RISK OF MASTOIDITIS IN TYPICAL OTITIS MEDIA NOT MANAGED BY ANTIBIOTICS
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111 MANAGEMENT OF ACUTE OTITIS MEDIA SIR,-In their trial of four approaches to acute otitis media (AOM) van Buchem et all cite the study by Laxdal et al. but do not mention that there was a significant difference in failure rate between the children treated symptomatically and children treated with ampicillin. The failure rate for children under 6 years of age treated without antibiotics was over 40%, whereas it was about 10% for those given ampicillin. Randomisation was done by the otolaryngologist who confirmed the diagnosis. Did he use a table of random numbers? If not, there could have been bias. The otolaryngologist is said to have been unaware of the treatment status of the child, at follow-up, but, unless another otolaryngologist was involved, how can he have been blind? He was the one who confirmed the diagnosis and randomised the child to treatment or placebo. The antibiotic was amoxycillin at a uniform dose for all age groups for 7 days only. Treatment with antibiotics should be on a weight basis and most authorities recommend 10-14 days of treatment for AOM. What is the incidence of resistant Haemophilus influenzae in the Tilburg area? In some communities resistance to amoxycillin is so common that this antibiotic is no longer the drug of choice for AOM. The lowest temperature and the earliest period of time of defervescence was for the group of children treated with antibiotics. If the 4 children excluded because of contralateral otitis media (all from the non-antibiotic group) and the 4 children who still had purulent drainage at 14 days (all from the non-antibiotic group) are added to the "irregular course group" of 4 children who still had fever after 3 or 4 days (none from the antibiotic plus myringotomy group) you have 12 children out of 76 who had problems without antibiotics. This is not a favourable outcome. Of the 95 antibiotic treated group none had to be excluded because of contralateral otitis media, none had drainage at 14 days, and none had persistent fever and malaise. For these figures X is 13 - 36 (p<0 0000. ). My reading of van Buchem’s paper leads me to a completely different conclusion-namely, that antibiotics are significantly superior to non-antibiotic treatment in AOM. Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada L8N 3Z5 WILLIAM FELDMAN RISK OF MASTOIDITIS IN TYPICAL OTITIS MEDIA NOT MANAGED BY ANTIBIOTICS SIR,-van Buchem et al .,3 in their study on the treatment of acute otitis media (AOM), conclude that there was no significant difference in clinical course or complications among patients treated with neither antibiotics nor myringotomy, by myringotomy only, with antibiotics only, or with both antibiotics and myringotomy..Myringotomy and antibiotics, they suggest, could be reserved for "irregular" cases of otitis media, for cases with mastoiditis or continued otorrhoea. Discussing a possible objection to this strategy-namely, that it might increase the incidence of mastoiditis-they dismiss this objection because three studies in the antibiotic era4-6 reported that the incidence of mastoiditis in AOM patients treated without antibiotics was 0-2-2°70. Diamant and Diamant acknowledge that their study was retrospective and that the patient denominator was incompletely defined. The number of patients given antibiotics before referral to the ear-nose-and-throat hospital is unknown. Thus, their 0-2% estimate for mastoiditis complicating AOM must be on the low side. 1. van Buchem FL, Dunk JHM, van’t Hof MA Therapy of acute otitis media. myringotomy, antibiotics, or neither? Lancet 1981, ii: 883-87. 2. Laxdal OE, Merida J, Trefor Jones RH. Treatment of acute otitis media: a controlled study of 142 children Can Med Assoc J 1970, 102: 263-68. 3. van Buchem FL, Dunk JHM, van’t Hof MA. Therapy of acute otitis media: Myringotomy, antibiotics, or neither? Lancet 1981; ii: 883-87. 4. Diamant M, Diamant B. Abuse and timing of use of antibiotics in acute otitis media. Arch Otolaryngol 1974, 100: 226-32. 5. Medical Research Council. Acute otitis media in general practice. Lancet; ii: 510-14. 