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Biomedical subjects

George Lewith

Publications and source records attributed to George Lewith.

At least 19 recordsLinked to original sources
PubMed2006

Circular instead of hierarchical: methodological principles for the evaluation of complex interventions.

BACKGROUND: The reasoning behind evaluating medical interventions is that a hierarchy of methods exists which successively produce improved and therefore more rigorous evidence based medicine upon which to make clinical decisions. At the foundation of this hierarchy are case studies, retrospective and prospective case series, followed by cohort studies with historical and concomitant non-randomized controls. Open-label randomized controlled studies (RCTs), and finally blinded, placebo-controlled RCTs, which offer most internal validity are considered the most reliable evidence. Rigorous RCTs remove bias. Evidence from RCTs forms the basis of meta-analyses and systematic reviews. This hierarchy, founded on a pharmacological model of therapy, is generalized to other interventions which may be complex and non-pharmacological (healing, acupuncture and surgery). DISCUSSION: The hierarchical model is valid for limited questions of efficacy, for instance for regulatory purposes and newly devised products and pharmacological preparations. It is inadequate for the evaluation of complex interventions such as physiotherapy, surgery and complementary and alternative medicine (CAM). This has to do with the essential tension between internal validity (rigor and the removal of bias) and external validity (generalizability). SUMMARY: Instead of an Evidence Hierarchy, we propose a Circular Model. This would imply a multiplicity of methods, using different designs, counterbalancing their individual strengths and weaknesses to arrive at pragmatic but equally rigorous evidence which would provide significant assistance in clinical and health systems innovation. Such evidence would better inform national health care technology assessment agencies and promote evidence based health reform.

Evidence-Based Medicine↗
PubMed2006

Developing CAM Research Capacity for Complementary Medicine.

This article describes initiatives that have been central to the development of complementary and alternative medicine (CAM) research capacity in the United Kingdom, Canada and the United States over the last decade. While education and service delivery are essential parts of the development of CAM, this article will focus solely on the development of research strategy. The development of CAM research has been championed by both patients and politicians, primarily so that we may better understand the popularity and apparent effectiveness of these therapies and support integration of safe and effective CAM in health care. We hope that the perspective provided by this article will inform future research policy.

Journal Article↗
PubMed2006

Acupuncture care for breast cancer patients during chemotherapy: a feasibility study.

Acupuncture care delivered pragmatically as an adjunct to conventional care may lead to improvements in quality of life and alleviation of conventional treatment-related side effects among breast cancer patients. Patient perceptions and expectations of treatment and the therapeutic relationship inherent to acupuncture care could modify treatment effects. The aim of this study was to design a rigorous feasibility study in preparation for trial to evaluate the effects of acupuncture care (a whole system) on the fatigue experienced by patients undergoing conventional treatment of their breast cancer. Phase 1 included the development of a treatment protocol for a short course of acupuncture care for patients with breast cancer undergoing chemotherapy. Defining best practice in this context will ensure that the intervention tested will have meaning and validity for all professional acupuncturists. Phase 2 will be a randomized feasibility pilot study using the acupuncture treatment protocol for 40 patients with breast cancer undergoing chemotherapy. The study will use a mixed-methods approach involving both qualitative and quantitative assessments. Outcome assessment will include validated measures for fatigue, quality of life, and depression. The proposed study will tell us what effects of acupuncture care are important to the patient and address acupuncture as it is practiced in the real world. Results from thisstudy will enable a definitive randomized controlled trial to evaluate the effectiveness of accupuncture care for fatigue in breast cancer patients undergoing chemotherapy.

Acupuncture Therapy↗
PubMed2005

Homeopathic care for the prevention of upper respiratory tract infections in children: a pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls.

OBJECTIVE: To investigate whether individualised treatment by homeopaths is effective in preventing childhood upper respiratory tract infection (URTI). METHODS: Open, pragmatic, randomised parallel-group trial with waiting-list group as control. One hundred and sixty-nine children below the age of 10 years, recruited by post from children previously diagnosed with URTI, were randomly assigned to receive either pragmatic homeopathic care from one of five homeopaths for 12 weeks or to a waiting-list control using self-selected, conventional health care. RESULT: There was a significant difference in median total symptom score in favour of homeopathic care (24 points) compared to the control group (44 points) (p = 0.026). The difference in the median number of days with URTI symptoms was statistically significant with 8 days in the homeopathic group and 13 days in the control group (p = 0.006). There was no statistical difference in the use of conventional medication or care between the two groups. CONCLUSION: In this study, there was a clinically relevant effect of individualised homeopathic care in the prevention of URTI in children.

Child↗
PubMed2005

Assessing homeopathic proving using questionnaire methodology: consideration and implications for future studies.

Homeopathic pathogenetic trials (or provings) provide the foundations for the clinical practice of homeopathy. The most recent review of proving studies indicated that provings are generally of poor methodological quality. Methods to improve the quality and scientific rigour are needed to critically assess the clinical basis of homeopathy. This article describes a methodology using a symptom diary with a selection of predefined remedy specific symptoms (proving questionnaire). The proving questionnaire was developed as an alternative to the traditional qualitative proving methods in an attempt to provide a quantitative method that could rigorously validate the original provings. This article considers the advantages and disadvantages of this approach and provides suggestions for future work in this area.

Atropa belladonna↗
PubMed2005

Expectancy and belief modulate the neuronal substrates of pain treated by acupuncture.

Both specific and non-specific factors may play a role in acupuncture therapy for pain. We explored the cerebral consequences of needling and expectation with real acupuncture, placebo acupuncture and skin-prick, using a single-blind, randomized crossover design with 14 patients suffering from painful osteoarthritis, who were scanned with positron emission tomography (PET). The three interventions, all of which were sub-optimal acupuncture treatment, did not modify the patient's pain. The insula ipsilateral to the site of needling was activated to a greater extent during real acupuncture than during the placebo intervention. Real acupuncture and placebo (with the same expectation of effect as real acupuncture) caused greater activation than skin prick (no expectation of a therapeutic effect) in the right dorsolateral prefrontal cortex, anterior cingulate cortex, and midbrain. These results suggest that real acupuncture has a specific physiological effect and that patients' expectation and belief regarding a potentially beneficial treatment modulate activity in component areas of the reward system.

Acupuncture↗
PubMed2005

Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT.

Complementary and alternative medicine (CAM) often consists of whole systems of care (such as naturopathic medicine or traditional Chinese medicine (TCM)) that combine a wide range of modalities to provide individualised treatment. The complexity of these interventions and their potential synergistic effect requires innovative evaluative approaches. Model validity, which encompasses the need for research to adequately address the unique healing theory and therapeutic context of the intervention, is central to whole systems research (WSR). Classical randomised controlled trials (RCTs) are limited in their ability to address this need. Therefore, we propose a mixed methods approach that includes a range of relevant and holistic outcome measures. As the individual components of most whole systems are inseparable, complementary and synergistic, WSR must not focus only on the "active" ingredients of a system. An emerging WSR framework must be non-hierarchical, cyclical, flexible and adaptive, as knowledge creation is continuous, evolutionary and necessitates a continuous interplay between research methods and "phases" of knowledge. Finally, WSR must hold qualitative and quantitative research methods in equal esteem to realize their unique research contribution. Whole systems are complex and therefore no one method can adequately capture the meaning, process and outcomes of these interventions.

Complementary Therapies↗
PubMed2005

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.

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.

Child↗
PubMed2004

Acupuncture versus placebo for the treatment of chronic mechanical neck pain: a randomized, controlled trial.

