Effect of Topical Clove (Syzygium aromaticum (L.) Merr. & L.M.Perry) Gel on Premature Ejaculation: A Pilot Randomized Double-Blind Placebo-Controlled Clinical Trial
Abstract
Premature ejaculation is one of the most common sexual disorders worldwide without a satisfying treatment. In this study, we investigated the efficacy of a topical formulation of clove oil in premature ejaculation patients. Eligible patients were randomly divided into two groups to use either Syzygium aromaticum (SA) 1% gel or placebo gel 10 minutes before the intercourse for a period of 8 weeks. Outcome measurement were Premature Ejaculation Diagnostic Tool (PEDT) and International Index of Erectile Function (IIEF) questionnaires in addition to Intravaginal Ejaculation Latency Time (IELT). A total number of 22 (11 patients in each group) participants completed the study. At the end of the intervention, the IELT scores changed from 29.84 ± 18.59 to 97.09 ± 91.86 and 42.51 ± 13.98 to 52.45 ± 32.7 seconds in SA gel and placebo groups, respectively (p-value = 0.003). Also, the changes of PEDT scores in the SA gel group (from 14 ± 3.55 to 9.2 ± 4.56) comparing to that of placebo gel group (from 14.63 ± 3.61 to 13.5 ± 3.78) was significantly different (p-value =0.001). Moreover, results of IIEF questionnaire revealed significant improvement of “Intercourse Satisfaction” in SA gel group (p-value = 0.016). No adverse event was observed. It seems that SA gel could be beneficial in the treatment of premature ejaculation; however, it should be further evaluated in larger studies.
Sun Y, Yang L, Bao Y, Liu Z, Liu L et al. Efficacy of PDE5Is and SSRIs in men with premature ejaculation: a new systematic review and five meta-analyses. World J Urol 2017;35;1817-1831.
Jannini EA, Lenzi A. Epidemiology of premature ejaculation. Curr Opin Urol 2005;15:399-403.
Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW et al. An update of the International Society of Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation (PE). J Sex Med 2014;11;1392-1422.
Saitz TR, Serefoglu EC. The epidemiology of premature ejaculation. Transl Androl Urol 2016;5;409-415.
Quek K. Epidemiology of premature ejaculation and its impact on quality of life. Public Health Open Jornal 2017;2;64-69.
Kaplan BJ. Kaplan and sadock’s synopsis of psychiatry. Behavioral sciences/clinical psychiatry. Tijdschr Psychiatr 2016;58;78-79.
Jannini EA, McMahon CG, Waldinger MD. Premature Ejaculation: From Etiology to Diagnosis and Treatment. Springer. Milan 2012.
Lim PHC. Men's Health. Springer. London 2013.
Abdel-Hamid IA, Abdel-Razek MM, Anis T. Risks factors in premature ejaculation: The neurological risk factor and the local hypersensitivity. In: Premature Ejaculation. Ed, Jannini E, McMahon C, Waldinger M. Springer, Milano 2013;167-185.
Mohee A, Eardley I. Medical therapy for premature ejaculation. Ther Adv Urol 2011;3;211-222.
Giuliano F, Hellstrom WJ. The pharmacological treatment of premature ejaculation.
BJU Int 2008;102:668-675.
Ghaffari F, Naseri M, Movahhed M, Zargaran A. Spinal Traumas and their Treatments According to Avicenna's Canon of Medicine. World Neurosurg 2015;84:173-177.
Ghaffari F, Naseri M, Hajati RJ, Zargaran A. Rhazes, a pioneer in contribution to trials in medical practice. AMHA-Acta medico-historica Adriatica 2017;15:261-270.
Goshtasebi A, Mazari Z, Gandevani SB, Naseri M. Anti-hemorrhagic activity of Punica granatum L. flower (Persian Golnar) against heavy menstrual bleeding of endometrial origin: a double-blind, randomized controlled trial. Medical journal of the Islamic Republic of Iran. 2015;29:199.
Mozaffarpur SA, Naseri M, Kamalinejad M, Shams MA, Memariani Z et al. Nine steps to discover new medicines from traditional sources: the example of persian medicine. J Altern Complement Med 2020;26;365-368.
Sharifi AR, Homayounfar A, Mosavat SH, Heydari M, Naseri M. Premature ejaculation and its remedies in medieval Persia. Urology 2016;90;225-228.
Alavi S. Makhzan Al-adviyah (The Storehouse of Medicaments). Intisharat va Amoozesh Enghelab. Tehran 2009.
