The impact of meridian balance method electro-acupuncture treatment on chronic pelvic pain in women: a three-armed randomised controlled feasibility study using a mixed-methods approach

Abstract

Introduction:

Chronic pelvic pain (CPP) is estimated to affect 6%–27% of women worldwide. In the United Kingdom, over 1 million women suffer from CPP and it has been highlighted as a key area of unmet need. Standard treatments are associated with unacceptable side effects. The meridian balance method electro-acupuncture (BMEA), and traditional Chinese medicine health consultation (TCM HC) (BMEA + TCM HC = BMEA treatment) may be an effective adjunct to standard treatment.

Aim:

The aim of our study was to evaluate the feasibility of a future trial, to determine the effectiveness of the BMEA treatment for CPP in women. The primary objectives were to determine recruitment and retention rates. The secondary objectives were to assess the effectiveness of the BMEA treatment and acceptability of the study’s methodology.

Methods:

Women with CPP were randomised into BMEA treatment (group 1), TCM HC alone (group 2) (each intervention administered twice weekly for 4 weeks) or National Health Service standard care (NHS SC, group 3). Primary outcomes were assessed by the proportion of eligible participants randomised, and the proportion of randomised participants who returned follow-up questionnaires. Interventions were assessed by validated pain/physical/emotional functioning questionnaires at baseline (0), 4, 8 and 12 weeks. Focus groups and semi-structured telephone interviews were embedded in the study.

Results:

A total of 30 women (51% of those referred) were randomised over 8 months. Retention rates were 80% (95% confidence interval (CI): 74–96), 53% (95% CI: 36–70) and 87% (95% CI: 63–90), in groups 1, 2, and 3, respectively. Qualitative data suggested a favourable trial experience in groups 1 and 3.

Discussion:

Group 2 retention rate was problematic and has implications for our next trial.

Conclusion:

Our study suggests that a future trial to determine the effectiveness of BMEA treatment for women with CPP is feasible but with modifications to the study design.

Keywords

Chronic pelvic pain randomised controlled trial mixed methods design electro-acupuncture meridian balance method acupuncture

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References

Kennedy

Moore

The initial management of chronic pelvic pain (guideline no. 41). London: Royal College of Obstetricians and Gynaecologists, 2005.

Donaldson

150 years of the annual report of the chief medical officer: on the state of public health 2008. London: Department of Health, 2009, pp. 32–39.

Ahangari

Prevalence of chronic pelvic pain among women: an updated review. Pain Physician 2014; 17: E141–E147.

Cheong

Stones

WR.

Chronic pelvic pain: aetiology and therapy. Best Pract Res Clin Obstet Gynaecol 2006; 20: 695–711.

Sundell

Milsom

IAN

Andersch

Factors influencing the prevalence and severity of dysmenorrhoea in young women. Br J Obstet Gynaecol 1990; 97: 588–594.

Daniels

Khan

KS.

Chronic pelvic pain in women. BMJ 2010; 341: c4834.

Vargas-Schaffer

Is the WHO analgesic ladder still valid? Twenty-four years of experience. Can Fam Physician 2010; 56: 514–517.

Braden

Young

Sullivan

et al . Predictors of change in pain and physical functioning among post-menopausal women with recurrent pain conditions in the women’s health initiative observational cohort. J Pain 2012; 13: 64–72.

Ballantyne

LaForge

SK.

Opioid dependence and addiction during opioid treatment of chronic pain. Pain 2007; 129: 235–255.

10.

Tan

Rush

Twelve and twelve in acupuncture, 2nd edn. San Diego, CA: Richard Tan Publishing, 1996.

11.

Deadman

Al-Khafaji

Baker

A manual of acupuncture. England: Journal of Chinese Medicine Publications, 2001, pp. 13–16.

12.

Chong

Critchley

Horne

et al . The BMEA study: the impact of meridian balanced method electroacupuncture on women with chronic pelvic pain – a three-arm randomised controlled pilot study using a mixed-methods approach. BMJ Open 2015; 5: e008621.

13.

McCann

Ross

Practical atlas of Tung’s acupuncture, 2nd edn. Munich: Verlag Müller & Steinicke, 2013.

14.

Twicken

Ching

Acupuncture: the balance method. Philadelphia, PA: Singing Dragon, 2012.

15.

