Randomized, placebo-controlled trial of low molecular weight heparin in active ulcerative colitis.
BACKGROUND
In several open and 1 controlled trial, unfractionated heparin was effective in the treatment of active ulcerative colitis (UC). Low molecular weight heparin (LMWH) had a similar effect in several open studies.


METHODS
We studied the efficacy, safety, and tolerability of LMWH in mild to moderately active UC in a randomized, double-blind, placebo-controlled trial. In all, 29 patients with a mild or moderate recurrence of UC during salicylate treatment were randomized to receive either reviparin 3,436 IU (n = 15) subcutaneously twice daily or placebo (n = 14). The study period was 8 weeks. Treatment was discontinued if there was no improvement at 4 weeks or at any disease progression. Primary outcome measure was clinical improvement at 8 weeks measured by the Colitis Activity Index (CAI) and the Clinical Symptoms Grading (CSG, based on the CAI). Endoscopic and histologic grading and quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) were secondary outcome measures. Patients were closely monitored for adverse events.


RESULTS
Twenty of 29 patients finished the 8-week treatment period (reviparin versus placebo: 11 versus 9; P = 0.70). There was no difference in CSG, CAI, endoscopic and histologic grading, or IBDQ. Treatment was well tolerated and no serious adverse events occurred.


CONCLUSIONS
In this study, treatment with LMWH showed no significant clinical advantage compared to placebo in mild to moderately active UC.
de Bièvre
M A
MA
Atrium Medical Center, Heerlen, Netherlands. mdebievre@wanadoo.nl
Vrij
A A
AA
Schoon
E J
EJ
Dijkstra
G
G
de Jong
A E
AE
Oberndorff-Klein Woolthuis
A H
AH
Hemker
H C
HC
Stockbrügger
R W
RW
D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology / Q000523:psychology; D003113:Colonoscopy; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D017060:Patient Satisfaction; D011788:Quality of Life; D012008:Recurrence; D012189:Retrospective Studies; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; C094240:reviparin