Epidermal growth factor (EGF) is a potent mitogenic peptide. It is produced by salivary glands.
In this study, scientists from England determined whether EGF enemas can be used to treat active left-sided ulcerative colitis, as well as, ulceration limited to the rectum (proctitis).
The team performed a randomized, double-blind clinical trial conducted at Leicester Royal Infirmary.
They included 24 patients with mild-to-moderate left-sided ulcerative colitis.
|83% of patients in the treatment group were in remission at 2 weeks, compared to 8% of patients in the control group.|
|New England Journal of Medicine|
Of these, 12 patients received daily enemas of 5 µg of EGF in 100mls of inert carrier, while 12 received daily enemas with carrier alone, for 14 days.
All patients were started on 1.2 g of oral mesalamine per day, or had their dose increased by 1.2 g per day.
The researchers clinically assessed all patients at weeks 0, 2, 4, and 12. They also assessed the patients using sigmoidoscopy and biopsy at weeks 0, 2, and 4.
The team's primary end point was disease remission at 2 weeks, and their secondary end points were clinically significant improvements in disease activity at 2 and 4 weeks.
The investigators performed any analyses according to the intention-to-treat principle.
The team found that 10 of the 12 patients in the EGF group were in remission at 2 weeks, compared with 1 of 12 in the control group.
In addition, they found that disease-activity scores, sigmoidoscopic score, and histologic scores were all significantly better in the EGF group than the placebo group at 2 weeks. This result was maintained at 4 and 12 weeks.
Dr Atul Sinha's team concluded, "This study provides preliminary data suggesting that EGF enemas are an effective treatment for active left-sided ulcerative colitis".