[Impact of conflicts of interest on guideline recommendations : Empirical study within the second update of the German interdisciplinary S3 guidelines on fibromyalgia syndrome]. / Der Einfluss von Interessenkonflikten auf Leitlinienempfehlungen : Eine empirische Studie zur zweiten Aktualisierung der interdisziplinären S3­Leitlinie zum Fibromyalgiesyndrom.

BACKGROUND: The impact of conflicts of interest (COI) in general and of academic COI in particular on guideline recommendations in pain medicine has not yet been studied. Whether the inclusion of patients and of representatives of all relevant healthcare professions into a guidelines group is protective against a systematic bias of decisions of a guidelines group is currently unknown. METHODS: All members of the guidelines group declared their COI before the consensus conferences by a standard form according to the rules and standards of the Association of the German Medical and Scientific Societies. The acceptance or rejection and the strength of consensus of recommendations of the second update of the interdisciplinary guidelines on fibromyalgia syndrome was analyzed twice by first including and then excluding the votes of the guideline group members with COI related to a recommendation from the results of anonymous voting via an internet platform. RESULTS: A total of 42 persons from different healthcare professions and patients participated in the online voting on recommendations. Of the participants 29% had no COI according to the predefined criteria, 53% met the criteria of academic and 33% the criteria of financial COI. In the case of exclusion of participants with a COI related to a specific recommendation, 2 out of 23 recommendations (homeopathy, tramadol) were not accepted. In all votes, there were more participants without COI than with COI. CONCLUSION: Academic COI were more frequent than financial COI in the second update of the German interdisciplinary guidelines group on fibromyalgia syndrome. The impact of COI on guideline recommendations was low. The inclusion of patients and of all relevant healthcare professionals into a guidelines group is a protective factor against the influence of COI on guideline recommendations.

[Complementary and alternative therapies for fibromyalgia syndrome. Systematic review, meta-analysis and guideline]. / Komplementäre und alternative Verfahren beim Fibromyalgiesyndrom. Systematische Übersicht, Metaanalyse und Leitlinie.

BACKGROUND: The scheduled update to the German S3 guidelines on fibromyalgia syndrome (FMS) by the Association of the Scientific Medical Societies ("Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften", AWMF; registration number 041/004) was planned starting in March 2011. MATERIALS AND METHODS: The development of the guidelines was coordinated by the German Interdisciplinary Association for Pain Therapy ("Deutsche Interdisziplinären Vereinigung für Schmerztherapie", DIVS), 9 scientific medical societies and 2 patient self-help organizations. Eight working groups with a total of 50 members were evenly balanced in terms of gender, medical field, potential conflicts of interest and hierarchical position in the medical and scientific fields. Literature searches were performed using the Medline, PsycInfo, Scopus and Cochrane Library databases (until December 2010). The grading of the strength of the evidence followed the scheme of the Oxford Centre for Evidence-Based Medicine. The recommendations were based on level of evidence, efficacy (meta-analysis of the outcomes pain, sleep, fatigue and health-related quality of life), acceptability (total dropout rate), risks (adverse events) and applicability of treatment modalities in the German health care system. The formulation and grading of recommendations was accomplished using a multi-step, formal consensus process. The guidelines were reviewed by the boards of the participating scientific medical societies. RESULTS AND CONCLUSION: Meditative movement therapies (qi gong, tai chi, yoga) are strongly recommended. Acupuncture can be considered. Mindfulness-based stress reduction as monotherapy and dance therapy as monotherapy are not recommended. Homeopathy is not recommended. In a minority vote, homeopathy was rated as "can be considered". Nutritional supplements and reiki are not recommended. The English full-text version of this article is available at SpringerLink (under "Supplemental").

International cooperation in support of homeopathy and complementary medicine in developing countries: the Tuscan experience.

Health is a fundamental human right which contributes to reducing poverty, and encourages social development, human safety, and economic growth. International initiatives have fallen far short of their goals. This paper describes collaboration between the region of Tuscany and Cuba, Western Sahara, Senegal and Serbia. These have introduced various forms of Complementary and Alternative Medicine, including homeopathy and Traditional Chinese Medicine into primary healthcare particularly obstetrics, and into veterinary medicine. Complementary and traditional medicine can represent a useful and sustainable resource in various fields of health care. Inclusion in the public health system must go hand in hand with scientific evaluation.

MotherNature: establishing a Canadian research network for natural health products (NHPs) during pregnancy and lactation.

