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Esteroides intranasales para la sinusitis aguda

Appendices

Appendix 1. Previous search strategy

For this update we searched the Cochrane Central Register of Controlled Trials (CENTRAL) 2011, Issue 2, part of The Cochrane Library, www.thecochranelibrary.com (accessed 25 May 2011), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register; MEDLINE (September 2008 to May week 2, 2011) and Embase.com (October 2008 to May 2011). See Appendix 1 for details of previous searches.

Previously we searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 4) which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1966 to October 2008), EMBASE (1990 to October 2008) and bibliographies of included studies.

MEDLINE was searched using the following keywords and MeSH terms in conjunction with the highly sensitive search strategy designed by The Cochrane Collaboration for identifying randomised controlled trials (Lefebvre 2008). The same strategy was used to search CENTRAL and adapted to search EMBASE.

MEDLINE (OVID)
1 exp SINUSITIS/
2 sinusit*.tw.
3 rhinosinusit*.tw.
4 or/1‐3
5 exp STEROIDS/
6 steroid*.tw.
7 exp Adrenal Cortex Hormones/
8 adrenal cortex hormone*.tw.
9 exp Anti‐Inflammatory Agents/
10 anti‐inflammat*.tw.
11 corticosteroid*.tw.
12 or/5‐11
13 exp Administration, Intranasal/
14 exp Administration, Topical/
15 (nasal* or intranasal* or topical*).tw.
16 or/13‐15
17 12 and 16
18 4 and 17

Appendix 2. Embase.com search strategy

#24 #16 AND #23
#23 #22 NOT #21
#22 #17 OR #18
#21 #19 NOT #20
#20 'human'/de
#19 'animal'/de OR 'nonhuman'/de OR 'animal experiment'/de
#18 random*:ab,ti OR placebo*:ab,ti OR crossover*:ab,ti OR 'cross over':ab,ti OR allocat*:ab,ti OR trial:ti OR ((doubl* OR singl*) NEAR/1 blind*):ab,ti
#17 'randomized controlled trial'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp
#16 #4 AND #11 AND #15
#15 #12 OR #13 OR #14
#14 nasal*:ab,ti OR intranasal*:ab,ti OR topical*:ab,ti
#13 'topical drug administration'/de
#12 'intranasal drug administration'/de
#11 #5 OR #6 OR #7 OR #8 OR #9 OR #10
#10 'adrenal cortex hormone':ab,ti OR 'adrenal cortex hormones':ab,ti
#9 'anti‐inflammatory':ab,ti OR 'anti‐inflammatories':ab,ti OR antiinflammat*:ab,ti OR 'anti inflammatory':ab,ti OR 'anti inflammatories':ab,ti
#8 'antiinflammatory agent'/exp
#7 'corticosteroid'/exp
#6 steroid*:ab,ti
#5 'steroid'/exp
#4 #1 OR #2 OR #3
#3 rhinosinusit*:ab,ti OR nasosinusit*:ab,ti
#2 sinusit*:ab,ti
#1 'sinusitis'/exp

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
Figure 1

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

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Figures and Tables -
Figure 2

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

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily).
Figures and Tables -
Analysis 1.1

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily).
Figures and Tables -
Analysis 1.2

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily).
Figures and Tables -
Analysis 1.3

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 4 Number of participants that dropped out from the study (MFNS 400 µg daily).
Figures and Tables -
Analysis 1.4

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 4 Number of participants that dropped out from the study (MFNS 400 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 5 Number of participants that dropped out from the study (MFNS 200 µg daily).
Figures and Tables -
Analysis 1.5

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 5 Number of participants that dropped out from the study (MFNS 200 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily).
Figures and Tables -
Analysis 1.6

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily).

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 7 Relapse (combined 200 and 400 µg daily).
Figures and Tables -
Analysis 1.7

Comparison 1 Intranasal corticosteroids versus placebo, Outcome 7 Relapse (combined 200 and 400 µg daily).

Table 1. Adverse events

Study

Intervention

Side effects

Comments

Dolor 2001

Fluticasone propionate 2 puffs ‐ total dose 200 µg or placebo nasal spray once daily in addition to 250 mg cefuroxime axetil orally twice daily and 2 puffs of xylometazoline hydrochloride twice daily

Headache, bloody nose, vaginal itching, yeast infection, nausea, stomach irritation, diarrhoea, increased congestion, hay fever, light‐headed, sore throat, thirsty, itching, rash, cough, fatigue, metallic taste, felt dried out, nasal tissue felt inflamed

No serious unexpected adverse events reported

Any adverse event ‐ 37% in the fluticasone group versus 20% in the placebo group (P value = 0.7) no statistical significant difference

Adverse events could be attributed also to the co‐treatment

Nayak 2002

Amoxicillin‐clavulanate potassium 875 mg
twice daily orally and MFNS 200, 400 µg or placebo nasal spray twice daily

Epistaxis was the most frequently reported adverse event
Nasal burning, irritation and headache occurred in less than 2% of any treatment group

Treatment well‐tolerated, adverse events similar for all 3 arms of mild/moderate intensity: 12%, 15%, 15% in the MFNS 400, 800 µg and placebo arms

50 patients discontinued treatment because of adverse events, most commonly diarrhoea and nausea due to the antibiotic and were equally distributed among groups. Epistaxis, nasal burning, irritation or infection were not a cause for discontinuation of treatment

Barlan 1997

Budesonide 50 µg or placebo nasal spray to each nostril bid in addition to amoxicillin clavulanate potassium 40 mg/kg/day tid

Rash after 1 week attributed to the antibiotic in 1 subject that was switched to cefaclor

No specific adverse events related to the INCS use were reported

Meltzer 2005

MFNS 200 µg once daily or twice daily nasal spray
Amoxicillin 500 mg tid
Placebo nasal spray and capsules

Headache and epistaxis were most common reported

Most adverse events were mild or moderate with a similar incidence among treatment groups: 36.2%,
35.4%, 33.5% and 38.1% with MFNS 200 µg, 400 µg,
amoxicillin and placebo
1%, 3%, 2% and 2% of participants discontinued treatment because of adverse events in the 200 µg, 400 µg INCS, antibiotic and placebo arms

bid: twice daily
INCS: intranasal corticosteroid
MFNS: mometasone furoate
tid: three times daily

Figures and Tables -
Table 1. Adverse events
Comparison 1. Intranasal corticosteroids versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Proportion of participants with resolution of symptoms or improved (MFNS 400 µg daily) Show forest plot

2

1130

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [1.02, 1.18]

2 Proportion of participants with resolution of symptoms or improved (MFNS 200 µg daily) Show forest plot

2

590

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [0.98, 1.11]

3 Proportion of participants with resolution of symptoms or improved (combined MFNS 200, 400 and 800 µg daily) Show forest plot

3

1792

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [1.04, 1.18]

4 Number of participants that dropped out from the study (MFNS 400 µg daily) Show forest plot

2

1130

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.61, 1.20]

5 Number of participants that dropped out from the study (MFNS 200 µg daily) Show forest plot

2

590

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.46, 1.21]

6 Number of participants that dropped out from the study (combined MFNS 200, 400 and 800 µg daily) Show forest plot

3

1792

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.64, 1.12]

7 Relapse (combined 200 and 400 µg daily) Show forest plot

2

825

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.44, 1.15]

Figures and Tables -
Comparison 1. Intranasal corticosteroids versus placebo