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

Niranjan J Sathianathen; Eu Chang Hwang; Ruma Mian; Joshua A Bodie; Ayman Soubra; Jennifer A Lyon; Shahnaz Sultan; Philipp Dahm

doi:10.1002/14651858.CD012799.pub2

Cochrane Database of Systematic Reviews

Inhibidores selectivos de la recaptación de serotonina para la eyaculación precoz en hombres adultos

Información

DOI:

https://doi.org/10.1002/14651858.CD012799.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

21 marzo 2021see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Urología

Copyright:

Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

Niranjan J Sathianathen

Correspondencia a: Department of Urology, University of Minnesota, Minneapolis, USA

[email protected]
Eu Chang Hwang

Department of Urology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun, Korea, South
Ruma Mian

Department of Urology, University of Minnesota, Minneapolis, USA
Joshua A Bodie

Department of Urology, University of Minnesota, Minneapolis, USA
Ayman Soubra

Department of Urology, University of Minnesota, Minneapolis, USA

Urology Section, Minneapolis VA Health Care System, Minneapolis, USA
Jennifer A Lyon

Library Services, Children's Mercy Hospital, Kansas City, USA
Shahnaz Sultan

Gastroenterology Section III-D, Minneapolis VA Health Care System, Minneapolis, USA
Philipp Dahm

Urology Section, Minneapolis VA Health Care System, Minneapolis, USA

Contributions of authors

NS: screened studies; performed full‐text review, data extraction and data analysis; and wrote the review.
ECH: screened studies; performed full‐text review, data extraction and data analysis; and revised the review.
RM: drafted the first version of the protocol; screened studies; performed full‐text review, data extraction and data analysis; and revised the review.
JB: provided clinical content expertise, reviewed and revised the protocol/review.
AS: provided clinical content expertise, reviewed and revised the protocol/review.
JL: developed the search strategies; performed and updated the search; and revised the protocol/review.
SS: provided methodologic expertise, reviewed and revised the protocol/review.
PD: provided guidance and oversight; screened studies; performed full‐text review, data extraction and data analysis; and revised the protocol/review.

Sources of support

Internal sources

Minneapolis VAMC, USA

Salary support for Philipp Dahm, Ayman Soubra, and Shahnaz Sultan
University of Minnesota, USA

Salary support for Niranjan Sathianathen, Joshua Bodie and Ayman Soubra

External sources

None, USA

N/A

Declarations of interest

NS: none.
ECH: none.
RM: none.
JB: none.
AS: none.
JL: none.
SS: none.
PD: none.

Acknowledgements

We thank Cochrane Urology for its support. We are grateful to Dr Yu Xie for translating articles. We are also appreciative of the feedback provided by Dr Josip Vukina, MD, MPH (University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA) and Dr Ege Can Serefoglu, MD, FECSM (Professor of Urology, Biruni University School of Medicine, Istanbul, Turkey; Editor‐in‐Chief, International Journal of Impotence Research, London, UK) who served as peer referees.

Version history

Published

Title

Stage

Authors

Version

2021 Mar 21

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

Review

Niranjan J Sathianathen, Eu Chang Hwang, Ruma Mian, Joshua A Bodie, Ayman Soubra, Jennifer A Lyon, Shahnaz Sultan, Philipp Dahm

https://doi.org/10.1002/14651858.CD012799.pub2

2017 Sep 18

Selective serotonin re‐uptake inhibitors for premature ejaculation

Protocol

Ruma Mian, Joshua A Bodie, Ayman Soubra, Jennifer A Lyon, Shahnaz Sultan, Philipp Dahm

https://doi.org/10.1002/14651858.CD012799

Differences between protocol and review

This review is based on a published protocol (Mian 2017) but there are two additional authors to this review: Dr Niranjan J Sathianathen and Dr Eu Chang Hwang.

Notes

We have based parts of the Methods and Appendix 2 sections of this Cochrane Review on a standard template established by the Cochrane Metabolic and Endocrine Disorders Group.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Adult; Humans; Male; Middle Aged; Young Adult;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgments about each risk of bias item for each included study.

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Figure 4

Forest plot of comparison: 1 SSRI versus placebo, outcome: 1.1 Participant perception of change with treatment.

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Figure 5

Forest plot of comparison: 1 SSRI versus placebo, outcome: 1.2 Participant satisfaction with intercourse.

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Figure 6

Forest plot of comparison: 1 SSRI versus placebo, outcome: 1.3 Study withdrawal due to adverse events.

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Analysis 1.1

Comparison 1: SSRI versus placebo, Outcome 1: Participant perception of change with treatment

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Analysis 1.2

Comparison 1: SSRI versus placebo, Outcome 2: Participant satisfaction with intercourse

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Analysis 1.3

Comparison 1: SSRI versus placebo, Outcome 3: Study withdrawal due to adverse events

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Analysis 1.4

Comparison 1: SSRI versus placebo, Outcome 4: Perceived control over ejaculation

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Analysis 1.5

Comparison 1: SSRI versus placebo, Outcome 5: Participant distress about PE

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Analysis 1.6

Comparison 1: SSRI versus placebo, Outcome 6: Relationship difficulties

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Analysis 1.7

Comparison 1: SSRI versus placebo, Outcome 7: Adverse events

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Analysis 1.8

Comparison 1: SSRI versus placebo, Outcome 8: Intravaginal ejaculatory latency time

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Analysis 1.9

Comparison 1: SSRI versus placebo, Outcome 9: Depression

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Analysis 2.1

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 1: Participant perception of change with treatment

