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Background: Acupuncture was shown to reduce symptoms of seasonal allergic rhinitis (SAR). The present study investigated (a) whether autonomic function would differ in SAR patients and healthy controls, and (b) whether acupuncture treatment would evoke changes in autonomic function compared to sham acupuncture., Patients and Methods: SAR patients (n = 30) were recruited from a larger randomized controlled trial investigating the efficacy of acupuncture in SAR. 21 patients received acupuncture, and 9 patients received sham acupuncture. Among other we measured resting heart rate variability and cardiovascular reactivity to a cold pressure test prior to and after 12 sessions of acupuncture or sham acupuncture. In addition, 30 age- and sex-matched healthy controls were tested once., Results: SAR patients showed higher resting heart rate and lower heart rate variability as well as blunted cardiovascular responses compared to controls. After treatment, resting heart rate had decreased, and systolic blood pressure response to the cold pressure test had increased in SAR patients. We found no significant differences in autonomic function changes between patients receiving acupuncture or sham acupuncture., Conclusion: SAR patients showed alterations in autonomic function, which had partially normalized after treatment. However, in this sample we found no specific effect of acupuncture compared to sham acupuncture., (© 2015 S. Karger GmbH, Freiburg.)

Background: 'Kneipp Therapy' (KT) is a form of Complementary and Alternative Medicine (CAM) that includes a combination of hydrotherapy, herbal medicine, mind-body medicine, physical activities, and healthy eating. Since 2007, some nursing homes for older adults in Germany began to integrate CAM in the form of KT in care. The study investigated how KT is used in daily routine care and explored the health status of residents and caregivers involved in KT., Methods: We performed a cross-sectional pilot study with a mixed methods approach that collected both quantitative and qualitative data in four German nursing homes in 2011. Assessments in the quantitative component included the Quality of Life in Dementia (QUALIDEM), the Short Form 12 Health Survey (SF-12), the Barthel-Index for residents and the Work Ability Index (WAI) and SF-12 for caregivers. The qualitative component addressed the residents' and caregivers' subjectively experienced changes after integration of KT. It was conceptualized as an ethnographic rapid appraisal by conducting participant observation and semi-structured interviews in two of the four nursing homes., Results: The quantitative component included 64 residents (53 female, 83.2 ± 8.1 years (mean and SD)) and 29 caregivers (all female, 42.0 ± 11.7 years). Residents were multimorbid (8 ± 3 diagnoses), and activities of daily living were restricted (Barthel-Index 60.6 ± 24.4). The caregivers' results indicated good work ability (WAI 37.4 ± 5.1), health related quality of life was superior to the German sample (SF-12 physical CSS 49.2 ± 8.0; mental CSS 54.1 ± 6.6). Among both caregivers and residents, 89% considered KT to be positive for well-being.The qualitative analysis showed that caregivers perceived emotional and functional benefits from more content and calmer residents, a larger variety in basic care practices, and a more self-determined scope of action. Residents reported gains in attention and caring, and recognition of their lay knowledge., Conclusion: Residents showed typical characteristics of nursing home inhabitants. Caregivers demonstrated good work ability. Both reported to have benefits from KT. The results provide a good basis for future projects, e.g. controlled studies to evaluate the effects of CAM in nursing homes.

Background: In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians., Methods: ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session, Results: Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6)., Conclusions: The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles., Trial Registration: ClinicalTrials.gov: NCT00610584.

Objectives: Acupuncture is increasingly used in patients with allergic asthma, but there is a lack of evidence on the cost-benefit relationship of this treatment. The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone. DESIGN, SUBJECTS, INTERVENTION, OUTCOME MEASURES: In a randomized controlled trial, patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting-list control group. Both groups were free to use routine care treatment. The resource consumption, costs, and health-related quality of life were evaluated at baseline, and after 3 and 6 months by using statutory health insurance information and standardized questionnaires. Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment., Results: Three hundred and six (306) patients (159 acupuncture; 147 controls) were included (mean age 46.5±13.11 years, female 57.2%) and were comparable at baseline. Acupuncture treatment was associated with significantly higher costs compared to control patients (overall costs: €860.76 [95% confidence interval (CI) 705.04-1016.47] versus €518.80 [95% CI 356.66-680.93]; p=0.003; asthma-related costs: €517.52 [95% CI 485.63-549.40] versus €144.87 [95% CI 111.70-178.05]; p<0.001). These additional costs seem essentially driven by acupuncture costs themselves (€378.40 [95% CI 367.10-389.69]). However, acupuncture was associated with superior effectiveness in terms of quality-adjusted life years (QALYs). Resulting ICER lay between €23,231 (overall) and €25,315 (diagnosis-specific) per additional QALY. When using German acupuncture prices of year 2012, the ICER would improve to €12.810 (overall) versus €14,911 (diagnosis-specific) per QALY gained., Conclusions: Treating patients who have allergic bronchial asthma with acupuncture in addition to routine care resulted in additional costs and better effects in terms of patients' quality of life. Acupuncture therefore seems to be a useful and cost-effective add-on treatment.

