Category: Statistics

Clin Drug Investig. 2025 Dec 4. doi: 10.1007/s40261-025-01501-3. Online ahead of print.

ABSTRACT

BACKGROUND: With shifting perceptions about the therapeutic potential of cannabis and evolving regulatory frameworks, global prescribing of medicinal cannabis is increasing. While some emerging evidence supports its use for conditions like multiple sclerosis and epilepsy, its efficacy and safety profile for the treatment of mental health conditions remains controversial and under-explored. Previous reviews found inconclusive evidence due to heterogeneity in study design and quality. Accordingly, this review was designed as a scoping review, consistent with established methodological frameworks to map and characterise all available randomised controlled trial (RCT) evidence in this emerging and heterogeneous field. It specifically sought to synthesise the highest-quality trial evidence to date, addressing the question: How effective is medicinal cannabis in treating mental health conditions, as classified by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), and how safe and tolerable is it, as assessed through adverse events and treatment withdrawals?

METHODS: A scoping review was conducted comprising RCTs investigating medicinal cannabis for mental health conditions. Eligible studies were required to meet predefined inclusion criteria based on population, intervention, comparator, outcomes, and study design (PICOS framework). PubMed, Web of Science, and PsycINFO databases were searched, supplemented by citation tracking and Google Scholar, for studies published between 1980 and 2024.

RESULTS: The search identified 8061 studies, with 28 RCTs meeting inclusion criteria across 12 DSM-5 mental health conditions. Indications most frequently studied were schizophrenia (n = 5), cannabis use disorder (n = 4), cocaine use disorder (n = 4), post-traumatic stress disorder (n = 3), anxiety disorders (n = 3), and opioid use disorder (n = 2); there were two trials in autism spectrum disorder and single trials in depression, attention-deficit/hyperactivity disorder, obsessive-compulsive disorder, tobacco use disorder, and Tourette syndrome. Sample sizes ranged from 6 to 150 participants (median = 42), and follow-up durations from 1 day to 13 weeks (median = 6 weeks). Interventions included purified cannabidiol (CBD; single doses of 300-800 mg and daily regimens up to 1000 mg/day), nabiximols or other tetrahydrocannabinol (THC)/CBD oromucosal sprays (up to 113 mg THC/105 mg CBD per day), and smoked or vaporised cannabis flower of varying THC/CBD content. Findings showed substantial heterogeneity and variable quality, with some short-term benefits reported (notably in cannabis use disorder, autism spectrum disorder, and schizophrenia), but no trial demonstrated long-term efficacy.

CONCLUSION: Despite growing interest, substantial heterogeneity limits current evidence for medicinal cannabis in mental health. This review highlights key gaps, underscoring the need for robust, well-powered RCTs with extended follow-up to clarify its role in the management of mental ill health.

PMID:41343139 | DOI:10.1007/s40261-025-01501-3

Obes Surg. 2025 Dec 4. doi: 10.1007/s11695-025-08376-5. Online ahead of print.

ABSTRACT

Obesity is caused by caloric intake exceeding over time, Obesity has multiple effects on the capacity to get and sustained an erection. Obesity and ED in males appear to be linked in many studies. Obesity is a significant risk factor for the progress of ED, which is a serious Clinical issue. This study was performed to assess the impact of weight loss induced by laparoscopic sleeve gastrectomy (LSG) on male sex hormones and erectile function among morbid obese male patients. The study was done over 32 morbidly obese married male cases who underwent LSG for weight reduction after doing assessments during their preoperative preparation. All subjects were evaluated by 4 questionnaires and serum hormone profiles pre-and postoperatively. Our study showed statistically significant improvement in the erectile function, and the Erection Hardness Score among morbid obese men undergoing LSG after 6 months of operation. Also showed statistically significant increasing levels of testosterone and decreasing levels of Estradiol (E2) after 6 months of operation. LSG is effective with significant enhancement of the Bariatric Quality of Life and Bariatric Body Image Satisfaction.

PMID:41343134 | DOI:10.1007/s11695-025-08376-5

Rheumatol Ther. 2025 Dec 4. doi: 10.1007/s40744-025-00811-4. Online ahead of print.

ABSTRACT

INTRODUCTION: This study evaluated the real-world effectiveness of tofacitinib monotherapy versus combination therapy in patients with psoriatic arthritis (PsA) enrolled in the CorEvitas PsA/Spondyloarthritis Registry.

