Comparison Between Hand-acupuncture and Electro-acupuncture Stimulation in the Treatment of Menopause

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Status: Completed

Conditions: Puncture Site Reaction; Menopause

Treatments: Behavioral: Hand-acupuncture; Device: Electrico-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02098928

2012BAI24B01

Details and patient eligibility

About

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

Enrollment: 242 patients

Sex: Female

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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242 participants in 2 patient groups, including a placebo group

Hand-acupuncture group

Active Comparator group

Description:

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.

Treatment:

Device: Electrico-acupuncture

Behavioral: Hand-acupuncture

Electric-acupuncture group

Placebo Comparator group

Description:

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.

Treatment:

Device: Electrico-acupuncture

Behavioral: Hand-acupuncture