OBJECTIVE: To investigate the efficacy and safety of tibolone on hypoestrogenic vasomotor symptoms and bone parameters in patients treated withgoserelin acetate. DESIGN: Prospective, randomized placebo controlled double-blind study. SETTING:Human volunteers in a university-based fertility clinic. PATIENT(S): Twenty-nine women of mean age 29.2 +/- 4.8 years with mild to severe endometriosis undergoing 6 months of treatment with 3.6 mggoserelin acetate in an SC depot formulation were studied. INTERVENTION(S): The patients were allocated randomly to either 2.5 mg/d tibolone (n = 15) or an iron pill (n = 14) in a double-blinded fashion beginning in the third cycle. MAIN OUTCOME MEASURE(S): Frequency and severity of hot flushes, sweating, irritability, loss of libido, nervousness, and sleeplessness were assessed by the patients using 0 to 6 point scoring system and compared. Samples of urine were obtained for calcium and creatinine (Ca:Cr) ratios at the start of treatment and monthly there after. The vasomotor scoring for each symptom and Ca:Cr ratios before the treatment and at the end of 6th month were analyzed by parametric and nonparametric tests. RESULT(S): The mean age, weight, vasomotor scores, pelvic scores, and urine Ca:Cr ratios were similar in both placebo and tibolone group (28.7 +/- 4.8 versus 27.6 +/- 6.3 years, 50.9 +/- 5.3 versus 53.1 +/- 7.1 kg, 4.7 +/- 1.1 versus 4.2 +/- 0.8, and 0.056 +/- 0.008 versus 0.059 +/- 0.006, respectively). The decreases in vasomotor scoring as regards to hot flushing, sweating, and other associated symptoms were statistically significant in tibolone group compared with placebo (10.4 +/- 1.6 versus 24.6 +/- 4.9). During the study significant reductions in urine Ca:Cr ratio was obtained in the tibolone patients compared with placebo (0.031 +/- 0.006 versus 0.0055 +/- 0.007). The incidence of side effects (weight change, vaginal bleeding) was low and did not differ from the placebo group. CONCLUSION(S): Considering the beneficial effects of tibolone on vasomotor symptoms and bone loss, our data suggest that this synthetic steroid is an effective and safe option in relieving symptoms induced by GnRH-analogue.
RCT Entities:
OBJECTIVE: To investigate the efficacy and safety of tibolone on hypoestrogenic vasomotor symptoms and bone parameters in patients treated with goserelin acetate. DESIGN: Prospective, randomized placebo controlled double-blind study. SETTING:Human volunteers in a university-based fertility clinic. PATIENT(S): Twenty-nine women of mean age 29.2 +/- 4.8 years with mild to severe endometriosis undergoing 6 months of treatment with 3.6 mg goserelin acetate in an SC depot formulation were studied. INTERVENTION(S): The patients were allocated randomly to either 2.5 mg/d tibolone (n = 15) or an iron pill (n = 14) in a double-blinded fashion beginning in the third cycle. MAIN OUTCOME MEASURE(S): Frequency and severity of hot flushes, sweating, irritability, loss of libido, nervousness, and sleeplessness were assessed by the patients using 0 to 6 point scoring system and compared. Samples of urine were obtained for calcium and creatinine (Ca:Cr) ratios at the start of treatment and monthly there after. The vasomotor scoring for each symptom and Ca:Cr ratios before the treatment and at the end of 6th month were analyzed by parametric and nonparametric tests. RESULT(S): The mean age, weight, vasomotor scores, pelvic scores, and urine Ca:Cr ratios were similar in both placebo and tibolone group (28.7 +/- 4.8 versus 27.6 +/- 6.3 years, 50.9 +/- 5.3 versus 53.1 +/- 7.1 kg, 4.7 +/- 1.1 versus 4.2 +/- 0.8, and 0.056 +/- 0.008 versus 0.059 +/- 0.006, respectively). The decreases in vasomotor scoring as regards to hot flushing, sweating, and other associated symptoms were statistically significant in tibolone group compared with placebo (10.4 +/- 1.6 versus 24.6 +/- 4.9). During the study significant reductions in urine Ca:Cr ratio was obtained in the tibolonepatients compared with placebo (0.031 +/- 0.006 versus 0.0055 +/- 0.007). The incidence of side effects (weight change, vaginal bleeding) was low and did not differ from the placebo group. CONCLUSION(S): Considering the beneficial effects of tibolone on vasomotor symptoms and bone loss, our data suggest that this synthetic steroid is an effective and safe option in relieving symptoms induced by GnRH-analogue.