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The article presents the discussion on integration of artificial intelligence (AI) in the field of medicine will bring about a profound transformation. Topics include hold the potential to revolutionize how medical professionals approach patient care, from early detection and proactive preventive measures; and brings with it a reevaluation of the roles and responsibilities within the health care system.

The article discusses the collaboration between the Society for Integrative Oncology (SIO) and the American Society for Clinical Oncology (ASCO) to formulate the published pain management guideline. Topics include purpose of the guideline, recommendations by the Society for Acupuncture Research (SAR) on acupuncture, and importance of effective dissemination and implementation of the guideline.

Importance: There are few robust evaluations of disease-specific question prompt sheets (QPS) in patient-physician communication among patients with advanced cancer. Objective: To compare the patient perception of helpfulness, global evaluation, and preference for the QPS vs a general information sheet (GIS), and to examine the effect of the QPS on participants' anxiety, participants' speaking time, number of questions asked, and length of the clinical encounter. Design: , setting, and participants: This controlled, double-blind randomized clinical trial was conducted at an outpatient palliative and supportive care clinic in a cancer center in the US. Eligible patients were 18 years or older, had a cancer diagnosis, and were undergoing their first outpatient consultation visit with a palliative care physician from September 1, 2017, to May 31, 2019. Data analysis used a modified intention-to-treat design. Data were analyzed from May 18 to June 27, 2022. Intervention: QPS, a 25-item list of questions developed by expert palliative care clinicians using a Delphi process and tested among ambulatory advanced cancer patients. The control was GIS, generic information material given routinely to patients seen at the supportive care clinic. Main outcomes and measures: The main outcome was patient perception of helpfulness. Secondary outcomes included global evaluation and preference of QPS compared with GIS immediately after the encounter. Results: A total of 130 patients (mean [SD] age, 58.6 [13.3] years; 79 [60.8%] female) were randomized to receive either QPS (67 patients [51.5%]) or GIS (63 patients [48.5%]). Patients considered QPS and GIS equally helpful, with no statistically significant difference (mean [SD] helpfulness score, 7.2 [2.3] points vs 7.1 [2.7] points; P =.79). The QPS group, compared with the GIS group, had a higher global positive view of the material (mean [SD] global perception score, 7.1 [1.3] vs 6.5 [1.7]; P =.03) and felt it prompted them more to generate new questions (mean [SD] rating, 7.0 [2.9] vs 5.3 [3.5]; P =.005). Of 47 patients asked their preference between the items, more participants preferred the QPS to the GIS in communicating with their physicians (24 patients [51.1%] vs 7 patients [14.9%]; P =.01) at the 4-week follow-up. No significant differences between the QPS and GIS groups were observed regarding participant anxiety, speaking time, number of questions asked, or consultation length (eg, mean [SD] anxiety rating, 2.3 [3.7] vs 1.6 [2.7]; P =.19). Conclusions: and relevance: In this randomized clinical trial, participants perceived both QPS and GIS as equally helpful, but they had a more positive global view of and preferred the QPS. QPS facilitated generation of new questions without increasing patient anxiety nor prolonging the consultation. The findings provide support for increased adoption and integration of QPS into routine oncologic care. [ABSTRACT FROM AUTHOR]

Background: The unmonitored use of complementary medicine in patients with cancer can be associated with an increased risk of safety-related issues, such as lower adherence to conventional cancer therapies. Training oncology physicians to advise their patients about the effectiveness and safety of these therapies could improve this situation.Methods: The objective of this study was to develop and pretest a consultation framework that has high potential to be widely implemented. The framework comprises: 1) a systematically developed and tested, manualized, guided consultation; and 2) blended learning training (e-learning and communication skills training workshop) to upskill oncology physicians in advising their patients on complementary and integrative medicine (CIM). For this implementation study, mixed methods were used to develop the manual (literature review, consensus procedure, pilot testing) and the training (questionnaires and interviews with oncology physicians and patients with cancer and an examination of the skills in a setting with standardized patients).Results: The training was tested with 47 oncology physicians from across Germany. The manual-guided consultation (context: general information on the setting and communication techniques; inform: consultation duration and content; capture: previous CIM use; prioritize: focus on consultation; advise: evidence-based CIM recommendations; discuss, advise, accept, or advise against other CIM; concretize advice: summary and implementation; and monitor: documentation) was considered suitable. The structure and time frame (maximum, 20 minutes) of the consultation as well as the training were feasible and well accepted.Conclusions: The current study demonstrates that the KOKON-KTO framework (a German acronym for Competence Network for Complementary Medicine - Consultation Training for Oncology Physicians) is suitable for training oncology physicians. Its implementation can lead to better physician-patient communication about CIM in cancer. [ABSTRACT FROM AUTHOR]

Interprofessional education is expected to promote collaborative practice and should therefore be included in health professionals' curricula. Reports on interprofessional curricular development and its evaluation are rare. We therefore undertook a comprehensive quantitative and qualitative evaluation of a new, mandatory course on interprofessional collaboration for medical students during their third year of the Bachelor of Medicine study programme. The newly developed and implemented course spans over six weeks and was designed in a hybrid, flipped-classroom format. It incorporates experience- and case-based learning as well as interactions with other health professionals. Each student completes an eLearning and a clinical workshadowing individually before attending the - due to the pandemic - virtual live lectures. To assess quality and usefulness of teaching-learning formats and course structure to learn about interprofessional collaboration and to develop interprofessional competencies and identity, a quantitative and qualitative evaluation was performed with more than 280 medical students and 26 nurse educators from teaching hospitals using online surveys (open & closedended format). Data were analyzed descriptively and using content analysis processes. Students appreciated the flipped-classroom concept, the real-world case-based learning scenarios with interprofessional lecturer teams, and the possibility of an experience-based learning opportunity in the clinical setting including interaction with students and professionals from other health professions. Interprofessional identity did not change during the course. Evaluation data showed that the course is a promising approach for teaching-learning interprofessional competencies to medical students. The evaluation revealed three factors that determined the success of this course, namely, a flipped-classroom concept, the individual workshadowing of medical students with another health professional, mainly nurses, and live sessions with interprofessional teaching-learning teams. The course structure and teaching-learning methods showed potential and could serve as a template for interprofessional course development in other institutions and on other course topics. [ABSTRACT FROM AUTHOR]

Background: Selective reporting of outcomes in clinical trials is a serious problem. We aimed to investigate the influence of the peer review process within biomedical journals on reporting of primary outcome(s) and statistical analyses within reports of randomised trials.Methods: Each month, PubMed (May 2014 to April 2015) was searched to identify primary reports of randomised trials published in six high-impact general and 12 high-impact specialty journals. The corresponding author of each trial was invited to complete an online survey asking authors about changes made to their manuscript as part of the peer review process. Our main outcomes were to assess: (1) the nature and extent of changes as part of the peer review process, in relation to reporting of the primary outcome(s) and/or primary statistical analysis; (2) how often authors followed these requests; and (3) whether this was related to specific journal or trial characteristics.Results: Of 893 corresponding authors who were invited to take part in the online survey 258 (29%) responded. The majority of trials were multicentre (n = 191; 74%); median sample size 325 (IQR 138 to 1010). The primary outcome was clearly defined in 92% (n = 238), of which the direction of treatment effect was statistically significant in 49%. The majority responded (1-10 Likert scale) they were satisfied with the overall handling (mean 8.6, SD 1.5) and quality of peer review (mean 8.5, SD 1.5) of their manuscript. Only 3% (n = 8) said that the editor or peer reviewers had asked them to change or clarify the trial's primary outcome. However, 27% (n = 69) reported they were asked to change or clarify the statistical analysis of the primary outcome; most had fulfilled the request, the main motivation being to improve the statistical methods (n = 38; 55%) or avoid rejection (n = 30; 44%). Overall, there was little association between authors being asked to make this change and the type of journal, intervention, significance of the primary outcome, or funding source. Thirty-six percent (n = 94) of authors had been asked to include additional analyses that had not been included in the original manuscript; in 77% (n = 72) these were not pre-specified in the protocol. Twenty-three percent (n = 60) had been asked to modify their overall conclusion, usually (n = 53; 88%) to provide a more cautious conclusion.Conclusion: Overall, most changes, as a result of the peer review process, resulted in improvements to the published manuscript; there was little evidence of a negative impact in terms of post hoc changes of the primary outcome. However, some suggested changes might be considered inappropriate, such as unplanned additional analyses, and should be discouraged. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months. Methods: Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache. Results: Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022–12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036–10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118–6,460]; control: EUR 5,498 [5,326–5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770–1,818]; control: EUR 1,438 [1,414–1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients. Conclusion: The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group. [ABSTRACT FROM AUTHOR]

