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Table 1 Summary of results in the individual randomised, double blind, placebo controlled trials.

From: Finasteride in the treatment of clinical benign prostatic hyperplasia: A systematic review of randomised 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

-

+

++

  1. + 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