A feasibility trial of acupuncture in cancer patients undergoing radiotherapy treatment.

OBJECTIVE: We conducted a feasibility trial of acupuncture in cancer patients undergoing radiotherapy treatment. The trial included training radiographers to deliver acupuncture within patients' routine NHS care. METHODS: Mixed methods pragmatic randomized parallel-group exploratory feasibility trial comparing standard care to standard care plus acupuncture. RESULTS: Most aspects of the research design and acupuncture intervention were acceptable to the 101 participants. Participants' valued the opportunity to receive acupuncture within their NHS care, perceived the treatment as eliciting a number of beneficial effects, and had a positive impact on their NHS cancer treatment. However, quantitative analysis of outcome measure data revealed no consistent significant differences between those receiving standard care and those receiving standard care plus acupuncture. CONCLUSION: It is feasible to implement acupuncture in a busy radiotherapy unit provided by specially trained radiographers. The methodology employed appears acceptable for the evaluation of acupuncture for radiotherapy patients.

Identifying patients with chronic pain who respond to acupuncture: results from an individual patient data meta-analysis.

BACKGROUND: In a recent individual patient data meta-analysis, acupuncture was found to be superior to sham and non-sham controls in patients with chronic pain. It has been suggested that a subgroup of patients has an exceptional response to acupuncture. We hypothesized the presence of exceptional acupuncture responders would lead to a different distribution of pain scores in acupuncture versus control groups, with the former being skewed to the right. METHODS: This individual patient data meta-analysis included 39 high-quality randomized trials of acupuncture for chronic headache, migraine, osteoarthritis, low back pain, neck pain and shoulder pain published before December 2015 (n = 20,827). In all, 25 involved sham acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). We analyzed the distribution of change scores and calculated the difference in the skewness statistic-which assesses asymmetry in the data distribution-between acupuncture and either sham or non-acupuncture control groups. We then entered the difference in skewness along with standard error into a meta-analysis. FINDINGS: Control groups were more right-skewed than acupuncture groups, although this difference was very small. The difference in skew was 0.124 for non-acupuncture-controlled trials (p = 0.047) and 0.141 for sham-controlled trials (p = 0.029). In a pre-specified sensitivity analysis excluding three trials with outlying results known a priori, the difference in skew between acupuncture and sham was no longer statistically significant (p = 0.2). CONCLUSION: We did not find evidence to support the notion that there are exceptional acupuncture responders. The challenge remains to identify features of chronic pain patients that can be used to distinguish those that have a good response to acupuncture treatment.

Do the effects of acupuncture vary between acupuncturists? Analysis of the Acupuncture Trialists' Collaboration individual patient data meta-analysis.

OBJECTIVES: The degree to which the effects of acupuncture treatment vary between acupuncturists is unknown. We used a large individual patient dataset of trials of acupuncture for chronic pain to assess practitioner heterogeneity. METHODS: Individual patient data linked to identifiable acupuncturists were drawn from a dataset of 39 high-quality trials of acupuncture, where the comparators were either sham acupuncture or non-acupuncture controls, such as standard care or waitlist. Heterogeneity among acupuncturists was assessed by meta-analysis. RESULTS: A total of 1206 acupuncturists in 13 trials were included. Statistically significant heterogeneity was found in trials with sham-control groups (p < 0.0001) and non-acupuncture control groups (p <0.0001). However, the degree of heterogeneity was very small, with the observed distribution of treatment effects virtually overlapping that expected by chance. For instance, for non-acupuncture-controlled trials, the proportion of acupuncturists with effect sizes half a standard deviation greater or less than average was expected to be 34%, but was observed to be 37%. A limitation is that the trials included a relatively limited range of acupuncturists, mainly physician-acupuncturists. DISCUSSION: Although differences in effects between acupuncturists were greater than expected by chance, the degree of variation was small. This suggests that most chronic pain patients in clinical practice would have similar results to those reported in high-quality trials; comparably, we did not find evidence to suggest that greater standardization of acupuncture practice would improve outcomes. Further research needs to be conducted exploring variability using a sample of acupuncturists with a broader range of practice styles, training and experience.

Assessment of the quality of reporting in studies of acupuncture for patients with cancer using the STRICTA guidelines.

