Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Meta-Analysis
. 2014 Mar 10;2014(3):CD006088.
doi: 10.1002/14651858.CD006088.pub4.

Over-the-counter (OTC) medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults

Christina C Chang  1 , Allen C Cheng, Anne B Chang
Affiliations
Meta-Analysis

Over-the-counter (OTC) medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults

Christina C Chang et al. Cochrane Database Syst Rev. .

Abstract

Background: Cough is often distressing for patients with pneumonia. Accordingly they often use over-the-counter (OTC) cough medications (mucolytics or cough suppressants). These might provide relief in reducing cough severity, but suppression of the cough mechanism might impede airway clearance and cause harm.

Objectives: To evaluate the efficacy of OTC cough medications as an adjunct to antibiotics in children and adults with pneumonia.

Search methods: We searched CENTRAL 2013, Issue 12, MEDLINE (January 1966 to January week 2, 2014), OLDMEDLINE (1950 to 1965), EMBASE (1980 to January 2014), CINAHL (2009 to January 2014), LILACS (2009 to January 2014) and Web of Science (2009 to January 2014).

Selection criteria: Randomised controlled trials (RCTs) in children and adults comparing any type of OTC cough medication with placebo, or control medication, with cough as an outcome and where the cough is secondary to acute pneumonia.

Data collection and analysis: We independently selected trials for inclusion. We extracted data from these studies, assessed them for methodological quality without disagreement and analyzed them using standard methods.

Main results: There are no new trials to include in this review update. Previously, four studies with a total of 224 participants were included; one was performed exclusively in children and three in adolescents or adults. One using an antitussive had no extractable pneumonia-specific data. Three different mucolytics (bromhexine, ambroxol, neltenexine) were used in the remaining studies, of which only two had extractable data. They demonstrated no significant difference for the primary outcome of 'not cured or not improved' for mucolytics. A secondary outcome of 'not cured' was reduced (odds ratio (OR) for children 0.36, 95% confidence interval (CI) 0.16 to 0.77; number needed to treat to benefit (NNTB) at day 10 = 5 (95% CI 3 to 16) and OR 0.32 for adults (95% CI 0.13 to 0.75); NNTB at day 10 = 5 (95% CI 3 to 19)). In a post hoc analysis combining data for children and adults, again there was no difference in the primary outcome of 'not cured or not improved' (OR 0.85, 95% CI 0.40 to 1.80) although mucolytics reduced the secondary outcome 'not cured' (OR 0.34, 95% CI 0.19 to 0.60; NNTB 4, 95% CI 3 to 8). The risk of bias was low or unclear.

Authors' conclusions: There is insufficient evidence to decide whether OTC medications for cough associated with acute pneumonia are beneficial. Mucolytics may be beneficial but there is insufficient evidence to recommend them as an adjunctive treatment for acute pneumonia. This leaves only theoretical recommendations that OTC medications containing codeine and antihistamines should not be used in young children.

PubMed Disclaimer

Conflict of interest statement

ABC: none known. CCC: none known. ACC: none known.

Figures

1
1
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Children ‐ global assessment, Outcome 1 Not cured or not improved.
1.2
1.2. Analysis
Comparison 1 Children ‐ global assessment, Outcome 2 Not improved.
1.3
1.3. Analysis
Comparison 1 Children ‐ global assessment, Outcome 3 Not cured.
2.1
2.1. Analysis
Comparison 2 Children ‐ secondary outcomes, Outcome 1 Mean cough score at day 3.
2.2
2.2. Analysis
Comparison 2 Children ‐ secondary outcomes, Outcome 2 Mean score at day 10.
2.3
2.3. Analysis
Comparison 2 Children ‐ secondary outcomes, Outcome 3 Adverse events (no. of people).
3.1
3.1. Analysis
Comparison 3 Adults ‐ global assessment, Outcome 1 Not cured or not improved.
3.2
3.2. Analysis
Comparison 3 Adults ‐ global assessment, Outcome 2 Not improved.
3.3
3.3. Analysis
Comparison 3 Adults ‐ global assessment, Outcome 3 Not cured.
4.1
4.1. Analysis
Comparison 4 Combined children and adults, Outcome 1 Not cured or not improved.
4.2
4.2. Analysis
Comparison 4 Combined children and adults, Outcome 2 Not improved.
4.3
4.3. Analysis
Comparison 4 Combined children and adults, Outcome 3 Not cured.
4.4
4.4. Analysis
Comparison 4 Combined children and adults, Outcome 4 Adverse events (no. of people).
See this image and copyright information in PMC

