Pelargonium sidoides root extract

The extract from Pelargonium sidoides roots (also: Pelargonium root extract and widespread Umckaloabo ) is obtained from the South African Cape Pelargonium ( Pelargonium sidoides ), a type of pelargonium , and used as a medicinal substance for the production of medicines for the treatment of acute bronchitis .

P. sidoides DC

pharmacology

properties

Pelargonium root extract is said to have an expectorant effect against viruses and bacteria .

In a fibroblast / encephalomyocarditis virus (EMCV) model, the extract increases the production of macrophages - interferon - in vitro . It has not been proven whether the results can be transferred to human pathogenic viruses in vivo .

In a further in-vitro model, an antibacterial effect against various gram-positive ( Staphylococcus aureus , Streptococcus pneumoniae ) and gram-negative bacteria ( Escherichia coli , Klebsiella pneumoniae , Proteus mirabilis , Haemophilus influenzae ) has been described. For this effect, however, the drug available on the market is underdosed 1000 times.

In addition, an indirect antibacterial effect is described. The aim is to prevent bacteria from adhering to and entering the cells of the airway mucosa (in vitro data). Mobilization and activation of the body's own phagocytes (macrophages) in vitro is also described.

In tests with regard to the antiviral effect of the root extract, it was possible to discover the potential of the polyphenols contained in it to protect healthy cells from infection with the HI virus. Clinical studies on this are not yet available.

The drug is intended to increase the beat frequency of the cilia in the bronchi and thus enable better removal of the mucus (in vitro data). It was not possible to demonstrate any superiority over a likewise unsecured therapy with acetylcysteine .

Contraindications and side effects

Mainly found coumarins in the roots of P. sidoides DC

Because of the coumarins contained in the extract , conditions that are associated with an increased tendency to bleed (congenital or acquired (drug therapy with phenprocoumon )) are considered contraindications. A direct anticoagulant effect could not be demonstrated in animal experiments.

With an ethanol content of 12 percent by volume, the intake in children is to be viewed critically. However, the manufacturer points out that the daily dose of the preparation is below the natural alcohol content of a glass of apple juice and is therefore harmless.

Occasionally, gastrointestinal complaints such as stomach pain, heartburn , nausea or diarrhea occur as side effects , rarely slight gum bleeding or nosebleeds. Mild and very rarely severe hypersensitivity reactions with the picture of anaphylactic shock are also observed rarely .

The most common side effects reported are rash, itching, and hypersensitivity. Elevations in liver function tests have also been observed occasionally. There are a number of reports on adverse effects on the liver, one of which suspected drug-toxic hepatitis . In a study, researchers from the University of Frankfurt am Main examined a total of 15 suspected cases and came to the conclusion that there was no convincing evidence that pelargonium-containing drugs had caused the liver damage in the cases analyzed. The competent authority in Germany ( BfArM ) considered measures to minimize risk to be necessary and operated a phased plan procedure ; Among other things, a post-authorization safety study should be carried out in order to further investigate the connection between the ingestion of Pelargonium sidoides and the occurrence of liver damage. Lt. Pharmaceutical PZ Zeitung online of March 31, 2014, the Federal Institute for Drugs and Medical Devices (BfArM) ordered that since July 2014 a note must be included in the package insert that indicates that pelargonium can have potential hepatotoxicity and can cause liver damage.

Manufacturing and chemical structure

The medicament includes an ethanolic extract (1: 8-10) from the roots of the South African Pelargonium sidoides from the family of geraniaceae . Part of the demand for raw material is covered by wild harvesting, another part by cultivation.

The root extract obtained by percolation and / or maceration contains, among other things, multiply substituted benzopyranone derivatives and condensed tannins . The benzopyranone derivatives are two to four times hydroxy, methoxy and / or sulfooxy-substituted 2 H -1-benzopyran-2-ones such as. B. Scopoletin and Umckalin , in the condensed tannins around proanthocyanidins, which are mainly composed of gallocatechin and epigallocatechin monomers . It also contains simple phenolic compounds, primarily gallic acid .

Admission and study situation

Pelargonium root extract is approved for the treatment of acute bronchitis in children from one year of age and adults. The indications previously claimed by the manufacturer: tonsillitis ( angina tonsillaris ), inflammation of the nasal and pharynx (rhinopharyngitis) and sinusitis ( sinusitis ) had to be abandoned with the subsequent approval in December 2005.

Several double-blind, placebo-controlled studies in adults and children have been published on efficacy in acute bronchitis . These have now been summarized in two meta-analyzes, one of which was commissioned by the manufacturer. In the meta-analysis of the Cochrane Collaboration , the effectiveness of the preparation in the treatment of various colds was also determined. However, it was restrictive to say that all included studies were manufacturer-financed and all come from the same region (Eastern Europe). The authors of the meta-analysis are therefore cautious about the reliability of the results, since contradictions between the studies and an unclear clinical relevance of the effect are apparent. There are no independent studies on this preparation.

