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Factors associated with oral health care behaviors of pregnant women in a northeastern province in Thailand: A hospital-based cross-sectional study

PLoS One. 2023 Aug 31;18(8):e0290334. doi: 10.1371/journal.pone.0290334. eCollection 2023.

ABSTRACT

BACKGROUND: Oral healthcare behavior leads to oral health status. Factors associated with oral healthcare behavior might affect oral hygiene in pregnant women, who are at high risk for gingivitis and dental caries. This study aimed to explore factors associated with oral healthcare behaviors during pregnancy among pregnant women in a northeastern province of Thailand.

METHOD: A total of 405 pregnant women who attended antenatal care clinics at one of the government hospitals in the province were invited to participate in this cross-sectional study. Dentists in the hospitals measured pregnant women’s gingivitis and dental calculus status using mouth mirrors and explorers. A structured questionnaire was used to obtain variables of interest. Linear regression analysis, Beta and 95% confidence interval (CI) were applied.

RESULTS: The majority were 20-24 years old (33.6%). Most of the participants had received upper secondary education (37.6%). Majority had gingivitis (88.1%) and dental calculus (88.6%). The findings revealed that age (Beta = -0.129, 95%CI = -0.269, -0.016), educational level (Beta = 0.118, 95% CI = 0.110, 0.183), and oral health literacy (Beta = 0.283, 95% CI = 0.156, 0.319) were statistically significant factors associated with oral healthcare behaviors.

CONCLUSION: Younger pregnant women had better oral healthcare behaviors than older pregnant women and pregnant women had better oral healthcare behaviors due to higher educational levels and oral health literacy. Oral health promotion should be improved through oral health literacy, and interventions should be added to improve oral care skills particularly in older pregnant women as they are at a greater risk for poor oral healthcare behaviors.

PMID:37651430 | DOI:10.1371/journal.pone.0290334

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How race, sex and age interact in association with COVID-19 outcomes over time: An analysis of Michigan data

PLoS One. 2023 Aug 31;18(8):e0288383. doi: 10.1371/journal.pone.0288383. eCollection 2023.

ABSTRACT

BACKGROUND: COVID-19 has had a disproportionate impact on racial and ethnic minorities compared to White people. Studies have not sufficiently examined how sex and age interact with race/ethnicity, and potentially shape COVID-19 outcomes. We sought to examine disparities in COVID-19 outcomes by race, sex and age over time, leveraging data from Michigan, the only state whose Department of Health and Human Services (DHSS) publishes cross-sectional race, sex and age data on COVID-19.

METHODS: This is an observational study using publicly available COVID-19 data (weekly cases, deaths, and vaccinations) from August 31 2020 to June 9 2021. Outcomes for descriptive analysis were age-standardized COVID-19 incidence and mortality rates, case-fatality rates by race, sex, and age, and within-gender and within-race incidence rate ratios and mortality rate ratios. We used descriptive statistics and linear regressions with age, race, and sex as independent variables.

RESULTS: The within-sex Black-White racial gap in COVID-19 incidence and mortality decreased at a similar rate among men and women but the remained wider among men. As of June 2021, compared to White people, incidence was lower among Asian American and Pacific Islander people by 2644 cases per 100,000 people and higher among Black people by 1464 cases per 100,000 people. Mortality was higher among those aged 60 or greater by 743.6 deaths per 100,000 people vs those 0-39. The interaction between race and age was significant between Black race and age 60 or greater, with an additional 708.5 deaths per 100,000 people vs White people aged 60 or greater. Black people had a higher case fatality rate than White people.

CONCLUSION: COVID-19 incidence, mortality and vaccination patterns varied over time by race, age and sex. Black-White disparities decreased over time, with a larger effect on Black men, and Older Black people were particularly more vulnerable to COVID-19 in terms of mortality. Considering different individual characteristics such as age may further help elucidate the mechanisms behind racial and gender health disparities.

PMID:37651422 | DOI:10.1371/journal.pone.0288383

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Twitter Sentiment About the US Federal Tobacco 21 Law: Mixed Methods Analysis

JMIR Form Res. 2023 Aug 31;7:e50346. doi: 10.2196/50346.

