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Assessment Report on Melaleuca Alternifolia (Maiden and Betch) Cheel, M

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Assessment Report on Melaleuca Alternifolia (Maiden and Betch) Cheel, M 9 July 2013 EMA/HMPC/320932/2012 Committee on Herbal Medicinal Products (HMPC) Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum Based on Article 16d(1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use) Draft Herbal substance(s) (binomial scientific name of Melaleuca alternifolia (Maiden and Betch) Cheel, the plant, including plant part) M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, leaf and terminal branchlets Herbal preparation(s) Melaleuca alternifolia, aetheroleum Pharmaceutical forms Herbal preparation in liquid dosage forms for oromucosal use or cutaneous use. Rapporteur Assessor(s) Note: This Assessment Report is published to support the release for public consultation of the draft Community herbal monograph on Melaeuca alternifolia, 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 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. 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7051 E -mail [email protected] Website www.ema.europa.eu An agency of the European Union © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. Table of contents Table of contents ................................................................................................................... 2 1. Introduction ....................................................................................................................... 4 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof ................ 4 1.2. Information about products on the market in the Member States ............................................. 7 1.3. Search and assessment methodology .................................................................................... 8 2. Historical data on medicinal use ........................................................................................ 8 2.1. Information on period of medicinal use in the Community ....................................................... 8 2.2. Information on traditional/current indications and specified substances/preparations ................ 14 2.3. Specified strength/posology/route of administration/duration of use for relevant preparations and indications ............................................................................................................................. 14 3. Non-Clinical Data ............................................................................................................. 23 3.1. Overview of available pharmacological data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................................... 23 3.2. Overview of available pharmacokinetic data regarding the herbal substance(s), herbal preparation(s) and relevant constituents thereof ......................................................................... 29 3.3. Overview of available toxicological data regarding the herbal substance(s)/herbal preparation(s) and constituents thereof .......................................................................................................... 30 3.4. Overall conclusions on non-clinical data ............................................................................... 35 4. Clinical Data ..................................................................................................................... 36 4.1. Clinical Pharmacology ....................................................................................................... 36 4.1.1. Overview of pharmacodynamic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ................................................................................................... 36 4.1.2. Overview of pharmacokinetic data regarding the herbal substance(s)/preparation(s) including data on relevant constituents ................................................................................................... 40 4.2. Clinical Efficacy ................................................................................................................ 40 4.2.1. Dose response studies .................................................................................................... 40 4.2.2. Clinical studies (case studies and clinical trials) ................................................................. 40 4.2.3. Clinical studies in special populations (e.g. elderly and children) .......................................... 64 4.3. Overall conclusions on clinical pharmacology and efficacy ...................................................... 65 5. Clinical Safety/Pharmacovigilance ................................................................................... 65 5.1. Overview of toxicological/safety data from clinical trials in humans ......................................... 65 5.2. Patient exposure .............................................................................................................. 71 5.3. Adverse events and serious adverse events and deaths ......................................................... 71 5.4. Laboratory findings ........................................................................................................... 72 5.5. Safety in special populations and situations ......................................................................... 72 5.6. Overall conclusions on clinical safety ................................................................................... 72 6. Overall conclusions .......................................................................................................... 72 Annex .................................................................................................................................. 73 Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum EMA/HMPC/320932/2012 Page 2/73 Abbreviations ASI Acne Severity Index CoNS Coagulase-Negative Staphylococci EMA European Medicines Agency ESCOP European Scientific Cooperative On Phytotherapy EO/LTTO Eucalyptus Oil and Lemon Tea Tree Oil pediculicide IgA Immunoglobulin A GI Gingival Index MBC Minimum Bactericidal Concentration MDCK Madin–Darby canine kidney (cell line) MIC Minimal Inhibitory Concentration MICs Minimal Inhibitory Concentrations MIC90 Minimal Inhibitory Concentration required inhibiting the growth of 90% of organisms MRSA Methicillin-resistant Staphylococcus aureus MSB Mitis Salivarius-Bacitracin agar MSSA Methicillin- susceptible Staphylococcus aureus OPC Oropharyngeal candidiasis PBI Papillary Bleeding Index RHL Recurrent herpes labialis SCCP Scientific Committee on Consumer Products TTO Tea Tree Oil TTO/LO Tea Tree Oil and Lavender Oil pediculicide VAS Visual Analogue Scale VRE Vancomycin-resistant enterococci VSC Volatile Sulphur Compounds Assessment report on Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum EMA/HMPC/320932/2012 Page 3/73 1. Introduction 1.1. Description of the herbal substance(s), herbal preparation(s) or combinations thereof • Herbal substance(s) Melaleuca alternifolia tree is a member of the botanical family Myrtaceae. The name tea tree was established for the plant because the leaves were used to prepare an aromatic tea. The term "Tea Tree" includes species of the genus Leptospermum and Melaleuca (more than 150 species) of the family Myrtaceae. The best known and economically most important species is the Australian Tea Tree (Saller et al. 1998). • Herbal preparation(s) The preparation with pharmacological interest is the oil from the leaves (called tea tree oil, TTO), because it has been reported as having immuno-stimulatory property and activity against bacterial, viral and fungal organisms. It is also known that it can attenuate inflammation and may help wound healing (Carson et al. 2006). There are several historical terms for TTO, including ‘‘melaleuca oil’’ and ‘‘ti tree oil’’, ‘‘ti tree’’ being a Maori and Samoan common name for plants in the genus Cordyline. The term ‘‘Melaleuca oil’’ has been selected as the official approved name by the Therapeutic Goods Administration of Australia (Carson & Riley 2001). About 2% essential oil can be obtained from the leaves of the Australian Tea Tree by extraction with lipophilic organic solvent or by steam distillation. According to the European Pharmacopoeia TTO is obtained by steam distillation from the foliage and terminal branchlets of Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F.
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