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Analysis 2.2

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 2: Participant satisfaction with intercourse

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Analysis 2.3

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 3: Study withdrawal due to adverse events

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Analysis 2.4

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 4: Perceived control over ejaculation

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Analysis 2.5

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 5: Participant distress about PE

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Analysis 2.6

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 6: Relationship difficulties

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Analysis 2.7

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 7: Adverse events

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Analysis 2.8

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 8: Intravaginal ejaculatory latency time

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Analysis 2.9

Comparison 2: Subgroup analysis: long‐acting versus short‐acting SSRI, Outcome 9: Depression

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Analysis 3.1

Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 1: Participant perception of change with treatment

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Analysis 3.2

Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 2: Study withdrawal due to adverse events

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Analysis 3.3

Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 3: Adverse events

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Analysis 3.4

Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 4: Intravaginal ejaculatory latency time

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Analysis 3.5

Comparison 3: Subgroup analysis: comparison of long‐acting agents, Outcome 5: Depression

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Analysis 4.1

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 1: Participant perception of change with treatment

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Analysis 4.2

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 2: Participant satisfaction with intercourse

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Analysis 4.3

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 3: Study withdrawal due to adverse events

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Analysis 4.4

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 4: Perceived control over ejaculation

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Analysis 4.5

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 5: Participant distress about PE

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Analysis 4.6

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 6: Relationship difficulties

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Analysis 4.7

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 7: Adverse events

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Analysis 4.8

Comparison 4: Subgroup analysis: different doses of dapoxetine, Outcome 8: Intravaginal ejaculatory latency time

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Analysis 5.1

Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 1: Study withdrawal due to adverse events

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Analysis 5.2

Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 2: Adverse events

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Analysis 5.3

Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 3: Intravaginal ejaculatory latency time

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Analysis 5.4

Comparison 5: Subgroup analysis: different doses of fluoxetine, Outcome 4: Depression

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Summary of findings 1. SSRI compared to placebo for premature ejaculation

Outcomes	№ of participants (studies)	Certainty of the evidence (GRADE)	Relative effect (95% CI)	*Anticipated absolute effects (95% CI)**		What happens
SSRI compared to placebo for premature ejaculation in adult men
Patient or population: adult men with premature ejaculation Setting: outpatient Intervention: SSRI Comparison: placebo
Outcomes	№ of participants (studies)	Certainty of the evidence (GRADE)	Relative effect (95% CI)	Risk with placebo	Risk difference with SSRI	What happens
Participant perception of change with treatment assessed with: Clinical Global Impression of Change questionnaire (event is good as it represents improvement in symptoms)	3260 (6 RCTs)	⊕⊕⊕⊝ Moderate^a	RR 1.92 (1.66 to 2.23)	Study population		SSRI probably results in perceived improvement compared to placebo.
	3260 (6 RCTs)	⊕⊕⊕⊝ Moderate^a	RR 1.92 (1.66 to 2.23)	220 per 1000	202 more per 1000 (145 more to 270 more)
Participant satisfaction with intercourse assessed with: Premature Ejaculation Profile questionnaire (event is good as it represents increased satisfaction)	4273 (3 RCTs)	⊕⊕⊕⊝ Moderate^a,b	RR 1.63 (1.42 to 1.87)	Study population		SSRI probably results in improved satisfaction with intercourse compared to placebo.
	4273 (3 RCTs)	⊕⊕⊕⊝ Moderate^a,b	RR 1.63 (1.42 to 1.87)	278 per 1000	175 more per 1000 (117 more to 242 more)
Study withdrawal due to adverse events	7367 (20 RCTs)	⊕⊕⊝⊝ Low^a,c	RR 3.80 (2.61 to 5.51)	Study population		SSRI may result in more withdrawals due to adverse events compared to placebo.
Study withdrawal due to adverse events	7367 (20 RCTs)	⊕⊕⊝⊝ Low^a,c	RR 3.80 (2.61 to 5.51)	11 per 1000	30 more per 1000 (17 more to 49 more)
Perceived control over ejaculation assessed with: Premature Ejaculation Profile questionnaire (event is good as it represents increased control over ejaculation)	4273 (3 RCTs)	⊕⊕⊕⊝ Moderate^a	RR 2.29 (1.72 to 3.05)	Study population		SSRI probably results in improved perceived control over ejaculation compared to placebo.
	4273 (3 RCTs)	⊕⊕⊕⊝ Moderate^a	RR 2.29 (1.72 to 3.05)	132 per 1000	170 more per 1000 (95 more to 270 more)
Participant distress about PE assessed with: Premature Ejaculation Profile questionnaire (event is good as it represents less distress)	652 (1 RCT)	⊕⊕⊕⊝ Moderate^a	RR 1.54 (1.26 to 1.88)	Study population		SSRI probably results in increased numbers of men not distressed about PE compared to placebo.
	652 (1 RCT)	⊕⊕⊕⊝ Moderate^a	RR 1.54 (1.26 to 1.88)	353 per 1000	191 more per 1000 (92 more to 311 more)
Adverse events	4624 (17 RCTs)	⊕⊕⊕⊝ Moderate^a	RR 1.71 (1.48 to 1.99)	Study population		SSRI probably results in increased adverse events compared to placebo.
Adverse events	4624 (17 RCTs)	⊕⊕⊕⊝ Moderate^a	RR 1.71 (1.48 to 1.99)	243 per 1000	173 more per 1000 (117 more to 241 more)
IELT	5872 (20 RCTs)	⊕⊕⊝⊝ Low^a,d	—	The mean IELT was 1.41 minutes	MD 3.09 minutes higher (1.94 higher to 4.25 higher)	SSRI probably results in extended IELT compared to placebo.
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; IELT: intravaginal ejaculatory latency time; MD: mean difference; PE: premature ejaculate; RCT: randomized controlled trial; RR: risk ratio; SSRI: selective serotonin reuptake inhibitor.
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aDowngraded one level for study limitations: most studies had an unclear or high risk of selection, performance and detection bias. ^bNot downgraded for high I² statistic since observed inconsistency did not appear clinically relevant. ^cDowngraded one level due to serious concerns regarding attrition bias. ^dDowngraded one level for serious inconsistency.

