Abstract
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.
Highlights
In the 17th edition of the Japanese Pharmacopoeia, Ephedra Herb has been defined as the terrestrial stem of Ephedra sinica Stapf., Ephedra intermedia Schrenk et C.A
Between the Ephedra Herb extract (EHE)-P group (6 subjects) and the EFEP group (6 subjects), there were no significant differences in variables such as age, height, weight, vital signs, and blood test results. (Table 2)
The adverse events were increased pulse rate, insomnia, hot flashes, and dysuria, all of which have been previously recognized as side effects of ephedrine alkaloids (EAs)
Summary
In the 17th edition of the Japanese Pharmacopoeia, Ephedra Herb has been defined as the terrestrial stem of Ephedra sinica Stapf., Ephedra intermedia Schrenk et C.A. Traditional Japanese Medicine (Kampo) formulations (such as eppikajutsuto, kakkonto, kakkontokasenkyusin’i, kakkonkajutsubuto, keishimaokakuhanto, gokoto, goshakusan, shoseiryuto, shimpito, zokumeito, bofutsushosan, maoto, maobushisaishinto, makyokansekito, makyoyokukanto, and yokuininto) for various treatments Kakkonto is used to treat the common cold in the early stage and stiff neck, and maoto is Evidence-Based Complementary and Alternative Medicine effective against early flu symptoms and rheumatoid arthritis. Makyoyokukanto alleviates joint, nerve, and muscle pain, while eppikajutsuto has a therapeutic effect on rheumatoid arthritis (http://mpdb.nibiohn.go.jp/stork/). Ephedra Herb is widely known for its diaphoretic, antipyretic, antitussive, anti-inflammatory, and analgesic effects, and these pharmacological effects are thought to be attributable to ephedrine alkaloids (EAs) [2]. The antiinflammatory effect of Ephedra Herb has been thought to be attributable to Pse [3]]. EAs have been reported to inhibit prostaglandin E2 biosynthesis [4]
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