Complementary Medicine Research Projects
Postgraduate Projects (PhD, MSc)
Current projects (5)
Clare Hill (PhD)
Supervisors: George Lewith/Peter White/Jan Walker
A qualitative study exploring the non specific effects of western acupuncture among participants of a randomized controlled trial
Funded by: Department of Health (£152,823)
Status:
Abstract: View / Close
Background This qualitative study was nested within a large, still ongoing clinical trial designed to test for non-specific treatment effects, notably the therapeutic relationship, in western acupuncture patients awaiting surgery for lower limb osteoarthritis. Together the two studies comprise a mixed methods protocol born out of the recommendation for such research whole system methodologies within the field of Complementary and Alternative Medicine (CAM).
Aim The aim of the qualitative study was to investigate the experiences of participants taking part in a randomized controlled trial designed to test for non-specific effects of western acupuncture.
Method Participants in the trial are randomized to one of three treatments (one real and two placebo controls – needle and non needle) delivered with or without empathic intent. The qualitative study, based on grounded theory, involved a combination of post-trial audio taped narrative interviews; post treatment debriefing, participant and non participant observation and personal reflections. Data collection and analysis were conducted using constant comparison. Purposive sampling was used to develop emergent concepts which were tested using progressively focused interview techniques and theoretical sampling.
Findings Data collection is now complete, and the findings are being written up. A substantive theory of participation has emerged and this will be available following the thesis submission in July 2008.
Susan Eardley (PhD)
Supervisors: George Lewith/Sarah Brien/Paul Little
Professional kinesiology practice; is it an effective treatment for back pain?
Status: In Progress, 2 papers published
(1) Hall S, Lewith G, Little P, Brien S. A review of the literature in applied and specialised kinesiology. Forschende. 2008; 15: 40-46.
Abstract: View / Close
Introduction: Kinesiology is a diagnostic, therapeutic complementary therapy utilising subtle change in manual muscle testing results to evaluate the body’s energetic balance and select healing modalities. Anecdotal evidence suggests kinesiology is helpful, therefore we wished to critically review the literature.
Aims: (1) To ascertain if diagnostic accuracy including inter-examiner reliability has been established. (2) To review whether there is evidence for its therapeutic effectiveness. (3) To critically assess the quality of relevant studies.
Methods: Electronic databases were searched. Diagnostic accuracy studies were analysed and scored for methodological quality and quality of reporting using the quality assessment tool for studies of diagnostic accuracy included in systematic reviews (QUADAS) and the Standards for Reporting of Diagnostic Studies (STARD). Clinical studies were analysed for methodological quality using the JADAD scale and for quality of reporting using the Consolidated Standards of Reporting Trials (CONSORT).
Results: 22 original relevant studies were identified. Their methodology was poor. Items reported on QUADAS scored 1-11 out of a possible 14, STARD scores were between6-13 out of 25, JADAD scores were all 0 out of 5and CONSORT 4-6 out of 22. Consequently, we were unable to answer any of our research questions.
Conclusion: There is insufficient evidence for diagnostic accuracy within kinesiology, the validity of muscle response and the effectiveness of kinesiology for any condition. The standards of reporting were low. We recommend a pragmatic study of the effectiveness of kinesiology as the most appropriate initial step to determine whether kinesiology has any clinical value.
(2) Hall S, Brien S, Lewith GT, Little P. An exploratory pilot study to design and assess the credibility of a sham kinesiology treatment. Forschende. 2008; 15: 321-326.
Abstract: View / Close
Introduction Kinesiology is a complementary therapy assessing subtle change in manual muscle testing results to select individualised treatments. We report the exploratory 2-stage development and pilot of a sham kinesiology treatment for use in a clinical trial to evaluate the specific effects of this intervention.
Aims 1. To design, pilot and assess the credibility of a sham kinesiology treatment in a kinesiology-aware population. 2. To pilot the sham kinesiology in a cross-over study of sham versus real kinesiology, and to make an exploratory assessment of its credibility in a kinesiology-naïve population.
Methods 1. 10 kinesiology-aware volunteers received a specially designed sham treatment weekly for 5 weeks which was subject to a credibility assessment. 2. 10 kinesiology-naïve patients with low back pain were randomised to receive 4 real and 4 sham treatments in a cross-over design; the treatments were subject to a credibility assessment.
Results 100% of participants found the sham protocol a credible treatment as measured by the credibility questionnaire. 100% of patients having real treatment first did not recognise that the second set of treatments were sham. Small numbers precluded the use of formal statistical tests.
Conclusion In this small sample it appeared feasible to deliver an apparently credible sham kinesiology treatment. This feasibility study has allowed us to develop a sham treatment for use in a larger prospective clinical trial of kinesiology in patients with low back pain.
Denise Gibson (PhD)
Supervisors: Anne Bruton/MaryArmstrong/Peter White
A randomised controlled trial of acupuncture for the treatment of hyperventilation syndrome.
Funded by: University doctoral fellowship in conjunction with the NHS/Physiotherapy Research Foundation (£15,000).
Status: In Progress
Article In Press -
Gibson DH, Bruton A, Lewith GT, Mullee M. The effects of acupuncture as a treatment for hyperventilation syndrome: a pilot randomised crossover trial. (JACM).
Abstract: View / Close
Sustained and subtle hyperventilation can result in a wide variety of symptoms, leading to a chronic condition which has been termed hyperventilation syndrome (HVS). Treatment options include physiotherapy, in the form of breathing retraining (BR), but additional approaches aim to reduce the anxiety which is recognised as being a frequent component of this condition.
Objectives: The aim of this study was to evaluate whether acupuncture is an appropriate treatment for HVS to reduce anxiety, and whether a crossover trial is an appropriate study design to evaluate acupuncture in this condition.