Update of

References

References to studies included in this review

Aquilina 2001 {published data only}
    1. Aquilina R, Bergero F, Noceti P, Michelis C. Double blind study with neltenexine vs placebo in patients affected by acute and chronic lung diseases. Minerva Pneumologica 2001;40(2):77‐82. [EMBASE 2001363447]
Azzopardi 1964 {published data only}
    1. Azzopardi JF, Vanscolina AB. Clinical trial of a new anti‐tussive ('Dimryl'). British Journal of Clinical Practice 1964;18:213‐4. - PubMed
Principi 1986 {published data only}
    1. Principi N, Zavattini G, Daniotti S. Possibility of interaction among antibiotics and mucolytics in children. International Journal of Clinical Pharmacology Research 1986;6:369‐72. - PubMed
Roa 1995 {published data only}
    1. Roa CC Jr, Dantes RB. Clinical effectiveness of a combination of bromhexine and amoxicillin in lower respiratory tract infection. A randomized controlled trial. Progress in Drug Research. Fortschritte der Arzneimittelforschung 1995;45(3):267‐72. [MEDLINE: ] - PubMed

References to studies excluded from this review

Aliprandi 2004 {published data only}
    1. Aliprandi P, Castelli C, Bernorio S, Dell'Abate E, Carrara M. Levocloperastine in the treatment of chronic nonproductive cough: comparative efficacy versus standard antitussive agents. Drugs under Experimental and Clinical Research 2004;30:133‐41. - PubMed
Balli 2007 {published data only}
    1. Balli F, Bergamini B, Calistru P, Ciofu EP, Domenici R, Doros G, et al. Clinical effects of erdosteine in the treatment of acute respiratory tract diseases in children. International Journal of Clinical Pharmacology and Therapeutics 2007;45:16‐22. - PubMed
Barberi 1993 {published data only}
    1. Barberi I, Macchia A, Spata N, Scaricabarozzi I, Nava ML. Double‐blind evaluation of nimesulide vs lysine‐aspirin in the treatment of paediatric acute respiratory tract infections. Drugs 1993;46(Suppl 1):219‐21. - PubMed
Bartolucci 1981 {published data only}
    1. Bartolucci L, Canini F, Fioroni E, Pinchi G, Carosi M. Clinical evaluation of the therapeutic effectiveness of a new drug with anti‐inflammatory‐balsamic action, guacetisal, in respiratory tract diseases. Minerva Medica 1981;72(7):325‐32. - PubMed
Basnet 2012 {published data only}
    1. Basnet S, Shrestha PS, Sharma A, Mathisen M, Prasai R, Bhandari N, et al. Zinc Severe Pneumonia Study Group. A randomized controlled trial of zinc as adjuvant therapy for severe pneumonia in young children. Pediatrics 2012;129:701‐8. - PubMed
Caporalini 2001 {published data only}
    1. Caporalini R, Giosue GL. Neltenexine in lung diseases: an open, randomised, controlled study versus N‐acetylcysteine comparison. Minerva Pneumologica 2001;40:57‐62.
Dotti 1970 {published data only}
    1. Dotti A. Clinical trial of the antitussive action of an association of codeine plus phenyltoloxamine. Giornale Italiano Delle Malattie del Torace 1970;24(3):147‐57. - PubMed
Finiguerra 1981 {published data only}