Background: An increasing number of clinics offer complementary or integrative medicine services; however, clear guidance about how complementary medicine could be successfully and efficiently integrated into conventional health care settings is still lacking. Combining conventional and complementary medicine into integrative medicine can be regarded as a kind of merger. In a merger, two or more organizations ? usually companies ? are combined into one in order to strengthen the companies financially and strategically. The corporate culture of both merger partners has an important influence on the integration. Purpose: The aim of this project was to transfer the concept of corporate culture in mergers to the merging of two medical systems. Methods: A two-step approach (literature analyses and expert consensus procedure) was used to develop practical guidance for the development of a cultural basis for integrative medicine, based on the framework of corporate culture in "mergers," which could be used to build an integrative medicine department or integrative medicine service. Results: Results include recommendations for general strategic dimensions (definition of the medical model, motivation for integration, clarification of the available resources, development of the integration team, and development of a communication strategy), and recommendations to overcome cultural differences (the clinic environment, the professional language, the professional image, and the implementation of evidence-based medicine). Conclusion: The framework of mergers in corporate culture provides an understanding of the difficulties involved in integrative medicine projects. The specific recommendations provide a good basis for more efficient implementation. [ABSTRACT FROM AUTHOR]

The interest in Comparative Effectiveness Research (CER) in the international community is growing. A panel titled 'What Can Comparative Effectiveness Research Contribute to Integrative Health in International Perspective?' took place at the 3rd International Research Congress on Integrative Medicine and Health in Portland, Oregon, in 2012. The presentations at this panel highlighted different perspectives on CER, including the funders' and the stakeholders' perspectives from the United States, as well as experiences with economic evaluations from Australia and pragmatic trials in Europe. The funders' perspective emphasized the need for innovation and controlling costs in large-scale studies. The stakeholder's perspective stressed the need to gather the input of stakeholders in shaping the framework for more informative, more decision-maker-driven research. Several examples of cost-effectiveness analyses were offered from Australia. The importance of balancing rigor and pragmatism was also discussed in a presentation of the efficacy-effectiveness continuum. A wide-ranging discussion explored additional questions concerning the translation of evidence into practice; the effect of pragmatic trials on funding or policy; evidentiary distinctions between and among pragmatic trials and traditional randomized clinical trials; and the multiple roles of stakeholders, particularly in generating new information and knowledge. The presentations and discussions showed that more development of methods is needed. This includes developments on study design and statistical approaches, as well as methods for stakeholder involvement and mechanisms to bring these results into practice. [ABSTRACT FROM AUTHOR]

Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. [ABSTRACT FROM AUTHOR]

Background: Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis. Methods and design: In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ⩾40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum. Discussion: This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism. [ABSTRACT FROM AUTHOR]

Abstract: Ethnopharmacological relevance: In the traditional context, herbs are often used as herbal whole system therapies, however, most clinical trials included highly selected patients and applied standardized treatment protocols with the aim to exclude as much bias as possible. These studies have contributed important information on the efficacy of herbal medicine extracts; however, their results are only marginally helpful to understand the value of herbal medicine and food items in a more traditional usual care context. Methods: The new development of comparative effectiveness research (CER) will be introduced and synergies with ethnopharmacology will be outlined. Results: CER provides great opportunities for guiding researchers and clinicians in improving management of disease. CER compares two or more health interventions in order to determine which of these options works best for which types of patients in settings that are similar to those in which the intervention will be used in practice. CER uses a broad spectrum of methodologies including randomized pragmatic trials that can also be applied to herbal whole system therapies. Ethnopharmacological research can provide highly relevant information for CER including data on characteristics of typical patients as well as traditional usage including methods of collection, extraction, and preparation. Recommendations for future research on traditional herbal medicine and food items are (1) a systematic cooperation between ethnopharmacology and clinical researchers and (2) a call for more CER on traditional herbal medicines and food items. Conclusion: Multiple stakeholders, including ethnopharmacologists, should cooperate to identify relevant study questions as well share their knowledge to determine the optimal placement of a clinical trial in the efficacy–effectiveness–continuum. [ABSTRACT FROM AUTHOR]

Abstract: Ethnopharmacological relevance: In the traditional context, herbs are often used as herbal whole system therapies, however, most clinical trials included highly selected patients and applied standardized treatment protocols with the aim to exclude as much bias as possible. These studies have contributed important information on the efficacy of herbal medicine extracts; however, their results are only marginally helpful to understand the value of herbal medicine and food items in a more traditional usual care context. Methods: The new development of comparative effectiveness research (CER) will be introduced and synergies with ethnopharmacology will be outlined. Results: CER provides great opportunities for guiding researchers and clinicians in improving management of disease. CER compares two or more health interventions in order to determine which of these options works best for which types of patients in settings that are similar to those in which the intervention will be used in practice. CER uses a broad spectrum of methodologies including randomized pragmatic trials that can also be applied to herbal whole system therapies. Ethnopharmacological research can provide highly relevant information for CER including data on characteristics of typical patients as well as traditional usage including methods of collection, extraction, and preparation. Recommendations for future research on traditional herbal medicine and food items are (1) a systematic cooperation between ethnopharmacology and clinical researchers and (2) a call for more CER on traditional herbal medicines and food items. Conclusion: Multiple stakeholders, including ethnopharmacologists, should cooperate to identify relevant study questions as well share their knowledge to determine the optimal placement of a clinical trial in the efficacy–effectiveness–continuum. [Copyright &y& Elsevier]

Background. Expectancies regarding a treatment play an important role in recovery as has been shown in placebo research. The role of expectations regarding the bodily capability to overcome illness is less investigated although in complementary and alternative medicine (CAM) such capability is the target of interventions. We introduced a new construct, body-efficacy expectation, defined as the conviction that ones body is able to deal with health-threatening factors by itself, and developed and validated a scale for its measurement. Methods. The scale was developed following expert recommendations. Using online survey data from 1054 participants an exploratory factor analysis was conducted and psychometric properties of the scale were examined (item characteristics, reliability, and validity). Results. The exploratory factor analysis yielded a one-factor solution explaining 51.96% of total variance (Cronbach's α = 0.77). One of the originally six items was removed due to poor item characteristics. Correlations with several validation measures were in line with the theoretical background of the construct. Most importantly, participants with better general health showed higher body-efficacy expectation than participants with poorer health status. Conclusions. Further studies confirming the factor structure and using clinical samples are recommended. Also, the relations with the appraisal of CAM and CAM use warrant further research. [ABSTRACT FROM AUTHOR]

Background: For Comparative Effectiveness Research (CER) there is a need to develop scales for appraisal of available clinical research. Aims were to 1) test the feasibility of applying the pragmatic-explanatory continuum indicator summary tool and the six CER defining characteristics of the Institute of Medicine to RCTs of acupuncture for treatment of low back pain, and 2) evaluate the extent to which the evidence from these RCTs is relevant to clinical and health policy decision making. Methods: We searched Medline, the AcuTrials™ Database to February 2011 and reference lists and included full-report randomized trials in English that compared needle acupuncture with a conventional treatment in adults with non-specific acute and/or chronic low back pain and restricted to those with ⩾30 patients in the acupuncture group. Papers were evaluated by 5 raters. Principal Findings: From 119 abstracts, 44 full-text publications were screened and 10 trials (4,901 patients) were evaluated. Due to missing information and initial difficulties in operationalizing the scoring items, the first scoring revealed inter-rater and inter-item variance (intraclass correlations 0.02-0.60), which improved after consensus discussions to 0.20-1.00. The 10 trials were found to cover the efficacy-effectiveness continuum; those with more flexible acupuncture and no placebo control scored closer to effectiveness. Conclusion: Both instruments proved useful, but need further development. In addition, CONSORT guidelines for reporting pragmatic trials should be expanded. Most studies in this review already reflect the movement towards CER and similar approaches can be taken to evaluate comparative effectiveness relevance of RCTs for other treatments. [ABSTRACT FROM AUTHOR]

