Pilot Study - Impact of Traditional Acupuncture on Menopause
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 12/16/2018 |
| Start Date: | January 2009 |
| End Date: | February 2010 |
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
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.
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.
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.
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.
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.
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