Unschuld

Huang Di Nei Jing Su Wen: nature, knowledge, imagery in an ancient Chinese medical text. Berkeley, CA: University of California Press, 2003.

16.

Paterson

Dieppe

Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. Br Med J 2005; 330: 1202–1205.

17.

Paterson

Britten

Acupuncture for people with chronic illness: combining qualitative and quantitative outcome assessment. J Altern Complement Med 2003; 9: 671–681.

18.

Kaptchuk

TJ.

The web that has no weaver: understanding Chinese medicine, 2nd edn. Chicago, IL: Contemporary Books, 2000.

19.

Beinfield

Korngold

Between heaven and earth: a guide to Chinese medicine. New York: Random House, 1991.

20.

Vase

Baram

Takakura

et al . Specifying the nonspecific components of acupuncture analgesia. Pain 2013; 154: 1659–1667.

21.

Kaptchuk

Kelley

Conboy

et al . Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008; 336: 999–1003.

22.

Wayne

Kerr

Schnyer

et al . Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents and young women: results of a randomized sham-controlled trial. J Pediatr Adolesc Gynecol 2008; 21: 247–257.

23.

Rubi-Klein

Kucera-Sliutz

Nissel

et al . Is acupuncture in addition to conventional medicine effective as pain treatment for endometriosis? A randomised controlled cross-over trial. Eur J Obstet Gynecol Reprod Biol 2010; 153: 90–93.

24.

De Sousa

de Souza

Zomkowisk

et al . The effect of acupuncture on pain, dyspareunia, and quality of life in Brazilian women with endometriosis: a randomized clinical trial. New York: Elsevier, 2016.

25.

Scharf

H-P

Mansmann

Streitberger

et al . Acupuncture and knee osteoarthritis: a three-armed randomized trial. Ann Intern Med 2006; 145: 12–20.

26.

Endres

Bowing

Diener

et al . Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial. J Headache Pain 2007; 8: 306–314.

27.

Ulett

GHSP

Han

. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry 1998; 44: 129–138.

28.

Farrar

Young

LaMoreaux

et al . Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 2001; 94: 149–158.

29.

Cleeland

Ryan

KM.

Pain assessment: global use of the brief pain inventory. Ann Acad Med Singapore 1994; 23: 129–138.

30.

Ware

Jr Kosinski

Keller

SD.

A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220–233.

31.

Zigmond

Snaith

RP.

The hospital anxiety and depression scale. Acta Psychiatr Scand 1983; 67: 361–370.

32.

Sullivan

Bishop

Pivik

The pain catastrophizing scale: development and validation. Psychol Assess 1995; 7: 524.

33.

Reilly

Zbrozek

Dukes

EM.

The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993; 4: 353–365.

34.

Thirlaway

Fallowfield

Cuzick

The sexual activity questionnaire: a measure of women’s sexual functioning. Qual Life Res 1996; 5: 81–90.

35.

Tan

Dr. Tan’s strategy of twelve magical points. San Diego, CA: Richard Tan Publishing, 2003.

36.

Schroeder

Meyer-Hamme

Zhang

et al . An acupuncture research protocol developed from historical writings by mathematical reflections: a rational individualized acupoint selection method for immediate pain relief. Evid Based Complement Alternat Med 2013; 2013: 256754.

37.

Dhond

Kettner

Napadow

Neuroimaging acupuncture effects in the human brain. J Altern Complement Med 2007; 13: 603–616.

38.

Han

Terenius

Neurochemical basis of acupuncture analgesia. Annu Rev Pharmacol Toxicol 1982; 22: 193–220.

39.

Dworkin

Turk

Wyrwich

et al . Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain 2008; 9: 105–121.

40.

Couilliot

M-F

Darees

Delahaye

et al . Acceptability of an acupuncture intervention for geriatric chronic pain: an open pilot study. J Integr Med 2013; 11: 26–31.

41.

Salter

Roman

Bland

et al . Acupuncture for chronic neck pain: a pilot for a randomised controlled trial. BMC Musculoskelet Di 2006; 7: 99.

42.

Wayne

Kerr

Schnyer

et al . Japanese-style acupuncture for endometriosis-related pelvic pain in adolescents and young women: results of a randomized sham-controlled trial. J Pediatr Adolesc Gynecol 2008; 21: 247–257.

43.

MacPherson

Thomas

Walters

et al . The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists. BMJ 2001; 323: 486–487.