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Friday, 24 April 2015

Herbalists’ perception of risks involving commonly sold medicinal plants in Italy


Summary

Objective

Although there are several studies which have investigated pharmacists’ knowledge of the safety of medicinal plants (MPs), no studies have examined herbalists’ perception of risks associated with MPs.

Methods

We conducted a survey of 159 herbalists (participation rate 85.9%) in the region of Tuscany (Italy). Data were collected by means of a semi-structured questionnaire using a face-to-face interview. Risk perception was rated on a 10 cm Visual Analogic Scale (VAS). Herbalists’ scores were then compared with those reported by a group of 10 experts in herbal medicine.

Results

When the overall risk was examined, herbalists had a low perception of the risks (VAS median ranged between 1.5 and 3.2) associated with the use of most MPs (Allium sativum, Aloe vera gel, Echinacea spp., Escholtzia californica, Harpagophytum procumbens, and propolis). They had an intermediate or high perception of risks associated with use of Cimicifuga racemosa, Citrus aurantium, and Panax ginseng (median ranged between 3.5 and 5.0), and for anthraquinone laxatives (median 7.2). Although the overall risk perceived by experts was generally higher than that reported by herbalists, differences were statistically significant only for Allium sativum and Escholtzia californica.

Conclusion

The study shows that herbalists in Tuscany are knowledgeable about the relative risks of MPs when compared with experts in herbal medicine.

Keywords

  • Herbalists;
  • Medicinal plants;
  • Risk perception;
  • Survey;
  • VAS

Introduction

The use of medicinal plants (MPs) is increasing in most Western countries 1, 2 and 3, including Italy [4]. “Natural” remedies are generally considered safe by users mainly because they are “natural” [5]. However, their consumption may lead to adverse reactions and/or undesired clinically significant interactions when taken in concomitance with pharmacological treatments 6 and 7 or when used by subjects with certain clinical conditions 8, 9 and 10.
While several studies have evaluated the knowledge of pharmacists and other public health providers about the safety of MPs, and found that these generally have poor understanding of the risks 11, 12, 13 and 14, we have found no studies investigating herbalists’ perception of the risks associated with certain MPs.
To address this issue, we carried out a survey among a sample of herbalists in Tuscany about the most commonly sold MPs. A group of experts in the field of herbal medicine was used as a reference to compare the herbalists’ scores.

Methods

The survey was conducted from January to June, 2010, in herbalist's shops in the provinces of Florence, Pistoia and Prato, (region of Tuscany, Italy), and involved 159 herbalists (participation rate equal to 85.9%) of 80 shops (covering 80% of herbalist's shops of the two provinces, and 20% of all herbalist shops in Tuscany). All eligible participants received written and oral information about the aim of the study.
Data were collected by means of a semi-structured questionnaire (Appendix) administered by a trained herbalist using a face-to-face interview. Risk perception was rated by means of a 10 cm Visual Analogic Scale (VAS). That is, subjects were asked to rate on the VAS from 0 (very low risk) to 10 cm (very high risk) how they perceived the global risk related to the use of 10 MPs (Allium sativum, Aloe vera gel, anthraquinone laxatives, Cimicifuga racemosa, Citrus aurantium, Echinacea spp., Escholtzia californica, Harpagophytum procumbent, Panax ginseng, propolis) and the risk of specific adverse effects (i.e., intestinal disturbances, hepatic damage, gastritis, cardiac damage, drowsiness, neurological damage and allergy) related to the use of each herb. The study was limited to the above 10 MPs because they are the most commonly sold in Italy. The questionnaire also collected socio-demographic characteristics (age, gender, education and occupation) of participants.
The questionnaire was tested and validated by an ad hoc panel of experts (pharmacologists, epidemiologists, toxicologists, pharmacists and clinicians) of the Tuscan Regional Center of Pharmacovigilance, and a clinician of the regional referring Center of Natural Medicine.
A group of 10 experts in herbal medicine, comprising pharmacologists, toxicologists, pharmacists and clinicians, was used as the gold standard group and these individuals were asked to complete the same questionnaire administered to the herbalists.
Values were presented as medians and interquartile ranges. In order to compare medians between the two groups (herbalists versus experts) the Median test was used. A p-value of <0.05 was considered statistically significant. Further analysis was conducted by stratifying herbalists according to their educational level and years of work in an herbalist shop.
We indicated the risk was a “low risk” if VAS values ranged between 0 and 3.3, “intermediate risk” if values ranged between 3.4 and 6.6, and “high risk” if values ranged between 6.7 and 10.

