Re: [escepticos] otras formas - para Ramón Díaz

[Ramon Diaz-Alersi]

Digo que es curioso porque esa terapia se sigue usando (de manera más
controlada), se sigue estudiando y el estudio original que levantó las
alarmas no justifica una tal reducción de la incidencia (por más que sea
RELATIVA). Y ese estudio que te he puesto no confirma los datos del "Women's
Health Initiative" (el estudio original).

Aquí va el resumen de  la madre del problema:

Risks and benefits of estrogen plus progestin in healthy postmenopausal
women: principal results From the Women's Health Initiative randomized
controlled trial.

CONTEXT: Despite decades of accumulated observational evidence, the balance
of risks and benefits for hormone use in healthy postmenopausal women
remains uncertain. OBJECTIVE: To assess the major health benefits and risks
of the most commonly used combined hormone preparation in the United States.
DESIGN: Estrogen plus progestin component of the Women's Health Initiative,
a randomized controlled primary prevention trial (planned duration,
8.5years) in which 16608 postmenopausal women aged 50-79 years with an
intact
uterus at baseline were recruited by 40 US clinical centers in 1993-1998.
INTERVENTIONS: Participants received conjugated equine estrogens,
0.625mg/d, plus medroxyprogesterone acetate,
2.5 mg/d, in 1 tablet (n = 8506) or placebo (n = 8102).

MAIN OUTCOMES MEASURES: The primary outcome was coronary heart disease (CHD)
(nonfatal myocardial infarction and CHD death), with invasive breast cancer
as the primary adverse outcome. A global index summarizing the balance of
risks and benefits included the 2 primary outcomes plus stroke, pulmonary
embolism (PE), endometrial cancer, colorectal cancer, hip fracture, and
death due to other causes. RESULTS: On May 31, 2002, after a mean of
5.2years of follow-up, the data and safety monitoring board
recommended
stopping the trial of estrogen plus progestin vs placebo because the test
statistic for invasive breast cancer exceeded the stopping boundary for this
adverse effect and the global index statistic supported risks exceeding
benefits. This report includes data on the major clinical outcomes through
April 30, 2002. Estimated hazard ratios (HRs) (nominal 95% confidence
intervals [CIs]) were as follows: CHD, 1.29 (1.02-1.63) with 286 cases;
breast cancer, 1.26 (1.00-1.59) with 290 cases; stroke, 1.41 (1.07-1.85)
with 212 cases; PE, 2.13 (1.39-3.25) with 101 cases; colorectal cancer, 0.63(
0.43-0.92) with 112 cases; endometrial cancer, 0.83 (0.47-1.47) with 47
cases; hip fracture, 0.66 (0.45-0.98) with 106 cases; and death due to other
causes, 0.92 (0.74-1.14) with 331 cases. Corresponding HRs (nominal 95% CIs)
for composite outcomes were 1.22 (1.09-1.36) for total cardiovascular
disease (arterial and venous disease), 1.03 (0.90-1.17) for total cancer,
0.76 (0.69-0.85) for combined fractures, 0.98 (0.82-1.18) for total
mortality, and 1.15 (1.03-1.28) for the global index. Absolute excess risks
per 10 000 person-years attributable to estrogen plus progestin were 7 more
CHD events, 8 more strokes, 8 more PEs, and 8 more invasive breast cancers,
while absolute risk reductions per 10 000 person-years were 6 fewer
colorectal cancers and 5 fewer hip fractures. The absolute excess risk of
events included in the global index was 19 per 10 000 person-years.

CONCLUSIONS: Overall health risks exceeded benefits from use of combined
estrogen plus progestin for an average 5.2-year follow-up among healthy
postmenopausal US women. All-cause mortality was not affected during the
trial. The risk-benefit profile found in this trial is not consistent with
the requirements for a viable intervention for primary prevention of chronic
diseases, and the results indicate that this regimen should not be initiated
or continued for primary prevention of CHD.

Saludos.







-- 
Ramón Díaz-Alersi