Treatment of erectile dysfunction using a nutraceutical mix. Preliminary data in a randomized, single-blind, placebo-controlled study
N. Stanojevic, V. Pesic, J. Alonso Lopez, A. Ruffo (Belgrade)
Introduction: Approximately 50% of men aged 40–70 years report suffering from some degree of erectile dysfunction (ED). PDE5-i is the first line treatment for this condition. Many patients serach for a different treatment, with less side effects. Use of food supplements is common and more patients are seeking for alternative treatment for ED. This study investigated the efficacy of a new supplement to improve male sexual function. Materials and methods: In this randomized, sinlge-blind, placebocontrolled study, 92 men with mild to moderate ED were enrolled. The mean age was 56.4 ± 15.9 years. Group A (56 pts) received the the active treatment containing a mix of L-citrulline 2500 mg, Moringa oleifera 1500 mg, Tribulus terrestris 400 mg (45% saponins), Panax ginseng 400 mg, Lepidium Meyenii 200 mg, Trigonella FoenumGraecum 200 mg, Zinc 15 mcg, Vitamin D3 7.5 mcg, Vitamin B6 1 mg. This treatment was administered twice a day for two months. Group B (36 pts) received a placebo. Patients were investigated by using the International Index of Erectile Function (IIEF-5) questionnaire, the Sexual Encounter Profile (SEP) diaries, SEP Question 2:“Were you able to insert your penis into your partner’s vagina?” and SEP Question 3:“Did your erection last long enough for you to have successful intercourse?.” In addition, patients underwent further evaluation with the Global Assessment Question (GAQ) by answering the two yes/no questions of the test: (GAQ-Q1) “Over the past four weeks has the treatment you have been taking improved your erectile function?” and (GAQ-Q2) “If yes, has the treatment improved your ability to engage in sexual activity over the past four weeks.”. Results: At one month follow-up 10 pts drop-outs (11%): consisting of 6 pts from Group A and 4 pts from Group B. 4 pts (8%) reported mild gastrointestinal symptoms. 6 pts (12%) reported mild insomnia. Group A showed a statistically significant improvement of the IIEF mean scores compare to the control group, from a baseline total score of 14.7 ± 4.0 to 20.2 ± 3.4 Vs 15.6 ± 3.4 to 17.2 ± 2.6. 42 pts (84%) answered ‘yes’ to SEP Q2 vs 30 pts (60%) pre-treatment. SEP Q3 was answered positively by 36 pts (72%) vs 27 pts (54%). For the GAQ questions, 30 pts (60%) answered “Yes” to the GAQ-Q1 while 29 pts (58%) answered “Yes” to the GAQ- Q2. When reviewing the change in SEP scores, a significant increase was noticeable between the baseline and followup data. Conclusions: The combination of these composite improves male sexual function.
https://www.researchgate.net/publication/345191692_Treatment_of_erectile_dysfunction_using_a_nutraceutical_mix_Preliminary_data_in_a_randomized_single-blind_placebo-controlled_study