INTRODUCTION: There has been a burgeoning of research evaluating acupuncture for various symptoms of cancer and the side-effects associated with its treatment. A systematic review was conducted to examine the quality of reporting in published studies of acupuncture in cancer according to the STRICTA (STandards for Reporting Interventions in Clinical Trials of Acupuncture) guidelines. METHODS: Systematic review of published research of acupuncture for symptoms of cancer and the side-effects associated with its treatment. Databases searched were: Medline, CINAHL, Cochrane (all databases), Scopus, and PubMed from their inception to December 2014. Clinical trials, pilot/feasibility studies, observational studies, and case studies were included. Only full journal papers published in English were included. The quality of reporting was evaluated using STRICTA guidelines. Each included paper was assessed by two independent reviewers, with disagreements adjudicated by a third reviewer. RESULTS: 88 papers were identified which met the inclusion criteria. The median number of STRICTA items reported in trials with a control or comparator arm (n=47) was 14 out of 17 (range 8 to 17, IQR 4). For studies without a control or comparator arm the median was 11 out of a possible 15 (range 5 to 15, IQR 3). Key weaknesses in reporting included details of other components of treatments, and details of the acupuncturist administering treatments. CONCLUSIONS: Despite the widespread use of the STRICTA guidelines in acupuncture research, adherence remains poor for a few specific items. Further research is required to explore the reasons why authors fail to report those items, and to develop strategies to improve the adherence to the guidelines.

Supporting informed choice in acupuncture: effects of a new person-, evidence- and theory-based website for patients with back pain.

OBJECTIVES: To test whether a newly developed person-, theory- and evidence-based website about acupuncture helps patients make informed decisions about whether or not to use acupuncture for back pain. METHODS: A randomised online study compared a newly developed 'enhanced website' to a 'standard website'. The enhanced website provided evidence-based information in a person-based manner and targeted psychological constructs. The standard website was based on a widely used patient information leaflet. In total, 350 adults with recent self-reported back pain were recruited from general practices in South West England. The two primary outcomes were knowledge change and making an informed choice about using acupuncture. Secondary outcomes were beliefs about and willingness to have acupuncture. RESULTS: Participants who viewed the enhanced acupuncture website had a significantly greater increase in knowledge about acupuncture (M = 1.1, standard deviation (SD) = 1.7) than participants who viewed the standard website (M = 0.2, SD = 1.1; F(1, 315) = 37.93, p < 0.001, η2 = .107). Participants who viewed the enhanced acupuncture website were also 3.3 times more likely to make an informed choice about using acupuncture than those who viewed the standard website (χ2(1) = 23.46, p < 0.001). There were no significant effects on treatment beliefs or willingness to have acupuncture. CONCLUSION: The enhanced website improved patients' knowledge and ability to make an informed choice about acupuncture, but did not optimise treatment beliefs or change willingness to have acupuncture. The enhanced website could be used to support informed decision-making among primary care patients and members of the general public considering using acupuncture for back pain.

The Effect of Patient Characteristics on Acupuncture Treatment Outcomes: An Individual Patient Data Meta-Analysis of 20,827 Chronic Pain Patients in Randomized Controlled Trials.

OBJECTIVES: To optimally select chronic pain patients for different treatments, as it is of interest to identify patient characteristics that might moderate treatment effect. Our aim was to evaluate the impact of possible moderators on the effect of acupuncture treatment using a large data set. METHODS: We used data from an individual patient data meta-analysis of high-quality randomized trials of acupuncture for chronic headache and migraine, osteoarthritis, and back, neck, and shoulder pain. Using meta-analytic trial-level and patient-level regression analyses, we explored the impact of 5 documented patient characteristics (patients' age at baseline, sex, pain duration, baseline pain severity and baseline psychological distress) on the effect of acupuncture. RESULTS: A total of 39 trials met the inclusion criteria: 25 use sham-acupuncture controls (n = 7097) and 25 non-acupuncture controls (n = 16,041). Of the 5 patient characteristics analyzed, only baseline pain severity was found to potentially moderate the treatment effect of acupuncture, with patients reporting more severe pain at baseline experiencing more benefit from acupuncture compared to either sham-control or non-acupuncture control. Baseline psychological distress showed small treatment moderating effects, and results for sex were inconsistent. There was no strong evidence that age or duration of pain influenced the response to acupuncture. DISCUSSION: Of 5 patient characteristics tested, we found only baseline severity of pain to potentially moderate the effect of acupuncture treatment. For clinical practice, the evidence from this analysis does not justify stratifying chronic pain patients into subgroups that should or should not receive acupuncture on the basis of these 5 characteristics. Future acupuncture trials should assess other potentially important effect moderators.

