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Meta-Analysis
. 2013 May 31;2013(5):CD003382.
doi: 10.1002/14651858.CD003382.pub3.

Strategies for managing sexual dysfunction induced by antidepressant medication

Matthew J Taylor  1 , Lisa Rudkin, Philippa Bullemor-Day, Jade Lubin, Christopher Chukwujekwu, Keith Hawton
Affiliations
Meta-Analysis

Strategies for managing sexual dysfunction induced by antidepressant medication

Matthew J Taylor et al. Cochrane Database Syst Rev. .

Abstract

Background: Sexual dysfunction (including altered sexual desire, orgasmic and ejaculatory dysfunction, erectile and other problems) is a relatively common side effect of antidepressant medication. These sexual side effects may compromise a person's lifestyle and result in a lack of compliance with the prescribed antidepressant to the detriment of the person's mental health. A wide range of management strategies are possible to address this problem, including behavioural, psychological and pharmacological approaches.

Objectives: 1. To determine the effectiveness of management strategies for sexual dysfunction caused by antidepressants.2. To determine the adverse effects and acceptability of the different management strategies.

Search methods: We searched the Cochrane Depression, Anxiety and Neurosis Group's Specialized Register (CCDANCTR, to 1 January 2013), which includes relevant randomised controlled trials from the following bibliographic databases: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). Additional searches were carried out by the author team on the same biomedical databases (using terms for 'sexual dysfunction' only) together with CINAHL (1982 to Jan 2012). The reference lists of reports of all included studies were screened.

Selection criteria: We included randomised controlled trials that compared management strategies for antidepressant-induced sexual dysfunction versus placebo or any alternative strategy.

Data collection and analysis: Two authors independently extracted data and assessed trial quality. Study authors were contacted for additional information.

Main results: We included 23 trials involving 1886 people in this updated review. Twenty-two of these trials investigated the addition of medication to treat the identified dysfunction, with most agents studied in only single studies. One study investigated switching to an alternative antidepressant.In men, data for the phosphodiesterase inhibitors sildenafil (three studies, 255 participants) and tadalafil (one study, 54 participants) indicated they led to a greater improvement in erectile function than placebo. Combined data from three sildenafil studies found benefit over placebo on International Index of Erectile Function ratings of ability to achieve (MD 1.04, 95% CI 0.65 to 1.44), and maintain erections (MD 1.18, 95% CI 0.78 to 1.59). A single point improvement on these ratings is equivalent to an improvement in frequency from 'sometimes' to 'most times'. Men receiving tadalafil were more likely to report improved erectile function (RR 11.50, 95% CI 3.03 to 43.67). For women it remains uncertain whether sildenafil is more effective than placebo. Unpublished data could reduce this uncertainty.Data from three studies in men and women of bupropion 150 mg twice daily indicate a benefit over placebo on rating scale scores (SMD 1.60, 95% CI 1.40 to 1.81), but response rates in two studies of bupropion 150 mg once daily demonstrated no statistically significant difference in effect (RR 0.62, 95% CI 0.09 to 4.41).Other augmentation strategies failed to demonstrate significant improvements in sexual dysfunction compared with placebo.One trial involving 75 people with sexual dysfunction due to sertraline assessed the effect of changing antidepressant. Switching to nefazodone was significantly less likely to result in the re-emergence of sexual dysfunction than restarting sertraline (RR 0.34, 95% CI 0.19 to 0.60), however, nefazodone is no longer available for clinical use.There is an absence of randomised trials assessing the effects of switching to currently-available antidepressant agents with lower rates of adverse sexual effects, the role of psychological or mechanical interventions, or of techniques such as drug holidays.We identified no data for any of the strategies included in the trials assessed that indicated that they led to a worsening of psychiatric symptoms. However, the relatively small numbers assessed for many of the interventions studied means that the possibility of such an effect cannot confidently be excluded in all cases.Given the small numbers of studies assessing most of the strategies assessed, the presence of any unpublished trials could have substantial effects on estimates of effect. In some cases, only results from particular items or subscales within ratings scales are available. It is likely that this could act to bias estimates of effect obtained, increasing apparent effectiveness.

Authors' conclusions: The evidence currently available is rather limited. For men with antidepressant-induced erectile dysfunction, the addition of sildenafil or tadalafil appears to be an effective strategy. For women with antidepressant-induced sexual dysfunction the addition of bupropion at higher doses appears to be the most promising approach studied so far.

PubMed Disclaimer

Conflict of interest statement

PBD, CC, JL: None known.

