Background Epidermal growth factor (EGF) is a potent mitogenicpeptide produced by salivary glands. We examined whether EGFenemas are an effective treatment for active left-sided ulcerativecolitis and ulceration limited to the rectum (proctitis).
Methods In a randomized, double-blind clinical trial conductedat Leicester Royal Infirmary, 12 patients with mild-to-moderateleft-sided ulcerative colitis received daily enemas of 5 µgof EGF in 100 ml of an inert carrier and 12 received daily enemaswith carrier alone for 14 days. All also began to receive 1.2g of oral mesalamine per day or had their dose increased by1.2 g per day. Patients were assessed clinically at 0, 2, 4,and 12 weeks and by sigmoidoscopy and biopsy at 0, 2, and 4weeks. The primary end point was disease remission (definedby a St. Marks score of 4 or less without sigmoidoscopic evidenceof inflammation) at two weeks. Secondary end points were clinicallysignificant improvements in disease activity (defined by a decreaseof more than 3 points in the St. Marks score or the ulcerativecolitis disease-activity index) at two and four weeks. Analyseswere performed according to the intention-to-treat principle.
Results After two weeks, 10 of the 12 patients given EGF enemaswere 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 histologicscores were all significantly better in the EGF group than inthe placebo group (P<0.01 for all comparisons), and thisbenefit was maintained at 4 weeks and at 12 weeks.
Conclusions This study provides preliminary data suggestingthat EGF enemas are an effective treatment for active left-sidedulcerative colitis.
Source Information
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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