THE IMPACT OF TRADITIONAL ACUPUNCTURE ON MENOPAUSAL VASOMOTOR SYMPTOMS

Lundquist Institute For Biomedical Innovation At Harbor-Ucla Medical Center, Torrance CA

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Abstract

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.