5 research outputs found
The BMEA Study: The impact of meridian balanced method electro-acupuncture on women with chronic pelvic pain: a three-arm randomised controlled pilot study using a mixed methods approach.
Introduction: Chronic pelvic pain (CPP) affects 3-4%
of women worldwide. Proven treatments for CPP are
limited and unsatisfactory. The meridian balance
method (BM) electroacupuncture (EA) treatment (BMEA
+ Traditional Chinese Medicine Health Consultation
(TCM HC) may be effective for CPP. Previous EA studies
have demonstrated an analgesic effect. Large-scale
studies on acupuncture for other chronic pain
conditions suggest that patient-healthcare provider
interaction might play a role in pain reduction. We
propose a pilot study to explore the effectiveness of the
meridian BMEA treatment in managing women with
CPP to inform a future large randomised controlled trial.
Methods and analysis: A 3-armed randomised
controlled pilot study is proposed with an aim to recruit
30 women with CPP in National Health Service (NHS)
Lothian. Randomisation will be to BMEA treatment,
TCM HC or standard care (SC). Validated pain, physical
and emotional functioning questionnaires will be
administered to all participants at weeks 0, 4, 8 and 12.
Focus group discussions will be conducted when week
12 questionnaires are completed. The primary objective
is to determine, recruitment and retention rates. The
secondary objectives are to assess the effectiveness and
acceptability of the proposed methods of recruitment,
randomisation, interventions and assessment tools.
Ethics and dissemination: Ethical approval has been
obtained from the Scotland Research Ethics Committee
(REC 14/SS/1022). Data will be published in peer-reviewed
journals and presented at international
conferences.Our Research Report for 2000-2002 reflects an outstanding level of achievement throughout the institution and demonstrates once again our high level of commitment to strategic and applied research particularly in areas that enhance the quality of life.sch_nur1. Daniels J, Khan KS. Chronic pelvic pain in women. BMJ 2010;341:
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Network (SIGN) Guideline #1365pub4883pub1
Chronic pelvic pain in women: an embedded qualitative study to evaluate the perceived benefits of the meridian balance method electro-acupuncture treatment, health consultation and National Health Service standard care
Ethical approval was granted by the Scotland Research Ethics Committee (REC 14/SS/1022).Trial registration: ClinicalTrials.gov (NCT02295111)Erna Haraldsdottir - orcid: 0000-0002-6451-1374
https://orcid.org/0000-0002-6451-1374Introduction:
Chronic pelvic pain (CPP) â defined as intermittent or constant pain in the lower abdomen or pelvis of at least 6âmonthsâ duration, not occurring exclusively with menstruation or intercourse and not associated with pregnancy â is estimated to affect 6â27% of women worldwide. In the United Kingdom, over 1âmillion women suffer from CPP, which has been highlighted as a key area of unmet need. Current medical treatments for CPP are often associated with unacceptable side effects. A specific style of acupuncture, the meridian balance method electro-acupuncture (BMEA) and traditional Chinese medicine health consultation (TCM HC (BMEAâ+âTCM HCâ=âBMEA treatment)), may be effective for CPP in women.
Aim:
Three focus group discussions and semi-structured telephone interviews were embedded in a randomised controlled feasibility trial to gain in-depth description of the perceived benefits of the participantsâ respective interventions.
Methods:
Women with CPP were randomised into the BMEA treatment, TCM HC or National Health Service standard care (NHS SC). Focus group discussions were recorded, transcribed and analysed thematically. Semi-structured telephone interviews were conducted post focus group discussions.
Findings:
A total of 30 women were randomised into BMEA treatment, TCM HC or NHS SC. A total of 11 participants attended the three focus group discussions. Thematic analysis of focus group discussions showed: a perceived pain reduction, enhanced sleep, energy level and sense of well-being in the BMEA treatment and TCM HC groups; a dislike for the adverse effects of medications, frustration at the lack of effective treatment, heavy reliance on medications and services that are helpful, in the NHS SC group. Semi-structured telephone interviews showed that the methodology was acceptable to the participants.
