TY - JOUR
T1 - Efficacy and Safety of Anthocyanin-Rich Extract in Patients with Ulcerative Colitis
T2 - A Randomized Controlled Trial
AU - Biedermann, Luc
AU - Doulberis, Michael
AU - Schreiner, Philipp
AU - Nielsen, Ole Haagen
AU - The, Frans Olivier
AU - Brand, Stephan
AU - Burk, Sabine
AU - Hruz, Petr
AU - Juillerat, Pascal
AU - Krieger-Grübel, Claudia
AU - Leu, Kristin
AU - Leventhal, Gabriel E
AU - Misselwitz, Benjamin
AU - Scharl, Sylvie
AU - Schoepfer, Alain
AU - Seibold, Frank
AU - Herfarth, Hans
AU - Rogler, Gerhard
PY - 2024/12/4
Y1 - 2024/12/4
N2 - Background: Bilberries are effective in inducing clinical, endoscopic, and biochemical improvement in ulcerative colitis (UC) patients. The aim of this study was to investigate the efficacy of anthocyanin-rich extract (ACRE), the bioactive ingredient of bilberries, in a controlled clinical trial in moderate-to-severe UC. Methods: A multi-center, randomized, placebo-controlled, double-blind study with a parallel group was conducted. Initially, the study was planned for 100 patients; nevertheless, it prematurely ended due to COVID-19. Patients had moderate-to-severe active UC at screening (a Mayo score of 6-12, an endoscopic sub-score ≥ 2) and were randomized at baseline. The primary endpoint was a clinical response (week 8, a total Mayo score reduction ≥ 3 points). Fecal calprotectin (FC) and a centrally read endoscopic response were among the secondary endpoints. Results: Out of 48 patients (6 Swiss centers), 34 were randomized. Eighteen ACRE and eight placebo patients could be analyzed (per protocol set). Half (9/18) of ACRE patients and 3/8 of placebo patients responded clinically (p = 0.278). An improvement in the Mayo score was observed in the ACRE arm (77.8% vs. 62.5% placebo). FC dropped from 1049 ± 1139 to 557 ± 756 μg/g for ACRE but not for the placebo group (947 ± 1039 to 1040 ± 1179; p = 0.035). Serious adverse events were rare. Conclusions: ACRE treatment did not yield significant superiority to the placebo. Furthermore, the placebo response was unusually high. Moreover, there was a significant calprotectin decrease at the end of treatment, indicative of ACRE efficacy in UC.
AB - Background: Bilberries are effective in inducing clinical, endoscopic, and biochemical improvement in ulcerative colitis (UC) patients. The aim of this study was to investigate the efficacy of anthocyanin-rich extract (ACRE), the bioactive ingredient of bilberries, in a controlled clinical trial in moderate-to-severe UC. Methods: A multi-center, randomized, placebo-controlled, double-blind study with a parallel group was conducted. Initially, the study was planned for 100 patients; nevertheless, it prematurely ended due to COVID-19. Patients had moderate-to-severe active UC at screening (a Mayo score of 6-12, an endoscopic sub-score ≥ 2) and were randomized at baseline. The primary endpoint was a clinical response (week 8, a total Mayo score reduction ≥ 3 points). Fecal calprotectin (FC) and a centrally read endoscopic response were among the secondary endpoints. Results: Out of 48 patients (6 Swiss centers), 34 were randomized. Eighteen ACRE and eight placebo patients could be analyzed (per protocol set). Half (9/18) of ACRE patients and 3/8 of placebo patients responded clinically (p = 0.278). An improvement in the Mayo score was observed in the ACRE arm (77.8% vs. 62.5% placebo). FC dropped from 1049 ± 1139 to 557 ± 756 μg/g for ACRE but not for the placebo group (947 ± 1039 to 1040 ± 1179; p = 0.035). Serious adverse events were rare. Conclusions: ACRE treatment did not yield significant superiority to the placebo. Furthermore, the placebo response was unusually high. Moreover, there was a significant calprotectin decrease at the end of treatment, indicative of ACRE efficacy in UC.
KW - Humans
KW - Colitis, Ulcerative/drug therapy
KW - Male
KW - Female
KW - Double-Blind Method
KW - Anthocyanins
KW - Plant Extracts/pharmacology
KW - Middle Aged
KW - Adult
KW - Treatment Outcome
KW - Feces/chemistry
KW - Leukocyte L1 Antigen Complex/analysis
KW - Vaccinium myrtillus/chemistry
KW - Aged
KW - COVID-19
U2 - 10.3390/nu16234197
DO - 10.3390/nu16234197
M3 - Journal article
C2 - 39683589
VL - 16
JO - Nutrients
JF - Nutrients
SN - 2072-6643
IS - 23
ER -