Pelargonium

Pelargonium (Pelargonium sidoides DC.): A Comprehensive Reference

1. Identity and Botanical Characterization

1.1 Nomenclature and Taxonomy

Pelargonium sidoides DC. (family Geraniaceae) has a long history of traditional use among indigenous peoples of Southern Africa for treating respiratory and gastrointestinal disorders. The species is commonly known as "South African geranium" or "African geranium," and is also widely referred to by its traditional Zulu name, Umckaloabo. The name umckaloabo is derived from two independent Zulu words: umkhuhlane, meaning fever and cough-related diseases, and uhlabo, meaning chest pain. A closely related species, Pelargonium reniforme Curt., is also used medicinally and is often treated together with P. sidoides in pharmacopeial contexts. Both species were used for the same purposes. The species are very similar and have been much confused in the past, and the existence of gradual variation contributed to general problems of taxonomic classification. The use of both species is accepted by the European Pharmacopoeia monograph describing Pelargonium sidoides DC and/or Pelargonium reniforme Curt. in one monograph without defining specific parameters for differentiation (Ph. Eur. 6.0, 2008).

The plant has also been known in historical commerce as "Stevens' Cure" and as "Umckaloabo." Its transformation into the modern pharmaceutical product Umckaloabo (EPs® 7630) exemplifies the transition from traditional medicine to evidence-based therapeutics.

1.2 Morphological Description and Distribution

The plant grows in a rosette pattern and forms thick and very dark brown underground roots that grow up to 15 cm in length. Sparsely branched stems grow from the base, and the species is distinguished from others by its long stalks, greyish-green crinkled leaves, which are mildly aromatic, heart-shaped and velvety. It bears lots of characteristic reddish-purple flowers throughout the year. Pelargonium sidoides is easily distinguished from closely related species by its blackish, rather than pink, petals.

P. sidoides has a wide distribution. It occurs throughout the Eastern Cape, Lesotho, Free State and Southern and South-Western Gauteng in the Republic of South Africa. It usually grows in short grassland, and sometimes with occasional shrubs and trees, on stony soil varying from sand to clay-loam, shale or basalt. The plant grows in places where the climatic conditions range from arid to dry, and although it has the ability to endure frosts, the plants become dormant during prolonged periods of drought or extremely cold conditions.

1.3 Commercial Forms and Preparations

The medicinally used part of the plant is the root (radix). Pelargonium product is obtained from the dried roots of Pelargonium sidoides DC and/or Pelargonium reniforme Curt. by extraction with aqueous ethanol. The most extensively studied and commercially prominent preparation is EPs® 7630. EPs® 7630 (Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany) is a proprietary extract from the milled roots of Pelargonium sidoides (1:8–10), with extraction solvent: ethanol 11% (w/w), that was approved for the treatment of acute bronchitis in Germany in 2005. It was determined that 3-year-old rhizomes contain an optimal amount of active constituents. Currently, P. sidoides is grown on specialized farms in South Africa using ecological cultivation methods.

Umckaloabo is a herbal extract derived from the plant Pelargonium sidoides and is available in both tablet and liquid forms. Products containing EPs 7630 have been approved in a number of countries in Europe, Asia, Australia, Central America, and South America for indications including acute bronchitis, common colds and acute respiratory tract infections, acute rhinosinusitis, and acute tonsillopharyngitis.

2. Traditional and Historical Use

2.1 Indigenous Use in Southern Africa

Available ethnobotanical information shows that several tuberous Pelargonium species (including Pelargonium sidoides) are important traditional medicines with a rich ethnobotanical history. The plant species indigenous to areas of South Africa are widely used by traditional healers of the Zulu, Basuto, Xhosa, and Mfengi tribes to treat dysentery, diarrhea, hepatic complaints, wounds, colds, fatigue, fevers, generalized weakness, and infections of the respiratory tract including tuberculosis.

Along with the closely related P. reniforme Curt., the root has been used for centuries by the Zulu to treat coughs, upper respiratory tract irritations, tuberculosis, and gastrointestinal complaints. In the late nineteenth century, a product made from the root gained some popularity in England as a cure for tuberculosis.