Design: A single-blind crossover trial was carried out comparing the effects of 4 weeks (twice weekly) acupuncture and BR on patients with HVS.
Subjects: Ten(10) patients diagnosed with HVS were recruited to the trial and randomised into two groups. Both groups received acupuncture and BR with a washout period of 1 week.
Outcome measures: The primary outcome measure used was the Hospital Anxiety and Depression Scale (HAD). Other outcome measures used were the Nijmegen questionnaire and Medical Research Council Dyspnoea scale.
Results: The results showed statistically significant treatment differences between acupuncture and breathing retraining, in favour of acupuncture. Reductions were found in the HAD A (anxiety) (p = 0.02) and Nijmegen (symptoms) (p = 0.03) scores. There was no statistical evidence of any carryover effects. However, when graphically examining individual anxiety scores, in those who received acupuncture first, there was a reduction in anxiety levels which persisted through the wash out period, suggesting that there may have been some carry over effect from this treatment.
Conclusions: This study suggests that acupuncture may be beneficial in the management of HVS in terms of reducing anxiety levels and symptom severity. However, there may be some carry over effect, after acupuncture treatment, which went undetected due to the small sample size. This preliminary study provides the basis for a larger, sufficiently powered and methodologically sound trial.
Sarah Price (PhD)
Supervisors: Kate Thomas/Andrew Long/George Lewith
Acupuncture care for breast cancer patients undergoing chemotherapy; what symptoms are important to patients, what are patients' perceptions of how acupuncture care affects these symptoms, and what are acupuncturists' experiences of delivering care?
Status:
Abstract:
Chantal Simon (MRC Fellowship)
Supervisors: George Lewith/Paul Little
Evaluating Carer burden in patients suffering from Stroke
Status:
Abstract:
Completed projects (8)
Caroline Eyles (PhD) 2009
Supervisors: Sarah Brien/Jan Walker
A qualitative study of homeopathic consultations.
Funded by: Department of Health (£162,509).
Status: 2 papers completed, 1 under review
Abstract: View / Close
Background Data has confirmed that patients receiving homeopathy feel satisfied with their treatment, yet currently no definitive mechanisms to explain how homeopathy works is available. Homeopathy is a complex medical intervention and a “whole systems” approach is necessary to understand the whole treatment process; this involves exploring aspects such as the patient/practitioner relationship. Recent interest in understanding its success is focussed on the patient practitioner dyad however little research has been done into the homeopathic consultation and there is currently no published work that explores the role of the homeopathic practitioner.
Aim This study therefore will focus on the nature of the homeopathic consultation and the role of the homeopathic practitioner with the aim of identifying factors that homeopathic practitioners perceive to be important in promoting therapeutically effective consultations.
Method In keeping with the explorative and emergent nature of this study qualitative methods will be used with a grounded theory approach to data collection and analysis. Grounded theory is an inductive qualitative research methodology designed to develop theory that is grounded in the data, which has been systematically gathered. Theory evolves during the research through a continuous interaction between data collection and analysis and by using constant comparison concepts and categories are formed until saturation of the data is achieved. A two phase process of data collection and analysis will be used.
Phase 1: Homeopaths will be sampled from the Faculty of Homeopathy and the Society of Homeopaths register and interviewed. Initially the participants will be purposefully sampled and following preliminary data analysis decisions regarding sampling will be guided by theoretical sampling and snowball sampling. The number of interviews required will be dependant on obtaining saturation of the categories. This phase of data collection and analysis will enable theory development and a tentative model of the homeopathic consultation.
Phase 2: the purpose of phase two of the data collection and analysis process is to confirm or refute aspects of the developing theory of the homeopathic consultation. This will entail purposeful sampling of practitioners who took part in phase 1 of the data collection. In phase 2 observations of consultations will take place and some practitioners will be asked to keep a diary for two weeks focusing on particular aspects of the consultation.
Results A tentative model of the homeopathic consultation is in development as data collection and analysis is ongoing in this study. The results will be available by November 2008.
(1) Homeopathic Practitioners' Experiences of the Homeopathic Consultation: A Protocol of a Grounded Theory Study. The Journal of Alternative and Complementary Medicine, 2009 15(4)pp 347-352
Abstract: View / Close
Background: The apparent success of homeopathy is often attributed to a collaborative, holistic and empathic consultation and to the practitioner patient relationship. Despite practitioner’s consultative style being shown to effect patient’s health outcomes in conventional medicine most research into the homeopathic consultation has focussed on patients’ experiences. However, the practitioner is a crucial component of the therapeutic context and may therefore have an important part to play in optimising health outcomes in homeopathy. Additionally the mechanisms underlying therapist effects are still poorly understood in clinical medicine generally and particularly so in homeopathy.
Aim: The aim of this research is to gain an in depth understanding of homeopathic practitioners’ perceptions and experiences of the consultation, and the process of engaging with the patient and prescribing the remedy. We propose to generate a theoretical model to explain the processes that underpin the homeopathic consultation.
Design: This is a qualitative study using grounded theory methodology. Two phases of data collection will be involved. Phase 1 will involve face to face in-depth interviews with homeopaths. From these interviews a theoretical model of the homeopathic consultation will be developed. Phase 2 of data collection will involve observations of homeopathic consultations and the use of practitioner diaries in order to test the emerging theoretical model from phase 1. Homeopaths will be sampled from the Faculty of Homeopathy and the Society of Homeopaths.
Results: Results will be available from summer 2009
Conclusion: The findings from this study will lead to the development of a theoretical model of how homeopaths view and enact the consultation process. Revealing this process may influence the training of new practitioners and improve the practice of experienced practitioners and will therefore be of benefit to patients. In addition, the findings may be of potential benefit to practitioners of other therapeutic consultations.
