Electro-acupuncture for Menopausal Transition Symptoms

NCT02471755 | Completed Results

• 1 other identifier: 2012BAI24B01-012
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.

Conditions

Menopause

Keywords

electro-acupuncture; menopause; menopausal transition symptoms; efficacy; RCT; placebo control

Outcome Measures

Primary Outcomes (1)

• Change of Average 24 h Hot Flash Score From Baseline

  Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe. Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.

  week8;wee4,20,32

Secondary Outcomes (5)

• Change of MRS (Menopause Rating Scale) From Baseline

  week8;wee4,20,32

• Change of FSH From Baseline

  week8,week20

• Change of LH From Baseline

  week8,week20

• Change of FSH/LH From Baseline

  week8,week20

• Change of E2 From Baseline

  week8,week20

Study Arms (2)

Electro-acupuncture Group

ACTIVE COMPARATOR

Device: Eelectro-acupuncture

Sham Electro-acupuncture Group

PLACEBO COMPARATOR

Device: Sham Eelectro-acupuncture

Interventions

Eelectro-acupuncture DEVICE

The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30\*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.

Electro-acupuncture Group

Sham Eelectro-acupuncture DEVICE

Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.

Sham Electro-acupuncture Group

Eligibility Criteria

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

You may qualify if:

• Participants meeting the following criteria were included in study:
• Had a diagnosis of MT (cycle length irregularity: 7 days earlier or later than usual, the last menstruation was no longer than 11 month earliar over the previous year; Specific symptoms of MT: hot flashes, night sweating, insomnia, sexual problems, anxiety, depression etc.);
• Aged from 40 to 55 years old;
• Pregnancy test was negative;
• Participants were informed about the study and signed a consent form voluntarily.

You may not qualify if:

• Participants with any of the following criteria were omitted from the study:
• month regular cycle length before enrollment;
• Took drugs for treatment in past month like estrogen, soybeans isoflavone, SSRIs, progestin, black sesame or vitamin E;
• Ovarian and uterine disease: ovarian cyst, uterine myoma more than 4cm in diameter, history of ovariectomy or hysterectomy;
• Willing or plan to become pregnant or to breast-feed;
• Regular took sedatives or anxiolytics;
• Habitual smoker or heavy alcoholic;
• Severe disease: history of radio-chemotherapy, coagulation disorders, severe dysfunction of liver or kidney, application of cardiac pacemaker or artificial joints, insufficiency controlled hypertension, diabetes, thyroid diseases, malignant tumor and psychiatric problems).

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Results Point of Contact

• Title: Dr.Xiaoxu Liu
• Organization: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

liuxiaoxu_lxx@163.com

+86 10 8800 1124

Study Officials

• Zhishun Liu, Doctor

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: doctor

Study Record Dates

• First Submitted: June 7, 2015
• First Posted: June 15, 2015
• Study Start: April 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 23, 2015
• Results First Posted: November 23, 2015

Record last verified: 2015-10

Locations

CN (1)