Results

Eighty-two percent (139 subjects out of 159) of interviewed herbalists were female, 42% (67 subjects) had a university degree, and 59% (94 subjects) had at least 10 years of work experience in an herbalist shop.
Table 1 shows medians and interquartile ranges of overall risk perception (using the Visual Analogic Scale related to the use of 10 medicinal plants) among the 159 herbalists and 10 experts. Herbalists had a low perception (medians ranged between 1.5 and 3.2) of the global risks associated with the use of most MPs under study (A. sativum, A. vera gel, Echinacea spp., E. californica, H. procumbens, and propolis), an intermediate one of C. racemosa, C. aurantium, and P. ginseng (medians ranged between 3.5 and 5.0), and a high perception for anthraquinone laxatives (median = 7.2). Experts graded A. vera gel (median = 1.6) and Echinacea spp. (median = 2.9) as low risk, and all other MPs (medians ranged between 3.4 and 5.6) as of intermediate risk. The global risks reported by the experts were generally higher than those perceived by herbalists with the exception of anthraquinone laxatives. However, the differences were statistically significant only for A. sativum (p-value = 0.048) and E. californica (p-value = 0.048).
Table 1. Medians and interquartile ranges of global risk perception (using the Visual Analogic Scale) associated with the use of 10 medicinal plants as perceived by 159 herbalists and 10 experts in the natural products area.
Medicinal plantsMedian(Interquartile range)p-Value a
Allium sativum
Herbalists2.1(0.9–4.0)0.048
Experts4.6(2.5–5.9)
Aloe vera gel
Herbalists1.5(0.5–3.4)0.985
Experts1.6(0.5–6.1)
Anthraquinone laxatives
Herbalists7.2(5.0–8.1)0.192
Experts5.3(4.2–7.3)
Cimicifuga racemosa
Herbalists3.5(2.1–5.4)0.514
Experts4.1(3.0–4.8)
Citrus aurantium
Herbalists4.0(1.7–5.8)0.172
Experts5.6(4.1–8.9)
Echinacea spp.
Herbalists2.0(0.0–8.4)0.408
Experts2.9(1.8–3.9)
Escholtzia californica
Herbalists2.5(1.0–4.1)0.016
Experts3.6(3.0–6.8)
Harpagophytum
Herbalists3.2(1.2–4.7)0.954
Experts3.4(3.0–4.8)
Panax ginseng
Herbalists5.0(3.7–6.8)0.832
Experts5.1(3.2–7.0)
Propolis
Herbalists2.6(1.1–4.5)0.150
Experts3.4(2.6–7.4)
a
Median test.
The herbalists correctly identified the risks related to certain MPs in relation to specific disorders (Fig. 1). In fact, all identified risks were in agreement with those reported by the experts (all differences in the medians reported by herbalists and by experts were not statistically significant).
Full-size image (95 K)
Figure 1.
Medians of risk perception of selected disturbances (using the Visual Analogic Scale) carried by the use of 10 MPs among 159 herbalists and 10 experts in the natural products area.
When results were stratified according to the herbalists’ educational level (university degree or lower degree) and work experience (≥10 and <10 years), no substantial differences were found. However, the perception of risk appeared higher among herbalists with a university degree when compared with those with a lower degree, as well as among those with less than 10 years of work experience when compared with those with 10 years or more of experience (data not shown).
Finally, more than half of the herbalists (54%) reported to have observed adverse reactions associated with the use of MPs. The herbal remedies and adverse reactions most frequently observed were: anthraquinone laxatives because of intestinal disturbances or gastritis, P. ginseng and Paulina cupana because of nervous system and cardiovascular disorders, Matricaria recutita, Echinacea spp., and propolis because of allergic reactions, and Hypericum perforatum because of photosensitivity reactions affecting the skin.