(2) Lewith G, Barlow F, Eyles E, Flower A, Hall S, Hopwood V, Walker J. The Context and Meaning of Placebos for Complementary Medicine. Forsch Komplementmed 2009;16:404–412
Abstract: View / Close
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.
Andrew Flower (PhD) 2009
Endometriosis. A feasibility study investigating the role of Chinese herbal medicine in the treatment of endometriosis.
Supervisors: George Lewith/Paul Little.
Funded by: NCCRCD Fellowship (£17,606)/Southampton Complementary Medical Research Trust (£10,000)
Status: Study completed, 1 paper published.
Flower A, Chen S, Liu JP, Lewith GT, Little P. Chinese herbs for endometriosis. Cochrane Library, 2009; issue 3
Abstract: View / Close
Background Endometriosis is characterized by the presence of tissue that is morphologically and biologically similar to normal endometrium in locations outside the uterus. Surgical and hormonal treatment of endometriosis have unpleasant side effects and high rates of relapse. In China, treatment of endometriosis using Chinese herbal medicine (CHM) is routine and considerable research into the role of CHM in alleviating pain, promoting fertility, and preventing relapse has taken place.
Objectives To review the effectiveness and safety of CHM in alleviating endometriosis-related pain and infertility.
Search strategy We searched the Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library) and the following English language electronic databases (from their inception to the present): MEDLINE, EMBASE, AMED, CINAHL, NLH on the 30/04/09.
We also searched Chinese language electronic databases: Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Sci & Tech Journals (VIP), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), and Chinese Medical Current Contents (CMCC).
Selection criteria Randomised controlled trials (RCTs) involving CHM versus placebo, biomedical treatment, another CHM intervention, or CHM plus biomedical treatment versus biomedical treatment were selected. Only trials with confirmed randomisation procedures and laparoscopic diagnosis of endometriosis were included.
Data collection and analysis Risk of bias assessment, and data extraction and analysis were performed independently by three review authors. Data were combined for meta-analysis using relative risk (RR) for dichotomous data. A fixed-effect statistical model was used, where appropriate. Data not suitable for meta-analysis are presented as descriptive data.
Main results Two Chinese RCTs involving 158 women were included in this review. Both these trials described adequate methodology. Neither trial compared CHM with placebo treatment.
There was no evidence of a significant difference in rates of symptomatic relief between CHM and gestrinone administered subsequent to laparoscopic surgery (95.65% versus 93.87%; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.93 to 1.12, one RCT). The intention-to-treat analysis also showed no significant difference between the groups (RR 1.04, 95% CI 0.91 to 1.18). There was no significant difference between the CHM and gestrinone groups with regard to the total pregnancy rate (69.6% versus 59.1%; RR 1.18, 95% CI 0.87 to 1.59, one RCT).
CHM administered orally and then in conjunction with a herbal enema resulted in a greater proportion of women obtaining symptomatic relief than with danazol (RR 5.06, 95% CI 1.28 to 20.05; RR 5.63, 95% CI 1.47 to 21.54, respectively).
Overall, 100% of women in all the groups showed some improvement in their symptoms.
Oral plus enema administration of CHM showed a greater reduction in average dysmenorrhoea pain scores than did danazol (mean difference (MD) -2.90, 95% CI -4.55 to -1.25; P < 0.01).
Combined oral and enema administration of CHM showed a greater improvement, measured as the disappearance or shrinkage of adnexal masses, than with danazol (RR 1.70, 95% CI 1.04 to 2.78). For lumbosacral pain, rectal discomfort, or vaginal nodules tenderness, there was no significant difference either between CHM and danazol.
Authors' conclusions Post-surgical administration of CHM may have comparable benefits to gestrinone but with fewer side effects. Oral CHM may have a better overall treatment effect than danazol; it may be more effective in relieving dysmenorrhea and shrinking adnexal masses when used in conjunction with a CHM enema. However, more rigorous research is required to accurately assess the potential role of CHM in treating endometriosis.
Article currently in submission/preparation -
Flower A, Lewith GT, Little P. Seeking an oracle: using the Delphi process to develop practice guidelines for the treatment of endometriosis with Chinese herbal medicine. Parts 1 & 2.
Abstract:
Damian Smith (MSc) 2007
A Cochrane systematic review of micronutrient supplementation for glycaemic control in type II diabetes.
Supervisor: George Lewith
Funded by: RCGP (£1,965).
Status: Study completed, 1 paper published
Smith DM, Pickering R, Lewith GT. A systematic review of Vanadium oral supplements for glycaemic control in Type 2 Diabetes mellitus. Quarterly Journal of Medicine; 2008; 101: 351-358.
Abstract: View / Close
Objective: To assess the effectiveness of oral vanadium supplementation for glycaemic control in type 2 diabetes by conducting a systematic review of the literature.
Design and Methods: Eligible studies were identified by searching 14 databases using standardized terms. Experts, study authors and manufacturers were also contacted. Hand-searching was not undertaken. Selection criteria for inclusion in the review were controlled human trials of vanadium vs. placebo in adults with type 2 diabetes of minimum 2 months duration, and a minimum of 10 subjects per arm. Data extraction, assessment of study quality and outcome analysis were undertaken by two independent reviewers.
Results: One hundred and fifty one studies were found but none met the inclusion criteria. We proceeded to summarize the state of existing evidence and plan for a future clinical trial by applying revised, less restrictive criteria to our search, for clinical trials of 30–150 mg daily oral vanadium supplementation in diabetic humans. Only five were identified. These demonstrated significant treatment effects, but due to poor study quality, must be interpreted with caution. Treatment with vanadium often results in gastrointestinal side–effects.
