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1.  Chinese Proprietary Herbal Medicine Listed in ‘China National Essential Drug List’ for Common Cold: A Systematic Literature Review 
PLoS ONE  2014;9(10):e110560.
Objective
Chinese proprietary herbal medicines (CPHMs) have long history in China for the treatment of common cold, and lots of them have been listed in the ‘China national essential drug list’ by the Chinese Ministry of Health. The aim of this review is to provide a well-round clinical evidence assessment on the potential benefits and harms of CPHMs for common cold based on a systematic literature search to justify their clinical use and recommendation.
Methods
We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the ‘China national essential drug list’ for common cold. There was no restriction on study design.
Results
A total of 33 CPHMs were listed in ‘China national essential drug list 2012’ for the treatment of common cold but only 7 had supportive clinical evidences. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) were included; no other study design was identified. All studies were conducted in China and published in Chinese between 1995 and 2012. All included studies had poor study design and methodological quality, and were graded as very low quality.
Conclusions
The use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.
doi:10.1371/journal.pone.0110560
PMCID: PMC4203808  PMID: 25329481
2.  How women manage recurrent urinary tract infections: an analysis of postings on a popular web forum 
BMC Family Practice  2014;15(1):162.
Background
Recurrent urinary tract infections (RUTIs) are commonly presented by women in primary care. In order to explore the poorly described experience of women with RUTIs a qualitative study was conducted that analysed data from a publically accessible internet-based self-help forum.
Methods
Qualitative Description was used to analyse the text with an emphasis on using the naturalistic language of the informants to portray their perceptions and experiences of RUTIs. Individual codes were identified inductively and grouped according to common ideas into related categories, before being incorporated into five main themes.
Results
Women of diverse ages and geographical location contributed to the website. Themes were identified that vividly explored the atypical symptomatology of RUTIs, the serious impact it had on many aspects of women’s lives, different attitudes to treatments options such as antibiotics, the use of unorthodox approaches such as complementary and alternative medicines (CAM) and contrasting experiences of medical practitioners.
Conclusion
A web-based analysis can vividly capture the views of a diverse population. RUTIs can have a disabling effect on women’s health, their intimate and social relationships, self-esteem, and capacity for work. Further research is required to clarify the wider relevance of the qualitative themes identified, to identify key elements of good practice, and to provide a more rigorous assessment of CAM interventions.
doi:10.1186/1471-2296-15-162
PMCID: PMC4262982  PMID: 25260870
3.  What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise 
BMJ Open  2014;4(6):e005083.
Background
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), in its most severe clinical presentation, can result in patients becoming housebound and bedbound so unable to access most available specialist services. This presents particular clinical risks and treatment needs for which the National Institute for Health and Care Excellence (NICE) advises specialist medical care and monitoring. The extent of National Health Service (NHS) specialist provision in England for severe CFS/ME is currently unknown.
Objectives
To establish the current NHS provision for patients with severe CFS/ME in England.
Setting and participants
All 49 English NHS specialist CFS/ME adult services in England, in 2013.
Method
Cross-sectional survey by email questionnaire.
Primary outcome measures
Adherence to NICE guidelines for severe CFS/ME.
Results
All 49 services replied (100%). 33% (16/49) of specialist CFS/ME services provided no service for housebound patients. 55% (27/49) services did treat patients with severe CFS/ME and their interventions followed the NICE guidelines. The remaining services (12%, 6/49) offered occasional or minimal support where funding allowed. There was one NHS unit providing specialist inpatient CFS/ME provision in England.
Conclusions
Study findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group.
doi:10.1136/bmjopen-2014-005083
PMCID: PMC4078780  PMID: 24984956
Neurology; Primary Care
5.  Influence of Control Group on Effect Size in Trials of Acupuncture for Chronic Pain: A Secondary Analysis of an Individual Patient Data Meta-Analysis 
PLoS ONE  2014;9(4):e93739.
Background
In a recent individual patient data meta-analysis, acupuncture was found to be superior to both sham and non-sham controls in patients with chronic pain. In this paper we identify variations in types of sham and non-sham controls used and analyze their impact on the effect size of acupuncture.
Methods
Based on literature searches of acupuncture trials involving patients with headache and migraine, osteoarthritis, and back, neck and shoulder pain, 29 trials met inclusion criteria, 20 involving sham controls (n = 5,230) and 18 non-sham controls (n = 14,597). For sham controls, we analysed non-needle sham, penetrating sham needles and non-penetrating sham needles. For non-sham controls, we analysed non-specified routine care and protocol-guided care. Using meta-regression we explored impact of choice of control on effect of acupuncture.
Findings
Acupuncture was significantly superior to all categories of control group. For trials that used penetrating needles for sham control, acupuncture had smaller effect sizes than for trials with non-penetrating sham or sham control without needles. The difference in effect size was −0.45 (95% C.I. −0.78, −0.12; p = 0.007), or −0.19 (95% C.I. −0.39, 0.01; p = 0.058) after exclusion of outlying studies showing very large effects of acupuncture. In trials with non-sham controls, larger effect sizes associated with acupuncture vs. non-specified routine care than vs. protocol-guided care. Although the difference in effect size was large (0.26), it was not significant with a wide confidence interval (95% C.I. −0.05, 0.57, p = 0.1).
Conclusion
Acupuncture is significantly superior to control irrespective of the subtype of control. While the choice of control should be driven by the study question, our findings can help inform study design in acupuncture, particularly with respect to sample size. Penetrating needles appear to have important physiologic activity. We recommend that this type of sham be avoided.
doi:10.1371/journal.pone.0093739
PMCID: PMC3976298  PMID: 24705624
6.  Depression and anxiety in prostate cancer: a systematic review and meta-analysis of prevalence rates 
BMJ Open  2014;4(3):e003901.
Objectives
To systematically review the literature pertaining to the prevalence of depression and anxiety in patients with prostate cancer as a function of treatment stage.
Design
Systematic review and meta-analysis.
Participants
4494 patients with prostate cancer from primary research investigations.
Primary outcome measure
The prevalence of clinical depression and anxiety in patients with prostate cancer as a function of treatment stage.
Results
We identified 27 full journal articles that met the inclusion criteria for entry into the meta-analysis resulting in a pooled sample size of 4494 patients. The meta-analysis of prevalence rates identified pretreatment, on-treatment and post-treatment depression prevalences of 17.27% (95% CI 15.06% to 19.72%), 14.70% (95% CI 11.92% to 17.99%) and 18.44% (95% CI 15.18% to 22.22%), respectively. Pretreatment, on-treatment and post-treatment anxiety prevalences were 27.04% (95% CI 24.26% to 30.01%), 15.09% (95% CI 12.15% to 18.60%) and 18.49% (95% CI 13.81% to 24.31%), respectively.
Conclusions
Our findings suggest that the prevalence of depression and anxiety in men with prostate cancer, across the treatment spectrum, is relatively high. In light of the growing emphasis placed on cancer survivorship, we consider that further research within this area is warranted to ensure that psychological distress in patients with prostate cancer is not underdiagnosed and undertreated.
doi:10.1136/bmjopen-2013-003901
PMCID: PMC3963074  PMID: 24625637
MENTAL HEALTH; STATISTICS & RESEARCH METHODS
7.  Responses to the Acupuncture Trialists' Collaboration individual patient data meta-analysis 
In September 2012, the Acupuncture Trialists' Collaboration published the results of an individual patient data meta-analysis of close to 18,000 patients in high quality-randomized trials. The results favored acupuncture. Although there was little argument about the findings in the scientific press, a controversy played out in blog posts and the lay press. This controversy was characterized by ad hominem remarks, anonymous criticism, phony expertise, and the use of opinion to contradict data, predominately by self-proclaimed skeptics. There was a near complete absence of substantive scientific critque. The lack of any reasoned debate about the main findings of the Acupuncture Trialists' Collaboration paper underlines that mainstream science has moved on from the intellectual sterility and ad hominem attacks that characterize the skeptics’ movement.
