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September 15, 1993, Vol 270, No. 11 >
ARTICLE | September 15, 1993

Use of Antibiotics in Preventing Recurrent Acute Otitis Media and in Treating Otitis Media With Effusion: Title and subTitle BreakA Meta-analytic Attempt to Resolve the Brouhaha FREE

Robert L. Williams, MD, MPH; Thomas C. Chalmers, MD; Kurt C. Stange, MD, PhD; Frances T. Chalmers, MD; Steven J. Bowlin, DO, MPH
[+] Author Affiliations

Reprints not available.


JAMA. 1993;270(11):1344-1351. doi:10.1001/jama.1993.03510110084037
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Published online
Article
References

Objective.  —To determine the efficacy of antibiotics for prophylaxis of recurrent otitis media and treatment of otitis media with effusion (OME) in children.

Data Sources.  —MEDLINE from 1966 through April 1993, textbooks, Current Contents, and bibliographies of selected articles.

Study Selection.  —Thirty-three studies initially identified were reviewed by three blinded reviewers assessing study quality and suitability for inclusion. Twenty-seven met inclusion criteria for the meta-analyses.

Data Extraction.  —We abstracted quantitative data and calculated rate differences (RDs) using tympanometry as the preferred outcome measure.

Data Synthesis.  —Nine studies of antibiotic prophylaxis of recurrent otitis media with 958 subjects had an RD of 0.11 (95% confidence interval [CI], 0.03 to 0.19) favoring antibiotic treatment. Twelve studies of short-term patient outcomes of OME with 1697 subjects had an RD favoring antibiotics of 0.16 (95% CI, 0.03 to 0.29), while eight studies using the ear as the outcome measure with 2052 ears studied had an RD of 0.25 (95% CI, 0.10 to 0.40). No significant difference was shown between placebo and antibiotics (RD, 0.06; 95% CI, -0.03 to 0.14) in the eight studies of longer-term outcome of OME. Subgroup analyses by antibiotic grouping, duration of treatment, and duration of disease did not show significant differences.

Conclusions.  —Antibiotics appear to have beneficial but limited effect on recurrent otitis media and short-term resolution of OME. Longer-term benefit for OME has not been shown. The findings are limited by the failure of most studies to consider potential confounders and by inability to identify groups of patients most likely to benefit.(JAMA. 1993;270:1344-1351)

