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ssociated with medical and psychiatric conditions. One trialas of prevention of postnatal depression. Further analysis

evealed that a range of different Chinese herbal formulae haveeen investigated, in some cases combined with other treat-ents.Discussion: The systematic review is in progress. From the

reliminary results, it appears that the variation in the herbalormulae that have been tested will preclude any firm conclu-ions but the review will highlight possible strategies for futuretudies in this area.

eferences

1] Pampallona S, Bollini P, Tibaldi G, Kupelnick B, Munizza C. Patient adher-ence in the treatment of depression. Br J Psychiatry 2002;180(2):104–9.

2] WHO. WHO initiative on depression in public health [on-line]. Avail-able from: http://www.who.int/mental health/management/depression/depressioninph/en/print.html [accessed 20th March, 2010]; 2009.

oi:10.1016/j.eujim.2011.04.011

rom research to practice: Do users of an ear acupunctureervice to manage breast cancer related hot flushes and nightweats do as well as research

everley de Valois ∗, Teresa Young, E.J. Maher

Lynda Jackson Macmillan Centre, United Kingdom

Background: Research participants often have better out-omes than patients do who receive the same treatment intandard care settings [1]. After introducing an ear acupunctureervice to treat hot flushes and night sweats that are the side-ffects of adjuvant hormonal treatment (AHT) for early breastancer, we aimed to test this by comparing the outcomes of ser-ice users with those of participants of our previous researchtudy [2].

Objective: To test the hypothesis that service users reportoorer outcomes than do research participants.

Methods: Ninety-three women self-reporting 4 or more hotushes per day and receiving AHT had eight weekly treatmentssing the National Acupuncture Detoxification AssociationNADA) ear acupuncture protocol, administered by trainedon-acupuncturists. Inclusion criteria and outcome measuresepeated those in our previous NADA study, and included Hotlush Diaries (to measure frequency), the Women’s Healthuestionnaire (to measure emotional and physical wellbeing)

nd the Problem Rating Score (to measure how troublesomeomen find these symptoms). We compared data, complianceith treatment and questionnaire completion with that from the

esearch study.Results: Nine service users were recruited in contravention

f the inclusion criteria (having less than 4 hot flushes per day),nd 17 did not return end of treatment data. Analysis of 67 ser-ice users with end of treatment data shows a 43.9% (95% CI

5.3–51.3) reduction in hot flush frequency at end of treatment.his is not significantly different from the reduction demon-trated during the research project, which was 35.9% (95%I 25.4–45.4). Overall, service users and research participants

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ive Medicine 3 (2011) e105–e116

howed similar scores and similar changes on the Women’sealth Questionnaire and the Problem Rating Scores. Five ser-ice users (6%) did not complete the course of eight treatments,ompared with two research participants (4%). 26.9% of theot flush diaries and follow-up questionnaires were missingompared to 10.1% in the research project.

Discussion: It is possible for service users to do as well asesearch participants. Service providers may prioritise patientare over rigorous application of inclusion criteria and followp of data return. Service users appear to be significantly lessompliant in completing paperwork. For those returning data,here is no significant difference in response rate compared tohat reported in the research study.

This is part of an on-going audit process to evaluate servicerovision. We have found that gathering and analysing these dataave contributed to improving application of inclusion criteriand reinforcing the message to service users that data returnelps us to monitor and maintain the service.

eferences

1] Elting L, Cooksley C, Nebiyou Bekele B, et al. Generalizability of can-cer clinical trial results: prognostic differences between participants andnonparticipants. Cancer 2006;106(11):2452–8.

2] de Valois B. Using acupuncture to manage hot flushes and night sweats inwomen taking tamoxifen for early breast cancer: two observational studies.PhD thesis, Thames Valley University; 2006.

oi:10.1016/j.eujim.2011.04.012

AM for supportive cancer care: Communication strategiessed by health professionals

. Evans ∗, A. Heawood, D. Sharp

University of Bristol, United Kingdom

Objective: To explore the value of ‘holistic assessment’ asdialogue between cancer patients and health professionals, inhich patients’ needs are assessed and guidance is provided inecisions about CAM use.

Method: Qualitative study carried out in two centres thatrovide CAM to people with cancer, following an initial hour-ong ‘holistic assessment’ carried out by trained assessors with

background in nursing and/or CAM. One centre operatedndependently and one operated with close links with statutoryancer treatment providers. Non-participant observation wassed of holistic assessment sessions, interviews with patientsnd focus groups with assessors. All data were transcribed andnalysed using a narrative approach incorporating techniquesrawn from conversation analysis.

Results: Communication strategies were identified andxplored using the model of ‘six category intervention’ anal-sis based on a person-centred theoretical tradition, comprising

Facilitative’ and ‘Authoritative’ strategies [1]. A model ofecision-making was developed based on the dialogue betweenssessors and patients. The model consists of four typesf decision-making: ‘Advice: assessor led decision’, ‘Con-

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rmation: joint decision’, ‘Access: patient-led decision’ andInformed: patient led decision’.

