Cochrane Database of Systematic Reviews Nasal decongestants for the common cold (Protocol) Ta’i SH, Ferguson KAM, Singh HK, Sharma AN, Kumar S, van Driel ML, De Sutter AIM Ta’i SH, Ferguson KAM, Singh HK, Sharma AN, Kumar S, van Driel ML, De Sutter AIM. Nasal decongestants for the common cold. Cochrane Database of Systematic Reviews 2012, Issue 2. Art. No.: CD009612. DOI: 10.1002/14651858.CD009612. www.cochranelibrary.com Nasal decongestants for the common cold (Protocol) Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 BACKGROUND .................................... 1 OBJECTIVES ..................................... 2 METHODS ...................................... 2 ACKNOWLEDGEMENTS . 5 REFERENCES ..................................... 5 CONTRIBUTIONSOFAUTHORS . 6 DECLARATIONSOFINTEREST . 6 Nasal decongestants for the common cold (Protocol) i Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Nasal decongestants for the common cold Shayan H Ta’i1, Kylie AM Ferguson1, Harsheel K Singh1, Atul N Sharma1, Shilpa Kumar1, Mieke L van Driel1,2,3, An IM De Sutter 3,4 1Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Australia. 2Discipline of General Practice, School of Medicine, The University of Queensland, Brisbane, Australia. 3Department of General Practice and Primary Health Care, Ghent University, Ghent, Belgium. 4Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium Contact address: Shayan H Ta’i, Faculty of Health Sciences and Medicine, Bond University, University Drive, Robina, Gold Coast, Queensland, 4229, Australia. [email protected]. [email protected]. Editorial group: Cochrane Acute Respiratory Infections Group. Publication status and date: New, published in Issue 2, 2012. Citation: Ta’i SH, Ferguson KAM, Singh HK, Sharma AN, Kumar S, van Driel ML, De Sutter AIM. Nasal decongestants for the common cold. Cochrane Database of Systematic Reviews 2012, Issue 2. Art. No.: CD009612. DOI: 10.1002/14651858.CD009612. Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT This is the protocol for a review and there is no abstract. The objectives are as follows: 1. To determine the efficacy of nasal decongestants in the common cold compared with placebo, in children and adults. 2. To identify the possible adverse effects associated with short-term and long-term use of nasal decongestants. BACKGROUND from school and 20 million absences from work annually, includ- ing days missed due to caring for ill children (Pappas 2008). In the United States, there are 25 million visits to the family physician annually due to the common cold and the total economic impact Description of the condition of the common cold in that country reached around USD 40 bil- lion annually (Fendrick 2003). The common cold is viral in nature, afflicts individuals of all Previous reviews have considered the safety and efficacy of thera- ages and often necessitates utilisation of over-the-counter (OTC) and prescription medications and complementary interventions pies for indications including seasonal and perennial allergic rhini- (Simasek 2007). Often caused by the rhinovirus, people typi- tis, chronic rhinitis, common cold and influenza (Dolansky 2008). Many marketed treatments for the common cold exist and consist cally experience rhinorrhoea, sneezing, headache, nasal conges- of multiple active agents with claimed decongestant, anti-secre- tion, cough, fatigue and pharyngitis. In Australia upper respiratory tory and anti-cough actions. tract infections, nasal congestion, pharyngitis and cough consti- Heated, humidified air is one type of treatment intervention. The tute 11% of all consultations in general practice (Fry 1993). Despite the common cold not being a serious condition, it has sub- mechanism behind its use includes its actions to firstly liquefy stantial impact on time lost from work and school, as well as money mucus if dry, thereby allowing it to be cleared more effectively. It also works by the heat of the steam killing the cold virus that may spent on both prescription and OTC medications (Heikkinnenn be present in the mucus. It is not routinely recommended as there 2003). The common cold contributes to 22 million missed days Nasal decongestants for the common cold (Protocol) 1 Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. is insufficient evidence for its use (Singh 2011). OBJECTIVES Analgesics (for example, aspirin, paracetamol and ibuprofen) are also used widely for relief from a range of symptoms experienced 1. To determine the efficacy of nasal decongestants in the with the common cold, such as headache, sore throat, fever and common cold compared with placebo, in