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Trial of trefoil factor 3 enemas, in combination with oral 5-aminosalicylic acid, for the treatment of mild-to-moderate left-sided ulcerative colitis
Citation
Mahmood, A and Melley, L and Fitzgerald, AJ and Ghosh, S and Playford, RJ, Trial of trefoil factor 3 enemas, in combination with oral 5-aminosalicylic acid, for the treatment of mild-to-moderate left-sided ulcerative colitis, Alimentary Pharmacology and Therapeutics, 21, (11) pp. 1357-1364. ISSN 0269-2813 (2005) [Refereed Article]
DOI: doi:10.1111/j.1365-2036.2005.02436.x
Abstract
Background: Current treatment of ulcerative colitis is imperfect. Trefoil peptides are known to stimulate repair in many models of injury, including animal models of colitis. Aim: To assess the efficacy of trefoil factor family-3 enema treatment in a clinical trial. Methods: A total of 16 patients with mild-to-moderate left sided ulcerative colitis were recruited into a double-blind randomized placebo-controlled study. Patients taking steroids or with proctitis only were excluded. Patients received 75 mL enemas containing either human recombinant trefoil factor family-3 (10 mg/mL) or saline alone once a day for 14 days. All patients also received an oral dose-increment of 1.2 g of mesalazine daily above their normal usage. Patients were assessed at 0, 2, 4 and 12 weeks. Remission was defined as Ulcerative Colitis Disease Activity Index of 0 or 1 with no blood in stool. Individual clinical improvement was defined as a Ulcerative Colitis Disease Activity Index reduction of >3. Data was analysed using chi-square test and ANOVA. Results: Median Ulcerative Colitis Disease Activity Index at entry were 8.5 (trefoil factor family-3 group) and 8 (placebo group). Analysed on an intention-to-treat basis, only one patient went into remission (in trefoil factor family-3 group at day 28). Clinical improvement was seen in two trefoil factor family-3 and three placebo patients on day 14 and two patients in each group on day 28. Conclusion: Increasing the dose of 5-aminosalicylic acid was moderately effective in reducing the Ulcerative Colitis Disease Activity Index but was insufficient to induce remission. Trefoil factor family-3 enemas were well-tolerated but did not provide additional benefit above that of adding additional 5-aminosalicylic acid alone. © 2005 Blackwell Publishing Ltd.
Item Details
| Item Type: | Refereed Article |
|---|---|
| Research Division: | Biomedical and Clinical Sciences |
| Research Group: | Clinical sciences |
| Research Field: | Gastroenterology and hepatology |
| Objective Division: | Health |
| Objective Group: | Clinical health |
| Objective Field: | Clinical health not elsewhere classified |
| UTAS Author: | Playford, RJ (Professor Ray Playford) |
| ID Code: | 72936 |
| Year Published: | 2005 |
| Web of Science® Times Cited: | 40 |
| Deposited By: | Research Division |
| Deposited On: | 2011-09-05 |
| Last Modified: | 2011-09-05 |
| Downloads: | 0 |
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