Acupuncture for fibromyalgia in primary care: a randomised controlled trial.

OBJECTIVES: To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia. METHODS: Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks. RESULTS: Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (-41.0%, 95% CI -47.2% to -34.8%) than in the SA group (-27.1%, 95% CI -33.2% to -20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: -19.9%, 95% CI -24.6% to -15.1%; vs SA: -6.2%, 95% CI -11.2% to -1.2%). CONCLUSIONS: Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended. TRIAL REGISTRATION NUMBER: ISRCTN60217348.

Interaction between oxidative stress and smoking is associated with an increased risk of rheumatoid arthritis: a case-control study.

OBJECTIVE: To investigate the relationship between oxidative stress and smoking and development of RA. METHODS: A case-control study was conducted in treatment-naïve early-onset RA patients and healthy controls, matched by age, gender and current smoking habit. Plasma lipid hydroperoxides (LOOH), carbonyl protein (CP) and malonyldialdehyde (MDA) levels were measured to estimate oxidative stress. Smoking exposure was quantified in pack-years. The presence of an interaction between oxidative stress and smoking exposure was investigated using three measures of additive interaction: relative excess risk due to the interaction (RERI), attributable proportion due to the interaction (AP) and the synergy index (S). RESULTS: A total of 65 RA patients and 65 healthy controls were included. Statistically significant differences were observed in RA-related variables, age, BMI and smoking dose between cases and controls. Plasma LOOH and CP levels were associated with RA risk, which was more prominent for LOOH levels >27.9 µM [odds ratio (OR) 18.8] and CP levels >64.3 µM (OR 24.9). A reverse association was observed between MDA levels and RA risk, OR 6.4 for MDA levels <8.5 µM. Having >20 pack-years increased risk for RA with an OR of 19.7. The interaction between smoking and oxidative stress increased RA risk significantly, and RERI between LOOH, CP or MDA and smoke exposure were 8.2, 5.0 and 51.5, respectively. CONCLUSION: These data suggest that the interaction between oxidative stress and smoking increases RA risk.

A pilot feasibility study of a questionnaire to determine European Union-wide CAM use.

BACKGROUND: No questionnaire specifically measuring the core components of complementary and alternative medicine (CAM) use has been validated for use across European Union (EU) countries. We aimed to determine the face validity, acceptability and the participants' comprehension of a pre-existing questionnaire designed to measure 'CAM use', to provide a comparative, standardised questionnaire for use by health care providers, policy makers and purchasers throughout Europe. METHODS: Established procedures were employed to translate the questionnaire into 4 EU languages. The translated questionnaires were piloted on 50 healthy adults from each country who may never have used CAM. 10 participants per country also took part in audio-recorded think aloud interviews about the questionnaire. The interviews were transcribed and analysed in the language in which they were conducted; findings were summarised in English. Questionnaire data were pooled across countries, and patterns of completion and missing data were analysed. RESULTS: The questionnaire was translated into Italian, Spanish, Dutch and Romanian. The mean age of the participants was 43.6 years. 34% were male, 87.4% were either light or heavy CAM users, and 12.6% were non-users. Qualitative analysis identified common problems across countries including a 'hard-to-read' layout, misunderstood terminology and uncertainty in choosing response options. Quantitative analysis confirmed that a substantial minority of respondents failed to follow questionnaire instructions and that some questions had substantial rates of missing data. CONCLUSIONS: The I-CAM-Q has low face validity and low acceptability, and is likely to produce biased estimates of CAM use if applied in England, Romania, Italy, The Netherlands or Spain. Further work is required to develop the layout, terms, some response options and instructions for completion before it can be used across the EU.

Towards a pan-European definition of complementary and alternative medicine--a realistic ambition?

BACKGROUND: The terms used for defining complementary and alternative medicine (CAM) including the methods, procedures and therapies vary greatly. The task of the CAMbrella working group on terminology was to explore the existing CAM terminologies and to develop a pragmatic definition of CAM that is acceptable Europe-wide. This can then be used to systematically research, e.g., its prevalence and legal status and to investigate the citizens' demands on CAM and the perspectives of providers of CAM in Europe. METHODS: Terms and definitions were collected from both scientific and non-scientific sources. The terms and definitions identified were analysed and discussed among the CAMbrella working group participants on several occasions with the aim of arriving at a consensus. RESULTS: We developed a proposal for a pragmatic European definition of CAM: 'Complementary and alternative medicine (CAM) utilised by European citizens represents a variety of different medical systems and therapies based on the knowledge, skills and practices derived from theories, philosophies and experiences used to maintain and improve health, as well as to prevent, diagnose, relieve or treat physical and mental illnesses. CAM has been mainly used outside conventional health care, but in some countries certain treatments are being adopted or adapted by conventional health care.' CONCLUSION: Developing a uniform, pragmatic pan-European definition of CAM was complicated by a number of factors. These included the vast diversity of existing definitions, systems, disciplines, procedures, methods and therapies available within the EU.