Most notably, extracts of the roots of P. sidoides have commonly been applied for the treatment of dysentery and diarrhoea, but only occasionally for respiratory complaints in the oldest documented traditions; use for respiratory conditions appears to be more strongly reported by some groups and periods. Traditional preparations included infusions and decoctions of the tuber.

2.2 Introduction to Europe: Stevens' Cure

The medicinal potential of Pelargonium sidoides was brought to Europe in the early 1900s, after a young British explorer, Charles Henry Stevens, was treated in South Africa for his pulmonary tuberculosis by a local healer. A bitter tea made of Pelargonium sidoides root drove his illness into remission. Western use of the P. sidoides and P. reniforme species to treat tuberculosis is traced back to the Englishman Major Charles Stevens in 1897 when he was treated by a tribal healer with an extract from the roots of Pelargonium species. Stevens subsequently commercialized the remedy in England as "Stevens' Cure," and the product later gained a following in continental Europe as "Umckaloabo."

After the plant was brought to Great Britain at the end of the 19th century, a root extract has been produced in Germany as a standardised drug under the name "Umckaloabo" since the 1960s. The drug is standardised as an aqueous-ethanolic extract from the root of this plant under the code name EPs 7630. In Germany, P. sidoides extracts are marketed since at least 1976 and are registered as a herbal medicinal product with the indication for symptomatic treatment of acute bronchitis.

3. Key Constituents and Active Compounds

3.1 Phytochemical Profile

A broad range of constituents were identified in EPs 7630 and other Pelargonium sidoides extracts, including members of different compound classes such as amino acids, phenolic acids, α-hydroxy-acids, vitamins, polyphenols, flavonoids, coumarins, coumarin glucosides, coumarin sulphates, nucleotides, monomeric and oligomeric carbohydrates, minerals, peptides, purine derivatives, and highly substituted benzopyranones.

The predominant group of compounds in the extract is oligoprodelphinidins (proanthocyanidins, flavonoids, tannins), which are likely responsible for some of the reported pharmacological effects of Pelargonium. Primary plant metabolites — carbohydrates, amino acids/peptides, and minerals/inorganic salts — make up the next most prevalent constituents.

The following specific compound classes and marker molecules are of primary pharmacological interest:

• Coumarins and benzopyranones: The plant is rich in polyphenols, flavonoids, tannins, diterpenes and proanthocyanidins, but the main constituent is a type of coumarin called umckalin (6-hydroxy-5,5-dimethoxy-coumarin). Additional oxygenated coumarins include 7-hydroxy-5,6-dimethoxycoumarin and 6,8-dihydroxy-5,7-dimethoxycoumarin, along with coumarin sulphates. These 7-hydroxycoumarin derivatives (including umckalin) differ in chemical structure from the known anticoagulant coumarins and are not associated with anticoagulant activity or interaction with warfarin and its pharmacokinetics.
• Polyphenols and catechins: The EPs 7630 extract contains primarily polyphenols (mainly catechin and gallocatechin), proteins, minerals, and, in lower concentrations, 7-hydroxycoumarin derivatives. Catechins such as gallocatechin, epigallocatechin, and epigallocatechin gallate have been identified in EPs® 7630.
• Gallic acid and phenolic acids: Gallic acid and its methyl ester were postulated as main active ingredients in macrophage activation studies. Gallic acid has additionally been characterized as one of the signature constituents of P. sidoides.
• Flavonoids: Taxifolin sulphate and other flavonoid sulphates were recently discovered as genuine constituents in P. sidoides root extract EPs® 7630.
• Proanthocyanidins (oligoprodelphinidins): These high-molecular-weight tannin-type structures constitute the single largest compound class by proportion in EPs 7630 and contribute to both antibacterial and antiviral effects.

3.2 Standardization

EPs 7630 is a herbal drug preparation from the roots of Pelargonium sidoides (1:8–10), extraction solvent: ethanol 11% (w/w). The extract is not standardized to a single marker compound; rather, its complex mixture of secondary metabolites is collectively responsible for its pharmacological profile, and the extract itself serves as the pharmaceutical standard.

4. Mechanisms of Action

4.1 Multi-Target Pharmacological Profile

The pharmacological profile of P. sidoides is defined by multi-target activity, encompassing immunomodulatory, antibacterial, and antiviral effects, including studies on SARS-CoV-2 and other respiratory pathogens. A wide range of mechanisms appears to contribute to the beneficial effects of EPs 7630, including antibacterial, antiviral, immunomodulatory, and epithelial barrier effects. This broad spectrum of pharmacological activities enables the clinical activity of EPs 7630 against multiple respiratory infections. In particular, the combination of antiviral and immunomodulatory effects may enable EPs 7630 to tackle acute viral respiratory infections both in early stages of the disease process, which are driven by virus replication, as well as in later stages, which are caused by an overshooting immune response.

4.2 Immunomodulatory Mechanisms

EPs 7630 stimulates nitric oxide release (NO) and induces antiviral type I interferon and different cytokines such as IL-22. An initial study showed that Pelargonium sidoides root extract protected murine macrophages from infection with the obligate intracellular protozoan Leishmania donovani without exerting direct anti-protozoan effects. The extract caused interferon-like effects and macrophage activation as indicated by TNF-alpha and nitric oxide (NO) induction.

Documented pharmacological activities of EPs 7630 include antiviral and antibacterial action as well as immune-modulatory capabilities. Several in vitro studies conducted with EPs 7630 showed an inhibitory effect (growth inhibition) against several bacterial strains (Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, and Staphylococcus aureus, especially multi-resistant strains). This effect is brought about by an immune modulation mechanism mediated by the activation of macrophages (with the involvement of cytokine interferon-gamma) and the consequent increase in the production of nitric oxide. The activated macrophages produce, in turn, different cytokines.

4.3 Antiadhesive and Antibacterial Properties

Experimental results from in vitro studies indicate that bioactive phytochemical constituents of Pelargonium sidoides may not possess a direct antimicrobial effect, but instead act by interfering with microbial binding to host cell receptors, inhibition of key enzymes and the production of antimicrobial effector molecules such as nitric oxide and interferons (IFNs) by the host cells.

The mode of action has been described as the exertion of a specific antagonistic effect against the adhesion proteins on the bacterial surface (group A Streptococcus), thus preventing adhesion to epithelial cells and subsequent penetration of them. This specific activity appears to be mediated by the proanthocyanidins contained in the extract.

4.4 Mucociliary Effects

The mucociliary system represents a defence mechanism of the nasal cavity and the bronchial tree for cleaning the air of bacteria and foreign particles, with the ciliary beat frequency (CBF) being an important parameter for determining its efficacy. EPs® 7630 significantly and concentration-dependently increased CBF of an adherent monolayer culture of human nasal epithelium cells. At 30 μg/mL, the increase was approximately 125% compared to the equilibrium phase. After washing procedures, the CBF returned to that of the equilibration period.

4.5 Antiviral Mechanisms

The antiviral effect of EPs 7630 is reported to be linked to the production of interferons, although a recent study highlighted a direct antiviral effect on several viruses (influenza, parainfluenza, respiratory syncytial viruses, rhinoviruses, coxsackie, and coronaviruses). At least two molecular constituents of EPs® 7630 — (−)-epigallocatechin and taxifolin — have been identified with antiviral effects on SARS-CoV-2 replication and cell entry.

4.6 Antimycobacterial Activity (Preclinical)

Using the radiorespirometric BACTEC method, extracts showed antimycobacterial activity against Mycobacterium tuberculosis (96% at 12.5 μg/mL), while none of the purified compounds tested reproduced this effect alone, suggesting the activity requires the complex mixture of constituents. Further research testing Pelargonium sidoides root extract against Mycobacterium smegmatis identified scopoletin, umckalin, catechin, and epigallocatechin as active ingredients.

