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 Nov 24;2014(11):CD001831.
doi: 10.1002/14651858.CD001831.pub5.

Over-the-counter (OTC) medications for acute cough in children and adults in community settings

Susan M Smith  1 , Knut Schroeder, Tom Fahey
Affiliations
Meta-Analysis

Over-the-counter (OTC) medications for acute cough in children and adults in community settings

Susan M Smith et al. Cochrane Database Syst Rev. .

Abstract

Background: Acute cough due to upper respiratory tract infection (URTI) is a common symptom. Non-prescription, over-the-counter (OTC) medicines are frequently recommended as a first-line treatment, but there is little evidence as to whether these drugs are effective.

Objectives: To assess the effects of oral OTC cough preparations for acute cough in children and adults in community settings.

Search methods: We searched CENTRAL (2014, Issue 1), MEDLINE (January 1966 to March week 3 2014), EMBASE (January 1974 to March 2014), CINAHL (January 2010 to March 2014), LILACS (January 2010 to March 2014), Web of Science (January 2010 to March 2014) and the UK Department of Health National Research Register (March 2010).

Selection criteria: Randomised controlled trials (RCTs) comparing oral OTC cough preparations with placebo in children and adults suffering from acute cough in community settings. We considered all cough outcomes; secondary outcomes of interest were adverse effects.

Data collection and analysis: Two review authors independently screened potentially relevant citations, extracted data and assessed study quality. We performed quantitative analysis where appropriate.

Main results: Due to the small numbers of trials in each category, the limited quantitative data available and the marked differences between trials in terms of participants, interventions and outcome measurement, we felt that pooling of the results was inappropriate.We included 29 trials (19 in adults, 10 in children) involving 4835 people (3799 adults and 1036 children). All studies were placebo-controlled RCTs. However, assessment of the risk of bias of the included studies was limited by poor reporting, particularly for the earlier studies.In the adult studies, six trials compared antitussives with placebo and had variable results. Three trials compared the expectorant guaifenesin with placebo; one indicated significant benefit, whereas the other two did not. One trial found that a mucolytic reduced cough frequency and symptom scores. Two studies examined antihistamine-decongestant combinations and found conflicting results. Four studies compared other combinations of drugs with placebo and indicated some benefit in reducing cough symptoms. Three trials found that antihistamines were no more effective than placebo in relieving cough symptoms.In the child studies, antitussives (data from three studies), antihistamines (data from three studies), antihistamine-decongestants (two studies) and antitussive/bronchodilator combinations (one study) were no more effective than placebo. No studies using expectorants met our inclusion criteria. The results of one trial favoured active treatment with mucolytics over placebo. One trial tested two paediatric cough syrups and both preparations showed a 'satisfactory response' in 46% and 56% of children compared to 21% of children in the placebo group. One new trial indicated that three types of honey were more effective than placebo over a three-day period.Twenty-one studies reported adverse effects. There was a wide range across studies, with higher numbers of adverse effects in participants taking preparations containing antihistamines and dextromethorphan.

Authors' conclusions: The results of this review have to be interpreted with caution because the number of studies in each category of cough preparations was small. Availability, dosing and duration of use of over-the-counter cough medicines vary significantly in different countries. Many studies were poorly reported making assessment of risk of bias difficult and studies were also very different from each other, making evaluation of overall efficacy difficult. There is no good evidence for or against the effectiveness of OTC medicines in acute cough. This should be taken into account when considering prescribing antihistamines and centrally active antitussive agents in children; drugs that are known to have the potential to cause serious harm.

PubMed Disclaimer

Conflict of interest statement

Susan Smith: none known. Knut Schroeder: none known. Tom Fahey: none known.

