and successful clinical implementation. Through this review, we aim to catalyze the scientific discourse and stimulate further investigation into these novel interventions for AD.

Differences in sex and age response to single pill combination based antihypertensive therapy reflecting in blood pressure and arterial stiffness.

There are noticeable sex differences in the treatment response to antihypertensives, with limited data on the response to single pill combinations. The aim of the PRECIOUS trial was to assess the treatment response to perindopril/amlodipine and perindopril/amlodipine/indapamide dual and triple single-pill combination in men and women. Four hundred and forty adults with essential hypertension were assessed in the 16-week interventional, open-label, prospective, international, multicentre trial. Based on the previous antihypertensive therapy, patients were assigned to either perindopril/amlodipine 4/5 mg or perindopril/amlodipine/indapamide 4/5/1.25 mg, with the initial dose up-titrated in 4-week intervals in case of uncontrolled blood pressure. An additional analysis was performed for sex- and age-related differences on the blood pressure response and arterial stiffness in men and women aged 35-74 years. Women achieved better overall blood pressure control in all age groups, except for the 35-44 age group. Women presented higher average 24 h aortic augmentation indexes than men, but had more pronounced decreasing trends. The pulse wave velocity was only age-dependent, with reductions slightly greater in women. Both the aortic augmentation index and pulse wave velocity were significantly decreased in all groups compared to baseline. The results of the PRECIOUS trial contribute significant data to the expanding body of evidence on sex differences in hypertension, including the aspect of age-related changes during the life course of women. The differences between same-aged men and women tend to be smaller with advancing age, but with a greater treatment response in women in all age groups for all observed blood pressure parameters and arterial stiffness. ClinicalTrials.gov identifier NCT03738761.

A multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of Tongmai Yangxin pill on ventricular remodeling in acute anterior STEMI patients after primary PCI

BackgroundAcute ST-segment elevation myocardial infarction (STEMI) is a severe form of coronary heart disease and a leading cause of mortality and morbidity. This can mainly be ascribed to adverse ventricular remodeling (VR). However, the efficacy of existing treatment strategies for STEMI is not entirely satisfactory. Tongmai Yangxin Pill (TMYX), a patented traditional Chinese medicine (TCM), has been approved for treating various cardiovascular diseases. PurposeThe purpose was to assess the effect of TMYX on VR in acute STEMI patients undergoing primary percutaneous coronary intervention (PPCI). Study DesignA multicenter, randomized, double-blinded, and placebo-controlled trial conducted across 11 hospitals in China. MethodA total of 270 patients with acute anterior STEMI, undergoing PPCI within 10 days of symptom onset were enrolled and randomly assigned to receive either a placebo or TMYX, in addition to guideline-directed treatments for STEMI. The primary endpoint was a change in left ventricular end-diastolic volume index (LVEDVI) at 12 weeks. ResultAmong the 270 randomized patients, 218 (TMYX: 109 and placebo: 109) were included in the per-protocol analysis. At 4 and 12 weeks, TXMY significantly improved LVEDVI than the placebo group ([-2.17(-9.24, 8.28) vs. 3.76(-2.38, 11.48), p < 0.05] and [-1.17 (-12.19, 12.88) vs. 4.46 (-2.89, 11.99), p < 0.05]). Changes in left ventricular end-diastolic volume (LVEDV) at 4 weeks were superior in the TMYX group than the placebo group (-4.37 (-17, 13.99) vs. 7.41 (-4.56, 21.79), p < 0.05). Cardiac magnetic resonance imaging (CMRI) showed that left ventricular ejection fraction (LVEF) was significantly greater in the TMYX group than in the placebo group at 4 weeks. There were no statistically significant differences between groups for left ventricular end-systolic volume (LVESV), left ventricular end-systolic volume index (LVESVI), 6 min walking distance (6MWD), and major adverse cardiac and cerebrovascular events (MACCEs) (p > 0.05). ConclusionTMYX, as an adjunctive therapy in addition to STEMI guideline-directed treatments, significantly delayed VR in patients with acute anterior STEMI undergoing PPCI within 10 days of symptom onset.

