Eleven (7%) patients had elevated liver function tests; most were mild, but one patient had a significant increase in transaminases (registered as hepatotoxicity) which led to the interruption of cannabidiol. All patients with liver or platelet abnormalities were also taking valproate. One (1%) patient, also with valproate CBD Gummies, developed hyperammonemia, which led to the discontinuation of cannabidiol.
A post-hoc analysis showed that the dose of cannabidiol at week 12 did not correlate in general with the number of adverse events (Spearman's rho -0.014, p = 0.37). In addition, there was no correlation with cannabidiol dose and reported somnolence and related side effects (eg, fatigue) at week 12 (Spearman's rho 0.029, p = 0.34).
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