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The Efficacy of ACupuncture On Menopausal Symptoms (ACOM) (ACOM)

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ClinicalTrials.gov Identifier: NCT02746497
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : November 8, 2017
Sponsor:
Collaborators:
Section of General Practice, University of Copenhagen
Research Unit Of General Practice, Copenhagen
Danish Society for Evidence Based Acupuncture (DSEA)
Idella Foundation
University of Southern Denmark
Information provided by (Responsible Party):
Kamma Sundgaard Lund, University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Menopause Procedure: Acupuncture Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of ACupuncture On Menopausal Symptoms (ACOM): A Randomized Controlled Trial
Study Start Date : October 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Procedure: Acupuncture

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.


Active Comparator: 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.
Procedure: Acupuncture

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.





Primary Outcome Measures :
  1. Hot flushes (based on the hot flushes scale from MSQ) [ Time Frame: 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.



Secondary Outcome Measures :
  1. 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 ]

    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.


  2. Legacy effect. [ Time Frame: 11 weeks ]
    Outcomes in week 11 express the legacy-effect of acupuncture treatment on menopausal related symptoms. Evaluated using the MSQ.

  3. Long term outcome [ Time Frame: 26 weeks ]
    Outcomes in week 26 express any possible longer-lasting effect. Evaluated using the MSQ.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746497


Locations
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Denmark
Section of General Practice
Copenhagen, Capital Region, Denmark, 1014
Sponsors and Collaborators
University of Copenhagen
Section of General Practice, University of Copenhagen
Research Unit Of General Practice, Copenhagen
Danish Society for Evidence Based Acupuncture (DSEA)
Idella Foundation
University of Southern Denmark
Investigators
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Principal Investigator: Kamma S Lund, MD Section of General Practice

Publications:
Skovgaard L, Cour SL, Kristensen M. Use of complementary and alternative medicine in Danish Hospitals as reported by charge nurses at department level. Journal of Hospital Administration wwwscieduca/jha; http://dxdoiorg/105430/jhav2n2p22. 2013;Vol 2, No 2.:22-6.
Rosted P. Akupunktur: på naturvidenskabeligt grundlag: Klim; 2003.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kamma Sundgaard Lund, Medical Doctor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02746497     History of Changes
Other Study ID Numbers: 1072031001
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kamma Sundgaard Lund, University of Copenhagen:
Menopause
Hot flushes
Acupuncture
Randomized controlled trial