Communication strategies and types of decision-making var-ed between the two centres and according to the needs ofhe presenting patients. In the independent centre there was

greater emphasis on patient led decisions reflecting a morenowledgeable group of patients. At the centre linked with main-tream care, there was more emphasis on assessor led decisions.atients valued the process of holistic assessment, althoughn occasions their expectations were not met or there wereis-matches in communication between patients and assessors.atients’ expectations and experiences of personal empower-ent in decision-making about CAM were explored. This study

llustrates the dual nature of taking agency in treatment deci-ions: patients want to help themselves but may need advice anduidance about how to do so.

Discussion: Previous research by the authors reported gaps inhe provision of support and information about CAM from healthrofessionals, leading to a reliance on informal lay networks andnternet sites, which are of variable quality [2,3]. It emerged thatatients wanted information and advice from a trusted individualo help them choose appraise and access AM therapies. Holis-ic assessment with trained and experienced professionals atespected CAM provide organisations offers a model of access,nformation exchange and quality control for cancer patientseeking to adopt CAM. This model, based on skilled communi-ation strategies, expert knowledge and, shared decision-makingay be transferable to other settings, for example to mainstream

ancer care.

eferences

1] Heron J. Six Category Intervention Analysis. Guildford, Human PotentialResearch Project, University of Surrey; 1975.

2] Evans M, Shaw ARG, Sharp DJ, Thompson EA, Falk S, Turton P, et al.Men with cancer: is their use of complementary and alternative medicinea response to needs unmet by conventional care? Eur J Cancer Care2007;16:517–25.

3] Evans M, Shaw A, Thompson EA, Falk S, Turton P, Thompson T, et al.Decisions to use complementary and alternative medicine (CAM) by malecancer patients: information-seeking roles and types of evidence used. BMCComplem Altern Med 2007;7:25.

oi:10.1016/j.eujim.2011.04.013

ilot study for a randomised controlled trial of mistletoen newly diagnosed breast cancer (MBC): Methodologicalssues in protocol development

.L. Huntley ∗, M. Evans, G. Lewith, S. Love, G. Feder, theistletoe Advisory Group

Background: Mistletoe as an adjunct treatment for cancerriginated in the anthroposophical teaching of Rudolph Steiner.hilst 14 trials have indicated benefit of mistletoe treatment,

he quality of these studies is generally poor and most are notlacebo-controlled. Thus, whilst mistletoe is a popular treatmentor cancer in mainland Europe, its use is not evidence-based,nd in the UK its use is relatively controversial. A Cochrane

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ive Medicine 3 (2011) e105–e116 e113

eview on the use of mistletoe for cancer suggests that it maye useful in enhancing quality of life and mitigating adverseffects of conventional cancer treatments, but that high qualitylacebo-controlled trials are required [1].

Therefore we are designing a placebo-controlled trial of these of mistletoe as an adjunct treatment for women with newlyiagnosed breast cancer (MBC). The first stage of our project iso test the feasibility of such a trial in a pilot study.

Methods: Based on previous studies and in collaboration withrial methodologists, oncologists and mistletoe prescribing clini-ians we have developed a protocol for a pilot study. We have alsoonsulted a group of breast cancer patients identified through theational Cancer Research Network on the design of the inter-ention and trial. One of the major challenges is choosing anppropriate placebo treatment. We have designed the pilot studyo investigate the feasibility of patient recruitment, retention ofatients for the full trial, completeness of follow up assessmentsnd blinding of both nurses and patients as to their treatment.e have a nested qualitative study to help us achieve these

bjectives. Our ultimate goal is the conduct of a fully poweredrial.

Preliminary findings: We have developed a protocol that ishe basis of a funding proposal, as well as MHRA and ethicspplications. In the presentation we will present the key fea-ures of the MBC trial, highlighting those that have proved mosthallenging to date.

Discussion: The design of the MBC pilot is an example ofandomised controlled trial methods applied to a complemen-ary therapy. In presenting it to the conference, we hope to bothnfluence others to use these methods and to learn from theiriews and experiences to improve MBC.

eference

1] Horneber M, Bueschel G, Huber R, Linde K, Rostock M. Mistletoe therapyin oncology. Cochrane Database Syst Rev 2008;(2) [Art. No.: CD003297].

oi:10.1016/j.eujim.2011.04.014

ffering aromatherapy hand/foot massage to people whoave suffered a brain injury

ouise Marsland

University of Essex, United Kingdom

Background: Aromatherapy massage is used for brain injuryurvivors in a number of healthcare settings [1], yet publishedesearch is virtually non-existent. Studies with other clinicalroups suggest that foot massage may have short-term benefits2,3], but this is yet to be established with brain injury clients.

Aims and objectives: A small-scale study was designed to:

explore the feasibility of providing aromatherapy to clientswith brain injuries;

identify any perceived or observed effects of aromatherapyhand/foot massage provided to these clients;inform the design of further research.