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Efficacy of a standardised acupuncture approach for women with bothersome menopausal symptoms: a pragmatic randomised study in primary care (the ACOM study)
  1. Kamma Sundgaard Lund1,
  2. Volkert Siersma2,
  3. John Brodersen1,3,
  4. Frans Boch Waldorff4
  1. 1 Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
  2. 2 Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
  3. 3 Primary Health Care Research Unit, University of Copenhagen, Copenhagen, Denmark
  4. 4 The Research Unit for General Practice, Department of Public Health, University of Southern Denmark, Odense, Denmark
  1. Correspondence to Dr Kamma Sundgaard Lund; kaml{at}sund.ku.dk

Abstract

Objective To investigate the efficacy of a standardised brief acupuncture approach for women with moderate-to-severe menopausal symptoms.

Design Randomised and controlled, with 1:1 allocation to the intervention group or the control group. The assessor and the statistician were blinded.

Setting Nine Danish primary care practices.

Participants 70 women with moderate-to-severe menopausal symptoms and nine general practitioners with accredited education in acupuncture.

Intervention The acupuncture style was western medical with a standardised approach in the predefined acupuncture points CV-3, CV-4, LR-8, SP-6 and SP-9. The intervention group received one treatment for five consecutive weeks. The control group was offered treatment after 6 weeks.

Main outcome measures Outcomes were the differences between the randomisation groups in changes to mean scores using the scales in the MenoScores Questionnaire, measured from baseline to week 6. The primary outcome was the hot flushes scale; the secondary outcomes were the other scales in the questionnaire. All analyses were based on intention-to-treat analysis.

Results 36 participants received the intervention, and 34 participants were in the control group. Four participants dropped out before week 6. The acupuncture intervention significantly decreased hot flushes: Δ −1.6 (95% CI [−2.3 to −0.8]; p<0.0001), day-and-night sweats: Δ −1.2 (95% CI [−2.0 to −0.4]; p=0.0056), general sweating: Δ −0.9(95% CI [−1.6 to −0.2]; p=0.0086), menopausal-specific sleeping problems: Δ −1.8 (95% CI [−2.7 to −1.0]; p<0.0001), emotional symptoms: Δ −3.4 (95% CI [−5.3 to −1.4]; p=0.0008), physical symptoms: Δ −1.7 (95% CI [−3 to −0.4]; p=0.010) and skin and hair symptoms: Δ −1.5 (95% CI [−2.5 to −0.6]; p=0.0021) compared with the control group at the 6-week follow-up. The pattern of decrease in hot flushes, emotional symptoms, skin and hair symptoms was already apparent 3 weeks into the study. Mild potential adverse effects were reported by four participants, but no severe adverse effects were reported.

Conclusions The standardised and brief acupuncture treatment produced a fast and clinically relevant reduction in moderate-to-severe menopausal symptoms during the six-week intervention. No severe adverse effects were reported.

Trial registration number NCT02746497; Results.

  • menopause
  • menopausal symptoms
  • hot flushes
  • primary care
  • acupuncture therapy
  • randomised controlled trial

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Footnotes

  • Patient consent for publication Not required.

  • Contributors FBW conceived the idea. All authors all took part in the design and planning of the study. KSL conducted the study supported by FBW, VS and JB. KSL drafted the manuscripts. FBW, VS and JB revised the entire manuscript critically and approved the final version for publication. The statistics was carried out by VS. FBW is guarantor for the study.

  • Funding The Idella Foundation, the University of Copenhagen, the Research Foundation of General Practice including the Foundation of Multipractice Studies.

  • Competing interests None declared.

  • Ethics approval Approvals from the Committees on Health Research Ethics (H-16016365), the Committee of Multipractice Studies in General Practice (MPU 08-2016) and the Danish Data Protection Agency (SUND-2016-24) were obtained before enrolment. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (ICH GCP).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement All authors had access to and take responsibility for the data and analyses. Relevant and only anonymised data (PROM scores) can be available for research on reasonable request (kaml@sund.ku.dk). Data will be saved for 5 years. The protocol was published in March 2017.

  • Author note Please refer to reference 28 for full trial protocol.

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