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
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Dongzhimen Hospital, Beijing |
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 |
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