Tagged: RCT

Study on Possible Data Fabrication in Numerous Randomized Controlled Trials Casts Shade of Doubt on Highly Cited Perio-Systemic Paper

In a recent analysis of thousands of randomized controlled trials (RCT) in eight journals a simple method was offered which might enable skeptical scientist identification of data fabrication. Editor of the Anaesthesia journal John B. Carlisle of Torbay Hospital, UK, looked at baseline differences of means in more than 5000 randomized controlled trials, mainly in the field of Anesthesiology, but also more than 500 published in JAMA and more than 900 published in the New England Journal of Medicine [1]. His study went online earlier this week. Analyzed articles were published between 2000 and 2015. In brief, if randomization was successful, baseline differences should be small. Giving p-values for baseline differences (in order to indicate successful randomization) is actually discouraged since they are not really interpretable, but Carlisle calculated them anyway. If the null hypothesis is true, p-values have a uniform distribution. So p-values between 0 and 1 would be equally likely.

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Possible Reporting Bias Leads to Downgrading of a Recent Adjunct Metronidazole Trial

Preus 2013

Concerns about increasing antibiotic resistance (e.g., methicillin-resistant Staphylococcus aureus, multidrug-resistant tuberculosis, antibiotic resistance of bacteria causing common infections of the urinary tract, pneumonia, or bloodstream infections), which jeopardizes effective prevention and treatment of life-threatening infections should be taken seriously when considering adjunct antibiotic therapy of periodontal diseases. After all, periodontal infections are not life-threatening diseases and can usually be controlled without adjunctive antibiotics. Apart from generalized severe cases, chronic periodontitis should not be treated in the first place with adjunct systemic antibiotics. In cases of aggressive or refractory periodontitis, microbiological diagnosis may allow targeting specific pathogens such as Aggregatibacter actinomycetemcomitans or Porphyromonas gingivalis. Responsible use of antibiotics takes into account the possible development of bacterial resistance, antibiotic toxicity and the risk of sensitizing.

Moreover, reducing the need for periodontal surgery by adjunct antibiotics may be short-sighted (note that I had written about this on several occasions here on this blog). Anatomical defects such as furcation involvement and infrabony lesions, which are the main indications for periodontal surgery, won’t resolve after subgingival scaling and adjunct antibiotic treatment. In light of the global problem of antibiotic resistance, any recommendation for repeat courses of antibiotic therapy to reduce the need for minor surgical intervention in a not life-threatening disease should be considered inappropriate.

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