Summary of findings 1. SSRI compared to placebo for premature ejaculation

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Table 1. Description of the interventions

Study	Intervention(s) (route, frequency, total dose/day)	Comparator(s) (route, frequency, total dose/day)
Ahn 1996	I1: fluoxetine 20 mg daily for first 1 week and 40 mg daily for remaining 5 weeks after breakfast	C1: placebo daily
Athanasios 2007	I1: duloxetine 20 mg daily for 1 week followed by 40 mg daily	C1: placebo daily
Atmaca 2002	I1: citalopram 20 mg daily up to 60 mg	C1: placebo daily up to 3 tablets
Biri 1998	I1: sertraline 50 mg daily	C1: placebo daily
Buvat 2009	I1: dapoxetine 30 mg on‐demand I2: dapoxetine 60 mg on‐demand	C1: placebo daily C2: placebo daily
Farnia 2009	I1: citalopram 20 mg on‐demand	C1: placebo on‐demand
Gameel 2013	I1: paroxetine 20 mg on‐demand + lubricating jelly	C1: placebo on‐demand + lubricating jelly
Gong 2011	I1: paroxetine 20 mg daily	C1: placebo
Hamidi Madani 2016	I1: tramadol 50 mg I2: paroxetine 20 mg	C1: placebo daily
Kara 1996	I1: fluoxetine 20 mg daily	C1: placebo daily
Kaufman 2009	I1: dapoxetine 60 mg on‐demand	C1: placebo daily
Khelaia 2012	I1: paroxetine 20 mg I2: paroxetine 20 mg 2–3 hours before intercourse	C1: placebo daily
Kim 1998	I1: fluoxetine 40 mg daily for 1 week then 80 mg for 3 weeks I2: sertraline 100 mg for 1 week then 200 mg for 3 weeks	C1: placebo daily C2: placebo daily
Mattos 2008	I1: fluoxetine 90 mg daily I2: fluoxetine 90 mg daily + tadalafil 20 mg on‐demand	C1: placebo daily C2: placebo + tadalafil 20 mg on‐demand
McMahon 1998	I1: sertraline 50 mg daily	C1: placebo daily
McMahon 1999	I1: paroxetine 20 mg I2: paroxetine as needed 3–4 hours before planned sexual intercourse I3: paroxetine 10 mg for 3 weeks then 20 mg paroxetine as needed for 4 weeks	C1: placebo daily for 3 weeks then placebo daily for 4 weeks
McMahon 2010	I1: dapoxetine 30 mg daily I2: dapoxetine 60 mg daily	C1: placebo daily C2: placebo daily
McMahon 2013	I1: dapoxetine 30 mg on‐demand, from week 4 up to 60 mg if tolerated + PDE5 inhibitor	C1: placebo on‐demand + PDE5 inhibitor
Mendels 1995	I1: sertraline 50 mg daily that could be titrated up to 200 mg daily	C1: placebo daily
Na 1996	I1: sertraline 50 mg at night that could be titrated up to 100 mg daily	C1: placebo daily
Novaretti 2002	I1: fluoxetine 20 mg daily	C1: placebo daily
Pryor 2006	I1: dapoxetine 30 mg on‐demand I2: dapoxetine 60 mg on‐demand	C1: placebo on‐demand 1–3 hours before anticipated sexual activity
Safarinejad 2006b	I1: dapoxetine 60 mg daily I2: paroxetine 20 mg daily	C1: placebo daily
Safarinejad 2006c	I1: citalopram 20 mg daily	C1: placebo daily
Safarinejad 2007	I1: escitalopram 10 mg daily	C1: placebo daily
Safarinejad 2008	I1: dapoxetine 30 mg twice daily	C1: placebo twice daily
Shang 2012	I1: citalopram 20 mg daily	C1: placebo daily
Tuncel 2008	I1: sertraline 50 mg nightly for 2 months	C1: placebo daily for 2 months
Waldinger 1994	I1: paroxetine 20 mg daily for 1 week and then 40 mg daily from week 2–6	C1: placebo daily
Waldinger 1998	I1: fluoxetine 20 mg daily I2: fluvoxamine 100 mg daily I3: paroxetine 20 mg daily I4: sertraline 50 mg daily	C1: placebo daily
Yilmaz 1999	I1: fluoxetine 20 mg daily	C1: placebo daily
C: comparator; I: intervention; PDE5: phosphodiesterase‐5.

