The Efficacy of ACupuncture On Menopausal Symptoms (ACOM)

NCT02746497 | Completed

• 1 other identifier: 1072031001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

As a natural part of the menopause the ovaries production of sex hormones declines. This can lead to different menopausal related symptoms. About two-thirds of postmenopausal women experience hot flushes and 10-20% find these hot flushes very stressful. The aim of this study is to determine and evaluate the efficacy of acupuncture on menopausal symptoms; in particular hot flushes. The study will be a randomized controlled trial. Primary outcome is change in hot flushes. Secondary outcome is change in other menopausal related symptoms.

Conditions

Menopause

Keywords

Menopause; Hot flushes; Acupuncture; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Hot flushes (based on the hot flushes scale from MSQ)

  Change in hot flushes from baseline to week 6 expressed by a score on the hot flushes scale from the MSQ. The MenoScores Questionnaire (MSQ) is developed and validated based on a literature review, 2 focus-groups, 4 single-interviews, 4 pilot-tests and a cross-sectional validation study where 1504 women answered a draft version of the questionnaire. Data collected in this validation study were analysed using Rasch models resulting in the MenoScores Questionnaire (MSQ), which encompasses 11 scales and 1 single item, measuring different dimension of menopausal symptoms. All study subjects (both Group E and L) will receive the MSQ by email in study week 0, 3, 6, 8, 11 and 26 and asked to answer within 1 or 2 days. The MSQ can be answered on computer or tablet. If responses are missing, reminders will be sent out. When receiving the planned acupuncture treatment the MSQ must be answered 1 or 2 days before the 3th treatment and 1 week after the 5th (the last) treatment.

  6 weeks

Secondary Outcomes (3)

• Change in other menopausal related symptoms, in particular day and night sweats and menopausal specific sleeping problems, also measured by scales from the MSQ.

  6 weeks

• Legacy effect.

  11 weeks

• Long term outcome

  26 weeks

Study Arms (2)

Group E (early intervention)

ACTIVE COMPARATOR

One weekly treatment with acupuncture in five consecutive weeks. In trial week 1-5 Group E will receive treatment and Group L will act as control group.

Procedure: Acupuncture

Group L (late intervention)

ACTIVE COMPARATOR

After trial week five the Groups must cross-over. Group L will then receive treatment for five weeks (trial week 6-11) and Group E will act as follow up group.

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Acupuncture style; Western Medical Acupuncture (WMA). In WMA all types of sham (placebo) acupuncture are believed to produce a certain amount of sensory stimulation and thereby a possible therapeutic effect. In addition, other studies have shown that sham acupuncture is associated with a moderately large nonspecific effect and compared to other inert placebo intervention the effect associated with sham acupuncture might be larger. Thus we use a control group instead of a placebo group. Needles; sterile disposable needles (Plandent) size 0.30x30mm. The needles will be inserted perpendicularly and rotated manual between finger and thumb for a few seconds to elicit "de-qi". Needle retention time will be 10 minutes. Afterward the needle will be removed. Acupuncture points; CV-3, CV-4, LR-8, SP-6, SP-9. In total 8 points as LR-8, SP-6, SP-9 are given bilaterally.

Group E (early intervention); Group L (late intervention)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman
• Age: 40-65 years
• "Quite a bit" or "a lot" bothered by hot flushes (score ≥4 on a validated scale measuring hot flushes (MenoScores questionnaire (MSQ))
• No conflicts of interests and have given oral and written consent
• Must have an email address

You may not qualify if:

• Hysterectomised and/or bilateral oophorectomised
• Hormone therapy for menopausal symptoms within the past 4 weeks
• Hormonal intrauterine device within the past 4 weeks
• Treatment with antidepressants and/or antiepileptics within the past 4 weeks
• Other medical treatment for hot flushes (e.g. clonidin) within the past 4 weeks
• Other herbal remedies/alternative treatment for menopausal symptoms (e.g. Black Cohosh, Red Clover, Evening Primrose oil, Melbrosia) within the past 4 weeks
• Alcohol consumption exceeding 21 drinks per week
• Using prescribed sleeping pills and/or prescribed sedatives
• Treatment with corticosteroids within the past 4 weeks (inhaled steroids not excluded)
• Previously diagnosed with breast cancer, endometrial cancer, cervical cancer or ovarian cancer
• Diagnosed with other severe cancer disease within the past 5 years
• Heart valve disease
• Insulin dependent and/or poorly controlled diabetes mellitus
• Diagnosed with Thyroid disease
• Under investigation for serious disease e.g. cancer

Sponsors & Collaborators

• University of Copenhagen: lead
• Research Unit Of General Practice, Copenhagen: collaborator
• Danish Society for Evidence Based Acupuncture (DSEA): collaborator
• Idella Foundation: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Section of General Practice

Copenhagen, Capital Region, 1014, Denmark

Location

Related Publications (25)

• Nelson HD. Menopause. Lancet. 2008 Mar 1;371(9614):760-70. doi: 10.1016/S0140-6736(08)60346-3.

