NEW YORK, March 03 (Reuters) -- Many people with the intestinal disorder ulcerative colitis may be helped with a treatment originally designed to help smokers quit, a study shows.
Use of high-dose nicotine skin patches significantly helped control the symptoms of the disease, such as bloody diarrhea and abdominal pain, in nearly 40% of colitis patients studied, say researchers at the Mayo Clinic in Rochester, Minnesota.
"Ulcerative colitis is primarily a disease of nonsmokers," notes Mayo gastroenterologist Dr. William Sandborn and colleagues in a report published in the medical journal, Annals of Internal Medicine.
"Nonsmokers who have ulcerative colitis and begin smoking may go into remission," they write, and add that this observation has led several groups of researchers to look at nicotine as a possible treatment for the disease, although reasons why it might work remain unclear.
The Mayo study compared results of 31 ulcerative colitis patients treated with nicotine patches daily for four weeks with 33 who received inactive placebo patches. The patients using the active transdermal patches started with patches that contained an 11 milligram dose of nicotine delivered through the skin, then after 7 days, changed to 22 milligram dose patches for 21 days.
All the patients had mild to moderately active ulcerative colitis, and were nonsmokers or had not used a nicotine product within three months of the study. And they all continued taking medication prescribed for them prior to the study, including steroid drugs.
Of the 31 active-patch participants, 12 showed significant clinical improvement as measured by three tests: direct examination of the colon (via a flexible endoscope inserted into the colon via the rectum); patients' diaries of their symptoms over four weeks; and their doctor's assessments.
By comparison, only 3 of 33 patients wearing placebo patches showed any improvement.
Clinical signs of the disease disappeared completely in only two individuals treated with the nicotine patches, compared with none in the placebo group. However, this did not meet statistical significance, that is, it could have occurred by chance.
The study authors say the study results were very similar to the findings of an earlier report, which found that 49% of people with ulcerative colitis were helped by high-dose nicotine patches over six weeks, compared with 24% who received a placebo patch.
But they also note that other studies using lower doses of nicotine have observed no significant benefits from the patches, probably because the nicotine doses used were too low, he says.
The researchers also note that, "adverse reactions to nicotine occurred frequently (77% of patients in the nicotine group); these reactions were severe enough to necessitate discontinuation of nicotine therapy in 13% of all nicotine recipients." Common side effects of the nicotine patches included skin rashes, nausea, and dizziness.
"In contrast to ulcerative colitis, Crohn's disease occurs more frequently in active smokers," write the study authors. "Additional studies are needed to determine whether transdermal nicotine therapy for... treatment of intestinal inflammation in patients with Crohn's disease is efficacious or detrimental."
Given the evidence of this and previous studies, the researchers say that use of high-dose nicotine patches for ulcerative colitis "seems reasonable."
SOURCE: Annals of Internal Medicine (1997;126(5):364-371)
