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Flow chart to illustrate separation of review between three comparisons. Six RCTs met the original entry criteria of the review. All of these had a placebo and long‐acting beta‐agonist arm, and five assessed combination against steroids. Seven new studies with one or more control comparisons were identified: five had a placebo arm, four had a long‐acting beta‐agonist arm, and two had an inhaled steroid treatment arm.
Figuras y tablas -
Figure 1

Flow chart to illustrate separation of review between three comparisons. Six RCTs met the original entry criteria of the review. All of these had a placebo and long‐acting beta‐agonist arm, and five assessed combination against steroids. Seven new studies with one or more control comparisons were identified: five had a placebo arm, four had a long‐acting beta‐agonist arm, and two had an inhaled steroid treatment arm.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Forest plot of comparison: 1 All Combined Inhalers ‐ Primary Outcomes, outcome: 1.1 Exacerbations.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 All Combined Inhalers ‐ Primary Outcomes, outcome: 1.1 Exacerbations.

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Forest plot of comparison: 1 All Combined Inhalers ‐ Primary Outcomes, outcome: 1.2 Mortality.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 All Combined Inhalers ‐ Primary Outcomes, outcome: 1.2 Mortality.

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Forest plot of comparison: 1 All Combined Inhalers ‐ Primary Outcomes, outcome: 1.3 Pneumonia.
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 All Combined Inhalers ‐ Primary Outcomes, outcome: 1.3 Pneumonia.

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Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 1 Exacerbations.
Figuras y tablas -
Analysis 1.1

Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 1 Exacerbations.

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Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 2 Mortality.
Figuras y tablas -
Analysis 1.2

Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 2 Mortality.

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Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 3 Pneumonia.
Figuras y tablas -
Analysis 1.3

Comparison 1 All Combined Inhalers ‐ Primary Outcomes, Outcome 3 Pneumonia.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 1 Number of participants with one or more exacerbation.
Figuras y tablas -
Analysis 2.1

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 1 Number of participants with one or more exacerbation.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 2 End of treatment mean number of exacerbations per participant.
Figuras y tablas -
Analysis 2.2

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 2 End of treatment mean number of exacerbations per participant.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 3 Exacerbations.
Figuras y tablas -
Analysis 2.3

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 3 Exacerbations.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 4 Exacerbations by type.
Figuras y tablas -
Analysis 2.4

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 4 Exacerbations by type.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 5 Mortality.
Figuras y tablas -
Analysis 2.5

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 5 Mortality.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 6 Change from baseline in St George's Respiratory Questionnaire (total score).
Figuras y tablas -
Analysis 2.6

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 6 Change from baseline in St George's Respiratory Questionnaire (total score).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 7 Change from baseline in St George's Respiratory Questionnaire (domain ‐ symptoms).
Figuras y tablas -
Analysis 2.7

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 7 Change from baseline in St George's Respiratory Questionnaire (domain ‐ symptoms).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 8 Change from baseline in St George's Respiratory Questionnaire (domain ‐ activity).
Figuras y tablas -
Analysis 2.8

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 8 Change from baseline in St George's Respiratory Questionnaire (domain ‐ activity).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 9 Change from baseline in St George's Respiratory Questionnaire (domain ‐ impact).
Figuras y tablas -
Analysis 2.9

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 9 Change from baseline in St George's Respiratory Questionnaire (domain ‐ impact).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 10 End of treatment St George's Respiratory Questionnaire scores (total score).
Figuras y tablas -
Analysis 2.10

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 10 End of treatment St George's Respiratory Questionnaire scores (total score).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 11 End of treatment St George's Respiratory Questionnaire scores (domain ‐ symptoms).
Figuras y tablas -
Analysis 2.11

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 11 End of treatment St George's Respiratory Questionnaire scores (domain ‐ symptoms).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 12 Change from baseline in Canadian Respiratory Disease Questionnaire scores.
Figuras y tablas -
Analysis 2.12

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 12 Change from baseline in Canadian Respiratory Disease Questionnaire scores.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 13 Change from baseline in Transitional Dyspnoea Index (TDI).
Figuras y tablas -
Analysis 2.13

