A randomized trial of nicotine enemas for active ulcerative colitis.
OBJECTIVE
Ulcerative colitis (UC) is largely a disease of nonsmokers in which transdermal nicotine improves the symptoms but often causes adverse events (AEs). Nicotine enemas cause fewer AEs and were used as supplemental treatment for active UC.


METHODS
We treated 104 patients with active UC with either 6-mg nicotine enemas or placebo enemas for 6 weeks in a randomized double-blind study. Patients continued their oral therapy, if any, for UC: 68 patients were taking mesalamine, 15 patients were taking prednisolone, and 12 patients were taking thiopurines during the study. Clinical, sigmoidoscopic, and histologic assessments were made at baseline and at the end of the study and symptoms were recorded daily on a diary card. The primary end point was induction of clinical remission and clinical improvement also was measured by the UC disease activity index. After the study, patients then used nicotine enemas daily for 4 weeks and sigmoidoscopy with a biopsy examination was repeated. AEs and salivary cotinine levels were monitored throughout the study.


RESULTS
Clinical remission was achieved in 14 of 52 (27%) patients on active treatment and 14 of 43 (33%) patients on placebo (P = .55). The UC disease activity index improved by 1.45 points in the active group and by 1.65 points for those on placebo (P = .88). Only 1 patient discontinued treatment because of an AE (abdominal pain). In the 47 patients taking mesalamine only, active treatment conferred benefit that was not statistically significant; disease remission occurred in 9 of 25 patients on active therapy and 4 of 21 patients on placebo (P = .20).


CONCLUSIONS
Six-milligram nicotine enemas were well tolerated but were not found to be efficacious for active UC.
Ingram
John R
JR
Department of Gastroenterology, Cardiff and Vale NHS Trust, Cardiff CF14 4XW, Wales, United Kingdom.
Thomas
Gareth A O
GA
Rhodes
John
J
Green
John T
JT
Hawkes
Neil D
ND
Swift
Jill L
JL
Srivastava
Emmanuel D
ED
Evans
Brian K
BK
Williams
Geraint T
GT
Newcombe
Robert G
RG
Courtney
Edward
E
Pillai
Suresh
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004311:Double-Blind Method; D004733:Enema; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage*; D011239:Prednisolone / Q000627:therapeutic use; D012812:Sigmoidoscopy
D019804:Mesalamine; D009538:Nicotine; D011239:Prednisolone