KH has previously acted as a temporary consultant for Pfizer (manufacturers of sildenafil).

MT has been paid to lecture and received travel expenses from Bristol‐Myers Squibb (manufacturers of buspirone) and Otsuka; his spouse is an employee of GlaxoSmithKline (manufacturers of bupropion).

Figures

1
1
Study flow diagram
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Forest plot of comparison 1: sildenafil vs placebo, outcome: 1.1 endpoint International Index of Erectile Function (IIEF) scores
5
5
Forest plot of comparison 1: sildenafil vs placebo, outcome: 1.5 endpoint Arizona Sexual Experience Scale (ASEX) total scores
6
6
Forest plot of comparison 3: bupropion vs placebo, outcome: 3.1 endpoint scale total scores
7
7
Forest plot of comparison 3: bupropion vs placebo, outcome: 3.2 response (as defined by study)
1.1
1.1. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 1 Endpoint International Index of Erectile Function (IIEF) scores.
1.2
1.2. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 2 Endpoint Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores.
1.3
1.3. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 3 Endpoint Clinical Global Impression ‐ Sexual Function.
1.4
1.4. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 4 Clinical Global Impression ‐Sexual Function not "much/very much improved" by endpoint.
1.5
1.5. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 5 Endpoint Arizona Sexual Experience Scale (ASEX) total scores.
1.6
1.6. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 6 Males: endpoint Arizona Sexual Experience Scale scores.
1.7
1.7. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 7 Endpoint MGH‐Sexual Functioning Questionnaire scores.
1.8
1.8. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 8 Sexual dysfunction defined by Arizona Sexual Experience Scale at trial endpoint.
1.9
1.9. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 9 Dropouts.
1.10
1.10. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 10 Endpoint Hamilton Rating Scale for Depression score.
1.11
1.11. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 11 Loss of remission: Hamilton Rating Scale for Depression score > 9.
1.12
1.12. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 12 Global Efficacy Questionnaire (questions 1 & 2).
1.13
1.13. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 13 Global efficacy questionnaire (question 3).
1.14
1.14. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 14 Endpoint Sexual Function Questionnaire (SFQ).
1.15
1.15. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 15 UNM Sexual Function Inventory.
1.16
1.16. Analysis
Comparison 1 Sildenafil vs placebo, Outcome 16 Females: endpoint Arizona Sexual Experience Scale scores.
2.1
2.1. Analysis
Comparison 2 Tadalafil vs placebo, Outcome 1 Global Assessment Questions.
2.2
2.2. Analysis
Comparison 2 Tadalafil vs placebo, Outcome 2 Endpoint Sexual Encounter Profile (SEP).
2.3
2.3. Analysis
Comparison 2 Tadalafil vs placebo, Outcome 3 Dropouts.
3.1
3.1. Analysis
Comparison 3 Bupropion vs placebo, Outcome 1 Endpoint scale total scores.
3.2
3.2. Analysis
Comparison 3 Bupropion vs placebo, Outcome 2 Response (as defined by study).
3.3
3.3. Analysis
Comparison 3 Bupropion vs placebo, Outcome 3 Endpoint International Index of Erectile Function (IIEF).
3.4
3.4. Analysis
Comparison 3 Bupropion vs placebo, Outcome 4 Endpoint Female Sexual Function Index score.
3.5
3.5. Analysis
Comparison 3 Bupropion vs placebo, Outcome 5 Endpoint Changes in Sexual Functioning Questionnaire score.
3.6
3.6. Analysis
Comparison 3 Bupropion vs placebo, Outcome 6 Dropouts.
3.7
3.7. Analysis
Comparison 3 Bupropion vs placebo, Outcome 7 Endpoint Hamilton Rating Scale for Depression score.
3.8
3.8. Analysis
Comparison 3 Bupropion vs placebo, Outcome 8 Endpoint Clinical Global Impression (CGI ‐ SF).
3.9
3.9. Analysis
Comparison 3 Bupropion vs placebo, Outcome 9 Endpoint ASEX.
3.10
3.10. Analysis
Comparison 3 Bupropion vs placebo, Outcome 10 Endpoint EDITS (participant).
