Fiona Barlow

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.

The Development and Validation of an Outcome Measure for Spiritual Healing: A Mixed Methods Study

Background: Spiritual healing, probably the oldest documented paramedical intervention, is a neglected area of research. In order to conduct further research into the effects of healing, a valid and reliable outcome measure is needed that captures the experience of individuals receiving healing (healees) and is not burdensome to complete. We aimed to develop such a measure. Methods: A mixed methods design was used. Focus groups and cognitive interviews were used to generate and refine questionnaire items grounded in the experiences and language of healees (Study 1). The resulting questionnaire was tested and its formal psychometric properties were evaluated (Study 2). Participants were recruited from a spiritual healing sanctuary and via individual healers (including registered spiritual healers, Reiki practitioners, healers affiliated with churches). Results: In Study 1, 24 participants took part in 7 focus groups and 6 cognitive interviews. 29 common effects were identified and grouped into 7 discrete dimensions that appeared to characterize potentially sustainable effects reported by participants following their experiences of spiritual healing. In Study 2, 393 participants returned completed baseline questionnaires, 243 of whom completed the questionnaire again 1–6 weeks later. Exploratory factor analysis generated 5 subscales, based on 20 of the items: outlook, energy, health, relationships and emotional balance. These subscales demonstrated acceptable internal consistency, convergent validity and test-retest reliability. Three of the subscales and the whole questionnaire demonstrated good sensitivity to change. Conclusions: We have produced a psychometrically sound healing impact questionnaire that is acceptable to healees, healers and researchers for use in future evaluations of spiritual healing.

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.

Experience of Proximate Spiritual Healing in Women with Breast Cancer, Who Are Receiving Long-Term Hormonal Therapy

BACKGROUND This paper presents the research protocol for a pragmatic study of the experience of spiritual healing. This unique qualitative study seeks to identify any qualitative benefits of hands-on or proximate spiritual healing for women experiencing adverse reactions to hormonal treatments. Healing will be administered as adjuvant therapy for the long-term management of breast cancer. DESIGN A purposive sample of up to 20 women who have completed their initial treatments at least 6 months previously will be recruited through the Oncology Department at Southampton General Hospital. The study will take place at the Wellcome Trust Clinical Research Facility within Southampton General Hospital, where spiritual healing will be provided by healers who are National Federation of Spiritual Healers registered. Patients will be offered up to 10 weekly healing sessions. OUTCOME Patients will be asked to keep a daily log noting any changes they have noticed during or after the healing sessions and their attributions of these. Audio recorded in-depth interviews will be carried out after completion of the final healing. Participants will also be invited to attend focus group meetings to discuss any effects of healing. Data will be analyzed initially using an ethnographic approach allowing further analysis using other appropriate qualitative methodologies. Depending on the findings, this study will also form the preliminary stage of a further study to develop and evaluate a healing-specific questionnaire.

The ethics of complementary therapy research recruitment: a case study

We suggest that physicians responsible for the clinical care of their patients have a moral and ethical duty to thoughtfully consider recruitment to appropriately approved, funded, and peer reviewed research that may possibly help the people for whom they are responsible. This facilitates the sustained development of evidence-based medicine while recognising the clinical needs of their patients and their rights to informed consent. We do not believe that physicians have the right to fail to inform or exclude patients from such studies based on their personal beliefs. We present a case study that illustrates this issue within the context of researching spiritual healing and cancer. CAM use has increased considerably in the Western industrialised nations over the last 25 years with around 83% of cancer patients using it in some form,1 almost invariably in conjunction with conventional medicine, to ameliorate the side effects of treatments.2 About 40% of CAM users consulted concurrently with their orthodox physician about the same problem and self manage their CAM and conventional medical treatments,3,4 an approach which has generated considerable debate within the context of oncology. There are currently about 14 000 registered spiritual healers in the UK.5 Spiritual healing is an ancient approach to illness which acknowledges the spiritual dimension of human existence. It does not refer in any way to religion or a specific religious belief system.6 There is some preliminary evidence to suggest it can create profound relaxation and pain relief7–11 which may also improve depression7,8,11–13 and anxiety8,10–12 as well as encourage sleep9,13 and engender inner peace,7,14 thus potentially improving wellbeing …

Contents Vol. 79, 2010

R. Balon, Detroit, Mich. P. Bech, Hillerød M. Biondi, Roma M. Bouvard, Chambery G. Chouinard, Montréal, Qué. P.M.G. Emmelkamp, Amsterdam S. Fassino, Torino M. Fava, Boston, Mass. H.J. Freyberger, Greifswald/Stralsund S. Grandi, Bologna D. Hellhammer, Trier J.I. Hudson, Belmont, Mass. I.M. Marks, London M.W. Otto, Boston, Mass. E.S. Paykel, Cambridge P. Porcelli, Castellana Grotte C. Rafanelli, Bologna C.D. Ryff , Madison, Wisc. U. Schnyder, Zürich J. Scott, Newcastle T. Sensky, London T. Th eorell, Stockholm E. Vieta, Barcelona T. Wise, Falls Church, Va. R. Zachariae, Aarhus Offi cial Journal of the International College of Psychosomatic Medicine (ICPM) Offi cial Journal of the International Federation for Psychotherapy (IFP)

Advanced Training Workshop: Psychosomatic Assessment

On March 24–26, 2011, at Istituto Canossiano in Venice, Italy, there will be a workshop concerned with the novel techniques and strategies of psychosomatic assessment. The faculty includes Richard Balon (USA), Antonio Barbosa (Portugal), Giovanni Fava (Italy), Gabor Keitner (USA), Dennis Linder (Italy), Chiara Rafanelli (Italy), Tom Sensky (UK), Nicoletta Sonino (Italy), Tom Wise (USA) and Jesse Wright (USA). The faculty will share with the participants how psychosomatic assessment actually takes place by discussing clinical cases and the use of role playing. At the end of the workshop the participant will be able to use the new psychosomatic approach in his/her clinical practice, to enhance clinical effectiveness and to be aware of new treatment opportunities. The workshop is aimed at physicians or psychologists, with special reference to those who have already achieved or wish to get the title of Psychosomatic Specialist by the International College of Psychosomatic Medicine. Those who intend to attend should contact the Scientific Secretary, Elena Tomba, PhD, Department of Psychology, University of Bologna, Viale Berti Pichat 5, IT–40127 Bologna, Italy, Tel. +39 051 209 1823, Fax +39 051 243 086, E-Mail elena.tomba @ unibo.it. Published online: September 16, 2010