Randomized controlled trial of erdosteine for acute cough in children with colds
Abstract
Background T h e prevalence of the common cold in children is high, v.ith 30% of cases exhibiting an acute cough, the most common complaint by parents. Erdosteine, a recently developed cough medicine, is available for children. Erdosteine has been reported to increase mucodliary clearance, act as an antioxidant and prevent bacterial adhesion.
Objective To assess the clinical improvement in acute cough in children \\lith a common cold taking erdosteine vs. a placebo.
Methods We conducted a doubleô€€¾blind, randomized, controlled trial at the Public Health Center of Gedongtengen, Yogyakarta with 140 children selected by a consecutive sampling method. Research subjects were randomized by computer program into two treatment groups, those receiving erdosteine therapy and those receiving a placebo. Both groups were monitored for 6 days. A scoring system was used to assess the improvement of acute cough symptoms and analyzed by Chi-square test.
Results No significant differences in basic characteristics, cough severity, or environment were found among the 140 children with common cold in the two groups. After 6 days of treatment, no significant difference in clinical improvement of acute cough was found between the erdosteine (65 subjects improved out of 70) and placebo groups (62/70),92.5% and 88.6%, respectively (P=0.382).
Conclusion Erdosteine was not more effective than the placebo for treatment of acute cough in children with common cold.
References
2. Hay AD, W ilson A, Fahey T, Peter TJ. T he duration of acute cough in pre-school children presenting to primary care: a prospective cohort study. Fam Prac. 2003;20:696-705.
3. Saunders NR, Tennis 0, Jacobson S, Gans M, Dick PT. Parents' responses to symptOms of respiratory tract infection in their children. CMAJ. 2003;168,25•30.
4. Massie]. Cough in children: when does it matter? Pediatr Res Rev. 2006;7,9-14.
5. Indonesian Health Ministry, Jakarta; 2004. p.1-3.
6. Olivieri D, Del Donno M, Casalini A, Dippolito R. Fregnan GB. Activity of erdosteine on mucociliary rransport in patients affected by chronic bronchitis.
7. Hosoe H, Kaise T, Ohmori K, lsohama Y, Kai H, Takahama K, et at. Mucolytic and antitussive effects of erdosteine. J Phann Pharmacol. 1999;51:959-66.
8. Braga PC, Dal Sasso M, Sala MF, Giannelle V. Effect of erdosteine and its metabolites on bacterial adhesiveness. Armeimittel• Forschung. 1999 ;49:344-50.
9. Hayashi KI, Hosoe H, Kaise T, Ohmori K. Protective effect of erdosteine against hypochlorous acid-induced acute lung injury and lipopolysaccharide-induced neutrophilic lung inflammation in mice. J Phann Pharmacol. 2000;52:1411-16.
10. Dal Sasso M, Culici M, Bianchi 1; Fonti E, Braga PC. Inhibitory effects of metabolite I of erdosteine on the generation of nitric oxide and peroxynitrite chemiluminescence by human neutrophils. Pharmacol. 2oo4;71:120-7.
11. T itti G, Lizzio A, Termini C, Negri P, Fazzio S, Mancini C. A controlled multicenter pediatric study in the treatment of acute respiratory tract diseases with the aid of a new specific compound, erdosteine (IPSE, Italian Pediatric Study Erdosteine). Int J Clin Pharmacol Ther. 2000;38:402-7.
12. Balli F, Bergamini B, Calistru P, Ciofu EP, Domenici R, Doros G, et al.C linical effects of erdosteine in the treatment of acute respiratory tract disease in children. Int J Clin Phannacol T her.2007;45:16-22.
13. Tolan RW & Nguyen MN. Rhinovirus infection. [cited on 2007 June 28] . Available from, http.f/www.emedicine .com! rhinovirus/topic2707.htm.
14. Braga PC, Zuccotti T, Oal Sasso MD. Bacterial adhesiveness: effects of the SH metabolite of erdosteine (mucoactive drug) plus clarithromycin versus clarithromycin alone. J Chemother. 2001;470:208-14.
15. Chang AB. T he physiology of cough. Pediatr Res Reviews. 2006;7:2-8.
16. Zhu Z, Tang WL, Gwaltney JM, Elias JA. Rhinovirus stimulation of interleukin-8 in vivo and in vitro-role of NF-kappa. Am J Physiol. 1997 ;17:814-24.
17. Kaul P, Singh I, T umer RB. Effect of nitric oxide on rhinovirus replication and virus􀃉induced interleukin-8 elaboration.A m J Respir Crit Care Med. 1999;159:1193-8.
18. Yoon Y), Jin HS, Yong KS, Eun SH, Chung SL. Depressant effects of ambroxol and erdosteine on cytokine synthesis, gmnule enzyme release, and free radical production in rat alveolar macrophages activated by lipopolysaccharide. J Pharmacol Toxic. 2003;92:173-9.
19. Stanea VL, Stanciu LA, Message SD, Edwards MR, Gem JE, Johnston SL. Rhinovirus replication in human macrophages induces NF'KB􀂘de pendent tumor necrosis factor alpha production. J Virol. 2006;80:8248-58.
20. Turner RB. New considerations in the treatment and prevention of rhinovirus infections. Pediatr Ann. 2005;34:53-7.
21. Schroeder K, Fahey T. Over,the,counter medications for acute cough in children and adults in ambulatory settings. [Cochrane review]. In: T he Cochrane Library, Issue 4. Oxford, Update Software; 2004.
22. Schroeder K, Fahey T. Should we advise parents to administer over the counter cough medicine for acute cough? Systematic review of randomized controlled trials. Arch Dis Child. 2002;86:170-5.
23. ChangAB, Landau LI, Van Asperen Pp, Gl sgow NJ, Robert;on CF, Marchant JM, et al. Cough in children: definitions and clinical evaluation. Med J Aust. 2006;184:398-403.
Authors who publish with this journal agree to the following terms:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
Accepted 2016-10-13
Published 2011-04-30