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Journal Article•DOI•

WITHDRAWN: Antihistamines for the common cold.

An De Sutter1, Marc Lemiengre, Harry Campbell2•
Ghent University1, University of Edinburgh2
07 Oct 2009-Cochrane Database of Systematic Reviews (Cochrane Database Syst Rev)-Iss: 4
TL;DR: Antihistamines in monotherapy - in children as well as in adults - do not alleviate to a clinical extent nasal congestion, rhinorrhoea and sneezing, or subjective improvement of the common cold.
Abstract: Background Although antihistamines are prescribed in large quantities for the common cold, there is little evidence as to whether these drugs are effective. Objectives To assess in patients with a common cold the effects of antihistamines in alleviating nasal symptoms, or the shortening the duration of illness. Search strategy We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2002, issue 4), which contains the Acute Respiratory Infections Group's Specilaized Register; MEDLINE (1966 to February 2003); and EMBASE (1987 to December 2002). Selection criteria Randomised, placebo-controlled trials on treatment of common cold with antihistamines, used either singly or in combination, in adults or children. Data collection and analysis Two review authors extracted data and trial authors were contacted for further data. Trials were subdivided into monotherapy and combination therapy. Data on general recovery, nasal obstruction, rhinorrhea, sneezing, and side-effects were extracted and summarized. Main results We included 32 papers describing 35 comparisons; 22 trials studied monotherapy, 13 trials a combination of antihistamines with other medication. A total of 8930 people suffering from the common cold were included. There were large differences in study designs, participants, interventions, and outcomes. There was no evidence of any clinically significant effect - in children or in adults - on general recovery of antihistamines in monotherapy. First generation - but not non-sedating - antihistamines have a small effect on rhinorrhea and sneezing. In trials with first generation antihistamines the incidence of side effects (especially sedation) is significantly higher with active treatment. Two trials, studying a combination of antihistamines with decongestives in small children, both failed to show any effect. Of the 11 trials on older children and adults, the majority show an effect on general recovery and on nasal symptom severity. Authors' conclusions Antihistamines in monotherapy - in children as well as in adults - do not alleviate to a clinical extent nasal congestion, rhinorrhoea and sneezing, or subjective improvement of the common cold. First generation antihistamines also cause more side-effects than placebo, in particular they increase sedation in cold sufferers.Combinations of antihistamines with decongestives are not effective in small children. In older children and adults most trials show a beneficial effect on general recovery as well as on nasal symptoms. However, it is not clear whether these effects are clinically significant.

Summary (1 min read)

Jump to: [De Sutter AIM, Saraswat A, van Driel ML. Antihistamines for the common cold.] – [Antihistamines for the common cold] – [Background] – [Selection criteria] – [Data collection and analysis] and [Main results]

De Sutter AIM, Saraswat A, van Driel ML. Antihistamines for the common cold.

  • Cochrane Database of Systematic Reviews 2015, Issue 11.
  • Change in severity of overall symptoms - all trials, Outcome 4 Short-term ITT analysis.
  • 71 Analysis 7.1. Comparison 7 Subjective severity assessment of rhinorrhoea - non-sedating antihistamines, Outcome 1 Fourth treatment day.
  • Comparison 10 Subjective severity assessment of sneezing - sedating antihistamines, Outcome 4 Fourth treatment day.
  • Published by John Wiley & Sons, Ltd. [Intervention Review].

Antihistamines for the common cold

  • An IM De Sutter1,2, Avadhesh Saraswat3, Mieke L van Driel1,4,5 1Department of Family Medicine and Primary Health Care, Ghent University, Ghent, Belgium.
  • 2Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium.
  • 4Discipline of General Practice, School of Medicine, The University of Queensland, Brisbane, Australia.
  • Cochrane Acute Respiratory Infections Group, also known as Editorial group.
  • New, published in Issue 11, 2015, also known as Publication status and date.

Background

  • On average, young children have six to eight colds per year and adults have two to four.
  • Common cold symptoms include sore throat, nasal stuffiness and discharge, sneezing and cough.
  • The common cold has a large impact on time off work or school.
  • As there is no cure for the common cold, only symptomatic treatment is available.
  • Antihistamines are effective for allergic symptoms such as hay fever.