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 13 Change from baseline in Transitional Dyspnoea Index (TDI).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 14 Change from baseline in FEV1 (Litres).
Figuras y tablas -
Analysis 2.14

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 14 Change from baseline in FEV1 (Litres).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 15 Change from baseline in predose FEV1 (Litres).
Figuras y tablas -
Analysis 2.15

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 15 Change from baseline in predose FEV1 (Litres).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 16 End of treatment FEV1 (Litres).
Figuras y tablas -
Analysis 2.16

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 16 End of treatment FEV1 (Litres).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 17 End of treatment postdose FEV1.
Figuras y tablas -
Analysis 2.17

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 17 End of treatment postdose FEV1.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 18 Change from baseline in postdose FEV1.
Figuras y tablas -
Analysis 2.18

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 18 Change from baseline in postdose FEV1.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 19 End of treatment am PEF (L/min).
Figuras y tablas -
Analysis 2.19

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 19 End of treatment am PEF (L/min).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 20 Absolute shuttle walk test.
Figuras y tablas -
Analysis 2.20

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 20 Absolute shuttle walk test.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 21 Change from baseline in rescue medication usage (puffs/day).
Figuras y tablas -
Analysis 2.21

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 21 Change from baseline in rescue medication usage (puffs/day).

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 22 Withdrawals.
Figuras y tablas -
Analysis 2.22

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 22 Withdrawals.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 23 Withdrawal due to lack of efficacy/exacerbation.
Figuras y tablas -
Analysis 2.23

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 23 Withdrawal due to lack of efficacy/exacerbation.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 24 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 2.24

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 24 Withdrawals due to adverse events.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 25 Adverse events ‐ any event.
Figuras y tablas -
Analysis 2.25

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 25 Adverse events ‐ any event.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 26 Adverse events ‐ candidiasis.
Figuras y tablas -
Analysis 2.26

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 26 Adverse events ‐ candidiasis.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 27 Adverse events ‐ pneumonia.
Figuras y tablas -
Analysis 2.27

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 27 Adverse events ‐ pneumonia.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 28 Adverse events ‐ headache.
Figuras y tablas -
Analysis 2.28

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 28 Adverse events ‐ headache.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 29 Adverse events ‐ upper respiratory tract infection.
Figuras y tablas -
Analysis 2.29

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 29 Adverse events ‐ upper respiratory tract infection.

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Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 30 Mortality ‐ cause specific.
Figuras y tablas -
Analysis 2.30

Comparison 2 Fluticasone/salmeterol (FPS) versus fluticasone (FP), Outcome 30 Mortality ‐ cause specific.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 1 Severe Exacerbations.
Figuras y tablas -
Analysis 3.1

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 1 Severe Exacerbations.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 2 Mean exacerbation rates per patient per year.
Figuras y tablas -
Analysis 3.2

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 2 Mean exacerbation rates per patient per year.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 3 Quality of life ‐ change scores.
Figuras y tablas -
Analysis 3.3

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 3 Quality of life ‐ change scores.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 4 Rescue medication use.
Figuras y tablas -
Analysis 3.4

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 4 Rescue medication use.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 5 Symptoms (change scores).
Figuras y tablas -
Analysis 3.5

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 5 Symptoms (change scores).

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 6 Mortality.
Figuras y tablas -
Analysis 3.6

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 6 Mortality.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 7 Mean FEV1 (% increase from baseline).
Figuras y tablas -
Analysis 3.7

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 7 Mean FEV1 (% increase from baseline).

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 8 Adverse events ‐ 'serious' events.
Figuras y tablas -
Analysis 3.8

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 8 Adverse events ‐ 'serious' events.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 10 Withdrawals due to worsening COPD symptoms.
Figuras y tablas -
Analysis 3.10

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 10 Withdrawals due to worsening COPD symptoms.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 11 Withdrawals due to adverse events.
Figuras y tablas -
Analysis 3.11

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 11 Withdrawals due to adverse events.

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Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 12 Adverse events ‐ pneumonia.
Figuras y tablas -
Analysis 3.12

Comparison 3 Budesonide/formoterol (BDF) versus budesonide (BD), Outcome 12 Adverse events ‐ pneumonia.