Table 1. Description of the interventions

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Table 2. Baseline characteristics

Study	Intervention(s) and comparator(s)	Duration of intervention	Trial period	Country	Setting	Age in years (mean)	Baseline IELT in minutes (mean)	Number of participants with primary/secondary PE
Ahn 1996	I1: fluoxetine 20 mg daily for first 1 week and 40 mg daily for remaining 5 weeks after breakfast C1: placebo daily	6 weeks	NR	South Korea	Outpatient	39.8 (range 34–48)	0.78 (range 0.17–2.0)	NA/NA
Ahn 1996		6 weeks	NR	South Korea	Outpatient	39.8 (range 34–48)	0.78 (range 0.17–2.0)	NA/NA
Athanasios 2007	I1: duloxetine 20 mg daily for 1 week followed by 40 mg daily C1: placebo daily	12 weeks	NR	Greece	Academic	31.35 (SD 8.23)	0.63 (SD 0.27)	NA/NA
Athanasios 2007		12 weeks	NR	Greece	Academic	32.65 (SD 7.49)	0.58 (SD 0.30)	NA/NA
Atmaca 2002	I1: citalopram 20 mg daily up to 60 mg C1: placebo daily	8 weeks	NR	Turkey	Outpatient	Range 24–46	0.55 (SD 0.29)	NA/NA
Atmaca 2002	I1: citalopram 20 mg daily up to 60 mg C1: placebo daily	8 weeks	NR	Turkey	Outpatient	Range 24–46	0.50 (SD 0.24)	NA/NA
Biri 1998	I1: sertraline 50 mg C1: placebo daily	4 weeks	1995–1997	Turkey	Outpatient	NR	0.68 (SD 0.21)	NA/NA
Biri 1998	I1: sertraline 50 mg C1: placebo daily	4 weeks	1995–1997	Turkey	Outpatient	NR	0.72 (SD 0.33)	NA/NA
Buvat 2009	I1: dapoxetine 30 mg on‐demand I2: dapoxetine 60 mg on‐demand C1: placebo daily	24 weeks	2004–2006	France	Academic	39.6 (SD 9.53)	0.9 (SD 0.50)	NA/NA
						40.5 (SD 9.62)	0.9 (SD 0.49)	NA/NA
						40.1 (SD 9.98)	0.9 (SD 0.51)	NA/NA
Farnia 2009	I1: citalopram 20 mg on‐demand C1: placebo daily	4 weeks	2006–2007	Iran	Outpatient	34.28 (SD 6.67)	1.11 (SD 0.61)	NA/NA
Farnia 2009	I1: citalopram 20 mg on‐demand C1: placebo daily	4 weeks	2006–2007	Iran	Outpatient	33.76 (SD 5.93)	1.10 (SD 0.56)	NA/NA
Gameel 2013	I1: paroxetine 20 mg on‐demand + lubricating jelly C1: placebo on‐demand + lubricating jelly	4 weeks	2009–2012	Egypt	Outpatient	NR	0.16 (SD 0.47)	NA/NA
Gong 2011	I1: paroxetine 20 mg daily C1: placebo daily	30 days	NR	China	likely outpatient	26.8 (SD 5.5)	0.89 (SD 0.21)	NA/NA
Gong 2011	I1: paroxetine 20 mg daily C1: placebo daily	30 days	NR	China	likely outpatient	29.2 (SD 6.7)	0.97 (SD 0.18)	NA/NA
Hamidi Madani 2016	I1: tramadol 50 mg I2: paroxetine 20 mg C1: placebo	12 weeks	NR	Iran	Outpatient	NR	NR	NA/NA
						NR	NR	NA/NA
						NR	NR	NA/NA
Kara 1996	I1: fluoxetine 20 mg daily C1: placebo daily	NR	NR	Turkey	Outpatient	Range 15–50	0.42 (SD 0.21)	NA/NA
Kara 1996	I1: fluoxetine 20 mg daily C1: placebo daily	NR	NR	Turkey	Outpatient	Range 15–50	0.5 (SD 0.14)	NA/NA
Kaufman 2009	I1: dapoxetine 60 mg on‐demand C1: placebo on‐demand	9 weeks	NR	USA and Canada	Outpatient	41.8 (SD 9.80)	NR	NA/NA
Kaufman 2009	I1: dapoxetine 60 mg on‐demand C1: placebo on‐demand	9 weeks	NR	USA and Canada	Outpatient	40.98 (SD 9.71)	NR	NA/NA
Khelaia 2012	I1: paroxetine 20 mg I2: paroxetine 20 mg 2–3 hours before intercourse C1: placebo	4 weeks	NR	Georgia	Academic	22.7 (range 19–39)	NR	NA/NA
						22.7 (range 19–39)	NR	NA/NA
						22.7 (range 19–39)	NR	NA/NA
Kim 1998	I1: fluoxetine 40 mg daily for 1 week then 80 mg for 3 weeks I2: sertraline 100 mg for 1 week then 200 mg for 3 weeks C1: placebo daily	16 weeks	NR	South Korea	Academic	44 (range 30–60)	0.77 (SD 0.68)	NA/NA
						44 (range 30–60)	0.77 (SD 0.68)	NA/NA
						44 (range 30–60)	0.77 (SD 0.68)	NA/NA
Mattos 2008	I1: fluoxetine 90 mg daily I2: fluoxetine 90 mg daily + tadalafil 20 mg on‐demand C1: placebo daily C2: placebo + tadalafil 20 mg on‐demand	12 weeks	NR	Brazil	Academic	50 (SD 8.51)	0.94 (SD 0.31)	NA/NA
						42.81 (SD 7.73)	0.83 (SD 0.43)	NA/NA
						45.93 (SD 9.96)	0.83 (SD 0.31)	NA/NA
						43.2 (SD 11.3)	0.83 (SD 0.32)	NA/NA
McMahon 1998	I1: sertraline 50 mg C1: placebo daily	12 weeks	NR	Australia	Academic	41 (range 19–70)	0.3	NA/NA
McMahon 1998	I1: sertraline 50 mg C1: placebo daily	12 weeks	NR	Australia	Academic	41 (range 19–70)	0.3	NA/NA
McMahon 1999	Study 1: I1: paroxetine 20 mg C1: paroxetine as needed 3–4 hours before planned sexual intercourse	17 weeks	NR	Australia	Academic	39.5	0.3	19/7
						39.5	0.3	19/7
	Study 2: I2: paroxetine 10 mg for 3 weeks then 20 mg paroxetine as needed for 4 weeks C2: placebo daily for 3 weeks then placebo daily for 4 weeks					40.5	0.5	32/10
