title: Effects of long-term androgen replacement therapy on the physical and mental statuses of aging males with late-onset hypogonadism: a multicenter randomized controlled trial in Japan (EARTH Study).
abstract: Androgen replacement therapy (ART) efficacy on late-onset hypogonadism (LOH) has been widely investigated in Western countries; however, it remains controversial whether ART can improve health and prolong active lifestyles. We prospectively assessed long-term ART effects on the physical and mental statuses of aging men with LOH in Japan. The primary endpoint was health-related quality of life assessed by questionnaires. Secondary endpoints included glycemic control, lipid parameters, blood pressure, waist circumference, body composition, muscular strength, International Prostate Symptom Scores (IPSS), International Index of Erectile Function-5 (IIEF-5) scores, and serum prostate-specific antigen levels. Of the 1637 eligible volunteers, 334 patients > 40 years with LOH were randomly assigned to either the ART (n = 169) or control groups (n = 165). Fifty-two weeks after the initial treatment, ART significantly affected the role physical subdomain of the short form-36 health survey (SF-36) scale (P = 0.0318). ART was also associated with significant decreases in waist circumstance (P = 0.002) and serum triglyceride (TG) (P = 0.013) and with significant increases in whole-body and leg muscle mass volumes (P = 0.071 and 0.0108, respectively), serum hemoglobin (P < 0.001), IPSS voiding subscore (P = 0.0418), and the second question on IIEF-5 (P = 0.0049). There was no significant difference between the groups in terms of severe adverse events. In conclusion, in patients with LOH, long-term ART exerted beneficial effects on Role Physical subdomain of the SF-36 scale, serum TG, waist circumstance, muscle mass volume, voiding subscore of IPSS, and the second question of IIEF-5. We hope our study will contribute to the future development of this area.
authors.affiliation: Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Konaka
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Sugimoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Orikasa
authors.forename: Teruaki
authors.initials: T
authors.lastname: Iwamoto
authors.forename: Toshinari
authors.initials: T
authors.lastname: Takamura
authors.forename: Yoshiyu
authors.initials: Y
authors.lastname: Takeda
authors.forename: Kazuyoshi
authors.initials: K
authors.lastname: Shigehara
authors.forename: Masashi
authors.initials: M
authors.lastname: Iijima
authors.forename: Eitetsu
authors.initials: E
authors.lastname: Koh
authors.forename: Mikio
authors.initials: M
authors.lastname: Namiki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000728:Androgens / Q000008:administration & dosage* / Q000009:adverse effects; D020249:Hormone Replacement Therapy; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000503:physiopathology; D007564:Japan; D008297:Male; D008875:Middle Aged; D011788:Quality of Life
chemical_list: D000728:Androgens