-
The Cochrane Database of Systematic... Oct 2016Many treatments for the common cold exist and are sold over-the-counter. Nevertheless, evidence on the effectiveness and safety of nasal decongestants is limited. (Meta-Analysis)
Meta-Analysis Review
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 topical decongestant); meta-analysis showed that there was no statistical difference between the number of adverse events in the treatment group (125 per 1000) compared to the placebo group (126 per 1000). The odds ratio (OR) for adverse events in the treatment group was 0.98 (95% CI 0.68 to 1.40; P = 0.90; GRADE: low-quality evidence). The results remained the same when we only considered studies using an oral decongestant (OR 0.95, 95% CI 0.65 to 1.39; P = 0.80; GRADE: low-quality evidence).
AUTHORS' CONCLUSIONS
We were unable to draw conclusions on the effectiveness of single-dose nasal decongestants due to the limited evidence available. For multiple doses of nasal decongestants, the current evidence suggests that these may have a small positive effect on subjective measures of nasal congestion in adults with the common cold. However, the clinical relevance of this small effect is unknown and there is insufficient good-quality evidence to draw any firm conclusions. Due to the small number of studies that used a topical nasal decongestant, we were also unable to draw conclusions on the effectiveness of oral versus topical decongestants. Nasal decongestants do not seem to increase the risk of adverse events in adults in the short term. The effectiveness and safety of nasal decongestants in children and the clinical relevance of their small effect in adults is yet to be determined.
Topics: Administration, Intranasal; Adult; Child; Common Cold; Humans; Imidazoles; Nasal Decongestants; Oxymetazoline; Phenylpropanolamine; Pseudoephedrine; Randomized Controlled Trials as Topic; Time Factors
PubMed: 27748955
DOI: 10.1002/14651858.CD009612.pub2 -
Frontiers in Psychiatry 2021Over the past 20 years or so, the drug misuse scenario has seen the emergence of both prescription-only and over-the-counter (OTC) medications being reported as...
Over the past 20 years or so, the drug misuse scenario has seen the emergence of both prescription-only and over-the-counter (OTC) medications being reported as ingested for recreational purposes. OTC drugs such as antihistamines, cough/cold medications, and decongestants are reportedly the most popular in being diverted and misused. While the current related knowledge is limited, the aim here was to examine the published clinical data on OTC misuse, focusing on antihistamines (e.g., diphenhydramine, promethazine, chlorpheniramine, and dimenhydrinate), dextromethorphan (DXM)- and codeine-based cough medicines, and the nasal decongestant pseudoephedrine. A systematic literature review was carried out with the help of Scopus, Web of Science databases, and the related gray literature. For data gathering purposes, both the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and PROSPERO guidelines were followed (PROSPERO identification code CRD42020209261). After completion of the selection, eligibility, and screening phases, some 92 articles were here taken into consideration; case reports, surveys, and retrospective case series analyses were included. Findings were organized according to the specific OTC recorded. Most articles focused here on DXM ( = 54) and diphenhydramine ( = 12). When specified, dosages, route(s) of administration, toxicity symptoms (including both physical and psychiatric ones), and outcomes were here reported. Results from the systematic review showed that the OTC misusing issues are both widespread worldwide and popular; vulnerable categories include adolescents and young adults, although real prevalence figures remain unknown, due to a lack of appropriate monitoring systems. Considering the potential, and at times serious, adverse effects associated with OTC misusing issues, healthcare professionals should be vigilant, and preventative actions should be designed and implemented.
PubMed: 34025478
DOI: 10.3389/fpsyt.2021.657397 -
BMJ Clinical Evidence Dec 2011Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is... (Review)
Review
INTRODUCTION
Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, additional malaise and fever. It affects 1% to 5% of the adult population each year in Europe.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with clinically diagnosed acute sinusitis, and in people with radiologically or bacteriologically confirmed acute sinusitis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2011 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics (amoxicillin, amoxicillin-clavulanic acid [co-amoxiclav], doxycycline, cephalosporins, macrolides; different doses, long-course regimens), antihistamines, decongestants (xylometazoline, phenylephrine, pseudoephedrine), saline nasal washes, steam inhalation, and topical corticosteroids (intranasal).
Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Double-Blind Method; Evidence-Based Medicine; Humans; Macrolides; Sinusitis
PubMed: 22189346
DOI: No ID Found -
BMJ Clinical Evidence Jun 2008Each year, children suffer up to 5 colds and adults have 2-3 infections, leading to time off school or work, and considerable discomfort. Most symptoms resolve within a... (Review)
Review
INTRODUCTION
Each year, children suffer up to 5 colds and adults have 2-3 infections, leading to time off school or work, and considerable discomfort. Most symptoms resolve within a week, but coughs often persist for longer.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for common cold? We searched: Medline, Embase, The Cochrane Library and other important databases up to May 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: analgesics or anti-inflammatory drugs, antibiotics, antihistamines, decongestants (norephedrine, oxymetazoline, or pseudoephedrine), decongestants plus antihistamine, echinacea, steam inhalation, vitamin C, and zinc (intranasal gel or lozenges).
