Keywords: antibiotic use; bronchitis; randomised controlled trial; Pelargonium sidoides extract

Background:

Acute bronchitis is a common primary care condition and a major cause of unnecessary antibiotic prescribing. The effectiveness of Pelargonium sidoides extract (EPs®7630) in the management of acute bronchitis remains uncertain due to a lack of pragmatic trials.

Research questions:

Does EPs®7630 reduces symptom duration or antibiotic use compared with usual care among adults with acute bronchitis?

Method:

We conducted a pragmatic, open-label, superiority randomised-controlled trial across 36 primary care practices and five walk-in clinics in Switzerland. Adults (≥18 years) consulting a general practitioner for the first time for a new episode of acute bronchitis, with a cough of up to eight days’ duration, were eligible for inclusion. The co-primary outcomes were (1) number of days required to achieve a 50% reduction in symptoms from the peak value, and (2) the proportion of participants who used antibiotics. Both outcomes were analysed in the intention-to-treat population.

Results:

332 participants were enrolled and randomly assigned: 155 to EPs®7630 and 177 to usual care. No significant difference in time to 50% reduction of symptoms between the EPs®7630 and usual care groups was observed (adjusted regression coefficient 0.05 [95% CI −0.13–0.23]; p=0.578). Antibiotic use was 7 percentage points lower in the EPs®7630 group (17.4%, 20 of 155) than in the usual care group (25.2%, 33 of 177), adjusted risk ratio 0.78 [95% CI 0.49–1.26]; p=0.309. Adverse events were reported more frequently in the EPs®7630 group (32.3%, 50 of 155) than in the usual care group (21.5%, 38 of 177; hazard ratio 1.40 [95% CI 1.03–1.89]; p=0.030); all adverse drug events were mild.

Conclusions:

Although EPs®7630 did not reduce symptom duration or antibiotic use significantly, EPs®7630 may contribute to lowering antibiotic use, by offering a well-tolerated alternative for acute bronchitis in primary care.

Points for discussion:

Does the pragmatic, open-label design strengthen or weaken the relevance of these findings for everyday primary care practice across different European health systems?

Should a non-significant reduction in antibiotic use, combined with higher but mild adverse events, be considered clinically meaningful when guiding primary care recommendations?

In the absence of statistically significant benefit, how should primary care clinicians interpret and communicate the potential role of herbal medicines such as EPs®7630 in antibiotic stewardship?