Informing Adults With Back Pain About Placebo Effects: Randomized Controlled Evaluation of a New Website With Potential to Improve Informed Consent in Clinical Research.

BACKGROUND: Placebo effects and their underpinning mechanisms are increasingly well understood. However, this is poorly communicated to participants in placebo-controlled trials. For valid informed consent, participants should be informed about the potential benefits and risks of participating in placebo-controlled trials. Existing information leaflets often fail to describe the potential benefits and adverse effects associated with placebo allocation. This study tested the effects of a new website designed to inform patients about placebo effects (The Power of Placebos, PoP). PoP was designed using qualitative methods in combination with theory- and evidence-based approaches to ensure it was engaging, informative, and addressed patients' concerns. OBJECTIVE: This study aimed to test the effects of PoP, compared with a control website, on people's knowledge about placebo and the ability to make an informed choice about taking part in a placebo-controlled trial. METHODS: A total of 350 adults with back pain recruited from 26 general practices in Southern England participated in this Web-based study. Participants were randomly assigned to PoP (which presented scientifically accurate information about placebo effects in an engaging way) or a control website (based on existing information leaflets from UK trials). Participants self-completed Web-based pre- and postintervention questionnaire measures of knowledge about placebo effects and preintervention questionnaire measures of attitudes toward and intentions to participate in a placebo-controlled trial. The 2 primary outcomes were (1) knowledge and (2) informed choice to take part in a placebo-controlled trial (computed from knowledge, attitudes, and intentions). RESULTS: After viewing PoP, participants had significantly greater knowledge about placebos (mean 8.28 [SD 1.76]; n=158) than participants who viewed the control (mean 5.60 [SD 2.24]; n=174; F1,329=173.821; P<.001; η2=.346). Participants who viewed PoP were 3.16 times more likely than those who viewed the control to make an informed choice about placebos (χ21=36.5; P<.001). CONCLUSIONS: In a sample of adults with back pain, PoP increased knowledge and rates of informed choice about placebos compared with a control website. PoP could be used to improve knowledge about placebo effects in back pain. After essential further development and testing in clinical trial settings, it could support informed consent in placebo-controlled trials.

The impact of patient-reported outcome measures in clinical practice for pain: a systematic review.

PURPOSE: Patient-reported outcome measures (PROMs) have increasingly been incorporated into clinical practice. Research suggests that PROMs could be viewed as active components of complex interventions and may affect the process and outcome of care. This systematic review examines PROMs in the context of treatment for non-malignant pain. METHODS: An electronic search on: MEDLINE, EMBASE, PsycINFO, PsycARTICLES, Cochrane Library and Web of Science identified relevant papers (February 2015). The inclusion criteria were: focused on implementing PROMs into clinical practice, adults, and primary data studies. Critical interpretive synthesis was used to synthesise qualitative and quantitative findings into a theoretical argument. RESULTS: Thirteen eligible studies were identified. Synthesis suggested that PROMs may be included in the initial consultation to assess patients and for shared decision-making regarding patient care. During the course of treatment, PROMs can be used to track progress, evaluate treatment, and change the course of care; using PROMs may also influence the therapeutic relationship. Post-treatment, using PROMs might directly influence other outcomes such as pain and patient satisfaction. However, although studies have investigated these areas, evidence is weak and inconclusive. CONCLUSION: Due to the poor quality, lack of generalisability and heterogeneity of these studies, it is not possible to provide a comprehensive understanding of how PROMs may impact clinical treatment of non-malignant pain. The literature suggests that PROMs enable pain assessment, decision-making, the therapeutic relationship, evaluation of treatment and may influence outcomes. Further research is needed to provide better evidence as to whether PROMs do indeed have any effects on these domains.

What trial participants need to be told about placebo effects to give informed consent: a survey to establish existing knowledge among patients with back pain.

