Clinical trial NCT02098928: Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause
Official title: Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Puncture Site Reaction
Keywords: Acupuncture
Electro acupuncture
Menopause
Lead sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
First posted: 2014-03-28
Enrollment: 242
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. in past of 12 months in, menstrual cycle not rules, menstrual ahead of or wrong Hou ≥ 7 days (menopause transition period early); in past of 12 months in, at least shedding had 2 a menstrual cycle, or amenorrhea over 60 days, but ≤ November (menopause transition period late); last once menstrual to stopped by Hou 3 years within (menopause 3 years within patients)
2. Menopause-related symptoms: baking heat, sweating, insomnia, migraines,irritability, sore vagina, sexual intercourse and so on
3. 40-55 years
4. Baseline scorch score ≥ 6 points
5. without hormone therapy indications for mandatory, such as during menopause, osteoporosis mobility
6. volunteered for this study, and sign the consent form

Exclusion Criteria:

1. test within 3 months before the menstrual cycle rules
2. nearly 4 weeks applied estrogen, SSRIs, soy isoflavones, progesterone, vitamin e, or Black Cohosh
3. diameter greater than 4cm fibroid ovarian cyst, ovarian or after hysterectomy
4. disease history of chemotherapy or who are undergoing chemotherapy
5. unexplained vaginal bleeding
6. coagulation disorders or taking anticoagulant drugs such as warfarin, heparin
7. suffered from skin diseases like eczema, psoriasis, etc
8. severe hepatic and renal insufficiency
9. yet controlled high blood pressure, diabetes, or thyroid disease
10. diabetic nerve damage, cancer and mental illnesses (including depression)
11. wishes are in pregnancy or pregnancy or breastfeeding
12. long-term use of sedatives or antidepressants
13. long-term smoking and alcoholism
14. installed pacemaker or artificial joints

Primary outcomes:
measure: Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks
timeFrame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
Secondary outcomes:
measure: Scores of menopause rating scale（MRS）
timeFrame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
measure: Scores of Menopause-Specific Quality of Life Questionnaire （MENQOL）
timeFrame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
measure: Scores of the Self-Rating Anxiety Scale（SAS）
timeFrame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
measure: Scores of the Self-rating depression scale（SDS）
timeFrame: into the group, into the group after the 4th, 8, 20 and 32 weeks.
measure: the serum levels of sex hormones
timeFrame: into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.
Other outcomes:
measure: safety evaluation of acupuncture
timeFrame: immediate records
measure: evaluation of discomfort when acupuncturing
timeFrame: 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.
measure: subjects acceptance evaluation
timeFrame: 1TH and 12th at the end of treatment with acupuncture and moxibustion, and taking the average.
measure: health economics indexes
timeFrame: into the group after 8th during recording.
measure: research evaluation
timeFrame: to 32nd after into the Group during recording
Locations:
city: Changsha
country: China
facility: The first affiliate hospital of Hunan university of chinese traditional medicine
state: Hunan
Study officials:
affiliation: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: zhang wei, Professor
role: STUDY_CHAIR
References: