Adenoidectomy versus chemoprophylaxis and placebo for recurrent acute otitis media in children aged under 2 years: randomised controlled tri
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《英国医生杂志》
1 University of Oulu, PO Box 5000, FIN-90014, Finland
Correspondence to: Petri Koivunen petri.koivunen@ppshp.fi
Abstract
About one third of all children experience recurrent episodes of acute otitis media.1-4 Although there are many preventive strategies, none seem to be indisputably effective.5-8 Adenoidectomy may benefit the middle ear by removing a source of infection from the nasopharynx5 and has been shown to be helpful in children over 4 years of age with chronic otitis media with effusion.9 10 In contrast, there is much less evidence of the efficacy of adenoidectomy in preventing recurrent episodes of acute otitis media. Paradise et al found that adenoidectomy, as the first surgical intervention, did not have a significant effect on recurrent episodes,11 but among children previously treated with tympanostomy tubes it reduced further attacks.12 Both of these trials involved children over 3 years of age, and there is virtually no empirical evidence on the effectiveness of adenoidectomy as the first surgical treatment in preventing recurrent acute otitis media in children aged under 2 years, who are clearly at the highest risk.
The short term objectives in otitis media prophylaxis are to reduce pain, fever, parental anxiety, and costs. With this in mind, we assessed the usefulness of adenoidectomy in preventing further acute episodes, relieving acute symptoms, and reducing the numbers of visits to a doctor because of any infection and prescriptions for antibiotics compared with chemoprophylaxis and placebo in a randomised controlled trial on children aged under 2 years with recurrent acute otitis media.
Methods
Follow up of participants—Altogether 180 children were randomly allocated to one of the treatment groups (table 1, fig 1). Children in the sulfafurazole and placebo groups discontinued intervention and received another prophylaxis more often than children in the adenoidectomy group (fig 1). Twelve children in the adenoidectomy group underwent concurrent tympanostomy because secretory middle ear fluid was found at the operation.
Table 1 Baseline characteristics of 180 children with recurrent acute otitis media randomised to receive adenoidectomy, sulfafurazole prophylaxis, or placebo. Figures are numbers of children unless stated otherwise
Outcome at six months—Intervention failed in 25 children in the adenoidectomy group (one drop out) and in 26 in the placebo group (13 drop outs) (difference in percentage failure 10%, 95% confidence interval -9% to 29%; protocol violations regarded as drop outs) (table 2). The figures when we counted protocol violation as failure were 26 in the adenoidectomy group (no drop outs) and 32 in the placebo group (seven drop outs) (15%, -3% to 33%) (table 2). Intervention failed in 17 children in the sulfafurazole group (14 drop outs), showing a 18% (-2% to 38%) decrease in risk compared with the placebo group. There were no significant differences between the groups in the time to intervention failure (fig 2). There were no significant differences between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection (table 3).
Table 2 Main outcome measures in children with recurrent acute otitis media randomised to receive adenoidectomy, sulfafurazole prophylaxis, or placebo
Fig 2 Cumulative occurrence of failures during two year follow up in 180 children, by treatment groups (adenoidectomy, chemoprophylaxis, placebo). Failure recorded if child had two episodes of acute otitis media within two months or three episodes within six months or middle ear effusion that persisted for two months. Protocol violations regarded as drop outs. No significant differences in time to failure between groups (P=0.22 at 6 months; P=0.28 at 24 months, log rank test)
Table 3 Secondary outcome measures in children with recurrent acute otitis media randomised to receive adenoidectomy, prophylaxis with sulfafurazole, or placebo*
Outcome at 24 months—At 24 months treatment failure was similar in the three groups (table 2). The number of children who needed tympanostomy tubes because of persistent middle ear fluid was somewhat lower in the adenoidectomy and sulfafurazole groups than in the placebo group (6, 6, and 11 children, respectively).
