Randomized Trials Built on Sand: Examples from COPD, Hormone Therapy, and Cancer.

This bias was illustrated in another cohort of COPD patients, with the hazard ratio changing from a highly significant 0.66 (95% CI 0.57–0.76) to a non-significant 0.94 (95% CI 0.81–1.09) after properly accounting for this bias. 32 The TORCH Randomized Trial In 2007, a large-scale randomized controlled trial was published, comparing an ICS+LABA (fluticasone+salmeterol) combination with placebo, LABA alone, or ICS alone, over a period of 3 years, on the primary outcome of death from any cause. 36 Of the 6,112 randomized patients, all-cause mortality was 12.6% in the ICS+LABA combination group, 15.2% in the placebo group, 13.5% in the LABA group, and 16.0% in the ICS group.

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