INTRODUCTION: Patients require an accurate knowledge about placebos and their possible effects to ensure consent for placebo-controlled clinical trials is adequately informed. However, few previous studies have explored patients' baseline (ie, pretrial recruitment) levels of understanding and knowledge about placebos. The present online survey aimed to assess knowledge about placebos among patients with a history of back pain. DESIGN: A 15-item questionnaire was constructed to measure knowledge about placebos. Additional questions assessed sociodemographic characteristics, duration and severity of back pain, and previous experience of receiving placebos. SETTING: Participants recruited from community settings completed the study online. RESULTS: 210 participants completed the questionnaire. 86.7% had back pain in the past 6 months, 44.3% currently had back pain. 4.3% had received a placebo intervention as part of a clinical trial and 68.1% had previously read or heard information about placebos. Overall knowledge of placebos was high, with participants on average answering 12.07 of 15 questions about placebos correctly (SD=2.35). However, few participants correctly answered questions about the nocebo effect (31.9% correct) and the impact of the colour of a placebo pill (55.2% correct). CONCLUSIONS: The findings identified key gaps in knowledge about placebos. The lack of understanding of the nocebo effect in particular has implications for the informed consent of trial participants. Research ethics committees and investigators should prioritise amending informed consent procedures to incorporate the fact that participants in the placebo arm might experience adverse side effects.

Predicting adherence to acupuncture appointments for low back pain: a prospective observational study.

BACKGROUND: Acupuncture is a popular form of complementary and alternative medicine (CAM), but it is not clear why patients do (or do not) follow acupuncturists' treatment recommendations. This study aimed to investigate theoretically-derived predictors of adherence to acupuncture. METHODS: In a prospective study, adults receiving acupuncture for low back pain completed validated questionnaires at baseline, 2 weeks, 3 months, and 6 months. Patients and acupuncturists reported attendance. Logistic regression tested whether illness perceptions, treatment beliefs, and treatment appraisals measured at 2 weeks predicted attendance at all recommended acupuncture appointments. RESULTS: Three hundred twenty-four people participated (aged 18-89 years, M = 55.9, SD = 14.4; 70% female). 165 (51%) attended all recommended acupuncture appointments. Adherence was predicted by appraising acupuncture as credible, appraising the acupuncturist positively, appraising practicalities of treatment positively, and holding pro-acupuncture treatment beliefs. A multivariable logistic regression model including demographic, clinical, and psychological predictors, fit the data well (χ 2 (21) = 52.723, p < .001), explained 20% of the variance, and correctly classified 65.4% of participants as adherent/non-adherent. CONCLUSIONS: The results partially support the dynamic extended common-sense model for CAM use. As hypothesised, attending all recommended acupuncture appointments was predicted by illness perceptions, treatment beliefs, and treatment appraisals. However, experiencing early changes in symptoms did not predict attendance. Acupuncturists could make small changes to consultations and service organisation to encourage attendance at recommended appointments and thus potentially improve patient outcomes.

Clinical effects of a standardized Chinese herbal remedy, Qili Qiangxin, as an adjuvant treatment in heart failure: systematic review and meta-analysis.

BACKGROUND: Qili Qiangxin capsule is a standardized Chinese herbal treatment that is commonly used in China for heart failure (HF) alongside conventional medical care. In 2014, Chinese guidelines for the treatment of chronic HF highlighted Qili Qiangxin capsules as a potentially effective medicine. However, there is at present no high quality review to evaluate the effects and safety of Qili Qiangxin for patients with HF. METHODS: We conducted a systematic review and meta-analysis and followed methods described in our registered protocol [PROSPERO registration: CRD42013006106]. We searched 6 electronic databases to identify randomized clinical trials (RCTs) irrespective of blinding or placebo control of Qili Qiangxin used as an adjuvant treatment for HF. RESULTS: We included a total of 129 RCTs published between 2005 and 2015, involving 11,547 patients, aged 18 to 98 years. Meta-analysis showed no significant difference between Qili Qiangxin plus conventional treatment and conventional treatment alone for mortality (RR 0.53, 95 % CI 0.27 to 1.07). However, compared with conventional treatment alone, Qili Qiangxin plus conventional treatment demonstrated a significant reduction in major cardiovascular events (RR 0.46, 95 % CI 0.34 to 0.64) and a significant reduction in re-hospitalization rate due to HF (RR 0.49, 95 % CI 0.38 to 0.64). Qili Qiangxin also showed significant improvement in cardiac function measured by the New York Heart Association scale (RR 1.38, 95 % CI 1.29 to 1.48) and quality of life as measured by Minnesota Living with Heart Failure Questionnaire (MD -8.48 scores, 95 % CI -9.56 to -7.39). There were no reports of serious adverse events relating to Qili Qiangxin administration. The majority of included trials were of poor methodological quality. CONCLUSIONS: When compared with conventional treatment alone, Qili Qiangxin combined with conventional treatment demonstrated a significant effect in reducing cardiovascular events and re-hospitalization rate, though not in mortality. It appeared to significantly improve quality of life in patients with HF and data from RCTs suggested that Qili Qiangxin is likely safe. This data was drawn from low quality trials and the results of this review must therefore be interpreted with caution. Further research is warranted, ideally involving large, prospective, rigorous trials, in order to confirm these findings.

