Scolaris Content Display Scolaris Content Display

Autoinsuflación para la hipoacusia asociada a la otitis media con derrame

Esta versión no es la más reciente

Contraer todo Desplegar todo

Referencias

Referencias de los estudios incluidos en esta revisión

Arick 2005 {published data only}

Arick D, Silman S. Nonsurgical home treatment of middle ear effusion and associated hearing loss in children Part I: Clinical trial. Ear, Nose and Throat Journal 2005;84(9):567‐78.

Blanshard 1993 {published data only}

Blanshard J, Maw A, Bawden R. Conservative treatment of otitis media with effusion by autoinflation of the middle ear. Clinical Otolaryngology and Allied Sciences 1993;18:188‐92.
Blanshard J, Maw A, Bawden R. The treatment of otitis media with effusion in children by autoinflation. 2nd European Congress of Oto‐Rhino‐Laryngology and cervico‐facial surgery. 1992:31‐7.

Brooker 1992 {published data only}

Brooker D, McNeice A. Autoinflation in the treatment of glue ear in children. Clinical Otolaryngology and Allied Sciences 1992;17:289‐90.

Fraser 1977 {published data only}

Fraser J, Mehta M, Fraser P. The medical treatment of secretory otitis media. A clinical trial of three commonly used regimes. Journal of Laryngology and Otology 1977;91(9):757‐65.

Lesinskas 2003 {published data only}

Lesinskas E. Factors affecting the results of nonsurgical treatment of secretory otitis media in adults. Auris, Nasus, Larynx 2003;30:7‐14.

Stangerup 1992 {published data only}

Stangerup S, Sederberg‐Olsen J, Balle V. Autoinflation as a treatment of secretory otitis media: a randomized controlled study. Archives of Otolaryngology ‐ Head and Neck Surgery 1992;118:149‐52.
Stangerup S, Tos M. Autoinflation in the treatment of Eustachian tube dysfunction, secretory otitis media and its sequelae. Recent advances in otitis media. Amsterdam/New York: Kugler Publications, 1994:759‐63.

Referencias de los estudios excluidos de esta revisión

Alper 1999 {published data only}

Alper CM, Swarts JD, Doyle W. Middle ear inflation for diagnosis and treatment of otitis media with effusion. Auris Nasus Larynx 1999;26:479‐86.

Arick 2000 {published data only}

Arick D, Silmasn S. Treatment of otitis media with effusion based on polizterization with an automated device. Ear, Nose and Throat Journal 2000;79(4):290‐8.

Blanshard 1995 {published data only}

Blanshard J. Autoinflation for otitis media with effusion. Maternal and Child Health 1995;September 1995:304‐7.

Chan 1989 {published data only}

Chan K, Bluestone CD. Lack of efficacy of middle‐ear inflation: treatment of otitis media with effusion in children. Otolaryngology ‐ Head and Neck Surgery 1989;100(4):317‐23.

Gottschalk 1966 {published data only}

Gottschalk GH. Further experience with controlled middle ear inflation in the treatment of serous otitis. The eye, ear, nose and throat monthly 1966;45:49‐51.

Gottschalk 1991 {published data only}

Gottschalk GH. Middle ear inflation: its place in the treatment of otitis media with effusion. The Eustachian Tube, clinical aspects. 1991:293‐5.

Hanner 1997 {published data only}

Hanner P. Non surgical treatment of otitis media with effusion. Indian Journal of Otology 1997;3(3):101‐7.

Havas 1995 {published data only}

Havas T, Koutsis A, Jacobson I. Nasal ballon auto‐inflation (Otovent) as a treatment of otitis media with effusion in children. Journal of the Oto‐laryngological Society of Australia 1995;2(1):37‐41.

Kaneko 1997 {published data only}

Kaneko Y, Takasaka T, Sakuma M, Kambayashi J, Okitsu T. Middle ear inflation as a treatment for secretory otitis media in children. Acta Otolaryngologica (Stockholm) 1997;117:564‐8.

Kouwen 2005 {published data only}

Kouwen H, van Balen FAM, Dejonckere PH. Functional tubal therapy for persistent otitis media with effusion in children: Myth or evidence?. International Journal of Pediatric Otorhinolaryngology 2005;69:943‐51.

Kutácová 2005 {published data only}

Kutácová, S, Komínek, P, Horník. P. S. Autoinflation in curing up the middle ear inflammation.. Otorinolaryngologie a Foniatrie {Otorinolaryngol‐Foniatr} 2005;54(1):52‐55.

Leunig 1995 {published data only}

Leunig A. Middle ear aeration with the Otovent‐latex membrane system. Laryno‐Rhino‐Otologie 1995;74(b):352‐4.

Luntz 1991 {published data only}

Luntz M, Sadé J. The diagnostic and therapeutic value of middle ear inflation. The Eustachian tube, basic aspects. 1991:183‐5.

Ogawa 2003 {published data only}

Ogawa I. Otitis media with effusion: treatment by autoinflation using a balloon. J Otolaryngol Jpn 2003;106:685‐91.

Yu 2003 {published data only}

Yu L, Ma X. Trans‐external ear canal blow oxygen method. Lin Chuang Er Bi Yan Hou Ke Zsa Zhi [Journal of Clinical Otorhinolaryngology] 2003;17(1):35‐6.

Referencias de los estudios en espera de evaluación

Niebuhr‐Jorgensen {published data only}

 

Scadding {unpublished data only}

 

Bluestone 1988

Bluestone CD, Klein JO. Otitis Media in Infants and Children. Philadelphia: WB Saunders Company, 1988.

Deeks 2005

Deeks JJ, Higgins, JPT, Altman DG. Section 8.11.2.2 Approximate analyses of cluster‐randomized trials for a meta‐analysis: Effective sample sizes. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. Cochrane Collaboration, May 2005. [http://www.cochrane.org/resources/handbook/hbook.htm]

Fiellau 1977

Fiellau‐Nikolajsen M, Lous J, Pedersen SV, Schousboe HH. Tympanometry in three‐year‐old children. I. a regional prevalence study on the distribution of tympanometric results in a non‐selected population of three‐year‐old children. Scandinavian Audiology 1977;6(4):199‐204.

Fiellau 1979

Fiellau‐Nikolajsen M, Lous J. Prospective tympanometry in three‐year‐old children: a study of the spontaneous course of tympanometry types in a non‐selected population. Archives of Otolaryngology 1979;105(8):461‐6.

Fiellau 1983

Fiellau‐Nikolajsen M. Tympanometry and secretory otitis media. Observations on diagnosis, epidemiology, treatment, and prevention in prospective cohort studies of three‐year‐old children [thesis]. Acta Oto‐Laryngologica Supplementum 1983;394:1‐73.

Golz 1998

Golz A, Netzer A, Angel‐Yeger B, Westerman ST, Gilbert LM, Joachims HZ. Effects of middle ear effusions on the vestibular system in children. Otolaryngology ‐ Head and Neck Surgery 1998;119(6):695‐9.

Grace 1990

Grace AR, Pfleiderer AG. Dysequilibrium and otitis media with effusion: what is the association?. Journal of Laryngology and Otology 1990;104(9):682‐4.

Hunt‐Williams 1968

Hunt‐Williams R. A method of maintaining middle ear ventilation in children. Journal of Laryngology and Otology 1968;82:921.

Jerger 1970

Jerger J. Clinical experience with impedance audiometry. Archives of Otolaryngology 1970;92(4):311‐24.

Lous 1981

Lous J, Fiellau‐Nikolajsen M. Epidemiology of middle ear effusion and tubal dysfunction: a one‐year prospective study comprising monthly tympanometry in 387 non‐selected 7‐year‐old children. International Journal of Pediatric Otorhinolaryngology 1981;3(4):303‐17.

Lous 1995

Lous J. Secretory otitis media in schoolchildren. Is screening for secretory otitis media advisable?. Danish Medical Bulletin 1995;42(1):71‐99.

