-
Canadian Association of Radiologists... Feb 2024Fungal rhinosinusitis (FRS) includes non-invasive and invasive subtypes with the latter having significant morbidity and mortality. This systematic review aims to... (Review)
Review
Fungal rhinosinusitis (FRS) includes non-invasive and invasive subtypes with the latter having significant morbidity and mortality. This systematic review aims to identify the imaging features most correlated with invasive fungal rhinosinusitis (IFRS) and present a checklist of these features to aid diagnosis. PubMed, Embase, CENTRAL, and Science Direct were searched from inception to May 2023, in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Primary research articles published in English describing the imaging features of IFRS were included. The systematic review was conducted in accordance with the PRISMA guidelines. Forty-eight articles were identified for inclusion. Six studies examined radiological features in acute invasive fungal rhinosinusitis (AIFRS), and 9 studies of chronic invasive fungal rhinosinusitis (CIFRS). A majority of studies did not specify whether IFRS cases were acute or chronic. On CT, bony erosion and mucosal thickening were the most common features. Other features include nasal soft tissue thickening, nasal cavity opacification, opacification of the affected sinus, and perisinus soft tissue infiltration. Extra-sinus extension was commonly observed on MRI, most often invading intraorbitally and intracranially. Other sites of extra-sinus extension included the cavernous sinus, pterygopalatine fossa, infratemporal fossa, masticator space, and facial soft tissue. IFRS is a condition with potential for high morbidity and mortality. Several radiological features are highly suggestive of IFRS. Early identification of high-risk radiological features using a checklist may aid prompt diagnosis and early treatment. Future research investigating the radiological differentiation between IFRS and other significant pathology including bacterial orbital cellulitis would be beneficial.
PubMed: 38344986
DOI: 10.1177/08465371241227424 -
Journal of Otolaryngology - Head & Neck... Aug 2020Acute exacerbations (AE) in chronic rhinosinusitis (CRS) have been increasingly recognized as an important clinical issue. The purpose of this study is to summarize the...
BACKGROUND
Acute exacerbations (AE) in chronic rhinosinusitis (CRS) have been increasingly recognized as an important clinical issue. The purpose of this study is to summarize the current definitions and evaluation parameters of AE and then identify and quantify the clinical and immunopathologic characteristics of AE in CRS.
METHODS
A systematic review of the literature was performed on PubMed, Scopus, and Cochrane databases from January 1990 through August 2020 to identify studies relating to AE in CRS. Exclusion criteria included non-English and non-human studies, and case reports.
RESULTS
The definitions of AE in CRS among all the studies were based on a description of short-term worsening sinonasal symptoms. Patient-reported sinus infection and exacerbation related medical treatment during the preceding 3 months to 1 year were used to evaluate the frequency of AE in CRS. The average decline in 22-item Sino-Nasal Outcome Test (SNOT-22) score during an exacerbation was 7.83 points relative to baseline. Comorbid asthma, SNOT-22 scores ≥24, allergic rhinitis, eosinophil count ≥150/μL and autoimmune disease were positively associated with an exacerbation-prone CRS phenotype. AE in chronic rhinosinusitis with nasal polyps (CRSwNP) was associated with increased expression of mucus cytokines including myeloperoxidase (percentage increase [PI] = 101%), IL-5 (PI = 125%), and IL-6 (PI = 162%) and could be predicted by the increasing mucus cystatin and periostin.
CONCLUSION
The definition of AE in CRS is largely driven by patient-reported symptoms and is associated with several risk factors. Quantitative changes in mucus cytokines associated with AE in CRSwNP and may be used to predict events. The development of a consistent definition of AE in CRS is critical to help define disease control and treatment efficacy.
