Pelargonium sidoides extract EPs 7630: a review of its clinical efficacy and safety for treating acute respiratory tract infections in children

Figures & data

Figure 1 Mechanism of action of EPs^® 7630.

Note: Adapted by permission from Springer Nature: Wien Med Wochenschr. Pelargonium sidoides-Extrakt (EPs^® 7630): Zulassung bestätigt Wirksamkeit und Verträglichkeit [Pelargonium sidoides-extract (EPs^® 7630): registration confirms efficacy and safety]. Conrad A, Kolodziej H, Schulz V. Copyright 2007.¹⁸

Table 1 Randomized controlled trials investigating the efficacy and safety of Pelargonium sidoides extract EPs 7630 in children and adolescents with different manifestations of acute respiratory tract infection

Trial	Investigation diagnosis	Primary outcome measure	Participants	Interventiona	Results on primary outcome measure (mean total score change ± SD or %)b
Kamin et al, 2010^Citation26	AB	BSS	Children and adolescents aged 1–18 years	Age-dependent drops EPs 7630 (n=103) or placebo (n=97), 7 d	Day 7: 3.4±1.8 (EPs 7630) 1.2±1.8 (placebo)
Kamin et al, 2010^Citation27	AB	BSS	Children and adolescents aged 6–18 years	EPs 7630 3×10 mg/d (n=100) or EPs 7630 3×20 mg/d (n=99) or EPs 7630 3×30 mg/d (n=99) or placebo (n=101), 7 d	Day 7: 3.6±2.4 (EPs 7630 3×10 mg/d) 4.4±2.4 (EPs 7630 3×20 mg/d) 5.0±1.9 (EPs 7630 3×30 mg/d) 3.3±2.6 (placebo)
Kamin et al, 2012^Citation28	AB	BSS	Children and adolescents aged 1–18 years	Age-dependent drops EPs 7630 (n=111) or placebo (n=109), 7 d	Day 7: 4.4±1.6 (EPs 7630) 2.9±1.4 (placebo)
Bereznoy et al, 2003^Citation29	ATP	TSS	Children aged 6–10 years	EPs 7630 3×20 drops/d (n=73) or placebo (n=70), 6 d	Day 4: 7.1±2.1 (EPs 7630) 2.5±3.6 (placebo)
Berezhnoi et al, 2016^Citation30	ATP	TSS	Children aged 6–10 years	EPs 7630 3×20 drops/d (n=60) or placebo (n=64), 6 d	Day 4c: 6.7±2.7 (EPs 7630) 3.3±4.2 (placebo)
Timen et al, 2015^Citation31	ATP	TSS	Children aged 6–10 years	Day 1–2: up to 12×20 drops/d EPs 7630 Day 3–6: 3×20 drops/d EPs 7630 (n=40) or placebo (n=38) 6 d	Responder rates day 4: 90.0% (EPs 7630) 44.7% (placebo)
Tahan and Yaman, 2013^Citation32	aRTI with mild asthma	Patient diary	Children and adolescents aged 1–14 years	Age-dependent drops EPs 7630 plus symptomatic treatment (n=30) or symptomatic treatment only (n=31), 5 d	Decreased nasal symptoms day 5: 57% (EPs 7630 plus symptomatic treatment) 26% (symptomatic treatment only) Decreased cough day 5: 44% (EPs 7630 plus symptomatic treatment) 10% (symptomatic treatment only)
Patiroglu et al, 2012^Citation33	aRTI with immune-deficiency	Parent-filled questionnaire	Children aged 1–5 years	EPs 7630 3×10 drops/d (n=14) or placebo (n=14), 7 d	Without nasal congestion day 7: 71.4% (EPs 7630) 21.5% (placebo)

Notes:

a Sample size of the full analysis set.

b Full analysis set, last observation carried forward.

c Values are derived from reference 19.

Abbreviations: AB, acute bronchitis; BSS, Bronchitis Severity Scale; ATP, acute tonsillopharyngitis; TSS, tonsillitis-specific symptoms; aRTI, acute respiratory tract infections; d, day(s).

ConradAKolodziejHSchulzVPelargonium sidoides-Extrakt (EPs® 7630): Zulassung bestätigt Wirksamkeit und Verträglichkeit [Pelargonium si (EPs® 7630): registration confirms efficacy and safety]Wien Med Wochenschr200715713–14331336 German [with English abstract]17704982

 PubMedGoogle Scholar

KaminWMaydannikVMalekFAKieserMEfficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis – a randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides rootsInt J Clin Pharmacol Ther201048318419120197012

 PubMed Web of Science ®Google Scholar

KaminWMaydannikVGMalekFAKieserMEfficacy and tolerability of EPs 7630 in patients (aged 6–18 years old) with acute bronchitis: a randomized, double-blind, placebo-controlled clinical dose-finding studyActa Paediatr201099453754320070280

 PubMed Web of Science ®Google Scholar

KaminWIlyenkoLIMalekFAKieserMTreatment of acute bronchitis with EPs 7630: randomized, controlled trial in children and adolescentsPediatr Int201254221922622360575

 PubMed Web of Science ®Google Scholar

BereznoyVVRileyDSWassmerGHegerMEfficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trialAltern Ther Health Med2003956879

 PubMed Web of Science ®Google Scholar

BerezhnoiVVHegerMLehmacherWSeifertGClinical efficacy and safety of liquid Pelargonium sidoides preparation (EPs 7630) in children with acute non-streptococcal tonsillopharyngitisJ Compr Ped201674e42158

 Google Scholar

TimenGZabolotnyiDHegerMLehmacherWEPs 7630 is effective in children with acute, non-β haemolytic streptococcal tonsillopharyngitis – results of a double-blind, placebo-controlled, multicentre trialMalays J Paediatr Child Health2015213650

 Google Scholar

TahanFYamanMCan the Pelargonium sidoides root extract EPs® 7630 prevent asthma attacks during viral infections of the upper respiratory tract in children?Phytomedicine201320214815023142309

 PubMed Web of Science ®Google Scholar

PatirogluTTuncAEke GungorHUnalEThe efficacy of Pelargonium sidoides in the treatment of upper respiratory tract infections in children with transient hypogammaglobulinemia of infancyPhytomedicine2012191195896122809962

 PubMed Web of Science ®Google Scholar

MatthysHLehmacherWZimmermannABrandesJKaminWEPs 7630 in acute respiratory tract infections – a systematic review and meta-analysis of randomized clinical trialsJ Lung Pulm Respir Res20163100068

 Google Scholar