Lous 2005

Lous J, Burton MJ, Felding JU, Ovesen T, Rovers MM, Williamson I. Grommets (ventilation tubes) for hearing loss associated with otitis media with effusion in children. Cochrane Database of Systematic Reviews 2005, Issue 1. [Art. No.: CD001801. DOI: 10.1002/14651858.CD001801.pub2]

Reidpath 1999

Reidpath DD, Glasziou PP, Del Mar CD. Systemic review of autoinflation for treatment of glue ear. British Medical Journal 1999;318:1177‐8.

Rovers 1999

Rovers MM, Zielhuis GA, Straatman H, Ingels K, van der Wilt GJ, Kauffman‐de Boer M. Comparison of the CAPAS and Ewing tests for screening of hearing in infants. Journal of Medical Screening 1999;6(4):188‐92.

Teele 1989

Teele DW, Klein JO, Rosner B. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. Journal of Infectious Diseases 1989;160(1):83‐94.

Thomas 2006

Thomas CL, Simpson S, Butler CC, van der Voort JH. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database of Systematic Reviews 2006, Issue 3. [Art. No.: CD001935. DOI: 10.1002/14651858.CD001935.pub2]

Zielhuis 1989

Zielhuis GA, Rach GH, van den Broek P. Screening for otitis media with effusion in preschool children. The Lancet 1989;1(8633):311‐4.

Zielhuis 1990

Zielhuis GA, Rach GH, van‐den‐Broek P. The occurrence of otitis media with effusion in Dutch pre‐school children. Clinical Otolaryngology and Allied Sciences 1990;15(2):147‐53.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Arick 2005

Methods

Randomised controlled trial

Participants

Bilateral or unilateral OME on audiometry and otoscopy.

94 Children.

Inclusion:
1) aged 4 to 11 years
2) at least 2 month history of MEE and associated hearing loss documented by physician
3) pure tone conduction thresholds of 20 dB HL or more (500 Hz to 4000 Hz)
4) a tympanometric peak pressure (TPP) of ‐100 daPa or less
5) otologic diagnosis of MEE at pretest
6) absence of enlarged adenoids, acute otitis media or other ear abnormalities at pretest.

Interventions

Modified Politzer device for 7 weeks. Parent administered twice daily alternating nostrils.

Control group received equal care except for the intervention.

Outcomes

Air conduction thresholds for each ear (500 Hz to 4000 Hz), TPP, hearing recovery (by patients and by ears).

Data on outcome was obtained for all individuals.

Adherence was reported in 97.9% in the intervention group.

Notes

Results reported as continuous for all outcomes except hearing recovery.

Randomisation not described in paper (e‐mail from author described randomisation as 4 pieces of paper (2 Exp, 2 contr) in a paper bag chosen by parent.

Groups were comparable at outset.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Blanshard 1993

Methods

Randomised controlled trial

Participants

Bilateral OME on tympanometry.

85 children.

3 to 10 years on waiting list for ventilation tubes

Interventions

TDS Otovent 3 times a day or no treatment for 3 months.

Control group received equal care except for the intervention.

Outcomes

Tympanometry (1, 2 and 3 months).

Pure tone audiometry (3 months).

Clearance of fluid on otoscopy (1, 2 and 3 months).

Adverse effects (3 months). Between 93.4 and 95.8% follow up. 45% had high compliance, 43% low and 12% were unable to use device.

Notes

Results reported as ears.

Intervention group subdivided into low compliance and high compliance.

Original data obtained by JH and RP.

Randomisation done by computer generated random numbers.

Groups were comparable at outset, except for smoke exposure.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Brooker 1992

Methods

Randomised controlled trial (ears).

Allocation was made "at random", there were no comparisons of the groups at baseline, and no statement about blinding.

Participants

Unilateral or bilateral OME diagnosed by otoscopy, audiometry and tympanometry.

40 children.

Aged 3 to 10 referred to ENT.

Interventions

TDS carnival balloon 3 times a day or no treatment for 3 weeks.

Both groups had equal care exept for the intervention.

Outcomes

Pure tone audiometry.
Tympanometry
(Both at 3 weeks).