doi:10.1136/acupmed-2013-010312
PMCID: PMC3658608  PMID: 23449559
Pain; Skepticism; Headache; Acupuncture; Statistics and Research Design
8.  High prevalence but limited evidence in complementary and alternative medicine: guidelines for future research 
The use of complementary and alternative Medicine (CAM) has increased over the past two decades in Europe. Nonetheless, research investigating the evidence to support its use remains limited. The CAMbrella project funded by the European Commission aimed to develop a strategic research agenda starting by systematically evaluating the state of CAM in the EU. CAMbrella involved 9 work packages covering issues such as the definition of CAM; its legal status, provision and use in the EU; and a synthesis of international research perspectives. Based on the work package reports, we developed a strategic and methodologically robust research roadmap based on expert workshops, a systematic Delphi-based process and a final consensus conference. The CAMbrella project suggests six core areas for research to examine the potential contribution of CAM to the health care challenges faced by the EU. These areas include evaluating the prevalence of CAM use in Europe; the EU cititzens’ needs and attitudes regarding CAM; the safety of CAM; the comparative effectiveness of CAM; the effects of meaning and context on CAM outcomes; and different models for integrating CAM into existing health care systems. CAM research should use methods generally accepted in the evaluation of health services, including comparative effectiveness studies and mixed-methods designs. A research strategy is urgently needed, ideally led by a European CAM coordinating research office dedicated to fostering systematic communication between EU governments, the public, charitable and industry funders, researchers and other stakeholders. A European Centre for CAM should also be established to monitor and further a coordinated research strategy with sufficient funds to commission and promote high quality, independent research focusing on the public’s health needs and pan-European collaboration. There is a disparity between highly prevalent use of CAM in Europe and solid knowledge about it. A strategic approach on CAM research should be established to investigate the identified gaps of knowledge and to address upcoming health care challenges.
doi:10.1186/1472-6882-14-46
PMCID: PMC3931324  PMID: 24499316
Complementary and alternative medicine; Research strategy; Randomized clinical trials; Safety; Qualitative studies; Comparative effectiveness research
9.  Developing Digital Interventions: A Methodological Guide 
Digital interventions are becoming an increasingly popular method of delivering healthcare as they enable and promote patient self-management. This paper provides a methodological guide to the processes involved in developing effective digital interventions, detailing how to plan and develop such interventions to avoid common pitfalls. It demonstrates the need for mixed qualitative and quantitative methods in order to develop digital interventions which are effective, feasible, and acceptable to users and stakeholders.
doi:10.1155/2014/561320
PMCID: PMC3932254  PMID: 24648848
10.  Can Chinese Herbal Medicine Improve Outcomes of In Vitro Fertilization? A Systematic Review and Meta-Analysis of Randomized Controlled Trials 
PLoS ONE  2013;8(12):e81650.
Background
A large number of infertile couples are choosing Chinese herbal medicine (CHM) as an adjuvant therapy to improve their success when undergoing in vitro fertilization (IVF). There is no systematic review to evaluate the impact of CHM on the IVF outcomes.
Objective
To evaluate the effectiveness of CHM with concurrent IVF versus IVF alone on the outcomes of IVF and its safety.
Methods
The protocol of this study is registered at PROSPERO. Eligible RCTs searched from 8 databases which compared a combination of CHM and IVF with IVF alone were included. Two authors independently selected studies, extracted data and assessed methodological quality. Meta-analysis of RCTs was conducted if there was non-significant heterogeneity (evaluated by I2 test) among trials. All statistical analysis was performed using RevMan 5.1 software.
