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International Journal of Environmental... Apr 2021The tobacco industry promotes electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP) as a safer alternative to conventional cigarettes with... (Review)
Review
The tobacco industry promotes electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP) as a safer alternative to conventional cigarettes with misleading marketing sustained by studies with conflict of interest. As a result, these devices sell without regulations and warnings about their adverse effects on health, with a growing user base targeting young people. This systematic review aimed to describe the adverse effects on the respiratory system in consumers of these devices. We conducted a systematic review and bibliometric analysis of 79 studies without conflict of interest evaluating ENDS and HTP effects in the respiratory system in experimental models, retrieved from the PubMed database. We found that the damage produced by using these devices is involved in pathways related to pulmonary diseases, involving mechanisms previously reported in conventional cigarettes as well as new mechanisms particular to these devices, which challenges that the tobacco industry's claims. The present study provides significant evidence to suggest that these devices are an emerging public health problem and that they should be regulated or avoided.
Topics: Adolescent; Electronic Nicotine Delivery Systems; Humans; Lung; Marketing; Tobacco Industry; Tobacco Products
PubMed: 33924379
DOI: 10.3390/ijerph18084079 -
International Journal of Environmental... Jun 2021This systematic review and meta-analysis aim to provide scientific evidence regarding the effects of training on respiratory muscle training's impact with the... (Meta-Analysis)
Meta-Analysis Review
Inspiratory Muscle Training Program Using the PowerBreath: Does It Have Ergogenic Potential for Respiratory and/or Athletic Performance? A Systematic Review with Meta-Analysis.
This systematic review and meta-analysis aim to provide scientific evidence regarding the effects of training on respiratory muscle training's impact with the PowerBreath. A systematic analysis based on the guides and a conducted research structured around the bases of Web of Science, Scopus, Medline/PubMed, SciELO y Cochrane Library Plus. Six articles published before January 2021 were included. The documentation and quantification of heterogeneity in every meta-analysis were directed through Cochran's Q test and the statistic I; additionally, a biased publication analysis was made using funnel plots, whose asymmetry was quantified Egger's regression. The methodological quality was assessed through McMaster's. PowerBreath administering a ≥ 15% resistive load of the maximum inspiratory pressure (PIM) achieves significant improvements (54%) in said pressure within 4 weeks of commencing the inspiratory muscle training. The maximal volume of oxygen (VOmax) considerable enhancements was achieved from the 6 weeks associated with the maximum inspiratory pressure ≥ 21.5% post inspiratory muscle training onwards. Conversely, a significant blood lactate concentration decrement occurred from the 4th week of inspiratory muscle training, after a maximum inspiratory pressure ≥ 6.8% increment. PowerBreath is a useful device to stimulate sport performance and increase pulmonary function.
Topics: Athletic Performance; Breathing Exercises; Lung; Respiratory Muscles; Respiratory Therapy
PubMed: 34206354
DOI: 10.3390/ijerph18136703 -
The European Respiratory Journal Apr 2023Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe... (Review)
Review
BACKGROUND
Effectiveness studies with biological therapies for asthma lack standardised outcome measures. The COMSA (Core Outcome Measures sets for paediatric and adult Severe Asthma) Working Group sought to develop Core Outcome Measures (COM) sets to facilitate better synthesis of data and appraisal of biologics in paediatric and adult asthma clinical studies.
METHODS
COMSA utilised a multi-stakeholder consensus process among patients with severe asthma, adult and paediatric clinicians, pharmaceutical representatives, and health regulators from across Europe. Evidence included a systematic review of development, validity and reliability of selected outcome measures plus a narrative review and a pan-European survey to better understand patients' and carers' views about outcome measures. It was discussed using a modified GRADE (Grading of Recommendations Assessment, Development and Evaluation) Evidence to Decision framework. Anonymous voting was conducted using predefined consensus criteria.
RESULTS
Both adult and paediatric COM sets include forced expiratory volume in 1 s (FEV) as z-scores, annual frequency of severe exacerbations and maintenance oral corticosteroid use. Additionally, the paediatric COM set includes the Paediatric Asthma Quality of Life Questionnaire and Asthma Control Test or Childhood Asthma Control Test, while the adult COM set includes the Severe Asthma Questionnaire and Asthma Control Questionnaire-6 (symptoms and rescue medication use reported separately).
