Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes

Dongzhimen Hospital, Beijing

Status: Not yet enrolling

Conditions: Perimenopausal Disorder; Hot Flashes; Postmenopausal Symptoms; Acupuncture Therapy

Treatments: Device: Electro Press Needle; Drug: Gamma-Oryzanol

Study type: Interventional

Funder types: Other

Identifiers

NCT05922800

2023DZMEC-155-02

Details and patient eligibility

About

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 gamma-oryzanol group among women during menopausal transition and postmenopausal periods.

Full 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.

Enrollment: 64 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 40-60 years old;

2. 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 ;

3. Fulfilling either condition mentioned below:

   1. The last menstrual period was more than 12 months ago (including 12 months);
   2. In the late menopausal transition, and has amenorrhea for more than 60 days;
   3. FSH≥25IU, and has vasomotor symptoms of HF, sweating, insomnia, migraine, or restlessness, etc.

4. Volunteer to participate in this study and sign the informed consent.

Exclusion criteria

1. 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;
2. Bilateral salpingo-oophorectomy;
3. Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc.;
4. Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months;
5. Received radiotherapy or chemotherapy before;
6. Coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present;
7. Suffering from skin diseases, such as eczema, psoriasis, etc.;
8. Severe hepatic and renal insufficiency;
9. Uncontrolled hypertension, diabetes or thyroid disease;
10. Diabetic neuropathy and mental illness (including depression);
11. Being pregnant, breastfeeding or planning to be pregnant during the trial;
12. Regular usage of sedatives or anti-anxiety drugs;
13. Smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse;
14. Installation of pacemakers;
15. Poor compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups

Electro Press Needle

Experimental group

Description:

Body acupoints of Yintang (GV29), Dazhui (GV14), Guanyuan (CV4), bilateral Zigong (EX-CA1), and bilateral Sanyinjiao (SP6) and auricular acupoints of Heart (CO15), Chuiqian (LO4) and Shenmen (TF4) will be selected for treatment. Auricular acupoints on right and left ear will be stimulated alternatively, one side on each time.The treatment will last 40mins for each session, 3 sessions a week (ideally every other day) for a succession of 6 weeks.

Treatment:

Device: Electro Press Needle

Gamma-Oryzanol

Active Comparator group

Description:

The patients in this group were given 10mgx100 tablets/bottle of gamma-oryzanol tablets (Tianjin Lishen Pharmaceutical), 20mg each time, three times a day, for 6 months.

Treatment:

Drug: Gamma-Oryzanol