Background: The CAMbrella coordination action was funded within the Framework Programme 7. Its aim is to provide a research roadmap for clinical and epidemiological research for complementary and alternative medicine (CAM) that is appropriate for the health needs of European citizens and acceptable to their national research institutes and healthcare providers in both public and private sectors. One major issue in the European research agenda is the demographic change and its impact on health care. Our vision for 2020 is that there is an evidence base that enables European citizens to make informed decisions about CAM, both positive and negative. This roadmap proposes a strategic research agenda for the field of CAM designed to address future European health care challenges. This roadmap is based on the results of CAMbrella’s several work packages, literature reviews and expert discussions including a consensus meeting., Methods: We first conducted a systematic literature review on key issues in clinical and epidemiological research in CAM to identify the general concepts, methods and the strengths and weaknesses of current CAM research. These findings were discussed in a workshop (Castellaro, Italy, September 7–9th 2011) with international CAM experts and strategic and methodological recommendations were defined in order to improve the rigor and relevance of CAM research. These recommendations provide the basis for the research roadmap, which was subsequently discussed in a consensus conference (Järna, Sweden, May 9–11th 2012) with all CAMbrella members and the CAMbrella advisory board. The roadmap was revised after this discussion in CAMbrella Work Package (WP) 7 and finally approved by CAMbrella’s scientific steering committee on September 26th 2012., Results: Our main findings show that CAM is very heterogenous in terms of definitions and legal regulations between the European countries. In addition, citizens’ needs and attitudes towards CAM as well as the use and provision of CAM differ significantly between countries. In terms of research methodology, there was consensus that CAM researchers should make use of all the commonly accepted scientific research methods and employ those with utmost diligence combined in a mixed methods framework., Conclusions: We propose 6 core areas of research that should be investigated to achieve a robust knowledge base and to allow stakeholders to make informed decisions. These are: Research into the prevalence of CAM in Europe: Reviews show that we do not know enough about the circumstances in which CAM is used by Europeans. To enable a common European strategic approach, a clear picture of current use is of the utmost importance. Research into differences regarding citizens’ attitudes and needs towards CAM: Citizens are the driver for CAM utilization. Their needs and views on CAM are a key priority, and their interests must be investigated and addressed in future CAM research. Research into safety of CAM: Safety is a key issue for European citizens. CAM is considered safe, but reliable data is scarce although urgently needed in order to assess the risk and cost-benefit ratio of CAM. Research into the comparative effectiveness of CAM: Everybody needs to know in what situation CAM is a reasonable choice. Therefore, we recommend a clear emphasis on concurrent evaluation of the overall effectiveness of CAM as an additional or alternative treatment strategy in real-world settings. Research into effects of context and meaning: The impact of effects of context and meaning on the outcome of CAM treatments must be investigated; it is likely that they are significant. Research into different models of CAM health care integration: There are different models of CAM being integrated into conventional medicine throughout Europe, each with their respective strengths and limitations. These models should be described and concurrently evaluated; innovative models of CAM provision in health care systems should be one focus for CAM research. We also propose a methodological framework for CAM research. We consider that a framework of mixed methodological approaches is likely to yield the most useful information. In this model, all available research strategies including comparative effectiveness research utilising quantitative and qualitative methods should be considered to enable us to secure the greatest density of knowledge possible. Stakeholders, such as citizens, patients and providers, should be involved in every stage of developing the specific and relevant research questions, study design and the assurance of real-world relevance for the research. Furthermore, structural and sufficient financial support for research into CAM is needed to strengthen CAM research capacity if we wish to understand why it remains so popular within the EU. In order to consider employing CAM as part of the solution to the health care, health creation and self-care challenges we face by 2020, it is vital to obtain a robust picture of CAM use and reliable information about its cost, safety and effectiveness in real-world settings. We need to consider the availability, accessibility and affordability of CAM. We need to engage in research excellence and utilise comparative effectiveness approaches and mixed methods to obtain this data. Our recommendations are both strategic and methodological. They are presented for the consideration of researchers and funders while being designed to answer the important and implicit questions posed by EU citizens currently using CAM in apparently increasing numbers. We propose that the EU actively supports an EU-wide strategic approach that facilitates the development of CAM research. This could be achieved in the first instance through funding a European CAM coordinating research office dedicated to foster systematic communication between EU governments, public, charitable and industry funders as well as researchers, citizens and other stakeholders. The aim of this office would be to coordinate research strategy developments and research funding opportunities, as well as to document and disseminate international research activities in this field. With the aim to develop sustainability as second step, a European Centre for CAM should be established that takes over the monitoring and further development of a coordinated research strategy for CAM, as well as it should have funds that can be awarded to foster high quality and robust independent research with a focus on citizens health needs and pan-European collaboration. We wish to establish a solid funding for CAM research to adequately inform health care and health creation decision-making throughout the EU. This centre would ensure that our vision of a common, strategic and scientifically rigorous approach to CAM research becomes our legacy and Europe’s reality. We are confident that our recommendations will serve these essential goals for EU citizens.

In the aging population of Germany the consequences of Dementia for the society and the health care sector are complex and solutions require a multidisciplinary approach. The aim of the two-day interdisciplinary expert conference was to consider dementia from different perspectives, to identify dementia-related problems and to discuss integrative solutions under consideration of complementary therapies. In different working groups the experts developed solutions and recommendations with regards to political need, health care and future research priorities. The present recommendations profited very much from the interdisciplinary participants of the conference and brought together the expertise of different fields resulting in a comprehensive picture about dementia in Germany.

Background: Allergic rhinitis (AR) is a frequent allergic disorder with a significant economic effect on health care costs and productivity., Objective: To assess the cost-effectiveness of acupuncture for patients with seasonal AR (SAR) in Germany., Methods: The present analysis was part of the Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) trial, a 3-arm randomized, controlled, multicenter trial in patients with SAR, comparing acupuncture plus rescue medication (RM), penetrating sham acupuncture plus RM, and a control group receiving RM alone. Measures for health economic analyses were costs and health-related quality of life. Incremental cost-effectiveness ratio was calculated for different scenarios on the duration of acupuncture effects and was expressed as costs per quality-adjusted life-year gained. The study was conducted from society's and from a third-party payer's perspective., Results: From 422 initially randomized patients, a total of 364 patients with complete data on costs and quality of life were included in the health economic evaluation. Patients receiving acupuncture or sham acupuncture caused higher costs than patients in the RM group. Patients in the acupuncture group gained significantly more quality-adjusted life-years compared with the RM group. Depending on different scenarios, the incremental cost-effectiveness ratio for acupuncture patients was between €31,241 (approximately US $38.569) and €118,889 (approximately US $146,777) from society's perspective and between €20,807 (approximately US $25,688) and €74,585 (approximately US $92.080) from a third-party payer's perspective., Conclusion: Acupuncture is an effective intervention that results in improved quality of life in patients with SAR. However, in times of limited resources for health care, acupuncture for AR may not be a cost-effective intervention., Trial Registration: clinicaltrials.gov Identifier: NCT00610584., (Copyright © 2013 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Unlabelled: HYPOTHESE: Cancer-related fatigue (CRF) and sleep disorders are some of the most wearing and common symptoms in disease-free breast cancer patients (BC). Aerobic training (AT) is the treatment with the best available evidence, even though it seems to be insufficient with regards to improvements in cognitive fatigue. We introduced a new multimodal therapy concept (MM) consisting of psycho-, sleep-education and new approaches based on anthroposophic medicine such as eurythmy and painting therapy., Study Design: This pilot study will test the implementation of MM and yield first results of the MM and AE in our centres., Methods: 31 out of 34 patients suffering from BC and CRF were fully assessed in a ten-week intervention study. 21 patients chose MM and 10 decided on AT. CRF was measured with the help of the Cancer Fatigue Scale (CFS-D), and the global quality of sleep was measured with the Pittsburgh Sleep Quality Index (PSQI). We also captured autonomic regulation (aR) and patients' satisfaction with questionnaires. Statistical analysis was done with SAS 9.1.3 for windows., Results: The new MM therapy can be implemented with high satisfaction among patients. Significant improvements were found in the MM group with regards to CFS-D, global quality of sleep, sleep efficiency (PSQI), aR and rest/activity regulation compared to baseline (all p<0.05). In the AT group aR orthostatic-circulatory and rest/activity regulation improved significantly (p<0.05), too. However, no improvement in cognitive fatigue was seen in either group., Conclusion: The multimodal therapy concept was feasible and improved cancer fatigue, sleep quality, autonomic and rest-/activity regulation in breast cancer patients. It may therefore constitute a valuable treatment option in addition to aerobic training for BC patients with CRF. A further study with larger sample size needs to be carried out to assess the efficacy of combined multimodal-aerobic therapy.