In Western countries, complementary and alternative medicine (CA M) is more and more provided by practitioners and family doctors. To base this reality of health care provision on an evidence-base, academic medicine needs to be included in the development. In the study we aimed to gain information on a structured approach to include CA M in academic health centers. We conducted a semi structured interview study with leading experts of integrative medicine to analyze strategies of existing academic institutions of integrative medicine. The study sample consisted of a purposive sample of ten leaders that have successfully integrated CA M into medical schools in the USA, Great Britain, and Germany and the Director of the National Center for Alternative and Complementary Medicine. Analysis was based on content analysis. The prerequisite to foster change in academic medicine was a strong educational and professional background in academic medicine and research methodologies. With such a skill set, the interviewees identified a series of strategies to align themselves with colleagues from conventional medicine, such as creating common goals, networking, and establishing well-functioning research teams. In addition, there must be a vision of what should be needed to be at the center of all efforts in order to implement successful change. [ABSTRACT FROM AUTHOR]

The increasing burden of chronic diseases presents not only challenges to the knowledge and expertise of the professional medical community, but also highlights the need to improve the quality and relevance of clinical research in this domain. Many patients now turn to complementary and integrative medicine (CIM) to treat their chronic illnesses; however, there is very little evidence to guide their decision-making in usual care. The following research recommendations were derived from a CIM Stakeholder SymposiumonComparative Effectiveness Research (CER): (1) CER studies should bemade a priority in this field; (2) stakeholders should be engaged at every stage of the research; (3) CER study designs should highlight effectiveness over efficacy; (4) research questions should be well defined to enable the selection of an appropriate CER study design; (5) the CIM community should cultivate widely shared understandings, discourse, tools, and technologies to support the use and validity of CER methods; (6) Effectiveness Guidance Documents on methodological standards should be developed to shape future CER studies. CER is an emerging field and its development and impact must be reflected in future research strategies within CIM. This stakeholder symposium was a first step in providing systematic guidance for future CER in this field. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to identify the factors that make a good doctor, both from a patient and a physician perspective. Is there a connection between practicing homeopathy and being a good doctor? Methods: This was a qualitative study of homeopathically trained physicians and their patients, using observation of patient-physician interactions ( n = 29) and interviews with patients ( n = 20) and with physicians ( n = 4). Results: Patients identified the availability of time, both in itself and as a prerequisite for other physician characteristics, as the single most important factor. Other factors include scope of diagnosis/holistic approach, patient-centeredness/empathy, and perceived competence/therapeutic success. Patients did not link these factors to the homeopathic orientation of their physician, while physicians clearly made this connection. Conclusions: The findings confirm other studies of patient satisfaction and physician characteristics. The availability of time, a holistic approach, and high physician empathy lead to high patient satisfaction. Homeopathic physicians probably are more likely to exhibit these characteristics. Practice implications: Health care policy should create conditions that enable individual physicians to be 'good doctors.' For medical education, a stronger emphasis on interpersonal skills and practitioner empathy could lead to higher patient satisfaction and potentially better treatment outcomes. Homeopathy might provide a good role model for this type of education. [ABSTRACT FROM AUTHOR]

Objectives and background: The objective of this study was to evaluate treatment details and possible effects of an individualized homeopathic treatment in patients with migraine in usual care. Design: This was a prospective multicenter observational study. Consecutive patients beginning homeopathic treatment in primary care practices were evaluated over 2 years using standardized questionnaires. The data recorded included diagnoses (International Classification of Diseases, Ninth Revision) and current complaints, including their severity (numeric rating scale = 0–10), health-related quality of life (QoL, 36-item Short-Form Health Survey), medical history, consultations, homeopathic and conventional treatments, as well as other health service use. Results: Two hundred and twelve (212) adults (89.2% women), mean age 39.4 ± 10.7 years were treated by 67 physicians. Patients had suffered from migraine for a period of 15.2 ± 10.9 years. Most patients (90.0%) were conventionally pretreated. The physician workload included taking the initial patient history (120 ± 45 minutes), case analysis (40 ± 47 minutes), and follow-ups (7.3 ± 7.0, totaling 165.6 ± 118.8 minutes). Patients received 6.2 ± 4.6 homeopathic prescriptions. Migraine severity showed marked improvement with a large effect size (Cohen's d = 1.48 after 3 months and 2.28 after 24 months. QoL improved accordingly (Mental Component Score and Physical Component Score after 24 months: 0.42 and 0.45). The use of conventional treatment and health services decreased markedly. Conclusions: In this observational study, patients seeking homeopathic treatment for migraine showed relevant improvements that persisted for the observed 24 month period. Due to the design of this study, however, it does not answer the question as to whether the effects are treatment specific or not. [ABSTRACT FROM AUTHOR]

Background: Anthroposophic medicine is a physician-provided complementary therapy system involving counselling, artistic and physical therapies, and special medications. The purpose of this analysis was to identify predictors of symptom improvement in patients receiving anthroposophic treatment for chronic diseases. Methods: 913 adult outpatients from Germany participated in a prospective cohort study. Patients were starting anthroposophic treatment for mental (30.4% of patients, n = 278/913), musculoskeletal (20.2%), neurological (7.6%), genitourinary (7.4%) or respiratory disorders (7.2%) or other chronic indications. Stepwise multiple linear regression analysis was performed with the improvement of Symptom Score (patients' assessment, 0: not present, 10: worst possible) after 6 and 12 months as dependent variables. 61 independent variables pertaining to sociodemographics, life style, disease status, co-morbidity, health status (SF-36), depression, and therapy factors were analysed. Results: Compared to baseline, Symptom Score improved by average 2.53 points (95% confidence interval 2.39- 2.68, p < 0.001) after six months and by 2.49 points (2.32-2.65, p < 0.001) after 12 months. The strongest predictor for improvement after six months was baseline Symptom Score, which alone accounted for 25% of the variance (total model 32%). Improvement after six months was also positively predicted by better physical function, better general health, shorter disease duration, higher education level, a diagnosis of respiratory disorders, and by a higher therapy goal documented by the physician at baseline; and negatively predicted by the number of physiotherapy sessions in the pre-study year and by a diagnosis of genitourinary disorders. Seven of these nine variables (not the two diagnoses) also predicted improvement after 12 months. When repeating the 0-6 month analysis on two random subsamples of the original sample, three variables (baseline Symptom Score, physical function, general health) remained significant predictors in both analyses, and three further variables (education level, respiratory disorders, therapy goal) were significant in one analysis. Conclusion: In adult outpatients receiving anthroposophic treatment for chronic diseases, symptom improvement after 6 and 12 months was predicted by baseline symptoms, health status, disease duration, education, and therapy goal. Other variables were not associated with the outcome. This secondary predictor analysis of data from a pre-post study does not allow for causal conclusions; the results are hypothesis generating and need verification in subsequent studies. [ABSTRACT FROM AUTHOR]