A study that is supposed to prove the superiority of pelargonium extract over placebo in children with non-streptococcal angina tonsillaris (tonsillitis without evidence of bacteria) is to be viewed critically at least to the extent that the rapid tests used for streptococci are incorrect in 9% of cases show negative results. The potential complications of non-antibiotic treatment are significant.

Because Hexal was unable to provide any scientific evidence that its registered product Pelasya is comparable to the approved drug Umckaloabo, the Ulm Regional Court issued an injunction in March 2014 , which prohibited comparative advertising.

history

In southern Africa, decoctions made from Pelargonium species have been used in traditional medicine for centuries.

Charles H. Stevens, an Englishman suffering from tuberculosis , was sent to warm Africa by his doctor in 1897. In Basutoland , today's Lesotho , he was treated with such an extract by a Basotho healer. Stevens recovered completely within three months and in 1904 founded a company to export the supposed miracle plant to Europe. Under the name "Stevens' Consumption Cure", the extract was popular as a tuberculosis drug for a while. It also did not disappear from the market when Stevens finally lost the legal battle with the British Medical Association after several trials in 1915. The professional organization had described his remedy as a fake and he himself as a fraud. After the First World War , Stevens built on his business success with dubious advertising methods. So he promised the repayment of the drug costs if this did not work, but did not keep these promises. After C. H. Stevens 'death in 1942, his son continued to run the company until some of his German customers partnered directly with Stevens' suppliers in the 1960s.

Stevens' arguments were also noticed on the continent. The Swiss missionary doctor Adrien Sechehaye (University of Geneva) treated around 800 tuberculosis patients with "Stevens' Cure" in the 1920s. During these treatments he is said to have had clear healing effects in many cases. Before publishing his report, Sechehaye asked the British Medical Association about research. After reporting on his own research in London in 1935, MPs called for a clinical study. This failed because the biological origin of the roots used could not be clarified, also because Stevens did not cooperate.

In German-speaking countries, Sechehaye's reports appeared in 1933 and 1951 together with the results of various experiments and case reports. The treatment of tuberculosis with Pelargonium sidoides root extract is obsolete today. Current research appears to focus on acute and chronic respiratory infections .

Patent dispute

A Pelargonium sidoides extract produced by extracting with ethanol is an active ingredient in finished medicinal products that are used under various trade names (see below) in the treatment of acute bronchitis. The manufacturing process for this extract ("Special Extract EPs 7630") was carried out by the German pharmaceutical company Dr. Willmar Schwabe developed. With a patent for the manufacturing process registered in September 2002 and granted in June 2007, Schwabe secured Europe-wide protection for the manufacture and sale of the extract up to a maximum of 2022. The patent was challenged by the South African community of Alice : The reason for the lawsuit was the “illegitimate and illegal monopoly of a genetic resource from southern Africa and traditional knowledge ”. The European Patent Office then revoked the patent on Pelargonium in full in January 2010. Schwabe initially announced that he would lodge a complaint against the decision, but declared in April 2010 that he would not appeal against the decision. This was justified with the wish not to become the plaything of a fundamental discussion that cannot be resolved by Schwabe in the area of ​​tension between the Convention on Biological Diversity and patent law , although the patent is ethically and legally correct. Schwabe sells its drugs through subsidiaries.

Trade names and dosage forms

Umckaloabo (CH, D), Pelargonium-ratiopharm (D), Pelasya (D; no longer sold), Kaloba (A, CH), Pelacur (A, HU)

The drug is in Germany and Austria in pharmacies , in Switzerland it is in the distribution category D classified. Pelargonium root extract is available in the form of a drip solution or film-coated tablets.

