Chong Ooi Thye, Critchley Hilary Od, Williams Linda J, Haraldsdottir Erna, Horne Andrew W, Fallon Marie
MRC Centre for Reproductive Health, University of Edinburgh, UK.
Centre for Population Health Sciences, University of Edinburgh, UK.
Br J Pain. 2018 Nov;12(4):238-249. doi: 10.1177/2049463718776044. Epub 2018 May 14.
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.
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.
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.
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.
Group 2 retention rate was problematic and has implications for our next trial.
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.
据估计，慢性盆腔疼痛（CPP）影响着全球6%至27%的女性。在英国，超过100万女性患有CPP，它已被视为一个未满足需求的关键领域。标准治疗伴有难以接受的副作用。经络平衡法电针（BMEA）和中医健康咨询（TCM HC）（BMEA + TCM HC = BMEA治疗）可能是标准治疗的有效辅助手段。
我们研究的目的是评估未来一项试验的可行性，以确定BMEA治疗对女性CPP的有效性。主要目标是确定招募率和留存率。次要目标是评估BMEA治疗的有效性以及该研究方法的可接受性。
患有CPP的女性被随机分为BMEA治疗组（第1组）、单纯中医健康咨询组（第2组）（每种干预每周进行两次，共4周）或国民健康服务标准护理组（NHS SC，第3组）。主要结局通过随机分组的合格参与者比例以及返回随访问卷的随机参与者比例进行评估。在基线（0周）、4周、8周和12周时，通过经过验证的疼痛/身体/情绪功能问卷对干预措施进行评估。研究中纳入了焦点小组和半结构化电话访谈。
在8个月内，共有30名女性（占转诊者的51%）被随机分组。第1组、第2组和第3组的留存率分别为80%（95%置信区间（CI）：74 - 96）、53%（95% CI：36 - 70）和87%（95% CI：63 - 90）。定性数据表明第1组和第3组有良好的试验体验。
第2组的留存率存在问题，这对我们的下一次试验有影响。
我们的研究表明，未来一项确定BMEA治疗对患有CPP女性有效性的试验是可行的，但需对研究设计进行修改。