100% follow up in both groups. Parents reported "good compliance".

Notes

Ears.

Children unable to use the carnival blower excluded prior to randomisation.

Randomisation procedure not described.

Comparability of groups not stated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Fraser 1977

Methods

Three factorial randomised controlled

Participants

Bilateral OME on tympanometry.

85 children.

Aged 3 to 12.

Interventions

BD carnival blower or no treatment for six weeks.

Other arms (factorial design) received equal care except for the intervention.

Outcomes

Pure tone audiometry.
Tympanometry.
(Both at 6 weeks).

97% follow up overall.

Adherence not reported.

Notes

Children.
Also randomised to one, both or neither of Dimotapp elixir or 0.5% ephedrine nosedrops.

Randomisation not described.

Groups were comparable at outset.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Lesinskas 2003

Methods

Randomised controlled trial

Participants

Unilateral or bilateral OME diagnosed by tympanometry and PTA.

198 adults aged 16 to 75.

Interventions

BD Politzer inflation 2 times a day for 10 days, with or without oral antibiotics, or no treatment.

Control group received equal care except for the intervention.

Outcomes

Pooled score combining pneumo‐otoscopic appearance, tympanometry, patient complaint and audiometry (days 3 to 5, 10 and 60).

100% follow up and adherence (done by ENT doctor).

Notes

Results reported by ears.

Randomisation of individuals done by independent person using envelopes.

No data on group comparability at outset.

Outcomes only presented as pooled data

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Stangerup 1992

Methods

Randomised controlled trial

Participants

Unilateral or bilateral OME for at least 3/12 diagnosed by tympanometry.

100 children.

Aged 3 to 10.

Interventions

TDS Otovent 3 times a day for 2 weeks, extended to 4 weeks in those with persistent OME, or no treatment.

Control group received equal care except for the intervention.

Outcomes

Tympanometry
Otits media (days 14, 30, 60 and 90).

Follow up of 82.4% in the intervention arm and 67.% in the control.

At 2 weeks the adherence was 71.7% in the intervention group.

Notes

Results reported as ears.

Randomisation done by individual, but not stated how.

Groups were comparable at outset.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Alper 1999

ALLOCATION:
Case report only.

Arick 2000

ALLOCATION:
Not a randomised controlled trial.

Blanshard 1995

ALLOCATION:
Comment ‐ not a randomised controlled trial.

Chan 1989

ALLOCATION:
Participants were stratified according to their ability of tubal opening during autoinflation. Within each strata children were randomised to autoinflation or control using a set of random numbers.

PARTICIPANTS:
Criteria for diagnosing OME was otoscopy alone. No tympanometry or audiometry.

Gottschalk 1966

ALLOCATION:
Comment ‐ not a randomised controlled trial.

Gottschalk 1991

ALLOCATION:
Not a randomised controlled trial.

Hanner 1997

ALLOCATION:
Randomised controlled trial. No details given on randomisation.

PARTICIPANTS:
76 children with unilateral or bilateral negative middle ear pressure lower than ‐200 mm water (type C2 or B tympanometry) for at least three months verified by tympanometry and older than three years.

INTERVENTION:
Both intervention groups (children) received an "Autoinflation" treatment. Otovent (28) versus Valsalva manoeuvre (27).

Havas 1995

ALLOCATION:
Not a randomised controlled trial.

Kaneko 1997

ALLOCATION:
Not a randomised controlled trial.

Kouwen 2005

ALLOCATION:
Randomised controlled trial. No information given on randomisation.

PARTICIPANTS:
32 children aged two to five years with bilateral OME diagnosed by combined and repeated tympanometry and otoscopy.

INTERVENTION:
Comparison is functional therapy (15) versus watchful waiting (17), no autoinflation intervention. Functional therapy consisted in therapy by a speech pathologist, combining hygiene and behavioural changes with specific motoric exercises once a week for a period of three months.

Kutácová 2005

ALLOCATION:
Comment ‐ not a randomised controlled trial.

Leunig 1995

ALLOCATION:
Unable to determine if this was a randomised controlled trial.

