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Link to original content: https://pubmed.ncbi.nlm.nih.gov/23744611
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Review
. 2013 Jun 7;2013(6):CD001396.
doi: 10.1002/14651858.CD001396.pub3.

Selective serotonin reuptake inhibitors for premenstrual syndrome

Jane Marjoribanks  1 , Julie Brown, Patrick Michael Shaughn O'Brien, Katrina Wyatt
Affiliations
Review

Selective serotonin reuptake inhibitors for premenstrual syndrome

Jane Marjoribanks et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Premenstrual syndrome (PMS) is a common cause of physical, psychological and social problems in women of reproductive age. The key characteristic of PMS is the timing of symptoms, which occur only during the two weeks leading up to menstruation (the luteal phase of the menstrual cycle). Selective serotonin reuptake inhibitors (SSRIs) are increasingly used as first line therapy for PMS. SSRIs can be taken either in the luteal phase or else continuously (every day). SSRIs are generally considered to be effective for reducing premenstrual symptoms but they can cause adverse effects.

Objectives: The objective of this review was to evaluate the effectiveness and safety of SSRIs for treating premenstrual syndrome.

Search methods: Electronic searches for relevant randomised controlled trials (RCTs) were undertaken in the Cochrane Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, PsycINFO, and CINAHL (February 2013). Where insufficient data were presented in a report, attempts were made to contact the original authors for further details.

Selection criteria: Studies were considered in which women with a prospective diagnosis of PMS, PMDD or late luteal phase dysphoric disorder (LPDD) were randomised to receive SSRIs or placebo for the treatment of premenstrual syndrome.

Data collection and analysis: Two review authors independently selected the studies, assessed eligible studies for risk of bias, and extracted data on premenstrual symptoms and adverse effects. Studies were pooled using random-effects models. Standardised mean differences (SMDs) with 95% confidence intervals (CIs) were calculated for premenstrual symptom scores, using separate analyses for different types of continuous data (that is end scores and change scores). Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated for dichotomous outcomes. Analyses were stratified by type of drug administration (luteal or continuous) and by drug dose (low, medium, or high). We calculated the number of women who would need to be taking a moderate dose of SSRI in order to cause one additional adverse event (number needed to harm: NNH). The overall quality of the evidence for the main findings was assessed using the GRADE working group methods.

Main results: Thirty-one RCTs were included in the review. They compared fluoxetine, paroxetine, sertraline, escitalopram and citalopram versus placebo. SSRIs reduced overall self-rated symptoms significantly more effectively than placebo. The effect size was moderate when studies reporting end scores were pooled (for moderate dose SSRIs: SMD -0.65, 95% CI -0.46 to -0.84, nine studies, 1276 women; moderate heterogeneity (I(2) = 58%), low quality evidence). The effect size was small when studies reporting change scores were pooled (for moderate dose SSRIs: SMD -0.36, 95% CI -0.20 to -0.51, four studies, 657 women; low heterogeneity (I(2)=29%), moderate quality evidence).SSRIs were effective for symptom relief whether taken only in the luteal phase or continuously, with no clear evidence of a difference in effectiveness between these modes of administration. However, few studies directly compared luteal and continuous regimens and more evidence is needed on this question.Withdrawals due to adverse effects were significantly more likely to occur in the SSRI group (moderate dose: OR 2.55, 95% CI 1.84 to 3.53, 15 studies, 2447 women; no heterogeneity (I(2) = 0%), moderate quality evidence). The most common side effects associated with a moderate dose of SSRIs were nausea (NNH = 7), asthenia or decreased energy (NNH = 9), somnolence (NNH = 13), fatigue (NNH = 14), decreased libido (NNH = 14) and sweating (NNH = 14). In secondary analyses, SSRIs were effective for treating specific types of symptoms (that is psychological, physical and functional symptoms, and irritability). Adverse effects were dose-related.The overall quality of the evidence was low to moderate, the main weakness in the included studies being poor reporting of methods. Heterogeneity was low or absent for most outcomes, though (as noted above) there was moderate heterogeneity for one of the primary analyses.

Authors' conclusions: SSRIs are effective in reducing the symptoms of PMS, whether taken in the luteal phase only or continuously. Adverse effects are relatively frequent, the most common being nausea and asthenia. Adverse effects are dose-dependent.