Conclusion: There is no rigorous evidence that oral vanadium supplementation improves glycaemic control in type 2 diabetes. The routine use of vanadium for this purpose cannot be recommended. A large-scale randomized controlled trial is needed to address this clinical question.
Philippa Wheeler (PhD)
Is it the psychological characteristics and belief systems of the practitioner that predict outcome in a CAM consultation?
Supervisor: Michael Hyland
Funded by: Southampton Complementary Medical Research Trust (£3,000)
Status: Study completed, paper in submission
Abstract for whole PhD thesis:
Hyland M, Lewith GT, Wheeler P. Measuring the outcome of complementary and alternative medical (CAM) treatment: symptoms versus mood versus sense of coherence. (JACM).
Abstract: View / Close
Objective To determine whether existing psychological scales of holistic health are sensitive to change following CAM treatment.
Design A study investigating change on several outcome measures over a 4 month period during CAM treatment. Patients attending the Centre for Complementary and Integrated Medicine (CCIM, Southampton, UK) for their first appointment were recruited and completed their baseline forms (T1) at the first consultation. Three further sets of questionnaires (T2, T3 and T4) were posted with SAE to them at monthly intervals and returned to CCIM.
Patients and location People visiting the CCIM and treated with an individualised combination of homeopathy, dietary advice and nutritional supplements for treatment of their chronic benign illness.
Outcome The measures were: (a) symptoms (Measure Yourself Medical Outcome Profile: MYMOP), (b) mood (Positive And Negative Affect Scale; PANAS) and (c) Brief Sense Of Coherence (BASOC).
Results Forty-five patients were recruited and 40 completed the study; MYMOP (p = .001), PANAS negative (p = .025) and BASOC (p = .019) all showed similar patterns of significant improvement over time; PANAS positive showed a non significant trend for improvement (p = .074). Change on one scale was correlated with change on other scales.
Conclusion Existing psychology scales of holistic health are sensitive to change following CAM treatment.
Felicity Bishop (PhD) 2005
Why patients (re)turn to complementary medicine (a series of ethnographic and questionnaire based studies).
Funded by: ESRC/Boots (£49,800)
Supervisors: Lucy Yardley/George Lewith
Status: Study completed, 7 papers published and 1 in press/preparation
Abstract for whole PhD thesis: View / Close
Use of complementary and alternative medicine (CAM) is substantial in the UK. This thesis is about why people return to CAM, in other words why people continue to use of adhere to CAM. Previous research suggests that people who use CMA do so because they hold beliefs about health, treatment and illness which are congruent with CAM, have chronic health problems, and are disillusioned with the experience and outcomes from orthodox medicine. Working within the self-regulation theoretical framework and combining quantitative and qualitative methods this PhD aimed to identify why people adhere to CAM.
Two new questionnaire measures were developed. The CAM beliefs inventory (CAMBI) was developed as a generic measure of treatment beliefs relevant to CAM which can be used in a range of CAM settings. The Treatment Process Questionnaire (TPQ) was developed as a generic measure of peoples’ experiences of non-pharmacological treatments and can be used in both CAM and non-CAM settings.
Two questionnaire studies were conducted to examine the relative importance of different beliefs in ongoing CMA use. The cross-sectional study found that beliefs in holistic health were the most important predictors of CAM use across difference CAM treatments. The prospective questionnaire study examined the relationship between beliefs, experiences of treatment, and adherence to CAM. This study showed that positive experiences of treatment are the most important predictors of adherence to CAM, compared to illness and treatment beliefs.
A qualitative study using ethnographic and grounded theory techniques was conducted to examine the processes involved in ongoing CAM use. This study developed a process-oriented model of CAM use which suggested ways in which people experience and evaluate CAM therapies, and highlighted the way in which individuals’ health care decisions are embedded in the socio-cultural context.
Overall this programme of research has provided rigorous and well-validated insights with questionnaire measures and valuable theory-driven processes in a much under-researched and over-debated area.
Abstracts for Individual Papers
Bishop FL, Lewith GT. Who uses CAM? A narrative review of demographic characteristics and health factors associated with CAM use. eCAM. 2008; doi: 10.1093/ecam/nen023 eCAM 2010;7(1) 11-28
Abstract: View / Close
Complementary and Alternative Medicines (CAM) are used by an extensive number of patients in the UK and elsewhere. In order to understand this pattern of behavior, it is helpful to examine the characteristics of people who use CAM. This narrative review collates and evaluates the evidence concerning the demographic characteristics and health status factors associated with CAM use in community-based non-clinical populations. A systematic literature search of computerized databases was conducted, and published research papers which present evidence concerning associations between CAM use and demographic and health characteristics are discussed and evaluated. The evidence suggests that people who use CAM tend to be female, of middle age and have more education. In terms of their health, CAM users tend to have more than one medical condition, but might not be more likely than non-users to have specific conditions such as cancer or to rate their own general health as poor. The multivariate studies that have been conducted suggest that both demographic and health characteristics contribute independently to CAM use. In conclusion, demographic characteristics and factors related to an individual's health status are associated with CAM use. Future research is needed to address methodological limitations in existing studies.
Bishop FL, Yardley L,Lewith GT. (IN PRESS) Why Consumers Maintain Complementary and Alternative Medicine Use: A Qualitative Study. The Journal of Alternative and Complementary Medicine.
Abstract: View / Close
Objectives: Although research evidence exists to suggest why consumers use CAM, there remains a need to distinguish between factors and processes involved in the initial uptake of therapies and those involved in their subsequent maintenance. We therefore conducted a qualitative study to explore and describe consumers’ reasons for maintaining or stopping CAM use.
Methods: This was a qualitative study. We interviewed 46 CAM consumers and 9 CAM practitioners, in two high-street CAM clinics in the UK. The interviews were analysed thematically using techniques from grounded theory.
Results: Consumers described and evaluated their CAM experiences along four dimensions: interpersonal (e.g. interactions with practitioners), physical (e.g. sensations such as touch or pain during treatment), affective (e.g. empowerment) and cognitive (e.g. beliefs about treatment). They evaluated their experiences in relation to their individual needs and expectations; financial considerations could limit maintenance of CAM use. Practitioners emphasised the effectiveness of treatment and themselves as contributing to consumers maintaining treatment, and recognised the role of financial considerations in decisions to stop CAM use.
Conclusions: This study suggests that experiences of conventional medicine are of limited importance after the decision to initiate CAM. Experiences of CAM were foremost in our consumers’ decisions to maintain or stop specific CAM therapies. Maintenance of CAM could occur even if consumers’ experiences were not entirely positive. Our findings provide novel, systematic, insights that will be of particular interest to practitioners who want to support consumers as they decide whether to maintain CAM use.
Bishop FL, Yardley L, & Lewith GT. Treat or treatment: a qualitative study conceptualising patients’ use of complementary and alternative medicine (CAM). American Journal of Public Health. 2008; 98 (9): 1700 – 1705.
Abstract: View / Close
Objectives To conceptualise how patients use complementary and alternative medicine (CAM) and to examine how patients’ perspectives relate to existing, expert-led taxonomies.
Methods A qualitative thematic analysis was carried out on semi-structured interviews conducted with 46 people using CAM in the South of England.
Results CAMs appeared to be used in four different ways; as treats, and as alternative, complementary, and conventional treatments. Treats were portrayed as personal luxuries, not directed at an identified health need. There were systematic differences in the context, anticipated benefits and implications for financial justification when non-medical therapies were viewed and used as alternative, complementary or conventional treatments. There was no simple relationship between patients’ ways of using therapies and CAM modality.
Conclusions Some people use CAMs as personal luxuries, and not as health care technologies. This is incongruent with existing expert-led taxonomies. Physicians and researchers need to be aware that patients’ views of what constitutes CAM can differ radically from their own views. They should choose their terminology carefully in order to initiate meaningful dialogue with their patients and research participants.
Bishop F, Yardley L, Lewith GT. Treatment appraisals and beliefs predict adherence to complementary therapies: a prospective study using a dynamic extended self-regulation model. Br J Health Psychol. 2008; 13 (4): 701-718.
Abstract: View / Close
Objectives Complementary and alternative medicine (CAM) is used by large numbers of the general public and is increasingly becoming integrated into the mainstream. An understanding of why people use CAM in general has been developed in the literature, but relatively little is known specifically about adherence to CAM. We tested hypotheses (derived from a dynamic extended version of Leventhal's common-sense model) that patients' beliefs about treatment, perceptions of illness, and treatment appraisals would predict adherence to CAM.
Design:
A prospective self-report questionnaire study was carried out with a 3-month follow-up period.
Methods A total of 240 patients from five CAM clinics completed self-report questionnaire measures of treatment beliefs, illness perceptions, and treatment appraisals at baseline. Three months later, they completed self-report measures of adherence to therapists' recommendations concerning attendance, remedy use, and life-style changes.
Results Logistic regression analyses showed that positive perceptions of one's therapist and belief that mental factors do not cause illness independently predicted adherence to appointments. Positive beliefs in holistic health and finding it difficult to travel to appointments predicted adherence to remedy use. Using homeopathy was the only independent predictor of adherence to life-style changes.
Conclusions Treatment appraisals, treatment beliefs, and illness perceptions explain modest proportions of the variance in adherence to CAM. This study highlights the value of operationalizing the appraisal element of the common-sense model when investigating adherence to treatment.
Bishop, F.L., Yardley, L., & Lewith, G.T. . A systematic review of beliefs involved in the use of complementary and alternative medicine. Journal of Health Psychology, 2007;12;851-867.
Abstract: View / Close
It has been suggested that people are attracted to and use complementary and alternative medicines (CAM) because they hold beliefs that are congruent with CAM. This article collates, examines and synthesises the evidence surrounding this hypothesis. The majority of studies are cross-sectional and focus on a limited number of beliefs. The small number of multivariate analyses suggest that beliefs related to control and participation, perceptions of illness, holism and natural treatments, and general philosophies of life predict CAM use when controlling for demographic and clinical factors. Further research is required to establish the robustness of these findings in different illness groups, whether pro-CAM beliefs are held prior to CAM use and to examine the role of such beliefs in the initiation and maintenance of CAM use over time.
Bishop, F.L., Yardley, L., & Lewith, G.T. (2006) Why do people use different forms of complementary medicine? Multivariate associations between treatment and illness beliefs and complementary medicine use. Psychology & Health, 21, 683-698.
Abstract: View / Close
This study investigated associations between complementary medicine use and treatment and illness beliefs. Previously validated questionnaire measures of treatment beliefs, illness beliefs, and complementary medicine use were presented and advertised online. Completed questionnaires were received from 247 participants. Logistic regression analysis showed that demographic characteristics, treatment beliefs and illness beliefs accounted for approximately 36% of the variance in complementary medicine use (χ2 (25) = 75.33, p <.01). Separate analyses were conducted to predict use of different types of complementary medicine. The strength of associations between beliefs and complementary medicine use was related to the type of complementary medicine used. The results suggest that people use complementary medicine because they are attracted to it rather than because they are disillusioned with orthodox medicine, and that both treatment and illness beliefs have an important role in explaining why people use complementary medicine.
