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Overview of Comments Received on Public Statement on Sambucus Nigra L., Fructus (EMA/HMPC/44208/2012)

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Overview of Comments Received on Public Statement on Sambucus Nigra L., Fructus (EMA/HMPC/44208/2012) 28 January 2014 EMA/HMPC/551899/2013 Committee on Herbal Medicinal Products (HMPC) Overview of comments received on Public statement on Sambucus nigra L., fructus (EMA/HMPC/44208/2012) Table 1: Organisations and/or individuals that commented on the draft Public statement Sambucus nigra L., fructus as released for public consultation on 15 April 2013 until 15 July 2013. Organisations and/or individuals 1 AESGP 2 PALM Research, Bergen, Norway 3 SURO, Quebec, Canada 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, 2014. Reproduction is authorised provided the source is acknowledged. Table 2: Discussion of comments GENERAL COMMENTS Interested Comment and Rationale Outcome party SURO I am writing on the fact that it is said that: Not endorsed. The requirement to show 30 years of medicinal use for an herbal The available information does not fulfil the criteria for inclusion in preparation with a defined posology for a traditional indication is not a Community herbal monograph as outlined in the regulation, fulfilled for elderberry. guidelines and the assessment report. Our company has submitted applications for Natural Products in http://www.ema.europa.eu/docs/en_GB/document_library/Scientifi Canada to government body "Health Canada", based on Sambucus c_guideline/2009/09/WC500003644.pdf nigra,L, Fructus. All our products have been granted a Natural Product Number because we have been able to prove the traditional use of elderberry with a defined posology. Sambucus nigra L., fructus should be included, with no doubt, in the EMA monographies because it DOES have a long standing use, much more than 30 years and DOES have posology given in the traditional references as you will see below. We thank you for the opportunity to send in comments. I cannot go thru the five years of work and research I had to do to prove this to Health Canada because I would divulgate to everyone all of my sources. I will however share some of them so you can see there is definitly traditional references that include posologies. Also, it should be noted that Health Canada has some of the highest standards in terms of Natural Products and has started this process before many other countries. The following references should be considered for the 30 years criteria for a traditional indication and they do include a posology: Overview of comments received on Public statement on Sambucus nigra L., fructus (EMA/HMPC/44208/2012) EMA/HMPC/551899/2013 Page 2/24 GENERAL COMMENTS SURO GRIEVE (original 1931, this version 1959): promoting perspiration Posology, indication and daily dosage are provided, but the herbal "diaphoretic" and demulcent: preparation is not described in a reproducible manner. This information was already assessed and not found acceptable for Grieve, Maud Mrs, A Modern Herbal, Hafner publishing Co., New York, 1959. inclusion in a monograph (see assessment report) for this reason. "To make Elerberry Rob, 5 lb. of fresh ripe, crushed berries are This syrup has not an exact ratio between berries, water and simmered with 1 lb of loaf sugar and the juice evaporated to the sugar. There are also many similarities between the syrup thickness of honey. It is cordial, aperient and diuretic. One or two described in Grieve 1931 and the description of Succus Sambuci tablespoonsful mixed with a tumblerful of hot water, taken at night, inspissatus in Pharmacopoeia Helvetica V. edition 1953. promotes perspiration and is demulcent to the chest". This version of Grieve from 1959 is not available, but the same information is already included in the assessed version of Grieve 1931. A syrup can be prepared as described in Grieve 1931 from elderberry and a density can be calculated and checked against the viscosity of honey, and the product can in theory be compared with a 10 ml of syrup at night as a posology for use in common cold. However, we don’t have this information available, and the herbal preparation can not be recommended for inclusion in a monograph. Now included in the assessment report: This syrup is also used according to Grieve 1931 to promote perspiration and to be demulcent to the chest. For this use the defined posology is one or two tablespoonsful mixed with a tumblerful of hot water, taken at night. It is described that the syrup should have a thickness as honey according to Grieve 1931. The description on how the syrup is prepared from berries does not provide the necessary information needed in order to calculate a defined strength that can be used to prepare a herbal preparation