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Cannabidiol and Liver Enzyme Level Elevations in Healthy Adults: A Randomized Clinical Trial

Author/s: 
Jeffry Florian, Pablo Salcedo, Keith Burkhart, Aanchal Shah, Lakshmi Manasa S Chekka, Dro Keshishi, Vikram Patel, ShanChao Yang, Melanie Fein, Ryan DePalma, Murali Matta, David G Strauss, Rodney Rouse

Importance The wide use of unregulated cannabidiol (CBD) products among consumers raises safety concerns. Most research on CBD has studied the relatively high doses used by patients taking prescription CBD. However, limited safety data are available at lower doses.

Objective To study the effects of 4-weeks of twice-daily CBD use on the liver and endocrine hormones using a dose within the range consumers are taking with unregulated CBD products.

Design, Setting, and Participants This randomized double-blinded placebo-controlled trial from January to August 2024, using per protocol analysis, included healthy adults recruited from a clinical pharmacology unit (Spaulding Clinical Research in West Bend, Wisconsin).

Interventions Healthy participants were randomized to CBD, 5 mg/kg/d (2.5 mg/kg/d twice daily), or placebo for 28 days with weekly laboratory assessments.

Main Outcomes and Measures The primary end point was the percentage of participants with an alanine aminotransferase or aspartate aminotransferase level elevation greater than 3 times the upper limit of normal during the study.

Results In 201 healthy participants (median age, 36 years [IQR, 30-43 years]; 89 women [44%]), 8 participants (5.6%; 95% CI, 1.8%-9.3%) in the CBD group and 0 participants (0%; 95% CI, 0%-7.6%) in the placebo group had liver enzyme level elevation greater than 3 times the upper limit of normal. Seven participants met withdrawal criteria for potential drug-induced liver injury, detected at day 21 in 2 participants and day 28 in 5 participants. No differences in change from baseline were observed between the CBD and placebo groups for total testosterone and inhibin B in male participants or thyrotropin, total triiodothyronine, and free thyroxine in all participants.

Conclusions and Relevance In this study, the incidence of elevated alanine aminotransferase or aspartate aminotransferase coupled with the finding of increased eosinophilia, underscores the need for further investigation on the long-term effects of CBD use, its impact on various populations, and the safety of lower doses commonly used by consumers.

Trial Registration ClinicalTrials.gov Identifier: NCT06192589

Keywords 
cannabidiol aspartate aminotransferases alanine transaminase Double-Blind Method liver cannabinoids

Testosterone Treatment in Middle-Aged and Older Men with Hypogonadism

Author/s: 
Shalender Bhasin, Peter J Snyder

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In clinical trials involving middle-aged and older men with hypogonadism, testosterone treatment led to improved sexual activity and libido, correction of anemia, and modestly improved energy, mood, and walking ability. (The following key points also refer to findings from clinical trials involving this patient population.)
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Testosterone treatment did not improve cognition in men without a previously diagnosed cognitive disorder and did not prevent progression to diabetes in men with prediabetes or improve glycemic control in those with diabetes.
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Testosterone treatment did not increase the risk of major cardiovascular events among men with preexisting cardiovascular disease.
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Testosterone treatment did not increase the risk of prostate cancer or acute urinary retention and did not worsen lower urinary tract symptoms.
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Testosterone treatment was associated with an increased risk of clinical fractures and pulmonary embolism.
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The decision to administer testosterone treatment in a man with hypogonadism should be based on the severity of the hypogonadism and an assessment of the potential benefits and risks of treatment.

Keywords 
testosterone hypogonadism Libido anemia pulmonary embolism

Long-Term Anticoagulation Discontinuation After Catheter Ablation for Atrial Fibrillation: The ALONE-AF Randomized Clinical Trial

Author/s: 
Daehoon Kim, MD, Jaemin Shim, MD, Eue-Keun Choi, MD

Importance: Data from randomized clinical trials on a long-term anticoagulation strategy for patients after catheter-based ablation for atrial fibrillation (AF) are lacking.

Objective: To evaluate whether discontinuing oral anticoagulant therapy provides superior clinical outcomes compared with continuing oral anticoagulant therapy in patients without documented atrial arrhythmia recurrence after catheter ablation for AF.

Design, setting, and participants: A randomized clinical trial including 840 adult patients (aged 19-80 years) who were enrolled and randomized from July 28, 2020, to March 9, 2023, at 18 hospitals in South Korea. Enrolled patients had at least 1 non-sex-related stroke risk factor (determined using the CHA2DS2-VASc score [range, 0-9]) and no documented recurrence of atrial arrhythmia for at least 1 year after catheter ablation for AF. The CHA2DS2-VASc score is used as an assessment of stroke risk among patients with AF (calculated using point values for congestive heart failure, hypertension, ≥75 years of age, diabetes, stroke or transient ischemic attack, vascular disease, between 65 and 74 years of age, and sex category). The date of final follow-up was June 4, 2025.

