Clinical trial NCT02746497: The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)
Official title: The Efficacy of ACupuncture On Menopausal Symptoms (ACOM): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Menopause
Hot flushes
Acupuncture
Randomized controlled trial
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Section of General Practice, University of Copenhagen
name: Research Unit Of General Practice, Copenhagen
name: Danish Society for Evidence Based Acupuncture (DSEA)
name: Idella Foundation
name: University of Southern Denmark
First posted: 2016-04-21
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Woman
2. Age: 40-65 years
3. "Quite a bit" or "a lot" bothered by hot flushes (score ≥4 on a validated scale measuring hot flushes (MenoScores questionnaire (MSQ))
4. No conflicts of interests and have given oral and written consent
5. Must have an email address

Exclusion Criteria:

1. Hysterectomised and/or bilateral oophorectomised
2. Hormone therapy for menopausal symptoms within the past 4 weeks
3. Hormonal intrauterine device within the past 4 weeks
4. Treatment with antidepressants and/or antiepileptics within the past 4 weeks
5. Other medical treatment for hot flushes (e.g. clonidin) within the past 4 weeks
6. Other herbal remedies/alternative treatment for menopausal symptoms (e.g. Black Cohosh, Red Clover, Evening Primrose oil, Melbrosia) within the past 4 weeks
7. Alcohol consumption exceeding 21 drinks per week
8. Using prescribed sleeping pills and/or prescribed sedatives
9. Treatment with corticosteroids within the past 4 weeks (inhaled steroids not excluded)
10. Previously diagnosed with breast cancer, endometrial cancer, cervical cancer or ovarian cancer
11. Diagnosed with other severe cancer disease within the past 5 years
12. Heart valve disease
13. Insulin dependent and/or poorly controlled diabetes mellitus
14. Diagnosed with Thyroid disease
15. Under investigation for serious disease e.g. cancer
16. Pregnancy or breast-feeding within the past two years
17. Received acupuncture treatment within the past 6 months
18. Participating in another trial or participated in another trial in the past 2 weeks before screening

Primary outcomes:
measure: Hot flushes (based on the hot flushes scale from MSQ)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in other menopausal related symptoms, in particular day and night sweats and menopausal specific sleeping problems, also measured by scales from the MSQ.
timeFrame: 6 weeks
measure: Legacy effect.
timeFrame: 11 weeks
measure: Long term outcome
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section of General Practice
state: Capital Region
Study officials:
affiliation: Section of General Practice
name: Kamma S Lund, MD
role: PRINCIPAL_INVESTIGATOR
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