EFFECTIVENESS OF TIBOLONE ON HYPOESTROGENIC SYMPTOMS INDUCED BY GOSERELIN TREATMENT IN PATIENTS WITH ENDOMETRIOSIS

Objective: To investigate the efficacy and safety of tibolone on hypoe strogenic vasomotor symptoms and bone parameters in patients treated w ith goserelin acetate. Design: Prospective, randomized placebo control led double-blind study. Setting: Human volunteers in a university-base d fertility clinic. Patient(s): Twenty-nine women of mean age 29.2 +/- 4.8 years with mild to severe endometriosis undergoing 6 months of tr eatment with 3.6 mg goserelin acetate in an SC depot formulation were studied. Intervention(s): The patients were allocated randomly to eith er 2.5 mg/d tibolone (n = 15) or an iran pill (n = 14) in a double-bli nded fashion beginning in the third cycle. Main Outcome Measure(s): Fr equency and severity of hot flushes, sweating, irritability, loss of l ibido, nervousness, and sleeplessness were assessed by the patients us ing 0 to 6 point scoring system and compared. Samples of urine were ob tained for calcium and creatinine (Ca:Cr) ratios at the start of treat ment and monthly there after. The vasomotor scoring for each symptom a nd Ca:Cr ratios before the treatment and at the end of 6th month were analyzed by parametric: and nonparametric tests. Result(s): The mean a ge, weight, vasomotor scores, pelvic scores, and urine Ca:Cf ratios we re 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 Bg, 4.7 +/- 1,1 vers us 4.2 +/- 0.8, and 0.056 +/- 0.008 versus 0.059 +/- 0.006, respective ly). The decreases in vasomotor scoring as regards to hot flushing, sw eating, and other associated symptoms were statistically significant i n 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 +/- 0.0 06 versus 0.0055 +/- 0.007). The incidence of side effects (weight cha nge, vaginal bleeding) was low and did not differ from the placebo gro up. Conclusion(s): Considering the beneficial effects of tibolone on v asomotor symptoms and bone loss, our data suggest that this synthetic steroid is an effective and safe option in relieving symptoms induced by GnRH-analogue.