						40.5	0.5	32/10
McMahon 2010	I1: dapoxetine 30 mg on‐demand I2: dapoxetine 60 mg on‐demand C1: placebo daily	12 weeks	2005–2006	Multicenter in Asia/Pacific	Academic	41.2 (SD 10.74)	3.9	92 (42.2%)/NA
						41.0 (SD 10.78)	4.2	92 (42.2%)/NA
						40.6 (SD 9.71)	2.4	96 (45.9%)/NA
McMahon 2013	I1: dapoxetine 30 mg on‐demand, from week 4 up to 60 mg if tolerated + PDE5 inhibitor taken 1–3 hours prior to sexual intercourse C1: placebo daily + PDE5 inhibitor taken 1–3 hours prior to intercourse	12 weeks	2010–2011	Australia	Academic	49.5 (SD 11.23)	NR	92 (42.2%)/NA
McMahon 2013		12 weeks	2010–2011	Australia	Academic	47.9 (SD 11.96)	NR	96 (45.9%)/NA
Mendels 1995	I1: sertraline 50 mg daily that could be titrated up to 200 mg daily C1: placebo daily	10 weeks	NR	USA	Academic	NR	0.98 (SD 1.15)	NA/NA
Mendels 1995		10 weeks	NR	USA	Academic	NR	1.10 (SD 1.35)	NA/NA
Na 1996	I1: sertraline 50 mg at night that could be titrated up to 100 mg daily C1: placebo daily	6 weeks	NR	South Korea	Academic	NR	NR	NA/NA
Na 1996		6 weeks	NR	South Korea	Academic	NR	NR	NA/NA
Novaretti 2002	I1: fluoxetine 20 mg C1: placebo daily	20 weeks	1998–2000	Brazil	Academic	37.4 (SD 10.7)	1.01 (SD 0.86)	NA/NA
Novaretti 2002	I1: fluoxetine 20 mg C1: placebo daily	20 weeks	1998–2000	Brazil	Academic	37.4 (SD 10.7)	1.05 (SD 1.07)	NA/NA
Pryor 2006	I1: dapoxetine 30 mg on‐demand 1–3 hours before anticipated sexual activity I2: dapoxetine 60 mg on‐demand 1–3 hours before anticipated sexual activity C1: placebo on‐demand 1–3 hours before anticipated sexual activity	12 weeks	2003–2004	USA	Academic	40.3 (SD 9.10)	0.90 (SD 0.47)	563/227
						40.9 (SD 9.09)	0.92 (SD 0.50)	571/234
						40.3 (SD 9.55)	0.91 (SD 0.48)	560/248
Safarinejad 2006b	I1: dapoxetine 60 mg daily I2: paroxetine 20 mg daily C1: placebo daily	12 weeks	2003–2005	Iran	Academic	33.4 (range 20–50)	0.63	64 (61.5%)/NA
						34.6 (range 21–49)	0.52	63 (60.0%)/NA
						34.3 (range 21–50)	0.57	11 (44.0%)/NA
Safarinejad 2006c	I1: citalopram 30 mg C1: placebo daily	6 months	NR	Iran	Academic	32 (21–49)	0.53	10/16
Safarinejad 2006c	I1: citalopram 30 mg C1: placebo daily	6 months	NR	Iran	Academic	34 (21–49)	0.47	11/14
Safarinejad 2007	I1: escitalopram 10 mg daily C1: placebo daily	12 weeks	2003–2005	Iran	Academic	33.5 (range 21–44)	NR	87 (70%)/NA
Safarinejad 2007	I1: escitalopram 10 mg daily C1: placebo daily	12 weeks	2003–2005	Iran	Academic	33.3 (range 19–46)	NR	88 (69.8%)/NA
Safarinejad 2008	I1: dapoxetine 30 mg daily C1: placebo daily	12 weeks	2004–2006	Iran	Academic	35.7 (range 21–54)	0.37	40 (37.7%)/NA
Safarinejad 2008	I1: dapoxetine 30 mg daily C1: placebo daily	12 weeks	2004–2006	Iran	Academic	36.3 (range 19–56)	0.48	43 (40.6%)/NA
Shang 2012	I1: citalopram 20 mg daily C1: placebo daily	4 weeks	2011–2012	China	Academic	39.1 (SD 2.5)	0.91 (SD 0.18)	NA/NA
Shang 2012	I1: citalopram 20 mg daily C1: placebo daily	4 weeks	2011–2012	China	Academic	37.8 (SD 2.8)	0.95 (SD 0.17)	NA/NA
Tuncel 2008	I1: sertraline 50 mg nightly for 2 months C1: placebo daily	8 weeks	NR	Turkey	Academic	36.9 (median) (SD 6.9)	NR	NA/NA
Tuncel 2008		8 weeks	NR	Turkey	Academic	34.9 (median) (SD 9.0)	NR	NA/NA
Waldinger 1994	I1: paroxetine 20 mg daily for 1 week and then 40 mg daily from week 2–6 C1: placebo daily	6 weeks	NR	The Netherlands	Outpatient	41 (range 27–48)	NR	7/8 (87.5%)/NA
Waldinger 1994		6 weeks	NR	The Netherlands	Outpatient	38 (range 30–47)	NR	7/9 (77.7%)/NA
Waldinger 1998	I1: fluoxetine 20 mg daily I2: fluvoxamine 100 mg daily I3: paroxetine 20 mg daily I4: sertraline 50 mg daily C1: placebo daily	6 weeks	NR	The Netherlands	Outpatient	38 (SD 7.0)	0.3 (SD 0.22)	NA/NA
						44 (SD 10.0)	0.3 (SD 0.22)	NA/NA
						41 (SD 8.0)	0.3 (SD 0.22)	NA/NA
						40 (SD 9.0)	0.3 (SD 0.22)	NA/NA
						45 (SD 4.0)	0.3 (SD 0.22)	NA/NA
Yilmaz 1999	I1: fluoxetine 20 mg daily C1: placebo	1 month	1997–1997	Turkey	Academic	36.5 (range 22–56)	1.2 (SD 1.0)	NA/NA
Yilmaz 1999	I1: fluoxetine 20 mg daily C1: placebo	1 month	1997–1997	Turkey	Academic	37.3 (range 24–58)	1.1 (SD 1.1)	NA/NA
C: comparator; I: intervention; IELT: intravaginal ejaculatory latency time; NA: not available; NR: not reported; PDE5: phosphodiesterase‐5; PE: premature ejaculation; SD: standard deviation.

