Literature searches identified a total of 52 records, one of which was a duplicate. Among the 51 remaining publications and registry entries, 42 were excluded during screening for reasons indicated in Figure 1. For meta-analysis, data on cough intensity as rated by the investigator was sought from the rating scale that was most commonly used across the eligible studies. For AB, data on cough severity for our analysis therefore derived from the applicable item of the investigator-rated Bronchitis Severity Scale (BSS). For CC, information on cough derived from the observer-rated Cold Intensity Score (CIS). Both items rate the severity of cough on a verbal rating scale ranging from 0 (‘absent’) to 4 points (‘very severe’). Day 7 had previously been identified as the most commonly reported time point of pre-defined day of follow up in most ARTIs [ 29, 31]. We therefore considered absolute intraindividual score change of the severity of cough at day 7 compared to baseline the most appropriate outcome in AB. In the subset of CC trials, day 5 was considered relevant in accordance with earlier research [ 35]. Moreover, the proportions of participants with complete remission of cough as well as with an at least 50% cough score reduction as compared to baseline were determined for those patients reporting cough at baseline. For analysis of disease-related quality of life (QoL), we also sought data from the rating scale that was most commonly used across eligible studies. We therefore analyzed health-related QoL as assessed by means of the European Quality of Life 5 Dimensions 3 Level (EQ-5D-3L) questionnaire, a descriptive system that comprises the 5 dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each of which is self-rated on a 3-point scale ranging from 1 (no problems) to 3 (extreme problems) [ 37]. In trials performed in children and adolescents, EQ-5D-3L was not assessed. We therefore analyzed data derived from the Children’s Health Status Questionnaire [Fragebogen zum Gesundheitszustand fur Kinder (FGK)] [ 38], a 6 item QoL questionnaire. By means of this questionnaire, participants of the studies or their caregivers were asked to rate each of the items (‘Everything is too much for me’, ‘I am feeling ill’, ‘I am scared’, ‘I have trouble playing or learning’, ‘I sleep badly’, ‘I have problems getting into conversation with others’) on a scale ranging from 1 to 5 points with values being represented by verbalizations (‘not at all’ through ‘very distinctive’) as well as by matching pictograms of faces. There were no significant differences found for mean symptom scores (cough, cough frequency, symptoms associated with cough, night-time cough or the frequency of taking cough medicines), and the outcomes of little or no improvement at 7 to 14 days, severe symptoms at 11 days, and adverse effects (hoarseness) during the treatment period (very low quality evidence).

Gastro-intestinal complaints such as stomach pain, heartburn, nausea, vomiting, difficulty swallowing (dysphagia) or diarrhoea. Rare side-effects (affecting more than 1 in 10,000 but fewer than 1 in 1000 people) Dextromethorphan was no more effective than placebo (in 4 RCTs) or diphenhydramine (in 1 RCT) in reducing various cough outcomes in children with an acute cough, a night cough or an upper respiratory tract infection (very low quality evidence). In 2 RCTs, there were no differences between the groups in adverse effects, which were generally mild. In another RCT, adverse events (mainly gastrointestinal and dizziness) were reported in 34% of the dextromethorphan group and 5% of the placebo group (p value not reported). A. In the case of geranium essential oil, you can dilute it with a carrier oil like sesame oil and apply it to the skin. It works well for spot treatments, itchy skins, acne. In addition, you can use it as a massage oil. However, some carrier oils cause an allergic reaction. Therefore, you should ensure that the carrier oil you’re using suits your skin. Q. Do Pelargonium sidoides help in treating common colds?Honey was well tolerated in the studies, and is readily available. However, it should not be given to children under 1 year of age because of concerns about infant botulism. It also contains sugars, and the committee discussed concerns about tooth decay. A. Geranium tea is also known as pelargonium sidoides tea. You can prepare it using dried or fresh leaves of the herb pelargonium sidoides. Based on Smith et al. (2014), a systematic review including 3 RCTs of adults and young people over 12 years with an acute cough or upper respiratory tract infection.

This medicinal product does not require any special storage conditions. 6.5 Nature and contents of container Based on evidence, the committee agreed that that limited evidence suggests that honey may have some benefit on cough symptoms and people over 1 year of age may wish to try this for the treatment of acute cough. However, honey did not reduce the frequency and severity of cough at 1 day follow-up compared with an antitussive (dextromethorphan; very low quality evidence). In the studies, honey was given as a single 10‑g dose in 1 trial, and 2 trials reported that honey was given before bedtime. A range of types of honey were used, with no studies using the same variety. Clemastine for 3 days was no more effective than placebo or chlorpheniramine in reducing cough scores in 1 RCT of children under 5 years with a common cold (very low quality evidence). Drowsiness and sleepiness was reported in 20% of children, with no difference between groups (p values not reported).

9. Date of first authorisation/renewal of the authorisation

Christ-Crain M, Jaccard-Stolz D, Bingisser R, et al. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004;363(9409):600-607. Do not use this product after the expiry date. Return any out-of-date product to your pharmacist who will dispose of it for you. The expiry date is printed on the box and also the bottle label. Metlay JP, Kapoor WN, Fine MJ. Does this patient have community-acquired pneumonia? Diagnosing pneumonia by history and physical examination. JAMA. 1997;278(17):1440-1445.

