Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial (THERESA-3)

Table 1 Demographic and baseline characteristics of the patients n (%)

	rSK (n = 110)	Phenylephrine (n = 110)	Total (n = 220)
Gender
Male/female (% male)	58/52 (52.7)	66/44 (60.0)	124/96 (56.4)
Ethnicity
White	60 (54.5)	56 (50.9)	116 (52.7)
Black	13 (11.8)	16 (14.5)	29 (13.2)
Mestizo	37 (33.6)	38 (34.5)	75 (34.1)
Age (yr)
Median ± QR (range)	46 ± 20 (18-74)	45 ± 18 (21-75)	45 ± 19 (18-75)
Days from start of symptoms to treatment onset
Median ± QR (range)	3 ± 2 (0-26)	3 ± 3 (0-38)	3 ± 3 (0-38)
Classification of the hemorrhoids
External	73 (66.4)	73 (66.4)	146 (66.4)
Internal	31 (28.2)	30 (27.3)	61 (27.7)
Mixed	6 (5.5)	7 (6.4)	13 (5.9)
Grade of prolapse (I or II:III or IV)	(13:24)	(7:30)	(20:54)
Presence of thrombosis	59 (53.6)	57 (51.8)	116 (52.7)
Debut of disease	48 (43.6)	44 (40.0)	92 (41.8)
Previous thrombectomy	17 (15.5)	16 (14.5)	33 (15.0)
Previous hemorrhoidectomy	2 (1.8)	1 (0.9)	3 (1.4)

QR: Quartile range; rSK: Recombinant streptokinase.

Table 2 Results of the clinical evaluations after treatment n (%)

	rSK (n = 110)	Phenylephrine (n = 110)	P value
Response after 3 d	41 (37.3)	7 (6.4)	< 0.0011
Response after 5 d (95%CI)3	83 (75.5%; 67.4-83.5)3	36 (32.7%; 24.0-41.5)3	< 0.00113
Difference (95%CI)3	42.7 (30.5-54.2)3
Response after 10 d	92 (83.6)	64 (58.2)	< 0.0011
Days to response: median (95%CI)	5 (4.8-5)	10 (9.8-10)	0.0312

¹Likelihood ratio χ²;

²Log-rank test;

³Main outcome. rSK: Recombinant streptokinase.

Table 3 Subgroup analyses: 5^th day complete response n (%)

	rSK	Phenylephrine	P value
Type of acute event
Without thrombosis	38/51 (74.5)	15/53 (28.3)	< 0.00011
With thrombosis	45/59 (76.3)	21/57 (36.8)	< 0.00011
Thrombectomy	1/59 (1.7)	8/57 (14.0)	0.0162
Hemorrhoid classification
External	54/73 (74.0)	22/73 (30.1)	< 0.00011
Internal + mixed	29/37 (78.4)	14/37 (37.8)	< 0.00011
Prolapse grade
I or II	11/13 (85)	4/7 (57)	0.292
III or IV	18/24 (75)	10/30 (33)	0.0021

¹Likelihood ratio χ²;

²Log-rank test. rSK: Recombinant streptokinase.

Table 4 Adverse events occurring in more than one patient

	rSK (n = 110)	Phenylephrine (n = 110)
Total subjects with adverse events	19 (17.3)	30 (27.3)
Events
Local burning sensation	3 (2.7)	11 (10.0)
Local pricking sensation	4 (3.6)	9 (8.2)
Rectal bleeding	5 (4.5)	4 (3.6)
Anal pruritus	3 (2.7)	5 (4.5)
Diarrhea	4 (3.6)	0
Headache	1 (0.9)	3 (2.7)
Anal pain	3 (2.7)	1 (0.9)
Local heat sensation	0	2 (1.8)

rSK: Recombinant streptokinase.