Antibiotics for sore throat.
Sore throat is a common reason for people to present for medical care. Although it remits spontaneously, primary care doctors commonly prescribe antibiotics for it. To assess the benefits of antibiotics for sore throat for patients in primary care settings. We searched CENTRAL 2013, Issue 6, MEDLINE (January 1966 to July week 1, 2013) and EMBASE (January 1990 to July 2013). Randomised controlled trials (RCTs) or quasi-RCTs of antibiotics versus control assessing typical sore throat symptoms or complications. Two review authors independently screened studies for inclusion and extracted data. We resolved differences in opinion by discussion. We contacted trial authors from three studies for additional information. We included 27 trials with 12,835 cases of sore throat. We did not identify any new trials in this 2013 update. 1. Symptoms Throat soreness and fever were reduced by about half by using antibiotics. The greatest difference was seen at day three. The number needed to treat to benefit (NNTB) to prevent one sore throat at day three was less than six; at week one it was 21. 2. Non-suppurative complications The trend was antibiotics protecting against acute glomerulonephritis but there were too few cases to be sure. Several studies found antibiotics reduced acute rheumatic fever by more than two-thirds within one month (risk ratio (RR) 0.27; 95% confidence interval (CI) 0.12 to 0.60). 3. Suppurative complications Antibiotics reduced the incidence of acute otitis media within 14 days (RR 0.30; 95% CI 0.15 to 0.58); acute sinusitis within 14 days (RR 0.48; 95% CI 0.08 to 2.76); and quinsy within two months (RR 0.15; 95% CI 0.05 to 0.47) compared to those taking placebo. 4. Subgroup analyses of symptom reduction Antibiotics were more effective against symptoms at day three (RR 0.58; 95% CI 0.48 to 0.71) if throat swabs were positive for Streptococcus, compared to RR 0.78; 95% CI 0.63 to 0.97 if negative. Similarly at week one the RR was 0.29 (95% CI 0.12 to 0.70) for positive and 0.73 (95% CI 0.50 to 1.07) for negative Streptococcus swabs. Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in high-income countries requires treating many with antibiotics for one to benefit. This NNTB may be lower in low-income countries. Antibiotics shorten the duration of symptoms by about 16 hours overall.
- Research Article
110
- 10.1002/14651858.cd000023.pub2
- Apr 19, 2004
- The Cochrane database of systematic reviews
Sore throat is a very common reason for people to seek medical care. It is a disease that remits spontaneously, that is, 'cure' is not dependent on treatment. Nonetheless primary care doctors commonly prescribe antibiotics for sore throat and other upper respiratory tract infections. To assess the benefits of antibiotics in the management of sore throat. Systematic search of the literature from 1945 to 2003, using electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, issue 2, 2003); MEDLINE (January 1966 to May 2003); EMBASE (January 1990 to March 2003), and the reference sections of the articles identified. We applied no language restrictions. We used abstracts of identified articles to identify trials. Trials of antibiotic against control with either measures of the typical symptoms (throat soreness, headache or fever), or suppurative complications (meaning: forming pus) and non-suppurative complications of sore throat. Two reviewers independently screened potential studies for inclusion and resolved differences in opinion by discussion. The reviewers then independently extracted the data from the selected studies. We contacted the authors of three studies to acquire additional information not available in published articles. Potential studies were screened independently by two reviewers for inclusion, with differences in opinion resolved by discussion. Data was then independently extracted from studies selected by inclusion by two reviewers. Authors of three studies were contacted to acquire additional information not available in published articles. We included twenty-six studies, covering 12,669 cases of sore throat in the review.1. Non-suppurative complications There was a trend for protection against acute glomerulonephritis by antibiotics, but insufficient cases were recorded to be sure of this effect. Several studies found that antibiotics reduced acute rheumatic fever, to less than one third (odds ratio (OR) = 0.30; 95% confidence interval (CI) = 0.20 to 0.45). 2. Suppurative complications Antibiotics reduced the incidence of acute otitis media to about one quarter of that in the placebo group (OR = 0.22; 95% CI 0.11 to 0.43) and reduced the incidence of acute sinusitis to about one half of that in the placebo group (OR = 0.46; 95% CI 0.10 to 2.05). The incidence of quinsy was also reduced in relation to placebo group (OR = 0.16; 95% CI 0.07 to 0.35). 3. Symptoms Symptoms of headache, throat soreness and fever were reduced by antibiotics to about one half. The greatest time for this to be evident was at about three and a half days (when the symptoms of about 50% of untreated patients had settled). About 90% of treated and untreated patients were free of symptoms by one week. The overall number needed to treat to prevent one sore throat at day three was about 5.0 (95% CI 4.5 to 5.8); and at one week was 14.2 (95% CI 11.5 to 20.6). 4. Subgroup analyses of symptom reduction Subgroup analysis by age; blind versus unblinded; or use of antipyretics yielded no significant differences. The results of swabs of the throat for Streptococcus influenced the effect of antibiotics. If the swab was positive, antibiotics were more effective (the OR reduced to 0.16, 95% CI 0.09 to 0.26) than if it was negative (OR 0.65; 95% CI 0.38 to 1.12). Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in modern Western society can be achieved only by treating with antibiotics many who will derive no benefit. In emerging economies where rates of for example acute rheumatic fever are high, the number needed to treat may be much lower. Antibiotics shorten the duration of symptoms by a mean of one day about half way through the illness (the time of maximal effect), and by about sixteen hours overall.
