The quality of evidence is downgraded by study quality (incomplete outcome data, lack of blinding and unclear allocation concealment).
A Cochrane review [Abstract] 1 included 3 studies with a total of 587 subjects to assess the effectiveness of probiotics for maintenance of remission in ulcerative colitis. The studies ranged in length from 3 to 12 months.
Three trials (n=555) compared probiotics to mesalazine. There was no statistically significant difference between probiotics and mesalazine. Relapse was reported in 40.1% of patients in the probiotics group compared to 34.1% of patients in the mesalazine group (OR 1.33; 95% CI 0.94 to 1.90; I2 = 11%). Adverse events were reported in two studies (n=430). Twenty-six per cent of patients in the probiotics group experienced at least one adverse event compared to 24% of patients in the mesalazine group (OR 1.21; 95% CI 0.80 to 1.84; I2 =27%). Adverse events reported include diarrhea, mucous secretion, bloody stools, abdominal pain, flatulence and distension, nausea and vomiting and headache.
A small placebo controlled trial (n = 32) found no statistically significant difference in efficacy. Seventy-five per cent of probiotic patients relapsed at one year compared to 92% of placebo patients (OR 0.27; 95% CI 0.03 to 2.68).
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