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.