薬理と治療

Abstract

Objectives　In this paper, we designed a randomized double-blind placebo-controlled methodology for verifying the clinical effects of a lotus-root extract as antiallergic components. Accordingly, we will report the therapeutic capabilities of the extract against some kind of eye-and nose-corresponding allergy. Methods　As the test food, a granular powder（3.0 g/package）containing a lotus-root extract （1.70 g）, maltodextrin（1.24 g）and a moisture-proof agent（0.06 g）, was used for oral ingestions of the powder to our test volunteers twice a day（total: 6.0 g powder）for 8 weeks. The control experiment was carried out in the same manner, except ingesting the equal amount of a placebo food. Forty healthy volunteers ranging in age from 20-56（nineteen subjects in their 20 s, nine subjects in their 30 s, seven subjects in their 40 s, and five subjects in their 50 s）participated in our clinical trial equipped with the above︱mentioned methodology. We divided them into two groups（n＝20）: placebo︱control group, 9 men and 11 women（mean age ±SD: 33.5 ±11.5）; and test group, 10 men and 10 women（mean age±SD: 32.7 ±10.8）. To observe the clinical effects derived by continuous consumption of the test food for 8 weeks, we measured possible primary╱secondly endpoints for eye- and nose-corresponding allergy. Results　In order to investigate variations in our volunteersʼ allergic conditions during their continuous consumption of the test food, we compared them to a placebo-control group. To begin with, the nose-related conditions in the test group were better than those in the control group, although no significant difference in the endpoint could be detected. Nevertheless, it was quite obvious that the test-food intake revealed remarkable improvements of our volunteersʼ allergies, especially in eye-related ones（P＜0.05）. All through this trial, there were no subjects who complained about any kind of side effect. Conclusions　We designed a randomized double-blind placebo-controlled methodology, andinvestigated the improvement effects with a lotus-root extract in eye- and nose-related allergic conditions. Our experimental results strongly suggest that daily ingestion of lotus root-derived functional foods can improve some kind of allergic reaction, especially in eye-corresponding one.（ UMIN ID: UMIN000038255）