ORCID Profile
0000-0003-4255-4768
Current Organisations
University of York
,
University of New South Wales
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Publisher: Springer Science and Business Media LLC
Date: 28-09-2010
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 02-2010
Publisher: Elsevier BV
Date: 06-2007
DOI: 10.1016/J.CTIM.2006.09.006
Abstract: To standardise a complex intervention by defining the characteristic (specific) components of treatment for a randomised controlled trial of acupuncture as an intervention for in iduals who have been diagnosed with depression using a consensus method. A nominal group technique was used. Potential components of the acupuncture intervention were generated from the literature, experts and participants. These were categorised as constant or variable, the latter including active management techniques (such as providing relevant explanations), auxiliary techniques (such as auricular acupuncture), and other aspects of patient care (such as offering life-style and dietary advice), all of which were underpinned by defined theoretical frameworks. Participants were selected on the basis of their experience and training, to encompass a erse range of styles of traditional acupuncture practice in the UK, and all rated components in two rounds. Fifteen practitioners rated 52 variable components in the first round and 55 in the second. There was group support for 16 active management components, three auxiliary techniques and five areas of life-style support, all driven by eight theoretical diagnostic and treatment frameworks. For the 39 components that were rated twice, group support increased between rounds from 75 to 79% (z=-2.2, p=0.03), while the absolute average deviation from the median dropped from 1.04 to 0.83 (z=-2.5, p=0.011). Standardising the characteristic components of a complex intervention for a randomised controlled trial of acupuncture for depression using a consensus approach is feasible. The method can be generalised to other clinical situations and other treatment modalities.
Publisher: Springer Science and Business Media LLC
Date: 11-02-2007
Publisher: BMJ
Date: 05-2014
Publisher: Hindawi Limited
Date: 2013
DOI: 10.1155/2013/286048
Abstract: Background . In a large randomised controlled trial of acupuncture, counselling, or usual care for depression, we document the acupuncture intervention and explore the relationship between traditional acupuncture diagnosis and outcome. Methods . Patients who were continuing to experience depression were recruited from primary care to the ACUDep trial ( n = 755 ). Practitioners documented for each patient the traditional Chinese medicine diagnosis, the points needled, and additional components of the treatment, such as lifestyle advice, as recommended by the STRICTA guidelines. Results . Over an 18-month period, 23 acupuncturists delivered 2741 treatments to 266 patients, an average of 10 sessions per patient. The primary and secondary zang fu syndromes were identified for 99% of patients. When combining primary and secondary diagnoses, there was a predominant Liver Qi Stagnation cluster (66% of patients) and a Spleen Deficiency cluster (34%). Practitioners sought de qi responses 96% of the time. Lifestyle advice was given to 66% of patients, most commonly dietary. When comparing patient outcomes, no significant differences were found between the two main syndrome clusters. Conclusion . In this large-scale trial, our documentation of diagnosis and treatment provides a useful snapshot of common patterns that patients present with when continuing to experience depression after consulting in primary care.
Publisher: Oxford University Press (OUP)
Date: 07-04-2009
Abstract: Acupuncture is a popular complementary therapy choice for depression in the UK but the evidence base lags behind its usage. Further effectiveness trials are required however, these need based on appropriate design for a complex intervention on a heterogeneous group of people. Aim. To identify subgroups of patients with depression who could be the focus of effectiveness trials. Qualitative research using in-depth interviews in UK primary care. In-depth interviews with 30 participants from three stakeholder groups: 10 acupuncture patients and 10 acupuncturists-to examine the reasons why acupuncture is used for depression and 10 physicians-to elicit who would be acceptable to refer into a trial of acupuncture for depression. Interviews were transcribed and analysed using a Framework approach. The data have highlighted that the acceptability of particular treatments for depression is influenced by the in iduals' illness career within their social context. In addition, the plausibility and associated acceptability of depression treatments are also closely tied to an in iduals' explanatory model of their condition. Seven patient subgroups were identified who could potentially find acupuncture of particular interest and on which effectiveness trials could be focused. We have identified the main reasons why people seek acupuncture for depression and the circumstances in which physicians would be willing to refer for depression were it to prove effective. We have also set out a number of potential patient subgroups who may be particularly interested participating in a randomized controlled trail of acupuncture for depression.
Publisher: SAGE Publications
Date: 06-2010
Abstract: The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and ex les of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture.
Publisher: Public Library of Science (PLoS)
Date: 24-09-2013
Publisher: Mary Ann Liebert Inc
Date: 10-2010
Abstract: The Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and ex les of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
Publisher: Mary Ann Liebert Inc
Date: 02-1999
Abstract: In response to recent reviews in the literature that have focused on adverse events due to acupuncture treatment, this article reexamines the original reports from which they derive, particularly the fatalities allegedly caused by acupuncture. The article explores some important issues relating to the debate on risk and safety. Education and research strategies need to be developed so that the acupuncture profession can continue to minimize the likelihood of adverse events occurring in the future.
Publisher: BMJ
Date: 10-2004
Publisher: Springer Science and Business Media LLC
Date: 24-10-2009
Abstract: There is some evidence that acupuncture for pain and osteoarthritis (OA) of the knee is more than a placebo, and short term clinical benefits have been observed when acupuncture is compared to usual care. However there is insufficient evidence on whether clinical benefits of acupuncture are sustained over the longer term. In this study our key objectives are to inform the design parameters for a fully powered pragmatic randomised controlled trial. These objectives include establishing potential recruitment rates, appropriate validated outcome measures, attendance levels for acupuncture treatment, loss to follow up and the s le size for a full scale trial. Potential participants aged over 50 with pain and osteoarthritis of the knee were identified from a GP database. Eligible patients were randomised to either 'acupuncture plus usual care' and 'usual care' alone, with allocation appropriately concealed. Acupuncture consisted of up to 10 sessions usually weekly. Outcome measures included Western Ontario and McMaster Universities (WOMAC) index with the s le size for a full scale trial determined from the variance. From the GP database of 15,927 patients, 335 potential trial participants were identified and invited to participate. After screening responses, 78 (23%) were identified as eligible and 30 patients who responded most promptly were randomised to 'acupuncture plus usual care' (15 patients) and 'usual care' alone (15 patients). Attendance for acupuncture appointments was high at 90% of the maximum. Although the trial was not powered to detect significant changes in outcome, the WOMAC pain index showed a statistically significant reduction at 3 months in the acupuncture group compared to usual care. This was not sustained at 12 months. The s le size for a fully powered two-arm trial was estimated to be 350. This pilot study provided the evidence that a fully powered study to explore the longer term impact of acupuncture would be worthwhile, and relevant design features for such a trial were determined. ISRCTN25134802.
Publisher: Springer Science and Business Media LLC
Date: 12-2016
Publisher: Elsevier BV
Date: 10-2012
DOI: 10.1016/J.CTIM.2012.05.002
Abstract: The economic burden that chronic pain conditions impose on in iduals and society is significant. Acupuncture appears to be a clinically effective treatment for some chronic pain conditions. Given the need for policy decisions to be informed by economic evaluations, the objective of this systematic review was to synthesise data from economic evaluations to determine whether acupuncture for the treatment of chronic pain conditions is good value for money. A literature search was conducted using health and economics databases, with additional hand-searching. Economic evaluations conducted alongside randomised controlled trials were eligible. Eight economic evaluations were included in this review, seven cost-utility analyses and one cost-effectiveness analysis. Conditions treated included low back pain, neck pain, dysmenorrhoea, migraine and headache, and osteoarthritis. From the seven cost-utility analyses, acupuncture was found to be clinically effective but cost more. The cost per quality adjusted life year (QALY) gained ranged from £2527 to £14,976 per QALY, below the commonly quoted threshold used by the UK National Institute for Health and Clinical Excellence of £20,000 to £30,000. The one cost-effectiveness study indicated that there might be both clinical benefits and cost savings associated with acupuncture for migraine. There was heterogeneity across the eight trials in terms of professional who provided the acupuncture, style of acupuncture, and country of origin. The cost per QALY gained in all seven cost-utility studies was found to be below typical thresholds of willingness to pay. Acupuncture appears to be a cost-effective intervention for some chronic pain conditions.
