The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02746497
• Date of registration: 04/04/2016
• Prospective Registration: Yes
• Primary sponsor: University of Copenhagen
• Public title: The Efficacy of ACupuncture On Menopausal Symptoms (ACOM) ACOM
• Scientific title: The Efficacy of ACupuncture On Menopausal Symptoms (ACOM): A Randomized Controlled Trial
• Date of first enrolment: October 2016
• Target sample size: 70
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02746497
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Kamma S Lund, MD
• Affiliation: Section of General Practice

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Menopause

Intervention(s)

Procedure: Acupuncture

Primary Outcome(s)

Hot flushes (based on the hot flushes scale from MSQ) [Time Frame: 6 weeks]

Secondary Outcome(s)

Legacy effect. [Time Frame: 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. [Time Frame: 6 weeks]

Long term outcome [Time Frame: 26 weeks]

Secondary ID(s)

1072031001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Section of General Practice, University of Copenhagen

Idella Foundation

Research Unit Of General Practice, Copenhagen

Danish Society for Evidence Based Acupuncture (DSEA)

University of Southern Denmark