Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial

Trials

Charlie Xue²  Stephen Myers⁵  Simon French⁴  Patty Chondros³  Helena Teede¹  Carolyn Ee³  Marie Pirotta³ 

[1] Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, Monash University, Australia Diabetes and Vascular Medicine Unit, Monash Health, Wellington Rd, Clayton VIC 3800, Australia;School of Health Sciences, RMIT University, 124 Little La Trobe St, Melbourne VIC 3000, Australia;Department of General Practice, University of Melbourne, Australia 200 Berkeley St, Carlton, Victoria 3053, Australia;Canada and Faculty of Health Sciences, School of Rehabilitation Therapy, Queen’s University, Ontario, 99 University Ave, Kingston, ON K7L 3N6, Canada;NatMed-Research Unit, Division of Research, Southern Cross University, Military Road, East Lismore NSW 2480, Australia

关键词: Placebo;    Quality of life;    Vasomotor symptoms;    Hot flashes;    Menopause;    Complementary medicine;    Acupuncture;   

Others  :  805006
DOI  :  10.1186/1745-6215-15-224

 received in 2014-01-22, accepted in 2014-05-30,  发布年份 2014

【 摘 要 】

Background

Hot flushes and night sweats (vasomotor symptoms) are common menopausal symptoms, often causing distress, sleep deprivation and reduced quality of life. Although hormone replacement therapy is an effective treatment, there are concerns about serious adverse events. Non-hormonal pharmacological therapies are less effective and can also cause adverse effects. Complementary therapies, including acupuncture, are commonly used for menopausal vasomotor symptoms. While the evidence for the effectiveness of acupuncture in treating vasomotor symptoms is inconclusive, acupuncture has a low risk of adverse effects, and two small studies suggest it may be more effective than non-insertive sham acupuncture. Our objective is to assess the efficacy of needle acupuncture in improving hot flush severity and frequency in menopausal women. Our current study design is informed by methods tested in a pilot study.

Methods/design

This is a stratified, parallel, randomised sham-controlled trial with equal allocation of participants to two trial groups. We are recruiting 360 menopausal women experiencing a minimum average of seven moderate hot flushes a day over a seven-day period and who meet diagnostic criteria for the Traditional Chinese Medicine diagnosis of Kidney Yin deficiency. Exclusion criteria include breast cancer, surgical menopause, and current hormone replacement therapy use. Eligible women are randomised to receive either true needle acupuncture or sham acupuncture with non-insertive (blunt) needles for ten treatments over eight weeks. Participants are blinded to treatment allocation. Interventions are provided by Chinese medicine acupuncturists who have received specific training on trial procedures. The primary outcome measure is hot flush score, assessed using the validated Hot Flush Diary. Secondary outcome measures include health-related quality of life, anxiety and depression symptoms, credibility of the sham treatment, expectancy and beliefs about acupuncture, and adverse events. Participants will be analysed in the groups in which they were randomised using an intention-to-treat analysis strategy.

Discussion

Results from this trial will significantly add to the current body of evidence on the role of acupuncture for vasomotor symptoms. If found to be effective and safe, acupuncture will be a valuable additional treatment option for women who experience menopausal vasomotor symptoms.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12611000393954 11/02/2009.

