The Women's Health Initiative Study of Cognitive Aging (WHISCA): a randomized clinical trial of the effects of hormone therapy on age-associated cognitive decline.
The Women's Health Initiative Study of Cognitive Aging (WHISCA): a randomized clinical trial of the effects of hormone therapy on age-associated cognitive decline.
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DOI：
10.1191/1740774504cn040oa
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发表时间：
2004-01-01
期刊：
影响因子：
--
通讯作者：
Shumaker, Sally A
中科院分区：
文献类型：
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作者：
Resnick, Susan M;Coker, Laura H;Shumaker, Sally A
妇女健康倡议认知衰老研究 (WHISCA) 是一项两项随机、安慰剂对照的临床试验，旨在评估绝经后激素治疗对特定认知功能年龄相关变化的疗效。 WHISCA 是妇女健康倡议 (WHI) 和 WHI 记忆研究 (WHIMS) 的一项辅助研究，招募了 2302 名年龄在 66 至 84 岁之间（平均年龄 73.9；标准差 3.8）的不符合痴呆症标准的女性。在第一次 WHISCA 评估之前，妇女被 WHI 随机分配接受激素治疗（如果没有子宫，则使用非对抗性结合雌激素 (CEE) 0.625 毫克/天；否则，CEE 联合醋酸甲羟孕酮 (MPA) 2.5 毫克/天）或安慰剂，平均治疗三年。 WHISCA 研究了激素疗法对记忆、认知其他方面（语言、注意力、空间能力）、运动功能和情绪随时间变化率的影响。在本文中，我们介绍了研究的基本原理和设计，包括具体的认知测量，以及将 WHISCA 纳入正在进行的随机试验的挑战。 WHISCA 提供了一个独特的机会来研究激素疗法在改变特定认知功能中与年龄相关的变化的潜力。 WHISCA 还证明了在正在进行的临床试验中添加详细的认知评估以解决女性健康中的重要问题的可行性，尽管在保持母研究的完整性、确保高保留率和实现跨站点高质量保证方面存在挑战。
The Women's Health Initiative Study of Cognitive Aging (WHISCA) was a two armed, randomized, placebo controlled, clinical trial designed to assess the efficacy of postmenopausal hormone therapy on age related changes in specific cognitive functions. WHISCA was an ancillary study to the Women's Health Initiative (WHI) and the WHI Memory Study (WHIMS) and enrolled 2302 women aged 66 to 84 years (mean 73.9; standard deviation 3.8) who did not meet criteria for dementia. Women were randomly assigned by the WHI to hormone treatment (unopposed conjugated estrogens (CEE) 0.625 mg/day if they were without a uterus; CEE combined with medroxyprogesterone acetate (MPA) 2.5 mg/day otherwise) or placebo for an average of three years before the first WHISCA assessment. WHISCA investigated the effects of hormone therapy on rates of change over time in memory, other aspects of cognition (language, attention, spatial ability), motor function, and mood. In this paper, we present the study rationale and design, including specific cognitive measures, and the challenges of incorporating WHISCA into an ongoing randomized trial. WHISCA provided a unique opportunity to investigate the potential of hormone therapy to modify age related changes in specific cognitive functions. WHISCA also demonstrated the feasibility of adding a detailed cognitive assessment into an ongoing clinical trial to address an important issue in women's health, despite the challenges of maintaining the integrity of the parent studies, ensuring high retention, and achieving high quality assurance across sites.