- Research Article
224
- 10.1002/14651858.cd000023.pub3
- Oct 18, 2006
- The Cochrane database of systematic reviews
Sore throat is a very common reason for people to present for medical care. Although it remits spontaneously, primary care doctors commonly prescribe antibiotics for it. To assess the benefits of antibiotics for sore throat. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) and the Database of Abstracts of Reviews of Effects (DARE) (The Cochrane Library, Issue 1, 2006), MEDLINE (January 1966 to March 2006) and EMBASE (January 1990 to December 2005). Trials of antibiotic against control with either measures of the typical symptoms (throat soreness, headache or fever), or suppurative or non-suppurative complications of sore throat. Potential studies were screened independently by two authors for inclusion, with differences in opinion resolved by discussion. Data were then independently extracted from studies selected by inclusion by two authors. Researchers from three studies were contacted for additional information. There were 27 studies with 2835 cases of sore throat. 1. Non-suppurative complications: There was a trend for antibiotics to protect against acute glomerulonephritis, but there were insufficient cases to be sure. Several studies found antibiotics reduced acute rheumatic fever by more than two thirds (relative risk (RR) 0.22; 95% CI 0.02 to 2.08). 2. Suppurative complications: Antibiotics reduced the incidence of acute otitis media (RR 0.30; 95% CI 0.15 to 0.58); of acute sinusitis (RR 0.48; 95% CI 0.08 to 2.76); and of quinsy (peritonsillar abscess) compared to those taking placebo (RR 0.15; 95% CI 0.05 to 0.47). 3. Throat soreness and fever were reduced by antibiotics by about one half. The greatest difference was seen at about 3 to 4 days (when the symptoms of about 50% of untreated patients had settled). By one week about 90% of treated and untreated patients were symptom-free. The overall number need to treat to prevent one sore throat at day 3 was just under six (95% CI 4.9 to 7.0); at week 1 it was 21 (95% CI 13.2 to 47.9). 4. Subgroup analyses of symptom reduction: Analysis by: age; blind versus unblinded; or use of antipyretics, found no significant differences. Analysis of results of throat swabs showed that antibiotics were more effective against symptoms at day 3, RR 0.58 (95% CI 0.48 to 0.71) if the swabs were positive for Streptococcus, compared to RR 0.78 (95% CI 0.63 to 0.97) if negative. Similarly at week 1, RRs 0.29 (95% CI 0.12 to 0.70) for positive, and 0.73 (95% CI 0.50 to 1.07) for negative swabs. Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in modern Western society can only be achieved by treating many with antibiotics, most of whom will derive no benefit. In emerging economies (where rates of acute rheumatic fever are high, for example), the number needed to treat may be much lower for antibiotics to be considered effective. Antibiotics shorten the duration of symptoms by about sixteen hours overall.
- Research Article
84
- 10.1002/14651858.cd000023.pub5
- Dec 9, 2021
- The Cochrane database of systematic reviews
Antibiotics probably reduce the number of people experiencing sore throat, and reduce the likelihood of headache, and some sore throat complications. As the effect on symptoms can be small, clinicians must judge on an individual basis whether it is clinically justifiable to use antibiotics to produce this effect, and whether the underlying cause of the sore throat is likely to be of bacterial origin. Furthermore, the balance between modest symptom reduction and the potential hazards of antimicrobial resistance must be recognised. Few trials have attempted to measure symptom severity. If antibiotics reduce the severity as well as the duration of symptoms, their benefit will have been underestimated in this meta-analysis. Additionally, more trials are needed in low-income countries, in socio-economically deprived sections of high-income countries, as well as in children.
