http://aim.bmj.com/ Latest from AIM en-us http://bmjopen.bmj.com/cgi/content/full/3/5/e002825?rss=1 IntroductionDry needling (DN) is an effective method for the treatment of myofascial trigger points (MTrPs). There is no report on the neurophysiological effects of DN in patients with MTrPs. The aim of the present study will be to assess the immediate neurophysiological efficacy of deep DN in patients with upper trapezius MTrPs. Methods and analysisA prospective, controlled clinical trial was designed to include patients with upper trapezius MTrPs and volunteered healthy participants to receive one session of DN. The primary outcome measures are neuromuscular junction response and sympathetic skin response. The secondary outcomes are pain intensity and pressure pain threshold. Data will be collected at baseline and immediately after intervention. Ethics and disseminationThis study protocol has been approved by the Research Council, School of Rehabilitation and the Ethics Committee of Tehran University of Medical Sciences. The results of the study will be disseminated in a peer-reviewed journal and presented at international congresses. http://bmjopen.bmj.com/cgi/content/full/3/5/e002825?rss=1 Thu, 23 May 2013 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/acupmed-2012-010268v1?rss=1 ObjectiveThis study evaluates the thermographic changes associated with moxa burner moxibustion at the SP6 acupuncture point to establish an appropriate, safe distance of efficacy for moxibustion. MethodsBaseline temperature changes using a moxa burner were obtained for a paper substrate at various distances and times, and the tested with volunteers in a pilot study. A single-group trial was then conducted with 36 healthy women to monitor temperature changes on the body surface at the acupuncture point (SP6). ResultsBased on the temperature changes seen for the paper substrate and in the pilot study, a distance of 3 cm was chosen as the intervention distance. Moxibustion significantly increased the SP6 point skin surface temperature, with a peak increase of 11{degrees}C at 4 min (p <0.001). This study also found that during moxibustion the temperature of the moxa burner's rubber layer and moxa cautery were 56.9{+/-}0.9{degrees}C and 65.8{+/-}1.2{degrees}C, as compared to baseline values of 35.1{degrees}C and 43.8{degrees}C (p<0.001). ConclusionsWe determined 3 cm was a safe distance between the moxa burner and acupuncture point. Moxibustion can increase the skin surface temperature at the SP6 point. This data will aid traditional Chinese medicine (TCM) practitioners in gauging safer treatment distances when using moxibustion treatments. http://aim.bmj.com/cgi/content/full/acupmed-2012-010268v1?rss=1 Thu, 18 Apr 2013 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://bmjopen.bmj.com/cgi/content/full/3/4/e002292?rss=1 ObjectiveThere has been a dramatic increase in the use of dietary supplements in Western societies over the past decades. Our understanding of the prevalence of {Omega}-3 fatty acid supplement consumption is of significance for future nutrition planning, health promotion and care delivery. However, we know little about {Omega}-3 fatty acid supplement consumption or users. This paper, drawing upon the largest dataset with regard to {Omega}-3 fatty acid supplement use (n=266 848), examines the use and users of this supplement among a large sample of older Australians living in New South Wales. DesignA cross-sectional study. Data were analysed from the 45 and Up Study, the largest study of healthy ageing ever undertaken in the Southern Hemisphere. SettingNew South Wales, Australia. Participants266 848 participants of the 45 and Up Study. Primary and secondary outcome measuresParticipants' use of {Omega}-3, demographics (geographical location, marital status, education level, income and level of healthcare insurance) and health status (quality of life, history of smoking and alcohol consumption, health conditions) were measured. ResultsOf the 266 848 participants, 32.6% reported having taken {Omega}-3 in the 4 weeks prior to the survey. Use of {Omega}-3 fatty acid supplements was higher among men, non-smokers, non-to-mild (alcoholic) drinkers, residing in a major city, having higher income and private health insurance. Osteoarthritis, osteoporosis, high cholesterol and anxiety and/or depression were positively associated with {Omega}-3 fatty acid supplement use, while cancer and high blood pressure were negatively associated with use of {Omega}-3 fatty acid supplements. ConclusionsThis study, analysing data from the 45 and Up Study cohort, suggests that a considerable proportion of older Australians consume {Omega}-3 fatty acid supplements. There is a need for primary healthcare practitioners to enquire with patients about this supplement use and for work to ensure provision of good-quality information for patients and providers with regard to {Omega}-3 fatty acid products. http://bmjopen.bmj.com/cgi/content/full/3/4/e002292?rss=1 Thu, 18 Apr 2013 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/3/4/e002170?rss=1 ObjectiveTo assess whether three novel interventions, formulated based on a systems medicine therapeutic concept, reduced disease activity in patients with relapsing-remitting multiple sclerosis (MS) who were either treated or not with disease-modifying treatment. DesignA 30-month randomised, double-blind, placebo-controlled, parallel design, phase II proof-of-concept clinical study. SettingsCyprus Institute of Neurology and Genetics. Participants80 participants were randomised into four groups of 20 each. A total of 41 (51%) patients completed the 30-month trial. The eligibility criteria were an age of 18-65; a diagnosis of relapsing-remitting MS according to the McDonald criteria; a score of 0.0-5.5 on the Expanded Disability Status Scale (EDSS); MRI showing lesions consistent with MS; at least one documented clinical relapse and either receiving or not a disease-modifying treatment within the 24-month period before enrolment in the study. Patients were excluded because of a recent (<30 days) relapse, prior immunosuppressant or monoclonal antibody therapy, pregnancy or nursing, other severe disease compromising organ function, progressive MS, history of recent drug or alcohol abuse, use of any additional food supplements, vitamins or any form of polyunsaturated fatty acids, and a history of severe allergic or anaphylactic reactions or known specific nutritional hypersensitivity. InterventionsThe first intervention (A) was composed of {Omega}-3 and {Omega}-6 polyunsaturated