5. Scientific Evidence by Area of Use

5.1 Acute Bronchitis

Evidence Strength: Moderate (Low to Moderate per Cochrane)

A Cochrane systematic review and meta-analysis published in 2013 concluded that P. sidoides showed potential benefits for acute bronchitis in both adults and children, as well as for sinusitis and the common cold in adults. The review examined 10 randomized clinical trials, of which eight were of sufficient quality for inclusion into analyses. Three trials dealt with acute bronchitis in adults and showed inconsistent but overall positive results for resolution of symptoms (all symptoms, cough and sputum production).

For acute bronchitis in children, there were also three studies showing an inconsistent but overall positive combined effect. The study quality was rated as moderate for all studies (unvalidated outcome assessment, minor attrition problems, investigator-initiated trials only). Based on the funnel plot there was suspicion of publication bias.

The review concluded that P. sidoides may be effective in relieving symptoms in acute bronchitis in adults and children, and sinusitis in adults. The overall quality of the evidence was considered low for main outcomes in acute bronchitis in children and adults, and very low for acute sinusitis.

All RCTs in an earlier meta-analysis reported findings suggesting the effectiveness of P. sidoides in treating acute bronchitis. Meta-analysis of four placebo-controlled RCTs suggested that EPs 7630 significantly reduced bronchitis symptom scores in patients with acute bronchitis by day 7. No serious adverse events were reported. There is encouraging evidence from currently available data that P. sidoides is effective compared to placebo for patients with acute bronchitis.

A large observational study provided further data: to evaluate the efficacy and safety of treatment with EPs 7630 in patients with acute bronchitis, a multi-centre, prospective, open observational study was conducted in 440 study sites in Germany. A total of 2,099 patients aged 0–93 years with productive cough for less than six days were given EPs 7630-solution in an age-dependent dosage for 14 days. The primary outcome criterion was the mean change of the Bronchitis Severity Score (BSS). During treatment, the mean BSS of all patients decreased from 7.1 ± 2.9 points at baseline to 1.0 ± 1.9 points at patients' individual last visit. Adverse events occurred in 26/2,099 (1.2%) patients. Serious adverse events were not reported.

It should be noted that the majority of included trials were manufacturer-funded, as was the lead author — a limitation that must be weighed when interpreting the body of evidence.

5.2 Acute Rhinosinusitis

Evidence Strength: Low to Very Low (Cochrane)

In one double-blind, placebo-controlled trial, 103 patients with acute rhinosinusitis of presumably bacterial origin were given an ethanolic extract of P. sidoides (EPs 7630) or matching placebo at a dose of 3 mL three times daily for a maximum of 22 days. The mean decrease in the Sinusitis Severity Score was 5.5 points in the EPs 7630 group compared with 2.5 points in the placebo group, a difference of 3.0 points. This result was confirmed by all secondary parameters, indicating a more favorable course and a faster recovery in the EPs 7630 group.

The Cochrane review concluded that P. sidoides may be effective in alleviating symptoms of acute rhinosinusitis and the common cold in adults, but doubt exists. It may be effective in relieving symptoms in acute bronchitis in adults and children, and sinusitis in adults.

5.3 Acute Tonsillopharyngitis

Evidence Strength: Preliminary (few RCTs; evidence base largely in children)

Analysis of available clinical data validates the therapeutic use of P. sidoides root preparations for managing acute bronchitis, rhinosinusitis, and tonsillopharyngitis. Out of eight RCTs identified in a narrative review focused on the pediatric population, three RCTs investigated EPs 7630 in children with acute tonsillopharyngitis, one open-label clinical trial studied the treatment of acute respiratory tract infections (aRTI) in children and adolescents suffering from preexisting mild asthma, and one RCT investigated the effects of the herbal extract on aRTI in immunocompromised children.

A separate systematic review and meta-analysis included 13 trials with a total of 3,392 participants, 10 of which could be entered into meta-analyses of efficacy (acute bronchitis: 6/8 trials; acute rhinosinusitis: 2/2 trials; acute tonsillopharyngitis: 2/3 trials).