Background: Self-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement., Methods: The study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design., Results: Stakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start., Conclusion: Stakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group., Trial Registration: Clinicaltrials.gov identifier http://NCT01582724.

Unlabelled: Chinese translation, Background: Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence., Objective: To evaluate the effects of acupuncture in patients with SAR., Design: Randomized, controlled multicenter trial. (ClinicalTrials.gov: NCT00610584), Setting: 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics., Patients: 422 persons with SAR and IgE sensitization to birch and grass pollen., Intervention: Acupuncture plus rescue medication (RM) (cetirizine) (n = 212), sham acupuncture plus RM (n = 102), or RM alone (n = 108). Twelve treatments were provided over 8 weeks in the first year., Measurements: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16 in the first year and week 8 in the second year after randomization, with predefined noninferiority margins of -0.5 point (RQLQ) and -1.5 points (RMS)., Results: Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point [97.5% CI, 0.2 to 0.8 point; P < 0.001]; RM vs. acupuncture mean difference, 0.7 point [97.5% CI, 0.4 to 1.0 point; P < 0.001]) and RMS (sham vs. acupuncture mean difference, 1.1 points [97.5% CI, 0.4 to 1.9 points; P < 0.001]; RM vs. acupuncture mean difference, 1.5 points [97.5% CI, 0.8 to 2.2 points; P < 0.001]). There were no differences after 16 weeks in the first year. After the 8-week follow-up phase in the second year, small improvements favoring real acupuncture over the sham procedure were noted (RQLQ mean difference, 0.3 point [95% CI, 0.03 to 0.6 point; P = 0.032]; RMS mean difference, 1.0 point [95% CI, 0.2 to 1.9 points; P = 0.018])., Limitation: The study was not powered to detect rare adverse events, and the RQLQ and RMS values were low at baseline., Conclusion: Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

Background. The aim of this randomized, controlled study was to investigate the effectiveness of a mindful walking program in patients with high levels of perceived psychological distress. Methods. Participants aged between 18 and 65 years with moderate to high levels of perceived psychological distress were randomized to 8 sessions of mindful walking in 4 weeks (each 40 minutes walking, 10 minutes mindful walking, 10 minutes discussion) or to no study intervention (waiting group). Primary outcome parameter was the difference to baseline on Cohen's Perceived Stress Scale (CPSS) after 4 weeks between intervention and control. Results. Seventy-four participants were randomized in the study; 36 (32 female, 52.3 ± 8.6 years) were allocated to the intervention and 38 (35 female, 49.5 ± 8.8 years) to the control group. Adjusted CPSS differences after 4 weeks were -8.8 [95% CI: -10.8; -6.8] (mean 24.2 [22.2; 26.2]) in the intervention group and -1.0 [-2.9; 0.9] (mean 32.0 [30.1; 33.9]) in the control group, resulting in a highly significant group difference (P < 0.001). Conclusion. Patients participating in a mindful walking program showed reduced psychological stress symptoms and improved quality of life compared to no study intervention. Further studies should include an active treatment group and a long-term follow-up.

Background: One in five children visiting a homeopathic physician suffers from atopic eczema., Objectives: We aimed to examine the long-term effectiveness, safety and costs of homoeopathic vs. conventional treatment in usual medical care of children with atopic eczema., Methods: In this prospective multi-centre comparative observational non-randomized rater-blinded study, 135 children (48 homoeopathy, 87 conventional) with mild to moderate atopic eczema were included by their respective physicians. Depending on the specialisation of the physician, the primary treatment was either standard conventional treatment or individualized homeopathy as delivered in routine medical care. The main outcome was the SCORAD (SCORing Atopic Dermatitis) at 36 months by a blinded rater. Further outcomes included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months after baseline. A multilevel ANCOVA was used, with physician as random effect and the following fixed effects: age, gender, baseline value, severity score, social class and parents' expectation., Results: The adjusted mean SCORAD showed no significant differences between the groups at 36 months (13.7 95% CI [7.9-19.5] vs. 14.9 [10.4-19.4], p = 0.741). The SCORAD response rates at 36 months were similar in both groups (33% response: homoeopathic 63.9% vs. conventional 64.5%, p = 0.94; 50% response: 52.0% vs. 52.3%, p = 0.974). Total costs were higher in the homoeopathic versus the conventional group (months 31-36 200.54 Euro [132.33-268.76] vs. 68.86 Euro [9.13-128.58], p = 0.005)., Conclusions: Taking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs.

We aimed to compare the effectiveness of standardized and individualized acupuncture treatment in patients with chronic low back pain. A single-center randomized controlled single-blind trial was performed in a general medical practice in Germany run by a Chinese-born medical doctor trained in western and Chinese medicine. One hundred and fifty outpatients with chronic low back pain were randomly allocated to two groups (78 standardized and 72 individualized acupuncture). Patients received either standardized acupuncture or individualized acupuncture. Treatment encompassed between 10 and 15 treatments based on individual symptoms with two treatments per week. The main outcome measure was the area under the curve (AUC) summarizing eight weeks of daily rated pain severity measured with a visual analogue scale (0 mm = no pain, 100 mm = worst imaginable pain). No significant differences between groups were observed for the AUC (individualized acupuncture mean: 1768.7 (95% CI, 1460.4; 2077.1); standardized acupuncture 1482.9 (1177.2; 1788.7); group difference, 285.8 (-33.9; 605.5) P = 0.080). In this single-center trial, individualized acupuncture was not superior to standardized acupuncture for patients suffering from chronic pain. As a next step, a multicenter noninferiority study should be performed to investigate whether standardised acupuncture treatment for chronic low back pain might be applicable in a broader usual care setting. This trial is registered with ClinicalTrials.gov NCT00758017.

Background: Integrative medicine (IM) is currently the most commonly used term to describe the integration of complementary and alternative medicine (CAM) into conventional medicine. In the definitions of IM the most important feature is the focus on evidence as crucial factor for therapeutic decision-making. However, there are discussions on the term "integrative medicine" with the most notable critique from within CAM that it describes the integration of complementary methods into conventional institutions and into a "conventional framework of thinking". The aim of this qualitative study was to understand the thoughts of leading experts on IM and on the scientific debate in the field as well as their personal opinions about terminology in general., Methods: We have conducted semi-standardized interviews with ten leading experts in the field of CAM and integrative medicine in the USA, England, and Germany, who have had leading positions at medical schools or the NIH in 2010 and 2011. Interviews were recorded, transcribed and analyzed using content analysis with the qualitative analysis software maxqda., Results: Overall the current terminology was seen as a problem, although most experts agreed that the term "integrative medicine" (IM) described well what they do or they think is useful for medical care. The terminology debate was discussed from four perspectives: 1) from the perspective of medical practice, 2) from the perspective of research, 3) from the perspective of public relations, and 4) from the perspective of health care delivery. These perspectives may be used to evaluate the appropriateness of different terms in use in the field. When interviewees discussed the terminology question, they also discussed the type of health care system they envisioned. Such reflections led the interviewees to caution about too narrow a focus on the terminology question. The question of naming was one about influencing and changing medicine., Conclusion: The discussion of the experts demonstrated that the discussion about terminology is an important debate about the shaping of medicine. The experts discussed terminology in the light of "how health care systems" should look like in the future.