fatty acids at 1:1 wt/wt. Specifically, the {Omega}-3 fatty acids were docosahexaenoic acid and eicosapentaenoic acid at 3:1 wt/wt, and the {Omega}-6 fatty acids were linoleic acid and {gamma}-linolenic acid at 2:1 wt/wt. This intervention also included minor quantities of other specific polyunsaturated, monounsaturated and saturated fatty acids as well as vitamin A and vitamin E (-tocopherol). The second intervention (B, PLP10) was a combination of A and {gamma}-tocopherol. The third intervention (C) was {gamma}-tocopherol alone. The fourth group of 20 participants received placebo. The interventions were administered per os (by mouth) once daily, 30 min before dinner for 30 months. Main outcome measuresThe primary end point was the annualised relapse rate (ARR) of the three interventions versus the placebo at 2 years. The secondary end point was the time to confirmed disability progression at 2 years. ResultsA total of 41 (51%) patients completed the 30-month trial. Overall, for the per-protocol analysis of the 2-year primary end point, eight relapses were recorded in the PLP10 group (n=10; 0.40 ARR) versus 25 relapses in the placebo group (n=12; 1.04 ARR), representing a 64% adjusted relative rate reduction for the PLP10 group (RRR 0.36, 95% CI 0.15 to 0.87, p=0.024). In a subgroup analysis that excluded patients on monoclonal antibody (natalizumab) treatment, the observed adjusted RRR became stronger (72%) over the 2 years (RRR 0.28, 95% CI 0.10 to 0.79, p=0.016). The per-protocol analysis for the secondary outcome at 2 years, the time to disability progression, was significantly longer only for PLP10. The cumulative probability of disability progression at 2 years was 10% in the PLP10 group and 58% in the placebo group (unadjusted log-rank p=0.019). In a subgroup analysis that excluded patients on natalizumab, the cumulative probability of progression was 10% for the 10 patients in the PLP10 group and 70% for the 12 patients in the placebo group, representing a relative 86% decrease in the risk of the sustained progression of disability in the PLP10 group (unadjusted log-rank p=0.006; adjusted HR, 0.11; 95% CI 0.01 to 0.97, p=0.047). No adverse events were reported. Interventions A (10 patients) and C (9 patients) showed no significant efficacy. ConclusionsIn this small proof-of-concept, randomised, double-blind clinical trial; the PLP10 treatment significantly reduced the ARR and the risk of sustained disability progression without any reported serious adverse events. Larger studies are needed to further assess the safety and efficacy of PLP10. Trial registrationInternational Standard Randomised Controlled Trial, number ISRCTN87818535. http://bmjopen.bmj.com/cgi/content/full/3/4/e002170?rss=1 Wed, 17 Apr 2013 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/acupmed-2012-010279v1?rss=1 ObjectivesDe qi is a sensation experienced by a patient or an acupuncturist during acupuncture treatment. Although de qi is considered to be important in acupuncture treatment, there are not many studies about de qi and its character. The purpose of this study is to review de qi questionnaires and evaluate the relationship between de qi and acupuncture points, stimulation and treatment effects. MethodsA search was conducted using three English-language databases (PubMed, Cochrane and ScienceDirect) and seven Korean databases with the keywords de qi' and needle sensation'. The included studies were then categorised as following: (1) de qi measurement tools, (2) the relationship between de qi and acupuncture points, (3) the relationship between de qi and stimulation, (4) the relationship between de qi and treatment effects and (5) attitudes and opinions toward de qi. ResultsSeveral questionnaires have been developed to evaluate de qi, and the most frequent sensation in those questionnaires was heavy' and numb'. Although a few studies showed specificity to acupuncture points, information is still lacking to be able to draw a clear conclusion about the relationship between de qi and acupuncture points. Also, greater de qi was elicited in real acupuncture than placebo acupuncture in many studies. The relationship between de qi and treatment effects was controversial. ConclusionsIt seems that real acupuncture induced greater de qi than sham acupuncture, and the relationship between de qi, acupuncture points and treatment effects was controversial. However, the current literature evaluating de qi is not sufficient to derive clear conclusions. Further studies with more objective indices and rigorous methodologies are needed. http://aim.bmj.com/cgi/content/full/acupmed-2012-010279v1?rss=1 Wed, 13 Mar 2013 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://bmjopen.bmj.com/cgi/content/full/3/3/e001802?rss=1 ObjectivesTo investigate whether progression-free survival (PFS) can be considered a surrogate endpoint for overall survival (OS) in advanced non-small-cell lung cancer (NSCLC). DesignMeta-analysis of individual patient data from randomised trials. SettingFive randomised controlled trials comparing docetaxel-based chemotherapy with vinorelbine-based chemotherapy for the first-line treatment of NSCLC. Participants2331 patients with advanced NSCLC. Primary and secondary outcome measuresSurrogacy of PFS for OS was assessed through the association between these endpoints and between the treatment effects on these endpoints. The surrogate threshold effect was the minimum treatment effect on PFS required to predict a non-zero treatment effect on OS. ResultsThe median follow-up of patients still alive was 23.4 months. Median OS was 10 months and median PFS was 5.5 months. The treatment effects on PFS and OS were correlated, whether using centres (R{superscript 2}=0.62, 95% CI 0.52 to 0.72) or prognostic strata (R{superscript 2}=0.72, 95% CI 0.60 to 0.84) as units of analysis. The surrogate threshold effect was a PFS hazard ratio (HR) of 0.49 using centres or 0.53 using prognostic strata. ConclusionsThese analyses provide only modest support for considering PFS as an acceptable surrogate for OS in patients with advanced NSCLC. Only treatments that have a major impact on PFS (risk reduction of at least 50%) would be expected to also have a significant effect on OS. Whether these results also apply to targeted therapies is an open question that requires independent evaluation. http://bmjopen.bmj.com/cgi/content/full/3/3/e001802?rss=1 Wed, 13 Mar 2013 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/3/2/e002187?rss=1 IntroductionNeonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns' length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs). Methods