Journal of Reproduction & Infertility

Journal of Reproduction & Infertility

The Efficacy and Safety of On-demand Tramadol and Paroxetine Use in Treatment of Life Long Premature Ejaculation: A Randomized Double-blind Placebo-controlled Clinical Trial

Authors
Ali Hamidi-Madani
Reza Motiee
Gholamreza Mokhtari
Hamidreza Nasseh
Samaneh Esmaeili
Ehsan Kazemnezhad
Urology Research Center, School of Medicine, Razi hospital, Guilan University of Medical Sciences, Rasht, Iran
Abstract
Background: Several medical therapies have been proposed for the treatment of premature ejaculation (PE). Paroxetine and tramadol were both reported to be effective in treatment of PE. In this study, the therapeutic effects of tramadol, paroxetine and placebo were compared in treatment of primary PE. Methods: In this randomized, double-blind, placebo-controlled clinical trial, 150 patients were divided into 3 groups. One group was treated with tramadol 50 mg on- demand, the other group took paroxetine 20 mg on-demand and the third group was treated with placebo. Before starting treatment and after 12 weeks, patients were asked to measure their average intravaginal ejaculation latency time (IELT) and fill the PEP (Premature Ejaculation Profile) questionnaire. Results: At the end of the 12th week, the mean IELT and average of PEP scores improved in all 3 groups. The increase in tramadol group was significantly higher than the paroxetine and placebo groups (p<0.0001). There were no significant differences in terms of side effects between the 3 groups. Conclusion: The results showed that despite an increase in mean IELT and PEP scores in all 3 groups, the rate of improvement in tramadol group was significantly more than the others. Thus, tramadol may be considered as an appropriate alternative therapeutic option for lifelong PE.
Keywords
IELT
Paroxetine
PEP
Premature Ejaculation
Tramadol
Montorsi F. Prevalence of premature ejaculation: a global and regional perspective. J Sex Med. 2005;2 Suppl 2:96-102.
Raisi F, Farnia V, Ghanbarian N, Ghafuri Z. Effects of herbal vigRX on premature ejaculation: a random-ized, double-blind study. Iran J Psychiatry. 2010;5(1):4-6.
Symonds T, Roblin D, Hart K, Althof S. How does premature ejaculation impact a man s life? J Sex Marital Ther. 2003;29(5):361-70.
Serefoglu EC, Yaman O, Cayan S, Asci R, Orhan I, Usta MF, et al. Prevalence of the complaint of eja-culating prematurely and the four premature ejacul-ation syndromes: results from the Turkish society of andrology sexual health survey. J Sex Med. 2011;8(2):540-8.
Porst H, Montorsi F, Rosen RC, Gaynor L, Grupe S, Alexander J. The premature ejaculation prevalence and attitudes (PEPA) survey: prevalence, com-orbidities, and professional help-seeking. Eur Urol. 2007;51(3):816-23.
Mohee A, Eardley I. Medical therapy for premature ejaculation. Ther Adv Urol. 2011;3(5):211-22.
McMahon CG, Althof S, Waldinger MD, Porst H, Dean J, Sharlip I, et al. An evidence-based definition of lifelong premature ejaculation: report of the international society for sexual medicine ad hoc committee for the definition of premature ejaculation. BJU Int. 2008;102(3):338-50.
Gameel TA, Tawfik AM, Abou-Farha MO, Basta-wisy MG, El-Bendary MA, El-Gamasy Ael-N. On-demand use of tramadol, sildenafil, paroxetine and local anaesthetics for the management of premature ejaculation: a randomised placebo-controlled clinical trial. Arab J Urol. 2013;11(4):392-7.
Cooper AJ, Cernovsky ZZ, Colussi K. Some clinical and psychometric characteistics of primary and se-condary premature ejaculations. J Sex Marital Ther. 1993;19(4):276-88.