Results
Twenty trials involving 1721 women were included in the meta-analysis. Three trials were evaluated as having an unclear risk of bias. The remaining trials were evaluated as having a high risk of bias. Combination of CHM and IVF significantly increases clinical pregnancy rates (OR 2.04, 95%CI 1.67 to 2.49, p<0.00001) and ongoing pregnancy rates (OR 1.91, 95%CI 1.17 to 3.10, p = 0.009). Use of CHM after embryo transfer had no better outcome in reducing the rate of ovarian hyper stimulation syndrome (OR 0.39, 95%CI 0.14 to 1.11, p = 0.08).
Conclusions
This meta-analysis showed that combination of IVF and CHM used in the included trials improve IVF success, however due to the high risk of bias observed with the trials, the significant differences found with the meta-analysis are unlikely to be accurate. No conclusion could be drawn with respect to the reproductive toxicity of CHM. Further large randomized placebo controlled trials are warranted to confirm these findings before recommending women to take CHM to improve their IVF success.
doi:10.1371/journal.pone.0081650
PMCID: PMC3858252  PMID: 24339951
12.  Acupuncture for chronic pain: individual patient data meta-analysis 
Archives of internal medicine  2012;172(19):1444-1453.
Background
Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for four chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.
Methods
We conducted a systematic review to identify randomized trials of acupuncture for chronic pain where allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible trials, with a total of 17,922 patients analyzed.
Results
In the primary analysis including all eligible trials, acupuncture was superior to both sham and no acupuncture control for each pain condition (all p<0.001). After exclusion of an outlying set of trials that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores 0.23 (95% C.I. 0.13, 0.33), 0.16 (95% C.I. 0.07, 0.25) and 0.15 (95% C.I. 0.07, 0.24) standard deviations lower than sham controls for back and neck pain, osteoarthritis, and chronic headache respectively; the effect sizes in comparison to no acupuncture controls were 0.55 (95% C.I. 0.51, 0.58), 0.57 (95% C.I. 0.50, 0.64) and 0.42 (95% C.I. 0.37, 0.46). These results were robust to a variety of sensitivity analyses, including those related to publication bias.
Conclusions
Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.
doi:10.1001/archinternmed.2012.3654
PMCID: PMC3658605  PMID: 22965186
13.  Characteristics of Acupuncture Treatment Associated with Outcome: An Individual Patient Meta-Analysis of 17,922 Patients with Chronic Pain in Randomised Controlled Trials  
PLoS ONE  2013;8(10):e77438.
Background
Recent evidence shows that acupuncture is effective for chronic pain. However we do not know whether there are characteristics of acupuncture or acupuncturists that are associated with better or worse outcomes.
Methods
An existing dataset, developed by the Acupuncture Trialists’ Collaboration, included 29 trials of acupuncture for chronic pain with individual data involving 17,922 patients. The available data on characteristics of acupuncture included style of acupuncture, point prescription, location of needles, use of electrical stimulation and moxibustion, number, frequency and duration of sessions, number of needles used and acupuncturist experience. We used random-effects meta-regression to test the effect of each characteristic on the main effect estimate of pain. Where sufficient patient-level data were available, we conducted patient-level analyses.
Results
When comparing acupuncture to sham controls, there was little evidence that the effects of acupuncture on pain were modified by any of the acupuncture characteristics evaluated, including style of acupuncture, the number or placement of needles, the number, frequency or duration of sessions, patient-practitioner interactions and the experience of the acupuncturist. When comparing acupuncture to non-acupuncture controls, there was little evidence that these characteristics modified the effect of acupuncture, except better pain outcomes were observed when more needles were used (p=0.010) and, from patient level analysis involving a sub-set of five trials, when a higher number of acupuncture treatment sessions were provided (p<0.001).
Conclusion
There was little evidence that different characteristics of acupuncture or acupuncturists modified the effect of treatment on pain outcomes. Increased number of needles and more sessions appear to be associated with better outcomes when comparing acupuncture to non-acupuncture controls, suggesting that dose is important. Potential confounders include differences in control group and sample size between trials. Trials to evaluate potentially small differences in outcome associated with different acupuncture characteristics are likely to require large sample sizes.
doi:10.1371/journal.pone.0077438
PMCID: PMC3795671  PMID: 24146995
14.  Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine: an empirical methodological study 
BMJ Open  2013;3(7):e002968.