  PMID: 18313505 BACKGROUND

• Stearns V, Ullmer L, Lopez JF, Smith Y, Isaacs C, Hayes D. Hot flushes. Lancet. 2002 Dec 7;360(9348):1851-61. doi: 10.1016/s0140-6736(02)11774-0.

  PMID: 12480376 BACKGROUND

• Avis NE, Crawford SL, Greendale G, Bromberger JT, Everson-Rose SA, Gold EB, Hess R, Joffe H, Kravitz HM, Tepper PG, Thurston RC; Study of Women's Health Across the Nation. Duration of menopausal vasomotor symptoms over the menopause transition. JAMA Intern Med. 2015 Apr;175(4):531-9. doi: 10.1001/jamainternmed.2014.8063.

  PMID: 25686030 BACKGROUND

• Green R, Polotsky AJ, Wildman RP, McGinn AP, Lin J, Derby C, Johnston J, Ram KT, Crandall CJ, Thurston R, Gold E, Weiss G, Santoro N. Menopausal symptoms within a Hispanic cohort: SWAN, the Study of Women's Health Across the Nation. Climacteric. 2010 Aug;13(4):376-84. doi: 10.3109/13697130903528272.

  PMID: 20136411 BACKGROUND

• Maclennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD002978. doi: 10.1002/14651858.CD002978.pub2.

  PMID: 15495039 BACKGROUND

• Prentice RL, Manson JE, Langer RD, Anderson GL, Pettinger M, Jackson RD, Johnson KC, Kuller LH, Lane DS, Wactawski-Wende J, Brzyski R, Allison M, Ockene J, Sarto G, Rossouw JE. Benefits and risks of postmenopausal hormone therapy when it is initiated soon after menopause. Am J Epidemiol. 2009 Jul 1;170(1):12-23. doi: 10.1093/aje/kwp115. Epub 2009 May 25.

  PMID: 19468079 BACKGROUND

• Pachman DR, Jones JM, Loprinzi CL. Management of menopause-associated vasomotor symptoms: Current treatment options, challenges and future directions. Int J Womens Health. 2010 Aug 9;2:123-35. doi: 10.2147/ijwh.s7721.

  PMID: 21072305 BACKGROUND

• Daley A, MacArthur C, Mutrie N, Stokes-Lampard H. Exercise for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006108. doi: 10.1002/14651858.CD006108.pub2.

  PMID: 17943886 BACKGROUND

• Dodin S, Blanchet C, Marc I, Ernst E, Wu T, Vaillancourt C, Paquette J, Maunsell E. Acupuncture for menopausal hot flushes. Cochrane Database Syst Rev. 2013 Jul 30;2013(7):CD007410. doi: 10.1002/14651858.CD007410.pub2.

  PMID: 23897589 BACKGROUND

• Borud EK, Alraek T, White A, Fonnebo V, Eggen AE, Hammar M, Astrand LL, Theodorsson E, Grimsgaard S. The Acupuncture on Hot Flushes Among Menopausal Women (ACUFLASH) study, a randomized controlled trial. Menopause. 2009 May-Jun;16(3):484-93. doi: 10.1097/gme.0b013e31818c02ad.

  PMID: 19423996 BACKGROUND

• Zaborowska E, Brynhildsen J, Damberg S, Fredriksson M, Lindh-Astrand L, Nedstrand E, Wyon Y, Hammar M. Effects of acupuncture, applied relaxation, estrogens and placebo on hot flushes in postmenopausal women: an analysis of two prospective, parallel, randomized studies. Climacteric. 2007 Feb;10(1):38-45. doi: 10.1080/13697130601165059.

  PMID: 17364603 BACKGROUND

• Venzke L, Calvert JF Jr, Gilbertson B. A randomized trial of acupuncture for vasomotor symptoms in post-menopausal women. Complement Ther Med. 2010 Apr;18(2):59-66. doi: 10.1016/j.ctim.2010.02.002. Epub 2010 Mar 23.

