Acupuncture/Reproductive Hormones/Ovulation/Polycystic

针灸/生殖激素/排卵/多囊

• 批准号: 6970579
• 负责人: LISA M PASTORE
• 金额: $ 20.66万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6970579
• 关键词: acupuncture /acupressure; alternative medicine; clinical research; clinical trials; female; follicle stimulating hormone; hormone regulation /control mechanism; human subject; human therapy evaluation; luteinizing hormone; ovulation; patient oriented research; pituitary gonadal axis; polycystic ovary syndrome

DESCRIPTION (provided by applicant): Polycystic Ovary Disease (PCOS) is the most common endocrine disorder among reproductive age women, and is the most common cause of irregular cycles and anovulatory infertility. Acupuncture may represent an alternative to hormonal treatment for these women, based on three studies with positive findings with fewer than 50 acupuncture subjects and no control group. The best of these studies examined 24 PCOS women and found that 38% of the women had restored ovulation (2+ ovulations) during the treatment plus follow-up time period. The proposed research will be a double-blind, placebo-controlled, randomized clinical trial to assess if acupuncture restores ovulation (2+ ovulations) and normalizes ovarian hormones in women v/ith PCOS. Participants (n=78 completers) will be randomized to receive either acupuncture treatment or a sham procedure (Park Sham Device) for a standard 8-week period of time. All participants will provide blood samples through the University of Virginia General Clinical Research Center before treatment, after treatment, and three months later from which reproductive hormones, androgens and insulin/glucose will be assayed. Urine samples will be provided weekly throughout the treatment and follow-up periods to determine if ovulation has occurred. To collect data on potential confounders, weight will be measured and questionnaires administered at the same three time periods as the blood samples. Results will be analyzed with a combination of odds ratios, multiple logistic regression, repeated measures analyses, generalized estimating equations, and analysis of covariance. This study will be a clear enhancement compared to the existing literature by inclusion of a sham treatment control group, rigorous diagnosis of PCOS, and collection of blood samples timed to the menstrual cycle (applicable when there is an ovulatory cycle). This research will assess within our PCOS population whether acupuncture increases ovulatory frequency, causes the ratio of follicle simulating hormone (FSH) to luteinizing hormone (LH) to normalize, and causes the mean levels of FSH and LH to adjust towards normal levels (increase and decrease, respectively). Toward future research, an exploratory analysis will also be conducted to estimate if some patient groups (e.g., normal insulin, smaller body mass index) are more responsive to acupuncture therapy. We will also compare enrollment strategies for population-based recruitment of women into an acupuncture clinical trial.

描述（由申请人提供）：多囊卵巢病（PCOS）是育龄妇女中最常见的内分泌疾病，也是导致周期不规律和无排卵性不孕的最常见原因。根据三项研究的积极结果，针灸可能是这些女性荷尔蒙治疗的替代方案，其中少于 50 名针灸受试者且没有对照组。其中最好的研究对 24 名 PCOS 女性进行了检查，发现 38% 的女性在治疗和随访期间恢复了排卵（2+排卵）。拟议的研究将是一项双盲、安慰剂对照、随机临床试验，旨在评估针灸是否可以恢复多囊卵巢综合症女性的排卵（2+排卵）并使卵巢激素正常化。参与者（n = 78 名完成者）将被随机分配接受针灸治疗或假手术（Park Sham 装置），为期标准 8 周。所有参与者将在治疗前、治疗后和三个月后通过弗吉尼亚大学综合临床研究中心提供血液样本，对生殖激素、雄激素和胰岛素/葡萄糖进行检测。在整个治疗和随访期间，每周都会提供尿液样本，以确定是否发生排卵。为了收集潜在混杂因素的数据，将在与血液样本相同的三个时间段测量体重并进行问卷调查。将结合比值比、多重逻辑回归、重复测量分析、广义估计方程和协方差分析来分析结果。与现有文献相比，这项研究将明显增强，包括假治疗对照组、PCOS 的严格诊断以及按月经周期采集血样（适用于有排卵周期时）。这项研究将在我们的 PCOS 人群中评估针灸是否会增加排卵频率，导致卵泡刺激素 (FSH) 与黄体生成素 (LH) 的比例正常化，并导致 FSH 和 LH 的平均水平调整至正常水平（增加和减少）。分别减少）。在未来的研究中，还将进行探索性分析，以估计某些患者群体（例如，正常胰岛素、较小的体重指数）是否对针灸治疗更敏感。我们还将比较以人群为基础招募女性参加针灸临床试验的招募策略。