- Research Article
1
- 10.1002/ebch.1805
- Jan 1, 2012
- Evidence-Based Child Health: A Cochrane Review Journal
BackgroundAntibiotics provide only modest benefit in treating sore throat, although effectiveness increases in participants with positive throat swabs for group A beta‐haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated.ObjectivesWe assessed the comparative efficacy of different antibiotics on clinical outcomes, relapse, complications and adverse events in GABHS tonsillopharyngitis.Search methodsWe searched The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL 2010, Issue 3) which includes the Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to July Week 4, 2010) and EMBASE (1974 to August 2010).Selection criteriaRandomised, double‐blind trials comparing different antibiotics reporting at least one of the following: clinical cure, clinical relapse, complications, adverse events.Data collection and analysisTwo authors independently screened trials for inclusion and extracted data.Main resultsSeventeen trials (5352 participants) were included; 16 compared with penicillin (six with cephalosporins, six with macrolides, three with carbacephem and one with sulfonamides), one trial compared clindamycin and ampicillin. Randomisation reporting, allocation concealment and blinding were poor.There was no difference in symptom resolution between cephalosporins and penicillin (intention‐to‐treat (ITT) analysis; N = 5; n = 2018; odds ratio for absence of resolution of symptoms (OR) 0.79, 95% confidence interval (CI) 0.55 to 1.12). Clinical relapse was lower with cephalosporins (N = 4; n = 1386; OR 0.55, 95% CI 0.31 to 0.99); overall number needed to treat to benefit (NNTB) 50), but found only in adults (OR 0.42, 95% CI 0.20 to 0.88; NNTB 33). There were no differences between macrolides and penicillin. Carbacephem showed better symptom resolution post‐treatment (N = 3; n = 795; OR 0.70, 95% CI 0.49 to 0.99; NNTB 14), but only in children (N = 2; n = 233; OR 0.57, 95% CI 0.33 to 0.99; NNTB 8.3). Children experienced more adverse events with macrolides (N = 1, n = 489; OR 2.33; 95% CI 1.06 to 5.15).Authors' conclusionsEvidence is insufficient for clinically meaningful differences between antibiotics for GABHS tonsillopharyngitis. Limited evidence in adults suggests cephalosporins are more effective than penicillin for relapse, but the NNTB is high. Limited evidence in children suggests carbacephem is more effective for symptom resolution. Data on complications are too scarce to draw conclusions. Based on these results and considering the low cost and absence of resistance, penicillin can still be recommended as first choice.Plain Language SummaryDifferent antibiotics for group A streptococcal pharyngitisPharyngitis or tonsillitis, a throat infection that usually presents with a sore throat, is a common upper respiratory tract infection. Most sore throats are caused by viruses, but sometimes bacteria are involved. Many people carry bacteria in their throat without becoming ill. However, sometimes a bacterial throat infection can occur.Infection with a specific type of bacteria, group A beta‐haemolytic streptococci (GABHS) is linked to serious complications such as acute rheumatic fever or kidney disease (post‐streptococcal glomerulonephritis). In order to prevent these complications antibiotics are often prescribed to treat patients presenting to their doctor with a sore throat. A previous Cochrane review found that there is only a modest benefit of antibiotics for treating an acute sore throat, even if group A beta‐haemolytic streptococci (GABHS) are present. Most throat infections, even with bacteria, are self‐limiting and the risk of complications is extremely low in most populations studied (in low‐income countries). However, sometimes antibiotics may be indicated.We found 17 trials with a total of 5352 participants that studied the effects of different classes of antibiotics on resolution of symptoms in patients with a sore throat and a positive culture for GABHS. Our review found that the effects of these antibiotics are very similar. All antibiotics studied also cause undesired side effects (such as nausea and vomiting, rash), but there was no strong evidence for meaningful differences between the antibiotics. The studies did not report on long‐term complications and therefore it is unclear if any class of antibiotics is better in preventing these serious but rare complications.As all the identified studies were carried out in populations in high‐income countries with a low risk of streptococcal complications, there is a need for trials in populations where this risk is still very high (low‐income countries and Aboriginal communities). Penicillin has been used for a very long time but resistance of the GABHS to penicillin has never been reported. Also, penicillin is a cheap antibiotic. Our review therefore supports the use of penicillin as a first choice antibiotic in patients with acute throat infections caused by GABHS.
- Research Article
170
- 10.1002/14651858.cd000023
- Jun 28, 2000
- The Cochrane database of systematic reviews
Sore throat is a very common reason for people to attend for medical care. It is a disease that remits spontaneously, that is, 'cure' is not dependent on treatment. Nonetheless primary care doctors commonly prescribe antibiotics for sore throat and other upper respiratory tract infections. To assess the benefits of antibiotics in the management of sore throat. Systematic search of the literature from 1945 to 1999, using electronic searches of MEDLINE (using the keywords, "pharyngitis", "sore throat" and "tonsillitis") after 1966, the Cochrane Library, the Cochrane collection of hand-searched trials, and the reference sections of the articles identified. Abstracts of identified articles were used to determine which studies were trials. Trials of antibiotic against control with either measures of the typical symptoms (throat soreness, headache or fever), or complications (suppurative and non-suppurative) of sore throat. RevMan 4.0.3 25 studies were included in the review. A total number of 11, 452 cases of sore throat have been studied. 1. Non-suppurative complications There was a trend for protection against acute glomerulonephritis by antibiotics, but insufficient cases were recorded to be sure of this effect. Several studies found benefit from antibiotics for acute rheumatic fever, which reduced this complication to less than one third (OR = 0.30; 95% CI = 0.20-0.45). 2. Suppurative complications Antibiotics reduced the incidence of acute otitis media to about one quarter of that in the placebo group (OR = 0.22; 95% CI = 0.11-0.43) and reduced the incidence of acute sinusitis to about one half of that in the placebo group (OR = 0.46; 95% CI = 0.10-2.05). The incidence of quinsy was also reduced in relation to placebo group (OR = 0.16; 95% CI = 0.07-0.35). 3. Symptoms Symptoms of headache, throat soreness and fever were reduced by antibiotics to about one half. The greatest time for this to be evident was at about three and a half days (when the symptoms of about 50% of untreated patients had settled). About 90% of treated and untreated patients were symptom-free by one week. 4. Subgroup analyses of symptom reduction Subgroup analysis by age; blind vs unblinded; or use of antipyretics yielded no significant differences. The results of swabs of the throat for Streptococcus influenced the effect of antibiotics. If the swab was positive, antibiotics were more effective (the OR reduced to 0.16, 95% CI 0.09, 0.26) than if it was negative (OR 0.65; 95% CI 0.38,1.1.2). Antibiotics confer relative benefits in the treatment of sore throat. However, the absolute benefits are modest. Protecting sore throat sufferers against suppurative and non-suppurative complications in modern Western society can only be achieved by treating many with antibiotics who will derive no benefit. Antibiotics shorten the duration of symptoms, but by a mean of only one day about half way through the illness (the time of maximal effect), and by about sixteen hours overall.