Bishop, F.L., Yardley, L., & Lewith, G.T. (2005). Developing a measure of treatment beliefs: the complementary and alternative medicine beliefs inventory. Complementary Therapies in Medicine, 13, 144-149.
Abstract: View / Close
Objectives The study aimed to develop a comprehensive generic measure of treatment beliefs, the Complementary and Alternative Medicine Beliefs Inventory (CAMBI), and to identify distinct dimensions of CAM-related beliefs.
Methods The CAMBI and other measures were presented and advertised online.
Results 328 completed questionnaires were received. Factor analysis indicated three dimensions of beliefs could be identified. Subscales of the CAMBI were developed measuring beliefs in natural treatment, participation in treatment and holistic health. The subscales all had satisfactory reliability and were significantly correlated with CAM use (Spearman’s rho = .18, .47 and .22 for natural treatments, holistic health and participation in treatment respectively).
Conclusions The CAMBI measures three distinct dimensions of treatment beliefs, all of which are related to CAM use.
Bishop, F.L., Yardley, L., & Lewith, G.T. (2004). Associations and explanations: Who uses complementary medicine and why? Health Psychology Update, 13(3), 12-19.
Abstract: View / Close
Complementary and alternative medicine (CAM) consists of a wide range of often disparate approaches to health, illness and wellbeing.
This paper outlines why CAM use is of interest to health psychology, the current state of knowledge about why people use CAM, and future directions for health psychology research into CAM use.
Aslak Steinsbekk (PhD) 2005
Homeopathy in the prevention of upper respiratory tract infections in children
Funded by: Norwegian Research Council
Supervisor: Niels Bentzen (Supervised in Southampton by George Lewith)
Status: Study completed Paper published
Abstract for the Thesis: View / Close
The aims with this thesis are to explore why parents bring their children to homeopaths and to investigate the effect of homeopathic treatment for prevention of upper respiratory tract infections (URTI) in children. The reason for doing studies on this is that there has been a nearly threefold increase in the proportion of children among patients visiting Norwegian homeopaths. This raised the question of why it is so. Furthermore, recurrent respiratory complaints are a main reason why child patients consult homeopaths. This raised the question of the effect of homeopathic treatment in this patient group, because there is very little research on this. The thesis builds on four different studies conducted between August 2002 and June 2004.
Parents of nine children that recently had been to a homeopath for the first time were interviewed to explore why parents take their children to homeopaths. All parents had been to a medical doctor before consulting the homeopath. It was the experiences with conventional medical treatment that led the parents to look for alternatives. The reasons were that 1) the parents did not want to give the medication prescribed by the doctor, 2) they wanted treatment while waiting for a problem to be assessed, 3) they did not want to continue to use the prescribed medication, 4) they stopped taking conventional medication due to side effects or 5) they were not offered any treatment by the medical doctor. The parents would consult a medical doctor if they felt insecure about the health conditions of the child and would visit a homeopath when they felt that situation was clarified. There are parents who take their child to homeopaths despite not understanding or having belief in how ultramolecular homeopathic medicines can have effects.
One hundred and sixty-one children who had been diagnosed with an URTI by a medical doctor were recruited to participate in a trial on the effect of treatment by homeopaths for prevention of URTI in children. The children were randomly allocated to two groups. One group received an appointment immediately with one of five homeopaths who treated the patients as they do in their everyday practice. The other group got such treatment after three months. The occurrence of URTI judged by the parents were significantly lower among those treated immediately by homeopaths (median 8 days in three months) compared to the other group who used self-selected conventional health care (median 13 days) (p=0.006).
Homeopathic medicines are frequently used for self-treatment (over the counter-OTC). It is not known if the choice of the patient is the same, as a homeopath would have prescribed. A study was therefore conducted to explore if it can be developed indications for homeopathic medicines that facilitate that parents can chose the same medicine as a homeopath would prescribe for children with URTI. Firstly, data from a survey was used to find three medicines Calcarea carb, Pulsatilla and Sulphur that accounted for 60% of all prescription made by Norwegian homeopaths for children with URTI. Simplified constitutional indications for these medicines were developed and tested by comparing the choices of 70 parents with the prescription of eleven homeopaths. The parents were able to choose the same homeopathic medicine as homeopaths prescribed for 55% of children the children.
Two hundred and fifty-nine children who had been diagnosed with an URTI by a medical doctor were recruited to participate in a trial on the effect of one of three self-selected ultramolecular homeopathic medicines for prevention of URTI in children. The indications developed were used. The children was randomly allocated to receive either ultramolecular homeopathic medicine (C-30) or placebo. There was no difference in the occurrence of URTI judged by the parents among getting ultramolecular homeopathic medicine (median 9 days in three months) compared to those getting placebo (median 9 days) (p=0.531).
Steinsbekk A, Bentzen N, Fonnebo V, Lewith G. The use of simplified constitutional indications for self-prescription of homeopathic medicine. Complementary Therapies in Medicine. 2004; 12: 112-117
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Objectives To develop simplified constitutional indications for homeopathic medicines so that parents of children with recurrent upper respiratory tract infection (URTI) could choose homeopathic medicines for their children more “accurately”, and to subsequently evaluate if these choices match the prescriptions of trained homeopaths.
Design and setting To initially select the most commonly used homeopathic medicines for URTI, data from a survey of 1097 patients visiting 80 different Norwegian homeopaths were used. A simplified constitutional indication was then developed for the three homeopathic medicines most frequently prescribed for recurrent URTI and otitis media. The constitutional indications were developed by a group of five homeopaths and were then sent to 20 homeopaths for further evaluation. To evaluate the parents’ choice of homeopathic medicines compared to the prescription by trained homeopaths, a group of 11 randomly selected homeopaths were asked to participate. They recruited parents of 70 child patients.
