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

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

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

Study Overview

• Status: Completed
• Conditions: Menopause; Puncture Site Reaction
• Intervention / Treatment: Behavioral: Hand-acupuncture; Device: Electrico-acupuncture

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410007
      • The first affiliate hospital of Hunan university of chinese traditional medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hand-acupuncture group; 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.	Behavioral: Hand-acupuncture; 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.; Other Names: Use Hua Tuo brand disposable acupuncture needles; Device: Electrico-acupuncture; 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.; Other Names: SDZ electro-acupuncture device
Placebo Comparator: Electric-acupuncture group; 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.	Behavioral: Hand-acupuncture; 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.; Other Names: Use Hua Tuo brand disposable acupuncture needles; Device: Electrico-acupuncture; 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.; Other Names: SDZ electro-acupuncture device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.
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.

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Collaborators: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Investigators: Study Chair: zhang wei, Professor, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Estimate): November 3, 2015
• Last Update Submitted That Met QC Criteria: October 31, 2015
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Acupuncture; Menopause; Electro acupuncture
• Other Study ID Numbers: 2012BAI24B01 (Other Grant/Funding Number: the Ministry of Science and Technology of PRC)