정상인에서 스트레스와 불안에 대한 돌외추출물의 효과와 안전성에 관한 무작위 배정 이중 맹검 임상시험
Randomized, Double-Blind Study of Efficacy and Safety of Gynostemma pentaphyllum Ethanol Extract in a Normal Population
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The purpose of this study was to evaluate the clinical efficacy of a standardized special ethanol extract from Gynostemma pentaphyllum as a management for anxiety and stress of normal population. This is a two-arm, parallelgroup,randomized, double blind clinical trial comparing Gynostemma pentaphyllum extract 200 mg bid (GP-EX, n=48)or placebo bid (n=54). The main outcome measures were the decrease in anxiety sensitivity index (ASI), the State version (S-STAI) of the Stait-Trait Anxiety Inventory (STAI) and the Trait version (T-STAT) of the STAI from baseline over a 6 weeks treatment period. In more anxious group (S-STAI50 or ASI19), the anxiety in group with GP-EX was decreased significantly than one in normal population with placebo [S-STAI50: T-STAI = from 57.7 ± 6.5 (mean ±S.D.) to 46.8 ± 11.2 in normal population with GP-EX, p=0.002 vs. from 54.1 ± 9.9 to 49.0 ± 9.6 in normal population with placebo, p>0.05; ASI19: T-STAI = from 47.2 ± 12.0 to 42.4 ± 11.1 in normal population with GP-EX,p=0.022 vs. from 48.7 ± 11.5 to 46.0 ± 10.4 in normal population with placebo, p>0.05]. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events. GP-EX is more effective than placebo and is well tolerated as a therapy for anxiety and stress of normal population.
Abstract
The purpose of this study was to evaluate the clinical efficacy of a standardized special ethanol extract from Gynostemma pentaphyllum as a management for anxiety and stress of normal population. This is a two-arm, parallelgroup,randomized, double blind clinical trial comparing Gynostemma pentaphyllum extract 200 mg bid (GP-EX, n=48)or placebo bid (n=54). The main outcome measures were the decrease in anxiety sensitivity index (ASI), the State version (S-STAI) of the Stait-Trait Anxiety Inventory (STAI) and the Trait version (T-STAT) of the STAI from baseline over a 6 weeks treatment period. In more anxious group (S-STAI50 or ASI19), the anxiety in group with GP-EX was decreased significantly than one in normal population with placebo [S-STAI50: T-STAI = from 57.7 ± 6.5 (mean ±S.D.) to 46.8 ± 11.2 in normal population with GP-EX, p=0.002 vs. from 54.1 ± 9.9 to 49.0 ± 9.6 in normal population with placebo, p>0.05; ASI19: T-STAI = from 47.2 ± 12.0 to 42.4 ± 11.1 in normal population with GP-EX,p=0.022 vs. from 48.7 ± 11.5 to 46.0 ± 10.4 in normal population with placebo, p>0.05]. The most frequently reported adverse reactions considered possibly related to treatment were mild gastrointestinal events. GP-EX is more effective than placebo and is well tolerated as a therapy for anxiety and stress of normal population.
참고문헌 (19)
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