Exploring association between gastrointestinal heat retention syndrome and recurrent respiratory tract infections in children: a prospective cohort study.

BACKGROUND: Recurrent respiratory tract infections (RRTIs) have a negative impact on both children's health and family wellbeing. Deficiency of ZhengQi used to be an instinct factor driving RRTI in Traditional Chinese Medicine (TCM). Our clinical observations suggest that children with gastrointestinal heat retention syndrome (GHRS) may have a greater risk of catching respiratory tract infections (RTIs). GHRS is a new predisposing factor for RRTI and it is dietary related. This study is aimed to explore association between GHRS and RRTI. METHODS: A prospective cohort study has been conducted in Beijing, China; children aged 1-18 were enrolled. TCM symptoms, demographic and physiological characteristics were recorded by using semi-structured questionnaire. GHRS was considered as a predisposing factor. Children were followed up for next 12 months. We contacted with their parents using a face-to-face questionnaire survey, via email or phone every 3 months. Episodes of RTIs were recorded in detail. RESULTS: Three hundred thirty four children were enrolled and 307 (91.92%) followed up for 12 months. The incidence of RTI was 4.32 episodes per child-year (95 % CI 4.03-4.61). 69 (43.13%) children in the group with GHRS suffered from RRTI; there were 48 (32.65%) children in group without GHRS. The risk ratio (RR) value of RRTI occurrence was 1.32 (95 % CI 0.91-1.91, P = 0.139), and the attributable risk percent (AR%) was 24.28%. Dry stool and irritability were positively correlated with RTI episodes, age and BMI were negatively correlated with RTI episodes in a linear regression model. Dry stool (OR = 1.510) was positively correlated with RRTI occurrence, age (OR = 0.889) and BMI (OR = 0.858) were negatively correlated with RRTI occurrence in our logistic regression model. CONCLUSIONS: GHRS is associated with RRTI in this cohort. Dry stool was positively associated with RRTI, and BMI was negatively associated with RRTI. Studies with larger sample size and longer follow up are needed to further evaluate this association. Relieving GHRS should be considered when TCM practitioners treat RRTI children, and this may protect children from suffering RTIs. TRIAL REGISTRATION: Chinese Clinical Trial Registry Number: ChiCTR-CCH-13003756.

Chinese herbal medicine for treating recurrent urinary tract infections in women.

