The efficacy of acupuncture on menopausal symptoms (ACOM study): protocol for a randomised study

TY - JOUR

T1 - The efficacy of acupuncture on menopausal symptoms (ACOM study)

T2 - protocol for a randomised study

AU - Lund, Kamma Sundgaard

AU - Brodersen, John

AU - Siersma, Volkert

AU - Waldorff, Frans Boch

PY - 2017/3/1

Y1 - 2017/3/1

N2 - 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.

AB - 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.

KW - Acupuncture Therapy

KW - Adult

KW - Cross-Over Studies

KW - Denmark

KW - Female

KW - Hot Flashes

KW - Humans

KW - Menopause

KW - Middle Aged

KW - Quality of Life

KW - Surveys and Questionnaires

KW - Journal Article

KW - Randomized Controlled Trial

M3 - Journal article

C2 - 28260598

SN - 2245-1919

VL - 64

SP - 1

EP - 6

JO - Danish Medical Journal

JF - Danish Medical Journal

IS - 3

M1 - A5344

ER -