The Efficacy of ACupuncture On Menopausal Symptoms (ACOM): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Hot flushes (based on the hot flushes scale from MSQ)
研究概览
简要总结
As a natural part of the menopause the ovaries production of sex hormones declines. This can lead to different menopausal related symptoms. About two-thirds of postmenopausal women experience hot flushes and 10-20% find these hot flushes very stressful.
The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal symptoms; in particular hot flushes. The study will be a randomized controlled trial. Primary outcome is change in hot flushes. Secondary outcome is change in other menopausal related symptoms.
详细描述
Hot flushes and night sweats are common menopausal symptoms. Around 75% of menopausal women experience hot flushes and 10-20% of all postmenopausal women find these hot flushes very stressful. Some menopausal women also experience other symptoms such as emotional vulnerability, sleeping problems, fatigue, joint pain, cognitive changes, vaginal dryness and loss of sexual desire.
On average women experience the menopause in the beginning of the early fifties. Menopausal symptoms are commonly experienced in 4-5 years and for some women even longer. Besides individual differences within a homogenous population the experience of menopausal symptoms also differs among different cultures and ethnic groups.
Hormone therapy (HT) has in many years been an effective treatment for menopausal symptoms. However, research has shown that long-term HT increases the risk of breast cancer and thromboembolic disorders. Other medications such as antidepressants or antiepileptics have been tried but are normally not recommended. Relaxation, exercise and use of different herbs have also been suggested but currently no convincing results. Hence, alternative effective treatments with few side effects are desired.
Acupuncture has in several studies shown an effect on menopausal hot flushes. However due to different study design, acupuncture style and outcome measures it is difficult to compare these studies. Moreover, many of these studies have been criticized for methodological errors and flaws e.g. poor design, lack of follow up, small sample size, inadequate control group, not standardized acupuncture points, problems with drop outs and blinding of the participants. Consequently, further research and more well-designed randomized controlled trials (RCTs) are needed.
It is estimated that approximately one-third of the general practitioners in Denmark on a regular basis are using acupuncture as part of their treatment of patients. A study from 2013 showed that about 20 % of the Danish hospital departments, distributed among 40% of the Danish hospitals, offered complementary and alternative medicine (CAM). Almost 70% of these treatments were acupuncture. Experience from this project could potentially kick start a research tradition of acupuncture, and lead to an expansion of an "evidence-based" use of acupuncture in the Danish health-care system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 40-65 years
- •"Quite a bit" or "a lot" bothered by hot flushes (score ≥4 on a validated scale measuring hot flushes (MenoScores questionnaire (MSQ))
- •No conflicts of interests and have given oral and written consent
- •Must have an email address
排除标准
- •Hysterectomised and/or bilateral oophorectomised
- •Hormone therapy for menopausal symptoms within the past 4 weeks
- •Hormonal intrauterine device within the past 4 weeks
- •Treatment with antidepressants and/or antiepileptics within the past 4 weeks
- •Other medical treatment for hot flushes (e.g. clonidin) within the past 4 weeks
- •Other herbal remedies/alternative treatment for menopausal symptoms (e.g. Black Cohosh, Red Clover, Evening Primrose oil, Melbrosia) within the past 4 weeks
- •Alcohol consumption exceeding 21 drinks per week
- •Using prescribed sleeping pills and/or prescribed sedatives
- •Treatment with corticosteroids within the past 4 weeks (inhaled steroids not excluded)
- •Previously diagnosed with breast cancer, endometrial cancer, cervical cancer or ovarian cancer
- •Diagnosed with other severe cancer disease within the past 5 years
- •Heart valve disease
- •Insulin dependent and/or poorly controlled diabetes mellitus
- •Diagnosed with Thyroid disease
- •Under investigation for serious disease e.g. cancer
- •Pregnancy or breast-feeding within the past two years
- •Received acupuncture treatment within the past 6 months
- •Participating in another trial or participated in another trial in the past 2 weeks before screening
研究组 & 干预措施
Group E (early intervention)
One weekly treatment with acupuncture in five consecutive weeks. In trial week 1-5 Group E will receive treatment and Group L will act as control group.
干预措施: Acupuncture (Procedure)
Group L (late intervention)
After trial week five the Groups must cross-over. Group L will then receive treatment for five weeks (trial week 6-11) and Group E will act as follow up group.
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Hot flushes (based on the hot flushes scale from MSQ)
时间窗: 6 weeks
Change in hot flushes from baseline to week 6 expressed by a score on the hot flushes scale from the MSQ. The MenoScores Questionnaire (MSQ) is developed and validated based on a literature review, 2 focus-groups, 4 single-interviews, 4 pilot-tests and a cross-sectional validation study where 1504 women answered a draft version of the questionnaire. Data collected in this validation study were analysed using Rasch models resulting in the MenoScores Questionnaire (MSQ), which encompasses 11 scales and 1 single item, measuring different dimension of menopausal symptoms. All study subjects (both Group E and L) will receive the MSQ by email in study week 0, 3, 6, 8, 11 and 26 and asked to answer within 1 or 2 days. The MSQ can be answered on computer or tablet. If responses are missing, reminders will be sent out. When receiving the planned acupuncture treatment the MSQ must be answered 1 or 2 days before the 3th treatment and 1 week after the 5th (the last) treatment.
次要结局
- Long term outcome(26 weeks)
- Legacy effect.(11 weeks)
- Change in other menopausal related symptoms, in particular day and night sweats and menopausal specific sleeping problems, also measured by scales from the MSQ.(6 weeks)
研究者
Kamma Sundgaard Lund
Medical Doctor
University of Copenhagen
