| Id |
Subject |
Object |
Predicate |
Lexical cue |
| T1 |
0-146 |
Sentence |
denotes |
No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis. |
| T2 |
147-165 |
Sentence |
denotes |
BACKGROUND & AIMS: |
| T3 |
166-340 |
Sentence |
denotes |
Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. |
| T4 |
341-413 |
Sentence |
denotes |
Topical tacrolimus is effective and safe in patients with refractory UP. |
| T5 |
414-510 |
Sentence |
denotes |
However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP. |
| T6 |
511-519 |
Sentence |
denotes |
METHODS: |
| T7 |
520-646 |
Sentence |
denotes |
We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. |
| T8 |
647-834 |
Sentence |
denotes |
Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. |
| T9 |
835-915 |
Sentence |
denotes |
The primary outcome was clinical response (decrease in Mayo score of 3 or more). |
| T10 |
916-1034 |
Sentence |
denotes |
Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. |
| T11 |
1035-1108 |
Sentence |
denotes |
Outcomes were compared using Fisher's exact test and Mann-Whitney U test. |
| T12 |
1109-1117 |
Sentence |
denotes |
RESULTS: |
| T13 |
1118-1335 |
Sentence |
denotes |
Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). |
| T14 |
1336-1710 |
Sentence |
denotes |
Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). |
| T15 |
1711-1775 |
Sentence |
denotes |
Adverse event rates did not differ significantly between groups. |
| T16 |
1776-1788 |
Sentence |
denotes |
CONCLUSIONS: |
| T17 |
1789-1966 |
Sentence |
denotes |
In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. |
| T18 |
1967-2029 |
Sentence |
denotes |
There were no significant differences in adverse events rates. |
| T19 |
2030-2159 |
Sentence |
denotes |
Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. |
| T20 |
2160-2226 |
Sentence |
denotes |
EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416. |
| T1 |
0-146 |
Sentence |
denotes |
No Superiority of Tacrolimus Suppositories vs Beclomethasone Suppositories in a Randomized Trial of Patients With Refractory Ulcerative Proctitis. |
| T2 |
147-165 |
Sentence |
denotes |
BACKGROUND & AIMS: |
| T3 |
166-340 |
Sentence |
denotes |
Ulcerative proctitis (UP) refractory to 5-aminosalicylic acid (5-ASA) suppositories is a challenge to treat, often requiring step up to immunomodulator or biological therapy. |
| T4 |
341-413 |
Sentence |
denotes |
Topical tacrolimus is effective and safe in patients with refractory UP. |
| T5 |
414-510 |
Sentence |
denotes |
However, it is not clear how tacrolimus suppositories fit into in the treatment algorithm of UP. |
| T6 |
511-519 |
Sentence |
denotes |
METHODS: |
| T7 |
520-646 |
Sentence |
denotes |
We performed a randomized controlled, double-blind study at 8 hospitals in the Netherlands and Belgium from 2014 through 2017. |
| T8 |
647-834 |
Sentence |
denotes |
Eighty-five patients with refractory UP (65% women) were randomly assigned to groups given once daily tacrolimus suppositories (2 mg; n = 43) or beclomethasone (3 mg; n = 42) for 4 weeks. |
| T9 |
835-915 |
Sentence |
denotes |
The primary outcome was clinical response (decrease in Mayo score of 3 or more). |
| T10 |
916-1034 |
Sentence |
denotes |
Secondary outcomes included clinical remission, endoscopic response and remission, adverse events and quality of life. |
| T11 |
1035-1108 |
Sentence |
denotes |
Outcomes were compared using Fisher's exact test and Mann-Whitney U test. |
| T12 |
1109-1117 |
Sentence |
denotes |
RESULTS: |
| T13 |
1118-1335 |
Sentence |
denotes |
Proportions of patients with clinical responses were 63% in the tacrolimus group and 59% in the beclomethasone group (P = .812); proportions of patients in clinical remission were 46% and 38%, respectively (P = .638). |
| T14 |
1336-1710 |
Sentence |
denotes |
Proportions of patients with an endoscopic response were 68% and 60% in the tacrolimus group and in the beclomethasone group (P = .636); proportions in endoscopic remission rates were 30% and 13%, respectively (P = .092) Median increases in the inflammatory bowel disease questionnaire score were 18.0 in the tacrolimus group and 20.5 in the beclomethasone group (P = .395). |
| T15 |
1711-1775 |
Sentence |
denotes |
Adverse event rates did not differ significantly between groups. |
| T16 |
1776-1788 |
Sentence |
denotes |
CONCLUSIONS: |
| T17 |
1789-1966 |
Sentence |
denotes |
In a 4-week randomized controlled trial, tacrolimus and beclomethasone suppositories induce comparable clinical and endoscopic responses in patients with UP refractory to 5-ASA. |
| T18 |
1967-2029 |
Sentence |
denotes |
There were no significant differences in adverse events rates. |
| T19 |
2030-2159 |
Sentence |
denotes |
Tacrolimus and beclomethasone suppositories are therefore each safe and effective treatment options for 5-ASA refractory disease. |
| T20 |
2160-2226 |
Sentence |
denotes |
EUDRACT 2013-001259-11; Netherlands Trial Register NL4205/NTR4416. |