ABSTRACT

BACKGROUND: On December 20, 2019, the US “Tobacco 21” law raised the minimum legal sales age of tobacco products to 21 years. Initial research suggests that misinformation about Tobacco 21 circulated via news sources on Twitter and that sentiment about the law was associated with particular types of tobacco products and included discussions about other age-related behaviors. However, underlying themes about this sentiment as well as temporal trends leading up to enactment of the law have not been explored.

OBJECTIVE: This study sought to examine (1) sentiment (pro-, anti-, and neutral policy) about Tobacco 21 on Twitter and (2) volume patterns (number of tweets) of Twitter discussions leading up to the enactment of the federal law.

METHODS: We collected tweets related to Tobacco 21 posted between September 4, 2019, and December 31, 2019. A 2% subsample of tweets (4628/231,447) was annotated by 2 experienced, trained coders for policy-related information and sentiment. To do this, a codebook was developed using an inductive procedure that outlined the operational definitions and examples for the human coders to annotate sentiment (pro-, anti-, and neutral policy). Following the annotation of the data, the researchers used a thematic analysis to determine emergent themes per sentiment category. The data were then annotated again to capture frequencies of emergent themes. Concurrently, we examined trends in the volume of Tobacco 21-related tweets (weekly rhythms and total number of tweets over the time data were collected) and analyzed the qualitative discussions occurring at those peak times.

RESULTS: The most prevalent category of tweets related to Tobacco 21 was neutral policy (514/1113, 46.2%), followed by antipolicy (432/1113, 38.8%); 167 of 1113 (15%) were propolicy or supportive of the law. Key themes identified among neutral tweets were news reports and discussion of political figures, parties, or government involvement in general. Most discussions were generated from news sources and surfaced in the final days before enactment. Tweets opposing Tobacco 21 mentioned that the law was unfair to young audiences who were addicted to nicotine and were skeptical of the law’s efficacy and importance. Methods used to evade the law were found to be represented in both neutral and antipolicy tweets. Propolicy tweets focused on the protection of youth and described the law as a sensible regulatory approach rather than a complete ban of all products or flavored products. Four spikes in daily volume were noted, 2 of which corresponded with political speeches and 2 with the preparation and passage of the legislation.

CONCLUSIONS: Understanding themes of public sentiment-as well as when Twitter activity is most active-will help public health professionals to optimize health promotion activities to increase community readiness and respond to enforcement needs including education for retailers and the general public.

PMID:37651169 | DOI:10.2196/50346

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Graphical User Interface Development for a Hospital-Based Predictive Risk Tool: Protocol for a Co-Design Study

JMIR Res Protoc. 2023 Aug 31;12:e47717. doi: 10.2196/47717.

ABSTRACT

BACKGROUND: This co-design research method details the iterative process developed to identify health professional recommendations for the graphical user interface (GUI) of an artificial intelligence (AI)-enabled risk prediction tool. Driving the decision to include a co-design process is the belief that choices regarding the aesthetic and functionality of an intervention are best made by its intended users and that engaging these users in its design will promote the tool’s adoption and use.

OBJECTIVE: The aim of this research is to identify health professional design and uptake recommendations for the GUI of an AI-enabled predictive risk tool.

METHODS: We will hold 3 research phases, each consisting of 2 workshops with health professionals, between mid-2023 and mid-2024. A total of 6 health professionals will be sought per workshop, resulting in a total enrollment of 36 health professionals at the conclusion of the research. A total of 7 workshop activities have been scheduled across the 3 workshops; these include context of use, notifiers, format, AI survey-Likert, prototype, AI survey-written, and testing. The first 6 of these activities will be repeated in each workshop to enable the iterative development and refinement of GUI. The last activity (testing) will be performed in the final workshop to examine health professionals’ thoughts on the final GUI iteration. Qualitative and quantitative results data will be produced from tasks in each research activity. Qualitative data will be examined through inductive thematic analysis or deductive thematic analysis in accordance with the Nonadoption, Abandonment, and Challenges to the Scale-up, Spread, and Sustainability (NASSS) framework; visual data will be examined in accordance with “framework of interactivity;” and quantitative data will be examined using descriptive statistics.

RESULTS: Project registration with the Australia and New Zealand Clinical Trial Registry has been requested (#384098). Finalized design recommendations are expected in early to mid-2024, with a results manuscript to be submitted in mid-2024. This research method has human research ethics approval from the South Australian Department of Health and Wellbeing (#2022/HRE00131) as well as from the Human Research Ethics Committee of the University of South Australia (application ID#204143).

