Evidence map›Paper›PMID 30975140›Full record

ArticleBMC complementary and alternative medicine2019

What has been the impact of the Traditional Herbal Registration (THR) scheme in the UK on information provided with herbal products bought over the counter?

R Dickinson, M C Kennedy, D K Raynor, P Knapp, M Thomas, E Adami

Abstract read
In one paragraph

Article in BMC complementary and alternative medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. Article
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

6 authors.

R DickinsonSchool of Health and Community Studies, Leeds Beckett University, Leeds, UK. r.j.dickinson@leedsbeckett.ac.uk.ORCID http://orcid.org/0000-0002-5811-8242
M C KennedySchool of Healthcare, University of Leeds, Leeds, UK.
D K RaynorSchool of Healthcare, University of Leeds, Leeds, UK.
P KnappDepartment of Health Sciences and the Hull York Medical School, University of York, York, UK.
M ThomasSchool of Languages, Cultures and Societies, Centre for Translation Studies, University of Leeds, Leeds, UK.
E AdamiSchool of Languages, Cultures and Societies, Centre for Translation Studies, University of Leeds, Leeds, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter.

methodsWe undertook a survey on 5 herbal products commonly available over-the-counter (St John's wort, echinacea, Ginkgo biloba, Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information.

resultsWe recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant.

conclusionThe introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products.

Indexed as

Databases, PharmaceuticalNonprescription DrugsPlant PreparationsRegistriesDrug LabelingHumansPatient SafetyUnited KingdomNonprescription DrugsPlant Preparations

Identifiers

PMID30975140
PMCPMC6460666

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.