CONCLUSIONS
This patient-centred collaboration has produced two COM sets for paediatric and adult severe asthma. It is expected that they will inform the methodology of future clinical trials, enhance comparability of efficacy and effectiveness of biological therapies, and help assess their socioeconomic value. COMSA will inform definitions of non-response and response to biological therapy for severe asthma.
Topics: Child; Humans; Adult; Quality of Life; Reproducibility of Results; Disease Progression; Asthma; Outcome Assessment, Health Care; Anti-Asthmatic Agents
PubMed: 36229046
DOI: 10.1183/13993003.00606-2022 -
The Journal of Allergy and Clinical... Nov 2022The comparative safety and efficacy of the biologics currently approved for asthma are unclear. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The comparative safety and efficacy of the biologics currently approved for asthma are unclear.
OBJECTIVE
We compared the safety and efficacy of mepolizumab, benralizumab, and dupilumab in individuals with severe eosinophilic asthma.
METHODS
We performed a systematic review of peer-reviewed literature published 2000 to 2021. We studied Bayesian network meta-analyses of exacerbation rates, prebronchodilator FEV, the Asthma Control Questionnaire, and serious adverse events in individuals with eosinophilic asthma.
RESULTS
Eight randomized clinical trials (n = 6461) were identified. We found in individuals with eosinophils ≥300 cells/μL the following: in reducing exacerbation rates compared to placebo: dupilumab (risk ratio [RR], 0.32; 95% credible interval [CI], 0.23 to 0.45), mepolizumab (RR, 0.37; 95% CI, 0.30 to 0.45), and benralizumab (RR, 0.49; 95% CI, 0.43 to 0.55); in improving FEV: dupilumab (mean difference in milliliters [MD] 230; 95% CI, 160 to 300), benralizumab (MD, 150; 95% CI, 100 to 200), and mepolizumab (MD, 150; 95% CI, 66 to 220); and in reducing Asthma Control Questionnaire scores: mepolizumab (MD, -0.63; 95% CI, -0.81 to -0.45), dupilumab (MD, -0.48; 95% CI, -0.83 to -0.14), and benralizumab (MD, -0.32; 95% CI, -0.43 to -0.21). In individuals with eosinophils 150-299 cells/μL, benralizumab (RR, 0.62; 95% CI, 0.52 to 0.73) and dupilumab (RR, 0.60; 95% CI, 0.38 to 0.95) were associated with lower exacerbation rates; and only benralizumab (MD, 81; 95% CI, 8 to 150) significantly improved FEV. These differences were minimal compared to clinically important thresholds. For serious adverse events in the overall population, mepolizumab (odds ratio, 0.67; 95% CI, 0.48 to 0.92) and benralizumab (odds ratio, 0.74; 95% CI, 0.59 to 0.93) were associated with lower odds of a serious adverse event, while dupilumab was not different from placebo (odds ratio, 1.0; 95% CI, 0.74 to 1.4).
CONCLUSION
There are minimal differences in the efficacy and safety of mepolizumab, benralizumab, and dupilumab in eosinophilic asthma.
Topics: Humans; Network Meta-Analysis; Bayes Theorem; Asthma; Pulmonary Eosinophilia; Eosinophils; Anti-Asthmatic Agents
PubMed: 35772597
DOI: 10.1016/j.jaci.2022.05.024 -
The Cochrane Database of Systematic... Apr 2023Acute bronchiolitis is the leading cause of medical emergencies during winter months in infants younger than 24 months old. Chest physiotherapy is sometimes used to... (Review)
Review
BACKGROUND
Acute bronchiolitis is the leading cause of medical emergencies during winter months in infants younger than 24 months old. Chest physiotherapy is sometimes used to assist infants in the clearance of secretions in order to decrease ventilatory effort. This is an update of a Cochrane Review first published in 2005 and updated in 2006, 2012, and 2016.