BACKGROUND: Despite substantial increases in its popularity and use, the efficacy of acupuncture for chronic mechanical neck pain remains unproved. OBJECTIVE: To compare acupuncture and placebo for neck pain. DESIGN: A randomized, single-blind, placebo-controlled, parallel-arm trial with 1-year follow-up. SETTING: The outpatient departments of 2 major hospitals in the United Kingdom, 1999 to 2001. PATIENTS: 135 patients 18 to 80 years of age who had chronic mechanical neck pain. Eleven patients withdrew from treatment, and 124 completed the primary end point. MEASUREMENTS: The primary outcome was pain 1 week after treatment, according to a visual analogue scale. Secondary outcomes were pain at other time points, score on the Neck Disability Index and the Short Form-36, and use of analgesic medications. INTERVENTIONS: Patients were randomly assigned to receive, over 4 weeks, 8 treatments with acupuncture or with mock transcutaneous electrical stimulation of acupuncture points using a decommissioned electroacupuncture stimulation unit. RESULTS: Both groups improved statistically from baseline, and acupuncture and placebo had similar credibility. For the primary outcome (weeks 1 to 5), a statistically significant difference in visual analogue scale score in favor of acupuncture (6.3 mm [95% CI, 1.4 to 11.3 mm]; P = 0.01) was observed between the 2 study groups, after adjustment for baseline pain and other covariates. However, this difference was not clinically significant because it demonstrated only a 12% (CI, 3% to 21%) difference between acupuncture and placebo. Secondary outcomes showed a similar pattern. LIMITATIONS: All treatments were provided by 1 practitioner. Although the control was credible, it did not mimic the process of needling. A nonintervention group was not present to control for regression to the mean. CONCLUSIONS: Acupuncture reduced neck pain and produced a statistically, but not clinically, significant effect compared with placebo. The beneficial effects of acupuncture for pain may be due to both nonspecific and specific effects.

Acetaminophen↗
PubMed2004

Bromelain as a Treatment for Osteoarthritis: a Review of Clinical Studies.

Bromelain, an extract from the pineapple plant, has been demonstrated to show anti-inflammatory and analgesic properties and may provide a safer alternative or adjunctive treatment for osteoarthritis. All previous trials, which have been uncontrolled or comparative studies, indicate its potential use for the treatment of osteoarthritis. This paper reviews the mechanism of its putative therapeutic actions, those clinical trials that have assessed its use in osteoarthritis to date, as well as considering the safety implications of this supplement for osteoarthritis and reviewing the evidence to date regarding the dosage for treating this condition. The data available at present indicate the need for trials to establish the efficacy and optimum dosage for bromelain and the need for adequate prospective adverse event monitoring in such chronic conditions as osteoarthritis.

Journal Article↗
PubMed2004

The core outcomes for neck pain: validation of a new outcome measure.

STUDY DESIGN: Patients enrolled in a randomized 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 that 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 experiencing 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 patients with neck pain. Repeatability was assessed by using a 1-week test/retest on 104 patients who were enrolled in 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/retest showed excellent repeatability with high intraclass correlations and P < 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.

Adult↗
PubMed2003

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

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

Acupuncture Therapy↗
PubMed2003

Ultramolecular homeopathy has no observable clinical effects. A randomized, double-blind, placebo-controlled proving trial of Belladonna 30C.

AIMS: To investigate if ultramolecular homeopathy has any clinical effects. This was assessed using the proving of the homeopathic remedy Belladonna given at an ultramolecular dose (30C), as a model. A proving states that when a homeopathic remedy is given to a healthy person, they will experience symptomatic effects specific to that remedy. If ultramolecular doses are clinically active, the Belladonna 30C group should experience more true Belladonna proving symptoms than the placebo group. METHODS: Healthy subjects (n = 253), aged 18-30 years, took part in this double-blind, randomized placebo-controlled study. Total study duration was 4 weeks. Subjects were randomized before 1 week placebo run-in. They received 2 weeks of treatment intervention (Belladonna 30C or placebo) and were followed up for 1 week. Subjects recorded any symptoms experienced during the total study period on a daily basis using a structured questionnaire. Symptom diaries were analysed blind to determine if each subject had proved or not (based on predefined criteria). The main outcome was the proportion of subjects who had proved in each treatment group. RESULTS: No significant group differences in proving rates were observed [Belladonna provers N = 14 (13.9%); placebo provers N = 15 (14.3%); mean difference -0.4%, 95% confidence interval -9.3, 10.1] based on intention to treat analysis. Primary outcome was not affected by seasonality or the individual's attitude to complementary medicine. CONCLUSION: Ultramolecular homeopathy had no observable clinical effects.

Adolescent↗
PubMedDate not supplied

The use of simplified constitutional indications for self-prescription of homeopathic medicine.

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.

Child, Preschool↗