5.4 Acute Respiratory Tract Infections in Children

Evidence Strength: Moderate across multiple RCTs; low by Cochrane grading

Eight RCTs investigating the application of EPs 7630 in acute bronchitis, acute tonsillopharyngitis, and acute respiratory tract infections in the context of chronic preconditions were identified in one review. Results showed a statistically significant improvement of acute respiratory tract infection symptom severity for EPs 7630 as compared to controls.

Three RCTs investigated a total of 820 patients aged between 1 and 18 years suffering from acute bronchitis. Acute bronchitis symptoms were required to have started less than 48 hours prior to admission.

In numerous randomized controlled trials (RCTs) and systematic reviews such as those published by the Cochrane Collaboration, Pelargonium sidoides extract EPs® 7630 was shown to be effective in acute respiratory tract infections (aRTI) in all investigated age groups.

5.5 COVID-19 / SARS-CoV-2 (Preclinical Only)

Evidence Strength: Preclinical (in vitro and animal); no completed clinical trials reported

EPs® 7630 reduced viral load early in the course of infection and displayed significant immunomodulatory properties in hamsters. In addition, EPs® 7630 differentially inhibits SARS-CoV-2 variants in nasal and bronchial human airway epithelial cells. Antiviral effects were more pronounced against Omicron BA.2 compared to B.1 and Delta. These findings remain at the preclinical stage and should not be extrapolated to clinical efficacy.

5.6 Tuberculosis (Preclinical / Traditional)

Pelargonium sidoides is an important traditional medicine in South Africa with a well-defined history of both traditional and documented use of an aqueous-ethanolic formulation of the roots of P. sidoides (EPs 7630). There is also historical evidence of use in the treatment of tuberculosis. At the preclinical level, extracts show antimycobacterial activity in laboratory assays, but no controlled human clinical trials have demonstrated efficacy for tuberculosis.

5.7 Reduction of Antibiotic Use

There is clinical evidence showing that the Pelargonium sidoides root extract EPs 7630 is a safe and effective treatment for a range of acute infectious respiratory illnesses. Moreover, EPs 7630 has been shown to reduce the use of antibiotics, which is important in the context of rising antibiotic resistance levels.

6. Body Systems and Health Areas

Based on the accumulated research literature, P. sidoides is primarily associated with the following body systems and health domains:

• Respiratory System: Acute bronchitis, acute rhinosinusitis, acute tonsillopharyngitis, and common cold. The extract acts on the respiratory epithelium through mucociliary enhancement and antiviral/antibacterial mechanisms.
• Immune System: Macrophage activation, interferon induction, natural killer cell enhancement, and cytokine modulation. At a dose of 30 μg/ml, EPs 7630 significantly increased the phagocytic activity of macrophages and natural killer (NK) cell cultures from the nasal mucosa and stimulated nitric oxide (NO) production.
• Gastrointestinal System: Traditional use by Southern African tribes for dysentery and diarrhea. EPs 7630 has also been found to inhibit Helicobacter pylori growth and to reduce bacterial adherence to gastric epithelial cells.
• Infectious disease / antimicrobial: Broad-spectrum antiviral and antibacterial activity demonstrated in laboratory studies, including activity against influenza viruses, respiratory syncytial virus, coronaviruses, and several bacterial pathogens. Several non-clinical studies demonstrated activity against a variety of respiratory viruses such as influenza A virus (H1N1, H3N2), respiratory syncytial virus, human coronavirus (HCoV) HCoV-229E, and parainfluenza virus.

