randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen...

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3. Van Woensel JB, van Aalderen WM. Treatment for bronchiolitis: the story continues. Lancet 2002;360:101-2. 4. Nelson R. Bronchiolitis drugs lack convincing evidence of efficacy. Lancet 2003;361:939. 5. Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL. Systemic corticosteroids in infant bronchiolitis: a meta-analysis. Pediatrics 2000;105:e44. 6. Goebel J, Estrada B, Quinonez J, Nagji N, Sanford D, Boerth RC. Prednisolone plus albuterol versus albuterol alone in mild to moderate bronchiolitis. Clin Pediatr 2000;39:213-20. 7. Schuh S, Coates AL, Binnie R, Allin T, Goia C, Corey M, et al. Efficacy of oral dexamethasone in outpatients with acute bronchiolitis. J Pediatr 2002;140:27-32. Evidence assessment of the accuracy of methods of diagnosing middle ear effusion in children with otitis media with effusion Takata GS, Chan LS, Morphew T, Mangione-Smith R, Morton SC, Shekelle P. Pediatrics 2003;112:1379-87 Context Recommendations for diagnosing otitis media with effusion (OME) have largely been based on limited evidence and expert opinion. Objective To assess the accuracy of methods of diagnosing middle ear effusion in children with OME. Design Systematic review of diagnostic studies. Study identification The authors searched Medline (1966- January 2000), the Cochrane Library (through January 2000), and Embase (1980-January 2000) and identified additional articles from reference lists in proceedings, published articles, reports, and guidelines. Study selection 52 studies of varying quality were selected for analysis. Results Among 8 diagnostic methods, pneumatic otoscopy had the best apparent performance with a sensitivity of 94% (95% CI, 92-96) and a specificity of 80% (95% CI, 75-86), with corresponding likelihood ratios of 4.7 for a positive test and 0.08 for a negative test. However, examiner qualifications were reported inconsistently, and training was not specified. Conclusions Pneumatic otoscopy was found to do as well as or better than tympanometry and acoustic reflectometry. Comment Takata and colleagues conducted a detailed assessment of the evidence for various diagnostic methods of identifying otitis media with effusion (OME) in children 12 years of age and younger. They established reasonable criteria to both conduct a literature search (through January 2000) and assess study quality. Fifty-two studies (1% of 4879 initial titles and abstracts) were ultimately selected for final assess- ment. Comparisons with three or more studies were subjected to meta-analyses. The authors did not assess combined diagnostic methods or algorithms. No study was excluded, however, on the basis of study quality. It would have been interesting to also have seen the data when studies deemed to have been of poor quality, relative to this analysis, were excluded. In the pneumatic otoscopy comparison, five of the seven studies were considered to have been of adequate to high quality. The authors concluded that pneumatic otoscopy and professional tympanometry had the highest pooled sensitivity, compared with myringotomy, the ‘‘gold standard.’’ Pneumatic otoscopy optimized both pooled sensitivity (94%) and speci- ficity (80%). Additional information on the assessment of each of the various diagnostic methods by age of the child would have been useful because otitis media occurs most frequently in infants and younger children. Moreover, the difficulty of accurately performing and interpreting these diagnostic modalities in- creases in very young age groups. Age distributions could not provided, however, due to limitations of the available data. In addition, specific data were not available regarding the degree of expertise of the otoscopists in each of the selected studies. One wonders how representative their skills are compared with those of pediatric practitioners. This report raises a number of other challenging questions. How much training will be required to achieve such a degree of otoscopic proficiency? How best can this training be provided? What level of otoscopic proficiency should be considered to be satisfactory at the end of a formal training process? The authors are to be commended for undertaking this prodigious study. Their report provides support for the recom- mendations, based at the time on limited scientific evidence and strong panel consensus, of the 1994 AHCPR (now AHRQ) OME Guideline promoting the use of pneumatic otoscopy. In skilled hands, pneumatic otoscopy provides a powerful and relatively inexpensive diagnostic modality. Phillip H. Kaleida, MD Professor of Pediatrics, Division of General Academic Pediatrics Children’s Hospital of Pittsburgh Pittsburgh, PA 15213-2583 Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children Whatley VN, Dodds CL, Paul RI. Arch Pediatr Adolesc Med 2003;157:1177-80 Context The efficacy of the variety of ceruminolytic agents used in clinical practice in children is not very well studied. Objectives To evaluate the efficacy of triethanolamine polypeptide and docusate as ceruminolytic agents in children with cerumen impaction. Design Randomized controlled trial. Setting Urban tertiary care children’s hospital emergency department and general pediatric clinic. Participants 92 children aged 6 months to 5 years who presented as a convenience sample to either of the study sites with cerumen impaction. 138 Clinical Research Abstracts for Pediatricians The Journal of Pediatrics July 2004

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Page 1: Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children

3. Van Woensel JB, van Aalderen WM. Treatment for bronchiolitis: the

story continues. Lancet 2002;360:101-2.

