Common OTC Products: Are They Effective?
This section reviews the available evidence for the active ingredients most commonly found in OTC pain relievers and cough and cold products.
Analgesics
OTC analgesics are commonly used for treatment of mild to moderate aches and pains. They are generally safe and effective for short-term use when taken as directed. Three types of pain relievers are used in OTC products: salicylates (including aspirin and the less commonly used choline salicylate and sodium salicylate); propionic acid derivatives (ibuprofen, naproxen, ketoprofen); and aminophenols (acetaminophen).10 Salicylates and the propionic acid derivatives are known collectively as nonsteroidal anti-inflammatory drugs, or NSAIDs.
Meta-analyses of randomized controlled trials trials (RCTs) have found evidence of effectiveness for oral OTC pain relievers including aspirin,11 NSAIDs12 and acetaminophen.13 Studies comparing acetaminophen (1,000-mg dose) and NSAIDs show that NSAIDs are more effective than acetaminophen in the relief of some types of pain (e.g., dental pain, menstrual pain) but provide equivalent analgesia in others (e.g., orthopedic surgery).14,15 There appears to be no clinically significant difference in efficacy between the different types of NSAIDs.12 Decisions about which analgesic to recommend should be based on the following:
Meta-analyses of randomized controlled trials trials (RCTs) have found evidence of effectiveness for oral OTC pain relievers including aspirin,11 NSAIDs12 and acetaminophen.13 Studies comparing acetaminophen (1,000-mg dose) and NSAIDs show that NSAIDs are more effective than acetaminophen in the relief of some types of pain (e.g., dental pain, menstrual pain) but provide equivalent analgesia in others (e.g., orthopedic surgery).14,15 There appears to be no clinically significant difference in efficacy between the different types of NSAIDs.12 Decisions about which analgesic to recommend should be based on the following:
- Type of pain (keeping in mind, for example, that acetaminophen has no anti-inflammatory effect);
- Contraindications (for example, aspirin should not be given to children under age 18 because of the risk of Reye’s syndrome);
- Each medication’s side effect profile (see “Potential Adverse Events”).
Antihistamines
Evidence-based Practice Recommendation:
Second-generation, nonsedating antihistamines are not effective for treatment of cough associated with the common cold and should not be used.19
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/72S
Level of evidence: Fair
Benefit: None
Grade of recommendation: D
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/72S
Level of evidence: Fair
Benefit: None
Grade of recommendation: D
Some older studies have shown that first-generation antihistamines may reduce sneezing and rhinorrhea associated with the common cold; they may produce relief because of their anticholinergic, rather than antihistamine, effects.16,17
However, a more recent Cochrane Review found that first- and second-generation antihistamines, when used as monotherapy (i.e., without a decongestant), do not alleviate nasal congestion, sneezing or rhinorrhea, or provide subjective improvement of cold symptoms in children or adults. The review did find that the combination of a first-generation antihistamine and a decongestant may have some effect on nasal obstruction, sneezing and rhinorrhea in adolescents and adults, but did not provide any benefit in children aged six months to five years.18 In addition, the combination of a first-generation antihistamine and a decongestant appears to be effective in treating acute cough associated with the common cold in adults (see “Cough Medications”).19
However, a more recent Cochrane Review found that first- and second-generation antihistamines, when used as monotherapy (i.e., without a decongestant), do not alleviate nasal congestion, sneezing or rhinorrhea, or provide subjective improvement of cold symptoms in children or adults. The review did find that the combination of a first-generation antihistamine and a decongestant may have some effect on nasal obstruction, sneezing and rhinorrhea in adolescents and adults, but did not provide any benefit in children aged six months to five years.18 In addition, the combination of a first-generation antihistamine and a decongestant appears to be effective in treating acute cough associated with the common cold in adults (see “Cough Medications”).19
Decongestants
Systematic reviews of oral and topical decongestants have shown mixed results. Two reviews found that a single dose of an oral or topical decongestant provided moderate short-term benefit for adolescents and adults who had nasal congestion. The same reviews found that evidence for use of an oral decongestant (pseudoephedrine) for more than five days is inconclusive.20,21 However, another clinical trial showed that a 60-mg dose of pseudoephedrine, repeated four times a day over three days, improved nasal airway blockage and subjective scores in adults.22 As a practical matter, adult and adolescent patients seeking relief from nasal congestion can be advised to try either an oral or a topical decongestant and to continue short-term use only if they notice significant relief from their symptoms. In order to avoid rebound congestion, patients who choose a topical decongestant should be instructed not to use it for more than three days.
Decongestants as monotherapy have not been studied in children younger than 12 years, but anecdotal reports of toxicity23 suggest that decongestants should be avoided in young children.
Decongestants as monotherapy have not been studied in children younger than 12 years, but anecdotal reports of toxicity23 suggest that decongestants should be avoided in young children.
Phenylephrine: An Effective Substitute?
Until relatively recently, pseudoephedrine was the only oral decongestant
commonly found in OTC cough and cold medications. In the past few years,
however, limits on access to pseudoephedrine have caused manufacturers to substitute the decongestant phenylephrine in some products. Unfortunately, studies comparing pseudoephedrine and phenylephrine are lacking,24 and data regarding the effectiveness of oral phenylephrine have been inconsistent. One recent meta-analysis found that a 10-mg single oral dose of phenylephrine is effective in treating nasal congestion in adults who have the common cold25; however, another systematic review found insufficient evidence of effectiveness.26 Given the inconsistency of evidence, substitution of phenylephrine for pseudoephedrine remains somewhat controversial.24
In December 2007, the FDA’s Nonprescription Drugs Advisory Committee met to discuss phenylephrine. The Committee voted 11-1 that the existing evidence supports the effectiveness of a 10-mg dose of phenylephrine, but also called for more research into the 10-mg dose and for studies to determine whether a 25-mg dose may be more effective.27
Physicians and pharmacists can point out to patients that if a cough and cold product that used to contain pseudoephedrine is on the shelf, phenylephrine has been substituted for pseudoephedrine in the formulation—or, in some cases, the decongestant component has been removed completely. Patients should be encouraged to read the labels on these medications to determine whether the medication contains a decongestant component and, if so, which one. Adult patients who have found relief from using pseudoephedrine in the past can try phenylephrine to see whether they feel it provides similar relief. It should be noted, however, that symptom relief provided by phenylephrine lasts four hours, whereas that conferred by pseudoephedrine can last six, 12 or 24 hours, depending on the formulation used.