REFERENCES

1 +
Stool SE, Field JM.  The impact of otitis media. Pediatr Infect Dis J . 1989;;8( (suppl 1) ):S11-S14.
2 +
Froom J, Culpepper L, Grob P, et al.  Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ . 1990;;300:582-586.
3 +
Claessen JQPJ, Appelman CLM, Touw-Otten FWMM, De Melker RA, Hordijk GJ.  A review of clinical trials regarding treatment of acute otitis media. Clin Otolaryngol . 1992;;17:251-257.
4 +
Casselbrant ML, Kaleida PH, Rockette HE, et al.  Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial. Pediatr Infect Dis J . 1992;;11:278-286.
5 +
Paradise JL.  Antimicrobial prophylaxis for recurrent acute otitis media. Ann Otol Rhinol Laryngol . 1981;;90( (suppl 84) ):53-57.
6 +
Smith IM, Maw AR.  Secretory otitis media: a review of management by consultant otolaryngologists. Clin Otolaryngol . 1991;;16:266-270.
7 +
Teele DW, Klein JO, Chase C, Menyuk P, Rosner BA, the Greater Boston Otitis Media Study Group.  Otitis media in infancy and intellectual ability, school achievement, speech, and language at age 7 years. J Infect Dis . 1990;;162:685-694.
8 +
Rosenthal R.  The 'File Drawer Problem' and tolerance for null results. Psychol Bull . 1979;;86: 638-641.
9 +
Chalmers TC, Smith H, Blackburn B, et al.  A method for assessing the quality of a randomized control trial. Controlled Clin Trials . 1981;;2:31-49.
10 +
Cantekin EI, McGuire TW, Griffith TL.  Antimicrobial therapy for otitis media with effusion ('secretory' otitis media). JAMA . 1991;;266:3309-3317.
11 +
Cantekin EI, Mandel EM, Bluestone CD, et al.  Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ('secretory' otitis media) in children. N Engl J Med . 1983;; 308:297-301.
12 +
DerSimonian R, Laird N.  Meta-analysis in clinical trials. Controlled Clin Trials . 1986;;7:177-188.
13 +
Marks NJ, Mills RP, Shaheen OH.  A controlled trial of cotrimoxazole therapy in serous otitis media. J Laryngol Otol . 1981;;95:1003-1009.
14 +
Schwartz RH, Puglise J, Rodriguez WJ.  Sulphamethoxazole prophylaxis in the otitis-prone child. Arch Dis Child . 1982;;57:590-593.
15 +
Hearey C, Hokanson J, Ury H, Chang C, Co-plan B, Hall M.  Lack of efficacy of short-term prednisone, trimethoprim-sulfamethoxazole, alone or combined, in persistent otitis media with effusion: season of entry as possible determinant of outcome. AJDC . 1990;;144:420. Abstract.
16 +
Otten FWA, Grote JJ.  Otitis media with effusion and chronic upper respiratory tract infection in children: a randomized, placebo-controlled clinical study. Laryngoscope . 1990;;100:627-633.
17 +
Giebink GS, Batalden PB, Le CT, et al.  Randomized controlled trial comparing trimethoprim-sulfamethoxazole, prednisone, ibuprofen, and no treatment in chronic otitis media with effusion.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:240-244.
18 +
Thomsen J, Sederberg-Olsen JF, Stangerup S, Balle V, Vejlsgaard R.  Long term antibiotic treatment of children with secretory otitis media: double blind, placebo controlled study.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:244-247.
19 +
Giebink GS, Batalden PB, Le CT, Lassman FM, Buran DJ, Seltz AE.  A controlled trial comparing three treatments for chronic otitis media with effusion. Pediatr Infect Dis J . 1990;;9:33-40.
20 +
Thomsen J, Sederberg-Olsen J, Balle V, Vejlsgaard R, Stangerup S, Bondesson G.  Antibiotic treatment of children with secretory otitis media: a randomized, double-blind, placebo-controlled study. Arch Otolaryngol Head Neck Surg . 1989;; 115:447-451.
21 +
Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ.  Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. N Engl J Med . 1987;; 316:432-437.
22 +
Corwin MJ, Weiner LB, Daniels D.  Efficacy of oral antibiotics for the treatment of persistent otitis media with effusion. Int J Pediatr Otorhinolaryngol . 1986;;11:109-112.
23 +
Corwin MJ, Weiner LB, Daniels DA.  Effects of oral antibiotics on the outcome of serous otitis media. Pediatr Res . 1982;;16:238A. Abstract.
24 +
Rennie D.  The Cantekin affair. JAMA . 1991;; 266:3333-3337.
25 +
Mandel EM, Rockette HE, Bluestone CD, Paradise JC, Nozza RJ.  Antibiotic therapy for otitis media with effusion: a response from Pittsburgh. JAMA . 1993;;269:516-517.
26 +
Reitman D, Sacks HS, Chalmers TC.  Technical quality assessment of randomized control trials (RCTs). Controlled Clin Trials . 1987;;8:282. Abstract.
27 +
Emerson JD, Burdick E, Hoaglin DC, Mosteller F, Chalmers TC.  An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Controlled Clin Trials . 1990;;11:339-352.
28 +
Maynard JE, Fleshman JK, Tschopp CF.  Otitis media in Alaskan Eskimo children: prospective evaluation of chemoprophylaxis. JAMA . 1972;;219:597-599.
29 +
Perrin JM, Charney E, MacWhinney JB Jr, Mclnerny TK, Miller RL, Nazarian LF.  Sulfisoxazole as chemoprophylaxis for recurrent otitis media. N Engl J Med . 1974;;291:664-667.
30 +
Gaskins JD, Holt RJ, Kyong CU, Weart CW, Ward J.  Chemoprophylaxis of recurrent otitis media using trimethoprim/sulfamethoxazole. Drug Intell Clin Pharm . 1982;;16:387-390.
31 +
Schuller DE.  Prophylaxis of otitis media in asthmatic children. Pediatr Infect Dis . 1983;;2:280-283.
32 +
Liston TE, Foshee WS, Pierson WD.  Sulfisoxazole chemoprophylaxis for frequent otitis media. Pediatrics . 1983;;71:524-530.
33 +
Varsano I, Volovitz B, Mimouni F.  Sulfisoxazole prophylaxis of middle ear effusion and recurrent acute otitis media. AJDC . 1985;;139:632-635.
34 +
Gonzalez C, Arnold JE, Woody EA, et al.  Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes. Laryngoscope . 1986;;96:1330-1334.
35 +
Principi N, Marchisio P, Massironi E, Grasso RM, Filiberti G.  Prophylaxis of recurrent acute otitis media and middle-ear effusion: comparison of amoxicillin with sulfamethoxazole and trimethoprim. AJDC . 1989;;143:1414-1418.
36 +
Schwartz RH, Rodriguez WJ.  Trimethoprim-sulfamethoxazole treatment of persistent otitis media with effusion. Pediatr Infect Dis . 1982;;1:333-335.
37 +
DeCastro FJ, Jaeger RW, Martin L, Temeck JW, Tournour B.  Serous otitis media: a double-blind trial with sulfisoxazole. Mo Med . 1982;;79:629-630.
38 +
Healy GB.  Antimicrobial therapy of chronic otitis media with effusion. Int J Pediatr Otorhinolaryngol . 1984;;8:13-17.
39 +
Ernstson S, Anari M.  Cefaclor in the treatment of otitis media with effusion. Acta Otolaryngol . 1985; ( (suppl 424) ):17-21.
40 +
Daly K, Giebink GS, Lindgren B, Anderson RS.  Controlled clinical trial for prevention of chronic otitis media with effusion.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:247-250.
41 +
Schloss MD, Dempsey EE, Rishikof E, Sorger S, Grace MGA.  Double blind study comparing erythromycin-sulfisoxazole (Pediazole) t.i.d. to placebo in chronic otitis media with effusion.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:261-263.
42 +
Møller P, Dingsør G.  Otitis media with effusion: can erythromycin reduce the need for ventilating tubes? J Laryngol Otol . 1990;;104:200-202.
43 +
Mandel EM, Rockette HE, Paradise JL, Bluestone CD, Nozza RJ.  Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children. Pediatr Infect Dis J . 1991;;10:899-906.
44 +
Bluestone CD.  Modern management of otitis media. Pediatr Clin North Am . 1989;;36:1371-1387.
45 +
Persico M, Podoshin L, Frandis M, et al.  Recurrent acute otitis media—prophylactic penicillin treatment: a prospective study, part I. Int J Pediatr Otorhinolaryngol . 1985;;10:37-46.
46 +
Donaldson JD, Martin GF, Maltby CC, Seywerd EB.  The efficacy of pulse-dosed antibiotic therapy in the management of persistent otitis media with effusion. J Otolaryngol . 1990;;19:175-178.
47 +
Marks NJ, Mills RP, Shaheen OH.  Cotrimoxazole in the treatment of serous otitis: a follow-up report. J Laryngol Otol . 1983;;97:213-215.
48 +
Podoshin L, Fradis M, Ben-David Y, Faraggi D.  The efficacy of oral steroids in the treatment of persistent otitis media with effusion. Arch Otolaryngol Head Neck Surg . 1990;;116:1404-1406.
49 +
Rosenfeld RM, Post JC.  Meta-analysis of antibiotics for the treatment of otitis media with effusion. Otolaryngol Head Neck Surg . 1992;;106:378-386.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Stool SE, Field JM.  The impact of otitis media. Pediatr Infect Dis J . 1989;;8( (suppl 1) ):S11-S14.
