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Meta-Analysis
. 2021 Mar 21;3(3):CD012799.
doi: 10.1002/14651858.CD012799.pub2.

Selective serotonin re-uptake inhibitors for premature ejaculation in adult men

Niranjan J Sathianathen  1 , Eu Chang Hwang  2 , Ruma Mian  1 , Joshua A Bodie  1 , Ayman Soubra  1   3 , Jennifer A Lyon  4 , Shahnaz Sultan  5 , Philipp Dahm  3
Affiliations
Meta-Analysis

Selective serotonin re-uptake inhibitors for premature ejaculation in adult men

Niranjan J Sathianathen et al. Cochrane Database Syst Rev. .

Abstract

Background: Premature ejaculation (PE) is a common problem among men that occurs when ejaculation happens sooner than a man or his partner would like during sex; it may cause unhappiness and relationship problems. Selective serotonin re-uptake inhibitors (SSRIs), which are most commonly used as antidepressants are being used to treat this condition.

Objectives: To assess the effects of SSRIs in the treatment of PE in adult men.

Search methods: We performed a comprehensive search using multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, CINAHL), clinical trial registries, conference proceedings, and other sources of grey literature, up to 1 May 2020. We applied no restrictions on publication language or status.

Selection criteria: We included only randomized controlled clinical trials (parallel group and cross-over trials) in which men with PE were administered SSRIs or placebo. We also considered 'no treatment' to be an eligible comparator but did not find any relevant studies.

Data collection and analysis: Two review authors independently classified and abstracted data from the included studies. Primary outcomes were participant-perceived change with treatment, satisfaction with intercourse and study withdrawal due to adverse events. Secondary outcomes included self-perceived control over ejaculation, participant distress about PE, adverse events and intravaginal ejaculatory latency time (IELT). We performed statistical analyses using a random-effects model. We rated the certainty of evidence according to GRADE.

Main results: We identified 31 studies in which 8254 participants were randomized to receiving either SSRIs or placebo. Primary outcomes: SSRI treatment probably improves self-perceived PE symptoms (defined as a rating of 'better' or 'much better') compared to placebo (risk ratio (RR) 1.92, 95% confidence interval (CI) 1.66 to 2.23; moderate-certainty evidence). Based on 220 participants per 1000 reporting improvement with placebo, this corresponds to 202 more men per 1000 (95% CI 145 more to 270 more) with improved symptoms with SSRIs. SSRI treatment probably improves satisfaction with intercourse compared to placebo (defined as a rating of 'good' or 'very good'; RR 1.63, 95% CI 1.42 to 1.87; moderate-certainty evidence). Based on 278 participants per 1000 reporting improved satisfaction with placebo, this corresponds to 175 more (117 more to 242 more) per 1000 men with greater satisfaction with intercourse with SSRIs. SSRI treatment may increase treatment cessations due to adverse events compared to placebo (RR 3.80, 95% CI 2.61 to 5.51; low-certainty evidence). Based 11 study withdrawals per 1000 participants with placebo, this corresponds to 30 more men per 1000 (95% CI 17 more to 49 more) ceasing treatment due to adverse events with SSRIs. Secondary outcomes: SSRI treatment likely improve participants' self-perceived control over ejaculation (defined as rating of 'good' or 'very good') compared to placebo (RR 2.29, 95% CI 1.72 to 3.05; moderate-certainty evidence). Assuming 132 per 1000 participants perceived at least good control, this corresponds to 170 more (95 more to 270 more) reporting at least good control with SSRIs. SSRI probably lessens distress (defined as rating of 'a little bit' or 'not at all') about PE (RR 1.54, 95% CI 1.26 to 1.88; moderate-certainty evidence). Based on 353 per 1000 participants reporting low levels of distress, this corresponds to 191 more men (92 more to 311 more) per 1000 reporting low levels of distress with SSRIs. SSRI treatment probably increases adverse events compared to placebo (RR 1.71, 95% CI 1.48 to 1.99; moderate-certainty evidence). Based on 243 adverse events per 1000 among men receiving placebo, this corresponds to 173 more (117 more to 241 more) men having an adverse event with SSRIs. SSRI treatment may increase IELT compared to placebo (mean difference (MD) 3.09 minutes longer, 95% CI 1.94 longer to 4.25 longer; low-certainty evidence).

Authors' conclusions: SSRI treatment for PE appears to substantially improve a number of outcomes of direct patient importance such as symptom improvement, satisfaction with intercourse and perceived control over ejaculation when compared to placebo. Undesirable effects are a small increase in treatment withdrawals due to adverse events as well as substantially increased adverse event rates. Issues affecting the certainty of evidence of outcomes were study limitations and imprecision.

