Randomized comparison of unfractionated heparin with corticosteroids in severe active inflammatory bowel disease

Background: Heparin therapy may be effective in steroid resistant inflammatory bowel disease. Aim: A randomized pilot study, to compare unfractionated heparin as a first-line therapy with corticosteroids in colonic inflammatory bowel disease. Methods: Twenty patients with severe inflammatory bowel disease (ulcerative colitis, n = 17; Crohn's colitis, n = 3) were randomized to either intravenous heparin for 5 days, followed by subcutaneous heparin for 5 weeks (n = 8), or high-dose intravenous hydrocortisone for 5 days followed by oral prednisolone 40 mg daily, reducing by 5 mg per day each week (n = 12). After 5 days, non-responders in each treatment group were commenced on combination therapy. Response to therapy was monitored by: clinical disease activity (ulcerative colitis: Truelove and Witt Index; Crohn's colitis: Harvey and Bradshaw Index), stool frequency, serum C-reactive protein and al acid glycoprotein, endoscopic and histopathological grading. Results: The response rates were similar in both treatment groups: clinical activity index (heparin vs, steroid; 75% vs, 57%; P = 0.23), stool frequency (75% vs. 67%; P = 0.61), endoscopic (75% vs, 67%; P = 0.4) and histopathological grading (63% vs. 50%; P = 0.67). Both treatments were well-tolerated with no serious adverse events. Conclusion: Heparin as a first line therapy is as effective as corticosteroids in the treatment of colonic inflammatory bowel disease. Large multicentre randomized comparative studies are required to determine the role of heparin in the management of inflammatory bowel disease.