BACKGROUND: Acute urinary tract infection (UTI) is a common bacterial infection that affects 40% to 50% of women. Between 20% and 30% of women who have had a UTI will experience a recurrence, and around 25% will develop ongoing recurrent episodes with implications for individual well-being and healthcare costs. Prophylactic antibiotics can prevent recurrent UTIs but there are growing concerns about microbial resistance, side effects from treatment and lack of long-term benefit. Consequently, alternative treatments are being investigated. Chinese herbal medicine (CHM) has a recorded history of treating UTI symptoms and more recent research suggests a potential role in the management of recurrent UTIs. This review aimed to evaluate CHM for recurrent UTI. OBJECTIVES: This review assessed the benefits and harms of CHM for the treatment of recurrent UTIs in adult women, both as a stand-alone therapy and in conjunction with other pharmaceutical interventions. SEARCH METHODS: We searched the Cochrane Kidney and Transplant's Specialised Register to 7 May 2015 through contact with the Trials Search Co-ordinator, using search terms relevant to this review. We also searched AMED, CINAHL and the Chinese language electronic databases Chinese BioMedical Literature Database (CBM), China Network on Knowledge Infrastructure (CNKI), VIP and Wan Fang Databases to July 2014. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing treatments using CHM with either an inactive placebo or conventional biomedical treatment. RCTs comparing different CHM strategies and treatments were eligible for inclusion. Quasi-randomised studies were excluded. DATA COLLECTION AND ANALYSIS: Data extraction was carried out independently by two authors. Where more than one publication of one study existed, these were grouped and the publication with the most complete data was used in the analyses. Where relevant outcomes were only published in earlier versions these data were used. All meta-analyses were performed using relative risk (RR) for dichotomous outcomes with 95% confidence intervals (CI). MAIN RESULTS: We included seven RCTs that involved a total of 542 women; of these, five recruited post-menopausal women (aged from 56 to 70 years) (422 women). We assessed all studies to be at high risk of bias. Meta-analyses comparing the overall effectiveness of treatments during acute phases of infection and rates of recurrence were conducted. Analysis of three studies involving 282 women that looked at CHM versus antibiotics suggested that CHM had a higher rate of effectiveness for acute UTI (RR 1.21, 95% CI 1.11 to 33) and reduced recurrent UTI rates (RR 0.28, 95% CI 0.09 to 0.82). Analysis of two studies involving 120 women that compared CHM plus antibiotics versus antibiotics alone found the combined intervention had a higher rate of effectiveness for acute UTI (RR 1.24, 95% CI 1.04 to 1.47) and resulted in lower rates of recurrent infection six months after the study (RR 0.53, 95% CI 0.35 to 0.80).One study comparing different CHM treatments found Er Xian Tang was more effective in treating acute infection in post-menopausal women than San Jin Pian (80 women: RR 1.28, 95% CI 1.03 to 1.57). Analysis showed that active CHM treatments specifically formulated for recurrent UTI were more effective in reducing infection incidence than generic CHM treatments that were more commonly used for acute UTI (RR 0.40, 95% CI 0.21 to 0.77).Only two studies undertook to report adverse events; neither reported the occurrence of any adverse events. AUTHORS' CONCLUSIONS: Evidence from seven small studies suggested that CHM as an independent intervention or in conjunction with antibiotics may be beneficial for treating recurrent UTIs during the acute phase of infection and may reduce the recurrent UTI incidence for at least six months post-treatment. CHM treatments specifically formulated for recurrent UTI may be more effective than herbal treatments designed to treat acute UTI. However, the small number and poor quality of the included studies meant that it was not possible to formulate robust conclusions on the use of CHM for recurrent UTI in women either alone or as an adjunct to antibiotics.

Characteristics of clinical studies of summer acupoint herbal patching: a bibliometric analysis.

BACKGROUND: Summer acupoint herbal patching (SAHP) has been widely used in China for thousands of years. This bibliometric analysis aims to provide a comprehensive review of the characteristics of clinical studies on SAHP for any condition. METHODS: We included clinical studies such as randomized clinical trials (RCTs), controlled clinical studies (CCTs), case series (CSs), case reports (CRs), and cross-sectional studies on SAHP for any condition. Six databases were searched from date of inception to March 2015. Bibliometric information and study details such as study type, characteristics of participants, details of the intervention and comparison, and outcome were extracted and analyzed. RESULTS: A total of 937 clinical studies were identified and which were published between 1977 and 2015. This included 404 RCTs, 52 CCTs, 458 CSs, 19 CRs and 4 cross-sectional studies and involved 232,138 participants aged 2 to 90 years from two countries. Almost all studies were from China (936, 99.89%). The five conditions most commonly treated by SAHP were asthma (401, 42.80%), chronic bronchitis (146, 15.58%), allergic rhinitis (117, 12.49%), chronic obstructive pulmonary disease (73, 7.79%), and recurrent respiratory tract infection (42, 4.48%). Among 502 controlled studies, the majority compared SAHP alone with different controls (16 categories, 275 comparisons). The most commonly used controls were western medicine, placebo, traditional Chinese medicine, no treatment and non-pharmaceutical traditional Chinese therapies. Composite outcome measures were the most frequently reported outcome (512, 69.19%). CONCLUSION: A substantial amount of research on SAHP has been published in China and which predominantly focuses on respiratory conditions. The findings from this study can be used to inform further research by highlighting areas of greatest impact for SAHP.

