The efficacy of acupuncture on menopausal symptoms (ACOM study): protocol for a randomised study
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- The efficacy of acupuncture on menopausal symptoms (AC OM study) protocol for a randomised study
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INTRODUCTION: 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.
FUNDING: The Idella Foundation, the University of Copenhagen and the Research Foundation of General Practice.
TRIAL REGISTRATION: Clinicaltrials NCT02746497.
|Journal||Danish Medical Journal|
|Number of pages||6|
|Publication status||Published - Mar 2017|
- Acupuncture Therapy, Adult, Cross-Over Studies, Denmark, Female, Hot Flashes, Humans, Menopause, Middle Aged, Quality of Life, Surveys and Questionnaires, Journal Article, Randomized Controlled Trial
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