Planta Med 2012; 78 - PI414
DOI: 10.1055/s-0032-1321101

New anxiolytic phytopharmaceutical elaborated with the standardized extract of Galphimia glauca

J Tortoriello 1, A Herrera-Arellano 1, M Herrera-Ruiz 1, A Zamilpa 1, M González 1, E Jiménez Ferrer 1
  • 1Southern Biomedical Research Center, Mexican Institute of Social Security. Argentina 1, Xochitepec, Mor. Mexico. 62790

A new phytopharmaceutical with anxiolytic effectiveness has been developed. This product was elaborated with the standardized extract obtained from the plant species Galphimia glauca Cav. (Malpighiaceae). Galphimia glauca has for many years been used in Mexican traditional medicine as a “tranquilizer”. Different in vivo and in vitro pharmacological studies have demonstrated the anxiolytic activity of crude extract obtained from G. glauca. The pharmacological effect produced by the G. glauca extract has been attributed to the nor-seco,triterpene galphimine-B (G-B). This compound has exhibited an innovative action mechanism, selective of dopaminergic neurons on ventral tegmental area.The therapeutic effectiveness, safety, and tolerability of the new phytopharmaceutical was compared 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's diagnostic criteria with a score of ≥19 points on the Hamilton Anxiety Scale (HAM-A) were included. The experimental group was treated orally with the phytopharmaceutical in capsules twice a day for 4 weeks. The control group received lorazepam (1mg) 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, the phytopharmaceutical showed important anxiolytic effectiveness, very similar to that produced with lorazepam. Both treatments showed therapeutic safety, nevertheless, concerning side effects the phytopharmaceutical evidenced considerably higher tolerability than lorazepam.