PMID- 28364864
OWN - NLM
STAT- MEDLINE
DCOM- 20170602
LR  - 20181202
IS  - 1873-4111 (Electronic)
IS  - 0378-5122 (Linking)
VI  - 99
DP  - 2017 May
TI  - Evaluation of the efficacy and safety of Tribulus terrestris in male sexual 
      dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical 
      trial.
PG  - 20-26
LID - S0378-5122(16)30297-3 [pii]
LID - 10.1016/j.maturitas.2017.01.011 [doi]
AB  - OBJECTIVE: The primary objectives were to compare the efficacy of extracts of the 
      plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with 
      placebo, for the treatment of men with erectile dysfunction (ED) and with or 
      without hypoactive sexual desire disorder (HSDD), as well as to monitor the 
      safety profile of the drug. The secondary objective was to evaluate the level of 
      lipids in blood during treatment. PARTICIPANTS AND DESIGN: Phase IV, prospective, 
      randomized, double-blind, placebo-controlled clinical trial in parallel groups. 
      This study included 180 males aged between 18 and 65 years with mild or moderate 
      ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients 
      with ED and hypertension, diabetes mellitus, and metabolic syndrome were included 
      in the study. In the trial, an herbal medicine intervention of Bulgarian origin 
      was used (Tribestan((R)), Sopharma AD). Each Tribestan film-coated tablet contains 
      the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg 
      which is standardized to furostanol saponins (not less than 112.5mg). Each 
      patient received orally 3x2 film-coated tablets daily after meals, during the 
      12-week treatment period. At the end of each month, participants' sexual 
      function, including ED, was assessed by International Index of Erectile Function 
      (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical 
      parameters were also determined. The primary outcome measure was the change in 
      IIEF score after 12 weeks of treatment. Complete randomization (random sorting 
      using maximum allowable% deviation) with an equal number of patients in each 
      sequence was used. This randomization algorithm has the restriction that unequal 
      treatment allocation is not allowed; that is, all groups must have the same 
      target sample size. Patients, investigational staff, and data collectors were 
      blinded to treatment. All outcome assessors were also blinded to group 
      allocation. RESULTS: 86 patients in each group completed the study. The IIEF 
      score improved significantly in the TT group compared with the placebo group 
      (capital ER, Cyrillic<0.0001). For intention-to-treat (ITT) there was a statistically significant 
      difference in change from baseline of IIEF scores. The difference between TT and 
      placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically 
      significant difference between TT and placebo was found for Intercourse 
      Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), 
      Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour 
      of TT. There were no differences in the incidence of adverse events (AEs) between 
      the two groups and the therapy was well tolerated. There were no drug-related 
      serious AEs. Following the 12-week treatment period, significant improvement in 
      sexual function was observed with TT compared with placebo in men with mild to 
      moderate ED. TT was generally well tolerated for the treatment of ED.
CI  - Copyright (c) 2017 Elsevier B.V. All rights reserved.
FAU - Kamenov, Zdravko
AU  - Kamenov Z
AD  - Clinic of Endocrinology, Alexandrovska University Hospital, Medical 
      University-Sofia, 1, Georgi Sofiiski Str 1431, Sofia, Bulgaria. Electronic 
      address: zkamenov@hotmail.com.
FAU - Fileva, Svetlana
AU  - Fileva S
AD  - Medical and Regulatory Affairs Department, Sopharma AD, Sofia, Bulgaria.
FAU - Kalinov, Krassimir
AU  - Kalinov K
AD  - Department of Informatics, New Bulgarian University, Sofia, Bulgaria.
FAU - Jannini, Emmanuele A
AU  - Jannini EA
AD  - Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170212
PL  - Ireland
TA  - Maturitas
JT  - Maturitas
JID - 7807333
RN  - 0 (Plant Extracts)
SB  - IM
MH  - Adult
MH  - Double-Blind Method
MH  - Erectile Dysfunction/complications/*drug therapy
MH  - Humans
MH  - Libido
MH  - Male
MH  - Middle Aged
MH  - *Phytotherapy
MH  - Plant Extracts/*therapeutic use
MH  - Prospective Studies
MH  - Sexual Dysfunctions, Psychological/complications/*drug therapy
MH  - Treatment Outcome
MH  - *Tribulus
OTO - NOTNLM
OT  - Erectile dysfunction
OT  - Randomized controlled trial
OT  - Tribulus terrestris
EDAT- 2017/04/04 06:00
MHDA- 2017/06/03 06:00
CRDT- 2017/04/03 06:00
PHST- 2016/10/28 00:00 [received]
PHST- 2017/01/16 00:00 [revised]
PHST- 2017/01/25 00:00 [accepted]
PHST- 2017/04/03 06:00 [entrez]
PHST- 2017/04/04 06:00 [pubmed]
PHST- 2017/06/03 06:00 [medline]
AID - S0378-5122(16)30297-3 [pii]
AID - 10.1016/j.maturitas.2017.01.011 [doi]
PST - ppublish
SO  - Maturitas. 2017 May;99:20-26. doi: 10.1016/j.maturitas.2017.01.011. Epub 2017 Feb 
      12.