Meta‐Analysis of Antibiotics for the Treatment of Otitis Media with Effusion

Rm, Rosenfeld; Jc, Post

doi:10.1177/019459989210600411

Cited by 126 publications

(60 citation statements)

References 34 publications

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“…That same analysis also showed that one can always selectively choose from the published RCTs to argue for drug efficacy. To reach a conclusion of efficacy, however, one has to exclude the two best RCTs with the largest study populations, an exclusion which cannot be ethically justified [72]. In addition to this primary RCT data, which clearly shows that antibiotics are not effective for OME, there are 6 different meta-analyses, more or less based on this dataset [71][72][73][74][75][76].…”

Section: Antibiotics For Omementioning

confidence: 99%

“…In addition to this primary RCT data, which clearly shows that antibiotics are not effective for OME, there are 6 different meta-analyses, more or less based on this dataset [71][72][73][74][75][76]. The results of those analyses range from Rosenfeld and Post [72] in 1992, claiming 23% efficacy and recommending mandatory antibiotic therapy for OME, to a Bailar [75] article in 1995 with 'nil' efficacy and which cites the article by Rosenfeld and Post [72] as an example of a seriously misleading meta-analysis.…”

Section: Antibiotics For Omementioning

confidence: 99%

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Aggressive and Ineffective Therapy for Otitis media

Cantekin¹

1998

Otorhinolaryngol Nova

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Objective: The standard American clinical practice for the management of acute otitis media (AOM), otitis media with effusion (OME), and recurrent otitis media (ROM) calls for repeated courses of wide-spectrum antibiotic therapy including extended duration antibiotic prophylaxis, followed by surgical insertion of typanostomy tubes with or without adenoidectomy. This is an attempt to assemble the scientific evidence to justify this practice. Methods: A systematic review of the literature involving clinical studies, randomized clinical trials (RCTs), and meta-analyses to summarize the existing database. Results: For the efficacy of antibiotics for AOM, only 3 of the 13 clinical studies and RCTs had positive results with marginal benefits. Among the 16 RCTs on the effectiveness of antibiotics for OME involving 2,067 children, 8 RCTs with placebo controls had pooled average antibiotic efficacy of 4% or less. Pooled data from 13 RCTs on antibiotic prophylaxis, ranging in duration 1 week to 2 years, for ROM provided no significant clinical prevention (less than 0.4 episodes per year). The surgery, based on the outcome of 22 RCTs, is not shown to be effective with the exception of extreme disease cases. In fact, it is estimated that over 90% of surgical cases for otitis media in the US are unnecessary. Conclusions: A scientific database is lacking to support the present American clinical practice of aggressive interventions. It is not an evidence-based medical practice that yields patient benefits. Rather, it is an unnecessary intervention with compelling adverse effects to the patient and the community.

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Section: Antibiotics For Omementioning

confidence: 99%

Section: Antibiotics For Omementioning

confidence: 99%

Aggressive and Ineffective Therapy for Otitis media

Cantekin¹

1998

Otorhinolaryngol Nova

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“…In 1991, two placebo-controlled RCTs were published, reporting the ineffectiveness of frequently used antibiotics (amoxicillin, pediazole and ceclor) for otitis media Rosenfeld and Post [8] Antibiotics Are Not Effective for Otitis media with Effusion: Reanalysis of Meta-Analyses Otorhinolaryngol Nova 1998;8:214-222 [10] 1993 1,080 0.12 0.02, 0.22 AHCPR Clinical Practice Guideline for OME, 1994 Hasselblad, in Stool et al [10] 1993 817 0.22 0.08, 0.36 AHCPR Cliical Practice Guideline for OME, 1994 Williams et al [9] 1993 1,697 0.16 0.03, 0.29 published in JAMA, simultaneously reviewed with Cantekin and McGuire 1992 Cantekin [2] 1994 1,028 0.03 JAMA letter, published after a long delay and substantial revisions Bailar [11] 1995 1,738 nil adopted from Cantekin with effusion (OME; 'secretory' otitis, glue ear, persistent middle ear effusion) [6,7]. Those two RCTs, supported by NIH grants involving 828 children, might well have ended the debate on the use of antibiotics for this condition because of the demonstrated lack of efficacy and the high recurrence rates associated with antibiotic use.…”

Section: Introductionmentioning

confidence: 99%

“…Those two RCTs, supported by NIH grants involving 828 children, might well have ended the debate on the use of antibiotics for this condition because of the demonstrated lack of efficacy and the high recurrence rates associated with antibiotic use. The clear and compelling evidence about the lack of antibiotic effectiveness shown in these RCTs has been muddled with the publication of a meta-analysis by Rosenfeld and Post in 1992 [8]. Rosenfeld and Post reported a rate differential of 23% and argued that this result was so robust that antibiotic therapy for OME should be mandatory.…”

Section: Introductionmentioning

confidence: 99%

Antibiotics Are Not Effective for Otitis media with Effusion: Reanalysis of Meta-Analyses

Cantekin

McGuire

1998

Otorhinolaryngol Nova

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Objective: To determine the effectiveness of antibiotic therapy for otitis media with effusion (OME) and to examine the validity of meta-analysis for combining the results of published randomized controlled trials (RCTs) to reach generalized efficacy conclusions. Data Sources: English-language publications in refereed journals and proceedings published between 1980 and 1997, inclusive, producing 16 usable RCTs involving 2,067 children. Study Selection: RCTs evaluating the efficacy of antimicrobials for the treatment of OME with or without placebo controls. Data Synthesis: We used the technique of Der Simonian and Laird to determine heterogeneity and estimated the mean rate difference (RD). We also used weighted regression analysis to evaluate efficacy trends in light of changing quality of the included randomized trials, and sensitivity analysis to investigate the effects of quality differences among the clinical trials on estimated RDs. Results: The placebo-controlled trials had RDs significantly lower than non-placebo-controlled trials (RD of 0.04 vs. RD of 0.32; p < 0.001). When conventional techniques of meta-analysis were used for data synthesis, the presence of significant heterogeneity (p < 0.0001) precludes reaching any efficacy conclusions. Using weighted regression analysis to account for the effects of study quality on efficacy, we found that antimicrobial efficacy for OME is insignificant, less than 2% for an ideal clinical trial (p = 0.660). Conclusions: We conclude that meta-analysis as applied conventionally is inadequate to detect selection bias and is not useful for estimating true RDs when the results of the RCTs vary systematically with study quality. Our meta-analysis fails to support the continued use of antibiotics in the treatment of OME.

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“…Even though this technique is designed to reduce bias and subjectivity, often results and conclusions remain controversial and a source of confusion for the readers. As an example, a meta-analysis by Rosenfeld and Post [1] showed that antibiotics have a 'clinically and statistically significant impact on the resolution of otitis media with effusion'. However, a reanalysis of many of the same studies by Williams et al [2] brought somewhat different conclusions.…”

mentioning

confidence: 99%