Result By using simplified constitutional indications for the three most commonly prescribed remedies, Calcarea carb, Pulsatilla and Sulphur, parents were able to choose the same homeopathic medicine as homeopaths’ prescribed for 55% (95% CI 43–67) of children with URTI. There was excellent agreement between parents’ choice and homeopaths’ prescription for the three medicines (Kappa of 0.77, p < 0.001).
Conclusion Simplified constitutional indications can be used to improve the quality of the choice of homeopathic medicines purchased over the counter (OTC) for self-treatment.
Steinsbekk A, Bentzen N, Fonnebo V, Lewith G. Randomized controlled trials on treatment by homeopaths and self-treatment with homeopathic medicines: design and protocol. J Alt Comp Med. 2004; 10 (6): 1027-1032.
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Background and objective This study investigates (1) whether treatment by homeopaths is more efficacious than self-selected conventional health care and (2) whether self-treatment with self-selected homeopathic medicines is more efficacious than placebo in preventing childhood upper respiratory tract infections (URTIs).
Design A four-arm randomized controlled trial involving two independent investigations, one open and pragmatic (evaluating the effect of treatment by homeopaths including homeopathic medicines) and one doubleblinded (evaluating the effect of self-treatment with homeopathic medicine).
Patients The planned sample size is 420 children below the age of 10, recruited by a postal invitation to all children diagnosed with URTIs when attending a casualty department in Trondheim, Norway.
Interventions The children are randomly assigned to receive either (1) self-selected homeopathic medicine or placebo (270 patients), (2) treatment by one of four different homeopaths who could prescribe any homeopathic medicine (75 patients), or (3) waiting list control using self-selected conventional health care (75 patients).
Main outcome measure Total URTI symptom scores from patients' diary over 12 weeks.
Plan The results of these two studies (available at the end of 2004) have the potential to provide information about the efficacy of treatment by homeopaths independently from the efficacy of homeopathic medicines in children with URTIs.
Steinsbekk A, Bentzen N, Fonnebo V, Lewith G. Self treatment with one of three self selected, ultramolecular homeopathic medicines for the prevention of upper respiratory tract infections in children. A double blind randomized placebo controlled trial. Br J Clin Pharmacol. 2005; 59 (4): 447-455
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Aims Homeopathic medicines are frequently purchased over the counter (OTC). Respiratory complaints are the most frequent reason for such purchases. Children with upper respiratory tract infection (URTI) are frequent users of homeopathy. This study investigates the effect of self treatment with one of three self selected ultramolecular homeopathic medicines for the prevention of childhood URTI.
Methods A double-blind randomized parallel group placebo controlled trial was carried out in 251 children below the age of 10 years, recruited by post from those previously diagnosed with URTI when attending a casualty department. The children were randomly assigned to receive either placebo or ultramolecular homeopathic medicines in C-30 potency (diluted 10−60) administered twice weekly for 12 weeks. Parents chose the medicine based on simplified constitutional indications for the three medicines most frequently prescribed by Norwegian homeopaths for this group of patients. The main outcome measure relates to the prevention of new episodes of URTI measured with median total symptom score over 12 weeks.
Results There was no difference in the predefined primary outcome between the two groups (P = 0.733). Median URTI scores over 12 weeks in the homeopathic medicine group were 26.0 (95% confidence interval (CI) 16.3, 43.7) and for placebo 25.0 (95% CI 14.2, 38.4). There was no statistical difference between the two groups in median number of days with URTI symptoms or in the use of conventional medication/care.
Conclusions In this study there was no effect over placebo for self treatment with one of three self selected, ultramolecular homeopathic medicines in preventing childhood URTI. This can be due to the lack of effect of the highly diluted homeopathic medicines or the process of selection and type of medicines.
Steinsbekk A, Lewith G, Bentzen N, Fønnebø V. The effect of the homeopathic consultation in the prevention of upper respiratory tract infections in children. A randomized controlled trial. Preventive Medicine. 2007; 45: 274–279.
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Objectives The aim of this study was to explore the contextual effect of homeopathic consultation by investigating the effect of homeopathic care compared to self-treatment with self prescribed homeopathic medicine in the prevention of childhood upper respiratory tract infections (URTI).
Methods Randomised parallel group trial with 208 children below the age of 10. The children were randomly assigned to receive either homeopathic care (HC: individual homeopathic consultations with any homeopathic medicine in any potency being prescribed) or one of three self-prescribed homeopathic medicines (SPH) in C-30 administered twice weekly, for 12 weeks.
Results There were no significant differences in clinical effects between SPH and HC for primary outcomes. Mean URTI scores over 12 weeks were 39.0 in the HC group and 43.9 in the SPH group (p = 0.782, difference − 5.0 points (95% C.I.; − 20.5 to + 10.5)). The mean number of days where the parents rated their child as ‘ill with URTI’ was 10.0 in the HC group and 13.7 in the SPH group (p = 0.394). There was a trend in favour of HC for other outcomes.
Conclusions In this innovative and exploratory study, there was no evidence for a clinically relevant effect of homeopathic care vs. a homeopathic medicine given by the child's parents and based on a pre-agreed homeopathic treatment protocol.
Peter White (PhD) 2003
A randomised, controlled, single blind trial to evaluate the efficacy of a "Western Style" acupuncture for chronic mechanical neck pain
Funded by Smith's Charity (£109,000); HSA, Wessex MT (£3,500)
Supervisor: George Lewith/Joy Conway
Status: Study completed, 4 papers published.