Interventions: The patients were randomly assigned in a 1:1 ratio to discontinue oral anticoagulant therapy (n = 417) or continue oral anticoagulant therapy (with direct oral anticoagulants; n = 423).

Main outcomes and measures: The primary outcome was the first occurrence of a composite of stroke, systemic embolism, and major bleeding at 2 years. Individual components of the primary outcome (such as ischemic stroke and major bleeding) were assessed as secondary outcomes.

Results: Of the 840 adults randomized, the mean age was 64 (SD, 8) years, 24.9% were women, the mean CHA2DS2-VASc score was 2.1 (SD, 1.0), and 67.6% had paroxysmal AF. At 2 years, the primary outcome occurred in 1 patient (0.3%) in the discontinue oral anticoagulant therapy group vs 8 patients (2.2%) in the continue oral anticoagulant therapy group (absolute difference, -1.9 percentage points [95% CI, -3.5 to -0.3]; P = .02). The 2-year cumulative incidence of ischemic stroke was 0.3% in the discontinue oral anticoagulant therapy group vs 0.8% in the continue oral anticoagulant therapy group (absolute difference, -0.5 percentage points [95% CI, -1.6 to 0.6]). Major bleeding occurred in 0 patients in the discontinue oral anticoagulant therapy group vs 5 patients (1.4%) in the continue oral anticoagulant therapy group (absolute difference, -1.4 percentage points [95% CI, -2.6 to -0.2]).

Conclusions and relevance: Among patients without documented atrial arrhythmia recurrence after catheter ablation for AF, discontinuing oral anticoagulant therapy resulted in a lower risk for the composite outcome of stroke, systemic embolism, and major bleeding vs continuing direct oral anticoagulant therapy.

Trial registration: ClinicalTrials.gov Identifier: NCT04432220.

Keywords 
clinical pharmacy and pharmacology Oral Anticoagulation Cardiology atrial fibrillation Rhythm Disorders

Prostatitis: A Review

Author/s: 
Benjamin J Borgert, Eric M Wallen, Minh N Pham

Importance Prostatitis is defined as infection, inflammation, or pain of the prostate gland and affects approximately 9.3% of men in their lifetime.

Observations Acute bacterial prostatitis consists of a urinary tract infection (UTI) that includes infection of the prostate, typically associated with fever or chills and caused by gram-negative bacteria, such as Escherichia coli, Klebsiella, or Pseudomonas, in 80% to 97% of cases. First-line therapy for acute prostatitis is broad-spectrum intravenous or oral antibiotics, such as intravenous piperacillin-tazobactam, ceftriaxone, or oral ciprofloxacin, which has a 92% to 97% success rate when prescribed for 2 to 4 weeks for people with febrile UTI and acute prostatitis. Chronic bacterial prostatitis is defined as a persistent bacterial infection of the prostate, typically presenting as recurrent UTIs from the same strain. Up to 74% of chronic bacterial prostatitis diagnoses are due to gram-negative organisms, such as E coli. First-line therapy for chronic bacterial prostatitis is a minimum 4-week course of levofloxacin or ciprofloxacin. Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) presents as pelvic pain or discomfort for at least 3 months and is associated with urinary symptoms, such as urinary frequency. CP/CPPS is diagnosed when evaluation, including history and physical examination, urine culture, and postvoid residual measurement, does not identify other causes for the symptoms, such as infection, cancer, urinary obstruction, or urinary retention. The National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) measures symptom severity (scale of 0-43), with a 6-point change considered clinically meaningful. First-line oral therapy for CP/CPPS with urinary symptoms is α-blockers (eg, tamsulosin, alfuzosin; ΔNIH-CPSI score difference vs placebo = −10.8 to −4.8). Other oral therapies are associated with modest changes in NIH-CPSI score compared with placebo, including anti-inflammatory drugs (eg, ibuprofen; ΔNIH-CPSI score difference = −2.5 to −1.7), pregabalin (ΔNIH-CPSI score difference = −2.4), and pollen extract (ΔNIH-CPSI score difference = −2.49).

