Pelargonium Uses, Benefits & Dosage - Drugs.com Herbal Database

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# Pelargonium

Scientific Name(s): Pelargonium graveolens, Pelargonium reniforme Curt., Pelargonium sidoides DC.
Common Name(s): African geranium, EPs 7630, Kaloba, Kalwerbossie, Rabassamin, Umcka, Umckabo, Umckaloaba, Zucol

Medically reviewed by Drugs.com. Last updated on Dec 19, 2022.

## Clinical Overview

### Use

Data support use in respiratory conditions including acute respiratory tract infections, bronchitis, common cold, chronic obstructive pulmonary disease (COPD), pharyngitis, and rhinosinusitis.

### Dosing

EPs 7630 (alcoholic extract) standard dose of 30 drops 3 times daily or high dose of 60 drops 3 times daily for up to 24 weeks (range, 10 to 60 drops 3 times daily from 6 days to 24 weeks). 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.

### Interactions

None well documented.

### Adverse Reactions

Pharmacovigilance studies and clinical trials enrolling nearly 2,500 adults and children document mostly allergic reactions or GI complaints (eg, gastric pain, heartburn, nausea, diarrhea). Case reports of fatalities linked to the use of a product containing the Pelargonium extract 1,3-dimethylamylamine (DMAA) have led to DMAA-containing products being banned by the US Department of Defense from military bases and resulted in a complete ban by the New Zealand Ministry of Health.

### Toxicology

No animal toxicology studies have been reported.

## Scientific Family

- Geraniaceae

## Botany

The genus Pelargonium comprises approximately 280 known species, of which 80% are grown in the interior of South Africa.(Kolodziej 2007) Both of the title plant species are distinguished by the color of the flowers, the shape of the leaves, and the pollen color. P. sidoides is a small geranium-like plant that grows in a rosette from thick and very dark brown underground roots that grow up to 15 cm in length. Sparsely branched stems grow from the base and display deep red to black flowers, and the species is distinguished by the cordate or heart-shaped leaves. The pollen of the plant species is yellow. In contrast, P. reniforme has magenta red to black flowers, kidney-shaped leaves, and white to green pollen.(Bladt 2007, Kolodziej 1998) 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 been developed to reduce pressure on natural populations.(Lewu 2006)

## 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.Kolodziej 2000, Lewu 2006 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.Kolodziej 1998

Originally, the plant source of the drug was identified as P. reniforme; however, further botanical investigations discovered the closely related species P. sidoides, which is now predominately used for therapeutic purposes.Kolodziej 1998

P. sidoides has been marketed under the brand name Umckaloaba and has been widely used in Europe since the 1980s. Economically, annual sales for the product in 2002 were $55 million or 4.1 million packages.Patrick 2008 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-Arzneimittel under license from Schwabe. The DMAA extract from P. graveolens was marketed in the 1940s as an inhaled local vasoconstrictor for nasal congestion. It is an ingredient in a pre-exercise product currently marketed as Jack3d.

## Chemistry

Chemical analyses have led to characterization of about 65 metabolites including phenolic and cinnamic acids, tannins, flavonoids, and coumarins in both plant species.Kolodziej 2000, Kolodziej 2005, Seidel 2004 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 oligomeric carbohydrates, minerals, peptides, purine derivatives, and highly substituted benzopyranones.Schoetz 2008 Nearly 230 components have been detected in each of the plant species' essential oils, with sesquiterpenes the most abundant.Kayser 1998

Coumarin, 5,6-dimethoxy,7-hydroxy-coumarin, and several related ethers, glycosides, and sulfates have been isolated from both species of Pelargonium.Kayser 1995, Kolodziej 2002, Wagner 1974, Wagner 1975 Many of these coumarins also are found in the roots of other South African Pelargonium species.Wagner 1975 A series of galloyl C-glycosidic flavones, along with related nongalloyl flavones, have been isolated from P. reniforme aerial parts.Latté 2002P. sidoides contains similar flavonoids and phenolics.Goedecke 2005 The high tannin content (about 9%) may justify the plant's use in GI complaints in cases of bacterial toxin-induced secretory diarrhea. The broad spectrum of activity against viruses and bacteria may be caused by the coumarins and phenolic acids.Kolodziej 2007, Kolodziej 1998

An extract of P. graveolens, DMAA, is an aliphatic amine with sympathomimetic properties and is known by numerous other names including methylhexaneamine, 1,3-dimethylpentylamine, and Geranamine.Smith 2014

## Uses and Pharmacology

Numerous in vitro, animal, and clinical studies document the plant's antibacterial activity. Several fairly large clinical trials examine the plant's efficacy in treating acute bronchitis, common cold, and pharyngitis or sore throat.(Kolodziej 2003)