- Research Article
51
- 10.1002/14651858.cd004406.pub3
- Apr 30, 2013
- The Cochrane database of systematic reviews
Antibiotics provide only modest benefit in treating sore throat, although effectiveness increases in participants with positive throat swabs for group A beta-haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated. To assess the evidence on the comparative efficacy of different antibiotics in: (a) alleviating symptoms (pain, fever); (b) shortening the duration of the illness; (c) preventing relapse; and (d) preventing complications (suppurative complications, acute rheumatic fever, post-streptococcal glomerulonephritis). To assess the evidence on the comparative incidence of adverse effects and the risk-benefit of antibiotic treatment for streptococcal pharyngitis. We searched CENTRAL 2012, Issue 10, MEDLINE (1966 to October week 2, 2012), EMBASE (1974 to October 2012) and Web of Science (2010 to October 2012). Randomised, double-blind trials comparing different antibiotics and reporting at least one of the following: clinical cure, clinical relapse, complications, adverse events. Two authors independently screened trials for inclusion and extracted data. Seventeen trials (5352 participants) were included; 16 compared with penicillin (six with cephalosporins, six with macrolides, three with carbacephem and one with sulfonamides), one trial compared clindamycin and ampicillin. Randomisation reporting, allocation concealment and blinding were poor.There was no difference in symptom resolution between cephalosporins and penicillin (intention-to-treat (ITT) analysis; N = 5; n = 2018; odds ratio for absence of resolution of symptoms (OR) 0.79, 95% confidence interval (CI) 0.55 to 1.12). Clinical relapse was lower with cephalosporins (N = 4; n = 1386; OR 0.55, 95% CI 0.31 to 0.99; overall number needed to treat to benefit (NNTB) 50), but found only in adults (OR 0.42, 95% CI 0.20 to 0.88; NNTB 33). There were no differences between macrolides and penicillin. Carbacephem showed better symptom resolution post-treatment (N = 3; n = 795; OR 0.70, 95% CI 0.49 to 0.99; NNTB 14), but only in children (N = 2; n = 233; OR 0.57, 95% CI 0.33 to 0.99; NNTB 8.3). Children experienced more adverse events with macrolides (N = 1, n = 489; OR 2.33; 95% CI 1.06 to 5.15). Evidence is insufficient to show clinically meaningful differences between antibiotics for GABHS tonsillopharyngitis. Limited evidence in adults suggests cephalosporins are more effective than penicillin for relapse, but the NNTB is high. Limited evidence in children suggests carbacephem is more effective for symptom resolution. Data on complications are too scarce to draw conclusions. Based on these results and considering the low cost and absence of resistance, penicillin can still be recommended as first choice.
- Research Article
132
- 10.1002/14651858.cd004406.pub4
- Sep 11, 2016
- Cochrane Database of Systematic Reviews
Antibiotics provide only modest benefit in treating sore throat, although effectiveness increases in participants with positive throat swabs for group A beta-haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated.We assessed the comparative efficacy of different antibiotics on clinical outcomes, relapse, complications and adverse events in GABHS tonsillopharyngitis.We searched The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL 2010, Issue 3) which includes the Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to July Week 4, 2010) and EMBASE (1974 to August 2010).Randomised, double-blind trials comparing different antibiotics reporting at least one of the following: clinical cure, clinical relapse, complications, adverse events.Two authors independently screened trials for inclusion and extracted data.Seventeen trials (5352 participants) were included; 16 compared with penicillin (six with cephalosporins, six with macrolides, three with carbacephem and one with sulfonamides), one trial compared clindamycin and ampicillin. Randomisation reporting, allocation concealment and blinding were poor.There was no difference in symptom resolution between cephalosporins and penicillin (intention-to-treat (ITT) analysis; N = 5; n = 2018; odds ratio for absence of resolution of symptoms (OR) 0.79, 95% confidence interval (CI) 0.55 to 1.12). Clinical relapse was lower with cephalosporins (N = 4; n = 1386; OR 0.55, 95% CI 0.31 to 0.99); overall number needed to treat to benefit (NNTB) 50), but found only in adults (OR 0.42, 95% CI 0.20 to 0.88; NNTB 33). There were no differences between macrolides and penicillin. Carbacephem showed better symptom resolution post-treatment (N = 3; n = 795; OR 0.70, 95% CI 0.49 to 0.99; NNTB 14), but only in children (N = 2; n = 233; OR 0.57, 95% CI 0.33 to 0.99; NNTB 8.3). Children experienced more adverse events with macrolides (N = 1, n = 489; OR 2.33; 95% CI 1.06 to 5.15).Evidence is insufficient for clinically meaningful differences between antibiotics for GABHS tonsillopharyngitis. Limited evidence in adults suggests cephalosporins are more effective than penicillin for relapse, but the NNTB is high. Limited evidence in children suggests carbacephem is more effective for symptom resolution. Data on complications are too scarce to draw conclusions. Based on these results and considering the low cost and absence of resistance, penicillin can still be recommended as first choice.
