Résumé
The objective of the present study was to evaluate the efficacy and safety of Prostina, a multi-ingredient herbal formulation in benign prostatic hyperplasia (BPH) in comparison with terazosin. A randomised, open, parallel, controlled clinical trial was carried out in ambulatory men aged between 40-80 years suffering from BPH, with American Urological Association (AUA) symptom index score of at least 8 or more at recruitment. One group received 2 Prostina capsules twice daily for 12 weeks; the other received terazosin 2 mg at bedtime for 12 weeks. Urodynamic parameters, AUA score, biochemical and clinical adverse effects were assessed. Twenty subjects completed the study in Prostina group and 20 in terazosin group. The groups were comparable at baseline in age and assessment criteria. Majority of urodynamic parameters showed improving trends in both the groups. AUA symptom score declined significantly from 19.50 +/- 1.40 (mean +/- standard error) to 1.04 +/- 0.68 in Prostina group and from 16.95 +/- 1.23 to 4.14 +/- 0.88 in terazosin group. The AUA symptom score in 12 weeks follow-up was significantly lower in Prostina group than terazosin group (p = 0.005). Other laboratory-parameters remained unaltered in both the groups. Prostina is as effective as terazosin in providing symptomatic relief in BPH.