{"id":312,"title":"Adjunctive effects of acupuncture and moxibustion in women with premature ovarian insufficiency receiving hormone replacement therapy: protocol for a multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial","title_zh":"针灸与艾灸作为激素替代治疗辅助手段用于早发性卵巢功能不全女性的多中心、评估者盲法2×2析因随机对照试验方案","url":"https://pubmed.ncbi.nlm.nih.gov/42973680","doi":"10.3389/fendo.2026.1952726","pmid":"42973680","journal":"Front Endocrinol (Lausanne)","kind":"paper","lang":"en","published_at":"2026-10-19T00:00:00+00:00","fetched_at":"2026-11-08T03:44:04+00:00","authors":["Lu C","Ye T","Cui J","Chen B"],"primary_topic":"repro-endo","topics":[{"slug":"repro-endo","score":8.0,"hits":["amh","anti-müllerian","estradiol","poi","premature ovarian insufficiency"]},{"slug":"oocyte","score":5.0,"hits":["antral follicle","ovarian"]},{"slug":"art-clinical","score":2.0,"hits":["clinical pregnancy","infertility"]}],"topic_score":8.0,"preference_score":0.0,"preference_labels":[],"llm_score":66.0,"final_score":66.0,"score_dims":{"novelty":62,"rigor":75,"impact":55,"relevance":88,"translation":58},"recommend_reason":"设计规范的析因RCT方案，可同时区分针刺与艾灸对POI患者卵巢储备指标的独立效应，对中西医结合生殖内分泌临床决策有参考价值；但仅为方案、无结果数据，且AFC作为POI主要结局的敏感性有限，暂属可浏览/值得关注类。","keywords":["早发性卵巢功能不全","针刺","艾灸","析因随机对照试验","窦卵泡计数","激素替代治疗"],"selected":1,"story_id":372,"llm_provider":"deepseek","llm_model":"deepseek-flash","llm_effort":"low","source_key":"pubmed-endo-genetics","source_name":"PubMed · 生殖内分泌/遗传/保存","source_tier":1,"mention_count":2,"has_interpretation":false,"journal_key":"front-endo","journal_tier":"standard","journal_if":3.9,"is_mock":false,"summary_zh":"本条目为一项前瞻性、多中心、评估者盲法2×2析因随机对照试验的研究方案，针对40岁前发病的早发性卵巢功能不全（POI）女性。计划从三家中心招募144例受试者，按1:1:1:1随机分为四组：单用雌二醇/地屈孕酮、针刺加激素替代治疗（HRT）、艾灸加HRT、针刺与艾灸联合加HRT，干预12周。主要结局为窦卵泡计数（AFC）自基线至第12周的变化；次要结局包括血清AMH、性激素、卵巢血流参数、绝经与焦虑症状、中医证候评分及月经状况；临床妊娠作为探索性生殖结局，在第24、48周随访中分析。析因模型用于估计针刺与艾灸的主效应，二者交互作用为探索性分析。方案尚未报告任何结果数据。","summary":"INTRODUCTION: Premature ovarian insufficiency (POI) is characterized by impaired ovarian function before 40 years of age and is associated with menstrual disturbance, infertility, hypoestrogenic symptoms, psychological distress, and long-term health risks. Hormone replacement therapy (HRT) is recommended for symptom control and prevention of estrogen-deficiency-related complications but does not reliably restore ovarian activity or fertility potential. Acupuncture and moxibustion are used as complementary interventions for ovarian dysfunction; however, evidence regarding their independent and combined adjunctive effects in women with POI remains limited. METHODS: This prospective, multicenter, assessor-blinded, 2 × 2 factorial randomized controlled trial will recruit 144 women with POI from three clinical centers. Participants will be randomly assigned in a 1:1:1:1 ratio to estradiol/dydrogesterone alone, acupuncture plus estradiol/dydrogesterone, moxibustion plus estradiol/dydrogesterone, or combined acupuncture and moxibustion plus estradiol/dydrogesterone. The intervention period will last 12 weeks. The primary outcome is the change from baseline to week 12 in antral follicle count (AFC). Secondary outcomes include serum anti-Müllerian hormone (AMH), sex hormones, ovarian hemodynamic parameters, menopausal and anxiety symptoms, Traditional Chinese Medicine syndrome scores, and menstrual status. Clinical pregnancy will be analyzed as an exploratory reproductive outcome during treatment and follow-up at weeks 24 and 48. Factorial models will estimate the main effects of acupuncture and moxibustion, whereas the acupuncture × moxibustion interaction will be considered exploratory. CONCLUSION: This trial will evaluate the adjunctive effects of acupuncture and moxibustion on AFC and related secondary clinical outcomes in a selected subgroup of women with POI receiving standard HRT. The factorial design will permit estimation of the independent effects of both interventions and exploratory assessment of their potential interaction. CLINICAL TRIAL NUMBER: https://itmctr.ccebtcm.org.cn/, identifier ITMCTR2025002408.","interpretation_basis":null,"fulltext_status":null,"interpretation":null,"fulltext":{"available":false,"status":null,"reason":"尚未抓取全文（未入选、分数未达阈值，或还没跑 fulltext 步骤）","pmcid":null,"license":null,"chars":0,"source":null,"fetched_at":null}}