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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098928
• Other study ID #: 2012BAI24B01
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: October 31, 2015
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2014
• Source: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Food and Drug AdministrationChina: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Menopause
• Puncture Site Reaction

Intervention

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.

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.

Locations

Country	Name	City	State
China	The first affiliate hospital of Hunan university of chinese traditional medicine	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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.	Yes
Other	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.	Yes
Other	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.	No
Other	research evaluation	Compliance, rejection and expulsion rates	to 32nd after into the Group during recording	No
Primary	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.	No
Secondary	Scores of menopause rating scale(MRS)		into the group, into the group after the 4th, 8, 20 and 32 weeks.	No
Secondary	Scores of Menopause-Specific Quality of Life Questionnaire (MENQOL)		into the group, into the group after the 4th, 8, 20 and 32 weeks.	No
Secondary	Scores of the Self-Rating Anxiety Scale(SAS)		into the group, into the group after the 4th, 8, 20 and 32 weeks.	No
Secondary	Scores of the Self-rating depression scale(SDS)		into the group, into the group after the 4th, 8, 20 and 32 weeks.	No
Secondary	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.	No