Figures

1
1
Flow diagram.
2
2
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

Comment in

References

References to studies included in this review

Adams 1993 {published data only}
    1. Adams R, Hosie J, James I, Khong T, Kohn H, Smith I, et al. Antitussive activity and tolerability of moguisteine in patients with acute cough: a randomized, double‐blind, placebo‐controlled study. Advances in Therapy 1993;10(6):263‐71.
Albrecht 2012 {published data only}
    1. Albrecht H, Vernon M, Solomon G. Patient‐reported outcomes to assess the efficacy of extended‐release guaifenesin for the treatment of acute respiratory tract infection symptoms. Respiratory Research 2012;13(118):1‐10. - PMC - PubMed
Avner Cohen 2012 {published data only}
    1. Avner Cohen H, Rozen J, Kristal H, Laks Y, Berkowitch M, Uziel Y, et al. Effect of honey on nocturnal cough and sleep quality: a double blind, randomized, placebo‐controlled study. Pediatrics 2012;130:465‐71. - PubMed
Berkowitz 1989 {published data only}
    1. Berkowitz RB, Connell JT, Dietz AJ, Greenstein SM, Tinkelman DG. The effectiveness of the non sedating antihistamine loratadine plus pseudoephedrine in the symptomatic management of the common cold. Annals of Allergy 1989;63(4):336‐9. - PubMed
Berkowitz 1991 {published data only}
    1. Berkowitz RB, Tinkelman DG. Evaluation of oral terfenadine for treatment of the common cold. Annals of Allergy 1991;67:593‐7. - PubMed
Bhattacharya 2012 {published data only}
    1. Bhattacharya M, Joshi N, Yadav S. To compare the effect of dextromethorphan, promethazine and placebo on nocturnal cough in children aged 1‐12 years with upper respiratory tract infections: a randomized controlled trial. Indian Journal of Pediatrics 2012;80(11):891‐5. - PubMed
Clemens 1997 {published data only}
    1. Clemens CJ, Taylor JA, Almquist JR, Quinn HC, Mehta A, Naylor GS. Is an antihistamine‐decongestant combination effective in temporarily relieving symptoms of the common cold in preschool children?. Journal of Pediatrics 1997;130(3):463‐6. - PubMed
Curley 1988 {published data only}
    1. Curley FJ, Irwin RS, Pratter MR, Stivers DH, Doern GV, Vernaglia PA, et al. Cough and the common cold. American Review of Respiratory Diseases 1988;138(2):305‐11. - PubMed
Eccles 1992 {published data only}
    1. Eccles R, Morris S, Jawad M. Lack of effect of codeine in the treatment of cough associated with acute upper respiratory tract infection. Journal of Clinical Pharmacy and Therapeutics 1992;17(3):175‐80. - PubMed
Freestone 1997 {published data only}
    1. Freestone C, Eccles R. Assessment of the antitussive efficacy of codeine in cough associated with common cold. Journal of Pharmacy and Pharmacology 1997;49:1045‐9. - PubMed
Gaffey 1988 {published data only}
    1. Gaffey MJ, Kaiser DL, Hayden FG. Ineffectiveness of oral terfenadine in natural colds: evidence against histamine as a mediator of common cold symptoms. Pediatric Infectious Diseases Journal 1988;7(3):215‐42. - PubMed
Hutton 1991 {published data only}
    1. Hutton N, Wilson MH, Mellits ED, Baumgartner R, Wissow LS, Bonuccelli C, et al. Effectiveness of an antihistamine‐decongestant combination for young children with the common cold: a randomized, controlled clinical trial. Journal of Pediatrics 1991;118(1):125‐30. - PubMed
Korppi 1991a {published data only}
    1. Korppi M, Laurikainen K, Pietikaenen M, Silvasti M. Antitussives in the treatment of acute transient cough in children. Acta Paediatrica Scandinavia 1991;80:969‐71. - PubMed
Korppi 1991b {published data only}
    1. Korppi M, Laurikainen K, Pietikaenen M, Silvasti M. Antitussives in the treatment of acute transient cough in children. Acta Paediatrica Scandinavia 1991;80:969‐71. - PubMed
Kuhn 1982 {published data only}
    1. Kuhn JJ, Hendley JO, Adams KF, Clark JW, Gwaltney JM Jr. Antitussive effect of guaifenesin in young adults with natural colds. Chest 1982;82(6):713‐8. - PubMed
Kurth 1978 {published data only}
    1. Kurth W. Secure therapeutic effectiveness of the traditional antitussive agent Minetten in a double‐blind study [Gesicherte therapeutische Wirksamkeit des traditionellen Antitussivums Minetten im Doppelblindversuch]. Medizinische Welt 1978;29(48):1906‐9. - PubMed
Lee 2000 {published data only}
    1. Lee PCL, Jawad MSM, Eccles R. Antitussive efficacy of dextromethorphan in cough associated with acute upper respiratory infection. Journal of Pharmacy and Pharmacology 2000;52:1137‐42. - PubMed
Mizoguchi 2007 {published data only}
    1. Mizoguchi H, Wilson A, Jerdack GR, Hull JD, Goodale M, Grender JM, et al. Efficacy of a single evening dose of a syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulphate in subjects with multiple common cold symptoms. International Journal of Clinical Pharmacology and Therapeutics 2007;45:230‐6. - PubMed
Nespoli 1989 {published data only}
    1. Nespoli L, Monafo V, Bonetti F, Terracciano L, Savio G. Clinical evaluation of letosteine activity in the treatment of acute febrile bronchitis in paediatric age. Controlled double blind vs placebo investigation [Valutazione clinica dell'attivita della letosteina nel trattamento della bronchite acuta febbrile in eta pediatrica. Indagine controllata in doppio cieco vs placebo]. Minerva Pediatrica 1989;41(10):515‐20. - PubMed
Nesswetha 1967 {published data only}
    1. Nesswetha W. Criteria of drug testing in industrial practice, demonstrated by a cough remedy [Kriterien der Arzneimittelpruefung in der werksaerztlichen Praxis, dargestellt am Beispiel eines Hustenloesers]. Arzneimittelforschung 1967;17(10):1324‐6. - PubMed
Parvez 1996 {published data only}
    1. Parvez L, Vaidya M, Sakhardande A, Subburaj S, Rajagopalan TG. Evaluation of antitussive agents in man. Pulmonary Pharmacology 1996;9(5‐6):299‐308. - PubMed
Paul 2004 {published data only}
    1. Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, et al. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics 2004;114(1):E85‐E90. - PubMed
Pavesi 2001 {published data only}
    1. Pavesi L, Subburaj S, Porter‐Shaw K. Application and validation of a computerized cough acquisition system for objective monitoring of acute cough: a meta‐analysis. Chest 2001;120:1121‐8. - PubMed
Reece 1966 {published data only}
    1. Reece CA, Cherry AC Jr, Reece AT, Hatcher TB, Diehl AM. Tape recorder for evaluation of coughs in children. American Journal of Diseases of Children 1966;112(2):124‐8. - PubMed
Robinson 1977 {published data only}
    1. Robinson RE, Cummings WB, Deffenbaugh ER. Effectiveness of guaifenesin as an expectorant: a cooperative double‐blind study. Current Therapeutic Research 1977;22(2):284‐96.
Sakchainanont 1990 {published data only}
    1. Sakchainanont B, Ruangkanchanasetr S, Chantarojanasiri T, Tapasart C, Suwanjutha S. Effectiveness of antihistamines in common cold. Journal of the Medical Association Thailand 1990;73(2):96‐101. - PubMed
Taylor 1993 {published data only}
    1. Taylor JA, Novack AH, Almquist JR, Rogers JE. Efficacy of cough suppressants in children. Journal of Paediatrics 1993;122:799‐802. - PubMed
Thackray 1978 {published data only}
    1. Thackray P. A double‐blind, crossover controlled evaluation of a syrup for the night‐time relief of the symptoms of the common cold, containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulphate. Journal of International Medical Research 1978;6(2):161‐5. - PubMed
Tukiainen 1986 {published data only}
    1. Tukiainen H, Karttunen P, Silvasti M, Flygare U, Korhonen R, Korhonen T, et al. The treatment of acute transient cough: a placebo‐controlled comparison of dextromethorphan and dextromethorphan‐beta 2‐sympathomimetic combination. European Journal of Respiratory Diseases 1986;69(2):95‐9. - PubMed