Publisher: Public Library of Science (PLoS)
Date: 04-04-2014
Publisher: Public Library of Science (PLoS)
Date: 16-09-2013
Publisher: Elsevier BV
Date: 09-2014
DOI: 10.1016/J.JCLINEPI.2014.05.004
Abstract: To examine the feasibility of collecting data relating to irritable bowel syndrome (IBS), symptoms by short message service (SMS) text and explore the data to assess its usefulness. In a randomized parallel group design substudy, 59 consenting participants recruited from primary care to a trial of acupuncture for IBS (ISRCTN 08827905) were randomized to receive a one-question SMS message at either 9:30 am or at 6:30 pm for 7 days: "On a scale of 0-9, with 0 being no symptoms and 9 being the worst symptoms you could have, how would you score your IBS symptoms now? Please text back a single number." Of the total messages, 59% (n = 203) were answered within 15 minutes, 73.4% (n = 254) within 1 hour, and 97% (n = 334) within 10 hours. Response rates to evening texts were higher (93.5% vs. 87.6% P = 0.05) and response times shorter though not significantly (median: 0 vs. 5 hours P = 0.12). There was no difference in mean scores, and morning symptoms varied more. Mean scores correlated significantly with IBS trial primary outcome measure, the IBS symptom severity score, and secondary outcome measures. Among IBS trial participants, data collection by SMS is feasible and acceptable, and there is potential for deriving meaningful data from the scores.
Publisher: Ovid Technologies (Wolters Kluwer Health)
Date: 09-2011
Publisher: Oxford University Press (OUP)
Date: 25-08-2012
DOI: 10.1093/RHEUMATOLOGY/KES200
Abstract: 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. 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. 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. 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.
Publisher: Public Library of Science (PLoS)
Date: 13-02-2008
Publisher: Elsevier BV
Date: 06-2018
Publisher: Elsevier BV
Date: 11-2014
DOI: 10.1016/J.CTCP.2014.07.003
Abstract: The survey aimed to assess how often and in what ways herbal practitioners use comfrey (Symphytum officinale L.) externally in everyday practice. A 2-sided A4 survey was sent to all UK members of the National Institute of Medical Herbalists, the College of Practitioners of Phytotherapy and the Association of Master Herbalists with viable practice addresses (n = 598). 239 herbalists responded, of whom 179 (75%) reported regularly using comfrey, in 15% of their consultations. It was most commonly prescribed as a cream for tendon, ligament and muscle problems, for fractures, and for wounds, the indications for which it was also perceived to be most effective. Comfrey was rated least effective for haemorrhoids, varicose veins and boils and was considered to carry the greatest risk when prescribed for ulcers, wounds and boils. Practitioner experience suggests that comfrey can be used safely and effectively externally for certain indications.
Publisher: BMJ
Date: 05-2016
Publisher: Mary Ann Liebert Inc
Date: 11-2012
Abstract: The aim of this study was to evaluate the treatments delivered during a pragmatic effectiveness study of acupuncture for irritable bowel syndrome (IBS) and to explore the roles of Traditional Chinese Medicine (TCM) diagnoses and preferences of the acupuncturists in treatment design. Patients allocated to an acupuncture arm of a study were offered up to ten sessions of acupuncture over 3 months. Acupuncturists followed a flexible treatment protocol that allowed for treatment in idualization, use of additional therapies such as moxa, and provision of lifestyle advice. All treatments were recorded in logbooks and analyzed by content analysis. Seven primary and eight secondary TCM patterns were identified among the 113 patients with IBS, and were combined in various ways to produce unique diagnoses for 84% patients. Liver Qi Stagnation and D Heat were the most commonly reported patterns. Of the 126 acupuncture points used, a distinct core and supporting group of points was associated with each primary pattern. Each practitioner also utilized a distinct core and supporting group of points that reflected his/her preferences. Use of additional therapies (e.g., moxa) and provision of lifestyle advice (e.g., diet) were generally consistent with a particular practitioner. Data suggest that a patient's TCM diagnosis, the practitioner's preferences, and a patient's in idual characteristics beyond his/her diagnosis influence treatment delivery. In particular, TCM diagnoses appear to influence the acupuncture (i.e., point selection) aspect of treatment more than the selection of additional therapies and lifestyle advice. From another perspective, the treatments incorporated pragmatic, in idualized, and disease-specific approaches with combinations that produced both treatment commonalities and ersities.
Publisher: BMJ
Date: 09-2001
Publisher: Elsevier BV
Date: 12-2001
Abstract: Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.
Publisher: Elsevier BV
Date: 08-2014
DOI: 10.1016/J.JCLINEPI.2014.04.004
Abstract: To investigate the feasibility of conducting a cohort, factorial randomized controlled trial (RCT) in the treatment of patients with low back pain (LBP). Pragmatic feasibility factorial RCT nested within an observational cohort study in two general practices in York, United Kingdom. Eight hundred forty-five patients aged between 18 and 65 years who had consulted their general practitioner about LBP within the preceding 12 months were mailed an invitation to participate in a cohort trial, with the possibility of later joining a treatment RCT. One hundred twenty-four patients consented to participate in the cohort and treatment trial, and one consented only to the cohort only. Ultimately, 59 patients were randomized into the nested RCT. Outcomes included recruitment, acceptability, and attrition rates as measures of the feasibility of the design and Roland Morris Disability Questionnaire. No statistically significant differences in outcome between treatment groups and usual care were found. The design was feasible for the evaluation of different back pain treatments. We found zero attrition after randomization and showed that for a remitting relapsing condition, the design allows us to recruit initially ineligible patients from the cohort. Additional statistical analysis using regression discontinuity can also be used with this design.
Publisher: Elsevier BV
Date: 02-2010
DOI: 10.1016/J.BRAINRES.2009.12.019
Abstract: The needling sensation of deqi is considered by most acupuncturists to be an important component of acupuncture, yet neuroimaging research that investigates this needle sensation has been limited. In this study we have investigated the effect of deqi and acute pain needling sensations upon brain fMRI blood oxygen level-dependent (BOLD) signals. Seventeen right-handed participants who received acupuncture at the right LI-4 (Hegu) acupoint were imaged in a 3T MRI scanner. fMRI datasets were classified, on the basis of psychophysical participants' reports of needling scores, into those that were associated with predominantly deqi sensations versus those with predominantly acute pain sensations. Brain areas showing changes in BOLD signal increases (activations) and decreases (deactivations) were identified. Differences were demonstrated in the pattern of activations and deactivations between groupings of scans associated with deqi versus pain sensations. For the deqi grouping, significant deactivations occurred, whereas significant activations did not. In contrast, the predominantly acute pain grouping was associated with a mixture of activations and deactivations. For the comparison between the predominately deqi sensation grouping and the acute pain sensation grouping (deqi>pain contrast), only negative Z value voxels resulted (mainly from deactivations in the deqi grouping and activations in the pain grouping) in the limbic/sub-cortical structures and the cerebellum regions of interest. Our results show the importance of collecting and accounting for needle sensation data in neuroimaging studies of acupuncture.
