Short‐course oral steroids alone for chronic rhinosinusitis

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

doi:10.1002/14651858.CD011991.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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Figure 4

Forest plot of comparison: 1 Oral steroids versus no treatment/placebo, outcome: 1.1 Disease‐specific health‐related quality of life ‐ no pooling (2 to 3 weeks).

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Figure 5

Forest plot of comparison: 1 Oral steroids versus no treatment/placebo, outcome: 1.3 Disease severity (patient‐reported total symptom score).

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Analysis 1.1

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 1 Disease‐specific health‐related quality of life ‐ no pooling (2 to 3 weeks).

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Analysis 1.2

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 2 Disease‐specific health‐related quality of life ‐ RQLQ (3 to 6 months).

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Analysis 1.3

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 3 Disease severity (patient‐reported total symptom score).

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Analysis 1.4

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 4 Individual symptoms: nasal obstruction (final value).

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Analysis 1.5

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 5 Individual symptoms: nasal obstruction (change from baseline).

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Analysis 1.6

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 6 Individual symptoms: nasal discharge (final value).

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Analysis 1.7

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 7 Individual symptoms: nasal discharge (change from baseline).

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Analysis 1.8

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 8 Individual symptoms: facial pressure (final value).

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Analysis 1.9

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 9 Individual symptoms: facial pressure (change from baseline).

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Analysis 1.10

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 10 Individual symptoms: loss of sense of smell (final value).

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Analysis 1.11

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 11 Individual symptoms: loss of sense of smell (change from baseline).

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Analysis 1.12

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 12 Adverse events ‐ significant mood disturbance.

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Analysis 1.13

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 13 Adverse events ‐ gastrointestinal disturbance.

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Analysis 1.14

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 14 Adverse events ‐ insomnia.

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Analysis 1.15

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 15 Endoscopy score ‐ nasal polyps (final value).

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Analysis 1.16

Comparison 1 Oral steroids versus no treatment/placebo, Outcome 16 Endoscopy score ‐ nasal polyps score (change from baseline).

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Summary of findings for the main comparison. Short‐course oral corticosteroids compared with placebo/no treatment for chronic rhinosinusitis

Short‐course oral corticosteroids compared with placebo/no treatment for chronic rhinosinusitis
Patient or population: chronic rhinosinusitis with nasal polyps Intervention: short‐course oral corticosteroids Comparison: placebo/no treatment
Outcomes № 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 measured by severity score of RSOM‐31 (unclear range) Follow‐up: 2 weeks № of participants: 40 (1 RCT)	—	Not estimable	—	The mean disease‐specific health‐related quality of life in the intervention group was 1.24 standard deviations lower (1.92 lower to 0.56 lower)	⊕⊕⊝⊝ LOW ¹	A lower score indicates reduced impairment. Treatment effect in favour of short‐course oral steroids. A SMD of 1.24 is considered a large effect size.
Disease severity, as measured by patient‐reported symptom score, measured by combining 4 individual symptoms № of participants: 22 (1 RCT) № of participants: 114 (1 RCT) № of participants: 114 (1 RCT)	—	—	—	The mean final symptom score² in the intervention group at 17 days was 2.84 standard deviations lower (4.00 lower to 1.59 lower) The change from baseline in symptom score⁷ in the intervention group at 2 weeks was 2.28 standard deviations lower (2.76 lower to 1.80 lower) The change from baseline in symptoms score⁷ at 3 months⁸ was 0.22 standard deviations lower (0.59 lower to 0.15 higher)	⊕⊕⊝⊝ LOW ³ ⊕⊕⊝⊝ LOW ⁹ ⊕⊕⊝⊝ LOW ¹⁰	A lower score indicates milder symptoms in favour of short‐course oral steroids. SMDs of 2.84 and 2.28 are considered to be large effect sizes. Patients treated with oral steroids probably had much milder symptoms at 2 to 3 weeks. A SMD of 0.22 is considered to be a small effect size. Patients treated with oral steroids and then intranasal steroids were probably not much different in their change in symptoms from baseline to 3 months than the patients who received placebo and then intranasal steroids.
Adverse events: significant mood disturbance Follow‐up: 2 weeks № of participants: 40 (1 RCT)	RR 2.50 (0.55 to 11.41)	Study population			⊕⊕⊝⊝ LOW ⁴	It is uncertain whether there were more mood disturbance adverse events in the oral corticosteroids group.
		100 per 1000	250 per 1000 (55 to 1000)	150 more per 1000 (45 fewer to 1041 more)
Health‐related quality of life, using generic quality of life scores	This outcome was not reported in any of the studies
Adverse events: gastrointestinal disturbance Follow‐up: 3 months № of participants:187 (3 RCTs)	RR 3.45 (1.11 to 10.78)	Study population			⊕⊕⊝⊝ LOW ⁵	There were more gastrointestinal disturbance adverse events in the oral corticosteroids group.
		47 per 1000	160 per 1000 (52 to 501)	114 more per 1000 (5 more to 455 more)
Adverse events: insomnia Follow‐up: 3 months № of participants:187 (3 RCTs)	RR 3.63 (1.10 to 11.95)	Study population			⊕⊕⊝⊝ LOW ⁶	There were more insomnia adverse events in the oral corticosteroids group.
		23 per 1000	84 per 1000 (26 to 278)	61 more per 1000 (2 more to 255 more)
*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; OR: odds ratio; RCT: randomised controlled trial; RR: risk ratio; RSOM‐31: Rhinosinusitis Outcome Measures‐31; SMD: standard mean difference
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
¹Downgraded to low quality due to limitations in study methodology and imprecision. Only the disease severity scale of the RSOM‐31 was used (unknown validity of this subscale and the range of scores is unclear). One small study (n = 40), which lacked information about the method of randomisation and allocation concealment. There is a also concern that the magnitude of improvement is not sustained; one study that used a non‐validated instrument reported smaller benefit at three to six months than at two to three weeks for health‐related quality of life. ²The individual symptoms measured were: nasal obstruction, nasal discharge, sense of smell and pressure over the sinuses. Scores for the individual symptoms (0 to 10 visual analogue scale (VAS)) were summed to find the total score.The effect size could be underestimated with this method. ³Downgraded to low quality due to imprecision. Results are from one very small study (n = 22) and the results were only measured at the end of treatment (17 days). There is a concern that the magnitude of improvement is not sustained. The outcome was not measured using a validated tool. ⁴Downgraded to low quality due to limitations in study methodology and imprecision. One small study (n = 40), which lacked information about the method of randomisation and allocation concealment. The definition of 'mood disturbance' is not provided in the paper. The results have large confidence intervals. ⁵Downgraded to low quality due to inconsistency and imprecision. The terminology between the papers for this outcome differed from "diarrhoea/GI disturbance" to "gastrointestinal disturbance" to "reflux and/or gastric pain". A low number of events were reported resulting in large confidence intervals. ⁶Downgraded to low quality due to inconsistency and imprecision. The definition of 'insomnia' is not provided in the papers. A low number of events were reported resulting in large confidence intervals. ⁷The individual symptoms measured were: blocked nose, rhinorrhoea, hyposmia and sinonasal pain. The results were measured as individual symptoms on a seven‐point Likert scale (0 = no symptoms) and presented as percentage change from baseline for each symptom, which was averaged across the four symptoms to create an average change from baseline. The effect size could be underestimated with this method. ⁸All patients in both groups received intranasal steroids at the end of the treatment period until the end of follow‐up (12 weeks). ⁹Downgraded to low quality due to limitations in study methodology and imprecision. Results are from one small study (n = 117) with unclear randomisation and allocation concealment. The results were measured at the end of treatment (two weeks). There is a concern that the results are not sustained. The outcome was not measured using a validated tool. ¹⁰Downgraded to low quality due to limitations in study methodology and imprecision. Results are from one small study (n = 117) with unclear randomisation and allocation concealment. There is a small effect size with large confidence intervals. The outcome was not measured using a validated tool.

Summary of findings for the main comparison. Short‐course oral corticosteroids compared with placebo/no treatment 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 steroids versus no treatment/placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Disease‐specific health‐related quality of life ‐ no pooling (2 to 3 weeks) Show forest plot	2		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 Severity score of RSOM	1	40	Std. Mean Difference (IV, Fixed, 95% CI)	‐1.24 [‐1.92, ‐0.56]
1.2 Mini‐RQLQ	1	58	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.79 [‐1.32, ‐0.25]
2 Disease‐specific health‐related quality of life ‐ RQLQ (3 to 6 months) Show forest plot	1	50	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.59 [‐1.16, ‐0.02]

3 Disease severity (patient‐reported total symptom score) Show forest plot	4		Std. Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3.1 Final value (2 to 3 weeks)	3		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.2 Change from baseline (2 to 3 weeks)	1		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.3 Final value (3 to 6 months)	1		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3.4 Change from baseline (3 to 6 months)	1		Std. Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 Individual symptoms: nasal obstruction (final value) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	‐4.5 [‐6.42, ‐2.58]

5 Individual symptoms: nasal obstruction (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 Change from baseline (2 to 3 weeks)	1	114	Mean Difference (IV, Fixed, 95% CI)	‐38.02 [‐48.16, ‐27.88]
5.2 Change from baseline (3 to 6 months)	1	114	Mean Difference (IV, Fixed, 95% CI)	0.90 [‐8.97, 10.77]
6 Individual symptoms: nasal discharge (final value) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	‐4.7 [‐6.79, ‐2.61]

7 Individual symptoms: nasal discharge (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

7.1 2 to 3 weeks	1	114	Mean Difference (IV, Fixed, 95% CI)	‐55.57 [‐69.23, ‐41.91]
7.2 3 to 6 months	1	114	Mean Difference (IV, Fixed, 95% CI)	‐1.83 [‐13.46, 9.81]
8 Individual symptoms: facial pressure (final value) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	‐3.7 [‐6.02, ‐1.38]

9 Individual symptoms: facial pressure (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

9.1 2 to 3 weeks	1	114	Mean Difference (IV, Fixed, 95% CI)	‐30.66 [‐46.28, ‐15.04]
9.2 3 to 6 months	1	114	Mean Difference (IV, Fixed, 95% CI)	0.60 [‐12.56, 13.76]
10 Individual symptoms: loss of sense of smell (final value) Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10.1 2 to 3 weeks	2	80	Mean Difference (IV, Fixed, 95% CI)	‐2.79 [‐4.11, ‐1.47]
10.2 3 to 6 months	1	50	Mean Difference (IV, Fixed, 95% CI)	‐1.20 [‐2.68, 0.28]
11 Individual symptoms: loss of sense of smell (change from baseline) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

11.1 2 to 3 weeks (after treatment)	1	114	Mean Difference (IV, Fixed, 95% CI)	‐44.35 [‐57.31, ‐31.39]
11.2 3 to 6 months	1	114	Mean Difference (IV, Fixed, 95% CI)	‐15.05 [‐29.69, ‐0.41]
12 Adverse events ‐ significant mood disturbance Show forest plot	1	40	Risk Ratio (M‐H, Fixed, 95% CI)	2.5 [0.55, 11.41]

13 Adverse events ‐ gastrointestinal disturbance Show forest plot	3	187	Risk Ratio (M‐H, Fixed, 95% CI)	3.45 [1.11, 10.78]

14 Adverse events ‐ insomnia Show forest plot	3	187	Risk Ratio (M‐H, Fixed, 95% CI)	3.63 [1.10, 11.95]

15 Endoscopy score ‐ nasal polyps (final value) Show forest plot	4		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

15.1 2 to 3 weeks	4	253	Mean Difference (IV, Fixed, 95% CI)	‐0.76 [‐0.92, ‐0.61]
15.2 3 to 6 months	1	50	Mean Difference (IV, Fixed, 95% CI)	‐0.25 [‐0.62, 0.12]
16 Endoscopy score ‐ nasal polyps score (change from baseline) Show forest plot	2		Std. Mean Difference (IV, Fixed, 95% CI)	Subtotals only

16.1 2 to 3 weeks	2	146	Std. Mean Difference (IV, Fixed, 95% CI)	‐1.77 [‐2.16, ‐1.38]
16.2 3 to 6 months	1	114	Std. Mean Difference (IV, Fixed, 95% CI)	‐0.52 [‐0.90, ‐0.14]

Comparison 1. Oral steroids versus no treatment/placebo

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