References to studies excluded from this review

Beiler 2007 {published data only}
    1. Beiler PIM, McMonagle J, Shaffer A, Duda ML, Berlin LCM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Archives of Pediatrics and Adolescent Medicine 2007;161(12):1140‐6. - PubMed
Kim 2009 {published data only}
    1. Kim YW, Lee SM, Lee CT, Chung HS, Chang J, Ahn CM. Clinical efficacy of theobromine for the treatment of cough in adults. Respirology 2009;14:A132.
MRC 1950 {published data only}
    1. Medical Research Council. Clinical trials of antihistaminic drugs in the prevention and treatment of the common cold. British Medical Journal 1950;2:425‐9. - PMC - PubMed
Shadkam 2010 {published data only}
    1. Shadkam MN, Mozaffari‐Khosravi H, Mozayan MR. A comparison of the effect of honey, dextromethorphan and diphenhydramine on nightly cough and sleep quality in children and their parents. Journal of Alternative and Complementary Medicine 2012;16(7):787‐93. - PubMed
Vornov 2012 {published data only}
    1. Vornov J, Birring S, Mazhari R, Fraser H, Casper R, Canning B, et al. Baseline cough frequency in a randomized, placebo‐controlled, phase 2 clinical trial in subjects with upper respiratory tract infection. Abstracts from the Fourth American Cough Conference. 2012.