CONCLUSIONS: Understanding whether an intervention is needed in a particular situation is just the start; designing an intervention so that it is used within that situation is paramount. This co-design process engages end users to create a GUI that includes the aesthetic and functional details they need in a manner that aligns with their existing work practices. Indeed, interventions that fail to do this may be disliked, and at worst, they may be dangerous.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47717.

PMID:37651166 | DOI:10.2196/47717

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Physical activity in recurrent colon cancer: Cancer and Leukemia Group B/SWOG 80702 (Alliance)

Cancer. 2023 Aug 31. doi: 10.1002/cncr.35007. Online ahead of print.

ABSTRACT

BACKGROUND: One in three patients with stage III colon cancer will experience tumor recurrence. It is uncertain whether physical activity during and after postoperative chemotherapy for stage III colon cancer improves overall survival after tumor recurrence.

METHODS: A prospective cohort study nested within a randomized multicenter trial of patients initially diagnosed with stage III colon cancer who experienced tumor recurrence (N = 399) was conducted. Postoperative physical activity before tumor recurrence was measured. Physical activity energy expenditure was quantified via metabolic equivalent task hours per week (MET-h/week). The primary end point was overall survival after tumor recurrence. Multivariable flexible parametric survival models estimated relative and absolute effects with two-sided hypothesis tests.

RESULTS: Compared with patients expending <3.0 MET-h/week of physical activity (comparable to <1.0 h/week of brisk walking), patients with ≥18.0 MET-h/week of physical activity (comparable to 6 h/week of brisk walking) had a 33% relative improvement in overall survival time after tumor recurrence (hazard ratio, 0.67; 95% CI, 0.42-0.96). The overall survival rate at 3 years after tumor recurrence was 61.3% (95% CI, 51.8%-69.2%) with <3.0 MET-h/week of physical activity and 72.2% (95% CI, 63.1%-79.6%) with ≥18 MET-h/week of physical activity (risk difference, 10.9 percentage points; 95% CI, 1.2-20.8 percentage points).

CONCLUSIONS: Higher postoperative physical activity is associated with improved overall survival after tumor recurrence in patients initially diagnosed with stage III colon cancer. These data may be relevant to patients who, despite optimal postoperative medical therapy, have a high risk of tumor recurrence.

PMID:37651160 | DOI:10.1002/cncr.35007

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Differences in Receipt of Immunotherapy Treatment Among Patients With Head and Neck Cancer

JAMA Otolaryngol Head Neck Surg. 2023 Aug 31. doi: 10.1001/jamaoto.2023.2420. Online ahead of print.

ABSTRACT

IMPORTANCE: The US Food and Drug Administration approved immune checkpoint inhibitors (immunotherapy) for select cases of head and neck squamous cell carcinoma (HNSCC) in 2016. However, it is unclear whether there are clinical or sociodemographic differences among patients receiving immunotherapy as part of their care. Given the known disparities in head and neck cancer care, we hypothesized that there are differences in receipt of immunotherapy among patients with HNSCC based on clinical and nonclinical characteristics.

OBJECTIVE: To characterize clinical and nonclinical factors associated with receipt of immunotherapy among older patients with HNSCC.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included patients 65 years or older diagnosed with HNSCC (n = 4860) in a community oncology care setting. Electronic health records from Navigating Cancer were assessed from January 1, 2017, to April 30, 2022.

MAIN OUTCOMES AND MEASURES: Multivariable logistic regression was used to characterize clinical (tumor stage [localized vs advanced] and anatomical subsite [oropharyngeal vs nonoropharyngeal]) and nonclinical (age, smoking history, race and ethnicity, sex, and marital status) factors associated with receipt of immunotherapy.

