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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 > or = 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.

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  • Authors+Show Affiliations

    ,

    Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (IMSS), Xochitepec, Morelos, Mexico.

    , , , ,

    Source

    Planta medica 73:8 2007 Jul pg 713-7

    MeSH

    Administration, Oral
    Adolescent
    Adult
    Aged
    Anti-Anxiety Agents
    Anxiety Disorders
    Double-Blind Method
    Female
    Galphimia
    Humans
    Lorazepam
    Male
    Middle Aged
    Phytotherapy
    Plant Extracts
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    17562493

    Citation

    Herrera-Arellano, Armando, et al. "Efficacy and Tolerability of a Standardized Herbal Product From Galphimia Glauca On Generalized Anxiety Disorder. a Randomized, Double-blind Clinical Trial Controlled With Lorazepam." Planta Medica, vol. 73, no. 8, 2007, pp. 713-7.
    Herrera-Arellano A, Jiménez-Ferrer E, Zamilpa A, et al. Efficacy and tolerability of a standardized herbal product from Galphimia glauca on generalized anxiety disorder. A randomized, double-blind clinical trial controlled with lorazepam. Planta Med. 2007;73(8):713-7.
    Herrera-Arellano, A., Jiménez-Ferrer, E., Zamilpa, A., Morales-Valdéz, M., García-Valencia, C. E., & Tortoriello, J. (2007). Efficacy and tolerability of a standardized herbal product from Galphimia glauca on generalized anxiety disorder. A randomized, double-blind clinical trial controlled with lorazepam. Planta Medica, 73(8), pp. 713-7.
    Herrera-Arellano A, et al. Efficacy and Tolerability of a Standardized Herbal Product From Galphimia Glauca On Generalized Anxiety Disorder. a Randomized, Double-blind Clinical Trial Controlled With Lorazepam. Planta Med. 2007;73(8):713-7. PubMed PMID: 17562493.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy and tolerability of a standardized herbal product from Galphimia glauca on generalized anxiety disorder. A randomized, double-blind clinical trial controlled with lorazepam. AU - Herrera-Arellano,Armando, AU - Jiménez-Ferrer,Enrique, AU - Zamilpa,Alejandro, AU - Morales-Valdéz,Marisol, AU - García-Valencia,Claudia E, AU - Tortoriello,Jaime, Y1 - 2007/06/11/ PY - 2007/6/15/pubmed PY - 2007/9/21/medline PY - 2007/6/15/entrez SP - 713 EP - 7 JF - Planta medica JO - Planta Med. VL - 73 IS - 8 N2 - 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 > or = 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. SN - 0032-0943 UR - https://www.unboundmedicine.com/medline/citation/17562493/Efficacy_and_tolerability_of_a_standardized_herbal_product_from_Galphimia_glauca_on_generalized_anxiety_disorder__A_randomized_double_blind_clinical_trial_controlled_with_lorazepam_ L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-2007-981539 DB - PRIME DP - Unbound Medicine ER -