Discussion

This is the first survey investigating herbalists’ perception of risks associated with the use of medicinal plants. Our findings show that herbalists in Tuscany are knowledgeable about the safety profile of MPs. The quantified estimates of their risk perception, overall or related to specific adverse effects, are similar to those of a group of experts in herbal medicine and pharmacovigilance.
Several studies have evaluated of the knowledge of pharmacists and other public health providers about the safety of MPs, and shown that their understanding is rather poor 11, 12, 13 and 14. A systematic review investigating United States and Canadian pharmacists’ attitudes about knowledge of and professional practice toward herbal or alternative therapies showed that approximately equal numbers of pharmacists report positive as well as negative attitudes about the safety and efficacy of these remedies, although it was not possible to draw a definitive conclusion due to the heterogeneity of the data [11]. This review clearly shows that there is a need for pharmacists to receive additional training in the field. A study from the USA interviewing 111 physicians, 30 advanced practice nurses, 46 pharmacists, and 350 dietitians, found that participants had key deficits in knowledge about the adverse effects of herbs and dietary supplements [12]. Another Australian study of 80 pharmacists showed that less than one-third of responders believed that “most complementary and alternative medicines are safe and have very few side effects”, and one-fifth neither agreed or disagreed with the same statement [13]. In Europe, an Italian survey investigating the attitudes and knowledge of 1420 consumers and pharmacists regarding the safety of natural products, concluded that pharmacists are more likely to answer correctly about the use of herbs rather than about caution, adverse effects and interactions [14].
In our survey A. sativum is considered safe by herbalists, and relatively safe by experts. Herbalists underestimated the risk of gastritis and allergy 15 and 16, as highlighted by experts, or the risk of cardiac damage (i.e., alteration of platelet function and coagulation, with a possible risk of bleeding) [15]. A. vera gel is perceived as safe. Side effects are rare, and only a case of hypersensitivity (contact dermatitis or slight itching after application) has been reported to date [17].
Anthraquinone laxatives are considered relatively safe by herbalists but as high risk by experts, with possibility of unfavorable effects on the intestine or provoking gastritis. Plants containing anthraquinones can induce diarrhea, abdominal pains or mucus in the feces [18], thus worsening constipation or irritable bowel syndrome [19].
C. racemosa is considered relatively safe. Herbalists, as well as experts, did not emphasize that it can give slight and transitory collateral effects such as headache, gastric problems and skin rash [20], or have unfavorable effects on the circulatory system or hepatitis [21].
C. aurantium is perceived as relatively safe. Herbalists did not indicate possible cardiac damage, as emphasized by the experts. C. aurantium is obtained from the pith of the unripe fruit containing synephrine, a substance that could be toxic for cardiomyocytes 22, 23 and 24. Instead the outer layer (the rind) of the mature fruit is safe. Herbalists suggested that C. aurantium has unfavorable neurological effects, although such beliefs are not supported by the scientific literature.
Echinacea spp. is perceived as safe, even if allergic episodes, contact and anaphylaxis dermatitis have been reported [25]. However, there is a one out of 100,000 possibility that serious unfavorable effects associated with the use of Echinacea spp. can occur [21].
E. californica is perceived as safe by herbalists, and relatively safe by experts. Herbalists, as well as experts, indicated that drowsiness is a possible unfavorable reaction [26]. In some cases, prolonged use or high doses of E. californica can cause addiction phenomena [27].
H. procumbens is perceived as safe by herbalists and relatively safe by experts who indicated gastritis as a possible adverse reaction [28]. Moreover, H. procumbens can cause cramping and nausea [28].
P. ginseng is considered relatively safe, with possible cardiac effects and neurological damage, as reported by experts and in the scientific literature 29, 30, 31, 32, 33 and 34.
Finally, propolis is considered safe by herbalists and relatively safe by experts. They highlighted that it can cause allergies [35]. Propolis can give possible hypersensitivity reactions such as asthma [36], edema, respiratory and cutaneous disorders [37], and can be not tolerated at the gastrointestinal level [19].
The characteristics of this present study mean that it is not possible to compare our findings with those of previous ones. First, we quantified the perception of risk and no other investigation has done this. Secondly, the present study was specifically focused on herbalists, professionals who are responsible for advising consumers on the use of medicinal plants but whose education and training are completely different from those of pharmacists.
Finally, in our survey half of the herbalists we surveyed reported having observed adverse reactions. Considering that from April 2002 to June 2010 only about 500 reports were recorded in the National Phytovigilance System of the Italian National Institute of Health, it appears that the majority of adverse reactions observed were not reported by herbalists.
Several limitations affect the present study. Our sample size was small. However, our survey involved 80 shops (and 150 herbalists) amounting to 80% of all the herbalist shops in the most populous provinces of Tuscany (Florence, Pistoia and Prato), so our sample may be considered to be a faithful representation of Tuscany herbalists. Our results may not be generalized to herbalists at a national level or to all healthcare professionals, being just from Tuscany. Finally, the questionnaire relied on self-reporting information, thus, our results may under- or over-estimate the real perception of risk associated with the use of MPs on the part of herbalists.

Conflict of interest statement

None declared.

Funding

This work was supported by a grant from the Italian Ministry of Health (“Progetto Giovani Ricercatori” 2007) and from the “Fondazione Cassa di Risparmio di Pistoia e Pescia” (Prot. n. 2008.0286).

Acknowledgements

The authors thank Dr. Francesca Mannini and Dr. Angelica Traina for questionnaire administration, data collection and recording.

References


Corresponding author at: Department of Neurosciences, Psychology, Drug Research and Children's Health, University of Florence, viale G. Pieraccini 6, 50139 Florence, Italy. Tel.: +39 055 4271270; fax: +39 055 4271280.
1
These authors have contributed equally to this work.