Home' Australian Pharmacist : Australian Pharmacist March 2013 Contents Australian Pharmacist March 2013 I © Pharmaceutical Society of Australia Ltd.
1. Pelargonium sidoides:
a) is a herbal extract used to treat fungal
b) is found in the extract known as EPs®
c) is not safe in children.
d) has not been studied in randomised
2. EPs® 7630 is:
a) a standardised herbal extract.
b) an extract containing the root of the
Pelargonium sidoides plant.
c) a phytomedicine that has been subject
to numerous clinical trials.
d) all of the above.
3. EPs® 7630 has been studied for:
a) reducing the symptoms of acute
b) reducing the symptoms of acute
c) reducing the symptoms of
4. The main mechanisms of action for
EPs® 7630 may include:
a) stimulating the non-specific immune
b) antiviral activity.
c) antibacterial activity.
d) all of the above.
5. The main side effects reported for
EPs® 7630 include:
a) gastrointestinal discomfort.
c) runny nose.
d) dry throat.
blind, placebo controlled, multi-centre
study of 406 adults with acute bronchitis
published in 2010.6 Patients were
randomly assigned to one of four parallel
treatment groups to receive different
doses of EPs 7630 tablets (10 mg EPs 7630
tablets three times a day [30 mg group],
20 mg EPs 7630 tablets three times a day
[60 mg group], 30 mg EPs 7630 tablets
three times a day [90 mg group] or
placebo three times a day) for a treatment
period of 7 days. Bronchitis-specific
symptoms were measured from baseline
to day 7 and the groups were compared.
Overall, the participants receiving EPs
7630 tablets had a highly statistically
significant improvement in symptoms
compared to the placebo group. The best
results were obtained for the two higher
dosage regimens. When the incidence of
side effects was considered, the optimal
dose was 20 mg tablets of EPs 7630 taken
three times daily.
As with most herbal treatments, EPs
7630 has multiple mechanisms of action
which have been demonstrated in test
tube and animal models. EPs 7630 has
demonstrated antiviral, antibacterial and
immunomodulatory and secretomotoric
effects. In particular, EPs 7630 appears to
primarily target enveloped viruses and
interferes with replication of seasonal
influenza A virus strains (H1N1, H3N2),
respiratory syncytial virus, human
coronavirus, parainfluenza virus, and
coxsackie virus.7 It also stimulates the
nonspecific immune system8 and has
direct antiviral activity against herpes
virus 1 and 2 amongst others.9 It
affects the herpes simplex virus before
penetration into the host cell and
reveals a different mode of action when
compared to acyclovir.
Overall, in all clinical and observational
studies, P. sidoides has shown good
tolerability with no serious adverse events
reported. Of the 13 spontaneous cases
of liver disease initially attributed to the
use of P. sidoides, further analysis has
failed to confirm causality in any of the
cases.10 Through the WHO international
pharmacovigilance program, it was
reported that the Uppsala Monitoring
Centre has received 34 case reports
of allergic reactions suspected to be
associated with the use of Pelargonium
extract, all originating from Germany.11
Although proof of causality is not
established for each of these cases, the
report describes a signal that merits
further study and validation.
1. Brendler T, van Wyk BE. A historical, scientific and commercial
perspective on the medicinal use of Pelargonium sidoides
(Geraniaceae). J Ethnopharmacol 2008;119:420–33 .
2. Agbabiaka TB, Guo R, Ernst E. Pelargonium sidoides for
acute bronchitis: a systematic review and meta-analysis.
3. Timmer A, Gunther J, Rucker G, et al. Pelargonium sidoides
extract for acute respiratory tract infections. Cochrane
Database of Systematic Reviews 2008, Issue 1. Art. No.:
4. Patiroglu T, Tunc A, Eke GH, et al. The efficacy of Pelargonium
sidoides in the treatment of upper respiratory tract infections
in children with transient hypogammaglobulinemia of infancy.
5. Tahan F, Yaman M. Can the Pelargonium sidoides root extract
EPs((R)) 7630 prevent asthma attacks during viral infections of
the upper respiratory tract in children? Phytomedicine 2012.
6. Matthys H, Lizogub VG, Funk P, et al. [Pelargonium sidoides in
acute bronchitis - Health-related quality of life and patient-
reported outcome in adults receiving EPs 7630 treatment].
Wien Med Wochenschr 2010;160:564–70.
7. Michaelis M, Doerr HW, Cinatl J, Jr. Investigation of the
influence of EPs(R) 7630, a herbal drug preparation from
Pelargonium sidoides, on replication of a broad panel of
respiratory viruses. Phytomedicine 2011;18:384–6 .
8. Kayser O, Kolodziej H, Kiderlen AF. Immunomodulatory
principles of Pelargonium sidoides. Phytother Res
9. Schnitzler P, Schneider S, Stintzing FC, et al. Efficacy of an
aqueous Pelargonium sidoides extract against herpesvirus.
10. Teschke R, Frenzel C, Wolff A, et al. Initially purported
hepatotoxicity by Pelargonium sidoides: the dilemma of
pharmacovigilance and proposals for improvement. Ann
11. de Boer HJ, Hagemann U, Bate J, et al. Allergic reactions
to medicines derived from Pelargonium species. Drug Saf
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