- Research Article
30
- 10.1002/14651858.cd004406.pub2
- Oct 6, 2010
- The Cochrane database of systematic reviews
Antibiotics provide only modest benefit in treating sore throat, although effectiveness increases in participants with positive throat swabs for group A beta-haemolytic streptococci (GABHS). It is unclear which antibiotic is the best choice if antibiotics are indicated. We assessed the comparative efficacy of different antibiotics on clinical outcomes, relapse, complications and adverse events in GABHS tonsillopharyngitis. We searched The Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL 2010, Issue 3) which includes the Acute Respiratory Infections Group's Specialised Register, MEDLINE (1966 to July Week 4, 2010) and EMBASE (1974 to August 2010). Randomised, double-blind trials comparing different antibiotics reporting at least one of the following: clinical cure, clinical relapse, complications, adverse events. Two authors independently screened trials for inclusion and extracted data. Seventeen trials (5352 participants) were included; 16 compared with penicillin (six with cephalosporins, six with macrolides, three with carbacephem and one with sulfonamides), one trial compared clindamycin and ampicillin. Randomisation reporting, allocation concealment and blinding were poor.There was no difference in symptom resolution between cephalosporins and penicillin (intention-to-treat (ITT) analysis; N = 5; n = 2018; odds ratio for absence of resolution of symptoms (OR) 0.79, 95% confidence interval (CI) 0.55 to 1.12). Clinical relapse was lower with cephalosporins (N = 4; n = 1386; OR 0.55, 95% CI 0.31 to 0.99); overall number needed to treat to benefit (NNTB) 50), but found only in adults (OR 0.42, 95% CI 0.20 to 0.88; NNTB 33). There were no differences between macrolides and penicillin. Carbacephem showed better symptom resolution post-treatment (N = 3; n = 795; OR 0.70, 95% CI 0.49 to 0.99; NNTB 14), but only in children (N = 2; n = 233; OR 0.57, 95% CI 0.33 to 0.99; NNTB 8.3). Children experienced more adverse events with macrolides (N = 1, n = 489; OR 2.33; 95% CI 1.06 to 5.15). Evidence is insufficient for clinically meaningful differences between antibiotics for GABHS tonsillopharyngitis. Limited evidence in adults suggests cephalosporins are more effective than penicillin for relapse, but the NNTB is high. Limited evidence in children suggests carbacephem is more effective for symptom resolution. Data on complications are too scarce to draw conclusions. Based on these results and considering the low cost and absence of resistance, penicillin can still be recommended as first choice.
- Research Article
560
- 10.1002/14651858.cd008965.pub4
- Apr 10, 2014
- The Cochrane database of systematic reviews
© 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Background: Neuraminidase inhibitors (NIs) are stockpiled and recommended by public health agencies for treating and preventing seasonal and pandemic influenza. They are used clinically worldwide. Objectives: To describe the potential benefits and harms of NIs for influenza in all age groups by reviewing all clinical study reports of published and unpublished randomised, placebo-controlled trials and regulatory comments. Search methods: We searched trial registries, electronic databases (to 22 July 2013) and regulatory archives, and corresponded with manufacturers to identify all trials. We also requested clinical study reports. We focused on the primary data sources of manufacturers but we checked that there were no published randomised controlled trials (RCTs) from non-manufacturer sources by running electronic searches in the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE (Ovid), EMBASE, Embase.com, PubMed (not MEDLINE), the Database of Reviews of Effects, the NHS Economic Evaluation Database and the Health Economic Evaluations Database. Selection criteria: Randomised, placebo-controlled trials on adults and children with confirmed or suspected exposure to naturally occurring influenza. Data collection and analysis: We extracted clinical study reports and assessed risk of bias using purpose-built instruments. We analysed the effects of zanamivir and oseltamivir on time to first alleviation of symptoms, influenza outcomes, complications, hospitalisations and adverse events in the intention-to-treat (ITT) population. All trials were sponsored by the manufacturers. Main results: We obtained 107 clinical study reports from the European Medicines Agency (EMA), GlaxoSmithKline and Roche. We accessed comments by the US Food and Drug Administration (FDA), EMA and Japanese regulator. We included 53 trials in Stage 1 (a judgement of appropriate study design) and 46 in Stage 2 (formal analysis), including 20 oseltamivir (9623 participants) and 26 zanamivir trials (14,628 participants). Inadequate reporting put most of the zanamivir studies and half of the oseltamivir studies at a high risk of selection bias. There were inadequate measures in place to protect 11 studies of oseltamivir from performance bias due to non-identical presentation of placebo. Attrition bias was high across the oseltamivir studies and there was also evidence of selective reporting for both the zanamivir and oseltamivir studies. The placebo interventions in both sets of trials may have contained active substances. Time to first symptom alleviation. For the treatment of adults, oseltamivir reduced the time to first alleviation of symptoms by 16.8 hours (95% confidence interval (CI) 8.4 to 25.1 hours, P 1000) and nausea whilst on treatment (RD 4.15%, 95% CI 0.86 to 9.51); NNTH = 25 (95% CI 11 to 116). Authors' conclusions: Oseltamivir and zanamivir have small, non-specific effects on reducing the time to alleviation of influenza symptoms in adults, but not in asthmatic children. Using either drug as prophylaxis reduces the risk of developing symptomatic influenza. Treatment trials with oseltamivir or zanamivir do not settle the question of whether the complications of influenza (such as pneumonia) are reduced, because of a lack of diagnostic definitions. The use of oseltamivir increases the risk of adverse effects, such as nausea, vomiting, psychiatric effects and renal events in adults and vomiting in children. The lower bioavailability may explain the lower toxicity of zanamivir compared to oseltamivir. The balance between benefits and harms should be considered when making decisions about use of both NIs for either the prophylaxis or treatment of influenza. The influenza virus-specific mechanism of action proposed by the producers does not fit the clinical evidence.
