Reference no: EM131772912

Question: In Example, the fact that many media stories mentioned increased risk of breast cancer and coronary heart disease but not any of the other results.

Example: Helpful and Harmful Outcomes from Hormone Replacement Therapy In July 2002 the results were released from a large clinical trial studying the effects of estrogen plus progestin hormone replacement for postmenopausal women. The trial was stopped early because of increased risk of breast cancer and coronary heart disease among the women taking the hormones. However, many news stories failed to report some of the other results of the study, which showed that the hormones actually decreased the risk of other adverse outcomes and were unresolved about others. The original article (Writing Group for the Women's Health Initiative Investigators, 2002) reported the results as follows: Absolute excess risks per 10,000 person-years attributable to estrogen plus progestin were 7 more CHD [coronary heart disease] events, 8 more strokes, 8 more PEs [pulmonary embolism], 8 more invasive breast cancers, while absolute risk reductions per 10,000 person-years were 6 fewer colorectal cancers and 5 fewer hip fractures. These results show that in fact some outcomes were more favorable for those taking the hormones, specifically colorectal cancer and hip fractures. Because different people are at varying risk for certain diseases, it is important to report all of these outcomes so that an individual can make an informed choice about whether to take the hormones. In fact, overall, 231 out of 8506 women taking the hormones died of any cause during the study, which is 2.72%. Of the 8102 women taking the placebo, 218 or 2.69% died, a virtually identical result with the hormone group. In fact, when the results are adjusted for the time spent in the study, the death rate was slightly lower in the hormone group, with an annualized rate of 0.52% compared with 0.53% in the placebo group. The purpose of this example is not to negate the serious and unexpected outcomes related to heart disease, which hormones were thought to protect against, or the serious breast cancer outcome. Instead, the purpose is to show that the results of a large and complex study such as this one are bound to be mixed and should be presented as such so that readers can make informed decisions.