Chiropractors' views on the use of patient-reported outcome measures in clinical practice: a qualitative study.

Background: Patient-reported outcome measures (PROMs) are widely available for use in musculoskeletal care. However, there is little research exploring the implementation of PROMs in clinical practice. This qualitative study explored chiropractors' views on PROMs to identify any barriers and facilitators to implementing PROMs in chiropractic care and the training needs of chiropractors regarding the use of PROMs. Methods: A qualitative study of chiropractors' views on PROMs was undertaken as part of a larger project to address the feasibility of conducting a randomised controlled trial of PROM use in chiropractic clinics for patients with low back pain. Contact was made with chiropractors working in chiropractic companies with multiple clinic sites. Semi-structured interviews were conducted with eight chiropractors, either face-to-face at their place of work or over the telephone. The interviews were transcribed verbatim and analysed using thematic analysis. The data were coded inductively by two authors. Results: Chiropractors discussed their knowledge and engagement with PROMs in clinical practice, identifying reasons for their use, such as understanding clinic performance, clinical practice, and research. They also discussed how they used PROMs within their clinical practice and the benefits of using them with individual patients, for example during the consultation, identifying yellow flags, and tracking patient progress. Chiropractors voiced concerns about patient engagement with PROMs, questioning if patients find them burdensome, and the appropriate PROMs to use with patients with pain. Finally, chiropractors acknowledged the organisational barriers and facilitators to using PROMs within their practice, such as busy practices, electronic systems, and use of reception staff. Conclusions: Using participating chiropractors' views of PROMs, the study identified barriers and facilitators to implementing PROMs in chiropractic care, such as clinician knowledge, engagement, and organisational concerns and identified the potential training needs of chiropractors regarding PROMs. The results from the study suggested chiropractors use PROMs with their individual patients, but PROMs should be meaningful to patients and chiropractors to improve engagement.

Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis.

Despite wide use in clinical practice, acupuncture remains a controversial treatment for chronic pain. Our objective was to update an individual patient data meta-analysis to determine the effect size of acupuncture for 4 chronic pain conditions. We searched MEDLINE and the Cochrane Central Registry of Controlled Trials randomized trials published up until December 31, 2015. We included randomized trials of acupuncture needling versus either sham acupuncture or no acupuncture control for nonspecific musculoskeletal pain, osteoarthritis, chronic headache, or shoulder pain. Trials were only included if allocation concealment was unambiguously determined to be adequate. Raw data were obtained from study authors and entered into an individual patient data meta-analysis. The main outcome measures were pain and function. An additional 13 trials were identified, with data received for a total of 20,827 patients from 39 trials. Acupuncture was superior to sham as well as no acupuncture control for each pain condition (all P < .001) with differences between groups close to .5 SDs compared with no acupuncture control and close to .2 SDs compared with sham. We also found clear evidence that the effects of acupuncture persist over time with only a small decrease, approximately 15%, in treatment effect at 1 year. In secondary analyses, we found no obvious association between trial outcome and characteristics of acupuncture treatment, but effect sizes of acupuncture were associated with the type of control group, with smaller effects sizes for sham controlled trials that used a penetrating needle for sham, and for trials that had high intensity of intervention in the control arm. We conclude that acupuncture is effective for the treatment of chronic pain, with treatment effects persisting over time. Although factors in addition to the specific effects of needling at correct acupuncture point locations are important contributors to the treatment effect, decreases in pain after acupuncture cannot be explained solely in terms of placebo effects. Variations in the effect size of acupuncture in different trials are driven predominantly by differences in treatments received by the control group rather than by differences in the characteristics of acupuncture treatment. PERSPECTIVE: Acupuncture is effective for the treatment of chronic musculoskeletal, headache, and osteoarthritis pain. Treatment effects of acupuncture persist over time and cannot be explained solely in terms of placebo effects. Referral for a course of acupuncture treatment is a reasonable option for a patient with chronic pain.

Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial.

BACKGROUND: Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use. METHODS/DESIGN: Adult women with suspected urinary tract infection presenting to primary care will be randomised using a factorial trial design in which patients will be randomised to one of two interventions as below: Group 1 - Uva-ursi + advice to take ibuprofen Group 2 - Placebo + advice to take ibuprofen Group 3 - Uva-ursi + no advice to take ibuprofen Group 4 - Placebo + no advice to take ibuprofen Patients and physicians will be blinded to the randomised group for the herb. The main outcome is symptom severity at days 2-4 recorded in a validated, self-report diary used in previous studies. Secondary outcomes include antibiotic use and symptom duration. In total the trial will require 328 patients in order to achieve at least 90% power for the primary endpoint and 80% for the secondary endpoint. In accordance with CONSORT guidelines all comparative analyses will be conducted on an intention-to-treat basis using SPSS or similar package. DISCUSSION: The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN43397016 . Registered on 11 February 2015.