Topics: Asthma; Chronic Disease; Humans; Nasal Polyps; Rhinitis; Risk Factors; Sino-Nasal Outcome Test; Sinusitis; Symptom Flare Up
PubMed: 32811568
DOI: 10.1186/s40463-020-00459-w -
Le Infezioni in Medicina 2021Coronavirus disease 2019 (COVID-19) is an acute viral illness caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Opportunistic infections such as... (Review)
Review
Coronavirus disease 2019 (COVID-19) is an acute viral illness caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Opportunistic infections such as mucormycosis have been reported among COVID-19 patients particularly in South Asian countries during the second wave of this pandemic. It is necessary to re-evaluate any changes in traditional risk factors associated with mucormycosis such as diabetes mellitus, organ transplant, etc in the precedent of ongoing COVID-19 pandemic. We conducted a systematic review using electronic databases. A total of 115 COVID-19 patients who were diagnosed with mucormycosis were included in this study. Diabetes mellitus was the most common co-morbidity with 77.1%, followed by hypertension (29.5%) and renal disease (14.3%). 55.2% of the patients had received dexamethasone for COVID-19 infection. Ten patients (11.5%) had received tocilizumab. Sinuses were the most common site of mucormycosis among COVID-19 patients at 79.4% with maxillary sinus (47.4%) being most commonly infected. Orbits were the second most prevalent site at 56.7% and lungs were infected with mucor at 11.3%. The mean duration between the diagnosis of COVID-19 infection and mucormycosis was 16.15 days (range 2-90 days). Cavernous sinus was either infiltrated or encased in 14 patients (14.4%). Cerebral involvement was seen in terms of abscess, infarcts, or edema in 12 patients (12.4%). Only 76 patients had data on the outcomes, out of which 37 (48.7%) patients had died. Diabetes mellitus is still the most common co-morbidity similar to non-COVID-19 patients. More than 90% of the patients with COVID-19 infection had received steroids. Complications such as cavernous sinus thrombosis, cerebral infarcts, abscesses were common. Indiscriminate use of steroids in patients needs to be avoided and focus needs to be put on tight blood sugar control in diabetic patients. Studies are needed to confirm the role of the SARS-CoV-2 virus in causing immune dysfunction and mucormycosis.
PubMed: 35146358
DOI: 10.53854/liim-2904-2 -
PloS One 2022This systematic review aims to assess the effects and safety of Chinese herbal medicines (CHMs) in the management of rhinosinusitis (RS); inform clinicians of the... (Meta-Analysis)
Meta-Analysis
This systematic review aims to assess the effects and safety of Chinese herbal medicines (CHMs) in the management of rhinosinusitis (RS); inform clinicians of the current state of the evidence; identify the best available evidence; and suggest further directions for research. Five English and four Chinese language databases, and four clinical trial registries were searched. Eligible studies were randomised controlled trials (RCTs). Participants were diagnosed with RS based on established criteria. Test interventions were CHMs administered orally and/or nasally, excluding injections and displacement techniques. Control interventions included placebos, no additional treatment, and conventional non-invasive treatments including pharmacotherapies and/or nasal irrigation, and/or inhalations. Polyposis and post-surgical recovery were excluded. Outcomes were Sino-Nasal Outcome Test (SNOT), visual analogue scales (VAS), Lund-Mackay computed tomography score (LM), Lund-Kennedy Endoscopic score (LK), Mucociliary transport time (MTT), Mucociliary transport rate (MTR), quality of life and adverse events (AEs). Risk of bias used the Cochrane tool. Meta-analysis in Review Manager 5.4.1 used random effects for mean difference (MD) or risk ratio (RR) with 95% confidence intervals. Heterogeneity was assessed as I2. Thirty-four RCTs were included, 30 of chronic RS (CRS) and four of acute RS (ARS). These enrolled 3,752 participants. Five RCTs blinded participants. For CRS, comparisons with placebo showed greater improvements in the CHM groups for SNOT-20 and VAS-TNS (total nasal symptoms). Blinded comparisons with pharmacotherapies showed no differences between groups in the degree of improvement for SNOT-20, VAS-TNS, and LM, suggesting these CHMs had similar effects, at least in the short term. In ARS, pooled results found improved scores on VAS-TNS and LK suggesting a benefit for combining these CHMs with pharmacotherapies. Limitations included inadequacies in study design and methodological reporting, and insufficient reporting of AEs. Heterogeneity in some pooled results precluded strong conclusions. Further well-designed studies are needed to test whether the results are replicable. Systematic review registration number: PROSPERO (CRD42019119586).
Topics: Humans; China; Nasal Lavage; Phytotherapy; Sinusitis
PubMed: 36454862
DOI: 10.1371/journal.pone.0278492 -
The Cochrane Database of Systematic... Apr 2016This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Nasal saline irrigation is commonly used to improve patient symptoms.