Publisher: BMJ
Date: 15-09-2006
Publisher: Mary Ann Liebert Inc
Date: 11-2006
Publisher: Public Library of Science (PLoS)
Date: 08-06-2010
Publisher: Springer Science and Business Media LLC
Date: 14-11-2012
Publisher: BMJ
Date: 15-09-2006
Publisher: BMJ
Date: 10-2018
DOI: 10.1136/BMJOPEN-2017-020222
Abstract: To identify potentially effective complementary approaches for musculoskeletal (MSK)–mental health (MH) comorbidity, by synthesising evidence on effectiveness, cost-effectiveness and safety from systematic reviews (SRs). Scoping review of SRs. We searched literature databases, registries and reference lists, and contacted key authors and professional organisations to identify SRs of randomised controlled trials for complementary medicine for MSK or MH. Inclusion criteria were: published after 2004, studying adults, in English and scoring % on Assessing the Methodological Quality of Systematic Reviews (AMSTAR) quality appraisal checklist). SRs were synthesised to identify research priorities, based on moderate/good quality evidence, s le size and indication of cost-effectiveness and safety. We included 84 MSK SRs and 27 MH SRs. Only one focused on MSK–MH comorbidity. Meditative approaches and yoga may improve MH outcomes in MSK populations. Yoga and tai chi had moderate/good evidence for MSK and MH conditions. SRs reported moderate/good quality evidence (any comparator) in a moderate/large population for: low back pain (LBP) (yoga, acupuncture, spinal manipulation/mobilisation, osteopathy), osteoarthritis (OA) (acupuncture, tai chi), neck pain (acupuncture, manipulation/manual therapy), myofascial trigger point pain (acupuncture), depression (mindfulness-based stress reduction (MBSR), meditation, tai chi, relaxation), anxiety (meditation/MBSR, moving meditation, yoga), sleep disorders (meditative/mind–body movement) and stress/distress (mindfulness). The majority of these complementary approaches had some evidence of safety—only three had evidence of harm. There was some evidence of cost-effectiveness for spinal manipulation/mobilisation and acupuncture for LBP, and manual therapy/manipulation for neck pain, but few SRs reviewed cost-effectiveness and many found no data. Only one SR studied MSK–MH comorbidity. Research priorities for complementary medicine for both MSK and MH (LBP, OA, depression, anxiety and sleep problems) are yoga, mindfulness and tai chi. Despite the large number of SRs and the prevalence of comorbidity, more high-quality, large randomised controlled trials in comorbid populations are needed.
Publisher: Wiley
Date: 02-2009
DOI: 10.1111/J.1756-5391.2009.01008.X
Abstract: First published in 2001, STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture) was designed to expand on the reporting of one item within the CONSORT (Consolidated Standards of Reporting Trials) Statement checklist, the item relating to the intervention. Two recent reviews had found that STRICTA was highly regarded in the field and that there was a need for minor revisions. To revise STRICTA within the CONSORT family of reporting guidelines. A collaborative effort involving the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was agreed. A consultation process with 47 international experts provided detailed feedback on an initial draft of a revised checklist. These data, along with the two review studies, comprised the documentation for a consensus meeting in Freiburg, Germany in October 2008. A total of 21 participants attended the meeting, bringing their expertise as research methodologists, reporting guideline developers, acupuncturists, physicians and journal editors. At the workshop, a revised draft checklist was agreed. There was general consensus that STRICTA should continue to function as a stand-alone guideline as well as an extension to CONSORT. It was agreed that STRICTA should be sufficiently broad to cover all type of clinical studies, from case reports through uncontrolled studies to randomised controlled trials. It was also decided that explanations and ex les, as with other CONSORT reporting guidelines, would provide a useful way of supporting the uptake to the new recommendations when published. The checklist will be subjected to further revision processes in order to further its impact and support wider dissemination. Journals that regularly publish acupuncture trials will be encouraged to adopt the revised STRICTA, include it in their guidelines for authors, and promote the adoption of its recommendations for clinical studies of acupuncture.
Publisher: Mary Ann Liebert Inc
Date: 08-2005
Abstract: The aim of this study was to establish the feasibility of conducting a national safety survey involving patients of herbalists monitoring and reporting adverse events associated with the routine practice of Chinese herbal medicine. In June 2004, 549 herbalists who were members of the UK Register of Chinese Herbal Medicine were invited to ask 10 consecutive patients to participate in the survey. Consenting patients returned their baseline survey forms direct to the research center. Four (4) weeks later, patients were sent a follow-up questionnaire in which they reported adverse events that they perceived were caused by the Chinese herbal medicine over the previous 4 weeks. The data were analyzed with regard to types and frequencies of adverse events as well as potential risk factors using multilevel logistic regression and taking into account the clustering of patients with practitioners. Of the 161 responding practitioners of Chinese herbal medicine, 71 agreed to participate, comprising 13% of the total membership. A total of 194 patients returned baseline questionnaires, an average of 2.7 patients per practitioner, and 144 (74%) patients completed the 4-week follow-up questionnaires. A total of 20 patients, who were treated by 14 of the herbal medicine practitioners, reported 32 adverse events associated with Chinese herbal medicine over the 4-week period (14% of patients, 95% confidence interval [CI]: 9%-20%). No serious adverse events were reported. The most commonly reported adverse events were diarrhea, fatigue, and nausea. When controlling for potential confounders, patients consulting for Chinese herbal medicine for the first time were more likely to report an adverse event than were those who had consulted repeatedly (OR 3.03 95% CI: 1.03-8.89, p < 0.02). In this pilot study, the recruitment rate was low, with only 13% of practitioners participating and only 27% of potential patients returning consent forms, raising questions about potential bias. This research has provided some useful data that will assist in the initiation of future studies.
Publisher: BMJ
Date: 05-06-2014
Publisher: SAGE Publications
Date: 03-2013
DOI: 10.1136/ACUPMED-2013-010312
Abstract: In September 2012 the Acupuncture Trialists’ Collaboration published the results of an in idual patient data meta-analysis of almost 18 000 patients in high quality randomised trials. The results favoured 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 characterised by ad hominem remarks, anonymous criticism, phony expertise and the use of opinion to contradict data, predominantly by self-proclaimed sceptics. There was a near complete absence of substantive scientific critique. The lack of any reasoned debate about the main findings of the Acupuncture Trialists’ Collaboration paper underlines the fact that mainstream science has moved on from the intellectual sterility and ad hominem attacks that characterise the sceptics’ movement.
Publisher: Elsevier BV
Date: 04-2008
DOI: 10.1016/J.CTIM.2008.02.010
Abstract: In the literature on acupuncture research, the active (or specific) component of acupuncture is almost always presented as acupuncture needling alone. However, specific components, by definition, should include all interventions driven by acupuncture theory that are also believed to be causally associated with outcome. In this paper, we explore the delivery of self-help advice as a component of the process of acupuncture care, and discuss the implications for future trial designs. In a nested qualitative study, six acupuncturists were interviewed about the treatments they provided within a pragmatic clinical trial. The acupuncturists practised in idualised acupuncture according to traditional principles. Audiotapes were transcribed and coded and the contents analysed by case and by theme. The analysis focuses on a priori and emergent themes associated with the process of delivering self-help advice as described by the practitioners. In idualised self-help advice is seen by practitioners as being an integral part of the acupuncture treatment that they provide for patients with low back pain. Several categories of generic advice were described all were embedded in the acupuncture diagnosis. These included movement, exercise and stretching to move 'qi stagnation' rest in cases of 'qi deficiency' diet when the digestive system was compromised protection from the elements where indicated by the diagnosis, e.g. Bi Syndrome. According to the practitioners, longer-term benefits require the active participation of patients in their self-care. Simplified concepts derived from acupuncture theory, such as 'stagnation' and 'energy', are employed as an integral part of the process of care, in order to engage patients in lifestyle changes, help them to understand their condition, and to see ways in which they can help themselves. Within acupuncture care, self-help advice is not seen as an 'add-on' but rather as an integral and interactive component of a theory-based complex intervention. Studies designed to evaluate the overall effectiveness of traditional acupuncture should accommodate the full range of therapeutic components, strategies and related patient-centred treatment processes. In acupuncture trials, non-needling components, such as self-help advice, when drawn directly from the diagnosis and integral to the process of care, should not be misclassified as incidental, non-specific, or placebo if we are to accurately assess the value of treatment as delivered.
