THE IMPACT OF TRADITIONAL ACUPUNCTURE ON MENOPAUSAL VASOMOTOR SYMPTOMS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这一试点项目是一项随机研究，旨在检查针灸对更年期症状的影响。该项目将收集60名受试者的数据，他们将被随机分为三个研究组之一：传统针刺组(TA)、替代针刺组(AA)和等待对照组(WC)。 这一试点项目将从NIH申请提案中所述的三个研究小组收集数据。第一个研究组将接受传统针灸(TA)。第二个研究组将接受替代针灸(AA)。第三组是等待对照组(WC)，在研究结束后将接受四周的针灸治疗。 传统针灸是指将针插在真正的穴位位置。另类针灸是一种与传统针灸略有不同的技术，用于评估哪种技术(如果有的话)产生最好的治疗效果。等待对照是一组在治疗期间既不接受传统针灸也不接受替代针灸的受试者，在这种情况下，治疗时间为3个月。 患者将被随机分到三个研究组中的一个，并有三分之一的机会被放入三个组中的一个。患者和调查人员都不能选择将患者分配到哪组。来自TA和AA组的患者将被要求在3-4个月内总共来西达斯-西奈39次(36次会议和3次诊所就诊)。本研究将比较传统针灸(TA)和交替针灸(AA)对更年期症状的疗效(好或坏)。WC组患者将被要求来Cedars-Siani共15次。其他研究程序包括体检、采集血液和尿液进行激素测试、问卷访谈等。 在这项研究的试点阶段，受试者将每天发生的轻度、中度、重度和/或非常严重潮热的次数记录在潮热日记中。患者也可以选择记录他们在那一周可能经历的除潮热以外的其他症状，以及一个补充评论的地方。受试者将连续七天完成日记。这是一种简单的表格，每天只需很少的时间(只需5-10分钟)就可以完成，而且不会影响学习参与的持续时间。 在这个试点项目中，不会进行任何基因研究。 明确的目标。我们的目标是以随机方式前瞻性地评估TA与AA或WC对60名围绝经期或绝经早期妇女VMS频率和严重程度的相对影响，其中包括乳腺癌幸存者和乳腺癌高危女性。利用这一实验方法，我们在围绝经期和早期绝经后VMS患者中提出了以下主要、次要和探索性目标： 主要目标： 1.目的：比较TA与AA和WC对VMS发生率和严重程度的影响。 假设：与AA或WC相比，TA可降低VMS的发生频率和严重程度。 2.目的：采用绝经后生活质量调查问卷评价TA对绝经后生活质量的影响，并与AA和WC进行比较。 假设：与AA和WC相比，TA技术将改善mQOL。 次要目标： 1.目的：比较TA与AA和WC在心理压力、抑郁、敌对、焦虑、社会支持和总体生活质量(QOL)方面的差异。 假设：与AA或WC相比，TA可以减少感知到的心理压力、抑郁、敌意和焦虑，并提高生活质量。 2.目的：探讨TA对VMS患者心理应激的缓解作用及其机制。 假设：根据感知的心理压力测量，对TA的心理压力水平降低的女性对TA的反应将得到改善。 探索性目标： 1.目的：探讨HPA轴基础活动程度和F代谢程度与VMS严重程度和(或)频率的关系。 假设：F产生程度最高的女性，或尿类固醇水平提示F分解代谢程度最低，或F重建水平最高(例如，通过夸大11？-HSD1活性)的女性，将有最高的VMS频率和/或严重程度。 2.目的：通过24小时尿类固醇测定来评估基础HPA轴活动程度与F代谢程度之间的关系，并与AA或WC比较VMS对TA的反应。 假设：与AA或WC相比，基础F产生程度最高或F分解代谢水平最低的女性，或治疗后F产生抑制程度最大的女性，对TA的VMS反应(频率和/或严重程度)将最大。 核心数据兴趣目标： 1.目的：探讨心理应激对VMS发生频率和(或)严重程度的影响。 假设：心理压力越大的女性VMS(频率或严重程度)越高。 2.目的：探讨心理应激反应与VMS对相同干预措施的反应之间的关系。 假设：对干预的心理压力水平降低的女性对该干预会有更好的VMS反应。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This pilot project is a randomized research study to examine the effects of acupuncture on menopausal symptoms. This project will collect data from 60 subjects who will be enrolled and randomized into one of the three study groups: traditional acupuncture (TA), alternative acupuncture (AA) and waiting control group (WC). This pilot project will collect data from three study groups as stated in the NIH application proposal. The first research study group will undergo traditional acupuncture (TA). The second research study group will receive alternative acupuncture (AA). The third group will be a waiting control group (WC) that will receive four weeks of acupuncture following completion of the study duration. Traditional acupuncture means that the needle is inserted in true acupuncture point locations. Alternative acupuncture is a technique that varies slightly from traditional acupuncture and is used to assess which technique, if any, produces the best therapeutic results. Waiting control is a group of subjects who get neither traditional nor alternative acupuncture during the duration of treatment, which in this case, is 3 months. Patients will be randomized into one of the three study groups, and will have one in three chance of being placed in one of the three groups. Neither patients nor the investigators can choose which group patients are assigned to. Patients from TA and AA groups will be asked to come to Cedars-Sinai a total of 39 times (36 sessions and 3 clinic visits) over a three-four month period. It will compare the effects (good or bad) of traditional acupuncture (TA) with alternative acupuncture (AA) on the menopausal symptoms to be studied in this research. Patients from WC group will be asked to come to Cedars-Siani a total of 15 times. Other study procedures include physical exam, blood and urine collection for hormone tests, questionnaire interview, etc. During