A systematic literature review of complementary and alternative medicine prevalence in EU.

BACKGROUND: Studies suggest that complementary and alternative medicine (CAM) is widely used in the European Union (EU). We systematically reviewed data, reporting research quality and the prevalence of CAM use by citizens in Europe; what it is used for, and why. METHODS: We searched for general population surveys of CAM use by using Ovid MEDLINE (1948 to September 2010), Cochrane Library (1989 to September 2010), CINAHL (1989 to September 2010), EMBASE (1980 to September 2010), PsychINFO including PsychARTICLES (1989 to September 2010), Web of Science (1989 to September 2010), AMED (1985 to September 2010), and CISCOM (1989 to September 2010). Additional studies were identified through experts and grey literature. Cross-sectional, population-based or cohort studies reporting CAM use in any EU language were included. Data were extracted and reviewed by 2 authors using a pre-designed extraction protocol with quality assessment instrument. RESULTS: 87 studies were included. Inter-rater reliability was good (kappa = 0.8). Study methodology and quality of reporting were poor. The prevalence of CAM use varied widely within and across EU countries (0.3-86%). Prevalence data demonstrated substantial heterogeneity unrelated to report quality; therefore, we were unable to pool data for meta-analysis; our report is narrative and based on descriptive statistics. Herbal medicine was most commonly reported. CAM users were mainly women. The most common reason for use was dissatisfaction with conventional care; CAM was widely used for musculoskeletal problems. CONCLUSION: CAM prevalence across the EU is problematic to estimate because studies are generally poor and heterogeneous. A consistent definition of CAM, a core set of CAMs with country-specific variations and a standardised reporting strategy to enhance the accuracy of data pooling would improve reporting quality.

International development of traditional medicine / complementary and alternative medicine research--what can Europe learn?

BACKGROUND: The aim of this study was to analyse global research and development (R&D) strategies for traditional medicine (TM) and complementary and alternative medicine (CAM) across the world to learn from previous and on-going activities. METHODS: 52 representatives within CAMbrella nominated 43 key international stakeholders (individuals and organisations) and 15 of these were prioritised. Information from policy documents including mission statements, R&D strategies and R&D activities were collected in combination with personal interviews. Data were analysed using the principles of content analysis. RESULTS: Key stakeholders vary greatly in terms of capacity, mission and funding source (private/public). They ranged from only providing research funding to having a comprehensive R&D and communication agenda. A common shift in R&D strategy was noted; whereas 10 years ago research focused mainly on exploring efficacy and mechanisms, today the majority of stakeholders emphasise the importance of a broad spectrum of research, including methodologies exploring context, safety and comparative effectiveness. CONCLUSION: The scarce public investment in this field in Europe stands in stark contrast to the large investments found in Australia, Asia and North America. There is an emerging global trend supporting a broad research repertoire, including qualitative and comparative effectiveness research. This trend should be considered by the EU given the experience and the substantial research funding committed by the included stakeholders. To facilitate international collaborative efforts and minimise the risk of investment failure, we recommend the formation of a centralised EU CAM research centre fostering a broad CAM R&D agenda with the responsibility for implementing the relevant findings of CAMbrella.

Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial.

BACKGROUND: Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. METHODS/DESIGN: Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. DISCUSSION: This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. TRIAL REGISTRATION: ISRCTN trial number ISRCTN60217348 (19 October 2010).

Glycated hemoglobin vs. the oral glucose tolerance test for the exclusion of impaired glucose tolerance in high-risk individuals.

BACKGROUND: The aim of this study was to compare the use of glycated hemoglobin (HbA(1c)) and the oral glucose tolerance test (OGTT) in the diagnosis of impaired glucose tolerance in high-risk individuals. METHODS: A total of 713 patients with at least two risk factors for the development of type 2 diabetes were enrolled in the study. Fasting glucose and HbA(1c) were measured in all individuals. Patients whose fasting glucose concentrations were below 7.0 mmol/L underwent an OGTT. RESULTS: From the 713 patients, 234 were euglycemic, 200 had impaired fasting glucose, 118 presented with impaired glucose tolerance and 161 met the diagnostic criteria for type 2 diabetes. OGTT was performed in a total of 596 patients (83.6%). Statistically significant differences were observed for HbA(1c) concentrations in all groups. Receiver operating characteristic curve analysis was performed to assess the capability of HbA(1c) to discriminate between normal glucose tolerance and impaired glucose tolerance. An HbA(1c) value of 36 mmol/mol (5.4%) gave an optimal sensitivity of 85% and a specificity of 73%, and a negative predictive value of 97% for identifying patients with impaired glucose tolerance. CONCLUSIONS: HbA(1c) can be used to rule out patients at high-risk of developing type 2 diabetes.