Publisher: Frontiers Media SA
Date: 2012
Publisher: Hindawi Limited
Date: 2011
DOI: 10.1093/ECAM/NEN044
Abstract: The objective of this study was to identify factors associated with general practitioner (GP) participation and the recruitment of people to trials in primary care, based on data from two trials of interventions for treating chronic low back pain. The study was based on data from two randomized controlled trials (RCTs), one involving exercise, the other acupuncture, and subsequent reporting by GPs in a postal questionnaire. The exercise trial achieved 62% recruitment whereas the acupuncture trial achieved 100% recruitment. In both trials GPs most efficient at referring patients were those with a special interest in the subject area, and those known personally to the research team. A follow-up GP questionnaire found that both trials had maintained a high profile with over 80% of GPs, and successful recruitment strategies included project reminder letters, updates and personal contacts. Achieving target recruitment of patients in the acupuncture trial was aided by the deliberate application of lessons learned in the exercise trial, in particular the need to keep initial study entry criteria broad, with subsequent filtering undertaken by the study researcher. In addition the use of effective methods of maintaining the trial profile, the involvement of a GP advisor, the decision to maximize the recruitment of GPs early in the trial and the direct recruitment of interested in idual GPs. The successful recruitment of patients to trials in primary care requires careful planning and continuous monitoring from the outset. Prior to starting recruitment, it is useful to identify previous trials in a similar environment in order to learn from their experience and optimize patient recruitment.
Publisher: SAGE Publications
Date: 08-2014
Publisher: Public Library of Science (PLoS)
Date: 21-02-2013
Publisher: Elsevier BV
Date: 11-2010
DOI: 10.1016/J.JCLINEPI.2010.01.010
Abstract: A survey of randomized controlled trials found that almost a quarter of trials had more than 10% of responses missing for the primary outcome. There are a number of ways in which data could be missing: the subject is unable to provide it, or they withdraw, or become lost to follow-up. Such attrition means that balance in baseline characteristics for those randomized may not be maintained in the subs le who has outcome data. For in idual trials, if the attrition is systematic and linked to outcome, then this will result in biased estimates of the overall effect. It then follows that if such trials are combined in a meta-analysis, it will result in a biased estimate of the overall effect and be misleading. The aim of this study was to investigate the impact of attrition on baseline imbalance within in idual trials and across multiple trials. In this article, we used in idual patient data from a convenience s le of 10 trials evaluating interventions for the treatment of musculoskeletal disorders. Meta-analyses using the mean difference at baseline between the trial arms were carried out using in idual patient data from these trials. The analyses were first carried out using all randomized participants and secondly only including participants with outcome data on the quality-of-life score. Meta-regression was carried out to evaluate whether the level of baseline imbalance was associated with the level of attrition. The overall attrition rates for the quality-of-life score ranged between 4% and 28% of the total randomized patients. All trials showed some level of differential attrition between the treatment arms, ranging from 1% to 14%. Attrition within the control group ranged from 3% to 25% and within the intervention group, it ranged from 0% to 31%. For in idual trials, there was no indication that attrition altered the results in favor of either the treatment or the control. Forest plots highlighted that the attrition had some impact on the baseline imbalance for the primary outcome score as more heterogeneity was introduced (I-squared value of 0.4% for the initial data set vs. I-squared value of 16.9% for the analyzed data set). However, the standardized mean difference increased only slightly (from 0.01 to 0.03 with 95% confidence interval [CI]: -0.05, 0.10). Meta-regression showed little or no evidence of a significant dose-response relationship between the level of attrition and the baseline imbalance (coefficient 0.73, 95% CI: -0.81, 2.28). Although, in theory, attrition can introduce selection bias in randomized trials, we did not find sufficient evidence to support this claim in our convenience s le of trials. However, the number of trials included was relatively small, which may have led to small but important differences in outcomes being missed. In addition, only 2 of 10 trials included had attrition levels greater than 15% suggesting a low level of potential bias. Meta-analyses and systematic reviews should always consider the impact of attrition on baseline imbalances and where possible any baseline imbalances in the analyzed data set and their impact on the outcomes reported.
Publisher: Mary Ann Liebert Inc
Date: 06-2001
DOI: 10.1089/107555301300328133
Abstract: To determine patients' experience of outcomes after acupuncture treatment. A patient questionnaire followed by semistructured interviews. Acupuncture practices in York, England. Questionnaires were distributed by 4 acupuncturists to all 132 of their patients over a 2-week period, 72 (55%) of whom responded. Of these, 11 patients were interviewed. Patients received normal care from their acupuncturists, all of whom were members of the British Acupuncture Council. Patients reported on physical symptoms, emotional/mental symptoms, lifestyle changes, major life changes and inner life changes affecting outlook and attitudes to health. Patients also reported on the extent they attributed change to acupuncture and what they valued about attending for treatment. Primary reasons for attending were categorized by patients as physical symptoms (90%), mental and emotional problems (9%) and general health and well-being (1%). For physical symptoms, 75% of patients reported definite change for emotional and mental symptoms, 67% lifestyle changes, 40%, major life changes, 27% and for inner life changes, 54%. Over time, many of the patients (42%) changed their primary reason for attending from their initial physical concerns, half of whom describing their new focus as related to general health and well-being. Some emotional changes were experienced by 83% of patients, irrespective of the initial reason for attending. For all these changes, 58% of patients reported that they "substantially" attributed the changes to acupuncture, and 25% "totally". The interviews provided additional data on the depth of the changes particularly for the longer term patients and on what they valued about treatment. Treatment with acupuncture results in a broad range of outcomes from physical and emotional change through to wider benefits involving the patients' lifestyle, outlook, and attitude toward their health. Existing outcome measures are not adequate to assess these wider benefits. The results suggest that patients experienced holistic benefits from acupuncture, an outcome that could be described as holism-in-action.
Publisher: Public Library of Science (PLoS)
Date: 08-09-2014
Publisher: Elsevier BV
Date: 05-2018
Publisher: Medical Association of Pharmacopuncture Institute
Date: 08-2012
DOI: 10.1016/J.JAMS.2012.05.001
Abstract: The rising incidence of chronic disease and stress-related illness in the West, coupled with an expanding awareness of the unwanted side effects of pharmaceutical treatment, has led to an increased utilization of acupuncture as a contemporary health care option. This increase in utilization, in turn, has paralleled a response to the call for evidence, with the result that acupuncture is now supported by a broad range of surveys of safety, clinical trials and basic science studies of physiologic action. The combined impact of these studies is linked to a growing acceptance of this traditional medical practice. The present review takes a wide-angle look at these three major areas of acupuncture research, namely: safety and the risks of serious adverse events clinical efficacy and effectiveness and physiologic action. We identify advances in knowledge and present a point counterpoint approach to controversial issues, with the aim of offering clarification if not a measure of resolution.
Publisher: American Medical Association (AMA)
Date: 22-10-2012
Publisher: Elsevier BV
Date: 03-2008
DOI: 10.1016/J.NEULET.2008.01.058
Abstract: The difference between superficial and deep needling at acupuncture points has yet to be mapped with functional magnetic resonance imaging (fMRI). Using a 3T MRI, echo planar imaging data were acquired for 17 right-handed healthy volunteer participants. Two fMRI scans of acupuncture needling were taken in random order in a block design, one for superficial and one for deep needling on the right hand at the acupuncture point LI-4 (Hegu), with the participant blind to the order. For both scans needle stimulation was used. Brain image analysis tools were used to explore within-group and between-group differences in the blood oxygen level dependent (BOLD) responses. The study demonstrated marked similarities in BOLD signal responses between superficial and deep needling, with no significant differences in either activations (increases in BOLD signal) or deactivations (decreases in BOLD signal) above the voxel Z score of 2.3 with corrected cluster significance of P=0.05. For both types of needling, deactivations predominated over activations. These fMRI data suggest that acupuncture needle stimulation at two different depths of needling, superficial and deep, do not elicit significantly different BOLD responses. This data is consistent with the equivalent therapeutic outcomes that are claimed by proponents of Japanese and Chinese styles of acupuncture that utilise superficial and deep needling, respectively.
Publisher: Springer Science and Business Media LLC
Date: 06-09-2012
Publisher: Elsevier BV
Date: 06-2004
DOI: 10.1016/J.CTIM.2004.07.043
Abstract: Both pragmatic and explanatory randomised controlled trials have a useful role to play in the evaluation of health care interventions. In this descriptive article, the key steps in conducting a pragmatic trial are described. The strengths and limitations of pragmatic trials are also discussed. The main strength of pragmatic trials is that they can evaluate a therapy as it is used in normal practice. Comparisons are made between pragmatic and explanatory trials, on the understanding that trials may have aspects to them that make the trial more of a hybrid. A case is made for the appropriate use and relevance of pragmatic trials in the evaluation of alternative and complementary medicine.
