薬理と治療

Abstract

Objectives The aim of this study was to validate the use of questionnaires as food supplements efficacy evaluation method. Methods Five hundred healthy volunteers（men and women）aged 20-80 years were randomly divided into a protease treated Royal jelly（p-RJ）group（n＝250）and a Bee energy(R) group （n＝250）. Four g of p-RJ╱day or 3 g╱day Bee energy(R) were administered for 8 weeks to each group. Written questionnaires about the present health condition and blood pressure measurements were performed before and after intake. Results The results obtained for p-RJ group showed that the symptoms like dizziness, chest pains, itchiness, arthralgia, irritation, and lumbago were significantly improved（P＜0.05）. The tinnitus and cold intolerance symptoms that already reported of efficacy in other studies have been ameliorated by RJ intake（P＝0.13）. The Bee energy(R) group evaluation pointed out a considerable decrease of symptoms like dizziness, tinnitus, palpitations, insomnia, eye strain, constipation and dysuria（P＜0.05）. Both groups showed the reduction of systolic blood pressure after intake（p︱RJ group, P＝0.046；Bee energy(R) group, P＝0.053）. Conclusions The beneficial effects of p-RJ intake have been recomfirmed with questionnaires, so this method could be considered an effective food evaluation method with minimum costs. Additionally, the useful information obtained from these questionnaires may lead to future strategies for other clinical trials.