PARTICIPANTS:
146 children above four years with unilateral or bilateral OME ascertained by audiometry and tympanometry.

INTERVENTION:
Comparison is autoinflation versus paracentesis, not autoinflation versus control.

Luntz 1991

ALLOCATION:
Not a randomised controlled trial.

Ogawa 2003

ALLOCATION:
Not a randomised controlled trial.

Yu 2003

ALLOCATION:
Not a randomised controlled trial.

Data and analyses

Open in table viewer
Comparison 1. Tympanometry Improvement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tympanogram improvement: 1 month or less Show forest plot

3

Relative risk (Random, 95% CI)

Subtotals only

Analysis 1.1

Comparison 1 Tympanometry Improvement, Outcome 1 Tympanogram improvement: 1 month or less.

Comparison 1 Tympanometry Improvement, Outcome 1 Tympanogram improvement: 1 month or less.

1.1 B or C2 to C1 or A

3

Relative risk (Random, 95% CI)

1.65 [0.49, 5.56]

1.2 B to C1 or A

2

Relative risk (Random, 95% CI)

2.71 [1.43, 5.12]

1.3 C2 to C1 or A

2

Relative risk (Random, 95% CI)

3.84 [1.94, 7.59]

2 Tympanogram improvement: > 1 month Show forest plot

2

Relative Risk (Random, 95% CI)

Subtotals only

Analysis 1.2

Comparison 1 Tympanometry Improvement, Outcome 2 Tympanogram improvement: > 1 month.

Comparison 1 Tympanometry Improvement, Outcome 2 Tympanogram improvement: > 1 month.

2.1 B or C2 to C1 or A

2

Relative Risk (Random, 95% CI)

1.89 [0.77, 4.67]

Open in table viewer
Comparison 2. Improvement (tympanogram or composite)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Improvement composite: 1 month or less Show forest plot

4

Relative Risk (Random, 95% CI)

2.47 [0.93, 6.58]

Analysis 2.1

Comparison 2 Improvement (tympanogram or composite), Outcome 1 Improvement composite: 1 month or less.

Comparison 2 Improvement (tympanogram or composite), Outcome 1 Improvement composite: 1 month or less.

2 Improvement composite: > 1 month Show forest plot

4

Relative Risk (Random, 95% CI)

2.20 [1.71, 2.82]

Analysis 2.2

Comparison 2 Improvement (tympanogram or composite), Outcome 2 Improvement composite: > 1 month.

Comparison 2 Improvement (tympanogram or composite), Outcome 2 Improvement composite: > 1 month.

3 Improvement composite by intervention: 1 month or less Show forest plot

4

Risk Ratio (Random, 95% CI)

2.47 [0.93, 6.58]

Analysis 2.3

Comparison 2 Improvement (tympanogram or composite), Outcome 3 Improvement composite by intervention: 1 month or less.

Comparison 2 Improvement (tympanogram or composite), Outcome 3 Improvement composite by intervention: 1 month or less.

3.1 Intervention A ‐Classic Otovent or Carnival blower+balloon

3

Risk Ratio (Random, 95% CI)

1.65 [0.49, 5.55]

3.2 Intervention C ‐ Politzer

1

Risk Ratio (Random, 95% CI)

7.07 [3.70, 13.51]

4 Improvement composite by intervention: > 1 month Show forest plot

4

Risk Ratio (Random, 95% CI)

2.20 [1.71, 2.82]

Analysis 2.4

Comparison 2 Improvement (tympanogram or composite), Outcome 4 Improvement composite by intervention: > 1 month.

Comparison 2 Improvement (tympanogram or composite), Outcome 4 Improvement composite by intervention: > 1 month.

4.1 Intervention A ‐Classic Otovent or Carnival blower+balloon

2

Risk Ratio (Random, 95% CI)

1.89 [0.77, 4.67]

4.2 Intervention C ‐ Politzer

2

Risk Ratio (Random, 95% CI)

2.25 [1.67, 3.04]

Open in table viewer
Comparison 3. Audiometry Improvement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz) Show forest plot

2

Relative Risk (Random, 95% CI)

0.80 [0.22, 2.88]

Analysis 3.1

Comparison 3 Audiometry Improvement, Outcome 1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz).

