THE IMPACT OF TRADITIONAL ACUPUNCTURE ON MENOPAUSAL VASOMOTOR SYMPTOMS

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这个试点项目是一项随机研究，以检查针灸对更年期症状的影响。本项目将收集60名受试者的数据，这些受试者将被招募并随机分配到三个研究组之一：传统针灸（TA）、替代针灸（AA）和等待对照组（WC）。 该试点项目将从NIH申请提案中所述的三个研究组收集数据。第一个研究小组将接受传统针灸（TA）。第二个研究小组将接受替代针灸（AA）。第三组为等待对照组（WC），在研究结束后接受四周针灸治疗。 传统的针灸是指针插入真正的穴位位置。替代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）产生最佳治疗效果。等待对照组是一组在治疗期间既没有接受传统针灸也没有接受替代针灸的受试者，在这种情况下，治疗持续时间为3个月。 患者将被随机分配到三个研究组之一，并有三分之一的机会被分配到三个组之一。患者和研究者都不能选择将患者分配到哪一组。TA组和AA组的患者将被要求在3 - 4个月的时间内前往Cedars-Sinai共39次（36次会议和3次诊所访视）。本研究将比较传统针刺与交替针刺对更年期症状的疗效。WC组的患者将被要求到Cedars-Siani共15次。其他研究程序包括体格检查、采集血液和尿液进行激素检测、问卷调查等。 在本研究的初步阶段，受试者将在潮热日记中记录每天发生的轻度、中度、重度和/或极重度潮热的次数。患者也可以选择记录他们在那一周内可能经历的其他症状，然后是潮热以及其他评论。受试者将连续7天完成日记。这是一份简单的表格，每天只需很少时间（仅5-10分钟）完成，不会影响研究参与的持续时间。 这项试验计划不会进行基因研究。 具体目标。我们的目的是以随机方式前瞻性评估TA与AA或WC对60名围绝经期或绝经早期妇女（包括乳腺癌幸存者和乳腺癌风险妇女）VMS频率和严重程度的相对影响。使用这种实验方法，我们提出了以下主要，次要和探索性目的，在围绝经期和绝经后早期妇女与VMS： 主要目标： 1.目的：确定TA与AA和WC相比对VMS频率和严重程度的影响。 假设：与AA或WC相比，TA将降低VMS的频率和严重程度。 2.目的：确定TA与AA和WC相比对绝经期生活质量（mQOL）的影响，使用MenQOL问卷进行评估。 假设：与AA和WC相比，TA技术将改善mQOL。 次要目标： 1.目的：确定TA与AA和WC相比对感知心理压力、抑郁、敌意、焦虑、社会支持和总体生活质量（QOL）的影响。 假设：与AA或WC相比，TA将减少感知的心理压力、抑郁、敌对和焦虑，并改善生活质量。 2.目的：探讨心理应激缓解是TA治疗VMS的机制。 假设：通过感知心理压力措施测量，对TA的心理压力水平降低的女性将对TA的VMS反应有所改善。 探索性目标： 1.目的：确定基础HPA轴活性程度和F代谢程度（通过24小时类固醇特征评估）与VMS严重程度和/或频率之间的关系。 假设：具有最高程度的F产生或尿类固醇特征表明F catabolism程度最低或F重建水平最高的女性（例如，通过夸大的11？- HSD 1活动），将具有VMS的最大频率和/或严重性。 2.目的：确定基础HPA轴活性程度与F代谢程度之间的关系（通过24小时尿类固醇特征评估），以及VMS对TA的反应（与AA或WC相比）。 假设：与AA或WC相比，具有最高基础程度的F产生或最低水平的F catabolism的女性，或具有对治疗响应的F产生的最大抑制的女性，将具有对TA的VMS（频率和/或严重程度）的最大响应。 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：探讨心理应激对治疗的反应与VMS对同一干预的反应之间的关系。 假设：心理压力水平降低的妇女对干预措施的反应将具有VMS对该干预措施的上级反应。

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.