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Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial.
Biomed Res Int 2019; 2019:1037036BR

Abstract

Galphimine-B (G-B), a compound isolated from Galphimia glauca, 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.

Authors+Show Affiliations

Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico.Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico.Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico.Facultad de Medicina de la Universidad Autónoma del Estado de Morelos, Cuernavaca, Morelos, Mexico.Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico.Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Morelos, Mexico.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30834253

Citation

Romero-Cerecero, Ofelia, et al. "Galphimine-B Standardized Extract Versus Alprazolam in Patients With Generalized Anxiety Disorder: a Ten-Week, Double-Blind, Randomized Clinical Trial." BioMed Research International, vol. 2019, 2019, p. 1037036.
Romero-Cerecero O, Islas-Garduño AL, Zamilpa A, et al. Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial. Biomed Res Int. 2019;2019:1037036.
Romero-Cerecero, O., Islas-Garduño, A. L., Zamilpa, A., Herrera-Arellano, A., Jiménez-Ferrer, E., & Tortoriello, J. (2019). Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial. BioMed Research International, 2019, p. 1037036. doi:10.1155/2019/1037036.
Romero-Cerecero O, et al. Galphimine-B Standardized Extract Versus Alprazolam in Patients With Generalized Anxiety Disorder: a Ten-Week, Double-Blind, Randomized Clinical Trial. Biomed Res Int. 2019;2019:1037036. PubMed PMID: 30834253.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Galphimine-B Standardized Extract versus Alprazolam in Patients with Generalized Anxiety Disorder: A Ten-Week, Double-Blind, Randomized Clinical Trial. AU - Romero-Cerecero,Ofelia, AU - Islas-Garduño,Ana Laura, AU - Zamilpa,Alejandro, AU - Herrera-Arellano,Armando, AU - Jiménez-Ferrer,Enrique, AU - Tortoriello,Jaime, Y1 - 2019/01/30/ PY - 2018/09/19/received PY - 2018/12/05/revised PY - 2019/01/13/accepted PY - 2019/3/6/entrez PY - 2019/3/6/pubmed PY - 2019/6/14/medline SP - 1037036 EP - 1037036 JF - BioMed research international JO - Biomed Res Int VL - 2019 N2 - Galphimine-B (G-B), a compound isolated from Galphimia glauca, 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. SN - 2314-6141 UR - https://www.unboundmedicine.com/medline/citation/30834253/Galphimine_B_Standardized_Extract_versus_Alprazolam_in_Patients_with_Generalized_Anxiety_Disorder:_A_Ten_Week_Double_Blind_Randomized_Clinical_Trial_ L2 - https://dx.doi.org/10.1155/2019/1037036 DB - PRIME DP - Unbound Medicine ER -