PubMed Disclaimer

Conflict of interest statement

Julie Brown and Jane Marjoribanks have no conflict of interest.

PMS O'Brien has been funded over many years for research personnel, consultancies, lectures and conferences by the following companies: Bayer Schering, Hoechst Marion Roussel Ltd, Shire Pharmaceuticals, Smith Kline Beecham, Eli Lilly, Searle, Sanofi Winthrop, Zeneca, Organon, Solvay Pharmaceuticals and Novo Nordisk.

KM Wyatt has no conflict of interest.

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' judgments about each risk of bias item for each included study.
4
4
Forest plot of comparison: 1 SSRIs versus placebo ‐ all symptoms (end scores), outcome: 1.2 Moderate dose SSRI.
5
5
Forest plot of comparison: 2 SSRIs versus placebo ‐ all symptoms (change scores), outcome: 2.2 Moderate dose SSRI.
6
6
Forest plot of comparison: 4 SSRIs versus placebo: withdrawal due to adverse events, outcome: 4.2 Mod dose.
7
7
Funnel plot of comparison: 1 SSRIs versus placebo ‐ all symptoms (end scores), outcome: 1.2 Moderate dose SSRI.
1.1
1.1. Analysis
Comparison 1 SSRIs versus placebo ‐ all symptoms (end scores), Outcome 1 Low dose SSRI.
1.2
1.2. Analysis
Comparison 1 SSRIs versus placebo ‐ all symptoms (end scores), Outcome 2 Moderate dose SSRI.
1.3
1.3. Analysis
Comparison 1 SSRIs versus placebo ‐ all symptoms (end scores), Outcome 3 High dose SSRI.
2.1
2.1. Analysis
Comparison 2 SSRIs versus placebo ‐ all symptoms (change scores), Outcome 1 Low dose SSRI.
2.2
2.2. Analysis
Comparison 2 SSRIs versus placebo ‐ all symptoms (change scores), Outcome 2 Moderate dose SSRI.
3.1
3.1. Analysis
Comparison 3 SSRIs versus placebo: withdrawal due to adverse effects, Outcome 1 Low dose.
3.2
3.2. Analysis
Comparison 3 SSRIs versus placebo: withdrawal due to adverse effects, Outcome 2 Mod dose.
3.3
3.3. Analysis
Comparison 3 SSRIs versus placebo: withdrawal due to adverse effects, Outcome 3 High dose.
4.1
4.1. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 1 Nausea.
4.2
4.2. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 2 Insomnia or sleep disturbance.
4.3
4.3. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 3 Sexual dysfunction or decreased libido.
4.4
4.4. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 4 Fatigue or sedation.
4.5
4.5. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 5 Dizziness or vertigo.
4.6
4.6. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 6 Tremor.
4.7
4.7. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 7 Somnolence/decreased concentration.
4.8
4.8. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 8 Sweating.
4.9
4.9. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 9 Dry mouth.
4.10
4.10. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 10 Yawning.
4.11
4.11. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 11 Asthenia/decreased energy.
4.12
4.12. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 12 Diarrhoea.
4.13
4.13. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 13 Constipation.
4.14
4.14. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 14 Gastrointestinal irritability or dyspepsia.
4.15
4.15. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 15 Headache.
4.16
4.16. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 16 Decreased appetite.
4.17
4.17. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 17 Increased appetite.
