BACKGROUND: The safety and efficacy of tibolone (Livial) were compared with the traditional cyclic, sequential conjugated estrogens/medroxyprogesterone acetate (Premarin/Provera; PP) regimen for the treatment of climacteric symptoms, prevention of postmenopausal bone loss, endometrial stimulation and influence on lipid profile. METHODS:Forty women, one to three years postmenopause, were randomly enrolled in one of two treatment groups, receiving either tibolone (2.5 mg) every day for six months or Premarin (0.625 mg) every day plus Provera (5 mg) from day 1 to day 12 every month for six months. The scores of climacteric complaints, using the Greene Climacteric Scales, and bleeding pattern were recorded at baseline and follow-up visits at months 1, 3 and 6. Bone resorption (deoxypyridinium) and formation (osteocalcin) markers were measured at baseline, three and six months. Lipid profiles, bone density of the lumbar spine and neck of the femur measured by dual energy X-ray absorptiometry were checked at baseline and six months. RESULTS:Tibolone was as effective as PP in alleviating climacteric complaints. Both regimens were effective in slowing bone metabolism and preventing bone loss. After six months of treatment, bone density of the lumbar spine increased 2.174% in the tibolone group. The endometrium of patients remained atrophic (< 4 mm); only one woman reported vaginal spotting after three months of tibolone therapy. Significant decreases in triglyceride (31.48%) and high-density lipoprotein (29.25%) were also observed. In the PP group, bone density of the lumbar spine increased 1.405%; cyclic withdrawal bleeding occurred in every patient. A significant increase in triglyceride (38.76%) and a significant decrease in low-density lipoprotein (15.10%) were observed. CONCLUSIONS:Tibolone proved to be effective and safe in the treatment of women with climacteric symptoms and postmenopausal bone loss. As a form of hormone replacement therapy without the need for withdrawal bleeding, tibolone has great appeal to postmenopausal women, and compliance is higher than reported with other forms of hormone replacement therapy.
RCT Entities:
BACKGROUND: The safety and efficacy of tibolone (Livial) were compared with the traditional cyclic, sequential conjugated estrogens/medroxyprogesterone acetate (Premarin/Provera; PP) regimen for the treatment of climacteric symptoms, prevention of postmenopausal bone loss, endometrial stimulation and influence on lipid profile. METHODS: Forty women, one to three years postmenopause, were randomly enrolled in one of two treatment groups, receiving either tibolone (2.5 mg) every day for six months or Premarin (0.625 mg) every day plus Provera (5 mg) from day 1 to day 12 every month for six months. The scores of climacteric complaints, using the Greene Climacteric Scales, and bleeding pattern were recorded at baseline and follow-up visits at months 1, 3 and 6. Bone resorption (deoxypyridinium) and formation (osteocalcin) markers were measured at baseline, three and six months. Lipid profiles, bone density of the lumbar spine and neck of the femur measured by dual energy X-ray absorptiometry were checked at baseline and six months. RESULTS:Tibolone was as effective as PP in alleviating climacteric complaints. Both regimens were effective in slowing bone metabolism and preventing bone loss. After six months of treatment, bone density of the lumbar spine increased 2.174% in the tibolone group. The endometrium of patients remained atrophic (< 4 mm); only one woman reported vaginal spotting after three months of tibolone therapy. Significant decreases in triglyceride (31.48%) and high-density lipoprotein (29.25%) were also observed. In the PP group, bone density of the lumbar spine increased 1.405%; cyclic withdrawal bleeding occurred in every patient. A significant increase in triglyceride (38.76%) and a significant decrease in low-density lipoprotein (15.10%) were observed. CONCLUSIONS:Tibolone proved to be effective and safe in the treatment of women with climacteric symptoms and postmenopausal bone loss. As a form of hormone replacement therapy without the need for withdrawal bleeding, tibolone has great appeal to postmenopausal women, and compliance is higher than reported with other forms of hormone replacement therapy.