OBJECTIVES
To evaluate the effects of saline irrigation in patients with chronic rhinosinusitis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 9); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 30 October 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing saline delivered to the nose by any means (douche, irrigation, drops, spray or nebuliser) with (a) placebo, (b) no treatment or (c) other pharmacological interventions.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of local irritation and discomfort. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included two RCTs (116 adult participants). One compared large-volume (150 ml) hypertonic (2%) saline irrigation with usual treatment over a six-month period; the other compared 5 ml nebulised saline twice a day with intranasal corticosteroids, treating participants for three months and evaluating them on completion of treatment and three months later. Large-volume, hypertonic nasal saline versus usual care One trial included 76 adult participants (52 intervention, 24 control) with or without polyps.Disease-specific HRQL was reported using the Rhinosinusitis Disability Index (RSDI; 0 to 100, 100 = best quality of life). At the end of three months of treatment, patients in the saline group were better than those in the placebo group (mean difference (MD) 6.3 points, 95% confidence interval (CI) 0.89 to 11.71) and at six months there was a greater effect (MD 13.5 points, 95% CI 9.63 to 17.37). We assessed the evidence to be of low quality for the three months follow-up and very low quality for the six months follow-up. Patient-reported disease severity was evaluated using a "single-item sinus symptom severity assessment" but the range of scores is not stated, making it impossible for us to determine the meaning of the data presented.No adverse effects data were collected in the control group but 23% of participants in the saline group experienced side effects including epistaxis. General HRQL was measured using SF-12 (0 to 100, 100 = best quality of life). No difference was found after three months of treatment (low quality evidence) but at six months there was a small difference favouring the saline group, which may not be of clinical significance and has high uncertainty (MD 10.5 points, 95% CI 0.66 to 20.34) (very low quality evidence). Low-volume, nebulised saline versus intranasal corticosteroids One trial included 40 adult participants with polyps. Our primary outcome of disease-specific HRQL was not reported. At the end of treatment (three months) the patients who had intranasal corticosteroids had less severe symptoms (MD -13.50, 95% CI -14.44 to -12.56); this corresponds to a large effect size. We assessed the evidence to be of very low quality.
AUTHORS' CONCLUSIONS
The two studies were very different in terms of included populations, interventions and comparisons and so it is therefore difficult to draw conclusions for practice. The evidence suggests that there is no benefit of a low-volume (5 ml) nebulised saline spray over intranasal steroids. There is some benefit of daily, large-volume (150 ml) saline irrigation with a hypertonic solution when compared with placebo, but the quality of the evidence is low for three months and very low for six months of treatment.
Topics: Administration, Intranasal; Adrenal Cortex Hormones; Adult; Chronic Disease; Humans; Hypertonic Solutions; Nasal Polyps; Nasal Sprays; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Sodium Chloride; Therapeutic Irrigation; Time Factors
PubMed: 27115216
DOI: 10.1002/14651858.CD011995.pub2 -
Antibiotics (Basel, Switzerland) Sep 2018Most antibiotics are prescribed in primary care, and commonly for respiratory tract infections (RTIs). Narrow-spectrum phenoxymethylpenicillin is the antibiotic of... (Review)
Review
Most antibiotics are prescribed in primary care, and commonly for respiratory tract infections (RTIs). Narrow-spectrum phenoxymethylpenicillin is the antibiotic of choice for RTIs in the Scandinavian countries, while broader spectrum amoxicillin is used in most other European countries. This review summarizes the knowledge of the effect of phenoxymethylpenicillin versus amoxicillin for infections treated in ambulatory care. We searched PubMed/Medline and Embase for trials comparing the clinical effect of phenoxymethylpenicillin and amoxicillin. The Norwegian Knowledge Centre for the Health Services' checklist was used to assess risk of bias. In total, 1687 studies were identified, and 18 of these fulfilled the inclusion criteria. One additional study was found as a reference. The randomized controlled trials revealed no significant differences in clinical effect in acute sinusitis (three RCTs), GAS tonsillitis (11 RCTs) and Lyme borreliosis (two RCTs). One RCT on community-acquired pneumonia found amoxicillin to be superior, while the results were conflicting in the two RCTs on acute otitis. The results suggest that non-Scandinavian countries should consider phenoxymethylpenicillin as the treatment of choice for RTIs because of its narrower spectrum. More studies should be conducted on the clinical effect of phenoxymethylpenicillin versus amoxicillin for acute otitis and lower RTIs.
