Complementary Medicine Research Projects
Other CAM Therapies
Completed projects (4)
Professional kinesiology practice; is it an effective treatment for back pain?
Supervisors: George Lewith/Sarah Brien/Paul Little
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.
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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.
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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.
A randomised factorial trial for patients with recurrent and chronic back pain of GP exercise prescription, the Alexander Technique (AT), and Massage
Investigators: Paul Little/George Lewith/Fran Webley
Funded by: MRC (£585,956)
Status: Study completed, 2 papers published, 1 paper in submission -
(1) Little P, Lewith G, Webley F, Evans M, Beattie A, Middleton K, et al. Randomised controlled trial of Alexander Technique lessons, exercise and massage (ATEAM) for chronic and recurrent back pain. BMJ.2008;337;a884.
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Objective To assess the effectiveness of therapeutic massage, exercise prescription, and lessons in the Alexander Technique for back pain.
Design, setting Factorial randomised controlled trial in 64 general practices
Patients 579 patients with chronic or recurrent low back pain
Intervention Four groups: normal care (control); 6 sessions of massage; 6 lessons in the Alexander Technique (6AT); 24 lessons in the Alexander Technique (24AT). Half of each group were randomised to GP exercise prescription and practice nurse behavioural counselling.
Primary outcome measures Roland-Morris score (the number of activities impaired by pain); days in pain
Results At 3 months the Roland score had decreased significantly for all interventions. At 1 year, the effects of Alexander Technique lessons and exercise, but not massage, were maintained (Roland score compared to control: massage - 0.58 (95% confidence intervals -1.94 to 0.77); 6AT -1.40 (-2.77 to -0.03); 24AT -3.4 (-4.76;-2.03); exercise -1.29 (-2.25 to -0.34)). Exercise with 6AT achieved 72% of the effect of 24AT alone (Roland score respectively -2.98, and -4.14). At 1 year, days of back pain reported in the last 4 weeks were much lower after Alexander Technique lessons (control median 21 days; compared with control, 24AT -18, 6AT -10 , massage -7) and quality of life also improved significantly.
Conclusion Lessons in the Alexander Technique from registered teachers have a substantial long term beneficial effect on pain and functioning for chronic back pain patients. Six Alexander Technique lessons followed by exercise prescription are nearly as effective as 24 lessons.
(2)Hollinghurst S, Sharp D, Ballard K, Barnett J, Beattie A, Evans M, Lewith G, Middleton K, Oxford F, Webley F, Little P. Randomised controlled trial of Alexander Technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation. BMJ. 2008; 337; a2656 doi: 10.1136/bmj.a2656.
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Objective An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.
Design Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial.
Participants 579 patients with chronic or recurrent low back pain recruited from primary care.
Interventions Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.
Main outcome measures Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves.
Results Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, £9 per additional pain-free day, £2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5332 per QALY gain).
Conclusions An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.
(3) Angela Mary Beattie, Alison Shaw, Lucy Yardley, Paul Little, Debbie Sharp
Professionals’ perspectives of participating in a randomised controlled trial of Lessons in the Alexander Technique, exercise and massage for chronic or recurrent back pain (ATEAM): a qualitative study.
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Background Little research has examined professionals’ perspectives of the acceptability of interventions delivered in primary care based randomised controlled trials.
Aim To explore the acceptability of lessons in the Alexander Technique, GP exercise prescription and massage therapy as interventions for chronic or recurrent back pain in primary care.
Design of study Qualitative study using semi-structured interviews.
Setting General practices and private practices of Alexander Technique Teachers (ATTs) and Massage Therapists (MTs) in Bristol.
Method Twenty interviews with GPs, nurses, ATTs and MTs. Data were analysed thematically.
Results Professionals from all groups recognised the importance of evidence to support new interventions. However, what counts as evidence of effectiveness differed across the professional groups. GPs wanted a scientific evidence base for the interventions, whilst the nurses, ATTs and MTs valued patient experience of benefit as ‘evidence.’ The structure of the GP exercise prescription was viewed as acceptable to patients, once reassured about its safety. Alexander Technique lessons were more acceptable than massage to GPs and nurses and viewed as more helpful for alleviating back pain. The cost of private Alexander Technique lessons and massage was perceived as a barrier to continuing the intervention outside the trial. There was little communication between professionals in the trial, which mirrored everyday practice.
Conclusions From the perspective of professionals, AT lessons and GP exercise prescription appear to be acceptable interventions for chronic back pain. The qualitative findings enhance the main trial results which suggest that a short series of AT lessons with GP exercise prescription is effective for preventing/reducing chronic back pain in primary care.
Enzyme-potentiated desensitisation in the treatment of seasonal allergic rhinitis; a double blind randomised controlled study
Investigators: Michael Radcliffe/George Lewith
Funded by: GUS Charity (£50,000); South East Region (£39,655); Vega Grieshaber (£3,000); AAIR (£1,000); AIM (£2,000)
Status: 2 papers published and 1 Editorial -
(1) Radcliffe MJ, Lewith GT, Turner RG, Prescott P, Church MK, Holgate ST. Enzyme-potentiated desensitisation in the treatment of seasonal allergic rhinitis; a double blind randomised controlled study. BMJ. 2003; 327: 251-254.
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Objective To assess the efficacy of enzyme potentiated desensitisation in the treatment of severe summer hay fever poorly controlled by pharmacotherapy.
Design Double blind randomised placebo controlled parallel group study.
Setting Hospital in Hampshire.
Participants 183 participants aged between 18 and 64 with a history of severe summer hay fever for at least two years; all were skin prick test positive to timothy grass pollen. 90 randomised to active treatment; 93 randomised to placebo.