Evaluating homeopathic treatment for dysmenorrhea. Prospective multicenter observational study in primary care, using standardized questionnaires to record for 2 years diseases, quality of life, medical history, consultations, all treatments, other health services use. Fifty-seven physicians treated 128 women (age 32.4 ± 7.5 years, mean ± SD) and 11 girls (13.7 ± 4.0). Women had dysmenorrhea for 11.6 ± 9.0 (girls 3.1 ± 1.5) years. Patients received 7.5 ± 6.5 (5.9 ± 3.7) homeopathic prescriptions. Diagnoses and complaints severity improved markedly [at 24 months, dysmenorrhea relieved by > 50% of baseline rating in 46.1% (59) of the women and 45.5% (5) of the girls] with large effect sizes (24 months: Cohen’s d from 1.18 to 2.93). In addition, QoL improved (24 months: SF-36 physical component score: 0.25, mental component score 0.25, KINDL sum score 0.27). Conventional medication changed little and use of other health services decreased. Patients with dysmenorrhea improved under homeopathic treatment. Controlled studies should investigate efficacy and effectiveness. [ABSTRACT FROM AUTHOR]

Objective: Medicinal plants are the primary ingredients of Tibetan medicinal formulae. The aim of the present study was to evaluate the spectrum of medical complaints treated by a Tibetan doctor in Sikkim and Nepal, and to determine which plants the doctor used most frequently to treat these complaints. Design: Two prospective observational studies were carried out at two locations (Sikkim and Nepal). Patients who visited the participating Tibetan doctor were included consecutively. Medical symptoms, Tibetan syndrome diagnoses, and treatments were documented. The most frequently used plants were identified retrospectively. Results: A total of 238 patients were included (Sikkim: n = 135, 62.2% women, mean age 33.9 3.4 years; Nepal: n = 103, 54.4% men, mean age 42.9 2.4 years). The most frequent medical complaint was pain (Sikkim: 46% of patients; Nepal: 51% of patients). The most frequent Tibetan syndrome diagnosis was Bad-kan in Sikkim (20.7% of patients; a cold disorder affecting the lower body) and a combination of Bad-kan and mKhris-pa in Nepal (28.2%; a mixed cold/hot disorder affecting the lower and middle body). A total of 71 different Tibetan medicines were prescribed, including 138 different plants. Of these 138 plants, 81 typically grow at high and medium altitudes, and 57 grow in tropical and subtropical areas. Nevertheless, most (93%) of the prescribed formulae contained high-altitude plants. Conclusions: For the first time, information on medical complaints and treatments has been evaluated systematically for patients receiving treatment from a Tibetan doctor. These data provide a good foundation for further research on Tibetan medicine. Further studies should go a step farther and include follow-up data and information about the effectiveness and safety of Tibetan medicines. [ABSTRACT FROM AUTHOR]

Background: In January 1998, the California state legislature extended a workplace smoking ban to bars. The purpose of this study was to explore the conditions that facilitate or hinder compliance with a smoking ban in bars. Methods: We studied the implementation of the smoking ban in bars by interviewing three sets of policy participants: bar employers responsible for complying with the law; local government officials responsible for enforcing the law; and tobacco control activists who facilitated implementation. We transcribed the interviews and did a qualitative analysis of the text. Results: The conditions that facilitated bar owners' compliance with a smoking ban in bars included: if the cost to comply was minimal; if the bars with which they were in competition were in compliance with the smoking ban; and if there was authoritative, consistent, coordinated, and uniform enforcement. Conversely, the conditions that hindered compliance included: if the law had minimal sanctions; if competing bars in the area allowed smoking; and if enforcement was delayed or inadequate. Conclusion: Many local enforcers wished to forfeit their local discretion and believed the workplace smoking ban in bars would be best implemented by a state agency. The potential implication of this study is that, given the complex nature of local politics, smoking bans in bars are best implemented at a broader provincial or national level. [ABSTRACT FROM AUTHOR]

Objective: Rhythmical massage therapy is used in 24 countries but has not yet been studied in outpatient settings. The objective was to study clinical outcomes in patients receiving rhythmical massage therapy for chronic diseases. Design: Prospective 4-year cohort study. Setting: Thirty-six (36) medical practices in Germany. Participants: Eighty-five (85) outpatients referred to rhythmical massage therapy. Outcome measures: Disease and Symptom Scores (physicians' and patients' assessment, respectively, 0–10) and SF-36. Disease Score was measured after 6 and 12 months, and other outcomes after 3, 6, 12, 18, 24, and 48 months. Results: Most common indications were musculoskeletal diseases (45% of patients; primarily back and neck pain) and mental disorders (18%, primarily depression and fatigue). Median disease duration at baseline was 2.0 years (interquartile range 0.5–6.0). Median number of rhythmical massage therapy sessions was 12 (interquartile range 9–12), and median therapy duration was 84 (49–119) days. All outcomes improved significantly between baseline and all subsequent follow-ups. From baseline to 12 months, Disease Score improved from (mean ± standard deviation) 6.30 ± 2.01 to 2.77 ± 1.97 ( p < 0.001), Symptom Score improved from 5.76 ± 1.81 to 3.13 ± 2.20 ( p < 0.001), SF-36 Physical Component score improved from 39.55 ± 9.91 to 45.17 ± 9.88 ( p < 0.001), and SF-36 Mental Component score improved from 39.27 ± 13.61 to 43.78 ± 12.32 ( p = 0.028). All these improvements were maintained until the last follow-up. Adverse reactions to rhythmical massage therapy occurred in 4 (5%) patients; 2 patients stopped therapy because of adverse reactions. Conclusions: Patients receiving rhythmical massage therapy had long-term reduction of chronic disease symptoms and improvement of quality of life. [ABSTRACT FROM AUTHOR]

Abstract: 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. [Copyright &y& Elsevier]

Background: Many patients with chronic diseases use complementary therapies, often provided by their physicians. In Germany, several physician-provided complementary therapies have been reimbursed by health insurance companies as part of health benefit programs. In most of these therapies, the patient has a predominantly passive role. In eurythmy therapy, however, patients actively exercise specific movements with the hands, the feet or the whole body. The purpose of this study was to describe clinical outcomes in patients practising eurythmy therapy exercises for chronic diseases. Methods: In conjunction with a health benefit program, 419 outpatients from 94 medical practices in Germany, referred to 118 eurythmy therapists, participated in a prospective cohort study. Main outcomes were disease severity (Disease and Symptom Scores, physicians' and patients' assessment on numerical rating scales 0-10) and quality of life (adults: SF-36, children aged 8-16: KINDL, children 1-7: KITA). Disease Score was documented after 0, 6 and 12 months, other outcomes after 0, 3, 6, 12, 18, 24, and (SF-36 and Symptom Score) 48 months. Results: Most common indications were mental disorders (31.7% of patients; primarily depression, fatigue, and childhood emotional disorder) and musculoskeletal diseases (23.4%). Median disease duration at baseline was 3.0 years (interquartile range 1.0-8.5). Median number of eurythmy therapy sessions was 12 (interquartile range 10-19), median therapy duration was 119 days (84-188). All outcomes improved significantly between baseline and all subsequent follow-ups (exceptions: KITA Psychosoma in first three months and KINDL). Improvements from baseline to 12 months were: Disease Score from mean (standard deviation) 6.65 (1.81) to 3.19 (2.27) (p < 0.001), Symptom Score from 5.95 (1.75) to 3.49 (2.12) (p < 0.001), SF-36 Physical Component Summary from 43.13 (10.25) to 47.10 (9.78) (p < 0.001), SF-36 Mental Component Summary from 38.31 (11.67) to 45.01 (11.76) (p < 0.001), KITA Psychosoma from 69.53 (15.45) to 77.21 (13.60) (p = 0.001), and KITA Daily Life from 59.23 (21.78) to 68.14 (18.52) (p = 0.001). All these improvements were maintained until the last follow-up. Improvements were similar in patients not using diagnosis-related adjunctive therapies within the first six study months. Adverse reactions to eurythmy therapy occurred in 3.1% (13/419) of patients. No patient stopped eurythmy therapy due to adverse reactions. Conclusion: Patients practising eurythmy therapy exercises had long-term improvement of chronic disease symptoms and quality of life. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that eurythmy therapy can be useful for patients motivated for this therapy. [ABSTRACT FROM AUTHOR]

