Association between 5<i>α</i>-reductase inhibitors and sexual dysfunction in subjects with benign prostatic hyperplasia: a meta-analysis_Chinese Journal of Evidence-Based Medicine

Authors：

WU Yanghaotian ¹ , GUO Man ² ,  HAN Xuemei ¹

1. School of Public Health, Lanzhou University, Lanzhou 730000, P.R.China;
2. Department of Endocrinology and Metabolism, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, P.R.China;

Corresponding author：

HAN Xuemei, Email: hanxm2001@163.com

Keywords：

5α-reductase inhibitor; Benign prostatic hyperplasia; Sexual dysfunction; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.202103037

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Objective To systematically review the association between 5α-reductase inhibitors (5ARIs) and risk of sexual dysfunction in subjects with benign prostatic hyperplasia (BPH).Methods PubMed, Web of Science, The Cochrane Library, EMbase, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect studies on the association between 5ARIs and risk of sexual dysfunction in subjects with BPH from inception to October 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Stata 12.0 software.Results A total of 15 studies involving 17 774 subjects were included. The results of the meta-analysis showed that compared with the placebo group, 5ARIs could significantly increase risk of erectile dysfunction (RR=1.52, 95%CI 1.36 to 1.69, P<0.000 1), while decrease libido (RR=1.79, 95%CI 1.37 to 2.32, P<0.000 1) and ejaculation disorder (RR=2.97, 95%CI 1.82 to 4.83, P<0.000 1) in subjects with BPH. Subgroup analysis of the type of 5ARIs, intervention period, publication year and sample size showed that the 5ARIs had a higher risk of sexual dysfunction than the placebo group.Conclusions Current evidence shows that 5ARIs can increase risk of erectile dysfunction, decrease libido and ejaculation disorder in subjects with BPH. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.

Citation： WU Yanghaotian, GUO Man, HAN Xuemei. Association between 5α-reductase inhibitors and sexual dysfunction in subjects with benign prostatic hyperplasia: a meta-analysis. Chinese Journal of Evidence-Based Medicine, 2021, 21(8): 915-921. doi: 10.7507/1672-2531.202103037 Copy

