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1.
The Powerful Placebo Effect in Cough: Relevance to Treatment and Clinical Trials.
Eccles, R
Lung. 2020;(1):13-21
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Abstract
Interest in the placebo effect of medicines has developed from the use of placebo treatments as controls in clinical trials into a whole new area of research around how placebos fit into a psychosocial model of therapeutics. The large placebo effect associated with cough medicines is both a problem and an opportunity for researchers: a problem for clinical trials on new actives as the active must beat the large placebo effect, and an opportunity for harnessing the placebo effect to produce effective cough medicines without any pharmacologically active ingredient. This review discusses the mechanisms associated with the placebo effect of cough medicines and distinguishes between a 'perceived placebo effect' and a true 'placebo effect'. The efficacy of sweeteners in cough syrups is discussed as well as viscosity, mucoadhesion, and flavoring. The complexity of modern cough medicines is demonstrated by an example of a medicine which contains one active ingredient, and eighteen excipients which provide a complex and intense sensory experience to enhance the placebo effect and complement the pharmacological activity of the medicine.
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2.
Honey for acute cough in children.
Oduwole, O, Udoh, EE, Oyo-Ita, A, Meremikwu, MM
The Cochrane database of systematic reviews. 2018;(4):CD007094
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Abstract
BACKGROUND Cough causes concern for parents and is a major cause of outpatient visits. Cough can impact quality of life, cause anxiety, and affect sleep in children and their parents. Honey has been used to alleviate cough symptoms. This is an update of reviews previously published in 2014, 2012, and 2010. OBJECTIVES To evaluate the effectiveness of honey for acute cough in children in ambulatory settings. SEARCH METHODS We searched CENTRAL (2018, Issue 2), which includes the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (2014 to 8 February 2018), Embase (2014 to 8 February 2018), CINAHL (2014 to 8 February 2018), EBSCO (2014 to 8 February 2018), Web of Science (2014 to 8 February 2018), and LILACS (2014 to 8 February 2018). We also searched ClinicalTrials.gov and the World Health Organization International Clinical Trial Registry Platform (WHO ICTRP) on 12 February 2018. The 2014 review included searches of AMED and CAB Abstracts, but these were not searched for this update due to lack of institutional access. SELECTION CRITERIA Randomised controlled trials comparing honey alone, or in combination with antibiotics, versus no treatment, placebo, honey-based cough syrup, or other over-the-counter cough medications for children aged 12 months to 18 years for acute cough in ambulatory settings. DATA COLLECTION AND ANALYSIS We used standard methodological procedures expected by Cochrane. MAIN RESULTS We included six randomised controlled trials involving 899 children; we added three studies (331 children) in this update.We assessed two studies as at high risk of performance and detection bias; three studies as at unclear risk of attrition bias; and three studies as at unclear risk of other bias.Studies compared honey with dextromethorphan, diphenhydramine, salbutamol, bromelin (an enzyme from the Bromeliaceae (pineapple) family), no treatment, and placebo. Five studies used 7-point Likert scales to measure symptomatic relief of cough; one used an unclear 5-point scale. In all studies, low score indicated better cough symptom relief.Using a 7-point Likert scale, honey probably reduces cough frequency better than no treatment or placebo (no treatment: mean difference (MD) -1.05, 95% confidence interval (CI) -1.48 to -0.62; I² = 0%; 2 studies; 154 children; moderate-certainty evidence; placebo: MD -1.62, 95% CI -3.02 to -0.22; I² = 0%; 2 studies; 402 children; moderate-certainty evidence). Honey may have a similar effect as dextromethorphan in reducing cough frequency (MD -0.07, 95% CI -1.07 to 0.94; I² = 87%; 2 studies; 149 children; low-certainty evidence). Honey may be better than diphenhydramine in reducing cough frequency (MD -0.57, 95% CI -0.90 to -0.24; 1 study; 80 children; low-certainty evidence).Giving honey for up to three days is probably more effective in relieving cough symptoms compared with placebo or salbutamol. Beyond three days honey probably had no advantage over salbutamol or placebo in reducing cough severity, bothersome cough, and impact of cough on sleep for parents and children (moderate-certainty evidence). With a 5-point cough scale, there was probably little or no difference between the effects of honey and bromelin mixed with honey in reducing cough frequency and severity.Adverse events included nervousness, insomnia, and hyperactivity, experienced by seven children (9.3%) treated with honey and two children (2.7%) treated with dextromethorphan (risk ratio (RR) 2.94, 95% Cl 0.74 to 11.71; I² = 0%; 2 studies; 149 children; low-certainty evidence). Three children (7.5%) in the diphenhydramine group experienced somnolence (RR 0.14, 95% Cl 0.01 to 2.68; 1 study; 80 children; low-certainty evidence). When honey was compared with placebo, 34 children (12%) in the honey group and 13 (11%) in the placebo group complained of gastrointestinal symptoms (RR 1.91, 95% CI 1.12 to 3.24; I² = 0%; 2 studies; 402 children; moderate-certainty evidence). Four children who received salbutamol had rashes compared to one child in the honey group (RR 0.19, 95% CI 0.02 to 1.63; 1 study; 100 children; moderate-certainty evidence). No adverse events were reported in the no-treatment group. AUTHORS' CONCLUSIONS Honey probably relieves cough symptoms to a greater extent than no treatment, diphenhydramine, and placebo, but may make little or no difference compared to dextromethorphan. Honey probably reduces cough duration better than placebo and salbutamol. There was no strong evidence for or against using honey. Most of the children received treatment for one night, which is a limitation to the results of this review. There was no difference in occurrence of adverse events between the honey and control arms.
