Pelargonium Sidoides e Reniforme e Malattie Da Raffreddamento

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Pelargonium sidoides:

nuovo rimedio per le malattie da raffreddamento

Ha origini sudafricane il nuovo rimedio naturale per le affezionitipiche della stagione invernale: il Pelargonium sidoides. Eraanticamente conosciuta per l'utilizzo popolare contro latubercolosi e oggi impiegata nel trattamento di affezionidell'apparato respiratorio, come raffreddore ed influenza.Sembra che le propriet terapeutiche della pianta siano statescoperte solo alla fine del secolo scorso grazie alle vicende diun militare inglese, che contratta la tubercolosi in SudAfrica,venne curato con un decotto di Pelargonium. Sembra cherientrato in Europa nel 1897 il militare abbia presentato la nuovapianta che venne poi impiegata con successo in molti casi di

tubercolosi. L'interesse del mondo scientifico verso questapianta medicinale della tradizione popolare stato risvegliato dairiscontri sulle sue propriet antibatteriche e sulle sue potenzialitcome rimedio efficace contro le patologie otorinolaringoiatrichequali per esempio tonsillite, bronchite, sinusite e rinofaringite.Infatti, anche alcuni studi di laboratorio condotti sulla pianta nehanno confermato e dimostrato spiccate attivit comeimmunostimolante e moderate propriet antibatteriche ad ampiospettro. Dalla pianta di utilizzano gli estratti ottenuti dalle radiciricchi in fenoli semplici (principalmente l'acido gallico) eproantocianidine cui sono state associate le attivitantibatteriche, immunostimolanti e mucoregolatrici della pianta.Il rimedio impedisce la riproduzione dei germi patogeniimpedendone la penetrazione nelle cellule della mucosa,aumenta le difese immunitarie impedendo l'adesione dei virusalle cellule della mucosa infine fluidifica il muco migliorandonotevolmente la respirazione. Alla luce dei documentati beneficiterapeutici del Pelargonium sidoides nel trattamento delle vierespiratorie, si deve notare che gli estratti della radice medianosignificative attivit simili a quelle dell'interferone notoriamenteimplicato nei meccanismi fisiologici di immunostimolazione. Per

quanto riguarda l'attivit antimicrobica della pianta studi dilaboratorio hanno evidenziato che il rimedio moderatamenteattivo contro una serie di batteri responsabili di diverse affezionidelle vie respiratorie; in particolare stata studiata l'azione delPelargonium sidoides nei confronti di ceppi particolarmenteresistenti di Staphylococcus aureus. Mentre molti antibiotici(ciproflloxacina, eritromicina, clindamicina, ossitetraciclina...)non hanno mostrato azione nei confronti di questi ceppiresistenti, il Pelargonium ha mostrato una migliore attivitantibatterica. Uno studio ha valutato l'efficacia dell'estratto di

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Pelargonium contro placebo in 143 bambini con faringotonsillitee ha concluso che il gruppo dei bambini trattati ha diminuito laseverit dei sintomi della malattia e ridotto di circa due giorni ladurata della malattia.Un altro studio condotto da 468 pazienti adulti affetti dabronchite acuta furono trattati con Pelargonium Sidoides aconfronto con placebo; i risultati mostrarono che il rimedioriduce i sintomi di bronchite acuta in tre-sette giorni. Nonostanteil sintomo della tosse possa persistere pi a lungo i pazienti sonocomunque in grado di ritornare a lavoro prima rispetto al gruppotrattato con placebo.Attualmente sono in corso ulteriori studi sulla pianta perapprofondire le sue modalit di azione e le sue applicazioniterapeutiche.

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PelargoniumScientific Name(s): Pelargonium sidoides DC.,Pelargonium reniforme Curt. Family: Geraniaceae

Common Name(s): African geranium , Umckaloaba(Zulu language, severe cough), kalwerbossie ,Rabassamin , Zucol

Uses of Pelargonium

P. sidoides and P. reniforme are marketed asUmckaloaba or Zucol for bronchitis and pharyngitis. The plant species has also been investigatedfor use in treating gastritis. Despite a murky beginning in early 20th century herbal promotions,there appears to be some evidence for efficacy in treating bronchitis due to Pelargonium's directantibiotic effect and host immune stimulation.

