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Climacteric. 2015 Jun;18(3):336-8. doi: 10.3109/13697137.2015.1038770.

Reliable evidence from placebo-controlled, randomized, clinical trials for menopausal hormone therapy's influence on incidence and deaths from breast cancer.

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  • 1Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center , Torrance, CA , USA.

Abstract

In an invited editorial, Dr Shapiro proposes that vaginal bleeding leading to unblinding and subsequent detection bias explains the breast cancer increase seen with estrogen plus progestin in the Women's Health Initiative (WHI) clinical trial (1) . In the context of a uniform detection program of protocol-mandated annual mammography and breast examinations, such a proposal is medically implausible. Dr Shapiro suggests detection bias would identify a larger number of 'slowly growing tumors that would otherwise remain clinically silent'. The findings of more advanced cancers with increased deaths from breast cancer in the estrogen plus progestin group refute this conjecture. During early post-intervention phases of both WHI hormone therapy trials, when breast cancer detection bias is asserted by Dr Shapiro because participants had been informed of randomization assignment, breast cancer incidence rates were lower (rather than higher) than during intervention. Thus, Dr Shapiro's claims are directly refuted by findings from the WHI randomized clinical trials. Health-care providers should be aware that randomized clinical trial evidence supports estrogen plus progestin increasing breast cancer incidence and deaths from breast cancer. In contrast, among women with prior hysterectomy, randomized clinical trial evidence supports estrogen alone reducing breast cancer incidence and deaths from breast cancer.

KEYWORDS:

BREAST CANCER; ESTROGEN; ESTROGEN PLUS PROGESTIN; PLACEBO-CONTROLS; RANDOMIZED CLINICAL TRIAL

Comment in

PMID:
25966858
DOI:
10.3109/13697137.2015.1038770
[PubMed - indexed for MEDLINE]
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