Conclusions and Relevance Prostatitis includes acute bacterial prostatitis, chronic bacterial prostatitis, and CP/CPPS, each of which is diagnosed and treated differently. First-line treatments are broad-spectrum antibiotics for acute bacterial prostatitis (such as piperacillin-tazobactam, ceftriaxone, or ciprofloxacin), at least 4 weeks of fluoroquinolones for chronic bacterial prostatitis, and α-blockers for CP/CPPS with urinary symptoms.

Keywords 
Urology Infectious diseases Reproductive Health prostate Prostatitis

Approach to lubricant use for sexual activity

Author/s: 
Ryleigh Vanderschee, Sanja Kostov

Objective: To present health care providers with an inclusive, evidence-based framework to identify patients who may benefit from lubricant use during sexual activity, and assist patients in selecting a lubricant tailored to their specific needs.

Sources of information: A MEDLINE, PubMed, Google Scholar, and Google search was performed for white and grey literature published from 2003 to 2024. Interdisciplinary experts in sexual health also conducted an iterative review.

Main message: Lubricant use during sexual activity has numerous benefits, minimal harms, and can play a role in managing many common sexual health concerns encountered in primary care. However, counselling on lubricant use can be challenging due to a lack of accessible, evidence-based clinical tools. Consequently, clinicians are often hesitant to discuss lubricant use and can only offer anecdotal advice. Lubricant use is especially beneficial for patients using condoms or experiencing dryness, pain (eg, dyspareunia), or dysfunction during sex. There are 3 main types of lubricants available: oil-, silicone-, and water-based products. For patients who use condoms or who experience recurrent vaginal infections or irritation, silicone- or water-based lubricants are recommended, which are free of harmful ingredients and are within recommended osmolality and pH ranges.

Conclusion: Lubricant use during sexual activity can enhance sexual well-being across diverse patient populations. This review summarizes evidence and provides practical tools to help clinicians integrate counselling on lubricant use into routine sexual health discussions.

Keywords 
Lubricant Sexual Health sexual behavior

What Is Prostate Cancer?

Author/s: 
Rebecca Voelker, MSJ

Prostate cancer is a common malignancy in older men. Prostate cancer typically affects older men (average age at diagnosis is 67 years) and is more common among Black men than White men.1 More than half of prostate cancer risk is due to genetic factors. Prostate cancer is the second most common cause of cancer in men worldwide, with about 1.5 million cases diagnosed in 2021. In the US, 3.4 million men were living with prostate cancer in 2021.

Keywords 
Patient Information jama Patient Information Reproductive Health oncology prostate cancer

Addictive Screen Use Trajectories and Suicidal Behaviors, Suicidal Ideation, and Mental Health in US Youths

Author/s: 
Yunyu Xiao, PhD, Yuan Meng, PhD, Timothy T. Brown, PhD

Importance: Increasing child and adolescent use of social media, video games, and mobile phones has raised concerns about potential links to youth mental health problems. Prior research has largely focused on total screen time rather than longitudinal addictive use trajectories.

Objectives: To identify trajectories of addictive use of social media, mobile phones, and video games and to examine their associations with suicidal behaviors and ideation and mental health outcomes among youths.

Design, setting, and participants: Cohort study analyzing data from baseline through year 4 follow-up in the Adolescent Brain Cognitive Development Study (2016-2022), with population-based samples from 21 US sites.

Exposures: Addictive use of social media, mobile phones, and video games using validated child-reported measures from year 2, year 3, and year 4 follow-up surveys.

Main outcomes and measures: Suicidal behaviors and ideation assessed using child- and parent-reported information via the Kiddie Schedule for Affective Disorders and Schizophrenia. Internalizing and externalizing symptoms were assessed using the parent-reported Child Behavior Checklist.

Results: The analytic sample (n = 4285) had a mean age of 10.0 (SD, 0.6) years; 47.9% were female; and 9.9% were Black, 19.4% Hispanic, and 58.7% White. Latent class linear mixed models identified 3 addictive use trajectories for social media and mobile phones and 2 for video games. Nearly one-third of participants had an increasing addictive use trajectory for social media or mobile phones beginning at age 11 years. In adjusted models, increasing addictive use trajectories were associated with higher risks of suicide-related outcomes than low addictive use trajectories (eg, increasing addictive use of social media had a risk ratio of 2.14 [95% CI, 1.61-2.85] for suicidal behaviors). High addictive use trajectories for all screen types were associated with suicide-related outcomes (eg, high-peaking addictive use of social media had a risk ratio of 2.39 [95% CI, 1.66-3.43] for suicidal behaviors). The high video game addictive use trajectory showed the largest relative difference in internalizing symptoms (T score difference, 2.03 [95% CI, 1.45-2.61]), and the increasing social media addictive use trajectory for externalizing symptoms (T score difference, 1.05 [95% CI, 0.54-1.56]), compared with low addictive use trajectories. Total screen time at baseline was not associated with outcomes.

