Effects and safety of Korean red ginseng on the clinical course of uterine leiomyoma: A double-blind randomized placebo-controlled trial.

Korean red ginseng (KRG) is widely used as a dietary supplement, but its effects on uterine leiomyoma growth and reproductive hormones are unclear. We evaluated whether KRG affects leiomyoma growth, routine laboratory indices, or endocrine profiles in premenopausal women with uterine leiomyoma managed expectantly.

In this single-center, double-blind, randomized, placebo-controlled, parallel-group trial, premenopausal women aged 20 to 45 years with a uterine leiomyoma of 1 to 8 cm suitable for expectant management were allocated 1:1 to KRG 3 g/d or matching placebo for 6 months. Participants, investigators, ultrasonography examiners, and analysts were blinded. The primary outcome was the between-group difference in the 6-month change in maximal diameter of the index leiomyoma on ultrasonography, analyzed by analysis of covariance adjusted for baseline diameter. Secondary outcomes were complete blood count, ferritin, liver enzymes, and reproductive hormones.

Between December 2015 and September 2019, 69 participants were randomized (placebo 34, KRG 35) and 61 completed the 6-month assessment (placebo 30, KRG 31); all 8 noncompletions were losses to follow-up. Maximal diameter increased modestly in both groups, with no significant between-group difference in change (mean difference -0.11 cm; 95% confidence interval: -0.33 to 0.12; P = .34); the upper confidence limit lay below the prespecified target difference of 0.33 cm. There were no significant between-group differences in laboratory changes or in baseline-, age-, and body mass index-adjusted log scale hormone ratios, and the multivariate hormone profile did not differ between groups (Pillai's trace = 0.056; P = .68). In exploratory post hoc analyses, the internal correlation structure among hormone changes was similar in both arms. No treatment-related serious adverse event and no discontinuation for intolerance was documented, although adverse events were ascertained passively.

In premenopausal women with uterine leiomyoma managed expectantly, 6 months of KRG supplementation did not meaningfully alter leiomyoma growth, routine laboratory indices, or reproductive hormone homeostasis compared with placebo. Within the constraints of a modest sample size, incomplete characterization of the study product, and passive adverse-event ascertainment, these findings do not establish the safety of KRG, and they support no conclusion regarding nonserious adverse effects.