Evidence map›Paper›PMID 29433155›Full record

ReviewBritish journal of clinical pharmacology2018

Nutraceuticals: opening the debate for a regulatory framework.

Antonello Santini, Silvia Miriam Cammarata, Giacomo Capone, Angela Ianaro, Gian Carlo Tenore, Luca Pani, Ettore Novellino

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 136 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

136 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Review

76 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Antonello SantiniDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano, 49 -, 80131, Naples, Italy.ORCID 0000-0001-5505-3327
Silvia Miriam CammarataAIFA - Agenzia Italiana del Farmaco, Via del Tritone, 181 -, 00187, Rome, Italy.
Giacomo CaponeAIFA - Agenzia Italiana del Farmaco, Via del Tritone, 181 -, 00187, Rome, Italy.
Angela IanaroDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano, 49 -, 80131, Naples, Italy.
Gian Carlo TenoreDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano, 49 -, 80131, Naples, Italy.
Luca PaniDepartment of Psychiatry and Behavioral Sciences, University of Miami, School of Medicine, 33136-1015, Miami, FL, USA.
Ettore NovellinoDepartment of Pharmacy, University of Napoli Federico II, Via D. Montesano, 49 -, 80131, Naples, Italy.ORCID 0000-0003-4324-7997

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Currently, nutraceuticals do not have a specific definition distinct from those of other food-derived categories, such as food supplements, herbal products, pre- and probiotics, functional foods, and fortified foods. Many studies have led to an understanding of the potential mechanisms of action of pharmaceutically active components contained in food that may improve health and reduce the risk of pathological conditions while enhancing overall well-being. Nevertheless, there is a lack of clear information and, often, the claimed health benefits may not be properly substantiated by safety and efficacy information or in vitro and in vivo data, which can induce false expectations and miss the target for a product to be effective, as claimed. An officially shared and accepted definition of nutraceuticals is still missing, as nutraceuticals are mostly referred to as pharma-foods, a powerful toolbox to be used beyond the diet but before the drugs to prevent and treat pathological conditions, such as in subjects who may not yet be eligible for conventional pharmaceutical therapy. Hence, it is of utmost importance to have a proper and unequivocal definition of nutraceuticals and shared regulations. It also seems wise to assess the safety, mechanism of action and efficacy of nutraceuticals with clinical data. A growing demand exists for nutraceuticals, which seem to reside in the grey area between pharmaceuticals and food. Nonetheless, given specific legislation from different countries, nutraceuticals are experiencing challenges with safety and health claim substantiation.

Indexed as

DietLegislation, FoodDietary SupplementsFunctional FoodHumansclaimshealthlabelsnutraceuticalsregulationregulatory

Identifiers

PMID29433155
PMCPMC5867125

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.