METHODS: This study (NCT05195814) included adult patients with PsA initiating tofacitinib (from December 14, 2017 to October 1, 2023) as monotherapy, or in combination with oral small molecules (OSMs: methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, and apremilast). Patients with baseline and 6-month follow-up visits (± 3 months) were included.

OUTCOMES: mean change from baseline (∆) in/proportions achieving, disease activity measures (including body surface area [BSA] = 0%), and patient-reported outcomes. Continuous endpoints at month 6 were analyzed as ∆ with an analysis of covariance model including treatment and baseline value as covariates. ∆ in least squares (LS) means and adjusted LS means/odds ratios are presented.

RESULTS: The study included 141 patients (66/141 monotherapy; 75/141 combination therapy). Patients were predominantly female (61.0%) and white (94.3%), and average age was 56.7 years. More monotherapy initiators were OSM treatment-naïve and had higher mean Patient Global Assessment of Arthritis, compared with combination therapy initiators. By 6 ± 3 months, 28.8% and 25.3% of monotherapy and combination therapy initiators, respectively, discontinued tofacitinib. At 6 ± 3 months, 15.0% of monotherapy initiators achieved minimal disease activity, and 27.1% had BSA = 0%. Corresponding data for combination therapy initiators were 20.7%, and 22.0%, respectively. Differences between groups were not significant. LS mean differences from baseline in overall work impairment/activity impairment were – 13.0/- 21.8 and 1.4/- 2.9 for monotherapy and combination therapy initiators, respectively.

CONCLUSION: Monotherapy and combination therapy initiators demonstrated improvements across effectiveness outcomes. Tofacitinib monotherapy initiators experienced numerical improvements in overall work impairment/activity impairment. This highlights tofacitinib effectiveness as monotherapy/combination therapy for a diverse PsA population. However, the small sample size limited the statistical power, and so results should be interpreted cautiously.

TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT05195814.

PMID:41343116 | DOI:10.1007/s40744-025-00811-4

J Gastrointest Cancer. 2025 Dec 4;56(1):237. doi: 10.1007/s12029-025-01364-z.

ABSTRACT

BACKGROUND: Approximately 35% of patients do not receive adjuvant chemotherapy (AC) after surgery for stage III colorectal cancer (CRC). We aimed to investigate the association between receipt of AC and sociodemographic and treatment factors.

METHODS: A retrospective case-control analysis of patients with stage III CRC who underwent radical resection was performed using data from the SEER registry (2010-2020). The main exposure was socioeconomic determinants, and the main outcome was receipt of AC. Multivariable binary logistic regression analyses were used to assess independent predictors of AC receipt.

RESULTS: A total of 81,720 patients (52.4% male; median age, 65 years) were included. Overall, 70.6% of tumors were colonic and 29.4% rectal. 41.7% of patients did not receive AC. Independent socioeconomic determinants of AC receipt were age < 50 years (OR: 2.36, p < 0.001), male sex (OR: 0.931, p = 0.002), Black race (OR: 1.12, p = 0.002), Hispanic ethnicity (OR: 1.13, p < 0.001), household income <$50,000 (OR: 1.16, p = 0.001), non-metropolitan residence (OR: 1.09, p = 0.035), and unmarried status (single-OR: 0.778, p < 0.001, divorced-OR: 0.87, p < 0.001, widowed-OR: 0.313, p < 0.001). Tumor characteristics associated with AC receipt included tumor location and size, perineural invasion, number of positive lymph nodes, and CEA levels. Neoadjuvant chemotherapy (OR: 0.37, 95%CI: 0.28-0.48) and neoadjuvant radiation therapy (OR: 0.42, 95%CI: 0.38-0.46) were associated with lower odds of receiving AC in patients with colon and rectal cancer, respectively.

CONCLUSIONS: Receipt of AC was less likely among elderly males and those who received neoadjuvant treatments. Black and Hispanic patients and patients with low household income were more likely to receive AC.

PMID:41343095 | DOI:10.1007/s12029-025-01364-z

Eurasian J Med. 2025 Oct 16;57(3):1-6. doi: 10.5152/eurasianjmed.2025.25987.

ABSTRACT

BACKGROUND: This study aimed to evaluate the complication rates in femoral neck fractures treated with dynamic hip screw (DHS), with a focus on associations with age, gender, and fracture classification. Additionally, the impact of reduction quality on clinical outcomes was assessed.

METHODS: A total of 172 patients aged 21-65 years were retrospectively reviewed. Fractures were classified according to the AO and Powell angle classification systems. Reduction quality was assessed using the Garden index. Complication rates were analyzed based on reduction method, age group, gender, and fracture type.