Placebo use in the UK: a qualitative study exploring GPs' views on placebo effects in clinical practice.

BACKGROUND: Surveys show GPs use placebos in clinical practice and reported prevalence rates vary widely. AIM: To explore GPs' perspectives on clinical uses of placebos. DESIGN AND SETTING: A web-based survey of 783 UK GPs' use of placebos in clinical practice. METHODS: Qualitative descriptive analysis of written responses ('comments') to three open-ended questions. RESULTS: Comments were classified into three categories: (i) defining placebos and their effects in general practice; (ii) ethical, societal and regulatory issues faced by doctors and (iii) reasons why a doctor might use placebos and placebo effects in clinical practice. GPs typically defined placebos as lacking something, be that adverse or beneficial effects, known mechanism of action and/or scientific evidence. Some GPs defined placebos positively as having potential to benefit patients, primarily through psychological mechanisms. GPs described a broad array of possible harms and benefits of placebo prescribing, reflecting fundamental bioethical principles, at the level of the individual, the doctor-patient relationship, the National Health Service and society. While some GPs were adamant that there was no place for placebos in clinical practice, others focused on the clinically beneficial effects of placebos in primary care. CONCLUSION: This study has elucidated specific costs, benefits and ethical barriers to placebo use as perceived by a large sample of UK GPs. Stand-alone qualitative work would provide a more in-depth understanding of GPs' views. Continuing education and professional guidance could help GPs update and contextualize their understanding of placebos and their clinical effects.

How women manage recurrent urinary tract infections: an analysis of postings on a popular web forum.

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.

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.

Patient preferences for technical skills versus interpersonal skills in chiropractors and physiotherapists treating low back pain.

BACKGROUND: Little is known about which characteristics of chiropractors and physiotherapists matter to patients and influence their preferences when seeking care. OBJECTIVE: To examine the impact of four factors (patient gender, practitioner gender, practitioner specialty-chiropractor or physiotherapist and practitioner reputation-technical ability or interpersonal skills) on patients' choice of therapist to treat low back pain. METHODS: Questionnaire-based vignette study in which participants sampled from the general population rated the likelihood of consulting eight fictional therapists. Each fictional therapist represented a different combination of the three practitioner factors (e.g. male chiropractor with reputation for good technical ability). The study was administered as a postal survey to a simple random sample of residences in one postal town in England. RESULTS: Respondents (n = 657) consistently reported that they considered a practitioner's qualifications and technical skills important when choosing either a physiotherapist or a chiropractor; and just less than a third thought it was important that a practitioner was a good listener. As hypothesized, female respondents preferred female practitioners and respondents had a general preference for physiotherapists over chiropractors. Contrary to our hypothesis, the practitioner's reputation had the largest effect on respondents' preferences and all practitioners with a reputation for technical ability were preferred over those with a reputation for interpersonal skills. CONCLUSION: Similar factors are important to patients whether they are choosing an individual chiropractor or physiotherapist; patients particularly value information about technical competence. An awareness of these factors should help primary care providers to direct patients to relevant information and support their decision-making.

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.

Science, practice and mythology: a definition and examination of the implications of scientism in medicine.

Scientism is a philosophy which purports to define what the world 'really is'. It adopts what the philosopher Thomas Nagel called 'an epistemological criterion of reality', defining what is real as that which can be discovered by certain quite specific methods of investigation. As a consequence all features of experience not revealed by those methods are deemed 'subjective' in a way that suggests they are either not real, or lie beyond the scope of meaningful rational inquiry. This devalues capacities that (we argue) are in fact essential components of good reasoning and virtuous practice. Ultimately, the implications of scientism for statements of value undermine value-judgements essential for science itself to have a sound basis. Scientism has implications, therefore, for ontology, epistemology and also for which claims we can assert as objective truths about the world. Adopting scientism as a world view will have consequences for reasoning and decision-making in clinical and other contexts. We analyse the implications of this approach and conclude that we need to reject scientism if we are to avoid stifling virtuous practice and to develop richer conceptions of human reasoning.

A systematic review of evidence for the effectiveness of practitioner-based complementary and alternative therapies in the management of rheumatic diseases: osteoarthritis.

