title: [Assessment of clinical usefulness of Eviprostat for benign prostatic hyperplasia--comparison of Eviprostat tablet with a formulation containing two-times more active ingredients].
abstract: We compared the usefulness of Eviprostat tablet, a therapeutic agent for benign prostatic hyperplasia (BPH), and EVI-F tablet, a new formulation of Eviprostat containing two times more active ingredients (Chimaphila umbellata extract, Populus tremula extract, Pulsatilla pratensis extract, Equisetum arvense extract and purified wheat germ oil) and consequently designed to reduce the number of tablets per dose by half. In this study, patients with BPH were randomly assigned to either Eviprostat group (6 tabs/day) or EVI-F group (3 tabs/day) using the envelope method. The clinical efficacy of these two drugs were evaluated by the International Prostate Symptom Score (IPSS) and QOL score at the end of the treatment period, and their safety was evaluated by the incidence of side effects. Based on the clinical study guidelines for dysuria, the change in the IPSS total score and QOL score were comparable to the previously reported data for other treatment agents for BPH, and these indices showed gradual improvement with the treatment period. Both treatments were well tolerated. The clinical usefulness of the monotherapy with EVI-F tablet or Eviprostat tablet was reasonably demonstrated in this study. Furthermore, both treatments reduced nocturia, which has an impact on the QOL of patients with BPH.
authors.affiliation: Department of Urology, Japanese Red Cross Society Wakayama Medical Center.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tamaki
authors.forename: Masakazu
authors.initials: M
authors.lastname: Nakashima
authors.forename: Ryuichi
authors.initials: R
authors.lastname: Nishiyama
authors.forename: Hiroki
authors.initials: H
authors.lastname: Ikeda
authors.forename: Masaru
authors.initials: M
authors.lastname: Hiura
authors.forename: Toshio
authors.initials: T
authors.lastname: Kanaoka
authors.forename: Tadasu
authors.initials: T
authors.lastname: Nakano
authors.forename: Tadashi
authors.initials: T
authors.lastname: Hayashi
authors.forename: Osamu
authors.initials: O
authors.lastname: Ogawa
mesh_terms: D000368:Aged; D004338:Drug Combinations; D004979:Ethamsylate / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D013607:Tablets
chemical_list: D004338:Drug Combinations; D010936:Plant Extracts; D013607:Tablets; D004979:Ethamsylate; C010152:eviprostat