Pelargonium Dosing

Clinical trials have used doses of extract corresponding to 1.2 g of plant material daily withoutadverse reactions. Manufacturer dosage guidelines for Zucol suggest 3 lozenges every day for 6

days, even if symptoms are reduced.

Contraindications

Avoid use with hypersensitivity to any of the components in EPs 7630 or Pelargonium species. Avoid use in patients with serious kidney or liver diseases.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. One report

recommends caution if used during pregnancy.

Pelargonium Interactions

None well documented.

Pelargonium Adverse Reactions

Clinical trials enrolling nearly 2,500 adults and children document mostly allergic reactions or GIcomplaints (eg, gastric pain, heartburn, nausea, diarrhea). In Germany, pharmacovigilance studies

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document allergic reactions associated with the use of Pelargonium extract.

Toxicology

No animal toxicology studies have been reported.

Botany

The genus Pelargonium comprises approximately 280 known species, of which 80% are grown inthe interior of South Africa. 1 Both of the title plant species are distinguished by the color of theflowers, the shape of the leaves, and the pollen color. P. sidoides is a small geranium-like plantthat grows in a rosette from thick and very dark brown underground roots that grow up to 15 cm inlength. Sparsely branched stems grow from the base and display deep red to black flowers, andthe species is distinguished by the cordate or heart-shaped leaves. The pollen of the plant speciesis yellow. In contrast, P. reniforme has magenta red to black flowers, kidney-shaped leaves, andwhite to green pollen. 2 , 3 Both plant species may be found along the seacoast and interior portions of South Africa. Because of poor seed viability, a clonal method of propagation has beendeveloped to reduce pressure on natural populations. 4

History

The plant species indigenous to areas of South Africa are widely used by traditional healers of theZulu, Basuto, Xhosa, and Mfengi tribes to treat dysentery, diarrhea, hepatic complaints, wounds,colds, fatigue, fevers, generalized weakness, and infections of the respiratory tract includingtuberculosis. 4 , 5 Western use of the P. sidoides and P. reniforme species to treat tuberculosis istraced back to the Englishman Major Charles Stevens in 1897 when he was treated by a tribalhealer with an extract from the roots of Pelargonium species. 2

Originally, the plant source of the drug was identified as P. reniforme ; however, further botanicalinvestigations discovered the closely related species P. sidoides , which is now predominatelyused for therapeutic purposes. 2

P. sidoides has been marketed under the brand name Umckaloaba and has been widely used inEurope since the 1980s. Economically, annual sales for the product in 2002 were $55 million or 4.1million packages. 6 The product is marketed as Zucol in the United States and is widely available.EPs 7630 is an ethanolic extract of the roots of P. sidoides , which is marketed by ISO-Arzneimittelunder license from Schwabe.

Chemistry

Chemical analyses have led to characterization of about 65 metabolites including phenolic andcinnamic acids, tannins, flavonoids, and coumarins in both plant species. 5 , 7 , 8 Extracts of P.sidoides are composed of 6 main components that account for 70% to 80% of the total weight:substituted and unsubstituted oligomeric prodelphinidins, monomeric and oligomericcarbohydrates, minerals, peptides, purine derivatives, and highly substituted benzopyranones. 9Nearly 230 components have been detected in each of the plant species' essential oils, withsesquiterpenes the most abundant. 10

Coumarin, 5,6-dimethoxy,7-hydroxy-coumarin, and several related ethers, glycosides, and sulfates


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have been isolated from both species of Pelargonium . 11 , 12 , 13 , 14 Many of these coumarinsalso are found in the roots of other South African Pelargonium species. 12 A series of galloylC-glycosidic flavones, along with related nongalloyl flavones, have been isolated from P. reniformeaerial parts. 15 P. sidoides contains similar flavonoids and phenolics. 16 The high tannin content(about 9%) may justify the plant's use in GI complaints in cases of bacterial toxin-inducedsecretory diarrhea. The broad spectrum of activity against viruses and bacteria may be caused bythe coumarins and phenolic acids. 1 , 2

Pelargonium Uses and Pharmacology

Numerous in vitro, animal, and clinical studies document the plant's antibacterial activity. Severalfairly large clinical trials examine the plant's efficacy in treating acute bronchitis, common cold,and pharyngitis or sore throat. 17

