H. Lepor et al., THE IMPACT OF MEDICAL THERAPY ON BOTHER DUE TO SYMPTOMS, QUALITY-OF-LIFE AND GLOBAL OUTCOME, AND FACTORS PREDICTING RESPONSE, The Journal of urology, 160(4), 1998, pp. 1358-1367
Purpose: We determine the effect of placebo, finasteride, terazosin an
d a combination of drugs on bother due to symptoms, quality of life an
d patient perception of improvement, and identify baseline clinical fa
ctors that predict clinical response to medical therapy. Materials and
Methods: A total of 1,229 subjects with clinical benign prostatic hyp
erplasia (BPH) were randomized to 1 year of placebo, finasteride, tera
zosin or drug combination. The primary outcome measures were American
Urological Association (AUA) symptom score and peak flow rate. Relevan
t secondary outcome measures were symptom problem score, BPH impact sc
ore and global rating of improvement. Results: Group mean differences
in symptom problem and BPH impact scores between the finasteride versu
s placebo, and terazosin versus combination groups were not statistica
lly or clinically significant. Group mean differences in all outcome m
easures were highly statistically significant between the terazosin an
d finasteride, and combination and finasteride groups. The percentage
of subjects who rated improvement as marked or moderate with placebo,
finasteride, terazosin and combination was 39, 44, 61 and 65%, respect
ively. In the subsets of men in the placebo, finasteride, terazosin an
d combination groups with prostates greater than 50 cm.(3) group mean
decrease from baseline in AUA symptom score was -2.5, -3.6, -6 and -7,
group mean increase in peak flow rate was 0.6, 2.7, 3.6 and 3.7 mi. p
er second, group mean decrease in symptom problem score was -2.2, -1.9
, -3.1 and -4.5, and group mean decrease in BPH impact score was -0.6,
-0.3, -1.1 and -1.5, respectively. A correlational analysis failed to
show a significant relationship between baseline prostate volume and
treatment response to finasteride. There was a significant but weak re
lationship between change in AUA symptom score and peak flow rate in t
he finasteride and combination groups. The symptom responses with tera
zosin were independent of baseline peak flow rate. Conclusions: In men
with clinical BPH finasteride and placebo are equally effective, whil
e terazosin and combination are significantly more effective. In men w
ith clinical BPH and large prostates the advantage of finasteride over
placebo in terms of symptom reduction, impact on bother due to sympto
ms and quality of life is small at best, while the advantage of terazo
sin and combination over finasteride and placebo is highly significant
. Baseline prostate volume was not a predictor of response to finaster
ide in the overall study population. On the basis of our results oil b
lockers, such as terazosin, should be first line medical treatment for
BPH.