title: Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.
abstract: OBJECTIVE
  To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels.
  
  
  METHODS
  Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way.
  
  
  RESULTS
  The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914).
  
  
  CONCLUSIONS
  At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone.
authors.affiliation: Departamento de Cirugía (Urología), Facultad de Ciencias Médicas, Universidad Estatal de Campinas UNICAMP, São Paulo, Brasil.
authors.forename: C A
authors.initials: CA
authors.lastname: Santos
authors.affiliation: Departamento de Cirugía (Urología), Facultad de Ciencias Médicas, Universidad Estatal de Campinas UNICAMP, São Paulo, Brasil; Facultad de Medicina (Urología), Centro de Ciencias de la Vida, Universidad Católica de Campinas PUC-Campinas, São Paulo, Brasil. Electronic address: reisleo@unicamp.br.
authors.forename: L O
authors.initials: LO
authors.lastname: Reis
authors.affiliation: Departamento de Cirugía (Urología), Facultad de Ciencias Médicas, Universidad Estatal de Campinas UNICAMP, São Paulo, Brasil.
authors.forename: R
authors.initials: R
authors.lastname: Destro-Saade
authors.affiliation: Departamento de Cirugía (Urología), Facultad de Ciencias Médicas, Universidad Estatal de Campinas UNICAMP, São Paulo, Brasil.
authors.forename: A
authors.initials: A
authors.lastname: Luiza-Reis
authors.affiliation: Departamento de Cirugía (Urología), Facultad de Ciencias Médicas, Universidad Estatal de Campinas UNICAMP, São Paulo, Brasil.
authors.forename: A
authors.initials: A
authors.lastname: Fregonesi
mesh_terms: D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010919:Placebos; D010936:Plant Extracts / Q000627:therapeutic use*; D011446:Prospective Studies; D032444:Tribulus
chemical_list: D010919:Placebos; D010936:Plant Extracts
keywords: Alternative medicine; Disfunción sexual; Fitoterapia; Herbal medicine; Impotence; Impotencia; Libido; Medicina alternativa; Placebo and Chinese medicine; Placebo y medicina china; Sexual dysfunction; Testosterona; Testosterone