6 Roelink H. Acute middenoorontsteking in de algemene praktijk Thesis, Nijmegen, 1965. The Diamants refer to a study by Hamberger who found that 5% of sulphonamide-treated AOM patients and 20% of untreated patients required mastoidectomy. Furthermore, a personal communication by G. F. Abercrombie, mentioned in the Medical Research Council report,5 indicates that, in 1937, 10% of 86 patients with one hundred and fifty AOM attacks were operated on for acute mastoiditis. Two reports not referred to by van Buchem et al. provide information on the incidence of acute mastoiditis during the pre-antibiotic era. In one series 6-1% of 6198 patients with purulent otitis media acquired acute mastoiditis and in another 16 cases of mastoiditis (2-7%) were recorded among 588 patients with AOM not treated with antibiotics. The true incidence of mastoiditis complicating AOM not treated with antibiotics is thus of the order of 5-1007o. The 95% confidence interval for a single observation, such as presence or absence of mastoiditis, in a group of given sample size with no observed complications can be calculated. 10 For the 40 no-treatment patients in van Buchem’s series the 95% confidence interval for the 0% observed mastoiditis rate is 0-7-2% and for the 36 managed by myringotomy only the 95% confidence interval for the 0% observed mastoiditis rate is 0-8%. Mastoiditis complication rates as high as 8% as would be unacceptable to most clinicians. Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, Minnesota 55455, U.S.A. University of Minnesota School of Public Health G. SCOTT GIEBINK CHAP T. LE SERUM CHOLESTEROL AND ISCHAEMIC HEART DISEASE SIR,-Professor Oliver’s review entitled Serum Cholesterol: The Knave of Hearts and the Joker (Nov. 14, p. 1090) discussed the dietary trial carried out by our research team. L2 However, Oliver’s paper contains some misunderstandings. Referring to our study, Oliver states (p. 1092): "Three criteria of different specificity and sensitivity were used to evaluate IHD events. Unfortunately, these were not clearly defined but are described as ’occurrence of coronary deaths’, ’appearance of a major ECG pattern or occurrence of coronary death’, and ’appearance of an intermediate ECG pattern or occurrence of coronary death’." .* Fortunately, our criteria were much better defined than that. In the methodological part of our paper we described (p. 105) our criteria for coronary death and the electrocardiographic patterns (Minnesota code 3) which were regarded as being indicative of IHD: major patterns I l, I 2, VI 1, VII 1; intermediate patterns IV 1, V 1, V 2; and minor patterns I 3, IV 2, IV 3, V 3. Of these patterns, the major and the intermediate ones were used as end-points, whereas the minor patterns were used only as a ground for the initial exclusion of subjects from the final study group. Our criteria were, we feel, very clearly defined. The designation of the third criterion as given in Oliver’s survey also needs correction. It should read as follows: "appearance of an intermediate or major ECG pattern or occurrence of coronary death". Department of Biochemistry, College of Veterinary Medicine, 00550 Helsinki 55, Finland; and institute of Occupational Health, Helsinki OSMO TURPEINEN MARTTI J. KARVONEN MATTI MIETTINEN 7 Hamberger CA Uber die behandlung der otitis media acuta und gewisser otogener komplikationen mit sulfonilamid-derivaten. Acta Otolaryngol 1942; 46 (suppl): 1-160. 8 Bakwin H, Jacobziner H. Prevention of purulent otitis media in infants J Pediatr 1939; 14: 730-36. 9 Heller G A statistical study of otitis media in children. II. The antibiotic era J Pediatr 1953; 42: 185-88. 8. Louis TA. Confidence intervals for a binomial parameter after observing no successes. Am Stat 1981; 35: 154. 1. Turpeinen O, Karvonen MJ, Pekkarinen M, Miettinen M, Elosuo R, Paavilainen E. Dietary prevention of coronary heart disease The Finnish mental hospital study. Int J Epidemiol 1979; 8: 99-118 2. Miettinen M, Turpeinen O. Karvonen MJ, Elosuo R, Paavilainen E. Effect of cholesterol-lowering diet on mortality from coronary heart-disease and other causes: a twelve-year clinical trial in men and women Lancet 1972, ii: 835-38. 3. Blackburn H, Keys A, Simonson E, Rautaharju P, Punsar S. The electrocardiogram in population studies a classification system Circulation 1960, 21: 1160-75
