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Meta-Analysis
. 2024 Aug 14;8(8):CD001396.
doi: 10.1002/14651858.CD001396.pub4.

Selective serotonin reuptake inhibitors for premenstrual syndrome and premenstrual dysphoric disorder

Cecilie Jespersen  1   2 , Mette Petri Lauritsen  3   4 , Vibe G Frokjaer  5   6 , Jeppe B Schroll  1   2   7
Affiliations
Meta-Analysis

Selective serotonin reuptake inhibitors for premenstrual syndrome and premenstrual dysphoric disorder

Cecilie Jespersen et al. Cochrane Database Syst Rev. .

Abstract

Background: Premenstrual syndrome (PMS) is a combination of physical, psychological and social symptoms in women of reproductive age, and premenstrual dysphoric disorder (PMDD) is a severe type of the syndrome, previously known as late luteal phase dysphoric disorder (LLPDD). Both syndromes cause symptoms during the two weeks leading up to menstruation (the luteal phase). Selective serotonin reuptake inhibitors (SSRIs) are increasingly used as a treatment for PMS and PMDD, either administered in the luteal phase or continuously. We undertook a systematic review to assess the evidence of the positive effects and the harms of SSRIs in the management of PMS and PMDD.

Objectives: To evaluate the benefits and harms of SSRIs in treating women diagnosed with PMS and PMDD.

Search methods: We searched the Cochrane Gynaecology and Fertility (CGF) Specialised Register of Controlled Trials, CENTRAL, MEDLINE, Embase and PsycINFO for randomised controlled trials (RCTs) in November 2023. We checked reference lists of relevant studies, searched trial registers and contacted experts in the field for any additional trials. This is an update of a review last published in 2013.

Selection criteria: We considered studies in which women with a prospective diagnosis of PMS, PMDD or LLPDD were randomised to receive SSRIs or placebo.

Data collection and analysis: We used standard Cochrane methods. We pooled data using a random-effects model. We calculated standardised mean differences (SMDs) with 95% confidence intervals (CIs) for premenstrual symptom scores, using 'post-treatment' scores for continuous data. We calculated odds ratios (ORs) with 95% CIs for dichotomous outcomes. We stratified analyses by type of administration (luteal phase or continuous). We calculated absolute risks and the number of women who would need to be taking SSRIs in order to cause one additional adverse event (i.e. the number needed to treat for an additional harmful outcome (NNTH)). We rated the overall certainty of the evidence for the main findings using GRADE.

Main results: We included 34 RCTs in the review. The studies compared SSRIs (i.e. fluoxetine, paroxetine, sertraline, escitalopram and citalopram) to placebo. SSRIs probably reduce overall self-rated premenstrual symptoms in women with PMS and PMDD (SMD -0.57, 95% CI -0.72 to -0.42; I2 = 51%; 12 studies, 1742 participants; moderate-certainty evidence). SSRI treatment was probably more effective when administered continuously than when administered only in the luteal phase (P = 0.03 for subgroup difference; luteal phase group: SMD -0.39, 95% CI -0.58 to -0.21; 6 studies, 687 participants; moderate-certainty evidence; continuous group: SMD -0.69, 95% CI -0.88 to -0.51; 7 studies, 1055 participants; moderate-certainty evidence). The adverse effects associated with SSRIs were nausea (OR 3.30, 95% CI 2.58 to 4.21; I2 = 0%; 18 studies, 3664 women), insomnia (OR 1.99, 95% CI 1.51 to 2.63; I2 = 0%; 18 studies, 3722 women), sexual dysfunction or decreased libido (OR 2.32, 95% CI 1.57 to 3.42; I2 = 0%; 14 studies, 2781 women), fatigue or sedation (OR 1.52, 95% CI 1.05 to 2.20; I2 = 0%; 10 studies, 1230 women), dizziness or vertigo (OR 1.96, 95% CI 1.36 to 2.83; I2 = 0%; 13 studies, 2633 women), tremor (OR 5.38, 95% CI 2.20 to 13.16; I2 = 0%; 4 studies, 1352 women), somnolence and decreased concentration (OR 3.26, 95% CI 2.01 to 5.30; I2 = 0%; 8 studies, 2050 women), sweating (OR 2.17, 95% CI 1.36 to 3.47; I2 = 0%; 10 studies, 2304 women), dry mouth (OR 2.70, 95% CI 1.75 to 4.17; I2 = 0%; 11 studies, 1753 women), asthenia or decreased energy (OR 3.28, 95% CI 2.16 to 4.98; I2 = 0%; 7 studies, 1704 women), diarrhoea (OR 2.06, 95% CI 1.37 to 3.08; I2 = 0%; 12 studies, 2681 women), and constipation (OR 2.39, 95% CI 1.09 to 5.26; I2 = 0%; 7 studies, 1022 women). There was moderate-certainty evidence for all adverse effects other than somnolence/decreased concentration, which was low-certainty evidence. Overall, the certainty of the evidence was moderate. The main weakness was poor reporting of study methodology. Heterogeneity was low or absent for most outcomes, although there was moderate heterogeneity in the analysis of overall self-rated premenstrual symptoms. Based on the meta-analysis of response rate (the outcome with the most included studies), there was suspected publication bias. In total, 68% of the included studies were funded by pharmaceutical companies. This stresses the importance of interpreting the review findings with caution.

