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A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE)
Ephedra Herb is an important crude drug; it is used in various Traditional Japanese Medicine (Kampo) formulations. Its significant pharmacological effects have been believed to be attributed to ephedrine and pseudoephedrine, which sometimes induce adverse effects. On the other hand, it has been repo...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6098921/ https://www.ncbi.nlm.nih.gov/pubmed/30174707 http://dx.doi.org/10.1155/2018/4625358 |
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author | Odaguchi, Hiroshi Sekine, Mariko Hyuga, Sumiko Hanawa, Toshihiko Hoshi, Keika Sasaki, Yoshinobu Aso, Masako Yang, Jinwei Hyuga, Masashi Kobayashi, Yoshinori Hakamatsuka, Takashi Goda, Yukihiro Kumagai, Yuji |
author_facet | Odaguchi, Hiroshi Sekine, Mariko Hyuga, Sumiko Hanawa, Toshihiko Hoshi, Keika Sasaki, Yoshinobu Aso, Masako Yang, Jinwei Hyuga, Masashi Kobayashi, Yoshinori Hakamatsuka, Takashi Goda, Yukihiro Kumagai, Yuji |
author_sort | Odaguchi, Hiroshi |
collection | PubMed |
description | Ephedra Herb is an important crude drug; it is used in various Traditional Japanese Medicine (Kampo) formulations. Its significant pharmacological effects have been believed to be attributed to ephedrine and pseudoephedrine, which sometimes induce adverse effects. On the other hand, it has been reported that some of these pharmacological effects are not dependent on ephedrine or pseudoephedrine. Ephedrine alkaloids-free Ephedra Herb extract has been newly developed. It has been reported to have analgesic, anti-influenza, and antimetastatic effects. This clinical trial was aimed at verifying the noninferiority of EFE's safety compared to that of Ephedra Herb extract (EHE) in humans. This was a single-institution, double-blinded, randomized, two-drug, two-stage, crossover comparative study. Twelve healthy male subjects were equally and randomly allocated into two groups: prior administration of EFE (EFE-P) and prior administration of EHE (EHE-P). In Stage 1, EFE and EHE were orally administered to the EFE-P and EHE-P groups, respectively, for six days. After a 4-week washout period, Stage 2 was initiated wherein the subjects were given a study drug different from Stage 1 study drug for six days. Eleven adverse events with a causal relationship to the study drugs (EHE: 8; EFE: 3) were noted; all events were mild in severity. With regard to the incidence of adverse events, EHE and EFE administration, respectively, accounted for 4 cases (out of 12 subjects, similarly below) and 1 case of increased pulse rate (p=0.32) and 3 cases and 1 case of insomnia (p=0.59). Further, there was one case of hot flashes (p=1.00) due to EFE administration and one case of dysuria (p=1.00) due to EHE administration. There were no significant differences in the incidences of adverse events between EHE administration and EFE administration. Therefore, we concluded that EFE is not inferior to EHE in terms of safety. |
format | Online Article Text |
id | pubmed-6098921 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-60989212018-09-02 A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) Odaguchi, Hiroshi Sekine, Mariko Hyuga, Sumiko Hanawa, Toshihiko Hoshi, Keika Sasaki, Yoshinobu Aso, Masako Yang, Jinwei Hyuga, Masashi Kobayashi, Yoshinori Hakamatsuka, Takashi Goda, Yukihiro Kumagai, Yuji Evid Based Complement Alternat Med Research Article Ephedra Herb is an important crude drug; it is used in various Traditional Japanese Medicine (Kampo) formulations. Its significant pharmacological effects have been believed to be attributed to ephedrine and pseudoephedrine, which sometimes induce adverse effects. On the other hand, it has been reported that some of these pharmacological effects are not dependent on ephedrine or pseudoephedrine. Ephedrine alkaloids-free Ephedra Herb extract has been newly developed. It has been reported to have analgesic, anti-influenza, and antimetastatic effects. This clinical trial was aimed at verifying the noninferiority of EFE's safety compared to that of Ephedra Herb extract (EHE) in humans. This was a single-institution, double-blinded, randomized, two-drug, two-stage, crossover comparative study. Twelve healthy male subjects were equally and randomly allocated into two groups: prior administration of EFE (EFE-P) and prior administration of EHE (EHE-P). In Stage 1, EFE and EHE were orally administered to the EFE-P and EHE-P groups, respectively, for six days. After a 4-week washout period, Stage 2 was initiated wherein the subjects were given a study drug different from Stage 1 study drug for six days. Eleven adverse events with a causal relationship to the study drugs (EHE: 8; EFE: 3) were noted; all events were mild in severity. With regard to the incidence of adverse events, EHE and EFE administration, respectively, accounted for 4 cases (out of 12 subjects, similarly below) and 1 case of increased pulse rate (p=0.32) and 3 cases and 1 case of insomnia (p=0.59). Further, there was one case of hot flashes (p=1.00) due to EFE administration and one case of dysuria (p=1.00) due to EHE administration. There were no significant differences in the incidences of adverse events between EHE administration and EFE administration. Therefore, we concluded that EFE is not inferior to EHE in terms of safety. Hindawi 2018-08-05 /pmc/articles/PMC6098921/ /pubmed/30174707 http://dx.doi.org/10.1155/2018/4625358 Text en Copyright © 2018 Hiroshi Odaguchi et al. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Odaguchi, Hiroshi Sekine, Mariko Hyuga, Sumiko Hanawa, Toshihiko Hoshi, Keika Sasaki, Yoshinobu Aso, Masako Yang, Jinwei Hyuga, Masashi Kobayashi, Yoshinori Hakamatsuka, Takashi Goda, Yukihiro Kumagai, Yuji A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) |
title | A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) |
title_full | A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) |
title_fullStr | A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) |
title_full_unstemmed | A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) |
title_short | A Double-Blind, Randomized, Crossover Comparative Study for Evaluating the Clinical Safety of Ephedrine Alkaloids-Free Ephedra Herb Extract (EFE) |
title_sort | double-blind, randomized, crossover comparative study for evaluating the clinical safety of ephedrine alkaloids-free ephedra herb extract (efe) |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6098921/ https://www.ncbi.nlm.nih.gov/pubmed/30174707 http://dx.doi.org/10.1155/2018/4625358 |
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