Out of control: Blinding, dose response, and psychosocial controls in psychedelic trials.

As psychedelic clinical trials expand in scale and influence, foundational challenges in trial design have come into sharper focus. In this commentary, we examine three interrelated issues: 1) the failure of blinding in psychedelic trials, 2) the potential of alternate controls including dose-response designs as an empirical workaround, and 3) the persistent ambiguity surrounding psychosocial control conditions. We argue that efforts to preserve traditional placebo-controlled frameworks are often inadequate due to the unmistakable subjective effects of psychedelics and the therapeutic relevance of those effects themselves.

Clinical outcomes of transcatheter aortic valve replacement in patients with radiation-induced aortic stenosis: a systematic review and meta-analysis.

Background: Transcatheter aortic valve replacement (TAVR) is an effective treatment for severe aortic stenosis, particularly in high-risk patients unsuitable for surgical aortic valve replacement (SAVR). However, the efficacy of TAVR in patients with radiation-induced aortic stenosis remains uncertain and controversial. This meta-analysis evaluates clinical outcomes of TAVR in patients with prior chest radiation (C-XRT).

The impact of weight loss interventions on thyroid function: a systematic review and meta-analysis.

Background: This study explores how weight loss impacts thyroid hormone levels, particularly free T3 (FT3) and FT4, in obese individuals, given the key role these hormones play in regulating metabolism and gene expression.

Methods: A comprehensive literature search in PubMed, ISI/Web of Science, and Scopus databases identified studies examining the correlation between weight, body mass index (BMI), and thyroid hormone levels.

Results: The analysis revealed that BMI reduction significantly decreases FT3 levels [odds ratio (OR) = 2.

Preoperative risk factors for laparoscopic to open appendectomy conversion: a systematic review and meta-analysis.

Background: Laparoscopic appendectomy (LA) is a standard treatment for acute appendicitis (AA), offering reduced complications and improved patient outcomes. However, in certain cases, the need for conversion to open appendectomy (OA) may arise. The present systematic review and meta-analysis aimed to identify preoperative risk factors associated with conversion from LA to OA.

Clinical outcomes of transcatheter edge-to-edge repair in patients with acute mitral regurgitation complicated by cardiogenic shock: a systematic review and meta-analysis.

Background: Acute mitral regurgitation (AMR) complicated by cardiogenic shock (CS) is a critical cardiovascular emergency associated with high morbidity and mortality. Surgical intervention is often not feasible due to the unstable clinical status of these patients. Transcatheter edge-to-edge repair (TEER) has emerged as a minimally invasive alternative, yet its safety and efficacy in this specific population remain uncertain.

Research trends in CAR-T cell therapy: A comprehensive bibliometric analysis highlighting cardiovascular toxicity and clinical implications.

Background: Chimeric antigen receptor T cell (CAR-T) therapy is an innovation in oncology, which provides targeted treatment alternatives for certain tumors. CAR-T therapy has been associated to adverse cardiovascular consequences despite its potential for therapeutic benefit. As research in this field expands rapidly, a bibliometric study is needed to map the current state of knowledge and highlight emerging areas of interest to guide future studies and optimize patient outcomes.

Prevalence of metabolic syndrome in ankylosing spondylitis: a multi national meta-analysis study.

Background: Ankylosing spondylitis (AS) is a chronic inflammatory disease associated with an increased risk of metabolic syndrome (MetS), a cluster of cardiometabolic risk factors. However, the prevalence of MetS in AS remains uncertain. This meta-analysis estimates the global prevalence of MetS in AS patients and identifies factors contributing to its variability.

Short-term clinical outcomes of open, laparoscopic, and robotic-assisted rectal resections: a multicenter real-world evidence study from Indian collaborative group on rectal resections (ICGRR).

This multi-centric real-world study was carried out to assess the perioperative and histopathological clinical outcomes of rectal resections employing open, laparoscopic, and robotic-assisted techniques. A retrospective chart review was undertaken for patients who underwent rectal resections for Stages I, II, and III rectal cancer (RC) between April 2012 and August 2023. All surgical procedures were performed with the principles of total mesorectal excision (TME) or partial mesorectal excision (for tumors located higher in the rectum).

A Field-Wide Review and Analysis of Study Materials Used in Psilocybin Trials: Assessment of Two Decades of Research.

Introduction: Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for personal and family history of potential contraindications, and psychoeducational preparation with psychological support. Research settings typically provide psychoeducation to participants verbally and in writing (e.

Adverse Events Should Not Be Surprising in Psychedelic Research.

Research has demonstrated both risks and benefits to using psychedelics as a therapeutic intervention for a variety of mental health conditions. In recent years, the public discourse around psychedelic treatments has been largely positive and focused on benefits more than risks. We believe the field would benefit from more balanced attention to the risks as well as benefits of psychedelics within the scientific community and broader public.

The Role of Touch in Psychedelic Therapy: Perspectives From a Survey of Practitioners in Research Settings.

Objective: Psychedelic therapies are promising new treatment options in psychiatry. Including the use of physical touch as part of treatment is an area of debate. This study aimed to characterize the viewpoints of practitioners on the use of touch in psychedelic therapy.

The predictive value of endocan as a novel biomarker: an umbrella study on meta-analyses.