Individual evidence

1. ↑ Encephalomyocarditis
2. ↑ ^{a b c} H. Kolodziej, V. Schulz: Umckaloabo. German Pharmacist Newspaper . 143rd Volume, No. 12, 2003, pp. 1303-1312.
3. ↑ U. Schwabe et al.: Drug Ordinance Report 2002. Springer, Berlin 2002, pp. 153–154.
4. ↑ A. Conrad et al.: Extract of Pelargonium sidoides (EPs 7630) inhibits the interactions of group A-streptococci and host epithelia in vitro. Phytomedicine 14, Suppl 6, 2007, pp. 52-59. PMID 17182236 .
5. ↑ A. Conrad et al.: Extract of Pelargonium sidoides (EPs 7630) improves phagocytosis, oxidative burst, and intracellular killing of human peripheral blood phagocytes in vitro. Phytomedicine 14, Suppl 6, 2007, pp. 46-51. PMID 17184983
6. ↑ M. Helfer, H. Koppensteiner, M. Schneider, S. Rebensburg, S. Forcisi, C. Müller, P. Schmitt-Kopplin, M. Schindler, R. Brack-Werner: The root extract of the medicinal plant Pelargonium sidoides is a potent HIV-1 attachment inhibitor. In: PloS ONE. January 29, 2014, accessed April 7, 2014 (Scientific Study). 
7. ↑ P. Neugebauer et al .: A new approach to pharmacological effects on ciliary beat frequency in cell cultures - exemplary measurements under Pelargonium sidoides extract (EPs 7630). Phytomedicine 12, 2005, pp. 47-52. PMID 15693707
8. ↑ B. Blochin et al.: The cash doctor. No. 49/50, 1999, pp. 46-50.
9. ↑ ^{a b} Red list  ( page no longer available , search in web archives ) online version; Rote Liste® Service GmbH, Frankfurt 2008.
10. ↑ E. Koch, A. Biber: Treatment of rats with the Pelargonium sidoides extract EPS 7630 has no effect on blood coagulation parameters or on the pharmacokinetics of warfarin. Phytomedicins. 14, Suppl 6, 2007, pp. 40-45. PMID 17188479
11. ↑ Umckaloabo ^® 20 mg film-coated tablets: Information for professionals, as of July 2009. ISO-Arzneimittel GmbH & Co. KG.
12. ↑ Hepatitis in connection with Umckaloabo® from July 29, 2011 ; Drug Commission of the German Medical Association (AkdÄ), last accessed on August 28, 2012.
13. ↑ Data analysis: Umckaloabo no hepatotoxin, Ärztezeitung dated April 2, 2012.
14. ↑ ^{a b} Federal Institute for Drugs and Medical Devices: Medicines containing pelargonium: Risk of liver damage , March 31, 2014.
15. ^ Pharmaceutical newspaper online: Pelargonium: Liver damage new in Fachinfo , March 31, 2014.
16. ↑ TB Agbabiaka et al.: Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis. Phytomedicins. 15 (5), May 2008, pp. 378-385. PMID 18222667
17. ↑ A. Timmer, J. Günther, E. Motschall, G. Rücker, G. Antes, WV Kern: Pelargonium sidoides extract for treating acute respiratory tract infections. In: Cochrane Database Syst Rev. Volume 10 , October 22, 2013, doi : 10.1002 / 14651858.CD006323.pub3 , PMID 24146345 (CD006323).
18. ↑ VV Bereznoy include: Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: A randomized, double-blind, placebo-controlled trial. Aging. Ther. Health Med. 9/2003, pp. 68-79. PMID 14526713
19. ↑ Streptococcal angina - diagnosis by rapid test. drug telegram. 2/98, p. 26. (PDF)
20. ^ LG Ulm , judgment of March 25, 2014, 10 O 17/14 KfH
21. ↑ ^{a b c} Peter Taylor et al: The strange story of umckaloabo. The Pharmaceutical Journal. Vol 275, December 2005, pp. 790f. (PDF, English) ( Memento of the original dated December 3, 2008 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. 
22. ^ EA Meyer (1997), Naturheilpraxis Fachforum 04, pp. 560-563.
23. ↑ Adrien Sechehaye: Le Traitement de la tuberculose pulmonaire et chirurgicale par l'umckaloabo, médication internal ("Stevens cure"), historique, recherches expérimentales, observations cliniques, résultats. Maloine, Paris 1929, OCLC 759725771
24. ↑ A. Sehechaye: The treatment of organic and surgical tuberculosis by Umckaloabo internal healing method (Stevens cure); History, experiment. Forschgn, clin. Observation, results. trans. by Wjera and Irene von Bojanowski. Self-published by W. v. Bojanowski, Freiburg i. B. 1933, DNB 576137049 . (2nd edition 1937); A. Sehechaye: The Umckaloabo cure and its use in all forms of tuberculosis. trans. by W. and I. von Bojanowski. Self-published v. Bojanowski, Freiburg i. B. 1936, DNB 576137065 .
25. ↑ W. v. Bojanowski: The biological anti-tuberculosis drug Umckaloabo. Advances in medicine. 55th volume, 11, 1937, pp. 141 ff.
26. ^ Adrien Sechehaye: Le traitement des affections tuberculeuses par l'Umcka, médication intern - exposé de la méthode, observations cliniques, conclusions - attestations de médecins suisses et étrangers. Impr. R. Cavadini, Geneva 1948; Adrien Sechehaye: Umckaloabo in the internal treatment of tuberculosis - presentation of the procedure, clinical observations, conclusions, reports from Swiss and other doctors. From d. French transferred by Jean Balzli . Commission publisher Karl Knödler, Reutlingen 1951, DNB 454629397 .
27. ↑ A rural community in South Africa is fighting against Pelargonium patents and biopiracy. Press release of the Evangelical Development Service, May 7, 2008.
28. ↑ Umckaloabo® manufacturer reacts with patent waiver, DAZ.online, April 27, 2010, accessed September 17, 2018
29. ↑ Umckaloabo® in discussion - current location and sustainable perspectives ( memento of the original from March 6, 2016 in the Internet Archive ) Info: The archive link was inserted automatically and has not yet been checked. Please check the original and archive link according to the instructions and then remove this notice. , Press release of April 27, 2010. 

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