Efficacy and Tolerability of a Standardized Herbal Product from Galphimia glauca on Generalized Anxiety Disorder. A Randomized, Double-Blind Clinical Trial Controlled with Lorazepam

Abstract

Galphimia glauca Cav. is a plant used in Mexican traditional medicine as a ”nerve tranquilizer”. Previous studies have demonstrated that the methanolic extract from this plant species possess an anxiolytic effect. Galphimine B (GB, a nor-seco-triterpene), is the active principle, with an innovative action mechanism. Against this background, a standardized herbal medicinal product was developed from the aqueous extract of G. glauca (GgHP). The present work compared the therapeutic effectiveness, safety, and tolerability of the new GgHP with lorazepam on patients with generalized anxiety disorder (GAD). By means of a controlled, randomized, double-blind clinical trial, outpatients of either sex who matched the DSM-IV diagnostic criteria with a score of ≥ 19 points on the Hamilton Anxiety Scale (HAM-A) were included. The experimental group was treated orally with GgHP in capsules twice a day for 4 weeks. The control group received lorazepam (1 mg) under the same conditions and presentation. A total of 152 patients were included in the trial (72 in the experimental group). From the first week of treatment, GgHP showed important anxiolytic effectiveness, very similar to that produced with lorazepam. Both treatments showed therapeutic safety (no alterations on biochemical analysis of hepatic and renal function). Nevertheless, concerning side effects, GgHP evidenced a considerably higher tolerability than lorazepam.

Abbreviations

ALP: alkaline phosphatase

ALT: alanine aminotransferase

AST: aspartate aminotransferase

GAD: generalized anxiety disorder

GB: galphimine B

GgHP: standardized herbal medicinal product from the aqueous extract of Galphimia glauca

HAM-A: Hamilton anxiety scale

SSRI: selective serotonin reuptake inhibitors

Key words

Galphimia glauca - Malpighiaceae - galphimine B - plant-derived medicine - anxiolytic, lorazepam - generalized anxiety disorder (GAD)

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