Hormone replacement for osteoporosis in women with primary biliary cirrhosis

Patients with primary biliary cirrhosis are mainly elderly women who are naturally prone to osteoporosis. Hormone replacement has been used worldwide to treat symptoms of menopause and to prevent chronic conditions such as osteoporosis. However, hormone replacement is associated with an increase in adverse events, several of which are serious. This review assessed the effect of hormone replacement on treatment of osteoporosis in women with primary biliary cirrhosis. We found no evidence of effect of hormone replacement on mortality and fractures in women with primary biliary cirrhosis. It seems that hormone replacement given to women with primary biliary cirrhosis is connected with a significant increase in the occurrence of adverse events compared with placebo or no intervention. Hormone replacement appears to have no effect on the lumbar bone mineral density compared with placebo or no intervention. Hormone replacement may decrease bone mineral density measured at the proximal femur. We did not find evidence to support the use of hormone replacement for osteoporosis in women with primary biliary cirrhosis.

Authors' conclusions: 

We did not find evidence to support the use of hormone replacement for women with primary biliary cirrhosis. It seems that hormone replacement is connected with a significant increase in the occurrence of adverse events.

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Background: 

Women with primary biliary cirrhosis often suffer from postmenopausal osteoporosis due to their age, or osteoporosis secondary to their liver disease, or treatments provided for their liver disease. Hormone replacement increases bone mineral density and reduces fractures in postmenopausal women. On the other hand, hormone replacement increases the risk of various adverse events. We could not identify any meta-analyses or systematic reviews on hormone replacement in women with primary biliary cirrhosis.

Objectives: 

To assess the beneficial and harmful effects of hormone replacement for osteoporosis in women with primary biliary cirrhosis.

Search strategy: 

The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, clinicaltrials.gov, the WHO International Clinical Trials Registry Platform, and full text searches were conducted until November 2011. Manufacturers and authors were contacted during the review conductance.

Selection criteria: 

All randomised clinical trials of hormone replacement in primary biliary cirrhosis administered by any route, or regimen, or dose compared with placebo or no intervention.

Data collection and analysis: 

Two authors extracted data. RevMan Analysis was used for statistical analysis of dichotomous data with risk ratio (RR) or risk difference (RD) and of continuous data with mean difference (MD), all with 95% confidence intervals (CI). Methodological domains were used to assess risk of systematic errors (bias). Trial sequential analysis was used to control for random errors (play of chance).

Main results: 

Two trials with 49 participants were included. One trial had low risk of bias. The other trial had high risk of bias. Hormone replacement had no effect on all-cause mortality (RD 0.00; 95% CI -0.11 to 0.11, I² = 0%) and fractures (RD -0.08; 95% CI -0.24 to 0.07, I² = 0%). Hormone replacement significantly increased adverse events and number of patients having hormone replacement withdrawn due to adverse events (RR 5.26; 95% CI 1.26 to 22.04, I² = 0%). Hormone replacement had no significant effect on lumbar spine bone mineral density (MD 1.25 g/cm² yearֿ¹; 95% CI -0.91 to 3.42, I² = 0%). On the other hand, a significant increase in proximal femur bone mineral density was observed in the control group (MD 2.24 g/cm² yearֿ¹; 95% CI 0.74 to 3.74, I² = 0%). Hormone replacement had no significant effect on liver-related mortality, liver transplantation, or liver-related morbidity. Hormone replacement had no significant effect on serum bilirubin concentration (MD 4.60 µmol/L; 95% CI -3.42 to 12.62, I² = 0%).

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