Adverse effects—There were no complications in the adenoidectomy procedures (no serious haemorrhage, fever, or persistent emesis). Five children in the sulfafurazole group (two had diarrhoea, two had skin rashes, one unknown) and two children in the placebo group (one had diarrhoea, one unknown) were reported to have adverse effects.
Compliance—The mean numbers of forgotten doses in the chemoprophylaxis and placebo groups during the six months were 4.5 (range 3-100) and 2.2 (1-17), respectively. This difference was due to one child who was given sulfafurazole irregularly.
Discussion
Sipil? M, Pukander J, Karma P. Incidence of acute otitis media up to the age of 1 1/2 years in urban infants. Acta Otolaryngol 1987;104: 138-45.
Teele DW, Klein JO, Rosner B, the Greater Boston Otitis Media Study Group. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. J Infect Dis 1989;160: 83-94.
Alho O-P. How common is recurrent acute otitis media? Acta Otolaryngol (Stockh) 1997;529: 8-10.
Lanphear BP, Byrd RS, Auinger P, Hall CB. Increasing prevalence of recurrent otitis media among children in the United States. Pediatrics 1997;99: e1-7.
Sade J, Luntz M. Adenoidectomy in otitis media—a review. Ann Otol Rhinol Laryngol 1991;100: 226-31.
Casselbrant ML, Kaleida PH, Rockette HE, Paradise JL, Bluestone CD, Kurs-Lasky M. 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: 278-86.
Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Pediatr Infect Dis J 1992;11: 270-7.
Williams RL, Chalmers TC, Stange KC, Chalmers FT, Bowlin SJ. Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion. A meta-analytic attempt to resolve the brouhaha. JAMA 1993;270: 1344-51.
Gates GA, Avery CA, Prihoda TJ, Cooper JC. Effectiveness of adenoidectomy and tympanostomy tubes in the treatment of chronic otitis media with effusion. New Engl J Med 1987;3: 1444-51.
Maw AR, Herod F. Otoscopic, impedance and audiometric findings in glue ear treated by adenoidectomy and tonsillectomy. Lancet 1986;1: 1399-402.
Paradise JL, Bluestone CD, Colborn DK, Bernard BS, Smith CG, Rockettte HE, et al. Adenoidectomy and adenotonsillectomy for recurrent acute otitis media. Parallel randomized clinical trials in children not previously treated with tympanostomy tubes. JAMA 1999;282: 945-53.
Paradise JL, Bluestone CD, Rogers KD, Taylor FH, Colborn DK, Bachman RZ, et al. Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement. Results of parallel randomized and nonrandomized trials. JAMA 1990;263: 2066-73.
Alho O-P, Koivunen P, Luotonen J. Diagnostic criteria for otitis media in children. Otorhinolaryngol Nova 1999;8: 123-8.
Alho O-P, L??r? E, Oja H. What is the natural history of recurrent acute otitis media in infancy? J Fam Pract 1996;43: 258-64.
Brown RA, Swanson Beck J. Medical statistics on personal computers. London: BMJ, 1994.
Gardner MJ, Altman DG. Statistics with confidence. London: BMJ Publishing, 1989.
Bluestone CD. Role of surgery in the era of resistant bacteria. Pediatr Infect Dis J 1998;17: 1090-8.
Mattila P, Joki-Erkkil? VP, Kilpi T, Jokinen J, Herva E, Puhakka H. Prevention of otitis media by adenoidectomy in children younger than 2 years. Arch Otolaryngol Head Neck Surg 2003;129: 163-8.
Coyte PC, Croxford R, McIsaac W, Feldman W, Friedberg J. The role of adjuvant adenoidectomy and tonsillectomy in the outcome of the insertion of tympanostomy tubes. N Engl J Med 2001;344: 1188-95.