and analysis690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation. The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique. Ethics and disseminationWritten informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n{degrees}22/int./CEI/27239) and it is under review by the other regional ethics committees. ResultsDissemination of results from this trial will be through scientific medical journals and conferences. Trial registrationThis trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137). http://bmjopen.bmj.com/cgi/content/full/3/2/e002187?rss=1 Wed, 20 Feb 2013 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/3/1/e002072?rss=1 ObjectivesTo determine whether humour therapy reduces depression (primary outcome), agitation and behavioural disturbances and improves social engagement and quality-of-life in nursing home residents. DesignThe Sydney Multisite Intervention of LaughterBosses and ElderClowns study was a single-blind cluster randomised controlled trial of humour therapy. Setting35 Sydney nursing homes. ParticipantsAll eligible residents within geographically defined areas within each nursing home were invited to participate. InterventionProfessional ElderClowns' provided 9-12 weekly humour therapy sessions, augmented by resident engagement by trained staff LaughterBosses'. Controls received usual care. MeasurementsDepression scores on the Cornell Scale for Depression in Dementia, agitation scores on the Cohen-Mansfield Agitation Inventory, behavioural disturbance scores on the Neuropsychiatric Inventory, social engagement scores on the withdrawal subscale of Multidimensional Observation Scale for Elderly Subjects, and self-rated and proxy-rated quality-of-life scores on a health-related quality-of-life tool for dementia, the DEMQOL. All outcomes were measured at the participant level by researchers blind to group assignment. RandomisationSites were stratified by size and level of care then assigned to group using a random number generator. ResultsSeventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Groups did not differ significantly over time on the primary outcome of depression, or on behavioural disturbances other than agitation, social engagement and quality of life. The secondary outcome of agitation was significantly reduced in the intervention group compared with controls over 26 weeks (time by group interaction adjusted for covariates: p=0.011). The mean difference in change from baseline to 26 weeks in Blom-transformed agitation scores after adjustment for covariates was 0.17 (95% CI 0.004 to 0.34, p=0.045). ConclusionsHumour therapy did not significantly reduce depression but significantly reduced agitation. Trial registrationAustralian New Zealand Clinical Trials Registry -ACTRN12611000462987. http://bmjopen.bmj.com/cgi/content/full/3/1/e002072?rss=1 Fri, 11 Jan 2013 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/30/4/286?rss=1 ObjectiveA systematic review of randomised controlled trials was conducted to evaluate the efficacy and effectiveness of intramuscular stimulation (IMS). MethodsElectronic databases including Medline, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, the Cochrane Library, China National Knowledge Infrastructure, KoreaMED, Korean Studies Information Service System, RISS and DBPIA were searched through June, 2012. The Cochrane criteria were used to assess the risk of bias for the individual studies. ResultsA total of 416 publications were initially collected and four studies were included in this review. One study evaluated the efficacy of IMS for chronic tension-type headaches; IMS showed a better effect than the sham (headache index: mean difference (MD) -4.90, 95% CI -9.53 to -0.27). Three studies tested the effectiveness of IMS for various conditions. In the first study no significant difference was observed in a comparison of IMS and meloxicam therapy for chronic shoulder pain (pain-visual analogue scale (VAS): MD -0.05, 95% CI -0.25 to 0.16). The second study in patients with myofascial pain syndrome of the upper trapezius muscle found that IMS had a greater effect than simple dry needling measured by the pain-VAS (MD -2.70, 95% CI -3.77 to -1.63). In the third study, patients with lower back pain who received IMS plus the standard treatment had a better status at discharge than those receiving the standard treatment alone (relative risk 1.63, 95% CI 1.18 to 2.24). ConclusionsDespite the positive results of these individual studies, the level of evidence supporting the efficacy and effectiveness of IMS for several conditions remains insufficient because of concerns about a lack of precision and a high risk of bias of the included studies. Rigorous large-scale clinical trials of IMS are needed to evaluate the clinical utility of this technique. http://aim.bmj.com/cgi/content/full/30/4/286?rss=1 Sat, 1 Dec 2012 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://bmjopen.bmj.com/cgi/content/full/2/6/e001498?rss=1 ObjectivesTo describe and compare patients seeking treatment for sleep, anxiety and depressive disorders (SADD) from physicians in general practice (GPs) with three different practice preferences: strictly conventional medicine (GP-CM), mixed complementary and conventional medicine (GP-Mx) and certified homeopathic physicians (GP-Ho). Design and settingThe EPI3 survey was a nationwide, observational study of a representative sample of GPs and their patients, conducted in France between March 2007 and July 2008. Participants1572 patients diagnosed with SADD. Primary and secondary outcomesThe patients' attitude towards complementary and alternative medicine; psychotropic drug utilisation. ResultsCompared to patients attending GP-CM, GP-Ho patients had healthier lifestyles while GP-Mx patients showed similar profiles. Psychotropic drugs were more likely to be prescribed by GP-CM (64%) than GP-Mx (55.4%) and GP-Ho (31.2%). The three groups of patients shared similar SADD severity. ConclusionOur results showed that patients with SADD, while differing principally in their sociodemographic profiles and conventional psychotropic prescriptions, were actually rather similar regarding the severity of SADD in terms of comorbidities and quality of life. This information may help to better plan resource allocation and management of these common health problems in primary care. http://bmjopen.bmj.com/cgi/content/full/2/6/e001498?rss=1 Thu, 22 Nov 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/2/6/e001813?rss=1 ObjectivesTo describe geographical