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 (ACOM study) : protocol for a randomised study. / Lund, Kamma Sundgaard; Brodersen, John; Siersma, Volkert; Waldorff, Frans Boch.
In: Danish Medical Journal, Vol. 64, No. 3, A5344, 03.2017, p. 1-6.Research output: Contribution to journal › Journal article › Research › peer-review
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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
Y1 - 2017/3
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
VL - 64
SP - 1
EP - 6
JO - Danish Medical Journal
JF - Danish Medical Journal
SN - 2245-1919
IS - 3
M1 - A5344
ER -
ID: 174843285