【 授权许可】

   
2014 Pirotta et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Guthrie JR, Dennerstein L, Taffe JR, Lehert P, Burger HG: The menopausal transition: a 9-year prospective population-based study. The Melbourne Women’s Midlife Health Project. Climacteric 2004, 7:375-389.
• [2]Col NF, Guthrie JR, Politi M, Dennerstein L: Duration of vasomotor symptoms in middle-aged women: a longitudinal study. Menopause 2009, 16:453-457.
• [3]Gracia CR, Freeman EW: Acute consequences of the menopausal transition: the rise of common menopausal symptoms. Endocrinol Metab Clin North Am 2004, 33:675.
• [4]Archer DF, Sturdee DW, Baber R, de Villiers TJ, Pines A, Freedman RR, Gompel A, Hickey M, Hunter MS, Lobo RA, Lumsden MA, Maclennan AH, Maki P, Palacios S, Shah D, Villaseca P, Warren M: Menopausal hot flushes and night sweats: where are we now? Climacteric 2011, 14:515-528.
• [5]Freeman EW, Sherif K: Prevalence of hot flushes and night sweats around the world: a systematic review. Climacteric 2007, 10:197-214.
• [6]Whiteman MK, Staropoli CA, Langenberg PW, McCarter RJ, Kjerulff KH, Flaws JA: Smoking, body mass, and hot flashes in midlife women. Obstet Gynecol 2003, 101:264-272.
• [7]Riley EH, Inui TS, Kleinman K, Connelly MT: Differential association of modifiable health behaviors with hot flashes in perimenopausal and postmenopausal women. J Gen Intern Med 2004, 19:740-746.
• [8]Freeman EW, Sammel MD, Lin H, Gracia CR, Pien GW, Nelson DB, Sheng L: Symptoms associated with menopausal transition and reproductive hormones in midlife women. Obstet Gynecol 2007, 110:230-240.
• [9]Archer DF, Oger E: Estrogen and progestogen effect on venous thromboembolism in menopausal women. Climacteric 2012, 15:235-240.
• [10]Henderson VW, Lobo RA: Hormone therapy and the risk of stroke: perspectives 10 years after the Women’s Health Initiative trials. Climacteric 2012, 15:229-234.
• [11]Gompel A, Santen RJ: Hormone therapy and breast cancer risk 10 years after the WHI. Climacteric 2012, 15:241-249.
• [12]Maki PM, Henderson VW: Hormone therapy, dementia, and cognition: the Women’s Health Initiative 10 years on. Climacteric 2012, 15:256-262.
• [13]Sturdee DW: The menopausal hot flush - anything new? Maturitas 2008, 60:42-49.
• [14]Hall E, Frey BN, Soares CN: Non-hormonal treatment strategies for vasomotor symptoms a critical review. Drugs 2011, 71:287-304.
• [15]Leach MJ, Moore V: Black cohosh (Cimicifuga spp.) for menopausal symptoms. Cochrane Database Syst Rev 2012, 9:CD007244.
• [16]Borrelli F, Ernst E: Alternative and complementary therapies for the menopause. Maturitas 2010, 66:333-343.
• [17]Taku K, Melby M, Kronenberg F, Kurzer M, Messina M: Extracted or synthesized soybean isoflavones reduce menopausal hot flash. Menopause 2012, 19:776-907.
• [18]van der Sluijs CP, Bensoussan A, Liyanage L, Shah S: Women’s health during mid-life survey: the use of complementary and alternative medicine by symptomatic women transitioning through menopause in Sydney. Menopause 2007, 14:397-403.
• [19]VanderPloeg K, Yi X: Acupuncture in modern society. J Acup Meridian Stud 2009, 2:26-33.
• [20]Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN: Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed 2009, 16:91-97.
• [21]Macpherson H, Scullion A, Thomas KJ, Walters S: Patient reports of adverse events associated with acupuncture treatment: a prospective national survey. Qual Saf Health Care 2004, 13:349-355.
• [22]Lin J-G, Chen W, Chen W-L: Acupuncture analgesia: a review of its mechanisms of actions. Am J Chin Med 2008, 36:45.
• [23]Zhao Z-Q: Neural mechanism underlying acupuncture analgesia. Prog Neurobiol 2008, 85:355-375.
• [24]Dhond RP, Kettner N, Napadow V: Neuroimaging acupuncture effects in the human brain. J Altern Complement Med 2007, 13:603-616.
• [25]Pariente J, White P, Frackowiak RSJ, Lewith G: Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture. Neuroimage 2005, 25:1161-1167.
