Table 2.

Key randomized trials with 5α-reductase inhibitors in men with benign prostatic enlargement and LUTS

Trial	Duration (month)	Treatment arms	Patients (n)	Symptom change (IPSS)	Q max change (ml/s)	Change PV (%)	BPH-surgery RR (%)	AUR RR (%)	Oxford level of evidence (1a–5)
Andersen et al. [24]a	24	Placebo	2,109						1b
		Finasteride	2,113	NA	NA	NA	−34c	−57c
McConnell et al. [13]	48	Placebo	1,503	−1.3	+0.2	+14.0			1b
		Finasteride	1,513	−3.3c	+1.9c	−18.0c	−55c	−57c
McConnell et al. [15]b	54	Placebo	737	−4.0	1.4	+24.0			1b
		Doxazosin	756	−6.0c	2.5c	+24.0	−3	−35
		Finasteride	768	−5.0c	2.2c	−19.0c,d	−64c,d	−68c,d
		Combination	786	−7.0c,d,e	3.7c,d,e	−19.0c,d	−67c,d	−81c,d
Roehrborn et al. [16]a	24	Placebo	2,158	−2.3	0.6	+1.5			1b
		Dutasteride	2,167	−4.5c	2.2c	−25.7c	−48c	−57c
Roehrborn et al. [21]	24	Tamsulosin	1,611	−4.3	0.9	0.0			1b
		Dutasteride	1,623	−4.9	1.9	−28.0	NA	NA
		Combination	1,610	−6.2d,e	2.4d,e	−26.9d	NA	NA
Roehrborn et al. [23]	48	Tamsulosin	1,611	−3.8	0.7	+4.6			1b
		Dutasteride	1,623	−5.3	2.0	−28.0d	−31.1d	−18.3d
		Combination	1,610	−6.3d,e	2.4d,e	−27.3d	−70.6d	−67.6d

Q _max maximum urinary flow rate, PV prostate volume, AUR acute urinary retention, RR risk reduction vs. placebo, NA not assessed

^aPooled data

^bMedian values

^cSignificant compared with placebo

^dSignificant compared with α-blocker

^eSignificant compared with 5α-reductase inhibitor