- Research Article
62
- 10.1002/14651858.cd009687.pub2
- Feb 26, 2016
- The Cochrane database of systematic reviews
The two-compound combination as well as corticosteroid monotherapy were more effective and safer than vitamin D monotherapy. Given the similar safety profile and only slim benefit of the two-compound combination over the steroid alone, monotherapy with generic topical steroids may be fully acceptable for short-term therapy.Future RCTs should investigate how specific therapies improve the participants' quality of life. Long-term assessments are needed (i.e. 6 to 12 months).
- Research Article
23
- 10.1002/14651858.cd012673.pub2
- Jun 20, 2019
- Cochrane Database of Systematic Reviews
The presence of oesophageal varices is associated with the risk of upper gastrointestinal bleeding. Endoscopic variceal ligation is used to prevent this occurrence but the ligation procedure may be associated with complications. To assess the beneficial and harmful effects of band ligation versus no intervention for primary prevention of upper gastrointestinal bleeding in adults with cirrhosis and oesophageal varices. We combined searches in the Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, LILACS, and Science Citation Index with manual searches. The last search update was 9 February 2019. We included randomised clinical trials comparing band ligation verus no intervention regardless of publication status, blinding, or language in the analyses of benefits and harms, and observational studies in the assessment of harms. Included participants had cirrhosis and oesophageal varices with no previous history of variceal bleeding. Three review authors extracted data independently. The primary outcome measures were all-cause mortality, upper gastrointestinal bleeding, and serious adverse events. We undertook meta-analyses and presented results using risk ratios (RRs) with 95% confidence intervals (CIs) and I2 values as a marker of heterogeneity. In addition, we calculated the number needed to treat to benefit (NNTTB) for the primary outcomes . We assessed bias control using the Cochrane Hepato-Biliary domains; determined the certainty of the evidence using GRADE; and conducted sensitivity analyses including Trial Sequential Analysis. Six randomised clinical trials involving 637 participants fulfilled our inclusion criteria. One of the trials included an additional small number of participants (< 10% of the total) with non-cirrhotic portal hypertension/portal vein block. We classified one trial as at low risk of bias for the outcome, mortality and high risk of bias for the remaining outcomes; the five remaining trials were at high risk of bias for all outcomes. We downgraded the evidence to moderate certainty due to the bias risk. We gathered data on all primary outcomes from all trials. Seventy-one of 320 participants allocated to band ligation compared to 129 of 317 participants allocated to no intervention died (RR 0.55, 95% CI 0.43 to 0.70; I2 = 0%; NNTTB = 6 persons). In addition, band ligation was associated with reduced risks of upper gastrointestinal bleeding (RR 0.44, 95% CI 0.28 to 0.72; 6 trials, 637 participants; I2 = 61%; NNTTB = 5 persons), serious adverse events (RR 0.55, 95% CI 0.43 to 0.70; 6 trials, 637 participants; I2 = 44%; NNTTB = 4 persons), and variceal bleeding (RR 0.43, 95% CI 0.27 to 0.69; 6 trials, 637 participants; I² = 56%; NNTTB = 5 persons). The non-serious adverse events reported in association with band ligation included oesophageal ulceration, dysphagia, odynophagia, retrosternal and throat pain, heartburn, and fever, and in the one trial involving participants with either small or large varices, the incidence of non-serious side effects in the banding group was much higher in those with small varices, namely ulcers: small versus large varices 30.5% versus 8.7%; heartburn 39.2% versus 17.4%. No trials reported on health-related quality of life.Two trials did not receive support from pharmaceutical companies; the remaining four trials did not provide information on this issue. This review found moderate-certainty evidence that, in patients with cirrhosis, band ligation of oesophageal varices reduces mortality, upper gastrointestinal bleeding, variceal bleeding, and serious adverse events compared to no intervention. It is unlikely that further trials of band ligation versus no intervention would be considered ethical.
