小檗碱在多内分泌代谢性卵巢综合征中的证据存疑：基于完整性的重新评估。
完整摘要 · 中文译文
引言：既往系统综述提示，小檗碱在多内分泌代谢性卵巢综合征（PMOS；既往称为多囊卵巢综合征）的代谢和激素结局方面可能达到或超过二甲双胍的效果。本综述旨在评估所报道的小檗碱疗效，并对PMOS女性现有证据进行基于完整性的重新评价。 方法：按照PRISMA指南进行系统综述，并前瞻性注册。检索MEDLINE、EMBASE、Cochrane Library和CINAHL，检索时间自建库至2025年10月。考察多囊卵巢综合征女性补充小檗碱的随机对照试验符合纳入标准。关注的结局包括代谢、激素和人体测量指标。所有符合条件的研究均采用两个经过验证的框架进行独立完整性评估：指南与证据合成中的研究完整性框架以及随机对照试验可信性清单。完整性受损风险被评为中等或高的研究被排除在定量合成之外。在排除前已联系作者以获取澄清。 结果：所有四项符合纳入标准的研究（n = 452）均被独立评定为完整性受损高风险，未纳入定量合成。所关注的问题包括缺乏试验注册、招募时间线不合理以及可能存在数据重复。未收到澄清回复。尽管胰岛素抵抗、血脂谱 虽然报告了雌激素和雄激素标志物，但鉴于已发现的问题，这些结果不能被认为是可靠的。 结论：我们的综述表明，基于当前证据基础，无法就小檗碱对PMOS的疗效得出可靠结论。
完整摘要 · 英文原文
INTRODUCTION: Prior systematic reviews suggest that berberine may match or exceed the effects of metformin on metabolic and hormonal outcomes in polyendocrine metabolic ovarian syndrome (PMOS; previously referred to as polycystic ovary syndrome). This review aimed to assess the reported efficacy of berberine and act as an integrity-based reappraisal of available evidence in women with PMOS. METHODS: A systematic review was conducted in accordance with PRISMA guidelines and prospectively registered. MEDLINE, EMBASE, the Cochrane Library and CINAHL were searched from inception to October 2025. Randomised controlled trials examining berberine supplementation in women with polycystic ovary syndrome were eligible for inclusion. Outcomes of interest included metabolic, hormonal, and anthropometric measures. All eligible trials underwent independent integrity assessment using two validated frameworks: the Research Integrity in Guidelines and Evidence Synthesis framework and the Trustworthiness in Randomised Controlled Trials checklist. Studies rated as moderate or high risk of compromised integrity were excluded from quantitative synthesis. Authors were contacted for clarification prior to exclusion. RESULTS: All four trials (n = 452) that met eligibility criteria were independently rated as high risk for compromised integrity, and were not included in quantitative synthesis. Concerns included absent trial registration, implausible recruitment timelines, and potential duplication of data. No clarifying responses were received. While improvements in insulin resistance, lipid profiles, and androgen markers were reported, these findings cannot be considered reliable given the identified concerns. CONCLUSIONS: Our review demonstrates that reliable conclusions regarding the efficacy of berberine in PMOS cannot be drawn from the current evidence base.