Introduction

Benign prostatic hyperplasia (BPH) is a common noncancerous enlargement of the prostate, affecting up to 50% of men over 50 and 90% by age 80. Risk factors include aging, family history, obesity, metabolic syndrome, hypertension, hormonal imbalance, and lifestyle habits. BPH often causes lower urinary tract symptoms (LUTS) such as frequency, urgency, nocturia, weak stream, and incomplete emptying, significantly impairing quality of life. Treatment aims to relieve symptoms, starting with medications like alpha-blockers, 5-alpha reductase inhibitors, anticholinergics, and phosphodiesterase-5 (PDE5) inhibitors. Surgery, such as transurethral resection of prostate (TURP), is reserved for severe cases or poor drug response. Alpha-blockers remain first-line therapy, though comparative efficacy data are limited.

Aim

To assess the clinical efficacy and safety of α-blockers in the management of BPH.

Method

Study Design

Study Selection and Data Extraction 

• The eligible studies were identified using comprehensive electronic search of PubMed, Ovid MEDLINE, EMBASE and Cochrane databases
• The studies that met the PICO (Population, Intervention, Comparator, Outcome) criteria were included in this NMA
• The studies that assessed the safety and efficacy of α-blockers in men aged >45 years with lower urinary tract symptoms (LUTS) related to BPH

Endpoints

Primary Endpoints

• International prostate symptom score (IPSS),
• Maximum flow rate (Qmax)
• Quality of life (QoL)
• Post-void residual volume (PVR)

Secondary Endpoints

Results

• This NMA included 22 studies covering 3371 patients with six kinds of α-blockers (Naftopidil 25 mg, 50 mg and 75 mg, Silodosin 8 mg, Tamsulosin 0.2 and 0.4 mg, Alfuzosin 2.5 and 10 mg, Doxazosin 2 mg, 4 mg and 8 mg and Terazosin 0.5 mg)
• A majority of trials (72.73%) had treatment duration of more than 4 weeks
• The mean age of patients was 65.3 years
• The baseline mean (SD) values of IPSS, QoL, Qmax and PVR were 18.1 (4.6), 4.2 (0.8), 10.2 ml/s (3.4), and 49.0 ml (34.2) respectively
• Significant reduction in IPSS was noted with tamsulosin 0.4 mg, followed by naftopidil 50 mg and silodosin 8 mg as compared to placebo
• Based on the p-score, the highest ranked treatment was tamsulosin 0.4 mg and the lowest-ranked treatment was doxazosin 2 mg
• Doxazosin 8 mg had the highest probability of improving QoL
• Tamsulosin 0.4 mg and naftopidil 50 mg had the highest probability of improving PVR
• Tamsulosin 0.4 mg had the highest probability of improving Qmax with a p-score of 0.75
• A total of 297 adverse events were reported among all the α-blockers, with 190 being reported with silodosin
• Ejaculation dysfunction, dizziness and hypotension were the most common AEs

Conclusion

• All the α-blockers reduced IPSS, tamsulosin 0.4 mas associated with superior improvements in IPSS, PVR, and Qmax as compared to the others in the management of BPH
• The treatment-related adverse events were notable with silodosin
• Larger, long-term studies and direct comparisons are needed for safety validation

Sci Rep. 2024 May 15;14(1):11116. Doi: 10.1038/s41598-024-61977-5.