  PMID: 20430288 BACKGROUND

• Smith CA, Carmady B. Acupuncture to treat common reproductive health complaints: An overview of the evidence. Auton Neurosci. 2010 Oct 28;157(1-2):52-6. doi: 10.1016/j.autneu.2010.03.013. Epub 2010 May 21.

  PMID: 20483671 BACKGROUND

• MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med. 2010 Aug;3(3):140-55. doi: 10.1111/j.1756-5391.2010.01086.x.

  PMID: 21349059 BACKGROUND

• Linde K, Niemann K, Schneider A, Meissner K. How large are the nonspecific effects of acupuncture? A meta-analysis of randomized controlled trials. BMC Med. 2010 Nov 23;8:75. doi: 10.1186/1741-7015-8-75.

  PMID: 21092261 BACKGROUND

• Prairie BA, Wisniewski SR, Luther J, Hess R, Thurston RC, Wisner KL, Bromberger JT. Symptoms of depressed mood, disturbed sleep, and sexual problems in midlife women: cross-sectional data from the Study of Women's Health Across the Nation. J Womens Health (Larchmt). 2015 Feb;24(2):119-26. doi: 10.1089/jwh.2014.4798. Epub 2015 Jan 26.

  PMID: 25621768 BACKGROUND

• Bokmand S, Flyger H. Acupuncture relieves menopausal discomfort in breast cancer patients: a prospective, double blinded, randomized study. Breast. 2013 Jun;22(3):320-3. doi: 10.1016/j.breast.2012.07.015. Epub 2012 Aug 18.

  PMID: 22906948 BACKGROUND

• Kim KH, Kang KW, Kim DI, Kim HJ, Yoon HM, Lee JM, Jeong JC, Lee MS, Jung HJ, Choi SM. Effects of acupuncture on hot flashes in perimenopausal and postmenopausal women--a multicenter randomized clinical trial. Menopause. 2010 Mar;17(2):269-80. doi: 10.1097/gme.0b013e3181bfac3b.

  PMID: 19907348 BACKGROUND

• Skovgaard L, Cour SL, Kristensen M. Use of complementary and alternative medicine in Danish Hospitals as reported by charge nurses at department level. Journal of Hospital Administration wwwscieduca/jha; http://dxdoiorg/105430/jhav2n2p22. 2013;Vol 2, No 2.:22-6.

  BACKGROUND

• Rosted P. Akupunktur: på naturvidenskabeligt grundlag: Klim; 2003.

  BACKGROUND

• Mintziori G, Lambrinoudaki I, Goulis DG, Ceausu I, Depypere H, Erel CT, Perez-Lopez FR, Schenck-Gustafsson K, Simoncini T, Tremollieres F, Rees M. EMAS position statement: Non-hormonal management of menopausal vasomotor symptoms. Maturitas. 2015 Jul;81(3):410-3. doi: 10.1016/j.maturitas.2015.04.009. Epub 2015 Apr 22.

  PMID: 25982505 BACKGROUND

• Rosted P. [The effect of acupuncture on musculoskeletal disorders]. Ugeskr Laeger. 2005 Sep 19;167(38):3573-7. Danish.

  PMID: 16219184 BACKGROUND

• Waldorff FB, Bang CW, Siersma V, Brodersen J, Lund KS. Factors associated with a clinically relevant reduction in menopausal symptoms of a standardized acupuncture approach for women with bothersome menopausal symptoms. BMC Complement Med Ther. 2021 Jan 13;21(1):29. doi: 10.1186/s12906-021-03208-2.

  PMID: 33441145 DERIVED

• Lund KS, Siersma V, Brodersen J, Waldorff FB. Efficacy of a standardised acupuncture approach for women with bothersome menopausal symptoms: a pragmatic randomised study in primary care (the ACOM study). BMJ Open. 2019 Feb 19;9(1):e023637. doi: 10.1136/bmjopen-2018-023637.

  PMID: 30782712 DERIVED

• Lund KS, Brodersen J, Siersma V, Waldorff FB. The efficacy of acupuncture on menopausal symptoms (ACOM study): protocol for a randomised study. Dan Med J. 2017 Mar;64(3):A5344.

  PMID: 28260598 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Kamma S Lund, MD

  Section of General Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 21, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)