ABSTRACT
Title
Clinical Trials on “Nutraceuticals”, trends in the methodological approach
Authors
V. Ghirardi; A. Nunziata
AKROSBioScience Srl, Pomezia, Rome, Italy
AKROSBioScience Srl, Pomezia, Rome, Italy
Abstract
In the last decade there’s been an escalating number of clinical studies concerning “Nutraceuticals (NTRs)“ worldwide. There’s a rising interest on food supplement, natural extracts and probiotical products (NTRs), defined as products intended for human healthcare and not regulated by Dir. 65/65/EEC. This analysis is focused specifically on the three groups of NTRs above mentioned.
The authors collected and analysed the clinical studies conducted in the world between 2005 and 2010 and mentioned in the database ClinTrials.gov.
Of 105.886 trials classified as ”registered clinical studies“1, 607 were on food supplement, 306 on probiotics, 46 on natural extracts as defined above. It is to be noticed a steep increase of the number of studies after 2008. The authors identified two main reasons for this trend:
- The implementation of regulations requiring stronger proof to support the claims of efficacy / safety, thus extending the principles of EBM to products whose use was often based on practical experience or medical tradition.
- The increasing interest of the industry towards products easier to develop, to manage in treatment and to introduce in the market.
The studies have been regrouped and analysed by product, by therapeutic indication or use, by geographic area and by nature of the sponsor (pharmaceutical or food company).
Furthermore, the authors analyzed the methodology applied to the study: use of blindness, group numbers, subject number, main end point and numbers of secondary end points, concomitant drug treatments.
The authors conclude that there’s a need for a stricter control of the objectives, the methods and the management of these trials. A higher methodological standard is necessary, in order to obtain more consistent data and to minimise the risks for the subjects involved in the studies.
1clinicaltrials.gov/ct2/home
The authors collected and analysed the clinical studies conducted in the world between 2005 and 2010 and mentioned in the database ClinTrials.gov.
Of 105.886 trials classified as ”registered clinical studies“1, 607 were on food supplement, 306 on probiotics, 46 on natural extracts as defined above. It is to be noticed a steep increase of the number of studies after 2008. The authors identified two main reasons for this trend:
- The implementation of regulations requiring stronger proof to support the claims of efficacy / safety, thus extending the principles of EBM to products whose use was often based on practical experience or medical tradition.
- The increasing interest of the industry towards products easier to develop, to manage in treatment and to introduce in the market.
The studies have been regrouped and analysed by product, by therapeutic indication or use, by geographic area and by nature of the sponsor (pharmaceutical or food company).
Furthermore, the authors analyzed the methodology applied to the study: use of blindness, group numbers, subject number, main end point and numbers of secondary end points, concomitant drug treatments.
The authors conclude that there’s a need for a stricter control of the objectives, the methods and the management of these trials. A higher methodological standard is necessary, in order to obtain more consistent data and to minimise the risks for the subjects involved in the studies.
1clinicaltrials.gov/ct2/home