OBJECTIVES
To determine the efficacy of chest physiotherapy in infants younger than 24 months old with acute bronchiolitis. A secondary objective was to determine the efficacy of different techniques of chest physiotherapy (vibration and percussion, passive exhalation, or instrumental).
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, CINAHL, LILACS, Web of Science, PEDro (October 2011 to 20 April 2022), and two trials registers (5 April 2022).
SELECTION CRITERIA
Randomised controlled trials (RCTs) in which chest physiotherapy was compared to control (conventional medical care with no physiotherapy intervention) or other respiratory physiotherapy techniques in infants younger than 24 months old with bronchiolitis.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane.
MAIN RESULTS
Our update of the searches dated 20 April 2022 identified five new RCTs with 430 participants. We included a total of 17 RCTs (1679 participants) comparing chest physiotherapy with no intervention or comparing different types of physiotherapy. Five trials (246 participants) assessed percussion and vibration techniques plus postural drainage (conventional chest physiotherapy), and 12 trials (1433 participants) assessed different passive flow-oriented expiratory techniques, of which three trials (628 participants) assessed forced expiratory techniques, and nine trials (805 participants) assessed slow expiratory techniques. In the slow expiratory subgroup, two trials (78 participants) compared the technique with instrumental physiotherapy techniques, and two recent trials (116 participants) combined slow expiratory techniques with rhinopharyngeal retrograde technique (RRT). One trial used RRT alone as the main component of the physiotherapy intervention. Clinical severity was mild in one trial, severe in four trials, moderate in six trials, and mild to moderate in five trials. One study did not report clinical severity. Two trials were performed on non-hospitalised participants. Overall risk of bias was high in six trials, unclear in five, and low in six trials. The analyses showed no effects of conventional techniques on change in bronchiolitis severity status, respiratory parameters, hours with oxygen supplementation, or length of hospital stay (5 trials, 246 participants). Regarding instrumental techniques (2 trials, 80 participants), one trial observed similar results in bronchiolitis severity status when comparing slow expiration to instrumental techniques (mean difference 0.10, 95% confidence interval (C) -0.17 to 0.37). Forced passive expiratory techniques failed to show an effect on bronchiolitis severity in time to recovery (2 trials, 509 participants; high-certainty evidence) and time to clinical stability (1 trial, 99 participants; high-certainty evidence) in infants with severe bronchiolitis. Important adverse effects were reported with the use of forced expiratory techniques. Regarding slow expiratory techniques, a mild to moderate improvement was observed in bronchiolitis severity score (standardised mean difference -0.43, 95% CI -0.73 to -0.13; I = 55%; 7 trials, 434 participants; low-certainty evidence). Also, in one trial an improvement in time to recovery was observed with the use of slow expiratory techniques. No benefit was observed in length of hospital stay, except for one trial which showed a one-day reduction. No effects were shown or reported for other clinical outcomes such as duration on oxygen supplementation, use of bronchodilators, or parents' impression of physiotherapy benefit.
AUTHORS' CONCLUSIONS
We found low-certainty evidence that passive slow expiratory technique may result in a mild to moderate improvement in bronchiolitis severity when compared to control. This evidence comes mostly from infants with moderately acute bronchiolitis treated in hospital. The evidence was limited with regard to infants with severe bronchiolitis and those with moderately severe bronchiolitis treated in ambulatory settings. We found high-certainty evidence that conventional techniques and forced expiratory techniques result in no difference in bronchiolitis severity or any other outcome. We found high-certainty evidence that forced expiratory techniques in infants with severe bronchiolitis do not improve their health status and can lead to severe adverse effects. Currently, the evidence regarding new physiotherapy techniques such as RRT or instrumental physiotherapy is scarce, and further trials are needed to determine their effects and potential for use in infants with moderate bronchiolitis, as well as the potential additional effect of RRT when combined with slow passive expiratory techniques. Finally, the effectiveness of combining chest physiotherapy with hypertonic saline should also be investigated.
