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We thank Dr. Fares for his letter regarding the statistically significant increase in cancer risk, especially in males, with a dose-dependent effect that we observed among subgroup analyses in our study.[1] We agree that the multiple testing problem is fundamental in clinical trials. To control the experiment-wise error rate or maximum experiment experiment-wise error rate, an adjustment for multiple tests is required. If it is the aim to demonstrate the effects of a priori-defined subgroups on the basis of existing hypotheses, an adjustment for multiple testing should be performed. However, exploratory studies, in which data are collected with an objective without a prespecified key hypothesis, could be exempted from multiple test adjustments.[2, 3] Because exploratory studies usually need a flexible approach for design and analysis, the number of tests is frequently large, and the results should be considered hypothesis-generating rather than hypothesis-confirming. Given the exploratory nature of this study, multiple test adjustment is controversial. If readers are willing to know the result after multiplicity corrections, Bonferroni correction or the Holm-Bonferroni method[4] could be easily implemented. In addition, the subgroup analysis in our study was planned a priori because the subgroups according to sex, age, duration of follow-up, and specific cancer types were commonly used in the studies using standardized incidence ratios.[5] To the best of our knowledge, the results of this study represent the most complete documentation to date in evaluating cancer risk in patients treated with amiodarone. Nonetheless, we should emphasize again that, as an observational study, the results should be treated circumspectly.

CONFLICT OF INTEREST DISCLOSURES

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  2. CONFLICT OF INTEREST DISCLOSURES
  3. REFERENCES

The authors made no disclosures.

  • Vincent Yi-Fong Su, MD

  • Department of Chest MedicineTaipei Veterans General HospitalTaipei, Taiwan

  • Yu-Wen Hu, MD

  • Cancer CenterTaipei Veterans General Hospital;School of MedicineNational Yang-Ming University;Institute of Public HealthNational Yang-Ming UniversityTaipei, Taiwan

  • Chia-Jen Liu, MD

  • Division of Hematology and OncologyDepartment of MedicineTaipei Veterans General Hospital;School of MedicineNational Yang-Ming UniversityTaipei, Taiwan;Department of Internal MedicineNational Yang-Ming University HospitalYilan, Taiwan;Institute of Public HealthNational Yang-Ming UniversityTaipei, Taiwan

REFERENCES

  1. Top of page
  2. CONFLICT OF INTEREST DISCLOSURES
  3. REFERENCES