薬理と治療

Abstract

Objectives　The aim of this study is to evaluate the effect of protease-digested Bee Larvae （pBL）supplementation on aging malesʼ symptoms（AMS）and erectile function, and to assess its safety. Methods　An open-label single arm clinical trial was conducted in healthy Japanese men. They were orally treated with pBL for 12 weeks. The AMS score, Sexual Health Inventory for Men（SHIM）, Self-rating Depression Scale（SDS）, a fatigue Visual Analogue Scale（VAS） and biochemical parameters（serum total- or free︱testosterone and dehydroepiandrosterone sulfate （DHEA-S））were measured. A safety assessment was also performed by blood tests and urinary tests and based on an interview with a medical doctor. The above Measurements were performed at baseline, week 4 and week 12. Results The data obtained from 11 volunteers were analyzed. At week 4 and week 12, the AMS and SHIM scores were significantly improved in comparison with baseline. SDS and a fatigue VAS score were significantly improved in comparison with baseline at week 12. The frequency of early morning erections（number/week）was increased but not significantly different（P＝0.062）. Serum testosterone and DHEA-S levels were not changed during the test period. No adverse effects were observed throughout the study period. Conclusions　These results suggest that pBL is effective and safe in improving subjective sensation of AMS, erectile function, depressive symptoms and fatigue in healthy Japanese adult men.