Abstract
ObjectiveFever is a very common adaptive immune response in acute respiratory tract disorders during infancy. Antipyretic / analgesic drugs such as paracetamol (acetaminophen) are widely used to improve the comfort of the child but may cause medically unneeded antipyresis and rare but potentially serious side effects. We assess whether treatment with Pelargonium sidoides extract EPs 7630 reduces the administration of paracetamol in children with acute tonsillopharyngitis (ATP) or acute bronchitis (AB).DesignMeta-analysis of randomised, placebo-controlled clinical trials.MethodsWe searched clinical trial registries (ISRCTN, ClinicalTrials.gov) and medical literature (MEDLINE, EMBASE), for randomised, placebo-controlled trials investigating the administration of EPs 7630 to children with ATP or AB and reporting the co-administration of paracetamol. Based on the individual participant data of the eligible trials, study populations were characterized according to sex and age, and meta-analyses were performed for cumulative paracetamol use and ability to attend school at treatment end.ResultsSix trials including a total of 523 children aged 6–10 years (EPs 7630: 265; placebo: 258) and suffering from non-β-hemolytic streptococcal ATP (3 trials) or from AB (3 trials) were identified and eligible. Children received EPs 7630 or placebo for 6 (ATP) or 7 days (AB). Compared to placebo, EPs 7630 reduced the cumulative dose of paracetamol in 5 out of the 6 trials, by an average of 244 mg (Hedges’ g; − 0.28; 95% confidence interval: [− 0.53; − 0.02]; p < 0.03). At treatment end, 30.2% (EPs 7630) and 74.4% (placebo) of the children were still unable to attend school (risk ratio: 0.43; 95% confidence interval: [0.29; 0.65]; p < 0.001).ConclusionsIn children aged 6–10 years with AB or ATP, EPs 7630 alleviated the symptom burden and accelerated recovery. Although EPs 7630 has no known antipyretic effect, concomitant use of paracetamol was reduced.
Highlights
Fever is among the most common symptoms in children consulting a paediatrician and has been estimated to account for about one third of all presenting conditions [1, 2]
EPs 7630 reduced the cumulative dose of paracetamol in 5 out of the 6 trials, by an average of 244 mg (Hedges’ g; − 0.28; 95% confidence interval: [− 0.53; − 0.02]; p < 0.03)
In this paper we present the results of a meta-analysis of randomised, placebo-controlled trials performed to investigate whether treatment with EPs 7630 may reduce the co-administration of paracetamol in children suffering from acute tonsillopharyngitis (ATP) or acute bronchitis (AB)
Summary
Fever is among the most common symptoms in children consulting a paediatrician and has been estimated to account for about one third of all presenting conditions [1, 2]. While there is no evidence that antipyresis reduces the duration of diseases [8], or that children with fever are at an increased risk of adverse outcomes [2], studies indicate overwhelmingly that the use of antipyretic drugs may prolong illness, may adversely affect clinical outcome during infection, and may even increase mortality in critically ill patients [4, 9,10,11]. The administration of antipyretic drugs may mask important clinical signs of a patient’s condition [12]. A contributing factor to antipyretics overuse in children is the still widespread misconception of parents that fever is a disease rather than a symptom or sign of illness [1]. It is important to note, that the drugs most commonly used for antipyresis, such as paracetamol (acetaminophen), acetylsalicylic acid, and ibuprofen, have an antipyretic, and an analgesic effect, and that their beneficial effect on the child’s well-being has been shown to be mainly attributable to their analgesic rather than to the antipyretic action [2, 4]
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