Effectiveness of Hizikia fusiformis Extract on Erosive Gastritis: A 4-week, Randomized, Double-blind and Placebo-controlled Trial

Abstract

In our previous study, Hizikia fusiformis extract (HFE) has gastroprotective effects in animal model for gastric ulcer. The purpose of this study was to investigate whether HFE had similar gastro-protective effects in human subjects. A randomized, double-blind, placebo-controlled trial was conducted. To fulfill this purpose, a group of subjects with erosive gastritis were orally supplemented with the HFE or placebo for 4 weeks and efficacy and safety were measured. Primary outcome (number of erosions, endoscopic score and estimated cure rates of erosions) and the secondary outcomes (estimated improvement rates of erosions, subjects' symptom questionnaires and blood profiles) before and after the 4-week intervention period were compared. The HFE supplementation showed a significant reduction in number of erosions compared with placebo group. In subjects whose endoscopic score were 4 points (erosions more than 6) at baseline, HFE supplementation resulted in a significant decrease of number of erosions compared with placebo group. High sensitive-C reactive protein (hs-CRP) levels showed a tendency to decrease in HFE-supplemented group. Finally, blood parameters and clinical findings for organ toxicity remained within the normal range. These results suggest that HFE may have therapeutic potential in subjects with erosive gastritis.