A double-blind comparison of the effect on quality of life of a combination of vital substances including standardized ginseng G115 and placebo

Abstract

The effect on quality of life (QOL) of a combination of vital substances, including ginseng extract G115, was compared with that of placebo in a double-blind, randomized study with a duration of 12 weeks. Healthy, employed volunteers older than 25 years were included. QOL was evaluated in two standard, self-administered questionnaires, the Psychological General Well- Being (PGWB) index and the Sleep Dysfunction scale. In addition to these, bipolar adjectives in visual analogue scales (VAS) were used to quantify changes in other behavioral aspects. In all, 185 subjects taking placebo and 205 subjects taking the combination of active substances completed the study. Both the combination and placebo groups improved their general well-being, but the improvement from baseline was more pronounced in those subjects taking the combination of active substances. According to the VAS scores, subjects receiving the combination of active substances improved significantly more in alertness (P = 0.05), relaxation (P = 0.02), appetite (P = 0.04), and overall score (P = 0.03). Among a subgroup of subjects with the 20% lowest scores at baseline, the combination improved both vitality (P = 0.03) and depressed mood (P = 0.05). It was concluded that despite the fact that healthy, employed subjects were evaluated, treatment with the combination of active substances had significant advantages over placebo therapy.