1.	Garg A, Bansal S, Saha S, et al. Study of correlation of urodynamic profile with symptom scoring and ultrasonographic parameters in patients with benign prostatic hyperplasia. J Family Med Prim Care, 2020, 9(1): 215-220.
2.	Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol, 2015, 22 (Suppl 1): 1-6.
3.	Basit A, Amory JK, Prasad B. Effect of dose and 5α-reductase inhibition on the circulating testosterone metabolite profile of men administered oral testosterone. Clin Transl Sci, 2018, 11(5): 513-522.
4.	Gacci M, Ficarra V, Sebastianelli A, et al. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med, 2014, 11(6): 1554-1566.
5.	Traish AM, Hassani J, Guay AT, et al. Adverse side effects of 5α-reductase inhibitors therapy: persistent diminished libido and erectile dysfunction and depression in a subset of patients. J Sex Med, 2011, 8(3): 872-884.
6.	Corona G, Rastrelli G, Maseroli E, et al. Inhibitors of 5α-reductase-related side effects in patients seeking medical care for sexual dysfunction. J Endocrinol Invest, 2012, 35(10): 915-920.
7.	Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
8.	Beisland HO, Binkowitz B, Brekkan E, et al. Scandinavian clinical study of finasteride in the treatment of benign prostatic hyperplasia. Eur Urol, 1992, 22(4): 271-277.
9.	Clark RV, Hermann DJ, Cunningham GR, et al. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. J Clin Endocrinol Metab, 2004, 89(5): 2179-2184.
10.	Fwu CW, Eggers PW, Kirkali Z, et al. Change in sexual function in men with lower urinary tract symptoms/benign prostatic hyperplasia associated with long-term treatment with doxazosin, finasteride and combined therapy. J Urol, 2014, 191(6): 1828-1834.
11.	Gormley GJ, Stoner E, Bruskewitz RC, et al. The effect of finasteride in men with benign prostatic hyperplasia. The finasteride study group. N Engl J Med, 1992, 327(17): 1185-1191.
12.	Lepor H, Williford WO, Barry MJ, et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans affairs cooperative studies benign prostatic hyperplasia study group. N Engl J Med, 1996, 335(8): 533-539.
13.	Marberger MJ. Long-term effects of finasteride in patients with benign prostatic hyperplasia: a double-blind, placebo-controlled, multicenter study. PROWESS study group. Urology, 1998, 51(5): 677-686.
14.	Na Y, Ye Z, Zhang S. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. Clin Drug Invest, 2012, 32(1): 29-39.
15.	Nickel JC, Fradet Y, Boake RC, et al. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar safety plus efficacy canadian two year study. CMAJ, 1996, 155(9): 1251-1259.
16.	Roehrborn CG, Boyle P, Nickel JC, et al. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology, 2002, 60(3): 434-441.
17.	Roehrborn CG, Manyak MJ, Palacios-Moreno JM, et al. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int, 2018, 121(4): 647-658.
18.	Tenover JL, Pagano GA, Morton AS, et al. Efficacy and tolerability of finasteride in symptomatic benign prostatic hyperplasia: a primary care study. Primary care investigator study group. Clin Ther, 1997, 19(2): 243-258.
19.	Toren P, Margel D, Kulkarni G, et al. Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. BMJ, 2013, 346: f2109.
20.	Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol, 2009, 16(9): 745-750.
21.	Vaughan D, Imperato-McGinley J, McConnell J, et al. Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia. Urology, 2002, 60(6): 1040-1044.
22.	Wessells H, Roy J, Bannow J, et al. Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. Urology, 2003, 61(3): 579-584.
23.	Corona G, Rastrelli G, Vignozzi L, et al. How to recognize late-onset hypogonadism in men with sexual dysfunction. Asian J Androl, 2012, 14(2): 251-259.
24.	McConnell JD, Bruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride long-term efficacy and safety study group. N Engl J Med, 1998, 338(9): 557-563.
25.	Giatti S, Foglio B, Romano S, et al. Effects of subchronic finasteride treatment and withdrawal on neuroactive steroid levels and their receptors in the male rat brain. Neuroendocrinology, 2016, 103(6): 746-757.
26.	Gur S, Kadowitz PJ, Hellstrom WJ. Effects of 5-alpha reductase inhibitors on erectile function, sexual desire and ejaculation. Expert Opin Drug Saf, 2013, 12(1): 81-90.
27.	Pinsky MR, Gur S, Tracey AJ, et al. The effects of chronic 5-alpha-reductase inhibitor (dutasteride) treatment on rat erectile function. J Sex Med, 2011, 8(11): 3066-3074.
28.	Corona G, Tirabassi G, Santi D, et al. Sexual dysfunction in subjects treated with inhibitors of 5α-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis. Andrology, 2017, 5(4): 671-678.
29.	Lee S, Lee YB, Choe SJ, et al. Adverse sexual effects of treatment with finasteride or dutasteride for male androgenetic alopecia: a systematic review and meta-analysis. Acta Derm Venereol, 2019, 99(1): 12-17.
30.	Liu L, Zhao S, Li F, et al. Effect of 5α-reductase inhibitors on sexual function: a meta-analysis and systematic review of randomized controlled trials. J Sex Med, 2016, 13(9): 1297-1310.
31.	杨勇军, 王东文. 5α-还原酶抑制剂对良性前列腺增生患者膀胱功能影响的研究进展. 现代泌尿外科杂志, 2016, 21(7): 567-570.