Selection criteria

  • The authors selected randomised controlled trials (RCTs) using antihistamines as monotherapy for the common cold.
  • The authors excluded any studies with combination therapy or using antihistamines in patients with an allergic component in their illness.

Data collection and analysis

  • Two authors independently assessed trial quality and extracted data.
  • The authors collected adverse effects information from the included trials.

Main results

  • The authors included 18 RCTs, which were reported in 17 publications (one publication reports on two trials) with 4342 participants (of which 212 were children) suffering from the common cold, both naturally occurring and experimentally induced.
  • In adults there was a short-term beneficial effect of antihistamines on severity of overall symptoms: on day one or two of treatment 45% had a beneficial effect with antihistamines versus 38% with placebo (odds ratio (OR) 0.74, 95% confidence interval (CI) 0.60 to 0.92).
  • There was no difference between antihistamines and placebo in the mid term (three to four days) to long term (six to 10 days).
  • Only two trials included children and the results were conflicting.
  • The majority of the trials had a low risk of bias although some lacked sufficient trial quality information.

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Cochrane Database of Systematic Reviews
Antihistamines for the common cold (Review)
De Sutter AIM, Saraswat A, van Driel ML
De Sutter AIM, Saraswat A, van Driel ML.
Antihistamines for the common cold.
Cochrane Database of Systematic Reviews 2015, Issue 11. Art. No.: CD009345.
DOI: 10.1002/14651858.CD009345.pub2.
www.cochranelibrary.com
Antihistamines for the common cold (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .
5BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
19ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . .
22DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
27CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
54DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Change in severity of overall symptoms - all trials, Outcome 1 Short-term (1 to 2 days). 57
Analysis 1.2. Comparison 1 Change in severity of overall symptoms - all trials, Outcome 2 Intermediate-term (3 to 4
days). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Analysis 1.3. Comparison 1 Change in severity of overall symptoms - all trials, Outcome 3 Long-term (6 to 10 days). 58
Analysis 1.4. Comparison 1 Change in severity of overall symptoms - all trials, Outcome 4 Short-term ITT analysis. 59
Analysis 1.5. Comparison 1 Change in severity of overall symptoms - all trials, Outcome 5 Intermediate-term ITT
analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Analysis 1.6. Comparison 1 Change in severity of overall symptoms - all trials, Outcome 6 Long-term ITT analysis. . 60
Analysis 2.1. Comparison 2 Change in severity of overall symptoms - trials with sedating antihistamines, Outcome 1 Short-
term (1 to 2 days). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
Analysis 2.2. Comparison 2 Change in severity of overall symptoms - trials with sedating antihistamines, Outcome 2 Long-
term (6 to 10 days). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
Analysis 3.1. Comparison 3 Subjective severity assessment of nasal obstruction - al l trials, Outcome 1 Mean severity score
after 1 day of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
Analysis 3.2. Comparison 3 Subjective severity assessment of nasal obstruction - al l trials, Outcome 2 Mean severity score
after 3 to 5 days of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
Analysis 4.1. Comparison 4 Subjective severity assessment of nasal obstruction - non-sedating antihistamines, O utcome 1
Mean se verity score after 1 day of treatment. . . . . . . . . . . . . . . . . . . . . . . . 65
Analysis 4.2. Comparison 4 Subjective severity assessment of nasal obstruction - non-sedating antihistamines, O utcome 2
Mean se verity score after 3 to 5 days of treatment. . . . . . . . . . . . . . . . . . . . . . 65
Analysis 5.1. Comparison 5 Subjective severity assessment of nasal obstruction - antihistamines, Outcome 1 Mean severity
score after 1 day of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
Analysis 5.2. Comparison 5 Subjective severity assessment of nasal obstruction - antihistamines, Outcome 2 Mean severity
score after 3 to 5 days of treatment. . . . . . . . . . . . . . . . . . . . . . . . . . . 67
Analysis 6.1. Comparison 6 Subjective severity assessment of rhinorrhoea - all trials, Outcome 1 First treatment day. 68
Analysis 6.2. Comparison 6 Subjective severity assessment of rhinorrhoea - all trials, Outcome 2 Second treatment day. 69
Analysis 6.3. Comparison 6 Subjective severity assessment of rhinorrhoea - all trials, Outcome 3 Third treatment day. 70
Analysis 6.4. Comparison 6 Subjective severity assessment of rhinorrhoea - all trials, Outcome 4 Fourth treatment day. 71
Analysis 7.1. Comparison 7 Subjective severity assessment of rhinorrhoea - non-sedating antihistamines, Outcome 1 Fourth
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Analysis 8.1. Comparison 8 Subjective severity assessment of rhinorrhoea - sedating antihistamines, Outcome 1 First
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