    1. Finiguerra M, Martini S, Negri L, Simonelli A. Clinical and functional effects of domiodol and sobrerol in hypersecretory bronchopneumonias. Minerva Medica 1981;72(21):1353‐60. - PubMed
Forssell 1966 {published data only}
    1. Forssell P, Salmi I. On objective registration of the effects of cough medication [Zur objektiven Registrierung des Effektes von Hustenmitteln]. Archiv für Kinderheilkunde 1966;175:33‐41. - PubMed
Hargrave 1975 {published data only}
    1. Hargrave SA, Palmer KN, Makin EJ. Effect of bromhexine on the incidence of postoperative bronchopneumonia after upper abdominal surgery. British Journal of Diseases of the Chest 1975;69:195‐8. - PubMed
Ida 1997 {published data only}
    1. Ida H. The nonnarcotic antitussive drug dimemorfan: a review. Clinical Therapeutics 1997;19(2):215‐31. - PubMed
Jayaram 2000 {published data only}
    1. Jayaram S, Desai A. Efficacy and safety of ascoril expectorant and other cough formula in the treatment of cough management in paediatric and adult patients ‐ a randomised double‐blind comparative trial. Journal of the Indian Medical Association 2000;98(2):68‐70. - PubMed
Mancini 1996 {published data only}
    1. Mancini C. Erdosteine, the second generation mucolytic: international up‐dating of clinical studies (adults and paediatrics). Archivio di Medicina Interna 1996;48:53‐7.
Pelucco 1981 {published data only}
    1. Pelucco D, Bernabo Di Negro G, Ravazzoni C. The use of B.I. 1070/P (guacetisal) in inflammatory bronchopneumopathies in the acute phase. Minerva Medica 1981;72(7):423‐7. - PubMed
Titti 2000 {published data only}
    1. Titti 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). International Journal of Clinical Pharmacology and Therapeutics 2000;38:402‐7. - PubMed
Turrisi 1984 {published data only}
    1. Turrisi E, Mea A, Bruno G, Vitagliano A. Controlled study of delayed‐action fenspiride in a pneumologic milieu [Studio controllato del fenspiride ritardo in ambito pnrumologico]. Clinica Terapeutica 1984;111(4):339‐46. - PubMed
Wang 2005 {published data only}
    1. Wang XF, Liu F, Dong D. Evaluation of clinical efficacy of treatment of children with pneumonia by combined internal‐external therapy of TCM. Zhongguo Zhong Xi Yi Jie He Za Zhi Zhongguo Zhongxiyi Jiehe Zazhi (Chinese Journal of Integrated Traditional & Western Medicine) 2005;25(6):537‐9. - PubMed
Wieser 1973 {published data only}
    1. Wieser O, Maieron B. Report on a multi‐center study of a new prenoxdiazine antitussive agent. Zeitschrift fur Allgemeinmedizin 1973;49(16):805‐9. - PubMed
Zhang 2005 {published data only}
    1. Zhang CJ, Wang SP, Chen HH, Chen Q, Guo HY, Zhang JR. Clinical study of wind‐warm and pulmonary heat syndrome treated with integrated traditional Chinese and Western medicine. Zhong Xi Yi Jie He Xue Bao (Journal of Chinese Integrative Medicine) 2005;3:108‐10. - PubMed
Zurcher 1966 {published data only}
    1. Zurcher HP. Clinical trial of Sinecod‐Hommel in a double blind study [Klinische Testung im Doppelblindversuch mit Sinecod‐Hommel]. Schweizerische Rundschau für Medizin Praxis 1966;55:1402‐8. - PubMed