Publisher: Elsevier BV
Date: 05-2018
Publisher: Wiley
Date: 20-01-2010
Publisher: Wiley
Date: 04-03-2011
Publisher: Oxford University Press (OUP)
Date: 06-2012
DOI: 10.1093/RHEUMATOLOGY/KES133
Abstract: To critically review the evidence on the effectiveness of complementary therapies for patients with RA. 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. 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 in idual time points in the healing therapy and magnet therapy studies. A small number of other outcomes showed comparative improvement in in idual trials. There were no reports of major adverse events. 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.
Publisher: Springer Science and Business Media LLC
Date: 24-10-2012
Publisher: Mary Ann Liebert Inc
Date: 11-2007
Abstract: To inform the potential revision of Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA), we sought the opinion of acupuncture trial authors and systematic reviewers to rank the utility of the guidelines and asked trial authors about their experiences using them. Questionnaires ranking STRICTA items and qualitative responses about experience using the guidelines. The authors of 38 randomized controlled acupuncture trials randomly selected from a systematic search of those published in 2004 and 2005 were contacted with a questionnaire. Authors of 14 Cochrane acupuncture systematic reviews or protocols published in the same time frame were also sent a questionnaire. Fifty-four percent (54%) (28/52) of the s le responded. Among the trial authors, 58% (11/19) used STRICTA to help guide their writing, but more than half of these reported that the editing process had removed some or all of the STRICTA-specific items. STRICTA was seen as a helpful reference, but authors requested that some items be clarified. Respondents tended to rank the utility of STRICTA highly overall, but five items in particular were not highly valued three of these pertained to details on the trial acupuncturists' background. Authors flagged potential difficulties of reporting unusual trial designs in the current format of STRICTA. Authors of acupuncture trials and systematic reviews believe that STRICTA contributes to the reporting of acupuncture interventions and rate it highly. Because very few acupuncture studies are published in STRICTA-adopting journals, the editing process for journals unaware of the guidelines may be responsible for deleting acupuncture intervention-specific items. Several items remain unclear, and the relevance of STRICTA to some trial designs is questioned. A review of STRICTA is warranted to clarify and reconsider items, and targeted promotion to non-complementary and alternative medicine journals should be considered.
Publisher: Public Library of Science (PLoS)
Date: 11-10-2013
Publisher: Mary Ann Liebert Inc
Date: 06-1999
Publisher: Elsevier BV
Date: 06-2003
DOI: 10.1016/S0965-2299(03)00042-6
Abstract: To investigate the attitudes of General Practitioners (GPs) to acupuncture, whether they think it should be available on the NHS and, if so, how it should be provided. Attitudinal postal survey. All 65 practising GPs in the 12 GP practices of the Melton Rutland & Harborough Primary Care Group, UK. A response rate of 83% was achieved. The main findings show that 59% of GPs agreed that acupuncture should be available on the NHS, 83% agreed that it can be clinically useful and 72% that it can be cost effective. Among GPs who acknowledged the potential for an increased role for acupuncture on the NHS there was support for the provision of treatment from either medical or non-medical practitioners, delivered at either NHS or non-NHS premises, and with the NHS providing some, or all, of the required funding. The findings suggest that a majority of GPs are in favour of acupuncture being more widely available on the NHS.
Publisher: Wiley
Date: 03-2010
DOI: 10.1111/J.1533-2500.2009.00337.X
Abstract: There is controversy as to whether or not acupuncture is more effective than placebo. To help clarify this debate, we synthesized the evidence gathered from systematic reviews on the pooled data of high-quality randomized controlled trials comparing acupuncture to sham acupuncture for chronic pain. Systematic reviews of acupuncture for the most commonly occurring forms of chronic pain (back, knee, and head) published between 2003 and 2008 were sourced from Ovid databases: Medline, Allied and Complementary Medicine database, Cochrane Library and Web of Science during December 2008. Eight systematic reviews with meta-analyses of pooled data were eligible for inclusion. Data were extracted for short- and longer-term outcomes for the most commonly occurring forms of pain. Two independent reviewers assessed methodological quality. For short-term outcomes, acupuncture showed significant superiority over sham for back pain, knee pain, and headache. For longer-term outcomes (6 to12 months), acupuncture was significantly more effective for knee pain and tension-type headache but inconsistent for back pain (one positive and one inconclusive). In general, effect sizes (standardized mean differences) were found to be relatively small. The accumulating evidence from recent reviews suggests that acupuncture is more than a placebo for commonly occurring chronic pain conditions. If this conclusion is correct, then we ask the question: is it now time to shift research priorities away from asking placebo-related questions and shift toward asking more practical questions about whether the overall benefit is clinically meaningful and cost-effective?
Publisher: Springer Science and Business Media LLC
Date: 24-10-2012
Publisher: Mary Ann Liebert Inc
Date: 09-2008
Publisher: Mary Ann Liebert Inc
Date: 09-2008
Publisher: Elsevier BV
Date: 06-1999
DOI: 10.1016/S0965-2299(99)80086-7
Abstract: To pilot procedures to be used in a randomized controlled trial of acupuncture for low back pain. Uncontrolled clinical trial. Primary care and acupuncture clinics in York, England. 20 patients with low back pain lasting 1 month or more. 10 sessions of in idualized acupuncture from a traditional acupuncturist. Change in Oswestry low back pain disability questionnaire present pain intensity scale effect on daily living scale, and SF-36 general health questionnaire at post-treatment and 6 months after the end of treatment. 14 patients completed follow-up. Patients had similar severity scores at baseline to those referred to an NHS outpatient clinic. Post-treatment, there were statistically significant improvements in Oswestry, present pain intensity, effect on daily living and the physical functioning, social functioning, bodily pain, vitality and mental health sub-scales of the SF36. Similar results were found at the six month follow-up. Oswestry scores showed reduced levels of pain at 6 months compared to than at post-treatment, falling approximately 40% from baseline. Though the improvements in pain and quality in life may be due to the natural course of back pain, the promising responses justify further research. The procedures used in the study are appropriate for a randomized controlled trial. Drop-out could be reduced by more careful patient monitoring.
Publisher: BMJ
Date: 2012
Publisher: Elsevier BV
Date: 03-2004
Publisher: Mary Ann Liebert Inc
Date: 09-2010
Publisher: BMJ
Date: 31-10-2008
DOI: 10.1136/BMJ.A1864
Abstract: To systematically review fully randomised patient preference trials and to explore the impact of preferences on attrition and outcome by meta-analysis of patient level data. Citation search using Science Citation Index and Google Scholar and search of the main electronic databases (Medline, CINAHL, Embase, and AMED) with a combination of key words. Fully randomised patient preference trials that compared treatments for any clinical condition were included. Other types of preference trials and crossover trials were excluded. Other inclusion criteria: participants aged 16 years and over primary, self-reported outcomes measured on a continuous numerical scale. From 167 studies identified and screened, 17 were identified as fully randomised patient preference trials. Of the 17 trials identified, 11 authors provided raw data for the meta-analysis. Data collected were baseline and follow-up data for the main outcome, randomised allocation data, preference data, and demographic data. Baseline and first post-intervention follow-up data for the main outcome were standardised. To improve homogeneity, data for only the eight musculoskeletal trials (n=1594) were combined. To estimate the effects of preferences on outcomes and attrition, three groups were compared: patients who had a preference and were randomly allocated to their preferred treatment patients who had a preference and were randomly allocated to the treatment they did not prefer and patients who had no preference. Patients who were randomised to their preferred treatment had a standardised effect size greater than that of those who were indifferent to the treatment assignment (effect size 0.162, 95% confidence interval 0.011 to 0.314 P=0.04). Participants who received their preferred treatment also did better than participants who did not receive their preferred treatment (effect size 0.152, -0.035 to 0.339), although this was not statistically significant (P=0.11). Participants allocated to their undesired treatment had outcomes that were no different from those who were indifferent. Participants who were allocated to their undesired treatment were less likely to be lost to first follow-up compared with indifferent participants (odds ratio 1.70, 1.076 to 2.693 P=0.02). No difference was found in attrition between patients allocated to their preference and those who were indifferent. Preferences among patients in musculoskeletal trials are associated with treatment effects. In open randomised trials, preferences should be ascertained before randomisation.
