Anti-inflammatory agents such as sulfasalazine, corticosteroids and mesalamine are the primary therapy for ulcerative colitis; the latter is available in both oral and rectal formulations. Safdi and associates studied the effectiveness of oral, rectal or combination mesalamine therapy in patients with ulcerative colitis.
Sixty patients with mild or moderate distal ulcerative colitis were enrolled in the six-week double-blind study. Eighteen patients received mesalamine rectal enemas (4 g once nightly), 22 patients received oral mesalamine (two 400-mg tablets three times a day), and 20 patients received both rectal and oral therapy. Patients who received only oral or rectal therapy were given placebo enemas or capsules to provide each patient with the same treatment regimen.
A disease activity index was completed at baseline and during the third and sixth weeks of the study. Patients also kept a daily diary of the amount of blood in the stool, urgency, straining at stool and abdominal pain. Patients and physicians assessed improvement at the two follow-up visits. Sigmoidoscopy was performed at baseline and at the end of the study.
After six weeks of therapy, the disease activity index showed more improvement in the combination therapy group than in the other two groups. Patients in the combination therapy group reported the absence of bloody diarrhea sooner. The mean number of days until cessation of rectal bleeding was 11.9 in the combination therapy group, 24.8 days in the rectal mesalamine group and 25.5 days in the oral mesalamine group. Rectal bleeding stopped in 89 percent of the combination therapy group, 69 percent of the rectal mesalamine group and 46 percent of the oral mesalamine group. By week 6, physicians rated 85 percent of the combination therapy group “much improved” or “very much improved.” This degree of improvement occurred in 45 percent of the oral mesalamine group.
The authors conclude that the combinaton of oral and rectal mesalamine produced earlier and more complete relief of rectal bleeding than either therapy alone. The combination was well tolerated when taken for six weeks. They note that maintenance therapy with mesalamine enema or oral tablets alone would be a cost savings if remission could be sustained with monotherapy.