and dispersion patterns of men who have sex with men (MSM)-related venues in a large East African city and their associations with times, participants and venue type. MethodsMapping of MSM sites in Dar es Salaam was carried out by community research workers who catalogued, observed and reported data on venue sites, formality, times of operation, type of participant, police or vigilante activity, length of operation and the degree to which it is known both in and outside the MSM and gay communities. ResultsThere is a large and widely disseminated MSM/gay satellite cultures of at least 98 sites, which has some formal sites, but is largely informal and operates within mixed entertainment environments and at particular times (including some weekend-only locales) across the city. There is a mix of places for sexual contact, largely social venues and sex on location sites. Cruising appears to be limited to open spaces and parks, with no vehicular component and almost no internet component. They are widely disseminated across all suburbs and there is no central location for MSM activities. MSM sex workers (SWs) operate at a third of these sites. ConclusionsThere is a large number of local' MSM contact, social and sex sites and any work with MSM will have to include these less-formal and less-known sites. The widely disseminated nature of the MSM sites, however, also suggests that sexual networks may not be closely linked between sites. The climate of stigma, abuse and potential violence appear to be limiting the development of more formal sites. This pattern is probably typical of other large urban areas in East Africa and perhaps across sub-Saharan Africa (SSA). http://bmjopen.bmj.com/cgi/content/full/2/6/e001813?rss=1 Thu, 22 Nov 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/2/6/e001079?rss=1 BackgroundMyalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a condition characterised by severe and persistent fatigue, neurological disturbances, autonomic and endocrine dysfunctions and sleep difficulties that have a pronounced and significant impact on individuals' lives. Current National Institute for Health and Clinical Excellence guidelines within the UK suggest that this condition should be treated with cognitive behavioural therapy and/or graded exercise therapy, where appropriate. There is currently a lack of an evidence base concerning alternative techniques that may be beneficial to those with ME/CFS. ObjectivesThis study aimed to investigate whether three modalities of psychology, nutrition and combined treatment influenced symptom report measures in those with ME/CFS over a 3-month time period and whether there were significant differences in these changes between groups. Design and settingThis is a preliminary prospective study with one follow-up point conducted at a private secondary healthcare facility in London, UK. Participants138 individuals (110 females, 79.7%; 42 participants in psychology, 44 in nutrition and 52 in combined) participated at baseline and 72 participants completed the battery of measures at follow-up (52.17% response rate; 14, 27 and 31 participants in each group, respectively). Outcome measuresSelf-reported measures of ME/CFS symptoms, functional ability, multidimensional fatigue and perceived control. ResultsBaseline comparisons showed those in the combined group had higher levels of fatigue. At follow-up, all groups saw improvements in fatigue, functional ability and symptomatology; those within the psychology group also experienced a shift in perceived control over time. ConclusionsThis study provides early evidence that psychological, nutritional and combined techniques for the treatment of ME/CFS may influence symptomatology, fatigue, function and perceived control. However, these results must be viewed with caution as the allocation to groups was not randomised, there was no control group and the study suffered from high drop-out rates. http://bmjopen.bmj.com/cgi/content/full/2/6/e001079?rss=1 Mon, 19 Nov 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/2/5/e001094?rss=1 ObjectiveAn economic model was developed to evaluate the cost-effectiveness of hawthorn extract as an adjunctive treatment for heart failure in Australia. MethodsA Markov model of chronic heart failure was developed to compare the costs and outcomes of standard treatment and standard treatment with hawthorn extract. Health states were defined by the New York Heart Association (NYHA) classification system and death. For any given cycle, patients could remain in the same NYHA class, experience an improvement or deterioration in NYHA class, be hospitalised or die. Model inputs were derived from the published medical literature, and the output was quality-adjusted life years (QALYs). Probabilistic sensitivity analysis was conducted. The expected value of perfect information (EVPI) and the expected value of partial perfect information (EVPPI) were conducted to establish the value of further research and the ideal target for such research. ResultsHawthorn extract increased costs by $1866.78 and resulted in a gain of 0.02 QALYs. The incremental cost-effectiveness ratio was $85 160.33 per QALY. The cost-effectiveness acceptability curve indicated that at a threshold of $40 000 the new treatment had a 0.29 probability of being cost-effective. The average incremental net monetary benefit (NMB) was -$1791.64, the average NMB for the standard treatment was $92 067.49, and for hawthorn extract $90 275.84. Additional research is potentially cost-effective if research is not proposed to cost more than $325 million. Utilities form the most important target parameter group for further research. ConclusionsHawthorn extract is not currently considered to be cost-effective in as an adjunctive treatment for heart failure in Australia. Further research in the area of utilities is warranted. http://bmjopen.bmj.com/cgi/content/full/2/5/e001094?rss=1 Sun, 14 Oct 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/2/5/e001046?rss=1 ObjectiveA comprehensive systematic review of economic evaluations of complementary and integrative medicine (CIM) to establish the value of these therapies to health reform efforts. Data sourcesPubMed, CINAHL, AMED, PsychInfo, Web of Science and EMBASE were searched from inception through 2010. In addition, bibliographies of found articles and reviews were searched, and key researchers were contacted. Eligibility criteria for selecting studiesStudies of CIM were identified using criteria based on those of the Cochrane complementary and alternative medicine