Randomized clinical trial of Plantago ovata seeds (dietary fiber) as compared with mesalamine in maintaining remission in ulcerative colitis

Objective: Butyrate enemas may be effective in the treatment of active dist al ulcerative colitis. Because colonic fermentation of Plantago ovata seeds (dietary fiber) yields butyrate, the aim of this study was to assess the e fficacy and safety of Plantago ovata seeds as compared with mesalamine in m aintaining remission in ulcerative colitis. Methods: An open label, paralle l-group, multicenter, randomized clinical trial was conducted. A total of 1 05 patients with ulcerative colitis who were in remission were randomized i nto groups to receive oral treatment with Plantago ovata seeds (10 g b.i.d. ), mesalamine (500 mg tid.), and Plantago ovata seeds plus mesalamine at th e same doses. The primary efficacy outcome was maintenance of remission for 12 months. Results: Of the 105 patients, 102 were included in the final an alysis. After 12 months, treatment failure rate was 40% (14 of 35 patients) in the Planta,oo ovata seed group, 35% (13 of 37) in the mesalamine group, and 30% (nine of 30) in the Plantago ovata plus mesalamine group. Probabil ity of continued remission was similar (Mantel-Cox test, p = 0.67; intent-t o-treat analysis). Therapy effects remained unchanged after adjusting for p otential confounding variables with a Cox's proportional hazards survival a nalysis. Three patients were withdrawn because of the development of advers e events consisting of constipation and/or flatulence (Plantago ovata seed group = 1 and Plantago ovata seed plus mesalamine group = 2). A significant increase in fecal butyrate levels (p = 0.018) was observed after Plantago ovata seed administration. Conclusions: Plantago ovata seeds (dietary fiber ) might be as effective as mesalamine to maintain remission in ulcerative c olitis. (Am J Gastroenterol 1999;94:427-433. (C) 1999 by Am. Cell. of Gastr oenterology).