Comparison 3 Audiometry Improvement, Outcome 1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz).

2 Pure tone threshold Show forest plot

2

Mean difference (Random, 95% CI)

7.02 [‐6.92, 20.96]

Analysis 3.2

Comparison 3 Audiometry Improvement, Outcome 2 Pure tone threshold.

Comparison 3 Audiometry Improvement, Outcome 2 Pure tone threshold.

Otovent package.Otovent® package containing balloons with device and instructions.
Figuras y tablas -
Figure 1

Otovent package.

Otovent® package containing balloons with device and instructions.

Child using Otovent.Child demonstrating the use of Otovent® device
Figuras y tablas -
Figure 2

Child using Otovent.

Child demonstrating the use of Otovent® device

Politzer ‐ EarPopper.Young woman demonstrating use of modified Politzer device (EarPopper™)
Figuras y tablas -
Figure 3

Politzer ‐ EarPopper.

Young woman demonstrating use of modified Politzer device (EarPopper™)

Comparison 1 Tympanometry Improvement, Outcome 1 Tympanogram improvement: 1 month or less.
Figuras y tablas -
Analysis 1.1

Comparison 1 Tympanometry Improvement, Outcome 1 Tympanogram improvement: 1 month or less.

Comparison 1 Tympanometry Improvement, Outcome 2 Tympanogram improvement: > 1 month.
Figuras y tablas -
Analysis 1.2

Comparison 1 Tympanometry Improvement, Outcome 2 Tympanogram improvement: > 1 month.

Comparison 2 Improvement (tympanogram or composite), Outcome 1 Improvement composite: 1 month or less.
Figuras y tablas -
Analysis 2.1

Comparison 2 Improvement (tympanogram or composite), Outcome 1 Improvement composite: 1 month or less.

Comparison 2 Improvement (tympanogram or composite), Outcome 2 Improvement composite: > 1 month.
Figuras y tablas -
Analysis 2.2

Comparison 2 Improvement (tympanogram or composite), Outcome 2 Improvement composite: > 1 month.

Comparison 2 Improvement (tympanogram or composite), Outcome 3 Improvement composite by intervention: 1 month or less.
Figuras y tablas -
Analysis 2.3

Comparison 2 Improvement (tympanogram or composite), Outcome 3 Improvement composite by intervention: 1 month or less.

Comparison 2 Improvement (tympanogram or composite), Outcome 4 Improvement composite by intervention: > 1 month.
Figuras y tablas -
Analysis 2.4

Comparison 2 Improvement (tympanogram or composite), Outcome 4 Improvement composite by intervention: > 1 month.

Comparison 3 Audiometry Improvement, Outcome 1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz).
Figuras y tablas -
Analysis 3.1

Comparison 3 Audiometry Improvement, Outcome 1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz).

Comparison 3 Audiometry Improvement, Outcome 2 Pure tone threshold.
Figuras y tablas -
Analysis 3.2

Comparison 3 Audiometry Improvement, Outcome 2 Pure tone threshold.

Table 1. Methodology of included studies

Study

Randomisation method

Groups comparable

Allocation concealed

Ascertainment

Notes

Brooker 1992

Sealed envelope

Not stated

Not used

100%

Stangerup 1992

Consecutively randomised

Yes

Not used

87% at 30 days, 74% at 90 days

Blanshard 1993

Computer generated

Yes

Not used

Over 90% at all outcome points

Intervention group analysed as low and high compliance subgroups

Fraser 1977

Not stated. Three factorial study

Yes

Not used

97%

Lesinskas 2003

Independent person envelopes

Not stated

Not used

100%

Autoinflation performed by the physician

Arick 2005

4 pieces of paper (2 Exp, 2 Control) in a bag, one selected by parent

Yes

Not used

100%

Autoinflation in children performed by parent using modyfied Politzer

Figuras y tablas -
Table 1. Methodology of included studies
Table 2. Side effects and compliance

Trial

Side effects

Compliance

Brooker 1992

None reported

Parents reported good compliance

Stangerup 1992

"We have not observed an increase incidence in middle ear infection or eardrum perforation in connection with autoinflation."
No comment given on baseline incidence level.

