【medical-news】Inflamm Bowel Dis：Profermin治疗活动期溃疡性结肠炎有效果
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Profermin isEfficacious in Patients with Active Ulcerative Colitis-A Randomized ControlledTrial
Krag A, Munkholm P, Israelsen H, von Ryberg B, Andersen KK, Bendtsen F.
http://europepmc.org/abstract/MED/24108114
Abstract
BACKGROUND:
Profermin isdeveloped for the dietary management of ulcerative colitis(UC). It consists of water, fermented oats, barley malt, lecithin, andLactobacillus plantarum 299v. The aim of this study was to assess the clinicalefficacy of Profermin.
METHODS:
Seventy-four patients with a mild-to-moderate flare-up of UC(defined as Simple Clinical Colitis Activity Index [SCCAI] score ≥5 and ≤11)were randomly assigned to Profermin (n= 32) or Fresubin (n= 41). The primary endpoint was to assess whetheraddition of Profermin inUC could significantly reduce SCCAI in comparison with Fresubin.
RESULTS:
In the run-in period, the meanSCCAI was 7.2 ± 1.50 in the Profermin groupand 7.6 ± 1.47 in the Fresubin group (not significant). After 8 weeks oftreatment, the mean reduction of SCCAI score was higher in the Profermin group (mean difference: -1.77 SCCAI,95% confidence interval -2.97 to -0.55; P < 0.005), in intention-to-treatanalyses. Remission defined as SCCAI ≤2.5 was achieved in 10 of 32 (31%) in the Profermin group and in 6 of 41 (15%) in theFresubin group (P = 0.048). The decrease in SCCAI scores of ≥50% was higher inthe Profermin group 17 of 32 (53%) versus 11 of 41(27%) (P = 0.04). The risk of dropping out due to treatment failure/lack ofeffect was higher in the Fresubin group (42% versus 13%, P = 0.02).
CONCLUSIONS:
Supplementation with Profermin is safe, well tolerated, palatable,and able to reduce SCCAI scores at a statistically andclinically significant level in patients withmild-to-moderate UC with a flare-up.
Krag A, Munkholm P, Israelsen H, von Ryberg B, Andersen KK, Bendtsen F.
http://europepmc.org/abstract/MED/24108114
Abstract
BACKGROUND:
Profermin isdeveloped for the dietary management of ulcerative colitis(UC). It consists of water, fermented oats, barley malt, lecithin, andLactobacillus plantarum 299v. The aim of this study was to assess the clinicalefficacy of Profermin.
METHODS:
Seventy-four patients with a mild-to-moderate flare-up of UC(defined as Simple Clinical Colitis Activity Index [SCCAI] score ≥5 and ≤11)were randomly assigned to Profermin (n= 32) or Fresubin (n= 41). The primary endpoint was to assess whetheraddition of Profermin inUC could significantly reduce SCCAI in comparison with Fresubin.
RESULTS:
In the run-in period, the meanSCCAI was 7.2 ± 1.50 in the Profermin groupand 7.6 ± 1.47 in the Fresubin group (not significant). After 8 weeks oftreatment, the mean reduction of SCCAI score was higher in the Profermin group (mean difference: -1.77 SCCAI,95% confidence interval -2.97 to -0.55; P < 0.005), in intention-to-treatanalyses. Remission defined as SCCAI ≤2.5 was achieved in 10 of 32 (31%) in the Profermin group and in 6 of 41 (15%) in theFresubin group (P = 0.048). The decrease in SCCAI scores of ≥50% was higher inthe Profermin group 17 of 32 (53%) versus 11 of 41(27%) (P = 0.04). The risk of dropping out due to treatment failure/lack ofeffect was higher in the Fresubin group (42% versus 13%, P = 0.02).
CONCLUSIONS:
Supplementation with Profermin is safe, well tolerated, palatable,and able to reduce SCCAI scores at a statistically andclinically significant level in patients withmild-to-moderate UC with a flare-up.
