Ingram JR et al. (2005) Preliminary observations of oral nicotine therapy for inflammatory bowel disease: an open-label Phase I–II study of tolerance. Inflamm Bowel Dis 11: 1092–1096

Some patients with ulcerative colitis have been shown to benefit from transdermal nicotine treatment; however, this approach is associated with adverse events leading to discontinuation of treatment. Fewer adverse events have been recorded with nicotine enemas, but these only reach the left side of the colon.

Nicolon, a new oral formulation, capable of slow, sustained release of nicotine in the colon, has been investigated in an open-label observational study by Ingram and colleagues. In all, 31 patients were included in the study; 26 with ulcerative colitis (11 with active disease and 12 in remission) and 5 with Crohn's colitis (2 with active disease and 3 in remission). Patients were asked to take one 3 mg Nicolon capsule daily for the first 3 days of the study, after which they were asked to gradually increase their dose to the maximum that they could tolerate. Follow-up was carried out on an outpatient basis for up to 12 months.

The maximum daily dose of nicotine tolerated varied greatly, from none (n = 2) to at least 18 mg/day (n = 5). Nicotine-related adverse events occurred in 24 participants; none were serious, but seven participants discontinued therapy as a result. Six patients with active disease went into remission during the course of the study and three asymptomatic patients developed active disease.

Despite the variation in tolerance of Nicolon in patients with inflammatory bowel disease, the authors conclude that it is potentially a safe treatment, and highlight the need for controlled trials.