Interventions Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, each comprising 200 Fishman units of
glucuronidase, 50 pg 1,3-cyclohexanediol, 50 ng protamine sulphate, and a mixed inhaled allergen extract (pollen mixes for trees, grasses, and weeds; allergenic fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution.
Main outcome measures Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weekly during pollen season.
Results The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred.
Conclusions Enzyme potentiated desensitisation showed no treatment effect in this study.
(2) Radcliffe MJ, Lewith GT, Prescott P, Church MK, Holgate ST. Do skin prick and conjunctival provocation tests predict symptom severity in seasonal allergic rhinoconjunctivitis? Clinical and Experimental Allergy. 2006; 36: 1488-1493.
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Background In the investigation of seasonal allergic rhinoconjunctivitis (SAR), quantitative skin and conjunctival allergen challenge tests are used to measure individual allergen sensitivity. These tests are reproducible and relate well to prevalence but their relationship to symptom severity is less well established.
Objective We wished to determine if quantitative skin prick tests (QSPT) and conjunctival provocation tests (CPTs) using a single grass pollen allergen extract are reproducible and predict symptom severity in SAR.
Methods We retrospectively analysed data from 91 participants in a previously published randomized placebo controlled study of low dosage allergen immunotherapy who were randomized to receive placebo treatment. We examined the relationship between pre-seasonal QSPT, CPT and SAR symptoms.
Results We found a high level of reproducibility when repeated measures were compared for both the QSPT (P o 0.001) and the CPT (P o 0.001) and moderate correlation (0.49) between the standard skin prick test (SPT) and the QSPT (P o 0.001). We found weak negative correlation ( 0.27) between the QSPT and the CPT (P o 0.001). We found no correlation between seasonal symptom, use of rescue medication or quality of life (QOL) scores and pre-seasonal QSPT or CPT.
Conclusion In the assessment of seasonal rhinoconjunctivitis, quantitative skin and conjunctival allergen challenge tests are strongly reproducible, although there is no correlation between these tests and seasonal symptom, use of rescue medication or QOL scores.
Editorial - Lewith GT. Can we evaluate electrodermal testing? Complementary Therapies in Medicine. 2003; 11: 115-117.
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Electrodermal testing (ED testing) is an acupuncture-based approach and was developed to refine homeopathic prescriptions. It is currently being used to advise patients about their “allergies”. The evidence for its use in “allergy testing” is limited and often misrepresented. This article addresses the research and clinical issues involved in investigating the reliability and validity of various ED testing machines.
A pilot project to investigate altered gene expression in chronic fatigue syndrome.
Investigators: Rob Powell and Wendy Barclay, University of Reading/George Lewith
Funded by: Persistent Virus Disease Research (£10,000)
Status: Pilot study completed and published -
Powell R, Ren J, Lewith G, Barclay W, Holgate S, Almond J. Identification of novel expressed sequences, up-regulated in the leukocytes of Chronic Fatigue Syndrome patients. Clinical and Experimental Allergy. 2003; 33 (10): 1450-6.
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Background Chronic fatigue syndrome (CFS) is an increasing medical phenomenon of unknown aetiology leading to high levels of chronic morbidity. Of the many hypotheses that purport to explain this disease, immune system activation, as a central feature, has remained prominent but unsubstantiated. Supporting this, a number of important cytokines have previously been shown to be over-expressed in disease subjects. The diagnosis of CFS is highly problematic since no biological markers specific to this disease have been identified. The discovery of genes relating to this condition is an important goal in seeking to correctly categorize and understand this complex syndrome.
Objective The aim of this study was to screen for changes in gene expression in the lymphocytes of CFS patients.
Methods 'Differential Display' is a method for comparing mRNA populations for the induction or suppression of genes. In this technique, mRNA populations from control and test subjects can be 'displayed' by gel electrophoresis and screened for differing banding patterns. These differences are indicative of altered gene expression between samples, and the genes that correspond to these bands can be cloned and identified. Differential display has been used to compare expression levels between four control subjects and seven CFS patients.
Results Twelve short expressed sequence tags have been identified that were over-expressed in lymphocytes from CFS patients. Two of these correspond to cathepsin C and MAIL1 – genes known to be upregulated in activated lymphocytes. The expression level of seven of the differentially displayed sequences have been verified by quantifying relative level of these transcripts using TAQman quantitative PCR.
Conclusion Taken as a whole, the identification of novel gene tags up-regulated in CFS patients adds weight to the idea that CFS is a disease characterized by subtle changes in the immune system.
The role of positivity to illness in chronic fatigue syndrome patients.
Investigators: Michael Hyland/George Lewith
Status: Study completed and paper published -
Hyland ME, Sodergren SC, Lewith GT. Chronic Fatigue Syndrome. The role of positivity to illness in chronic fatigue syndrome patients. Journal of Health Psychology. 2006; 11 (5): 731-741
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Fifty-three chronic fatigue syndrome patients treated at a complementary medical centre were assessed over 12 months. Measures included the Chalder Fatigue scale, the General Health Questionnaire (GHQ) and positivity in illness (Silver Lining Questionnaire, SLQ). The SLQ measured at 6 and 9 months predicted (p<.01) mental (but not physical) fatigue at 12 months independently of current mental fatigue, initial mental fatigue, duration since diagnosis and time between start of treatment and entry to the study. The GHQ did not predict fatigue at any time point. The results suggest that a caring therapeutic intervention increases positive interpretations of illness prior to improvements in mental fatigue, but that positivity does not play a causal role in the reduction of fatigue.