PubMed: 30181520
DOI: 10.3390/antibiotics7030081 -
The British Journal of General Practice... Jul 2019The overall clinical impression ('clinical gestalt') is widely used for diagnosis but its accuracy has not been systematically studied. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The overall clinical impression ('clinical gestalt') is widely used for diagnosis but its accuracy has not been systematically studied.
AIM
To determine the accuracy of clinical gestalt for the diagnosis of community-acquired pneumonia (CAP), acute rhinosinusitis (ARS), acute bacterial rhinosinusitis (ABRS), and streptococcal pharyngitis, and to contrast it with the accuracy of clinical decision rules (CDRs).
DESIGN AND SETTING
Systematic review and meta-analysis of outpatient diagnostic accuracy studies in ambulatory care.
METHOD
PubMed and Google were searched for studies in outpatients that reported sufficient data to calculate accuracy of the overall clinical impression and that used the same reference standard. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2), and measures of accuracy calculated using bivariate meta-analysis.
RESULTS
The authors identified 16 studies that met the inclusion criteria. The summary estimates for the positive (LR+) and negative likelihood ratios (LR-) were LR+ 7.7, 95% confidence interval (CI) = 4.8 to 11.5, and LR- 0.54, 95% CI = 0.42 to 0.65 for CAP in adults, LR+ 2.7, 95% CI = 1.1 to 4.3 and LR- 0.63, 95% CI = 0.20 to 0.98 for CAP in children, LR+ 3.0, 95% CI = 2.1 to 4.4 and LR- 0.37, 95% CI = 0.29 to 0.46 for ARS in adults, LR+ 3.9, 95% CI = 2.4 to 5.9 and LR- 0.33, 95% CI = 0.20 to 0.50 for ABRS in adults, and LR+ 2.1, 95% CI = 1.6 to 2.8 and LR- 0.47, 95% CI = 0.36 to 0.60 for streptococcal pharyngitis in adults and children. The diagnostic odds ratios were highest for CAP in adults (14.2, 95% CI = 9.0 to 21.0), ARS in adults (8.3, 95% CI = 4.9 to 13.1), and ABRS in adults (13.0, 95% CI = 5.0 to 27.0), as were the C-statistics (0.80, 0.77, and 0.84 respectively).
CONCLUSION
The accuracy of the overall clinical impression compares favourably with the accuracy of CDRs. Studies of diagnostic accuracy should routinely include the overall clinical impression in addition to individual signs and symptoms, and research is needed to optimise its teaching.
Topics: Acute Disease; Clinical Decision Rules; Community-Acquired Infections; Humans; Odds Ratio; Pharyngitis; Pneumonia; Rhinitis; Sensitivity and Specificity; Sinusitis; Streptococcal Infections
PubMed: 31208974
DOI: 10.3399/bjgp19X704297 -
BMJ (Clinical Research Ed.) Apr 2014To describe the potential benefits and harms of oseltamivir by reviewing all clinical study reports (or similar document when no clinical study report exists) of... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To describe the potential benefits and harms of oseltamivir by reviewing all clinical study reports (or similar document when no clinical study report exists) of randomised placebo controlled trials and regulatory comments ("regulatory information").
DESIGN
Systematic review of regulatory information.
DATA SOURCES
Clinical study reports, trial registries, electronic databases, regulatory archives, and correspondence with manufacturers.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
Randomised placebo controlled trials on adults and children who had confirmed or suspected exposure to natural influenza.
MAIN OUTCOME MEASURES
Time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population.