Antibacterial activityIn vitro data

The extracts of both Pelargonium species have modest direct antibacterial activity, with isolatedcoumarins and phenolics having minimum inhibitory concentration values from 200 to 1,000mcg/mL in agar dilution assays versus common test bacteria. 18 Unsaturated fatty acids from theroots, especially linoleic acid, had antimycobacterial activity at 2 mcg/mL in vitro. 7

Immune stimulation of the host is a potential course for antimycobacterial activity. Immunestimulation by P. sidoides extracts, coumarins, and phenolics has been documented in a variety of functional assays, 19 , 20 including enhancement of interferon-beta synthesis and activation of natural killer cell activity. 21 Tannins from the plant induced nitric oxide synthase and cytokinegene expression in a macrophage-like cell line. 8 The butanol root extract has antimycobacterialactivity. 22

Ciliary beat frequency increased in a model system after exposure to EPs 7630 extract. 23 Theeffect was reversible and may be relevant in diverse lung and airway infections because cilia areimportant in removal of bacteria and foreign particulates.

Bronchitis

A meta-analysis of 4 randomized clinical trials, including 1,647 patients, supported the plant'sefficacy in reducing bronchitis symptoms. The mechanism of action is associated with EPs 7630antagonism of bacterial adhesion to intact epithelia, leading to protection from bacteriacolonization and infection in the upper respiratory tract. 24

Clinical data

Clinical trials of EPs 7630 in acute bronchitis have been conducted in children and adults. 25 , 26 ,27 , 28 , 29 , 30 , 31 The primary outcome or review of efficacy for most of the trials are changes inthe Bronchitis Severity Score (ie, coughing, expectoration, chest pain, dyspnea, wheezing) frombaseline versus the last observation (ie, final observation typically within 1 week). Inclusion criteriainvolved patients diagnosed with acute bronchitis within 48 hours who were not receiving antibiotictherapy, and who had no obvious contraindications to therapy. Dosage regimens included either EPs 7630 solution (30 to 90 drops per day) or tablets (10 to 30 mg per day), or placebo for 7 days.Results document the efficacy of EPs 7630 versus placebo in reducing severity of symptoms,improving quality of life, and shortening the duration of sick leave by nearly 2 days. The therapy


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was well tolerated, with no serious adverse reactions during the trials examined.

Pharyngitis

The mechanism of action may be associated with EPs 7630 antagonizing bacteria and virusadhesion to the tonsil surface or site of infection. 32

Clinical data

In 2 multicenter, prospective, randomized clinical trials, EPs 7630 was more effective than placeboin the initial treatment of children (6 to 10 years of age) with acute nonstreptococcal tonsillo-pharyngitis. Patients treated with EPs 7630 had reduced severity of symptoms and shortenedduration of illness by at least 2 days. The therapy also protected against complications. Thetreatment regimen consisted of 20 drops 3 times a day (3 mL per day), 30 minutes before or after meals for a maximum period of 6 days. No serious adverse reactions were reported. 32 , 33

Other pharmacological activityGastritis

EPs 7630 inhibited Helicobacter pylori growth and reduced bacterial adherence to gastric epithelialadrenogenital syndrome cells. EPs 7630 suppressed H. pylori growth in brain-heart infusion brothat a concentration of 100 mcg/mL and reduced H. pylori adherence at concentrations of 50mcg/mL or more. The mechanism of action is primarily related to its antiadhesion activity. 34 , 35

Dosage

EPs 7630 is an 11% aqueous ethanolic extract in which 100 g of finished product corresponds to 8g of extracted plant material. One clinical trial administered 4.5 mL 3 times daily for 7 days,corresponding to a total daily dose of plant material of approximately 1.2 g. 25 A second trial usedthe same dosing schedule. 26 Other dosage regimens used in clinical trials include the following17 :

Other Dosage Regimens Used in Clinical Trials

Age Dosage regimen

Children < 6 years of age 10 drops 3 times a day

Children 6 to 12 years of age 20 drops 3 times a day

> 12 years of age 30 drops 3 times a day

Manufacturer dosage guidelines for Zucol suggest 3 lozenges every day for 6 days, even if symptoms are reduced.