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Conflict of interest statement

  1. NS: none.

  2. ECH: none.

  3. RM: none.

  4. JB: none.

  5. AS: none.

  6. JL: none.

  7. SS: none.

  8. PD: none.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgments about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 SSRI versus placebo, outcome: 1.1 Participant perception of change with treatment.
5
5
Forest plot of comparison: 1 SSRI versus placebo, outcome: 1.2 Participant satisfaction with intercourse.
6
6
Forest plot of comparison: 1 SSRI versus placebo, outcome: 1.3 Study withdrawal due to adverse events.
1.1
1.1. Analysis
Comparison 1: SSRI versus placebo, Outcome 1: Participant perception of change with treatment
1.2
1.2. Analysis
Comparison 1: SSRI versus placebo, Outcome 2: Participant satisfaction with intercourse
1.3
1.3. Analysis
Comparison 1: SSRI versus placebo, Outcome 3: Study withdrawal due to adverse events
1.4
1.4. Analysis
Comparison 1: SSRI versus placebo, Outcome 4: Perceived control over ejaculation
1.5
1.5. Analysis
Comparison 1: SSRI versus placebo, Outcome 5: Participant distress about PE
1.6
1.6. Analysis
Comparison 1: SSRI versus placebo, Outcome 6: Relationship difficulties
1.7
1.7. Analysis
Comparison 1: SSRI versus placebo, Outcome 7: Adverse events
1.8
1.8. Analysis
Comparison 1: SSRI versus placebo, Outcome 8: Intravaginal ejaculatory latency time
1.9
1.9. Analysis
Comparison 1: SSRI versus placebo, Outcome 9: Depression
2.1
2.1. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 1: Participant perception of change with treatment
2.2
2.2. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 2: Participant satisfaction with intercourse
2.3
2.3. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 3: Study withdrawal due to adverse events
2.4
2.4. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 4: Perceived control over ejaculation
2.5
2.5. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 5: Participant distress about PE
2.6
2.6. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 6: Relationship difficulties
2.7
2.7. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 7: Adverse events
2.8
2.8. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 8: Intravaginal ejaculatory latency time
2.9
2.9. Analysis
Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 9: Depression
3.1
3.1. Analysis
Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 1: Participant perception of change with treatment
3.2
3.2. Analysis
Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 2: Study withdrawal due to adverse events
3.3
3.3. Analysis
Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 3: Adverse events
3.4
3.4. Analysis
Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 4: Intravaginal ejaculatory latency time
3.5
3.5. Analysis
Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 5: Depression
4.1
4.1. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 1: Participant perception of change with treatment
4.2
4.2. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 2: Participant satisfaction with intercourse
4.3
4.3. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 3: Study withdrawal due to adverse events
4.4
4.4. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 4: Perceived control over ejaculation
4.5
4.5. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 5: Participant distress about PE
4.6
4.6. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 6: Relationship difficulties
4.7
4.7. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 7: Adverse events
4.8
4.8. Analysis
Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 8: Intravaginal ejaculatory latency time
5.1
5.1. Analysis
Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 1: Study withdrawal due to adverse events
5.2
5.2. Analysis
Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 2: Adverse events
5.3
5.3. Analysis
Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 3: Intravaginal ejaculatory latency time
5.4
5.4. Analysis
Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 4: Depression
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    1. Lee W K, Lee S H, Cho S T, Lee Y S, Oh C Y, Yoo C, Cho J S, Lee S K, Yang D Y. Comparison between on-demand dosing of dapoxetine alone and dapoxetine plus mirodenafil in patients with lifelong premature ejaculation: prospective, randomized, double-blind, placebo-controlled, multicenter study. J Sex Med 2013;10(11):2832-41. - PubMed
Li 2015 {published data only}
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Luigi 2012 {published data only}
    1. Luigi P A, Giovanni P, Luigi S, Antonino L, Domenico A, Andrea R, Antonio C. A prospective randomized study to compare pelvic floor muscle rehabilitation and dapoxetine for treatment of lifelong premature ejaculation. Neurourology and Urodynamics 2012;31:S36-S37.
Manasia 2003 {published data only}
    1. Manasia P, Pomerol J, Ribe N, Gutierrez del Pozo R, Alcover Garcia J. Comparison of the efficacy and safety of 90 mg versus 20 mg fluoxetine in the treatment of premature ejaculation. The Journal of Urology 2003;170(1):164-5. - PubMed
