The aim of this study was to examine what fertility acupuncturists consider key components of best practice acupuncture during an ART cycle, and to establish an acupuncture protocol by consensus for women using ART, and on the day of embryo transfer for use in a clinical trial. The study participants confirmed the importance of needling aspects relating to the dose of acupuncture, the therapeutic relationship, tailoring treatment to the individual, and the role of co-interventions. From two rounds of the Delphi process a consensus was achieved on seven treatment parameters for a protocol to be used in a clinical trial.
Our findings reinforce our understanding of acupuncture as a complex intervention, and participant feedback from working with this clinical group of patients highlighted the relevance and particular importance of the non needling aspects of care and treatment. Individualisation of care was reflected through participant’s responses relating to treatment during the stimulation phase of the ART cycle, the selection of acupuncture points, tailoring of advice on self care and use of co-interventions to improve follicular and endometrial responsiveness and manage stress. The importance of the practitioner-patient relationship was acknowledged by the thoughtful contributions and suggestions from participants particularly during the initial exploratory questions relating to the practitioners intention, or yi. Clearly yi was much more than establishing rapport through warmth and friendliness, but the preparation and nurturing of intent when healing. Participation by a diverse group of practitioners and acupuncture researchers has enabled us to develop a treatment protocol to address the research question for which funding has now been received. The treatment protocol defines the characteristics of the needling processes to be used, incorporates flexibility during the initial treatment to tailor treatment to the individual, and to address aspects of the therapeutic relationship.
Acupuncture is increasingly being used by women seeking fertility support, with evidence on the use of acupuncture for infertility support informed by two surveys. Firstly, data from 9,408 patients consulting acupuncturists identified 1.3% as using acupuncture for fertility support . Secondly, a survey of UK acupuncturists indicates 15% provide fertility support, and for some practitioners this has become a large proportion of their caseload . Eighty percent reported most of this work was related to assisted conception, and 20% of practitioners indicated additional benefits to their patients including reduced stress levels, and improved relaxation as benefits from acupuncture. The additional benefits to patients from acupuncture were similarly highlighted by our group of practitioners and researchers.
The external validity of our treatment protocol is supported by similarities with the acupuncture treatment protocol developed for a pragmatic design evaluating the role of acupuncture for women experiencing delays with conceiving in a primary care setting . In this study a process of consensus building for the trial protocol emphasised the high value placed on a differential diagnosis, and the importance of the therapeutic relationship in working towards the therapeutic outcome.
The strengths of this study include the comprehensive approach taken to identifying the dimensions for consideration relating to this area of clinical practice. We also achieved consensus from experienced practising acupuncturists from this area of clinical practice, and active researchers contributing to examining the evidence base for acupuncture. There are several limitations to this study. Not all items explored in round one were explored further in the subsequent rounds, this may reflect the diversity of acupuncture styles practiced by our Delphi participants, and the differing emphasis given to different items. There was some missing data to most items, and it was unclear for some items why this occurred. The characteristics of our responders indicate they were experienced practitioners, or researchers in terms of qualifications and the focus of their clinical practice with seeking fertility support. Their acupuncture training and experience will have influenced their responses to the Delphi rounds, and although we asked responders the style of acupuncture they use to treat women, we do not know if this reflected their initial training. Other limitations could relate to the participation of experts. We set out to be inclusive, however not all who were invited accepted our invitation, and there may be other styles of acupuncture practiced that were not included, or were under-represented. Our methodology did not consistently allow us the explore the reasons for participants responses to some questions. For example we do not know the rationale for participants indicating their agreement or disagreement with selected acupuncture points. This study offers no insight to some practitioner concerns about the use of points such as Spleen 6 in pregnancy, or in the pre-implantation phase.
A limitation of this study has implications for future research directions. Although the majority of study participants gave agreement to the treatment protocol we would use in our trial there was concern about the low dosage of acupuncture to be used. A view was shared that future protocols should be more pragmatic and in particular allow a greater number of treatments to be administered over a longer period of time, and allow treatments to be individualised. The problem of low dose or sub optimal use of acupuncture used in clinical trials has also been highlighted by several authors. White et al. , highlight the importance of defining an adequate dose of acupuncture using a neurobiological; approach, and more recently in the Langevin, et al., . Areas for future research for acupuncture and treatment of individuals with infertility or sub-fertility proposed by our study participants concur with some of the directions highlighted in the article Paradoxes in Acupuncture Research: Strategies for Moving Forward article which identified the apparent disconnect between experimental results and clinical trial results in acupuncture research .