Pregnancy/Lactation

Information regarding safety and efficacy in pregnancy and lactation is lacking. One reportrecommends caution if used during pregnancy. 36

Interactions


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An interaction may be possible when patients are receiving anticoagulant medications (eg,warfarin) or antiplatelet drugs (eg, aspirin). However, a study in rats documented nopharmacokinetic or pharmacodynamic interactions between EPs 7630 and warfarin. 36 , 37

Adverse Reactions

Clinical trials enrolling nearly 2,500 adults and children document mostly allergic reactions or GI

complaints (eg, gastric pain, heart burn, nausea, diarrhea). In Germany, pharmacovigilancestudies found case reports of allergic reactions associated with the use of Pelargonium extract. 36 Additional surveillance studies document similar results. 28

Toxicology

No reports on toxic effects of EPs 7630 are available. One investigation noted weak cytotoxiceffects on coumarins in 2 human cell lines (lung carcinoma GLC4 and colorectal cancer cellsCOLO 320). Similar results were observed in a Salmonella reversion test. The toxic potential wasclassified as safe according to results from an assay on Artemia salina (brine shrimp) usingextracts of EPs 7630 .

Bibliography

1. Kolodziej H. Fascinating metabolic pools of Pelargonium sidoides and Pelargonium reniforme ,traditional and phytomedicinal sources of the herbal medicine Umckaloabo . Phytomedicine .2007;14(suppl 6):9-17.2. Kolodziej H, Berlin OK. Pelargonium sidoides DC.: Latest findings towards understanding thephytotherapeutic preparation Umckaloabo. Z Phytother . 1998;19:141-151.3. Bladt S, Wagner H. From the Zulu medicine to the European phytomedicine Umckaloabo.Phytomedicine . 2007;14(suppl 6):2-4.

4. Lewu FB, Grierson DS, Afolayan AJ. Clonal propagation of Pelargonium sidoides : a threatenedmedicinal plant of South Africa. Afr J Biotechnol . 2006;5:123-125.5. Kolodziej H. Traditionally used Pelargonium species: Chemistry and biological activity of umckaloabo extracts and their constituents. Curr Top Phytochem . 2000;3:77-93.6. Patrick G, Hickner J. This obscure herb works for the common cold. J Fam Pract .2008;57(3):157-161.7. Seidel V, Taylor PW. In vitro activity of extracts and constituents of Pelargonium against rapidlygrowing mycobacteria. Int J Antimicrob Agents . 2004;23(6):613-619.8. Kolodziej H, Burmeister A, Trun W, et al. Tannins and related compounds induce nitric oxidesynthase and cytokines gene expressions in Leishmania major -infected macrophage-like RAW264.7 cells. Bioorg Med Chem . 2005;13(23):6470-6476.

9. Schoetz K, Erdelmeier C, Germer S, Hauer H. A detailed view on the constituents of EPs 7630 .Planta Med . 2008;74(6):667-674.10. Kayser O, Latte K, Kolodziej H, Hammerschmidt F. Composition of the essential oils of Pelargonium sidoides DC and Pelargonium reniforme Curt. Flavour Fragrance J .1998;13(3):209-212.11. Wagner H, Bladt S. Neue cumarine aus Pelargonium reniforme Curt.-wurzel. Tetrahedron Lett. 1974;43:3807-3808.12. Wagner H, Bladt S. Cumarine aus Sdafrikanischen Pelargonium -arten. Phytochem .1975;14:2061-2064.13. Kayser O, Kolodziej H. Highly oxygenated coumarins from Pelargonium sidoides .Phytochemistry . 1995;39:1181-1185.