Authors' conclusions: SSRIs probably reduce premenstrual symptoms in women with PMS and PMDD and are probably more effective when taken continuously compared to luteal phase administration. SSRI treatment probably increases the risk of adverse events, with the most common being nausea, asthenia and somnolence.

PubMed Disclaimer

Conflict of interest statement

CJ: none.

LM: none.

VF has received consultancy fees from Gedeon Richter, Jannsen‐Cilag and H. Lundbeck A S.

JS: none.

Figures

1
1
PRISMA 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
Funnel plot: SSRIs versus placebo for overall premenstrual symptoms.
6
6
Funnel plot: SSRI versus placebo for response rate.
1.1
1.1. Analysis
Comparison 1: SSRI versus placebo, Outcome 1: Self‐rated overall premenstrual symptoms
1.2
1.2. Analysis
Comparison 1: SSRI versus placebo, Outcome 2: Nausea
1.3
1.3. Analysis
Comparison 1: SSRI versus placebo, Outcome 3: Insomnia or sleep disturbance
1.4
1.4. Analysis
Comparison 1: SSRI versus placebo, Outcome 4: Sexual dysfunction or decreased libido
1.5
1.5. Analysis
Comparison 1: SSRI versus placebo, Outcome 5: Fatigue or sedation
1.6
1.6. Analysis
Comparison 1: SSRI versus placebo, Outcome 6: Dizziness or vertigo
1.7
1.7. Analysis
Comparison 1: SSRI versus placebo, Outcome 7: Tremor
1.8
1.8. Analysis
Comparison 1: SSRI versus placebo, Outcome 8: Somnolence/decreased concentration
1.9
1.9. Analysis
Comparison 1: SSRI versus placebo, Outcome 9: Sweating
1.10
1.10. Analysis
Comparison 1: SSRI versus placebo, Outcome 10: Dry mouth
1.11
1.11. Analysis
Comparison 1: SSRI versus placebo, Outcome 11: Asthenia/decreased energy
1.12
1.12. Analysis
Comparison 1: SSRI versus placebo, Outcome 12: Diarrhoea
1.13
1.13. Analysis
Comparison 1: SSRI versus placebo, Outcome 13: Constipation
1.14
1.14. Analysis
Comparison 1: SSRI versus placebo, Outcome 14: Withdrawal due to adverse effects
1.15
1.15. Analysis
Comparison 1: SSRI versus placebo, Outcome 15: Psychological symptoms
1.16
1.16. Analysis
Comparison 1: SSRI versus placebo, Outcome 16: Physical symptoms
1.17
1.17. Analysis
Comparison 1: SSRI versus placebo, Outcome 17: Functional symptoms
1.18
1.18. Analysis
Comparison 1: SSRI versus placebo, Outcome 18: Irritability
1.19
1.19. Analysis
Comparison 1: SSRI versus placebo, Outcome 19: Response rates
1.20
1.20. Analysis
Comparison 1: SSRI versus placebo, Outcome 20: Withdrawal for any reason
2.1
2.1. Analysis
Comparison 2: SSRI versus placebo: PMS/PMDD subgroup, Outcome 1: Self‐rated overall premenstrual symptoms
2.2
2.2. Analysis
Comparison 2: SSRI versus placebo: PMS/PMDD subgroup, Outcome 2: Response rates
3.1
3.1. Analysis
Comparison 3: SSRI versus placebo: SSRI type subgroup, Outcome 1: Self‐rated overall premenstrual symptoms, SSRI type
4.1
4.1. Analysis
Comparison 4: Luteal SSRI versus continuous SSRI, Outcome 1: Response rate
See this image and copyright information in PMC