3.11
3.11. Analysis
Comparison 3 Bupropion vs placebo, Outcome 11 Endpoint EDITS (partner).
4.1
4.1. Analysis
Comparison 4 Nefazodone vs sertraline, Outcome 1 Re‐emergence of antidepressant‐induced sexual dysfunction (physician rated).
4.2
4.2. Analysis
Comparison 4 Nefazodone vs sertraline, Outcome 2 Overall degree of sexual satisfaction (participant rated).
4.3
4.3. Analysis
Comparison 4 Nefazodone vs sertraline, Outcome 3 Dropouts.
4.4
4.4. Analysis
Comparison 4 Nefazodone vs sertraline, Outcome 4 Hamilton Rating Scale for Depression score.
5.1
5.1. Analysis
Comparison 5 Ginkgo biloba vs placebo, Outcome 1 Endpoint sexual function ratings (investigator questionnaire).
5.2
5.2. Analysis
Comparison 5 Ginkgo biloba vs placebo, Outcome 2 Sexual Dysfunction Scale (investigator developed).
5.3
5.3. Analysis
Comparison 5 Ginkgo biloba vs placebo, Outcome 3 Dropouts.
6.1
6.1. Analysis
Comparison 6 Granisetron vs placebo, Outcome 1 Change from baseline on Sexual Side Effects Scale (SSES) total score.
6.2
6.2. Analysis
Comparison 6 Granisetron vs placebo, Outcome 2 Endpoint Feiger Sexual Function and Satisfaction Questionnaire score.
6.3
6.3. Analysis
Comparison 6 Granisetron vs placebo, Outcome 3 Endpoint Arizona Sexual Experience Scale (ASEX) score.
6.4
6.4. Analysis
Comparison 6 Granisetron vs placebo, Outcome 4 Dropouts.
6.5
6.5. Analysis
Comparison 6 Granisetron vs placebo, Outcome 5 Recurrence of mood symptoms.
7.1
7.1. Analysis
Comparison 7 VML‐670 vs placebo, Outcome 1 Absence of sexual dysfunction at end point.
7.2
7.2. Analysis
Comparison 7 VML‐670 vs placebo, Outcome 2 'Improved' or 'much improved' on Clinical Global Impression.
7.3
7.3. Analysis
Comparison 7 VML‐670 vs placebo, Outcome 3 Change in Arizona Sexual Experiences Scale (ASEX) item scores.
7.4
7.4. Analysis
Comparison 7 VML‐670 vs placebo, Outcome 4 Dropouts.
8.1
8.1. Analysis
Comparison 8 Buspirone vs placebo, Outcome 1 Change in patient‐rated visual analogue scales.
8.2
8.2. Analysis
Comparison 8 Buspirone vs placebo, Outcome 2 Dropouts.
9.1
9.1. Analysis
Comparison 9 Bethanecol vs placebo, Outcome 1 Visual analogue scale of orgasmic function ‐ best score achieved.
10.1
10.1. Analysis
Comparison 10 Olanzapine vs placebo, Outcome 1 Change in patient rated assessment of sexual function.
10.2
10.2. Analysis
Comparison 10 Olanzapine vs placebo, Outcome 2 Change in diary ratings (visual analogue scales).
10.3
10.3. Analysis
Comparison 10 Olanzapine vs placebo, Outcome 3 Dropouts due to adverse effects.
11.1
11.1. Analysis
Comparison 11 Mirtazapine vs placebo, Outcome 1 Change in patient rated assessment of sexual function.
11.2
11.2. Analysis
Comparison 11 Mirtazapine vs placebo, Outcome 2 Change in diary ratings (visual analogue scales).
11.3
11.3. Analysis
Comparison 11 Mirtazapine vs placebo, Outcome 3 Endpoint modified Kinsey Structured Interview.
11.4
11.4. Analysis
Comparison 11 Mirtazapine vs placebo, Outcome 4 Dropouts.
12.1
12.1. Analysis
Comparison 12 Yohimbine vs placebo, Outcome 1 Change in patient rated assessment of sexual function.
12.2
12.2. Analysis
Comparison 12 Yohimbine vs placebo, Outcome 2 Change in diary ratings (visual analogue scales).
12.3
12.3. Analysis
Comparison 12 Yohimbine vs placebo, Outcome 3 Dropouts.
13.1
13.1. Analysis
Comparison 13 Amantadine vs placebo, Outcome 1 Change in patient‐rated visual analogue scales.
13.2
13.2. Analysis
Comparison 13 Amantadine vs placebo, Outcome 2 Dropouts.
14.1
14.1. Analysis
Comparison 14 ephedrine vs placebo, Outcome 1 Endpoint Brief Index of Sexual Functioning for Women (BISF‐W).
15.1
15.1. Analysis
Comparison 15 Maca root: high vs low dose, Outcome 1 Endpoint Arizona Sexual Experiences Scale (ASEX) score.
15.2
15.2. Analysis
Comparison 15 Maca root: high vs low dose, Outcome 2 Endpoint MGH‐SFQ.
15.3
15.3. Analysis
Comparison 15 Maca root: high vs low dose, Outcome 3 Dropouts.
15.4
15.4. Analysis
Comparison 15 Maca root: high vs low dose, Outcome 4 Endpoint ratings of psychiatric symptoms.
See this image and copyright information in PMC

