Risk profile of plant food supplements

Riskiprofiili perustuu EU-rahoitteisessa PlantLibra-projektissa kerättyn kyselyaineiston Suomea koskevaan osuuteen sekä kirjallisuudesta saatuun tietoon kasviravintolisien koostumuksesta ja niiden sisältämien yhdisteiden toksisuudesta sekä ominaisiin aineisiin mahdollisesti liittyvistä farmakokineettisistä yhteisvaikutuksista lääkeaineiden kanssa. Tarkastelltuihin ominaisiin aineisiin ei liittynyt merkittävää suoraa toksisuutta käytetyillä annoksilla. Sen sijaan moniin ominaisiin aineisiin (erityisesti inkivääri, peltokorte) liittyy merkittävä yhteisvaikutusten potentiaali, etenkin CYP3A4:n välityksellä metaboloituviin lääkeaineisiin. Koska CYP3A4:n kautta metaboloituvia lääkkeitä käytetään paljon, yhteisvaikutusten riski korostuu. Erityistä huolta liittyy varfariiniin (metaboloituu CYP2C9 ja osittain CYP3A4:n kautta), sillä sen terapeuttinen ikkuna on kapea (pitoisuudet veressä voivat helposti olla liian pieniä tai suuria). On kuitenkin huomattava, että vahvaa näyttöä farmakokineettisistä yhteisvaikutuksista on vähän, sillä käytettävissä on lähinnä in vitro -tutkimuksia kasviravintolisien sisältämien ominaisten aineiden ja lääkeaineiden välillä. Lisäksi on huomattava, että useat kasviravintolisät sisälsivät useasta kasvista peräisin olevia ominaisia aineita ja että kasviravintolsien käyttäjät käyttivät usein useita valmisteita yhdessä lääkkeiden kanssa.Riskprofilen bygger på den del som gäller Finland av det enkätmaterial som samlats in inom det av EU finansierade projektet PlantLibra och på ur litteraturen erhållen information om de vegetabiliska kosttillskottens sammansättning och toxiciteten hos föreningarna som de innehåller och de farmakokinetiska samverkningarna med läkemedel som eventuellt hänför sig till de kännetecknande ämnena. Till de granskade kännetecknande ämnena hänförde sig inte någon betydande direkt toxicitet med de doser som användes. Till många kännetecknande ämnen (särskilt ingefära, åkerfräken) hänför sig däremot en betydande potential av samverkningar, i synnerhet med läkemedel som metaboliseras via CYP3A4. Eftersom det används en hel del läkemedel som metaboliseras via CYP3A4, understryks risken för samverkningar. Särskild oro väcker varfarinet (metaboliseras via CYP2C9 och delvis via CYP3A4) eftersom dess terapeutiska fönster är smalt (halterna i blodet kan lätt bli för låga eller höga). Det är ändå skäl att beakta att det endast finns blygsamma bevis på de farmakokinetiska samverkningarna, eftersom vi främst har tillgång till in vitro-undersökningar av samverkningarna mellan de kännetecknande ämnena som vegetabiliska läkemedel innehåller och läkemedlen. Det är också skäl att beakta att flera vegetabiliska kosttillskott innehöll kännetecknande ämnen som härstammar från flera växter och att de personer som använde vegetabiliska kosttillskott ofta använde flera preparat tillsammans med läkemedel.Risk profile is based on survey data collected in an EU funded PlantLibra project concerning Finland and information from scientific litterature on composition of plant food supplements (PFSs), toxicity of the compounds they contain and possible pharmacokinetic interactions of these compounds or substances in PFS with medication. There were no significant direct toxicological risks related to substances in PFS. However, many substances in PFSs (especially ginger and Equisetum arvense) were related to potential interactions with medications, especially with medications which are metabolised through CYP3A4. Since medications which are metabolised through CYP3A4 are used frequently among PFS user, the risk of intercations may be significant – especially warfarin with narrow therapeutic window. However, there is no strong evidence o finteractions between these PFSs and medications, since there from litterature there is mainly in vitro studies available. It should also be noted that manny used PFSs contained several plant subtances and that PFSs were used with several medications simultaneously

Usage of Plant Food Supplements (PFS) for weight control in six European countries: results from the PlantLIBRA PFS Consumer Survey 2011-2012

