. 2009 Mar 5;30(3):271–281. doi: 10.1038/aps.2009.1

Table 3. Effect of SPE on IPSS, peak urinary flow rate (Q_max) and mean values of urinary frequency (nocturia) in men with BPH in clinical trials.

Study	Group	Dose	Duration	IPSS		Q_max		Nocturia
Study	Group	Dose	Duration	n	change	n	change	n	change
Placebo-controlled study
Bent S et al⁸	SPE	160^*2	12m	112	−0.68#	112	0.42
	Placebo	Placebo		113	−0.72#	113	−0.01
Willetts KE et al¹⁷	SPE	160^*2	12m			46	1.5
	Placebo	Placebo				47	4.4
Gerber GS et al⁵⁸	SPE	160^*2	6m	41	−4.4	41	1.0
	Placebo	Placebo		44	−2.2	44	1.4
Marks LS et al⁵⁹	SPE (blend)	106^*3	6m	21	−2.24	21	1.27
	Placebo	Placebo		23	−1.39	23	0.09
Descotes JL et al⁶⁰	SPE	160^*2	1m			82	3.42	82	−0.67
	Placebo	Placebo				94	1.06	94	−0.32
Reece SH et al⁶¹	SPE	160^*2	3m			33	2.35	33	−1.0
	Placebo	Placebo				37	2.3	37	−1.0
Cukier J et al⁶²	SPE	2^80^2	2–3m					43	−1.1
	Placebo	Placebo						47	−0.5
Tasca A et al⁶³	SPE	160^*2	3m			14	3.3	14	−2.6
	Placebo	Placebo				13	0.6	13	−1.2
Champault G et al⁶⁴	SPE	2^80^2	1m			46	2.7	47	−1.4
	Placebo	Placebo				39	0.25	41	−0.5
Boccafoschi C et al⁶⁵	SPE	160^*2	2m			11	4.13	11	−2.2
	Placebo	Placebo				11	1.96	11	−1.0
Emili E et al⁶⁶	SPE	160^*2	1m			15	3.37	15	−1.6
	Placebo	Placebo				15	0.2	15	−0.4
Active-controlled study
Debruyne F et al¹⁶	SPE	320^*1	12m	350	−4.4		1.79
	Tamsulosin	0.4^*1		354	−4.4		1.89
Carraro JC et al¹¹	SPE	160^*2	6m	464	−5.8		2.68	464	−0.74
	Finasteride	5		477	−6.2		3.26	477	−0.69
Grasso M et al⁶⁷	SPE	160^*2	0.75m			31	2.8	32	−1.0
	Alfuzosin	7.5				32	4.7	31	−0.9
Adriazola Semino et al⁶⁸	SPE	160^*2	3m			20	1.5	20	−0.2
	Prazosin					22	0.47	22	−0.4

AUASI: American Urological Association Symptom Index

Table 3. Effect of SPE on IPSS, peak urinary flow rate (Qmax) and mean values of urinary frequency (nocturia) in men with BPH in clinical trials.