Combined oral sodium butyrate and mesalazine treatment compared to oral mesalazine alone in ulcerative colitis - Randomized, double-blind, placebo-controlled pilot study

Butyrate represents the main source of energy for colonic epithelial cells; however, its availabilty/utilization is impaired in ulcerative colitis (UC ). In the present randomized, double-blind, placebo-controlled pilot study, the safety and efficacy of colonic targeted oral sodium butyrate tablets, coated with a pH-dependent soluble polymer, have been evaluated in ulcerati ve colitis. Thirty patients with mild to moderate colitis underwent a six-w eek course of oral sodium butyrate (4 g/day) plus oral mesalazine (2.4 g/da y), (Group A) or of oral mesalazine plus placebo (Group B). Clinical, endos copic, and histologic data were collected at the beginning and the end of t he study. Twenty-five patients completed the study (12 in group A, 13 in gr oup B). No untoward side effects were reported. In group A, seven patients underwent remission and four improved; in Group B the numbers were 5 and 5, respectively. After treatment, all clinical parameters had significantly i mproved in both treatment arms compared to pretreatment findings. The UC di sease activity index (UCDAI) score decreased from 7.27 +/- 2.02 to 2.58 +/- 2.19 (P < 0.05) in the combined treatment group and from 6.07 +/- 1.60 to 3.46 +/- 1.98 (P < 0.05) in group B. The endoscopic and histologic scores a lso significantly improved after treatment in bath groups (P < 0.05). The d ifference between the two treatment arms was not significant, but a signifi cantly better improvement vs baseline values (P < 0.05) was observed in the combined treatment group vs the mesalazine group, when considering both th e clinical index (Delta 9.58 +/- 4.19 vs 5.92 +/- 3.48) and the UCDAI score (Delta 4.67 +/- 2.19 vs 2.54 +/- 2.18). A more favorable trend, although n ot significant, was observed for all individual parameters in group A. In c onclusion, results of the present pilot study indicate that oral butyrate i s safe and well tolerated. These data also suggest that oral butyrate may i mprove the efficacy of oral mesalazine in active ulcerative colitis and pro mpt the need of a large scale investigation to confirm the present findings .