Table 7.

Summary of efficacy, bioavailability, safety and tolerability clinical studies with a proprietary spearmint extract (PSE) of Mentha spicata L. standardized with 15.4% rosmarinic acid.

Refs.	Study Design	Endpoints	Dosage & Duration	Results
[144]	Open-label pilot	Tolerability, bioavailability, efficacy (cognitive function)	900 mg X 30 days	PSE was well-tolerated, rosmarinic acid and metabolites detectable in plasma, improvement in computerized cognitive function scores.
[145]	RDBPCa	Safety and tolerability	600 mg, 900 mg PSE or placebo daily X 90 days	No effects on any safety parameters measured, no AEs deemed relevant to PSE.
[146]	RDBPC	Cognitive function (performance, sleep, mood)	600 mg, 900 mg, or placebo daily X 90 days	Working memory and spatial working memory accuracy improved by 15% and 9% (900 mg PSE). Subjects reported improvement in ability to fall asleep at 900 mg PSE. Treatment-related trends for vigor-activity and total mood disturbance vs. placebo. The only treatment-related AE was heartburn (1 subject,600 mg PSE).
[147]	RDBPC, parallel design	Cognition	900 mg daily PSE X 90 days	Significant treatment effects observed for attention (sustained, complex, shifting).

^aRandomized, double-blinded, placebo-controlled.