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Table 1. Search history

Version

Detail

1st published version ‐ Issue 4, 2003 (All years to April 2002)

References identified: 34
References retrieved: 7
Studies excluded 3 (Cazzola 2000; Chapman 2002; Soriano 2002)
Studies identified from supplementary searching: 4 (Dal Negro 2003; Hanania 2003 ‐ both included; Cazzola 2002a; Cazzola 2004 ‐ both excluded).
Studies included: 4

2nd published version ‐ Issue 3, 2004 (April 2003‐April 2004)

References identified: 12
References retrieved: 3 (2 papers full publication of a previously included or cited studies study (Dal Negro 2003; Hanania 2003). Hand searching identified two further references to the COSMIC 2003 study.
Studies identified from supplementary searching: 1 (TRISTAN)
New studies included: 2
Total studies included: 6

3rd published version ‐ Issue 3, 2005 (April 2004‐April 2005)

References identified: 52
References retrieved: 46 (references to studies already included/excluded/ongoing: 24)
New unique studies identified: 10 (ongoing studies: 2)
New studies included: 0
Total studies included: 6

4th published version ‐ April 2005 ‐ April 2007

References identified: 66
References retrieved: 27 (references to studies already included/excluded/ongoing: )
New unique studies identified: 8 (ongoing studies: 0)
New studies included: 7
Total studies included: 13

Figuras y tablas -
Table 1. Search history
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Table 2. Rates and NNT of mortality

Study ID

Study duration

ICS rate (%)

NNT

SFCT01

52

0

NA

TORCH

156 weeks

16

32 (19 to 123)

TRISTAN

52 weeks

0.8

547 (340 to 2100)

Calverley 2003

52 weeks

2.3

193 (120 to 741)

Szafranski 2003

52 weeks

2.5

178 (110 to 683)
Figuras y tablas -
Table 2. Rates and NNT of mortality
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Comparison 1. All Combined Inhalers ‐ Primary Outcomes

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Exacerbations Show forest plot

4

Rate ratio (Fixed, 95% CI)

0.91 [0.85, 0.97]

1.1 Fluticasone/salmeterol

2

Rate ratio (Fixed, 95% CI)

0.91 [0.85, 0.98]

1.2 Budesonide/formoterol

2

Rate ratio (Fixed, 95% CI)

0.88 [0.73, 1.07]

2 Mortality Show forest plot

5

4978

Odds Ratio (M‐H, Fixed, 95% CI)

0.77 [0.63, 0.94]

2.1 Fluticasone/salmeterol

3

4061

Odds Ratio (M‐H, Fixed, 95% CI)

0.76 [0.62, 0.93]

2.2 Budesonide/formoterol

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.98 [0.42, 2.29]

3 Pneumonia Show forest plot

5

5033

Odds Ratio (M‐H, Fixed, 95% CI)

1.13 [0.92, 1.38]

3.1 Fluticasone/salmeterol

4

4522

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.91, 1.37]

3.2 Budesonide/formoterol

1

511

Odds Ratio (M‐H, Fixed, 95% CI)

1.64 [0.53, 5.08]
Figuras y tablas -
Comparison 1. All Combined Inhalers ‐ Primary Outcomes
Ir a la tabla de la revisión
Comparison 2. Fluticasone/salmeterol (FPS) versus fluticasone (FP)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with one or more exacerbation Show forest plot

3

965

Odds Ratio (M‐H, Fixed, 95% CI)

0.99 [0.74, 1.33]

1.1 Partially reversible population (mixed population)

2

703

Odds Ratio (M‐H, Fixed, 95% CI)

0.85 [0.59, 1.22]

1.2 Poorly reversible population

1

262

Odds Ratio (M‐H, Fixed, 95% CI)

1.32 [0.81, 2.15]

2 End of treatment mean number of exacerbations per participant Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Exacerbations Show forest plot

2

Rate ratio (Fixed, 95% CI)

0.91 [0.85, 0.98]

3.1 Partially reversible population (mixed population)

0

Rate ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Poorly reversible population

2

Rate ratio (Fixed, 95% CI)

0.91 [0.85, 0.98]

4 Exacerbations by type Show forest plot

2

Rate ratio (Random, 95% CI)

Subtotals only

4.1 Requirement for oral steroids

2

Rate ratio (Random, 95% CI)