group. All studies of CIM reporting economic outcomes were included. Study appraisal methodsAll recent (and likely most cost-relevant) full economic evaluations published 2001-2010 were subjected to several measures of quality. Detailed results of higher-quality studies are reported. ResultsA total of 338 economic evaluations of CIM were identified, of which 204, covering a wide variety of CIM for different populations, were published 2001-2010. A total of 114 of these were full economic evaluations. And 90% of these articles covered studies of single CIM therapies and only one compared usual care to usual care plus access to multiple licensed CIM practitioners. Of the recent full evaluations, 31 (27%) met five study-quality criteria, and 22 of these also met the minimum criterion for study transferability ( generalisability'). Of the 56 comparisons made in the higher-quality studies, 16 (29%) show a health improvement with cost savings for the CIM therapy versus usual care. Study quality of the cost-utility analyses (CUAs) of CIM was generally comparable to that seen in CUAs across all medicine according to several measures, and the quality of the cost-saving studies was slightly, but not significantly, lower than those showing cost increases (85% vs 88%, p=0.460). ConclusionsThis comprehensive review identified many CIM economic evaluations missed by previous reviews and emerging evidence of cost-effectiveness and possible cost savings in at least a few clinical populations. Recommendations are made for future studies. http://bmjopen.bmj.com/cgi/content/full/2/5/e001046?rss=1 Mon, 3 Sep 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/30/3/170?rss=1 BackgroundAcupuncture has been provided in nurse-led group clinics in St Albans since 2008. It is funded by a commissioning group within the National Health Service, on a trial basis, for patients with knee osteoarthritis who would otherwise be referred to an orthopaedic surgeon. AimTo evaluate the patients seen in the service's first year of operation and their outcome up to the end of 2010. MethodsService evaluation was made of patient data from the referral centre and the acupuncture clinics, including baseline characteristics, attendance data and Measure Yourself Medical Outcome Profile (MYMOP) symptom, function and well-being scores over at least 2 years. Results114 patients were offered acupuncture, of whom 90 patients were assessed in the acupuncture clinics. 41 of these were still attending after 1 year and 31 (34%) after 2 years. MYMOP scores showed clinically significant improvements at 1 month for pain (4.2 (SD 1.2) to 2.9 (SD 1.4)), stiffness (4.1 (SD 1.3) to 2.9 (SD 1.3)) and function (4.5 (SD 1.1) to 3.3 (SD 1.2)) which continued up to 2 years. Well-being scores did not change. ConclusionsThis is the first evaluation of nurse-led group (multibed) acupuncture clinics for patients with knee osteoarthritis to include a 2 year follow-up. It shows the practicability of offering a low-cost acupuncture service as an alternative to knee surgery and the service's success in providing long-term symptom relief in about a third of patients. Using realistic assumptions, the cost consequences for the local commissioning group are an estimated saving of {pound}100 000 a year. Sensitivity analyses are presented using different assumptions. http://aim.bmj.com/cgi/content/full/30/3/170?rss=1 Sat, 1 Sep 2012 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://bmjopen.bmj.com/cgi/content/full/2/3/e001164?rss=1 IntroductionSome general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition. The aim of this study was to evaluate whether a single treatment session with acupuncture can reduce time to recovery when applied in addition to standard LBP treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out. Methods and analysisIn this randomised, controlled multicentre study in general practice in Southern Norway, 270 patients will be allocated into one of two treatment groups, using a web-based application based on block randomisation. Outcome assessor will be blinded for group allocation of the patients. The control group will receive standard treatment, while the intervention group will receive standard treatment plus acupuncture treatment. There will be different GPs treating the two groups, and both groups will just have one consultation. Adults who consult their GP because of acute LBP will be included. Patients with nerve root affection, red flags', pregnancy, previous sick leave more than 14 days and disability pension will be excluded. The primary outcome of the study is the median time to recovery (in days). The secondary outcomes are rated global improvement, back-specific functional status, sick leave, medication, GP visits and side effects. A pilot study will be conducted. Ethics and disseminationParticipation is based on informed written consent. The authors will apply for an ethical approval from the Regional Committee for Medical and Health Research Ethics when the study protocol is published. Results from this study, positive or negative, will be disseminated in scientific medical journals. Trial Registration NumberClinicalTrials.gov Identifier: NCT01439412. http://bmjopen.bmj.com/cgi/content/full/2/3/e001164?rss=1 Mon, 25 Jun 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/30/2/113?rss=1 ObjectivesThe highly variable nature of acupuncture needling creates challenges to systematic research. The goal of this study was to test the feasibility of quantifying acupuncture needle manipulation using motion and force measurements. It was hypothesised that distinct needling styles and techniques would produce different needle motion and force patterns that could be quantified and differentiated from each other. MethodsA new needling sensor tool (Acusensor) was used to record needling in real time as performed by six New England School of Acupuncture staff from the Chinese acupuncture' (style 1) and Japanese acupuncture' (style 2) programmes (three from each). Each faculty expert needled 12 points (6 bilateral locations) in 12 healthy human subjects using tonification (technique 1) and dispersal (technique 2). Parameters calculated from the raw needling data were displacement amplitude, displacement frequency, rotation amplitude, rotation frequency, force amplitude and torque amplitude. ResultsData analysis revealed significant differences in the amplitude of displacement and rotation between needling performed by staff from two different acupuncture styles. Significant overall differences in the frequency of displacement