Background: Obesity is increasing worldwide and weight-control strategies, including the consumption of plant food supplements (PFS), are proliferating. This article identifies the herbal ingredients in PFS consumed for weight control and by overweight/obese dieters in six European countries, and explores the relationship between their consumption and their self-reported BMI. Methods: Data used were a subset from the PlantLIBRA PFS Consumer Survey 2011-2012, a retrospective survey of 2359 PFS consumers. The survey used a bespoke frequency-of-PFS-usage questionnaire. Analyses were performed in two consumer subsamples of 1) respondents taking the products for "body weight reasons", and 2) "dieters for overweight/obesity", to identify the herbal ingredients consumed for these reasons. The relationship between the 5 most consumed herbal ingredients and self-reported BMI in groups 1 and 2 is explored by comparing BMI proportions of consumers vs. non-consumers (using Chi-squared test). Results: 252 PFS (8.8 %) were consumed for "body weight reasons" (by 240 PFS consumers); 112 PFS consumers (4.8 %) were "dieting for overweight/obesity". Spain is the country where consuming herbal ingredients for body weight control and dieting were most popular. Artichoke was the most consumed herbal ingredient. Considering only the 5 top products consumed by those who responded "body weight", when using the total survey sample, a greater proportion of BMI 65 25 was observed among consumers of PFS containing artichoke and green tea as compared to non-consumers (58.4 % vs. 49.1 % and 63.2 % vs. 49.7 % respectively). Considering only the 5 top products consumed by "dieters" and using only the "dieters" sample, a lower proportion of BMI 65 25 was observed among pineapple-containing PFS consumers (38.5 % vs. 81.5 %); however, when using the entire survey sample, a greater proportion of BMI 65 25 was observed among artichoke-containing PFS consumers (58.4 % vs. 49.1 %). Conclusions: A comparison of results among the scarce publications evaluating the use of weight-loss supplements at the population level is limited. Nevertheless every hint is important in finding out which are the self-treatment strategies used by overweight/obese individuals in European countries. Although limited by a small sample size, our study represents a first attempt at analysing such data in six EU countries. Our findings should encourage the conduction of further studies on this topic, long-term and large sample-sized studies, ideally conducted in the general population

Usage of Plant Food Supplements across Six European Countries : Findings from the PlantLIBRA Consumer Survey

BACKGROUND: The popularity of botanical products is on the rise in Europe, with consumers using them to complement their diets or to maintain health, and products are taken in many different forms (e.g. teas, juices, herbal medicinal products, plant food supplements (PFS)). However there is a scarcity of data on the usage of such products at European level. OBJECTIVE: To provide an overview of the characteristics and usage patterns of PFS consumers in six European countries. DESIGN: Data on PFS usage were collected in a cross-sectional, retrospective survey of PFS consumers using a bespoke frequency of PFS usage questionnaire. SUBJECTS/SETTING: A total sample of 2359 adult PFS consumers from Finland, Germany, Italy, Romania, Spain and the United Kingdom. DATA ANALYSES: Descriptive analyses were conducted, with all data stratified by gender, age, and country. Absolute frequencies, percentages and 95% confidence intervals are reported. RESULTS: Overall, an estimated 18.8% of screened survey respondents used at least one PFS. Characteristics of PFS consumers included being older, well-educated, never having smoked and self-reporting health status as “good or very good”. Across countries, 491 different botanicals were identified in the PFS products used, with Ginkgo biloba (Ginkgo), Oenothera biennis (Evening primrose) and Cynara scolymus (Artichoke) being most frequently reported; the most popular dose forms were capsules and pills/tablets. Most consumers used one product and half of all users took single-botanical products. Some results varied across countries. CONCLUSIONS: The PlantLIBRA consumer survey is unique in reporting on usage patterns of PFS consumers in six European countries. The survey highlights the complexity of measuring the intake of such products, particularly at pan-European level. Incorporating measures of the intake of botanicals in national dietary surveys would provide much-needed data for comprehensive risk and benefit assessments at the European level

Validation study results.

a<p>Concordance between both methods: the PFS usage questionnaire and the 6-month usage diary.</p

PlantLIBRA's PFS consumer survey – distribution of the overall top-40 botanicals' reported consumption and the ranking of these botanicals when stratified by gender and age group.

a<p>Products ordered according to the consumer distribution of the overall top-40 used botanicals (unweighted ranking).</p>b<p>Ranks show the shifts of the botanicals in the position of the overall 1–40 unweighted ranking when stratified by gender and age group.</p

PlantLIBRA's PFS consumer survey – PFS usage patterns, per product used by a respondent, overall and by country.

<p><b><i>Questions asked.</i></b> During the last 12 months, in what months have you taken this supplement? (mark all that apply) <b><i>Possible responses</i></b>: Jan, Feb, Mar, Apr, May, June, July, Aug, Sep, Oct, Nov, Dec, All year round; Why did you decide to take this supplement in the months stated? (one answer only) <b><i>Possible responses</i></b>: I took it whenever/sporadically; I take it periodically, during those times only; When I had a flare up/worsening of condition; Other reason; Not sure.</p

PlantLIBRA's PFS consumer survey – number and type of products taken, overall distribution and by gender and age group.

<p>PlantLIBRA's PFS consumer survey – number and type of products taken, overall distribution and by gender and age group.</p

PlantLIBRA's PFS consumer survey – number and type of products taken, by country.

<p>PlantLIBRA's PFS consumer survey – number and type of products taken, by country.</p

PlantLIBRA's PFS consumer survey – PFS dose forms, per product used by a respondent, by country.

<p><b><i>Question asked</i></b>. And in which form do you usually take it? (mark the applicable form). <i>Possible responses</i>: Pills/tablets/lozenges; Softgel capsules/pearls; Hard capsules; Liquid (extract/syrup/drops); Sachets/packets; Ampoules; Other (specify); Not sure.</p>a<p>Capsules: softgels/pearls/hard capsules.</p>b<p>Liquid: extract/syrups/drops.</p>c<p>Other: Powders, Sachets/Packets, Bars and “Not sure”.</p