Topics: Child; Child, Preschool; Humans; Infant; Infant, Newborn; Bronchiolitis; Bronchodilator Agents; Drainage, Postural; Oxygen; Physical Therapy Modalities; Respiratory Therapy
PubMed: 37010196
DOI: 10.1002/14651858.CD004873.pub6 -
Nutrients Mar 2023The purpose of this study was to summarize the evidence from epidemiological studies concerning associations between diet and the effectiveness of treatment for lung... (Review)
Review
The purpose of this study was to summarize the evidence from epidemiological studies concerning associations between diet and the effectiveness of treatment for lung cancer. For this review, a literature search has been conducted in the EMBASE and PubMed databases, including papers published between 1977 and June 2022. The term "lung cancer" was used in conjunction with "diet". Footnotes from the selected papers were also analyzed. The present study is in line with the recommendations included in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The review included studies involving adults, including randomized controlled trials (RCTs) and cohort and observational studies. In total, 863 papers were found, with duplicates excluded. Ultimately, 20 papers were reviewed. The present systematic review indicates that vitamin A, ascorbic acid (vitamin C), vitamin E, selenium, and zinc-as antioxidants-can strengthen the body's antioxidant barrier. Furthermore, preoperative immunonutrition may not only improve perioperative nutritional status following induction chemoradiotherapy in lung cancer surgery patients but also reduce the severity of postoperative complications. Similarly, a protein supply may exert a beneficial effect on human health by increasing average body weight and muscle mass. Omega-3 fatty acid content in the diet and the consumption of their main source, fish, may have some regulatory effect on inflammation in patients with lung cancer treated with chemotherapy and radiotherapy. In addition, -3 fatty acids inhibit tumor cell proliferation and may reduce the toxicity of chemotherapy. Increased energy and protein intake are strongly associated with improved quality of life, functional outcomes, hand grip strength, symptoms, and performance in patients with lung cancer. The use of a supportive diet should be the standard of care, alongside pharmaceutical therapy, in treatment for patients with lung cancer.
Topics: Adult; Animals; Humans; Diet; Antioxidants; Vitamins; Ascorbic Acid; Lung Neoplasms; Fatty Acids, Omega-3; Lung
PubMed: 36986207
DOI: 10.3390/nu15061477 -
Anesthesia and Analgesia Apr 2021Laryngeal injury from intubation can substantially impact airway, voice, and swallowing, thus necessitating multidisciplinary interventions. The goals of this systematic... (Meta-Analysis)
Meta-Analysis
Laryngeal injury from intubation can substantially impact airway, voice, and swallowing, thus necessitating multidisciplinary interventions. The goals of this systematic review were (1) to review the types of laryngeal injuries and their patient-reported symptoms and clinical signs resulting from endotracheal intubation in patients intubated for surgeries and (2) to better understand the overall the frequency at which these injuries occur. We conducted a search of 4 online bibliographic databases (ie, PubMed, Embase, Cumulative Index of Nursing and Allied Health Literature [CINAHL], and The Cochrane Library) and ProQuest and Open Access Thesis Dissertations (OPTD) from database inception to September 2019 without restrictions for language. Studies that completed postextubation laryngeal examinations with visualization in adult patients who were endotracheally intubated for surgeries were included. We excluded (1) retrospective studies, (2) case studies, (3) preexisting laryngeal injury/disease, (4) patients with histories of or surgical interventions that risk injury to the recurrent laryngeal nerve, (5) conference abstracts, and (6) patient populations with nonfocal, neurological impairments that may impact voice and swallowing function, thus making it difficult to identify isolated postextubation laryngeal injury. Independent, double-data extraction, and risk of bias assessment followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the Cochrane Collaboration's criteria. Twenty-one articles (1 cross-sectional, 3 cohort, 5 case series, 12 randomized controlled trials) representing 21 surgical studies containing 6140 patients met eligibility criteria. The mean patient age across studies reporting age was 49 (95% confidence interval [CI], 45-53) years with a mean intubation duration of 132 (95% CI, 106-159) minutes. Studies reported no injuries in 80% (95% CI, 69-88) of patients. All 21 studies presented on type of injury. Edema was the most frequently reported mild injury, with a prevalence of 9%-84%. Vocal fold hematomas were the most frequently reported moderate injury, with a prevalence of 4% (95% CI, 2-10). Severe injuries that include subluxation of the arytenoids and vocal fold paralysis are rare (<1%) outcomes. The most prevalent patient complaints postextubation were dysphagia (43%), pain (38%), coughing (32%), a sore throat (27%), and hoarseness (27%). Overall, laryngeal injury from short-duration surgical intubation is common and is most often mild. No uniform guidelines for laryngeal assessment postextubation from surgery are available and hoarseness is neither a good indicator of laryngeal injury or dysphagia. Protocolized screening for dysphonia and dysphagia postextubation may lead to improved identification of injury and, therefore, improved patient outcomes and reduced health care utilization.
