Clinical trial NCT05922800: Effectiveness of Electro-Press Needle and Gamma-Oryzanol for Menopause-associated Hot Flashes
Official title: Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hot Flashes
Acupuncture Therapy
Perimenopausal Disorder
Postmenopausal Symptoms
Keywords: gamma-oryzanol
Electro-Press Needle
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 64
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
timeFrame: week 6
Secondary outcomes:
measure: The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline
timeFrame: week 3,18,30
measure: The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline24-hour HF score from baseline
timeFrame: week 3,6,18,30
measure: The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity from baselineHF frequency from baseline24-hour HF score from baseline
timeFrame: week 3,6,18,30
measure: The changes in the mean 24-h HF score from baseline
timeFrame: week 3,6,18,30
measure: The change of Menopause rating scale (MRS) score from baseline
timeFrame: week 6,18 and 30
measure: The change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline
timeFrame: week 6,18 and 30
measure: Time domain analysis of 24-hour heart rate variability(HRV)
timeFrame: week 6,30
measure: Frequency domain analysis of 24-hour heart rate variability(HRV)
timeFrame: week 6,30
measure: The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)
timeFrame: week 3,6,18,30
Other outcomes:
measure: Participants'acceptability towards EPN
timeFrame: week 1 and 3,at the end of the first and ninth treatments
measure: Participants' belief that EPN might help
timeFrame: Baseline assessmentweek 0
measure: Participants' expectations of improvement to menopausal associated hot flashes
timeFrame: Baseline assessment week 0
measure: Safety assessment
timeFrame: Through study completion, an average of 30 weeks
Locations:
Study officials:
References: