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©2014 Baishideng Publishing Group Co.
World J Gastroenterol. Feb 14, 2014; 20(6): 1594-1601
Published online Feb 14, 2014. doi: 10.3748/wjg.v20.i6.1594
Published online Feb 14, 2014. doi: 10.3748/wjg.v20.i6.1594
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) |
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 |
Table 3 Subgroup analyses: 5th 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 |
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) |
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Citation: Hernández-Bernal F, Castellanos-Sierra G, Valenzuela-Silva CM, Catasús-Álvarez KM, Valle-Cabrera R, Aguilera-Barreto A, Investigators PALSTT3GO. Recombinant streptokinase
vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial (THERESA-3). World J Gastroenterol 2014; 20(6): 1594-1601 - URL: https://www.wjgnet.com/1007-9327/full/v20/i6/1594.htm
- DOI: https://dx.doi.org/10.3748/wjg.v20.i6.1594