4. Nelson R. Bronchiolitis drugs lack convincing evidence of efficacy. Lancet

2003;361:939.

5. Garrison MM, Christakis DA, Harvey E, Cummings P, Davis RL.

Systemic corticosteroids in infant bronchiolitis: a meta-analysis. Pediatrics

2000;105:e44.

6. Goebel J, Estrada B, Quinonez J, Nagji N, Sanford D, Boerth RC.

Prednisolone plus albuterol versus albuterol alone in mild to moderate

bronchiolitis. Clin Pediatr 2000;39:213-20.

7. Schuh S, Coates AL, Binnie R, Allin T, Goia C, Corey M, et al. Efficacy

of oral dexamethasone in outpatients with acute bronchiolitis. J Pediatr

2002;140:27-32.

Evidence assessment of the accuracy of methodsof diagnosing middle ear effusion in childrenwith otitis media with effusion

TakataGS,Chan LS,MorphewT,Mangione-Smith R,Morton SC, Shekelle P.

Pediatrics 2003;112:1379-87

Context Recommendations for diagnosing otitis media with

effusion (OME) have largely been based on limited evidence

and expert opinion.

Objective To assess the accuracy of methods of diagnosing

middle ear effusion in children with OME.

Design Systematic review of diagnostic studies.

Study identification The authors searched Medline (1966-

January 2000), the Cochrane Library (through January 2000),

and Embase (1980-January 2000) and identified additional

articles from reference lists in proceedings, published articles,

reports, and guidelines.

Study selection 52 studies of varying quality were selected

for analysis.

Results Among 8 diagnostic methods, pneumatic otoscopy

had the best apparent performance with a sensitivity of 94%

(95% CI, 92-96) and a specificity of 80% (95% CI, 75-86), with

corresponding likelihood ratios of 4.7 for a positive test and

0.08 for a negative test. However, examiner qualifications were

reported inconsistently, and training was not specified.

Conclusions Pneumatic otoscopy was found to do as well as

or better than tympanometry and acoustic reflectometry.

Comment Takata and colleagues conducted a detailed

assessment of the evidence for various diagnostic methods of

identifying otitis media with effusion (OME) in children 12

years of age and younger. They established reasonable criteria

to both conduct a literature search (through January 2000)

and assess study quality. Fifty-two studies (1% of 4879 initial

titles and abstracts) were ultimately selected for final assess-

ment. Comparisons with three or more studies were subjected

to meta-analyses. The authors did not assess combined

diagnostic methods or algorithms. No study was excluded,

however, on the basis of study quality. It would have been

interesting to also have seen the data when studies deemed to

have been of poor quality, relative to this analysis, were

excluded. In the pneumatic otoscopy comparison, five of the

seven studies were considered to have been of adequate to high

quality. The authors concluded that pneumatic otoscopy and

professional tympanometry had the highest pooled sensitivity,

compared with myringotomy, the ‘‘gold standard.’’ Pneumatic

otoscopy optimized both pooled sensitivity (94%) and speci-

ficity (80%).

Additional information on the assessment of each of the

various diagnostic methods by age of the child would have been

useful because otitis media occurs most frequently in infants

and younger children. Moreover, the difficulty of accurately

performing and interpreting these diagnostic modalities in-

creases in very young age groups. Age distributions could not

provided, however, due to limitations of the available data. In

addition, specific data were not available regarding the degree

of expertise of the otoscopists in each of the selected studies.

One wonders how representative their skills are compared

with those of pediatric practitioners. This report raises

a number of other challenging questions. How much training

will be required to achieve such a degree of otoscopic

proficiency? How best can this training be provided? What

level of otoscopic proficiency should be considered to be

satisfactory at the end of a formal training process?

The authors are to be commended for undertaking this

prodigious study. Their report provides support for the recom-

mendations, based at the time on limited scientific evidence

and strong panel consensus, of the 1994 AHCPR (now AHRQ)

OME Guideline promoting the use of pneumatic otoscopy. In

skilled hands, pneumatic otoscopy provides a powerful and

relatively inexpensive diagnostic modality.

Phillip H. Kaleida, MDProfessor of Pediatrics, Division of General Academic Pediatrics

Children’s Hospital of PittsburghPittsburgh, PA 15213-2583

138 Clinical Research Abstracts for Pediatricians

Randomized clinical trial of docusate,triethanolamine polypeptide, and irrigation incerumen removal in children

Whatley VN, Dodds CL, Paul RI. Arch Pediatr Adolesc Med

2003;157:1177-80

Context The efficacy of the variety of ceruminolytic agents

used in clinical practice in children is not very well studied.

