Details

Autor(en) / Beteiligte

• Atieh, Jessica
• Maselli, Daniel
• Breen-Lyles, Margaret
• Torres, Monique
• Katzka, David
• Ryks, Michael
• Busciglio, Irene
• Burton, Duane
• Carlson, Paula
• Harmsen, W Scott
• Camilleri, Michael

Titel

CANNABIDIOL FOR FUNCTIONAL DYSPEPSIA WITH NORMAL GASTRIC EMPTYING: A RANDOMIZED, CONTROLLED TRIAL

Ist Teil von

• The American journal of gastroenterology, 2022-08, Vol.117 (8), p.1296-1304

Ort / Verlag

United States: Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins

Erscheinungsjahr

2022

Link zum Volltext

Beschreibungen/Notizen

• Cannabidiol (CBD), a CBR2 agonist with limited psychic effects, antagonizes CB1/CB2 receptors. Allelic variation CNR1 (gene for CBR1) rs806378 and FAAH rs324420 were associated with altered gut motility and sensation. This study aimed to compare pharmacodynamics and clinical effects of 4-week treatment with pharmaceutical grade CBD vs. placebo and also to assess interactions of FAAH and CNR1 gene variants on effects of CBD in patients with functional dyspepsia (FD). We performed a randomized, double-blinded, placebo-controlled (1:1 ratio) study of CBD b.i.d. (20mg/kg/day according to FDA escalation guidance) in FD patients with non-delayed gastric emptying (GE) at baseline. Symptoms were assessed by validated daily symptom diary (0-4 scale for upper abdominal pain, nausea, bloating), weekly assessment of adequate relief, Leuven Postprandial Distress Scale (LPDS, 8 symptoms, adjectival scores rated 0-4 for severity), and quality of life [Short Form Nepean Dyspepsia Index (average of 10 dimensions each on 5-point scale)]. After 4-week treatment, all patients underwent measurements of GE of solids, gastric volumes, and Ensure® nutrient satiation test. Statistical analysis compared 2 treatments for all endpoints and effects of CBD in association with FAAH rs324420 and CNR1 rs806378. CBD and placebo effects on physiological and patient response outcomes were not significantly different. There were borderline CBD treatment-by-genotype interactions: rs806378 CNR1 with LPDS (p=0.06), and GE solids (p=0.12). Approved doses of CBD used off-label do not relieve FD with normal baseline GE solids or alter gastric motor functions and satiation. CBD treatment-by-gene interactions suggest potential benefit for postprandial distress with CNR1 rs806378 T allele.