OBJECTIVE: To critically review the evidence on the efficacy and effectiveness of practitioner-based complementary therapies for patients with osteoarthritis. We excluded t'ai chi and acupuncture, which have been the subject of recent reviews. METHODS: Randomized controlled trials, published in English up to May 2011, were identified using systematic searches of bibliographic databases and searching of reference lists. Information was extracted on outcomes, statistical significance in comparison with alternative treatments and reported side effects. The methodological quality of the identified studies was determined using the Jadad scoring system. Outcomes considered were pain and patient global assessment. RESULTS: In all, 16 eligible trials were identified covering 12 therapies. Overall, there was no good evidence of the effectiveness of any of the therapies in relation to pain or global health improvement/quality of life because most therapies only had a single randomized controlled trial. Where positive results were reported, they were often comparing an active intervention with no intervention. Therapies with multiple trials either provided null (biofeedback) or inconsistent results (magnet therapy), or the trials available scored poorly for quality (chiropractic). There were few adverse events reported in the trials. CONCLUSION: There is not sufficient evidence to recommend any of the practitioner-based complementary therapies considered here for the management of OA, but neither is there sufficient evidence to conclude that they are not effective or efficacious.

A systematic review of evidence for the effectiveness of practitioner-based complementary and alternative therapies in the management of rheumatic diseases: rheumatoid arthritis.

OBJECTIVE: To critically review the evidence on the effectiveness of complementary therapies for patients with RA. METHODS: Randomized controlled trials, published in English up to May 2011, were identified using systematic searches of bibliographic databases and searching of reference lists. Information was extracted on outcomes and statistical significance in comparison with alternative treatments and reported side effects. The methodological quality of the identified studies was determined using the Jadad scoring system. All outcomes were considered but with a focus on patient global assessment and pain reporting. RESULTS: Eleven eligible trials were identified covering seven therapies. Three trials that compared acupuncture with sham acupuncture reported no significant difference in pain reduction between the groups but one out of two reported an improvement in patient global assessment. Except for reduction in physician's global assessment of treatment and disease activity reported in one trial, no other comparative benefit of acupuncture was seen. There were two studies on meditation and one each on autogenic training, healing therapy, progressive muscle relaxation, static magnets and tai chi. None of these trials reported positive comparative effects on pain but some positive effects on patient global assessment were noted at individual time points in the healing therapy and magnet therapy studies. A small number of other outcomes showed comparative improvement in individual trials. There were no reports of major adverse events. CONCLUSION: The very limited evidence available indicates that for none of the practitioner-based complementary therapies considered here is there good evidence of efficacy or effectiveness in the management of RA.

Chinese herbal medicine for endometriosis.

