Pilot Study - Impact of Traditional Acupuncture on Menopause

Menopause Clinical Trial

Official title:

Pilot Study - The Impact of Traditional Acupuncture on Menopausal Vasomotor Symptoms, Psychological Stress and the Hypothalamic Pituitary Adrenal (HPA) - Sympathetic Nervous System (SNS) Axis: A Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950482
• Other study ID #: IRB# 16997
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Women with menopausal Vasomotor symptoms (VMS) bothersome enough to warrant treatment;

2. Minimum of 7 hot flashes per day (on average);

3. Age limits: women ages 40-70 who have had at least one missed menstrual cycle or have undergone spontaneous menopause, women of any age who have medically induced menopause, women of any age who have had oophorectomy;

4. Informed written consent;

5. Ability to follow treatment protocols

Exclusion Criteria:

Exclusion Criteria (cohort):

1. Concomitant illness with reasonable likelihood of limiting survival to less than one year;

2. Current substance abuse (alcohol or drug);

3. Pregnancy known, suspected or planned in next year;

4. Non-English speaking patients

5. Men

Exclusion Criteria (TA intervention):

1. Other concomitant menopause treatment;

2. Participating in acupuncture treatment or formal psychological stress management program within the last year;

3. Participating in another treatment for VMS, unless willing to stop it 4 weeks in advance of participation;

4. HIV infection, chronic or active hepatitis or other blood-borne illness.

Related Conditions & MeSH terms

• Menopause

Intervention

Procedure:
• TA
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.

Other:
• AA
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.
• WC
Waiting Group

Locations

Country	Name	City	State
United States	Cedars-Sinai Women's Heart Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vasomotor symptoms (VMS) frequency and severity	vasomotor symptoms (VMS) frequency and severity	3 months
Secondary	The Pittsburgh Sleep Diary (PghSD)		60 minutes
Secondary	Pittsburgh Sleep Quality Index (PSQI)		30minutes
Secondary	Beck Depression Inventory (BDI)		30 minutes