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

Hot Flashes Clinical Trial

Official title:

Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05922800
• Other study ID #: 2023DZMEC-155-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Dongzhimen Hospital, Beijing
• Contact: Shudan Yu, Doctor
• Phone: 15011460149
• Email: miaomiao101[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture Therapy
• Hot Flashes
• Perimenopausal Disorder
• Postmenopausal Symptoms

Intervention

Device:
• Electro Press Needle
Body acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China). After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin. Then, the electric device (f44×15.8mm Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively. The electric device will be switch to the mode of "dense intermittent wave", and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed).

Drug:
• Gamma-Oryzanol
The patients in this group were given orally gamma-oryzanol tablets 20mg each time, three times a day, for 6 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participants'acceptability towards EPN	Use the 3-point method to evaluate, unacceptable (0 points), acceptable (1 points), easy to accept (2 points), patients who cannot accept should be written the reason clearly.Only patients in electric press needle group will score.	week 1 and 3,at the end of the first and ninth treatments
Other	Participants' belief that EPN might help	Participants in the EPN group will answer the following question before the first intervention: "Do you think acupuncture will be effective for treating the disease?"The participants can answer "Yes", "No", or "Unclear."	Baseline assessmentweek 0
Other	Participants' expectations of improvement to menopausal associated hot flashes	Participants in the EPN group will answer the following question before the first intervention: "Do you think acupuncture will be effective for improving menopausal associated HF?" The participants can answer "Yes", "No", or "Unclear."	Baseline assessment week 0
Other	Safety assessment	Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not.	Through study completion, an average of 30 weeks
Primary	The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline	The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.	week 6
Secondary	The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline	The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.	week 3,18,30
Secondary	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	The mean 24-hour HF frequency = total number of HF reported/Number of days reported.	week 3,6,18,30
Secondary	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	The mean 24-hour HF severity = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/ Number of HF reported.	week 3,6,18,30
Secondary	The changes in the mean 24-h HF score from baseline	The mean 24-hour HF score = (1 × number of mild HF + 2 × number of moderate HF + 3 × number of severe HF + 4 × number of very severe HF)/Number of days reported.	week 3,6,18,30
Secondary	The change of Menopause rating scale (MRS) score from baseline	MRS is a common menopause specific subscale, including 11 items from psychological, somatic to urogenital, with 5 as minimal clinically important differences(MCID).	week 6,18 and 30
Secondary	The change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline	MENQOL consists of 29 items assessing four domains: VMS, physical symptoms, psychological symptoms, and urogenital/sexual symptoms,with 4 as minimal clinically important differences(MCID).	week 6,18 and 30
Secondary	Time domain analysis of 24-hour heart rate variability(HRV)	The indexes included total autonomic energy (SDNN) and sympathetic sensation Nerve tone (SDANN) and vagal tone (rMSSD)	week 6,30
Secondary	Frequency domain analysis of 24-hour heart rate variability(HRV)	the indexes included total power spectrum (TP) reflecting the total energy of autonomic nerve, The low frequency power (LF, 0.04~0.15Hz) reflects the sympathetic nerve activity and the high vagus nerve activity.Frequency power (HF, 0.15~0.4Hz), LF/HF reflecting the balance between sympathetic and vagal tension.	week 6,30
Secondary	The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)	The response of participants to the treatments are divided into seven grades by GRA: significantly reduced, moderately reduced, slightly reduced, no change, slightly aggravated, moderately aggravated and significantly aggravated. The proportion of participants reporting "significantly reduced" or "moderately reduced" are recorded as the response rate of the overall efficacy.	week 3,6,18,30