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Comparative Efficacy and Tolerability of Pholcodine and Dextromethorphan in the Management of Patients with Acute, Non-Productive Cough

A Randomized, Double-Blind, Multicenter Study

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Treatments in Respiratory Medicine

Abstract

Introduction: The aim of this study was to compare the efficacy and tolerability of pholcodine with that of dextromethorphan, one of the most used cough sedative products, in patients with acute, non-productive cough.

Methods: 129 adults with a diagnosis of acute, frequent, non-productive cough participated in a randomized, double-blind, parallel-group, multicenter trial. Medications were in a syrup formulation and were taken orally three times daily for 3 days. The efficacy endpoints were the change from baseline in the daytime and night-time cough frequency on 5-point scales at day 3, and cough intensity.

Results: A reduction of 1.4 and 1.3 points in the mean daytime cough frequency at day 3 was seen in the pholcodine and dextromethorphan groups, respectively, in the per-protocol population. The reduction in mean night-time cough was 1.3 for both groups. Cough intensity reduction was 0.7 for pholcodine and 0.8 for dextromethorphan.

Conclusions: These findings indicate that the efficacy of a 3-day course of pholcodine is similar to that of dextromethorphan in the treatment of adult patients with acute, non-productive cough. Both medications were well tolerated.

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Table I
Table II

Notes

  1. 1 The use of trade names is for product identification purposes only and does not imply endorsement.

  2. 2 One did not receive any study drug; two had no efficacy assessments after randomization.

References

  1. Morice AH, Widdecombe P, Dicpinigaitis P, et al. Epidemiology of cough. Pulm Pharmacol Ther 2002; 15: 253–9

    Article  PubMed  CAS  Google Scholar 

  2. Widdicombe J, Kamath S. Acute cough in the elderly. Drugs Aging 2004; 21(4): 243–58

    Article  PubMed  Google Scholar 

  3. Wong DM, Blumberg DA, Lowe LG. Guidelines for the use of antibiotics in acute upper respiratory tract infections. Am Fam Physician 2006 Sep 15; 74(6): 956–66

    PubMed  Google Scholar 

  4. Irwin RS, Curley FJ, Bennett FM. Appropriate use of antitussives and protussives: a practical review. Drugs 1993; 46(1): 80–90

    Article  PubMed  CAS  Google Scholar 

  5. Morica AH, McGarvey L, Pavord I, et al. Recommendations for the management of cough in adults. Thorax 2006; 61: 1–24

    Article  Google Scholar 

  6. Findlay JW. Pholcodine. J Clin Pharm Ther 1988 Feb; 13(1): 5–17

    Article  PubMed  CAS  Google Scholar 

  7. Chang AB, Newman RG, Carlin JB, et al. Subjective scoring of cough in children: parent-completed vs child-completed diary cards vs an objective method. Eur Respir J 1998; 11: 462–6

    Article  PubMed  CAS  Google Scholar 

  8. Catena E, Daffonchio L. Efficacy of levodropropizine in adult patients with non productive cough: comparison with dextrometorphan. Pulm Pharmacol Therap 1997; 10: 89–96

    Article  CAS  Google Scholar 

  9. Chung KF. Measurement and assessment of cough. In: Chung KF, Widdicombe J, Boushey H, et al. editors. Cough: causes, mechanisms and therapy. 1st ed. Malden (MA): Blackwell, 2003

    Chapter  Google Scholar 

  10. Chabrier P, Giudicelli R, Thuillier K, et al. Etude chimique, pharmacologique et clinique d’un nouveau sedative de la toux: la morpholyethylmorphine (M.E.M.). Ann Pharm Fr 1950; 8: 261–73

    PubMed  CAS  Google Scholar 

  11. Heffron CE. Preliminary evaluation of pholcodine, a new antitussive agent. J New Drugs 1961; 1 (Sep–Oct): 217–22

    PubMed  CAS  Google Scholar 

  12. Mullinos MG, Nair KG, Epstein IG. Clinical investigation of antitussive properties of pholcodine. NY State J Med 1962; 15: 2373–7

    Google Scholar 

  13. Edwards GF, Lewis HE, Stafford D. The effect of pholcodine with and without an antihistamine on cough and expectoration. Br J Dis Chest 1977; 71: 245–52

    Article  PubMed  CAS  Google Scholar 

  14. Jaffé G, Grimshaw JJ. Randomized single-blind trial in general practice comparing the efficacy and palatability of two cough linctus preparations, “Pholcolix” and “Actifed” compound, in children with acute cough. Curr Med Res Opin 1983; 8: 594–9