Introduction: Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA)., Methods: In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome., Results: 21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9)., Conclusion: In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed., Trial Registration: Clinicaltrials.gov Identifier: NCT01057043.

Background: Metabolic syndrome (METS) is an increasingly prevalent but poorly understood clinical condition characterized by insulin resistance, glucose intolerance, dyslipidemia, hypertension, and obesity. Increased oxidative stress catalyzed by accumulation of iron in excess of physiologic requirements has been implicated in the pathogenesis of METS, but the relationships between cause and effect remain uncertain. We tested the hypothesis that phlebotomy-induced reduction of body iron stores would alter the clinical presentation of METS, using a randomized trial., Methods: In a randomized, controlled, single-blind clinical trial, 64 patients with METS were randomly assigned to iron reduction by phlebotomy (n = 33) or to a control group (n = 31), which was offered phlebotomy at the end of the study (waiting-list design). The iron-reduction patients had 300 ml of blood removed at entry and between 250 and 500 ml removed after 4 weeks, depending on ferritin levels at study entry. Primary outcomes were change in systolic blood pressure (SBP) and insulin sensitivity as measured by Homeostatic Model Assessment (HOMA) index after 6 weeks. Secondary outcomes included HbA1c, plasma glucose, blood lipids, and heart rate (HR)., Results: SBP decreased from 148.5 ± 12.3 mmHg to 130.5 ± 11.8 mmHg in the phlebotomy group, and from 144.7 ± 14.4 mmHg to 143.8 ± 11.9 mmHg in the control group (difference -16.6 mmHg; 95% CI -20.7 to -12.5; P < 0.001). No significant effect on HOMA index was seen. With regard to secondary outcomes, blood glucose, HbA1c, low-density lipoprotein/high-density lipoprotein ratio, and HR were significantly decreased by phlebotomy. Changes in BP and HOMA index correlated with ferritin reduction., Conclusions: In patients with METS, phlebotomy, with consecutive reduction of body iron stores, lowered BP and resulted in improvements in markers of cardiovascular risk and glycemic control. Blood donation may have beneficial effects for blood donors with METS., Trial Registration: ClinicalTrials.gov: NCT01328210 Please see related article: http://www.biomedcentral.com/1741-7015/10/53.

Background: In the last 2 decades there has been a large increase in publications on complementary and alternative medicine (CAM). However, CAM research methodology was heterogeneous and often of low quality. The aim of this systematic review was to investigate scientific publications with regards to general issues, concepts and strategies. We also looked at research priorities and methods employed to evaluate the clinical and epidemiological research of CAM in the past to identify the basis for consensus-based research strategies., Methods: We performed a systematic literature search for papers published between 1990 and 2010 in 7 electronic databases (Medline, Web of Science, PsychArticles, PsycInfo, CINAHL, EMBASE and Cochrane Library) on December 16 and 17, 2010. In addition, experts were asked to nominate relevant papers. Inclusion criteria were publications dealing with research methodology, priorities or complexities in the scientific evaluation of CAM. All references were assessed in a multistage process to identify relevant papers., Results: From the 3,279 references derived from the search and 98 references contributed by CAM experts, 170 papers fulfilled the criteria and were included in the analysis. The following key issues were identified: difficulties in past CAM research (e.g., randomisation, blinding), utility of quantitative and qualitative research methods in CAM, priority setting in CAM research and specific issues regarding various CAM modalities., Conclusions: Most authors vote for the use of commonly accepted research methods to evaluate CAM. There was broad consensus that a mixed methods approach is the most suitable for gathering conclusive knowledge about CAM.

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.

Objectives: Current quality of life inventories used in oncology mainly measure the effects of chemo- or radiotherapy alongside functional and role scales. A new approach is to measure the autonomic state of regulation with the trait-inventory of autonomic regulation (Trait-aR). Loss of Trait-aR has been shown in different medical conditions such as breast cancer (BC) but not in colorectal cancer patients (CRC). In this paper we report the validation of a new state autonomic regulation scale (State-aR) of the last week., Methods: Study 1 included 114 participants: (41 women/16 men with cancer and 57 age- and gender-matched healthy people) to conduct a reliability-, factor- and validity-analysis. Concurrent and convergent validity was evaluated with Trait-aR, Fatigue-Numerical-Scale, Hospital Anxiety and Depression Scale (HADS-D) and the self-regulation scale, 65 participants were retested. Study 2 completed 42 participants: 17 with BC and 25 with CRC receiving chemotherapy. The State-aR was administered prior, during and after chemotherapy for measuring responsiveness., Results: The factor analysis loaded to four subscales of State-aR (rest-activity, orthostatic-circulatory, thermo-sweating and digestive regulation) with a: Cronbach-α r(α) = 0.77?0.83 and a test-retest-reliability r(rt) = 0.60?0.80. The sum- and subscales correlated with their concurrent subscales in the Trait-aR (0.48?0.74) and with the sum-scale moderately with all convergent criteria (r = 0.41?-0.44; p <0.001). During chemotherapy the State-aR-sum and rest-activity-scale decreased significantly compared to the change in the Trait-aR (p <0.05)., Conclusions: These findings support that the state autonomic regulation scale has satisfactory to good reliability, good validity and acceptable responsiveness in the context of chemotherapy treatment.

