Tibolone in the treatment of menopause : compliance, efficacy and safety in a ten year experience

AIM : To assess tibolone compliance, efficacy and safety in everyday clinical practice a non-randomized, prospective, cohort clinical study was carried out. METHODS: One hundred and fifty post-menopausal women aged 48 to 73 years were prescribed tibolone: 72 of them were treated for 36.4 months, 55 terminated treatment after less than 1 year, while 23 never took the tablets after seeking for menopause counseling and having agreed upon the treatment. We examined: endometrial thickness and histology, total cholesterol, triglycerides, fibrinogen, AST, ALT, gamma-gt, and the body weight. RESULTS: Side effects were the main causes of withdrawal (32%), and insufficient therapeutic effect and adverse events for a small number of cases (5.5% and 4.7% respectively), while various causes (fear of cancer, missing tablets, family doctor or other specialist's advice, remission of symptoms) were responsible for terminating treatment after extended periods. Laboratory findings showed a favorable trend; only the (GT showed slightly higher mean values, although within a normal range. On average, weight during treatment increased of 1.5 kg, and endometrial thickness grew of 1.3 mm in a mean time of 34.5 months of observation. An average of 2.3%/year increase of bone mineral density was reported, though bone mass didn't improve in some patients. CONCLUSIONS: Different causes of terminating treatment are related to the length of treatment, side effects being the main reason for early withdrawals, efficacy on symptoms or medical advice or fear of treatment for extended periods of time. Effectiveness on bone mass, safety as resulting from endometrial thickness and laboratory measures are confirmed. It is suggested to enhance follow-up accuracy and reinforce counseling as measures to improve compliance.