Background
Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.
Objective
To describe the characteristics of TCM trials, estimate bias risk and outcome-reporting bias in clinical trials.
Data sources and study selection
Fifteen trial registries were searched from their inception to July 2012 to identify randomised trials on TCM including Chinese herbs, acupuncture and/or moxibustion, cupping, tuina, qigong, etc.
Data extraction
We extracted data including TCM specialty and treated disease/conditions from the registries and searched for subsequent publications in PubMed and Chinese databases. We compared information in the registries of completed trials with any publications focusing on study design, sample size, randomisation, bias risk including reporting bias from the register protocol.
Results
1096 registered randomised trials were identified evaluating TCM, of which 505 were completed studies (46.1%). The most frequent conditions were pain (13.3%), musculoskeletal (11.7%), nervous (8.7%), digestive (7.1%), circulatory (6.5%), respiratory (6.3%), mental and behavioural disorders (6.2%) and cancer (6.0%). The trial register data identified parallel, phase II/III randomised trials with sample size estimations and blinding, but limited information about randomisation (sequence generation and allocation concealment). Comparing trial registration data of 115 completed trials (22.8%) with their subsequent 136 publications, inconsistencies were identified in one or more of the following: sample size (11%), outcome assessor blinding (37.5%), primary outcomes (29%) and safety (28%) reporting.
Conclusions
Increasing numbers of clinical trials investigating a variety of TCM interventions have been registered in international trial registries. The study design of registered TCM trials has improved in estimating sample size, use of blinding and placebos. However, selective outcome reporting is widespread and similar to conventional medicine and therefore study conclusions should be interpreted with caution.
doi:10.1136/bmjopen-2013-002968
PMCID: PMC3717464  PMID: 23864210
15.  Identifying patients’ beliefs about treatments for chronic low back pain in primary care: a focus group study 
The British Journal of General Practice  2013;63(612):e490-e498.
Background
Current evidence-based guidelines for low back pain (LBP) recommend multiple diverse approaches to treatment and suggest considering patient preferences when formulating a treatment plan.
Aim
To explore patient preferences and to identify patients’ beliefs about LBP treatments.
Design and setting
Qualitative study using focus groups in primary care in South-West England.
Method
Thirteen focus groups were organised with a purposive sample of 75 adults with LBP. Group discussions of LBP treatments were facilitated, audiorecorded, and the verbatim transcripts thematically analysed.
Results
Eight themes were identified, four related to treatment beliefs and four to seeking treatment. Treatment beliefs comprised participants’ expectations and appraisals of specific treatments, which were underpinned by four distinct dimensions: credibility, effectiveness, concerns and individual fit. Treatment beliefs were expressed in the broader context of treatment seeking: participants’ primary concern was to obtain a clear explanation of their LBP which went beyond a diagnostic label and provided an understanding of the cause(s) of their LBP. They described engaging in self-management activities and claimed they were willing to try anything if it might help them. Participants wanted an empathic and expert practitioner who could deliver a suitable treatment (or refer them on to someone else) and help them to negotiate the challenges of the healthcare system.
Conclusion
These findings highlight the importance of helping patients develop coherent illness representations about their LBP before trying to engage them in treatment-decisions, uptake, or adherence. Addressing patients’ illness and treatment perceptions in clinical practice could improve shared decision making and patient outcomes.
doi:10.3399/bjgp13X669211
PMCID: PMC3693806  PMID: 23834886
back pain; health knowledge, attitudes, practice; illness behaviour; patient preference; primary health care; qualitative research
16.  Patients’ preconceptions of acupuncture: a qualitative study exploring the decisions patients make when seeking acupuncture 
Background
Like any other form of healthcare, acupuncture takes place in a particular context which can enhance or diminish treatment outcomes (i.e. can produce contextual effects). Patients’ expectations of acupuncture might be an important component of contextual effects, but we know relatively little about the origins and nature of patients’ expectations or wider preconceptions about acupuncture. Our aim was to identify the processes the underpin patients’ decisions to try acupuncture and thus begin to tease out the origins and nature of patients’ preconceptions.
