We reviewed the evidence for the benefits and harms of a short course (typically up to 21 days) of corticosteroid given by mouth to people with chronic rhinosinusitis compared with giving a placebo or no treatment, or another type of treatment.
Chronic rhinosinusitis is a common condition that is defined as inflammation of the nose and paranasal sinuses (a group of air-filled spaces behind the nose, eyes and cheeks). Patients with chronic rhinosinusitis experience at least two or more of the following symptoms for at least 12 weeks: blocked nose, discharge from their nose or runny nose, pain or pressure in their face and/or a reduced sense of smell (hyposmia). Some people will also have nasal polyps, which are grape-like swellings of the normal nasal lining inside the nasal passage and sinuses.
Short courses of oral corticosteroids are a widely used treatment for chronic rhinosinusitis. They work by controlling the inflammatory response and when polyps are present they rapidly reduce the size of the polyps to improve symptoms. The adverse effects of corticosteroids can include insomnia, mood changes and gastrointestinal changes (such as stomach pain, heartburn, diarrhoea, constipation, nausea and vomiting). When given over the longer term, or through many repeated short courses, it is also possible to develop osteoporosis (fragile bones).
This review includes evidence up to 11 August 2015. We included eight randomised controlled trials with a total of 474 participants. All of the patients were adults who had chronic rhinosinusitis with nasal polyps. All of the studies followed patients until the end of treatment (two to three weeks) and three studies (210 participants) followed up people for three to six months after the initial treatment had ended. Five of the eight reports mentioned how the trial was funded. None of the funding sources were pharmaceutical companies.
At the end of a two- or three-week treatment course, people who took oral steroids may have had a better quality of life, less severe symptoms and smaller nasal polyps than people who had placebo or did not receive any treatment. After three to six months, there was little or no difference in quality of life, symptom severity or nasal polyps between the people who had oral steroids and the people who had placebo or no intervention.
The people who took oral steroids may have had more gastrointestinal disturbances and insomnia than the people who had placebo or no intervention. It is not clear if the people who took oral steroids had more mood disturbances than the people who had placebo or no intervention.
Quality of the evidence
We judged the quality of the evidence for oral steroids plus intranasal steroids for adults with nasal polyps to be low (further research is very likely to have an important impact on our confidence in the effect estimate and is likely to change the estimate), as the some of the results are only from one or two studies, which do not have a lot of participants. Most of the trials do not have a high risk of bias, but only people with nasal polyps were included in the review.
At the end of the treatment course (two to three weeks) there is an improvement in health-related quality of life and symptom severity in patients with chronic rhinosinusitis with nasal polyps taking oral corticosteroids compared with placebo or no treatment. The quality of the evidence supporting this finding is low. At three to six months after the end of the oral steroid treatment period, there is little or no improvement in health-related quality of life or symptom severity for patients taking an initial course of oral steroids compared with placebo or no treatment.
The data on the adverse effects associated with short courses of oral corticosteroids indicate that there may be an increase in insomnia and gastrointestinal disturbances but it is not clear whether there is an increase in mood disturbances. All of the adverse events results are based on low quality evidence.
More research in this area, particularly research evaluating patients with chronic rhinosinusitis without nasal polyps, longer-term outcomes and adverse effects, is required.
There is no evidence for oral steroids compared with other treatments.
This review is one of a suite of six Cochrane reviews looking at the primary medical management options for patients with chronic rhinosinusitis.
Chronic rhinosinusitis is a common condition involving inflammation of the lining of the nose and paranasal sinuses. It is characterised by nasal blockage and nasal discharge, facial pressure/pain and loss of sense of smell. The condition can occur with or without nasal polyps. Oral corticosteroids are used to control the inflammatory response and improve symptoms.
To assess the effects of oral corticosteroids compared with placebo/no intervention or other pharmacological interventions (intranasal corticosteroids, antibiotics, antifungals) for chronic rhinosinusitis.
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.
Randomised controlled trials (RCTs) comparing a short course (up to 21 days) of oral corticosteroids with placebo or no treatment or compared with other pharmacological interventions.
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 adverse event of mood or behavioural disturbances. Secondary outcomes included general HRQL, endoscopic nasal polyp score, computerised tomography (CT) scan score and the adverse events of insomnia, gastrointestinal disturbances and osteoporosis. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.
We included eight RCTs (474 randomised participants), which compared oral corticosteroids with placebo or no intervention. All trials only recruited adults with chronic rhinosinusitis with nasal polyps. All trials reported outcomes at two to three weeks, at the end of the short-course oral steroid treatment period. Three trials additionally reported outcomes at three to six months. Two of these studies prescribed intranasal steroids to patients in both arms of the trial at the end of the oral steroid treatment period.
Oral steroids versus placebo or no intervention
Disease-specific health-related quality of life was reported by one study. This study reported improved quality of life after treatment (two to three weeks) in the group receiving oral steroids compared with the group who received placebo (standardised mean difference (SMD) -1.24, 95% confidence interval (CI) -1.92 to -0.56, 40 participants, modified RSOM-31), which corresponds to a large effect size. We assessed the evidence to be low quality (we are uncertain about the effect estimate; the true effect may be substantially different from the estimate of the effect).
Disease severity as measured by patient-reported symptom scores was reported by two studies, which allowed the four key symptoms used to define chronic rhinosinusitis (nasal blockage, nasal discharge, facial pressure, hyposmia) to be combined into one score. The results at the end of treatment (two to three weeks) showed an improvement in patients receiving oral steroids compared to placebo, both when presented as a mean final value (SMD -2.84, 95% CI -4.09 to -1.59, 22 participants) and as a change from baseline (SMD -2.28, 95% CI -2.76 to -1.80, 114 participants). These correspond to large effect sizes but we assessed the evidence to be low quality.
One study (114 participants) followed patients for 10 weeks after the two-week treatment period. All patients in both arms received intranasal steroids at the end of the oral steroid treatment period. The results showed that the initial results after treatment were not sustained (SMD -0.22, 95% CI -0.59 to 0.15, 114 participants, percentage improvement from baseline). This corresponds to a small effect size and we assessed the evidence to be low quality.
There was an increase in adverse events in people receiving orals steroids compared with placebo for gastrointestinal disturbances (risk ratio (RR) 3.45, 95% CI 1.11 to 10.78; 187 participants; three studies) and insomnia (RR 3.63, 95% CI 1.10 to 11.95; 187 participants; three studies). There was no significant impact of oral steroids on mood disturbances at the dosage used in the included study (risk ratio (RR) 2.50, 95% CI 0.55 to 11.41; 40 participants; one study). We assessed the evidence to be low quality due to the lack of definitions of the adverse events and the small number of events or sample size, or both).
No studies that compared short-course oral steroids with other treatment for chronic rhinosinusitis met the inclusion criteria.