The Efficacy and Safety of Dutasteride and Finasteride in Patients With Benign Prostatic Hyperplasia

A Systematic Review and Meta-Analysis

Yao Li; Jie Ma; Xin-Hua Qin; Chuan-Yi Hu


Transl Androl Urol. 2022;11(3):313-324. 

In This Article

Abstract and Introduction


Background: Although the efficacy and safety of monotherapy in the treatment of benign prostatic hyperplasia (BPH) have been established clinically, the efficacy and safety of dutasteride and finasteride have not been compared. The aim was to systematically evaluate the efficacy and safety of the two drugs in the treatment of BPH to provide medical evidence for clinical treatment.

Methods: A search of relevant articles was conducted using the electronic databases PubMed, Embase, Medline, Cochrane Library, China Academic Journals Full-text Database (CJFD), Chinese Science and Technology Journal Database (VIP) and Wanfang Database. Randomized controlled trials (RCTs) comparing the efficacy of finasteride (control group) with that of dutasteride (experimental group) in the treatment of BPH with respect to the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), prostate volume (PV), quality of life (QOL), serum prostate-specific antigen (PSA) level and adverse drug reactions (ADRs) after medication were strictly evaluated and considered for inclusion. Rev Man 5.4 software was used for the meta-analysis.

Results: A total of 8 RCTs were included, with a total of 2,116, patients. The meta-analysis showed that compared with finasteride, dutasteride can effectively improve the Qmax of patients with BPH [mean difference (MD) =0.32; 95% confidence interval (CI): (0.01, 0.63); P=0.04]. There was no significant difference in reducing IPSS [MD =0.13; 95% CI: (−0.55, 0.82); P=0.70], improving PV [MD =−1.25; 95% CI: (−3.30, 0.79); P=0.23], reducing QOL [MD =−0.44; 95% CI: (−0.93, 0.05); P=0.08] and serum PSA level [MD =−0.04; 95% CI: (−0.15, 0.07); P=0.50], and the occurrence of ADRs [relative risk (RR) =−0.01; 95% CI: (−0.05, 0.04); P=0.72], there was no significant difference.

Discussion: Dutasteride is better than finasteride in improving the Qmax of patients with BPH. There was no statistically significant difference in symptoms, PV, PSA, QOL, or adverse reactions. Dutasteride is an effective and safe treatment for BPH. Due to the limitations of the methodological quality and sample size of the included studies, this conclusion needs to be verified by stratified RCTS with high volumes and long follow-up times.


Benign prostatic hyperplasia (BPH) is a common disease in middle-aged and elderly men. A meta-analysis has shown that the incidence of BPH in Chinese men increases significantly with age, with an incidence of 69.2% in men over 80 years old.[1] There are many treatments for BPH: (I) drug therapy, including alpha blockers, 5-alpha reductase inhibitors, and combination drug therapy; (II) minimally invasive therapies, such as transurethral microwave thermotherapy, transurethral needle ablation, homium laser enulcleation of prostate; (III) surgery procedures include: transurethral resection of the prostate, transurethral incision of the prostate, simple prostatectomy, laser surgery. Drug therapy is one of the curative treatments for BPH. Finasteride and dutasteride are the most frequently considered in treating BPH. Finasteride is a 5α-reductase (5α-R) inhibitor, which is the first-line therapy for BPH. Nevertheless, it has been reported that finasteride can increase the risk of loss of libido and ejaculatory dysfunction.[2,3] Dutasteride is a 5α-R inhibitor as well. It has been found that dutasteride has advantages in improving symptoms related to prostatic hyperplasia and reducing acute urinary retention in the treatment of BPH.[4,5] The 5α-R inhibitor decreases the level of dihydrotestosterone (DHT), which is responsible for prostate growth. Finasteride reduces 70% of circulating DHT levels, while dutasteride almost completely reduces DHT levels in both the serum and the prostate. A study found that in treating BPH, compared with finasteride, dutasteride showed a greater decrease in prostate-specific antigen (PSA) and International Prostate Symptom Score (IPSS).[6] Whereas, results of Yin et al. suggested no significant differences between dutasteride and finasteride in treating BPH, except dutasteride improves BPH symptoms in IPSS.[7] Therefore, this study systematically compared the efficacy of dutasteride and finasteride for BPH to provide medical evidence for clinical treatment.

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