BACKGROUND: It has been estimated that between 7% and 55% of expectant mothers use herbal medicines or other types of natural health products (NHPs). Unfortunately, the safety and efficacy of NHPs during pregnancy and lactation is largely unknown. The Motherisk Program, at the Hospital for Sick Children, Toronto, Ontario, Canada, the is the major Canadian group to counsel and monitor outcomes of women using medications or NHPs, or of women exposed to chemicals, radiation or infection during pregnancy and lactation. OBJECTIVE: To create a network for research on NHPs during pregnancy and lactation by forming longstanding collaborations among Canadian medical and complementary and alternative medicine (CAM) practitioners and scientists. METHODOLOGY: MotherNature Network members participated in three 2-day workshops and three conference calls throughout the length of this study. Each member was responsible to lead discussions surrounding one theme and address the following: initiation; development; presentation; and synthesis of comments of all members on the designated theme. RESULTS: We prioritized areas in high need for future research and collaborative means to conduct such research. NHPs were prioritized for their importance for future study. Areas for the prospective collection of data on NHP use in pregnancy and lactation were identified. A research and business plan was developed for the long-term sustainability of the Network. CONCLUSIONS: The MotherNature Network is well-situated to create a new climate in Canada, where data are collected and interpreted on the effects and safety of NHPs during pregnancy and lactation.

The IMCO scheme as a tool in developing team-based treatment for people with multiple sclerosis.

BACKGROUND: The Danish Multiple Sclerosis Society (a patient organization) has initiated a research-based bridge-building and integrative treatment project to take place from 2004 to 2010 at a specialized MS hospital. The background for initiating the project was an increasing use of alternative treatment documented among persons with multiple sclerosis (PwMS). From PwMS there has been an increasing demand upon The Danish Multiple Sclerosis Society to initiate the project. OBJECTIVE: The overall purpose of the project is to examine whether collaboration between 5 conventional and 5 alternative practitioners may optimize treatment results for people who have multiple sclerosis (MS). The specific aim of this paper is to present tools used in developing collaboration between the conventional and alternative practitioners. MATERIALS AND METHODS: Two main tools in developing collaboration between the practitioners are described: (1) the planning and conduction of 4 practitioner-researcher seminars in the prephase of the project before recruiting patients with MS; and (2) the IMCO scheme (which is an abbreviation of Intervention, Mechanism, Context, and Outcomes). This tool was developed and used at practitioner-researcher seminars to make visible the different practitioners' treatment models and the patient-related treatment courses. RESULTS: Examples of IMCO schemes filled in by the medical doctor and the classical homeopath illustrate significant differences in interventions, assumptions concerning effect mechanisms, and awareness of contexts facilitating and inhibiting the intervention to generate the outcomes expected and obtained. CONCLUSIONS: The IMCO schemes have been an important tool in developing the team-based treatment approaches and to facilitate self-reflection on the professional role as a health care provider. We assume that the IMCO scheme will be of real value in the development of effective treatment based on collaboration between conventional and alternative practitioners.

NHS letter stimulates international dialogue on interpretation and possible implications of CAM research.

Prompted by the open letter by 13 prominent British scientists to National Health Science (NHS) trusts questioning the use of homeopathy, Vinjar Fønnebø, M.D., Ph.D., and Michael Baum, M.B., Ch.M., F.R.C.S., M.D.(Hon) entered into an e-mail exchange about the issues of research and documentation of practices in "complementary," "alternative," and "integrated" medicine. The paper presents the whole exchange unedited. Researchers who are well-acquainted with the field benefit from discussing and challenging, and will achieve a clearer understanding of both the understanding and opinions of the others as well as their own positions.

Status of credentialing alternative providers within a subset of U.S. academic health centers.

BACKGROUND: Complementary and alternative medicine (CAM) clinical services are increasingly provided within conventional health care settings. OBJECTIVE: To determine how a subset of U.S. academic health centers is credentialing CAM providers. DESIGN: An electronic survey was created focusing on the credentialing method utilized for six specific types of CAM clinical practitioners within academic medical settings. METHODS: This survey was electronically distributed to 33 academic health centers in the United States during the summer 2004. RESULTS: Ninety-five percent (95%) of academic centers surveyed provide some CAM clinical care. Acupuncture and massage are most common, with naturopathy and homeopathy least common. State licensure requirements for CAM providers appear to not be well-understood. Most commonly, CAM professionals do not receive full medical staff credentials. LIMITATIONS: Results cannot be extrapolated to remaining academic health centers within the United States. Mind-body practitioners were not included in the survey. CONCLUSIONS: Credentialing and privileges are most commonly granted via indirect methods. Variability in state licensure compounds the challenge of credentialing CAM practitioners. Suggestions for beginning discussions on guiding principles for integrating CAM practitioners within conventional settings are proposed.

