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Original Article
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Volume 349:350-357 July 24, 2003 Number 4
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Epidermal Growth Factor Enemas with Oral Mesalamine for Mild-to-Moderate Left-Sided Ulcerative Colitis or Proctitis
Atul Sinha, M.R.C.P., Jeremy M.D. Nightingale, F.R.C.P., Kevin P. West, F.R.C.Path., Jorge Berlanga-Acosta, Ph.D., and Raymond J. Playford, F.R.C.P.

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ABSTRACT

Background Epidermal growth factor (EGF) is a potent mitogenic peptide produced by salivary glands. We examined whether EGF enemas are an effective treatment for active left-sided ulcerative colitis and ulceration limited to the rectum (proctitis).

Methods In a randomized, double-blind clinical trial conducted at Leicester Royal Infirmary, 12 patients with mild-to-moderate left-sided ulcerative colitis received daily enemas of 5 µg of EGF in 100 ml of an inert carrier and 12 received daily enemas with carrier alone for 14 days. All also began to receive 1.2 g of oral mesalamine per day or had their dose increased by 1.2 g per day. Patients were assessed clinically at 0, 2, 4, and 12 weeks and by sigmoidoscopy and biopsy at 0, 2, and 4 weeks. The primary end point was disease remission (defined by a St. Marks score of 4 or less without sigmoidoscopic evidence of inflammation) at two weeks. Secondary end points were clinically significant improvements in disease activity (defined by a decrease of more than 3 points in the St. Marks score or the ulcerative colitis disease-activity index) at two and four weeks. Analyses were performed according to the intention-to-treat principle.

Results After two weeks, 10 of the 12 patients given EGF enemas were in remission, as compared with 1 of 12 in the control group (83 percent vs. 8 percent, P<0.001). At the 2-week assessment, disease-activity scores, sigmoidoscopic score, and histologic scores were all significantly better in the EGF group than in the placebo group (P<0.01 for all comparisons), and this benefit was maintained at 4 weeks and at 12 weeks.

Conclusions This study provides preliminary data suggesting that EGF enemas are an effective treatment for active left-sided ulcerative colitis.


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From the Departments of Gastroenterology (A.S., J.M.D.N.) and Pathology (K.P.W.), Leicester Royal Infirmary, Leicester, United Kingdom; the Center for Genetic Engineering and Biotechnology, Havana, Cuba (J.B.-A.); and the Gastroenterology Section, Imperial College Faculty of Medicine, Hammersmith Hospital Campus, London (R.J.P.).

Address reprint requests to Dr. Nightingale at the Gastroenterology Centre, Leicester Royal Infirmary, Leicester LE1 5WW, United Kingdom, or at jeremy.nightingale{at}uhl-tr.nhs.uk.

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