Objectives: A prospective study was conducted in a community hospital in order to evaluate the therapeutic effect of dibenyline, finasteride, and a combination of the two drugs for symptomatic benign prostatic hyperplasia (BPH).
Methods: 190 men suffering from severe prostatism entered this study. They were assessed by IPSS symptom score, digital rectal examination, transrectal sonography of the prostate, uroflowmetry and residual urine. The patients were randomly selected for medical treatment with dibenyline 10 mg b.i.d. (n = 71), finasteride 5 mg q.d. (n = 54), and a combination (n = 65). Clinical assessments were carried out before treatment and 3 and 6 months after starting treatment. Patients who could not complete the treatment and those with prostatic cancer were excluded from the final statistics. The quality of life after 6 months of treatment and side effects were also assessed.
Results: A total of 172 patients completed the treatment course and 153 patients completed the periodic clinical assessments. Improvement in IPSS was noted in all 3 groups of patients both at 3 and 6 months. The prostatic volume was found to decrease in the finasteride group and the combination group at 6 months by 24.3 and 10.5%, respectively. Maximal flow rate (Qmax) was significantly improved in the dibenyline and combination groups but not in the finasteride group at 3 months. At 6 months a significant increase in Qmax was noted in all groups with a mean increase of 1.4-1.8 ml/s. The quality of life after treatment was satisfactory in 71.9% of the dibenyline group, 70.4% of the finasteride group and 83.1% of the combination group. Side effects were higher in the dibenyline than the finasteride or combination group. The dropout rate was higher in the dibenyline group (15.5%) than in the finasteride (7.5%) and combination (4.6%) groups. After 6 months of treatment, some of the patients discontinued medication and symptom relapse was noted in 92.6% of the dibenyline group, 57.6% of the finasteride group, and 71% of the combination group.
Conclusions: Medical treatment is effective in treating symptomatic BPH. Combination dibenyline and finasteride provides a weak synergistic clinical effect without additive side effects.