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 months’ duration. In the United Kingdom, over 1 million women suffer from CPP, with an estimated annual healthcare cost above £150 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 participants’ 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 “whole person effects” where participants reported an improvement in pain, sleep and a general sense of wellbeing in the two intervention groups; the “experience of standard care” and “impact of living with CPP”. 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.