Antihistamines and/or decongestants for otitis media with effusion (OME) in children

Glenn Griffin; Cheryl A Flynn

doi:10.1002/14651858.CD003423.pub3

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Figure 1

Forest plot of comparison: 1 Antihistamine versus control, outcome: 1.1 Secondary outcome: cure or no cure at 1‐3 months.

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Figure 2

Forest plot of comparison: 1 Antihistamine versus control, outcome: 1.3 Outcome: surgery (tympanostomy (myringotomy)).

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Analysis 1.1

Comparison 1 Antihistamine versus control, Outcome 1 Secondary outcome: cure or no cure at 1‐3 months.

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Analysis 1.2

Comparison 1 Antihistamine versus control, Outcome 2 Complication: AOM.

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Analysis 1.3

Comparison 1 Antihistamine versus control, Outcome 3 Outcome: surgery (tympanostomy (myringotomy)).

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Analysis 2.1

Comparison 2 Decongestant versus control, Outcome 1 Primary outcome: cure or no cure at or before 1 month.

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Analysis 2.2

Comparison 2 Decongestant versus control, Outcome 2 Secondary outcome: cure or no cure at 1‐3 months.

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Analysis 2.3

Comparison 2 Decongestant versus control, Outcome 3 Side effect: any significant side effects at or before 1 month.

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Analysis 2.4

Comparison 2 Decongestant versus control, Outcome 4 Outcome: hearing on or about 1 month.

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Analysis 2.5

Comparison 2 Decongestant versus control, Outcome 5 Outcome: surgery (tympanostomy (myringotomy)).

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Analysis 2.6

Comparison 2 Decongestant versus control, Outcome 6 Complication: AOM.

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Analysis 3.1

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 1 Primary outcome: cure or no cure at or before 1 month.

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Analysis 3.2

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 2 Secondary outcome: cure or no cure at 1‐3 months.

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Analysis 3.3

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 3 Late outcome: cure or no cure after 3 months.

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Analysis 3.4

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 4 Side effect: any significant side effects at or before 1 month.

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Analysis 3.5

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 5 Outcome: hearing at or less than 3 months.

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Analysis 3.6

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 6 Late outcome: hearing at 1 year.

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Analysis 3.7

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 7 Late outcome: school performance at 1 year.

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Analysis 3.8

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 8 Outcome: surgery (tympanostomy (myringotomy)).

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Analysis 3.9

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 9 Complication: recurrent OME.

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Analysis 3.10

Comparison 3 Antihistamine/decongestant combination versus control, Outcome 10 Complication: AOM.

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Analysis 4.1

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 1 Primary outcome: cure or no cure at or before 1 month.

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Analysis 4.2

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 2 Secondary outcome: cure or no cure at 1‐3 months.

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Analysis 4.3

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 3 Late outcome: cure or no cure after 3 months.

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Analysis 4.4

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 4 Side effects: any significant side effects at or before 1 month.

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Analysis 4.5

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 5 Outcome: hearing on or about 1 month.

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Analysis 4.6

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 6 Late outcome: hearing at 1 year.

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Analysis 4.7

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 7 Late outcome: school performance at 1 year.

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Analysis 4.8

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 8 Outcome: surgery (tympanostomy (myringotomy)).

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Analysis 4.9

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 9 Complication: recurrent OME.

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Analysis 4.10

Comparison 4 Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control, Outcome 10 Complication: AOM.

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Comparison 1. Antihistamine versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Secondary outcome: cure or no cure at 1‐3 months Show forest plot	3	206	Risk Difference (M‐H, Fixed, 95% CI)	0.02 [‐0.11, 0.16]

2 Complication: AOM Show forest plot	1	46	Risk Ratio (M‐H, Fixed, 95% CI)	0.89 [0.46, 1.73]

3 Outcome: surgery (tympanostomy (myringotomy)) Show forest plot	1	66	Odds Ratio (M‐H, Fixed, 95% CI)	2.08 [0.77, 5.58]

Comparison 1. Antihistamine versus control

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Comparison 2. Decongestant versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary outcome: cure or no cure at or before 1 month Show forest plot	3	276	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.92, 1.22]