iAntihistamines for the common cold (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Analysis 8.2. Comparison 8 Subjective severity assessment of rhinorrhoea - sedating antihistamines, Outcome 2 Second
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Analysis 8.3. Comparison 8 Subjective severity assessment of rhinorrhoea - sedating antihistamines, Outcome 3 Third
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
Analysis 8.4. Comparison 8 Subjective severity assessment of rhinorrhoea - sedating antihistamines, O utcome 4 Fourth
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Analysis 9.1. Comparison 9 Subjective severity assessment of sneezing - all trials, Outcome 1 First treatment day. . . 77
Analysis 9.2. Comparison 9 Subjective severity assessment of sneezing - all trials, Outcome 2 Second treatment day. . 78
Analysis 9.3. Comparison 9 Subjective severity assessment of sneezing - all trials, Outcome 3 Third treatment day. . 79
Analysis 9.4. Comparison 9 Subjective severity assessment of sneezing - all trials, Outcome 4 Fourth treatment day. . 80
Analysis 10.1. Comparison 10 Subjective severity assessment of sneezing - sedating antihistamines, Outcome 1 First
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Analysis 10.2. Comparison 10 Subjective severity assessment of sneezing - sedating antihistamines, Outcome 2 Second
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Analysis 10.3. Comparison 10 Subjective severity assessment of sneezing - sedating antihistamines, Outcome 3 Third
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Analysis 10.4. Comparison 10 Subjective severity assessment of sneezing - sedating antihistamines, Outcome 4 Fourth
treatment day. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
Analysis 11.1. Comparison 11 Side effects, Outcome 1 All side effects - all trials. . . . . . . . . . . . . . 85
Analysis 11.2. Comparison 11 Side effects, Outcome 2 All side effects - non-sedating antihistamines. . . . . . . 86
Analysis 11.3. Comparison 11 Side effects, Outcome 3 Gastrointestinal side effects. . . . . . . . . . . . . 87
Analysis 11.4. Comparison 11 Side effects, Outcome 4 Sedation - all trials. . . . . . . . . . . . . . . . 88
Analysis 11.5. Comparison 11 Side effects, Outcome 5 Sedation - non-sedating antihistamines. . . . . . . . . 89
Analysis 11.6. Comparison 11 Side effects, Outcome 6 Sedation - sedating antihistamine. . . . . . . . . . . 90
Analysis 11.7. Comparison 11 Side effects, Outcome 7 All side effects - se dating antihistamines. . . . . . . . 91
Analysis 11.8. Comparison 11 Side effects, Outcome 8 Sleeplessness. . . . . . . . . . . . . . . . . . 92
Analysis 11.9. Comparison 11 Side effects, Outcome 9 Dry nose. . . . . . . . . . . . . . . . . . . 92
Analysis 11.10. Comparison 11 Side effects, Outcome 10 Headache. . . . . . . . . . . . . . . . . . 93
Analysis 11.11. Comparison 11 Side effects, Outcome 11 Vertigo/dizziness. . . . . . . . . . . . . . . 94
Analysis 11.12. Comparison 11 Side effects, Outcome 12 Dry mouth. . . . . . . . . . . . . . . . . 95
95ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
97APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
101CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
101DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
101SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
102DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
102INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
iiAntihistamines for the common cold (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Review]
Antihistamines for the common cold
An IM De Sutter
1, 2
, Avadhesh Saraswat
3
, Mieke L van Driel
1, 4, 5
1
Department of Family Medicine and Primary Health Care, Ghent University, Ghent, Bel gium.
2
Heymans Institute of Pharmacology,
Ghent University, Ghent, Belgium.
3
Gold Coast University Hospital, Q ueensland Health, Southport, Australia.
4
Discipline of General
Practice, School of Medicine, The University of Queensland, Brisbane, Australia.
5
Centre for Research in Evidence-Based Practice
(CREBP), Bond University, Gold Coast, Australia
Contact address: An IM De Sutter, Department of Family Medicine and Primary Health Care, Ghent University, De Pintelaan 185,
UZ 1K3, Ghent, B-9000, Belgium.
an.desutter@UGent.be.
Editorial group: Cochrane Acute Respiratory Infections Group.
Publication status and date: New, published in Issue 11, 2015.
Review content assessed as up-to-date: 19 August 2015.
Citation: De Sutter AIM, Saraswat A, van Driel ML. Antihistamines for the common cold. Cochrane Database of Systematic Reviews
2015, Issue 11. Art. No.: CD009345. DOI: 10.1002/14651858.CD009345.pub2.
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
A B S T R A C T
Background
The common cold is an upper respiratory tract infection, most commonly caused by a rhinovirus. It affects people of all age groups
and although in most cases it is self limiting, the common cold still causes significant morbidity. Antihistamines are commonly offe red
over the counter to relieve symptoms for patients affecte d by the common cold, however there is not much evidence of their efficacy.
Objectives
To assess the effects of antihistamines on the common cold.
Search methods
We searched CENTRAL (2015, Issue 6), MEDLINE (1948 to July week 4, 2015), EMBASE (2010 to August 2015), CINAHL (1981