0.89 [0.81, 0.98]

4.2 Requirement for antibiotic treatment

0

Rate ratio (Random, 95% CI)

0.0 [0.0, 0.0]

4.3 Requirement for oral steroid or antibiotic treatment

0

Rate ratio (Random, 95% CI)

0.0 [0.0, 0.0]

4.4 Hospitalisation

1

Rate ratio (Random, 95% CI)

0.95 [0.82, 1.11]

5 Mortality Show forest plot

4

4394

Odds Ratio (M‐H, Fixed, 95% CI)

0.76 [0.62, 0.93]

5.1 Mortality: three year data

1

3067

Odds Ratio (M‐H, Fixed, 95% CI)

0.75 [0.62, 0.92]

5.2 Mortality: >one and <three year data

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 Mortality: one year data

2

994

Odds Ratio (M‐H, Fixed, 95% CI)

1.03 [0.23, 4.57]

5.4 Mortality: 6 month data

1

333

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Change from baseline in St George's Respiratory Questionnaire (total score) Show forest plot

3

SGRQ units (Fixed, 95% CI)

‐1.30 [‐2.04, ‐0.57]

6.1 Partially reversible population (mixed population)

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Poorly reversible population

3

SGRQ units (Fixed, 95% CI)

‐1.30 [‐2.04, ‐0.57]

7 Change from baseline in St George's Respiratory Questionnaire (domain ‐ symptoms) Show forest plot

1

SGRQ units (Fixed, 95% CI)

Totals not selected

7.1 Partially reversible population (mixed population)

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 Poorly reversible population

1

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

8 Change from baseline in St George's Respiratory Questionnaire (domain ‐ activity) Show forest plot

1

SGRQ units (Fixed, 95% CI)

Totals not selected

8.1 Partially reversible population (mixed population)

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Poorly reversible population

1

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

9 Change from baseline in St George's Respiratory Questionnaire (domain ‐ impact) Show forest plot

1

SGRQ units (Fixed, 95% CI)

Totals not selected

9.1 Partially reversible population (mixed population)

0

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 Poorly reversible population

1

SGRQ units (Fixed, 95% CI)

0.0 [0.0, 0.0]

10 End of treatment St George's Respiratory Questionnaire scores (total score) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

10.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11 End of treatment St George's Respiratory Questionnaire scores (domain ‐ symptoms) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

11.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

12 Change from baseline in Canadian Respiratory Disease Questionnaire scores Show forest plot

2

696

Mean Difference (IV, Random, 95% CI)

2.34 [‐3.15, 7.82]

12.1 Partially reversible population (mixed population)

2

696

Mean Difference (IV, Random, 95% CI)

2.34 [‐3.15, 7.82]

12.2 Poorly reversible population

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

13 Change from baseline in Transitional Dyspnoea Index (TDI) Show forest plot

2

690

Mean Difference (IV, Random, 95% CI)

0.31 [‐0.45, 1.08]

13.1 Partially reversible population (mixed population)

2

690

Mean Difference (IV, Random, 95% CI)

0.31 [‐0.45, 1.08]

13.2 Poorly reversible population

0

0

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

14 Change from baseline in FEV1 (Litres) Show forest plot

2

L/min (Fixed, 95% CI)

0.09 [0.06, 0.12]

14.1 Partially reversible population (mixed population)

0

L/min (Fixed, 95% CI)

0.0 [0.0, 0.0]

14.2 Poorly reversible population

2

L/min (Fixed, 95% CI)

0.09 [0.06, 0.12]

15 Change from baseline in predose FEV1 (Litres) Show forest plot

2

690

Mean Difference (IV, Fixed, 95% CI)

0.05 [0.02, 0.09]

15.1 Reversible population

2

380

Mean Difference (IV, Fixed, 95% CI)

0.07 [0.01, 0.12]

15.2 Partially reversible population (mixed population)

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

15.3 Poorly reversible population

2

310

Mean Difference (IV, Fixed, 95% CI)

0.04 [‐0.01, 0.09]

16 End of treatment FEV1 (Litres) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

16.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

16.2 Poorly reversible population

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

17 End of treatment postdose FEV1 Show forest plot

2

Litres (Fixed, 95% CI)