Automated segment-level coronary artery calcium scoring on non-contrast CT: a multi-task deep-learning approach

ObjectivesTo develop and evaluate a multi-task deep-learning (DL) model for automated segment-level coronary artery calcium (CAC) scoring on non-contrast computed tomography (CT) for precise localization and quantification of calcifications in the coronary artery tree.MethodsThis study included 1514 patients (mean age, 60.0 ± 10.2 years; 56.0% female) with stable chest pain from 26 centers participating in the multicenter DISCHARGE trial (NCT02400229). The patients were randomly assigned to a training/validation set (1059) and a test set (455). We developed a multi-task neural network for performing the segmentation of calcifications on the segment level as the main task and the segmentation of coronary artery segment regions with weak annotations as an auxiliary task. Model performance was evaluated using (micro-average) sensitivity, specificity, F1-score, and weighted Cohen’s κ for segment-level agreement based on the Agatston score and performing interobserver variability analysis.ResultsIn the test set of 455 patients with 1797 calcifications, the model assigned 73.2% (1316/1797) to the correct coronary artery segment. The model achieved a micro-average sensitivity of 0.732 (95% CI: 0.710–0.754), a micro-average specificity of 0.978 (95% CI: 0.976–0.980), and a micro-average F1-score of 0.717 (95% CI: 0.695–0.739). The segment-level agreement was good with a weighted Cohen’s κ of 0.808 (95% CI: 0.790–0.824), which was only slightly lower than the agreement between the first and second observer (0.809 (95% CI: 0.798–0.845)).ConclusionAutomated segment-level CAC scoring using a multi-task neural network approach showed good agreement on the segment level, indicating that DL has the potential for automated coronary artery calcification classification.Critical relevance statementMulti-task deep learning can perform automated coronary calcium scoring on the segment level with good agreement and may contribute to the development of new and improved calcium scoring methods.Key PointsSegment-level coronary artery calcium scoring is a tedious and error-prone task.The proposed multi-task model achieved good agreement with a human observer on the segment level.Deep learning can contribute to the automation of segment-level coronary artery calcium scoring.Graphical

P4.04C.04 Epidemiological Characteristics of Incidental Pulmonary Nodules and in China: A Prospective Multicenter Trial of 10,560 Cases

P4.04C.04 Epidemiological Characteristics of Incidental Pulmonary Nodules and in China: A Prospective Multicenter Trial of 10,560 Cases

Semaglutide 2.4 mg in Participants With Metabolic Dysfunction-Associated Steatohepatitis: Baseline Characteristics and Design of the Phase 3 ESSENCE Trial.

Semaglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated potential beneficial effects in metabolic dysfunction-associated steatohepatitis (MASH). To describe the trial design and baseline characteristics of the 'Effect of Semaglutide in Subjects with Non-cirrhotic Non-alcoholic Steatohepatitis' (ESSENCE) trial (NCT04822181). ESSENCE is a two-part, phase 3, randomised, multicentre trial evaluating the effect of subcutaneous semaglutide 2.4 mg in participants with biopsy-proven MASH and fibrosis stage 2 or 3. The primary objective of Part 1 is to demonstrate that semaglutide improves liver histology compared with placebo. The two primary endpoints are: resolution of steatohepatitis and no worsening of liver fibrosis, and improvement in liver fibrosis and no worsening of steatohepatitis. The Part 2 objective is based on clinical outcomes. The current work reports baseline characteristics of the first 800 randomised participants which includes demographics, laboratory parameters, liver histology, non-invasive tests and presence of metabolic dysfunction-associated steatotic liver disease (MASLD) cardiometabolic criteria. Of 800 participants, 250 (31.3%) had fibrosis stage 2 and 550 (68.8%) had fibrosis stage 3. In the overall population, mean (standard deviation [SD]) age was 56 (11.6) years, 57.1% were female, mean (SD) body mass index was 34.6 (7.2) kg/m2, 55.5% had type 2 diabetes and > 99% had at least one MASLD cardiometabolic criterion according to the published definition. The ESSENCE baseline population includes participants with clinically significant fibrosis stages 2 and 3. Although MASLD cardiometabolic criteria were not a requirement for study enrolment, almost all participants (> 99%) had at least one MASLD cardiometabolic criterion. NCT04822181.

Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk

Sciatica is commonly caused by herniated lumbar disc and contributes to severe pain and prolonged disability. Although acupuncture is widely used by patients with chronic sciatica, the evidence of its efficacy is scarce. To investigate the efficacy and safety of acupuncture compared with sham acupuncture in patients with chronic sciatica from herniated disk. This was a multicenter 2-arm randomized clinical trial conducted in 6 tertiary-level hospitals in China of patients with chronic sciatica from herniated disk. Participants were recruited from March 25, 2021, to September 23, 2021, with a final follow-up through September 22, 2022. Data analyses were performed from December 2022 to March 2023. Participants were randomly assigned to receive 10 sessions of acupuncture (n = 110) or sham acupuncture (n = 110) over 4 weeks. Participants, outcome assessors, and statisticians were blinded. The 2 coprimary outcomes were changes in visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) from baseline to week 4. Secondary outcomes were adverse events. A total of 216 patients (mean [SD] age, 51.3 [15.2] years; 147 females [68.1%] and 69 males [31.9%]) were included in the analyses. The VAS for leg pain decreased 30.8 mm in the acupuncture group and 14.9 mm in the sham acupuncture group at week 4 (mean difference, -16.0; 95% CI, -21.3 to -10.6; P < .001). The ODI decreased 13.0 points in the acupuncture group and 4.9 points in the sham acupuncture group at week 4 (mean difference, -8.1; 95% CI, -11.1 to -5.1; P < .001). For both VAS and ODI, the between-group difference became apparent starting in week 2 (mean difference, -7.8; 95% CI, -13.0 to -2.5; P = .004 and -5.3; 95% CI, -8.4 to -2.3; P = .001, respectively) and persisted through week 52 (mean difference, -10.8; [95% CI, -16.3 to -5.2; P < .001; and -4.8; 95% CI, -7.8 to -1.7; P = .003, respectively). No serious adverse events occurred. This randomized clinical trial found that in patients with chronic sciatica from herniated disk, acupuncture resulted in less pain and better function compared with sham acupuncture at week 4, and these benefits persisted through week 52. Acupuncture should be considered as a potential treatment option for patients with chronic sciatica from a herniated disk. Chictr.org Identifier: ChiCTR2100044585.

Effect of endoscopic ultrasound guided celiac plexus block on the palliation of pain in chronic pancreatitis (EPOCH Trial): study protocol for a randomized multicenter sham-controlled trial {1}

BackgroundCeliac plexus block has been commonly utilized for the treatment of chronic pancreatitis-associated abdominal pain. Prospective studies suggest efficacy in 30 to 50% of patients, although no randomized sham-controlled trials have been performed. The objective of this study is to assess the effect of endoscopic ultrasound (EUS)-guided celiac plexus block on abdominal pain in patients with documented chronic pancreatitis. MethodsThis is a two-arm randomized sham-controlled trial with blinded evaluators. The study will be conducted at multiple academic sites in the United States who are members of the United States Pancreatic Disease Study Group (USPG). Patients referred for EUS to exclude chronic pancreatitis as a cause of abdominal pain as well as those with established painful chronic pancreatitis undergoing EUS for another indication will be eligible. At the time of EUS with confirmation of chronic pancreatitis by standard EUS diagnostic criteria, patients will be randomized to either celiac plexus block or sham whereby an anesthetic and steroid combination will be injected into the celiac plexus or saline will be injected into the gastric lumen with the same type of needle as used for celiac plexus block, respectively. The main outcome measure will be a 50% reduction in abdominal pain using the Brief Pain Inventory Short Form (BPI-SF) at 1 month post-intervention. A number of secondary outcomes will be measured including visual analog scale (VAS), Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) pain scores, and quality of life using a pancreas-specific validated measure (PANQOLI).DiscussionIn this study, the effect of celiac plexus block on abdominal pain in patients with chronic pancreatitis will be compared to a sham intervention. This randomized trial will offer a definitive assessment of the role of celiac plexus block for the treatment of abdominal pain in this setting.Trial registration {2}ClinicalTrials.gov NCT 06178315. Registered on December 21, 2023

Rise of the robots: implementing robotic surgery into the acute care surgery practice.

