To the Editor: Female pattern hair loss (FPHL) is the most common form of alopecia in women. Currently, topical minoxidil is the only treatment approved by the US Food and Drug Administration; however, the systemic agent spironolactone is prescribed off-label despite few physician-reported outcome studies supporting its efficacy in FPHL.1Van Zuuren E.J. Fedorowicz Z. Carter B. Evidence-based treatments for female pattern hair loss: a summary of a Cochrane systematic review.Br J Dermatol. 2012; 167: 995-1010Crossref PubMed Scopus (34) Google Scholar,2Famenini S. Slaught C. Duan L. Goh C. Demographics of women with female pattern hair loss and the effectiveness of spironolactone therapy.J Am Acad Dermatol. 2015; 73: 705-706Abstract Full Text Full Text PDF PubMed Scopus (18) Google Scholar One open-intervention study concluded that high-dose spironolactone (200 mg daily) was as effective as the potent androgen receptor blocker cyproterone acetate.3Sinclair R. Wewerinke M. Jolley D. Treatment of female pattern hair loss with oral antiandrogens.Br J Dermatol. 2005; 152: 466-473Crossref PubMed Scopus (142) Google Scholar Another prospective observational study showed hair growth with combination oral minoxidil and spironolactone 25 mg daily.4Sinclair R.D. Female pattern hair loss: a pilot study investigating combination therapy with low-dose oral minoxidil and spironolactone.Int J Dermatol. 2018; 57: 104-109Crossref PubMed Scopus (58) Google Scholar In this retrospective, observational study, we evaluated the efficacy and adverse effect profile of spironolactone as combination therapy or monotherapy in FPHL. Data from adult women with FPHL who were prescribed spironolactone between March 2015 and March 2019 were retrospectively analyzed. All patients were examined to exclude other hair loss disorders and clinical signs of hyperandrogenism. The average spironolactone dose was 100 mg daily (range, 25-200 mg daily) for a minimum of 6 months. Patients receiving concomitant hair loss treatments were divided into 2 groups: those who had been using topical minoxidil or a low-level laser light device for longer than 6 months experiencing a plateau in hair density and those who started concomitant treatment at the time of spironolactone initiation. Overall, 87% of patients were receiving spironolactone monotherapy or added spironolactone to a long-term hair loss treatment regimen. Baseline hair density was documented per the Sinclair grading scale in whole and half integers by the treating dermatologist and hair specialist and was verified through standardized photographs by a second physician during data collection.5Sinclair R.D. Antiandrogen therapy for androgenetic alopecia.Expert Rev Dermatol. 2006; 1: 261-269Crossref Google Scholar Assessments occurred at 6-month intervals. Data from 79 women with mean age of 50 years (range, 21-79 years) were analyzed. Population characteristics are summarized in Table I. Nearly half of the patients were premenopausal, and of these, 22% had been using hormonal or other contraception for an average of 1.5 years (range, 6-60 months). All patients maintained or improved initial Sinclair score (SS), with an average overall change of 0.65, as shown in Fig 1. The absolute change in SS was linearly correlated with the presenting severity of FPHL, as shown in Table II (correlation coefficient, R = 0.96). Notably, this improvement was independent of concomitant use of hair loss therapies, contraception, or menopause status. Additionally, of the 45 patients using spironolactone for longer than 6 months, 29 (64%) had the best recorded SS at 1 year of use or longer. Twenty-six patients (33%) reported an adverse event, as detailed in Table I. Overall, 3.8% of patients discontinued spironolactone secondary to reported adverse events, and 82% of patients maintained or increased their dose of spironolactone without issue.Table IPatient demographics (N = 79)CharacteristicsValueAge, y Mean50 Range21-79Premenopausal, n (%)39 (49) Combination OCP12 (15) Progesterone IUD5 (6) Copper IUD1 (1) None21 (27)Postmenopausal40 (51)Known PCOS diagnosis, n (%)7 (9)History of breast cancer, n (%)3 (4)Spironolactone dose, initial (N = 79), n (%) 25 mg BID8 (10) 50 mg BID62 (79) Other9 (11)Spironolactone monotherapy (N = 79), n (%) Yes42 (53) No37 (47)Prior use of concomitant therapies (>6 months) (n = 22), n (%) Topical minoxidil19 (24) Low-level laser light device8 (10)Concomitant therapies started with spironolactone (n = 22), n (%) Topical minoxidil10 (13) Low-level laser light device9 (11) Iron supplement5 (6)Dose change of spironolactone (N = 79), n (%) Discontinued3 (4) Dose decreased11 (14) Dose maintained39 (49) Dose increased26 (33)Duration of spironolactone use (N = 79), n (%) 6 months31 (39) 1 year23 (29) >1 year22 (28) Discontinued3 (4)Adverse events reported (n = 26), n (%) Dizziness/lightheadedness13 (17) Menstrual spotting2 (2) Rash2 (2) Nausea2 (2) Increased urination2 (2) Breast tenderness1 (1) Self-resolving hyperkalemia1 (1) Other6 (7)BID, Twice daily; IUD, intrauterine device; OCP, oral contraception; PCOS, polycystic ovary syndrome. Open table in a new tab Table IIAverage change in Sinclair Score after a minimum of 6 months of taking spironolactone, either as monotherapy or in combination with topical minoxidil, low-level laser light therapy, and/or iron supplementationInitial Sinclair scoreNumber of patientsAverage change in Sinclair score1.5-2.0400.32 Mono240.36 Combo160.272.5-3.0270.93 Mono150.90 Combo120.963.5-4.091.19 Mono21.25 Combo71.15Combo, Combination therapy; Mono, monotherapy. Open table in a new tab BID, Twice daily; IUD, intrauterine device; OCP, oral contraception; PCOS, polycystic ovary syndrome. Combo, Combination therapy; Mono, monotherapy. Although improvement in patients with initial SS of 1.5 or 2.0 was modest, patients with a baseline SS of 2.5 or higher showed nearly a full integer change in improvement. This was independent of concomitant use of hair loss treatments, menopausal status, or hormonal contraception use. The duration of spironolactone use also proved important for efficacy, because approximately two thirds of patients had the best recorded SS at 1 year or longer. Current therapies for women's hair loss remain limited, especially oral agents that offer ease of use and increased compliance. This study provides additional evidence for spironolactone, either as monotherapy or adjunct therapy, as an effective and well-tolerated option for FPHL.