- Research Article
9
- 10.1111/coa.12150
- Aug 1, 2013
- Clinical Otolaryngology
Background Grommets are frequently inserted in children's ears for acute otitis media and otitis media with effusion. A common complication is postoperative ear discharge (otorrhoea). A wide range of treatments are used to prevent the discharge, but there is no consensus on whether or not intervention is necessary nor which is the most effective intervention. Objectives To assess the effectiveness of prophylactic interventions, both topical and systemic, in reducing the incidence of otorrhoea following the surgical insertion of grommets in children. Search methods We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 3 July 2012. Selection criteria We included randomised controlled trials (RCTs) that compared the efficacy of prophylactic interventions against placebo/control and/or with other prophylactic interventions for postoperative otorrhoea in children. Data collection and analysis Two review authors independently assessed study eligibility and risk of bias, and extracted data. The outcome data were dichotomous for all the included trials. We calculated individual and pooled risk ratios (RR) using the Mantel-Haenszel fixed-effect method. We also calculated the numbers needed to treat to benefit (NNTB). Main results We found 15 eligible RCTs (2476 children, aged from four months to 17 years). We graded seven RCTs as being at a low risk of bias (n = 926 children) and for an eighth RCT we also graded two of the arms as being at a low risk of bias. We graded the other seven trials as being at a high risk of bias. For a single application at surgery, there was evidence from two low risk of bias trials that at two weeks postoperatively the risk of otorrhoea was reduced by multiple saline washouts (from 30% to 16%; RR 0.52, 95% confidence interval (CI) 0.27 to 1.00; NNTB 7; one RCT; 140 children) and antibiotic/steroid ear drops (from 9% to 1%; RR 0.13, 95% CI 0.03 to 0.57; NNTB 13; one RCT; 322 ears). A meta-analysis of two low risk of bias trials (222 ears) failed to find an effect of a single application of antibiotic/steroid ear drops at four to six weeks postoperatively. For a prolonged application of an intervention, there was evidence from four low risk of bias trials that the risk of otorrhoea was reduced two weeks postoperatively by antibiotic ear drops (from 15% to 8%; RR 0.54, 95% CI 0.30 to 0.97; NNTB 15; one RCT; 372 children), antibiotic/steroid ear drops (from 39% to 5%; RR 0.13, 95% CI 0.05 to 0.31; NNTB 3; one RCT; 200 children), aminoglycoside/steroid ear drops (from 15% to 5%; RR 0.37, 95% CI 0.18 to 0.74; NNTB 11; one RCT; 356 children) or oral antibacterial agents/steroids (from 39% to 5%; RR 0.13, 95% CI 0.03 to 0.51; NNTB 3; one RCT; 77 children). Only one trial assessed the secondary outcome of ototoxicity, but no effect was found. There were no trials that assessed quality of life. Authors' conclusions Our review found that each of the following were effective at reducing the rate of otorrhoea up to two weeks following surgery: (1) multiple saline washouts at surgery, (2) a single application of topical antibiotic/steroid drops at surgery, (3) a prolonged application of topical drops (namely antibiotic ear drops, antibiotic/steroid eardrops or aminoglycoside/steroid ear drops) and (4) a prolonged application of oral antibacterial agents/steroids. However, the rate of otorrhoea between RCTs varied greatly and the higher the rates of otorrhoea within a RCT, the smaller the NNTB for therapy. We conclude that if a surgeon has a high rate of postoperative otorrhoea in children then either saline irrigation or antibiotic ear drops at the time of surgery would significantly reduce that rate. If topical drops are chosen, it is suggested that to reduce the cost and potential for ototoxic damage this be a single application at the time of surgery and not prolonged thereafter.
- Research Article
38
- 10.1002/14651858.cd008512.pub2
- Apr 30, 2013
- The Cochrane database of systematic reviews
Grommets are frequently inserted in children's ears for acute otitis media and otitis media with effusion. A common complication is postoperative ear discharge (otorrhoea). A wide range of treatments are used to prevent the discharge, but there is no consensus on whether or not intervention is necessary nor which is the most effective intervention. To assess the effectiveness of prophylactic interventions, both topical and systemic, in reducing the incidence of otorrhoea following the surgical insertion of grommets in children. We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 3 July 2012. We included randomised controlled trials (RCTs) that compared the efficacy of prophylactic interventions against placebo/control and/or with other prophylactic interventions for postoperative otorrhoea in children. Two review authors independently assessed study eligibility and risk of bias, and extracted data. The outcome data were dichotomous for all the included trials. We calculated individual and pooled risk ratios (RR) using the Mantel-Haenszel fixed-effect method. We also calculated the numbers needed to treat to benefit (NNTB). We found 15 eligible RCTs (2476 children, aged from four months to 17 years). We graded seven RCTs as being at a low risk of bias (n = 926 children) and for an eighth RCT we also graded two of the arms as being at a low risk of bias. We graded the other seven trials as being at a high risk of bias.For a single application at surgery, there was evidence from two low risk of bias trials that at two weeks postoperatively the risk of otorrhoea was reduced by multiple saline washouts (from 30% to 16%; RR 0.52, 95% confidence interval (CI) 0.27 to 1.00; NNTB 7; one RCT; 140 children) and antibiotic/steroid ear drops (from 9% to 1%; RR 0.13, 95% CI 0.03 to 0.57; NNTB 13; one RCT; 322 ears). A meta-analysis of two low risk of bias trials (222 ears) failed to find an effect of a single application of antibiotic/steroid ear drops at four to six weeks postoperatively.For a prolonged application of an intervention, there was evidence from four low risk of bias trials that the risk of otorrhoea was reduced two weeks postoperatively by antibiotic ear drops (from 15% to 8%; RR 0.54, 95% CI 0.30 to 0.97; NNTB 15; one RCT; 372 children), antibiotic/steroid ear drops (from 39% to 5%; RR 0.13, 95% CI 0.05 to 0.31; NNTB 3; one RCT; 200 children), aminoglycoside/steroid ear drops (from 15% to 5%; RR 0.37, 95% CI 0.18 to 0.74; NNTB 11; one RCT; 356 children) or oral antibacterial agents/steroids (from 39% to 5%; RR 0.13, 95% CI 0.03 to 0.51; NNTB 3; one RCT; 77 children).Only one trial assessed the secondary outcome of ototoxicity, but no effect was found. There were no trials that assessed quality of life. Our review found that each of the following were effective at reducing the rate of otorrhoea up to two weeks following surgery: (1) multiple saline washouts at surgery, (2) a single application of topical antibiotic/steroid drops at surgery, (3) a prolonged application of topical drops (namely antibiotic ear drops, antibiotic/steroid eardrops or aminoglycoside/steroid ear drops) and (4) a prolonged application of oral antibacterial agents/steroids. However, the rate of otorrhoea between RCTs varied greatly and the higher the rates of otorrhoea within a RCT, the smaller the NNTB for therapy.We conclude that if a surgeon has a high rate of postoperative otorrhoea in children then either saline irrigation or antibiotic ear drops at the time of surgery would significantly reduce that rate. If topical drops are chosen, it is suggested that to reduce the cost and potential for ototoxic damage this be a single application at the time of surgery and not prolonged thereafter.