RESULTS: In the study cohort of 4860 patients, 3593 (73.9%) were men; 4230 (87.0%) were White and 630 (13.0%) were of other races. A total of 552 patients (11.4%) had received immunotherapy. After adjusting for covariates, in the final model, White patients with HNSCC had 80% increased odds of receiving immunotherapy (adjusted odds ratio [AOR], 1.80 [95% CI, 1.30-2.48]) compared with patients of other races. There were no statistically significant differences in the odds of receiving immunotherapy based on age, sex, or smoking history. Patients with nonoropharyngeal disease were significantly more likely to receive immunotherapy than those with oropharyngeal cancer (AOR, 1.29 [95% CI, 1.05-1.59]), as were those with advanced compared with local disease (AOR, 2.39 [95% CI, 1.71-3.34]).

CONCLUSIONS AND RELEVANCE: The findings of this cohort study suggest that among older patients with HNSCC, White patients may be more likely to receive immunotherapy as part of their care. Equitable access to immunotherapy and other treatment options will reduce cancer-related health disparities and improve survival of patients with HNSCC.

PMID:37651149 | DOI:10.1001/jamaoto.2023.2420

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Assessment of Prior Infection With Hepatitis B Virus and Fecundability in Couples Planning Pregnancy

JAMA Netw Open. 2023 Aug 1;6(8):e2330870. doi: 10.1001/jamanetworkopen.2023.30870.

ABSTRACT

IMPORTANCE: The association of hepatitis B virus (HBV) infection with reduced fecundability among reproductive-aged couples lacks large-population, in-depth study evidence.

OBJECTIVE: To investigate the association of HBV infection with time to pregnancy in couples planning pregnancy, and to explore whether this association varied by gravidity, health statuses, or lifestyles.

DESIGN, SETTING, AND PARTICIPANTS: This is a population-based cohort study of Chinese couples participating in the National Free Preconception Check-up Projects during 2015 to 2017. They were planning pregnancy and were followed-up every 3 months until getting pregnant, as confirmed by gynecologic ultrasonography, or were followed-up for 1 year. Data were analyzed between March 1, 2022, and September 30, 2022.

MAIN OUTCOMES AND MEASURES: The main outcome was time to pregnancy, assessed using fecundability hazard ratios (HRs). The Cox proportional hazards regression models were used to estimate the association of HBV infection with fecundability.

RESULTS: Among 2 419 848 couples (mean [SD] age, 27.87 [5.20] years for women and 29.58 [5.50] years for men), 126 728 women (5.24%) and 156 572 men (6.47%) were infected with HBV. Compared with the HBV-negative group, the fecundability of both women and men in the HBV-positive group decreased by 5% (HR, 0.95; 95% CI, 0.94-0.95). Compared with couples in which both partners were HBV negative, the fecundability of those in which both partners were HBV positive declined by 6% (HR, 0.94; 95% CI, 0.93-0.96) among all couples, by 3% (HR, 0.97; 95% CI, 0.95-0.99) among nulligravidas couples, and by 7% (HR, 0.93; 95% CI, 0.91-0.95) among multigravidas couples. Both the female-male and couple models suggested that the association of HBV infection with decreased fecundability was more pronounced in couples with multigravidas. The negative association was greater in people with overweight and obesity and was inconsistent in certain subgroups; in particular, it was more pronounced in women with reproductive tract infections, normal fasting plasma glucose, and no alcohol intake and in men with normal blood pressure.

CONCLUSIONS AND RELEVANCE: In this population-based cohort study, HBV infection was associated with decreased fecundability in a general reproductive-aged population, especially in couples with multigravidas. For women and men with certain health statuses and lifestyles, a comprehensive consideration of this association is recommended to provide personalized fertility guidance.

PMID:37651142 | DOI:10.1001/jamanetworkopen.2023.30870

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Association of Birth Weight Centiles and Gestational Age With Cognitive Performance at Age 5 Years

JAMA Netw Open. 2023 Aug 1;6(8):e2331815. doi: 10.1001/jamanetworkopen.2023.31815.

ABSTRACT

IMPORTANCE: Birth weight percentiles (BWPs) are often dichotomized at the 10th percentile and show statistically significant association with later cognitive performance, for both preterm and term-born children. However, research testing nonlinear associations between BWPs and cognitive performance is scarce.

OBJECTIVE: To investigate culturally invariant, nonlinear associations of BWPs and gestational age with later cognitive performance.