to August 2015), LILACS (1982 to August 2015) and Biosis Previews (1985 to August 2015).
Selection criteria
We selected randomised controlled trials (RCTs) using antihistamines as monotherapy for the common cold. We excluded any studies
with combination therapy or using antihistamines in patients with an allergic component in their illness.
Data collection and analysis
Two authors independently assessed trial quality and extracted data. We collected adverse ef fects information from the included trials.
Main results
We included 18 RCTs, which were reported in 17 publications (one publication reports on two trials) with 4342 participants (of which
212 were children) suffering from the common cold, both naturally occurring and experimentally induced. The interventions consisted
of an antihistamine as monotherapy compared with placebo. In adults there was a short-term beneficial effect of antihistamines on
severity of overall symptoms: on day one or two of treatment 45% had a beneficial effect with antihistamines versus 38% with placebo
(odds ratio (OR) 0.74, 95% confidence interval (CI) 0.60 to 0.92). However, there was no difference between antihistamines and
placebo in the mid term (three to four days) to long term (six to 10 days). When evaluating individual symptoms such as nasal congestion,
rhinorrhoea and sneezing, there was some beneficial e ffect of the sedating antihistamines compared to placebo (e.g. rhinorrhoea on
1Antihistamines for the common cold (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
day three: mean difference (MD) -0.23, 95% CI -0.39 to -0.06 on a four- or five-point severity scale; sneezing on day three: MD -
0.35, 95% CI -0.49 to -0.20 on a four-point severity scale), but this effect is clinically non-significant. Adverse events such as sedation
were more commonly reported with sedating antihistamines although the differences were not statistically significant. Only two trials
included children and the results were conflicting. The majority of the trials had a low risk of bias although some lacked sufficient trial
quality information.
Authors’ conclusions
Antihistamines have a limited short-term (days one and two of treatment) beneficial e ffect on severity of overall symptoms but not
in the mid to long term. There is no clinically significant effect on nasal obstruction, rhinorrhoea or sneezing. Although side effects
are more common with sedating antihistamines, the difference is not statistically significant. There is no evidence of effectiveness of
antihistamines in children.
P L A I N L A N G U A G E S U M M A R Y
Antihistamines for the common cold
Review question
We reviewed evidence f or the effectiveness of antihistamines on signs and symptoms of the common cold. We identified 18 trials with
4342 participants.
Background
On average, young children have six to eight colds per y ear and adults have two to four. Common cold symptoms include sore throat,
nasal stuffiness and discharge, sneezing and cough. It is caused by viruses and usually resolves by itself within one to two weeks. However,
the common cold has a large impact on time off work or school.
As there is no cure for the common cold, only symptomatic treatment is available. Antihistamines are effective for aller gic symptoms
such as hay f ever. Nasal symptoms of hay fever are similar to common cold symptoms and so trials h ave been conducted to see whether
antihistamines improve common cold symptoms.
Study characteristics
The e vidence is current to August 2015.
The participants were adults or children with a common cold. We excluded studies with participants suffering f r om hay fever, asthma or
eczema. The effect of different antihistamines was compared to placebo. A beneficial effect meant a decrease in the severity or duration
of the general feeling of illness and/or of specific symptoms such as stuffy nose, runny nose or sneezing. We al so investigated whether
side effects were more common with antihistamines than placebo.
As the common cold usually resolves in seven to 10 days, most studies were of short duration. Where possible we studied the immediate
effect and the effect after six to 10 days. Most studies were of good quality although in some studies information to allow us to assess
quality was lacking. We considered five out of 16 adults studies and one out of two paediatric studies to be of excellent quality.
All trials outlined the financial support received from pharmaceutical companies in the form of grants, supplying the respective
intervention drug or having an author currently employed by a pharmaceutical company.
Key results
In adults, there is a short-term beneficial effect on severity of overall symptoms on the first or second day of treatment (45% f elt better
versus 38% with placebo), but there was no difference between antihistamines and placebo in the mid to long term. The effect of
sedating antihistamines on rhinorrhoea and sneezing is too small to be relevant to the patient and involves a risk of side effects such as
sedation (9% versus 5.2% with placebo). Trials in children were smaller and of lower quality and lacked evidence of effectiveness.
2Antihistamines for the common cold (Review)
Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Citations
More filters
Journal Article•DOI•
Risk of first-generation H(1)-antihistamines: a GA(2)LEN position paper