• [26]Joffe HLN, Deckersbach T, McCurnin K, Jameson M, Fischman A, Dougherty D, Hall J: PET scan activity in the insular cortex prior to onset of hot flashes on endocrine therapies. 2008 Breast Cancer Symposium 2008.
• [27]Cho SH, Whang WW: Acupuncture for vasomotor menopausal symptoms: a systematic review. Menopause 2009, 16:1065-1073.
• [28]Lee MS, Shin BC, Ernst E: Acupuncture for treating menopausal hot flushes: a systematic review. Climacteric 2009, 12:16-25.
• [29]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, 16:484-493.
• [30]Sunay D, Ozdiken M, Arslan H, Seven A, Aral Y: The effect of acupuncture on postmenopausal symptoms and reproductive hormones: a sham controlled clinical trial. Acupunct Med 2011, 29:27-31.
• [31]Kim DI, Jeong JC, Kim KH, Rho JJ, Choi MS, Yoon SH, Choi S-M, Kang KW, Ahn HY, Lee MS: Acupuncture for hot flushes in perimenopausal and postmenopausal women: a randomised, sham-controlled trial. Acupunct Med 2011, 29:249-256.
• [32]de Luca ACB, da Fonseca AM, Lopes CMC, Bagnoli VR, Soares JM, Baracat EC: Acupuncture-ameliorated menopausal symptoms: single-blind, placebo-controlled, randomized trial. Climacteric 2011, 14:140-145.
• [33]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, 17:269-280.
• [34]Langevin HM, Wayne PM, MacPherson H, Schnyer R, Milley RM, Napadow V, Lao L, Park J, Harris RE, Cohen M, Sherman KJ, Haramati A, Hammerschlag R: Paradoxes in acupuncture research: strategies for moving forward. Evid Based Complement Alternat Med 2011, 2011:1-11.
• [35]Wyon Y, Wijma K, Nedstrand E, Hammar M: A comparison of acupuncture and oral estradiol treatment of vasomotor symptoms in postmenopausal women. Climacteric 2004, 7:153-164.
• [36]Wyon Y, Lindgren R, Lundeberg T, Hammar M: Effects of acupuncture on climacteric vasomotor symptoms, quality-of-life, and urinary excretion of neuropeptides among postmenopausal women. Menopause 1995, 2:3-12.
• [37]Kim D, Rho J, Choi M: A clinical trial to assess the efficacy of acupuncture on hot flashes in postmenopausal women. Korean J Oriental Medicine 2007, 28:74-85.
• [38]Vincent A, Barton DL, Mandrekar JN, Cha SS, Zais T, Wahner-Roedler DL, Keppler MA, Kreitzer MJ, Loprinzi C: Acupuncture for hot flashes: a randomized, sham-controlled clinical study. Menopause 2007, 14:45-52.
• [39]Avis NE, Legault C, Coeytaux RR, Pian-Smith M, Shifren JL, Chen W, Valaskatgis P: A randomized, controlled pilot study of acupuncture treatment for menopausal hot flashes. Menopause 2008, 15:1070-1078.
• [40]Streitberger K, Kleinhenz J: Introducing a placebo needle into acupuncture research. Lancet 1998, 352:364-365.
• [41]Park J, White A, Stevinson C, Ernst E, James M: Validating a new non-penetrating sham acupuncture device: two randomised controlled trials. Acupunct Med 2002, 20:168-174.
• [42]Fink M, Gutenbrunner C, Rollnik J, Karst M: Credibility of a newly designed placebo needle for clinical trials in acupuncture research. Forsch Komplementarmed Klass Naturheilkd 2001, 8:368-372.
• [43]White P, Lewith G, Hopwood V, Prescott P: The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial. Pain 2003, 106:401-409.
• [44]Enblom A, Hammar M, Steineck G, Borjeson S: Can individuals identify if needling was performed with an acupuncture needle or a non-penetrating sham needle? Complement Ther Med 2008, 16:288-294.
• [45]Tough EA, White AR, Richards SH, Lord B, Campbell JL: Developing and validating a sham acupuncture needle. Acupunct Med 2009, 27:118-122.
• [46]Nir Y, Huang MI, Schnyer R, Chen B, Manber R: Acupuncture for postmenopausal hot flashes. Maturitas 2007, 56:383-395.
• [47]Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG, Consort: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg 2012, 10:28-55.
• [48]MacPherson H, Altman DG, Hammerschlag R, Li Y, Wu T, White A, Moher D, Group SR: Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. Acupunct Med 2010, 28:83-93.