2 +
Froom J, Culpepper L, Grob P, et al.  Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ . 1990;;300:582-586.
3 +
Claessen JQPJ, Appelman CLM, Touw-Otten FWMM, De Melker RA, Hordijk GJ.  A review of clinical trials regarding treatment of acute otitis media. Clin Otolaryngol . 1992;;17:251-257.
4 +
Casselbrant ML, Kaleida PH, Rockette HE, et al.  Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial. Pediatr Infect Dis J . 1992;;11:278-286.
5 +
Paradise JL.  Antimicrobial prophylaxis for recurrent acute otitis media. Ann Otol Rhinol Laryngol . 1981;;90( (suppl 84) ):53-57.
6 +
Smith IM, Maw AR.  Secretory otitis media: a review of management by consultant otolaryngologists. Clin Otolaryngol . 1991;;16:266-270.
7 +
Teele DW, Klein JO, Chase C, Menyuk P, Rosner BA, the Greater Boston Otitis Media Study Group.  Otitis media in infancy and intellectual ability, school achievement, speech, and language at age 7 years. J Infect Dis . 1990;;162:685-694.
8 +
Rosenthal R.  The 'File Drawer Problem' and tolerance for null results. Psychol Bull . 1979;;86: 638-641.
9 +
Chalmers TC, Smith H, Blackburn B, et al.  A method for assessing the quality of a randomized control trial. Controlled Clin Trials . 1981;;2:31-49.
10 +
Cantekin EI, McGuire TW, Griffith TL.  Antimicrobial therapy for otitis media with effusion ('secretory' otitis media). JAMA . 1991;;266:3309-3317.
11 +
Cantekin EI, Mandel EM, Bluestone CD, et al.  Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ('secretory' otitis media) in children. N Engl J Med . 1983;; 308:297-301.
12 +
DerSimonian R, Laird N.  Meta-analysis in clinical trials. Controlled Clin Trials . 1986;;7:177-188.
13 +
Marks NJ, Mills RP, Shaheen OH.  A controlled trial of cotrimoxazole therapy in serous otitis media. J Laryngol Otol . 1981;;95:1003-1009.
14 +
Schwartz RH, Puglise J, Rodriguez WJ.  Sulphamethoxazole prophylaxis in the otitis-prone child. Arch Dis Child . 1982;;57:590-593.
15 +
Hearey C, Hokanson J, Ury H, Chang C, Co-plan B, Hall M.  Lack of efficacy of short-term prednisone, trimethoprim-sulfamethoxazole, alone or combined, in persistent otitis media with effusion: season of entry as possible determinant of outcome. AJDC . 1990;;144:420. Abstract.
16 +
Otten FWA, Grote JJ.  Otitis media with effusion and chronic upper respiratory tract infection in children: a randomized, placebo-controlled clinical study. Laryngoscope . 1990;;100:627-633.
17 +
Giebink GS, Batalden PB, Le CT, et al.  Randomized controlled trial comparing trimethoprim-sulfamethoxazole, prednisone, ibuprofen, and no treatment in chronic otitis media with effusion.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:240-244.
18 +
Thomsen J, Sederberg-Olsen JF, Stangerup S, Balle V, Vejlsgaard R.  Long term antibiotic treatment of children with secretory otitis media: double blind, placebo controlled study.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:244-247.
19 +
Giebink GS, Batalden PB, Le CT, Lassman FM, Buran DJ, Seltz AE.  A controlled trial comparing three treatments for chronic otitis media with effusion. Pediatr Infect Dis J . 1990;;9:33-40.
20 +
Thomsen J, Sederberg-Olsen J, Balle V, Vejlsgaard R, Stangerup S, Bondesson G.  Antibiotic treatment of children with secretory otitis media: a randomized, double-blind, placebo-controlled study. Arch Otolaryngol Head Neck Surg . 1989;; 115:447-451.
21 +
Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ.  Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. N Engl J Med . 1987;; 316:432-437.
22 +
Corwin MJ, Weiner LB, Daniels D.  Efficacy of oral antibiotics for the treatment of persistent otitis media with effusion. Int J Pediatr Otorhinolaryngol . 1986;;11:109-112.
23 +
Corwin MJ, Weiner LB, Daniels DA.  Effects of oral antibiotics on the outcome of serous otitis media. Pediatr Res . 1982;;16:238A. Abstract.
24 +
Rennie D.  The Cantekin affair. JAMA . 1991;; 266:3333-3337.
25 +
Mandel EM, Rockette HE, Bluestone CD, Paradise JC, Nozza RJ.  Antibiotic therapy for otitis media with effusion: a response from Pittsburgh. JAMA . 1993;;269:516-517.
26 +