Transcript of RISK OF MASTOIDITIS IN TYPICAL OTITIS MEDIA NOT MANAGED BY ANTIBIOTICS
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MANAGEMENT OF ACUTE OTITIS MEDIA
SIR,-In their trial of four approaches to acute otitis media (AOM)van Buchem et all cite the study by Laxdal et al. but do notmention that there was a significant difference in failure rate
between the children treated symptomatically and children treatedwith ampicillin. The failure rate for children under 6 years of agetreated without antibiotics was over 40%, whereas it was about 10%for those given ampicillin.Randomisation was done by the otolaryngologist who confirmed
the diagnosis. Did he use a table of random numbers? If not, therecould have been bias. The otolaryngologist is said to have beenunaware of the treatment status of the child, at follow-up, but,unless another otolaryngologist was involved, how can he have beenblind? He was the one who confirmed the diagnosis and randomisedthe child to treatment or placebo.The antibiotic was amoxycillin at a uniform dose for all age
groups for 7 days only. Treatment with antibiotics should be on aweight basis and most authorities recommend 10-14 days oftreatment for AOM. What is the incidence of resistant Haemophilusinfluenzae in the Tilburg area? In some communities resistance toamoxycillin is so common that this antibiotic is no longer the drug ofchoice for AOM.The lowest temperature and the earliest period of time of
defervescence was for the group of children treated with antibiotics.If the 4 children excluded because of contralateral otitis media (all
from the non-antibiotic group) and the 4 children who still hadpurulent drainage at 14 days (all from the non-antibiotic group) areadded to the "irregular course group" of 4 children who still hadfever after 3 or 4 days (none from the antibiotic plus myringotomygroup) you have 12 children out of 76 who had problems withoutantibiotics. This is not a favourable outcome. Of the 95 antibiotictreated group none had to be excluded because of contralateral otitismedia, none had drainage at 14 days, and none had persistent feverand malaise. For these figures X is 13 - 36 (p<0 0000. ).My reading of van Buchem’s paper leads me to a completely
different conclusion-namely, that antibiotics are significantlysuperior to non-antibiotic treatment in AOM.Department of Pediatrics,McMaster University,Hamilton, Ontario, Canada L8N 3Z5 WILLIAM FELDMAN
RISK OF MASTOIDITIS IN TYPICAL OTITIS MEDIANOT MANAGED BY ANTIBIOTICS
SIR,-van Buchem et al .,3 in their study on the treatment of acuteotitis media (AOM), conclude that there was no significantdifference in clinical course or complications among patientstreated with neither antibiotics nor myringotomy, by myringotomyonly, with antibiotics only, or with both antibiotics and
myringotomy..Myringotomy and antibiotics, they suggest, could bereserved for "irregular" cases of otitis media, for cases withmastoiditis or continued otorrhoea. Discussing a possible objectionto this strategy-namely, that it might increase the incidence ofmastoiditis-they dismiss this objection because three studies in theantibiotic era4-6 reported that the incidence of mastoiditis in AOMpatients treated without antibiotics was 0-2-2°70.Diamant and Diamant acknowledge that their study was
retrospective and that the patient denominator was incompletelydefined. The number of patients given antibiotics before referral tothe ear-nose-and-throat hospital is unknown. Thus, their 0-2%estimate for mastoiditis complicating AOM must be on the low side.
1. van Buchem FL, Dunk JHM, van’t Hof MA Therapy of acute otitis media.
myringotomy, antibiotics, or neither? Lancet 1981, ii: 883-87.2. Laxdal OE, Merida J, Trefor Jones RH. Treatment of acute otitis media: a controlled
study of 142 children Can Med Assoc J 1970, 102: 263-68.3. van Buchem FL, Dunk JHM, van’t Hof MA. Therapy of acute otitis media:
Myringotomy, antibiotics, or neither? Lancet 1981; ii: 883-87.4. Diamant M, Diamant B. Abuse and timing of use of antibiotics in acute otitis media.
Arch Otolaryngol 1974, 100: 226-32.5. Medical Research Council. Acute otitis media in general practice. Lancet; ii: 510-14.6 Roelink H. Acute middenoorontsteking in de algemene praktijk Thesis, Nijmegen,
1965.
