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The Women’s Health Initiative Randomized Trials and Clinical Practice
JAMA ( IF 120.7 ) Pub Date : 2024-05-01 , DOI: 10.1001/jama.2024.6542
JoAnn E. Manson 1 , Carolyn J. Crandall 2 , Jacques E. Rossouw 3 , Rowan T. Chlebowski 4 , Garnet L. Anderson 5 , Marcia L. Stefanick 6 , Aaron K. Aragaki 5 , Jane A. Cauley 7 , Gretchen L. Wells 8 , Andrea Z. LaCroix 9 , Cynthia A. Thomson 10 , Marian L. Neuhouser 5 , Linda Van Horn 11 , Charles Kooperberg 5 , Barbara V. Howard 12 , Lesley F. Tinker 5 , Jean Wactawski-Wende 13 , Sally A. Shumaker 14 , Ross L. Prentice 5
Affiliation  

ImportanceApproximately 55 million people in the US and approximately 1.1 billion people worldwide are postmenopausal women. To inform clinical practice about the health effects of menopausal hormone therapy, calcium plus vitamin D supplementation, and a low-fat dietary pattern, the Women’s Health Initiative (WHI) enrolled 161 808 postmenopausal US women (N = 68 132 in the clinical trials) aged 50 to 79 years at baseline from 1993 to 1998, and followed them up for up to 20 years.ObservationsThe WHI clinical trial results do not support hormone therapy with oral conjugated equine estrogens plus medroxyprogesterone acetate for postmenopausal women or conjugated equine estrogens alone for those with prior hysterectomy to prevent cardiovascular disease, dementia, or other chronic diseases. However, hormone therapy is effective for treating moderate to severe vasomotor and other menopausal symptoms. These benefits of hormone therapy in early menopause, combined with lower rates of adverse effects of hormone therapy in early compared with later menopause, support initiation of hormone therapy before age 60 years for women without contraindications to hormone therapy who have bothersome menopausal symptoms. The WHI results do not support routinely recommending calcium plus vitamin D supplementation for fracture prevention in all postmenopausal women. However, calcium and vitamin D are appropriate for women who do not meet national guidelines for recommended intakes of these nutrients through diet. A low-fat dietary pattern with increased fruit, vegetable, and grain consumption did not prevent the primary outcomes of breast or colorectal cancer but was associated with lower rates of the secondary outcome of breast cancer mortality during long-term follow-up.Conclusions and RelevanceFor postmenopausal women, the WHI randomized clinical trials do not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases. Menopausal hormone therapy is appropriate to treat bothersome vasomotor symptoms among women in early menopause, without contraindications, who are interested in taking hormone therapy. The WHI evidence does not support routine supplementation with calcium plus vitamin D for menopausal women to prevent fractures or a low-fat diet with increased fruits, vegetables, and grains to prevent breast or colorectal cancer. A potential role of a low-fat dietary pattern in reducing breast cancer mortality, a secondary outcome, warrants further study.

中文翻译:

妇女健康倡议随机试验和临床实践

重要性美国约有 5500 万人,全球约有 11 亿人是绝经后妇女。为了让临床实践了解更年期激素疗法、钙加维生素 D 补充剂和低脂饮食模式对健康的影响,女性健康倡议 (WHI) 招募了 161 808 名绝经后美国女性(临床试验中 N = 68 132 人) 1993年至1998年基线年龄为50至79岁,并对她们进行了长达20年的随访。观察结果WHI临床试验结果不支持对绝经后妇女采用口服结合马雌激素加醋酸甲羟孕酮的激素治疗,也不支持对绝经后妇女单独使用结合马雌激素进行激素治疗。事先进行子宫切除术以预防心血管疾病、痴呆或其他慢性疾病。然而,激素疗法对于治疗中度至重度血管舒缩和其他更年期症状有效。绝经早期激素治疗的这些好处,加上与绝经后期相比,早期激素治疗的不良反应发生率较低,支持对于没有激素治疗禁忌症且有烦人的更年期症状的女性在 60 岁之前开始激素治疗。 WHI 结果并不支持常规建议所有绝经后妇女补充钙加维生素 D 来预防骨折。然而,钙和维生素 D 适合那些不符合通过饮食推荐摄入这些营养素的国家指南的女性。增加水果、蔬菜和谷物摄入量的低脂饮食模式并不能预防乳腺癌或结直肠癌的主要结局,但在长期随访期间与较低的乳腺癌死亡率次要结局相关。结论和相关性 对于绝经后女性,WHI 随机临床试验不支持通过绝经激素治疗来预防心血管疾病或其他慢性疾病。更年期激素疗法适用于治疗更年期早期女性的烦人血管舒缩症状,无禁忌症,且对激素疗法感兴趣。 WHI 证据并不支持更年期妇女通过常规补充钙加维生素 D 来预防骨折,也不支持通过低脂饮食增加水果、蔬菜和谷物来预防乳腺癌或结直肠癌。低脂饮食模式在降低乳腺癌死亡率方面的潜在作用(次要结果)值得进一步研究。
更新日期:2024-05-01
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