RESULTS: A total of 172 patients were included. The overall complication rate was 7.5% (n=13), with nonunion (n=7), avascular necrosis (n=4), and implant failure (n=2) being the primary complications. Although complication and nonunion rates were higher in females, the differences were not statistically significant (P > .05). Similarly, no significant differences were observed between age groups (P > .05). However, unstable fractures (AO type B3) and high-angle fractures (Powell group 3) were significantly associated with increased complication rates (P < .05). Anatomical reduction significantly reduced complication rates compared to poor reduction (P < .01).

CONCLUSION: Fracture type and reduction quality were the most important factors influencing complications. In particular, unstable and high-angle fractures were associated with increased risk, and the quality of reduction had a direct impact on treatment success. Age and gender did not show a significant effect on complication rates. The DHS stands out as both a biomechanically and economically effective treatment choice.

PMID:41342249 | DOI:10.5152/eurasianjmed.2025.25987

Logoped Phoniatr Vocol. 2025 Dec 4:1-12. doi: 10.1080/14015439.2025.2591104. Online ahead of print.

ABSTRACT

In typically developing (TD) children, early gestures emerge before first words and predict spoken language. Language development in children with cochlear implants (CI) vary due to factors such as implantation age and exposure to spoken language, but variation is largely unexplained. Little is known about gestures in children with CI and how this is related to vocabulary. In this study, spontaneous use of gestures during assessment of receptive and expressive vocabulary was examined and related to vocabulary test results in ten children with CI, aged 25-39 months. The results were compared to those of individually age and sex matched TD children with normal hearing. All children were tested with the vocabulary test, the Picture Naming Game (PiNG). The test situation was video recorded to capture the children’s use of deictic, iconic, and conventional gestures. Children with CI had lower vocabulary scores and used fewer gestures than TD children. Observable but statistically non-significant relationships between gestures and vocabulary were found in children with CI, as well as between vocabulary score and implantation age. The findings indicate that gestures should be included in the assessment and intervention of young children with challenges in their development of spoken language.

PMID:41342244 | DOI:10.1080/14015439.2025.2591104

Eurasian J Med. 2025 Oct 23;57(3):1-7. doi: 10.5152/eurasianjmed.2025.251103.

ABSTRACT

BACKGROUND: Systemic sclerosis (SSc) is a chronic autoimmune inflammatory disease. The most significant and prevalent complication of SSc is interstitial lung disease (ILD). It is difficult to monitor disease activity. In outpatient clinic conditions, C-reactive protein remains nonspecific and specific methods such as the European Scleroderma Trials and Research group take a long time. This study aimed to evaluate the effectiveness of new inflammation markers obtained from blood parameters, which is a rapid and inexpensive method, in SSc patients with ILD.

METHODS: A total of 53 patients with SSc and 54 healthy subjects were included in this retrospective crosssectional study.

RESULTS: The neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic inflammatory index (SII), systemic inflammatory response index (SIRI), and pan-immune-inflammation values (PIV) were found to be higher in the patient group than in the control group. The lymphocyte-to-monocyte ratio (LMR) value was significantly lower in the patient group. Besides, these patients with ILD had significantly higher NLR, PLR, SII, and PIV values. The SIRI values were also high, but not statistically significant. The LMR value was found to be significantly lower. The SIRI values with 66% sensitivity and 66.7% specificity for SSc patients, and SII values with 75% sensitivity and 74.7% specificity for SSc patients with ILD can indicate disease activity.

CONCLUSION: The novel indices may prove superior to rudimentary indices by virtue of their capacity to more accurately reflect inflammatory activity in inflammatory connective tissue diseases, particularly those accompanied by fibrotic lung involvement. These indices have the potential to serve as a cost-effective predictive instrument.

PMID:41342238 | DOI:10.5152/eurasianjmed.2025.251103

Womens Health (Lond). 2025 Jan-Dec;21:17455057251399893. doi: 10.1177/17455057251399893. Epub 2025 Dec 4.

ABSTRACT

BACKGROUND: Menstrual cycles are a natural part of many people’s health, yet are subject to stigma and misinformation, which can affect the experience of menstrual-related symptoms and overall well-being.

OBJECTIVES: The study explored how perceptions of the menstrual cycle are associated with symptom severity and their impact on daily life, including work, social activities, and intimate relationships.

DESIGN: A cross-sectional observational study.