Andrographis paniculata (Chuan Xin Lián) for symptomatic relief of acute respiratory tract infections in adults and children: A systematic review and meta-analysis.

INTRODUCTION: Antimicrobial resistance (AMR) is a substantial threat to public health. Safe and effective alternatives are required to reduce unnecessary antibiotic prescribing. Andrographis Paniculata (A. Paniculata, Chuan Xin Lián) has traditionally been used in Indian and Chinese herbal medicine for cough, cold and influenza, suggesting a role in respiratory tract infections (RTIs). This systematic review aimed to evaluate the clinical effectiveness and safety of A. Paniculata for symptoms of acute RTIs (ARTIs). MATERIALS AND METHODS: English and Chinese databases were searched from their inception to March 2016 for randomised controlled trials (RCTs) evaluating oral A. Paniculata without language barriers (Protocol ID: CRD42016035679). The primary outcomes were improvement in ARTI symptoms and adverse events (AEs). A random effects model was used to pool the mean differences and risk ratio with 95% CI reported. Methodological quality was evaluated using the Cochrane risk of bias tool; two reviewers independently screened eligibility and extracted data. RESULTS: Thirty-three RCTs (7175 patients) were included. Most trials evaluated A. Paniculata (as a monotherapy and as a herbal mixture) provided commercially but seldom reported manufacturing or quality control details. A. Paniculata improved cough (n = 596, standardised mean difference SMD: -0.39, 95% confidence interval CI [-0.67, -0.10]) and sore throat (n = 314, SMD: -1.13, 95% CI [-1.37, -0.89]) when compared with placebo. A. Paniculata (alone or plus usual care) has a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. Evidence also suggested that A. Paniculata (alone or plus usual care) shortened the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. No major AEs were reported and minor AEs were mainly gastrointestinal. The methodological quality of included trials was overall poor. CONCLUSIONS: A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted.

Mulberry-extract improves glucose tolerance and decreases insulin concentrations in normoglycaemic adults: Results of a randomised double-blind placebo-controlled study.

BACKGROUND: High sugar and refined carbohydrate intake is associated with weight gain, increased incidence of diabetes and is linked with increased cardiovascular mortality. Reducing the health impact of poor quality carbohydrate intake is a public health priority. Reducose, a proprietary mulberry leaf extract (ME), may reduce blood glucose responses following dietary carbohydrate intake by reducing absorption of glucose from the gut. METHODS: A double-blind, randomised, repeat measure, phase 2 crossover design was used to study the glycaemic and insulinaemic response to one reference product and three test products at the Functional Food Centre, Oxford Brooks University, UK. Participants; 37 adults aged 19-59 years with a BMI ≥ 20kg/m2 and ≤ 30kg/m2. The objective was to determine the effect of three doses of mulberry-extract (Reducose) versus placebo on blood glucose and insulin responses when co-administered with 50g maltodextrin in normoglycaemic healthy adults. We also report the gastrointestinal tolerability of the mulberry extract. RESULTS: Thirty-seven participants completed the study: The difference in the positive Incremental Area Under the Curve (pIAUC) (glucose (mmol / L x h)) for half, normal and double dose ME compared with placebo was -6.1% (-18.2%, 5.9%; p = 0.316), -14.0% (-26.0%, -2.0%; p = 0.022) and -22.0% (-33.9%, -10.0%; p<0.001) respectively. The difference in the pIAUC (insulin (mIU / L x h)) for half, normal and double dose ME compared with placebo was -9.7% (-25.8%, 6.3%; p = 0.234), -23.8% (-39.9%, -7.8%; p = 0.004) and -24.7% (-40.8%, -8.6%; p = 0.003) respectively. There were no statistically significant differences between any of the 4 groups in the odds of experiencing one or more gastrointestinal symptoms (nausea, abdominal cramping, distension or flatulence). CONCLUSIONS: Mulberry leaf extract significantly reduces total blood glucose rise after ingestion of maltodextrin over 120 minutes. The pattern of effect demonstrates a classical dose response curve with significant effects over placebo. Importantly, total insulin rises were also significantly suppressed over the same time-period. There were no statistically significant differences between any of the treatment groups (including placebo) in the odds of experiencing one or more gastrointestinal symptoms. Mulberry extract may have multiple modes of action and further studies are necessary to evaluate ME as a potential target for the prevention of type 2 diabetes and the regulation of dysglycaemia.

Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.

OBJECTIVES: To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. DESIGN: Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. SETTING: 2 private herbal practices in the UK. PARTICIPANTS: 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. INTERVENTION: 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. MAIN OUTCOME MEASURES: Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. RESULTS: Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. CONCLUSIONS: A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. TRIAL REGISTRATION NUMBER: ISRCTN 31072075; Results.

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.

Assessing knowledge about acupuncture: A survey of people with back pain in the UK.

OBJECTIVES: Despite the prevalence of acupuncture treatment in the UK, and the increasing evidence of safety and effectiveness, the information presented to patients by practitioners frequently contains inaccuracies. As knowledge of treatment affects both patient decision-making and treatment outcomes, this study aimed to establish what is known about acupuncture in a sample of people who had, and had not, previously experienced acupuncture. DESIGN: A 15-item questionnaire was constructed to assess knowledge of acupuncture. SETTING: Online survey of people with a history of back pain. RESULTS: 202 participants completed the questionnaire. 66.8% of the sample was female and 33.2% male, with a mean age of 35 years (range 18-74 years). 87.6% had back pain in the past six months, 44.1% currently. 21.8% had previously received acupuncture, and 69.8% had previously read or heard information about acupuncture. On average participants answered 11.03 of 15 questions about acupuncture correctly (SD=2.64). Items relating to common concerns about acupuncture, acupuncture efficacy, and types of acupuncture were correctly answered by ≥80% of participants. Participants possessed less knowledge of accessibility, Government legislation, and methods of administration. CONCLUSIONS: The study identified key gaps in knowledge about acupuncture among patients. In particular, many participants were unaware that acupuncture is available from the UK National Health Service and that acupuncturists are not subject to statutory regulation in the UK. These knowledge gaps should be addressed in order to increase people's understanding of and access to acupuncture.

Using psychological theory and qualitative methods to develop a new evidence-based website about acupuncture for back pain.

INTRODUCTION: Potential acupuncture patients seek out information about acupuncture from various sources including websites, many of which are unreliable. We aimed to create an informative, scientifically accurate and engaging website to educate patients about acupuncture for back pain and modify their beliefs in a way that might enhance its clinical effects. METHODS: We used psychological theory and techniques to design an evidence-based website, incorporating multimedia elements. We conducted qualitative "think aloud" audio-recorded interviews to elicit user views of the website. A convenience sample of ten participants (4 male; aged 21-64 years from the local community) looked at the website in the presence of a researcher and spoke their thoughts out loud. Comments were categorised by topic. RESULTS: The website comprises 11 main pages and addresses key topics of interest to potential acupuncture patients, including beneficial and adverse effects, mechanisms of action, safety, practicalities, and patients' experiences of acupuncture. It provides information through text, evidence summaries and audio-clips of four patients' stories and two acupuncturists' descriptions of their practice, and three short films. Evidence from the think aloud study was used to identify opportunities to make the website more informative, engaging, and user-friendly. CONCLUSIONS: Using a combination of psychological theory and qualitative interviews enabled us to produce a user-friendly, evidence-based website that is likely to change patients' beliefs about acupuncture for back pain. Before using the website in clinical settings it is necessary to test its effects on key outcomes including patients' beliefs and capacity for making informed choices about acupuncture.

A qualitative exploration of how patients conceptualise their acupuncturists: Technicians, caring professionals, and wise healers.

OBJECTIVES: To explore how patients conceptualise acupuncturists, the meanings ascribed to the therapeutic relationship and valued therapeutic behaviours. DESIGN: Qualitative study. Semi-structured face-to-face interviews explored patients' experiences of acupuncture. A diverse sample of 35 participants took part; they had used acupuncture for a variety of predominantly chronic conditions. Inductive thematic analysis was used to identify themes. SETTING: Southern England. RESULTS: Participants conceptualised acupuncturists in three ways: technician, caring professional, and wise and gifted healer. Each conceptualisation had different implications for patient health. For example, lifestyle advice from a wise healer was seen as inspirational wisdom, while lifestyle advice from a caring professional was seen as evidence of caring. Participants inferred empathy when acupuncturists took a detailed history, took notes during treatment, and provided therapeutic commentaries. Participants inferred knowledge and/or wisdom when acupuncturists made changes to treatments over time, provided explanatory frameworks for their symptoms, and made effective recommendations concerning lifestyle and health behaviours. CONCLUSIONS: The findings provide novel insights into how patients view acupuncturists, suggesting acupuncture-specific models that do not directly map onto conventional models of doctor-patient relationships. Understanding how patients think about their acupuncturist and make sense of clinical interactions could help acupuncturists to hone their therapeutic skills.