7. Dosage Forms and Reported Dosages

EPs 7630 is available in both tablet and liquid forms. The following dosages have been reported in clinical studies:

• Liquid solution (drops): The recommended daily doses of liquid solution are 3 × 10 drops for young children aged between 1–5 years, 3 × 20 drops for children aged between 6–12 years, and 3 × 30 drops for adults and adolescents over the age of 12 years.
• Liquid solution (mL): In one placebo-controlled trial in adults with acute rhinosinusitis, participants received 3 mL three times daily for a maximum of 22 days.
• Capsules (20 mg): One post-authorization safety study enrolled 300 adult patients prescribed Pelargonium sidoides DC. 20 mg capsule three times a day for seven days during routine clinical care.
• Duration: In a large observational study, EPs 7630-solution was administered in an age-dependent dosage for 14 days.
• Immunomodulatory assessment study: A clinical trial conducted to evaluate the immunomodulatory potential of P. sidoides had participants ingest 30 drops of a solution of approximately 800 mg/mL of P. sidoides 3 times a day for 28 days. P. sidoides altered the synthesis of IL-6 and IL-15 in serum and nasal epithelium, cytokines essential to trigger allergic processes.

8. Safety Considerations

8.1 Common Adverse Events

Adverse events were more common with P. sidoides than placebo, but none were serious in the Cochrane-reviewed trials. In clinical studies, the most commonly reported adverse events are gastrointestinal in nature. No side effects were observed in some studies, except for unpleasant taste, which was reported in some patients in the EPs® 7630 group.

8.2 Hepatotoxicity Signal and Regulatory Assessment

Spontaneous reports of herb-induced liver injury (HILI) represent a major regulatory issue. In a total of 13 spontaneous cases, liver disease was initially attributed to the use of Pelargonium sidoides. A formal pharmacovigilance investigation found that there is currently no evidence of hepatotoxicity related to the use of Pelargonium. Nevertheless, the warning of hepatitis when taking Pelargonium remains on the SmPC (Summary of Product Characteristics) and information leaflet of licensed products, but the frequency cannot be estimated from the available evidence. A recent Pharmacovigilance Risk Assessment Committee (PRAC) report of the European Medicines Agency (EMA) recommended that cases of hepatotoxicity should be closely monitored.

In 2011, EMA described a favorable benefit/risk ratio and a lack of unwanted hepatic effects in causal relationship to P. sidoides use in European countries. Animal studies also provide reassurance: Koch (2006) examined the hepatotoxic effect of extracts from the roots of Pelargonium sidoides. Studies on rats and dogs involving the oral administration of up to 3,000 mg/kg EPs® 7630 provided no evidence of liver-damaging effects.

Additionally, unlike other coumarins, 7-hydroxycoumarin derivatives contained in EPs 7630 do not possess hepatotoxic properties.

8.3 Hypersensitivity

Hypersensitivity reactions following ingestion of Pelargonium are recognised and rare; anaphylaxis is very rare. Most reactions are mild in the form of a rash, pruritus, urticaria, dermatitis, rhinitis, and asthmatic symptoms. A smaller number of cases of anaphylaxis have been reported with circumoral and tongue oedema, dyspnoea, and circulatory collapse.

8.4 Special Populations and Contraindications

The EMA herbal monograph lists hypersensitivity to the active substance(s) as a contraindication. No fertility data are available. The European Pharmacopoeia and EMA monograph do not define specific use in pregnancy or lactation based on available data.

8.5 Publication Bias and Funding

The majority of included trials in systematic reviews were manufacturer-funded, as was the lead author of some key reviews. Based on the funnel plot analysis of the Cochrane review, there was suspicion of publication bias. These factors must be considered when interpreting the overall evidence base.

8.6 Coumarin and Drug Interaction Clarification

The 7-hydroxycoumarin derivatives (including umckalin) in EPs 7630 differ in chemical structure from the known anticoagulant coumarins and are not associated with anticoagulant activity or interaction with warfarin and its pharmacokinetics. This is an important distinction from the anticoagulant coumarins (e.g., warfarin), with which P. sidoides constituents should not be confused.

9. Conservation Considerations

Pelargonium sidoides is endemic to Lesotho and South Africa. It is harvested from the wild for the manufacture of traditional medicine (phytomedicines) by local and international pharmaceutical industries. The pharmacological usefulness of Pelargonium sidoides must take cognisance of the broader context involving the need for conservation-friendly approaches in its utilisation. In this regard, plant biotechnology applications can play a meaningful role in a holistic conservation strategy. Commercial producers have responded by transitioning to cultivated plant sources in South Africa, as noted above.

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