Table 2. Baseline characteristics

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Comparison 1. SSRI versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Participant perception of change with treatment Show forest plot	6	3260	Risk Ratio (M‐H, Random, 95% CI)	1.92 [1.66, 2.23]

1.2 Participant satisfaction with intercourse Show forest plot	3	4273	Risk Ratio (M‐H, Random, 95% CI)	1.63 [1.42, 1.87]

1.3 Study withdrawal due to adverse events Show forest plot	20	7367	Risk Ratio (M‐H, Random, 95% CI)	3.80 [2.61, 5.51]

1.4 Perceived control over ejaculation Show forest plot	3	4273	Risk Ratio (M‐H, Random, 95% CI)	2.29 [1.72, 3.05]

1.5 Participant distress about PE Show forest plot	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.54 [1.26, 1.88]

1.6 Relationship difficulties Show forest plot	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.20 [1.07, 1.34]

1.7 Adverse events Show forest plot	17	4624	Risk Ratio (M‐H, Random, 95% CI)	1.71 [1.48, 1.99]

1.8 Intravaginal ejaculatory latency time Show forest plot	20	5872	Mean Difference (IV, Random, 95% CI)	3.09 [1.94, 4.25]

1.9 Depression Show forest plot	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

Comparison 1. SSRI versus placebo

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Comparison 2. Subgroup analysis: long‐acting versus short‐acting SSRI

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Participant perception of change with treatment Show forest plot	6	3260	Risk Ratio (M‐H, Random, 95% CI)	1.92 [1.66, 2.23]

2.1.1 Long‐acting SSRI	2	46	Risk Ratio (M‐H, Random, 95% CI)	8.48 [2.21, 32.51]
2.1.2 Short‐acting SSRI	4	3214	Risk Ratio (M‐H, Random, 95% CI)	1.87 [1.66, 2.10]
2.2 Participant satisfaction with intercourse Show forest plot	3	4273	Risk Ratio (M‐H, Random, 95% CI)	1.63 [1.42, 1.87]

2.2.1 Short‐acting SSRI	3	4273	Risk Ratio (M‐H, Random, 95% CI)	1.63 [1.42, 1.87]
2.3 Study withdrawal due to adverse events Show forest plot	20	7367	Risk Ratio (M‐H, Random, 95% CI)	3.71 [2.56, 5.38]

2.3.1 Long‐acting SSRI	14	1315	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.92, 4.34]
2.3.2 Short‐acting SSRI	6	6052	Risk Ratio (M‐H, Random, 95% CI)	4.33 [2.60, 7.23]
2.4 Perceived control over ejaculation Show forest plot	3	4273	Risk Ratio (M‐H, Random, 95% CI)	2.29 [1.72, 3.05]

2.4.1 Short‐acting SSRI	3	4273	Risk Ratio (M‐H, Random, 95% CI)	2.29 [1.72, 3.05]
2.5 Participant distress about PE Show forest plot	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.54 [1.26, 1.88]

2.5.1 Short‐acting SSRI	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.54 [1.26, 1.88]
2.6 Relationship difficulties Show forest plot	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.20 [1.07, 1.34]

2.6.1 Short‐acting SSRI	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.20 [1.07, 1.34]
2.7 Adverse events Show forest plot	17	4624	Risk Ratio (M‐H, Random, 95% CI)	1.71 [1.48, 1.99]

2.7.1 Long‐acting SSRI	13	1162	Risk Ratio (M‐H, Random, 95% CI)	1.90 [1.37, 2.64]
2.7.2 Short‐acting SSRI	4	3462	Risk Ratio (M‐H, Random, 95% CI)	1.70 [1.42, 2.03]
2.8 Intravaginal ejaculatory latency time Show forest plot	19	5804	Mean Difference (IV, Random, 95% CI)	2.74 [1.57, 3.92]

2.8.1 Long‐acting SSRI	14	576	Mean Difference (IV, Random, 95% CI)	3.36 [1.62, 5.10]
2.8.2 Short‐acting SSRI	5	5228	Mean Difference (IV, Random, 95% CI)	1.52 [1.27, 1.77]
2.9 Depression Show forest plot	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