Laumann EO, Nicolosi A, Glasser DB, Paik A, Gingell C, Moreira E, et al. Sexual problems among women and men aged 40-80 y: prevalence and correlates identified in the global study of sex-ual attitudes and behaviores. Int J Impot Res. 2005;17(1):39-57.
Patrick DL, Althof SE, Pryor JL, Rosen R, Row-land DL, Ho KF, et al. Premature ejaculation: an observational study of men and their partners. J Sex Med. 2005;2(3):358-67.
Wu T, Yue X, Duan X, Luo D, Cheng Y, Tian Y, et al. Efficacy and safety of tramadol for premature ejaculation: a systematic review and meta-analysis. Urology. 2012;80(3):618-24.
Ozcan L, Polat EC, Otunctemur A, Ozbek E. Dulo-xetine, dual serotonin and norepinephrine reuptake inhibitor, versus paroxetine, selective serotonin reuptake inhibitor, in the treatment for premature ejaculation. Int Urol Nephrol. 2015;47(2):283-7.
Kaynar M, Kilic O, Yurdakul T. On-demand tra-madol hydrochloride use in premature ejaculation treatment. Urology. 2012;79(1):145-9.
Pryor JL, Althof SE, Steidle C, Rosen RC, Hell-strom WJ, Shabsigh R, et al. Efficacy and toler-ability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet. 2006; 368(9539):929-37.
Waldinger MD, Hengeveld MW, Zwinderman AH, Olivier B. Effect of SSRI antidepressants on eja-culation: a double-blind, randomized, placebo-con-trolled study with fluoxetine, fluvoxamine, paroxe-tine, and sertraline. J Clin Psychopharmacol. 1998;18(4):274-81.
Roblin D. Premature ejaculation: diagnosis and pharmacotherapy. Int J Pharm Med. 2000;14(6):313-8.
Safarinejad MR. Once-daily high-dose pindolol for paroxetine-refractory premature ejaculation: a double-blind, placebo-controlled and randomized study. J Clin Psychopharmacol. 2008;28(1):39-44.
Safarinejad MR, Hosseini SY. Safety and efficacy of tramadol in the treatment of premature ejaculation: a double-blind, placebo-controlled, fixed-dose, randomized study. J Clin Psychopharmacol. 2006;26(1):27-31.
Salem EA, Wilson SK, Bissada NK, Delk JR, Hel-lstrom WJ, Cleves MA. Tramadol HCL has promise in on-demand use to treat premature ejaculation. J Sex Med. 2008;5(1):188-93.
Bar-Or D, Salottolo KM, Orlando A, Winkler JV; Tramadol ODT Study Group. A randomized double-blind, placebo-controlled multicenter study to evalu-ate the efficacy and safety of two doses of the tramadol orally disintegrating tablet for the treat-ment of premature ejaculation within less than 2 minutes. Eur Urol. 2012;61(4):736-43.
Giuliano F, Clément P. Serotonin and premature ejaculation: from physiology to patient manage-ment. Eur Urol. 2006;50(3):454-66.
Giuliano FA. Tramadol for the treatment of pre-mature ejaculation. Eur Urol. 2012;61(4):744-5.
Waldinger MD, Zwinderman AH, Olivier B. On-demand treatment of premature ejaculation with clomipramine and paroxetine: a randomized, double blind fixed-dose study with stopwatch assessment. Eur Urol. 2004;46(4):510-6.
Marcou TA, Marque S, Mazoit JX, Benhamou D. The median effective dose of tramadol and mor-phine for postoperative patients: a study of inter-actions. Anesth Analg. 2005;100(2):469-74.
Alghobary M, El-Bayoumy Y, Mostafa Y, Mah-moud el-HM, Amr M. Evaluation of tramadol on demand vs. daily paroxetine as a long-term treat-ment of lifelong premature ejaculation. J Sex Med. 2010;7(8):2860-7.
Eid MA, Ahmed HH, Ismail NN, Shehaat SY. Comparative study between tramadol (50 mg) on demand and paroxetine HCl (20 mg) on demand in the treatment of premature ejaculation. Hum J Androl. 2011;1(2):69-73.
Powell JA, Wyllie MG. “Up and coming” treatments for premature ejaculation: progress towards an approved therapy. Int J Impot Res. 2009;21(2):107-15.
Journal of Reproduction & Infertility
Volume 19, Issue 1
Winter 2018
Pages 10-15