Bao Y, Gao Y, Koch E, Pan X, Jin Y, Cui X. Evaluation of pharmacodynamic activities of EPs(R) 7630, a special extract from roots of Pelargonium sidoides, in animals models of cough, secretolytic activity and acute bronchitis. Phytomedicine. 2015;22(4):504–9. While most patients taking tablets did not notice a particular taste, half of the participants taking the liquid noticed a particular taste which was described as “ bitter –sour”, “ unusual fruity”, “ like it was a root extract… very organic … a nice change”, “ mildly strange”, “ something like Bach’s flowers rescue remedy”, “ evil and gross”. Patients were asked whether they thought they had taken the real trial medicine or the placebo. About a third of patients thought they might have had the real medicine (because of the unusual taste, because they felt better, or had an adverse effect). About a third of patients thought they might have had the placebo (because they did not feel any improvement in their symptoms). Seven patients had no idea and could not tell either way. Three patients had not understood that they could be given a placebo. “ I am a bit worried about this dummy business. Are you saying you are giving some people pills that you know don’t work?”. Overall blinding appeared to be successful in the 29 patients included in the qualitative study – only 50% of those on active liquid, and fewer than 50% in the other groups, correctly guessed their allocation, no more than would be expected by chance. Almost all based their guess on whether or not they felt they had improved, rather than on the appearance or taste of the medicine. Kaloba is one of the few herbal cold remedies on the market that contains Pelargonium. Pelargonium sidoides is a member of the geranium family, which has long stalked leaves that are mildly aromatic, heart shaped and velvety. This formulation is not suitable for children under 12 years of age. 4.5 Interaction with other medicinal products and other forms of interaction

The extract (EPs® 7630) used in the herbal medicinal product (Kaloba® manufactured by Dr. Willmar Schwabe GmbH & Co. KG, Germany) is classified by the European Pharmacopoeia as “other extract” and therefore not adjusted to a particular content of constituents. Independent of this formal classification, the constituents of this herbal active ingredient have been described in detail [ 36]. Approximately 80% m/m of the extract are assigned to six major groups of constituents, oligomeric prodelphinidines (commonly designated in this context as polyphenols) being the most significant group (approximately 40% of the dried extract).Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions Limitations included a delay of up to 3 months between patients completing the trial and the qualitative interview, so some interview participants could not recall all details. When asking patients whether they preferred liquid or tablets in the qualitative interviews, each patient had only tried one of these options. They were not aware that the Cochrane review [ 30] suggests that the liquid may be more effective than tablets; knowing this may have changed their responses. Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed. 6 Pharmaceutical particulars 6.1 List of excipients If you take more than the recommended dose, speak to your doctor, pharmacist or healthcare practitioner and take this leaflet with you. If you forget to take this product Conrad A, Jung I, Tioua D, Lallemand C, Carrapatoso F, Engels I, et al. Extract of Pelargonium sidoides (EPs 7630) inhibits the interactions of group A-streptococci and host epithelia in vitro. Phytomedicine. 2007;14(Suppl 6):52–9.

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.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. Consult a doctor immediately if your condition does not improve within one week, in case of fever lasting for several days or in case of shortness of breath or blood in the sputum. 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). Tell your doctor or qualified healthcare professional if you notice any other side-effect. After taking this product

Herbal medicine is another option for relieving symptoms and so reducing inappropriate use of antibiotics [ 12]. Qualitative research has shown that herbal medicine is widely used and accepted as a viable option for treatment of mild respiratory infections, especially by ethnic minorities, but very few studies have included white Caucasian adults [ 13, 14, 15, 16]. Many patients feel that they need trustworthy advice on whether to use alternative treatments, which to use, and when [ 17]. If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted. 4.3 Contraindications Familiarization: repeated readings of transcripts and listening to recordings assisted familiarisation with the data, identification of initial codes and interesting pieces of data Willcox M, Donovan E, Hu X-Y, Elboray S, Jerrard N, Roberts N, et al. Views regarding use of complementary therapies for acute respiratory infections: systematic review of qualitative studies. Complementary Therapies in Medicine. 2020;50:102382.Round, reddish-brown, smooth surface film coating without ruptures. 4 Clinical particulars 4.1 Therapeutic indications Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or “Kaloba®”, is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design