between techniques 1 and 2 that were not dependent of the style of acupuncture being performed were also found. The relationships between displacement and rotation frequencies, as well as between displacement and force amplitudes showed considerable variability across individual acupuncturists and subjects. ConclusionsNeedling motion and force parameters can be quantified in a treatment-like setting. Needling data can subsequently be analysed, providing an objective method for characterising needling in basic and clinical acupuncture research. http://aim.bmj.com/cgi/content/full/30/2/113?rss=1 Fri, 1 Jun 2012 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://aim.bmj.com/cgi/content/full/acupmed-2011-010111v1?rss=1 ObjectivesThe highly variable nature of acupuncture needling creates challenges to systematic research. The goal of this study was to test the feasibility of quantifying acupuncture needle manipulation using motion and force measurements. It was hypothesised that distinct needling styles and techniques would produce different needle motion and force patterns that could be quantified and differentiated from each other. MethodsA new needling sensor tool (Acusensor) was used to record needling in real time as performed by six New England School of Acupuncture staff from the Chinese acupuncture' (style 1) and Japanese acupuncture' (style 2) programmes (three from each). Each faculty expert needled 12 points (6 bilateral locations) in 12 healthy human subjects using tonification (technique 1) and dispersal (technique 2). Parameters calculated from the raw needling data were displacement amplitude, displacement frequency, rotation amplitude, rotation frequency, force amplitude and torque amplitude. ResultsData analysis revealed significant differences in the amplitude of displacement and rotation between needling performed by staff from two different acupuncture styles. Significant overall differences in the frequency of displacement between techniques 1 and 2 that were not dependent of the style of acupuncture being performed were also found. The relationships between displacement and rotation frequencies, as well as between displacement and force amplitudes showed considerable variability across individual acupuncturists and subjects. ConclusionsNeedling motion and force parameters can be quantified in a treatment-like setting. Needling data can subsequently be analysed, providing an objective method for characterising needling in basic and clinical acupuncture research. http://aim.bmj.com/cgi/content/full/acupmed-2011-010111v1?rss=1 Fri, 16 Mar 2012 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://bmjopen.bmj.com/cgi/content/full/2/2/e000848?rss=1 IntroductionHypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives. Methods and analysisMen and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) [≥]135/85 mm Hg or 24 h ABP [≥]130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives. Ethics and disseminationThis research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012. Trial registration numberThis study is registered with http://clinicaltrials.gov (NCT00825526). http://bmjopen.bmj.com/cgi/content/full/2/2/e000848?rss=1 Mon, 5 Mar 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/30/1/47?rss=1 PC6 is a classic acupuncture point in traditional Chinese medicine. It is considered to be effective when treating cardiovascular disorders. In the present review the authors have focused on the neurophysiological bases of the effects of PC6 stimulation on cardiovascular mechanisms. Experimental studies have shown that the hypothalamic rostral ventrolateral medulla, arcuate nucleus and ventrolateral periaqueductal gray are involved in acupuncture attenuation of sympathoexcitatory cardiovascular reflex responses. This long-loop pathway also appears to contribute to the long-lasting, acupuncture-mediated attenuation of sympathetic premotor outflow and excitatory cardiovascular reflex responses. Acupuncture of PC6 modulates the activity in the cardiovascular system, an effect that may be attributed to attenuation of sympathoexcitatory cardiovascular reflex responses. http://aim.bmj.com/cgi/content/full/30/1/47?rss=1 Thu, 1 Mar 2012 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://bmjopen.bmj.com/cgi/content/full/2/1/e000456?rss=1 BackgroundThere is relatively limited knowledge about the practitioners who provide acupuncture treatment within the UK, what conditions patients consult for and the treatment provided. ObjectivesTo characterise the conditions treated and by whom, to examine characteristics of the treatment and to explore trends over time. MethodA cross-sectional survey of the UK acupuncture practitioners was conducted; 800 practitioners were selected by computer-generated randomisation sequences from the four major UK-based professional associations. Data collected on the practitioners included demographic details, association membership, statutorily regulated status, practice setting, style of acupuncture, diagnostic methods and needle response sought. Practitioners recorded details of their 10 most recent patients, including demographic details, primary reason for consulting and lifestyle advice provided. Results330 practitioners responded comprising doctors (29%) physiotherapists (29%), nurses (15%) and independent acupuncturists (27%): 62% were women with median age of 48 years. The majority (68%) practiced in independent settings and 42% practiced within the National Health Service. Patients most commonly consulted for low back, neck, shoulder and knee pain, as well as headaches and migraine. Treatment for infertility by independent acupuncturists was found to have increased fivefold in 10 years. ConclusionAcupuncture provides a substantial contribution to the healthcare of the UK, with an estimated 4 million sessions provided annually. The primary complaints for which patients consult reflect the growing evidence base on acupuncture for these conditions. These data provide a basis for decision-making regarding policy and practice. http://bmjopen.bmj.com/cgi/content/full/2/1/e000456?rss=1 Wed, 11 Jan 2012 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/1/2/e000265?rss=1 ObjectiveTo evaluate effectiveness of physiotherapy management in patients experiencing whiplash associated disorder II, on clinically relevant outcomes in the short and longer term. DesignSystematic review and meta-analysis. Two reviewers independently searched information sources, assessed studies for inclusion, evaluated risk of bias and extracted data. A third