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The potential of methylxanthine-based therapies in pediatric respiratory tract diseases.
Oñatibia-Astibia, A, Martínez-Pinilla, E, Franco, R
Respiratory medicine. 2016;:1-9
Abstract
Caffeine, theophylline and theobromine are the most known methylxanthines as they are present in coffee, tea and/or chocolate. In the last decades, a huge experimental effort has been devoted to get insight into the variety of actions that these compounds exert in humans. From such knowledge it is known that methylxanthines have a great potential in prevention, therapy and/or management of a variety of diseases. The benefits of methylxanthine-based therapies in the apnea of prematurity and their translational potential in pediatric affections of the respiratory tract are here presented.
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Honey for treatment of cough in children.
Goldman, RD
Canadian family physician Medecin de famille canadien. 2014;(12):1107-8, 1110
Abstract
Question Cough is a very common presentation among sick children in my clinic. There is almost no day without a child being examined for upper respiratory tract infection and cough. While I understand that no medications are recommended for relief of cough—prescribed or over the counter—is it true that honey might help relieve cough symptoms in children? Answer Most prescribed and over-the-counter preparations for cough in children are not effective and might carry the risk of adverse events. A single dose of honey before bedtime was shown in recent studies to diminish cough and the discomfort experienced by children and their parents. Recent evidence also supports administering a few daily doses, but this practice will need further study to assess its effectiveness and safety.
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[Pharmacological treatment of acute cough].
Småbrekke, L, Melbye, H
Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke. 2009;(10):998-9
Abstract
Acute cough may cause considerable distress for patients with upper airway infections, and is a symptom commonly presented to doctors. We wanted to assess the evidence basis for pharmacological treatment of this condition. Predefined terms (MeSH and Emtree) and free text were used to search PubMed and Embase for double-blind randomized trials, reviews and guidelines. Little evidence supports the use of guaifenesine, bromhexine and acetylcysteine for acute cough associated with upper airway infections. Likewise, there is insufficient evidence to decide whether noscapine, codeine and ehylmorphine are beneficial for acute cough on this indication. Well-designed randomized controlled trials with valid outcomes are needed to document possible benefits of treatment. Treatment with codeine or ethylmorphine may be at the expense of adverse effects, abuse or dependence.
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Mucoactive agents for airway mucus hypersecretory diseases.
Rogers, DF
Respiratory care. 2007;(9):1176-93; discussion 1193-7
Abstract
Airway mucus hypersecretion is a feature of a number of severe respiratory diseases, including asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF). However, each disease has a different airway inflammatory response, with consequent, and presumably linked, mucus hypersecretory phenotype. Thus, it is possible that optimal treatment of the mucus hypersecretory element of each disease should be disease-specific. Nevertheless, mucoactive drugs are a longstanding and popular therapeutic option, and numerous compounds (eg, N-acetylcysteine, erdosteine, and ambroxol) are available for clinical use worldwide. However, rational recommendation of these drugs in guidelines for management of asthma, COPD, or CF has been hampered by lack of information from well-designed clinical trials. In addition, the mechanism of action of most of these drugs is unknown. Consequently, although it is possible to categorize them according to putative mechanisms of action, as expectorants (aid and/or induce cough), mucolytics (thin mucus), mucokinetics (facilitate cough transportability), and mucoregulators (suppress mechanisms underlying chronic mucus hypersecretion, such as glucocorticosteroids), it is likely that any beneficial effects are due to activities other than, or in addition to, effects on mucus. It is also noteworthy that the mucus factors that favor mucociliary transport (eg, thin mucus gel layer, "ideal" sol depth, and elasticity greater than viscosity) are opposite to those that favor cough effectiveness (thick mucus layer, excessive sol height, and viscosity greater than elasticity), which indicates that different mucoactive drugs would be required for treatment of mucus obstruction in proximal versus distal airways, or in patients with an impaired cough reflex. With the exception of mucoregulatory agents, whose primary action is unlikely to be directed against mucus, well-designed clinical trials are required to unequivocally determine the effectiveness, or otherwise, of expectorant, mucolytic, and mucokinetic agents in airway diseases in which mucus hypersecretion is a pathophysiological and clinical issue. It is noteworthy that, of the more complex molecules in development, it is simple inhaled hypertonic saline that is currently receiving the greatest attention as a mucus therapy, primarily in CF.