Methods
One-off semi-structured interviews were conducted with a purposive, varied sample of 35 adults who had tried acupuncture for various conditions. Interviews explored people’s experiences of acupuncture treatment and techniques from framework and inductive thematic analysis were used to relate the data to the research question.
Results
We identified four distinct processes within participants’ accounts of deciding to try acupuncture: establishing a need for treatment, establishing a need for a new treatment, deciding to try acupuncture, and finding an acupuncturist. Family, friends and health care professionals played a role in these processes, providing support, advice, and increasing people’s general familiarity with acupuncture. When they came to their first acupuncture appointment, participants had hopes, concerns, and occasionally concrete expectations as to the nature of acupuncture treatment and its likely effects.
Conclusions
Existing theories of how context influences health outcomes could be expanded to better reflect the psychological components identified here, such as hope, desire, optimism and open-mindedness. Future research on the context of acupuncture should consider these elements of the pre-treatment context in addition to more established components such as expectations. There appears to be a need for accessible (i.e. well-disseminated), credible, and individualised, patient-centred materials that can allay people’s concerns about the nature of acupuncture treatment and shape realistic hopes and expectations.
doi:10.1186/1472-6882-13-102
PMCID: PMC3658911  PMID: 23664032
Placebo; Context; Acupuncture; Health care utilisation; Complementary medicine; Expectations; Health knowledge attitudes practice; Illness behaviour; Qualitative research; Patient preference; Treatment seeking
17.  Placebo Use in the United Kingdom: Results from a National Survey of Primary Care Practitioners 
PLoS ONE  2013;8(3):e58247.
Objectives
Surveys in various countries suggest 17% to 80% of doctors prescribe ‘placebos’ in routine practice, but prevalence of placebo use in UK primary care is unknown.
Methods
We administered a web-based questionnaire to a representative sample of UK general practitioners. Following surveys conducted in other countries we divided placebos into ‘pure’ and ‘impure’. ‘Impure’ placebos are interventions with clear efficacy for certain conditions but are prescribed for ailments where their efficacy is unknown, such as antibiotics for suspected viral infections. ‘Pure’ placebos are interventions such as sugar pills or saline injections without direct pharmacologically active ingredients for the condition being treated. We initiated the survey in April 2012. Two reminders were sent and electronic data collection closed after 4 weeks.
Results
We surveyed 1715 general practitioners and 783 (46%) completed our questionnaire. Our respondents were similar to those of all registered UK doctors suggesting our results are generalizable. 12% (95% CI 10 to 15) of respondents used pure placebos while 97% (95% CI 96 to 98) used impure placebos at least once in their career. 1% of respondents used pure placebos, and 77% (95% CI 74 to 79) used impure placebos at least once per week. Most (66% for pure, 84% for impure) respondents stated placebos were ethical in some circumstances.
Conclusion and implications
Placebo use is common in primary care but questions remain about their benefits, harms, costs, and whether they can be delivered ethically. Further research is required to investigate ethically acceptable and cost-effective placebo interventions.
doi:10.1371/journal.pone.0058247
PMCID: PMC3604013  PMID: 23526969
18.  Building a Strategic Framework for Comparative Effectiveness Research in Complementary and Integrative Medicine 
The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder Symposium on Comparative Effectiveness Research (CER): (1) CER studies should be made a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field.
doi:10.1155/2012/531096
PMCID: PMC3544532  PMID: 23346206
19.  Relevant to today's society? Evidence 
doi:10.1258/jrsm.2009.09k068
PMCID: PMC2789022  PMID: 19966123
21.  Chinese herbal medicines for hypercholesterolemia 
Background
Hypercholesterolemia is an important key contributory factor for ischemic heart disease and is associated with age, high blood pressure, a family history of hypercholesterolemia, and diabetes. Chinese herbal medicines have been used for a long time as lipid-lowering agents.
