Efficacy and safety of the syrup “KalobaTUSS®” as a treatment for cough in children: a randomized, double blind, placebo-controlled clinical trial

Carnevali, Ilaria; Paglia, Rita La; Pauletto, Laura; Raso, Floriana; Testa, Marco; Mannucci, Carmen; Sorbara, Emanuela Elisa; Calapai, Gioacchino

doi:10.1186/s12887-020-02490-2

Cited by 11 publications

(8 citation statements)

References 26 publications

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“…Paulsen [30], in agreement with Amorim [31], later cautioned towards the systemic allergic dermatitis associated with SL-containing plants in general, while emphasising the need to determine the pathogenesis of haptens, associated with the plant species, more specifically. Clinical data for the herb is limited, with one randomised, double-blind, placebo-controlled clinical trial documented for a cough syrup (KalaboTUSS ® ), which proved to be safe and efficacious [32]. Regarding isolated compounds, there are conflicting reports of sensitization [33][34][35] and opposing anti-allergenic properties [36,37].…”

Section: Traditional Use To Modern Researchmentioning

confidence: 99%

From Monographs to Chromatograms: The Antimicrobial Potential of Inula helenium L. (Elecampane) Naturalised in Ireland

et al. 2022

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With antimicrobial resistance rising globally, the exploration of alternative sources of candidate molecules is critical to safeguard effective chemotherapeutics worldwide. Plant natural products are accessible, structurally diverse compounds with antimicrobial potential. The pharmacological applications of plants in medicine can be guided by the attestation of traditional use, as demonstrated in this study. In Irish ethnomedical literature, Inula helenium L. (elecampane) is often indicated for respiratory and dermal ailments. This is the first assessment of antimicrobial sesquiterpene lactones from the roots of elecampane, naturalised in Ireland. Traditional hydro-ethanolic extracts were prepared from multi-origin elecampane roots. A novel clean-up strategy facilitated the bioactivity-guided fractionation of a subset of anti-staphylococcal fractions (the compositions of which were investigated using HPLC-DAD, supported by 1H NMR). The natural products attributing to the antimicrobial activity, observed in vitro, were identified as alantolactone (1), isoalantolactone (2), igalan (3), and an unseparated mixture of dugesialactone (4) and alloalantolactone (5), as major compounds. The findings suggest that the geographical origin of the plant does not influence the anti-bacterial potency nor the chemical composition of traditional elecampane root. Considering the prevalence of staphylococci-associated infections and associated broad spectrum resistance in Irish hospitals, currently, further research is warranted into the usage of the identified compounds as potential candidates in the control of staphylococcal carriage and infection.

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Section: Traditional Use To Modern Researchmentioning

confidence: 99%

From Monographs to Chromatograms: The Antimicrobial Potential of Inula helenium L. (Elecampane) Naturalised in Ireland

et al. 2022

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“…MDMSs are often used to treat coughs in children, and some data are present in the literature (Canciani et al, 2014;Cohen et al, 2017;Carnevali et al, 2021). Acute cough associated with upper respiratory tract infections is a frequent cause of distress and sleep disturbance, and the reason for many paediatric visits and drug prescriptions.…”

Section: Medical Device Made Of Substances In Paediatricsmentioning

confidence: 99%

“…Acute cough associated with upper respiratory tract infections is a frequent cause of distress and sleep disturbance, and the reason for many paediatric visits and drug prescriptions. MDMSs seem to be effective and safe in reducing acute and persistent cough in children, leading to a reduction in the use of specific drugs in this age group (Canciani et al, 2014;Cohen et al, 2017;Carnevali et al, 2021).…”

Section: Medical Device Made Of Substances In Paediatricsmentioning

confidence: 99%

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Stagi

2022

Front. Drug Saf. Regul.

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Paediatricians are often called on to weigh up potential side effects and interferences associated with drug treatments. Ethical concerns often prevent clinical trials in children, meaning that specific data for the paediatric population can be lacking. This is true for pharmacological therapies and also natural remedies used as add-on therapy. Among natural health products are “medical devices made of substances” (MDMS) which have become increasingly important in the treatment of many disorders; the substances contained in MDMSs frequently consist of molecular structures present in a standardized preparation derived from a natural source which act as a “system.” The benefits of using MDMSs to treat paediatric conditions such as gastrointestinal disorders and obesity have been proven, although there remains a degree of uncertainty about the precise mechanism of action underlying their therapeutic effectiveness. This paper argues in favour of using MDSMs when there is scientific grounds to prove their efficacy.

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“…The safety and efficacy of a pediatric cough syrup KalobaTUSS ® , which consists of acacia honey and extracts from Inula helenium L., M. sylvestris , Helichrysum stoechas (L.) Moench and Plantago major L. have been evaluated in a randomized controlled trial [ 20 ]. One hundred and six children with persistent cough were recruited for the study and were treated with cough syrup or a placebo at four times, 5 mL doses daily for eight days.…”

Section: Food Supplements and Childhood Illnessesmentioning

confidence: 99%

Beneficial Effects of Plant Extracts and Bioactive Food Components in Childhood Supplementation

et al. 2021

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The pivotal role of childhood nutrition has always roused a growing interest from the scientific community. Plant extracts and bioactive dietary components play a significant role in the maintenance of human health and wellness, with the potential to modulate risk factors and manage symptoms for a large number of common childhood disorders such as memory impairment, respiratory illnesses, gastrointestinal disorders, metabolic derangements, and pathologies related to the oral cavity. This review is designed to highlight the health benefits of botanical extracts and bioactive dietary components in children as evidenced by clinical trials, considering their safety with regards to childhood sensibilities. The supplementation of children with the herbal extracts or bioactive components mentioned in this review leads to the conclusion that they are useful for treating various ailments, with no serious adverse events being reported. However, for the limited number of investigations specifically focused on the safety of such products in children, time is needed to expand the literature data covering the safety of childhood supplementation with botanical extract and bioactive food components.

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Efficacy and safety of the syrup “KalobaTUSS®” as a treatment for cough in children: a randomized, double blind, placebo-controlled clinical trial

Cited by 11 publications

References 26 publications

From Monographs to Chromatograms: The Antimicrobial Potential of Inula helenium L. (Elecampane) Naturalised in Ireland

From Monographs to Chromatograms: The Antimicrobial Potential of Inula helenium L. (Elecampane) Naturalised in Ireland

Medical Devices Made of Substances: The Need for a Change in Approach in Paediatrics

Beneficial Effects of Plant Extracts and Bioactive Food Components in Childhood Supplementation

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