Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial

Paulo Dornelles Picon, Marisa Boff Costa, Rafael da Veiga Picon, Lucia Costa Cabral Fendt, Maurício Leichter Suksteris, Indara Carmanim Saccilotto, Alicia Dorneles Dornelles, Luis Felipe Carissimi Schmidt, Paulo Dornelles Picon, Marisa Boff Costa, Rafael da Veiga Picon, Lucia Costa Cabral Fendt, Maurício Leichter Suksteris, Indara Carmanim Saccilotto, Alicia Dorneles Dornelles, Luis Felipe Carissimi Schmidt

Abstract

Background: The common cold and other viral airway infections are highly prevalent in the population, and their treatment often requires the use of medications for symptomatic relief. Paracetamol is as an analgesic and antipyretic; chlorphenamine is an antihistamine; and phenylephrine, a vasoconstrictor and decongestant. This randomized, double-blind, placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults.

Methods: This study enrolled 146 individuals aged 18 to 60 years who had moderate to severe flu-like syndrome or common cold. After clinical examination and laboratory tests, individuals were randomly assigned to receive the fixed-dose combination (73) or placebo (73), five capsules per day for 48 to 72 hours. The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale. To evaluate treatment safety, the occurrence of adverse events was also measured.

Results: Mean age was 33.5 (±9.5) years in the placebo group and 33.8 (±11.5) in the treatment group. There were 55 women and 18 men in the placebo group, and 46 women and 27 men in the treatment group. Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group (p = 0.015). Analysis at the first 13 dose intervals (± 66 h of treatment) showed a greater reduction of symptom scores in the treatment group than in the placebo group (p < 0.05). The number and distribution of adverse events were similar in both groups.

Conclusion: A fixed-dose combination of paracetamol, chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults.

Trial registration: NCT01389518.

Figures

Figure 1
Figure 1
Study flowchart.
Figure 2
Figure 2
Mean symptom score before and after treatment. * Comparison between mean overall scores: Student t-test for independent samples; ** Mean score variation in the two groups (V1-V2): Student t-test for independent samples.
Figure 3
Figure 3
Overall patient-reported score in each group (treatment vs. placebo) at 11-dose intervals. * Repeated-measures analysis of variance (ANOVA).

References

    1. Mossad SB. Treatment of the common cold. BMJ. 1998;317:33–36. doi: 10.1136/bmj.317.7150.33.
    1. Kirkpatrick GL. The common cold. Prim Care. 1996;23:657–675. doi: 10.1016/S0095-4543(05)70355-9.
    1. Jackson GG, Dowling HF, Spiesman IG, Boand AV. Transmission of the common cold to volunteers under controlled conditions. I. The common cold as a clinical entity. AMA Arch Intern Med. 1958;101:267–278. doi: 10.1001/archinte.1958.00260140099015.
    1. Roll S, Nocon M, Willich SN. Reduction of common cold symptoms by encapsulated juice powder concentrate of fruits and vegetables: a randomised, double-blind, placebo-controlled trial. Br J Nutr. 2011;105:118–122. doi: 10.1017/S000711451000317X. Epub 2010 Aug 23.
    1. Mossad SB. Effect of zincum gluconicum nasal gel on the duration and symptom severity of the common cold in otherwise healthy adults. QJM. 2003;96:35–43. doi: 10.1093/qjmed/hcg004.
    1. Heikkinen T, Järvinen A. The common cold. Lancet. 2003;361:51–59. doi: 10.1016/S0140-6736(03)12162-9.
    1. Forleo-Neto E, Halker E, Santos VJ, Paiva TM, Toniolo-Neto J. Influenza. Rev Soc Bras Med Trop. 2003;36:267–274. doi: 10.1590/S0037-86822003000200011.
    1. Audera C, Patulny RV, Sander BH, Douglas RM. Mega-dose vitamin C in treatment of the common cold: a randomised controlled trial. Med J Aust. 2001;175:359–362.
    1. Barrett BP, Brown RL, Locken K, Maberry R, Bobula JA, D’Alessio D. Treatment of the common cold with unrefined Echinacea. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2002;137:939–946. doi: 10.7326/0003-4819-137-12-200212170-00006.
    1. Yale SH, Liu K. Echinacea purpurea therapy for the treatment of the common cold: a randomized, double-blind, placebo-controlled clinical trial. Arch Intern Med. 2004;164:1237–1241. doi: 10.1001/archinte.164.11.1237.
    1. Linde K, Barrett B, Wölkart K, Bauer R, Melchart D. Echinacea for preventing and treating the common cold. Cochrane Database Syst Rev. 2006;1 CD000530.
    1. Barrett B, Brown R, Rakel D, Mundt M, Bone K, Barlow S, Ewers T. Echinacea for treating the common cold: a randomized trial. Ann Intern Med. 2010;153:769–777. doi: 10.7326/0003-4819-153-12-201012210-00003.
    1. Jackson JL, Peterson C, Lesho E. A meta-analysis of zinc salts lozenges and the common cold. Arch Intern Med. 1997;157:2373–2376. doi: 10.1001/archinte.1997.00440410105012.
    1. Jackson JL, Lesho E, Peterson C. Zinc and the common cold: a meta-analysis revisited. J Nutr. 2000;130(Suppl 5S):1512S–1515S.
    1. Simasek S, Blandino DA. Treatment of the common cold. Am Fam Phys. 2007;75(4):443–590.
    1. Sutter AI, Lemiengre M, Campbell H, Mackinnon HF. Antihistamines for the common cold. Cochrane Database Syst Rev. 2005;3 CD001267.
    1. Schroeder K, Fahey T. Over-the-counter medications for acute cough in children and adults in ambulatory settings. Cochrane Database System Rev. 2004;4 CD001831.
    1. Taverner D, Latte J, Draper M. Nasal descongestants for the common cold. Cochrane Database Syst Rev. 2004;3 CD001953.
    1. Sutter AI, Lemiengre M, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev. 2012;2 CD004976.
    1. Dolin R. Prevention and Treatment of Influenza. [ ]
    1. Panasiuk L, Lukas W, Paprzycki P, Verheij T, Godycki-Ćwirko M, Chlabicz S. Antibiotics in the treatment of upper respiratory tract infections in Poland. Is there any improvement? J Clin Pharm Ther. 2010;35:665–669. doi: 10.1111/j.1365-2710.2009.01136.x.
    1. Jefferson T, Jones M, Doshi P, Del Mar C. Neuraminidase inhibitors for preventing and treating influenza in healthy adults: systematic review and meta-analysis. BMJ. 2009;339:b5106. doi: 10.1136/bmj.b5106.
    1. Grebe W, Ionescu E, Gold MS, Liu JH, Frank WO. A multicenter, randomized, double-blind, double-dummy, parallel-group comparision of diclofenac-K and ibuprofen for the treatment of adults with influenza-like symptoms. Clin Therap. 2003;23:444–458.

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