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14. Kolodziej H, Kayser O, Tan N. Novel coumarin sulfates from Pelargonium sidoides : isolation,structure and synthetic approach. Proc Phytochem Soc Eur . 2002;47:59-64.15. Latt KP, Ferreira D, Venkatraman MS, Kolodziej H. O -galloyl- C -glycosylflavones fromPelargonium reniforme . Phytochemistry . 2002;59(4):419-424.16. Goedecke T, Kaloga M, Kolodziej H. A phenol glucoside, uncommon coumarins and flavonoidsfrom Pelargonium sidoides DC. Z Naturforsch B . 2005;60:677-682.17. Kolodziej H, Schutz V. Umchaloabo-from traditional application to modern phytodrug.Independent Pharm J Sci Prac . 2003;12:9.18. Kayser O, Kolodziej H. Antibacterial activity of extracts and constituents of Pelargoniumsidoides and Pelargonium reniforme . Planta Med . 1997;63(6):508-510.19. Kolodziej H, Kayser O, Radtke OA, Kiderlen AF, Koch E. Pharmacological profile of extracts of Pelargonium sidoides and their constituents. Phytomedicine . 2003;10(suppl 4):18-24.20. Kayser O, Kolodziej H, Kiderlen AF. Immunomodulatory principles of Pelargonium sidoides .Phytother Res . 2001;15(2):122-126.21. Koch E, Lanzendrfer-Goossens, Wohn C. Stimulation of interferon (IFN)--synthesis andnatural killer (NK) cell activity by an aqueous-ethanolic extract from roots of Pelargonium sidoides(Umckaloabo). Naunyn-Schmiederberg's Arch Pharmacol . 2002;365(suppl 1):R75.22. Mativanlela SP, Meyer JJ, Hussein AA, Lall N. Antitubercular activity of compounds isolatedfrom Pelargonium sidoides . Pharm Biol . 2007;45(8):645-650.23. Neugebauer P, Mickenhagen A, Siefer O, Walger M. A new approach to pharmacologicaleffects on ciliary beat frequency in cell culturesexemplary measurements under Pelargoniumsidoides extract ( EPs 7630 ). Phytomedicine . 2005;12(1-2):46-51.24. Agbabiaka TB, Guo R, Ernst E. Pelargonium sidoides for acute bronchitis: a systematic reviewand meta-analysis. Phytomedicine . 2008;15(5):378-385.25. Matthys H, Eisebitt R, Seith B, Heger M. Efficacy and safety of an extract of Pelargoniumsidoides ( EPs 7630 ) in adults with acute bronchitis. A randomised, double-blind, placebo-controlled trial. Phytomedicine . 2003;10(suppl 4):7-17.26. Chuchalin AG, Berman B, Lehmacher W. Treatment of acute bronchitis in adults with aPelargonium sidoides preparation ( EPs 7630 ): a randomized, double-blind, placebo-controlledtrial. Explore (NY) . 2005;1(6):437-445.27. Haidvogl M, Graz R, Schuster M, Heger E. Acute bronchitis in childhood. Zeitschrift fur Phytotherapie . 1996;17(5):19.28. Golovatiouk A, Chuchalin AG. Efficacy of an extract from Pelargonium sidoides (EPs 7630)compared to placebo in patients with acute bronchitis. Phytopharmaka VIII . 2002:3-12.29. Matthys H, Heger M. EPs 7630 -solutionan effective therapeutic option in acute andexacerbating bronchitis. Phytomedicine . 2007;14(suppl 6):65-68.30. Matthys H, Kamin W, Funk P, Heger M. Pelargonium sidoides preparation ( EPs 7630 ) in thetreatment of acute bronchitis in adults and children. Phytomedicine . 2007;14(suppl 6):69-73.31. Schulz V. Liquid herbal drug preparation from the root of Pelargonium sidoides is effectiveagainst acute bronchitis: results of a double-blind study with 124 patients. Phytomedicine .2007;14(suppl 6):74-75.32. Bereznoy VV, Riley DS, Wassmer G, Heger M. Efficacy of extract of Pelargonium sidoides inchildren with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized,double-blind, placebo-controlled trial. Altern Ther Health Med . 2003;9(5):68-79.33. Heger M, Bereznoy VV. Non-streptococcal tonsillo-pharyngitis in children: Efficacy of an extractfrom Pelargonium sidoides ( EPs 7630 ) compared to placebo. Phytopharmaka VII Darmstadt:Steinkopff Verlag . 2002.34. Beil W, Kilian P. EPs 7630 , an extract from Pelargonium sidoides roots inhibits adherence of Helicobacter pylori to gastric epithelial cells. Phytomedicine . 2007;14(suppl 6):5-8.35. Wittschier N, Faller G, Hensel A. An extract of Pelargonium sidoides ( EPs 7630 ) inhibits insitu adhesion of Helicobacter pylori to human stomach. Phytomedicine . 2007;14(4):285-288.


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36. de Boer HJ, Hagemann U, Bate J, Meyboom RH. Allergic reactions to medicines derived fromPelargonium species. Drug Saf . 2007;30(8):677-680.37. Koch E, Biber A. Treatment of rats with the Pelargonium sidoides extract EPs 7630 has noeffect on blood coagulation parameters or on the pharmacokinetics of warfarin. Phytomedicine .2007;14(suppl 6):40-45.

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Pelargonium Sidoides e Reniforme e Malattie Da Raffreddamento

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