commonly found in OTC cough and cold medications. In the past few years,
however, limits on access to pseudoephedrine have caused manufacturers to substitute the decongestant phenylephrine in some products. Unfortunately, studies comparing pseudoephedrine and phenylephrine are lacking,24 and data regarding the effectiveness of oral phenylephrine have been inconsistent. One recent meta-analysis found that a 10-mg single oral dose of phenylephrine is effective in treating nasal congestion in adults who have the common cold25; however, another systematic review found insufficient evidence of effectiveness.26 Given the inconsistency of evidence, substitution of phenylephrine for pseudoephedrine remains somewhat controversial.24
In December 2007, the FDA’s Nonprescription Drugs Advisory Committee met to discuss phenylephrine. The Committee voted 11-1 that the existing evidence supports the effectiveness of a 10-mg dose of phenylephrine, but also called for more research into the 10-mg dose and for studies to determine whether a 25-mg dose may be more effective.27
Physicians and pharmacists can point out to patients that if a cough and cold product that used to contain pseudoephedrine is on the shelf, phenylephrine has been substituted for pseudoephedrine in the formulation—or, in some cases, the decongestant component has been removed completely. Patients should be encouraged to read the labels on these medications to determine whether the medication contains a decongestant component and, if so, which one. Adult patients who have found relief from using pseudoephedrine in the past can try phenylephrine to see whether they feel it provides similar relief. It should be noted, however, that symptom relief provided by phenylephrine lasts four hours, whereas that conferred by pseudoephedrine can last six, 12 or 24 hours, depending on the formulation used.
Cough Medications
Evidence-based Practice Recommendation:
In patients who have a cough associated with a URI, peripheral and central cough suppressants have limited efficacy for symptomatic relief and are not
recommended for this use.29
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/238S
Level of evidence: Good
Benefit: None
Grade of recommendation: D
recommended for this use.29
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/238S
Level of evidence: Good
Benefit: None
Grade of recommendation: D
Evidence-based Practice Recommendation:
Patients who have acute cough associated with thecommon cold can be treated with a antihistamine/decongestant preparation containing a first-generation antihistamine (brompheniramine and sustained-release pseudoephedrine were studied).19
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/72S
Level of evidence: Fair
Benefit: Substantial
Grade of recommendation: A
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/72S
Level of evidence: Fair
Benefit: Substantial
Grade of recommendation: A
Evidence-based Practice Recommendation:
In children who have a cough, cough suppressants and other OTC cough medicines should not be used because patients, especially young children, may experience significant morbidity and mortality.35
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/260S
Level of evidence: Good
Benefit: None
Grade of recommendation: D
Available at: http://www.chestjournal.org/
cgi/content/full/129/1_suppl/260S
Level of evidence: Good
Benefit: None
Grade of recommendation: D
In 2006, the American College of Chest Physicians (ACCP) published evidence-based practice guidelines on the treatment and management of cough in adults.28 For cough associated with a URI, the literature review on which the guidelines are based show limited efficacy for peripheral and central cough suppressants (e.g., codeine and dextromethorphan) (level of evidence: good); as such, these agents are not recommended by the guidelines.29 Although the ACCP guidelines state that dextromethorphan is not effective, some other studies concluded that it does confer a modest benefit for cough associated with URI in adults.30,31
The only inhaled anticholinergic agent that was recommended for cough suppression was ipratropium bromide (level of evidence = fair), which is only available by prescription.29 For acute cough (lasting fewer than three weeks) associated with the common cold, the guidelines recommend against using OTC combination cold medicines for symptom relief because of lack of evidence of effectiveness, with the exception of the use of the combination of a first-generation antihistamine and a decongestant (level of evidence: fair).19 It should be noted that the recommendation for this combination was made on the basis of one study, which looked at a preparation containing sustained-release pseudoephedrine and brompheniramine.32
The ACCP guidelines, as well as a Cochrane Review, found mixed evidence for the effective-ness of the expectorant guaifenesin. Neither gives a firm recommendation for or against its use.28,33
The ACCP guidelines do not address the treatment of acute cough in children, and no medication available in the United States has been shown to effectively treat acute cough associated with the common cold in children.33,34
The only inhaled anticholinergic agent that was recommended for cough suppression was ipratropium bromide (level of evidence = fair), which is only available by prescription.29 For acute cough (lasting fewer than three weeks) associated with the common cold, the guidelines recommend against using OTC combination cold medicines for symptom relief because of lack of evidence of effectiveness, with the exception of the use of the combination of a first-generation antihistamine and a decongestant (level of evidence: fair).19 It should be noted that the recommendation for this combination was made on the basis of one study, which looked at a preparation containing sustained-release pseudoephedrine and brompheniramine.32
The ACCP guidelines, as well as a Cochrane Review, found mixed evidence for the effective-ness of the expectorant guaifenesin. Neither gives a firm recommendation for or against its use.28,33
The ACCP guidelines do not address the treatment of acute cough in children, and no medication available in the United States has been shown to effectively treat acute cough associated with the common cold in children.33,34
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