Pharma-standard (PS) supplement registry studies define the field of activity of pharma-standard supplements and their possible, preventive, pre-clinical applications. The best fields of application for supplements are pre-clinical, borderline applications or the supplementary management of risk conditions. PS supplements studies procedure supplementary data to be compared to “background” historical data (i.e., based on the best available management for comparable subjects or conditions) or to other management plans. In these studies, the supplement or the combination of supplements was used according to the following rules:
1. The use of the supplement is suggested to the evaluation subjects; it is not prescribed but indicated as an option, possibly capable of improving the management of the risk condition
2. The supplement is only used on top of what is considered the “standard” or best-management/care available, for that condition, according to international guidelines;
3. The use of the supplement should not interfere with any other treatment, management or preventive measure;
4. Time: the period of follow-up is considered variable, according to the needs and availability of the patients or registry subjects. The observation period – in these registries – is therefore variable, not prefixed. Ideally, the PS supplement should be used as long as needed to see results or changes:
5. The type of evaluation for these studies is always a registry.
The evaluation of the compliance concerning the use of the supplement is a significant value indicating how many subjects are willing to use the supplements. In these supplement studies sthere is no defined group allocation, no randomization organized by the investigators. Subjects decide – on the basis of an initial briefing – the management group they want to join including the control (non-supplement) group. No placebo is used. The evaluation of safety is absolutely essential. The field of PS supplements is expanding. Self-medication, individual management and “natural” products are more often considered with great attention. Most, high-quality products are available from the web from qualified sellers (i.e. Amazon). This meeting and this book present some interesting new research in the field of PS supplements and indicate new possible “soft” but effective management ways for many patients and physicians.
|Dimensioni||15 × 21 cm|
Pharma standard ( PS ) supplements – Papers from the London sessions January 2018
Belcaro – Dugall – Ledda