Table 1

Summary of results in the individual randomised, double blind, placebo controlled trials.

Author
Number of patients
Quality score
Duration (months)
ITT or PP
Symptom score
Max urinary flow rate (mL/s)
Prostate volume (cm3)

McConnell et al, 1998 PLESS
3040
4
48
PP
++
++
++
Marbergher et al, 1998 PROWESS
2902
5
24
PP
++
++
++
Byrnes et al, 1995
2417
3
12
ITT
+
No data

Tenover et al, 1997
2112
3
12
PP
++
No data

Andersen et al, 1995
707
3
24
PP
++
++
++
Lepor et al, 1996 VA cooperative study.
615
4
12
PP
-
-
++
Nickel et al, 1996 PROSPECT
613
5
24
ITT
++
++
++
Gormley et al, 1992 North American study
598
3
12
ITT
++
++
++
Finasteride study group, 1993 International study
501
3
12
PP
++
+
++
Beisland et al, 1992
182
3
6
ITT
+
+
++
Abrams et al, 1999
121
3
12
PP
-
+
++
Kirby et al, 1992
50
4
3
PP
++
++
-
Yu et al, 1995
50
3
6
PP
+
+
+
Marks et al, 1997
41
4
6
PP
-
-
++
Tammela & Kontturi, 1993
36
3
6
ITT
No data
-
++

Studies with finasteride plus additional interventions
Lukkarinen et al, 1999
61
3
24
PP
-
-
++
Isotalo et al, 2001
55
4
18
ITT
-
+
++

+ p < 0.05 ++ p < 0.01 – No significant difference between finasteride and placebo ITT Intention to treat analysis – all randomised patients PP Per protocol analysis – may have included men who discontinued treatment

Edwards and Moore BMC Urology 2002 2:14   doi:10.1186/1471-2490-2-14