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Cited by 107Respiratory viral infections researchPediatric health and respiratory diseasesHerbal Medicine Research Studies

Nasal decongestants in monotherapy for the common cold

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Deckx, Laura, De Sutter, An IM, Guo, Linda, Mir, Nabiel A, van Driel, Mieke L·2016·Cochrane Database of Systematic Reviews
DOI 10.1002/14651858.cd009612.pub2PMC PMC6461189
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Abstract

BACKGROUND: Many treatments for the common cold exist and are sold over-the-counter. Nevertheless, evidence on the effectiveness and safety of nasal decongestants is limited. OBJECTIVES: To assess the efficacy, and short- and long-term safety, of nasal decongestants used in monotherapy to alleviate symptoms of the common cold in adults and children. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 6, June 2016), which contains the Cochrane Acute Respiratory Infections (ARI) Specialised Register, MEDLINE (1946 to July 2016), Embase (2010 to 15 July 2016), CINAHL (1981 to 15 July 2016), LILACS (1982 to July 2016), Web of Science (1955 to July 2016) and clinical trials registers. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs investigating the effectiveness and adverse effects of nasal decongestants compared with placebo for treating the common cold in adults and children. We excluded quasi-RCTs. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted and summarised data on subjective measures of nasal congestion, overall patient well-being score, objective measures of nasal airway resistance, adverse effects and general recovery. One review author acted as arbiter in cases of disagreement. We categorised trials as single and multi-dose and analysed data both separately and together. We also analysed studies using an oral or topical nasal decongestant separately and together. MAIN RESULTS: We included 15 trials with 1838 participants. Fourteen studies included adult participants only (aged 18 years and over). In six studies the intervention was a single dose and in nine studies multiple doses were used. Nine studies used pseudoephedrine and three studies used oxymetazoline. Other decongestants included phenylpropanolamine, norephedrine and xylometazoline. Phenylpropanolamine (or norephedrine) is no longer available on the market therefore we did not include the results of these studies in the meta-analyses. Eleven studies used oral decongestants; four studies used topical decongestants.Participants were included after contracting the common cold. The duration of symptoms differed among studies; in 10 studies participants had symptoms for less than three days, in three studies symptoms were present for less than five days, one study counted the number of colds over one year, and one study experimentally induced the common cold. In the single-dose studies, the effectiveness of a nasal decongestant was measured on the same day, whereas the follow-up in multi-dose studies ranged between one and 10 days.Most studies were conducted in university settings (N = eight), six at a specific university common cold centre. Three studies were conducted at a university in collaboration with a hospital and two in a hospital only setting. In two studies the setting was unclear.There were large differences in the reporting of outcomes and the reporting of methods in most studies was limited. Therefore, we judged most studies to be at low or unclear risk of bias. Pooling was possible for a limited number of studies only; measures of effect are expressed as standardised mean differences (SMDs). A positive SMD represents an improvement in congestion. There is no defined minimal clinically important difference for measures of subjective improvement in nasal congestion, therefore we used the SMDs as a guide to assess whether an effect was small (0.2 to 0.49), moderate (0.5 to 0.79) or large (≥ 0.8).Single-dose decongestant versus placebo: 10 studies compared a single dose of nasal decongestant with placebo and their effectiveness was tested between 15 minutes and 10 hours after dosing. Seven of 10 studies reported subjective symptom scores for nasal congestion; none reported overall patient well-being. However, pooling was not possible due to the large diversity in the measurement and reporting of symptoms of congestion. Two studies recorded adverse events. Both studies used an oral decongestant and each of them showed that there was no statistical difference between the number of adverse events in the treatment group versus the placebo group.Multi-dose decongestant versus placebo: nine studies compared multiple doses of nasal decongestants with placebo, but only five reported on the primary outcome, subjective symptom scores for nasal congestion. Only one study used a topical decongestant; none reported overall patient well-being. Subjective measures of congestion were significantly better for the treatment group compared with placebo approximately three hours after the last dose (SMD 0.49, 95% confidence interval (CI) 0.07 to 0.92; P = 0.02; GRADE: low-quality evidence). However, the SMD of 0.49 only indicates a small clinical effect. Pooling was based on two studies, one oral and one topical, therefore we were unable to assess the effects of oral and topical decongestants separately. Seven studies reported adverse events (six oral and one to

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  • Deckx 2016 concluded that a single oral dose of nasal decongestant is modestly effective for short-term relief of congestion in adults, and that these medications also provide benefit after regular use over three to five days.