Publisher: Elsevier BV
Date: 10-2006
DOI: 10.1016/J.PEC.2005.11.006
Abstract: To measure acupuncture patients' perceptions of practitioner empathy at the initial consultation and its relationship with patient enablement, and prospectively reported changes in symptoms. Fifteen acupuncturists asked consecutive new patients to complete a questionnaire within 2 days of the first consultation. The questionnaire included the Consultation and Relational Empathy (CARE) measure (a consultation process measure), the Patient Enablement Instrument (PEI, a consultation outcome measure) and the Measure Yourself Medical Outcome Profile (MYMOP), a patient-centred symptom, well-being and activity outcome measure. A postal follow-up questionnaire was completed at 8 weeks, which repeated these measures. Fifty-two patients (58% of all new patients) completed the initial questionnaire. Of these, 41 (79%) completed the follow-up questionnaire. From a multiple regression analysis, which controlled for known confounders, empathy was found to be associated with enablement at the initial consultation (Beta coefficient=0.16, 95% CI: 0.02-0.31, p=0.03) and empathy-predicted changes in health outcome (MYMOP) at 8 weeks (Beta=0.07, 95% CI: 0.004-0.13, p=0.04). Patients' perception of practitioner empathy was associated with patient enablement at initial consultation and predicted changes in health outcome at 8 weeks. The empathy of practitioners, as perceived by patients, has a direct impact on patient enablement and health outcome.
Publisher: Elsevier BV
Date: 12-2013
DOI: 10.1016/J.CTIM.2013.09.009
Abstract: External preparations of the herb comfrey (most commonly Symphytum officinale L.) are widely available for over-the-counter, practitioner and healthcare professional usage. Traditional practice suggests comfrey can be used to treat musculoskeletal disorders, wounds and various other conditions however a full and critical coverage of the evidence base has not yet been undertaken. A critical scoping review was undertaken. Six bibliographic databases, 10 grey literature databases and nine trials registers were searched plus reference lists of included studies and a descriptive overview of comfrey. Randomised or non-randomised clinical trials assessing the external use of comfrey for any indication were included and methodological and reporting quality were assessed. Observational studies were included only in the assessment of adverse events. Studies were grouped and summarised according to the type of indication treated. Of 1348 identified records, 64 full texts were screened for inclusion and 26 were included in the review - 13 RCTs, 5 non-randomised controlled trials and 8 observational studies evaluating treatments for ankle distortion, back pain, abrasion wounds, venous leg ulcers and osteoarthritis. The majority of included trials had an overall unclear risk of bias due to poor quality of reporting. Few adverse events were reported. In idual clinical trials showed evidence of benefit for ankle distortion, back pain, abrasion wounds and osteoarthritis. Topical application appears to be safe but further rigorous assessment is needed. Systematic reviews focussing on particular indications may clarify the treatment effect and safety of external comfrey preparations.
Publisher: Elsevier BV
Date: 11-2016
DOI: 10.1016/J.JCLINEPI.2016.05.011
Abstract: To assess whether short message service (SMS) text messages sent as prenotification or postnotification reminders improve questionnaire response rates in randomized controlled trial (RCT) follow-up. Three "trials within a trial" assessed text message notifications sent before or after receipt of a follow-up questionnaire within an RCT for patients with depression. Consenting patients (n = 523) were randomized to receive a prenotification or no notification at 3 months, prenotification or postnotification at 6 months, and a postnotification or no notification at 12-month follow-up. Unadjusted and adjusted questionnaire return rates and time to return were compared. The two trials comparing prenotification or postnotification with no notification at 3- and 9-month follow-up found no evidence of an effect on questionnaire response rates (3-month response rate: 82.9% vs. 84.7% (difference 1.79%, 95% confidence interval [CI] -4.53% to 8.11%, P = 0.58) 9-month response rate: 77.1% vs. 78.5% (difference = -1.44%, 95% CI -8.56% to 5.67%, P = 0.69). For the trial at 6-month follow-up, there was a statistically significant difference in response rates for postnotification (83.2%) compared with prenotification (75.2%), (difference 7.95%, 95% CI 1.00% to 14.91%, P = 0.02). SMS as a prenotification device seems ineffective. For postnotification, the evidence is unclear.
Publisher: Mary Ann Liebert Inc
Date: 11-2006
Abstract: In the medical and scientific literature, there is a dearth of reports about how acupuncturists work and deliver care in practice. An informed characterization of the treatment process is needed to support the appropriate design of evaluative studies in acupuncture. The design was that of a nested qualitative study within a pragmatic clinical trial. Six acupuncturists who treated up to 25 patients each were interviewed after the treatment phase of the trial to obtain an account of their experiences of providing acupuncture care to patients with low back pain referred by their GP. Using semistructured interviews and a topic guide, data were collected and analyzed for both a priori and emergent themes. This paper focuses on practitioners' accounts of the goals and processes of care, and describes the strategies employed in addition to needling and other hands-on treatments. From the interview data, it is clear that a coherent body of theoretical knowledge informed clinical decisions and practice, and that the goals of treatment went beyond the alleviation of immediate pain-related symptoms. Acupuncturists in this study all described a pattern of patient-centered care based on a therapeutic partnership. Study participants confirmed the importance of three processes that characterized acupuncture care in this trial, each contributing to the goal of a positive long-term outcome building a therapeutic relationship in idualizing care and facilitating the active engagement of patients in their own recovery. Acupuncturists described elements of care that characterized these processes including establishing rapport, facilitating communication throughout the period of care, using an interactive diagnostic process, matching treatment to the in idual patient, and the use of explanatory models from Chinese medicine to aid the development of a shared understanding of the patient's condition and to motivate lifestyle changes that reinforce the potential for a recovery of health. Acupuncturists did not view these therapeutic goals, processes, and strategies as a departure from their usual practice. This study suggests that acupuncture care for patients with chronic conditions such as low back pain is likely to be a complex intervention that utilizes a number of patient-centered strategies to elicit longterm therapeutic benefits. Research designed to evaluate the effectiveness of acupuncture as it is practiced in the UK needs to accommodate the full range of therapeutic goals and related treatment processes.
Publisher: Elsevier BV
Date: 06-2001
Publisher: Elsevier BV
Date: 08-2018
Publisher: BMJ
Date: 09-2009
DOI: 10.1136/BMJ.B3335
Publisher: Mary Ann Liebert Inc
Date: 12-2009
Publisher: SAGE Publications
Date: 06-2013
DOI: 10.1136/ACUPMED-2012-010286
Abstract: In trials, ‘therapist intensive’ complex interventions are typically delivered over time, during which a relationship between the practitioner and participant may develop. Such relationships are sometimes criticised as obscuring any ‘true’ treatment effect. Limiting interactions is one strategy that might be used to try to control for the effect of a therapeutic relationship. We conducted systematic review into the rationale, methods and effects of constraining relationships in controlled trials and cohort studies of acupuncture, including studies published before 2008 with an update citation search in 2010. We searched six databases without keyword restrictions. Meta-analysis and meta-regression were used to explore the effect of relationship constraint on pain outcomes. Eighty-one of 785 (10.3%) trials reported constraining relationships. Most did not state the reason for constraint, describe the nature of the limitation, provide information on how the constrained relationship was monitored or note protocol adherence. Where a reason was reported, this was primarily to maintain participant blinding, rarely was it stated that the constraint was to control the therapeutic relationship. We found no evidence of an effect of constraint on pain outcomes (percentage heterogeneity explained, p=0.89). These results were robust to variation in trial quality and design. Acupuncture trials appear to be constrained mostly to try to prevent participant unblinding to their allocated treatment, not to control the therapeutic relationship. The apparent lack of monitoring and negligible effects on pain outcomes of the included trials indicate the need for more high-quality randomised controlled trials investigating the effect of constraint.
