Participation in dementia research: rates and correlates of capacity to give informed consent.

BACKGROUND: Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research. AIMS: To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research. METHODS: As part of a pragmatic randomised controlled trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity. RESULTS: Most participants (76%) with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity. CONCLUSION: Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements.

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.

An overview of two Cochrane systematic reviews of complementary treatments for chronic asthma: acupuncture and homeopathy.

BACKGROUND: Acupuncture and homeopathy are commonly used complementary treatments for chronic asthma. This review summarizes two recently updated Cochrane systematic reviews that assess the safety and efficacy of homeopathy or acupuncture in individuals with chronic stable asthma. INCLUSION CRITERIA: Only randomized-controlled trials were considered for inclusion. Statistical aggregation of the data was undertaken where possible. SEARCH STRATEGY: Searches for both reviews were done with the assistance of the Cochrane Airways Group, and through electronic alerts. RESULTS: ACUPUNCTURE: 11 studies with 324 participants met the inclusion criteria. Trial reporting was poor, and the trial quality was deemed inadequate to generalize the findings. There was variation in the type of active and sham acupunctures, the outcomes assessed and the time points measured. The points used in the sham arm of some studies are used for the treatment of asthma according to traditional Chinese medicine. Two studies used individualized treatment strategies, and one study used a combination strategy of formula acupuncture with the addition of individualized points. No statistically significant or clinically relevant effects were found for acupuncture compared with sham acupuncture. When data from two small studies were pooled, no difference in lung function was observed (post-treatment FEV1): standardized mean difference 0.12, 95% confidence interval 0.31 to 0.55). CONCLUSION: ACUPUNCTURE: There is not enough evidence to recommend the use of acupuncture in the treatment of asthma. Further research needs to be undertaken, and this should take into account the different types of acupuncture practiced. RESULTS: HOMEOPATHY: Six trials with a total of 556 people were included in the review. These trials were all placebo-controlled and double-blind, but were of variable quality. Standardized treatments in these trials are unlikely to represent common homeopathic practice where treatment tends to be individualized. The results of the studies are conflicting in terms of effects on lung function. There has been only a limited attempt to measure a "package of care" effect (i.e. the effect of the medication as well as the consultation, which is considered a vital part of individualized homeopathic practice). CONCLUSION: HOMEOPATHY: There is not enough evidence to reliably assess the possible role of homeopathy in the treatment of asthma. Further studies could assess whether individuals respond to a "package of care" rather than the homeopathic intervention alone.

Acupuncture for chronic asthma.

BACKGROUND: Acupuncture has traditionally been used to treat asthma in China and is used increasingly for this purpose internationally. OBJECTIVES: The objective of this review was to assess the effects of acupuncture for the treatment of asthma or asthma-like symptoms. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register (searched August 2003), the Cochrane Complementary Medicine Field trials register, the Alternative Medicine Database (August 2003) and reference lists of articles. We also contacted trialists and researchers in the field of complementary and alternative medical research. SELECTION CRITERIA: Randomised and possibly randomised trials using needle acupuncture or other forms of stimulation of acupuncture. Any form of control treatment was considered (no treatment in addition to conventional asthma treatment, sham or placebo interventions, active comparator interventions). Studies were included provided outcome was assessed at one week or more. DATA COLLECTION AND ANALYSIS: At least two reviewers independently assessed trial quality. A reviewer experienced in acupuncture assessed the adequacy of the active and sham acupunctures used in the studies. Study authors were contacted for missing information. MAIN RESULTS: Eleven studies met the inclusion criteria with 324 participants. Trial reporting was poor and trial quality was deemed inadequate to generalise findings. There was variation in the type of active and sham acupunctures, the outcomes measured and time-points presented. The points used in the sham arm of some studies are used for the treatment of asthma according to traditional Chinese medicine. Two studies used individualised treatment strategies and one study used a combination strategy of formula acupuncture with the addition of individualised points. No statistically significant or clinically relevant effects were found for acupuncture compared to sham acupuncture. Data from two small studies were pooled for lung function (post-treatment FEV1): Standardised Mean Difference 0.12, 95% confidence interval -0.31 to 0.55). REVIEWER'S CONCLUSIONS: There is not enough evidence to make recommendations about the value of acupuncture in asthma treatment. Further research needs to consider the complexities and different types of acupuncture.

Homeopathy for chronic asthma.

