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12 SPECIAL REPORT Adverse Sexual Effects of Treatment with Finasteride or Dutasteride for Male Androgenetic Alopecia: A Systematic Review and Meta- analysis Solam LEE, Young Bin LEE, Sung Jay CHOE and Won-Soo LEE Department of Dermatology and Institute of Hair and Cosmetic Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea Treatment of male androgenetic alopecia with 5α-reductase inhibitors is efficacious. However, the risk of adverse sexual effects remains controversial. This systematic review and meta-analysis investiga- ted the risk of adverse sexual effects due to treat- ment of androgenetic alopecia in male patients with finasteride, 1 mg/day, or dutasteride, 0.5 mg/day. Fifteen randomized double-blinded placebo-control- led trials (4,495 subjects) were meta-analysed. Use of 5α-reductase inhibitors carried a 1.57-fold risk of sexual dysfunction (95% confidence interval (95% CI) 1.19–2.08). The relative risk was 1.66 (95% CI 1.20– 2.30) for finasteride and 1.37 (95% CI 0.81–2.32) for dutasteride. Both drugs were associated with an increased risk, although the increase was not statis- tically significant for dutasteride. As studies into du- tasteride were limited, further trials are required. It is important that physicians are aware of, and assess, the possibility of sexual dysfunction in patients treated with 5α-reductase inhibitors. Key words: finasteride; dutasteride; 5α-reductase inhibitor; androgenetic alopecia; sexual dysfunction; erectile dysfunction. Accepted Sep 11, 2018; Epub ahead of print Sep 12, 2018 Acta Derm Venereol 2019; 99: 12–17. Corr: Won-Soo Lee, Department of Dermatology, Yonsei University Wonju College of Medicine, Ilsan-ro 20, Wonju, Gangwon-do 26426, Republic of Korea. E-mail: [email protected] A ndrogenetic alopecia (AGA) is the most common form of hair loss (1). AGA affects over 58% of ma- les aged 50 years or older, and its prevalence increases with age (2). Patients with AGA experience loss of self-esteem and socioemotional deprivation due to their elderly appearance (3, 4). Various therapeutic options for AGA have been introduced, including oral or topical 5α-reductase inhibitors (5-ARIs), 3% or 5% minoxidil, and low-level laser (light) therapy, and their effectiveness for AGA has been discussed in a recent systematic review and meta-analysis (5). Among these agents, 5-ARIs represent one of the main therapeutic options for male AGA. 5-ARIs decrease the dihydrotestosterone concentration in the serum and scalp by 60–70% through inhibition of 5α-reductase (6). Two 5-ARIs, finasteride and dutasteride, are currently used in doi: 10.2340/00015555-3035 Acta Derm Venereol 2019; 99: 12–17 SIGNIFICANCE Oral 5α-reductase inhibitors, including finasteride and dutasteride, are the preferred and most efficacious treat­ ment modalities for male androgenetic alopecia (male pat- tern baldness). Despite their promising efficacy on hair regrowth, there is debate about their adverse effect of these drugs on sexual function. In this systematic review and meta-analysis of randomized double-blinded placebo- controlled trials, the use of oral 5α-reductase inhibitors had an overall 1.55-fold risk of sexual dysfunction, including erectile dysfunction, decreased libido and ejaculatory dys- function. Therefore, potential sexual adverse events should be assessed in patients treated with oral finasteride or du- tasteride. clinical practice. Despite their promising efficacy, there is much debate regarding possible adverse sexual effects due to treatment with 5-ARIs. Some meta-analyses have evaluated their association; however, the results are con- flicting (7–9). Mella et al. (9) reported that treatment with oral finasteride, 1 mg/day or 5 mg/day, increased the risk of sexual dysfunction. Conversely, Gupta et al. (7) and Liu et al. (8) reported that treatment with 5-ARIs did not increase the risk when these agents were indicated for male AGA. To date, their association with sexual dysfunction remains controversial. Moreover, there has been an increase in the number of reports describing the risks of sexual dysfun- ction associated with the use of 5-ARIs (10, 11). The preferred treatment regimens for AGA are cur- rently 1 mg/day finasteride or 0.5 mg/day dutasteride. However, in previous meta-analyses (8, 9), heteroge- neous 5-ARI regimens consisting of 1 mg/day or 5 mg/day finasteride or 0.5 mg/day dutasteride were not separately analysed. As a result, their individual risk has not been well demonstrated. In this context, summarizing the risk of adverse sexual effects in male patients with AGA treated with finasteride 1 mg/day or dutasteride 0.5 mg/day was required. METHODS A systematic review and meta-analysis was performed following the principles of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) (12). This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta Journal Compilation © 2019 Acta Dermato-Venereologica.