Topics: Acute Disease; Common Cold; Cough; Echinacea; Humans; Nasal Decongestants; Phenylpropanolamine
PubMed: 19450292
DOI: No ID Found -
BMJ Clinical Evidence Mar 2008Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is... (Review)
Review
INTRODUCTION
Acute sinusitis is defined pathologically, by transient inflammation of the mucosal lining of the paranasal sinuses lasting less than 4 weeks. Clinically, it is characterised by nasal congestion, rhinorrhoea, facial pain, hyposmia, sneezing, and, if more severe, additional malaise and fever. It affects 1-5% of the adult population each year in Europe.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments in people with clinically diagnosed acute sinusitis, and with radiologically or bacteriologically confirmed acute sinusitis? We searched: Medline, Embase, The Cochrane Library and other important databases up to August 2007 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 19 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: antibiotics (amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides, different doses [amoxicillin, co-amoxiclav, doxycycline, cephalosporins, macrolides], long-course regimens), antihistamines, cephalosporins or macrolides, decongestants (xylometazoline, phenylephrine, pseudoephedrine), doxycycline, saline nasal washes, steam inhalation, and topical corticosteroids (intra-nasal).
Topics: Acute Disease; Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Double-Blind Method; Evidence-Based Medicine; Humans; Macrolides; Sinusitis
PubMed: 19450327
DOI: No ID Found -
BMJ Clinical Evidence Jan 2015Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children... (Review)
Review
INTRODUCTION
Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children might have changes to the ear drum after a flight, although perforation is rare. Symptoms usually resolve spontaneously.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent middle-ear pain during air travel? We searched: Medline, Embase, The Cochrane Library and other important databases up to July 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found three studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: nasal balloon inflation, nasal decongestants (topical), and oral pseudoephedrine.
Topics: Air Travel; Earache; Humans; Nasal Decongestants; Pseudoephedrine
PubMed: 25599243
DOI: No ID Found -
Orphanet Journal of Rare Diseases Jan 2024The aetiology of gastroschisis is considered multifactorial. We conducted a systematic review and meta-analysis to assess whether the use of medications during... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
The aetiology of gastroschisis is considered multifactorial. We conducted a systematic review and meta-analysis to assess whether the use of medications during pregnancy, is associated with the risk of gastroschisis in offspring.
METHODS
PubMed, EMBASE, and Scopus were searched from 1st January 1990 to 31st December 2020 to identify observational studies examining the association between medication use during pregnancy and the risk of gastroschisis. The Newcastle-Ottawa Scale was used for the quality assessment of the individual studies. We pooled adjusted measures using a random-effect model to estimate relative risk [RR] and the 95% confidence interval [CI]. I statistic for heterogeneity and publication bias was calculated.
RESULTS
Eighteen studies providing data on 751,954 pregnancies were included in the meta-analysis. Pooled RRs showed significant associations between aspirin (RR 1.66, 95% CI 1.16-2.38; I = 58.3%), oral contraceptives (RR 1.52, 95% CI 1.21-1.92; I = 22.0%), pseudoephedrine and phenylpropanolamine (RR 1.51, 95% CI 1.16-1.97; I = 33.2%), ibuprofen (RR 1.42, 95% CI 1.26-1.60; I = 0.0%), and gastroschisis. No association was observed between paracetamol and gastroschisis (RR 1.16, 95% CI 0.96-1.41; I = 39.4%).
CONCLUSIONS
These results suggest that the exposure in the first trimester of pregnancy to over the counter medications (OTC) such as aspirin, ibuprofen, pseudoephedrine and phenylpropanolamine as well as to oral contraceptives, was associated with an increased risk of gastroschisis. However, these associations are significant only in particular subgroups defined by geographic location, adjustment variables and type of control. Therefore, further research is needed to investigate them as potential risk factors for gastroschisis, to assess their safety in pregnancy and to develop treatment strategies to reduce the risk of gastroschisis in offspring. PROSPERO registration number: CRD42021287529.
Topics: Female; Humans; Pregnancy; Aspirin; Contraceptives, Oral; Gastroschisis; Ibuprofen; Phenylpropanolamine; Pseudoephedrine; Observational Studies as Topic
PubMed: 38287353
DOI: 10.1186/s13023-023-02992-z -
BMJ Clinical Evidence Sep 2007Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children... (Review)
Review
INTRODUCTION
Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children might have damage to the ear drum after a flight, although perforation is rare. Symptoms usually resolve spontaneously.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent middle ear pain during air travel? We searched: Medline, Embase, The Cochrane Library and other important databases up to April 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 4 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: nasal balloon inflation, oral pseudoephedrine, and topical nasal decongestants.
