Efficacy and Safety of Anthocyanin-Rich Extract in Patients with Ulcerative Colitis: A Randomized Controlled Trial
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View abstract on PubMed
Summary
This summary is machine-generated.Anthocyanin-rich extract (ACRE) from bilberries showed a significant decrease in fecal calprotectin for ulcerative colitis (UC) patients. However, ACRE did not demonstrate superiority over placebo in clinical response due to a high placebo effect.
Area Of Science
- Gastroenterology
- Clinical Nutrition
- Pharmacology
Background
- Bilberries are known for their therapeutic effects in ulcerative colitis (UC).
- Anthocyanin-rich extract (ACRE), a key component of bilberries, was investigated for UC treatment.
- Previous findings suggest bilberry efficacy in improving clinical, endoscopic, and biochemical markers in UC patients.
Purpose Of The Study
- To evaluate the efficacy of anthocyanin-rich extract (ACRE) in patients with moderate-to-severe ulcerative colitis (UC).
- To conduct a multi-center, randomized, placebo-controlled, double-blind clinical trial.
- To assess clinical response, fecal calprotectin levels, and endoscopic response as primary and secondary endpoints.
Main Methods
- A multi-center, randomized, placebo-controlled, double-blind study design was employed.
- Patients with moderate-to-severe active UC were randomized to receive either ACRE or placebo.
- The study assessed clinical response at week 8, fecal calprotectin, and endoscopic response.
Main Results
- Half of the ACRE group (9/18) and 3/8 of the placebo group showed clinical response (p=0.278).
- Fecal calprotectin levels significantly decreased in the ACRE group (p=0.035) but not in the placebo group.
- Serious adverse events were infrequent, and an improvement in Mayo score was noted in the ACRE arm.
Conclusions
- Anthocyanin-rich extract (ACRE) did not show significant superiority over placebo in inducing clinical response in UC patients.
- A high placebo response rate was observed, potentially impacting the study's statistical power.
- The significant decrease in fecal calprotectin suggests potential efficacy of ACRE in reducing gut inflammation in UC.
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