Pelargonium (Umckaloabo) cough and cold medicines

Pelargonium root extract is unusual among herbal remedies because three separate layers of scrutiny exist: a European herbal monograph, a Cochrane systematic review and, in the UK, products carrying a traditional herbal registration. Reading them together shows how far "traditional" authorisation goes and where it stops.

The extract is made by soaking the root in a solvent such as ethanol, sometimes evaporating it to a dry powder. The resulting liquid or solid preparations are taken by mouth. Combination products with other herbs exist but are assessed separately and are not covered by the monograph discussed here.

The Committee on Herbal Medicinal Products at the European Medicines Agency concluded that, on the basis of long-standing use, these preparations can be used to treat symptoms of the common cold. They should only be used from the age of 6 years, and a doctor or qualified healthcare practitioner should be consulted if symptoms last longer than a week or worsen while taking the medicine.

The committee also reviewed three studies in acute bronchitis in which the extract was compared with placebo. It saw a possible improvement in symptoms such as cough, but design weaknesses stopped it drawing firm conclusions, so the traditional-use route was chosen. "Traditional use" here means that effectiveness is plausible and that the product has been used safely for at least 30 years, including at least 15 years in the EU, for a condition that does not need medical supervision.

The UK left the EU system, but the MHRA's own traditional herbal registration scheme follows the same philosophy, and European monographs remain a widely used reference when companies compile UK dossiers.

Cochrane authors searched for double-blind randomised trials comparing the extract with placebo or other treatment. Of ten eligible studies, eight were analysed. Three trials in adults with acute bronchitis (746 people) and three in children (819 children) suggested effectiveness for most outcomes with the liquid preparation but not with tablets. One trial in adults with sinusitis (103 people) also showed a treatment effect, though the quality of evidence was very low.

The reviewers concluded that the extract may be effective in easing symptoms of acute rhinosinusitis and the common cold in adults, but that doubt exists, and that it may relieve symptoms in acute bronchitis in adults and children. They rated the quality of evidence as low for bronchitis and very low for sinusitis and the common cold, and noted suspicion of publication bias. Adverse events were more common with the extract than with placebo, but none were serious.

• Evidence quality: low to very low, mostly investigator-initiated trials with some attrition problems.

• Preparation matters: liquid products outperformed tablets in the pooled analyses.

• No valid data were found for other acute respiratory infections.

The EU public summary describes very rare side effects, affecting fewer than one in 10,000 users: mild diarrhoea, stomach discomfort, nausea or vomiting, difficulty swallowing, mild nasal and gum bleeding and allergic reactions. Liver problems have also been reported, with unknown frequency. Anyone who develops yellow skin or eyes, dark urine, severe itching or unexplained abdominal pain should stop the product and seek medical advice promptly.

Because bleeding has been reported, people on anticoagulants or antiplatelet medicines should speak to a pharmacist first. The NHS also advises care with herbal medicines in children, pregnancy, breastfeeding and kidney or liver disease. Those cautions apply here, and the European minimum age of 6 is a regulatory threshold, not a recommendation to use it for all children over that age.

A manufactured herbal medicine sold for a minor condition in the UK needs a traditional herbal registration, shown by a THR number and certification mark on the packaging. The MHRA requires a quality dossier, an expert safety review and evidence of traditional use. It does not require proof of efficacy from modern trials, which is why a registered product can legitimately sit beside a Cochrane review that calls the evidence low in quality.

To tell whether a product is registered, check for the number and mark on the pack and read the leaflet. Products with no THR number sold with cough or cold claims should be treated with caution, since the NHS advises against buying unlicensed herbal medicines online.

For an adult with an ordinary cold, a registered pelargonium product is a low-risk option whose benefit is uncertain but plausible. It is not a substitute for assessment of a persistent cough, breathlessness, a cough with blood, a fever that will not settle, or symptoms in a person with asthma, COPD, heart failure or reduced immunity. Fluids, rest, simple analgesia and time remain the foundation of cold care, and a pharmacist can advise on other over-the-counter options.