reviewer mediated disagreement. Assessment of risk of bias was tabulated across included trials. Quantitative synthesis was conducted on comparable outcomes across trials with similar interventions. Meta-analyses compared effect sizes, with random effects as primary analyses. Data sourcesPredefined terms were employed to search electronic databases. Additional studies were identified from key journals, reference lists, authors and experts. Eligibility criteria for selecting studiesRandomised controlled trials (RCTs) published in English before 31 December 2010 evaluating physiotherapy management of patients (>16 years), experiencing whiplash associated disorder II. Any physiotherapy intervention was included, when compared with other types of management, placebo/sham, or no intervention. Measurements reported on [≥]1 outcome from the domains within the international classification of function, disability and health, were included. Results21 RCTs (2126 participants, 9 countries) were included. Interventions were categorised as active physiotherapy or a specific physiotherapy intervention. 20/21 trials were evaluated as high risk of bias and one as unclear. 1395 participants were incorporated in the meta-analyses on 12 trials. In evaluating short term outcome in the acute/sub-acute stage, there was some evidence that active physiotherapy intervention reduces pain and improves range of movement, and that a specific physiotherapy intervention may reduce pain. However, moderate/considerable heterogeneity suggested that treatments may differ in nature or effect in different trial patients. Differences between participants, interventions and trial designs limited potential meta-analyses. ConclusionsInconclusive evidence exists for the effectiveness of physiotherapy management for whiplash associated disorder II. There is potential benefit for improving range of movement and pain short term through active physiotherapy, and for improving pain through a specific physiotherapy intervention. http://bmjopen.bmj.com/cgi/content/full/1/2/e000265?rss=1 Mon, 14 Nov 2011 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/1/1/e000085?rss=1 ObjectivesSince ageing is associated with a decline in pulmonary function, heart rate variability and spontaneous baroreflex, and recent studies suggest that yoga respiratory exercises may improve respiratory and cardiovascular function, we hypothesised that yoga respiratory training may improve respiratory function and cardiac autonomic modulation in healthy elderly subjects. Design76 healthy elderly subjects were enrolled in a randomised control trial in Brazil and 29 completed the study (age 68{+/-}6 years, 34% males, body mass index 25{+/-}3 kg/m2). Subjects were randomised into a 4-month training program (2 classes/week plus home exercises) of either stretching (control, n=14) or respiratory exercises (yoga, n=15). Yoga respiratory exercises (Bhastrika) consisted of rapid forced expirations followed by inspiration through the right nostril, inspiratory apnoea with generation of intrathoracic negative pressure, and expiration through the left nostril. Pulmonary function, maximum expiratory and inspiratory pressures (PEmax and PImax, respectively), heart rate variability and blood pressure variability for spontaneous baroreflex determination were determined at baseline and after 4 months. ResultsSubjects in both groups had similar demographic parameters. Physiological variables did not change after 4 months in the control group. However, in the yoga group, there were significant increases in PEmax (34%, p<0.0001) and PImax (26%, p<0.0001) and a significant decrease in the low frequency component (a marker of cardiac sympathetic modulation) and low frequency/high frequency ratio (marker of sympathovagal balance) of heart rate variability (40%, p<0.001). Spontaneous baroreflex did not change, and quality of life only marginally increased in the yoga group. ConclusionRespiratory yoga training may be beneficial for the elderly healthy population by improving respiratory function and sympathovagal balance. Trial RegistrationCinicalTrials.gov identifier: NCT00969345; trial registry name: Effects of respiratory yoga training (Bhastrika) on heart rate variability and baroreflex, and quality of life of healthy elderly subjects. http://bmjopen.bmj.com/cgi/content/full/1/1/e000085?rss=1 Fri, 2 Sep 2011 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/1/1/e000074?rss=1 ObjectiveTo investigate the views and practices of UK medical schools regarding the inclusion (or exclusion) of complementary and alternative medicine (CAM) in undergraduate medical curricula. DesignSurvey (by email) of UK medical schools offering MBBS (or equivalent) degrees. ResultsThe overall response rate was 58.1% (18/31). All respondents indicated that their curricula included CAM elements. However, the quantity of CAM within curricula varied widely between medical schools, as did the methods by which CAM education was delivered. General Medical Council requirements were the strongest factor influencing the inclusion of CAM, although medical student preferences were also important. Respondents were generally satisfied with the extent of CAM provision within their curricula, while a wide range of views on the appropriateness of CAM in the medical curriculum were held by faculty members. ConclusionsIt may be useful for the General Medical Council to clarify the extent to which CAM should be incorporated into the curriculum. Current CAM education appears to exist primarily as a means of educating future doctors on the modalities that their patients may use or request. However, some forms of pedagogy arguably risk students assimilating CAM advocacy in an uncritical fashion. http://bmjopen.bmj.com/cgi/content/full/1/1/e000074?rss=1 Fri, 2 Sep 2011 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/1/1/e000021?rss=1 IntroductionApproximately 25% of all babies in North America are delivered via Caesarean section (C-section). Though a common surgical procedure, C-section recovery can be painful. Opioids, specifically codeine, are commonly used to ease pain; however, its active metabolite, morphine, passes into breast milk, and may produce unwanted side effects in neonates; therefore, alternatives to opioids are being sought. Reiki is an ancient Japanese form of healing where practitioners transfer healing energy through light touch and positive healing intention. Although 1.2 million Americans use reiki to reduce pain or depression, there is a lack of strong evidence supporting its effectiveness. A recent