Multicenter Randomized Controlled Trial on Comparison of Efficacy Between Hand Acupuncture and Electro-acupuncture in Treatment of Menopausal Hot Flashes Symptoms

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine1 site in 1 country242 target enrollmentApril 2014

ConditionsMenopause Puncture Site Reaction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Menopause
Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Enrollment: 242
Locations: 1
Primary Endpoint: Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2014

End Date

September 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)
•Menopause-related symptoms: baking heat, sweating, insomnia, migraines,irritability, sore vagina, sexual intercourse and so on
•40-55 years
•Baseline scorch score ≥ 6 points
•without hormone therapy indications for mandatory, such as during menopause, osteoporosis mobility
•volunteered for this study, and sign the consent form

Exclusion Criteria

•test within 3 months before the menstrual cycle rules
•nearly 4 weeks applied estrogen, SSRIs, soy isoflavones, progesterone, vitamin e, or Black Cohosh
•diameter greater than 4cm fibroid ovarian cyst, ovarian or after hysterectomy
•disease history of chemotherapy or who are undergoing chemotherapy
•unexplained vaginal bleeding
•coagulation disorders or taking anticoagulant drugs such as warfarin, heparin
•suffered from skin diseases like eczema, psoriasis, etc
•severe hepatic and renal insufficiency
•yet controlled high blood pressure, diabetes, or thyroid disease
•diabetic nerve damage, cancer and mental illnesses (including depression)

Outcomes

Primary Outcomes

Change from Baseline in average scores of 24-hour hot flashes symptoms at 32 weeks

Time Frame: into the group, into the group after the 4th, 8, 20 and 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.

Secondary Outcomes

the serum levels of sex hormones(into the group, into the group after the 8th week; secondary evaluation points: into the group after the 20th week.)
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.)
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.)