METHODS: An anonymised online survey, distributed through social media, email, and newsletters. Participants aged 18 and older who menstruated in the previous 12 months were included. Demographic data, menstrual cycle characteristics, and self-reported symptom severity were collected. Perceptions of menstruation were measured using a 5-point Likert scale. Nonparametric statistical tests, including Kruskal-Wallis, chi-square, and Spearman’s rank-order correlation, were used for data analysis.

RESULTS: In total, 4735 responses were included in the analysis. Positive perceptions of menstruation were associated with lower reported pain levels and reduced disruption to daily activities, including work and academic performance. Notably, 90.71% reported that menstrual symptoms disrupted their work, with 31.8% taking time off in the past 12 months. Intimate relationships were affected for 84.31% of participants, with significant correlations between comfort in seeking support from partners and the disruption of intimacy (r_s(8) = -0.117; p < 0.001). Participants who viewed menstruation positively experienced fewer mental health symptoms, such as depression and anxiety, compared to those with negative perceptions. The study found that positive perceptions of the menstrual cycle were associated with less severe symptoms and a reduced impact on daily activities.

CONCLUSIONS: The findings suggest an association between menstrual perceptions in shaping the experience of symptoms and their broader psychosocial impacts. Enhancing menstrual health literacy and promoting positive perceptions could improve individual health outcomes and societal attitudes. Future public health policies should integrate menstrual health education and supportive workplace policies to enhance the quality of life for those who menstruate.

REGISTRATION: Not applicable.

PMID:41342221 | DOI:10.1177/17455057251399893

Pharm Stat. 2026 Jan-Feb;25(1):e70057. doi: 10.1002/pst.70057.

ABSTRACT

Quantitative decision-making frameworks provide objective criteria for advancing a drug development program. Within this process, two types of decision error can occur: proceeding to the next phase and failing (incorrect go) or not proceeding when success would have been achieved (incorrect no-go). This paper discusses strategies to reduce these errors in the context of a phase 2/3 development programme by selecting an optimal go threshold, which minimises the combined risk of an incorrect go or incorrect no-go decision. If the importance of these two errors differs, we propose the use of a weighted decision error rate (WDER) to select the optimal go threshold. We explore the influence of the choice of weighting and the prior beliefs about the drug efficacy on the optimal decision rule and demonstrate how the WDER can guide phase 2 sample size determination, often resulting in a larger sample size paired with a more stringent go threshold for efficiency. We advocate for a new definition of the probability of success in phase 2, emphasizing that it should reflect the probability of making the correct decision about proceeding, rather than just the probability of advancing to phase 3. This approach ensures that decision-making in drug development is both robust and tailored, enhancing the risk-benefit assessment for each phase transition.

PMID:41342216 | DOI:10.1002/pst.70057

Restor Dent Endod. 2025 Nov;50(4):e41. doi: 10.5395/rde.2025.50.e41. Epub 2025 Nov 28.

ABSTRACT

OBJECTIVES: The study aimed to investigate how environmental conditions impact the setting time and microhardness of premixed calcium silicate-based sealers.

METHODS: The setting time and microhardness of three sealers (Endoseal MTA [MARUCHI], One-Fil [MEDICLUS], and Well-Root ST [VERICOM]) were evaluated under four environmental conditions: unsoaked, distilled water-soaked, phosphate-buffered saline-soaked, and pH 5-soaked gypsum molds (n = 12/group/condition). The setting time was measured with Gilmore needles, and microhardness was assessed using a Vickers tester after 3 days. Welch’s analysis of variance and Games-Howell post hoc tests were used for statistical analysis.

RESULTS: The sealer type and environmental conditions significantly influenced setting time and microhardness (p < 0.001). The initial and final setting times were the shortest in the unsoaked samples. For Endoseal MTA and One-Fil, the unsoaked condition exhibited significantly shorter setting times than the soaked conditions. Well-Root ST exhibited significantly longer setting times in acidic conditions. Surface microhardness was highest in the unsoaked group (p < 0.001). Among the soaked groups, the phosphate-buffered saline-soaked group had the lowest hardness for Endoseal MTA, whereas the pH 5-soaked group exhibited the lowest hardness for One-Fil and Well-Root ST. Endoseal MTA consistently demonstrated a lower microhardness than the other sealers (p < 0.001).

CONCLUSIONS: Moisture, pH, and solution chemistry influenced the setting time and microhardness of premixed calcium silicate sealers. Although acidic conditions generally prolong the setting time and reduce hardness, the effects vary based on the sealers used and the setting environment.

PMID:41342211 | DOI:10.5395/rde.2025.50.e41