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.

Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial.

BACKGROUND: In the UK, urinary tract infections (UTIs) are the most common bacterial infection presented by women in primary care. Recurrent urinary tract infections (RUTIs) are defined as three episodes of UTI in the last 12 months, or two episodes in the last 6 months. Between 20 and 30 % of women who have had one episode of UTI will have an RUTI, and approximately 25 % of these will develop subsequent recurrent episodes. RUTIs can have a significant negative effect on the quality of life, and have a high impact on health care costs as a result of outpatient visits, diagnostic tests and prescriptions. Chinese herbal medicine (CHM) has a recorded history of treatments for the symptoms of UTIs for more than 2000 years. More recent clinical research in China has provided some preliminary evidence that CHM can alleviate the symptoms of UTIs and reduce the rate of recurrence, but more rigorous investigation is required. METHODS/DESIGN: The RUTI trial is a double-blind, randomised, placebo-controlled, feasibility trial. A total of 80 women will be randomised to 'individualised' herbs prescribed by a Chinese herbal practitioner or to 'standardised' herbs provided by primary care clinicians. Both arms will have herbs for prevention of UTIs and treatment of acute episodes. Treatment duration is for 16 weeks. The primary outcomes are the number of episodes of recurrent UTIs during the trial period and in the 6 months of follow-up, and the number of days of symptoms rated moderately bad or worse based on patient diaries. Secondary outcomes will assess participant expectations and beliefs, adherence to the treatment, adverse events and health economics and provide quantitative and qualitative assessments of the impact of recurrent infections on the lives of women. DISCUSSION: The RUTI trial is the first instance of CHM delivered as a clinical trial of an investigatory medicinal product in the UK. This study provides important information regarding the feasibility and acceptability of researching and using CHM in Primary care. Once completed, it will provide provisional estimates of the variance of change in continuous outcomes to inform a power calculation for a larger, more definitive trial. TRIAL REGISTRATION: EudraCT, 2013-004657-24 . Registered on 5 September 2014.

Non-specific mechanisms in orthodox and CAM management of low back pain (MOCAM): theoretical framework and protocol for a prospective cohort study.

INTRODUCTION: Components other than the active ingredients of treatment can have substantial effects on pain and disability. Such 'non-specific' components include: the therapeutic relationship, the healthcare environment, incidental treatment characteristics, patients' beliefs and practitioners' beliefs. This study aims to: identify the most powerful non-specific treatment components for low back pain (LBP), compare their effects on patient outcomes across orthodox (physiotherapy) and complementary (osteopathy, acupuncture) therapies, test which theoretically derived mechanistic pathways explain the effects of non-specific components and identify similarities and differences between the therapies on patient-practitioner interactions. METHODS AND ANALYSIS: This research comprises a prospective questionnaire-based cohort study with a nested mixed-methods study. A minimum of 144 practitioners will be recruited from public and private sector settings (48 physiotherapists, 48 osteopaths and 48 acupuncturists). Practitioners are asked to recruit 10-30 patients each, by handing out invitation packs to adult patients presenting with a new episode of LBP. The planned multilevel analysis requires a final sample size of 690 patients to detect correlations between predictors, hypothesised mediators and the primary outcome (self-reported back-related disability on the Roland-Morris Disability Questionnaire). Practitioners and patients complete questionnaires measuring non-specific treatment components, mediators and outcomes at: baseline (time 1: after the first consultation for a new episode of LBP), during treatment (time 2: 2 weeks post-baseline) and short-term outcome (time 3: 3 months post-baseline). A randomly selected subsample of participants in the questionnaire study will be invited to take part in a nested mixed-methods study of patient-practitioner interactions. In the nested study, 63 consultations (21/therapy) will be audio-recorded and analysed quantitatively and qualitatively, to identify communication practices associated with patient outcomes. ETHICS AND DISSEMINATION: The protocol is approved by the host institution's ethics committee and the NHS Health Research Authority Research Ethics Committee. Results will be disseminated via peer-reviewed journal articles, conferences and a stakeholder workshop.

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.