See the summaries of product characteristics for information on contraindications, cautions and adverse effects of individual medicines. It’s important to continue treatment for 3 days after symptoms have resolved to prevent a relapse. Pelargonium safety This product is a traditional herbal medicinal product containing Pelargonium sidoides DC root dried extract. 100g (=93.985 ml) syrup contain 0.2506g dried liquid extract from the roots of Pelargonium sidoides DC (EPs ® 7630).

5. Pharmacological properties

See the BNF for children for appropriate use and dosing in specific populations, for example, hepatic impairment and renal impairment. Trials A through C performed in the indication AB included a total of 719 children and adolescents, 412 of whom received EPs 7630. Cough intensity at baseline was comparable for EPs 7630 and placebo, with a meta-analysis difference of 0.04 points; 95% confidence interval, 95% CI: -0.04, 0.13 points on a 5- point scale. The main results of the meta-analysis for change in cough intensity between baseline and day 7 are shown in Figure 2. The reduction in cough intensity was significantly more pronounced in participants randomized to EPs 7630 across all trials (point estimate for difference: 0.6 points) as well as in the single trials A, C, and in the 3 x 30 mg/d group of trial B. Substantial heterogeneity between the trials was attributable to differences between the effect sizes for the individual treatment comparisons - all of which favored EPs 7630 - and not differences regarding the direction of the effect. Confidence intervals for the point estimates in trial B were wider than those for trials A and C because the placebo group of trial B had to be split to enable the comparison for the two different dosages of EPs 7630. Across all trials, 328/412 (79.6%) children and adolescents treated with EPs 7630 and 126/307 (41.0%) in the placebo group showed a reduction in the cough intensity score by at least 50% of the baseline value [meta-analysis rate/risk ratio (RR), EPs 7630 / placebo: 1.86; 95% CI: 1.34, 2.59], and 74/412 (18.0%) and 17/307 (5.5%) presented with complete remission of cough (RR: 2.91; 95% CI: 1.26, 6.72). Kaloba Pelargonium Cough & Cold Relief syrup is an orange to light brown syrup. However it is a natural product and therefore slight variations in colour and taste may occur. This product also contains the following ingredients: Experience in Germany suggests that Pelargonium sidoides extracts are safe, with 1 in 189,000 patients experiencing a side effect during an average treatment period of 10 days. A few reports of potential liver problems were found to relate to other causes.

Viral acute respiratory tract infections (ARTIs) are the most prevalent diseases in primary care, regardless of patient age and sex [ 1-3]. In ARTIs such as acute bronchitis (AB) and the common cold (CC), cough is a leading symptom [ 4], causing over 50% of new patient attendance in primary care and being the major source of consultation in pharmacies [ 5-7]. Antibiotics (erythromycin, cefuroxime, doxycycline or co-amoxiclav) did not significantly reduce the number of adults and children with acute bronchitis without improvement at physician follow-up compared with placebo (very low quality evidence). When a subgroup of people with non-purulent tracheo-bronchitis from an upper respiratory tract infection study was omitted, antibiotics were significantly better than placebo (5 RCTs, n=816, 7.7% versus 17.6%; NNT 11 [7 to 19]; moderate quality evidence). However, only 1 RCT in this analysis of cefuroxime versus placebo (accounting for 35.5% of the weight in the meta‑analysis) showed a significant improvement compared with placebo. Subsequent or excessive intake of pelargonium sidoides might lead to liver injury. According to a surveillance study from Germany in 2016, pelargonium sidoides was among the five herbs suspected to be the cause of liver toxicity when used for medicinal purposes. The other four herbs included were peppermint (Mentha piperita), valerian (Valeriana), Tasmanian blue gum (Eucalyptus globulus) and St. John’s wort (Hypericum perforatum). Therefore, it’s best to avoid these herbs if you’re suffering from liver disease, are on medication mobilised by the liver or are an alcohol addict. Honey significantly reduced bothersome cough by about 2 points on a 7‑point Likert scale compared with placebo (moderate quality evidence), but not compared with no treatment or dextromethorphan (low quality evidence). Based on experience, the committee agreed that people with acute cough who present with any symptoms or signs suggesting a more serious illness or condition (for example, sepsis, a pulmonary embolism or lung cancer) should be referred to hospital, or specialist advice should be sought on further investigation and management.Macrolides should be used with caution in people with a predisposition to QT interval prolongation. Nausea, vomiting, abdominal discomfort, and diarrhoea are the most common side effects of macrolides. These are less frequent with clarithromycin than with erythromycin ( BNF, December 2018). Paul IM, Yoder KE, Crowell KR, et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics. 2004;114(1):e85-e90. 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 Yale SH, Liu K. Echinacea purpurea therapy for the treatment of the common cold: a randomized, double-blind, placebo-controlled clinical trial. Arch Intern Med. 2004;164(11):1237-1241.