Heravi A. Alabnie an Haghaegh ol Advieh (The book of remedies). Tehran University Press. Tehran 1992.
Chaieb K, Hajlaoui H, Zmantar T, Kahla-Nakbi AB, Rouabhia M et al. The chemical composition and biological activity of clove essential oil, Eugenia caryophyllata (Syzigium aromaticum L. Myrtaceae): a short review. Phytother Res 2007;21;501-506.
Singh J, Baghotia A, Goel S. Eugenia caryophyllata Thunberg (family myrtaceae): a review. International Journal of Research in Pharmaceutical and Biomedical Sciences 2012;3;1469-1475.
Gruenwald J, Brendler T, Jaenicke C. Physician’s desk reference (PDR) for herbal medicines. Medical Economics Company. New Jersey 2000.
Ahmad S, Latif A, Qasmi IA. Effect of 50% ethanolic extract of Syzygium aromaticum (L.) Merr. & Perry.(clove) on sexual behaviour of normal male rats. BMC Complement Altern Med 2004;4;1-7.
Yilmaz Oral D, Onder A, Gur S, Carbonell Barrachina AA, Kaya Sezginer E et al. The beneficial effect of clove essential oil and its major component, eugenol, on erectile function in diabetic rats. Andrologia 2020;52:e13606.
Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, et al. Development and Validation of a Premature Ejaculation Diagnostic Tool. Eur Urol 2007;52;565-573.
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49;822-830.
Pakpour AH, Zeidi IM, Yekaninejad MS, Burri A. Validation of a translated and culturally adapted Iranian version of the International Index of Erectile Function. J Sex Marital Ther 2014;40;541-551.
Waldinger MD, Quinn P, Dilleen M, Mundayat R, Schweitzer DH et al. Ejaculation disorders: A multinational population survey of intravaginal ejaculation latency time. J Sex Med 2005;2;492-497.
Pozzi E, Belladelli F, Bebi C, Salonia A, Boeri L. Topical Treatment of Premature Ejaculation: The Rise of Anesthetic Spray Formulations? Uro 2021;1:30-38.
Quarto G, Castaldo L, Grimaldi G, Izzo A, Muscariello R et al. Observational study on the effects of a topical formulation in patients with premature ejaculation. Arch Ital Urol Androl 2020;92.
Moosavi-Asil SH, Ahmadian-Attari MM, Shirzad M, Yekaninejad MS, Nikoobakht MR et al. Effect of a topical polyherbal formulation for premature ejaculation: A randomized triple-blind placebo-controlled trial. Adv Integr Med 2020; In Press.
Kamatou GP, Vermaak I, Viljoen AM. Eugenol-from the remote Maluku Islands to the international market place: a review of a remarkable and versatile molecule. Molecules 2012;17;6953-6981.
Kamkar Asl M, Nazariborun A, Hosseini M. Analgesic effect of the aqueous and ethanolic extracts of clove. Avicenna J Phytomed 2013;3;186-192.
Riella K, Marinho R, Santos J, Pereira-Filho R, Cardoso J et al. Anti-inflammatory and cicatrizing activities of thymol, a monoterpene of the essential oil from Lippia gracilis, in rodents. J Ethnopharmacol 2012;143;656-663.
Bianchini AE, Garlet QI, da Cunha JA, Bandeira G, Brusque ICM et al. Monoterpenoids (thymol, carvacrol and S-(+)-linalool) with anesthetic activity in silver catfish (Rhamdia quelen): evaluation of acetylcholinesterase and GABAergic activity. Braz J Med Biol Res 2017;e6346.
Fachini-Queiroz FC, Kummer R, Estevão-Silva CF, Carvalho MDdB, Cunha JM et al. Effects of thymol and carvacrol, constituents of thymus vulgaris L. essential oil, on the Inflammatory Response. Evid Based Complement Alternat Med 2012;2012;657026.
Xin W, Huang C, Zhang X, Xin S, Zhou Y et al. Methyl salicylate lactoside inhibits inflammatory response of fibroblast-like synoviocytes and joint destruction in collagen-induced arthritis in mice. Br J Pharmacol 2014;171;3526-3538.
Files | ||
Issue | Vol 6, No 3, 2021 | |
Section | Research Article(s) | |
DOI | https://doi.org/10.18502/tim.v6i3.7312 | |
Keywords | ||
Clove Eugenia caryophyllata Thunb Integrative medicine Premature ejaculation Persian medicine Randomized controlled trial Syzygium aromaticum Urology Sexual disorders |
Rights and permissions | |
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |