Systemic corticosteroids for acute sinusitis

Roderick P Venekamp; Matthew J Thompson; Gail Hayward; Carl J Heneghan; Chris B Del Mar; Rafael Perera; Paul P Glasziou; Maroeska M Rovers

doi:10.1002/14651858.CD008115.pub2

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Figure 1

'Risk of bias' summary

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Figure 2

Forest plot of comparison: 1 Oral corticosteroids versus placebo or NSAID, outcome: 1.1 Proportion of patients with resolution or improved symptoms at days 3 to 7, stratified to very short‐term (days 3 to 4) and short‐term (days 6‐7).

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Figure 3

Forest plot of comparison: 1 Oral corticosteroids versus placebo or NSAID, outcome: 1.2 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12.

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Figure 4

Forest plot of comparison: 2 Sensitivity analysis ‐ Oral corticosteroids versus placebo, outcome: 2.1 Proportion of patients with resolution or improved symptoms at days 3 to 6.

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Figure 5

Forest plot of comparison: 2 Sensitivity analysis ‐ Oral corticosteroids versus placebo, outcome: 2.2 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12.

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Figure 6

Funnel plot of comparison: 1 Oral corticosteroids versus placebo or NSAID, outcome: 1.1 Proportion of patients with resolution or improved symptoms at days 3 to 7.

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Analysis 1.1

Comparison 1 Oral corticosteroids versus placebo or NSAID, Outcome 1 Proportion of patients with resolution or improved symptoms at days 3 to 7.

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Analysis 1.2

Comparison 1 Oral corticosteroids versus placebo or NSAID, Outcome 2 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12.

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Analysis 2.1

Comparison 2 Sensitivity analysis ‐ oral corticosteroids versus placebo, Outcome 1 Proportion of patients with resolution or improved symptoms at days 3 to 6.

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Analysis 2.2

Comparison 2 Sensitivity analysis ‐ oral corticosteroids versus placebo, Outcome 2 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12.

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Analysis 3.1

Comparison 3 Best and worst‐case scenario ‐ oral corticosteroids versus NSAID or placebo, Outcome 1 Proportion of patients with resolution or improved symptoms at days 3 to 7 ‐ best‐case scenario.

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Analysis 3.2

Comparison 3 Best and worst‐case scenario ‐ oral corticosteroids versus NSAID or placebo, Outcome 2 Proportion of patients with resolution or improved symptoms at days 3 to 7 ‐ worst‐case scenario.

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Analysis 3.3

Comparison 3 Best and worst‐case scenario ‐ oral corticosteroids versus NSAID or placebo, Outcome 3 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 ‐ best‐case scenario.

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Analysis 3.4

Comparison 3 Best and worst‐case scenario ‐ oral corticosteroids versus NSAID or placebo, Outcome 4 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 ‐ worst‐case scenario.

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Analysis 4.1

Comparison 4 Best and worst‐case scenario ‐ oral corticosteroids versus placebo, Outcome 1 Proportion of patients with resolution or improved symptoms at days 3 to 6 ‐ best‐case scenario.

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Analysis 4.2

Comparison 4 Best and worst‐case scenario ‐ oral corticosteroids versus placebo, Outcome 2 Proportion of patients with resolution or improved symptoms at days 3 to 6 ‐ worst‐case scenario.

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Analysis 4.3

Comparison 4 Best and worst‐case scenario ‐ oral corticosteroids versus placebo, Outcome 3 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 ‐ best‐case scenario.

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Analysis 4.4

Comparison 4 Best and worst‐case scenario ‐ oral corticosteroids versus placebo, Outcome 4 Proportion of patients with resolution or improved symptoms at days 4 to 10 to 12 ‐ worst‐case scenario.

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Corticosteroids compared with placebo or NSAIDs for acute sinusitis
Outcomes	Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)
Proportion of patients with resolution or improved symptoms at days 3 to 7	RR 1.40 (1.08 to 1.81)	869 (4)	Moderate
Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12	RR 1.32 (1.04 to 1.68)	945 (4)	Moderate
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.