1. Garg A, Bansal S, Saha S, et al. Study of correlation of urodynamic profile with symptom scoring and ultrasonographic parameters in patients with benign prostatic hyperplasia. J Family Med Prim Care, 2020, 9(1): 215-220.
2. Vuichoud C, Loughlin KR. Benign prostatic hyperplasia: epidemiology, economics and evaluation. Can J Urol, 2015, 22 (Suppl 1): 1-6.
3. Basit A, Amory JK, Prasad B. Effect of dose and 5α-reductase inhibition on the circulating testosterone metabolite profile of men administered oral testosterone. Clin Transl Sci, 2018, 11(5): 513-522.
4. Gacci M, Ficarra V, Sebastianelli A, et al. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med, 2014, 11(6): 1554-1566.
5. Traish AM, Hassani J, Guay AT, et al. Adverse side effects of 5α-reductase inhibitors therapy: persistent diminished libido and erectile dysfunction and depression in a subset of patients. J Sex Med, 2011, 8(3): 872-884.
6. Corona G, Rastrelli G, Maseroli E, et al. Inhibitors of 5α-reductase-related side effects in patients seeking medical care for sexual dysfunction. J Endocrinol Invest, 2012, 35(10): 915-920.
7. Higgins JP, Altman DG, Gøtzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ, 2011, 343: d5928.
8. Beisland HO, Binkowitz B, Brekkan E, et al. Scandinavian clinical study of finasteride in the treatment of benign prostatic hyperplasia. Eur Urol, 1992, 22(4): 271-277.
9. Clark RV, Hermann DJ, Cunningham GR, et al. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. J Clin Endocrinol Metab, 2004, 89(5): 2179-2184.
10. Fwu CW, Eggers PW, Kirkali Z, et al. Change in sexual function in men with lower urinary tract symptoms/benign prostatic hyperplasia associated with long-term treatment with doxazosin, finasteride and combined therapy. J Urol, 2014, 191(6): 1828-1834.
11. Gormley GJ, Stoner E, Bruskewitz RC, et al. The effect of finasteride in men with benign prostatic hyperplasia. The finasteride study group. N Engl J Med, 1992, 327(17): 1185-1191.
12. Lepor H, Williford WO, Barry MJ, et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans affairs cooperative studies benign prostatic hyperplasia study group. N Engl J Med, 1996, 335(8): 533-539.
13. Marberger MJ. Long-term effects of finasteride in patients with benign prostatic hyperplasia: a double-blind, placebo-controlled, multicenter study. PROWESS study group. Urology, 1998, 51(5): 677-686.
14. Na Y, Ye Z, Zhang S. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. Clin Drug Invest, 2012, 32(1): 29-39.
15. Nickel JC, Fradet Y, Boake RC, et al. Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECT study). PROscar safety plus efficacy canadian two year study. CMAJ, 1996, 155(9): 1251-1259.
16. Roehrborn CG, Boyle P, Nickel JC, et al. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology, 2002, 60(3): 434-441.
17. Roehrborn CG, Manyak MJ, Palacios-Moreno JM, et al. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int, 2018, 121(4): 647-658.
18. Tenover JL, Pagano GA, Morton AS, et al. Efficacy and tolerability of finasteride in symptomatic benign prostatic hyperplasia: a primary care study. Primary care investigator study group. Clin Ther, 1997, 19(2): 243-258.
19. Toren P, Margel D, Kulkarni G, et al. Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. BMJ, 2013, 346: f2109.
20. Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol, 2009, 16(9): 745-750.
21. Vaughan D, Imperato-McGinley J, McConnell J, et al. Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia. Urology, 2002, 60(6): 1040-1044.
22. Wessells H, Roy J, Bannow J, et al. Incidence and severity of sexual adverse experiences in finasteride and placebo-treated men with benign prostatic hyperplasia. Urology, 2003, 61(3): 579-584.
23. Corona G, Rastrelli G, Vignozzi L, et al. How to recognize late-onset hypogonadism in men with sexual dysfunction. Asian J Androl, 2012, 14(2): 251-259.
24. McConnell JD, Bruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride long-term efficacy and safety study group. N Engl J Med, 1998, 338(9): 557-563.
25. Giatti S, Foglio B, Romano S, et al. Effects of subchronic finasteride treatment and withdrawal on neuroactive steroid levels and their receptors in the male rat brain. Neuroendocrinology, 2016, 103(6): 746-757.
26. Gur S, Kadowitz PJ, Hellstrom WJ. Effects of 5-alpha reductase inhibitors on erectile function, sexual desire and ejaculation. Expert Opin Drug Saf, 2013, 12(1): 81-90.
27. Pinsky MR, Gur S, Tracey AJ, et al. The effects of chronic 5-alpha-reductase inhibitor (dutasteride) treatment on rat erectile function. J Sex Med, 2011, 8(11): 3066-3074.
28. Corona G, Tirabassi G, Santi D, et al. Sexual dysfunction in subjects treated with inhibitors of 5α-reductase for benign prostatic hyperplasia: a comprehensive review and meta-analysis. Andrology, 2017, 5(4): 671-678.
29. Lee S, Lee YB, Choe SJ, et al. Adverse sexual effects of treatment with finasteride or dutasteride for male androgenetic alopecia: a systematic review and meta-analysis. Acta Derm Venereol, 2019, 99(1): 12-17.
30. Liu L, Zhao S, Li F, et al. Effect of 5α-reductase inhibitors on sexual function: a meta-analysis and systematic review of randomized controlled trials. J Sex Med, 2016, 13(9): 1297-1310.
31. 杨勇军, 王东文. 5α-还原酶抑制剂对良性前列腺增生患者膀胱功能影响的研究进展. 现代泌尿外科杂志, 2016, 21(7): 567-570.

Chinese Journal of Evidence-Based Medicine

Association between 5α-reductase inhibitors and sexual dysfunction in subjects with benign prostatic hyperplasia: a meta-analysis

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