Clare Relton

Prevalence of complementary and alternative medicine (CAM) use by the general population: a systematic review and update

Objectives:  To update previous systematic reviews of 12‐month prevalence of complementary and alternative medicine (CAM) use by general populations; to explore trends in CAM use by national populations; to develop and apply a brief tool for assessing methodological quality of published CAM‐use prevalence surveys.

Rethinking pragmatic randomised controlled trials: introducing the “cohort multiple randomised controlled trial” design

Pragmatic trials are important for informing routine clinical practice, but current designs have shortcomings. Clare Relton and colleagues outline the new “cohort multiple randomised controlled trial” design, which could help address the problems associated with existing approaches

Can we deliver randomized trials of focal therapy in prostate cancer

Tissue-preserving focal therapies, such as brachytherapy, cryotherapy, high-intensity focused ultrasound and photodynamic therapy, aim to target individual cancer lesions rather than the whole prostate. These treatments have emerged as potential interventions for localized prostate cancer to reduce treatment-related adverse-effects associated with whole-gland treatments, such as radical prostatectomy and radiotherapy. In this article, the Prostate Cancer RCT Consensus Group propose that a novel cohort-embedded randomized controlled trial (RCT) would provide a means to study men with clinically significant localized disease, which we defined on the basis of PSA level (≤15 ng/ml or ≤20 ng/ml), Gleason grade (Gleason pattern ≤4 + 4 or ≤4 + 3) and stage (≤cT2cN0M0). This RCT should recruit men who stand to benefit from treatment, with the control arm being whole-gland surgery or radiotherapy. Composite outcomes measuring rates of local and systemic salvage therapies at 3–5 years might best constitute the basis of the primary outcome on which to change practice.

Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial

OBJECTIVES To assess the feasibility of a Randomised Controlled Trial (RCT) design of usual care compared with usual care plus adjunctive care by a homeopath for patients with Fibromyalgia syndrome (FMS). METHODS In a pragmatic parallel group RCT design, adults with a diagnosis of FMS (ACR criteria) were randomly allocated to usual care or usual care plus adjunctive care by a homeopath. Adjunctive care consisted of five in depth interviews and individualised homeopathic medicines. The primary outcome measure was the difference in Fibromyalgia Impact Questionnaire (FIQ) total score at 22 weeks. RESULTS 47 patients were recruited. Drop out rate in the usual care group was higher than the homeopath care group (8/24 vs 3/23). Adjusted for baseline, there was a significantly greater mean reduction in the FIQ total score (function) in the homeopath care group than the usual care group (-7.62 vs 3.63). There were significantly greater reductions in the homeopath care group in the McGill pain score, FIQ fatigue and tiredness upon waking scores. We found a small effect on pain score (0.21, 95% CI -1.42 to 1.84); but a large effect on function (0.81, 95% CI -8.17 to 9.79). There were no reported adverse events. CONCLUSIONS Given the acceptability of the treatment and the clinically relevant effect on function, there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS.

Homeopathy for insomnia: A systematic review of research evidence

BACKGROUND Insomnia is a common problem which impacts on quality of life. Current management includes psychological and behavioural therapies and/or pharmacological treatments. OBJECTIVE To systematically review research evidence for effectiveness of homeopathy in the management of insomnia. METHODS Comprehensive searches of biomedical databases (MEDLINE, EMBASE, CINAHL, Cochrane library, Science Citation Index), homeopathy-specific and complementary medicine-specific databases were conducted. RESULTS (A) Homeopathic medicines: four randomised controlled trials (RCTs) compared homeopathic medicines to placebo. All involved small patient numbers and were of low methodological quality. None demonstrated a statistically significant difference in outcomes between groups, although two showed a trend favouring homeopathic medicines and three demonstrated significant improvements from baseline in both groups. A cohort study reported significant improvements from baseline. (B) Treatment by a homeopath: No randomised controlled trials of treatment by a homeopath were identified. One cohort study, three case series and over 2600 case studies were identified. CONCLUSIONS The limited evidence available does not demonstrate a statistically significant effect of homeopathic medicines for insomnia treatment. Existing RCTs were of poor quality and were likely to have been underpowered. Well-conducted studies of homeopathic medicines and treatment by a homeopath are required to examine the clinical and cost effectiveness of homeopathy for insomnia.

Cohort Profile: The Yorkshire Health Study

The Yorkshire Health Study is a longitudinal observational regional health study collecting health information on the residents from the Yorkshire and Humberside region in England. The second wave of data collection is currently under way. The study aims to inform National Health Service (NHS) and local authority health-related decision making in Yorkshire, with wider implications from findings as well. The first wave contains records for 27 806 individuals (2010-12), aged between 16 and 85, from one part of Yorkshire (South Yorkshire), with the second wave expanding data collection to the whole of the Yorkshire and Humberside region. Data were collected on current and long-standing health, health care usage and health-related behaviours, with a particular focus on weight and weight management. The majority of individuals have also given consent for record linkage with routine clinical data, allowing the linking to disease diagnosis, medication use and health care usage. The study encourages researchers to utilize the sample through the embedding of randomized controlled trials, other controlled trials and qualitative studies. To access the anonymized data or use the sample to recruit participants to studies, researchers should contact Clare Relton (c.relton@sheffield.ac.uk).