Topics: Airway Extubation; Anesthesia; Female; Humans; Intubation, Intratracheal; Larynx; Male; Middle Aged; Postoperative Complications; Risk Assessment; Risk Factors; Treatment Outcome
PubMed: 33196479
DOI: 10.1213/ANE.0000000000005276 -
British Journal of Anaesthesia Oct 2022Tracheal intubation is a commonly performed procedure that can be associated with complications and result in patient harm. Videolaryngoscopy (VL) may decrease this risk... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Tracheal intubation is a commonly performed procedure that can be associated with complications and result in patient harm. Videolaryngoscopy (VL) may decrease this risk as compared with Macintosh direct laryngoscopy (DL). This review evaluates the risk and benefit profile of VL compared with DL in adults.
METHODS
We searched MEDLINE, Embase, CENTRAL, and Web of Science on February 27, 2021. We included RCTs comparing VL with DL in patients undergoing tracheal intubation in any setting. We separately compared outcomes according to VL design: Macintosh-style, hyperangulated, and channelled.
RESULTS
A total of 222 RCTs (with 26 149 participants) were included. Most studies had unclear risk of bias in at least one domain, and all were at high risk of performance and detection bias. We found that videolaryngoscopes of any design likely reduce rates of failed intubation (Macintosh-style: risk ratio [RR]=0.41; 95% confidence interval [CI], 0.26-0.65; hyperangulated: RR=0.51; 95% CI, 0.34-0.76; channelled: RR=0.43, 95% CI, 0.30-0.61; moderate-certainty evidence) with increased rates of successful intubation on first attempt and better glottic views across patient groups and settings. Hyperangulated designs are likely favourable in terms of reducing the rate of oesophageal intubation, and result in improved rates of successful intubation in individuals presenting with difficult airway features (P=0.03). We also present other patient-oriented outcomes.
CONCLUSIONS
In this systematic review and meta-analysis of trials of adults undergoing tracheal intubation, VL was associated with fewer failed attempts and complications such as hypoxaemia, whereas glottic views were improved.
SYSTEMATIC REVIEW REGISTRATION
This article is based on a Cochrane Review published in the Cochrane Database of Systematic Reviews (CDSR) 2022, Issue 4, DOI: 10.1002/14651858.CD011136.pub3 (see www.cochranelibrary.com for information). Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and the CDSR should be consulted for the most recent version of the review.
Topics: Adult; Esophagus; Glottis; Humans; Intubation, Intratracheal; Laryngoscopes; Laryngoscopy
PubMed: 35820934
DOI: 10.1016/j.bja.2022.05.027 -
JAMA Network Open Mar 2022The Global Initiative for Asthma (GINA) recommends 2 alternative treatments for patients receiving treatment at steps 3 to 5: single inhaler combination inhaled... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
The Global Initiative for Asthma (GINA) recommends 2 alternative treatments for patients receiving treatment at steps 3 to 5: single inhaler combination inhaled corticosteroid-formoterol as both maintenance and reliever (SMART) or inhaled corticosteroid-long-acting β2-agonist as maintenance plus short-acting β2-agonist as reliever.
OBJECTIVE
To assess whether switching to SMART is associated with longer time to first severe asthma exacerbation compared with a step up or continuation of GINA treatment step with maintenance inhaled corticosteroid-long-acting β2-agonist plus short-acting β2-agonist reliever among patients with poorly controlled asthma.
