Recombinant streptokinase vs hydrocortisone suppositories in acute hemorrhoids: A randomized controlled trial

Table 1 Patient demographic and baseline characteristics n (%)

		rSK-A	rSK-B	Hydrocortisone	Total
n		170	170	170	510
Gender	Male/female (%male)	90/80 (52.9)	95/75 (55.9)	92/78 (54.1)	277/233 (54.3)
Ethnicity	White	76 (44.7)	98 (57.6)	80 (47.1)	254 (49.8)
	Black	18 (10.6)	18 (10.6)	20 (11.8)	56 (11.0)
	Mestizo	76 (44.7)	54 (31.8)	70 (41.2)	200 (39.2)
Age	Median ± QR (Min; Max)	46 ± 19 (19; 75)	46 ± 14 (19; 75)	46 ± 18 (18; 74)	46 ± 17 (18; 75)
Days from start of symptoms to treatment onset	Median ± QR (Min; Max)	3 ± 2 (0; 22)	2 ± 1 (0; 27)	2 ± 1 (0; 15)	3 ± 1 (0; 27)
Classification of the hemorrhoids	External	103 (60.6)	112 (65.9)	112 (65.9)	327 (64.1)
	Internal	56 (32.9)	51 (30.0)	48 (28.2)	155 (30.4)
	Mixed	11 (6.5)	7 (4.1)	10 (5.9)	28 (5.5)
Grade of prolapse, (I or II):(III or IV)		54:13	37:21	43:15	134:49
Presence of thrombosis		122 (71.8)	129 (75.9)	133 (78.2)	384 (75.3)
Debut of disease		130 (76.5)	122 (71.8)	123 (72.4)	375 (73.5)
Previous thrombectomy		12 (7.1)	12 (7.1)	11 (6.5)	35 (6.9)

QR: Quartile range; rSK: Recombinant streptokinase.

Table 2 Results of clinical evaluations after treatment

	I: rSK schedule A	II: rSK schedule B	III: Hydrocortisone	P value
n	170	170	170
Response after 3 d	117 (68.8)	109 (64.1)	12 (7.1)	< 0.0011
Response after 5 d (95%CI)	156 (91.8) (87.3-96.2)	155 (91.2) (86.6-95.7)	46 (27.1) (20.1-34.0)	< 0.0011
Difference with III (95%CI)	64.6 (56.7-72.2)	63.9 (55.7-72.0)
Response after 10 d	165 (97.1)	159 (93.5)	114 (67.1)	< 0.0011
Days to response, median (95%CI)	3 (2.9-3.1)	3 (2.9-3.1)	10 (9.3-10.7)	< 0.0012

¹Likelihood ratio χ²;

² Log-rank test. Main outcome are represented in bold. rSK: Recombinant streptokinase.

Table 3 Subgroup analyses: 5^th day complete response

	I: rSK schedule A	II: rSK schedule B	III: Hydrocortisone	P value1
Type of acute event
Without thrombosis	42/48 (87.5)	36/41 (87.8)	10/37 (27.0)	< 0.0001
With thrombosis	114/122 (93.4)	119/129 (92.2)	36/133 (27.1)	< 0.0001
Thrombectomy	2/122 (1.6)	2/129 (1.6)	14/133 (10.5)	< 0.001
Hemorrhoid classification
External	96/103 (93.2)	100/112 (89.3)	19/112 (17.0)	< 0.0001
Internal + mixed	60/67 (89.6)	55/58 (94.8)	27/58 (46.6)	< 0.0001
Prolapse grade
I or II	49/54 (91)	35/37 (95)	21/43 (49)	< 0.0001
III or IV	11/13 (85)	20/21 (95)	6/15 (40)	< 0.001

¹Likelihood ratio χ². rSK: Recombinant streptokinase.

Table 4 Adverse events n (%)

	I: rSK schedule A	II: rSK schedule B	III: Hydrocortisone
n	170	170	170
Total subjects with adverse events	5 (2.9)	7 (4.1)	11 (6.5)
Events
Anal pruritus	2 (1.2)	4 (2.4)	2 (1.2)
Rectal bleeding	2 (1.2)	1 (0.6)	1 (0.6)
Anal fissure	1 (0.6)	0	3 (1.8)
Headache	1 (0.6)	2 (1.2)	0
Anal pain	0	0	2 (1.2)
Local burning sensation	1 (0.6)	0	1 (0.6)
Tenesmus	1 (0.6)	0	1 (0.6)
Constipation	0	0	1 (0.6)
Diarrhea	0	0	1 (0.6)
Discomfort due to mass sensation	1 (0.6)	0	0
Edema	0	0	1 (0.6)
Stroke	0	0	1 (0.6)

rSK: Recombinant streptokinase.