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January 27, 1993, Vol 269, No. 4 >
ARTICLE | January 27, 1993

Antibiotic Therapy for Otitis Media With Effusion: Title and subTitle BreakA Response From Pittsburgh FREE

Ellen M. Mandel, MD; Howard E. Rockette, PhD; Charles D. Bluestone, MD; Jack L. Paradise, MD; Robert J. Nozza, PhD
[+] Author Affiliations

Reprint requests to ENT Department, Children's Hospital of Pittsburgh, 3705 Fifth Ave at DeSoto Street, Pittsburgh, PA 15213 (Dr Mandel).


JAMA. 1993;269(4):516-517. doi:10.1001/jama.1993.03500040082042
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References

CANTEKIN et al1 have recently challenged our 1987 New England Journal of Medicine report2 that in infants and children with otitis media with effusion (secretory otitis media), amoxicillin treatment modestly increased the likelihood of resolution. From reanalyses of our clinical trial data, Cantekin et al concluded instead that amoxicillin had been no more efficacious than placebo, and that otoscopic diagnoses in our trial had been biased. Further, they cited reports "indicat[ing] that antimicrobial treatment is not effective even for acute otitis media."

To arrive at these positions, Cantekin et al committed a series of methodological improprieties, invoked fallacious concepts and invalid assumptions, and inadequately represented the findings of cited studies. Space constraints preclude our discussing these fully, but the most important were the following:

Post Hoc Use of an Altered and Invalid Method for Determining Outcome.  —Our amoxicillin trial was conducted from 1981 through 1984. Its original protocol

REFERENCES

1 +
Drs Bluestone and Paradise have received honoraria for presentations at postgraduate courses supported by Smith-Kline Beecham Inc.
2 +
Cantekin El, McGuire TW, Griffith TL.  Antimicrobial therapy for otitis media with effusion ('secretory' otitis media). JAMA . 1991;;266:3309-3317.
3 +
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: results of a double blind, randomized trial. N Engl J Med . 1987;;316:432-437.
4 +
Cantekin EI, Bluestone CD, Fria TJ, Stool SE, Berry QC, Sabo DL.  Identification of otitis media with effusion in children. Ann Otol Rhinol Laryngol . 1980;;89 ( (suppl 68) ):190-195.
5 +
Cantekin EI.  Algorithm for diagnosis of otitis media with effusion. Ann Otol Rhinol Laryngol . 1983;;92( (suppl 107) ):6.
6 +
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.
7 +
Paradise JL, Smith CG, Bluestone CD.  Tympanometric detection of middle ear effusion in infants and young children. Pediatrics . 1976;;58:198-210.
8 +
Paradise JL.  Testing for otitis media: diagnosis ex machina. N Engl J Med . 1977;; 296:445-448.
9 +
Smith CG, Paradise JL, Young TI.  Modified schema for classifying positive-pressure tympanograms. Pediatrics . 1982;;69:351-354.
10 +
Brostoff LM, Cantekin EI.  Observer invariant diagnosis of middle ear effusions.  In: Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media . Burlington, Ontario: BC Decker Inc; 1988;:47-49.
11 +
Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology: The Essentials . 2nd ed. Baltimore, Md: Williams & Wilkins; 1988;:54-61.
12 +
Paradise JL, Smith CG.  Impedance screening for preschool children: state of the art. Ann Otol Rhinol Laryngol . 1979;;88:56-65.
13 +
Van Buchem FL, Dunk JMM, Van't Hof MA.  Therapy of acute otitis media: myringotomy, antibiotics or neither? Lancet . 1981;;2:883-887.
14 +
Mygind N, Meistrup-Larsen KI, Thomsen J, Thomsen VF, Josefsson K, Sorensen H.  Penicillin in acute otitis: a double-blind placebo-controlled trial. Clin Otolaryngol . 1981;;6:5-13.
15 +
Van Buchem FL, Peeters MF, Van't Hof MA.  Acute otitis media: a new treatment strategy. BMJ . 1985;;290:1033-1037.
16 +
Tha[ill]in A, Densert O, Larsson A, Lyden E, Ripa T.  Is penicillin necessary in the treatment of acute otitis media?  In: Proceedings of the International Conference on Acute and Secretory Otitis Media . Amsterdam, the Netherlands: Kugler Publications; 1986;:441-446.
17 +
Ostfeld E, Segal J, Kaufstein M, Gelernter I.  Management of acute otitis media without primary administration of systemic antimicrobial agents.  In: Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media . Burlington, Ontario: BC Decker Inc; 1988;:235-239.
18 +
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.
19 +
Saah AJ, Blackwelder WC, Kaslow RA.  Treatment of acute otitis media. JAMA . 1982;;248:1071-1072.
20 +
Van Dishoeck HAE, Derks ACW, Voorhorst R.  Bacteriology and treatment of acute otitis in children. Acta Otolaryngol . 1959;;50:250-261.
21 +
Halsted C, Lepow ML, Balassanian N, Emmerich J, Wolinsky E.  Otitis media: clinical observations, microbiology and evaluations of therapy. AJDC . 1968;;115:542-551.
22 +
Laxdal OE, Merida J, Jones RHT.  Treatment of acute otitis media: a controlled study of 142 children. Can Med Assoc J . 1970;;102:263-268.
23 +
Howie VM, Ploussard JH.  Efficacy of fixed combination antibiotics versus separate components in otitis media. Clin Pediatr . 1972;;11:205-214.
24 +
Lorentzen P, Haugsten P.  Treatment of acute suppurative otitis media. J Laryngol Otol . 1977;;91:331-340.
25 +
Engelhard D, Strauss N, Jorczak-Sarni L, Cohen D, Sacks TG, Shapiro M.  Randomised study of myringotomy, amoxicillin/clavulanate, or both for acute otitis media in infants. Lancet . 1989;;2:141-143.
26 +
Kaieida PH, Casselbrant ML, Rockette HE, et al.  Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics . 1991;; 87:466-474.
27 +
Burke P, Bain J, Robinson D, Dunleavey J.  Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ . 1991;;303:558-562.