Additional references

Birring 2006
    1. Birring SS, Matos S, Patel RB, Prudon B, Evans DH, Pavord ID. Cough frequency, cough sensitivity and health status in patients with chronic cough. Respiratory Medicine 2006;100(6):1105‐9. - PubMed
Britt 2002
    1. Britt H, Miller GC, Knox S, Charles J, Valenti L, Henderson J, et al. Bettering the Evaluation and Care of Health ‐ A Study of General Practice Activity. Australian Institute of Health and Welfare 2002, issue AIHW Cat. No. GEP‐10.
Cates 2003 [Computer program]
    1. Cates C. Visual Rx. Online NNT Calculator (http://www.nntonline.net/). Cates C, 2003.
Chang 2003
    1. Chang AB, Phelan PD, Robertson CF, Roberts RDG, Sawyer SM. Relationship between measurements of cough severity. Archives of Disease in Childhood 2003;88:57‐60. - PMC - PubMed
Chang 2005
    1. Chang AB. Cough: are children really different to adults?. Cough 2005;1:7. - PMC - PubMed
Chang 2006
    1. Chang AB, Landau LI, Asperen PP, Glasgow NJ, Robertson CF, Marchant JM, et al. The Thoracic Society of Australia and New Zealand. Position statement. Cough in children: definitions and clinical evaluation. Medical Journal of Australia 2006;184:398‐403. - PubMed
Cherry 2003
    1. Cherry DK, Burt CW, Woodwell DA. National Ambulatory Medical Care Survey: 2001 summary. Advance Data 2003;337:1‐44. - PubMed
Cornford 1993
    1. Cornford CS, Morgan M, Ridsdale L. Why do mothers consult when their children cough?. Family Practice 1993;10(2):193‐6. - PubMed
de Sutter 2012
    1. Sutter AIM, Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine‐decongestant‐analgesic combinations for the common cold. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD004976.pub3] - DOI - PubMed
Eccles 2002
    1. Eccles R. The powerful placebo in cough studies?. Pulmonary Pharmacology & Therapeutics 2002;15(3):303‐8. - PubMed
Elbourne 2002
    1. Elbourne DR, Altman DG, Higgins JPT, Curtin F, Worthington HV, Vail A. Meta‐analyses involving cross‐over trials: methodological issues. International Journal of Epidemiology 2002;31(1):140‐9. - PubMed
French 2002
    1. French CT, Irwin RS, Fletcher KE, Adams TM. Evaluation of a cough‐specific quality‐of‐life questionnaire. Chest 2002;121(4):1123‐31. - PubMed
Gunn 2001
    1. Gunn VL, Taha SH, Liebelt EL, Serwint JR. Toxicity of over‐the‐counter cough and cold medications. Pediatrics 2001;108(3):E52. - PubMed
Higgins 2003
    1. Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327:557‐60. - PMC - PubMed
Higgins 2011
    1. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 [updated March 2011]. The Cochrane Collaboration. Available from www.cochrane‐handbook.org. Chichester, UK: John Wiley & Sons, Ltd, 2011.
Kelly 2004
    1. Kelly LF. Pediatric cough and cold preparations. Pediatrics in Review 2004;25(4):115‐23. - PubMed
RevMan 2012 [Computer program]
    1. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.2. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2012.
Siempos 2008
    1. Siempos II, Vardakas KZ, Kopterides P, Falagas ME. Adjunctive therapies for community‐acquired pneumonia: a systematic review. Journal of Antimicrobial Chemotherapy 2008;62(4):661‐8. - PubMed
Smith 2012
    1. Smith SM, Schroeder K, Fahey T. Over‐the‐counter (OTC) medications for acute cough in children and adults in ambulatory settings. Cochrane Database of Systematic Reviews 2012, Issue 8. [DOI: 10.1002/14651858.CD001831.pub4] - DOI - PubMed

References to other published versions of this review

Chang 2007
    1. Chang CC, Cheng AC, Chang AB. Over‐the‐counter (OTC) medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults. Cochrane Database of Systematic Reviews 2007, Issue 4. [DOI: 10.1002/14651858.CD006088.pub2] - DOI - PubMed
Chang 2010
    1. Chang CC, Cheng AC, Chang AB. Over‐the‐counter (OTC) medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults. Cochrane Database of Systematic Reviews 2010, Issue 1. [DOI: 10.1002/14651858.CD006088.pub2] - DOI
Chang 2012
    1. Chang CC, Cheng AC, Chang AB. Over‐the‐counter (OTC) medications to reduce cough as an adjunct to antibiotics for acute pneumonia in children and adults. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD006088.pub3] - DOI - PubMed

Publication types

LinkOut - more resources