Arginine and Caries Prevention: A Systematic Review.

OBJECTIVES: To evaluate the available evidence that the use of arginine-containing dental care products prevents the development of new caries lesions and the progression of existing lesions. SEARCH METHODS: We performed a systematic literature search of databases including PubMed, the Cochrane Library and EMBASE. SELECTION CRITERIA: We selected randomized controlled trials of treatment with arginine in fluoride-containing dental products measuring dental caries incidence or progression in children, adults and elderly subjects. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for risk of bias and evaluated overall study quality using the GRADE classification. MAIN RESULTS: Due to conflicts of interest and weak transferability to Swedish conditions, no conclusions can be drawn from studies on the effects of arginine-fluoride toothpaste in children. Arginine-containing toothpaste costs about 40% more than basic fluoride toothpaste; to determine whether it is more cost-effective, the higher cost must be considered in relation to any additional caries-preventive effect. The literature review also disclosed some questionable research ethics: in several of the studies, the children in the control group used non-fluoride toothpaste. Toothpaste without fluoride is not as effective against dental caries as the standard treatment - fluoride toothpaste - which has a well-documented effect. This contravenes the fundamental principles of research ethics. CONCLUSION: At present there is insufficient evidence in support of a caries-preventive effect for the inclusion of arginine in toothpastes. More rigorous studies, and studies which are less dependent on commercial interests, are required.

Framework for systematic identification of ethical aspects of healthcare technologies: the SBU approach.

OBJECTIVES: Assessment of ethical aspects of a technology is an important component of health technology assessment (HTA). Nevertheless, how the implementation of ethical assessment in HTA is to be organized and adapted to specific regulatory and organizational settings remains unclear. The objective of this study is to present a framework for systematic identification of ethical aspects of health technologies. Furthermore, the process of developing and adapting the framework to a specific setting is described. METHODS: The framework was developed based on an inventory of existing approaches to identification and assessment of ethical aspects in HTA. In addition, the framework was adapted to the Swedish legal and organizational healthcare context, to the role of the HTA agency and to the use of non-ethicists. The framework was reviewed by a group of ethicists working in the field as well as by a wider set of interested parties including industry, interest groups, and other potential users. RESULTS: The framework consists of twelve items with sub-questions, short explanations, and a concluding overall summary. The items are organized into four different themes: the effects of the intervention on health, its compatibility with ethical norms, structural factors with ethical implications, and long term ethical consequences of using the intervention. CONCLUSIONS: In this study, a framework for identifying ethical aspects of health technologies is proposed. The general considerations and methodological approach to this venture will hopefully inspire and present important insights to organizations in other national contexts interested in making similar adaptations.