the pilot phase of this study subjects will record the number of mild, moderate, severe and/or very severe hot flashes that occur each day in a hot flash diary. There is also an option for patients to record other symptoms they may experience during that week other then hot flashes as well as a place for additional comments. Subjects will complete the diary for seven consecutive days. It is a simple form that takes very little time to complete each day (only 5-10 minutes) and will not impact the duration of the study participation. No genetic study will be conducted in this pilot project. Specific Aims. We aim to prospectively evaluate in a randomized manner the relative effect of TA vs. AA or WC, on the frequency and severity of VMS in 60 women who are perimenopausal or early postmenopausal, including breast cancer survivors and women at risk for breast cancer. Using this experimental approach we propose the following primary, secondary and exploratory aims in perimenopausal and early postmenopausal women with VMS: Primary Aims: 1. Objective: To determine the effects of TA, compared to AA and WC, on VMS frequency and severity. Hypothesis: TA will reduce the frequency and severity of VMS in, compared to AA or WC. 2. Objective: To determine the effects of TA, compared to AA and WC, on menopausal quality of life (mQOL), assessed using the MenQOL questionnaire. Hypothesis: TA technique will improve mQOL compared to AA and WC. Secondary Aims: 1. Objective: To determine the effects of TA, compared to AA and WC, on measures of perceived psychological stress, depression, hostility, anxiety, social support, and overall QOL (QOL). Hypothesis: TA will reduce perceived psychological stress, depression, hostility, and anxiety, and improve QOL compared to AA or WC. 2. Objective: To explore psychological stress reduction as a mechanism underlying the beneficial effect of TA on VMS. Hypothesis: Women who respond with decreased psychological stress levels to TA, measured by perceived psychological stress measures, will have an improved response of VMS to TA. Exploratory Aims: 1. Objective: To determine the relationship between the degree of basal HPA axis activity and the degree of F metabolism, as assessed by the 24-hour steroid profile, and the severity and/or frequency of VMS. Hypothesis: Women with the highest degrees of F production or with urinary steroid profiles suggesting the lowest degrees of F catabolism, or highest levels of F reconstitution (e.g. via an exaggerated 11?-HSD1 activity), will have the greatest frequency and/or severity of VMS. 2. Objective: To determine the relationship between the degree of basal HPA axis activity and the degree of F metabolism, as assessed by the 24-hour urinary steroid profile, and the response of VMS to TA, compared to AA or WC. Hypothesis: Women with either the highest basal degrees of F production or lowest levels of F catabolism, or women with the greatest suppression in F production in response to therapy, will have the greatest response of VMS (frequency and/or severity) to TA, compared to AA or WC. Core Data Interest Aims: 1. Objective: To determine the effect of psychological stress on the frequency and/or severity of VMS. Hypothesis: Women with the higher psychological stress have higher VMS (frequency or severity). 2. Objective: To determine the association between the response of psychological stress to therapy and the response of VMS to the same intervention. Hypothesis: Women who respond with decreased psychological stress levels to an intervention will have a superior response of VMS to this intervention.