RESULTS
From the European Medicines Agency and Roche, we obtained clinical study reports for 83 trials. We included 23 trials in stage 1 (reliability and completeness screen) and 20 in stage 2 (formal analysis). In treatment trials on adults, oseltamivir reduced the time to first alleviation of symptoms by 16.8 hours (95% confidence interval 8.4 to 25.1 hours, P<0.001). There was no effect in children with asthma, but there was an effect in otherwise healthy children (mean difference 29 hours, 95% confidence interval 12 to 47 hours, P=0.001). In treatment trials there was no difference in admissions to hospital in adults (risk difference 0.15%, 95% confidence interval -0.91% to 0.78%, P=0.84) and sparse data in children and for prophylaxis. In adult treatment trials, oseltamivir reduced investigator mediated unverified pneumonia (risk difference 1.00%, 0.22% to 1.49%; number needed to treat to benefit (NNTB) 100, 95% confidence interval 67 to 451). The effect was not statistically significant in the five trials that used a more detailed diagnostic form for "pneumonia," and no clinical study reports reported laboratory or diagnostic confirmation of "pneumonia." The effect on unverified pneumonia in children and for prophylaxis was not significant. There was no significant reduction in risk of unverified bronchitis, otitis media, sinusitis, or any complication classified as serious or that led to study withdrawal. 14 of 20 trials prompted participants to self report all secondary illnesses to an investigator. Oseltamivir in the treatment of adults increased the risk of nausea (risk difference 3.66%, 0.90% to 7.39%; number needed to treat to harm (NNTH) 28, 95% confidence interval 14 to 112) and vomiting (4.56%, 2.39% to 7.58%; 22, 14 to 42). In treatment of children, oseltamivir induced vomiting (5.34%, 1.75% to 10.29%; 19, 10 to 57). In prophylaxis trials, oseltamivir reduced symptomatic influenza in participants by 55% (3.05%, 1.83% to 3.88%; NNTB 33, 26 to 55) and households (13.6%, 9.52% to 15.47%; NNTB 7, 6 to 11) based on one study, but there was no significant effect on asymptomatic influenza and no evidence of a reduction in transmission. In prophylaxis studies, oseltamivir increased the risk of psychiatric adverse events during the combined "on-treatment" and "off-treatment" periods (risk difference 1.06%, 0.07% to 2.76%; NNTH 94, 36 to 1538) and there was a dose-response effect on psychiatric events in two "pivotal" treatment trials of oseltamivir, at 75 mg (standard dose) and 150 mg (high dose) twice daily (P=0.038). In prophylaxis studies, oseltamivir increased the risk of headaches on-treatment (risk difference 3.15%, 0.88% to 5.78%; NNTH 32, 18 to 115), renal events with treatment (0.67%, -0.01% to 2.93%), and nausea while receiving treatment (4.15%, 0.86% to 9.51%; NNTH 25, 11 to 116).
CONCLUSIONS
In prophylactic studies oseltamivir reduces the proportion of symptomatic influenza. In treatment studies it also modestly reduces the time to first alleviation of symptoms, but it causes nausea and vomiting and increases the risk of headaches and renal and psychiatric syndromes. The evidence of clinically significant effects on complications and viral transmission is limited because of rarity of such events and problems with study design. The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir for treatment, prophylaxis, or stockpiling.
Topics: Adult; Age Factors; Antiviral Agents; Child; Headache; Humans; Influenza, Human; Kidney Diseases; Nausea; Oseltamivir; Randomized Controlled Trials as Topic; Treatment Outcome; Vomiting
PubMed: 24811411
DOI: 10.1136/bmj.g2545 -
The Cochrane Database of Systematic... Apr 2016This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Systemic and topical antibiotics are used with the aim of eliminating infection in the short term (and some to reduce inflammation in the long term), in order to normalise nasal mucus and improve symptoms.
