EFFICACY OF ASTAXANTHIN, A NATURAL ANTIOXIDANT FROM ALGAE, IN THE TREATMENT OF FUNCTIONAL DYSPEPSIA: A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, AND PLACEBO-CONTROLLED STUDY

Abstract

The aim of this study was to evaluate the efficacy of the natural antioxidant astaxanthin from algae in functional dyspepsia in different doses and compared with a placebo. Materials and methods: The study was a controlled, prospective, randomized, and double blind trial. Patients with functional dyspepsia were divided into three groups with 44 individuals in each group (placebo, 16 mg, or 40 mg astaxanthin respectively). Participants were asked to accept gastroscopy before treatment and they had to fill out questionnaires: GSRS and SF-36. A urea breath test (UBT) was done before the treatment. Main outcome: The primary objective was to test the hypothesis that the antioxidant astaxanthin at two doses regimens compared to the placebo should ameliorate gastrointestinal discomfort, measured as GSRS, in patients with functional dyspepsia, who were either positive or negative for Helicobacter pylori, after 4 weeks of treatment. Results: At the end of the therapy (week 4) no difference between the three treatment groups was observed regarding the mean Gastrointestinal Symptom Rating Scale (GSRS) scores of abdominal pain, indigestion and reflux syndromes. The same results were observed at the end of the follow-up. However the reduction of reflux syndrome before treatment to week 4 was significantly pronounced in the higher (40 mg) dose compared to the other treatment groups (16 mg and placebo, p=0.04). Conclusion: In general, no curative effect of astaxanthin was found in functional dyspepsia patients. Significantly greater reduction of reflux symptoms were detected in patients treated with the highest dose of the natural antioxidant astaxanthin. The response was more pronounced in H. pylori-infected patients.