title: The efficacy of acupuncture on menopausal symptoms (ACOM study): protocol for a randomised study.
abstract: BACKGROUND
  Around 75% of menopausal women experience hot flushes (HF) and 10-20% of all postmenopausal women find this very distressing. The aim of this study is to evaluate the efficacy of acupuncture on moderate-to-severe menopausal symptoms in general and HF in particular.
  
  
  METHODS
  An un-blinded randomised trial (cross-over) with 1:1 allocation to early (intervention) versus late (control) acupuncture. The included women suffer from moderate-to-severe HF and will receive a weekly treatment during five consecutive weeks in the following predefined acupuncture points: CV-3, CV-4, LR-8, SP-6, SP-9. All acupuncturists will be medical doctors educated in acupuncture. The primary outcome is change in HF from baseline to week 6 measured by the HF scale from the MenoScores Questionnaire (MSQ). Secondary outcomes are change in other menopausal symptoms, in particular day and night sweats and menopausal-specific sleeping problems, also measured by other scales from the MSQ. A total of 68 patients must be enrolled to detect a relevant clinical reduction on the above MSQ scales. Both intention-to-treat and per-protocol analyses will be conducted; four or more treatments are considered adequate adherence.
  
  
  CONCLUSIONS
  In the ACOM study, we explore the potential benefits of acupuncture on moderate-to-severe meno-pausal symptoms. The cross-over design offers the possi-bility of examining the legacy effect of acupuncture.
  
  
  BACKGROUND
  The Idella Foundation, the University of Copenhagen and the Research Foundation of General Practice.
  
  
  BACKGROUND
  Clinicaltrials NCT02746497.
authors.affiliation: kaml@sund.ku.dk.
authors.forename: Kamma Sundgaard
authors.initials: KS
authors.lastname: Lund
authors.forename: John
authors.initials: J
authors.lastname: Brodersen
authors.forename: Volkert
authors.initials: V
authors.lastname: Siersma
authors.forename: Frans Boch
authors.initials: FB
authors.lastname: Waldorff
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D018592:Cross-Over Studies; D003718:Denmark; D005260:Female; D019584:Hot Flashes / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008593:Menopause / Q000502:physiology / Q000523:psychology; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires