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.

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.

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.

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)

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.

A randomized controlled trial comparing topical piroxicam gel with a homeopathic gel in osteoarthritis of the knee.

OBJECTIVE: : To evaluate the efficacy and safety of a homeopathic gel vs an NSAID (piroxicam) gel in the treatment of osteoarthritis of the knee. METHOD: : One hundred and eighty-four out-patients with radiographically confirmed symptomatic osteoarthritis of the knee were entered into a pragmatic, randomized, double-blind controlled trial and treated with 1 g of gel three times daily for 4 weeks. Main outcome measures were pain on walking as a Visual Analogue Score (VAS) and a single-joint Ritchie index. RESULTS: : One hundred and seventy-two of the 184 enrolled patients had endpoints for the main outcome parameters. The pain reduction was 16.5 mm VAS in the homeopathy group (n = 86) and 8.1 mm in the piroxicam group (n = 86); the difference between treatment groups was 8.4 mm (95% confidence interval 0.8-15.9), and after adjustment for pain at baseline it was 6.8 mm (95% confidence interval -0.3 to 13.8). There was no significant difference between treatment groups in the single-joint Ritchie index (P = 0.78). Adverse events occurred in 28 patients (12 homeopathy group, 5 withdrawn; 16 piroxicam group, 9 withdrawn); 18 of the events involved a local reaction (7 homeopathy group, 2 withdrawn; 11 piroxicam group, 5 withdrawn). CONCLUSION: : The homeopathic gel was at least as effective and as well tolerated as the NSAID gel. The presence of a clinically relevant difference between treatment groups cannot be excluded. The homeopathic gel supplemented by simple analgesics if required may provide a useful treatment option for patients with osteoarthritis.

The relationship between homeopathy and the Dr Bach system of flower remedies: a critical appraisal.

The relationship between homeopathy and the Dr Bach system of flower remedies is explored. A historical perspective is given, doctrinal similarities and dissimilarities between both systems are discussed and the relationship between remedies used in homeopathy as well as in Dr Bach's system of flower remedies is explored. It is concluded that although both systems are clearly different, some common ground exists and that both systems may have a complementary role which is perhaps insufficiently recognised.

The costs of treating rheumatoid arthritis patients with complementary medicine: exploring the issue.

OBJECTIVES: To measure the marginal costs of providing complementary medicine services (mostly homoeopathy) in outpatient clinics for patients with rheumatoid arthritis (RA) and to illustrate how parameters to which the cost of complementary medicine may be sensitive can be identified. DESIGN: Retrospective, observational costing study. SETTING: The outpatient clinic of the Royal London Homoeopathic Hospital. SUBJECTS: Random sample of 89 patients from the 427 (RA) patients attending outpatient clinics from April 1995 to March 1996. MAIN OUTCOME MEASURES: The marginal costs incurred by the hospital of treating 89 patients attending outpatient clinics and the relative contribution of the different resources to the total costs. RESULTS: The total costs of treating 89 patients were 7,124 Pounds of which 543 Pounds was assumed to be fixed and the remainder variable. The marginal costs of treating additional patients, starting from zero patients treated, are presented. Consultation time (doctors and dietician) contributed to 29% of the total costs, non-conventional drugs contributed to 22% of the total costs. CONCLUSIONS: Understanding the marginal costs of providing complementary care to RA patients will inform the debate over whether these therapies are likely to be cost-effective. In addition, those who would like to explore the practicalities of establishing a service involving complementary medicine will gain an understanding of the likely provider costs. The cost of complementary medicine appears to be most sensitive to the time spent with the patient by the doctor.

The efficacy of Prrrikweg gel in the treatment of insect bites: a double-blind, placebo-controlled clinical trial.

OBJECTIVE: This study was conducted to examine the efficacy of Prrikweg gel, a homeopathic after-bite gel, in relieving the effects of mosquito bites, in particular itching and erythema. DESIGN: A double-blind, randomized, placebo-controlled clinical trial. SETTING: London School of Hygiene and Tropical Medicine. SUBJECTS: 100 healthy volunteers. METHODS: All subjects were bitten under laboratory conditions by Aedes aegypti mosquitoes at one spot on the ventral aspect of the left forearm and another on a corresponding position on the right forearm. One spot was treated with the homeopathic after-bite gel and the other with a placebo gel. MAIN OUTCOME MEASURES: Itching was assessed on a 5-point discrete rating scale at 0, 0.5, 1, 26.5, and 48 h post-bite to compare the itch-relieving efficacy of the two treatments. Erythema development was assessed by photographing the bite sites, measuring length and width of the erythema with a calliper, and comparing the ratio of the erythema surface at baseline T(0) to the mean erythema surface at 0.5, 1, 26.5, and 48 h post-bite (T mean) for the two treatments. RESULTS: Testing erythema development by comparing the ratio T(0)/T (mean, after-bite gel) and the ratio T(0)/T (mean, placebo gel) gave a two-tailed p = 0.098(95% Cl, -0.031-0.361) in favour of the after-bite gel. There was not a statistically significant difference between the itch relief provided by the two treatments (two-tailed p = 0.424; 95 percent Cl, -0.541-0.191). The correlation between itching and erythema was significant (r = 0.46; p < 0.001). CONCLUSIONS. There are strong indications that the homeopathic after-bite gel reduces erythema development following mosquito bites. The homeopathic mother tinctures of Echinacea angustifolia DC., Ledum palustre L., Urtica urens L. as well as the Hamamelis extract in this gel, whether alone or in combination, are the biologically active ingredients. The homeopathic after-bite gel was not demonstrated to relieve itching; however, based on the correlation between erythema and itching, an effect on itching is not inconceivable.

A placebo controlled clinical trial investigating the efficacy of a homeopathic after-bite gel in reducing mosquito bite induced erythema.

A randomised, placebo controlled clinical trial was conducted to examine the efficacy of a homeopathic after-bite gel in the symptomatic relief of mosquito bites. Sixty eight healthy volunteers were bitten under laboratory conditions by Aedes aegypti mosquitoes at three spots, on the ventral aspect of the forearm. One bite was treated with the homeopathic after-bite gel, another bite with a placebo gel which was identical in appearance and smell to the homeopathic after-bite gel, and the third bite remained untreated. Immediately after the bites and 1, 3, 6, 26 and 31 hours post-bite, the length and width of the erythema were measured with a calliper, and photographs were taken of the bite sites from which the size of the erythema was subsequently determined. This was followed by assessment of the extent of itching with a verbal analogue scale, and finally treatment took place. For each spot the total erythema was calculated as the area under the plotted curve of the erythema at different time points (mm2*h) and the total sum of the itch scores was determined. For the bites treated with the homeopathic after-bite gel the median total erythema was 10.500 mm2*h. For the spots treated with the placebo gel and the untreated spots the median total erythema was 12.900 mm2*h and 13.300 mm2*h, respectively. The difference between the spots treated with the homeopathic after-bite gel and the untreated spots came close to significance (two-tailed P = 0.06), which was not the case for the difference between the spots treated with the homeopathic after-bite gel and the spots treated with placebo gel (P = 0.13). After pooling the data of a very similar previous pilot study and the present study (ntotal = 83), the homeopathic after-bite gel was significantly superior to no treatment (two-tailed P = 0.003) as well as to placebo gel (two-tailed P = 0.03). Comparing itching after the three treatments, no significant differences could be demonstrated. The extent of itching was positively correlated with the area of the erythema (r = 0.63). Treatment of mosquito bites with the homeopathic after-bite gel will reduce the erythema compared to no treatment. Comparison with the placebo gel suggests it is the plant extracts which are the active components of this gel.