Topics: Administration, Oral; Air Travel; Barotrauma; Ear, Middle; Earache; Humans; Incidence; Nasal Decongestants; Pain; Travel
PubMed: 19450303
DOI: No ID Found -
The Cochrane Database of Systematic... Jul 2013Acetaminophen is frequently prescribed for treating patients with the common cold, but there is little evidence as to whether it is effective. (Review)
Review
BACKGROUND
Acetaminophen is frequently prescribed for treating patients with the common cold, but there is little evidence as to whether it is effective.
OBJECTIVES
To determine the efficacy and safety of acetaminophen in the treatment of the common cold in adults.
SEARCH METHODS
We searched CENTRAL 2013, Issue 1, Ovid MEDLINE (1950 to January week 5, 2013), EMBASE (1980 to February 2013), CINAHL (1982 to February 2013) and LILACS (1985 to February 2013).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing acetaminophen to placebo or no treatment in adults with the common cold. Studies were included if the trials used acetaminophen as one ingredient of a combination therapy. We excluded studies in which the participants had complications. Primary outcomes included subjective symptom score and duration of common cold symptoms. Secondary outcomes were overall well being, adverse events and financial costs.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened studies for inclusion, assessed risk of bias and extracted data. We performed standard statistical analyses.
MAIN RESULTS
We included four RCTs involving 758 participants. We did not pool data because of heterogeneity in study designs, outcomes and time points. The studies provided sparse information about effects longer than a few hours, as three of four included studies were short trials of only four to six hours. Participants treated with acetaminophen had significant improvements in nasal obstruction in two of the four studies. One study showed that acetaminophen was superior to placebo in decreasing rhinorrhoea severity, but was not superior for treating sneezing and coughing. Acetaminophen did not improve sore throat or malaise in two of the four studies. Results were inconsistent for some symptoms. Two studies showed that headache and achiness improved more in the acetaminophen group than in the placebo group, while one study showed no difference between the acetaminophen and placebo group. None of the included studies reported the duration of common cold symptoms. Minor side effects (including gastrointestinal adverse events, dizziness, dry mouth, somnolence and increased sweating) in the acetaminophen group were reported in two of the four studies. One of them used a combination of pseudoephedrine and acetaminophen.
AUTHORS' CONCLUSIONS
Acetaminophen may help relieve nasal obstruction and rhinorrhoea but does not appear to improve some other cold symptoms (including sore throat, malaise, sneezing and cough). However, two of the four included studies in this review were small and allocation concealment was unclear in all four studies. The data in this review do not provide sufficient evidence to inform practice regarding the use of acetaminophen for the common cold in adults. Further large-scale, well-designed trials are needed to determine whether this intervention is beneficial in the treatment of adults with the common cold.
Topics: Acetaminophen; Adult; Common Cold; Humans; Nasal Obstruction; Randomized Controlled Trials as Topic; Rhinitis
PubMed: 23818046
DOI: 10.1002/14651858.CD008800.pub2 -
BMJ Open Sport & Exercise Medicine 2015Pseudoephedrine is a stimulant that can be purchased over-the-counter to relieve symptoms of nasal and sinus congestion. Owing to its similar composition to ephedrine...
OBJECTIVE
Pseudoephedrine is a stimulant that can be purchased over-the-counter to relieve symptoms of nasal and sinus congestion. Owing to its similar composition to ephedrine and other amphetamines, pseudoephedrine mirrors some of its ergogenic effects. This study investigates its possible ergogenic effect through a systematic review. Our primary aim was to determine the effects of pseudoephedrine in sport and its potential for performance enhancement.
DESIGN
We searched EMBASE, MEDLINE, PsychINFO and The Cochrane Library for trials conducted from their beginning to March 2015. Any published trial that used randomised assignment to the intervention and control groups in full text and measured pseudoephedrine as an independent variable were included.
RESULTS
Overall, the review showed that the ergogenic effect of pseudoephedrine is dose-dependent. None of the reviewed studies showed an ergogenic effect at the therapeutic dose of the drug (60-120 mg); however, supratherapeutic doses (≥180 mg) yielded clinically significant results.
CONCLUSIONS
Owing to the limitations of the published studies in this field, we were unable to make any firm conclusions with respect to the overall effect of pseudoephedrine and its ergogenic effect. It is evident that there is a correlation between the dose administered and its ergogenic effects, but it is also evident that the side effects of using above the therapeutic dose outweigh the possible benefits of using pseudoephedrine in sport. Further research with larger sample sizes is required to determine the relationship between doses (≥180 mg) and concentrations in urine that cause an ergogenic effect.
PubMed: 27900142
DOI: 10.1136/bmjsem-2015-000066