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
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A standardised extract containing 0.374 mg of Galphimine-B per dose demonstrated similar efficacy in reducing anxiety, but better tolerability after four and 10 weeks of treatment as compared with the active comparators lorazepam and alprazolam.
“It was reported that the standardised extract containing 0.374 mg of Galphimine-B per dose demonstrated similar efficacy in reducing anxiety, but better tolerability after four and 10 weeks of treatment as compared with the active comparators lorazepam and alprazolam (Herrera-Arellano et al., 2007;Romero-Cerecero et al., 2019).”
From Novel pharmacological targets in drug development for the treatment of anxiety and anxiety-related disorders (2019) · cites this paper as Herrera-Arellano et al., 2007
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Katzman, M. A., Bleau, P., Blier, P., Chokka, P., Kjernisted, K., Van Ameringen, M., & the Canadian Anxiety Guidelines Initiative Group on behalf of the Anxiety Disorders Association of Canada/Association Canadienne des troubles anxieux and McGill University (2014) · BMC Psychiatry · doi:10.1186/1471-244x-14-s1-s1 · Cited by 1,090 · see citing works
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“This herbal product showed important anxiolytic effectiveness, very similar to that observed with lorazepam, and both treatments showed therapeutic safety (Herrera-Arellano et al., 2007).”
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“The results for both treatments, as measured with the HAM‐A, demonstrated that Galphimia glauca exerted anxiolytic effects in patients with GAD, even at different doses and with different treatment times, although the age range was similar [62,63].”
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“Furthermore, the anxiolytic effect caused by Galphimia glauca was noticed during the first week of administration, which is not the case for other drugs (azapirones and selective serotonin reuptake inhibitors, SSRIs) that require at least 3 to 4 weeks to start with this effect, therefore this is an advantage for patie…”
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“In a clinical study performed with subjects exhibiting symptoms of general anxiety, standardized preparations of Galphimia glauca, administered to the patients produced anxiolytic effects (Herrera-Arellano et al., 2007).”
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“In a double-blind clinical trial, a phytopharmaceutical elaborated with a standardized Galphimia glauca extract proved to be effective and tolerable in patients with generalized anxiety disease [5].”
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“This product, administered during 4 weeks, demonstrated that it possesses therapeutic effectiveness similar to that exerted by Lorazepam in patients with a diagnosis of Generalized Anxiety Disorder (GAD), however, without evidencing important adverse effects (Herrera-Arellano et al., 2007).”
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- Authors
- Herrera-Arellano, A., Jiménez-Ferrer, E., Zamilpa, A., Morales-Valdéz, M., García-Valencia, C., & Tortoriello, J.
- Affiliations
- Mexican Social Security Institute (MX)
- Venue
- Planta Medica
- Publisher
- Georg Thieme Verlag KG
- Published
- 2007-07
- Volume
- 73
- Issue
- 8
- Pages
- 713-717
- ISSN
- 0032-0943 (ISSN-L)
- 1439-0221
- OpenAlex
- W2049272894
- Cited by
- 62
- References
- 0
- Citations by year
- 2025: 1 · 2024: 3 · 2023: 3 · 2022: 5 · 2021: 5 · 2020: 6 · 2019: 5 · 2018: 5 · 2016: 2 · 2015: 4 · 2014: 5 · 2013: 4 · 2012: 5
- FWCI
- 6.14
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Planta Medica (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Medicinal Plant Extracts Effects
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Phytochemistry Medicinal Plant Applications
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Medicinal Plants and Bioactive Compounds
- Keywords
- Galphimia glauca, generalized anxiety disorder, anxiolytic effects, lorazepam, tolerability, safety, traditional Mexican medicine, aqueous plant extract
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Anxiety Disorders, Double-Blind Method, Female, Humans, Lorazepam, Male, Phytotherapy, Middle Aged, Plant Extracts, Anti-Anxiety Agents, Treatment Outcome, Galphimia
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