Conclusions and relevance: High or increasing trajectories of addictive use of social media, mobile phones, or video games were common in early adolescents. Both high and increasing addictive screen use trajectories were associated with suicidal behaviors and ideation and worse mental health.

Keywords 
adolescent addictive behavior mental health Cohort Studies cell phone child behavior suicide video games screen time social media

Prostate Cancer: A Review

Author/s: 
Ruben Raychaudhuri, Daniel W Lin, R Bruce Montgomery

Importance: Prostate cancer is the most common nonskin cancer in men in the US, with an estimated 299 010 new cases and 35 250 deaths in 2024. Prostate cancer is the second most common cancer in men worldwide, with 1 466 680 new cases and 396 792 deaths in 2022.

Observations: The most common type of prostate cancer is adenocarcinoma (≥99%), and the median age at diagnosis is 67 years. More than 50% of prostate cancer risk is attributable to genetic factors; older age and Black race (annual incidence rate, 173.0 cases per 100 000 Black men vs 97.1 cases per 100 000 White men) are also strong risk factors. Recent guidelines encourage shared decision-making for prostate-specific antigen (PSA) screening. At diagnosis, approximately 75% of patients have cancer localized to the prostate, which is associated with a 5-year survival rate of nearly 100%. Based on risk stratification that incorporates life expectancy, tumor grade (Gleason score), tumor size, and PSA level, one-third of patients with localized prostate cancer are appropriate for active surveillance with serial PSA measurements, prostate biopsies, or magnetic resonance imaging, and initiation of treatment if the Gleason score or tumor stage increases. For patients with higher-risk disease, radiation therapy or radical prostatectomy are reasonable options; treatment decision-making should include consideration of adverse events and comorbidities. Despite definitive therapy, 2% to 56% of men with localized disease develop distant metastases, depending on tumor risk factors. At presentation, approximately 14% of patients have metastases to regional lymph nodes. An additional 10% of men have distant metastases that are associated with a 5-year survival rate of 37%. Treatment of metastatic prostate cancer primarily relies on androgen deprivation therapy, most commonly through medical castration with gonadotropin-releasing hormone agonists. For patients with newly diagnosed metastatic prostate cancer, the addition of androgen receptor pathway inhibitors (eg, darolutamide, abiraterone) improves survival. Use of abiraterone improved the median overall survival from 36.5 months to 53.3 months (hazard ratio, 0.66 [95% CI, 0.56-0.78]) compared with medical castration alone. Chemotherapy (docetaxel) may be considered, especially for patients with more extensive disease.

Conclusions and relevance: Approximately 1.5 million new cases of prostate cancer are diagnosed annually worldwide. Approximately 75% of patients present with cancer localized to the prostate, which is associated with a 5-year survival rate of nearly 100%. Management includes active surveillance, prostatectomy, or radiation therapy, depending on risk of progression. Approximately 10% of patients present with metastatic prostate cancer, which has a 5-year survival rate of 37%. First-line therapies for metastatic prostate cancer include androgen deprivation and novel androgen receptor pathway inhibitors, and chemotherapy for appropriate patients.

Keywords 
prostate prostate cancer adenocarcinoma

Surveillance Colonoscopy Findings in Older Adults With a History of Colorectal Adenomas

Author/s: 
Lee, JK, Roy, A., Jensen, C.D., Chan, J.T., Zhao, W.K.

Importance
Postpolypectomy surveillance is a common colonoscopy indication in older adults; however, guidelines provide little direction on when to stop surveillance in this population.

Objective
To estimate surveillance colonoscopy yields in older adults.

Design, Setting, and Participants
This population-based cross-sectional study included individuals 70 to 85 years of age who received surveillance colonoscopy at a large, community-based US health care system between January 1, 2017, and December 31, 2019; had an adenoma detected 12 or more months previously; and had at least 1 year of health plan enrollment before surveillance. Individuals were excluded due to prior colorectal cancer (CRC), hereditary CRC syndrome, inflammatory bowel disease, or prior colectomy or if the surveillance colonoscopy had an inadequate bowel preparation or was incomplete. Data were analyzed from September 1, 2022, to February 22, 2024.

Exposures
Age (70-74, 75-79, or 80-85 years) at surveillance colonoscopy and prior adenoma finding (ie, advanced adenoma vs nonadvanced adenoma).