BACKGROUND: Endometriosis is characterized by the presence of tissue that is morphologically and biologically similar to normal endometrium in locations outside the uterus. Surgical and hormonal treatment of endometriosis have unpleasant side effects and high rates of relapse. In China, treatment of endometriosis using Chinese herbal medicine (CHM) is routine and considerable research into the role of CHM in alleviating pain, promoting fertility, and preventing relapse has taken place.This review is an update of a previous review published in the Cochrane Database of Systematic Reviews 2009, issue No 3. OBJECTIVES: To review the effectiveness and safety of CHM in alleviating endometriosis-related pain and infertility. SEARCH METHODS: We searched the Menstrual Disorders and Subfertility Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library) and the following English language electronic databases (from their inception to 31/10/2011): MEDLINE, EMBASE, AMED, CINAHL, and NLH.We also searched Chinese language electronic databases: Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Sci & Tech Journals (VIP), Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS), and Chinese Medical Current Contents (CMCC). SELECTION CRITERIA: Randomised controlled trials (RCTs) involving CHM versus placebo, biomedical treatment, another CHM intervention; or CHM plus biomedical treatment versus biomedical treatment were selected. Only trials with confirmed randomisation procedures and laparoscopic diagnosis of endometriosis were included. DATA COLLECTION AND ANALYSIS: Risk of bias assessment, and data extraction and analysis were performed independently by three review authors. Data were combined for meta-analysis using relative risk (RR) for dichotomous data. A fixed-effect statistical model was used, where appropriate. Data not suitable for meta-analysis were presented as descriptive data. MAIN RESULTS: Two Chinese RCTs involving 158 women were included in this review. Both these trials described adequate methodology. Neither trial compared CHM with placebo treatment.There was no evidence of a significant difference in rates of symptomatic relief between CHM and gestrinone administered subsequent to laparoscopic surgery (95.65% versus 93.87%; risk ratio (RR) 1.02, 95% confidence interval (CI) 0.93 to 1.12, one RCT). The intention-to-treat analysis also showed no significant difference between the groups (RR 1.04, 95% CI 0.91 to 1.18). There was no significant difference between the CHM and gestrinone groups with regard to the total pregnancy rate (69.6% versus 59.1%; RR 1.18, 95% CI 0.87 to 1.59, one RCT).CHM administered orally and then in conjunction with a herbal enema resulted in a greater proportion of women obtaining symptomatic relief than with danazol (RR 5.06, 95% CI 1.28 to 20.05; RR 5.63, 95% CI 1.47 to 21.54, respectively). Overall, 100% of women in all the groups showed some improvement in their symptoms.Oral plus enema administration of CHM showed a greater reduction in average dysmenorrhoea pain scores than did danazol (mean difference (MD) -2.90, 95% CI -4.55 to -1.25; P < 0.01). Combined oral and enema administration of CHM also showed a greater improvement measured as the disappearance or shrinkage of adnexal masses than with danazol (RR 1.70, 95% CI 1.04 to 2.78). For lumbosacral pain, rectal discomfort, or vaginal nodules tenderness, there was no significant difference between CHM and danazol. AUTHORS' CONCLUSIONS: Post-surgical administration of CHM may have comparable benefits to gestrinone but with fewer side effects. Oral CHM may have a better overall treatment effect than danazol; it may be more effective in relieving dysmenorrhoea and shrinking adnexal masses when used in conjunction with a CHM enema. However, more rigorous research is required to accurately assess the potential role of CHM in treating endometriosis.

Manipulative therapies for infantile colic.