DATA SOURCES
For this systematic review and meta-analysis, the literature, internal study databases at AstraZeneca and the Medical Research Institute of New Zealand, and references from a previous systematic review and meta-analysis on SMART were searched to identify randomized clinical trials published from January 1990 to February 2018, that compared budesonide-formoterol by SMART with maintenance inhaled corticosteroid-long-acting β2-agonist plus short-acting β2-agonist reliever.
STUDY SELECTION
Trials of at least 24 weeks' duration were included if they reported baseline data on GINA treatment step, asthma control status, and efficacy measures of severe exacerbations. Included patients were adults and adolescents with asthma and baseline Asthma Control Questionnaire 5-item version scores of 1.5 or higher.
DATA EXTRACTION AND SYNTHESIS
Patient-level data were identified by independent extraction, and analyses were performed using a fixed-effect model. Data analysis was performed from August 2018 to November 2021.
MAIN OUTCOMES AND MEASURES
The primary outcome was time to first severe asthma exacerbation associated with each treatment, analyzed by Cox proportional hazards regression.
RESULTS
Overall, 4863 patients were included (3034 [62.4%] female; mean [SD] age, 39.8 [16.3] years). Switching patients with uncontrolled asthma at GINA step 3 (n = 1950) to SMART at either step 3 or 4 was associated with a prolonged time to first severe asthma exacerbation, with a 29% reduced risk compared with stepping up to step 4 inhaled corticosteroid-long-acting β2-agonist maintenance plus short-acting β2-agonist reliever (hazard ratio, 0.71; 95% CI, 0.52-0.97). For patients with uncontrolled asthma at step 3 and step 4 (n = 2913), switching to SMART was associated with a prolonged time to first severe asthma exacerbation and a 30% reduced risk compared with remaining at the same treatment step (hazard ratio, 0.70; 95% CI, 0.58-0.85).
CONCLUSIONS AND RELEVANCE
In this systematic review and meta-analysis, for patients with poorly controlled asthma, SMART was associated with longer time to first severe asthma exacerbation compared with a step up or continuation of GINA step with maintenance inhaled corticosteroid-long-acting β2-agonist plus short-acting β2-agonist reliever. These findings suggest that if an adult or adolescent receiving treatment at GINA step 3 or 4 has poorly controlled asthma, it is preferable to switch to the SMART regimen rather than to step up or continue the GINA treatment step with maintenance inhaled corticosteroid-long-acting β2-agonist plus short-acting β2-agonist reliever therapy.
Topics: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones; Adult; Anti-Asthmatic Agents; Asthma; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Drug Combinations; Female; Formoterol Fumarate; Humans; Male; Randomized Controlled Trials as Topic
PubMed: 35230437
DOI: 10.1001/jamanetworkopen.2022.0615 -
The Cochrane Database of Systematic... Jan 2022Although combination formulas containing antihistamines, decongestants, and/or analgesics are sold over-the-counter in large quantities for the common cold, the evidence... (Review)
Review
BACKGROUND
Although combination formulas containing antihistamines, decongestants, and/or analgesics are sold over-the-counter in large quantities for the common cold, the evidence for their effectiveness is limited. This is an update of a review first published in 2012.
OBJECTIVES
To assess the effectiveness of antihistamine-decongestant-analgesic combinations compared with placebo or other active controls (excluding antibiotics) in reducing the duration of symptoms and alleviating symptoms (general feeling of illness, nasal congestion, rhinorrhoea, sneezing, and cough) in children and adults with the common cold.
SEARCH METHODS
We searched CENTRAL, MEDLINE via EBSCOhost, Embase, CINAHL via EBSCOhost, LILACS, and Web of Science to 10 June 2021. We searched the WHO ICTRP and ClinicalTrials.gov on 10 June 2021.
SELECTION CRITERIA
Randomised controlled trials investigating the effectiveness of antihistamine-decongestant-analgesic combinations compared with placebo, other active treatment (excluding antibiotics), or no treatment in children and adults with the common cold.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. We assessed the certainty of the evidence using the GRADE approach. We categorised the included trials according to the active ingredients.