Mathers 2009 {published data only}
    1. Mathers M J, Klotz T, Roth S, Lummen G, Sommer F. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study. Andrologia 2009;41(3):169-75. - PubMed
McMahon 2002 {published data only}
    1. McMahon CG. Long term results of treatment of premature ejaculation with selective serotonin re-uptake inhibitors. Int J Impot Res 2002;14:3.
McMahon 2007 {published data only}
    1. McMahon C. Dapoxetine in the treatment of premature ejaculation. Clinical Neuropharmacology 2007;30(5):314-315. - PubMed
McMahon 2010a {published data only}
    1. McMahon C G, Kim S W, Park N C, Chang C P, Rivas D, Tesfaye F, Rothman M, Aquilina J W. Improvements in intravaginal ejaculatory latency time (IELT) and patient-reported outcomes (PROS) in dapoxetine-treated men from the Asia-Pacific region with lifelong or acquired premature ejaculation (PE). Journal of Sexual Medicine 2010;7:177. - PubMed
McMahon 2010b {published data only}
    1. McMahon C G, Kim S W, Park N C, Chang C P, Rivas D, Tesfaye F, Rothman M, Aquilina J W. Comparison of baseline characteristics of men with lifelong and acquired premature ejaculation (PE) in the Asia-Pacific region. Journal of Sexual Medicine 2010;7:176. - PubMed
McMahon 2016 {published data only}
    1. McMahon C, Lee S W, Kim S W, Moon du G, Kongkanand A, Tantiwongse K. The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study. Sexual Medicine 2016;4(1):e18-27. - PMC - PubMed
Mostafa 2017 {published data only}
    1. Mostafa R, Hassan M, NasrAlla Y, Mohammed R, Naguib N. A comparative study between two different doses of dapoxetine and a single dose of paroxetine on demand in the treatment of cases of premature ejaculation. Journal of Sexual Medicine 2017;14(1):S129.
Murat 1999 {published data only}
    1. Murat Basar M, Atan A, Yildiz M, Baykam M, Aydoganli L. Comparison of sertraline to fluoxetine with regard to their efficacy and side effects in the treatment of premature ejaculation. Archivos espanoles de urologia 1999;52(9):1008-11. - PubMed
Nada 2009 {published data only}
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Nada 2012 {published data only}
    1. Nada E, Saleh R, Ali M, Azab H. A comparison between citalopram and escitalopram in treatment of patients with premature ejaculation: a double-blind controlled clinical study. Journal of Sexual Medicine 2012;9:261-2.
Okulu 2013 {published data only}
    1. Okulu E, Ener K, Aldemir M, Aǧras K, Fuat Özcan M, Kayigil O. Comparison of efficacy of sertralin on patients with premature ejaculation by penile biothesiometry. Journal of Clinical and Analytical Medicine 2013;4(4):302-306.
Otunctemur 2014 {published data only}
    1. Otunctemur A, Ozbek E, Kirecci SL, Ozcan L, Dursun M, Cekmen M, et al. Relevance of serum nitric oxide levels and the efficacy of selective serotonin reuptake inhibitors treatment on premature ejaculation: decreased nitric oxide is associated with premature ejaculation. Andrologia 2014;46(9):951-5. - PubMed
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    1. Ozcan L, Polat E C, Otunctemur A, Ozbek E. Duloxetine, dual serotonin and norepinephrine reuptake inhibitor, versus paroxetine, selective serotonin reuptake inhibitor, in the treatment for premature ejaculation. International urology and nephrology 2015;47(2):283-7. - PubMed
Pastore 2011 {published data only}
    1. Pastore Al, Palleschi G, Silvestri L, Ripoli A, Autieri D, Leto A, Carbone A. Premature ejaculation: A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine, a novel selective serotonin reuptake inhibitor. Journal of sexual medicine 2011;8:374.
Pastore 2012 {published data only}
    1. Pastore Al, Palleschi G, Leto A, Iori F, Leonardo C, Petrozza V, Pacini L, Carbone A. Premature ejaculation: A prospective randomized study to compare pelvic floor rehabilitation and dapoxetine, a novel selective serotonin reuptake inhibitor. European Urology Supplements 2012;11(1):e696-e696a. - PubMed
Polat 2015 {published data only}
    1. Polat E C, Ozbek E, Otunctemur A, Ozcan L, Simsek A. Combination therapy with selective serotonin reuptake inhibitors and phosphodiesterase-5 inhibitors in the treatment of premature ejaculation. Andrologia 2015;47(5):487-92. - PubMed
Rezakhaniha 2010 {published data only}
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Rezakhaniha 2014 {published data only}
    1. Rezakhaniha B, Siroosbakhat S. Comparative study of therapeutic effects of two medicinal procedures of citalopram in premature ejaculation. Biosciences Biotechnology Research Asia 2014;11(2):953-958.
Rivera 2005 {published data only}
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Safarinejad 2008a {published data only}
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Sahin 2016 {published data only}
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Sahin 2016a {published data only}
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Salokangas 2006 {published data only}
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Sanzovo 2011 {published data only}
