A prospective study to evaluate the efficacy and adverse effects of alpha-blockers in the management of benign prostatic hyperplasia

ABSTRACT

Background: Benign prostatic hyperplasia (BPH) is the most common cause for the lower urinary tract symptoms in men. The conservative management of BPH comprises of alpha blockers, especially selective alpha 1 adrenergic blockers for symptomatic relief. Aims and Objectives: We aimed to evaluate the efficacy and adverse effects of alpha blockers in managing BPH. Materials and Methods: After getting approval from the Institutional Human Ethics Committee and consent from subjects, this prospective, randomized, and controlled trial was conducted. In this study, patients under inclusion criteria were divided into two groups. Group I received silodosin 8 mg once daily for 8 weeks. Group II received tamsulosin 0.4 mg once daily for 8 weeks. Primary outcome measure was reduction in international prostate symptom score (IPSS). Adverse events during study period were recorded. Results: A total of 90 patients were enrolled in this study. Ten patients were excluded and remaining 80 patients were divided as 40 in Group I (Silodosin) and 40 in Group II (Tamsulosin), patients were followed up for 8 weeks. As primary outcome, the IPSS at 8th week was significantly <0 week, that is, baseline in both the groups. The comparison of IPSS within Group I and Group II at 0 week and 8th week was significant (P < 0.05). The quality of life comparison within Group I and Group II at 0 week and 8th week was significant (P < 0.05). Both the drugs were well tolerated. Retrograde ejaculation and diarrhea were noted with silodosin (Group I), dizziness and orthostatic hypotension were noted with Tamsulosin (Group II). Conclusion: The obtained results showed that both silodosin and tamsulosin produced significant improvement in IPSS and quality of Life in BPH patients. In silodosin group, retrograde ejaculation and diarrhea were notable adverse effects and in tamsulosin group, dizziness and orthostatic hypotension were noted.