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. 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 Reporting of side-effects Conrad A, Hansmann C, Engels I, Daschner FD, Frank U. Extract of Pelargonium sidoides (EPs 7630) improves phagocytosis, oxidative burst, and intracellular killing of human peripheral blood phagocytes in vitro. Phytomedicine. 2007;14(Suppl 6):46–51. 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.

Roth M, Fang L, Stolz D, Tamm M. Pelargonium sidoides radix extract EPs 7630 reduces rhinovirus infection through modulation of viral binding proteins on human bronchial epithelial cells. PLoS One. 2019;14(2):e0210702. Kaloba is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines Transcripts were analysed using inductive thematic analysis, following the framework approach [ 37]. The transcripts were compared within and between each other to search for themes, which were then reviewed, defined and named. The analysis followed three key steps: Gastro-intestinal complaints such as stomach pain, heartburn, nausea, vomiting, difficulty swallowing (dysphagia) or diarrhoea.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. MLW: Conceptualisation, funding acquisition, investigation, methodology, formal analysis, supervision, writing – original draft, review and editing. CS: investigation, methodology, project administration, resources, supervision, validation, visualisation, writing – review and editing. SW: Formal analysis, writing – review and editing. BLS: Conceptualisation, Formal analysis, methodology, software, visualisation, writing – original draft, review and editing. DS: Investigation, project administration, formal analysis, writing – review and editing. AW: Conceptualisation, Methodology, software, Formal analysis. AM: project administration, investigation. EW: Data curation. SZ: Formal analysis (health economics), writing – original draft, review and editing. GY: Formal analysis (health economics), writing – review and editing. FW: Funding acquisition, supervision, writing – review and editing. RY: investigation, writing – review and editing. JB: PPI contributor, conceptualisation, writing – review and editing. MB: PPI contributor, conceptualisation, writing – review and editing. GG: Conceptualisation, methodology, supervision, writing – review and editing. GL: methodology, supervision, writing – review and editing. PL: Conceptualisation, methodology, writing – review and editing. CB: Conceptualisation, methodology, writing – review and editing. ADH: Conceptualisation, methodology, writing – review and editing. MM: Conceptualisation, Funding acquisition, methodology, project administration, supervision, writing – review and editing. The author(s) read and approved the final manuscript. Corresponding author However, due to the potential effect of Kaloba on coagulation parameters, this product may enhance the effect of coagulation-inhibiting drugs such as warfarin and should not be taken concomitantly with these drugs. (see section 4.3). 4.6 Pregnancy and lactation 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).

Schoetz K, Erdelmeier C, Germer S, Hauer H. A detailed view on the constituents of EPs® 7630. Planta Med. 2008;74(06):667–74.Joos S, Glassen K, Musselmann B. Herbal medicine in primary healthcare in Germany: the Patient's perspective. Evid Based Complement Alternat Med. 2012;2012:10. A detailed statistical analysis plan was developed prior to the analysis. All analyses were conducted using STATA version 15 [ 35]. We aimed to present descriptive feasibility data rather than to test hypotheses and patients were analysed as randomised. Health economic methods Although patients suggested changes to the severity of illness rating scale and to the EQ-5D-5L, it will not be possible to make these changes in future trials because these scales are only validated in their current format. Restrictions on which type of contraception were used by women were stringent and were misunderstood by some of the GPs enrolling patients. Implications for further research 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].

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]. Costelloe C, Metcalfe C, Lovering A, Mant D, Hay AD. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ (Clinical research ed). 2010;340:c2096. This is the first feasibility trial to be conducted on the use of a herbal medicine for acute bronchitis in UK primary care. A strength of this trial is the use of both quantitative and qualitative methods to explore several feasibility aspects. The trial was not powered to detect effectiveness, so we are unable to comment on the effectiveness of the herbal medicine. However, there was no evidence of any serious side-effects due to the intervention and the patient withdrawal rate was low. Although the study was only open for 9 months as opposed to the 12 months initially planned, we recruited at a faster rate than anticipated.

10 Date of revision of the text

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. Whitehead A, Simpson C, Willcox M, Webley F, Hay AD, Butler C, et al. HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial. Pilot and Feasibility Studies. 2019;5(1):98. Goossens H, Ferech M, Vander Stichele R, Elseviers M. Outpatient antibiotic use in Europe and association with resistance: a cross-national database study. Lancet (London, England). 2005;365(9459):579–87. 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. 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.

This formulation is not suitable for children under the age of 12 years. If you take too much of this product (overdose) Serious hypersensitivity reactions with swelling of the face, breathlessness and drop in blood pressure. Dosage: oral drops can be taken directly from a spoon or mixed with half a glass of water. The entire contents of the glass should be drunk straight away film-coated tablet contains 20 mg of extract (as dry extract) from the roots of Pelargonium sidoides DC (1 : 8 - 10) (EPs® 7630) Extraction solvent 11% ethanol (w/w). Unfortunately, it proved very difficult to interview patients who did not agree to participate in the trial. The two non-participants explained that they were both initially willing to participate, but one was not eligible and the second declined due to potential side effects (headaches), imminent holiday plans and she was not keen to commit to filling in a daily diary.We 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 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.