Clinical Question: Does estrogen th...

Clinical Question: Does estrogen therapy increase the risk of gallbladder disease among postmenopausal women?

Setting: Outpatient (any)

contemplation Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: As part of the Women's Health Initiative postmenopausal hormone trial, investigators gathered more rigorous evidence to assess the risk of gallbladder disease with the use of estrogen therapy. Women with hysterectomy were randomized to receive conjugated equine estrogen in a dosage of 0625 mg by day or matched placebo. Women without hysterectomy were randomized to receive estrogen plus progestin, given as 25 mg through day of medroxyprogesterone acetate or matched placebo. Participants were blinded to treatment cluster assignment and self-reported hospitalizations for gallbladder disease and related procedures

These circumstances were judged by medical record acquisition. The mean follow-up times were 71 and 56 years for the estrogen-only and estrogen-plus-progestin trials, respectively.

Using intention-to-treat analysis, the annual incidence of any gallbladder incident (e.g., cholecystitis, cholelithiasis, cholecystectomy) in the estrogen-only trial was 78 by means of 10,000 person-years in the active treatment clump compared with 47 per 10000 person-years in the placebo assign places to (number needed to treat to harm [NNTH] in single year = 323). For the estrogen-plus-progestin trial, the annual incidence of any gallbladder result was 55 per 10,000 person-years in the active treatment assign places to com-pared with 35 per 10000 person-years in the placebo assemblage (NNTH in one year = 500) the two of these differences were statistically significant.

Bottom Line: Evidence from the Women's Health Initiative, the largest randomized trial available, confirms an increase in gallbladder disease and related managements among post-menopausal women treated with supplemental estrogen This is single more risk to consider when helping each patient weigh the risks and benefits of estrogen therapy. (Level of Evidence: 1b)

cogitation Reference: Cirillo DJ, et al. result of estrogen therapy on gallbladder disease. JAMA January 19 2005;293:330-9

Used with permission from Slawson D Estrogen increases risk of gallbladder disease. Accessed online March 1 2005 at: http://www.InfoPOEMs.com.

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