2.9.1 Long‐acting SSRI	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

Comparison 2. Subgroup analysis: long‐acting versus short‐acting SSRI

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Comparison 3. Subgroup analysis: comparison of long‐acting agents

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Participant perception of change with treatment Show forest plot	2	46	Risk Ratio (M‐H, Random, 95% CI)	8.48 [2.21, 32.51]

3.1.1 Citalopram	1	26	Risk Ratio (M‐H, Random, 95% CI)	9.00 [1.32, 61.24]
3.1.2 Duloxetine	1	20	Risk Ratio (M‐H, Random, 95% CI)	8.00 [1.21, 52.69]
3.2 Study withdrawal due to adverse events Show forest plot	14	1315	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.92, 4.34]

3.2.1 Citalopram	3	164	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.13, 70.74]
3.2.2 Dapoxetine	2	383	Risk Ratio (M‐H, Random, 95% CI)	7.64 [0.99, 58.71]
3.2.3 Duloxetine	1	20	Risk Ratio (M‐H, Random, 95% CI)	Not estimable
3.2.4 Escitalopram	1	276	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.37, 10.74]
3.2.5 Fluoxetine	3	72	Risk Ratio (M‐H, Random, 95% CI)	2.59 [0.34, 19.59]
3.2.6 Fluvoxamine	1	15	Risk Ratio (M‐H, Random, 95% CI)	1.54 [0.09, 25.86]
3.2.7 Paroxetine	4	281	Risk Ratio (M‐H, Random, 95% CI)	1.76 [0.35, 8.91]
3.2.8 Sertraline	3	104	Risk Ratio (M‐H, Random, 95% CI)	0.43 [0.05, 3.56]
3.3 Adverse events Show forest plot	13	1204	Risk Ratio (M‐H, Random, 95% CI)	2.00 [1.44, 2.78]

3.3.1 Citalopram	2	106	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.51, 17.57]
3.3.2 Clomipramine	1	42	Risk Ratio (M‐H, Random, 95% CI)	4.40 [1.06, 18.32]
3.3.3 Dapoxetine	2	356	Risk Ratio (M‐H, Random, 95% CI)	2.54 [1.34, 4.81]
3.3.4 Duloxetine	1	20	Risk Ratio (M‐H, Random, 95% CI)	3.00 [0.37, 24.17]
3.3.5 Escitalopram	1	254	Risk Ratio (M‐H, Random, 95% CI)	1.69 [0.69, 4.15]
3.3.6 Fluoxetine	4	140	Risk Ratio (M‐H, Random, 95% CI)	2.50 [1.29, 4.86]
3.3.7 Paroxetine	1	155	Risk Ratio (M‐H, Random, 95% CI)	2.50 [0.91, 6.90]
3.3.8 Sertraline	3	131	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.74, 2.39]
3.4 Intravaginal ejaculatory latency time Show forest plot	14	576	Mean Difference (IV, Random, 95% CI)	3.36 [1.62, 5.10]

3.4.1 Citalopram	3	157	Mean Difference (IV, Random, 95% CI)	4.85 [3.14, 6.56]
3.4.2 Duloxetine	1	20	Mean Difference (IV, Random, 95% CI)	1.52 [0.80, 2.24]
3.4.3 Fluoxetine	5	149	Mean Difference (IV, Random, 95% CI)	2.46 [1.52, 3.39]
3.4.4 Fluvoxamine	1	12	Mean Difference (IV, Random, 95% CI)	0.59 [‐0.35, 1.53]
3.4.5 Paroxetine	3	107	Mean Difference (IV, Random, 95% CI)	6.51 [0.33, 12.68]
3.4.6 Sertraline	4	131	Mean Difference (IV, Random, 95% CI)	2.55 [1.54, 3.56]
3.5 Depression Show forest plot	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

3.5.1 Fluoxetine	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

Comparison 3. Subgroup analysis: comparison of long‐acting agents

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Comparison 4. Subgroup analysis: different doses of dapoxetine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Participant perception of change with treatment Show forest plot	4	3214	Risk Ratio (M‐H, Random, 95% CI)	1.87 [1.66, 2.10]

4.1.1 Dapoxetine 30 mg daily	1	508	Risk Ratio (M‐H, Random, 95% CI)	1.87 [1.37, 2.54]
4.1.2 Dapoxetine 30 mg on‐demand	2	1021	Risk Ratio (M‐H, Random, 95% CI)	2.00 [1.33, 3.01]
4.1.3 Dapoxetine 60 mg daily	1	500	Risk Ratio (M‐H, Random, 95% CI)	1.68 [1.23, 2.30]
4.1.4 Dapoxetine 60 mg on‐demand	2	1185	Risk Ratio (M‐H, Random, 95% CI)	1.98 [1.58, 2.48]
4.2 Participant satisfaction with intercourse Show forest plot	3	2968	Risk Ratio (M‐H, Random, 95% CI)	1.53 [1.37, 1.71]

4.2.1 Dapoxetine 30 mg daily	1	500	Risk Ratio (M‐H, Random, 95% CI)	1.41 [1.08, 1.85]
4.2.2 Dapoxetine 30 mg on‐demand	1	1309	Risk Ratio (M‐H, Random, 95% CI)	1.59 [1.33, 1.90]
4.2.3 Dapoxetine 60 mg daily	1	507	Risk Ratio (M‐H, Random, 95% CI)	1.39 [1.07, 1.82]
4.2.4 Dapoxetine 60 mg on‐demand	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.61 [1.32, 1.98]
4.3 Study withdrawal due to adverse events Show forest plot	7	6378	Risk Ratio (M‐H, Random, 95% CI)	4.54 [2.89, 7.14]