Objectives: The objective of this study was to determine the efficacy of individually designed herbal formulas according to the rules of Traditional Chinese Medicine (TCM) in patients with osteoarthritis of the hip and knee., Design: This was a randomized, controlled, double-blind study with two parallel groups., Settings/location: This study was conducted at the University-centre in Gars am Kamp/Austria and was organized by the Institute of TCM and Complementary Medicine of the Danube University Krems /Austria., Subjects: The study comprised female and male patients with osteoarthritis of hip or knee aged between 45 and 75 years., Interventions: Patients were randomized into a treatment with individualized, water-based herbal decoctions prepared in a standardized cooking process (Verum group) or to a treatment with nonspecific presumably ineffective, water-based herbal decoctions (Control group)., Outcome Measures: The primary outcome was the comparison of change between the intervention groups in the Western Ontario and McMaster Universities lower limb global index questionnaire (WOMAC global index) between baseline and week 20. Secondary outcomes included subscales of WOMAC for pain (A), stiffness (B), and functional impairment (C) and general quality of life in the form of the SF-36 questionnaire., Results: Altogether, 102 patients were randomized in this trial. The demographic and medical baseline characteristics were comparable in the 2 groups. The change of the WOMAC global index and all three subscales was significant in both groups between week 20 and baseline (verum group, global WOMAC: at baseline 47 [SD ± 11.8] and at week 20: 24 (SD ± 18.3); change of mean 23; p > 0.001; control group; global WOMAC: at baseline: 48 (SD ± 14.7) and at week 20: 25 (SD ± 18.3); change of mean 23; p > 0.001). However, there was no significant difference (p = 0.783) between the treatment groups. There were significant changes in the subscales "physical functioning," "bodily pain," "vitality," "social-functioning," and "role-physical" of the SF-36 in both study groups between 20 weeks and baseline, but again no significant difference between the groups. There were no drug-related serious adverse events., Conclusions: While the individual prescription consisting of medicinal herbs according to TCM diagnosis investigated in this trial tend to improve the osteoarthritis, the same effect was also achieved with the nonspecific prescription.

Background and Objective: Complementary and alternative medicine (CAM) is frequently used in patients in industrialised countries. Despite this popularity, there remains a considerable deficit of discourse and cooperation between physicians practicing CAM and conventional medicine. The aim is to present the methodology and results of the first international case conference on integrative medicine (IM) dealing with a patient with low back pain. In this paper the methodological tool "case conference on IM" is also described., Methods: The interactive case conference took place on November 20th, 2009 as part of the "2nd European Congress of IM" in Berlin, Germany. An experienced expert panel from both conventional medicine and CAM developed integrative medical diagnoses and therapeutic strategies using as their starting point an individual patient case on chronic low back pain (LBP). The case was selected because LBP is a common diagnosis with considerable economic impact and a problem which is often treated with CAM., Results: In this case conference, the expert panel agreed on a diagnosis of "chronic non-specific LBP with somatic and psychological factors" and proposed multi-modal short- and long-term treatment including of CAM. The importance of the patient-physician-relationship and the consultation process with appropriate consultation time for treatment success was highlighted. There was consensus that the diagnostic process and resulting treatment plan should be individualised and focussed on the patient as a complete person, identifying the significance the disease has for the patient and not just on the disease for itself. Considerable differences were found amongst the experts regarding the first steps of treatment and each expert saw possibilities of "effective and adequate treatment" being met by their own individual treatment method., Conclusion: The case conference on integrative medicine stimulated an intensive exchange between the approaches used by conventional medicine and CAM clarifying different treatment possibilities for low back pain. Therefore, case conferences on integrative medicine could serve as a model for evaluating similar activities in academic hospitals and establishing such approaches in routine medical care. This strategy has the potential to improve patient centred care., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs in patients with chronic low back or neck pain. This prospective observational study included patients who received acupuncture for chronic low back pain or chronic neck pain. After treatment all patients documented adverse events associated with acupuncture (defined as adverse effects) and provided details e.g. on treatment. Cost data was provided by the health insurance companies. We used a societal perspective including direct health care costs related to the acupuncture and the indirect costs caused through lost workdays. From 73,406 patients, 5440 patients (7.4% [95% CI 7.2%; 7.6%] reported experiencing at least one adverse effect and 1422 patients (1.9% [1.8%; 2.0%]) required treatment. The subsequent treatments reported were either self-treatment (1.2% [1.09%; 1.25%]), treatment with medication and/or by a physician (0.6% [0.57%; 0.68%]), or treatment in a hospital (0.03% [0.02%; 0.04%]). Patients reporting adverse effects that required treatment had higher costs compared to patients without adverse effects (at 3months €1265 [1179; 1351] vs. €1140 [1128; 1153] and at 12months € 3534 [3256; 3812] vs. € 3249 [3209; 3289]. The difference was caused through the expense of visiting physicians and higher indirect costs (difference at 3months: €125 [38; 211], p=0.005 and at 12months: €285 [4; 566], p=0.047). Adverse effects from acupuncture occur in about 7% of patients and were mainly treated by themselves. When these effects needed treatment by a health professional additional expenses were the consequence., (Copyright © 2010 European Federation of International Association for the Study of Pain Chapters. Published by Elsevier Ltd. All rights reserved.)

Background: The status of complementary and alternative medicine (CAM) within the EU needs clarification. The definition and terminology of CAM is heterogeneous. The therapies, legal status, regulations and approaches used vary from country to country but there is widespread use by EU citizens. A coordination project funded by the EU has been launched to improve the knowledge about CAM in Europe., Objectives and Methods: The project aims to evaluate the conditions surrounding CAM use and provision in Europe and to develop a roadmap for European CAM research. Specific objectives are to establish an EU network involving centres of research excellence for collaborative projects, to develop consensus-based terminology to describe CAM interventions, to create a knowledge base that facilitates the understanding of patient demand for CAM and its prevalence, to review the current legal status and policies governing CAM provision, and to explore the needs and attitudes of EU citizens with respect to CAM. Based on this information a roadmap will be created that will enable sustainable and prioritised future European research in CAM. CAMbrella encompasses 16 academic research groups from 12 European countries and will run for 36 months starting from January 2010. The project will be delivered in 9 work packages coordinated by a Management Board and directed by a Scientific Steering Committee with support of an Advisory Board., Output: The outcomes generated will be disseminated through the project's website, peer review open access publications and a final conference, with emphasis on current and future EU policies, addressing different target audiences., (Copyright © 2011 S. Karger AG, Basel.)

Background: The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain., Methodology/principal Findings: In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0-100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported., Conclusions/significance: The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief., Trial Registration: ClinicalTrials.gov NCT00567736.

Background: The results of a survey of decision makers (directors of clinical departments, along with research and education institutes) at German medical schools in 1997 demonstrated that although most respondents were in favour of integrating complementary and alternative medicine (CAM) into medical school curricula, only a minority had implemented these into their medical schools. The aims of this study were to evaluate the current opinions on CAM from decision makers at medical schools in three German-speaking countries and the present extent to which it has been integrated., Methods: In 2004 we sent a standardised questionnaire to 1,017 department directors at medical schools in Austria (A, n = 75), Germany (G, n = 873) and Switzerland (CH, n = 69)., Results: 487 questionnaires (overall response rate: 48%, country-specific response rate: A 39%; G 49%; S 42%) were returned. 40% of respondents had a positive opinion on CAM, whereas 28% had a neutral and 29% a negative opinion and 3% were unsure with a significant difference between Germany (44% positive opinion) in favour for CAM vs. Switzerland (22%; p = 0,021). The CAM therapies rated most positively were acupuncture (53%), osteopathy (52%) and naturopathy (38%) with no statistical differences between the countries. Naturopathy (39%) and herbal medicine (34%) were viewed more positively in Germany compared to Austria (4%, p = 0.001 and 8%, p = 0.01), but not to Switzerland (27%, p = 0.289 and 24%, p = 0.353). The majority of respondents favoured the integration of CAM into the medical system (research 85%, teaching 84% and treatment 60%). However, only 162 respondents (34%) indicated that CAM therapies had already been integrated into the curriculum at their medical schools (treatment 26%, research 19% and education 18%) with no significant differences between the countries. Respondents of Switzerland indicated lower activity of CAM integration (treatment 10% and research 10%) compared to Austria (28%, p = 0.016 and 28%, p = 0.016) and Germany (27%, p = 0.01 and 20%, p = 0.174)., Conclusions: The majority of respondents favoured the integration of CAM into the medical system. However, this integration remains limited and does not reflect the high usage of CAM in the population.