Compliance at 2 weeks:
33/51 (65%) High compliance,
10/51 (20%) Low compliance,
3/51 ( 6%) No compliance
No data given on the other 5 children.

Blanshard 1993

Stratified by compliance level:
Attacks of OM
44% control, 36% HC, 30% LC.
URTI
61% LC, 32% HC, 23% control
Tonsillitis
22% LC, 5% HC, 13% Control
Antibiotics
43% LC, 21% HC, 33% control
"No complications arose from using the treatment."

45% High compliance(HC), 43% low compliance (LC), 12% unable to use device

Some children with OME find doing the Valsalva manoeuvre painful.

Fraser 1977

Some children developed further symptoms and abnormal signs while receiving treatments (do not mention which group)

Not reported

Lesinskas 2003

Treatment ME inflation stopped for 1 adult patient due to painfulness of procedure

100% follow up and compliance (done by physician)

Arick 2005

As part of 1 year follow up
2 children with MEE (hearing restored)
3 children had either grommets inserted and/or enlarged adenoid

Compliance of 97.9% (46/47)

Figuras y tablas -
Table 2. Side effects and compliance
Comparison 1. Tympanometry Improvement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Tympanogram improvement: 1 month or less Show forest plot

3

Relative risk (Random, 95% CI)

Subtotals only

1.1 B or C2 to C1 or A

3

Relative risk (Random, 95% CI)

1.65 [0.49, 5.56]

1.2 B to C1 or A

2

Relative risk (Random, 95% CI)

2.71 [1.43, 5.12]

1.3 C2 to C1 or A

2

Relative risk (Random, 95% CI)

3.84 [1.94, 7.59]

2 Tympanogram improvement: > 1 month Show forest plot

2

Relative Risk (Random, 95% CI)

Subtotals only

2.1 B or C2 to C1 or A

2

Relative Risk (Random, 95% CI)

1.89 [0.77, 4.67]

Figuras y tablas -
Comparison 1. Tympanometry Improvement
Comparison 2. Improvement (tympanogram or composite)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Improvement composite: 1 month or less Show forest plot

4

Relative Risk (Random, 95% CI)

2.47 [0.93, 6.58]

2 Improvement composite: > 1 month Show forest plot

4

Relative Risk (Random, 95% CI)

2.20 [1.71, 2.82]

3 Improvement composite by intervention: 1 month or less Show forest plot

4

Risk Ratio (Random, 95% CI)

2.47 [0.93, 6.58]

3.1 Intervention A ‐Classic Otovent or Carnival blower+balloon

3

Risk Ratio (Random, 95% CI)

1.65 [0.49, 5.55]

3.2 Intervention C ‐ Politzer

1

Risk Ratio (Random, 95% CI)

7.07 [3.70, 13.51]

4 Improvement composite by intervention: > 1 month Show forest plot

4

Risk Ratio (Random, 95% CI)

2.20 [1.71, 2.82]

4.1 Intervention A ‐Classic Otovent or Carnival blower+balloon

2

Risk Ratio (Random, 95% CI)

1.89 [0.77, 4.67]

4.2 Intervention C ‐ Politzer

2

Risk Ratio (Random, 95% CI)

2.25 [1.67, 3.04]

Figuras y tablas -
Comparison 2. Improvement (tympanogram or composite)
Comparison 3. Audiometry Improvement

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Average improvement >= 10 dB in pure tone audiogram (freq. 250 Hz to 2000 Hz) Show forest plot

2

Relative Risk (Random, 95% CI)

0.80 [0.22, 2.88]

2 Pure tone threshold Show forest plot

2

Mean difference (Random, 95% CI)

7.02 [‐6.92, 20.96]

Figuras y tablas -
Comparison 3. Audiometry Improvement