The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. HYPOTHESIS Treatment with acupuncture can reduce menopausal symptoms; in particular hot flushes. AIM To determine and evaluate the efficacy of acupuncture on menopausal symptoms. METHOD The study is designed as a randomized controlled trial and reporting will follow the STRICTA method which is an official extension of CONSORT statement. RECRUITMENT AND SETTING Study subjects will primarily be recruited through general practitioners, the Danish Society for Evidence based Acupuncture (DSEA) and groups for menopausal women on social media. The trial will take place in Danish primary care medical clinics.

Official Title
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The Efficacy of ACupuncture On Menopausal Symptoms (ACOM): A Randomized Controlled Trial

Conditions
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Menopause

Intervention / Treatment
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* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group E (early intervention)<br>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. | Procedure: Acupuncture<br>* Acupuncture style; Western Medical Acupuncture (WMA). In WMA all types of sham (placebo) acupuncture are believed to produce a certain amount of sensory stimulation and thereby a possible therapeutic effect. In addition, other studies have shown that sham acupuncture is associated with a moderately large nonspecific effect and compared to other inert placebo intervention the effect associated with sham acupuncture might be larger. Thus we use a control group instead of a placebo group. Needles; sterile disposable needles (Plandent) size 0.30x30mm. The needles will be inserted perpendicularly and rotated manual between finger and thumb for a few seconds to elicit de-qi. Needle retention time will be 10 minutes. Afterward the needle will be removed. Acupuncture points; CV-3, CV-4, LR-8, SP-6, SP-9. In total 8 points as LR-8, SP-6, SP-9 are given bilaterally.<br>|
| Active Comparator: Group L (late intervention)<br>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. | Procedure: Acupuncture<br>* Acupuncture style; Western Medical Acupuncture (WMA). In WMA all types of sham (placebo) acupuncture are believed to produce a certain amount of sensory stimulation and thereby a possible therapeutic effect. In addition, other studies have shown that sham acupuncture is associated with a moderately large nonspecific effect and compared to other inert placebo intervention the effect associated with sham acupuncture might be larger. Thus we use a control group instead of a placebo group. Needles; sterile disposable needles (Plandent) size 0.30x30mm. The needles will be inserted perpendicularly and rotated manual between finger and thumb for a few seconds to elicit de-qi. Needle retention time will be 10 minutes. Afterward the needle will be removed. Acupuncture points; CV-3, CV-4, LR-8, SP-6, SP-9. In total 8 points as LR-8, SP-6, SP-9 are given bilaterally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hot flushes (based on the hot flushes scale from MSQ) | 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. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other menopausal related symptoms, in particular day and night sweats and menopausal specific sleeping problems, also measured by scales from the MSQ. | The secondary outcomes and assessment of these will be as followed: Change in day-and-night-sweats assessed by a scale from the MSQ, Change in general sweating assessed by a scale from the MSQ, Change in menopausal specific sleeping problems assessed by a scale from the MSQ, Change in emotional symptoms assessed by a scale from the MSQ, Change in memory assessed by a scale from the MSQ, Change in skin-hair symptoms assessed by a scale from the MSQ, Change in physical symptoms assessed by a scale from the MSQ, Change in abdominal symptoms assessed by a scale from the MSQ, Change in urinary and vaginal symptoms assessed by a scale from the MSQ, Change in sexual symptoms assessed by a scale from the MSQ, Change in tiredness assessed by a single item from the MSQ. All measured as change from baseline at week 6. | 6 weeks | 
| Legacy effect. | Outcomes in week 11 express the legacy-effect of acupuncture treatment on menopausal related symptoms. Evaluated using the MSQ. | 11 weeks | 
| Long term outcome | Outcomes in week 26 express any possible longer-lasting effect. Evaluated using the MSQ. | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, Hot flushes, Acupuncture, Randomized controlled trial