Alho O-P, Koivu M, Sorri M, Rantakallio P. The occurrence of acute otitis media in infants—a life table analysis. Int J Pediatr Otorhinolaryngol 1991;21: 7-14.(Petri Koivunen, consultan)
Correspondence to: Petri Koivunen petri.koivunen@ppshp.fi
Abstract
About one third of all children experience recurrent episodes of acute otitis media.1-4 Although there are many preventive strategies, none seem to be indisputably effective.5-8 Adenoidectomy may benefit the middle ear by removing a source of infection from the nasopharynx5 and has been shown to be helpful in children over 4 years of age with chronic otitis media with effusion.9 10 In contrast, there is much less evidence of the efficacy of adenoidectomy in preventing recurrent episodes of acute otitis media. Paradise et al found that adenoidectomy, as the first surgical intervention, did not have a significant effect on recurrent episodes,11 but among children previously treated with tympanostomy tubes it reduced further attacks.12 Both of these trials involved children over 3 years of age, and there is virtually no empirical evidence on the effectiveness of adenoidectomy as the first surgical treatment in preventing recurrent acute otitis media in children aged under 2 years, who are clearly at the highest risk.
The short term objectives in otitis media prophylaxis are to reduce pain, fever, parental anxiety, and costs. With this in mind, we assessed the usefulness of adenoidectomy in preventing further acute episodes, relieving acute symptoms, and reducing the numbers of visits to a doctor because of any infection and prescriptions for antibiotics compared with chemoprophylaxis and placebo in a randomised controlled trial on children aged under 2 years with recurrent acute otitis media.
Methods
Follow up of participants—Altogether 180 children were randomly allocated to one of the treatment groups (table 1, fig 1). Children in the sulfafurazole and placebo groups discontinued intervention and received another prophylaxis more often than children in the adenoidectomy group (fig 1). Twelve children in the adenoidectomy group underwent concurrent tympanostomy because secretory middle ear fluid was found at the operation.
Table 1 Baseline characteristics of 180 children with recurrent acute otitis media randomised to receive adenoidectomy, sulfafurazole prophylaxis, or placebo. Figures are numbers of children unless stated otherwise
Outcome at six months—Intervention failed in 25 children in the adenoidectomy group (one drop out) and in 26 in the placebo group (13 drop outs) (difference in percentage failure 10%, 95% confidence interval -9% to 29%; protocol violations regarded as drop outs) (table 2). The figures when we counted protocol violation as failure were 26 in the adenoidectomy group (no drop outs) and 32 in the placebo group (seven drop outs) (15%, -3% to 33%) (table 2). Intervention failed in 17 children in the sulfafurazole group (14 drop outs), showing a 18% (-2% to 38%) decrease in risk compared with the placebo group. There were no significant differences between the groups in the time to intervention failure (fig 2). There were no significant differences between the groups in the numbers of episodes of acute otitis media, visits to a doctor, antibiotic prescriptions, and days with symptoms of respiratory infection (table 3).
Table 2 Main outcome measures in children with recurrent acute otitis media randomised to receive adenoidectomy, sulfafurazole prophylaxis, or placebo
Fig 2 Cumulative occurrence of failures during two year follow up in 180 children, by treatment groups (adenoidectomy, chemoprophylaxis, placebo). Failure recorded if child had two episodes of acute otitis media within two months or three episodes within six months or middle ear effusion that persisted for two months. Protocol violations regarded as drop outs. No significant differences in time to failure between groups (P=0.22 at 6 months; P=0.28 at 24 months, log rank test)
Table 3 Secondary outcome measures in children with recurrent acute otitis media randomised to receive adenoidectomy, prophylaxis with sulfafurazole, or placebo*
Outcome at 24 months—At 24 months treatment failure was similar in the three groups (table 2). The number of children who needed tympanostomy tubes because of persistent middle ear fluid was somewhat lower in the adenoidectomy and sulfafurazole groups than in the placebo group (6, 6, and 11 children, respectively).
Adverse effects—There were no complications in the adenoidectomy procedures (no serious haemorrhage, fever, or persistent emesis). Five children in the sulfafurazole group (two had diarrhoea, two had skin rashes, one unknown) and two children in the placebo group (one had diarrhoea, one unknown) were reported to have adverse effects.