Update of

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Pearlstein 1997 {published data only}
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Pearlstein 2005 {published data only}
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Su 1997 {published data only}
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References to studies excluded from this review

Alpay 2001 {published data only}
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Freeman 1999b {published data only}
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Freeman 2000 {published data only}
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Freeman 2002 {published data only}
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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
GlaxoSmithKline 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. www.gsk-clinicalstudyregister.com/result_detail.jsp?protocolId=29060%2F7... (accessed 16 August 2012).
Hunter 2002 {published data only}
    1. Hunter MS, Ussher JM, Browne SJ, Cariss M, Jelley R, Katz M. A randomized comparison of psychological (cognitive behavior therapy), medical (fluoxetine) and combined treatment for women with premenstrual dysphoric disorder. Journal of Psychosomatic Obstetrics & Gynecology 2002;23(3):193-9. [DOI: 10.3109/01674820209074672] - DOI - PubMed
IRCT20190430043433N1 {unpublished data only}
    1. IRCT20190430043433N1. Compare the effect of acupressure therapy and fluoxetine on the symptoms of premenstrual syndrome: a randomized clinical trial. irct.behdasht.gov.ir/trial/39241 (first received 11 May 2019).
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
Maranho 2020 {published and unpublished data}
    1. Maranho MC. Ensaio Clínico com Fluoxetina em Baixa Dose para o Tratamento da Síndrome Pré-menstrual: um Estudo Piloto [Clinical Trial with Low Dose of Fluoxetine for the Treatment of Premenstrual Syndrome: a Pilot Study] [Masters thesis]. Ribeirão Preto (Brazil): Ribeirão Preto Medical School, University of São Paulo, 2020. [URL: www.teses.usp.br/teses/disponiveis/17/17163/tde-02122020-122142/]
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
Nazari 2013 {published data only}
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NCT00048854 {unpublished data only}
    1. Yonkers KA. Antidepressant treatment for premenstrual syndrome and premenstrual dysphoric disorder. clinicaltrials.gov/ct2/show/NCT00048854 (first received 8 November 2002).
Nemat‐Shahi 2020 {published data only}
    1. Nemat-Shahi M, Asadi A, Nemat-Shahi M, Soroosh D, Mozari S, Bahrami-Taghanaki H, et al. Comparison of saffron versus fluoxetine in treatment of women with premenstrual syndrome: a randomized clinical trial study. Indian Journal of Forensic Medicine and Toxicology 2020;14(2):1760-5.
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; 1998 May 30-Jun 4; Toronto (Canada).
    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
Ramos 2003 {published data only}
    1. Ramos MF, Ontiveros Uribe M, Cortes Sotres J. Comparison between continuous and intermittent treatment with citalopram for premenstrual dysphoric disorder [Comparacion entre el tratamiento continuo y el intermitente con citalopram para el trastorno disforico premenstrual]. Salud Mental 2003;26(003):37-45.
Rickels 1990 {published data only}
    1. Rickels K. Fluoxetine in the treatment of PMS. Current Therapeutic Research 1990;48:161-8.
Shehata 2020 {published data only}
    1. Shehata NA, Moety G, El Wahed HA, Fahim AS, Katta MA, Hussein GK. Does adding fluoxetine to combined oral contraceptives containing drospirenone improve the management of severe premenstrual syndrome? A 6-month randomized double-blind placebo-controlled three-arm trial. Reproductive sciences (Thousand Oaks, Calif.) 2020;27(2):743-50. [DOI: 10.1007/s43032-019-00080-x] - DOI - PubMed
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}
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Wu 2008 {published data only}
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Yonkers 1996 {published data only}
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Yonkers 2006 {published data only}
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References to ongoing studies

NCT02427334 {unpublished data only}
    1. NCT02427334. Dienogest versus luteal phase fluoxetine in the management of premenstrual syndrome. clinicaltrials.gov/ct2/show/NCT02427334 (first received 20 April 2015).
NCT02562053 {unpublished data only}
    1. NCT02562053. Does adding oral contraceptives to fluoxetine improve the management of premenstrual syndrome? clinicaltrials.gov/ct2/show/NCT02562053 (first received 26 September 2015).

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References to other published versions of this review

Brown 2002
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