systematic review showed existing studies to be of poor methodological quality, with the common limitation of lack of blinding. To overcome this issue, the authors used distant reiki to assess its effectiveness in reducing pain following an elective C-section. MethodsIn this randomised, double-blinded study, women who underwent an elective C-section were allocated to either usual care (control, n=40) or three distant reiki sessions in addition to usual care (n=40). Pain was assessed using a visual analogue scale (VAS). The primary endpoint was the Area Under the VAS-Time Curve (AUC) for days 1-3. Secondary measures included: the proportion of women who required opioid medications and dose consumed, rate of healing and vital signs. ResultsAUC for pain was not significantly different in the distant reiki and control groups (mean{+/-}SD; 212.1{+/-}104.7 vs 223.1{+/-}117.8; p=0.96). There were no significant differences in opioid consumption or rate of healing; however, the distant reiki group had a significantly lower heart rate (74.3{+/-}8.1 bpm vs 79.8{+/-}7.9 bpm, p=0.003) and blood pressure (106.4{+/-}9.7 mm Hg vs 111.9{+/-}11.0 mm Hg, p=0.02) post surgery. ConclusionDistant reiki had no significant effect on pain following an elective C-section. Clinical Trial Registration NumberISRCTN79265996. http://bmjopen.bmj.com/cgi/content/full/1/1/e000021?rss=1 Fri, 2 Sep 2011 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://bmjopen.bmj.com/cgi/content/full/1/1/e000035?rss=1 ObjectivesTo summarise and critically evaluate the evidence from randomised clinical trials (RCTs) of t'ai chi as a treatment for patients with osteoarthritis (OA). DesignEleven databases were searched from their inception to July 2010. RCTs testing t'ai chi against any type of controls in human patients with OA localised in any joints that assessed any type of clinical outcome measures were considered. Two reviewers independently performed the selection of the studies, data abstraction and validations. The risk of bias was assessed using Cochrane criteria. ResultsNine RCTs met the inclusion criteria, and most of them had significant methodological weaknesses. Six RCTs tested the effects of t'ai chi compared with that of an attention-control programme, a waiting list and routine care or self-help programmes in patients with OA in the knee. The meta-analysis suggested that t'ai chi has favourable effects on pain (n=256; standard mean difference (SMD), -0.79; 95% CI -1.19 to -0.39; p=0.0001; I2=55%), physical function (n=256; SMD, -0.86; 95% CI -1.20 to -0.52; p<0.00001; I2=38%) and joint stiffness (n=256; SMD, -0.53; 95% CI -0.99 to -0.08; p=0.02; I2=67%). ConclusionThe results are encouraging and suggest that t'ai chi may be effective in controlling pain and improving physical function in patients with OA in the knee. However, owing to the small number of RCTs with a low risk of bias, the evidence that t'ai chi is effective in patients with OA is limited. http://bmjopen.bmj.com/cgi/content/full/1/1/e000035?rss=1 Fri, 2 Sep 2011 00:00:00 +0000 BMJ Open Subject Collection: Complementary medicine http://aim.bmj.com/cgi/content/full/29/3/170?rss=1 BackgroundLymphoedema is a distressing problem affecting many women after breast cancer surgery. There is no cure and existing treatments are marginally beneficial, rarely reducing arm swelling in any meaningful way. Needling and even lifting of objects using the affected arm has been prohibited, but our clinical experience and that of others suggested that acupuncture was safe and that it might be a useful treatment for lymphoedema. ObjectiveWe sought to conduct a pilot study of the safety and effectiveness of acupuncture in women diagnosed with chronic lymphoedema for at least 6 months and less than 5 years. MethodsWomen with chronic lymphoedema (affected arm with >2 cm circumference than unaffected arm) after breast cancer surgery received acupuncture twice a week for 4 weeks. Response was defined as at least a 30% reduction in the difference in size between the affected and unaffected arms. Monthly follow-up calls for 6 months following treatment were made to obtain information about side effects. ResultsStudy goals were met after nine subjects were treated: four women showed at least a 30% reduction in the extent of lymphoedema at 4 weeks when compared with their respective baseline values. No serious adverse events occurred during or after 73 treatment sessions. LimitationsThis pilot study requires a larger, randomised follow-up investigation plus enquiries into possible mechanisms. Both are in development by our group. ConclusionAcupuncture appears safe and may reduce lymphoedema associated with breast cancer surgery. http://aim.bmj.com/cgi/content/full/29/3/170?rss=1 Thu, 1 Sep 2011 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access http://aim.bmj.com/cgi/content/full/aim.2011.004069v1?rss=1 BackgroundLymphoedema is a distressing problem affecting many women after breast cancer surgery. There is no cure and existing treatments are marginally beneficial, rarely reducing arm swelling in any meaningful way. Needling and even lifting of objects using the affected arm has been prohibited, but our clinical experience and that of others suggested that acupuncture was safe and that it might be a useful treatment for lymphoedema. ObjectiveWe sought to conduct a pilot study of the safety and effectiveness of acupuncture in women diagnosed with chronic lymphoedema for at least 6 months and less than 5 years. MethodsWomen with chronic lymphoedema (affected arm with >2 cm circumference than unaffected arm) after breast cancer surgery received acupuncture twice a week for 4 weeks. Response was defined as at least a 30% reduction in the difference in size between the affected and unaffected arms. Monthly follow-up calls for 6 months following treatment were made to obtain information about side effects. ResultsStudy goals were met after nine subjects were treated: four women showed at least a 30% reduction in the extent of lymphoedema at 4 weeks when compared with their respective baseline values. No serious adverse events occurred during or after 73 treatment sessions. LimitationsThis pilot study requires a larger, randomised follow-up investigation plus enquiries into possible mechanisms. Both are in development by our group. ConclusionAcupuncture appears safe and may reduce lymphoedema associated with breast cancer surgery. http://aim.bmj.com/cgi/content/full/aim.2011.004069v1?rss=1 Sat, 18 Jun 2011 00:00:00 +0000 Acupuncture in Medicine Subject Collection: Open access