The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)
Condition: Menopause
Study type: Interventional

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.
    

Intervention name(s): Acupuncture
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Menopause; Hot flushes; Acupuncture; Randomized controlled trial