MAIN RESULTS
We identified 30 studies (6304 participants) including 31 treatment comparisons. The control intervention was placebo in 26 trials and an active substance (paracetamol, chlorphenindione + phenylpropanolamine + belladonna, diphenhydramine) in six trials (two trials had placebo as well as active treatment arms). Reporting of methods was generally poor, and there were large differences in study design, participants, interventions, and outcomes. Most of the included trials involved adult participants. Children were included in nine trials. Three trials included very young children (from six months to five years), and five trials included children aged 2 to 16. One trial included adults and children aged 12 years or older. The trials took place in different settings: university clinics, paediatric departments, family medicine departments, and general practice surgeries. Antihistamine-decongestant: 14 trials (1298 participants). Eight trials reported on global effectiveness, of which six studies were pooled (281 participants on active treatment and 284 participants on placebo). The odds ratio (OR) of treatment failure was 0.31 (95% confidence interval (CI) 0.20 to 0.48; moderate certainty evidence); number needed to treat for an additional beneficial outcome (NNTB) 3.9 (95% CI 3.03 to 5.2). On the final evaluation day (follow-up: 3 to 10 days), 55% of participants in the placebo group had a favourable response compared to 70% on active treatment. Of the two trials not pooled, one showed some global effect, whilst the other showed no effect. Adverse effects: the antihistamine-decongestant group experienced more adverse effects than the control group: 128/419 (31%) versus 100/423 (13%) participants suffered one or more adverse effects (OR 1.58, 95%CI 0.78 to 3.21; moderate certainty of evidence). Antihistamine-analgesic: four trials (1608 participants). Two trials reported on global effectiveness; data from one trial were presented (290 participants on active treatment and 292 participants on ascorbic acid). The OR of treatment failure was 0.33 (95% CI 0.23 to 0.46; moderate certainty evidence); NNTB 6.67 (95% CI 4.76 to 12.5). Forty-three per cent of participants in the control group and 70% in the active treatment group were cured after six days of treatment. The second trial also showed an effect in favour of the active treatment. Adverse effects: there were not significantly more adverse effects in the active treatment group compared to placebo (drowsiness, hypersomnia, sleepiness 10/152 versus 4/120; OR 1.64 (95 % CI 0.48 to 5.59; low certainty evidence). Analgesic-decongestant: seven trials (2575 participants). One trial reported on global effectiveness: 73% of participants in the analgesic-decongestant group reported a benefit compared with 52% in the control group (paracetamol) (OR of treatment failure 0.28, 95% CI 0.15 to 0.52; moderate certainty evidence; NNTB 4.7). Adverse effects: the decongestant-analgesic group experienced significantly more adverse effects than the control group (199/1122 versus 75/675; OR 1.62 95% CI 1.18 to 2.23; high certainty evidence; number needed to treat for an additional harmful outcome (NNTH 17). Antihistamine-analgesic-decongestant: six trials (1014 participants). Five trials reported on global effectiveness, of which two studies in adults could be pooled: global effect reported with active treatment (52%) and placebo (34%) was equivalent to a difference of less than one point on a four- or five-point scale; the OR of treatment failure was 0.47 (95% CI 0.33 to 0.67; low certainty evidence); NNTB 5.6 (95% CI 3.8 to 10.2). One trial in children aged 2 to 12 years, and two trials in adults found no beneficial effect. Adverse effects: in one trial 5/224 (2%) suffered adverse effects with the active treatment versus 9/208 (4%) with placebo. Two other trials reported no differences between treatment groups.
AUTHORS' CONCLUSIONS
We found a lack of data on the effectiveness of antihistamine-analgesic-decongestant combinations for the common cold. Based on these scarce data, the effect on individual symptoms is probably too small to be clinically relevant. The current evidence suggests that antihistamine-analgesic-decongestant combinations have some general benefit in adults and older children. These benefits must be weighed against the risk of adverse effects. There is no evidence of effectiveness in young children. In 2005, the US Food and Drug Administration issued a warning about adverse effects associated with the use of over-the-counter nasal preparations containing phenylpropanolamine.
Topics: Adolescent; Adult; Analgesics; Child; Child, Preschool; Common Cold; Cough; Histamine Antagonists; Humans; Nasal Decongestants; United States
PubMed: 35060618
DOI: 10.1002/14651858.CD004976.pub4