Update of

References

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Jacobsen 1996 {published and unpublished data}
    1. Jacobsen FM, Comas‐Diaz L. A double‐blind placebo‐controlled trial of yohimbine for treatment of SRI‐induced sexual dysfunction. 149th Annual Meeting of the American Psychiatric Association. 1996.
Jespersen 2004 {published data only}
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Kang 2002 {published data only}
    1. Kang BJ, Lee SJ, Kim MD, Cho MJ. A placebo‐controlled, double‐blind trial of Ginkgo biloba for antidepressant‐induced sexual dysfunction. Human Psychopharmacology 2002;17:279‐84. [MEDLINE: ] - PubMed
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Masand 2001 {published data only}
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Meston 2004 {published data only}
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Michelson 2000 {published data only}
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Michelson 2002 {published and unpublished data}
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Nelson 2001 {published data only}
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Nurnberg 2002 {published data only}
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Nurnberg 2003 {published and unpublished data}
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Nurnberg 2008 {published data only}
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References to studies excluded from this review

Aizenberg 2003 {published data only}
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Amiaz 2011 {published data only}
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Ashton 1998 {published data only}
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Berk 2000 {published data only}
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Cohen 1999 {published data only}
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Dording 2012 {published data only}
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Gelenberg 2000 {published data only}
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Landen 1999 {published data only}
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Moore 2002 {published data only}
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Nurnberg 2001 {published data only}
    1. Nurnberg HG, Gelenberg A, Hargreave TB, Harrison WM, Siegel RL, Smith MD. Efficacy of sildenafil citrate for the treatment of erectile dysfunction in men taking serotonin reuptake inhibitors. American Journal of Psychiatry 2001;158:1926‐8. - PubMed
Ozmenler 2008 {published data only}
    1. Ozmenler NK, Karlidere T, Bozkurt A, Yetkin S, Doruk A, Sutcigil L, et al. Mirtazapine augmentation in depressed patients with sexual dysfunction due to selective serotonin reuptake inhibitors. Human Psychopharmacology 2008;23:321‐6. [CENTRAL: CN‐00738528; DOI: 10.1002/hup.929] - DOI - PubMed
Pae 2009 {published data only}
    1. Pae C, Marks DM, Masand PS, Peindl K, Hooper‐Wood C, Han C, et al. Methylphenidate extended release (OROS MPH) for the treatment of antidepressant‐related sexual dysfunction in patients with treatment‐resistant depression: results from a 4‐week, double‐blind, placebo‐controlled trial. Clinical Neuropharmacology 2009;32:85‐8. [CENTRAL: CN‐00723063; DOI: 10.1097/WNF.0b013e31817e559b; PUBMED: 19512961] - DOI - PubMed
Salerian 2000 {published data only}
    1. Salerian AJ, Deibler WE, Vittone BJ, Geyer SP, Drell L, Mirmirani N, et al. Sildenafil for psychotropic‐induced sexual dysfunction in 31 women and 61 men. Journal of Sex & Marital Therapy 2000;26:133‐40. - PubMed
Salerian 2002 {published data only}
    1. Salerian AJ, Motto H, Baum AL. Dronabinol for antidepressant‐induced sexual dysfunction. 155th Annual Meeting of the American Psychiatric Association; 2002 May 18‐23rd; Philadelphia, PA. 2002.
Segraves 2007 {published and unpublished data}
    1. Carson CC, Rajfer J, Eardley I, Carrier S, Denne JS, Walker DJ, et al. The efficacy and safety of tadalafil: an update. BJU International 2004;93:1276‐81. [MEDLINE: ] - PubMed
    1. Segraves RT, Lee J, Stevenson R, Walker DJ, Wang WC, Dickson RA. Tadalfil for treatment of erectile dysfunction in men on antidepressants. Journal of Clinical Psychopharmacology 2007;27:62‐6. [PUBMED: 17224715] - PubMed
    1. Segraves RT, Stevenson RW, Lee J, Walker DJ, Wang W, Dickson R. Tadalafil treatment of erectile dysfunction in men on antidepressants. 157th Annual Meeting of the American Psychiatric Association; 2004 May 01‐06; New York, NY. 2004.
Tignol 2004 {published data only}
    1. Tignol J, Furlan PM, Gomez‐Beneyto M, Opsomer R, Schreiber W, Sweeney M, et al. Efficacy of sildenafil citrate (Viagra(R)) for the treatment of erectile dysfunction in men in remission from depression. International Clinical Psychopharmacology 2004;19:191‐9. [MEDLINE: ] - PubMed
    1. Tignol JL, Benkert O. Sildenafil citrate effectively treats erectile dysfunction in men who have been successfully treated for depression. 155th Annual Meeting of the American Psychiatric Association; 2002 May 18‐23rd; Philadelphia, PA. 2002. [CN‐00429611]
Walker 1993 {published data only}
    1. Walker PW, Cole JO, Gardner EA, Hughes AR, Johnston A, Batey SR, et al. Improvement in fluoxetine‐associated sexual dysfunction in patients switched to bupropion. Journal of Clinical Psychiatry 1993;54:459‐65. - PubMed
Worthington 2002 {published data only}
    1. Worthington JJ 3rd, Simon NM, Korbly NB, Perlis RH, Pollack MH. Ropinirole for antidepressant‐induced sexual dysfunction. International Clinical Psychopharmacology 2002;17:307‐10. [MEDLINE: ] - PubMed