Figures

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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 +
Drs Bluestone and Paradise have received honoraria for presentations at postgraduate courses supported by Smith-Kline Beecham Inc.
2 +
Cantekin El, McGuire TW, Griffith TL.  Antimicrobial therapy for otitis media with effusion ('secretory' otitis media). JAMA . 1991;;266:3309-3317.
3 +
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: results of a double blind, randomized trial. N Engl J Med . 1987;;316:432-437.
4 +
Cantekin EI, Bluestone CD, Fria TJ, Stool SE, Berry QC, Sabo DL.  Identification of otitis media with effusion in children. Ann Otol Rhinol Laryngol . 1980;;89 ( (suppl 68) ):190-195.
5 +
Cantekin EI.  Algorithm for diagnosis of otitis media with effusion. Ann Otol Rhinol Laryngol . 1983;;92( (suppl 107) ):6.
6 +
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.
7 +
Paradise JL, Smith CG, Bluestone CD.  Tympanometric detection of middle ear effusion in infants and young children. Pediatrics . 1976;;58:198-210.
8 +
Paradise JL.  Testing for otitis media: diagnosis ex machina. N Engl J Med . 1977;; 296:445-448.
9 +
Smith CG, Paradise JL, Young TI.  Modified schema for classifying positive-pressure tympanograms. Pediatrics . 1982;;69:351-354.
10 +
Brostoff LM, Cantekin EI.  Observer invariant diagnosis of middle ear effusions.  In: Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media . Burlington, Ontario: BC Decker Inc; 1988;:47-49.
11 +
Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology: The Essentials . 2nd ed. Baltimore, Md: Williams & Wilkins; 1988;:54-61.
12 +
Paradise JL, Smith CG.  Impedance screening for preschool children: state of the art. Ann Otol Rhinol Laryngol . 1979;;88:56-65.
13 +
Van Buchem FL, Dunk JMM, Van't Hof MA.  Therapy of acute otitis media: myringotomy, antibiotics or neither? Lancet . 1981;;2:883-887.
14 +
Mygind N, Meistrup-Larsen KI, Thomsen J, Thomsen VF, Josefsson K, Sorensen H.  Penicillin in acute otitis: a double-blind placebo-controlled trial. Clin Otolaryngol . 1981;;6:5-13.
15 +
Van Buchem FL, Peeters MF, Van't Hof MA.  Acute otitis media: a new treatment strategy. BMJ . 1985;;290:1033-1037.
16 +
Tha[ill]in A, Densert O, Larsson A, Lyden E, Ripa T.  Is penicillin necessary in the treatment of acute otitis media?  In: Proceedings of the International Conference on Acute and Secretory Otitis Media . Amsterdam, the Netherlands: Kugler Publications; 1986;:441-446.
17 +
Ostfeld E, Segal J, Kaufstein M, Gelernter I.  Management of acute otitis media without primary administration of systemic antimicrobial agents.  In: Proceedings of the Fourth International Symposium on Recent Advances in Otitis Media . Burlington, Ontario: BC Decker Inc; 1988;:235-239.
18 +
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.
19 +
Saah AJ, Blackwelder WC, Kaslow RA.  Treatment of acute otitis media. JAMA . 1982;;248:1071-1072.
20 +
Van Dishoeck HAE, Derks ACW, Voorhorst R.  Bacteriology and treatment of acute otitis in children. Acta Otolaryngol . 1959;;50:250-261.
21 +
Halsted C, Lepow ML, Balassanian N, Emmerich J, Wolinsky E.  Otitis media: clinical observations, microbiology and evaluations of therapy. AJDC . 1968;;115:542-551.
22 +
Laxdal OE, Merida J, Jones RHT.  Treatment of acute otitis media: a controlled study of 142 children. Can Med Assoc J . 1970;;102:263-268.
23 +
Howie VM, Ploussard JH.  Efficacy of fixed combination antibiotics versus separate components in otitis media. Clin Pediatr . 1972;;11:205-214.
24 +
Lorentzen P, Haugsten P.  Treatment of acute suppurative otitis media. J Laryngol Otol . 1977;;91:331-340.
25 +
Engelhard D, Strauss N, Jorczak-Sarni L, Cohen D, Sacks TG, Shapiro M.  Randomised study of myringotomy, amoxicillin/clavulanate, or both for acute otitis media in infants. Lancet . 1989;;2:141-143.
26 +
Kaieida PH, Casselbrant ML, Rockette HE, et al.  Amoxicillin or myringotomy or both for acute otitis media: results of a randomized clinical trial. Pediatrics . 1991;; 87:466-474.
27 +
Burke P, Bain J, Robinson D, Dunleavey J.  Acute red ear in children: controlled trial of non-antibiotic treatment in general practice. BMJ . 1991;;303:558-562.

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