4.18
4.18. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 18 Anxiety.
4.19
4.19. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 19 Cardiovascular symptoms.
4.20
4.20. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 20 Respiratory disorder.
4.21
4.21. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 21 Sinusitis.
4.22
4.22. Analysis
Comparison 4 SSRIs versus placebo: adverse events, Outcome 22 Infection.
5.1
5.1. Analysis
Comparison 5 SSRIs versus placebo ‐ psychological symptoms (end scores), Outcome 1 Low dose SSRI.
5.2
5.2. Analysis
Comparison 5 SSRIs versus placebo ‐ psychological symptoms (end scores), Outcome 2 Moderate dose SSRI.
6.1
6.1. Analysis
Comparison 6 SSRIs versus placebo ‐ psychological symptoms (change scores), Outcome 1 Low dose SSRI.
6.2
6.2. Analysis
Comparison 6 SSRIs versus placebo ‐ psychological symptoms (change scores), Outcome 2 Moderate dose SSRI.
7.1
7.1. Analysis
Comparison 7 SSRIs versus placebo ‐ physical symptoms (end scores), Outcome 1 Moderate dose SSRI.
7.2
7.2. Analysis
Comparison 7 SSRIs versus placebo ‐ physical symptoms (end scores), Outcome 2 High dose SSRI.
8.1
8.1. Analysis
Comparison 8 SSRIs versus placebo ‐ physical symptoms (change scores), Outcome 1 Low dose SSRI.
8.2
8.2. Analysis
Comparison 8 SSRIs versus placebo ‐ physical symptoms (change scores), Outcome 2 Moderate dose SSRI.
9.1
9.1. Analysis
Comparison 9 SSRIs versus placebo ‐ functional symptoms (end scores), Outcome 1 Low dose SSRI.
9.2
9.2. Analysis
Comparison 9 SSRIs versus placebo ‐ functional symptoms (end scores), Outcome 2 Moderate dose SSRI.
10.1
10.1. Analysis
Comparison 10 SSRIs versus placebo ‐ functional symptoms (change scores), Outcome 1 Low dose SSRI.
10.2
10.2. Analysis
Comparison 10 SSRIs versus placebo ‐ functional symptoms (change scores), Outcome 2 Moderate dose SSRI.
11.1
11.1. Analysis
Comparison 11 SSRIs versus placebo ‐ irritability (end scores), Outcome 1 Low dose SSRI.
11.2
11.2. Analysis
Comparison 11 SSRIs versus placebo ‐ irritability (end scores), Outcome 2 Moderate dose SSRI.
12.1
12.1. Analysis
Comparison 12 SSRIs versus placebo ‐ irritability (change scores), Outcome 1 Low dose SSRI.
12.2
12.2. Analysis
Comparison 12 SSRIs versus placebo ‐ irritability (change scores), Outcome 2 Moderate dose SSRI.
13.1
13.1. Analysis
Comparison 13 SSRIs versus placebo: response rates, Outcome 1 Low dose SSRI.
13.2
13.2. Analysis
Comparison 13 SSRIs versus placebo: response rates, Outcome 2 Moderate dose SSRI.
13.3
13.3. Analysis
Comparison 13 SSRIs versus placebo: response rates, Outcome 3 High dose SSRI.
14.1
14.1. Analysis
Comparison 14 SSRIs versus placebo: withdrawal for any reason, Outcome 1 Low dose.
14.2
14.2. Analysis
Comparison 14 SSRIs versus placebo: withdrawal for any reason, Outcome 2 Mod dose.
15.1
15.1. Analysis
Comparison 15 Luteal SSRI versus continuous SSRI, Outcome 1 All symptoms (end scores).
15.2
15.2. Analysis
Comparison 15 Luteal SSRI versus continuous SSRI, Outcome 2 Response rate.
15.3
15.3. Analysis
Comparison 15 Luteal SSRI versus continuous SSRI, Outcome 3 Adverse effects.
16.1
16.1. Analysis
Comparison 16 Semi‐intermittent versus other regimens, Outcome 1 Response rate.
16.2
16.2. Analysis
Comparison 16 Semi‐intermittent versus other regimens, Outcome 2 Withdrawal due to adverse effects.
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References