Abstract: Acupuncture is widely used by patients with neck pain, but there is a lack of information about its effectiveness in routine medical care. The aim was to investigate the effectiveness of acupuncture in addition to routine care in patients with chronic neck pain compared to treatment with routine care alone. We performed a randomized controlled multicentre trial plus non-randomized cohort in general practices in Germany. 14,161 patients with chronic neck pain (duration >6 months). Patients were randomly allocated to an acupuncture group or a control group receiving no acupuncture. Patients in the acupuncture group received up to 15 acupuncture sessions over three months. Patients who did not consent to randomization received acupuncture treatment. All subjects were allowed to receive usual medical care in addition to study treatment. Neck pain and disability (NPAD Scale by Wheeler) after three months. Of 14,161 patients (mean age 50.9±13.1 years, 68% female) 1880 were randomized to acupuncture and 1886 to control, and 10,395 included into the non-randomized acupuncture group. At three months, neck pain and disability improved by 16.2 (SE: 0.4) to 38.3 (SE: 0.4); and by 3.9 (SE: 0.4) to 50.5 (SE: 0.4), difference 12.3 (p <0.001) in the acupuncture and control group, respectively. Treatment success was essentially maintained through six months. Non-randomized patients had more severe symptoms at baseline and showed higher neck pain and disability improvement compared to randomized patients. Treatment with acupuncture added to routine care in patients with chronic neck pain was associated with improvements in neck pain and disability compared to treatment with routine care alone. [Copyright &y& Elsevier]

Objective: Descriptions of the interventions used in acupuncture studies are often incomplete. The aim of this paper is to describe participating trial physicians and interventions in a randomised trial of acupuncture for low back pain. Design: Three-armed, randomized, controlled multicenter trial with 1-year follow-up. A total of 301 patients with low-back pain were randomized to 12 sessions of semistandardized acupuncture (at least six local and two distant points needled bilaterally from a selection of predefined points, but individual choice of additional body or ear acupuncture points possible), minimal acupuncture (superficial needling of at least 6 of 10 predefined, bilateral, distant nonacupuncture points), or a waiting list control (2 months no acupuncture followed by semistandardised acupuncture described above). Outcome measures: Participating trial physicians and interventions. Results: Forty-five (45) physicians specializing in acupuncture (mean age 44 ± 7.8 years, 23 (51%) female) in 30 outpatient centers in Germany provided the interventions. The median duration of acupuncture training of trial physicians was 350 hours (range 140–2508). The most frequently reported Chinese diagnosis was Kidney deficiency (39%), followed by qi and Blood stagnation (24%), and bi syndrome (20%). The total number of needles used was 17.3 ± 4.2 in the acupuncture group compared to 12.3 ± 1.2 in the minimal acupuncture group. In total, 40 physicians (89%) stated that they would have treated patients similarly or in exactly the same way outside of the trial, whereas 5 (11%) stated that they would have treated patients differently. Conclusions: For most trial physicians, the semistandardized acupuncture strategy used in this trial was an acceptable compromise for an efficacy study. However, a relevant minority of participating trial physicians stated that they would have treated patients differently outside of the trial. [ABSTRACT FROM AUTHOR]

BACKGROUND AND OBJECTIVE: Anthroposophic medications (AMED) are prescribed by physicians in 56 countries worldwide and are used for the treatment of a variety of conditions. However, safety data on long-term use of AMED from large prospective studies are sparse. The objective of this analysis was to determine the frequency of patient-reported and physician-assessed adverse drug reactions (ADRs) to AMED in outpatients using AMED for chronic diseases over a 2-year period.A total of 1861 adverse events (AEs) were documented. The most frequent AEs were non-specific symptoms, signs and findings (International Classification of Diseases [10th Edition] R00-R99: 27.6%, 513 of 1861 AEs), musculoskeletal (M00-M99: 16.9%), respiratory (J00-J99: 8.2%) and digestive diseases (K00-K93: 6.6%). No serious AEs attributable to any medication occurred. Out of the 1861 reported AEs, 284 (15.3%) AEs were suspected by the physician or the patient to be an adverse reaction to non-medication therapy (n = 42 AEs), non-AMED (n = 187) or AMED (n = 55 AEs in 29 patients). Twenty of these 29 patients had confirmed ADRs to 21 AMED. These ADRs were local reactions to topical application (n = 6 patients), systemic hypersensitivity (n = 1) and aggravation of pre-existing symptoms (n = 13). In ten patients, AMED was stopped due to ADRs; two patients had ADRs of severe intensity. Median number of days with ADRs was 7 (range 1–39 days). All ADRs subsided, none were serious. The frequency of confirmed ADRs to AMED was 2.2% (21 of 949) of all different AMED used, 3.0% (20 of 662) of AMED users and one ADR per 382 patient-months of AMED use. METHODS: We conducted a prospective observational cohort study involving 131 medical practices in Germany. In total, 662 consecutive outpatients aged 1–75 years were enrolled in the study. The patients were using AMED for mental (primarily depression and fatigue), musculoskeletal, respiratory, neurological and other chronic diseases. Main outcome measures were use of AMED and ADRs to AMED.A total of 1861 adverse events (AEs) were documented. The most frequent AEs were non-specific symptoms, signs and findings (International Classification of Diseases [10th Edition] R00-R99: 27.6%, 513 of 1861 AEs), musculoskeletal (M00-M99: 16.9%), respiratory (J00-J99: 8.2%) and digestive diseases (K00-K93: 6.6%). No serious AEs attributable to any medication occurred. Out of the 1861 reported AEs, 284 (15.3%) AEs were suspected by the physician or the patient to be an adverse reaction to non-medication therapy (n = 42 AEs), non-AMED (n = 187) or AMED (n = 55 AEs in 29 patients). Twenty of these 29 patients had confirmed ADRs to 21 AMED. These ADRs were local reactions to topical application (n = 6 patients), systemic hypersensitivity (n = 1) and aggravation of pre-existing symptoms (n = 13). In ten patients, AMED was stopped due to ADRs; two patients had ADRs of severe intensity. Median number of days with ADRs was 7 (range 1–39 days). All ADRs subsided, none were serious. The frequency of confirmed ADRs to AMED was 2.2% (21 of 949) of all different AMED used, 3.0% (20 of 662) of AMED users and one ADR per 382 patient-months of AMED use. RESULTS: Throughout the 2-year follow-up, patients used 949 different AMED for a total of 11 487 patient-months. The origin of AMED was mineral (8.1%, 77 of 949 AMED), botanical (41.8%), zoological (7.8%), chemically defined (10.5%) and mixed (31.7%). Most frequently used AMED ingredients were Viscum album (11.5%, 76 of 662 patients), Bryophyllum (9.4%), Arnica (7.9%) and Silicea (7.7%). Non-AMED products were used by 94.2% of patients for a total of 11 202 patient-months; 45.2% of this use was accounted for by medication for the CNS, the cardiovascular system and the alimentary tract and metabolism.A total of 1861 adverse events (AEs) were documented.… [ABSTRACT FROM AUTHOR]

Background: Homeopathic drugs even with dilutions beyond 10–23 (high potencies) are frequently used, although their working mechanism is still unknown. Curative information preserved in solvent structure is postulated to exert biologic effects. Objective: The objective was to test for a stimulating or inhibiting effect of high potencies of the homeopathic remedy HgCl2 (Mercurius corrosivus) on two sugar hydrolases. Methods: High potencies were produced using stepwise dilution plus shaking. Controls included potentized solvent (aqua bidestillata), equimolar dilutions without shaking, and enzyme-free references. Tested were potencies with dilution factors 1:200 (CC) on diastase extract from winter barley, and 1:100 (C) on α-amylase from hog pancreas. Enzyme activity was colorimetrically determined by Lugol's iodine-starch reaction. Results: An inhibiting effect of HgCl2 on enzyme activities was observed only in low potencies and dilutions. Statistically significant differences between potencies and controls were not found in randomized and blinded experiments. Conclusions: This experimental design provided independent reproducible results of cell-free in vitro assays. However, it did not indicate an effect of potentized HgCl2 on hydrolases. Demonstrating potency effects may require additional experimental features. [ABSTRACT FROM AUTHOR]

The article investigates the efficaciousness of acupuncture compared with minimal acupuncture and with no acupuncture patients with chronic low back pain. Researchers found out that acupuncture was more operational in meliorating pain than no acupuncture treatment in patients with chronic low back pain. Further, it was revealed that there is no substantial differences between acupuncture and minimal acupuncture.