- Research Article
20
- 10.1002/14651858.cd006088.pub3
- Feb 15, 2012
- The Cochrane database of systematic reviews
Cough is often distressing for patients with pneumonia. Accordingly they often use over-the-counter (OTC) cough medications (mucolytics or cough suppressants). These might provide relief in reducing cough severity, but suppression of the cough mechanism might impede airway clearance and cause harm. To evaluate the efficacy of OTC cough medications as an adjunct to antibiotics in children and adults with pneumonia. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2011, Issue 3) which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1966 to July week 4, 2011), OLDMEDLINE (1950 to 1965), EMBASE (1980 to August 2011), CINAHL (2009 to August 2011), LILACS (2009 to August 2011) and Web of Science (2009 to August 2011). Randomised controlled trials (RCTs) in children and adults comparing any type of OTC cough medication with placebo, or control medication, with cough as an outcome and where the cough is secondary to acute pneumonia. We independently selected trials for inclusion. We extracted data from these studies, assessed them for methodological quality without disagreement and analyzed using standard methods. Four studies with a total of 224 participants were included; one was performed exclusively in children and three in adolescents or adults. One using an antitussive had no extractable pneumonia-specific data. Three different mucolytics (bromhexine, ambroxol, neltenexine) were used in the remaining studies, of which only two had extractable data. They demonstrated no significant difference for the primary outcome of 'not cured or not improved' for mucolytics. A secondary outcome of 'not cured' was reduced (odds ratio (OR) for children 0.36, 95% confidence interval (CI) 0.16 to 0.77; number needed to treat to benefit (NNTB) at day 10 = 5 (95% CI 3 to 16) and OR 0.32 for adults (95% CI 0.13 to 0.75); NNTB at day 10 = 5 (95% CI 3 to 19). In a post hoc analysis combining data for children and adults, again there was no difference in the primary outcome of 'not cured or not improved' (OR 0.85, 95% CI 0.40 to 1.80) although mucolytics reduced the secondary outcome 'not cured' (OR 0.34, 95% CI 0.19 to 0.60; NNTB 4, 95% CI 3 to 8). There is insufficient evidence to decide whether OTC medications for cough associated with acute pneumonia are beneficial. Mucolytics may be beneficial but there is insufficient evidence to recommend them as an adjunctive treatment for acute pneumonia. This leaves only theoretical recommendations that OTC medications containing codeine and antihistamines should not be used in young children.
- Research Article
1
- 10.13201/j.issn.2096-7993.2020.06.016
- Jun 1, 2020
- Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery
Objective:To explore the correlation between acute otitis media(AOM), acute pharyngitis(AP) and allergic rhinitis(AR) and environmental-meteorological factors in children in Lanzhou. Method:Data were collected in 2015-2017 from the outpatient department and emergency department of Otolaryngology of one hospital in Lanzhou. The association between clinical data and the environmental meteorological factors during the same period, including the air quality index(AQI), PM2.5, PM10, CO, NO₂, SO₂, O3, average temperature, average air pressure, average wind speed, average humidity in Lanzhou, was analyzed. Result:The incidence of AOM was positively correlated with AQI, PM2.5, PM10, CO, NO₂, SO₂, average air pressure, and was negatively correlated with O3, average wind speed and average air temperature, but not correlated with average humidity. The incidence of AP was positively correlated with average temperature and average humidity, and not correlated with other 9 factors. The incidence of AR was correlated with all 10 environmental meteorological factors except for O3.The number of children with AOM, AP and AR varied with different seasons. Environmental meteorological factors have single lag and cumulative lag effects on the incidence of children with AOM, AP and AR, and difference between the single lag and cumulative lag time was observed. Conclusion:There may be some correlation between the environmental meteorological factors and the incidence of AOM, AP, AR in children, and there is a lag effect. The incidence of pediatric AOM, AP and AR is affected by seasonal factors.