Background And Aim: In recent years, endocan has emerged as a potential biomarker in various medical conditions. This multifaceted molecule, involved in key processes such as inflammation and endothelial dysfunction, has shown promise in predicting disease progression and therapeutic response across a spectrum of pathologies. However, the heterogeneity of studies and the complexity of endocan's role in different diseases necessitate a comprehensive review.

Artificial intelligence in cardiovascular procedures: a bibliometric and visual analysis study.

Background: The integration of artificial intelligence (AI) into cardiovascular procedures has significantly advanced diagnostic accuracy, outcome prediction, and robotic-assisted surgeries. However, a comprehensive bibliometric analysis of AI's impact in this field is lacking. This study examines research trends, key contributors, and emerging themes in AI-driven cardiovascular interventions.

Exploring the evolution of evidence synthesis: a bibliometric analysis of umbrella reviews in medicine.

Background: Umbrella review studies have become increasingly vital in evidence synthesis, offering a comprehensive overview by analyzing multiple systematic reviews and meta-analyses. This bibliometric study aimed to delineate the growth and thematic evolution of umbrella reviews within evidence-based medicine, illuminating their integral role in synthesizing high-level evidence.

Methods: Utilizing the Web of Science Core Collection, we performed a search for publications on umbrella reviews, identifying relevant articles through a refined strategy.

Clinical Outcomes and Prognostic Implications of TAVR in Patients With Active Cancer: A Meta-Analysis.

Background: Transcatheter aortic valve replacement (TAVR) is an alternative to surgical aortic valve replacement (SAVR) for high-risk patients with severe aortic stenosis (AS). However, the clinical outcomes and prognostic implications of TAVR in patients with active cancer remain uncertain. This meta-analysis evaluates procedural success, complications, and survival outcomes of TAVR in patients with and without active cancer.

Outcomes of transcatheter aortic valve implantation in Africa: A systematic review and meta-analysis.

Background: Transcatheter Aortic Valve Implantation (TAVI) has become the routine standard of care in patients with severe aortic stenosis and prohibitive surgical risk worldwide. However, data on TAVI outcomes from Africa remain sparse. This study aimed to evaluate the outcomes of TAVI in Africa.

Acute coronary syndrome in patients with autosomal dominant polycystic kidney disease: a systematic review and meta-analysis.

Background: Autosomal dominant polycystic kidney disease (ADPKD) is associated with various cardiovascular abnormalities, including spontaneous coronary artery dissection and atrial fibrillation. However, limited data exist to describe the association between ADPKD and acute coronary syndrome or heart failure.

Aims: This systematic review and meta-analysis evaluated the occurrence of cardiovascular events among patients with ADPKD compared to those without ADPKD.

Perceived Risk of Trying Lysergic Acid Diethylamide in the United States from 2015 to 2019: Are Americans Assessing Lysergic Acid Diethylamide's Risk Profile More Favorably?

Background: Though lysergic acid diethylamide (LSD) use is rising in the United States amid expanding research into the therapeutic potential of psychedelics, little scholarly work exists on whether perceived risk of trying LSD (prLSD) is changing or factors influencing prLSD among the general public. Therefore, we sought to investigate changes in prLSD from 2015 to 2019 and identify characteristics associated with prLSD among respondents to the National Survey on Drug Use and Health (NSDUH).

Methods: Using NDSUH data from 2015 to 2019, we investigated correlates of and temporal trends in prLSD, reporting results for the entire sample, as well under age 18 (<18) and age 18 and older (18+) subgroups.

Psychological Support Approaches in Psychedelic Therapy: Results From a Survey of Psychedelic Practitioners.

To assess the viewpoints of psychedelic practitioners in research settings on approaches to psychological support for psychedelic treatments. An anonymous survey was distributed via email to contacts listed on ClinicalTrials.gov for clinical trials of psilocybin and LSD, personal contacts of authors, and through snowball sampling.

Shame, Guilt and Psychedelic Experience: Results from a Prospective, Longitudinal Survey of Real-World Psilocybin Use.

The classic psychedelic psilocybin has attracted special interest across clinical and non-clinical settings as a potential tool for mental health. Despite increasing attention to challenging psychedelic experiences, few studies have explored the relevance of shame-related processes with psychedelic use. This prospective, longitudinal study involved sequential, automated, web-based surveys that collected data from 679 adults planning to use psilocybin in naturalistic settings at timepoints before and after psilocybin use.

Practical considerations in the establishment of psychedelic research programs.

Rationale: There is increasing interest in establishing psychedelic research programs at academic medical centers. However, psychedelics are intensely psychoactive, carry considerable sociopolitical baggage, and most are Schedule I drugs, creating significant potential impediments to implementation. There is little formal guidance for investigators on navigating the complex on-the-ground obstacles associated with establishing psychedelic research programs.

Psychedelic risks and benefits: A cross-sectional survey study.

Background: As classic psychedelics' therapeutic potential is studied and their popularity continues to rise, it is important to establish their relative risks and benefits. Previous surveys have tended to use convenience sampling on social media, select participants who have had either extremely positive or negative effects, and have not compared the risk/benefit profile of psychedelics to other substances.

Aims: To address these limitations, we gathered samples from an opt-in panel service using quota-based sampling to approximate demographics representing US Census data, did not pre-specify positive or negative experiences, and compared experiences with psychedelics to those with cannabis.