Background: Anthroposophic therapies (counselling, special medication, art, eurythmy movement, and rhythmical massage) aim to stimulate long-term self-healing processes, which theoretically could lead to a reduction of healthcare use. In a prospective two-year cohort study, anthroposophic therapies were followed by a reduction of chronic disease symptoms and improvement of quality of life. The purpose of this analysis was to describe health costs in users of anthroposophic therapies. Methods: 717 consecutive outpatients from 134 medical practices in Germany, starting anthroposophic therapies for chronic diseases, participated in a prospective cohort study. We analysed direct health costs (anthroposophic therapies, physician and dentist consultations, psychotherapy, medication, physiotherapy, ergotherapy, hospital treatment, rehabilitation) and indirect costs (sick leave compensation) in the prestudy year and the first two study years. Costs were calculated from resource utilisation, documented by patient self-reporting. Data were collected from January 1999 to April 2003. Results: Total health costs in the first study year (bootstrap mean 3,297 Euro; 95% confidence interval 95%-CI 3,157 Euro to 3,923 Euro) did not differ significantly from the pre-study year (3,186 Euro; 95%-CI 3,037 Euro to 3,711 Euro), whereas in the second year, costs (2,771 Euro; 95%-CI 2,647 Euro to 3,256 Euro) were significantly reduced by 416 Euro (95%-CI 264 Euro to 960 Euro) compared to the pre-study year. In each period hospitalisation and sick-leave together amounted to more than half of the total health costs. Anthroposophic therapies and medication amounted to 3%, 15%, and 8% of total health costs in the pre-study year, first year, and second study year, respectively. The cost reduction in the second year was largely accounted for by a decrease of inpatient hospitalisation, leading to a hospital cost reduction of 519 Euro (95%-CI 377 Euro to 904 Euro) compared to the pre-study year. Conclusion: In patients starting anthroposophic therapies for chronic disease, total health costs did not increase in the first year, and were reduced in the second year. This reduction was largely explained by a decrease of inpatient hospitalisation. Within the limits of a pre-post design, study findings suggest that anthroposophic therapies are not associated with a relevant increase in total health costs. [ABSTRACT FROM AUTHOR]

Background: Depressive disorders are common, cause considerable disability, and do not always respond to standard therapy (psychotherapy, antidepressants). Anthroposophic treatment for depression differs from ordinary treatment in the use of artistic and physical therapies and special medication. We studied clinical outcomes of anthroposophic therapy for depression. Methods: 97 outpatients from 42 medical practices in Germany participated in a prospective cohort study. Patients were aged 20-69 years and were referred to anthroposophic therapies (art, eurythmy movement exercises, or rhythmical massage) or started physician-provided anthroposophic therapy (counselling, medication) for depression: depressed mood, at least two of six further depressive symptoms, minimum duration six months, Center for Epidemiological Studies Depression Scale, German version (CES-D, range 0-60 points) of at least 24 points. Outcomes were CES-D (primary outcome) and SF-36 after 3, 6, 12, 18, 24, and 48 months. Data were collected from July 1998 to March 2005. Results: Median number of art/eurythmy/massage sessions was 14 (interquartile range 12-22), median therapy duration was 137 (91-212) days. All outcomes improved significantly between baseline and all subsequent follow-ups. Improvements from baseline to 12 months were: CES-D from mean (standard deviation) 34.77 (8.21) to 19.55 (13.12) (p < 0.001), SF-36 Mental Component Summary from 26.11 (7.98) to 39.15 (12.08) (p < 0.001), and SF-36 Physical Component Summary from 43.78 (9.46) to 48.79 (9.00) (p < 0.001). All these improvements were maintained until last follow-up. At 12-month follow-up and later, 52%-56% of evaluable patients (35%-42% of all patients) were improved by at least 50% of baseline CESD scores. CES-D improved similarly in patients not using antidepressants or psychotherapy during the first six study months (55% of patients). Conclusion: In outpatients with chronic depression, anthroposophic therapies were followed by long-term clinical improvement. Although the pre-post design of the present study does not allow for conclusions about comparative effectiveness, study findings suggest that the anthroposophic approach, with its recourse to non-verbal and artistic exercising therapies can be useful for patients motivated for such therapies. [ABSTRACT FROM AUTHOR]

Background: On the range of diagnoses, course of treatment, and long-term outcome in patients who chose to receive homeopathic medical treatment very little is known. We investigated homeopathic practice in an industrialized country under everyday conditions. Methods: In a prospective, multicentre cohort study with 103 primary care practices with additional specialisation in homeopathy in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: Patient and physician assessments (numeric rating scales from 0 to 10) and quality of life at baseline, and after 3, 12, and 24 months. Results: A total of 3,981 patients were studied including 2,851 adults (29% men, mean age 42.5 ± 13.1 years; 71% women, 39.9 ± 12.4 years) and 1,130 children (52% boys, 6.5 ± 3.9 years; 48% girls, 7.0 ± 4.3 years). Ninety-seven percent of all diagnoses were chronic with an average duration of 8.8 ± 8 years. The most frequent diagnoses were allergic rhinitis in men, headache in women, and atopic dermatitis in children. Disease severity decreased significantly (p < 0.001) between baseline and 24 months (adults from 6.2 ± 1.7 to 3.0 ± 2.2; children from 6.1 ± 1.8 to 2.2 ± 1.9). Physicians' assessments yielded similar results. For adults and young children, major improvements were observed for quality of life, whereas no changes were seen in adolescents. Younger age and more severe disease at baseline were factors predictive of better therapeutic success. Conclusion: Disease severity and quality of life demonstrated marked and sustained improvements following homeopathic treatment period. Our findings indicate that homeopathic medical therapy may play a beneficial role in the long-term care of patients with chronic diseases. [ABSTRACT FROM AUTHOR]

Background. During the COVID-19 pandemic, people affected by cancer were in need of information about the virus and about the (self-) management of cancer symptoms and treatment. It is important to understand how patients with cancer navigated through the pandemic and to explore their experience relating to their supportive care needs. Aim. This study aimed to describe the experience of Swiss oncological patients during the COVID-19 pandemic with additional supportive cancer care. Methods. A single-center study was conducted in 2021. Patients with melanoma, breast, lung, or colon cancer who received active systemic anticancer treatment at the time of the COVID-19 pandemic and who were additionally seeing either oncology clinical nurse specialists, integrative medicine physicians, or both were included. We conducted semistructured interviews alongside the patient-reported quantitative assessment of distress and resilience. Thematic analysis was performed for the qualitative data and descriptive statistics for the quantitative data. Results. Eighteen patients with cancer were interviewed. Patients seeing an integrative medicine physician highlighted that they positively felt being addressed as a whole person during the consultations. The oncology clinical nurse specialists were perceived as the first point of contact for the patients and had more time during the pandemic compared to what the patients normally received. In general, patients did not experience delays or disruptions in their cancer treatment. As immunosuppressed and fatigued patients with cancer, they felt supported by the restrictions and hygienic measures. Access to vaccination reassured patients against the risk of infection. These results were reflected in the quantitative data, as we found moderate distress levels (M = 4.1; SD = 2.5) and high resilience scores (M = 7.5; SD = 0.9) in this patient population. Conclusion. During the COVID-19 pandemic, patients with cancer felt particularly supported by integrative medicine and cancer nurse consultations. Secured resources for nursing consultations and integrative medicine services can help to address the supportive care needs of patients with cancer. [ABSTRACT FROM AUTHOR]

To address the needs of cancer patients, two things are important: (1) oncology physicians and other health professionals in cancer care should receive training so that they can guide their patients through the maze of available offers in complementary and integrative medicine (CIM), and (2) more CIM providers should possess competencies to provide evidence-informed CIM treatments to cancer patients. [ABSTRACT FROM AUTHOR]