References to studies awaiting assessment

Croft 2012 {published data only}
    1. Croft H, Mulroy A, Sambunaris A, Goldstein S, DeRogatis L, Pyke R, et al. A 12‐week, randomized, double‐blind, placebo‐controlled, phase III safety trial of flibanserin tablets (100 MG Q.D.) in women taking a selective serotonin or serotonin‐norepinephrine reuptake inhibitor. Journal of Sexual Medicine 2012;9(s3):168.
    1. Croft H, Mulroy A, Sambunaris A, Goldstein S, DeRogatis L, Pyke R, et al. A 12‐week, randomized, double‐blind, placebo‐controlled, phase III safety trial of flibanserin tablets (100mg q.d.) in women taking a selective serotonin or serotonin‐norepinephrine reuptake inhibitor. Journal of Sexual Medicine 2011;9(s1):23.
Kashani 2013 {published data only}
    1. Kashani L, Raisi F, Saroukhani S, Sohrabi H, Modabbernia A, et al. Saffron for treatment of fluoxetine‐induced sexual dysfunction in women: randomized double‐blind placebo‐controlled study. Human Psychopharmocology 2013;28:54‐60. [PUBMED: 23280545] - PubMed
Modabbernia 2012 {published data only}
    1. Modabbernia A, Sohrabi H, Nasehi A‐A, Raisi F, Saroukhani S, Jamshidi A, et al. Effect of saffron on fluoxetine‐induced sexual impairment in men: randomized double‐blind placebo‐controlled trial. Psychopharmacology 2012;223:381‐8. [PUBMED: 22552758] - PubMed

References to ongoing studies

Chiang 2010 {published data only}
    1. Trazodone for SSRI‐sexual dsyfunction (T‐SSRI‐SD).
Dording 2010 {published data only}
    1. Study of maca root for the treatment of antidepressant‐induced sexual dysfunction in females (MGH).
Hellerstein 2008 {published data only}
    1. Treating sexual dysfunction from selective serotonin reuptake inhibitor (SSRI) medication: a study comparing Requip CR to placebo.
Meston 2008 {published data only}
    1. Meston C. Ginkgo biloba: antidepressant‐induced sexual dysfunction. [NCT00034021]
    1. Meston CM, Rellini AH, Telch MJ. Short‐ and long‐term effects of Ginkgo biloba extract on sexual dysfunction in women. Archives of Sexual Behavior 2008;37:530‐47. [DOI: 10.1007/s10508-008-9316-2; PUBMED: 18274887] - DOI - PMC - PubMed
Takeda 2011 {published data only}
    1. Takeda Global Research & Development Center, Inc. A randomized, double‐blind, parallel‐group, active‐controlled, flexible‐dose study evaluating the effect of Lu AA21004 vs escitalopram on sexual functioning in adults with well‐treated major depressive disorder experiencing selective serotonin reuptake inhibitor‐induced sexual dysfunction.
Van Rooiji 2010 {published data only}
    1. Lybrido(s) and SSRIs @Home: A double blind, randomized, cross‐over placebo controlled study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female subjects with Female Sexual Dysfunction in combination with SSRI use.

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