[...]

M. K. Church1, M. K. Church2, Marcus Maurer1, F. E. R. Simons3, Carsten Bindslev-Jensen4, P. Van Cauwenberge5, Jean Bousquet, S. T. Holgate2, T. Zuberbier1 •
Charité1, University of Southampton2, University of Manitoba3, Odense University Hospital4, Ghent University5
01 Apr 2010-Allergy
TL;DR: Risk of first‐generation H1‐antihistamines: a GA2LEN position paper and implications for clinical practice are outlined.
Abstract: BACKGROUND: First-generation H(1)-antihistamines obtained without prescription are the most frequent form of self-medication for allergic diseases, coughs and colds and insomnia even though they have potentially dangerous unwanted effects which are not recognized by the general public. AIMS: To increase consumer protection by bringing to the attention of regulatory authorities, physicians and the general public the potential dangers of the indiscriminate use first-generation H(1)-antihistamines purchased over-the counter in the absence of appropriate medical supervision. METHODS: A GA(2)LEN (Global Allergy and Asthma European Network) task force assessed the unwanted side-effects and potential dangers of first-generation H1-antihistamines by reviewing the literature (Medline and Embase) and performing a media audit of US coverage from 1996 to 2008 of accidents and fatal adverse events in which these drugs were implicated. RESULTS: First-generation H(1)-antihistamines, all of which are sedating, are generally regarded as safe by laypersons and healthcare professionals because of their long-standing use. However, they reduce rapid eye movement (REM)-sleep, impair learning and reduce work efficiency. They are implicated in civil aviation, motor vehicle and boating accidents, deaths as a result of accidental or intentional overdosing in infants and young children and suicide in teenagers and adults. Some exhibit cardiotoxicity in overdose. CONCLUSIONS: This review raises the issue of better consumer protection by recommending that older first-generation H(1)-antihistamines should no longer be available over-the-counter as prescription- free drugs for self-medication of allergic and other diseases now that newer second- generation nonsedating H(1)-antihistamines with superior risk/benefit ratios are widely available at competitive prices. Language: en

344 citations

Journal Article•DOI•
Prevention and treatment of the common cold: making sense of the evidence

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G. Michael Allan, Bruce Arroll
18 Feb 2014-Canadian Medical Association Journal
TL;DR: The common cold is an acute, self-limiting viral infection of the upper respiratory tract involving the nose, sinuses, pharynx and larynx.
Abstract: The common cold is an acute, self-limiting viral infection of the upper respiratory tract involving the nose, sinuses, pharynx and larynx. The virus is spread by hand contact with secretions from an infected person (direct or indirect) or aerosol of the secretions and virus.[1][1] The incubation

161 citations

Journal Article•DOI•
Parental Misinterpretations of Over-the-Counter Pediatric Cough and Cold Medication Labels

[...]