Objectives
To assess the effects of Chinese herbal medicines on hypercholesterolemia.
Search strategy
We searched the following databases: The Cochrane Library (issue 8, 2010), MEDLINE (until July 2010), EMBASE (until July 2010), Chinese BioMedical Database (until July 2010), Traditional Chinese Medical Literature Analysis and Retrieval System (until July 2010), China National Knowledge Infrastructure (until July 2010), Chinese VIP Information (until July 2010), Chinese Academic Conference Papers Database and Chinese Dissertation Database (until July 2010), and Allied and Complementary Medicine Database (until July 2010).
Selection criteria
We considered randomized controlled clinical trials in hypercholesterolemic participants comparing Chinese herbal medicines with placebo, no treatment, and pharmacological or non-pharmacological interventions.
Data collection and analysis
Two review authors independently extracted data and assessed the risk of bias. We resolved any disagreements with this assessment through discussion and a decision was achieved based by consensus. We assessed trials for the risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, incomplete outcome data, selective outcome reporting and other sources of bias.
Main results
We included 22 randomized trials (2130 participants). The mean treatment duration was 2.3 ± 1.3 months (ranging from one to six months). Twenty trials were conducted in China and 18 trials were published in Chinese. Overall, the risk of bias of included trials was high or unclear. Five different herbal medicines were evaluated in the included trials, which compared herbs with conventional medicine in six comparisons (20 trials), or placebo (two trials). There were no outcome data in any of the trials on cardiovascular events and death from any cause. One trial each reported well-being (no significant differences) and economic costs. No serious adverse events were observed. Xuezhikang was the most commonly used herbal formula investigated. A significant effect on total cholesterol (two trial, 254 participants) was shown in favor of Xuezhikang when compared with inositol nicotinate (mean difference (MD) −0.90 mmol/L, 95% confidence interval (CI) −1.13 to −0.68) .
Authors’ conclusions
Some herbal medicines may have cholesterol-lowering effects. Our findings have to be interpreted with caution due to high or unclear risk of bias of the included trials.
doi:10.1002/14651858.CD008305.pub2
PMCID: PMC3402023  PMID: 21735427
22.  Informed Consent and Placebo Effects: A Content Analysis of Information Leaflets to Identify What Clinical Trial Participants Are Told about Placebos 
PLoS ONE  2012;7(6):e39661.
Background
Placebo groups are used in randomised clinical trials (RCTs) to control for placebo effects, which can be large. Participants in trials can misunderstand written information particularly regarding technical aspects of trial design such as randomisation; the adequacy of written information about placebos has not been explored. We aimed to identify what participants in major RCTs in the UK are told about placebos and their effects.
Methods and Findings
We conducted a content analysis of 45 Participant Information Leaflets (PILs) using quantitative and qualitative methodologies. PILs were obtained from trials on a major registry of current UK clinical trials (the UKCRN database). Eligible leaflets were received from 44 non-commercial trials but only 1 commercial trial. The main limitation is the low response rate (13.5%), but characteristics of included trials were broadly representative of all non-commercial trials on the database. 84% of PILs were for trials with 50∶50 randomisation ratios yet in almost every comparison the target treatments were prioritized over the placebos. Placebos were referred to significantly less frequently than target treatments (7 vs. 27 mentions, p<001) and were significantly less likely than target treatments to be described as triggering either beneficial effects (1 vs. 45, p<001) or adverse effects (4 vs. 39, p<001). 8 PILs (18%) explicitly stated that the placebo treatment was either undesirable or ineffective.
