PMID- 16271342
OWN - NLM
STAT- MEDLINE
DCOM- 20060113
LR  - 20191109
IS  - 1542-3565 (Print)
IS  - 1542-3565 (Linking)
VI  - 3
IP  - 11
DP  - 2005 Nov
TI  - A randomized trial of nicotine enemas for active ulcerative colitis.
PG  - 1107-14
AB  - BACKGROUND & AIMS: 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.
FAU - Ingram, John R
AU  - Ingram JR
AD  - Department of Gastroenterology, Cardiff and Vale NHS Trust, Cardiff CF14 4XW, 
      Wales, United Kingdom.
FAU - Thomas, Gareth A O
AU  - Thomas GA
FAU - Rhodes, John
AU  - Rhodes J
FAU - Green, John T
AU  - Green JT
FAU - Hawkes, Neil D
AU  - Hawkes ND
FAU - Swift, Jill L
AU  - Swift JL
FAU - Srivastava, Emmanuel D
AU  - Srivastava ED
FAU - Evans, Brian K
AU  - Evans BK
FAU - Williams, Geraint T
AU  - Williams GT
FAU - Newcombe, Robert G
AU  - Newcombe RG
FAU - Courtney, Edward
AU  - Courtney E
FAU - Pillai, Suresh
AU  - Pillai S
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Gastroenterol Hepatol
JT  - Clinical gastroenterology and hepatology : the official clinical practice journal 
      of the American Gastroenterological Association
JID - 101160775
RN  - 4Q81I59GXC (Mesalamine)
RN  - 6M3C89ZY6R (Nicotine)
RN  - 9PHQ9Y1OLM (Prednisolone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Colitis, Ulcerative/*drug therapy
MH  - Double-Blind Method
MH  - *Enema
MH  - Female
MH  - Humans
MH  - Male
MH  - Mesalamine/therapeutic use
MH  - Middle Aged
MH  - Nicotine/*administration & dosage
MH  - Prednisolone/therapeutic use
MH  - Sigmoidoscopy
EDAT- 2005/11/08 09:00
MHDA- 2006/01/18 09:00
CRDT- 2005/11/08 09:00
PHST- 2005/11/08 09:00 [pubmed]
PHST- 2006/01/18 09:00 [medline]
PHST- 2005/11/08 09:00 [entrez]
AID - S1542-3565(05)00849-9 [pii]
AID - 10.1016/s1542-3565(05)00849-9 [doi]
PST - ppublish
SO  - Clin Gastroenterol Hepatol. 2005 Nov;3(11):1107-14. doi: 
      10.1016/s1542-3565(05)00849-9.