Randomized Controlled Trial
Copyright ©The Author(s) 2015.
World J Gastroenterol. Jun 21, 2015; 21(23): 7305-7312
Published online Jun 21, 2015. doi: 10.3748/wjg.v21.i23.7305
Table 1 Patient demographic and baseline characteristics n (%)
rSK-ArSK-BHydrocortisoneTotal
n170170170510
GenderMale/female (%male)90/80 (52.9)95/75 (55.9)92/78 (54.1)277/233 (54.3)
EthnicityWhite76 (44.7)98 (57.6)80 (47.1)254 (49.8)
Black18 (10.6)18 (10.6)20 (11.8)56 (11.0)
Mestizo76 (44.7)54 (31.8)70 (41.2)200 (39.2)
AgeMedian ± 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 onsetMedian ± QR (Min; Max)3 ± 2 (0; 22)2 ± 1 (0; 27)2 ± 1 (0; 15)3 ± 1 (0; 27)
Classification of the hemorrhoidsExternal103 (60.6)112 (65.9)112 (65.9)327 (64.1)
Internal56 (32.9)51 (30.0)48 (28.2)155 (30.4)
Mixed11 (6.5)7 (4.1)10 (5.9)28 (5.5)
Grade of prolapse, (I or II):(III or IV)54:1337:2143:15134:49
Presence of thrombosis122 (71.8)129 (75.9)133 (78.2)384 (75.3)
Debut of disease130 (76.5)122 (71.8)123 (72.4)375 (73.5)
Previous thrombectomy12 (7.1)12 (7.1)11 (6.5)35 (6.9)
Table 2 Results of clinical evaluations after treatment
I: rSK schedule AII: rSK schedule BIII: HydrocortisoneP value
n170170170
Response after 3 d117 (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 d165 (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
Table 3 Subgroup analyses: 5th day complete response
I: rSK schedule AII: rSK schedule BIII: HydrocortisoneP value1
Type of acute event
Without thrombosis42/48 (87.5)36/41 (87.8)10/37 (27.0)< 0.0001
With thrombosis114/122 (93.4)119/129 (92.2)36/133 (27.1)< 0.0001
Thrombectomy2/122 (1.6)2/129 (1.6)14/133 (10.5)< 0.001
Hemorrhoid classification
External96/103 (93.2)100/112 (89.3)19/112 (17.0)< 0.0001
Internal + mixed60/67 (89.6)55/58 (94.8)27/58 (46.6)< 0.0001
Prolapse grade
 I or II49/54 (91)35/37 (95)21/43 (49)< 0.0001
III or IV11/13 (85)20/21 (95)6/15 (40)< 0.001
Table 4 Adverse events n (%)
I: rSK schedule AII: rSK schedule BIII: Hydrocortisone
n170170170
Total subjects with adverse events5 (2.9)7 (4.1)11 (6.5)
Events
Anal pruritus2 (1.2)4 (2.4)2 (1.2)
Rectal bleeding2 (1.2)1 (0.6)1 (0.6)
Anal fissure1 (0.6)03 (1.8)
Headache1 (0.6)2 (1.2)0
Anal pain002 (1.2)
Local burning sensation1 (0.6)01 (0.6)
Tenesmus1 (0.6)01 (0.6)
Constipation001 (0.6)
Diarrhea001 (0.6)
Discomfort due to mass sensation1 (0.6)00
Edema001 (0.6)
Stroke001 (0.6)

  • Citation: Hernández-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM, Catasús-Álvarez KM, Martínez-Serrano O, Lazo-Diago OC, Bermúdez-Badell CH, Causa-García JR, Domínguez-Suárez JE, Investigators PALST4(OHWRSAGO. Recombinant streptokinase vs hydrocortisone suppositories in acute hemorrhoids: A randomized controlled trial. World J Gastroenterol 2015; 21(23): 7305-7312
  • URL: https://www.wjgnet.com/1007-9327/full/v21/i23/7305.htm
  • DOI: https://dx.doi.org/10.3748/wjg.v21.i23.7305