### Acute respiratory tract infections

#### Clinical data

A 2007 double-blind, randomized, placebo-controlled, phase 3 trial conducted in adults who presented with symptoms of the common cold for 24 to 48 hours reported a significant improvement in mean symptom scores at day 5 in the P. sidoides root alcoholic liquid extract group compared to placebo (P<0.0001). Additionally, the responder rates were significantly higher with the extract than placebo for day 5 symptom score less than 7 points (42.3% vs 3.9%) and reduction in symptom score of at least 7 points (94.2% vs 43.1%), as well as day 10 clinical cure based on a symptom score of zero (63.5% vs 11.8%) and the presence of no more than 1 symptom (78.8% vs 31.4%; P<0.0001 for each). Individual symptoms including limb pain, weakness, exhaustion, and fatigue (P=0.0001 to 0.0074), as well as duration of inability to work, duration of activity limitation, and general well-being (P<0.001 to 0.008) also improved significantly in the extract group compared to controls. The extract was well tolerated with mild epistaxis in one patient considered possibly related to treatment.(Lizogub 2007)

A meta-analysis of 8 double-blind, randomized, placebo-controlled, manufacturer-funded trials (N=746) of low to very low quality revealed effectiveness of P. sidoides (EPs 7630) alcoholic extract for relieving acute bronchitis symptoms in adults and children, and possibly sinusitis in adults as well. Very weak evidence supported effectiveness for symptom relief of acute rhinosinusitis and the common cold in adults. Formulations studied included tablets (10 to 30 mg 3 times daily × 7 days) and alcohol-extract liquid preparations (3 × 10 to 60 drops × 7 to 30 days). Adverse events were slightly higher with treatment versus placebo and none were serious (eg, GI, allergic skin reactions, urticarial).(Timmer 2013) Safety and efficacy of both the standard (30 drops 3 times daily) and high dose (60 drops 3 times daily ) of EPs 7630 were demonstrated in a phase 3 multicenter, double-blind, randomized, placebo-controlled trial (N=207) that enrolled strep-negative adults with major and minor symptoms of the common cold. Both doses were well tolerated with transient mild epistaxis and mild epigastric discomfort possibly related to treatment; no serious adverse events were reported.(Riley 2018)

### Antimicrobial/Antiviral activity

#### In vitro data

The extracts of both Pelargonium species have modest direct antibacterial activity, with isolated coumarins and phenolics having minimum inhibitory concentration values from 200 to 1,000 mcg/mL in agar dilution assays versus common test bacteria.(Kayser 1997) Unsaturated fatty acids from the roots, especially linoleic acid, had antimycobacterial activity at 2 mcg/mL in vitro.(Seidel 2004)

Immune stimulation of the host is a potential course for antimycobacterial activity. Immune stimulation by P. sidoides extracts, coumarins, and phenolics has been documented in a variety of functional assays(Kayser 2001, Kolodziej 2003) including enhancement of interferon-beta synthesis and activation of natural killer cell activity.(Koch 2002) Tannins from the plant induced nitric oxide synthase and cytokine gene expression in a macrophage-like cell line.(Kolodziej 2005) The butanol root extract has antimycobacterial activity.(Mativanlela 2007)

Ciliary beat frequency increased in a model system after exposure to EPs 7630 extract.(Neugebauer 2005) The effect was reversible and may be relevant in diverse lung and airway infections because cilia are important in removal of bacteria and foreign particulates.

EPs 7630 inhibited Helicobacter pylori growth and reduced bacterial adherence to gastric epithelial adrenogenital syndrome cells. EPs 7630 suppressed H. pylori growth in brain-heart infusion broth at a concentration of 100 mcg/mL and reduced H. pylori adherence at concentrations of 50 mcg/mL or more. The mechanism of action is primarily related to its antiadhesion activity.(Beil 2007, Wittschier 2007)

In bronchial epithelial and smooth muscle tissue samples obtained from patients with asthma or COPD as well as those from controls, EPs 7630 reduced rhinovirus infection in a concentration-dependent manner and the expression of rhinovirus RNA. The mechanism involved both a reduction in the expression of viral docking proteins on host cells and increased expression of anti-viral host defense proteins.(Roth 2019)

### Bronchitis

A meta-analysis of 4 randomized clinical trials, including 1,647 patients, supported the plant's efficacy in reducing bronchitis symptoms. The mechanism of action is associated with EPs 7630 antagonism of bacterial adhesion to intact epithelia, leading to protection from bacteria colonization and infection in the upper respiratory tract.(Agbabiaka 2008)

#### Clinical data

Clinical trials of EPs 7630 in acute bronchitis have been conducted in children and adults.(Chuchalin 2005, Golovatiouk 2002, Haidvogl 1996, Matthys 2003, Matthys 2007, Matthys 2007, Schulz 2007) The primary outcome or review of efficacy for most of the trials are changes in the Bronchitis Severity Score (ie, coughing, expectoration, chest pain, dyspnea, wheezing) from baseline versus the last observation (ie, final observation typically within 1 week). Inclusion criteria involved patients diagnosed with acute bronchitis within 48 hours who were not receiving antibiotic therapy, 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 was well tolerated, with no serious adverse reactions during the trials examined.

