Catalan
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Pilot Study - Impact of Traditional Acupuncture on Menopause

Només els usuaris registrats poden traduir articles
Inicieu sessió / registreu-vos
L'enllaç es desa al porta-retalls
EstatCompletat
Patrocinadors
Cedars-Sinai Medical Center

Paraules clau

Resum

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.

Descripció

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.

Dates

Darrera verificació: 03/31/2019
Primer enviat: 07/29/2009
Inscripció estimada enviada: 07/29/2009
Publicat per primera vegada: 07/30/2009
Última actualització enviada: 04/07/2019
Publicació de l'última actualització: 04/09/2019
Data d'inici de l'estudi real: 12/31/2008
Data estimada de finalització primària: 01/31/2010
Data estimada de finalització de l’estudi: 01/31/2010

Condició o malaltia

Menopause

Intervenció / tractament

Procedure: TA

Other: AA

Other: WC

Fase

-

Grups de braços

BraçIntervenció / tractament
Active Comparator: TA
Active TA
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.
Active Comparator: AA
Alternative Acupuncture
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.
Active Comparator: WC
Waiting Group
Other: WC
Waiting Group

Criteris d'elegibilitat

Edats elegibles per estudiar 40 Years Per a 40 Years
Sexes elegibles per estudiarFemale
Accepta voluntaris saludables
Criteris

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.

Resultat

Mesures de resultats primaris

1. vasomotor symptoms (VMS) frequency and severity [3 months]

vasomotor symptoms (VMS) frequency and severity

Mesures de resultats secundaris

1. The Pittsburgh Sleep Diary (PghSD) [60 minutes]

2. Pittsburgh Sleep Quality Index (PSQI) [30minutes]

3. Beck Depression Inventory (BDI) [30 minutes]

Uneix-te a la nostra
pàgina de Facebook

La base de dades d’herbes medicinals més completa avalada per la ciència

  • Funciona en 55 idiomes
  • Cures a base d'herbes recolzades per la ciència
  • Reconeixement d’herbes per imatge
  • Mapa GPS interactiu: etiqueta les herbes a la ubicació (properament)
  • Llegiu publicacions científiques relacionades amb la vostra cerca
  • Cerqueu herbes medicinals pels seus efectes
  • Organitzeu els vostres interessos i estigueu al dia de les novetats, els assajos clínics i les patents

Escriviu un símptoma o una malaltia i llegiu sobre herbes que us poden ajudar, escriviu una herba i vegeu malalties i símptomes contra els quals s’utilitza.
* Tota la informació es basa en investigacions científiques publicades

Google Play badgeApp Store badge