OBJECTIVES
To assess the effects of systemic and topical antibiotics in people with chronic rhinosinusitis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Trials Register; CENTRAL (2015, Issue 8); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 29 September 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing systemic or topical antibiotic treatment to (a) placebo or (b) no treatment or (c) other pharmacological interventions.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - gastrointestinal disturbance. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of suspected allergic reaction (rash or skin irritation) and anaphylaxis or other very serious reactions. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included five RCTs (293 participants), all of which compared systemic antibiotics with placebo or another pharmacological intervention.The varying study characteristics made comparison difficult. Four studies recruited only adults and one only children. Three used macrolide, one tetracycline and one a cephalosporin-type antibiotic. Three recruited only patients with chronic rhinosinusitis without nasal polyps, one recruited patients with chronic rhinosinusitis with nasal polyps and one had a mixed population. Three followed up patients for 10 to 12 weeks after treatment had finished. Systemic antibiotics versus placebo Three studies compared antibiotics with placebo (176 participants).One study (64 participants, without polyps) reported disease-specific HRQL using the SNOT-20 (0 to 5, 0 = best quality of life). At the end of treatment (three months) the SNOT-20 score was lower in the group receiving macrolide antibiotics than the placebo group (mean difference (MD) -0.54 points, 95% confidence interval (CI) -0.98 to -0.10), corresponding to a moderate effect size favouring antibiotics (moderate quality evidence). Three months after treatment, it is uncertain if there was a difference between groups.One study (33 participants, with polyps) provided information on gastrointestinal disturbances and suspected allergic reaction (rash or skin irritation) after a short course of tetracycline antibiotic compared with placebo. We are very uncertain if antibiotics were associated with an increase in gastrointestinal disturbances (risk ratio (RR) 1.36, 95% CI 0.22 to 8.50) or skin irritation (RR 6.67, 95% CI 0.34 to 128.86) (very low quality evidence). Systemic antibiotics plus saline irrigation and intranasal corticosteroids versus placebo plus saline irrigation and intranasal corticosteroids One study (60 participants, some with and some without polyps) compared a three-month course of macrolide antibiotic with placebo; all participants also used saline irrigation and 70% used intranasal corticosteroids. Disease-specific HRQL was reported using SNOT-22 (0 to 110, 0 = best quality of life). Data were difficult to interpret (highly skewed and baseline imbalances) and it is unclear if there was an important difference at any time point (low quality evidence). To assess patient-reported disease severity participants rated the effect of treatment on a five-point scale (-2 for "desperately worse" to 2 for "cured") at the end of treatment (three months). For improvement in symptoms there was no difference between the antibiotics and placebo groups; the RR was 1.50 (95% CI 0.81 to 2.79; very low quality evidence), although there were also slightly more people who felt worse after treatment in the antibiotics group. There was no demonstrable difference in the rate of gastrointestinal disturbances between the groups (RR 1.07, 95% CI 0.16 to 7.10). General HRQL was measured using the SF-36. The authors stated that there was no difference between groups at the end of treatment (12 weeks) or two weeks later. Systemic antibiotics versus intranasal corticosteroids One study (43 participants, without polyps) compared a three-month course of macrolide antibiotic with intranasal corticosteroids. Patient-reported disease severity was assessed using a composite symptom score (0 to 40; 0 = no symptoms). It is very uncertain if there was a difference as patient-reported disease severity was similar between groups (MD -0.32, 95% CI -2.11 to 1.47; low quality evidence). Systemic antibiotics versus oral corticosteroids One study (28 participants, with polyps) compared a short course of tetracycline antibiotic (unclear duration, ˜20 days) with a 20-day course of oral corticosteroids. We were unable to extract data on any of the primary efficacy outcomes. It is uncertain if there was a difference ingastrointestinal disturbances (RR 1.00, 95% CI 0.16 to 6.14) or skin irritation (RR 2.00, 95% CI 0.20 to 19.62) as the results for these outcomes were similar between groups (very low quality evidence).
AUTHORS' CONCLUSIONS
We found very little evidence that systemic antibiotics are effective in patients with chronic rhinosinusitis. We did find moderate quality evidence of a modest improvement in disease-specific quality of life in adults with chronic rhinosinusitis without polyps receiving three months of a macrolide antibiotic. The size of improvement was moderate (0.5 points on a five-point scale) and only seen at the end of the three-month treatment; by three months later no difference was found.Despite a general understanding that antibiotics can be associated with adverse effects, including gastrointestinal disturbances, the results in this review were very uncertain because the studies were small and few events were reported.No RCTs of topical antibiotics met the inclusion criteria.More research in this area, particularly evaluating longer-term outcomes and adverse effects, is required.
Topics: Administration, Intranasal; Administration, Oral; Administration, Topical; Adrenal Cortex Hormones; Adult; Anti-Bacterial Agents; Child; Chronic Disease; Drug Hypersensitivity; Humans; Nasal Polyps; Nasal Sprays; Quality of Life; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Time Factors
PubMed: 27113482
DOI: 10.1002/14651858.CD011994.pub2 -
The Cochrane Database of Systematic... Apr 2016This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is... (Review)
Review
BACKGROUND
This review is one of six looking at the primary medical management options for patients with chronic rhinosinusitis.Chronic rhinosinusitis is common and is characterised by inflammation of the lining of the nose and paranasal sinuses leading to nasal blockage, nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Topical (intranasal) corticosteroids are used with the aim of reducing inflammation in the sinonasal mucosa in order to improve patient symptoms.
