韩国红参对子宫平滑肌瘤临床病程的影响与安全性：一项双盲随机安慰剂对照试验。
完整摘要 · 中文译文
背景：韩国红参（KRG）被广泛用作膳食补充剂，但其对子宫平滑肌瘤生长和生殖激素的影响尚不清楚。我们评估了KRG是否影响接受期待治疗的绝经前子宫平滑肌瘤女性的肌瘤生长、常规实验室指标或内分泌特征。 方法：在这项单中心、双盲、随机、安慰剂对照、平行组试验中，年龄20至45岁、患有1至8 cm适合期待治疗的子宫平滑肌瘤的绝经前女性按1：1分配接受KRG 3 g/d或匹配安慰剂治疗6个月。参与者、研究者、超声检查者和分析人员均设盲。主要结局是超声检查所示索引平滑肌瘤最大直径6个月变化的两组间差异，采用协方差分析并校正基线直径进行分析。次要结局为全血细胞计数、铁蛋白、肝酶和生殖激素。 结果：2015年12月至2019年9月期间，69名参与者被随机分组（安慰剂组34名，KRG组35名），61名完成了6个月评估（安慰剂组30名，KRG组31名）；全部8名未完成者均为失访。两组最大直径均轻度增加，变化组间无显著差异（平均差-0.11 cm；95%置信区间：-0.33至0.12；P = .34）；置信上限低于预设目标差异0.33 cm。实验室指标变化或经基线、年龄和体重指数校正的l 在对数尺度上的激素比值方面，以及多变量激素谱方面，组间均无差异（Pillai轨迹 = 0.056；P = .68）。在探索性事后分析中，两臂激素变化之间的内部相关结构相似。未记录到与治疗相关的严重不良事件，也未记录到因不耐受而停药，尽管不良事件是被动确定的。 结论：在接受期待治疗的子宫平滑肌瘤绝经前女性中，与安慰剂相比，补充KRG 6个月并未有意义地改变平滑肌瘤生长、常规实验室指标或生殖激素稳态。在样本量适中、研究产品表征不完整以及不良事件被动确定的限制下，这些发现不能确立KRG的安全性，且不支持关于非严重不良效应的任何结论。
完整摘要 · 英文原文
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.