Abstract
To compare efficacy of combined use of fluoxetine and combined oral contraceptives (COC) versus COC alone in treating severe premenstrual syndrome (PMS), a randomized double-blind placebo-controlled three-arm trial was conducted at Cairo and Beni-Suef University Hospitals. PMS was diagnosed prospectively using the Daily Record of Severity of Problems (DRSP). Three hundred women with severe PMS were randomly divided into three equal groups. Group 1 received oral fluoxetine 20 mg daily in addition to COC containing drospirenone daily for 21 days. Group 2 received COC containing drospirenone daily for 21 days in addition to daily oral placebo. Group 3 received placebo similar to COC and oral placebo similar to fluoxetine. Drug duration was 6 months, and women kept daily records of their symptoms using the Daily Record of Severity of Problems (DSRP) form. The main outcome was the number of women with improved PMS in the final cycle of treatment. Women with improved PMS decreased progressively between groups during last treatment month (65% vs. 50% and 2% respectively; p < 0.0001). Combined use of fluoxetine and COC containing drospirenone is superior to COC in severe PMS.
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Nuckols CC. American Psychiatric Association: diagnostic and statistical manual of mental health disorders. 5th edn, vol. 2. Washington, DC: American Psychiatric Association; 2013. pp. 45–6.
Wittchen HU, Becker E, Lieb R, Krause P. Prevalence, incidence and stability of premenstrual dysphoric disorder in the community. Psychol Med. 2002;32:119–321.
Royal College of Obstetricians and Gynecologists. Green Top Guideline No 48. London: RCOG press; 2007.
Yonkers KA, Brown C, Pearlstein TB, Foegh M, Sampson-landers C, Rapkin A. Efficacy of a new low-dose oral contraceptive with drospirenone in premenstrual dysphoric disorder. Obstet Gynecol. 2005;106(3):492–501.
Freeman EW, Kroll R, Rapkin A, Pearlstein T, Brown C, Parsey K, et al. Evaluation of a unique oral contraceptive in the treatment of premenstrual dysphoric disorder. J Womens Health Gend Based Med. 2001;10(6):561–9.
Lete I, Lapuente O. Contraceptive options for women with premenstrual dysphoric disorder: current insights and a narrative review. Open Access J Contracept. 2016;7:117–25.
Lopez LM, Kaptein AA, Helmerhorst FM. Oral contraceptives containing drospirenone for premenstrual syndrome. Cochrane Database Syst Rev. 2012;2:CD006586.
Baker LJ, O’Brien PMS. Premenstrual syndrome (PMS): A peri-menopausal perspective. Maturitas. 2012;72:121–5.
Marjoribanks J, Brown J, O'brien PM, Wyatt K. Selective serotonin reuptake inhibitors for premenstrual syndrome. Cochrane Database Syst Rev. 2013;6:CD001396.
Yonkers KA, Pearlstein TB, Gotman N. A pilot study to compare fluoxetine, calcium, and placebo in the treatment of premenstrual syndrome. J Clin Psychopharmacol. 2013;33(5):614–20.
Cohen LS, Miner C, Brown EW, Freeman E, Halbreich U, Sundell K, et al. Premenstrual daily fluoxetine for premenstrual dysphoric disorder: a placebo-controlled, clinical trial using computerized diaries. Obstet Gynecol. 2002;100(3):435–44.
Cohen LS, Soares CN, Lyster A, Cassano P, Brandes M, Leblanc GA. Efficacy and tolerability of premenstrual use of venlafaxine (flexible dose) in the treatment of premenstrual dysphoric disorder. J Clin Psychopharmacol. 2004;24:540–3.
Endicott J, Nee J, Harrison W. Daily Record of Severity of Problems (DRSP): reliability and validity. Arch Womens Ment Health. 2006;9(1):41–9.
Trull TJ, Ebner-priemer U. Ambulatory assessment. Annu Rev Clin Psychol. 2013;9:151–76.
O’Brien PM, Bäckström T, Brown C, Dennerstein L, Endicott J, Epperson CN, et al. Towards a consensus on diagnostic criteria, measurement and trial design of the premenstrual disorders: the ISPMD Montreal consensus. Arch Womens Ment Health. 2011;14:13–21.
Apter D, Borsos A, Baumgärtner W, Melis GB, Vexiau-Robert D, Colligs-Hakert A, et al. Effect of an oral contraceptive containing drospirenone and ethinylestradiol on general well-being and fluid-related symptoms. Eur J Contracept Reprod. 2003;8(1):37–51.
Brown C, Ling F, Wan J. A new monophasic oral contraceptive containing drospirenone. Effect on premenstrual symptoms. J Reprod Med. 2002;47(1):14–22.
Baulieu E-E, Robel P. Neuroactive steroids, a new brain function? J Steroid Biochem Mol Biol. 1990;37:395–403.
Reddy DS. Neurosteroids: endogenous role in the human brain and therapeutic potentials. Prog Brain Res. 2010;186:113–37.
Wichianpitaya J, Taneepanichskul S. A comparative efficacy of low-dose combined oral contraceptives containing desogestrel and drospirenone in premenstrual symptoms. Obstet Gynecol Int. 2013;2013:487143.
Graham CA, Sherwin BB. A prospective treatment study of premenstrual symptoms using a triphasic oral contraceptive. J Psychosom Res. 1992;36(3):257–66.
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Shehata, N.A.A., Moety, G.A.F.A., El Wahed, H.A.A. et al. 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. Reprod. Sci. 27, 743–750 (2020). https://doi.org/10.1007/s43032-019-00080-x
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DOI: https://doi.org/10.1007/s43032-019-00080-x