Background: Cancer patients often suffer from high levels of distress. Mobile health (mHealth) applications might be an innovative way to deliver mindfulness and relaxation interventions for cancer patients. However, data about the implementation of apps in health care are lacking. Adherence to mHealth interventions is an important indicator for a successful implementation and might be needed to maximize treatment effects. However, the decrease in distress might reduce the motivation of patients to engage in such self-care tools in the long run. Therefore, the aim of this analysis was to investigate the association between the course of distress over time and the adherence to a relaxation self-care app in cancer patients. Methods: We developed an app for cancer patients (CanRelax) and 83 patients who participated in the prospective observational study used the app at least once. The evaluation was guided by the RE-AIM framework, and this analysis focused on the implementation of the app. Patients were grouped into five subgroups according to their course of distress over 10 weeks (Distress Thermometer). These subgroups of patients were compared with each other to identify different user groups. Findings: About half of the patients were adherent over 10 weeks. However, a decrease in distress was associated with lower adherence to the app intervention, whereas patients with moderate distress or an increase in distress showed more adherence. Conclusion: Adherence to an app intervention might be also driven by patients' distress level. A decrease in distress might reduce patients' motivation to continue with a self-care intervention. The interplay between adherence and treatment outcomes should be explored in upcoming mHealth trials to get a better understanding for the implementation of such interventions. Encouraging patients to continue self-care interventions is a major challenge in integrative medicine if they are delivered digitally. The Clinical Trial Registration number: DRKS00010481. [ABSTRACT FROM AUTHOR]

Background: A number of German statutory health insurance companies are offering integrated care contracts for homeopathy (ICCHs) that cover the reimbursement of homeopathic treatment. The effectiveness and cost-effectiveness of these contracts are highly debated.Methods: To evaluate the effectiveness and cost-effectiveness of treatment after an additional enrollment in an ICCH, a comparative, prospective, observational study was conducted in which participants in the ICCH (HOM group) were compared with matched (on diagnosis, sex and age) insured individuals (CON group) who received usual care alone. Those insured with either migraine or headache, allergic rhinitis, asthma, atopic dermatitis and depression were included. Primary effectiveness outcomes were the baseline adjusted scores of diagnosis-specific questionnaires (e.g. RQLQ, AQLQ, DLQI, BDI-II) after 6 months. Primary cost-effectiveness endpoints were the baseline adjusted total costs from an insurer perspective in relation to the achieved quality-adjusted life years (QALYs). Costs were derived from health claims data and QALYs were calculated based on SF-12 data.Results: Data from 2524 participants (1543 HOM group) were analyzed. The primary effectiveness outcomes after six months were statistically significant in favor of the HOM group for migraine or headache (Δ = difference between groups, days with headache: - 0.9, p = 0.042), asthma (Δ-AQLQ(S): + 0.4, p = 0.014), atopic dermatitis (Δ-DLQI: - 5.6, p ≤ 0.001) and depression (Δ-BDI-II: - 5.6, p ≤ 0.001). BDI-II differences reached the minimal clinically important difference. For all diagnoses, the adjusted mean total costs over 12 months were higher in the HOM group from an insurer perspective, with migraine or headache, atopic dermatitis and depression suggesting cost-effectiveness in terms of additional costs per QALY gained.Conclusion: After an additional enrollment in the ICCH, the treatment of participants with depression showed minimally clinically relevant improvements. From an insurer perspective, treatment with an ICCH enrollment resulted in higher costs over all diagnoses but seemed to be cost-effective for migraine or headache, atopic dermatitis and depression according to international used threshold values. Based on the study design and further limitations, our findings should be considered cautiously and no conclusions regarding the effectiveness of specific treatment components can be made. Further research is needed to overcome limitations of this study and to confirm our findings.Trial Registration: clinicaltrials.gov , NCT01854580. Registered 15 March 2013 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01854580. [ABSTRACT FROM AUTHOR]

Background: There is currently no effective treatment against coronavirus disease 2019 (COVID-19). The optimal selection of interventions targeting the virus is unknown. Therefore, evidence from randomized controlled trials (RCTs) to support specific treatment against COVID-19 is urgently needed. The use of Chinese herbal medicines (CHMs) might have a role in the treatment and symptomatic management of patients with COVID-19. It was aimed at providing an overview of the available evidence and ongoing trials concerning the effects of CHMs for the treatment of COVID-19. Methods: This is a narrative review of relevant studies. Searches were conducted to identify documents published till April 22, 2020. Electronic databases, evidence-based collections, websites of relevant organizations, and trial registries were consulted. Results: A total of 25 guidelines on the treatment of patients with COVID-19 were identified. Four guidelines provided recommendations on the use of CHMs; these guidelines were developed in China and South Korea and were based on the consensus of experts exclusively. The remaining 21 guidelines provided no guidance on CHMs. No finished RCTs of CHMs for the treatment of patients with COVID-19 was found. According to the evidence evaluated in this review, a Cochrane review of CHMs for severe acute respiratory syndrome and five uncontrolled observational studies of the effects of CHMs in patients with COVID-19, the effects of CHMs for COVID-19 are unknown. A total of 52 ongoing clinical trials of CHM interventions for the treatment of COVID-19 were found. These trials will be carried out mostly in China (n = 51). Forty (77%) of the ongoing trials will be randomized, whereas 12 (23%) have an unclear sequence generation procedure. Forty-seven trials (90%) will have a sample size <400 participants. Conclusions: To the authors' knowledge, only the Chinese and the South Korean guidelines recommend CHMs as a treatment option for patients with COVID-19. These guidelines base their recommendations on the consensus of experts. Clinical guidelines or health authorities from other countries do not provide advice on CHMs. Due to the absence of RCT, there is currently no reliable evidence on the effects of any specific CHM intervention for the treatment of patients with COVID-19. A high number of clinical trials of different herbal products are being currently conducted in China. [ABSTRACT FROM AUTHOR]

Background: Many oncology physicians are confronted with the topic of complementary and integrative medicine (CIM) by cancer patients. This study examined whether a blended learning (e-learning and a workshop) to train oncology physicians in providing advice on CIM therapies to their cancer patients, in addition to distributing an information leaflet about reputable CIM websites, had different effects on physician-reported outcomes in regard to consultations compared with only distributing the leaflet. Methods: In a multicenter, cluster-randomized trial, 48 oncology physicians were randomly allocated to an intervention group (CIM consultation and an information leaflet) or a control group (information leaflet only). After the training, the oncology physicians conducted 297 consultations with their cancer patients. Measurements were assessed at oncology physician, physician–patient-interaction (measured by external reviewers), and patient levels. This analysis focused on the physician outcomes of stress reaction and perceived consultation skill competency. In addition, qualitative interviews were conducted with a subsample of oncology physicians who experienced both, the intervention and control condition. Results: The oncology physicians in the intervention group showed a lower stress reaction in all measured dimensions after CIM consultations than those in the control group. There was no significant difference between oncology physicians in the intervention and control groups regarding the perceived consultation skill competency (overburden: intervention 1.4 [95% CI: 0.7;2.1]; control 2.1 [95% CI: 1.4;2.7], tension: 1.3 [95% CI: 0.7;2.0] vs. 1.9 [95% CI: 1.3;2.5], and discomfort with consultation situations: 1.0 [95% CI: 0.4;1.7]; vs. 1.7 [95% CI: 1.2;2.3]). The qualitative data showed that only providing the leaflet seemed impersonal to oncology physicians, while the training made them feel well prepared to conduct a full conversation about CIM and provide the information leaflet. Conclusions: In our exploratory study providing structured CIM consultations showed positive effects on the perceived stress of oncology physicians, and the training was subjectively experienced as an approach that improved physician preparation for advising cancer patients about CIM, however no effects regarding perceived consultation skill competency were found. Trial registration: The trial registration number of the KOKON-KTO study is DRKS00012704 in the German Clinical Trials Register (Date of registration: 28.08.2017). [ABSTRACT FROM AUTHOR]

