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NATURAL COUGH REMEDIES FOR CHILDREN CPD ACTIVITY 73 Zaheeda Patel Zaheeda has a background in community pharmacy with more than 12 years’ experience in the industry. Working as a regulatory scientist, she is an accredited pharmacist who enjoys conducting HMRs. Zaheeda has a keen interest in ensuring continuing education is developed at a high standard and is relevant to pharmacists practising in all areas of the industry. LEARNING OBJECTIVES After completing this CPD activity, pharmacists should be able to: • Describe the restrictions surrounding the sale of cough and cold preparations for children in Australia. • Identify which natural remedies for coughs have evidence to support their use in children. • Identify cough related symptoms in children that would require a referral. 2016 Competency Standards: 1.3, 2.1, 3.2, 3.5, 3.6. Accreditation Number: A2105RP1 (exp: 30/04/2023). Introduction Cough is a common complaint in children, usually caused by respiratory tract infections (RTIs). Young children may experience RTIs six to 12 times a year.1 In 2012, limitations were placed on the sale of cough and cold preparations in Australia after the Therapeutic Goods Administration (TGA) conducted a review of the use of cough and cold medicines in children.2 The review was aimed at investigating the safety and efficacy of these products in children aged two to 12 years and included antihistamines, antitussives, expectorants/ mucolytics and decongestants. The TGA concluded that there are potential risks when these products are used in children, with only limited benefits. Recommendations included that children under six years of age should not be given these cough and cold medicines, and children aged six to 11 years should be given them only on the advice of a doctor, pharmacist or nurse practitioner. Since this time, several natural cough remedies have arrived on the market, aimed at replacing the restricted products, with claims that they are much safer for younger patients. Some of these are supported by evidence for use in this age group, and others not. This article aims to compare the efficacy between some of these natural remedies, so that pharmacists can confidently recommend products for treatment and or symptom relief in this age group. Ivy leaf, English ivy Hedera helix Ivy leaf extract preparations are available over the counter in many pharmacies and are marketed as safe in most age groups. However, these should not be used in children under two years without medical advice. Ivy leaf extract preparations contain saponins, the main active compounds, which have expectorant properties. The clinical effects of ivy leaf have been examined in a number of studies, many of which included children who were suffering from upper respiratory tract infections (URTIs).3,4 In vitro studies of ivy leaf only containing products have shown evidence of potential antispasmodic and bronchodilating activity, anti-inflammatory effects and antitussive properties.3 Kruttschnitt et al3 studied the efficacy of ivy leaf extract EA 575 by comparing its efficacy and safety with acetylcysteine (ACC). EA 575 is a commercial extract of Hedera helix used in many products and has been the specific ivy leaf extract used in many studies over recent years. Kruttschnitt et al3 found patients who received EA 757 orally demonstrated a marked improvement in cough symptoms such as coughing fits, production of sputum, dyspnoea and severity of disease. When compared with the ACC group, the EA 575 group showed better improvement for dyspnoea during cough. It’s important to note, however, that these symptoms were assessed subjectively by the patient or parent during an interview with a physician, which may reduce the reliability of the findings in this study. Sierocinski, Holzinger and Chenot4 conducted a systemic review of clinical trials using ivy leaf mono or combination products from December 2009 to January 2020. The authors’ conclusions note that ivy preparations may lead to a marginal reduction in cough symptoms. The lack of robust methodologies used in the studies reduced the significance of these findings. Of the 10 trials and observational studies included in their review, they found that the risk of selection bias was high (inadequate descriptions of both the populations screened for eligibility and selection process) and overall quality of reporting was low. This could be due to the natural course of URTIs and bronchitis and the unlikelihood of high-quality large-scale trials being established. The safety profile of ivy leaf extract was well demonstrated, with the review concluding serious adverse reactions are unlikely to occur. Overall, these trials do show a favourable result for ivy leaf preparations to be used for treating coughs. Knowing that ivy leaf extract containing expectorant preparations have a good safety profile, pharmacists may choose to recommend these products for relief of chesty coughs in children over two years old. Black elderberry Sambucus nigra Berries of the black elder plant Sambucus nigra have a history of traditional use to treat cold and flu symptoms, including cough, nasal congestion and mucous discharge, as well as being used as an immune boosting agent.5 Elderberries contain anthocyanins, ascorbic acid and quercetin, which have been shown to boost immune function and exhibit antiviral affects.6 In vitro and in vivo studies have suggested the berries show antiviral activity against common URTIs, including the common cold and influenza.7 Hawkins et al7 conducted a meta analysis of randomised controlled clinical trials (RCTs) in 2019 and concluded that supplementation with a standardised elderberry extract is significantly more effective than placebo at reducing the duration and severity of upper respiratory symptoms. However, the total number of RCTs used for their analysis was small with only 180 total patients included in all trials studied, and of these only one study (Zakay-Rones et al, 1995) included children from five years of age (n = 60 in total). This suggests that although black elderberry has a long-established history of use, and has shown benefit in the adult population, large scaled controlled trials are needed to establish the safety and efficacy for the use of this ingredient in children. TO PAGE 74 RETAIL PHARMACY • MAY 2021 2 CPD CREDITS