Acute Care Surgery (ACS) admissions and procedures are substantially increasing. ACS disproportionally accounts for a majority of morbidity and mortality among surgical patients. Minimally invasive techniques are associated with improved outcomes and shorter hospital length of stay within the ACS population. While laparoscopy is widespread, ACS surgeons have been slower to adopt the use of robotics. We aimed to evaluate the feasibility of incorporating robotic surgery within ACS practice. Robotic General Surgery operations performed by 8 Acute Care Surgeons from 5 local facilities within a large integrated healthcare system were queried over a 15 month period. Patients who underwent emergent, urgent, sub-acute, and elective robotic operations by ACS staff were identified. Demographics collected included age, gender, BMI, and ASA score. Outcomes recorded included procedure classification, total supply and implant charges (TSI), conversion to open, hospital length of stay (LOS), 30 day readmission, and 30 day mortality. Of 200 operations, the most common were Cholecystectomy (43.5%), Inguinal hernia repair (26.0%), Ventral hernia repair (18.0%), Appendectomy (5.0%), and Sigmoid Colectomy (3.5%). The median (± std dev) age was 48 ± 16.66years and BMI was 29.9 ± 8.79kg/m2. 46% of cases were sub-acute (n = 92), 33.5% were elective (n = 67), 14% were emergent (n = 28), and 6.5% were urgent (n = 13). Most patients were ASA 2 (107, 46.1%) or ASA 3 (71, 45.9%). The median (IQR) TSI and LOS were $1,770 (889.50) USD and 0.1 (0.9) days. Forty-one inpatient procedures were performed. Median LOS was 3days and expected LOS was 3.1days (O:E = 0.96). Five patients were readmitted within 30days, and there were no deaths within 30days. Robotic techniques may be safely implemented by ACS surgeons, potentially benefitting both patient and surgeon. LOS was similar between laparoscopic and robotic cases and only two cases required conversion to an open procedure. Next steps include a multi-center prospective trial comparing robotic to laparoscopic cases.

Practice and reflections on regional mutual recognition of clinical research ethics review——based on survey results from medical and health institutions in Jiangsu Province

With the continuous advancement of medical research, the number of multi-center clinical studies has been steadily increasing, bringing about significant challenges to ethical review. Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry. Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials. The promotion of mutual recognition of ethical reviews is both feasible and practically significant; however, progress has been less than ideal. Through conducting surveys, this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province, identify the reasons hindering the implementation of mutual recognition, and propose possible solutions. The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews, the majority remain in a wait-and-see attitude. Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews.

Whole body magnetic resonance imaging (WB MRI) in the diagnosis and evaluation of the effectiveness of treatment of metastatic prostate cancer: Met-RADS-P system standards

INTRODUCTION: Whole-body magnetic resonance imaging (WB MRI) including diffusion-weighted imaging (DWI) is increasingly used in clinical practice. For metastatic prostate cancer, the radiologic reporting and data system Met-RADS-P (METastasis Reporting and Data System for Prostate Cancer) has been proposed to determine the prevalence of the metastatic process and subsequently evaluate the response to specific treatment based on WB MRI data.OBJECTIVE: To present an overview of the methodological aspects of WB MRI in patients with metastatic prostate cancer in relation to the Met-RADS-P system, to outline its terminology and principles for assessing study results, and to discuss the possibilities of its clinical use.MATERIALS AND METHODS: A search was conducted for publications for the period from January 1, 2017 to December 1, 2023 in Russian and English in the electronic databases eLibrary, Medline, PubMed, using the keywords: «диффузионно-взвешенная томография всего тела», «метастатический рак предстательной железы», «Met-RADS-P», «Whole Body MRI, WB MRI», «Whole Body DWI, WB DWI», «metastatic prostate cancer», supplemented by examination of references in the retrieved articles.RESULTS: Based on the literature data and our own experience, WB MRI protocols in patients with metastatic prostate cancer are described, the algorithm of MR image analysis, the criteria for evaluating the response of metastatic foci in the skeleton, lymph nodes, and internal organs, and the response assessment categories according to the RAC (response assessment categories) scale, as well as summarize the results and discuss the prospects for the clinical use of Met-RADS-P.DISCUSSION: The few publications in the literature using the Met-RADS-P system primarily concern the assessment of its reliability (inter-reader agreement). The authors conclude that it is appropriate to use it in monitoring metastases in patients with castration-resistant prostate cancer, emphasizing the clinical importance of identifying discordant responses after therapy. They also note the obstacles to the widespread introduction of WB MRI imaging into clinical practice, including the duration of the examination procedure and the large volume of diagnostic data that requires significant time for analysis and reporting, which can be overcome by automating the assessment of MR images using artificial intelligence.CONCLUSION: The Met-RADS-P system systematizes the approach to performing and describing WB MRI in patients with advanced prostate cancer, allowing the technique to be reproduced on virtually any modern scanner, from the scan protocol to a standardized report of findings. This makes the WB MRI technique reproducible in a variety of medical settings, and therefore increases its value. Nevertheless, Met-RADS-P is a relatively new system and requires large multicenter clinical trials to confirm its efficacy and representativeness, as well as to level out its shortcomings.