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- Title
Effect of Estrogen Therapy on Gallbladder Disease.
- Authors
Cirillo, Dominic J.; Wallace, Robert B.; Rodabough, Rebecca J.; Greenland, Philip; LaCroix, Andrea Z.; Limacher, Marian C.; Larson, Joseph C.
- Abstract
Context Estrogen therapy is thought to promote gallstone formation and cholecystitis but most data derive from observational studies rather than randomized trials. Objective To determine the effect of estrogen therapy in healthy postmenopausal women on gallbladder disease outcomes. Design, Setting, and Participants Two randomized, double-blind, placebo-controlled trials conducted at 40 US clinical centers. The volunteer sample was 22 579 community-dwelling women aged 50 to 79 years without prior cholecystectomy. Intervention Women with hysterectomy were randomized to 0.625 mg/d of conjugated equine estrogens (CEE) or placebo (n = 8376). Women without hysterectomy were randomized to estrogen plus progestin (E + P), given as CEE plus 2.5 mg/d of medroxyprogesterone acetate (n = 14 203). Main Outcome Measures Participants reported hospitalizations for gallbladder diseases and gallbladder-related procedures, with events ascertained through medical record review. Cox proportional hazards regression was used to assess hazard ratios (HRs) and 95% confidence intervals (CIs) using intention-to-treat and time-to-event methods. Results The CEE and the E + P groups were similar to their respective placebo groups at baseline. The mean follow-up times were 7.1 years and 5.6 years for the CEE and the E + P trials, respectively. The annual incidence rate for any gallbladder event was 78 events per 10 000 person-years for the CEE group (vs 47/10 000 person-years for placebo) and 55 per 10 000 person-years for E + P (vs 35/10 000 person-years for placebo). Both trials showed greater risk of any gallbladder disease or surgery with estrogen (CEE: HR, 1.67; 95% CI, 1.35-2.06; E + P: HR, 1.59; 95% CI, 1.28-1.97). Both trials indicated a higher risk for cholecystitis (CEE: HR, 1.80; 95% CI, 1.42-2.28; E + P: HR, 1.54; 95% CI 1.22-1.94); and for cholelithiasis (CEE: HR, 1.86; 95% CI, 1.48-2.35; E + P: HR, 1.68; 95% CI, 1.34-2.11) for estrogen users. Also, women undergoing estrogen thera...
- Subjects
ESTROGEN; HORMONE therapy; GALLBLADDER diseases; HYSTERECTOMY; PLACEBOS; CHOLECYSTECTOMY; DISEASES in women
- Publication
JAMA: Journal of the American Medical Association, 2005, Vol 293, Issue 3, p330
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.293.3.330