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
Oriental Medicine Research Center, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo 108-8642, Japan.
Department of Hygiene, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan.
Evid Based Complement Alternat Med. 2018 Aug 5;2018:4625358. doi: 10.1155/2018/4625358. eCollection 2018.
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.
麻黄是一种重要的中药材，用于多种日本传统医学（汉方）配方中。其显著的药理作用被认为归因于麻黄碱和伪麻黄碱，而这两种成分有时会引发不良反应。另一方面，有报道称其中一些药理作用并不依赖于麻黄碱或伪麻黄碱。新开发了无麻黄碱生物碱的麻黄提取物。据报道，它具有镇痛、抗流感和抗转移作用。这项临床试验旨在验证无麻黄碱生物碱的麻黄提取物（EFE）在人体中的安全性不劣于麻黄提取物（EHE）。这是一项单机构、双盲、随机、双药、两阶段、交叉对照研究。12名健康男性受试者被平均随机分为两组：先服用EFE组（EFE-P）和先服用EHE组（EHE-P）。在第1阶段，分别给EFE-P组和EHE-P组口服EFE和EHE，持续6天。经过4周的洗脱期后，开始第2阶段，在此阶段给受试者服用与第1阶段研究药物不同的研究药物，持续6天。记录到11起与研究药物有因果关系的不良事件（EHE：8起；EFE：3起）；所有事件严重程度均为轻度。关于不良事件的发生率，服用EHE和EFE分别导致4例（12名受试者中，下同）和1例脉搏加快（p = 0.32），以及3例和1例失眠（p = 0.59）。此外，服用EFE导致1例潮热（p = 1.00），服用EHE导致1例排尿困难（p = 1.00）。服用EHE和服用EFE之间不良事件的发生率没有显著差异。因此，我们得出结论，EFE在安全性方面不劣于EHE。