In general, allergic rhinitis can be divided into seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR). In the following sections a summary of efficacy and effectiveness studies is presented. For this narrative review we selected studies based on the following parameters: publication in English, sample size ≥30 patients, and at least 6 acupuncture sessions. Most studies aimed to evaluate the specific effects of acupuncture treatment. Only one study evaluated effectiveness and cost-effectiveness of additional acupuncture treatment. The studies which compared acupuncture with sham acupuncture always used a penetrating sham control. A medication control group was used in only two studies and one study combined acupuncture and Chinese herbal medicine. This overview shows that the trials on efficacy and on effectiveness of acupuncture are very heterogeneous. Although penetrating sham controls were used predominantly, these also varied from superficial penetration at acupuncture points to superficial insertion at non-acupuncture points. Although there is some evidence that acupuncture as additional treatment is beneficial and relatively cost-effective, there is insufficient evidence for an acupuncture specific effect in SAR. In contrast, there is some evidence that acupuncture might have specific effects in patients with PAR. However, all of the published efficacy studies are small and conclusions should be made with care. Further studies with a larger sample size are urgently needed to draw more rigorous conclusions and the results of the ongoing trials will provide us with further information within the next two years., (Copyright © 2010 Elsevier B.V. All rights reserved.)

Background: We report on the study design and protocol of a randomised controlled trial (Acupuncture in Seasonal Allergic Rhinitis, ACUSAR) that investigates the efficacy of acupuncture in the treatment of seasonal allergic rhinitis (SAR)., Objective: To investigate whether acupuncture is non-inferior or superior to (a) penetrating sham acupuncture and (b) rescue medication in the treatment of SAR., Design: 3-armed, randomised controlled multi-centre trial with a total follow-up time of 16 weeks in the 1st year and 8 weeks in the 2nd year., Setting: 41 physicians in 37 out-patient units in Germany specialised in acupuncture treatment., Patients: 400 seasonal allergic rhinitis patients with clinical symptoms and test-positive (skin-prick test and/or specific IgE) to both birch and grass pollen., Interventions: Patients will be randomised in a 2:1:1 ratio to one of three groups: (a) semi-standardised acupuncture plus rescue medication (cetirizine); (b) penetrating sham acupuncture at non-acupuncture points plus rescue medication; or (c) rescue medication alone for 8 weeks (standard treatment group). Acupuncture and sham acupuncture will consist of 12 treatments per patient over 8 weeks., Main Outcome Measures: Average means of the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the Rescue Medication Score (RMS) between weeks 6 and 8 in the first year, adjusted for baseline values., Outlook: The results of this trial available in 2011 will have a major impact on the decision of whether acupuncture should be considered as a therapeutic option in the treatment of SAR., (Copyright 2010 S. Karger AG, Basel.)

Objectives: The aim of the study was to examine the infrared spectrum and the irradiance of different types of moxa sticks to develop a basis for a moxa stick control therapy., Design: An IR radiometer was used to measure the spectral infrared irradiance of seven glowing moxa sticks of different types in dependence of distance to the heat., Results: All sticks investigated showed a similar spectral distribution of the emitted IR radiation with maxima of about 83.5-87.5% in the range long-wavelength IR radiation (IR-C) and with small contributions of both short wavelength IR radiation (IR-A) between 2.2% and 5.5% and of middle wavelength IR radiation (IR-B) between 9.0% and 12.1% of the total IR emission., Conclusions: Study results showed that only a small proportion of the IR radiation emitted by moxa sticks is capable of affecting subepidermal tissue. This finding indicates that thermal effects of moxa sticks are caused primarily by superficial effects on the skin. Because most heat receptors are located in the superficial skin, it thus appears impossible to separate the effects of moxa sticks from the sensation of heat. These results should be taken into account while developing placebo or sham moxibustion devices.

Background: To evaluate the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture., Methods: The prospective observational study included patients who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhoea. After treatment, all patients documented adverse events associated with acupuncture (defined as adverse effects). Patients who reported a need for treatment due to an adverse effect completed an additional standardised questionnaire on the most important adverse effect. Based on this data and considering ethical and legal aspects a new consent form was developed., Results: A total of 229,230 patients received on average 10.2 +/- 3.0 acupuncture treatments. Altogether, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 (2.2%) reported one which required treatment. Common adverse effects were bleedings or haematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%) and vegetative symptoms (0.7%). Two patients experienced a pneumothorax (one needed hospital treatment, the other observation only). The longest duration of a side effect was 180 days (nerve lesion of the lower limb). The resulting medical consent form consists of five modules: Introduction to acupuncture and moxibustion, Risks of acupuncture treatment, Conditions which can increase the risk, Doctor's statement, and Consent., Conclusion: Acupuncture provided by physicians is a relatively safe treatment and the proposed consent form could support both patients and professionals in the process of obtaining informed consent., (Copyright (c) 2009 S. Karger AG, Basel.)

To assess quality of life and cost-effectiveness of additional acupuncture treatment for allergic rhinitis, patients were randomly allocated to 2 groups; both received usual care, but one group received an additional 10 acupuncture sessions. Quality of life (according to the SF-36 Health Survey), and direct and indirect costs, were assessed at baseline and after 3 months, and the incremental cost-effectiveness ratio of acupuncture treatment was calculated. This German study (December 2000-June 2004) involved 981 patients (64% women, mean age 40.9 years (standard deviation, 11.2); 36% men, mean age 43.2 years (standard deviation, 13.0)). At 3 months, quality of life was higher in the acupuncture group than in the control group (mean Physical Component Score 51.99 (standard error (SE), 0.33) vs. 48.25 (SE, 0.33), P < 0.001; mean Mental Component Score 48.55 (SE, 0.42) vs. 45.35 (SE, 0.42), respectively, P < 0.001). Overall costs in the acupuncture group were significantly higher than those in the control group (Euro (euro; 1 euro = US $1.27) 763, 95% confidence interval: 683, 844 vs. 332 euro, 95% confidence interval: 252, 412; mean difference 432 euro, 95% confidence interval: 318, 545). The incremental cost-effectiveness ratio was 17,377 euro per quality-adjusted life year (women, 10,155 euro; men, 44,871 euro) and was robust in sensitivity analyses. Acupuncture, supplementary to routine care, was beneficial and, according to international benchmarks, cost-effective. However, because of the study design, it remains unclear whether the effects are acupuncture specific.

