Homeopathic clinical case reports: Development of a supplement (HOM-CASE) to the CARE clinical case reporting guideline.

OBJECTIVE: Develop a criteria catalog serving as a guideline for authors to improve the quality of reporting clinical case reports in homeopathy. METHOD: An online Delphi process was initiated with a panel of 19 homeopathic experts from Europe, the USA and India. Homeopathy specific item selection took place in three rounds of adjusting. The selected items can be used as an extension of the CARE clinical case reporting guideline. RESULTS: Eight homeopathy specific 'core' items were selected from a list of 31 suggested items; (1) the clinical history from a homeopathic perspective; (2) the type of homeopathy; detailed description of the medication--(3) nomenclature, (4) manufacture, (5) galenic form+dosage; outcomes--(6) objective evidence if available, (7) occurrence homeopathic aggravation, (8) assessment possible causal attribution of changes to the homeopathic treatment. A further 4 items were recommended for consideration as optional items when case reports are used for specific, in particular educational, purposes. The 8 core items can be used, merged into 6 items, as a homeopathy specific (HOM-CASE) extension to the CARE clinical case reporting guideline items 6, 9 and 10. CONCLUSION: Use of the HOM-CASE guideline extension will contribute to transparent and accurate reporting and can significantly improve the quality and reliability of clinical case reports in homeopathy.

Towards improving the reporting quality of clinical case reports in complementary medicine: assessing and illustrating the need for guideline development.

BACKGROUND: Case reports have had a varying level of recognition as a source of evidence throughout the history of medicine. In recent years, there has been a revival of interest in clinical case reports in both conventional and complementary medicine. There is a need to further improve the reporting quality of clinical case reports of different Complementary and Alternative Medicine (CAM) therapies. OBJECTIVES: To provide an overview of the different objectives for clinical case reports, identify those that are most relevant for CAM, and to develop a conceptual framework for purpose orientated clinical case reporting guidelines for CAM therapies. To practically illustrate the chosen approach by developing a clinical case reporting guideline for homeopathic cases. METHODS: The various objectives of clinical case reports were described by Prof. Milos Jenicek, and the potential relevance of these objectives for CAM were discussed and graded by a mixed panel of experts. A conceptual framework for developing clinical case reporting guidelines for CAM treatments with specific objectives is proposed. The aim is to integrate both 'generic' and 'CAM therapy specific' quality items. This framework has been practically applied to the development of a reporting guideline for clinical case reports in homoeopathy which will be reported in a second article. RESULTS: An overview is given of the clinical case reporting literature. The conceptual framework for the development of purpose orientated CAM clinical case reporting guidelines is presented. This framework is based on alignment with the recently published 'generic' CARE guideline for reporting of clinical case reports, whilst addressing the CAM specific elements at the same time. CONCLUSIONS: The scope and importance of clinical case reporting guideline development in CAM is illustrated. A conceptual framework for developing CAM specific clinical case reporting guidelines was established. It has been implemented using homoeopathy as an illustration, and this will be reported in a separate article. Further improvements in clinical case reporting in CAM will greatly contribute to CAM research and education, as well as to improved patient care.

Acupuncture of chronic headache disorders in primary care: randomised controlled trial and economic analysis.

OBJECTIVES: To determine the effects of a policy of using acupuncture, compared with a policy of avoiding acupuncture, on headache in primary care patients with chronic headache disorders. The effects of acupuncture on medication use, quality of life, resource use and days off sick in this population and the cost-effectiveness of acupuncture were also examined. DESIGN: Randomised, controlled trial. SETTING: General practices in England and Wales. PARTICIPANTS: The study included 401 patients with chronic headache disorder, predominantly migraine. INTERVENTIONS: Patients were randomly allocated to receive up to 12 acupuncture treatments over 3 months or to a control intervention offering usual care. MAIN OUTCOME MEASURES: Outcome measures included headache score; assessment of Short Form 36 (SF-36) health status and use of medication at baseline, 3 months and 12 months; assessment of use of resources every 3 months; and assessment of incremental cost per quality-adjusted life-year (QALY) gained. RESULTS: Headache score at 12 months, the primary end-point, was lower in the acupuncture group than in controls. The adjusted difference between means was 4.6. This result was robust to sensitivity analysis incorporating imputation for missing data. Patients in the acupuncture group experienced the equivalent of 22 fewer days of headache per year. SF-36 data favoured acupuncture, although differences reached significance only for physical role functioning, energy and change in health. Compared with controls, patients randomised to acupuncture used 15% less medication, made 25% fewer visits to GPs and took 15% fewer days off sick. Total costs during the 1-year period of the study were on average higher for the acupuncture group than for controls because of the acupuncture practitioners' costs. The mean health gain from acupuncture during the year of the trial was 0.021 QALYs, leading to a base-case estimate of GBP9180 per QALY gained. This result was robust to sensitivity analysis. Cost per QALY dropped substantially when the analysis incorporated likely QALY differences for the years after the trial. CONCLUSIONS: The study suggests that acupuncture leads to persisting, clinically relevant benefits for primary care patients with chronic headache, particularly migraine. It is relatively cost-effective compared with a number of other interventions provided by the NHS. Further studies could examine the duration of acupuncture effects beyond 1 year and the relative benefit to patients with migraine with compared to tension-type headache. Trials are also warranted examining the effectiveness and cost-effectiveness of acupuncture in patients with headache receiving more aggressive pharmacological management.

The importance of considering research design in a wider context.

This paper reflects on the importance of considering research design in relation to the question at hand, and argues that the "best" method maximises both rigor and appropriateness. It comments on some of the papers published in this supplement, and emphasises that different audiences will have different needs in terms of the level of evidence required. Suggestions are made how some of the problems associated with randomized trials of Complementary Therapies can be overcome.

Providing Complementary and Alternative Medicine in primary care: the primary care workers' perspective.

BACKGROUND: The use of Complementary and Alternative Medicine (CAM) in primary care is growing, but still not widespread. Little is known about how CAM can/should be integrated into mainstream care. OBJECTIVES: To assess primary care health professionals' perceptions of need and of some ways to integrate CAM in primary care. METHOD: Questionnaire survey of primary health care workers in Northwest London. General Practitioners (GPs) were targeted in a postal survey, other members of the primary care team, such as district and practice nurses, were targeted via colleagues. The questionnaire assessed health care professionals' perspective on complementary medicine, referrals, ways to integrate complementary medicine into primary care and interest in research on CAM. RESULTS: Responses were obtained from 149 GPs (40% response rate after one reminder) and 24 nurses and 32 other primary care team members. One hundred and seventy-one (83%) respondents had previously referred (or influenced referral) for CAM treatments, the main reasons cited were: patients request (68%), conventional treatments failed (58%) and evidence (36%) (more than one reason could be given). Acupuncture and homoeopathy were the therapies for which patients were most frequently referred, followed by manual therapies. There was a significant interest in more training/information on CAM (66%). Only 12 respondents (6%) were against any integration of CAM in mainstream primary care. Most respondents felt that CAM therapies should be provided by doctors (66%) or other health professionals trained in CAM (82%). Twenty-six percent of respondents agreed with provision of CAM by non-state-registered practitioners. It was felt that the integration of CAM could lead to cost savings (70%), particularly in conditions involving pain, but also cost increases (55%) particularly in 'poorly defined conditions'. Fifty-six percent of respondents would consider participating in studies investigating CAM. The greatest interest was in acupuncture (41% of those who expressed an interest in research), homoeopathy (30%) and therapeutic massage/aromatherapy (26%). CONCLUSIONS: There is considerable interest in CAM among primary care professionals, and many are already referring or suggesting referral. Such referrals are driven mainly by patient demand and by dissatisfaction with the results of conventional medicine. Most of our respondents were in favour of integrating at least some types of CAM in mainstream primary care. There is an urgent need to further educate/inform primary care health professionals about CAM.

Homeopathy for dementia.

BACKGROUND: Dementia is a common illness in older people and has major implications for individuals with the disease, their carers and society. A meta-analysis of population based studies in Europe found the prevalence of dementia in individuals over 65 to be 6.4%. Homeopathy (also spelt "homoeopathy") is a popular form of "complementary" or "alternative" treatment. Some studies have found evidence for efficacy of homeopathic treatment for some conditions, but any mechanism of action of the ultra molecular dilutions used in homeopathy is not comprehensible in terms of current scientific concepts. OBJECTIVES: To evaluate the effectiveness and safety profile of homeopathically prepared medications used in treating dementia, as established by randomized controlled trials. SEARCH STRATEGY: The trials were identified from a search of the Specialized Register of the Cochrane Dementia and Cognitive Improvement Group on 10 May 2002 using the terms alum*, homeop*, "nat sulph" and "natrum sulphate". This Register contains records from all major medical databases. In addition the reviewers searched CISCOM, AMED and Hom-Inform. Leading homeopathic researchers, practitioners and manufacturers were also contacted. SELECTION CRITERIA: All types of randomized controlled trials with a sample size of more than 20 were considered. DATA COLLECTION AND ANALYSIS: The database searches resulted in one trial being identified. After examining the abstract, a paper copy was obtained and independently assessed for inclusion by RM and JW. MAIN RESULTS: There were no studies that fulfilled the criteria for inclusion and no data to present. REVIEWER'S CONCLUSIONS: In view of the absence of evidence it is not possible to comment on the use of homeopathy in treating dementia. The extent of homeopathic prescribing for people with dementia is not clear and so it is difficult to comment on the importance of conducting trials in this area.

NHS patients' perspective on complementary medicine: a survey.

OBJECTIVES: To examine patients' reasons for seeking complementary and alternative medicine (CAM) in the National Health Service, including the nature and duration of the patient's main health problem, the impact of CAM on this, satisfaction with clinical care, and usage of conventional prescription medication. DESIGN: Survey (n=499). SETTING: Out-patient Department, The Royal London Homeopathic Hospital, a National Health Service facility dedicated to CAM. RESULTS: Five hundred and six questionnaires were returned, 499 were analysed. Patients' most frequent reasons for seeking CAM were that other treatment had not helped, and concerns about or experience of adverse treatment reactions. Two hundred and ninety-seven patients (63%) had had their main problem for more than 5 years. Musculoskeletal system problems were the most frequent diagnostic group (n=151, 32%). Satisfaction with clinical care was high (443/490: 90%). Three hundred and eighty patients (81%) indicated their main problem had improved very much, moderately or slightly. Of the 262 patients who had been taking prescription medicines when they first attended, 76 (29%) had stopped, and 84 (32%) had reduced their intake. CONCLUSIONS: The results suggest that orthodox medicine is not meeting the needs of some patients and that CAM may wholly or partly substitute for conventional medicines. Most patients indicated their problem had improved with CAM. Implications for future research are discussed.

Accruing large numbers of patients in primary care trials by retrospective recruitment methods.

There is a need for large scale, pragmatic trials of complementary and alternative medicine in a primary care setting to answer questions about the 'real world' effectiveness of such methods. Randomisation and treatment in such trials should be prospective, but retrospective recruitment is possible, especially in chronic conditions. This involves contacting patients who have previously consulted their GP (identified through GP database searches) rather than encouraging GPs to refer patients as they present. We describe a prospective randomised trial of acupuncture for chronic headache, currently underway, as an example of retrospective recruitment. A pilot study of recruitment and recruitment modelling was undertaken. The target sample size was 300, 26% (n = 36) of general practices approached took part in the study, 32 completed the required database search. Practices used diagnostic term searches, prescription searches, or a combination of both. On average 1.7% of the total practice populations were identified as headache consulters, letters were sent to 4128 patients. 12% of identified patients were randomised (n = 401). Retrospective recruitment methods are feasible for CAM trials in chronic, stable conditions modelling can provide accurate data for planning such studies. Retrospective recruitment can be more efficient than prospective, further research is required on the generalisibility of results from populations recruited in this way.

Assessing patients' preferences for characteristics associated with homeopathic and conventional treatment of asthma: a conjoint analysis study.

BACKGROUND: A study was undertaken to investigate the preferences of patients with asthma for attributes or characteristics associated with treatment for their asthma and to investigate the extent to which such preferences may differ between patient subgroups. METHODS: The economic technique of conjoint analysis (CA) was used to investigate patients' strength of preference for several key attributes associated with services for the treatment of asthma. A CA questionnaire was administered to two groups of asthma outpatients aged 18 years or older, 150 receiving conventional treatment at Whipps Cross Hospital (WC) and 150 receiving homeopathic treatment at the Royal London Homoeopathic Hospital (RL). RESULTS: An overall response rate of 47% (n=142) was achieved. Statistically significant attributes in influencing preferences for both the WC and RL respondents were (1) the extent to which the doctor gave sufficient time to listen to what the patient has to say, (2) the extent to which the treatment seemed to relieve symptoms, and (3) the travel costs of attending for an asthma consultation. The extent to which the doctor treated the patient as a whole person was also a statistically significant attribute for the RL respondents. CONCLUSIONS: This study has shown that aspects associated with the process of delivery of asthma services are important to patients in addition to treatment outcomes. The homeopathic respondents expressed stronger preferences for the doctor to treat them as a whole person than the patients receiving conventional treatment. Overall, the preferences for the attributes included in the study were similar for both groups.

Can homeopaths detect homeopathic medicines by dowsing? A randomized, double-blind, placebo-controlled trial.

Dowsing is a method of problem-solving that uses a motor automatism, amplified through a pendulum or similar device. In a homeopathic context, it is used as an aid to prescribing and as a tool to identify miasm or toxin load. A randomized double-blind trial was conducted to determine whether six dowsing homeopaths were able to distinguish between Bryonia in a 12c potency and placebo by use of dowsing alone. The homeopathic medicine Bryonia was correctly identified in 48.1% of bottle pairs (n=156; 95% confidence interval 40.2%, 56.0%; P=0.689). These results, wholly negative, add to doubts whether dowsing in this context can yield objective information.

Can homeopaths detect homeopathic medicines? A pilot study for a randomised, double-blind, placebo controlled investigation of the proving hypothesis.

Homeopaths believe that a medicine, which causes a particular symptom in a healthy volunteer, will cure a similar symptom in a sick patient. From this phenomenon, it is possible to deduce a hypothesis: homeopaths should be able to distinguish a homeopathic medicine from a placebo by taking both and observing their effects. If true, this would support an effect of homeopathic medicines different from that of placebo. If false, it casts serious doubt on the contemporary homeopathic knowledge base and on homeopathic pathogenetic trials (HPTs) as currently practised. The study design was a double-blinded, crossover trial. It consisted of a 1-week study medication period, a 2-week washout period and a further 1-week on study medication. Bryonia in a 12c potency was chosen as the trial medication. Participants were recruited in the UK from the Faculty of Homeopathy and the Society of Homeopaths and were currently healthy, aged 18 or over with at least three years' clinical experience of homeopathy. Of the 500 recruitment packs despatched, we received 88 responses (17.6%). Seventy homeopaths were randomised of whom 50 completed the trial. In the main analysis 60% correctly identified the bottle containing Bryonia (n=40; 95% confidence interval 43%, 75%; P=0.27). There was evidence of an order effect: subjects were much more likely to think they received active Bryonia in the first rather than the second period. In this study a promising trend was observed that symptoms reported by some homeopaths may not be completely attributable to placebo. A multi-national, large-scale trial will be required to investigate this phenomena with adequate statistical power.

The Constitutional Type Questionnaire: validation in the patient population of the Royal London Homoeopathic Hospital.

In homeopathy the choice of a medicine is based on the total 'picture' presented by the patient. This picture includes 'constitutional type' which comprises personality, and general physical features. The Constitutional Type Questionnaire (CTQ) is designed to systematically assess constitutional types. This study examines the reliability and validity of the CTQ. Four hundred and seventy-two outpatients attending clinics at the Royal London Homoeopathic Hospital completed the CTQ, a 152-item scale rating features traditionally considered typical of 19 constitutional homeopathic medicine 'pictures' on 5-point frequency or severity scales. A subsample was retested after 1 week to measure the test-retest reliability. Another subsample was prescribed a medicine by a homeopathic doctor. Prescriptions were compared with the CTQ, to assess the content validity of the scale. The construct validity was measured by Grade of Membership (GOM) analysis. The scale demonstrated good test-retest reliability (r=0.73), internal consistency (r=0.95). The correlation between CTQ results and the medicine prescribed by the homeopathic doctor was 75.8%. The GOM analyses are reported by Davidson et al elsewhere in this issue of the journal. Although the CTQ could be improved, the scale displays good reliability and validity.

Do constitutional types really exist? A further study using grade of membership analysis.

'Constitutional types' are a feature of homeopathy. Constitutions are constellations of mental, physical and general features. We present results of a 152-item 'Constitutional Type Questionnaire' (CTQ), relating to 19 major constitutional remedies. Patients referred to the Royal London Homoeopathic Hospital (RLHH) were recruited from outpatient clinics. Each remedy was assigned eight associated features. Each item is rated as it applies to the subject most of the time on a five-point scale. Grade of Membership analysis (GOM) was used for evaluation of remedy profiles. Four hundred and forty-seven individuals provided usable data. Demographic data were collected. A nine pure type solution provided the best fit to the data. Few subjects had exclusive 'membership' of one pure type. There are some difficulties in interpretation; for instance some groups were characterised by the absence of 'constitutional' features. Some pure types are coherent, recognisable types. The results give some support to the homeopathic concept of constitution. CTQ results correlate quite well with the actual prescribing of homeopaths. Further validation with other cohorts is required and with refinement it might become a useful screening method. It cannot simulate complex information processing performed by homeopathic practitioners.

Can homeopaths detect homeopathic medicines? A pilot study for a randomised, double-blind, placebo controlled investigation of the proving hypothesis

Homeopaths believe that a medicine, which causes a particular symptom in a healthy volunteer, will cure a similar symptom in a sick patient. From this phenomenon, it is possible to deduce a sypothesis: homeopaths should be able to distinguish a homeopathic medicine from a placebo by... (AU)

The constitutional type questionnaire: validation in the patient population of the Royal London Homoeopathic Hospital

In homeopathy the choice of a medicine is based on the total 'picture' presented by the patient. This picture includes 'constitutional type' which comprises personality, and general physical features. The Constitutional Type Questionnaire (CTQ) is designed... (AU)

Do constitutional types really exist? A further study using grade of membership analysis

'Constitutional types' are a feature of homeopathy. Constitutions are constellations of mental, physical and general features. We present results of a 152-item 'Constitutional Type Questionnaire' (CTQ), relating to 19 major constitutional remedies. Patients... (AU)

Can homeopathically prepared mercury cause symptoms in healthy volunteers? A randomized, double-blind placebo-controlled trial.

OBJECTIVE: To pilot a method for determining whether homeopathically prepared mercury causes more symptoms (a "drug proving") in healthy volunteers than placebo. METHODS: One hundred and eighteen (118) healthy volunteers ages 18 to 65 were recruited by local advertising. Subjects unfamiliar with homeopathy undertook a 1-week single-blind placebo run-in, a 1-week of double-blind, randomized treatment on either homeopathically prepared mercury 12C or placebo, and a third week of placebo run-out. Each day, symptoms were recorded on a checklist that included both true mercury symptoms and symptoms not expected to be caused by mercury (false symptoms). Additional symptoms were assessed by open reporting. Outcome was assessed by calculating a score for each day as the number of true symptoms minus the number of false symptoms. The mean score during placebo was then subtracted from the mean score for weeks two and three of the trial. RESULTS: Fourteen (14) subjects dropped out during placebo run-in. The remaining 104 completed the trial. Baseline comparability was good. Mean difference score was -0.125 (SD 3.47) for mercury and -0.221 (SD 3.01) for placebo (p > 0.2). No significant differences between groups were found for the number of subjects meeting predefined criteria for a drug-proving reaction. CONCLUSION: This pilot study failed to find evidence that mercury 12C causes significantly more symptoms in healthy volunteers than placebo. Questionnaires with a limited number of gross symptoms do not seem to be an appropriate methodological technique in drug proving research. If drug-proving phenomena exist, they appear to be rare.

The efficacy and safety of a homeopathic gel in the treatment of acute low back pain: a multi-centre, randomised, double-blind comparative clinical trial.

Acute low back pain is a very common condition in Western industrialised countries. In most cases analgesics or topical medications are prescribed at first encounter with the general practitioner (GP). The aim of this study was to investigate whether the homeopathic gel Spiroflor SRL gel (SRL) is equally effective and better tolerated than Cremor Capsici Compositus FNA (CCC) in patients with acute low back pain. A multi-centre, randomised, double-blind, controlled clinical trial was conducted in the practices of 19 GPs in the districts of Bristol and Manchester, UK. One hundred and sixty-one subjects suffering from acute low back pain were treated for one week either with SRL or with CCC. Pain was scored on a 100 mm visual analogue scale (VAS). Main efficacy parameter VAS reduction was compared between treatments. Evaluation of safety was primarily based on the number of subjects with adverse events (AEs), withdrawals due to an AE and adverse drug reactions (ADRs). The mean difference between the VAS reduction in the SRL group and the CCC group adjusted for VAS at baseline and age was -0.6mm (90% CI = -6.5-5.3mm). Fewer subjects in the SRL group (11%) experienced an AE than in the CCC group (26%). The same applies to the number of subjects with an ADR (3/81 = 4% vs 18/74 = 24%) and the number of subjects withdrawn due to an ADR (0/81 = 0% vs 8/74 = 11%). In conclusion, SRL and CCC are equally effective in the treatment of acute low back pain, however, SRL has a better safety profile. Spiroflor SRL gel is preferable to Capsicum-based products for the topical treatment of low back pain, because of the lower risk of adverse effects.

Inter-rater reliability of symptom repertorisation: a pragmatic empirical study.

OBJECTIVE: To determine the extent to which two homeopaths agree on whether symptoms reported by patients in a proving are possibly associated with Mercurius solubilis. DESIGN: Blinded, inter-rater reliability study. PARTICIPANTS: 104 subjects in a randomised, double-blind mercury proving. OUTCOME MEASURES: 557 symptom episodes spontaneously reported by subjects were classified as 'mercury' or 'not mercury' by two homeopaths working blind to each other's conclusions and to patient allocation. RESULTS: Initial agreement between homeopaths was 70.2%, a kappa of 0.39, (95% CI 0.31, 0.47). Some disagreements appear to have resulted from differing interpretations of the study instructions. After suitable correction, agreement was 76.5% and kappa 0.56 (95% CI 0.49, 0.63). CONCLUSIONS: The study homeopaths had only a moderate level degree of agreement greater than that expected by chance. The main factor seems to have been differences between data from different sources. There is an urgent need for more research on the methods of choosing homoeopathic medicines in order to improve the reliability and validity of homoeopathic diagnoses.

The economic evaluation of complementary medicine: a staged approach at the Royal London Homeopathic Hospital.

OBJECTIVE: The practical implementation of a staged, multifaceted research agenda for the economic evaluation of complementary medicine (CM) at the Royal London Homeopathic Hospital (RLHH). METHOD: The relative importance of economic evaluation as an evidence base of CM was assessed via a survey conducted with purchasers (n=481). The marginal costs of providing complementary care for patients with rheumatoid arthritis were calculated. The use, and changes in the use, of conventional medicines for patients' main complaints were established retrospectively (n=499) and prospectively (n=70). Health-related quality of life (patient utility) of newly referred patients was assessed with the EQ-5D (EuroQol) instrument (n = 70) on a 100 mm (0 = worst, 100 = best) scale. RESULTS: Economic evaluation was rated 'important' as an evidence base, after safety and RCT data ('very important'). Consultation time (doctors and dietician) contributed 29% of the total costs of treating rheumatoid arthritis. The retrospective survey showed that many patients on conventional medication were able to stop (29%) or reduce (32%) intake in the course of treatment. The median (quartiles) health state of newly referred patients was 70 mm (50,78) in men and 60 mm (36,73) in women. Some results of an interim analysis of 6 months follow-up data are reported. CONCLUSIONS: Economic evaluation of CM is becoming increasingly important and should take place by using a multifaceted, staged approach. Before embarking on randomised trials, observational data on cost, effectiveness and utility should be collected. The cost-effectiveness of CM appears to be most sensitive to the duration of the consultation.