Background: Cancer patients often search for information about their health conditions online. Cancer patient narratives have established themselves as a way of providing information and education but also as an effective approach to improving coping with the disease. Objective: We investigated how people affected by cancer perceive cancer patient narratives and whether such stories can potentially improve coping during their own cancer journeys. Additionally, we reflected on whether our co‐creative citizen science approach can contribute to gaining knowledge about cancer survival stories and providing peer support. Design, Setting and Stakeholders: We applied a co‐creative citizen science approach by using quantitative and qualitative research methods with stakeholders (i.e., cancer patients, their relatives, friends and health professionals). Main Outcome Measures: Understandability and perceived benefits of cancer survival stories, coping, emotional reactions to the stories and helpful characteristics of the stories. Results: Cancer survival stories were considered intelligible and beneficial, and they potentially support positive emotions and coping in people affected by cancer. Together with the stakeholders, we identified four main characteristics that evoked positive emotions and that were considered especially helpful: (1) positive attitudes towards life, (2) encouraging cancer journeys, (3) individual coping strategies for everyday challenges and (4) openly shared vulnerabilities. Conclusions: Cancer survival stories potentially support positive emotions and coping in people affected by cancer. A citizen science approach is suitable for identifying relevant characteristics of cancer survival stories and may become a helpful educational peer support resource for people coping with cancer. Patient or Public Contributions: We adopted a co‐creative citizen science approach, wherein citizens and researchers were equally involved throughout the entire project. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented which discusses a medical study on children who suffered atopic eczema after homoepathic treatment.

Purpose: This study aims to describe the experience of Swiss oncological patients during the COVID-19 pandemic. Methods: A national multi-center study including five hospitals covering the three main language regions of Switzerland was conducted between March and July 2021. Patients with melanoma, breast, lung, or colon cancer receiving active systemic anti-cancer treatment at the time of the COVID-19 pandemic were included. We conducted semi-structured telephone or onsite interviews alongside the administration of distress and resilience-validated questionnaires. Thematic analysis was performed for the qualitative data and descriptive statistics for the quantitative data. Results: Sixty-two cancer patients with a mean age of 61 (SD=14) (58% female) were interviewed. Based on the interviews, we identified that the experience of having cancer during the COVID-19 pandemic was related to five dimensions: psychological, social, support, healthcare, and vaccination. Three themes transverse the five dimensions: (a) needs, (b) positive changes, and (c) phases of the pandemic. In general, patients did not experience delays or disruptions in their cancer treatment nor felt additionally burdened by the pandemic. Lockdown and isolation were reported as mixed experiences (positive and negative), and access to vaccination reassured patients against the risk of infection and instilled hope to return to normalcy. Additionally, we found low distress levels (M=2.9; SD=2.5) and high resilience scores (M=7; SD=1.3) in these patients. Conclusion: Swiss patients with cancer did not express major needs or disruptions in their care during this period of the COVID-19 pandemic. Results identify the mixed experiences of patients and highlight the high resilience levels. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effectiveness and safety of acupuncture for the prevention of chemotherapy‐induced nausea and vomiting (CINV), with a specific intention on exploring sources of between‐study variation in treatment effects. Methods: MEDLINE, EMBASE, Cochrane CENTRAL, CINAHL, Chinese Biomedical Literature Database, VIP Chinese Science and Technology Periodicals Database, China National Knowledge Infrastructure, and Wanfang were searched to identify randomized controlled trials (RCTs) that compared acupuncture to sham acupuncture or usual care (UC). The main outcome is complete control (no vomiting episodes and/or no more than mild nausea) of CINV. GRADE approach was used to rate the certainty of evidence. Results: Thirty‐eight RCTs with a total of 2503 patients were evaluated. Acupuncture in addition to UC may increase the complete control of acute vomiting (RR, 1.13; 95% CI, 1.02 to 1.25; 10 studies) and delayed vomiting (RR, 1.47; 95% CI, 1.07 to 2.00; 10 studies) when compared with UC only. No effects were found for all other review outcomes. The certainty of evidence was generally low or very low. None of the predefined moderators changed the overall findings, but in an exploratory moderator analysis we found that an adequate reporting of planned rescue antiemetics might decrease the effect size of complete control of acute vomiting (p = 0.035). Conclusion: Acupuncture in addition to usual care may increase the complete control of chemotherapy‐induced acute vomiting and delayed vomiting but the certainty of evidence was very low. Well‐designed RCTs with larger sample sizes, standardized treatment regimens, and core outcome measures are needed. [ABSTRACT FROM AUTHOR]

Purpose: This systematic review aims to summarize eHealth studies with mindfulness- and relaxation-based interventions for medical conditions and to determine whether eHealth interventions have positive effects on health.Method: A comprehensive search of five databases was conducted for all available studies from 1990 to 2015. Studies were included if the intervention was mainly technology delivered and included a mindfulness- or relaxation-based intervention strategy and if patients with a medical condition were treated. Treatment effects were summarized for different outcomes.Results: A total of 2383 records were identified, of which 17 studies with 1855 patients were included in this systematic review. These studies were conducted in patients with irritable bowel syndrome, chronic fatigue syndrome, cancer, chronic pain, surgery, and hypertension. All but one study were delivered online through a web-based platform; one study delivered the intervention with iPods. The studies indicate that mindfulness- and relaxation-based eHealth interventions can have positive effects on patients’ general health and psychological well-being. No effects were found for stress or mindfulness. Only five studies reported economic analyses of eHealth interventions without any clear conclusion.Conclusion: There is some evidence that mindfulness- and relaxation-based eHealth interventions for medical conditions can have positive effects on health outcomes. Therefore, such interventions might be a useful addition to standard medical care. No app studies were retrieved, even though a vast number of smartphone apps exist which aim at increasing users’ health. Therefore, more studies investigating those health apps are needed. [ABSTRACT FROM AUTHOR]

Background: There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making.Methods: The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document.Results: Recommendations were developed for "using available data" and "future clinical studies". The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication.Conclusion: The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. [ABSTRACT FROM AUTHOR]

Background: Traditional Indian Ayurvedic medicine uses complex treatment approaches, including manual therapies, lifestyle and nutritional advice, dietary supplements, medication, yoga, and purification techniques. Ayurvedic strategies are often used to treat osteoarthritis (OA) of the knee; however, no systematic data are available on their effectiveness in comparison with standard care. The aim of this study is to evaluate the effectiveness of complex Ayurvedic treatment in comparison with conventional methods of treating OA symptoms in patients with knee osteoarthritis.Methods and Design: In a prospective, multicenter, randomized controlled trial, 150 patients between 40 and 70 years, diagnosed with osteoarthritis of the knee, following American College of Rheumatology criteria and an average pain intensity of ≥40 mm on a 100 mm visual analog scale in the affected knee at baseline will be randomized into two groups. In the Ayurveda group, treatment will include tailored combinations of manual treatments, massages, dietary and lifestyle advice, consideration of selected foods, nutritional supplements, yoga posture advice, and knee massage. Patients in the conventional group will receive self-care advice, pain medication, weight-loss advice (if overweight), and physiotherapy following current international guidelines. Both groups will receive 15 treatment sessions over 12 weeks. Outcomes will be evaluated after 6 and 12 weeks and 6 and 12 months. The primary endpoint is a change in the score on the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) after 12 weeks. Secondary outcome measurements will use WOMAC subscales, a pain disability index, a visual analog scale for pain and sleep quality, a pain experience scale, a quality-of-life index, a profile of mood states, and Likert scales for patient satisfaction, patient diaries, and safety. Using an adapted PRECIS scale, the trial was identified as lying mainly in the middle of the efficacy-effectiveness continuum.Discussion: This trial is the first to compare the effectiveness of a complex Ayurvedic intervention with a complex conventional intervention in a Western medical setting in patients with knee osteoarthritis. During the trial design, aspects of efficacy and effectiveness were discussed. The resulting design is a compromise between rigor and pragmatism.Trial Registration: NCT01225133. [ABSTRACT FROM AUTHOR]