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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

Lung cancer crash course

Author/s: 
Wilkinson, A. N.

Lung cancer has the highest mortality rate of any cancer in Canada, causing 25.5% of all cancer deaths, with a 5-year survival rate of only 19%. More than half of lung cancers are metastatic at diagnosis, with common sites of metastases in the brain, bone, liver, and adrenal glands. Lung cancer is a heterogeneous group of cancers broadly separated into small cell lung cancer (SCLC)—approximately 15% of all lung cancer cases—and non–small cell lung cancer (NSCLC), which is further divided into predominantly adenocarcinoma and squamous cell carcinoma subtypes. More than 80% of lung cancer cases are related to smoking, meaning smoking cessation remains the cornerstone of lung cancer prevention. Low-dose computed tomography is a valuable screening tool for lung cancer that can identify lung cancers at an earlier stage and reduce lung cancer–specific mortality and all-cause mortality. Although lung cancer screening is recommended by the Canadian Task Force on Preventive Health Care, it is currently available in only a few Canadian provinces.

Keywords 
liver brain Survival Rate Small Cell Lung Carcinoma Canada

Management of Hepatitis C in 2019.

Author/s: 
Kristen, Naggie, Susanna

In the United States, hepatitis C virus (HCV) infection affects more than 2 million adults and is the leading cause of liver-related mortality. Therapies that eradicate HCV may prevent progression to cirrhosis, liver decompensation, hepatocellular carcinoma, need for liver transplant, and death. HCV eradication also appears to reduce the risk of extrahepatic diseases, including cryoglobulinemic vasculitis and cardiovascularevents. Direct-acting antivirals (DAAs), oral drugs that target multiple mechanisms of the HCV lifecycle, have been usedincombination since 2013. Because of their efficacy and safety, the use of DAAshas substantiall yimproved HCV treatment and made HCV eradication possible for most patients, including patients with HIV infection, severe renal and hepatic impairment, and history of organ transplantation. Individuals living with HCV should be treated to reduce liver-related and all-cause morbidity and mortality and to prevent HCV transmission...

Keywords 
Pregnancy U.S. hepatitis vaccination RNA HIV Genotype liver
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