Background: Acupuncture is often used for migraine prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for tension-type headache') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library., Objectives: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with migraine., Search Strategy: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008., Selection Criteria: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (no prophylactic treatment or routine care only), a sham acupuncture intervention or another intervention in patients with migraine., Data Collection and Analysis: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (outcome of primary interest), migraine attacks, migraine days, headache days and analgesic use. Pooled effect size estimates were calculated using a random-effects model., Main Results: Twenty-two trials with 4419 participants (mean 201, median 42, range 27 to 1715) met the inclusion criteria. Six trials (including two large trials with 401 and 1715 patients) compared acupuncture to no prophylactic treatment or routine care only. After 3 to 4 months patients receiving acupuncture had higher response rates and fewer headaches. The only study with long-term follow up saw no evidence that effects dissipated up to 9 months after cessation of treatment. Fourteen trials compared a 'true' acupuncture intervention with a variety of sham interventions. Pooled analyses did not show a statistically significant superiority for true acupuncture for any outcome in any of the time windows, but the results of single trials varied considerably. Four trials compared acupuncture to proven prophylactic drug treatment. Overall in these trials acupuncture was associated with slightly better outcomes and fewer adverse effects than prophylactic drug treatment. Two small low-quality trials comparing acupuncture with relaxation (alone or in combination with massage) could not be interpreted reliably., Authors' Conclusions: In the previous version of this review, evidence in support of acupuncture for migraine prophylaxis was considered promising but insufficient. Now, with 12 additional trials, there is consistent evidence that acupuncture provides additional benefit to treatment of acute migraine attacks only or to routine care. There is no evidence for an effect of 'true' acupuncture over sham interventions, though this is difficult to interpret, as exact point location could be of limited importance. Available studies suggest that acupuncture is at least as effective as, or possibly more effective than, prophylactic drug treatment, and has fewer adverse effects. Acupuncture should be considered a treatment option for patients willing to undergo this treatment.

Background: Acupuncture is often used for tension-type headache prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for migraine prophylaxis') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library., Objectives: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with episodic or chronic tension-type headache., Search Strategy: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008., Selection Criteria: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another intervention in patients with episodic or chronic tension-type headache., Data Collection and Analysis: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use., Main Results: Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acute headaches or routine care only. Both found statistically significant and clinically relevant short-term (up to 3 months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond 3 months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for meta-analyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret, but collectively suggest slightly better results for some outcomes in the control groups., Authors' Conclusions: In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches.

Background: One of five children visiting a homoeopathic physician is suffering from atopic eczema., Objective: To examine the effectiveness, safety and costs of homoeopathic versus conventional treatment in usual care., Methods: In a prospective multicentre comparative observational non-randomised study, 135 children (homoeopathy n = 48 vs. conventional n = 87) with mild to moderate atopic eczema were included. The primary outcome was the SCORAD (Scoring Atopic Dermatitis) at 6 months. Further outcomes at 6 and 12 months also included quality of life of parents and children, use of conventional medicine, treatment safety and disease-related costs., Results: The adjusted SCORAD showed no significant differences between the groups at both 6 months (homoeopathy 22.49 + or - 3.02 [mean + or - SE] vs. conventional 18.20 + or - 2.31, p = 0.290) and 12 months (17.41 + or - 3.01 vs. 17.29 + or - 2.31, p = 0.974). Adjusted costs were higher in the homoeopathic than in the conventional group: for the first 6 months EUR 935.02 vs. EUR 514.44, p = 0.026, and for 12 months EUR 1,524.23 vs. EUR 721.21, p = 0.001. Quality of life was not significantly different between both groups., Conclusion: Taking patient preferences into account, homoeopathic treatment was not superior to conventional treatment for children with mild to moderate atopic eczema., (Copyright 2009 S. Karger AG, Basel.)

Background: Acupuncture is widely used in patients with allergic rhinitis, but the available evidence of its effectiveness is insufficient., Objective: To evaluate the effectiveness of acupuncture in addition to routine care in patients with allergic rhinitis compared with treatment with routine care alone., Methods: In a randomized controlled trial, patients with allergic rhinitis were randomly allocated to receive up to 15 acupuncture sessions during a period of 3 months or to a control group receiving no acupuncture. Patients who did not consent to random assignment received acupuncture treatment. All patients were allowed to receive usual medical care. The Rhinitis Quality of Life Questionnaire (RQLQ) and general health-related quality of life (36-Item Short-Form Health Survey) were evaluated at baseline and after 3 and 6 months., Results: Of 5,237 patients (mean [SD] age, 40 [12] years; 62% women), 487 were randomly assigned to acupuncture and 494 to control, and 4,256 were included in the nonrandomized acupuncture group. At 3 months, the RQLQ improved by a mean (SE) of 1.48 (0.06) in the acupuncture group and by 0.50 (0.06) in the control group (3-month scores, 1.44 [0.06] and 2.42 [0.06], respectively; difference in improvement, 0.98 [0.08]; P < .001). Similarly, quality-of-life improvements were more pronounced in the acupuncture vs the control group (P < .001). Six-month improvements in both acupuncture groups were lower than they had been at 3 months., Conclusions: The results of this trial suggest that treating patients with allergic rhinitis in routine care with additional acupuncture leads to clinically relevant and persistent benefits. In addition, it seems that physician characteristics play a minor role in the effectiveness of acupuncture treatment, although this idea needs further investigation.

We aimed to investigate the effectiveness of acupuncture in addition to routine care in patients with primary headache (> 12 months, two or more headaches/month) compared with treatment with routine care alone and whether the effects of acupuncture differ in randomized and non-randomized patients. In a randomized controlled trial plus non-randomized cohort, patients with headache were allocated to receive up to 15 acupuncture sessions over 3 months or to a control group receiving no acupuncture during the first 3 months. Patients who did not consent to randomization received acupuncture treatment immediately. All subjects were allowed usual medical care in addition to study treatment. Number of days with headache, intensity of pain and health-related quality of life (SF-36) were assessed at baseline, and after 3 and 6 months using standardized questionnaires. Of 15,056 headache patients (mean age 44.1 +/- 12.8 years, 77% female), 1613 were randomized to acupuncture and 1569 to control, and 11,874 included in the non-randomized acupuncture group. At 3 months, the number of days with headache decreased from 8.4 +/- 7.2 (estimated mean +/-s.e.) to 4.7 +/- 5.6 in the acupuncture group and from 8.1 +/- 6.8 to 7.5 +/- 6.3 in the control group (P < 0.001). Similarly, intensity of pain and quality of life improvements were more pronounced in the acupuncture vs. control group (P < 0.001). Treatment success was maintained through 6 months. The outcome changes in non-randomized patients were similar to those in randomized patients. Acupuncture plus routine care in patients with headache was associated with marked clinical improvements compared with routine care alone.