Objectives To evaluate the efficacy of triethanolamine

polypeptide and docusate as ceruminolytic agents in children

with cerumen impaction.

Design Randomized controlled trial.

Setting Urban tertiary care children’s hospital emergency

department and general pediatric clinic.

Participants 92 children aged 6 months to 5 years who

presented as a convenience sample to either of the study sites

with cerumen impaction.

The Journal of Pediatrics � July 2004

Page 2: Randomized clinical trial of docusate, triethanolamine polypeptide, and irrigation in cerumen removal in children

ALSO NOTED

Valvular dysfunction and carotid, subclavian, andcoronary artery disease in survivors of Hodgkinlymphoma treated with radiation therapy

Hull MC, Morris CG, Pepine CJ, Mendenhall NP. JAMA 2003;290:2831-7

This is an important study of survivors of Hodgkin’s

lymphoma designed to estimate the incidence and risk factors

for three potential radiation treatment-related complications:

coronary and noncoronary atherosclerotic vascular disease

and clinically important valvular disease. The authors docu-

ment a high rate of valve surgery (observed:expected ratio

8.42; 95% CI, 3.20-13.65) and coronary revascularization

procedures (1.63; 95% CI, 0.98-2.28) 10 to 20 years after the

radiation treatments. The coronary disease seems to be

associated with the radiation dose received and other

traditional coronary disease risk factors.

Intervention Children were computer randomized to receive

1-mL instillation of triethanolamine polypeptide, docusate, or

saline placebo. The study drug was left in place for 15 minutes,

then flushed with a standardized amount and technique of

warm tap water up to two times.

Main outcome measures Percentage of children in each

group that had complete visualization of the tympanic

membrane (light reflex, ossicles, and mobility).

Results Groups were similar in age, race, sex, ear enrolled,

wax consistency, and degree of obstruction. There was no

statistical difference in the percentage of children who had

complete resolution of cerumen impaction (docusate 53%,

triethanolamine polypeptide 43%, and placebo 68%).

Conclusion There was no difference between either of the

two drugs used or placebo in alleviating cerumen impaction in

children.

Comment Earache is the fourth most common complaint of

children who present to a pediatrician. The diagnosis of the

various ear disorders requires careful history and examination

of the ear canal and tympanic membrane. All too often, the

pediatrician is frustrated by the inability to adequately

examine the ear due to cerumen impaction. There are several

studies of the agents used commonly in practice to alleviate

cerumen obstruction,1-6 but they include very few children.

There is even a meta-analysis on the topic7 that shows

heterogeneous effects based on the studies of low quality that

existed before this study.

This study sought to identify any differences in efficacy of

the most commonly used agents, docusate, and

triethanolamine polypeptide (Cerumenex). Their study design

was sound, but found no difference between the two drugs

studied, and even had a trend toward the saline control being

more effective. Unfortunately, it was relatively underpowered

with an 80% chance of finding a 40% difference between groups.

Perhaps pediatricians would be happy deciding between the

two alternatives if only a 10% to 20% difference existed.

Detecting this difference would have required a much larger

sample size to achieve (>300 in each group). In the meantime,

pediatricians are left with their clinical judgment and

Clinical Research Abstracts for Pediatricians

experience in selecting from the variety of agents and

procedures to clear ear wax for a good view.

Brett Robbins, MDUniversity of RochesterRochester, NY 14620

REFERENCES1. Jaffe G, Grimshaw J. A multicentric clinical trial comparing Otocerol�with Cerumol� as cerumenolytics. J Int Med Res 1978;6:241-4.

2. Fahmy S, Whitefield M. Multicentre clinical trial of Exterol� as

a cerumenolytic. Br J Clin Pract 1982;36:197-204.

3. Keane EM, Wilson H, McGrane D, Coakley D, Walsh JB. Use of

solvents to disperse ear wax. Br J Clin Pract 1995;49:7-12.

4. Lyndon S, Roy P, Grillage MG, Miller AJ. A comparison of the efficacy

of two ear drop preparations (Audax� and Earex�) in the softening and

removal of impacted ear wax. Curr Med Res Opin 1992;13:21-5.

5. Meehan P, Isenhour JL, Reeves R, Wrenn K. Ceruminolysis in the

pediatric patient: a prospective, double-blinded, randomized controlled trial.

Acad Emerg Med 2002;9:521-2.

6. Singer AJ, Sauris E, Viccellio AW. Ceruminolytic effects of docusate

sodium: a randomized, controlled trial. Ann Emerg Med 2000;36:228-32.

7. Burton MJ, Doree CJ. Ear drops for the removal of ear wax. The

Cochrane Database of Systematic Reviews. Vol 1, 2003.

139