Vegetative states--an integrative approach.

The integrative approach to vegetative state remains a challenge. In this article we have presented the evidence for conventional and alternative therapies that can be applied to this condition. Some are intended to support the patient and prevent complications; others enhance the ability of relatives to interact with their loved ones; while others are intended to shorten the vegetative state period. The approaches we reviewed were based on availability of data on MEDLINE and/or their potential to broaden our conceptual approach to vegetative state. Some approaches highlighted within the article including nutritional support, acupuncture, and homeopathy, seem to have a reasonable risk/benefit ratio. Yet, the complexity of vegetative state makes it challenging to recommend an integrative protocol. Rather we recommend an individualized approach, based on patient co-morbidities, caregiver and health professional preferences, and availability of therapists. Other approaches, including herbal medicine, mind-body therapies, intercessory prayer, energy medicine, and shamanism were not included due to the lack of available information and evidence. We acknowledge that a lack of evidence for efficacy is not equivalent to evidence for a lack of efficacy. Further research is critically needed to advance our treatment approach to this challenging state. Vegetative state is a condition that continues to humble the medical world. What we do not know eclipses that which we know. The critical question of what the vegetative state patient experiences continues to mystify us. Our philosophical stance insists that we treat the patient as one who is aware. Simultaneously we struggle with what, if anything, we can successfully do to "reawaken" the patient.

A complex systems science perspective for whole systems of complementary and alternative medicine research.

Whole systems complementary and alternative medicine (WS-CAM) approaches share a basic worldview that embraces interconnectedness; emergent, non-linear outcomes to treatment that include both local and global changes in the human condition; a contextual view of human beings that are inseparable from and responsive to their environments; and interventions that are complex, synergistic, and interdependent. These fundamental beliefs and principles run counter to the assumptions of reductionism and conventional biomedical research methods that presuppose unidimensional simple causes and thus dismantle and individually test various interventions that comprise only single aspects of the WSCAM system. This paper will demonstrate the superior fit and practical advantages of using complex adaptive systems (CAS) and related modeling approaches to develop the scientific basis for WS-CAM. Furthermore, the details of these CAS models will be used to provide working hypotheses to explain clinical phenomena such as (a) persistence of changes for weeks to months between treatments and/or after cessation of treatment, (b) nonlocal and whole systems changes resulting from therapy, (c) Hering's law, and (d) healing crises. Finally, complex systems science will be used to offer an alternative perspective on cause, beyond the simple reductionism of mainstream mechanistic ontology and more parsimonious than the historical vitalism of WS-CAM. Rather, complex systems science provides a scientifically rigorous, yet essentially holistic ontological perspective with which to conceptualize and empirically explore the development of disease and illness experiences, as well as experiences of healing and wellness.

Methodological implications of nonlinear dynamical systems models for whole systems of complementary and alternative medicine.

This paper focuses on the worldview hypotheses and research design approaches from nonlinear dynamical complex systems (NDS) science that can inform future studies of whole systems of complementary and alternative medicine (WS-CAM), e.g., Ayurveda, traditional Chinese medicine, and homeopathy. The worldview hypotheses that underlie NDS and WS-CAM (contextual, organismic, interactive-integrative - Pepper, 1942) overlap with each other, but differ fundamentally from those of biomedicine (formistic, mechanistic). Differing views on the nature of causality itself lead to different types of study designs. Biomedical efficacy studies assume a simple direct mechanistic cause-effect relationship between a specific intervention and a specific bodily outcome, an assumption less relevant to WS-CAM outcomes. WS-CAM practitioners do not necessarily treat a symptom directly. Rather, they intervene to modulate an intrinsic central imbalance of the person as a system and to create a more favorable environmental context for the emergence of health, e.g., with dietary changes compatible with the constitutional type. The rebalancing of the system thereby fosters the emergence of indirect, diffuse, complex effects throughout the person and the person's interactions with his/her environment. NDS theory-driven study designs thus have the potential for greater external and model validity than biomedically driven efficacy studies (e.g., clinical trials) for evaluating the indirect effects of WS-CAM practices. Potential applications of NDS analytic techniques to WS-CAM include characterizing different constitutional types and documenting the evolution and dynamics of whole-person healing and well-being over time. Furthermore, NDS provides models and methods for examining interactions across organizational scales, from genomic/proteomic/metabolomic networks to individuals and social groups.