    “Deckx 2016 concluded that a single oral dose of nasal decongestant is modestly effective for short‐term relief of congestion in adults, and that these medications also provide benefit after regular use over three to five days.”

    From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Deckx 2016

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  • Decongestants can reduce nasal blockage and secretion through vasoconstriction of the nasal vessels.

    “Decongestants can reduce nasal blockage and secretion through vasoconstriction of the nasal vessels (Deckx 2016).”

    From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Deckx 2016

    The Types of interventions section says nasal decongestants cause vasoconstriction in upper-respiratory-tract blood vessels, and the Discussion reports a small benefit for nasal congestion. The review does not establish that decongestants in monotherapy reduce nasal secretion; the Description of the intervention discusses anti-secretory actions of multi-agent treatments separately. (LLM, conf=0.87)

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  • Analgesics, decongestants, and antihistamines have some effect in monotherapy.

    “Analgesics, decongestants, and antihistamines have some effect in monotherapy (Deckx 2016; De Sutter 2015; Eccles 2006b).”

    From Oral antihistamine-decongestant-analgesic combinations for the common cold (2022) · cites this paper as Deckx 2016

    Deckx 2016 is relevant to the decongestant part of this multi-citation sentence, not the claims about analgesics or antihistamines. Its Authors’ conclusions say that multiple doses of nasal decongestants may have a small positive effect on subjective congestion in adults with the common cold, but the evidence is insufficient for firm conclusions; it cannot establish effectiveness for a single dose. The unqualified statement that decongestants 'have some effect' overstates that finding. (LLM, conf=0.84)

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  • Prolonged use of decongestants produces drug-induced rhinitis and organic nasal lesions and may cause serious systemic alterations.

    “However, the adverse effects of prolonged use of these drugs not only produce drug-induced rhinitis and organic nasal lesions, but may also be responsible for serious systemic alterations [119-124].”

    From Position Paper on Nasal Obstruction: Evaluation and Treatment (2018) · cites this paper as [122]

    The Description of the intervention (page not provided) warns of rebound congestion with use beyond five days and possible systemic effects, including hypertension. The review does not report organic nasal lesions, and its Implications for research says the long-term risk of rhinitis medicamentosa needs further study; it does not establish that prolonged use causes all the stated harms. (LLM, conf=0.86)

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  1. C O N T R I B U T I O N S O F A U T H O R S Laura Deckx (LD) contributed to the data extraction, performed the data analyses and wrote the first draft of the review. An De Sutter (ADS) and Mieke van Driel (MLvD) commented on the draft and contributed to the final version.

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Authors
Deckx, L., De Sutter, A. I., Guo, L., Mir, N. A., & van Driel, M. L.
Affiliations
  • The University of Queensland (AU)
  • Ghent University; Department of Family Medicine and Primary Health Care; De Pintelaan 185 UZ 1K3 Ghent Belgium B-9000
  • The University of Queensland; Discipline of General Practice, School of Medicine; Building 16/910 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
ORCID
Venue
Cochrane Database of Systematic Reviews
Publisher
Wiley
Published
2016-10-17
Volume
2016
Issue
10
Pages
CD009612-CD009612
ISSN
  • 1361-6137 (ISSN-L)
  • 1465-1858
DOI
10.1002/14651858.cd009612.pub2
PMC
PMC6461189
OpenAlex
W2535184582
Cited by
107
References
74
Citations by year
2026: 1 · 2025: 9 · 2024: 8 · 2023: 16 · 2022: 15 · 2021: 21 · 2020: 11 · 2019: 11 · 2018: 7 · 2017: 6 · 2016: 1 · 2015: 1
FWCI
1.13
Type
journal article
Language
en
Open access
Locations
  • Cochrane Database of Systematic Reviews (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Ghent University Academic Bibliography (Ghent University) (submittedVersion, other-oa)
Topics
  • Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
  • Health Sciences › Health Professions › Emergency Medical Services › Pediatric health and respiratory diseases
  • Health Sciences › Medicine › Complementary and alternative medicine › Herbal Medicine Research Studies
Keywords
nasal decongestants, common cold, monotherapy, pseudoephedrine, oxymetazoline, phenylpropanolamine, xylometazoline, nasal congestion, nasal resistance, adverse effects, over-the-counter cold remedies, children, adults, recovery time, over-the-counter drug safety
MeSH terms
Administration, Intranasal, Adult, Child, Common Cold, Humans, Imidazoles, Oxymetazoline, Phenylpropanolamine, Time Factors, Nasal Decongestants, Randomized Controlled Trials as Topic, Pseudoephedrine

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