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Yonkers 1997 {published data only}
    1. Yonkers KA, Halbriech U, Freeman E, Brown C, Endicott J, Frank E, et al. Symptomatic improvement of premenstrual dysphoric disorder with sertraline treatment. JAMA 1997;278(12):983‐8. - PubMed
Young 1998 {published data only}
    1. Young SA, Hurt PH, Benedeck DM, Howard RS. Treatment of PDD with sertraline during the luteal phase: a randomised, double‐blind, placebo controlled crossover trial. Journal of Clinical Psychiatry 1998;59:76‐80. - PubMed
    1. Young SA, Hurt PH, Benedek DM, Howard RS. Treatment of premenstrual dysphoric disorder with sertraline during the luteal phase: A randomized, double blind placebo controlled crossover trial. American Psychiatric Association 150th Annual Meeting, San Diego USA. 1997. - PubMed
    1. Young SA, Hurt PH, Benedek DM, Howard RS. Treatment of premenstrual dysphoric disorder with sertraline during the luteal phase: A randomized, double blind placebo controlled crossover trial. Journal of Clinical Psychiatry 1998;59:76‐80. - PubMed

References to studies excluded from this review

Alpay 2001 {published data only}
    1. Alpay F, Turhan N. Intermittant versus continuous sertraline therapy in the treatment of premenstrual dysphoric disorders. International Journal of Fertility 2001;46:228‐31. - PubMed
Brandenburg 1993 {published data only}
    1. Brandenburg S, Tuynman‐Qua H, Verheij R, Pepplinkhuizen L. Treatment of premenstrual syndrome with fluoxetine: an open study. International Clinical Psychopharmacology 1993;8:315‐7. - PubMed
De la Gandara 1997 {published data only}
    1. Gandara Martin JJ. Trastorno disforico premenstrual: Tratamiento a largo plazo con fluoxetina y discontinuacion [Premenstrual dysphoric disorder:long term treatment with fluoxetine and discontinuation]. Actas Luso‐Espanolas de Neurologia, Psiquiatria y Ciencias Afines 1997;25:235‐42. - PubMed
Diegoli 1998 {published data only}
    1. Diegoli M, DaFonseca A, Diegoli CA, Pinotti JA. A double blind trial of four medications to treat severe premenstrual syndrome. International Journal of Gynecology and Obstetrics 1998;62:63‐7. - PubMed
Elks 1993 {published data only}
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Flores Ramos 2003 {published data only}
    1. Fores Ramos M, Ontiveros Uribe M, Cortes Sotres J. Comparison between continuous and intermittent treatment with citalopram..... [Comparacion entre el tratamiento continuo y el intermitente con citalopram para el trastorno disforico premenstrual]. Salud Mental 2003;26(003):37‐45.
Freeman 1996 {published data only}
    1. Freeman EW, Rickels K, Sondheimer SJ. Comparison of serotonergic and noradrenergic antidepressant medications in treatment of premenstrual syndrome (PMS). XXIst Collegium Internationale Neuro‐psychopharmacologicum, Glasgow, Scotland. 12‐16th July 1998.
    1. Freeman EW, Rickels K, Sondheimer SJ. Sertraline versus desipramine in PMS treatment. 151st Annual Meeting of the American Psychiatric Association, Toronto, Canada. 30th May‐4th June 1998, issue 118C.
    1. Freeman EW, Rickels K, Sondheimer SJ, Wittmaack FM. Sertraline versus desipramine in the treatment of premenstrual syndrome: an open label trial. Journal of Clinical Psychiatry 1996;57:7‐11. - PubMed
Freeman 1999b {published data only}
    1. Freeman EW, Rickels K, Arredono F, Lee‐Chuan K, Pollack S, Sondheimer S. Full or half cycle treatment of severe premenstrual syndrome with a serotonergic antidepressant. Journal of Cliniical Psychopharmacology 1999;19(1):3‐9. - PubMed
Freeman 2000 {published data only}
    1. Freeman EW, Sondheimer SJ, Polansky M, Garcia‐Espagna B. Predictors of response to sertraline treatment of severe premenstrual syndromes. Journal of Clinical Psychiatry 2000;61(8):579‐84. - PubMed
Freeman 2002 {published data only}
    1. Freeman E, Jabara S, Sondheimer S, Auletto R. Citalopram in PMS patients with prior SSRI treatment failure: A preliminary study. Journal of Womens Health & Gender‐based Medicine 2002;11(5):459‐64. - PubMed
Freeman 2005 {published data only}
    1. Freeman E, Sondheimer S, Sammel M, Ferdousi T, Lin H. A preliminary study of luteal phase versus symptom‐onset dosing with escitalopram for premenstrual dysphoric disorder. Journal of Clinical Psychiatry 2005;66(6):769‐73. - PubMed
