Electro-acupuncture for Menopausal Transition Symptoms
2015年10月22日 更新者：xiaoxuliu、Guang'anmen Hospital of China Academy of Chinese Medical Sciences
A Randomized Pilot Study of Electro-acupuncture for Menopausal Transition Symptoms
This trial aimed at exploring the efficacy as well as safety of electro-acupuncture for MT symptoms.
研究概览
详细说明
This was a RCT pilot study to assess the efficacy of Electro-acupuncture for menopausal transition participants.90
patients were randomly assigned to electro-acupuncture or sham electro-acupuncture group with a ratio of 1:1.During the whole process,all participants, evaluators and statisticians apart from acupuncturists remained strictly blinded.The changes of average 24 h hot flash scores of week8 from baseline was set as primary outcome.
With statistical power of 90%, and a two-sided α at 0.05, as well as a drop-out rate less than 20%, sample size was estimated at 90 participants.
Data analysis was based on ITT principles, and 89 participants were included in data analysis(1 participant didn't want to participate).According to methods of LOCF, missing data were imputed to fill any gaps according to the last visit.
For comparison between baseline and treatment (average 24h hot flash scores, MRS, hormone levels), data was tested by the t test or nonparametric test; for comparison between two independent samples, data were tested with t test, nonparametric test or X2 test.
P<0.05 was regarded as statistically significance.
研究类型
介入性
注册 (实际的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing
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Beijing、Beijing、中国、100053
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
Participants meeting the following criteria were included in study:
- Had a diagnosis of MT (cycle length irregularity: 7 days earlier or later than usual, the last menstruation was no longer than 11 month earliar over the previous year; Specific symptoms of MT: hot flashes, night sweating, insomnia, sexual problems, anxiety, depression etc.);
- Aged from 40 to 55 years old;
- Pregnancy test was negative;
Participants were informed about the study and signed a consent form voluntarily.
Exclusion Criteria:
Participants with any of the following criteria were omitted from the study:
- 3 month regular cycle length before enrollment;
- Took drugs for treatment in past month like estrogen, soybeans isoflavone, SSRIs, progestin, black sesame or vitamin E;
- Ovarian and uterine disease: ovarian cyst, uterine myoma more than 4cm in diameter, history of ovariectomy or hysterectomy;
- Willing or plan to become pregnant or to breast-feed;
- Regular took sedatives or anxiolytics;
- Habitual smoker or heavy alcoholic;
- Severe disease: history of radio-chemotherapy, coagulation disorders, severe dysfunction of liver or kidney, application of cardiac pacemaker or artificial joints, insufficiency controlled hypertension, diabetes, thyroid diseases, malignant tumor and psychiatric problems).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Electro-acupuncture Group
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The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints.
For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking.
For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times.
Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA.
The current intensity was adjusted to abdomen shivering without pain.
Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
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安慰剂比较：Sham Electro-acupuncture Group
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Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location.
Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin.
Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times.
Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied.
Any other interventions were rigorously maintained the same as in the EA group.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of Average 24 h Hot Flash Score From Baseline
大体时间：week8;wee4,20,32
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Every day during the 4th, 8th, 20th, and 32nd weeks, symptoms and specific times of hot flashes were recorded in hot flash diaries by the participants.Data from weeks 4, 20 and 32 were recorded as the second time frame.According to the severity categories suggested by Food and Drug Administration (FDA), hot flashes were assessed as mild, moderate, or severe.
Hot flash scores are calculated as (hot flash frequency x severity)/7, with severity scores ranging from 1=mild 2=moderate to 3=severe.
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week8;wee4,20,32
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change of MRS (Menopause Rating Scale) From Baseline
大体时间：week8;wee4,20,32
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MRS(Menopause Rating Scale) was designed to measure MT symptoms and to explore the influences on life qualities in a standardized way.
In MRS, symptoms such as impaired memory, depression, insomnia, sweating, hot flashes, nervousness, joints complaints, lack of concentration were evaluated and calculated in numbers to describe the situation of patient.
Scores on MRS range from 0 to 44, with higher scores indicating more severe symptoms.
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week8;wee4,20,32
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Change of FSH From Baseline
大体时间：week8,week20
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Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
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week8,week20
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Change of LH From Baseline
大体时间：week8,week20
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Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
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week8,week20
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Change of FSH/LH From Baseline
大体时间：week8,week20
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Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
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week8,week20
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Change of E2 From Baseline
大体时间：week8,week20
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Serum sample of participants was examined at the 2nd to 4th day of menstrual period; if the participant was not in menstrual period, Serum sample would be tested in coming cycle length; for participants in menopause period, Serum sample was examined at the end of the week of 8th and 20th.
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week8,week20
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zhishun Liu, Doctor、Guang'anmen Hospital of China Academy of Chinese Medical Sciences
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年4月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2015年6月7日
首先提交符合 QC 标准的
2015年6月10日
首次发布 (估计)
2015年6月15日
研究记录更新
最后更新发布 (估计)
2015年11月23日
上次提交的符合 QC 标准的更新
2015年10月22日
最后验证
2015年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.