Effect and Safety of Electroacupuncture for Symptoms of Menopausal Transition -a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- Change From Baseline in Menopause Rating Scale Total Score
研究概览
简要总结
The primary object is to evaluate the efficacy and safety of electroacupuncture for symptoms of women during menopausal transition .
详细描述
Menopause transition is called perimenopause in the past time. 40-80% women aged 40 to 65 have symptoms during this period. Hormone therapy is the recommended therapy for menopause and there is not enough evidence in favor of alternative medicine's effect.
Our pilot trial showed that electroacupuncture had better effect for menopause transition symptoms than sham electroacupuncture. We are going to conduct a phase Ⅱ clinical trial to further evaluate the safety and effect of electroacupuncture for menopause transition symptoms.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cycle irregularity (periods occur 7 days or over earlier or later ) in the past 12 months (early menopausal transition); subjects with the last menstruation at least 2 but no longer than 12 months in the past 12 months (late menopausal transition).
- •Menopausal transition symptoms such as hot flushes, sweating, sleep disturbance, migraine, anxiety, vaginal dryness and sexual problems.
- •40 to 55 years old.
- •Volunteer to join in the trial and sign the informed consent. Patients conformed with the 4 items at the same time will be included. -
排除标准
- •Regular cycles during the past 3 months before enrollment.
- •use of estrogen, SSRIs, soybean isoflavone, progestin, vitamin E or black sesame in the past 4 weeks.
- •Patients with ovarian cyst, uterine myoma (diameter≥4cm) or after hysterectomy/ ovariectomy.
- •Patients with radiochemotherapy history or undergoing radiochemotherapy.
- •Cryptogenic vaginal bleeding
- •Coagulation disorder or use of anticoagulants like warfarin and heparin sodium.
- •Existing skin diseases like eczema or psoriasis.
- •Severe hepatic/renal insufficiency.
- •Insufficiently controlled hypertension, diabetes or thyroid diseases.
- •Existing diabetic neuropathy, malignant tumor and psychiatric disorders.
- •Wish to become pregnant or is pregnant or breast-feeding.
- •Regular use of sedative or anxiolytic.
- •Smoking or alcohol intake.
- •Subjects with mandatory indication for HT (e.g. postsurgical menopause or active osteoporosis).
- •With cardiac pacemaker or artificial joint.
研究组 & 干预措施
electroacupuncture
Electroacupuncture at RN4, EX-CA1，ST25, SP6 (double sides). One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.
干预措施: electroacupuncture (Other)
sham electroacupuncture
Sham electroacupuncture at non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides).Specially constructed EA apparatus were used with no skin penetration, electricity output, or de qi requirement for needle manipulation One session will be given every two days, 3 sessions per week (24 sessions in all) and each session lasts for 30 minutes.
干预措施: sham electroacupuncture (Other)
结局指标
主要结局
Change From Baseline in Menopause Rating Scale Total Score
时间窗: at baseline and week 8
The change in menopause rating scale (MRS) total score compared with baseline at week 8 equals MRS total score at week 8 minus MRS total score at baseline. MRS is a self-report questionnaire for evaluating the severity of menopausal symptoms in women, which contains 11 items. Each of the 11 symptoms contained a scoring scale from "0" (no complaints) to "4" (very severe symptoms). The total score will be calculated as the all items ranging from 0 to 44, with higher scores indicating worse symptoms. The MRS including 3 dimensions: psychological, somatic-vegetative, and urogenital.
次要结局
- Change From Baseline in Mean 24-h Hot Flash Score(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in Psychological Domain of Menopause Rating Scale(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in Menopause-Specific Quality of Life Questionnaire Total Score(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in the Vasomotor Domain of Menopause-Specific Quality of Life Questionnaire(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in Menopause Rating Scale Total Score(at baseline，and weeks 4, 20 and 32)
- Change From Baseline in Urogenital Domain of Menopause Rating Scale(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in Serum FSH Level(at baseline, and weeks 8 and 20)
- Change From Baseline in Somatic-vegetative Domain of Menopause Rating Scale(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in the Psychosocial Domain of Menopause-Specific Quality of Life Questionnaire(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in the Physical Domain of Menopause-Specific Quality of Life Questionnaire(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in the Sexual Functioning Domain of Menopause-Specific Quality of Life Questionnaire(at baseline, and weeks 4, 8, 20 and 32)
- Change From Baseline in Serum LH Level(at baseline, and weeks 8 and 20)
- Change From Baseline in Serum FSH/LH Level(at baseline, weeks 8 and 20)
- Number of Participants Who Used Other Treatment During Study(weeks 1-8; weeks 9-32)
- Change From Baseline in Serum E2 Level(at baseline, and weeks 8 and 20)
研究者
Liu Zhishun
Dean of Acupuncture Department of Guangan'men Hospital
Guang'anmen Hospital of China Academy of Chinese Medical Sciences