Additional references

Anonymous 1999
    1. Anonymous. Cough medications in children. Drugs and Therapeutics Bulletin 1999;37(3):19‐21. - PubMed
Banderali 1995
    1. Banderali G, Riva E, Fiocchi A, Cordaro CI, Giovannini M. Efficacy and tolerability of levodropropizine and dropropizine in children with non‐productive cough. Journal of International Medical Research 1995;23:175‐83. - PubMed
Bjórnsdóttir 2001
    1. Bjórnsdóttir I, Einarson TR, Gudmundsson LS, Einarsdóttir RA. Efficacy of diphenhydramine against cough in humans: a review. Pharmacy World and Science 2007;29:577‐83. - PubMed
FDA 2007
    1. Food, Drug Administration. Nonprescription Drug Advisory Committee Meeting. Cold, cough, allergy, bronchodilator, antiasthmatic drug products for over‐the‐counter human use. www.fda.gov/ohrms/dockets/ac/07/briefing/2007‐4323b1‐02‐FDA.pdf 2007 (accessed 6 October 2008).
Gastpar 1984
    1. Gastpar H, Cricuolo D, Dieterich HA. Efficacy and tolerability of glaucine as an antitussive agent. Current Medical Research and Opinion 1984;9:21‐7. - PubMed
Higgins 2011
    1. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Irwin 1993
    1. Irwin RS, Curley FJ, Bennett FM. Appropriate use of antitussives and protussives. A practical review. Drugs 1993;46(1):80‐91. - PubMed
Lefebvre 2011
    1. Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.
Morice 1998
    1. Morice A, Abdul‐Manap R. Drug treatments for coughs and colds. Prescriber 1998;9(17):74‐9.
Oduwole 2012
    1. Oduwole O, Meremikwu MM, Oyo‐Ita A, Udoh EE. Honey for acute cough in children. Cochrane Database of Systematic Reviews 2012, Issue 3. [DOI: 10.1002/14651858.CD007094.pub3] - DOI - PubMed
PAGB 2000
    1. The Proprietary Association of Great Britain. Annual Review and Report. London: PAGB, 2000.
RevMan 2014 [Computer program]
    1. The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Reynolds 1993
    1. Reynolds JEF. Cough suppressants, expectorants and mucolytics. Martindale ‐ The Extra Pharmacopeia. 30th Edition. London: The Pharmaceutical Press, 1993:741‐53.
Smith 1993
    1. Smith MBH, Feldman W. Over‐the‐counter cold medications. A critical review of clinical trials between 1950 and 1991. JAMA 1993;269(17):2258‐63. - PubMed
Smith 2008a
    1. Smith SM, Henman M, Schroeder K, Fahey T. Over the counter (OTC) cough medicines in children: neither safe or efficacious?. British Journal of General Practice 2008;58(556):757‐8. - PMC - PubMed
Vernacchio 2008
    1. Vernacchio L, Kelly JP, Kaufman DW, Mitchell AA. Cough and cold medication use by US children, 1999‐2006: Results from the Slone survey. Pediatrics 2008;122(2):e323‐e9. - PubMed
Ziment 1976
    1. Ziment I. What to expect from expectorants. JAMA 1976;236:193‐4. - PubMed

References to other published versions of this review

Acuin 1999
    1. Acuin J, Smith A, Mackenzie I. Treatment of chronic suppurative otitis media. Cochrane Database of Systematic Reviews 1999, Issue 1. [DOI: 10.1002/14651858.CD001831.pub3] - DOI
Schroeder 2001
    1. Schroeder K, Fahey T. Over‐the‐counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database of Systematic Reviews 2001, Issue 3. [DOI: 10.1002/14651858.CD001831.pub3] - DOI - PubMed
Schroeder 2004
    1. Schroeder K, Fahey T. Over‐the‐counter (OTC) medications for acute cough in children and adults in ambulatory settings. Cochrane Database of Systematic Reviews 2004, Issue 4. [DOI: 10.1002/14651858.CD001831.pub3] - DOI - PubMed
Smith 2008b
    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 2008, Issue 1. [DOI: 10.1002/14651858.CD001831.pub3] - DOI - PubMed
Smith 2010
    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 2010, Issue 9. [DOI: 10.1002/14651858.CD001831.pub3] - DOI - 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

Publication types

MeSH terms