Short‐course oral steroids as an adjunct therapy for chronic rhinosinusitis

Karen Head; Lee Yee Chong; Claire Hopkins; Carl Philpott; Anne GM Schilder; Martin J Burton

doi:10.1002/14651858.CD011992.pub2

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Figure 1

Process for sifting search results and selecting studies for inclusion.

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Figure 2

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Oral corticosteroids versus no treatment (intranasal steroids in both groups), Outcome 1 Nasal polyp grading.

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Analysis 2.1

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 1 Total symptom score.

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Analysis 2.2

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 2 Nasal obstruction.

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Analysis 2.3

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 3 Purulent nasal discharge.

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Analysis 2.4

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 4 Headache/facial pain.

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Analysis 2.5

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 5 Cough.

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Analysis 2.6

Comparison 2 Oral corticosteroids versus placebo (antibiotics in both arms), Outcome 6 CT score.

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Summary of findings for the main comparison. Short‐course oral corticosteroids compared to no oral corticosteroid treatment (intranasal steroids in both groups) for chronic rhinosinusitis

Short‐course oral corticosteroids compared to no oral corticosteroid treatment (intranasal steroids in both arms) for chronic rhinosinusitis
Patient or population: chronic rhinosinusitis Setting: ENT departments Intervention: short‐course oral steroids and intranasal steroids Comparison: intranasal steroids alone (no oral steroid treatment)
Outcomes No. of participants (studies)	Relative effect (95% CI)	*Anticipated absolute effects^ (95% CI)**			Quality	What happens
		Without oral steroids	With oral steroids	Difference
Disease‐specific health‐related quality of life	—	No RCT reported this outcome
Disease severity ‐ patient‐reported symptom score	—	No RCT reported this outcome
Adverse effect: mood or behavioural disturbances	—	No RCT reported this outcome
Health‐related quality of life	—	No RCT reported this outcome
Adverse effect: insomnia	—	No RCT reported this outcome
Adverse effect: gastrointestinal disturbances ‐ not measured	—	No RCT reported this outcome
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval;RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Summary of findings for the main comparison. Short‐course oral corticosteroids compared to no oral corticosteroid treatment (intranasal steroids in both groups) for chronic rhinosinusitis

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Summary of findings 2. Short‐course oral corticosteroids compared to placebo (antibiotics in both arms) for chronic rhinosinusitis

Short‐course oral corticosteroids compared to placebo (antibiotics in both groups) for chronic rhinosinusitis
Patient or population: chronic rhinosinusitis Setting: paediatric allergy and ENT department Intervention: oral corticosteroids and antibiotics Comparison: placebo and antibiotics
Outcomes No of participants (studies)	*Anticipated absolute effects^ (95% CI)**			Quality	What happens
	Without oral steroids	With oral steroids	Difference
Disease‐specific health‐related quality of life	No RCT reported this outcome
Disease severity ‐ patient‐reported symptom score, assessed with: 4 individual symptoms measured on 0 to 10 visual analogue scale summed to provide a range of 0 to 40 Follow‐up: 30 days ² No. of participants: 45 (1 RCT)	The mean disease severity score without oral steroids was 15.2	The mean disease severity score with oral steroids was 3.6	The mean disease severity score in the intervention group was 7.10 lower (9.59 lower to 4.61 lower)	⊕⊕⊝⊝ LOW ¹	A lower score indicates less severe symptoms. The results relate to a standardised mean difference of 1.61 standard deviations lower (‐2.29 to 0.93 lower), corresponding to a large difference.
Adverse effect: mood or behavioural disturbances	No RCT reported this outcome
Health‐related quality of life	No RCT reported this outcome
Adverse effect: insomnia	No RCT reported this outcome
Adverse effect: gastrointestinal disturbances	No RCT reported this outcome
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RCT: randomised controlled trial
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹Study completed only in children (mean age 8 years old). Study follow‐up time was less than 3 months (1 month). Scales were not validated and were completed by "parents and children". ²Symptoms included in this score were: purulent nasal discharge, nasal obstruction, cough and facial pain/headache.

Summary of findings 2. Short‐course oral corticosteroids compared to placebo (antibiotics in both arms) for chronic rhinosinusitis

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Table 1. Summary of the most commonly reported side effects of systemic steroids

System	Adverse events	Notes
Musculoskeletal	Osteoporosis	Largely limited to long‐term use Significantly increased risk of fractures with prolonged use
Musculoskeletal	Osteonecrosis	Rare; appears to be dose‐dependent
Endocrine	Hyperglycaemia	Common; dose‐dependent, usually reversible
Cardiovascular	Hypertension	Common; dose‐dependent, usually reversible
Dermatological	Striae, bruising	Dose‐dependent, occurs after > 1 month usage
Ophthalmological	Cataracts	Irreversible; largely related to long‐term usage
Ophthalmological	Glaucoma	High risk with pre‐existing disease
Gastrointestinal tract	Peptic ulceration	Increased risk largely due to concomitant NSAIDs
Psychological	Psychosis	Common; increased risk with dosages > 40 mg/day
References: Da Silva 2006; Naber 1996; Stanbury 1998 NSAIDs: non‐steroidal anti‐inflammatory drugs

Table 1. Summary of the most commonly reported side effects of systemic steroids

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Comparison 1. Oral corticosteroids versus no treatment (intranasal steroids in both groups)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Nasal polyp grading Show forest plot	1	30	Mean Difference (IV, Fixed, 95% CI)	‐0.46 [‐0.87, ‐0.05]

Comparison 1. Oral corticosteroids versus no treatment (intranasal steroids in both groups)

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Comparison 2. Oral corticosteroids versus placebo (antibiotics in both arms)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total symptom score Show forest plot	1	45	Mean Difference (IV, Fixed, 95% CI)	‐7.10 [‐9.59, ‐4.61]

2 Nasal obstruction Show forest plot	1	45	Mean Difference (IV, Fixed, 95% CI)	‐3.50 [‐4.71, ‐2.29]

3 Purulent nasal discharge Show forest plot	1	45	Mean Difference (IV, Fixed, 95% CI)	‐0.20 [‐1.54, 1.14]

4 Headache/facial pain Show forest plot	1	45	Mean Difference (IV, Fixed, 95% CI)	‐1.3 [‐2.55, ‐0.05]

5 Cough Show forest plot	1	45	Mean Difference (IV, Fixed, 95% CI)	‐2.10 [‐3.35, ‐0.85]

6 CT score Show forest plot	1	45	Mean Difference (IV, Fixed, 95% CI)	‐2.90 [‐4.91, ‐0.89]

Comparison 2. Oral corticosteroids versus placebo (antibiotics in both arms)

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