(1) White P, Lewith GT, Berman B, Birch S. Reviews of acupuncture for chronic neck pain: pitfalls in conducting systematic reviews. Rheumatology. 2002; 41: 1224-1231.
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This paper examines some of the problems specifically associated with conducting research into acupuncture and how this can lead to further problems with subsequent systematic reviews. Studies for the treatment of chronic neck pain have been used as examples of how presented information can be misleading to an acupuncture naive reader and how researchers must be sensitive to these problems when compiling their inclusion and exclusion criteria. The problems associated with scoring trials are discussed and further work to increase the scope of scoring mechanisms is recommended in order to produce meaningful systematic reviews in the future.
(2) White P. Attitude and outcome – is there a link in complementary medicine? Letter. Am J Public Health. 2003; 93(7): 1038.
(3) White P, Lewith G, Prescott P. The core outcomes for neck pain – validation of a new outcome measure. Spine. 2004; 29 (17): 1923-1930.
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Study Design Patients enrolled onto a randomised controlled trial were asked to complete various questionnaires which were then compared to establish validity for a new neck pain questionnaire.
Objectives To validate a new and brief outcome measure for use with patients with mechanical neck pain
Summary of Background Data Neck pain is a very common problem and one which clinicians will be required to treat with some regularity. In today’s climate of evidence based practice and the need to quantify and justify clinical intervention, a quick and easy method to evaluate progress is required. Such a measure has already been produced for those suffering with back pain but as yet there is no such measure for neck pain and this needs to be addressed.
Methods The back pain measure was adapted to enable its use with neck pain patients. Repeatability was assessed by using a one week, test re-test on 104 patients who were enrolled onto a neck pain trial. Validity was assessed by comparing the new questionnaire against other already well validated measures i.e. the Neck Disability Index and a Visual Analogue Scale for pain, with 133 patients.
Results The test re-test showed excellent repeatability with high Intraclass correlations and p values <0.001 for each question tested. The Core Neck Pain Questionnaire also showed good validity, giving close agreement to the other comparison measures.
Conclusion The short Core Neck Pain Questionnaire has been demonstrated to be repeatable and valid as a brief outcome measure for use with patients with mechanical neck pain.
(4) White P, Lewith G, Prescott P, Conway J. Acupuncture versus placebo for the treatment of chronic mechanical neck pain. A randomised, controlled trial. Annals of Internal Medicine. 2004; 141(12): 911-920.
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Background. Despite large increases in popularity and use, the efficacy of acupuncture for chronic mechanical neck pain remains unproven.
Objective. To determine if ‘western’ acupuncture treatment is superior to placebo intervention for this condition.
Design. A randomised, single blind, placebo controlled, parallel arm trial with follow-up over 1 year post-treatment.
Setting. Subjects were referred from rheumatologists, family physicians or physiotherapy waiting lists between 1999 and 2001 and attended the outpatient departments of 2 major U.K hospitals.
Patients. Patients aged 18 to 80 years, with chronic mechanical neck pain and with pain > 3/10 on Visual Analogue Scale (VAS). 458 subjects were referred onto the trial and 135 were randomised for treatment. 11 subjects withdrew from treatment, thus 124 reached the primary end point.
Interventions. Patients received 8 treatments (20 minutes duration). The acupuncture group receiving largely individualised treatment with an average of 6 needles each session. The placebo group received mock electrical stimulation to acupuncture points using a decommissioned electro acupuncture stimulation unit via TENS electrodes.
Prime outcome. This was comparison of group mean pain at 1-week post treatment using a VAS.
Results. Both groups significantly improved from baseline. A statistically significant difference between groups was observed but examination of the confidence intervals suggests that is real terms, this difference was negligible but no significant difference was found between the groups (p=0.106). Secondary outcomes showed a similar pattern.
Conclusion. Western style acupuncture was shown to be effective at reducing neck pain in the short and long term, but performed no better than the placebo. Improvements in outcomes are therefore probably due to the non-specific effects of treatment rather than the process of needling.
Val Hopwood (PhD) 2003
Evaluating the effectiveness of acupuncture in defined aspects of stroke recovery).
Supervisor: George Lewith/Trevor Bryant/Tony Postle
Funded by NHS South & West Region (£173,000)
Status: Study completed, Paper in press - Journal of Neurology -
Evaluating the efficacy of acupuncture in defined aspects of stroke recovery; a randomised, placebo controlled single blind study.
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Objective To investigate the efficacy of acupuncture on stroke recovery compared to an inert placebo.
Design Placebo-controlled, randomised, clinical trial.
Setting Post-stroke rehabilitation wards in five NHS hospitals in the UK.
Subjects Patients between 4 and 10 days after their first stroke.
Interventions and outcome measures The patients received 12 acupuncture or placebo treatments over four weeks,
Acupuncture with electrical stimulation was compared with mock TENS, and assessments continued for 12 months after entry. Primary outcome was the Barthel Index, (BI). Secondary outcomes were muscle power, Motricity Index (MI), mood, Nottingham Health Profile (NHP) and treatment credibility.
Results 92 patients completed data sets. Data were analysed using both t tests and a structural equation based on longitudinal analysis of both BI and MI, using generalised estimating equations with an exchangeable correlation structure.
While both acupuncture and placebo (mock TENS) appeared to have had an equal effect on stroke recovery, there is no significant difference between the two interventions at 12 (p=0.737, 95% CI -2.00 to 2.81) and 52 weeks (p=0.371, 95% CI -3.48 to1.32).
An apparently accelerated improvement in the MI scores in the acupuncture group at 3 weeks, (p= 0.009, 95% CI 1.55 to 10.77), is interesting.
Conclusions Acupuncture did not demonstrate specific efficacy over placebo and both groups did as well as normally expected with this condition.