Benefit-risk assessment of cinnamon

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15 July 2010

EMA/HMPC/246773/2009

Committee on Herbal Medicinal Products (HMPC)

Assessment report on Cinnamomum verum J. S. Presl (Cinnamomum zeylanicum Nees), cortex and corticis aetheroleum

Draft

Based on Article 10a of Directive 2001/83/EC as amended (well-established use)

Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use)

Herbal substance(s) (binomial scientific name of the plant, including plant part)	Cinnamomum verum J. S. Presl. Nees, dried bark
Herbal preparation(s)	a) Comminuted herbal substance b) Liquid extract (DER 1:1) extraction solvent: 70% ethanol c) Tincture (ratio of herbal substance to extraction solvent 1:5) extraction solvent 70% ethanol d) Essential oil obtained by steam distillation from the cortex
Pharmaceutical forms	Comminuted herbal substance as herbal tea for oral use. Herbal preparation in liquid dosage forms. The pharmaceutical form should be described by the European Pharmacopoeia full standard term.

Note: This draft Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Cinnamomum verum J. S. Presl, cortex and corticis aetheroleum. It should be noted that this document is a working document, not yet fully edited, and which shall be further developed after the release for consultation of the monograph. Interested parties are welcome to submit comments to the HMPC secretariat, which the Rapporteur and the MLWP will take into consideration but no ‘overview of comments received during the public consultation’ will be prepared in relation to the comments that will be received on this draft assessment report. The publication of this draft assessment report has been agreed to facilitate the understanding by Interested Parties of the assessment that has been carried out so far and led to the preparation of the draft monograph.

Introduction

Description of the herbal substance(s), herbal preparation(s) or combinations thereof

• Herbal substance(s)

1. Cinnamomum verum J. S. Presl. (=Cinnamomum zeylanicum Nees), dried bark, freed from the outer cork and the underlying parenchyma (ESCOP, 2003; European Pharmacopoeia 6.2, 2009).

2. Cinnamomum verum J. S. Presl. is also known by the synonym Cinnamomum zeylanicum Blume and is member of Lauraceae family (Keller 1992).

This assessment report does not evaluate Cinnamomum aromaticum Nees (synonym: Cinnamomum cassia Blume), cortex although they are both comparable in composition and widely used in flavouring agents in foods and in pharmaceutical and cosmetic preparations (Kommission E, 1990; Barnes et al., 2007).

The drug consists of the dried bark, freed from the outer cork and the underlying parenchyma, of the shoots grown cut stock of Cinnamomum verum J. S. Presl. The matt pieces of bark, 0.2-0.7 mm thick and in the form of single or double compound quills, are light brown on the outside and somewhat darker on the inside. The surface is longitudinally striated and the fracture is short and splintery. It contains not less than 12 ml/kg essential oil obtained by steam distillation It has a characteristic and pleasantly aromatic odour. Its taste is pungently spicy, somewhat sweet and mucilaginous, and only slightly sharp (Bisset, 1994).

Cinnamon bark contains up to 4% of essential oil consisting primarily of cinnamaldehyde (60-75%), cinnamyl acetate (1-5%), eugenol (1-10%) (WHO Vol. 1999), β-caryophyllene(1-4%), linalool (1-3%) and 1.8-cineole (1-2%) (ESCOP, 2003).

Other constituents are oligopolymeric procyanidins, cinnamic acid, phenolic acids, pentacyclic diterpenes cinnzeylanol and it's acetyl derivative cinnzeylanine and the sugars mannitol, L-arabino-D-xylanose, L-arabinose, D-xylose, α-D-glucane as well as mucilage polysaccharides (Hänsel et al., 1992, ESCOP, 2003).

The essential oil of the bark is described in the European Pharmacopoeia 6.2 (2009) . There exists a summary report on the essential oil of cinnamon bark. This report has been made by the Committee for Veterinary Medicinal Products. According to this information the oil mainly contains cinnamaldehyde (55-76%), eugenol (5-18%) and saffrole (up to 2%). This document refers also to human use (CVMP 2000).

Cinnamon bark oil may be adulterated with cinnamon leaf oil and oil of cassia (Price & Price, 2007).

Figure 1: cinnamaldehyde

Figure 2: eugenol

Figure 2: eugenol

• Herbal preparation(s)

a) Comminuted herbal substance

b) Liquid extract (DER 1:1) extraction solvent: 70% ethanol

c) Tincture (ratio of herbal substance to extraction solvent 1:5) extraction solvent: 70% ethanol

d) Essential oil obtained by steam distillation from the cortex

• Combinations of herbal substance(s) and/or herbal preparation(s) including a description of vitamin(s) and/or mineral(s) as ingredients of traditional combination herbal medicinal products assessed, where applicable.

See overview data from member states.

Vitamin(s)

The drug contains per 100 g:

- vitamin A: 260 IU

- thiamine: 0.02 mg

- riboflavin: 0.14 mg

- niacin: 1.3 mg

- ascorbic acid: 28 mg

(Duke, 1988)

Mineral(s)

The drug contains per 100 g:

- Ca: 1.228 mg

- P: 61 mg

- Fe: 38 mg

- Mg: 56 mg

- Na: 26 mg

- K: 500 mg

- Zn: 2 mg

(Duke, 1988)

Information about products on the market in the Member States

Regulatory status overview

MA: Marketing Authorisation

TRAD: Traditional Use Registration

Other TRAD: Other national Traditional systems of registration

This regulatory overview is not legally binding and does not necessarily reflect the legal status of the products in the MSs concerned.