Publisher: Hindawi Limited
Date: 2007
DOI: 10.1093/ECAM/NEL079
Abstract: The purpose of this paper is to bring clarity to the emerging conceptual and methodological literature that focuses on understanding and evaluating complex or ‘whole’ systems of healthcare. An international working group reviewed literature from interdisciplinary or interprofessional groups describing approaches to the evaluation of complex systems of healthcare. The following four key approaches were identified: a framework from the MRC (UK), whole systems research, whole medical systems research described by NCCAM (USA) and a model from NAFKAM (Norway). Main areas of congruence include acknowledgment of the inherent complexity of many healthcare interventions and the need to find new ways to evaluate these the need to describe and understand the components of complex interventions in context (as they are actually practiced) the necessity of using mixed methods including randomized clinical trials (RCTs) (explanatory and pragmatic) and qualitative approaches the perceived benefits of a multidisciplinary team approach to research and the understanding that methodological developments in this field can be applied to both complementary and alternative medicine (CAM) as well as conventional therapies. In contrast, the approaches differ in the following ways: terminology used, the extent to which the approach attempts to be applicable to both CAM and conventional medical interventions the prioritization of research questions (in order of what should be done first) especially with respect to how the ‘definitive’ RCT fits into the process of assessing complex healthcare systems and the need for a staged approach. There appears to be a growing international understanding of the need for a new perspective on assessing complex healthcare systems.
Publisher: SAGE Publications
Date: 02-2014
DOI: 10.1136/ACUPMED-2013-010364
Abstract: To illustrate the pitfalls of using meta-analysis to combine estimates of effect in trials that are highly varied and have a high potential for bias. We used a random-effects meta-analysis to pool the results of 51 sham-controlled acupuncture trials of chronic pain published in English before 2008 and explored the heterogeneity using meta-regression. We repeated the process on a subset of these trials that used a visually credible non-penetrating sham device as control (N = 12). In both analyses there were high levels of heterogeneity and many studies were at risk from potential bias. The heterogeneity was not explained by meta-regression. Trials of interventions that have high potential for bias, such as many in the acupuncture literature, do not meet the assumptions of the statistical procedure that underlie random-effects meta-analysis. Even in the absence of bias, heterogeneity in meta-analyses is not accounted for by the CIs around the pooled estimate.
Publisher: Springer Science and Business Media LLC
Date: 2013
Publisher: Springer Science and Business Media LLC
Date: 10-2012
Abstract: Difficulty in controlling attention can lead to mental fatigue in the healthy population. We identified one trial reporting a benefit in patients’ attention using a homeopathic formula preparation. One component of the preparation was potassium phosphate, widely available off the shelf as Kali phos 6x for cognitive problems. The aim of this exploratory trial was to assess the effectiveness of Kali phos 6x for attention problems associated with mental fatigue. We recruited student and staff volunteers (University of York) with self-reported mental fatigue, excluding any using homeopathy or prescribed stimulants, or with a diagnosis of chronic fatigue syndrome. In a triple blind, cross-over, placebo-controlled clinical trial, 86 volunteers were randomized to receive Kali phos 6x or identical placebo 10 minutes before taking a psychological test of attention (Stroop Colour-Word Test). One week later they were crossed over and took the other preparation before repeating the test. We found no evidence of a treatment effect in a comparison of Kali phos 6x with placebo ( Kali phos minus placebo = −1.1 (95% CI −3.0 to 0.9, P = 0.3) Stroop score units, Cohen effect size = −0.17) even when allowing for a weak period effect with accuracy scores in the second period being higher than those in the first (P = 0.05). We observed a ceiling effect in the Stroop test which undermined our ability to interpret this result. Kali phos 6x was not found to be effective in reducing mental fatigue. A ceiling effect in our primary outcome measure meant that we could not rule out a type II error. Thorough piloting of an adequate outcome measure could have led to an unequivocal result. ISRCTN16521161
Publisher: Mary Ann Liebert Inc
Date: 09-2006
Abstract: Many English language words have been used to describe the acupuncture needle sensation known as de qi, words such as dull, aching, and spreading. However, there is little agreement on which actual words are acceptable as descriptors. In experimental trials of acupuncture in which the needle sensation is an important variable, a quantitative measure is needed to monitor and control for variability in de qi. An established scale in the literature provides a list of 25 sensations associated with acupuncture needling that patients might experience. An international group of acupuncture experts rated these 25 sensations in two categories: those predominantly associated with de qi and those with acute pain at the site of needling. For each category, sensations were classified into hierarchic clusters, one for de qi and one for acute pain, and the results were presented in dendrograms. Twenty-nine international experts were invited to participate 22 (76%) responded and 20 completed the questionnaire. On average, they had 21 years' experience in acupuncture practice (range 10-30 years). Seven sensations were found to be in the cluster associated with de qi: aching, dull, heavy, numb, radiating, spreading, and tingling. Nine sensations were found to be in a cluster associated with acute pain at the site of needling: burning, hot, hurting, pinching, pricking, sharp, shocking, stinging, and tender. The experts also raised a number of issues regarding the limitations of the questionnaire used, providing useful data for future research. Data from experienced acupuncturists have been analyzed to provide two separate clusters of sensations associated with acupuncture needling: a de qi cluster and an acute pain cluster. In the design of experimental trials involving acupuncture needling, researchers will find these two clusters of sensations useful for monitoring and controlling for variation in needle sensation.
Publisher: Mary Ann Liebert Inc
Date: 05-2014
Publisher: Oxford University Press (OUP)
Date: 08-01-2007
Abstract: Rapid Access Chest Pain Clinics have recently been introduced to assist in the management of primary care patients experiencing suspected cardiac chest pain. To study the longer term outcome for patients referred to a Rapid Access Chest Pain Clinic and then given a non-cardiac diagnosis. The study collected retrospective data from a cohort of all patients attending the Rapid Access Chest Pain Clinic based in the cardiorespiratory Department at the York District Hospital, England. Questionnaires were sent to all patients who attended the Rapid Access Chest Pain Clinic during the previous 14 months and were diagnosed with non-cardiac chest pain. Participants reported on their chest pain, subsequent episodes of primary and secondary care and their beliefs about causation of pain. Of the patients referred to the Rapid Access Chest Pain Clinic, 235 (52%) did not have cardiac chest pain. Of these patients, 161 (69%) returned the questionnaire, nearly half of whom reported ongoing chest pain. The mean time since Clinic attendance was approximately 8 months and the median duration of ongoing chest pain was 5.4 months. Women were twice as likely as men to continue to be experiencing pain but did not report more frequent or severe pain on average. More than 50% of the non-cardiac group were not convinced by their negative cardiac diagnosis. There is an ongoing challenge to support patients with non-cardiac chest pain, including the provision of reassurance that their pain is very unlikely to be caused by their heart.
Publisher: Mary Ann Liebert Inc
Date: 02-2002
DOI: 10.1089/107555302753507212
Abstract: Acupuncture treatment and control group interventions in parallel-group randomized trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.
Publisher: Hindawi Limited
Date: 2011
DOI: 10.1155/2011/180805
Abstract: In November 2007, the Society for Acupuncture Research (SAR) held an international symposium to mark the 10th anniversary of the 1997 NIH Consensus Development Conference on Acupuncture. The symposium presentations revealed the considerable maturation of the field of acupuncture research, yet two provocative paradoxes emerged. First, a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture, findings apparently at odds with traditional theories regarding acupuncture point specificity. Second, although many studies using animal and human experimental models have reported physiological effects that vary as a function of needling parameters (e.g., mode of stimulation) the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. This White Paper, collaboratively written by the SAR Board of Directors, identifies gaps in knowledge underlying the paradoxes and proposes strategies for their resolution through translational research. We recommend that acupuncture treatments should be studied (1) “top down” as multi-component “whole-system” interventions and (2) “bottom up” as mechanistic studies that focus on understanding how in idual treatment components interact and translate into clinical and physiological outcomes. Such a strategy, incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for such complex interventions as acupuncture.
