title: Rhodiola rosea, folic acid, zinc and biotin (EndEP®) is able to improve ejaculatory control in patients affected by lifelong premature ejaculation: Results from a phase I-II study.
abstract: The therapeutic armamentarium currently available for the treatment of premature ejaculation (PE) is not highly satisfactory. However, phytotherapeutics appear to be an interesting option for PE management. The present study aimed to evaluate the tolerability and efficacy of a phytotherapeutic combination ofRhodiola rosea, folic acid, biotin and zinc (EndEP®) in the treatment of patients affected by lifelong PE. All patients affected by lifelong PE who were attending three Urological Institutions from July to December 2014 were enrolled in this prospective, multicentre, phase I-II study. All patients were assigned to receive oral tablets of EndEP®(one tablet per day) for 90 days. Clinical and instrumental analyses were carried out at enrolment and at the end of the study. International Prostatic Symptom Score (IPSS), International Index of Erectile Function (IIEF)-15, Premature Ejaculation Diagnostic Tool (PEDT) and Short Form (SF)-36 questionnaires were used. The intravaginal ejaculation latency time (IELT) for each event was also evaluated using the stop-watch technique. The main outcome measure was the difference from baseline in PEDT questionnaire and mean IELT at the end of the follow-up period. In total, 91 patients (mean age, 32.3±5.6 years) were analysed. The baseline questionnaires mean scores were 1.1±1.6, 26.1±2.9, 15.3±3.4 and 98.2±0.5, for IPSS, IIEF-15, PEDT and SF-36, respectively. The mean IELT at baseline was 73.6±46.9s. At the follow-up examination (90 days after the start of treatment), no statistically significant differences were identified in terms of IPSS (1.4±1.5) or IIEF-15 (26.3±3.1) compared with the pre-treatment values (P=0.19 and P=0.64, respectively). A statistically significant difference was detected between the mean IELT at enrolment and after treatment (73.6±46.9 vs. 102.3±60.0; P<0.001) and SF-36 questionnaire (98.2±0.5 vs. 99.4±0.1; P<0.001). Fifty-five patients reported improvement in the control of ejaculation (60.4%). Very few adverse events were reported (4.4%). In conclusion, it was found that EndEP®significantly improved ejaculatory control and the quality of sexual life in patients affected by lifelong PE, with a very low rate of adverse events.
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, I-38123 Trento, Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Cai
authors.affiliation: Department of Urology, University Federico II of Naples, I-80121 Naples, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Verze
authors.affiliation: Department of Urology and Renal Transplantation, University of Foggia, I-71121 Foggia, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Massenio
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, I-38123 Trento, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Tiscione
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, I-38123 Trento, Italy.
authors.forename: Gianni
authors.initials: G
authors.lastname: Malossini
authors.affiliation: Department of Urology and Renal Transplantation, University of Foggia, I-71121 Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Cormio
authors.affiliation: Department of Urology and Renal Transplantation, University of Foggia, I-71121 Foggia, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Carrieri
authors.affiliation: Department of Urology, University Federico II of Naples, I-80121 Naples, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
keywords: Rhodiola rosea; biotin; folic acid; premature ejaculation; quality of life; zinc