The Diamants refer to a study by Hamberger who found that 5% ofsulphonamide-treated AOM patients and 20% of untreated patientsrequired mastoidectomy. Furthermore, a personal communicationby G. F. Abercrombie, mentioned in the Medical Research Councilreport,5 indicates that, in 1937, 10% of 86 patients with onehundred and fifty AOM attacks were operated on for acutemastoiditis. Two reports not referred to by van Buchem et al.
provide information on the incidence of acute mastoiditis during thepre-antibiotic era. In one series 6-1% of 6198 patients withpurulent otitis media acquired acute mastoiditis and in another 16cases of mastoiditis (2-7%) were recorded among 588 patients withAOM not treated with antibiotics.The true incidence of mastoiditis complicating AOM not treated
with antibiotics is thus of the order of 5-1007o. The 95% confidenceinterval for a single observation, such as presence or absence ofmastoiditis, in a group of given sample size with no observedcomplications can be calculated. 10 For the 40 no-treatment patientsin van Buchem’s series the 95% confidence interval for the 0%observed mastoiditis rate is 0-7-2% and for the 36 managed bymyringotomy only the 95% confidence interval for the 0% observedmastoiditis rate is 0-8%. Mastoiditis complication rates as high as8% as would be unacceptable to most clinicians.
Department of Pediatrics,University of Minnesota School of Medicine,Minneapolis, Minnesota 55455, U.S.A.
University of Minnesota School of Public Health
G. SCOTT GIEBINK
CHAP T. LE
SERUM CHOLESTEROL AND ISCHAEMIC HEARTDISEASE
SIR,-Professor Oliver’s review entitled Serum Cholesterol: TheKnave of Hearts and the Joker (Nov. 14, p. 1090) discussed thedietary trial carried out by our research team. L2 However, Oliver’spaper contains some misunderstandings.Referring to our study, Oliver states (p. 1092): "Three criteria of
different specificity and sensitivity were used to evaluate IHDevents. Unfortunately, these were not clearly defined but are
described as ’occurrence of coronary deaths’, ’appearance of a majorECG pattern or occurrence of coronary death’, and ’appearance ofan intermediate ECG pattern or occurrence of coronary death’." .*
Fortunately, our criteria were much better defined than that. In themethodological part of our paper we described (p. 105) our criteriafor coronary death and the electrocardiographic patterns(Minnesota code 3) which were regarded as being indicative of IHD:major patterns I l, I 2, VI 1, VII 1; intermediate patterns IV 1, V 1, V2; and minor patterns I 3, IV 2, IV 3, V 3. Of these patterns, themajor and the intermediate ones were used as end-points, whereasthe minor patterns were used only as a ground for the initialexclusion of subjects from the final study group. Our criteria were,we feel, very clearly defined.The designation of the third criterion as given in Oliver’s survey
also needs correction. It should read as follows: "appearance of anintermediate or major ECG pattern or occurrence of coronarydeath".
Department of Biochemistry,College of Veterinary Medicine,00550 Helsinki 55, Finland;and institute of Occupational Health,
Helsinki
OSMO TURPEINENMARTTI J. KARVONEN
MATTI MIETTINEN
7 Hamberger CA Uber die behandlung der otitis media acuta und gewisser otogenerkomplikationen mit sulfonilamid-derivaten. Acta Otolaryngol 1942; 46 (suppl):1-160.
8 Bakwin H, Jacobziner H. Prevention of purulent otitis media in infants J Pediatr 1939;14: 730-36.
9 Heller G A statistical study of otitis media in children. II. The antibiotic era J Pediatr1953; 42: 185-88.
8. Louis TA. Confidence intervals for a binomial parameter after observing no successes.Am Stat 1981; 35: 154.
1. Turpeinen O, Karvonen MJ, Pekkarinen M, Miettinen M, Elosuo R, Paavilainen E.Dietary prevention of coronary heart disease The Finnish mental hospital study. IntJ Epidemiol 1979; 8: 99-118
2. Miettinen M, Turpeinen O. Karvonen MJ, Elosuo R, Paavilainen E. Effect of
cholesterol-lowering diet on mortality from coronary heart-disease and other causes:a twelve-year clinical trial in men and women Lancet 1972, ii: 835-38.
3. Blackburn H, Keys A, Simonson E, Rautaharju P, Punsar S. The electrocardiogram inpopulation studies a classification system Circulation 1960, 21: 1160-75