0.03 [0.01, 0.06]

17.1 Partially reversible population (mixed population)

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

17.2 Poorly reversible population

2

Litres (Fixed, 95% CI)

0.03 [0.01, 0.06]

18 Change from baseline in postdose FEV1 Show forest plot

1

Litres (Fixed, 95% CI)

Totals not selected

18.1 Reversible population

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

18.2 Partially reversible population (mixed population)

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

18.3 Poorly reversible population

1

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

18.4 Unclear reversibility

0

Litres (Fixed, 95% CI)

0.0 [0.0, 0.0]

19 End of treatment am PEF (L/min) Show forest plot

1

L/min (Fixed, 95% CI)

Totals not selected

19.1 Partially reversible population (mixed population)

0

L/min (Fixed, 95% CI)

0.0 [0.0, 0.0]

19.2 Poorly reversible population

1

L/min (Fixed, 95% CI)

0.0 [0.0, 0.0]

20 Absolute shuttle walk test Show forest plot

1

Metres (Fixed, 95% CI)

Totals not selected

20.1 Partially reversible population (mixed population)

0

Metres (Fixed, 95% CI)

0.0 [0.0, 0.0]

20.2 Poorly reversible population

1

Metres (Fixed, 95% CI)

0.0 [0.0, 0.0]

21 Change from baseline in rescue medication usage (puffs/day) Show forest plot

2

686

Mean Difference (IV, Fixed, 95% CI)

‐0.80 [‐1.31, ‐0.29]

21.1 Partially reversible population (mixed population)

2

686

Mean Difference (IV, Fixed, 95% CI)

‐0.80 [‐1.31, ‐0.29]

21.2 Poorly reversible population

0

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

22 Withdrawals Show forest plot

5

4756

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.76, 0.97]

22.1 Partially reversible population (mixed population)

2

694

Odds Ratio (M‐H, Fixed, 95% CI)

0.87 [0.63, 1.20]

22.2 Poorly reversible population

3

4062

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.76, 0.98]

23 Withdrawal due to lack of efficacy/exacerbation Show forest plot

4

4395

Odds Ratio (M‐H, Fixed, 95% CI)

0.73 [0.49, 1.08]

23.1 Partially reversible population (mixed population)

1

333

Odds Ratio (M‐H, Fixed, 95% CI)

1.02 [0.20, 5.12]

23.2 Poorly reversible population

3

4062

Odds Ratio (M‐H, Fixed, 95% CI)

0.72 [0.48, 1.08]

24 Withdrawals due to adverse events Show forest plot

4

4424

Odds Ratio (M‐H, Fixed, 95% CI)

0.75 [0.64, 0.88]

24.1 Partially reversible population (mixed population)

1

342

Odds Ratio (M‐H, Fixed, 95% CI)

0.48 [0.22, 1.02]

24.2 Poorly reversible population

3

4082

Odds Ratio (M‐H, Fixed, 95% CI)

0.77 [0.65, 0.90]

25 Adverse events ‐ any event Show forest plot

5

4795

Odds Ratio (M‐H, Fixed, 95% CI)

0.94 [0.80, 1.10]

25.1 Partially reversible population (mixed population)

2

703

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.66, 1.30]

25.2 Poorly reversible population

3

4092

Odds Ratio (M‐H, Fixed, 95% CI)

0.94 [0.78, 1.13]

26 Adverse events ‐ candidiasis Show forest plot

4

1697

Odds Ratio (M‐H, Fixed, 95% CI)

1.08 [0.74, 1.58]

26.1 Partially reversible population (mixed population)

2

703

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.62, 1.83]

26.2 Poorly reversible population

2

994

Odds Ratio (M‐H, Fixed, 95% CI)

1.09 [0.63, 1.86]

27 Adverse events ‐ pneumonia Show forest plot

4

4522

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.91, 1.37]

27.1 Partially reversible population (mixed population)

2

694

Odds Ratio (M‐H, Fixed, 95% CI)

0.73 [0.14, 3.72]

27.2 Poorly reversible population

2

3828

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.91, 1.38]

27.3 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

28 Adverse events ‐ headache Show forest plot

4

4538

Odds Ratio (M‐H, Fixed, 95% CI)

