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

Disclosures

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

In This Article

Results

Characteristic of Eligible Studies

A total of 240 potentially relevant articles were selected, including 28 Chinese articles and 212 English articles. After reading the abstracts and titles, 222 publications were excluded. Of the remaining 18 studies, 10 were excluded due to being non-RCTs or having incomplete data or an absence of BPH disease Finally, 8 RCTs comparing the efficacy of dutasteride and finasteride in the treatment of BPH over 6 months of treatment or longer were included in this meta-analysis; 2,116 subjects were involved. The study selection process is illustrated in Figure 1. The main characteristics of the 8 studies are presented in Table 1.

Figure 1.

Literature search flow chart.

Quality Assessment and Risk of Bias Assessment

The Jadad scores of the 8 included articles were all greater than 3, as shown in Table 1. The risks of bias of the 8 included studies are shown in Figures 2,3.

Figure 2.

Risk of bias for the 8 included studies.

Figure 3.

Risk of bias summary for the 8 included studies. +: low risk of bias; −: high risk of bias; ?: unclear risk of bias.

In the Cochrane risk of bias (RoB 2.0) analysis, all literature had no data miss and selection bias. Most literature was a low risk of bias. Little literature had high-risk selection bias and performance bias (Figure 2).

Only one literature had a high-risk bias in selection bias and another one literature had performance bias individually (Figure 3).

Meta-analysis Results of Outcomes

IPSS. Five RCTs[10–12,16,17] were included to analyze the IPSS scores after treatment. There was no significant heterogeneity (P=0.63; I2=0%). The forest plots indicated that there was no significant difference in IPSS between the subset analyses of BPH patients who were administered dutasteride versus finasteride [MD =0.13; 95% CI: (−0.55, 0.82); P=0.70] (Figure 4).

Figure 4.

Forest plot of the IPSS of patients with BPH treated with dutasteride or finasteride. SD, standard deviation; CI, confidence interval; IPSS, International Prostate Symptom Score; BPH, benign prostatic hyperplasia.

Qmax. Five RCTs[10–13,16] with a total of 1,887 patients were included to analyze Qmax after treatment. There was no significant heterogeneity (P=0.57; I2=0%). The forest plots indicated a significantly greater increase in Qmax in the dutasteride group than in the finasteride group [MD =0.32; 95% CI: (0.01, 0.63); P=0.04] (Figure 5).

Figure 5.

Forest plot of the Qmax in patients with BPH treated with dutasteride or finasteride. SD, standard deviation; CI, confidence interval; Qmax, maximum urinary flow rate; BPH, benign prostatic hyperplasia.

PV. Six RCTs[10–15] with a total of 1,964 patients were included to analyze PV after treatment. There was no significant heterogeneity (P=0.84; I2=0%). The forest plots indicated that there was no significant difference in PV between the subset analyses of BPH patients who were administered dutasteride versus finasteride [MD =−1.25; 95% CI: (−3.30, 0.79); P=0.23] (Figure 6).

Figure 6.

Forest plot of PV in patients with BPH treated with dutasteride or finasteride. SD, standard deviation; CI, confidence interval; PV, prostate volume; BPH, benign prostatic hyperplasia.

QOL. Four RCTs[10–12,17] were included to analyze the QOL of these patients after treatment. There was significant heterogeneity (P=0.01; I2=73%). The random effects model was used. The forest plots indicated that there was no significant difference in QOL between the subset analyses of BPH patients who were administered dutasteride versus finasteride [MD =−0.44; 95% CI: (−0.93, 0.05); P=0.08] (Figure 7).

Figure 7.

Forest plot of the QOL of patients with BPH treated with dutasteride or finasteride. SD, standard deviation; CI, confidence interval; QOL, quality of life; BPH, benign prostatic hyperplasia.

Serum PSA Level. Four RCTs[12,13,16,17] were included to analyze the serum PSA levels after treatment. There was no significant heterogeneity (P=0.70; I2=0%). The forest plots indicated that there was no significant difference in the serum PSA levels between the subset analyses of BPH patients who were administered dutasteride versus finasteride [MD =−0.04; 95% CI: (−0.15, 0.07); P=0.50] (Figure 8).

Figure 8.

Forest plot of serum PSA levels of patients with BPH treated with dutasteride or finasteride. SD, standard deviation; CI, confidence interval; PSA, prostate-specific antigen; BPH, benign prostatic hyperplasia.

ADRs. Four RCTs[10–13,15] with a total of 1,870 patients were included to analyze adverse reactions. There was no significant difference in heterogeneity (P=0.73; I2=0%). The forest plots indicated that there was no significant difference in ADRs between the subset analyses of BPH patients who were administered dutasteride versus finasteride [MD =−0.01; 95% CI: (−0.05, 0.04); P=0.72] (Figure 9).

Figure 9.

Forest plot of adverse effects of dutasteride and finasteride in patients with BPH. CI, confidence interval; BPH, benign prostatic hyperplasia.

Publication Bias

Funnel plots were drawn based on the literature whose main indicators are IPSS, Qmax, PV, QOL, serum PSA, and adverse events indicating that there was no significant publication bias and that the results were mostly stable and reliable (Figure 10). However, considering that few studies were included in this meta-analysis and most of them dispersed at the bottom of funnel plots, publication bias cannot be completely ruled out.

Figure 10.

Funnel plots of randomized controlled studies included in the meta-analysis. (A) Funnel plots of studies included IPSS. (B) Funnel plots of studies included Qmax. (C) Funnel plots of studies included PV. (D) Funnel plots of studies included QOL. (E) Funnel plots of studies included PSA. (F) Funnel plots of studies included adverse events. SMD, standard mean difference; IPSS, International Prostate Symptom Score; Qmax, maximum urinary flow rate; PV, prostate volume; QOL, quality of life; PSA, prostate-specific antigen.

Sensitivity Analysis

As indicated in Figure 11, the sensitivity analysis of the meta-analysis literature that included IPSS, Qmax, PV, QOL, serum PSA, and adverse events individually, the significance of the combined effect sizes did not change significantly after the corresponding literature for each indicator was excluded from inclusion in turn. That means there were no extremes in the included studies.

Figure 11.

Sensitivity analysis of meta-analysis literature. (A) Sensitivity analysis of meta-analysis literature included IPSS. (B) Sensitivity analysis of meta-analysis literature included Qmax. (C) Sensitivity analysis of meta-analysis literature included PV. (D) Sensitivity analysis of meta-analysis literature included QOL. (E) Sensitivity analysis of meta-analysis literature included PSA. (F) Sensitivity analysis of meta-analysis literature included adverse events. SMD, standard mean difference; CI, confidence interval; IPSS, International Prostate Symptom Score; Qmax, maximum urinary flow rate; PV, prostate volume; QOL, quality of life; PSA, prostate-specific antigen.

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