2 Secondary outcome: cure or no cure at 1‐3 months Show forest plot	2	216	Risk Ratio (M‐H, Fixed, 95% CI)	1.05 [0.85, 1.30]

3 Side effect: any significant side effects at or before 1 month Show forest plot	1	172	Risk Ratio (M‐H, Fixed, 95% CI)	11.05 [0.66, 185.38]

4 Outcome: hearing on or about 1 month Show forest plot	1	15	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.16, 4.68]

5 Outcome: surgery (tympanostomy (myringotomy)) Show forest plot	1	172	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.71, 1.62]

6 Complication: AOM Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.55 [0.23, 1.31]

Comparison 2. Decongestant versus control

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Comparison 3. Antihistamine/decongestant combination versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary outcome: cure or no cure at or before 1 month Show forest plot	4	901	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.89, 1.04]

2 Secondary outcome: cure or no cure at 1‐3 months Show forest plot	3	158	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.85, 1.40]

3 Late outcome: cure or no cure after 3 months Show forest plot	2	119	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.72, 2.13]

4 Side effect: any significant side effects at or before 1 month Show forest plot	5	972	Risk Ratio (M‐H, Fixed, 95% CI)	2.54 [1.76, 3.67]

5 Outcome: hearing at or less than 3 months Show forest plot	3	343	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.93, 1.27]

6 Late outcome: hearing at 1 year Show forest plot	1	48	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.63, 3.56]

7 Late outcome: school performance at 1 year Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.35, 1.86]

8 Outcome: surgery (tympanostomy (myringotomy)) Show forest plot	2	57	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.09, 3.41]

9 Complication: recurrent OME Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 Quality score 3 or greater	1	94	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [0.92, 3.01]
9.2 Quality score less than 3	1	48	Risk Ratio (M‐H, Fixed, 95% CI)	0.75 [0.31, 1.83]
9.3 Allocation concealment adequate	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9.4 Allocation concealment not adequate	2	142	Risk Ratio (M‐H, Fixed, 95% CI)	1.3 [0.80, 2.11]
10 Complication: AOM Show forest plot	1	636	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.46, 1.26]

10.1 Quality score 3 or greater	1	318	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.37, 1.55]
10.2 Quality score less than 3	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.3 Allocation concealment adequate	0	0	Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
10.4 Allocation concealment not adequate	1	318	Risk Ratio (M‐H, Fixed, 95% CI)	0.76 [0.37, 1.55]

Comparison 3. Antihistamine/decongestant combination versus control

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Comparison 4. Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Primary outcome: cure or no cure at or before 1 month Show forest plot	7	1177	Risk Ratio (M‐H, Fixed, 95% CI)	0.99 [0.92, 1.05]

2 Secondary outcome: cure or no cure at 1‐3 months Show forest plot	8	580	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.92, 1.22]

3 Late outcome: cure or no cure after 3 months Show forest plot	2	119	Risk Ratio (M‐H, Fixed, 95% CI)	1.24 [0.72, 2.13]

4 Side effects: any significant side effects at or before 1 month Show forest plot	6	1144	Risk Ratio (M‐H, Fixed, 95% CI)	2.70 [1.87, 3.88]

5 Outcome: hearing on or about 1 month Show forest plot	4	358	Risk Ratio (M‐H, Fixed, 95% CI)	1.08 [0.93, 1.27]

6 Late outcome: hearing at 1 year Show forest plot	1	48	Risk Ratio (M‐H, Fixed, 95% CI)	1.5 [0.63, 3.56]

7 Late outcome: school performance at 1 year Show forest plot	1	42	Risk Ratio (M‐H, Fixed, 95% CI)	0.81 [0.35, 1.86]

8 Outcome: surgery (tympanostomy (myringotomy)) Show forest plot	4	295	Risk Ratio (M‐H, Fixed, 95% CI)	1.07 [0.81, 1.41]

9 Complication: recurrent OME Show forest plot	2	142	Risk Ratio (M‐H, Fixed, 95% CI)	1.3 [0.80, 2.11]

10 Complication: AOM Show forest plot	3	408	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.48, 1.14]

Comparison 4. Any medication: antihistamine, decongestant or antihistamine/decongestant combination versus control

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