with an acceptable level of reproducibility from batch to batch. Overview of comments received on Public statement on Sambucus nigra L., fructus (EMA/HMPC/44208/2012) EMA/HMPC/551899/2013 Page 3/24 GENERAL COMMENTS SURO BRITISH FLORA MEDICA (1837): for promoting diaphoretic action, Reference available at: sore throats and acute rheumatic affections.: http://archive.org/stream/britishfloramedi02bartuoft/britishflorame di02bartuoft_djvu.txt Barton B. Castle T. 1837. The British Flora Medica, London : E.Cox, St. Thomas's Street, Southwark. This reference is searched for the available information, but the "Elder Rob. Take of ripe Elder-berries five parts, sugar one part. Boil information was not found. No information on daily dosage. with a gentle heat to the consistency of a thick honey. This is Included in the assessment report. prescribed as a diaphoretic, in the dose of an ounce and a half to two ounces, in febrile disease, and in acute rheumatic affections; likewise made into a gargle for sore throats." SURO LA PHARMACOPÉE UNIVERSELLE OU CONSPECTUS DES Reference available at: PHARMACOPÉES (1828): promoting diaphoretic action: http://archive.org/stream/pharmacopeunive00jourgoog#page/n6/ mode/2up Jourdan A.-J.-L.,1828. Pharmacopée universelle ou Conspectus des pharmacopées. J._B. Baillere, Libraire de Not included as the information is very similar to the information l'Académie Royale de Médecine. Bruxelles. Belgique. from the British Flora Medica already included. No information on "Suc exprimé de baies de sureau. Faites dépurer par le repos, puis daily dosage is provided. évaporez convenablement, sur un feu modéré. Diaphorétique: Dose, une once et demie à deux onces." AESGP AESGP is aware of the problem that only limited information on the Not endorsed. The provided references are included and discussed traditional use of elderberries is available, particularly on the in the assessment report. posology. However, we have had a closer look into some (older) textbooks and we would like to submit the following comments. The provided reference to Karl 1970 with a specified posology for According to Hagers Handbuch 1979 (quoted in the HMPC reference use in neuralgia will be included in the LoR and discussed in the list) [1], a traditional use of elderberries can in general be proven. It assessment report. relates to the pressed juice from fresh berries which have been used against neuralgia and to “Roob Sambuci” as well as to the dried Hagers Handbuch 1979 will be included in the assessment report. berries used as a laxative, diuretic and diaphoretic agent [Hager 1979 page 259, so far not mentioned in the HMPC reference list). For inclusion in the assessment report under 2.3 Specified Overview of comments received on Public statement on Sambucus nigra L., fructus (EMA/HMPC/44208/2012) EMA/HMPC/551899/2013 Page 4/24 GENERAL COMMENTS strength/posology/route of administration/duration of use for [1], a traditional use can be assumed. relevant preparations and indications Moreover, Karl (1970) [3] describes a use in neuralgia with a Assessor’s comment: posology of 2 times daily 20 g of the freshly prepared juice, each dose together with 15 g of port wine for 14 days. The pharmaceutical dosage form, freshly prepared juice in combination with port wine as described by Karl 1970 for use in For these reasons we cannot support the conclusion of the neuralgia, is not defined as required for a herbal preparation for Assessment Report stating that the requirement to show 30 years of medicinal use for an herbal preparation with a defined posology for a inclusion in a Community monograph. traditional indication is not fulfilled for elderberries. Hagers Handbuch 1979 refers to juice pressed from the fresh References (attached) berries used by Epstein as Spezificum against genuine neuralgia in folk medicine (“Volksmedicine”), and it is written that addition of [1] List PH, Hörhammer L (eds.) Hagers Handbuch der 20 % alcohol improves the effects. Pharmazeutischen Praxis, Vol. 6. Berlin-Heidelberg-New York 1979:254-264. Neuralgia is associated with a variety of pain conditions, and is therfore considered to be an indication not suitable to prevent [2] Teuscher E, Willuhn G, Loew D. Sambuci fructus. In: Wichtl M (ed.). Teedrogen und Phytopharmaka. 5th ed. Stuttgart: treatment of more serious pathologies. * Traditional herbal Wissenschaftliche Verlagsgesellschaft 2009: 601-602. medicinal products are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for [3] Karl J. Phytotherapie - Ein Lehr- und Verordnungsbuch. prescription or monitoring of treatment.** Puchheim: T. Marczell 1970: 312. “Roob Sambuci” and the dried berries are included in the assessment report and listed for use as laxatives, diuretics and diaphoretic remedies in handbooks. No
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