Prevalence of visits to five types of complementary and alternative medicine practitioners by the general population: A systematic review

OBJECTIVE To systematically review surveys of 12-month prevalence of visits to complementary and alternative medicine (CAM) practitioners for five therapies: acupuncture, homeopathy, osteopathy, chiropractic, and medical herbalism. METHODS Studies were identified via database searches to 2011. Study quality was assessed using a six-item tool. RESULTS Forty-one surveys across 12 countries were included. Twenty-five (61%) met four of six quality criteria. Prevalence of visits by adults were (median, range): acupuncturists 1.4% (0.2-7.5%, N = 27 surveys), homeopaths 1.5% (0.2-2.9%, N = 20 surveys), osteopaths 1.9% (0.2-4.4%, N = 9 surveys), chiropractors 7.5% (0.3-16.7, N = 33 surveys), medical herbalists 0.9% (0.3-4.7%, N = 14 surveys). Estimates were slightly lower for children and higher for older adults. There was little change over the past 15-20 years. CONCLUSIONS This review summarises 12-month prevalence of visits to CAM practitioners in Europe, North America, Australia, East Asia, Saudi Arabia and Israel. A small but significant percentage of these general populations visit CAM practitioners each year.

Healthcare providers’ views on the acceptability of financial incentives for breastfeeding: a qualitative study

BackgroundDespite a gradual increase in breastfeeding rates, overall in the UK there are wide variations, with a trend towards breastfeeding rates at 6–8 weeks remaining below 40% in less affluent areas. While financial incentives have been used with varying success to encourage positive health related behaviour change, there is little research on their use in encouraging breastfeeding. In this paper, we report on healthcare providers’ views around whether using financial incentives in areas with low breastfeeding rates would be acceptable in principle. This research was part of a larger project looking at the development and feasibility testing of a financial incentive scheme for breastfeeding in preparation for a cluster randomised controlled trial.MethodsFifty–three healthcare providers were interviewed about their views on financial incentives for breastfeeding. Participants were purposively sampled to include a wide range of experience and roles associated with supporting mothers with infant feeding. Semi-structured individual and group interviews were conducted. Data were analysed thematically drawing on the principles of Framework Analysis.ResultsThe key theme emerging from healthcare providers’ views on the acceptability of financial incentives for breastfeeding was their possible impact on ‘facilitating or impeding relationships’. Within this theme several additional aspects were discussed: the mother’s relationship with her healthcare provider and services, with her baby and her family, and with the wider community. In addition, a key priority for healthcare providers was that an incentive scheme should not impact negatively on their professional integrity and responsibility towards women.ConclusionHealthcare providers believe that financial incentives could have both positive and negative impacts on a mother’s relationship with her family, baby and healthcare provider. When designing a financial incentive scheme we must take care to minimise the potential negative impacts that have been highlighted, while at the same time recognising the potential positive impacts for women in areas where breastfeeding rates are low.

Brief Report : Staged-informed Consent in the Cohort Multiple Randomized Controlled Trial Design

The “cohort multiple randomized controlled trial,” a new design for pragmatic trials, embeds multiple trials within a cohort. The cohort multiple RCT is an attractive alternative to conventional RCTs in fields where recruitment is slow, multiple new (competing) interventions for the same condition have to be tested, new interventions are highly preferred by patients and doctors, and the risk of disappointment bias, cross-over, and contamination is considerable. To prevent these unwanted effects, the cohort multiple RCT provides information on randomization to the intervention group/arm only, and only after randomization (i.e., prerandomization). To some, especially in a clinical setting, this is not ethically acceptable. In this article, we argue that prerandomization in the cohort multiple randomized controlled trial (cmRCT) can be avoided by adopting a staged-informed consent procedure. In the first stage, at entry into the cohort, all potential participants are asked for their informed consent to participate in a cohort study and broad consent to be either randomly selected to be approached for experimental interventions or to serve as control without further notice during participation in the cohort. In a second stage, at the initiation of an RCT within the cohort, informed consent to receive the intervention is then only sought in those randomly selected for the intervention arm. At the third stage, after completion of each RCT, all cohort participants receive aggregate disclosure of trial results. This staged-informed consent procedure avoids prerandomization in cmRCT and aims to keep participants actively engaged in the research process.

Who are the obese? A cluster analysis exploring subgroups of the obese

BACKGROUND Body mass index (BMI) can be used to group individuals in terms of their height and weight as obese. However, such a distinction fails to account for the variation within this group across other factors such as health, demographic and behavioural characteristics. The study aims to examine the existence of subgroups of obese individuals. METHODS Data were taken from the Yorkshire Health Study (2010-12) including information on demographic, health and behavioural characteristics. Individuals with a BMI of ≥30 were included. A two-step cluster analysis was used to define groups of individuals who shared common characteristics. RESULTS The cluster analysis found six distinct groups of individuals whose BMI was ≥30. These subgroups were heavy drinking males, young healthy females; the affluent and healthy elderly; the physically sick but happy elderly; the unhappy and anxious middle aged and a cluster with the poorest health. CONCLUSIONS It is important to account for the important heterogeneity within individuals who are obese. Interventions introduced by clinicians and policymakers should not target obese individuals as a whole but tailor strategies depending upon the subgroups that individuals belong to.