Transdermal nicotine compared with oral prednisolone therapy for active ulcerative colitis

Area of Science:

• Gastroenterology
• Pharmacology
• Clinical Medicine

Background:

• Ulcerative colitis (UC) primarily affects non-smokers.
• Previous studies indicated nicotine's benefit in active UC when combined with 5-aminosalicylic acid, but not as monotherapy for maintenance.

Purpose of the Study:

• To compare the efficacy of transdermal nicotine versus prednisolone for treating active ulcerative colitis.

Main Methods:

• A randomized, double-blind study involving 61 patients with active UC.
• Patients received either transdermal nicotine patches or 15 mg of prednisolone for 6 weeks.
• Clinical, sigmoidoscopic, and histological assessments were performed, alongside symptom diaries and global clinical evaluations.

Main Results:

• Prednisolone showed a trend towards better sigmoidoscopic remission (14/24) compared to nicotine (6/19), though not statistically significant (P=0.08).
• Both treatments improved St Mark's score, Global Clinical Grade, stool blood, abdominal pain, and sigmoidoscopic scores, with trends favoring prednisolone.
• Intention-to-treat analysis revealed significantly greater sigmoidoscopic improvement with prednisolone versus nicotine (P≤0.05). Nicotine group experienced more withdrawals and reported more side effects (nausea, light-headedness, tremor).

Conclusions:

• Transdermal nicotine monotherapy offered very modest benefits in active ulcerative colitis over 6 weeks.
• Prednisolone (15 mg daily) was more effective than transdermal nicotine in this patient cohort.
• Higher rates of side effects and withdrawals were observed with nicotine treatment.