BACKGROUND: Infantile colic is a common disorder, affecting around one in six families, and in 2001 was reported to cost the UK National Health Service in excess of £65 million per year (Morris 2001). Although it usually remits by six months of age, there is some evidence of longer-term sequelae for both children and parents.Manipulative therapies, such as chiropractic and osteopathy, have been suggested as interventions to reduce the severity of symptoms. OBJECTIVES: To evaluate the results of studies designed to address efficacy or effectiveness of manipulative therapies (specifically, chiropractic, osteopathy and cranial manipulation) for infantile colic in infants less than six months of age. SEARCH METHODS: We searched following databases: CENTRAL (2012, Issue 4), MEDLINE (1948 to April Week 3 2012), EMBASE (1980 to 2012 Week 17), CINAHL (1938 to April 2012), PsycINFO (1806 to April 2012), Science Citation Index (1970 to April 2012), Social Science Citation Index (1970 to April 2012), Conference Proceedings Citation Index - Science (1990 to April 2012) and Conference Proceedings Citation Index - Social Science & Humanities (1970 to April 2012). We also searched all available years of LILACS, PEDro, ZETOC, WorldCat, TROVE, DART-Europe, ClinicalTrials.gov and ICTRP (May 2012), and contacted over 90 chiropractic and osteopathic institutions around the world. In addition, we searched CentreWatch, NRR Archive and UKCRN in December 2010. SELECTION CRITERIA: Randomised trials evaluating the effect of chiropractic, osteopathy or cranial osteopathy alone or in conjunction with other interventions for the treatment of infantile colic. DATA COLLECTION AND ANALYSIS: In pairs, five of the review authors (a) assessed the eligibility of studies against the inclusion criteria, (b) extracted data from the included studies and (c) assessed the risk of bias for all included studies. Each article or study was assessed independently by two review authors. One review author entered the data into Review Manager software and the team's statistician (PP) reviewed the chosen analytical settings. MAIN RESULTS: We identified six studies for inclusion in our review, representing a total of 325 infants. There were three further studies that we could not find information about and we identified three other ongoing studies. Of the six included studies, five were suggestive of a beneficial effect and one found no evidence that manipulative therapies had any beneficial effect on the natural course of infantile colic. Tests for heterogeneity imply that there may be some underlying difference between this study and the other five.Five studies measured daily hours of crying and these data were combined, suggesting that manipulative therapies had a significant effect on infant colic - reducing average crying time by one hour and 12 minutes per day (mean difference (MD) -1.20; 95% confidence interval (CI) -1.89 to -0.51). This conclusion is sustained even when considering only studies with a low risk of selection bias (sequence generation and allocation concealment) (MD -1.24; 95% CI -2.16 to -0.33); those with a low risk of attrition bias (MD -1.95; 95% CI -2.96 to -0.94), or only those studies that have been published in the peer-reviewed literature (MD -1.01; 95% CI -1.78 to -0.24). However, when combining only those studies with a low risk of performance bias (parental 'blinding'), the improvement in daily crying hours was not statistically significant (MD -0.57; 95% CI -2.24 to 1.09).One study considered whether the reduction in crying time was clinically significant. This found that a greater proportion of parents of infants receiving a manipulative therapy reported clinically significant improvements than did parents of those receiving no treatment (reduction in crying to less than two hours: odds ratio (OR) 6.33; 95% CI 1.54 to 26.00; more than 30% reduction in crying: OR 3.70; 95% CI 1.15 to 11.86).Analysis of data from three studies that measured 'full recovery' from colic as reported by parents found that manipulative therapies did not result in significantly higher proportions of parents reporting recovery (OR 11.12; 95% CI 0.46 to 267.52).One study measured infant sleeping time and found manipulative therapy resulted in statistically significant improvement (MD 1.17; 95% CI 0.22 to 2.12).The quality of the studies was variable. There was a generally low risk of selection bias but only two of the six studies were evaluated as being at low risk of performance bias, three at low risk of detection bias and one at low risk of attrition bias.One of the studies recorded adverse events and none were encountered. However, with only a sample of 325 infants, we have too few data to reach any definitive conclusions about safety. AUTHORS' CONCLUSIONS: The studies included in this meta-analysis were generally small and methodologically prone to bias, which makes it impossible to arrive at a definitive conclusion about the effectiveness of manipulative therapies for infantile colic.The majority of the included trials appeared to indicate that the parents of infants receiving manipulative therapies reported fewer hours crying per day than parents whose infants did not, based on contemporaneous crying diaries, and this difference was statistically significant. The trials also indicate that a greater proportion of those parents reported improvements that were clinically significant. However, most studies had a high risk of performance bias due to the fact that the assessors (parents) were not blind to who had received the intervention. When combining only those trials with a low risk of such performance bias, the results did not reach statistical significance. Further research is required where those assessing the treatment outcomes do not know whether or not the infant has received a manipulative therapy.There are inadequate data to reach any definitive conclusions about the safety of these interventions.

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.

Monitoring improvement in health during homeopathic intervention. Development of an assessment tool based on Hering's Law of Cure: the Hering's Law Assessment Tool (HELAT).

INTRODUCTION: Hering's 'Law of Cure' is considered important in homeopathy and thought to predict a positive outcome to treatment. No formal outcome measures are currently available to monitor response to homeopathic treatment on the basis of these assumptions. We describe a simple assessment tool, the Hering's Law Assessment Tool (HELAT) to identify and differentiate patient responses to homeopathic treatment as corresponding to Hering's Law from other symptomatic responses. We describe the development of the tool and assess its face, content and predictive validity. METHOD: The HELAT was initially developed through literature review, discussion between homeopaths and clinical experience. In phase one, the tool was reviewed by three experienced homeopaths to assess face and content validity. In phase two, we tested its predictive validity by hypothesizing that the HELAT total score may predict changes in a clinical response (using standard validated rheumatological outcome, the American College of Rheumatology (ACR)20%) in 32 patients with rheumatoid arthritis receiving homeopathic intervention over 24 weeks as part of a clinical trial. RESULTS: The HELAT was piloted and changed to improve face and content validity and the final version was then employed for phase two as a predictor of outcome. HELAT total score predicted patient's clinical response (ACR20) [B = 1.142, SE = 0.462, P = 0.013] which was independent of practitioner assessing the patients treatment response [B = 1.04, SE = 1.01, P = 0.302]. CONCLUSION: The initial data suggests that the HELAT may hold promise for a potential clinical and research outcome measure in homeopathy. Further work is now needed to formally assess its reliability and validity for potential use in clinical practice and trials.