We recruited patients from 20 GP practices in southern England. We included adults aged 18 years and over, presenting to their GP with an acute cough (≤21 days’ duration) as their main symptom, and with symptoms localising to the lower tract (e.g. sputum, chest pain, dyspnoea, wheeze). This illness definition has been used in other studies in this population [ 6, 34]. We excluded patients with suspected pneumonia on the basis of focal chest signs (focal crepitations, bronchial breathing) and systemic features (severe breathlessness, high fever, vomiting, severe diarrhoea), patients with serious illness who required hospital admission, exacerbations of COPD, serious comorbidities, and pregnant women (or at risk of pregnancy – defined as any woman of reproductive age not using the combined oral contraceptive pill, a hormonal intrauterine device, a hormonal contraceptive injection, or a subcutaneous hormonal implant). Not required as per article 16 c (1) (a) (iii) of Directive 2001/83/EC as amended. 5.2 Pharmacokinetic properties Baars EW, Zoen EBV, Breitkreuz T, Martin D, Matthes H, Schoen-Angerer TV, et al. The Contribution of Complementary and Alternative Medicine to Reduce Antibiotic Use: A Narrative Review of Health Concepts, Prevention, and Treatment Strategies. Evidence-based Complementary and Alternative Medicine. 2019;2019 (no pagination).

Our results suggest that progression to a full randomised phase III trial is feasible. The feasibility trial has identified some key modifications which will be needed. It would be easier to choose only one formulation to test (liquid or tablet). Although most patients reported that they would prefer tablets, the Cochrane review [ 30] suggested that the liquid may be more effective. If the liquid is to be taken into a full trial, a more convenient dosage method may need to be provided as many patients struggled accurately to count 30 drops per dose. If a full study uses both liquid and tablet preparations, we would need to adapt the design to prevent imbalance in the antibiotic use. This could be achieved by individual randomisation (tablet/liquid/active/placebo) or through stratification of practices according to prior antibiotic prescribing history. Pelargonium sidoides are generally meant for short-term use, which is no longer than five to seven days at most. The supplements and remedies are readily available online and at many local health-food stores. The Bottom LineWe explored several possible outcome measures for clinical effectiveness (Table 3). “Duration of symptoms rated as moderately bad or worse” was used in the largest clinical trial of treatment for acute bronchitis [ 6]. The “last day” definitions allow for the possibility that the illness may fluctuate in severity over the 28-day period and the “first day” definitions do not. Therefore, the last day will tend to be later than or equal to the first day. “Proportion of patients with symptom resolution at day 7” was used in the Cochrane review [ 30]. Statistical methods In single cases, signs indicating disturbances of liver function have been reported after the intake of Kaloba; the causal relationship between this effect and the use of the product has not been demonstrated. No studies have been conducted on the effects on trafficability and ability to operate machinery. How should the medicine be taken? Feasibility outcomes were: recruitment rate, withdrawal rate from the study, return rate of patient diaries, percentage of completion of patient diaries, compliance with medication according to diary data and returned medication, type of antibiotic prescription given (i.e. immediate/delayed/not given), percentage of patients who took antibiotics, time to antibiotic usage, mean symptom severity (at days 2–4), percentage of patients resolved, time to resolution of symptoms and duration of treatment with herbal medication. The minimum key outcome dataset from the diaries was considered to be [ 1] antibiotic use in the 28 days post randomisation, [ 2] no longer experiencing moderate symptoms for two consecutive days and [ 3] study medication use. A health economic study was a part of the feasibility study which aimed to develop the methods of data collection both for quality of life and for usage of key resources for the design of the future phase III trial.

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or do not intend to take/use any other medicines. Kaloba is a herbal medicinal product made from Pelargonium root (Pelargonii radix) (Capeland Pelargonium) for the symptomatic treatment of acute bronchial infections with cough and mucus production. In very rare cases (≤ 1/10,000) serious hypersensitivity reaction with swelling of the face, dyspnoea and drop in blood pressure may occur.

5 Pharmacological properties

Tell your doctor or pharmacist if any of the above side-effects becomes serious or if you notice any other side-effects not listed above. a

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or healthcare practitioner. Possible side-effects

In single cases, signs indicating disturbances of liver function have been reported after intake of Kaloba; the causal relationship between this effect and the use of the product has not been demonstrated. Several strategies have attempted to reduce inappropriate use of antibiotics. “Delayed” prescriptions (which patients are advised to take only if they are not starting to improve after a certain time) reduce consumption of antibiotics while maintaining patient satisfaction [ 9], but many patients would still like to take medication to relieve their symptoms because a moderately bad cough is known to persist for around three weeks on average [ 6, 10]. Commonly recommended treatments like steam and ibuprofen make little or no difference to symptom severity [ 11]. Other potential symptomatic treatments in adults (the expectorant guaifenesin, mucolytics and antihistamine-decongestant combinations) have not been shown to have consistent benefit in a recently updated Cochrane systematic review [ 7]. In the UK, the National Institute for Health and Care Excellence (NICE) suggests that some people may wish to try Pelargonium as a “self-care treatment”, which has “limited evidence of some benefit for the relief of cough symptoms” [ 32]. There is currently sufficient evidence to recommend the use of Pelargonium sidoides root extract to warrant undertaking a high quality independent clinical trial.

The use in children under 6 years of age is not recommended (see section 4.4 “Special warnings and precautions for use”.)

Possible side-effects

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted. 4.9 Overdose