0.97 [0.79, 1.20]

28.1 Partially reversible population (mixed population)

2

694

Odds Ratio (M‐H, Fixed, 95% CI)

1.07 [0.72, 1.60]

28.2 Poorly reversible population

2

3844

Odds Ratio (M‐H, Fixed, 95% CI)

0.94 [0.73, 1.20]

28.3 Unclear reversibility

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

29 Adverse events ‐ upper respiratory tract infection Show forest plot

4

4538

Odds Ratio (M‐H, Random, 95% CI)

1.03 [0.67, 1.58]

29.1 Partially reversible population (mixed population)

2

694

Odds Ratio (M‐H, Random, 95% CI)

1.22 [0.79, 1.90]

29.2 Poorly reversible population

2

3844

Odds Ratio (M‐H, Random, 95% CI)

0.89 [0.39, 2.01]

29.3 Unclear reversibility

0

0

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

30 Mortality ‐ cause specific Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

30.1 COPD‐related death

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.2 Cancer

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

30.3 Cardiovascular

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 2. Fluticasone/salmeterol (FPS) versus fluticasone (FP)
Ir a la tabla de la revisión
Comparison 3. Budesonide/formoterol (BDF) versus budesonide (BD)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe Exacerbations Show forest plot

2

Rate ratio (Fixed, 95% CI)

0.88 [0.73, 1.07]

1.1 Partially reversible

0

Rate ratio (Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Poorly reversible

2

Rate ratio (Fixed, 95% CI)

0.88 [0.73, 1.07]

2 Mean exacerbation rates per patient per year Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2.1 Partially reversible population (mixed population)

0

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Poorly reversible population

2

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Quality of life ‐ change scores Show forest plot

2

SGRQ (Fixed, 95% CI)

‐3.26 [‐5.10, ‐1.42]

3.1 Partially reversible (mixed population)

0

SGRQ (Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Poorly reversible

2

SGRQ (Fixed, 95% CI)

‐3.26 [‐5.10, ‐1.42]

4 Rescue medication use Show forest plot

2

Puffs per day (Fixed, 95% CI)

‐0.8 [‐1.06, ‐0.54]

4.1 Partially reversible

0

Puffs per day (Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Poorly reversible

2

Puffs per day (Fixed, 95% CI)

‐0.8 [‐1.06, ‐0.54]

5 Symptoms (change scores) Show forest plot

2

Symptom scale (Fixed, 95% CI)

‐0.43 [‐0.69, ‐0.18]

5.1 Partially reversible (mixed population)

0

Symptom scale (Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Poorly reversible

2

Symptom scale (Fixed, 95% CI)

‐0.43 [‐0.69, ‐0.18]

6 Mortality Show forest plot

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.98 [0.42, 2.29]

6.1 Mortality as primary outcome

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Mortality data collected as secondary/unpublished outcome

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.98 [0.42, 2.29]

7 Mean FEV1 (% increase from baseline) Show forest plot

2

% increase (Fixed, 95% CI)

10.17 [7.71, 12.62]

7.1 Partially reversible

0

% increase (Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 Poorly reversible

2

% increase (Fixed, 95% CI)

10.17 [7.71, 12.62]

8 Adverse events ‐ 'serious' events Show forest plot

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.64, 1.16]

8.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Poorly reversible population

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.64, 1.16]

9 Adverse events ‐ candidiasis

0

Odds Ratio (M‐H, Fixed, 95% CI)

Subtotals only

9.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 Poorly reversible population

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Withdrawals due to worsening COPD symptoms Show forest plot

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.65 [0.44, 0.97]

10.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Poorly reversible population

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

0.65 [0.44, 0.97]

11 Withdrawals due to adverse events Show forest plot

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

1.05 [0.64, 1.71]

11.1 Partially reversible population (mixed population)

0

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

11.2 Poorly reversible population

2

917

Odds Ratio (M‐H, Fixed, 95% CI)

1.05 [0.64, 1.71]

12 Adverse events ‐ pneumonia Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

12.1 Partially reversible population (mixed population)

0

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

12.2 Poorly reversible population

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 3. Budesonide/formoterol (BDF) versus budesonide (BD)
Ir a la tabla de la revisión