DESIGN, SETTING, AND PARTICIPANTS: In this cohort study, participants with valid neonatal and cognitive data were combined from 4 observational cohorts, including the Millennium Cohort Study, the National Longitudinal Survey of Youth 1979 Child and Young Adult cohort, Growing Up in Ireland, and the Longitudinal Study of Australian Children, with children born between 2000 and 2002, 1980 and 2010, 2007 and 2008, and 2003 and 2004, respectively. Neonatal data were parent reported before age 1 year. At approximately 5 years of age, multiple cognitive tests were performed. Follow-up at 5 years of age was the predominant focus. Data were analyzed July 17, 2023.

EXPOSURE: The parent-reported neonatal data were used to calculate BWPs according to the Fenton growth chart.

MAIN OUTCOME AND MEASURE: Scores for IQ were created from multiple measures of cognition, which were z standardized separately within each cohort.

RESULTS: Of 30 643 participants (50.8% male), 7.5% were born preterm (before 37 weeks gestation) and 92.5% were term born (between 37 and 42 weeks gestation). In the pooled data using multivariate adaptive regression splines, IQ linearly increased by 4.2 points as BWPs increased from the first to the 69th percentile before completely plateauing. For gestational age, IQ linearly increased by 1.3 points per week up until 32 weeks, with the association reducing to 0.3 points per week after 32 weeks. The association of BWP with IQ was not moderated by gestational age. For term-born infants, the estimated IQ score was only clinically meaningfully lower than average when birth weight was below the third percentile. Consistent results were found when instead using multivariable regression where gestational age and BWPs were categorized into groups.

CONCLUSIONS AND RELEVANCE: In this cohort study, lower BWPs and gestational age were independently associated with lower IQ. For term-born infants, a cutoff of the third percentile would be more appropriate than the traditionally used 10th percentile when the aim is estimating meaningful cognitive differences.

PMID:37651137 | DOI:10.1001/jamanetworkopen.2023.31815

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Nivolumab Plus Ipilimumab vs Nivolumab Alone in Advanced Cancers Other Than Melanoma: A Meta-Analysis

JAMA Oncol. 2023 Aug 31. doi: 10.1001/jamaoncol.2023.3295. Online ahead of print.

ABSTRACT

IMPORTANCE: Although the combination of nivolumab plus ipilimumab has unquestionable benefit over nivolumab monotherapy in advanced melanoma, currently no summative analyses have compared the combination with nivolumab monotherapy for advanced cancers other than melanoma.

OBJECTIVE: To examine whether the addition of ipilimumab to standard-dose nivolumab safely improves clinical outcomes in patients with advanced cancers other than melanoma.

DATA SOURCES: Electronic databases (PubMed, EBSCO Information Services, Embase, and Cochrane Library) were systematically searched for studies of standard-dose nivolumab plus ipilimumab vs nivolumab alone in the treatment of advanced cancers other than melanoma published from database inception to October 31, 2022.

STUDY SELECTION: Eight studies (total patients, 1727; nivolumab plus ipilimumab group, 854; nivolumab monotherapy group, 873) met the selection criteria. Patients had squamous cell lung cancer, non-small cell lung cancer with programmed death ligand 1 level of 1% or higher, small cell lung cancer, pleural mesothelioma, urothelial carcinoma, esophagogastric carcinoma, sarcoma, or glioblastoma multiforme.

DATA EXTRACTION AND SYNTHESIS: For comparison of overall survival (OS) and progression-free survival (PFS) outcomes, estimation of log(hazard ratios [HRs]) and SEs was initially performed for OS and PFS of each included study based on summary statistics extracted from individual Kaplan-Meier curves. Inverse-variance weighting was then used to compute pooled HRs (95% CIs). For comparison of dichotomous data (treatment-related grade 3 to 4 adverse events and discontinuations), odds ratios (ORs) were used, and the Mantel-Haenszel method was used to estimate pooled ORs (95% CIs).

RESULTS: Treatment with nivolumab plus ipilimumab was not associated with improvement in OS over treatment with nivolumab alone (pooled HR, 0.95; 95% CI, 0.85-1.06; P = .36), with 4 of the 8 studies having numerically lower median OS with the combination. Nivolumab plus ipilimumab combination therapy was associated with marginal, but not clinically meaningful, improvement in PFS over nivolumab alone (pooled HR, 0.88; 95% CI, 0.79-0.98; P = .02). The combination was associated with substantially higher treatment-related grade 3 to 4 adverse events (pooled OR, 1.84; 95% CI, 1.47-2.31; P < .001) and treatment-related discontinuations (pooled OR, 1.96; 95% CI, 1.44-2.65; P < .001). This finding was recapitulated in meta-analyses of individual grade 3 to 4 adverse events of hepatotoxicity, gastrointestinal toxicity, pneumonitis, endocrine dysfunction, dermatitis, fatigue.

