Pilot Study - Impact of Traditional Acupuncture on Menopause
Condition: Menopause
Study type: Interventional

Summary: 
      This pilot project is a randomized research study to examine the effects of acupuncture on
      menopausal symptoms. The investigators will recruit up to 45 Cedars employees (excluding Dr
      Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. If a
      patient is interested in this study, she may contact the research team for further
      information. Once a patient is identified as being eligible for the study, she will be
      contacted to schedule the screening visit. They will receive an explanation of the study.
      They will be sent the consent form to review prior to the initial visit. At the initial
      visit, prior to any study-related procedures, the consent will be reviewed with the patient.
      After all questions have been answered and the patient appears to fully understand the study,
      the patient will be asked to provide written consent.

      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.
    

Detailed description: 
      This pilot project is a randomized research study to examine the effects of acupuncture on
      menopausal symptoms. The investigators will recruit up to 45 Cedars employees (excluding Dr
      Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. If a
      patient is interested in this study, she may contact the research team for further
      information. Once a patient is identified as being eligible for the study, she will be
      contacted to schedule the screening visit. They will receive an explanation of the study.
      They will be sent the consent form to review prior to the initial visit. At the initial
      visit, prior to any study-related procedures, the consent will be reviewed with the patient.
      After all questions have been answered and the patient appears to fully understand the study,
      the patient will be asked to provide written consent.

      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.
    

Intervention name(s): TA; AA; WC
Intervention type(s): Procedure; Other; Other
Intervention description(s): In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.; In Alternative acupuncture (AA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.; Waiting Group
Other intervention name(s): Traditional Acupuncture; Alternative Acupuncture; Waiting Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Menopause; Acupuncture; Hotflash