Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition

NCT01849172 | Completed Results

• 1 other identifier: BAI24B01
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .

Conditions

Menopausal Syndrome

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Menopause Rating Scale Total Score

  The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.

  at baseline and week 8

Secondary Outcomes (15)

• Change From Baseline in Menopause Rating Scale Total Score

  at baseline，and weeks 4, 20 and 32

• Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale

  at baseline, and weeks 4, 8, 20 and 32

• Change From Baseline in Psychological Domain of Menopause Rating Scale

  at baseline, and weeks 4, 8, 20 and 32

• Change From Baseline in Urogenital Domain of Menopause Rating Scale

  at baseline, and weeks 4, 8, 20 and 32

• Change From Baseline in Mean 24-h Hot Flash Score

  at baseline, and weeks 4, 8, 20 and 32

Study Arms (2)

electroacupuncture

EXPERIMENTAL

Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.

Other: electroacupuncture

sham electroacupuncture

SHAM COMPARATOR

Sham electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).Specially constructed EA apparatus were used with no skin penetration, electricity output, or de qi requirement for needle manipulation One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.

Other: sham electroacupuncture

Interventions

electroacupuncture OTHER

Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).

electroacupuncture

sham electroacupuncture OTHER

Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6). Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually.

sham electroacupuncture

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
• Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
• to 55 years old.
• Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -

You may not qualify if:

• Regular cycles during the past 3 months before enrollment.
• use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
• Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
• Patients with radiochemotherapy history or undergoing radiochemotherapy.
• Cryptogenic vaginal bleeding
• Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.
• Existing skin diseases like eczema or psoriasis.
• Severe hepatic/renal insufficiency.
• Insufficiently controlled hypertension, diabetes or thyroid diseases.
• Existing diabetic neuropathy, malignant tumor and psychiatric disorders.
• Wish to become pregnant or is pregnant or breast-feeding.
• Regular use of sedative or anxiolytic.
• Smoking or alcohol intake.
• Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).
• With cardiac pacemaker or artificial joint.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

Guangan'men Hospital

Beijing, 100053, China

Location

Related Publications (1)

• Liu Z, Wang Y, Xu H, Wu J, He L, Jiang JY, Yan S, Du R, Liu B. Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:242. doi: 10.1186/1745-6215-15-242.

  PMID: 24950841 DERIVED

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Results Point of Contact

• Title: Dr.Zhishun Liu
• Organization: Guang'an Men Hospital, China Academy of Chinese Medical Sciences

liuzhishun@aliyun.com

+86 01088002331

Study Officials

• Zhishun Liu, Ph.D

  Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Acupuncture Department of Guangan'men Hospital

Study Record Dates

• First Submitted: May 5, 2013
• First Posted: May 8, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 2, 2019
• Results First Posted: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)