CONCLUSIONS AND RELEVANCE: In this meta-analysis of 8 advanced cancers other than melanoma, the differences detected in OS and PFS between nivolumab plus ipilimumab and nivolumab were not clinically meaningful (even though statistical significance was detected in PFS). Treatment-related higher-grade toxicity and discontinuations were substantially higher with the combination therapy. The data indicate that investigations of anti-programmed death 1 (PD1) plus anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapies in any nonmelanoma advanced cancer should be conducted along with anti-PD1 monotherapy to ensure that the net effect of the addition of anti-CTLA-4 to anti-PD1 can be clearly established for that cancer and setting and that unnecessary CTLA-4 inhibition with related toxic effects (both clinical and financial) can be avoided.

PMID:37651124 | DOI:10.1001/jamaoncol.2023.3295

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Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial

JAMA. 2023 Aug 31. doi: 10.1001/jama.2023.14530. Online ahead of print.

ABSTRACT

IMPORTANCE: Psilocybin shows promise as a treatment for major depressive disorder (MDD).

OBJECTIVE: To evaluate the magnitude, timing, and durability of antidepressant effects and safety of a single dose of psilocybin in patients with MDD.

DESIGN, SETTING, AND PARTICIPANTS: In this phase 2 trial conducted between December 2019 and June 2022 at 11 research sites in the US, participants were randomized in a 1:1 ratio to receive a single dose of psilocybin vs niacin placebo administered with psychological support. Participants were adults aged 21 to 65 years with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of MDD of at least 60 days’ duration and moderate or greater symptom severity. Exclusion criteria included history of psychosis or mania, active substance use disorder, and active suicidal ideation with intent. Participants taking psychotropic agents who otherwise met inclusion/exclusion criteria were eligible following medication taper. Primary and secondary outcomes and adverse events (AEs) were assessed at baseline (conducted within 7 days before dosing) and at 2, 8, 15, 29, and 43 days after dosing.

INTERVENTIONS: Interventions were a 25-mg dose of synthetic psilocybin or a 100-mg dose of niacin in identical-appearing capsules, each administered with psychological support.

MAIN OUTCOMES AND MEASURES: The primary outcome was change in central rater-assessed Montgomery-Asberg Depression Rating Scale (MADRS) score (range, 0-60; higher scores indicate more severe depression) from baseline to day 43. The key secondary outcome measure was change in MADRS score from baseline to day 8. Other secondary outcomes were change in Sheehan Disability Scale score from baseline to day 43 and MADRS-defined sustained response and remission. Participants, study site personnel, study sponsor, outcome assessors (raters), and statisticians were blinded to treatment assignment.

RESULTS: A total of 104 participants (mean [SD] age, 41.1 [11.3] years; 52 [50%] women) were randomized (51 to the psilocybin group and 53 to the niacin group). Psilocybin treatment was associated with significantly reduced MADRS scores compared with niacin from baseline to day 43 (mean difference,-12.3 [95% CI, -17.5 to -7.2]; P <.001) and from baseline to day 8 (mean difference, -12.0 [95% CI, -16.6 to -7.4]; P < .001). Psilocybin treatment was also associated with significantly reduced Sheehan Disability Scale scores compared with niacin (mean difference, -2.31 [95% CI, 3.50-1.11]; P < .001) from baseline to day 43. More participants receiving psilocybin had sustained response (but not remission) than those receiving niacin. There were no serious treatment-emergent AEs; however, psilocybin treatment was associated with a higher rate of overall AEs and a higher rate of severe AEs.

CONCLUSIONS AND RELEVANCE: Psilocybin treatment was associated with a clinically significant sustained reduction in depressive symptoms and functional disability, without serious adverse events. These findings add to increasing evidence that psilocybin-when administered with psychological support-may hold promise as a novel intervention for MDD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03866174.

PMID:37651119 | DOI:10.1001/jama.2023.14530