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在有酒精使用障碍的成年人中有针对性地使用葛根进行狂饮:2b随机试验

Targeted Use of Kudzu for Binge Drinking Among Adults With Alcohol Use Disorder: A Phase 2b Randomized Trial.

科研进展PubMed 论文(中药安全)机译
  • 期刊The American journal of psychiatry(Am J Psychiatry)
  • 发表时间2026-11-04
  • 作者Santos GM, Coffin P, Dunham A, Hoffmann T, Walker J, Matheson T, Batki S
  • 卷期页码appiajp20251354
  • DOI10.1176/appi.ajp.20251354
  • PMID42978081

摘要机译

[目的]本研究的目的是确定有针对性地使用葛根(一种草药补充剂)对酗酒的成人酒精使用障碍(AUD)的有效性和可接受性。

[方法]在一项双盲安慰剂对照试验中,120名狂饮的AUD成年人被随机以1:1的比例与有针对性(根据需要)使用口服葛根提取物(在预期狂饮的日子服用2克)或匹配安慰剂,加上每周咨询12周。主要结果是过去一周狂饮的天数。

预先确定的次要结果包括自我报告的狂饮周数、饮酒次数,以及使用生物标志物(包括乙基葡糖苷酸(EtG)和磷脂酰乙醇(PEth))测量酒精使用的变化。[结果]保留率很高:88%完成了试验,86%完成了每周随访。

在初级意向治疗(ITT)分析中,葛根与安慰剂相比减少了狂饮天数(发生率比[IRR]=0.73,95%CI=0.54,0.99);治疗时(每周服药≥2.7天)分析估计效果更强(IRR=0.58,95%CI=0.38,0.89)。次要结果显示ITT分析中狂饮周数较低(相对风险[RR]=0.79,95%CI=0.62,0.99)。

在治疗分析中,狂饮周数(RR=0.68,95%CI=0.47,0.98)和PEth阳性(RR=0.82,95%CI=0.67,0.99)也显著减少。在治疗后3个月的访问中,狂饮天数显示出显著的持续减少(RR=0.68,95%CI=0.47,0.97)。组间不良事件的总体频率相似。随访期间没有发生与葛根相关的严重不良事件。

[结论]与安慰剂相比,葛根的定向使用降低了AUD患者在治疗期间自我报告的狂饮结果。在更频繁服药的人群中,狂饮和PEth的减少幅度更大。在治疗后就诊时,自我报告狂饮的减少持续存在。葛根可能是AUD患者狂饮的有益药理学治疗。

展开英文摘要原文

【OBJECTIVE】The aim of this study was to determine the efficacy and acceptability of targeted use of kudzu, an herbal supplement, in adults with alcohol use disorder (AUD) who binge drink.

【METHODS】In a double-blind placebo-controlled trial, 120 adults with AUD who binge drink were randomized in a 1:1 ratio to targeted (as-needed) use of oral kudzu extract (2 grams taken on days when binge drinking was anticipated) or matching placebo, plus weekly counseling for 12 weeks. The primary outcome was number of binge-drinking days in the past week. Prespecified secondary outcomes included number of self-reported binge-drinking weeks, number of drinks, and measurements of changes in alcohol use using biomarkers, including ethyl glucuronide (EtG) and phosphatidylethanol (PEth).

【RESULTS】Retention was high: 88% completed the trial, and 86% of weekly follow-up visits were completed. In the primary intention-to-treat (ITT) analysis, assignment to kudzu versus placebo reduced number of binge-drinking days (incidence rate ratio [IRR]=0.73, 95% CI=0.54, 0.99); as-treated (taking medication ≥2.7 days per week) analysis estimated a stronger effect (IRR=0.58, 95% CI=0.38, 0.89). Secondary outcomes showed lower number of binge-drinking weeks in ITT analysis (relative risk [RR]=0.79, 95% CI=0.62, 0.99). In as-treated analyses, reductions in number of binge-drinking weeks (RR=0.68, 95% CI=0.47, 0.98) and PEth positivity (RR=0.82, 95% CI=0.67, 0.99) were also significant. The number of binge-drinking days showed significant sustained reductions at the 3-month posttreatment visit (RR=0.68, 95% CI=0.47, 0.97). The overall frequency of adverse events was similar between groups. No serious adverse events related to kudzu occurred during follow-up.

【CONCLUSIONS】Targeted use of kudzu reduced self-reported binge-drinking outcomes among adults with AUD during treatment compared to placebo. Greater reductions in binge drinking and PEth were observed among those who took medication more frequently. Reductions in self-reported binge drinking persisted at the posttreatment visit. Kudzu may be a helpful pharmacologic treatment for binge drinking among people with AUD.

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