    Article  PubMed  Google Scholar 

  15. Snell ES, Armitage P. Clinical comparison of diamorphine and pholcodine as cough suppressant. Lancet 1957 April 27; 272(6974): 860–2

    Article  PubMed  CAS  Google Scholar 

  16. Kelly DF. Comparative clinical test of pholcodine with codeine as control. Northwest Med 1963; 62: 871–4

    PubMed  CAS  Google Scholar 

  17. Bolser DC. Cough suppressant and pharmacologic protussive therapy: ACCP evidence-based clinical practice guidelines. Chest 2006; 129: 238–49

    Article  Google Scholar 

  18. Matthys H, Bleicher B, Bleicher U. Dextromethorphan and codeine: objective assessment of antitussive activity in patients with chronic cough. J Int Med Res 1983; 11(2): 92–100

    PubMed  CAS  Google Scholar 

  19. Aylward M, Maddock J, Davies DE, et al. Dextromethorphan and codeine: comparison of plasma kinetics and antitussive effects. Eur J Resp Dis 1984 May; 65(4): 283–91

    CAS  Google Scholar 

  20. Lee PCL, Jawad MSM, Eccles R. Antitussive efficacy of dextromethorphan in cough associated with acute upper respiratory tract infection. J Pharm Pharmacol 2000; 52: 1137–42

    Article  PubMed  CAS  Google Scholar 

  21. Pavesi L, Subburaji 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

    Article  PubMed  CAS  Google Scholar 

  22. Lee PCL, Jawad MSM, Hull JD, et al. The antitussive effect of placebo treatment on cough associated with acute upper respiratory infection. Psychosom Med 2005; 67: 314–7

    Article  PubMed  Google Scholar 

  23. Eccles R. Mechanisms of the placebo effect of sweet cough syrups. Resp Physiol Neurobiol 2006; 152: 340–8

    Article  Google Scholar 

  24. Committee on drugs: use of codeine- and dextromethorphan-containing cough remedies in children. Pediatrics 1997; 99: 918–20

    Article  Google Scholar 

  25. Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. The Cochrane Database of Systematic Reviews 2004; Issue 4. Art. No.: CD001831.pub 2. DOI: 10.1002/14651858.CD001831.pub2

  26. Zambon. Pholcodine (Biocalyptol®): periodic safety update reports 1993–2005. (data on file, Zambon)

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Acknowledgments

Thanks to Gabrielle Boissard for the planning and execution of the statistical analyses and to Hippocrates Research s.r.l. for carrying out the clinical study. This study was funded by Zambon Group S.p.A., Bresso, Milan, Italy. The authors have no conflict of interest relevant to the content of this manuscript.

The Italian Investigational Study Group on Pholcodine in Acute Cough consisted of: ASL 3 Umbria: M. Acciarresi (Foligno, Perugia); P. Bonifazi (Foligno, Perugia); R. Equinozzi (Foligno, Perugia); R. Falcinelli (Montefalco, Perugia); M. Montironi (Gualdo Tadino, Perugia), L. Piselli (Spoleto, Perugia); ASL 1 Imperiese: G. Amoretti (Imperia); A. Astorino (San Lorenzo al Mare, Imperia); R. Buccelli (Imperia); F. Dolmetta (San Lorenzo al Mare, Imperia); G. Lanteri (Imperia); A. Novaro (Imperia); M. Pinelli (Imperia); ASL Versilia: GL Balderi (Marina di Pietrasanta, Lucca); F. Bertuccelli (Viareggio, Lucca); C. Bonin (Montemagno, Lucca); PL Franceschi (Stiava, Lucca); M. Pardini (Viareggio, Lucca); M. Pardini (Lido di Camaiore, Lucca); A. Serafini (Viareggio, Lucca).

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Authors and Affiliations

  1. General Practitioner, Via Roma 84, Foligno, Perugia, Italy

    Roberto Equinozzi (Coordinating Investigator)

  2. Centro di Ricera per lo studio dell’asma e delle Broncocardiopatie Cronico-Ostruttive, Università Milano Bicocca, Ospedale San Gerardo, Monza, Milan, Italy

    Maria Robuschi

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  1. Roberto Equinozzi
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  2. Maria Robuschi
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Italian Investigational Study Group on Pholcodine in Acute Cough

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Correspondence to Roberto Equinozzi.

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Equinozzi, R., Robuschi, M. & Italian Investigational Study Group on Pholcodine in Acute Cough. Comparative Efficacy and Tolerability of Pholcodine and Dextromethorphan in the Management of Patients with Acute, Non-Productive Cough. Treat Respir Med 5, 509–513 (2006). https://doi.org/10.2165/00151829-200605060-00014

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  • DOI: https://doi.org/10.2165/00151829-200605060-00014

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