To assess quality of life (QoL), costs, and cost-effectiveness of acupuncture treatment plus routine care versus routine care alone in osteoarthritis patients, a randomised, controlled trial was conducted in 255 general practices in Germany. Four hundred and eighty-nine patients with chronic pain due to osteoarthritis of the knee or hip were included to evaluated QoL and costs at baseline and after 3 months using health insurance funds data and standardized questionnaires. Patients receiving acupuncture had an improved QoL associated with significantly higher costs over the 3 months treatment period compared to routine care alone (mean cost-difference: 469.50 euros [95%CI 135.80-803.19 euros]). This increase in costs was primarily due to the costs of acupuncture. The overall ICER was 17,845 euros per QALY gained. The degree of cost-effectiveness was influenced by gender, with female patients achieving a better cost-effectiveness ratio than men. In conclusion, acupuncture was a cost-effective treatment strategy in patients with chronic osteoarthritis pain.

The aim was to assess costs and cost-effectiveness of additional acupuncture treatment in patients with headache compared with patients receiving routine care alone. A randomized, controlled trial was conducted, including patients (> or =18 years old) with primary headache (more than 12 months, at least two headaches/month). Outcome parameters were quality of life (Short Form 36), direct and indirect costs differences during the 3-month study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment. A total of 3182 patients (1613 acupuncture; 1569 controls) with headache were included (77.4% women, mean age and standard deviation 42.6 +/- 12.3; 22.6% men, 47.2 +/- 13.4). Over 3 months costs were higher in the acupuncture group compared with the control [euro857.47; 95% confidence interval 790.86, 924.07, vs. euro527.34 (459.81, 594.88), P < 0.001, mean difference: euro330.12 (235.27, 424.98)]. This cost increase was primarily due to costs of acupuncture [euro365.64 (362.19, 369.10)]. The ICER was euro11 657 per QALY gained. According to international cost-effectiveness threshold values, acupuncture is a cost-effective treatment in patients with primary headache.

Randomised placebo-controlled trials (RCT) are an invaluable tool for testing the efficacy of new treatment strategies. The choice of placebo in an RCT can affect not only patients' physical and psychological response to a particular intervention, but also the trial setting, the success of patient blinding to the intervention, and therefore the outcome of the study and the efficacy of treatment in general. Therefore the placebo is intrinsically tied to the trial's methodology and results. However, although placebos are an important component in randomised trials, their quality is often left unquestioned. A placebo which was not properly validated may even have specific effects that lead to false negative results. To address this deficit, we propose a measure of placebo quality using the term placebo to assess the physical aspect of a dummy treatment used in the placebo group of a randomised controlled trial (RCT). The Placebo Quality Checklist (PQC) described here may help investigators select an appropriate placebo and help both investigators and critical readers interpret the findings of studies with more care.

Objective: To investigate the clinical effectiveness and cost-effectiveness of acupuncture in patients with dysmenorrhea., Study Design: In a randomized controlled trial plus non-randomized cohort, patients with dysmenorrhea were randomized to acupuncture (15 sessions over three months) or to a control group (no acupuncture). Patients who declined randomization received acupuncture treatment. All subjects were allowed to receive usual medical care., Results: Of 649 women (mean age 36.1 +/- 7.1 years), 201 were randomized. After three months, the average pain intensity (NRS 0-10) was lower in the acupuncture compared to the control group: 3.1 (95% CI 2.7; 3.6) vs. 5.4 (4.9; 5.9), difference -2.3 (-2.9; -1.6); P<.001. The acupuncture group had better quality of life and higher costs. (overall ICER 3,011 euros per QALY)., Conclusion: Additional acupuncture in patients with dysmenorrhea was associated with improvements in pain and quality of life as compared to treatment with usual care alone and was cost-effective within usual thresholds.

Objective: The aim of this paper is to describe the treatment and physician characteristics in a randomised trial of acupuncture for osteoarthritis of the knee., Design: Three-armed, randomised, controlled multicentre trial with 1-year follow-up., Setting: Twenty-eight outpatient centres in Germany., Interventions: A total of 294 patients with osteoarthritis of the knee were randomised to 12 sessions of semi-standardised acupuncture (at least 6 local and 2 distant points needled per affected knee from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), 12 sessions of minimal acupuncture (superficial needling of at least 8 of 10 predefined, bilateral, distant non-acupuncture points) or a waiting list control (2 months no acupuncture)., Outcome: Participating trial physicians and interventions., Results: Forty-seven physicians specialised in acupuncture (mean age 43+/-8 years, 26 females) provided study interventions in 28 outpatient centres in Germany. The median duration of acupuncture training completed by participating physicians was 350 h (range 140-2508). The total number of needles used was 17.4+/-4.8 in the acupuncture group compared to 12.9+/-3.3 in the minimal acupuncture group. In total, 39 physicians (83%) stated that they would have treated patients in either a similar or in exactly the same way outside of the trial, whereas 7 (15%) stated that they would have treated patients differently (1 missing)., Conclusions: Our documentation of the trial interventions shows that semi-standardised acupuncture strategy represents an acceptable compromise for efficacy studies. However, a substantial minority of participating trial physicians stated that they would have treated patients differently outside of the trial.

In a pooled analysis of four randomized controlled trials of acupuncture in patients with migraine, tension-type headache, chronic low back pain, and osteoarthritis of the knee we investigated the influence of expectations on clinical outcome. The 864 patients included in the analysis received either 12 sessions of acupuncture or minimal (i.e. sham) acupuncture (superficial needling of non-acupuncture points) over an 8 week period. Patients were asked at baseline whether they considered acupuncture to be an effective therapy in general and what they personally expected from the treatment. After three acupuncture sessions patients were asked how confident they were that they would benefit from the treatment strategy they were receiving. Patients were classified as responders if the respective main outcome measure improved by at least fifty percent. Both univariate and multivariate analyses adjusted for potential confounders (such as condition, intervention group, age, sex, duration of complaints, etc.) consistently showed a significant influence of attitudes and expectations on outcome. After completion of treatment, the odds ratio for response between patients considering acupuncture an effective or highly effective therapy and patients who were more sceptical was 1.67 (95% confidence interval 1.20-2.32). For personal expectations and confidence after the third session, odds ratios were 2.03 (1.26-3.26) and 2.35 (1.68-3.30), respectively. Results from the 6-month follow-up were similar. In conclusion, in our trials a significant association was shown between better improvement and higher outcome expectations.