BACKGROUND: Homeopathy involves the use, in dilution, of substances which cause symptoms in their undiluted form. It is one of the most widespread forms of complementary medicines and is also used to treat asthma. OBJECTIVES: The objective of this review was to assess the effects of homeopathy in people with chronic stable asthma. SEARCH STRATEGY: We searched the Cochrane Airways Group trials register, the Cochrane Complementary Medicine Field trials register, the Glasgow Homeopathic Hospital database, the Münchener Modell database and reference lists of articles. Searches were current as of August 2003. SELECTION CRITERIA: Randomised trials of homeopathy for the treatment of stable chronic asthma, with observation periods of at least one week were included. DATA COLLECTION AND ANALYSIS: Data extraction was undertaken by two reviewers. Trial quality was assessed by the reviewers. MAIN RESULTS: Six trials with a total of 556 people were included. These trials were all placebo-controlled and double-blind, but of variable quality. They used different homeopathic treatments which precluded quantitative pooling of results for the primary outcome. Standardised treatments in these trials are unlikely to represent common homeopathic practice, where treatment tends to be individualised. No trial reported a significant difference on validated symptom scales. There were conflicting results in terms of lung function between the studies. There has been only a limited attempt to measure a 'package of care' effect (i.e., the effect of the medication as well as the consultation, which is considered a vital part of individualised homeopathic practice). REVIEWER'S CONCLUSIONS: There is not enough evidence to reliably assess the possible role of homeopathy in asthma. As well as randomised trials, there is a need for observational data to document the different methods of homeopathic prescribing and how patients respond. This will help to establish to what extent people respond to a 'package of care' rather than the homeopathic intervention alone.

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.

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.

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.

Chronic shoulder pain in the community: a syndrome of disability or distress?

OBJECTIVES: To investigate two questions in a community based population of people with chronic shoulder pain. Firstly, does chronic pain lead to impaired psychological health over time? Secondly, how does restriction of daily activity influence pain perception and psychological health? METHODS: Two postal surveys, two years apart, were carried out to identify a group of subjects with chronic shoulder pain. The first survey was sent to a random sample of adults (n=40026) registered with a primary care practice, and included a pain manikin, demographic information, and the Hospital Anxiety and Depression scale (HAD). The second survey was sent to those subjects who reported unilateral shoulder region pain in the first survey and it included a shoulder-specific disability scale, pain severity score, and the HAD. RESULTS: 2606 (65.1%) people responded to the initial survey. Of these, 304 (11.7%) reported unilateral shoulder region pain at baseline. In the subsequent survey, there were 234 responders (83.3% adjusted response): 142 of these reported shoulder pain and formed our study group of "subjects with chronic shoulder pain". Within this group there was no significant change in psychological distress scores between baseline and follow up. Both the disability score and psychological distress scores correlated significantly with pain severity (disability v pain r=0.536, p<0.001; psychological distress v pain r=0.269, p=0.002). When the correlation between disability and pain severity was corrected for possible confounders, it remained significant (r=0.490, p<0.001). This was not the case for the correlation between psychological distress and pain (p>0.05). Disability was significantly correlated with psychological distress on univariate (r=0.445, p<0.001) and multivariate analysis (r=0.341, p=0.002). CONCLUSION: In those with chronic shoulder pain the relation between pain and psychological health seems to be linked to disability. Psychological distress was not explained by persistent pain itself.

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.

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)

Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care.

BACKGROUND: Osteoarthritis is the single most common cause of disability in older adults, and most patients with the condition will be managed in the community and primary care. AIM: To discuss case definition of knee osteoarthritis for primary care and to summarise the burden of the condition in the community and related use of primary health care in the United Kingdom. DESIGN: Narrative review. METHOD: A literature search identified studies of incidence and prevalence of knee pain, disability, and radiographic osteoarthritis in the general population, and data related to primary care consultations. Findings from UK studies were summarised with reference to European and international studies. RESULTS: During a one year period 25% of people over 55 years have a persistent episode of knee pain, of whom about one in six in the UK and the Netherlands consult their general practitioner about it in the same time period. The prevalence of painful disabling knee osteoarthritis in people over 55 years is 10%, of whom one quarter are severely disabled. CONCLUSION: Knee osteoarthritis sufficiently severe to consider joint replacement represents a minority of all knee pain and disability suffered by older people. Healthcare provision in primary care needs to focus on this broader group to impact on community levels of pain and disability.

Does psychological status predict the presentation in primary care of women with a menstrual disturbance?

Thirty per cent of women aged 35 years and over suffer from heavy menstruation, but only 7% have consulted a doctor in the previous six months, suggesting that a significant number of these women do not consult a general practitioner. There is evidence that women who report heavy menstruation are more likely to have symptoms of psychological disturbance. This study sets out to determine whether the presence of symptoms of anxiety and depression might be linked to subsequent consultation for increased vaginal bleeding in primary care.

The introduction of a routine monitoring system in primary care for patients with a first episode of cardiovascular disease.

A study at a group general practice in the English midlands found that health promotion advice had not been routinely provided to some patients with cardiovascular disease and stroke. The purpose of this project therefore was to introduce a monitoring system to ensure that health promotion issues were covered systematically with patients following a first episode of cardiovascular disease. Patients with a first episode of a relevant condition would be identified by an automated search on the practice database, and contacted by the health visitor. A checklist would ensure that all appropriate issues were covered. The system was easily introduced at the practice and no difficulties were experienced with its administration. A total of 62 patients were seen during the year. A substantial number of secondary prevention issues were addressed through advice and information leaflets. The project was felt to be a useful addition to care by the workers involved. Although some of the issues may have been addressed in routine care, early organized nurse contact ensures systematic coverage and early referrals where necessary, as well as potential psychological benefit to patients.