Nicole Lokker1, Lee M. Sanders2, Eliana M. Perrin, Disha Kumar3, Joanne P. Finkle4, Vivian I. Franco2, Leena Choi3, Philip E. Johnston5, Russell L. Rothman3 •
University of Wisconsin Hospital and Clinics1, University of Miami2, Vanderbilt University3, University of North Carolina at Chapel Hill4, Belmont University5
01 Jun 2009-Pediatrics
TL;DR: Caregivers with lower numeracy skills were more likely to provide inappropriate reasons for giving an over-the-counter medication, and opportunities exist for the Food and Drug Administration and manufacturers to revise existing labels to improve parental comprehension and enhance child safety.
Abstract: Over-the-counter (OTC) cough and cold products for infants have come under increased scrutiny in the past year by the US Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and consumer health care groups1–5 Use of OTC cold and cough products containing antihistamines and decongestants have been implicated in the deaths of >100 infants nationwide in the past 40 years and have been associated with many adverse events and emergency department visits from overdose or misuse5–7 Although these products are FDA-approved for use in adults, they have not been adequately tested for safety or efficacy in young children,8–15 and several studies have not found significant clinical efficacy8,10–15 Recently, an FDA advisory committee recommended against the use of OTC cough and cold medications in children under 6 years of age, and a subsequent FDA public health advisory was issued recommending against the use of these medications in children <2 years of age9,16,17 Although most manufacturers voluntarily removed products aimed toward children <2 years of age from the market, and have revised labels to warn against use in children under 4, some major manufacturers have disagreed with the recommendations against the use of these products for children ages 4 and above18,19 Various pediatric cold and cough products, including many products aimed at children age ≥4, remain on the market, with no specific FDA ban9,17 The FDA expects a long process before any new regulations governing these medications are enacted, and studies of how parents use and interpret child OTC cold products may inform help this process9,20,21 Many parents may have difficulty understanding the indications and appropriate dosing of OTC medications In 2003, the National Assessment of Adult Literacy found that ~90 million Americans have basic or below basic literacy skills, and >110 million people have basic or poor quantitative skills22 Low-literacy skills are associated with worse understanding of medication labels, worse knowledge of one’s disease, and worse clinical outcomes23–33 The role of quantitative skills, or numeracy, has been less studied,34,35 but one recent study found that low numeracy was associated with poorer understanding of food labels36 Little is known about caregivers’ ability to choose and dose medications appropriately for their infants and young children37 The objectives of this study were to (1) examine caregiver understanding of the age indication of OTC cold and cough medication labels of products that were commonly marketed for infants or young children <2 years of age, (2) assess the relationship between caregiver literacy and numeracy skills and understanding of OTC labels, and (3) determine how language and graphics on OTC products influences caregivers’ decisions Although the OTC products used in this study were subsequently voluntarily removed from the market by manufacturers, these products could potentially return to the market, and the study has important implications relevant to caregiver understanding and safety of all OTC medications marketed for use with infants and children

130 citations

Journal Article•
Treatment of the common cold in children and adults.

[...]

Julia Fashner, Kevin Ericson, Sarah Werner
15 Jul 2012-American Family Physician
TL;DR: Prophylactic vitamin C modestly reduces cold symptom duration in adults and children, and nonsteroidal anti-inflammatory drugs and some herbal preparations, including Echinacea purpurea, improve symptoms in adults.
Abstract: The common cold, or upper respiratory tract infection, is one of the leading reasons for physician visits. Generally caused by viruses, the common cold is treated symptomatically. Antibiotics are not effective in children or adults. In children, there is a potential for harm and no benefits with over-the-counter cough and cold medications; therefore, they should not be used in children younger than four years. Other commonly used medications, such as inhaled corticosteroids, oral prednisolone, and Echinacea, also are ineffective in children. Products that improve symptoms in children include vapor rub, zinc sulfate, Pelargonium sidoides (geranium) extract, and buckwheat honey. Prophylactic probiotics, zinc sulfate, nasal saline irrigation, and the herbal preparation Chizukit reduce the incidence of colds in children. For adults, antihistamines, intranasal corticosteroids, codeine, nasal saline irrigation, Echinacea angustifolia preparations, and steam inhalation are ineffective at relieving cold symptoms. Pseudoephedrine, phenylephrine, inhaled ipratropium, and zinc (acetate or gluconate) modestly reduce the severity and duration of symptoms for adults. Nonsteroidal anti-inflammatory drugs and some herbal preparations, including Echinacea purpurea, improve symptoms in adults. Prophylactic use of garlic may decrease the frequency of colds in adults, but has no effect on duration of symptoms. Hand hygiene reduces the spread of viruses that cause cold illnesses. Prophylactic vitamin C modestly reduces cold symptom duration in adults and children.