children and adults. muscular pain. It is theorised that the prostaglandins that are in- 2. To identify the possible adverse effects associated with hibited by drugs such as ibuprofen cause a reduction in local va- short-term and long-term use of nasal decongestants. sodilation and nasal congestion although there is little reported evidence (Eccles 2009; Eccles 2000). Analgesia administered in OTC doses has a relatively good safely profile. Contra-indications include aspirin in children due to the risk of Reye’s syndrome and METHODS paracetamol in patients who use alcohol in excess (Eccles 2009). Corticosteroids are also used for the treatment of the common cold and are currently being reviewed (Hayward 2009). Intranasal Criteria for considering studies for this review ipratropium bromide has been reviewed and was found to be ef- fective in reducing rhinorrhoea but ineffective in reducing nasal congestion (AlBalawi 2011). Types of studies A Cochrane Review of saline nasal irrigation reported limited ev- Randomised controlled trials (RCTs) and cluster-RCTs compar- idence of efficacy in relieving symptoms from upper respiratory ing nasal decongestants to placebo. We will not include quasi-ran- tract infections (Kassel 2010). domised trials. Combination medications have also been studied. It was reported that combinations of antihistamine, decongestants and analgesics have proved to be more effective compared to placebo (De Sutter Types of participants 2012). Adults and children of all ages and either gender with the common Since these medications for the common cold have already been cold, characterised by defined symptoms of an upper respiratory previously researched, this review will concentrate on nasal decon- tract infection (URTI). We will only include participants who gestants. have had symptoms for no more than seven days prior to the start of the study. We will exclude studies where another upper respiratory condition (such as influenza, sinusitis or rhinitis) has Description of the intervention been diagnosed. Nasal congestion is one of the most uncomfortable symptoms ex- perienced with the common cold (Fry 1993). There is no cure for Types of interventions the common cold, therefore symptomatic therapy is the only treat- ment option. Nasal decongestants are widely utilised for symp- Oral or topical nasal decongestants versus placebo (oral or spray tomatic relief in both adults and children and can be administered as appropriate). in oral or topical form (Del Mar 2003). We will include trials using topical and oral nasal decongestants ad- ministered as aqueous spray, drops, dry powder, tablets or capsules. We will only focus on nasal decongestants, which work by stim- ulating the alpha-adrenergic receptors in upper respiratory tract How the intervention might work blood vessels, leading to vasoconstriction (Wicker 2009). We will Nasal decongestants are sympathomimetic amines that stimulate exclude studies reporting combined interventions such as warm the alpha-adrenergic receptors leading to vasoconstriction in blood humidified air, steam, aromatic vapours, inhaled corticosteroids vessels supplying the upper respiratory tract structures (Wicker and interventions using menthol. We will analyse single-dose and 2009). This results in a net reduction in oedema and nasal secre- multiple-dose studies separately. tions. Types of outcome measures Why it is important to do this review The purpose of this systematic review is to study the efficacy and Primary outcomes safety of nasal decongestants in people with a common cold. This 1. Subjective symptom scores for nasal congestion (self review will provide evidence-based guidance to clinicians as well reported scores of congestion). as patients suffering from the common cold. 2. Overall patient well being score (self reported). Nasal decongestants for the common cold (Protocol) 2 Copyright © 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Secondary outcomes 25 oxymetazoline.tw,nm. 1. Objective measures of nasal airways resistance (NAR). 26 norepinephrine.tw,nm. 2. Adverse events (for example, dry mucous membranes, 27 pseudoephedrine.tw,nm. rebound congestion). 28 phenylephrine.tw,nm. 3. Complications (for example, sinusitis, otitis media, lower 29 xylometazoline.tw,nm. respiratory tract infections). 30 tramazoline.tw. 4. Time to full recovery. 31 Ephedrine/ 5. Time to return to school/work. 32 ephedrin*.tw,nm. 33 or/23-33 34 22 and 34 Search methods for identification of studies Searching other resources We will search www.clinicaltrials.gov and other appropriate trials Electronic searches databases to identify