A double‐blind placebo controlled study of tamsulosin in the management of benign prostatic hyperplasia in an Indian population

Abstract

Objective: Benign prostatic hyperplasia is a common disorder in ageing males worldwide affecting one out of four males over 50 years of age. The aim of the present study is to demonstrate safety and efficacy of tamsulosin in its medical management. Methods: A total of 72 patients were enrolled; 38 patients given tamsulosin and 34 in the placebo group were enrolled. The mean age group was 61 years. Patients with an International Prostate Symptom Score (IPSS) of > 10, maximum flow rate < 13 mL/s and average flow rate < 6 mL/s with post residual urine volume (PRUV) > 100 mL and prostate-specific antigen < 4 ng/mL, were given 0.4 mg of tamsulosin/placebo daily on a randomized double-blind controlled study for 2 months. Patients with renal or hepatic failure, carcinoma prostate, stricture urethra, neurogenic bladder were excluded. All patients were followed up at the end of the second, fourth and eighth week. Results: There were three dropouts leaving 69 patients for evaluation. Improvement in the IPSS score was significantly greater with tamsulosin compared with the placebo. Similarly there was significant improvement in uroflowrate with tamsulosin compared to the placebo. The PRUV decreased by 38.8% with tamsulosin compared with the placebo. No significant change in blood biochemistry was noted between the two groups excepting for blood pressure, which showed a fall with tamsulosin compared to placebo. Adverse reaction was noted in five patients (7%), but none were withdrawn from the study. Conclusions: Our study confirms tamsulosin as a very effective and safe drug in the management of benign prostatic hyperplasia patients not having absolute indication for surgery with excellent patient compliance.

Measuring symptomatic relief in men with lower urinary tract symptoms

“…We found that a difference of more than 3 points was reported in only four out of 28 studies. In these studies the mean decrease in the IPSS score was 6.8 (tamsulosin v placebo), 8 3.1 (doxazosin and finasteride v placebo, but in combination not better than doxazosin monotherapy), 9 3.9 (terazosin v placebo), 10 and 3.1 (terazosin and finasteride v placebo, but in combination not better than terazosin monotherapy). 11 Therefore, hardly any of the available drugs is better than placebo at a "clinically relevant" level.…”