Main Outcomes and Measures
The main outcomes were yields of CRC, advanced adenoma, and advanced neoplasia overall (all ages) by age group and by both age group and prior adenoma finding. Multivariable logistic regression was used to identify factors associated with advanced neoplasia detection at surveillance.

Results
Of 9740 surveillance colonoscopies among 9601 patients, 5895 (60.5%) were in men, and 5738 (58.9%), 3225 (33.1%), and 777 (8.0%) were performed in those aged 70-74, 75-79, and 80-85 years, respectively. Overall, CRC yields were found in 28 procedures (0.3%), advanced adenoma in 1141 (11.7%), and advanced neoplasia in 1169 (12.0%); yields did not differ significantly across age groups. Overall, CRC yields were higher for colonoscopies among patients with a prior advanced adenoma vs nonadvanced adenoma (12 of 2305 [0.5%] vs 16 of 7435 [0.2%]; P = .02), and the same was observed for advanced neoplasia (380 of 2305 [16.5%] vs 789 of 7435 [10.6%]; P < .001). Factors associated with advanced neoplasia at surveillance were prior advanced adenoma (adjusted odds ratio [AOR], 1.65; 95% CI, 1.44-1.88), body mass index of 30 or greater vs less than 25 (AOR, 1.21; 95% CI, 1.03-1.44), and having ever smoked tobacco (AOR, 1.14; 95% CI, 1.01-1.30). Asian or Pacific Islander race was inversely associated with advanced neoplasia (AOR, 0.81; 95% CI, 0.67-0.99).

Conclusions and Relevance
In this cross-sectional study of surveillance colonoscopy yield in older adults, CRC detection was rare regardless of prior adenoma finding, whereas the advanced neoplasia yield was 12.0% overall. Yields were higher among those with a prior advanced adenoma than among those with prior nonadvanced adenoma and did not increase significantly with age. These findings can help inform whether to continue surveillance colonoscopy in older adults.

Keywords 
Adenoma Colonoscopy older adults

Evaluating the Association Between Low-Density Lipoprotein Cholesterol Reduction and Relative and Absolute Effects of Statin Treatment: A Systematic Review and Meta-analysis

Author/s: 
Byrne, P., Demasi, M., Jones, M., Smith, S. M., O'Brien, K. K., DuBroff, R.

Importance: The association between statin-induced reduction in low-density lipoprotein cholesterol (LDL-C) levels and the absolute risk reduction of individual, rather than composite, outcomes, such as all-cause mortality, myocardial infarction, or stroke, is unclear.

Objective: To assess the association between absolute reductions in LDL-C levels with treatment with statin therapy and all-cause mortality, myocardial infarction, and stroke to facilitate shared decision-making between clinicians and patients and inform clinical guidelines and policy.

Data sources: PubMed and Embase were searched to identify eligible trials from January 1987 to June 2021.

Study selection: Large randomized clinical trials that examined the effectiveness of statins in reducing total mortality and cardiovascular outcomes with a planned duration of 2 or more years and that reported absolute changes in LDL-C levels. Interventions were treatment with statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) vs placebo or usual care. Participants were men and women older than 18 years.

Data extraction and synthesis: Three independent reviewers extracted data and/or assessed the methodological quality and certainty of the evidence using the risk of bias 2 tool and Grading of Recommendations, Assessment, Development and Evaluation. Any differences in opinion were resolved by consensus. Meta-analyses and a meta-regression were undertaken.

Main outcomes and measures: Primary outcome: all-cause mortality. Secondary outcomes: myocardial infarction, stroke.

Findings: Twenty-one trials were included in the analysis. Meta-analyses showed reductions in the absolute risk of 0.8% (95% CI, 0.4%-1.2%) for all-cause mortality, 1.3% (95% CI, 0.9%-1.7%) for myocardial infarction, and 0.4% (95% CI, 0.2%-0.6%) for stroke in those randomized to treatment with statins, with associated relative risk reductions of 9% (95% CI, 5%-14%), 29% (95% CI, 22%-34%), and 14% (95% CI, 5%-22%) respectively. A meta-regression exploring the potential mediating association of the magnitude of statin-induced LDL-C reduction with outcomes was inconclusive.

Conclusions and relevance: The results of this meta-analysis suggest that the absolute risk reductions of treatment with statins in terms of all-cause mortality, myocardial infarction, and stroke are modest compared with the relative risk reductions, and the presence of significant heterogeneity reduces the certainty of the evidence. A conclusive association between absolute reductions in LDL-C levels and individual clinical outcomes was not established, and these findings underscore the importance of discussing absolute risk reductions when making informed clinical decisions with individual patients.

Keywords 
"Cholesterol Statin Treatment meta-analysis Systemic Review
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