120 citations

Journal Article•DOI•
H1 Antihistamines: Current Status and Future Directions

[...]

F. Estelle R. Simon, Keith J. Simons1•
University of Manitoba1
15 Sep 2008-World Allergy Organization Journal
TL;DR: This review compares and contrasts the clinical pharmacology, efficacy, and safety of first-generation and second-generation H1 antihistamines, which have been in use for more than 6 decades and are the H1Antihistamines of choice in the treatment of allergic rhinitis, allergic conjunctivitis, and urticaria.
Abstract: In this review, we compare and contrast the clinical pharmacology, efficacy, and safety of first-generation H1 antihistamines and second-generation H1 antihistamines. First-generation H1 antihistamines cross the blood-brain barrier, and in usual doses, they potentially cause sedation and impair cognitive function and psychomotor performance. These medications, some of which have been in use for more than 6 decades, have never been optimally investigated. Second-generation H1 antihistamines such as cetirizine, desloratadine, fexofenadine, levocetirizine, and loratadine cross the blood-brain barrier to a significantly smaller extent than their predecessors. The clinical pharmacology, efficacy, and safety of these medications have been extensively studied. They are therefore the H1 antihistamines of choice in the treatment of allergic rhinitis, allergic conjunctivitis, and urticaria. In the future, clinically advantageous H1 antihistamines developed with the aid of molecular techniques might be available.

93 citations

References
More filters
Journal Article•DOI•
Assessing the quality of reports of randomized clinical trials : is blinding necessary?

[...]

Alejandro R. Jadad1, R. A. Moore1, Dawn Carroll1, C. Jenkinson1, David Reynolds1, David J. Gavaghan1, Henry J McQuay1 •
University of Oxford1
01 Feb 1996-Controlled Clinical Trials
TL;DR: An instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research is described and its use to determine the effect of rater blinding on the assessments of quality is described.
Abstract: It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process There is very little evidence in the literature to substantiate this This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality A multidisciplinary panel of six judges produced an initial version of the instrument Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples Seven were allocated randomly to perform the assessments under blind conditions The final version of the instrument included three items These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples Blind assessments produced significantly lower and more consistent scores than open assessments The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed

15,740 citations

Journal Article•DOI•
Transmission of the Common Cold to Volunteers Under Controlled Conditions: I. The Common Cold as a Clinical Entity

[...]

George Gee Jackson, Harry F. Dowling, Irwin G. Spiesman, Arthur V. Boand
01 Feb 1958-A.M.A. archives of internal medicine
TL;DR: Transmission to humans appears to be the best method for study of the nature of the infection, factors that influence the susceptibility or resistance of the human host, and conditions that favor spread of the illness.
Abstract: The common cold is one of the most frequent and universal infections of man. Nevertheless, little is known regarding its specific etiology, and the diagnosis must be a clinical one. Until the infectious agent can be propagated, characterized by microbiologic and pathologic methods and consistently transmitted to experimental animals or in tissue cultures, transmission to humans appears to be the best method for study. In this manner, information can be obtained about the nature of the infection, factors that influence the susceptibility or resistance of the human host, and conditions that favor spread of the illness. During the past five years we have made observations upon more than 1000 volunteers who were challenged with infectious nasal secretions obtained from persons with a common cold or with a blank solution used as a control. The clinical findings were re- corded daily. Examination of the nose and throat was of no value

389 citations

Journal Article•DOI•
2000 Annual report of the American Association of Poison Control Centers Toxic Exposure Surveillance System.

[...]

Toby L. Litovitz1, Wendy Klein-Schwartz, Suzanne White, Daniel J. Cobaugh, Jessica Youniss, Judith C. Omslaer, Alison Drab, Blaine E. Benson •
Children's of Alabama1
01 Sep 2001-American Journal of Emergency Medicine

330 citations

Journal Article•DOI•
Over-the-counter cold medications. A critical review of clinical trials between 1950 and 1991.

[...]

