Effectiveness and Safety of Electro-press Needle and Gamma-oryzanol for Menopause-associated Hot Flashes: Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 主要终点
- The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The statisticians and outcome assessors will be blinded to the allocation.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •The last menstrual period was more than 12 months ago (including 12 months);
- •In the late menopausal transition, and has amenorrhea for more than 60 days;
- •FSH≥25IU, and has vasomotor symptoms of HF, sweating, insomnia, migraine, or restlessness, etc.
- •Volunteer to participate in this study and sign the informed consent.
排除标准
- •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;
- •Bilateral salpingo-oophorectomy;
- •Amenorrhea secondary to premature ovarian failure, ovarian cyst or tumor, thyroid disease, hyperprolactinemia, or Cushing's syndrome, etc.;
- •Accepted acupuncture or drugs to treat the symptoms of HF within the previous 3 months;
- •Received radiotherapy or chemotherapy before;
- •Coagulation dysfunction, or taking warfarin, heparin and other anticoagulant drugs at present;
- •Suffering from skin diseases, such as eczema, psoriasis, etc.;
- •Severe hepatic and renal insufficiency;
- •Uncontrolled hypertension, diabetes or thyroid disease;
- •Diabetic neuropathy and mental illness (including depression);
- •Being pregnant, breastfeeding or planning to be pregnant during the trial;
- •Regular usage of sedatives or anti-anxiety drugs;
- •Smoking for more than 5 years (at least twenty cigarettes a day on average) , or with the problem of alcohol abuse;
- •Installation of pacemakers;
- •Poor compliance.
研究组 & 干预措施
Electro Press Needle
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.
干预措施: Electro Press Needle (Device)
Gamma-Oryzanol
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.
干预措施: Gamma-Oryzanol (Drug)
结局指标
主要结局
The proportion of patients with a reduction of 50% or more on the mean 24-hour HF score from baseline
时间窗: week 6
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.
次要结局
- 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(week 3,6,18,30)
- The proportion of participants with a reduction of 50% or more on the mean 24-hour HF score from baseline(week 3,18,30)
- 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(week 3,6,18,30)
- The change of Menopause rating scale (MRS) score from baseline(week 6,18 and 30)
- The change of Menopause-Specific Quality of Life Questionnaire (MENQOL) score from baseline(week 6,18 and 30)
- The changes in the mean 24-h HF score from baseline(week 3,6,18,30)
- Time domain analysis of 24-hour heart rate variability(HRV)(week 6,30)
- Frequency domain analysis of 24-hour heart rate variability(HRV)(week 6,30)
- The proportion of participants reporting "significantly reduced" or "moderately reduced" based on Global Response Assessment (GRA)(week 3,6,18,30)
研究者
Yu Shudan
Doctor
Dongzhimen Hospital, Beijing