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

Glenn Griffin; Cheryl A Flynn; R Eugene Bailey; Jennifer K Schultz

doi:10.1002/14651858.CD003423.pub2

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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 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 one 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 one 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 effect: 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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Table 1. Search filter

Filter

40. limit 39 to (clinical trial or clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or meta analysis or multicenter study or randomized controlled trial)
41. clinical trial.pt.
42. exp Clinical trials/
43. ((clinical or control$ or compar$) adj (study or studies or trial$)).ti,ab,sh.
44. multicenter study.pt.
45. (multicenter$ or multicentre$ or multi‐centre$ or multi‐center$).ti,ab,sh.
46. random$.ti,ab,sh. or randomized controlled trial.pt.
47. (blind$ or mask$ or placebo$).ti,ab,sh.
48. (single‐blind$ or double‐blind$ or triple‐blind$).ti,ab,sh.
49. Double‐blind method/ or Meta‐analysis/ or Random allocation/ or Research design/
50. 39 and (41 or 42 or 43 or 44 or 45 or 46 or 47 or 48 or 49)
51. meta‐analy$.mp. [mp=title, abstract, registry number word, mesh subject heading]
52. metaanaly$.mp. [mp=title, abstract, registry number word, mesh subject heading]
53. meta‐analysis.pt.
54. meta‐analysis/
55. overview$.ti,ab.
56. (quantitativ$ adj (review or overview)).tw.
57. (systematic$ adj (review or overview)).tw.
58. (methodologic$ adj (review or overview)).tw.
59. (integrative research review or research integration).mp. [mp=title, abstract, registry number word, mesh subject heading]
60. (quantitativ$ adj synthes$).mp. [mp=title, abstract, registry number word, mesh subject heading]
61. 39 and (51 or 52 or 53 or 54 or 55 or 56 or 57 or 58 or 59 or 60)
62. (40 or 50 or 61) not animal.mp. [mp=title, abstract, registry number word, mesh subject heading]
63. 40 or 50 or 61
64. limit 63 to human
65. 62 or 64
66. from 65 keep 1‐43

Table 1. Search filter

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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	2	140	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.65, 1.36]

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

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 one 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 one 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	284	Risk Ratio (M‐H, Fixed, 95% CI)	1.3 [0.92, 1.83]

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	7	514	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.89, 1.21]

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	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	3	229	Risk Ratio (M‐H, Fixed, 95% CI)	0.96 [0.69, 1.32]

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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