Michael B. H. Smith1, William Feldman•
Boston Children's Hospital1
05 May 1993-JAMA
TL;DR: No good evidence has demonstrated the effectiveness of over-the-counter cold medications in preschool children, and further studies are required to clarify the role of these medications in children.
Abstract: Objective. —To determine whether over-the-counter cold medications have been shown to be effective in relieving symptoms in children, adolescents, and adults. Data Sources. —The MEDLINE database using the key words combined with medications and research and review articles. Articles were retrieved if they were written in English and published between January 1950 and January 1991. Study Selection. —Articles were selected if they described a controlled clinical trial on the treatment of the common cold. Forty-eight percent of 106 articles met the selection criteria, and these were grouped by age into child studies ( Data Extraction. —Each article was scored on 11 criteria to determine scientific validity. Those articles scoring above 70% were included in the final analysis. Two authors independently scored a sample of articles to determine interrater reliability. Data Synthesis. —Very few studies have been performed on children. Of those, two done on preschool children demonstrated no symptom relief, whereas two done on older children showed some benefit. In the adolescent/adult studies, chlorpheniramine maleate, pseudoephedrine hydrochloride, oxymetazoline hydrochloride, phenylpropanolamine hydrochloride, ipratropium bromide, and atropine methonitrate all improved nasal symptoms. Combination therapy (using an antihistamine-decongestant mix) was shown to relieve a variety of symptoms. Conclusions. —No good evidence has demonstrated the effectiveness of over-the-counter cold medications in preschool children. Furthur studies are required to clarify the role of these medications in children. Certain single over-the-counter medications and combinations have been shown to reduce cold symptoms in adolescents and adults. (JAMA. 1993;269:2258-2263)

223 citations

Journal Article•DOI•
Cough and the common cold

[...]

Frederick J. Curley1, Richard S. Irwin, Melvin R. Pratter, Diane H. Stivers, Gary V. Doern, Paul A. Vernaglia, Andrew B. Larkin, Stephen P. Baker •
University of Massachusetts Medical School1
01 Aug 1988-The American review of respiratory disease
TL;DR: It is concluded that the cough of the common cold arose from upper respiratory tract stimuli and that cough and other cardinal symptoms of thecommon cold were reduced with antihistamine-decongestant therapy when these symptoms were at their worst.
Abstract: To determine whether the cough of the common cold arises from upper respiratory stimuli and whether antihistamine-decongestant therapy is an effective treatment for this cough, we prospectively evaluated volunteers with uncomplicated common colds in a randomized, double-blind, placebo-controlled study. After completing a standardized questionnaire and undergoing a physical examination, throat-culturing, and pulmonary function testing, subjects took the active drug or identical-appearing placebo for 7 days while they kept a diary in which they ranked the severity of 17 symptoms for 14 days. Pulmonary function testing was repeated, on average, on Days 4, 8, and 14. Forty-six percent of the variation in cough severity could be explained by throat-clearing and 47% of the variation in throat-clearing severity by postnasal drip. FIF50%, the only physiologic parameter that significantly correlated with cough, rose as cough severity fell. Antihistamine-decongestant therapy reduced postnasal drip and significantly decreased the severity of cough, nasal obstruction, nasal discharge, and throat-clearing during the first few days of the common cold. In addition, cough was 20 to 30% less prevalent in the active drug group within 3 days of starting therapy. We conclude that the cough of the common cold arose from upper respiratory tract stimuli and that cough and other cardinal symptoms of the common cold were reduced with antihistamine-decongestant therapy when these symptoms were at their worst.

162 citations

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Frequently Asked Questions (1)
Q1. What are the contributions in "Cochrane database of systematic reviews" ?

The authors reviewed evidence for the effectiveness of antihistamines on signs and symptoms of the common cold. The authors also investigated whether side effects were more common with antihistamines than placebo. Where possible the authors studied the immediate effect and the effect after six to 10 days. The authors considered five out of 16 adults studies and one out of two paediatric studies to be of excellent quality. All trials outlined the financial support received from pharmaceutical companies in the form of grants, supplying the respective intervention drug or having an author currently employed by a pharmaceutical company. No of participants ( studies ) Quality of the evidence ( GRADE ) Comments Assumed risk Corresponding risk Placebo Antihistamines Change in severity of overall symptoms: short-term Subjective severity score Follow-up: 1 to 2 days Study population OR 0. 74 ( 0. 60 to 0. 92 ) 1490 ( 3 studies ) ⊕⊕⊕© moderate1 623 per 1000 550 per 1000 ( 498 to 603 )