The efficacy of acupuncture is a less controversial topic comparing its mechanism for the efficacy is approvable while the whole theory of Traditional Chinese Medicine (TCM) is complexity, or we should say, abstruse.
The study carried out by Alexander Molassiotis et al. is to approve if acupuncture is effective in Cancer Related Fatigue (CRF) and a conclusion of “Acupuncture is an effective intervention for managing the symptom of CRF and improving patients’ quality of life” is drawn (1).
Professor Alexander Molassiotis (Figure 1), Chair Professor of Nursing & Head of School, Hong Kong Polytechnic University, was professor of University of Manchester when conducting the study together with other researchers. In the interview, Prof. Molassiotis would illustrate the study and reveal stories behind it. Topic of Acupuncture in UK will be discussed as well.
What question did your study answer?
The study aimed to answer if a course of acupuncture is effective for managing cancer-related fatigue in a sample of patients with breast cancer who had completed adjuvant chemotherapy.
How did you get involved in this research?
Earlier in my career I was often frustrated, as a specialist oncology nurse, from our inability to manage optimally many symptoms affecting cancer patients. Then I worked in Hong Kong for a few years and I had the opportunity to undertake training in acupuncture and Traditional Chinese Medicine in China. This made be aware of other, unexplored till then, possibilities to support patients. As an academic and researcher in symptom management, I am trying to see how I can involve appropriately some of these ‘traditional’ approaches and establish the evidence-base for such therapies, with acupuncture to manage some complex symptoms in cancer.
How did you select the three pairs of acupoints in this study?
The points were selected based on the literature, TCM theory and discussions with acupuncture practitioners.
Among 302 patients, 246 patients completed the trial. What would be the main reason for those 56 patients who quit the trial?
Based on the requirements of the ethical approval, we were not able to ask patients to provide a reason for this. However, travel difficulties to come to the hospital to receive the acupuncture session was a key reason for this. This drop-out rate is not unusual in trials, expected and probably not very high.
Since the multidimensional fatigue inventory (MFI) is a self-report instrument designed to measure fatigue, are there any more objective measurements that would make the fatigue index (score) from MFI more convincible?
Self-reports are appropriate primary outcomes, as we evaluate patient-reported outcomes in a patient-centred health care system. However, it would be advantageous in future trials to combine patient-reported and objective measures. Such objective measures could be related to cytokine activity as biological markers, as there is initial evidence of alterations in several cytokine levels in fatigued patients.
Eligible patients had a diagnosis of stage I, II, or IIIA breast cancer and the ratio of the control group and intervention group study groups is 1:3, how did you make sure that patients in different phases are distributed reasonably?
This is taken care of during the randomization process, and we have used block randomization for key patient characteristics so as to have equal distribution of these characteristics in the two groups.
How can you exclude the possibility of acupuncture’s placebo theory except “conversation between acupuncturists and patients was kept to minimum”? Why not a sham acupunctural control group?
There is an ongoing debate about the use of such ‘sham’ approaches in acupuncture trials, with no real consensus. So, whatever we do, a part of the scientific community will liked it and accept it and a part will criticize it. We need to understand more the scientific basis of such ‘sham’ methods (are they really equivalent to placebos or minimal needling often used in such approaches is actually a treatment itself?). Also we need to consider the ethicality of the selected approach, weighing the prons and cons of using sham methods.
Nevertheless, we have used an ‘enhanced’ usual care group for our comparisons, and this group received additionally a booklet talking about fatigue, factors contributing to its development, keeping a diary, and approaches to manage fatigue including exercise, nutritional changes and prioritizing activities.
Is there any limit of the study?
Yes, there are limitations, including a recruitment approach based on self-referrals making sample potentially highly selected, lack of blinding and susceptibility to assessment bias, and some missing data.
What is the role or position of alternative therapy in your opinion?
First of all we need to be clear that not all alternative therapies are helpful; hence it is of primary importance to establish the evidence base of such therapies. For those have proven effects through appropriate methodological designs, their role can be very important in the supportive care of patients, and should be incorporated in the care provided to them. The role of such therapies in improving the survivorship of patients is also very important.
What does the public in the United Kingdom think about acupuncture? Is there any policies regarding it?
Generally speaking both the public and the medical community are quite accepting of acupuncture. Many hospitals across the UK provide complementary therapies services to their patients, and acupuncture is one of the most common therapies offered within such therapies. Acupuncture is a self-regulated profession in the UK and practitioners are expected to be registered with one of the Acupuncture Councils (although this is not necessary). The British Acupuncture Council and other related societies have produced various guidelines for the use of acupuncture.
Is there any story to be shared with the readers, such as the particular challenges, setbacks, or successes that you’ve encountered along the way?
One of the difficulties we had in recruitment was to identify women with moderate or severe fatigue levels; despite the literature showing high incidence of fatigue, much of the fatigue reported by patients in our study was of low severity, and we needed to screen many hundreds of patients to identify those with at least moderate fatigue. We also had to resolve many hotly debated issues within and among the research and clinical teams involved in the various study sites, including whether we use TCM acupuncture approach with eliciting ‘de Qi’ or western acupuncture, whether we need to standardize treatment or not, etc. In qualitative data we have from the participants, talking about fatigue and being part of a fatigue trial allowed them to legitimize their symptom experience. Also, interestingly women spontaneously reported improvements they felt in other symptoms, not being the focus of this trial, including hot flushes and arthralgia related to the use of aromatase inhibitors.
What would you say to health care worker who are interested in this field?
We need to enhance the quality of acupuncture trials. This will need to take into account accepted ways of doing a high quality trial, and built a programmatic approach with initial feasibility and pilot work before developing larger trials. We also need to have the wider possible consensus in our approach in some methodological aspects that are highly debated and contested. Acupuncturists, health professionals and researchers need to work together to develop approaches that are enhancing the care patients receive and develop the evidence base of acupuncture. Good quality trials will also need multi-centre trials, so we need to team up with other collaborators and develop more ‘concrete’ research work.
What is the ultimate goal of your study? Where do you see your research leading in the future?
I would like to look into repeating this study with a sham group, incorporating some biological markers alongside self-report scales, and also looking at health care utilization in trials of acupuncture (health economics evaluations).
Disclosure: The author declares no conflict of interest.
- Molassiotis A, Bardy J, Finnegan-John J, et al. Acupuncture for cancer-related fatigue in patients with breast cancer: a pragmatic randomized controlled trial. J Clin Oncol 2012;30:4470-6.