    1. Sanzovo S, Prior M, Bianchin G L, Rosso C, Furlan P M. Premature ejaculation therapies: Randomized controlled experimental study escitalopram vs. cognitive behavioural therapy. Gazzetta Medica Italiana Archivio per le Scienze Mediche 2011;170(2):129-134.
Schmidt 2001 {published data only}
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Shang 2010 {published data only}
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Shao 2008 {published data only}
    1. Shao X, Li J. Clinical study on treatment of premature ejaculation with Paroxetine and behavior-therapy. Chinese Journal of Andrology 2008;22(1):18-20.
Shin 2017 {published data only}
    1. Shin D, Lee S, Yi S, Yoon S H, Cho J Y, Bahng M Y, Jang I J, Yu K S. Pharmacokinetics and tolerability of DA-8031, a novel selective serotonin reuptake inhibitor for premature ejaculation in healthy male subjects. Drug Des Devel Ther 2017;11:713-723. - PMC - PubMed
Sun 2004 {published data only}
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Sun 2007 {published data only}
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Sun 2010 {published data only}
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Sunay 2011 {published data only}
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Swartz 1994 {published data only}
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Vella 2015 {published data only}
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Waldinger 1997 {published data only}
    1. Waldinger MD, Hengeveld MW, Zwinderman AH. Ejaculation-retarding properties of paroxetine in patients with primary premature ejaculation: a double-blind, randomized, dose-response study. British Journal of Urology 1997;79(4):592-5. - PubMed
Waldinger 2000 {published data only}
    1. Waldinger M D, Olivier B. Selective serotonin reuptake inhibitors (SSRIs) and sexual side effects: Differences in delaying ejaculation. Advances in Preclinical and Clinical Psychiatry, 2000;1:117-130.
Waldinger 2001 {published data only}
    1. Waldinger M D, Zwinderman A H, Olivier B. Antidepressants and ejaculation: a double-blind, randomized, placebo-controlled, fixed-dose study with paroxetine, sertraline, and nefazodone. J Clin Psychopharmacol 2001;21(3):293-7. - PubMed
Waldinger 2001a {published data only}
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Waldinger 2001b {published data only}
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Waldinger 2003 {published data only}
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Waldinger 2004b {published data only}
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Waldinger 2006b {published data only}
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Weixing 2012 {published data only}
    1. Weixing Z, Junchang Q, Rui W, Lei W, Jie Z. Effect evaluation of Paroxetine and Sertraline in the treatment of premature ejaculation. Chinese Journal of Andrology 2012;26(1):41-43.
Xu 2014 {published data only}
    1. Xu G, Jiang H W, Fang J, Wen H, Gu B, Liu J, Zhang L M, Ding Q, Zhang Y F. An improved dosage regimen of sertraline hydrochloride in the treatment for premature ejaculation: an 8-week, single-blind, randomized controlled study followed by a 4-week, open-label extension study. Journal of clinical pharmacy and therapeutics 2014;39(1):84-90. - PubMed
Yang 2015 {published data only}
    1. Yang L, Luo L, Chen X F, Fan J H, Liu R M, Wang X N, Nan X Y, Zhang Y, Lin X F, Wang M Z, Xing J P, Yang Z S, Jian B L, He H, Wu D P, He D L. Efficacy and tolerability of dapoxetine in the treatment of premature ejaculation. Journal of Sexual Medicine 2015;21(10):892-5. - PubMed
Yang 2016 {published data only}
    1. Yang L, Chen X, He D. Efficacy and tolerability of dapoxetine and sertraline for the treatment of chinese patients with premature ejaculation. Journal of Sexual Medicine 2016;13(5):S79.
Yang 2017 {published data only}
    1. Yang L, Chen XF, He DL. Efficacy and tolerability of dapoxetine and sertraline for the treatment of Chinese patients with premature ejaculation. Journal of Sexual Medicine 2017;14(1):S17.
Yang 2017a {published data only}
    1. Yang L, Chen X F, He D L. Efficacy and tolerability of dapoxetine and sertraline for the treatment of Chinese patients with premature ejaculation. Journal of Sexual Medicine 2017;14(1):S17.
Yuan 2008 {published data only}
    1. Yuan P, Dai J, Yang Y, Guo J, Liang R. A comparative study on treatment for premature ejaculation: citalopram used in combination with behavioral therapy versus either Citalopram or behavioral therapy alone. Chinese journal of andrology 2008;22(5):35-38.
Zhang 2005 {published data only}
    1. Zhang X S, Wang Y X, Huang X Y, Leng J, Li Z, Han Y F. [Comparison between sildenafil plus sertraline and sertraline alone in the treatment of premature ejaculation]. Zhonghua Nan Ke Xue 2005;11(7):520-2. - PubMed
Zhu 2015 {published data only}
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References to studies awaiting assessment

Kolomazník 2002 {published data only}
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References to other published versions of this review

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