Conclusion:
The embedded focus group discussions captured the rich and complex narratives of the participants and provided insights into the perceived benefits of the BMEA treatment, TCM HC and NHS SC interventions.The research was partly supported by the Morag Robinson Legacy, the Alexander Dykes Fund and Barbour Watson Trust.13pubpub
Mixed methods study of acupuncture treatment for chronic pelvic pain in women
Chronic pelvic pain (CPP) is defined as constant or intermittent lower, cyclical or non-cyclical
abdominal pain of at least six monthsâ duration. In the United Kingdom, over 1
million women suffer from CPP, with an estimated annual healthcare cost above ÂŁ150
million. The aetiology of CPP is unknown in up to 50% of women, and in the remainder,
the symptoms of CPP is associated with endometriosis, pelvic adhesions, irritable bowel
syndrome or painful bladder syndrome. CPP is often accompanied by painful periods, pain
during sexual intercourse and defaecation. Fatigue, sleep disturbances and depression are
also common among this group of women. CPP asserts a heavy emotional, social and
economic burden. Standard treatments such as hormonal and analgesic regimens are often
associated with unacceptable side effects, even if helpful for the pain, underlining an urgent
need for a satisfactory treatment. The meridian balanced method (BM) electro-acupuncture
(EA) treatment (acupuncture needling + traditional Chinese medicine health consultation
[TCM HC]) may be effective in managing CPP symptoms. Thus, I have completed a pilot
study comprising of a three-armed randomised controlled trial (RCT), using a mixed
methods research (MMR) approach, to assess the feasibility of a future large-scale RCT to
determine the effectiveness of the meridian BMEA treatment on CPP in women. My
hypothesis is that it is feasible to conduct such a large-scale RCT for CPP in women. The
primary objectives were to determine recruitment and retention rates. The secondary
objectives were to evaluate the, acceptability of the methods of recruitment, randomisation,
interventions and assessment tools and any signals of effectiveness of the interventions.
Thirty (30) women with CPP were randomised into three groups: BMEA treatment, TCM
HC, or National Health Service standard care (NHS SC) group. The effects of my
interventions were assessed by validated pain, physical and emotional functioning
questionnaires, completed at weeks 0, 4, 8 and 12 of the study. Semi-structured telephone
interviews and focus group discussions to explore participantsâ experience of the study were
conducted.
Of the 59 women who were referred to the study, 30 women (51%) were randomised. There
was a statistically significant difference in retention rates between the three groups. The
retention rates were 80% (95% CI 74-96), in the BMEA treatment group, 53 % (95% CI 36-
70) in the TCM HC group and 87% (95% CI 63-90) in the NHS SC group. (Chi-square test,
p=0.08) The attendance rates of the BMEA treatment group were 90% compared to 56% in
the TCM HC group. There was a statistically significant difference (Mann-Whitney test,
p=0.023) in attendance between the two intervention groups. Telephone interviews
regarding the acceptability of the methods of recruitment, randomisation, assessment tools
and interventions were positive. No adverse effects that were directly related to BMEA
treatments were reported or observed.
A higher proportion of the BMEA treatment group achieved clinical significance in the
VAS-pain, BPI-pain severity, interference, and sleep scores, when compared to the other
two groups. Due to small sample sizes, there was insufficient power to show statistically
significant difference. (Fishers Exact Test, p=1.0)
Analyses of the questionnaire data per group showed statistically significant differences in
the following: the BMEA treatment group experienced less in pain at weeks 4 (p=0.01) and
8 (p=0.005); less helplessness (p=0.03) and their anxiety and depression scores declined at
week 4 (p=0.04). The NHS SC group also reported less pain at week 4 (p=0.04). However,
this group scored higher in anxiety and depression at weeks 8 and 12 (p=0.04).
No statistically significant differences were achieved between the three groups at baseline,
weeks 4, 8 and 12 in all scores. The therapeutic benefits gained by the TCM HC group were
less compared to those of the BMEA treatment group, but better when compared to the NHS
SC group. The BMEA treatment and TCM HC groups showed lower scores in anxiety and
depression while the NHS SC group showed higher scores in anxiety and depression. The
NHS SC group also tended to ruminate and magnify their problems as well as feeling more
helpless than the other two groups.
The three key themes that emerged from thematic analysis of focus group discussions were
the âwhole person effectsâ where participants reported an improvement in pain, sleep and a
general sense of wellbeing in the two intervention groups; the âexperience of standard careâ
and âimpact of living with CPPâ.
In conclusion, the results of my pilot study are supportive of the feasibility of a future large-scale
study. There were signals of effectiveness of interventions but the sample size was too
small to make a definitive conclusion