### Chronic obstructive pulmonary disease

#### Clinical data

A randomized, double-blind, placebo-controlled trial enrolling 200 adults with a history of stable chronic bronchitis who experienced at least 3 exacerbations in the previous 12 months evaluated the efficacy of EPs 7630 for managing chronic obstructive pulmonary disease exacerbations. EPs 7630 (3 × 30 drops/day for 24 weeks) or placebo was added to standard inhalation therapy. Time to first exacerbation was significantly prolonged by a median of 14 days with EPs 7630 (P=0.005), the number of moderate versus mild exacerbations was significantly lower (P<0.0001), and fewer patients overall on the study treatment experienced exacerbations. Additionally, significantly fewer patients treated with add-on EPs 7630 required antibiotics during exacerbations compared with placebo (37.8% vs 73.3%, respectively, P<0.0001). Health status, patient satisfaction, mean number of days off work during an exacerbation (2 vs 4 days), and total number of days off work during the 24-week study (3 vs 7 days) were all significantly better with EPs 7630 versus placebo (P<0.01, P<0.0001, P=0.004, P<0.001, respectively). More adverse events (eg, GI) were experienced in the treatment group, most of which were mild and none were serious. Secondary patient-reported outcomes from this trial published 5 years later predominantly reflected significant improvement in quality of life, respiratory health, and satisfaction with EPs 7630 treatment by week 24 (P<0.001 for each). Additionally, symptom severity scores were significantly better than placebo (P=0.021).(Matthys 2013, Matthys 2018)

### Pharyngitis

The mechanism of action may be associated with EPs 7630 antagonizing bacteria and virus adhesion to the tonsil surface or site of infection.(Bereznoy 2003)

#### Clinical data

In 2 multicenter, prospective, randomized clinical trials, EPs 7630 was more effective than placebo in 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 shortened duration of illness by at least 2 days. The therapy also protected against complications. The treatment 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.(Bereznoy 2003, Heger 2002)

## Dosing

EPs 7630 is an 11% aqueous ethanolic extract in which 100 g of finished product corresponds to 8 g of extracted plant material.Chuchalin 2005, Matthys 2003

### Acute respiratory tract infections, bronchitis, common cold, COPD, pharyngitis, rhinosinusitis

EPs 7630 (alcoholic extract): Standard dose of 30 drops 3 times daily or high dose of 60 drops 3 times daily for up to 24 weeks (range, 10 to 60 drops 3 times daily from 6 days to 24 weeks).Bereznoy 2003, Heger 2002, Matthys 2013, Riley 2018, Timmer 2013 Tablet doseform: 10 to 30 mg 3 times daily for 7 days.Timmer 2013

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 report recommends caution if used during pregnancy.de Boer 2007

## Interactions

An interaction may be possible when patients are receiving anticoagulant medications (eg, warfarin) or antiplatelet drugs (eg, aspirin). However, a study in rats documented no pharmacokinetic or pharmacodynamic interactions between EPs 7630 and warfarin.de Boer 2007, Koch 2007

## 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); mild epistaxis has also been reported as possibly related to treatment. In Germany, pharmacovigilance studies found case reports of allergic reactions associated with the use of Pelargonium extract.de Boer 2007 Additional surveillance studies document similar results.Golovatiouk 2002

Case studies linking the use of DMAA-containing products (ie, Jack3d) to fatal and nonfatal myocardial infarctions and cerebral hemorrhage have led to these products being banned by the New Zealand Ministry of Health and from being sold in stores on military bases by the US Department of defense. Additionally, the Medicines and Healthcare Products Regulatory Agency has extended warnings to several companies to stop selling DMAA-containing products in the UK.Smith 2014

## Toxicology

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

## References

## Disclaimer

This information relates to an herbal, vitamin, mineral or other dietary supplement. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. This information should not be used to decide whether or not to take this product. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this product. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from your health care provider. You should talk with your health care provider for complete information about the risks and benefits of using this product.

This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. This product may be unsafe when used before surgery or other medical procedures. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age.

## More about pelargonium

- Reviews (3)

### Related treatment guides

- Herbal Supplementation

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Bereznoy VV, Riley DS, Wassmer G, Heger M. Efficacy of extract of Pelargonium sidoides in children with acute non-group A beta-hemolytic streptococcus tonsillopharyngitis: a randomized, double-blind, placebo-controlled trial. Altern Ther Health Med. 2003;9(5):68-79.14526713
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