Ulcerative proctitis usually presents as fresh rectal bleeding.
Successful treatment using topical mesalamine 5-aminosalicyclic acid 500 mg BID suppository led to developing a once-a-day formulation that could contribute to better acceptability and ease of use by patients.
Dr Mark Lamet conducted a randomized trial in 18 centers.
The research team compared efficacy of 2 modes of treatment with 5-aminosalicyclic acid suppositories.
|Both groups showed a significant reduction in disease activity index|
|Inflammatory Bowel Diseases|
The researchers included 99 patients with mild or moderate ulcerative proctitis limited to 15 cm of the anal margin.
Mild to moderate ulcerative proctitis was evidenced by a disease activity index between 4 and 11.
The team randomized the patients to 5-aminosalicyclic acid 500 mg suppository BID or 1 g at bedtime for 6 weeks.
The researchers used a noninferiority hypothesis based on the mean difference in disease activity index values after 6 weeks of treatment.
The research team applied intent-to-treat basis using analysis of covariance.
The team derived disease activity index from a composite of the measures of stool frequency, and rectal bleeding.
The disease activity index also included measures of mucosal visualization at endoscopy, and general well being.
The researchers found no difference between groups at baseline for demographic and clinical parameters.
The team noted that mean disease activity indeces fell from 7 to 2 in the 500 mg BID group and from 6 to 1 in the mesalamine 1 g group.
There was no significant difference observed in mean disease activity index at week 6 between the 2 groups.
The researchers found that both groups showed a significant reduction in disease activity index over the course of the 6 weeks.
Both formulations showed effectiveness in reducing each individual component of the disease activity index.
In addition, the team noted no difference between treatments in adverse events, and both groups had an overall drug compliance of greater than 95%.
Dr Lamet concluded “This study showed that 1 g mesalamine and 500 mg BID mesalamine suppository treatments of ulcerative proctitis patients were equivalent in all facets of efficacy, safety, and compliance in a 6-week trial.”