OBJECTIVES
To assess the effects of different types of intranasal steroids in people with chronic rhinosinusitis.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the ENT Trials Register; Central Register of Controlled Trials (CENTRAL 2015, Issue 7); MEDLINE; EMBASE; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 11 August 2015.
SELECTION CRITERIA
Randomised controlled trials (RCTs) with a follow-up period of at least three months comparing first-generation intranasal corticosteroids (e.g. beclomethasone dipropionate, triamcinolone acetonide, flunisolide, budesonide) with second-generation intranasal corticosteroids (e.g. ciclesonide, fluticasone furoate, fluticasone propionate, mometasone furoate, betamethasone sodium phosphate), or sprays versus drops, or low-dose versus high-dose intranasal corticosteroids.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were disease-specific health-related quality of life (HRQL), patient-reported disease severity and the commonest adverse event - epistaxis (nosebleed). Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse event of local irritation. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
MAIN RESULTS
We included nine RCTs (911 participants), including four different comparisons. None of the studies evaluated our first primary outcome measure, disease-specific HRQL. Fluticasone propionate versus beclomethasone dipropionate We identified two small studies (56 participants with polyps) that evaluated disease severity and looked at the primary adverse effect: epistaxis , but no other outcomes. We cannot report any numerical data but the study authors reported no difference between the two steroids. The evidence was of very low quality. Fluticasone propionate versus mometasone furoate We identified only one study (100 participants with polyps) that evaluated disease severity (nasal symptoms scores), which reported no difference (no numerical data available). The evidence was of very low quality. High-dose versus low-dose steroidsWe included five studies (663 participants with nasal polyps), three using mometasone furoate (400 µg versus 200 µg in adults and older children, 200 µg versus 100 µg in younger children) and two using fluticasone propionate drops (800 µg versus 400 µg). We found low quality evidence relating to disease severity and nasal polyps size, with results from the high-dose and low-dose groups being similar. Although all studies reported more improvement in polyp score in the high-dose group, the significance of this is unclear due to the small size of the improvements.The primary adverse effect, epistaxis , was more common when higher doses were used (risk ratio (RR) 2.06, 95% confidence interval (CI) 1.20 to 3.54, 637 participants, moderate quality evidence). Most of the studies that contributed data to this outcome used a broad definition of epistaxis, which ranged from frank bleeding to bloody nasal discharge to flecks of blood in the mucus. Aqueous nasal spray versus aerosol spray We identified only one poorly reported study (unclear number of participants for comparison of interest, 91 between three treatment arms), in which there were significant baseline differences between the participants in the two groups. We were unable to draw meaningful conclusions from the data.
AUTHORS' CONCLUSIONS
We found insufficient evidence to suggest that one type of intranasal steroid is more effective than another in patients with chronic rhinosinusitis, nor that the effectiveness of a spray differs from an aerosol. We identified no studies that compared drops with spray.It is unclear if higher doses result in better symptom improvements (low quality evidence), but there was moderate quality evidence of an increased risk of epistaxis as an adverse effect of treatment when higher doses were used. This included all levels of severity of epistaxis and it is likely that the proportion of events that required patients to discontinue usage is low due to the low numbers of withdrawals attributed to it. If epistaxis is limited to streaks of blood in the mucus it may be tolerated by the patient and it may be safe to continue treatment. However, it may be a factor that affects compliance.There is insufficient evidence to suggest that the different types of corticosteroid molecule or spray versus aerosol have different effects. Lower doses have similar effectiveness but fewer side effects.Clearly more research in this area is needed, with specific attention given to trial design, disease-specific health-related quality of life outcomes and evaluation of longer-term outcomes and adverse effects.
Topics: Administration, Intranasal; Adult; Beclomethasone; Child; Chronic Disease; Fluticasone; Humans; Mometasone Furoate; Nasal Polyps; Nasal Sprays; Randomized Controlled Trials as Topic; Rhinitis; Sinusitis; Steroids
PubMed: 27115215
DOI: 10.1002/14651858.CD011993.pub2