Glaxo 2002 {unpublished data only}
    1. GlaxoSmithKline. A 3‐Month, Double‐blind, Placebo‐controlled, Fixed‐dose, Extension Study of Paroxetine CR (12.5 mg and 25 mg/day) Continuous Treatment for PMDD Patients Completing Studies 29060/677, 688 or 689 [Study no 29060/711]. http://www.gsk‐clinicalstudyregister.com/result_detail.jsp?protocolId=29060%2F711&study... Accessed 16 August 2012.
Landen 2009 {published data only}
    1. Landen M, Erlandsson H, Bengtsson F, Andersch B, Eriksson E. Short onset of action of a serotonin reuptake inhibitor when used to reduce premenstrual irritability. Neuropsychopharmacology 2009;34:585‐92. - PubMed
Miller 2008 {published data only}
    1. Miller MN, Newell CL, Miller BE, Frizzell PG, Kayser RA, Ferslew KE. Variable dosing of sertraline for premenstrual exacerbation of depression: a pilot study. Journal of Women's Health 2008;17(6):993‐7. - PubMed
Pearlstein 1994 {published data only}
    1. Pearlstein TB, Stone AB. Long term fluoxetine treatment of late luteal phase dysphoric disorder. Journal of Clinical Psychiatry 1994;55:332‐5. - PubMed
Pearlstein 2000 {published data only}
    1. Pearlstein T, Haskett R, Stout A, Frank E, Endicott J. Sertraline improves psychosocial functioning in premenstrual dysphoric disorder. 151st Annual Meeting of the American Psychiatric Association, 30th May‐ 4th June Toronto, Canada. 1998.
    1. Pearlstein TB, Halbreich U, Batzar ED, Brown CS, Endicott J, Frank E, et al. Psychosocial functioning in women with premenstrual dysphoric disorder before and after treatment with sertraline or placebo. Journal of Clinical Psychiatry 2000;61(2):101‐9. - PubMed
Rickels 1990 {published data only}
    1. Rickels K. Fluoxetine in the treatment of PMS. Current Therapeutic Research 1990;48:161‐8.
Steiner 1997 {published data only}
    1. Steiner M, Korzekwa MI, Lamont J, Wilkins A. Intermittent fluoxetine dosing in the treatment of women with premenstrual dysphoria. Psychopharmacology Bulletin 1997;33:771‐4. - PubMed
Sundblad 1992 {published data only}
    1. Sundblad C, Modigh K, Andersch B, Eriksson E. Clomipramine effectively reduces irritability and dysphoria: a placebo controlled trial. Acta Psychiatrica Scandinavia 1992;85:39‐47. - PubMed
Sundblad 1993 {published data only}
    1. Sundblad C, Hedberg M, Eriksson E. Clomipramine administered during the luteal phase reduces the symptoms of premenstrual syndrome: A placebo controlled trial. Neuropsychopharmacology 1993;9(2):133‐45. - PubMed
Sundblad 1997 {published data only}
    1. Sundblad C Wikander I, Andersch B, Eriksson E. A naturalistic study of paroxetine in premenstrual syndrome: efficacy and side‐effects during ten cycles of treatment. European Neuropsychopharmacology 1997;7(3):201‐6. - PubMed
Veeninga 1990 {published data only}
    1. Veeninga AT, Westenberg HG, Weusten JT. Fluvoxamine in the treatment of menstrually related disorders. Psychopharmacology 1990;102:414‐6. - PubMed
Wu 2008 {published data only}
    1. Wu K‐Y, Liu C‐Y, Hsiao M‐C. Six‐month paroxetine treatment of premenstrual dysphoric disorder: continuous versus intermittent treatment protocols. Psychiatry and Clinical Neurosciences 2008;62:109‐14. - PubMed
Yonkers 1996 {published data only}
    1. Yonkers KA, Gullion C, Williams A, Novak K, Rush AJ. Paroxetine as a treatment for premenstrual dysphoric disorder. Journal of Clinical Psychopharmacology 1996;16(1):3‐8. - PubMed
Yonkers 2002 {unpublished data only}
    1. Yonkers KA. Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. http://clinicaltrials.gov/ct2/show/NCT00048854.
Yonkers 2006 {published data only}
    1. Yonkers K, Holthausen G, Poschman K, Howell H. Symptom‐onset treatment for women with premenstrual dysphoric disorder. Journal of Clinical Psychopharmacology 2006;26(2):198‐202. - PubMed

References to ongoing studies

Yonkers 2007 {unpublished data only}
    1. Yonkers KA, Altemus M, Kornstein S. Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder. http://www.clinicaltrials.gov/ct2/show/NCT00536198 2007.
Yonkers 2010 {unpublished data only}
    1. Yonkers KA. Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS). http://clinicaltrials.gov/ct2/show/NCT00965562 2010.

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Dimmock 2000
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