• [49]Harlow SD, Gass M, Hall JE, Lobo R, Maki P, Rebar RW, Sherman S, Sluss PM, de Villiers TJ: Executive summary of the Stages of Reproductive Aging Workshop +10: addressing the unfinished agenda of staging reproductive aging. Fertil Steril 2012, 15:105-114.
• [50]Archer DF, Dupont CM, Constantine GD, Pickar JH, Olivier S: Desvenlafaxine for the treatment of vasomotor symptoms associated with menopause: a double-blind, randomized, placebo-controlled trial of efficacy and safety. Am J Obstet Gynecol 2009, 200:238. e231–238.e210
• [51]Sloan JA, Loprinzi CL, Novotny PJ, Barton DL, Lavasseur BI, Windschitl H: Methodologic lessons learned from hot flash studies. J Clin Oncol 2001, 19:4280-4290.
• [52]State Administration of TCM: Criteria of Diagnosis and Therapeutic Effect of Disease and Syndromes in TCM. Nanjing: Nanjing University Press; 1995.
• [53]Zell B, Hirata J, Marcus A, Ettinger B, Pressman A, Ettinger KM: Diagnosis of symptomatic postmenopausal women by traditional Chinese medicine practitioners. Menopause 2000, 7:129-134.
• [54]Borud EK, Alraek T, White A, Grimsgaard S: The acupuncture treatment for postmenopausal hot flushes (Acuflash) study: traditional Chinese medicine diagnoses and acupuncture points used, and their relation to the treatment response. Acupunct Med 2009, 27:101-108.
• [55]Lee H, Bang H, Kim Y, Park J, Lee S, Lee H, Park H-J: Non-penetrating sham needle, is it an adequate sham control in acupuncture research? Complement Ther Med 2011, 19(Suppl 1):S41-S48.
• [56]White AR, Filshie J, Cummings TM: Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med 2001, 9:237-245.
• [57]Borud E, White A: A review of acupuncture for menopausal problems. Maturitas 2010, 66:131-134.
• [58]Chae Y, Lee H, Kim H, Sohn H, Park J-H, Park H-J: The neural substrates of verum acupuncture compared to non-penetrating placebo needle: an fMRI study. Neurosci Lett 2009, 450:80-84.
• [59]Lewis JE, Hilditch JR, Wong CJ: Further psychometric property development of the Menopause-Specific Quality of Life questionnaire and development of a modified version, MENQOL-Intervention questionnaire. Maturitas 2005, 50:209-221.
• [60]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370.
• [61]van Die MD, Teede HJ, Bone KM, Reece JE, Burger HG: Predictors of placebo response in a randomized, controlled trial of phytotherapy in menopause. Menopause 2009, 16:792-796.
• [62]Devilly GJ, Borkovec TD: Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry 2000, 31:73-86.
• [63]Sackett DL: Commentary: measuring the success of blinding in RCTs: don’t, must, can’t or needn’t? Int J Epidemiol 2007, 36:664-665.
• [64]Bang H, Ni L, Davis CE: Assessment of blinding in clinical trials. Control Clin Trials 2004, 25:143-156.
• [65]Soules MR, Sherman S, Parrott E, Rebar R, Santoro N, Utian W, Woods N: Executive summary: Stages of Reproductive Aging Workshop (STRAW). Climacteric 2001, 4:267-272.
• [66]Whitcomb BW, Whiteman MK, Langenberg P, Flaws JA, Romani WA: Physical activity and risk of hot flashes among women in midlife. J Womens Health (Larchmt) 2007, 16:124-133.
• [67]Whiteman MK, Staropoli CA, Benedict JC, Borgeest C, Flaws JA: Risk factors for hot flashes in midlife women. J Womens Health (Larchmt) 2003, 12:459-472.
• [68]Gold EB, Sternfeld B, Kelsey JL, Brown C, Mouton C, Reame N, Salamone L, Stellato R: Relation of demographic and lifestyle factors to symptoms in a multi-racial/ethnic population of women 40 to 55 years of age. Am J Epidemiol 2000, 152:463-473.
• [69]McRae C, Cherin E, Yamazaki TG, Diem G, Vo AH, Russell D, Ellgring JH, Fahn S, Greene P, Dillon S, Winfield H, Bjugstad KB, Freed CR: Effects of perceived treatment on quality of life and medical outcomes in a double-blind placebo surgery trial. Arch Gen Psychiatry 2004, 61:412-420.
• [70]StataCorp: Stata statistical software series 13. 13th edition. College Station, TX; 2013.
• [71]White IR, Carpenter J, Horton NJ: Including all individuals is not enough: lessons for intention-to-treat analysis. Clin Trials 2012, 9:396-407.