Abstract
Galphimia glauca Cav. has demonstrated anxiolytic activity attributable to nor-seco-triterpenes denominated
galphimines, the most active of which is galphimine-B. Galphimine-B inhibits ventral
tegmental area dopaminergic neurons and interacts with the serotoninergic system of
the dorsal hippocampus. A previous clinical study that administered a G. glauca herbal medicinal product for 4 weeks evidenced high percentages of therapeutic effectiveness
and safety in patients with generalized anxiety disorder. Based on the previous findings,
the goal of the present study was to evaluate the effectiveness, safety, and tolerability
of G. glauca herbal medicinal product administered during 15 weeks in patients with generalized
anxiety disorder. Study design: double-blind, randomized, lorazepam-controlled clinical
trial. Study subjects: adult males and females, ambulatory, diagnosed with generalized
anxiety disorder, with 20 or more points on the Hamilton anxiety scale, without data
of depression, and without anxiolytic treatment in the previous month. Interventions
were as follows. Experimental treatment: G. glauca herbal medicinal product in capsules containing the dry extract of G. glauca standardized in 0.175 mg of galphimine-B, one or two capsules twice a day, during
12 weeks plus 3 withdrawal weeks, and control treatment: lorazepam 0.5 mg with the
same presentation and posology. Primary outcome: anxiolytic effectiveness (≥ 50 %
reduction of initial Hamilton anxiety scale score). Secondary outcomes: tolerability
and safety. One hundred ninety-one patients initiated the study with 94 in the experimental
group. One hundred four patients concluded the study, 51 of these in the experimental
group. Anxiolytic effectiveness, measured as 0 in a negative case and as 1 in a positive
case, was assessed 593 times in the experimental group and 631 in the control; the
mean effectiveness observed was 0.686 ± 0.019 vs. 0.588 ± 0.019 (repeated-measures
ANOVA; p = 0.0003). In the same way, G. glauca-herbal medicinal product diminished the score in the Hamilton anxiety scale to 11.51 ± 8.27
points and lorazepam to 12.40 ± 8.07 points (repeated-measures ANOVA; p = 0.05). The
tolerability analysis, which comprised patients who concluded the treatment plus 11
patients who withdrew due to adverse reactions did not show differences between treatments
(p = 0.35), nor did therapeutic safety demonstrate differences between groups (p = 0.21).
There were no cases of tolerance, intoxication, dependence, or suppression syndrome.
We concluded that G. glauca herbal medicinal product, standardized in 0.175 mg of galphimine-B and administered
for 15 weeks to patients with generalized anxiety disorder, showed greater anxiolytic
effectiveness than that obtained with lorazepam, with high percentages of therapeutic
tolerability and safety.
Key words
Galphimia glauca
- Malpighiaceae - nor-seco-triterpenes - herbal medicinal product - generalized anxiety
disorder - randomized controlled clinical trial
