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| Name | Class |
|---|---|
| The Affiliated Hospital of the Chinese Academy of Military Medical Sciences | OTHER |
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Main objective: to compare the effects of hand-acupuncture and electro-acupuncture stimulation on the baking heat symptoms of menopause Secondary objective: to evaluate the safety and acceptability of hand acupuncture and electroacupuncture stimulation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand-acupuncture group | Active Comparator | Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. |
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| Electric-acupuncture group | Placebo Comparator | Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-acupuncture | Behavioral | Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks | The average scores of 24 hours hot flashes integration consists of integrating the hot flashes times and hot flashes extent, hot flashes degree of mild, moderate and severe hot flashes three categories. Recorded by diary cards of hot flashes symptoms diary cards. | into the group, into the group after the 4th, 8, 20 and 32 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Scores of menopause rating scale（MRS） | into the group, into the group after the 4th, 8, 20 and 32 weeks. | |
| Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL） | into the group, into the group after the 4th, 8, 20 and 32 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| safety evaluation of acupuncture | Content including broken needle, and left needle, and during, and acupuncture pain and the VAS scoring, and difficult endured of acupuncture pain (VAS ≥ 8 points, 10 points system), and needle Hou pain and the scoring, and continued time over 2 hours of more dramatic of needle Hou pain (VAS ≥ 4 points, 10 points system), and local hematoma, and infection or abscess; acupuncture Hou other does not apply sense (refers to acupuncture Hou appeared of fatigue, and palpitations, and dizzy, and headache, and insomnia, symptoms of VAS scoring of average degree and the average continued time; other is not foreseen of bad event. Form sheet for specific, when the diagnosis and treatment of patients at a time, asks if there are adverse events and reactions, if any, immediate records. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhang wei, Professor | The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliate hospital of Hunan university of chinese traditional medicine | Changsha | Hunan | 410007 | China |
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| Electrico-acupuncture | Device | Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time. |
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| Scores of the Self-Rating Anxiety Scale（SAS） | into the group, into the group after the 4th, 8, 20 and 32 weeks. |
| Scores of the Self-rating depression scale（SDS） | into the group, into the group after the 4th, 8, 20 and 32 weeks. |
| the serum levels of sex hormones | Menstruation are required in the first 2-4 days of the menstrual blood test, then if no menstruation, menstrual cycles can wait until next month before testing; menopause, while those in the first eight weeks and 20 weekend testing. | into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week. |
| immediate records |
| evaluation of discomfort when acupuncturing | evaluation of VAS maximum discomfort occurs during treatment. | 1TH and 12th within 5 minutes after the end of acupuncture treatment, take these two averages. Where a VAS value is missing, a VAS for the result. |
| subjects acceptance evaluation | an evaluation using the 0-4 system, that is divided into unacceptable (0 points), is more difficult to accept (1), moderate access (2 points), the more acceptable (3 points), very easy to take (4 points), causes unacceptable to write out. | 1TH and 12th at the end of treatment with acupuncture and moxibustion, and taking the average. |
| health economics indexes | Includes direct medical costs (check fees, fees and other costs of acupuncture and moxibustion) and hidden costs (such as round trip transportation, lost) | into the group after 8th during recording. |
| research evaluation | Compliance, rejection and expulsion rates | to 32nd after into the Group during recording |