Reitman D, Sacks HS, Chalmers TC.  Technical quality assessment of randomized control trials (RCTs). Controlled Clin Trials . 1987;;8:282. Abstract.
27 +
Emerson JD, Burdick E, Hoaglin DC, Mosteller F, Chalmers TC.  An empirical study of the possible relation of treatment differences to quality scores in controlled randomized clinical trials. Controlled Clin Trials . 1990;;11:339-352.
28 +
Maynard JE, Fleshman JK, Tschopp CF.  Otitis media in Alaskan Eskimo children: prospective evaluation of chemoprophylaxis. JAMA . 1972;;219:597-599.
29 +
Perrin JM, Charney E, MacWhinney JB Jr, Mclnerny TK, Miller RL, Nazarian LF.  Sulfisoxazole as chemoprophylaxis for recurrent otitis media. N Engl J Med . 1974;;291:664-667.
30 +
Gaskins JD, Holt RJ, Kyong CU, Weart CW, Ward J.  Chemoprophylaxis of recurrent otitis media using trimethoprim/sulfamethoxazole. Drug Intell Clin Pharm . 1982;;16:387-390.
31 +
Schuller DE.  Prophylaxis of otitis media in asthmatic children. Pediatr Infect Dis . 1983;;2:280-283.
32 +
Liston TE, Foshee WS, Pierson WD.  Sulfisoxazole chemoprophylaxis for frequent otitis media. Pediatrics . 1983;;71:524-530.
33 +
Varsano I, Volovitz B, Mimouni F.  Sulfisoxazole prophylaxis of middle ear effusion and recurrent acute otitis media. AJDC . 1985;;139:632-635.
34 +
Gonzalez C, Arnold JE, Woody EA, et al.  Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes. Laryngoscope . 1986;;96:1330-1334.
35 +
Principi N, Marchisio P, Massironi E, Grasso RM, Filiberti G.  Prophylaxis of recurrent acute otitis media and middle-ear effusion: comparison of amoxicillin with sulfamethoxazole and trimethoprim. AJDC . 1989;;143:1414-1418.
36 +
Schwartz RH, Rodriguez WJ.  Trimethoprim-sulfamethoxazole treatment of persistent otitis media with effusion. Pediatr Infect Dis . 1982;;1:333-335.
37 +
DeCastro FJ, Jaeger RW, Martin L, Temeck JW, Tournour B.  Serous otitis media: a double-blind trial with sulfisoxazole. Mo Med . 1982;;79:629-630.
38 +
Healy GB.  Antimicrobial therapy of chronic otitis media with effusion. Int J Pediatr Otorhinolaryngol . 1984;;8:13-17.
39 +
Ernstson S, Anari M.  Cefaclor in the treatment of otitis media with effusion. Acta Otolaryngol . 1985; ( (suppl 424) ):17-21.
40 +
Daly K, Giebink GS, Lindgren B, Anderson RS.  Controlled clinical trial for prevention of chronic otitis media with effusion.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:247-250.
41 +
Schloss MD, Dempsey EE, Rishikof E, Sorger S, Grace MGA.  Double blind study comparing erythromycin-sulfisoxazole (Pediazole) t.i.d. to placebo in chronic otitis media with effusion.  In: Lim DJ, Bluestone CD, Klein JO, Nelson JD, eds. Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media; 1987 June 1-4; Bal Harbour (FL) . Toronto, Ontario: BC Decker; 1988;:261-263.
42 +
Møller P, Dingsør G.  Otitis media with effusion: can erythromycin reduce the need for ventilating tubes? J Laryngol Otol . 1990;;104:200-202.
43 +
Mandel EM, Rockette HE, Paradise JL, Bluestone CD, Nozza RJ.  Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children. Pediatr Infect Dis J . 1991;;10:899-906.
44 +
Bluestone CD.  Modern management of otitis media. Pediatr Clin North Am . 1989;;36:1371-1387.
45 +
Persico M, Podoshin L, Frandis M, et al.  Recurrent acute otitis media—prophylactic penicillin treatment: a prospective study, part I. Int J Pediatr Otorhinolaryngol . 1985;;10:37-46.
46 +
Donaldson JD, Martin GF, Maltby CC, Seywerd EB.  The efficacy of pulse-dosed antibiotic therapy in the management of persistent otitis media with effusion. J Otolaryngol . 1990;;19:175-178.
47 +
Marks NJ, Mills RP, Shaheen OH.  Cotrimoxazole in the treatment of serous otitis: a follow-up report. J Laryngol Otol . 1983;;97:213-215.
48 +
Podoshin L, Fradis M, Ben-David Y, Faraggi D.  The efficacy of oral steroids in the treatment of persistent otitis media with effusion. Arch Otolaryngol Head Neck Surg . 1990;;116:1404-1406.
49 +
Rosenfeld RM, Post JC.  Meta-analysis of antibiotics for the treatment of otitis media with effusion. Otolaryngol Head Neck Surg . 1992;;106:378-386.

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