Tribulus terrestris versus placebo in the treatment of erectile dysfunction and lower urinary tract symptoms in patients with late-onset hypogonadism: A placebo-controlled study.

Aging is associated with a series of morphological and functional modifications that leads to reduced physiological efficiency and atrophy of various organs and systems. Tribulus terrestris induces its effect in fertility and sexual functions through the steroidal saponins, particularly the dominant saponins protodioscin. We aimed in this study to evaluate the efficacy and safety profiles of Tribulus terrestris in aging males with partial androgen deficiency who suffered from erectile dysfunction and lower urinary tract symptoms. A total of 70 randomized aging patients with erectile dysfunction and lower urinary tract symptoms were recruited from June 2017 to March 2018 from our andrology outpatient clinic. Thirty-five patients (group A) received Tribulus terrestris three times daily for 3 months and the other 35 patients (group B) received placebo. The mean of aspartate transaminase was elevated in group A after 3 months of receiving Tribulus terrestris (26.5 (before), 27.8 (after), respectively, p = 0.03). Moreover, there were significant elevations in the means of both total testosterone together with the score of the validated Arabic index of erectile function (5-item version of the International Index of Erectile Function) (2.2, 10.7 (before), 2.7, 16.1 (after), p < 0.001, p < 0.001, respectively). Finally, the mean of the total prostate-specific antigen was elevated in this group (1.4 (before), 1.7 (before), p = 0.007, respectively). Interestingly, there were no worsening of the lower urinary tract symptoms in group A as there was no change in the mean score of the international prostate symptom score, which was used to assess these symptoms before and after treatment (mean 14.4 (before), 14.6 (after), p = 0.67, respectively). In sum, this study replicates the findings of previous reports about the robust effect of this herbal medicine in elevating the testosterone level and improving the sexual function of patients who suffered from erectile dysfunction with partial androgen deficiency.