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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-Press Needle group | Experimental | 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. |
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| Waiting-list group | No Intervention | Participants in the waiting-list group will receive no intervention for 6 weeks and be followed up till weeks 30. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro Press needle | Device | 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 (φ44×15.8mm 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The proportion of participants with a reduction of 50% or more in the mean 24-hour HF frequency from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
Volunteer to participate in this study and sign the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shudan Yu, master | Contact | 15011460149 | miaomiao101@126.com | |
| Xin He, bachelor | Contact | 15910448046 | 394564518@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Acupuncture, Guang'anmen Hospital | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35147087 | Derived | Yu S, He X, Shi H, Chen Y, Liu Z. Effectiveness of electro-press needle for menopause-associated hot flashes: Protocol of a randomized controlled trial. Medicine (Baltimore). 2022 Feb 11;101(6):e28597. doi: 10.1097/MD.0000000000028597. |
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Individual participant data that underline the results reported in the article after deidentification, excluding the private information of participants.
Beginning immediately after publication and ending 6 months following article publication
Proposals should be directed to miaomiao101@126.com. To gain access, data requestors wil need to sign a data access agreement.
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| ID | Term |
|---|---|
| D019584 | Hot Flashes |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The statisticians and outcome assessors will be blinded to the allocation.
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The mean 24-hour HF frequency = total number of HF reported/Number of days reported. |
| week 3,6,18,30 |
| The proportion of patients with at least a 50% reduction in the mean 24-hour HF severity 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 |
| 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 |
| 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). | week6, 18 and 30 |
| TThe 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 |
| 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 and 30 |
| 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 |
| 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 |
| Safety assessment | Adverse events and severe adverse events will be recorded in case report form, whether related to interventions or not. | Through study completion |