Effectiveness of Electro-Press Needle for Menopause-associated Hot Flashes

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    122
  • sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Updated on 3 January 2022

Summary

The investigators plan to conduct the randomized controlled trial to evaluate the effectiveness of electro-press needle (EPN), a novel acupuncture needle combining shallow and gentle insertion with transdermal electrical stimulation, on menopause-associated hot flash in comparison with waiting-list group among women during menopausal transition and postmenopausal periods.

Description

As the most common type of menopause-associated symptoms, hot flashes affect up to 85% of women aging between 40 and 65 years . In China, women suffer from hot flushes as long as 4 to 5 years on average, some of whom may bear the symptoms for 12 years.Hormone replacement therapy (HRT) is generally recommended to relieve menopause-associated hot flashes.However, long-term usage of HRT may increase the incidence of endometrial, breast and ovarian cancer, thrombosis and strokes.Results of previous studies indicated that acupuncture might help to relieve the symptoms.There is insufficient evidence supporting its effectiveness for relieving the hot flash symptom.

Details
Condition Hot Flashes, Acupuncture Therapy, Perimenopausal Disorder, Postmenopausal Symptoms
Treatment Electro Press needle
Clinical Study IdentifierNCT04995107
SponsorGuang'anmen Hospital of China Academy of Chinese Medical Sciences
Last Modified on3 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged between 40-60 years old
Scoring 14 points or more in at least one day during the one-week baseline assessment, or having an average of ≥ 7 moderate or severe heating per 24 hours recorded in HF Dairy
Fulfilling either condition mentioned below
The last menstrual period was more than 12 months ago (including 12 months)
In the late menopausal transition, and has amenorrhea for more than 60 days
FSH≥25IU, and has vasomotor symptoms of HF, sweating, insomnia, migraine, or restlessness, etc
Volunteer to participate in this study and sign the informed consent

Exclusion Criteria

Usage of HRT via transdermal administration in the previous one month, or via oral or intrauterine administration in the previous two months; usage of phytoestrogens therapy, transvaginal estrogen administration, or estrogen or progesterone injections in the previous three months
Bilateral salpingo-oophorectomy
Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc
Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months
Received radiotherapy or chemotherapy before
Coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present
Suffering from skin diseases, such as eczema, psoriasis, etc
Severe hepatic and renal insufficiency
Uncontrolled hypertension, diabetes or thyroid disease
Diabetic neuropathy and mental illness (including depression)
Being pregnant, breastfeeding or planning to be pregnant during the trial
Regular usage of sedatives or anti-anxiety drugs
Smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse
Installation of pacemakers
Poor compliance
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