The meaning of evidence: can practitioners be researchers?

Our research group at Southampton contains a combination of non-clinical researchers as well as CAM and conventional clinicians who have become researchers. The transition from practitioner to practitioner-researcher has led us to question, challenge and re-consider the paradigmatic differences in our practices compared to conventional medicine and how we might understand and interpret evidence derived from both quantitative and qualitative research. We very much value the randomised controlled trial (RCT) but have all come to understand its limitations and constraints when trying to encapsulate a complete, rigorous, and honest understanding of our complex interventions and how they are delivered in practice. Equally, our expertise in qualitative research leads us to understand the patient's perspective and to value a more individual agenda. We believe that we share these tensions with clinicians working in primary care. We appreciate that we need to understand contextual effects so we can better utilise and research them appropriately, rather than dismiss them as mere placebo. These issues represent both personal and transcendent conflicts that we have expressed as a series of vignettes each written by a practitioner/researcher working in that filed. Our principle aim in writing this essay is to offer our practical experience and insight as issues for thoughtful debate for those clinicians and academics involved in clinical research in controversial areas such as CAM.

The context and meaning of placebos for complementary medicine.

Calls for placebo-controlled randomised trials in complementary and alternative medicine (CAM) are entirely reasonable. However, they present major methodological problems, particularly when we understand so little about the underlying biological mechanisms involved for many of these therapies. Designing a placebo in CAM is frequently dependent on unsubstantiated assumptions about the specificity of a particular CAM intervention. In this paper we address the development and application of placebos to clinical trials of homeopathy, acupuncture, kinesiology, Chinese herbal medicine and healing. Each therapy-based vignette is authored by a researcher from the Complementary and Integrated Medicine Research Unit at the University of Southampton who has specific expertise in the field. The essential research question within this review is; can we legitimately claim to have placebos for these particular CAM interventions? In some areas of CAM the debate has become very involved and sophisticated, for instance in acupuncture but for other areas, such as healing, our understanding of placebos is currently limited and very naïve. For instance, if acupuncture is not point specific, then many so-called 'placebo-controlled' acupuncture trials are both misconceived and misleading. We have addressed this debate in what we hope is a thoughtful and rigorous manner with a view to developing realistic, reliable and credible placebos for randomised controlled studies when and where possible. However, our conclusions suggest that we are some way from developing valid, credible and reliable placebos for most CAM therapies.

Does acupuncture help stroke patients become more independent?

This short speculative report describes the outcome of three studies looking at the effect of acupuncture on stroke recovery and the subsequent place of residence of the subjects entered. It is not a systematic review and does not endeavor to provide comprehensive data on the effect of acupuncture on post-stroke recovery. Our observations demonstrate that patients may be more likely to remain independent and in their own homes one year post stroke if they receive acupuncture. This conclusion is supported by our study and two previous trials. It may be that acupuncture improves post-stroke perception, thereby enhancing independence.

Debate--patients should be encouraged to treat themselves.

In favour of self-acupuncture, this is a useful way to prolong the effects of acupuncture when the response is only brief or patients cannot attend frequently. If the patient is capable and the condition is suitable for self-acupuncture, patients can be taught how to do it and then seen for review. Patients should be provided with complete information sheets, and one example is presented. Against self-acupuncture, patient safety is paramount and would be compromised by teaching them how to do acupuncture. In addition, serious accidents have happened with self-acupuncture, including a death. Other arguments against it are that it is less effective than standard acupuncture, the patient misses out on the therapeutic relationship, and safer alternative methods exist.

The placebo needle, is it a valid and convincing placebo for use in acupuncture trials? A randomised, single-blind, cross-over pilot trial.

The issue of what constitutes an effective and realistic acupuncture placebo control has been a continuing problem for acupuncture research. In order to provide an effective placebo, the control procedure must be convincing, visible and should mimic, in all respects, apart from a physiological effect, the real active treatment. The 'Streitberger' needle might fulfil these criteria and this paper reports on a validation study. This was a single-blind, randomised, cross-over pilot study. Patients were drawn from the orthopaedic hip and knee, joint replacement waiting list. Intervention consisted of either 2 weeks of treatment with real acupuncture followed by 2 weeks on placebo, or vice versa. The prime outcome was a needle sensation questionnaire and there was a range of secondary outcomes. Thirty-seven patients were randomised and completed treatment. Groups were well balanced at baseline. No significant differences between groups or needle types were found for any of the sensations measured. Most patients were unable to discriminate between the needles by penetration; however, nearly 40% were able to detect a difference in treatment type between needles. No major differences in outcome between real and placebo needling could be found. The fact that nearly 40% of subjects did not find that the two interventions were similar, however, raises some concerns with regard to the wholesale adoption of this instrument as a standard acupuncture placebo. Further work on inter-tester reliability and standardisation of technique is highly recommended before we can be confident about using this needle in further studies.