Compliance—The mean numbers of forgotten doses in the chemoprophylaxis and placebo groups during the six months were 4.5 (range 3-100) and 2.2 (1-17), respectively. This difference was due to one child who was given sulfafurazole irregularly.
Discussion
Sipil? M, Pukander J, Karma P. Incidence of acute otitis media up to the age of 1 1/2 years in urban infants. Acta Otolaryngol 1987;104: 138-45.
Teele DW, Klein JO, Rosner B, the Greater Boston Otitis Media Study Group. Epidemiology of otitis media during the first seven years of life in children in greater Boston: a prospective, cohort study. J Infect Dis 1989;160: 83-94.
Alho O-P. How common is recurrent acute otitis media? Acta Otolaryngol (Stockh) 1997;529: 8-10.
Lanphear BP, Byrd RS, Auinger P, Hall CB. Increasing prevalence of recurrent otitis media among children in the United States. Pediatrics 1997;99: e1-7.
Sade J, Luntz M. Adenoidectomy in otitis media—a review. Ann Otol Rhinol Laryngol 1991;100: 226-31.
Casselbrant ML, Kaleida PH, Rockette HE, Paradise JL, Bluestone CD, Kurs-Lasky M. 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: 278-86.
Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion. Pediatr Infect Dis J 1992;11: 270-7.
Williams RL, Chalmers TC, Stange KC, Chalmers FT, Bowlin SJ. Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion. A meta-analytic attempt to resolve the brouhaha. JAMA 1993;270: 1344-51.
Gates GA, Avery CA, Prihoda TJ, Cooper JC. Effectiveness of adenoidectomy and tympanostomy tubes in the treatment of chronic otitis media with effusion. New Engl J Med 1987;3: 1444-51.
Maw AR, Herod F. Otoscopic, impedance and audiometric findings in glue ear treated by adenoidectomy and tonsillectomy. Lancet 1986;1: 1399-402.
Paradise JL, Bluestone CD, Colborn DK, Bernard BS, Smith CG, Rockettte HE, et al. Adenoidectomy and adenotonsillectomy for recurrent acute otitis media. Parallel randomized clinical trials in children not previously treated with tympanostomy tubes. JAMA 1999;282: 945-53.
Paradise JL, Bluestone CD, Rogers KD, Taylor FH, Colborn DK, Bachman RZ, et al. Efficacy of adenoidectomy for recurrent otitis media in children previously treated with tympanostomy-tube placement. Results of parallel randomized and nonrandomized trials. JAMA 1990;263: 2066-73.
Alho O-P, Koivunen P, Luotonen J. Diagnostic criteria for otitis media in children. Otorhinolaryngol Nova 1999;8: 123-8.
Alho O-P, L??r? E, Oja H. What is the natural history of recurrent acute otitis media in infancy? J Fam Pract 1996;43: 258-64.
Brown RA, Swanson Beck J. Medical statistics on personal computers. London: BMJ, 1994.
Gardner MJ, Altman DG. Statistics with confidence. London: BMJ Publishing, 1989.
Bluestone CD. Role of surgery in the era of resistant bacteria. Pediatr Infect Dis J 1998;17: 1090-8.
Mattila P, Joki-Erkkil? VP, Kilpi T, Jokinen J, Herva E, Puhakka H. Prevention of otitis media by adenoidectomy in children younger than 2 years. Arch Otolaryngol Head Neck Surg 2003;129: 163-8.
Coyte PC, Croxford R, McIsaac W, Feldman W, Friedberg J. The role of adjuvant adenoidectomy and tonsillectomy in the outcome of the insertion of tympanostomy tubes. N Engl J Med 2001;344: 1188-95.
Alho O-P, Koivu M, Sorri M, Rantakallio P. The occurrence of acute otitis media in infants—a life table analysis. Int J Pediatr Otorhinolaryngol 1991;21: 7-14.(Petri Koivunen, consultan)