Results of a comparative multi-center randomized clinical study of efficacy and safety of EFFEX Tribulus and Tribestan in patients with erectile dysfunction


Дәйексөз келтіру

Толық мәтін

Ашық рұқсат Ашық рұқсат
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Рұқсат жабық Рұқсат ақылы немесе тек жазылушылар үшін

Аннотация

Relevance. Erectile dysfunction (ED) is a common condition. Pharmacological management of ED involves medications produced by chemical synthesis. Despite high efficiency, their use is often accompanied by some side effects. Considering this, herbal preparations with sufficient efficacy and greater safety have received much attention. Aim. To compare the efficacy and safety of two herbal preparations (EFFEX Tribulus and Tribestan) based on Tribulus Terrestris herb dry extract in patients with ED. Materials and methods. A total of 173 patients were enrolled in the study, of whom 87 (group I) and 86 (group II) received EFFEX Tribulus and Tribestan, respectively. The mean age of patients was 42.2+11.5 years in group I and 42.8+11.2 years in group II. One hundred fifty two patients completed the study. The follow-up was 13 weeks (the herbal preparation dose was titrated at week five after the treatment initiation). The effectiveness of treatment was assessed on five follow-up visits using the IIEF, AMS, MSF, GAQ questionnaires, and a complex of diagnostic and laboratory studies. Results. At visit five compared to visit 1, the mean IIEF erectile function domain score increased by 5.7+4.6 and 5.2+4.3 points in group I and II, respectively. In both groups, all other IIEF domain scores demonstrated a statistically significant increase. The AMS scores decreased from 32.93+10.04 to 25.02+7.62 points in group I and 31.78+10.37 to 24.55+7.31 points in group II. The SMF scores increased from 22.36+4.85 to 27.16+4.80 points in group I and from 22.13+3.69 to 26.10+5.69 points in group II. Besides, the use of the herbal preparations was associated with a decrease in the serum cholesterol level, more pronounced with increasing patient age (correlation coefficient -0.06, p=0.41). Conclusion. The herbal preparations EFFEX Tribulus and Tribestan have a similar efficacy and safety profiles.

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Рұқсат жабық

Авторлар туралы

L. Spivak

I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenov University)

Email: leonid.spivak@gmail.com
Ph.D., Associate Professor at the Department of Urology

D. Platonova

I.M. Sechenov First MSMU (Sechenov University)

Junior Researcher at the Research Institute for Uronephrology and Human Reproductive Health

D. Enikeev

I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenov University)

Deputy Director for Science, Research Institute of Uronephrology and Human Reproductive Health

L. Rapoport

I.M. Sechenov First MSMU (Sechenov University) of Minzdrav of Russia

Email: leonidrapoport@yandex.ru
Dr.Med.Sci., Professor at the Department of Urology; Director of the Clinic of Urology

A. Vinarov

I.M. Sechenov First MSMU (Sechenov University) of Minzdrav of Russia

Dr.Med.Sci., Professor at the Department of Urology

Yu. Demidko

I.M. Sechenov First MSMU of Minzdrav of Russia (Sechenov University)

Dr.Med.Sci., Physician at the Clinic of Urology

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