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Cough suppressant and pharmacologic protussive therapy: ACCP evidence-based clinical practice guidelines.
Bolser, DC
Chest. 2006;(1 Suppl):238S-249S
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Abstract
BACKGROUND Cough-suppressant therapy, previously termed nonspecific antitussive therapy, incorporates the use of pharmacologic agents with mucolytic effects and/or inhibitory effects on the cough reflex itself. The intent of this type of therapy is to reduce the frequency and/or intensity of coughing on a short-term basis. METHODS Data for this review were obtained from several National Library of Medicine (PubMed) searches (from 1960 to 2004), which were performed between May and September 2004, of the literature published in the English language, limited to human studies, using combinations of the search terms "cough," "double-blind placebo-controlled," "antitussive," "mucolytic," "cough clearance," "common cold," "protussive," "guaifenesin," "glycerol," and "zinc." RESULTS Mucolytic agents are not consistently effective in ameliorating cough in patients with bronchitis, although they may be of benefit to this population in other ways. Peripheral and central antitussive agents can be useful in patients with chronic bronchitis, but can have little efficacy in patients with cough due to upper respiratory infection. Some protussive agents are effective in increasing cough clearance, but their long-term effectiveness has not been established. DNase is not effective as a protussive agent in patients with cystic fibrosis. Inhaled mannitol is acutely effective in this patient population, but its therapeutic potential must be investigated further. CONCLUSIONS These findings suggest that suppressant therapy is most effective when used for the short-term reduction of coughing. Relatively few drugs are effective as cough suppressants.
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8.
Leukotriene receptor antagonist for prolonged non-specific cough in children.
Chang, AB, Winter, D, Acworth, JP
The Cochrane database of systematic reviews. 2006;(2):CD005602
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Abstract
BACKGROUND Non-specific cough is defined as non-productive cough in the absence of identifiable respiratory disease or known aetiology. It is commonly seen in paediatric practice. These children are treated with a variety of therapies including a variety of asthma medications. The leukotriene pathway is reported to be involved in the sensory (neurogenic) pathway, which is a mechanism thought to be involved in the pathogenesis of chronic cough. OBJECTIVES To evaluate the effectiveness of leukotriene receptor antagonist (LTRA) in treating children with prolonged non-specific cough. SEARCH STRATEGY The Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE and EMBASE databases were searched by the Cochrane Airways Group. The latest searches were carried out in September 2005. SELECTION CRITERIA All randomised controlled trials comparing LTRA with a placebo medication in children with non-specific cough. DATA COLLECTION AND ANALYSIS Results of searches were reviewed against pre-determined criteria for inclusion. One eligible trial was identified but no data was available for analysis. It was not possible to separate results from children with non-specific cough from those without. MAIN RESULTS There was no significant difference in all study endpoints between the montelukast and placebo groups (total N=256). AUTHORS' CONCLUSIONS With the lack of evidence, the routine use of LRTA in treating children with non-specific cough cannot be recommended.
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Gastroesophageal reflux and chronic cough.
Everett, CF, Morice, AH
Minerva gastroenterologica e dietologica. 2004;(3):205-13
Abstract
Gastroesophageal reflux (GOR) disease is one of the 3 commonest causes of chronic cough. It can be difficult to diagnose as the traditionally recognised symptoms of GOR, such as heartburn and acid regurgitation, are often absent. More subtle indicators of a link between the cough and the oesophagus should therefore be sought. These include cough which occurs in relation to eating or phonation, cough which settles at night and does not tend to wake the patient from sleep and symptoms suggestive of laryngopharyngeal reflux. Investigations such as oesophageal manometry and 24 hour pH monitoring can be useful in characterising any underlying oesophageal abnormality, but may underestimate the problem since non-acid reflux can precipitate cough. Empirical trials of treatment are therefore often employed, but should be continued for at least 2 months, as symptoms can be slow to improve due to plasticity of the cough reflex. Pharmacologic treatment options include proton pump inhibitors, H2 receptor antagonists, pro-motility agents and liquid alginate preparations. Surgical fundoplication can also be effective when performed in appropriately selected individuals.
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Cough. 3: chronic cough and gastro-oesophageal reflux.
Fontana, GA, Pistolesi, M
Thorax. 2003;(12):1092-5
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Abstract
The pathogenesis and clinical features of gastro-oesophageal reflux related cough are complex and the diagnostic tests available are of limited reliability. Treatment needs to be tailored to the specific needs of individual patients and other possible causes of chronic cough should be investigated. Treatment should only be considered to have failed when cough persists after administration of proton pump inhibitors at an adequate dosage for a sufficient length of time.