Publisher: Springer Science and Business Media LLC
Date: 09-01-2009
Publisher: Elsevier BV
Date: 03-2006
DOI: 10.1016/J.CTIM.2005.07.005
Abstract: To explore patient perceived benefits of acupuncture for tinnitus. Controlled n=1 trials, with two phases A and B. Six patients with tinnitus. Primary outcome was Daily Diary records related to four tinnitus symptoms: loudness of tinnitus pitch of tinnitus waking hours affected with tinnitus quality of sleep. Secondary outcomes were the Tinnitus Handicap Inventory (THI) and Measure Your Medical Outcome Profile (MYMOP). Patients received a course of 10 acupuncture treatments over a 2-week period. Daily Diary entries related to the four tinnitus symptoms were recorded by patients for 14 days pre-treatment (phase A) and 14 days post-treatment (phase B). A hierarchical Bayesian model was used to combine the results from the in idual patients to obtain estimates of the population and in idual patient treatment effects, incorporating random variations at both levels (between patients and within patient). Tinnitus Handicap Inventory (THI) and Measure Your Medical Outcome Profile (MYMOP) were recorded at assessment points pre-treatment and post-treatment. Six patients participated in the trials, each receiving 10 treatments and completing all Daily Diary entries and outcome measures. For the of symptoms of loudness and pitch, there were variable treatment effects between patients, with a trend for the median overall reduction for loudness of -2.49 (-5.04, 0.02) and for pitch -1.39 (-3.74, 0.89), 95% credibility intervals being shown in brackets. For the other two symptoms, the waking hours affected and quality of sleep, patients' responses were more consistent, with amore credible overall median reduction for affected waking hours of -2.76 (-3.94, -1.63) and for quality of sleep -2.72 (-3.45, -2.03). The THI and MYMOP measures showed a trend of improvement after treatment. The n=1 trial methodology, with an AB design and Bayesian analysis, can be considered of value in exploring treatment effects for small numbers of patients receiving in idualised treatments, as is common within complementary medicine. When the treatment effects from six patients were synthesized, the results of this study suggest that acupuncture may have a beneficial role in the treatment of tinnitus.
Publisher: Elsevier BV
Date: 03-2006
DOI: 10.1016/J.CTIM.2005.07.006
Abstract: The primary aim was to describe the characteristics of acupuncture patients and in particular the main problem or symptom for which they were seeking treatment. Our secondary aim was to compare the profiles of acupuncture patients with those of a patient survey undertaken in 1988. We used the data from a recent prospective adverse event survey of a representative s le of 9408 acupuncture patients who were consulting members of the British Acupuncture Council. We analysed patient reports of demographic details, pathways to care, whether the National Health Service paid for their treatment, whether they had previously consulted a GP or hospital specialist for their main problem and whether they were consulting an acupuncturist for the first time. We separately analysed equivalent data from a survey funded by the Nuffield Provincial Hospital Trust undertaken in 1988. Seventy-four percent of patients were female, and with an average age of 51 years. Most commonly, patients had self-referred (39%), had previously consulted their doctor about their problem or symptom (78%), were paying for their own treatment (95%), and had received acupuncture before (87%). The most common main problem or symptom reported by patients was musculo-skeletal (38%), followed by psychological (11%), general (9%), neurological (8%) and gynaecological/obstetric (8%), while 5% of patients were seeking treatment for their general well-being. In comparing our data with that of the 1988 survey, we found a number of changes over time, in particular the proportion of musculo-skeletal conditions had dropped significantly (chi(2) = 17.36, d.f. = 1, p < 0.001), indicating a wider case mix amongst patients compared with those seeking care in 1988. This evidence from acupuncture patients' reports shows that musculo-skeletal problems provide the main reason for seeking treatment. The large dataset from this study provides a wealth of information and a fresh raft of questions which will inform future research and policy-making.
Publisher: Elsevier BV
Date: 12-2018
Publisher: Elsevier BV
Date: 03-2013
DOI: 10.1016/J.JCLINEPI.2012.09.011
Abstract: To review reporting of preferences in acupuncture studies and their effect on clinical outcomes. Systematic review of published randomized and quasi-randomized controlled trials of acupuncture reporting participant preferences for randomization or treatment or using a preference design. Of the 31 included trials, 5 reported on randomization preference, 18 on treatment preference, and 1 reported on both. Seven used a preference design. Four out of seven trials noted that the group with preferences had different baseline characteristics (less education, worse baseline measure score, and greater or fewer years with pain). There was a tendency for greater attrition in nonpreference arms at 6 months but not earlier. Around three-quarters of participants turned down randomization in favor of nontrial treatment, and preference for acupuncture was around 20% when offered multiple treatments. Questions used to elicit preferences varied across trials and were poorly reported. Ten trials reported the effects of preferences on outcomes only one detected a statistically (but not clinically) significant difference. There is little evidence that preferences cause detectable effects on outcomes in acupuncture trials however, trials use inconsistent methods and poorly report these data. Monitoring the level and effect of preferences in trials is recommended.
Publisher: Springer Science and Business Media LLC
Date: 17-06-2010
Publisher: Springer Science and Business Media LLC
Date: 12-2006
Abstract: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the s le size for the full scale study. Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The s le size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a s le size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this s le, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.
Publisher: Elsevier BV
Date: 06-1999
DOI: 10.1016/S0965-2299(99)80087-9
Abstract: This paper presents the research protocol for a pragmatic study of the benefits of providing an acupuncture service to patients in primary care with chronic low back pain. The proposal was written in response to a call for bids from the NHS Executive's centrally funded research programme for Health Technology Assessment (HTA). The research question posed was 'Does acupuncture have long-term effectiveness in the management of pain in primary care?' The present study was designed as a collaboration between an interdisciplinary team drawn from health services researchers at the University of Sheffield, acupuncture researchers from the Foundation for Traditional Chinese Medicine in York, and practitioners from general practice and acupuncture in York. The proposal presented here was submitted in response to an invitation from the Commissioning Board following a successful outline bid. It is reproduced here, largely as submitted in January 1998, using the headings under which information was requested. We also present an appendix describing methodological alterations made to the design in response the Commissioning Board's comments on the proposal. We present it in this format to give an idea of the evolution of the design and the process by which the research proposal was shaped. The final working protocol comprises a combination of these two elements.
Publisher: Mary Ann Liebert Inc
Date: 12-2003
DOI: 10.1089/107555303771952226
Abstract: To conduct an exploratory, retrospective study of acupuncture patients' perceptions of practitioner empathy, patient enablement, and health outcome, and to investigate the associations between them. In a retrospective, observational study, questionnaires were distributed to 192 patients randomly selected from a population of 6348 who, several months previously, had participated in a survey of acupuncture safety, and had agreed to be contacted again. The main measures included patients' perceptions of their practitioners' empathy using the Consultation and Relational Empathy Measure, the Patient Enablement Instrument, and the Glasgow Homeopathic Hospital Outcome Scale (measuring change in main complaint and well-being). A total of 143 (74%) patients responded (27% men and 73% women) with an average age of 51 years. Comparisons between the population, the s le selected, and the responding s le showed reasonable equivalence. The majority of patients (71%) were in the middle of an ongoing course of treatment at the time of completing the questionnaires for this study. 36% of patients were attending for reasons of "general well-being," 34% for musculoskeletal problems, 11% for emotional or psychological problems, and 19% for other reasons. Empathy and enablement scores were not influenced by age or reason for attendance, but men showed significantly lower scores than women (p < 0.05). Patient enablement was significantly positively correlated with perception of their practitioners' empathy (Spearman's rho = 0.256, p < 0.01). Enablement in turn was strongly positively correlated with the outcome of both the main complaint (rho = 0.457, p < 0.0001) and improved well-being (rho = 0.521, p < 0.0001). Patients' perceptions of consultations with their acupuncturists suggest that their experience of empathy is significantly associated with patient enablement, which in turn is highly correlated with improved self-reported health outcomes.
Publisher: Elsevier BV
Date: 09-2013
Publisher: Wiley
Date: 08-2010
DOI: 10.1111/J.1756-5391.2010.01086.X
Abstract: The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and ex les of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Hugh MacPherson.