4.3.1 Dapoxetine 30 mg daily	1	533	Risk Ratio (M‐H, Random, 95% CI)	3.03 [0.37, 25.01]
4.3.2 Dapoxetine 30 mg on‐demand	3	2390	Risk Ratio (M‐H, Random, 95% CI)	2.44 [1.06, 5.59]
4.3.3 Dapoxetine 60 mg daily	3	916	Risk Ratio (M‐H, Random, 95% CI)	8.76 [2.10, 36.49]
4.3.4 Dapoxetine 60 mg on‐demand	3	2539	Risk Ratio (M‐H, Random, 95% CI)	6.51 [3.64, 11.66]
4.4 Perceived control over ejaculation Show forest plot	3	4273	Risk Ratio (M‐H, Random, 95% CI)	2.29 [1.72, 3.05]

4.4.1 Dapoxetine 30 mg daily	1	500	Risk Ratio (M‐H, Random, 95% CI)	1.79 [1.26, 2.53]
4.4.2 Dapoxetine 30 mg on‐demand	1	1305	Risk Ratio (M‐H, Random, 95% CI)	3.70 [2.72, 5.04]
4.4.3 Dapoxetine 60 mg daily	1	507	Risk Ratio (M‐H, Random, 95% CI)	1.78 [1.26, 2.52]
4.4.4 Dapoxetine 60 mg on‐demand	2	1961	Risk Ratio (M‐H, Random, 95% CI)	2.28 [1.65, 3.16]
4.5 Participant distress about PE Show forest plot	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.54 [1.26, 1.88]

4.5.1 Dapoxetine 60 mg on‐demand	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.54 [1.26, 1.88]
4.6 Relationship difficulties Show forest plot	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.20 [1.07, 1.34]

4.6.1 Dapoxetine 60 mg on‐demand	1	652	Risk Ratio (M‐H, Random, 95% CI)	1.20 [1.07, 1.34]
4.7 Adverse events Show forest plot	6	3818	Risk Ratio (M‐H, Random, 95% CI)	1.74 [1.46, 2.07]

4.7.1 Dapoxetine 30 mg daily	2	1028	Risk Ratio (M‐H, Random, 95% CI)	1.64 [1.30, 2.07]
4.7.2 Dapoxetine 30 mg on‐demand	1	581	Risk Ratio (M‐H, Random, 95% CI)	1.47 [1.20, 1.79]
4.7.3 Dapoxetine 60 mg daily	3	891	Risk Ratio (M‐H, Random, 95% CI)	2.73 [2.03, 3.66]
4.7.4 Dapoxetine 60 mg on‐demand	2	1318	Risk Ratio (M‐H, Random, 95% CI)	1.56 [1.23, 1.99]
4.8 Intravaginal ejaculatory latency time Show forest plot	4	5173	Mean Difference (IV, Random, 95% CI)	1.48 [1.20, 1.75]

4.8.1 Dapoxetine 30 mg daily	1	502	Mean Difference (IV, Random, 95% CI)	1.80 [1.27, 2.33]
4.8.2 Dapoxetine 30 mg on‐demand	3	2329	Mean Difference (IV, Random, 95% CI)	1.37 [0.86, 1.89]
4.8.3 Dapoxetine 60 mg daily	1	504	Mean Difference (IV, Random, 95% CI)	1.50 [0.98, 2.02]
4.8.4 Dapoxetine 60 mg on‐demand	2	1838	Mean Difference (IV, Random, 95% CI)	1.53 [1.09, 1.97]

Comparison 4. Subgroup analysis: different doses of dapoxetine

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Comparison 5. Subgroup analysis: different doses of fluoxetine

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
5.1 Study withdrawal due to adverse events Show forest plot	3	72	Risk Ratio (M‐H, Random, 95% CI)	2.09 [0.26, 16.82]

5.1.1 Fluoxetine 20 mg daily	3	72	Risk Ratio (M‐H, Random, 95% CI)	2.09 [0.26, 16.82]
5.2 Adverse events Show forest plot	4	140	Risk Ratio (M‐H, Random, 95% CI)	2.50 [1.29, 4.86]

5.2.1 Fluoxetine 20 mg daily	2	57	Risk Ratio (M‐H, Random, 95% CI)	9.32 [1.88, 46.26]
5.2.2 Fluoxetine 40 mg daily	1	23	Risk Ratio (M‐H, Random, 95% CI)	2.29 [0.55, 9.49]
5.2.3 Fluoxetine 90 mg daily	1	60	Risk Ratio (M‐H, Random, 95% CI)	1.78 [0.76, 4.17]
5.3 Intravaginal ejaculatory latency time Show forest plot	5	149	Mean Difference (IV, Random, 95% CI)	2.46 [1.52, 3.39]

5.3.1 Fluoxetine 20 mg daily	3	66	Mean Difference (IV, Random, 95% CI)	2.87 [1.26, 4.48]
5.3.2 Fluoxetine 40 mg daily	1	23	Mean Difference (IV, Random, 95% CI)	‐0.54 [‐3.57, 2.49]
5.3.3 Fluoxetine 90 mg daily	1	60	Mean Difference (IV, Random, 95% CI)	2.72 [1.83, 3.61]
5.4 Depression Show forest plot	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

5.4.1 Fluoxetine 20 mg daily	1	14	Risk Ratio (M‐H, Random, 95% CI)	2.00 [0.23, 17.34]

Comparison 5. Subgroup analysis: different doses of fluoxetine

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