Specific information about preparations in the EU

• Austria

Several liquid extracts of the drug in combination products for gastrointestinal complaints of as a flavouring excipient.

• Czech Republic

Solution for oral or external use containing extract from Melissae folium, Inulae radix, Angelicae radix, Zingiberis radix, Caryophylli flos, Galangae radix, Piperis nigri fructus, Gentianae radix, Myristicae semen, Aurantii pericarpium, Cinnamomi cortex, Cassiae flos, Cardamomi fructus.

• Germany

Cinnamon is one of the 13 ingredients of a solution for oral or external use (see above).

• Estonia

The same combination preparation as mentioned above.

• Lithuania

The same combination preparation as mentioned above and aetheroleum in a Polish product.

• Poland

Aromatol is a combined preparation containing Melissae aetheroleum, Caryophylli aetheroleum, Cinnamoni aetheroleum, Citri limoni aetheroleum, Menthae piperitae aetheroleum, Lavandulae aetheroleum and menthol in ethanol.

Historical data on medicinal use

Information on period of medicinal use in the Community

Cinnamon has been used as a spice for thousands of years; several references to it are found in the Bible. In Egypt, cinnamon was a spice used in embalming fluid. In Ayurvedic medicine, cinnamon bark was used as an antiemetic, antidiarrheal, antiflatulent, and general stimulant. The Portuguese found cinnamon trees growing in Sri Lanka (Ceylon) during the early 16th century; they subsequently imported cinnamon to Europe during the 16th and 17th centuries. The Dutch occupied Sri Lanka in the mid-17th century until the British captured the island in 1796. The East India Company then became the main exporter of cinnamon to Europe. The Dutch cultivated cinnamon in Java, and the exports of Ceylon cinnamon decreased as a result of heavy export duties. Nevertheless, Sri Lanka is the only regular supplier of cinnamon bark and leaf oils. The food industry prefers Ceylon cinnamon, but pharmaceutical manufacturers use both oils from Ceylon cinnamon (cinnamon oil) and from Chinese cinnamon (cassia oil) interchangeably. China is the main exporter of cassia cinnamon (Barceloux 2009).

Information on traditional/current indications and specified substances/preparations

The herbal preparations are in traditional medicinal use for over 30 years (Wahrig & Richter, 2009).

• The following indications have been reported for cinnamon:

Dyspeptic complaints such as gastrointestinal spasms, bloating and flatulence, loss of appetite and diarrhoea (ESCOP, 2003).

Cinnamon is used primarily as a taste enhancer and as a spice, and to some extent also in preparation of liquors.

Indications in folk medicine: diarrhoea, dyspeptic complaints, cold and flu, topical use for wound-cleaning. Except for dyspeptic complaints, the indications in folk medicine have not been sufficiently documented (Hänsel et al., 1992). The essential oil is used drop-wise (“cinnamondrops”) as a remedy on dysmenorrhoea and to stop bleeding (Bisset, 1994).

Another source lists the following indications: application as an astringent, germicide, and antispasmodic. Cinnamon was one of the early treatments for chronic bronchitis, treatment of impotence, frigidity, dyspnea, inflammation of the eye, leukorrhea, vaginitis, rheumatism, and neuralgia, as well as wounds and toothaches (Barceloux, 2009).

• Indications for combination preparations:

Czech Republic, Estonia and Lithuania: Solution for oral use as an adjuvant at mild psychovegetative disturbances such as loss of appetite and gastrointestinal complaints, mood changes and headache of different origin, nervosity, restlessness, sleep disorders and as an adjuvant in common cold. Externally used as mild remedy in neuritis, muscle pains, lumbago and gingivitis.

Specified strength/posology/route of administration/duration of use for relevant preparations and indications

Posology and method of administration:

Adolescents, adults:

dried bark 1.5-4 g daily: 0.5-1.0 g as an infusion three times daily (Barceloux, 2009; Hänsel et al., 1992; Delfosse 1998; ESCOP 2003; WHO 1999; Kommission E 1990; Barnes et al., 2007).

fluid extract 0.5-1.0 ml (1:1) extraction solvent: 70% ethanol V/V three times daily (Hänsel et al., 1992; ESCOP 2003; Barnes et al., 2007).

tincture 2-4 ml daily (1:5) extraction solvent: 70% ethanol V/V: to be given in 3 doses (Hänsel et al., 1992; ESCOP 2003; Barnes et al., 2007; Todd 1967).

aetheroleum 50-200 mg daily: to be given in 3 doses (CVMP 2000; Delfosse 1998; WHO 1999; Todd 1967).

spiritus (1 part of oil in 10 of ethanol 90%) 0.3 to 1.2 ml daily: to be given in 3 doses (Todd 1967).

All preparations are orally administered.

Elderly: the same dose as for adults

Method of administration

Oral use

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

(Barnes et al., 2007; ESCOP, 2003; Kommission E, 1990)