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Table 1. Adverse events

Study	Intervention	Comparison	Side effects	Comments
Cannoni 1990	Prednisolone 40 mg once daily for participants with a weight < 60 kg and prednisolone 60 mg once daily for participants with a weight > 60 kg for 7 days	Niflumic acid (NSAID) 250 mg 3 daily for 7 days	Nausea, vomiting, gastric complaints	Adverse events NSAID group versus corticosteroid group: 51 versus 23 (P < 0.05) Discontinuation of study participation due to adverse events NSAID group versus corticosteroid group: 7 versus 0 (P < 0.05)
Gehanno 2000	Methylprednisolone 8 mg 3 daily for 5 days	Placebo	Nausea, vomiting, diarrhoea, gastric pain, skin reactions and candidal superinfection	Intercurrent events corticosteroid group versus placebo group: 24 (11%) versus 22 (10%) Discontinuation of treatment due to intercurrent events corticosteroid group versus placebo group: 5 versus 3
Klossek 2004	Prednisone 0.8 to 1.2 mg/kg (weight 40 to 60 kg: 40 mg, weight 60 to 80 kg: 60 mg, weight > 80 kg: 80 mg) for 3 days	Placebo	Vomiting, diarrhoea abdominal pain, allergic reaction	46 adverse events were noted; no statistical difference between the groups 7/46 were rated as severe by the patient: 3 in corticosteroid group (1 diarrhoea, 1 acute gastroenteritis, 1 abdominal pain) versus 4 in placebo group (1 vomiting, 1 abdominal pain, 1 neuralgia, 1 ear pain) 5 adverse events are possibly related to the treatment: 4 in corticosteroid group (diarrhoea, acute gastroenteritis, abdominal pain, allergic reaction) and 1 in placebo group (moderate colitis)
Ratau 2004	Betamethasone 1 mg orally once daily for 5 days	Placebo	No adverse events reported	No adverse events or eruptions of new diseases associated with the use of betamethasone were reported Two adverse reactions were reported in the placebo group: cough and maculopapular rash
NSAID: non‐steroidal anti‐inflammatory drug

Table 1. Adverse events

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Comparison 1. Oral corticosteroids versus placebo or NSAID

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of patients with resolution or improved symptoms at days 3 to 7 Show forest plot	4	869	Risk Ratio (M‐H, Random, 95% CI)	1.40 [1.08, 1.81]

1.1 Very short‐term (days 3 to 4)	2	624	Risk Ratio (M‐H, Random, 95% CI)	1.18 [1.05, 1.32]
1.2 Short‐term (days 6 to 7)	2	245	Risk Ratio (M‐H, Random, 95% CI)	1.83 [1.44, 2.31]
2 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 Show forest plot	4	945	Risk Ratio (M‐H, Random, 95% CI)	1.32 [1.04, 1.68]

Comparison 1. Oral corticosteroids versus placebo or NSAID

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Comparison 2. Sensitivity analysis ‐ oral corticosteroids versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of patients with resolution or improved symptoms at days 3 to 6 Show forest plot	3	666	Risk Ratio (M‐H, Fixed, 95% CI)	1.20 [1.07, 1.35]

2 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 Show forest plot	3	742	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [1.04, 1.24]

Comparison 2. Sensitivity analysis ‐ oral corticosteroids versus placebo

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Comparison 3. Best and worst‐case scenario ‐ oral corticosteroids versus NSAID or placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of patients with resolution or improved symptoms at days 3 to 7 ‐ best‐case scenario Show forest plot	4	1008	Risk Ratio (M‐H, Random, 95% CI)	1.74 [1.15, 2.64]

2 Proportion of patients with resolution or improved symptoms at days 3 to 7 ‐ worst‐case scenario Show forest plot	4	1008	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.72, 1.66]

3 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 ‐ best‐case scenario Show forest plot	4	1008	Risk Ratio (M‐H, Random, 95% CI)	1.42 [1.12, 1.82]

4 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 ‐ worst‐case scenario Show forest plot	4	1008	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.93, 1.52]

Comparison 3. Best and worst‐case scenario ‐ oral corticosteroids versus NSAID or placebo

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Comparison 4. Best and worst‐case scenario ‐ oral corticosteroids versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Proportion of patients with resolution or improved symptoms at days 3 to 6 ‐ best‐case scenario Show forest plot	3	789	Risk Ratio (M‐H, Random, 95% CI)	1.62 [0.97, 2.69]

2 Proportion of patients with resolution or improved symptoms at days 3 to 6 ‐ worst‐case scenario Show forest plot	3	789	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.57, 1.59]

3 Proportion of patients with resolution or improved symptoms at days 4 to 10 or 12 ‐ best‐case scenario Show forest plot	3	789	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [1.11, 1.32]

4 Proportion of patients with resolution or improved symptoms at days 4 to 10 to 12 ‐ worst‐case scenario Show forest plot	3	789	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.87, 1.26]

Comparison 4. Best and worst‐case scenario ‐ oral corticosteroids versus placebo

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