Galphimine-B standardized extract versus alprazolam in patients with generalized anxiety disorder: A ten-week, double-blind, randomized clinical trial
Open accessAbstract
, has been shown to possess important anxiolytic activity. In this study, we evaluated the effectiveness and tolerability of a G-B standardized extract (experimental treatment) that was administered daily for 10 weeks in patients with moderate or severe Generalized Anxiety Disorder (GAD). Alprazolam was used as control treatment and administered under the same conditions. A total of 167 patients were included. At the start of the study, the severe anxiety condition prevailed, with an average on the Hamilton Anxiety Scale of 35.1 ± 8.8 and 35.8 ± 8.1 points in the control and experimental groups, respectively. After the 10 weeks of administration, the average was reduced in the control group to 4.6 ± 6.5 points and in the experimental group to 3.5 ± 5.5 points. Therapeutic success in the control group was 85.7% and in the experimental group, 92.0%. A high proportion of patients (22.2%) treated with Alprazolam manifested daytime sleepiness, while in the group treated with the G-B standardized extract, daytime sleepiness was found in 4.7%. In conclusion, a G-B standardized extract demonstrated therapeutic effectiveness in patients with GAD, without exhibiting significant difference with Alprazolam, but showing fewer cases of daytime sleepiness. The trial was registered at http://clinicaltrials.gov by identifier: NCT03702803.
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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 Romero-Cerecero et al., 2019
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- Authors
- Romero-Cerecero, O., Islas-Garduño, A. L., Zamilpa, A., Herrera-Arellano, A., Jiménez-Ferrer, E., & Tortoriello, J.
- Affiliations
- Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico
- Mexican Social Security Institute (MX)
- Universidad Autónoma del Estado de Morelos (MX)
- Corresponding author
- Tortoriello, Jaime
- ORCID
- Venue
- BioMed Research International
- Publisher
- Wiley
- Published
- 2019-01-30
- Volume
- 2019
- Pages
- 1-9
- ISSN
- 1110-7243 (ISSN-L)
- 2314-6133
- 2314-6141
- PMC
- PMC6374797
- OpenAlex
- W2914509438
- Cited by
- 11
- References
- 12
- Citations by year
- 2025: 1 · 2024: 3 · 2023: 2 · 2021: 3 · 2020: 1 · 2019: 1
- FWCI
- 1.61
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- BioMed Research International (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Consejo Nacional de Ciencia y Tecnología (2015-CO1-261591)
- IMSS-Foundation (2015-CO1-261591)
- Topics
- Health Sciences › Medicine › Complementary and alternative medicine › Medicinal Plant Extracts Effects
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Medicinal Plants and Bioactive Compounds
- Keywords
- standardized herbal extract, generalized anxiety disorder, alprazolam, anxiolytic effects, daytime sleepiness, tolerability, herbal medicine
- MeSH terms
- Patient Health Questionnaire, Alprazolam, Anxiety Disorders, Double-Blind Method, Female, Humans, Male, Middle Aged, Plant Extracts, Triterpenes, Galphimia
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