Conclusions
PILs from recent high quality clinical trials emphasise the benefits and adverse effects of the target treatment, while largely ignoring the possible effects of the placebo. Thus they provide incomplete and at times inaccurate information about placebos. Trial participants should be more fully informed about the health changes that they might experience from a placebo. To do otherwise jeopardises informed consent and is inconsistent with not only the science of placebos but also the fundamental rationale underpinning placebo controlled trials.
doi:10.1371/journal.pone.0039661
PMCID: PMC3384614  PMID: 22761859
23.  Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial 
Rheumatology (Oxford, England)  2010;50(6):1070-1082.
Objectives. To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both.
Methods. Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). Secondary outcomes: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers.
Results. Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference − 4.497; 95% CI −8.071, −0.923; P = 0.015; ES 0.90).
Conclusion. Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA.
Trial registration. Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.
doi:10.1093/rheumatology/keq234
PMCID: PMC3093927  PMID: 21076131
Clinical trial; Homeopathy; Rheumatoid arthritis; Consultation
24.  Randomised controlled trial of Alexander technique lessons, exercise, and massage (ATEAM) for chronic and recurrent back pain: economic evaluation 
Objective An economic evaluation of therapeutic massage, exercise, and lessons in the Alexander technique for treating persistent back pain.
Design Cost consequences study and cost effectiveness analysis at 12 month follow-up of a factorial randomised controlled trial.
Participants 579 patients with chronic or recurrent low back pain recruited from primary care.
Interventions Normal care (control), massage, and six or 24 lessons in the Alexander technique. Half of each group were randomised to a prescription for exercise from a doctor plus behavioural counselling from a nurse.
Main outcome measures Costs to the NHS and to participants. Comparison of costs with Roland-Morris disability score (number of activities impaired by pain), days in pain, and quality adjusted life years (QALYs). Comparison of NHS costs with QALY gain, using incremental cost effectiveness ratios and cost effectiveness acceptability curves.
Results Intervention costs ranged from £30 for exercise prescription to £596 for 24 lessons in Alexander technique plus exercise. Cost of health services ranged from £50 for 24 lessons in Alexander technique to £124 for exercise. Incremental cost effectiveness analysis of single therapies showed that exercise offered best value (£61 per point on disability score, £9 per additional pain-free day, £2847 per QALY gain). For two-stage therapy, six lessons in Alexander technique combined with exercise was the best value (additional £64 per point on disability score, £43 per additional pain-free day, £5332 per QALY gain).
Conclusions An exercise prescription and six lessons in Alexander technique alone were both more than 85% likely to be cost effective at values above £20 000 per QALY, but the Alexander technique performed better than exercise on the full range of outcomes. A combination of six lessons in Alexander technique lessons followed by exercise was the most effective and cost effective option.
doi:10.1136/bmj.a2656
PMCID: PMC3272680  PMID: 19074232
25.  Integrated medicine in the management of chronic illness: a qualitative study 
Background
Complementary and alternative medicine (CAM) is popular with patients, yet how patients use CAM in relation to orthodox medicine (OM) is poorly understood.
Aim
To explore how patients integrate CAM and OM when self-managing chronic illness.
Design of study
Qualitative analysis of interviews.
Method
Semi-structured interviews were conducted with individuals attending private CAM practices in the UK, who had had a chronic benign condition for 12 months and were using CAM alongside OM for more than 3 months. Patients were selected to create a maximum variation sample. The interviews were analysed using framework analysis.
Results
Thirty five patient interviews were conducted and seven categories of use were identified: using CAM to facilitate OM use; using OM to support long-term CAM use; using CAM to reduce OM; using CAM to avoid OM; using CAM to replace OM; maximising relief using both CAM and OM; and returning to OM. Participants described initiating CAM use following a perceived lack of suitable orthodox treatment. Participants rejecting OM for a specific condition never totally rejected OM in favour of CAM.
Conclusion
Patients utilise CAM and OM in identifiably different ways, individualising and integrating both approaches to manage their chronic conditions. To support patients and prevent potential adverse interactions, open dialogue between patients, OM practitioners, and CAM practitioners must be improved.
doi:10.3399/bjgp11X556254
PMCID: PMC3026175  PMID: 21276333
complementary medicine; chronic disease; qualitative

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