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Objectives. -To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomised to continuous combined Climodiè ne (estradiol valerate 2 mg/dienogest 2 mg) or cyclic Climè ne (estradiol valerate 2 mg, from D1 to D21/cyproterone acetate 1 mg, from D12 to D21, followed by 7 days off), switching from previous sequential estroprogestative HRT because of side effects. Patients and methods. -One hundred forty three postmenopausal women aged 54.39-years were recruited and randomised to Climè ne (N = 68) or Climodiè ne (N=75)was evaluated by the continuation rate in the 2 groups at the end of the 12 cycles study. Assessment of quality of life was obtained from the responses to the women’ s health questionnaire (WHQ) and to an ad hoc satisfaction questionnaire at baseline, and at the 12th cycle of treatment. Results. -No significant difference in baseline characteristics of volunteers were found in the 2 treatment groups except for the socioeconomic status (more town-dwellers in Climè ne group). Total WHQ score significantly improved after 12 months of treatment with Climè ne and Climè ne respectively decreasing from 68.9 to 64.37(-4.53) and from 69.95 to 62.06(-7.89), with a trend towards higher improvement with Climodiè ne , particularly in the hot flushes subscale. In Climodiè ne group, a significant decrease in sleep problems and cognitive function subscales was found, which is consistent with previous polysomnography and psycho physiological measures data with Climodiè ne . The evolution of Satisfaction Index is positive and of the same magnitude in the 2 groups, showing an improvement at 12 months: respectively -2.79 (P = 0.002) et -2.26 (P = 0.02) for Climè ne and Climodiè ne . Discussion and conclusions. -Even though the benefit/risk ratio of the hormonal substitutive treatment is recognized effective against climateric symptoms which affect the quality of life, this work is the first randomised prospective study on the effects of Climodiè ne on quality of life in postmenopausal women assessed by the French validated version of the world-wide used WHQ. Decreases in “ sleep problems” and “ cognitive function” subscales scores in this study are of a magnitude clinically relevant and consistent with previous data on Climodiè ne impact on postmenopausal symptoms.
Objectives. -To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomized to continuous combined Climodi Ne ne (estradiol valerate 2 mg / dienogest 2 mg) or cyclic Climè ne (estradiol valerate 2 mg, from D1 to D21 / cyproterone acetate 1 mg, from D12 to D21, followed by 7 days off), switching from previous sequential estroprogestative HRT because of side effects. Patients and methods. -One hundred forty three postmenopausal women aged 54.39-years were recruited and randomized to Climè ne (N = 68) or Climodiè ne (N = 75) was evaluated by the continuation rate in the 2 groups at the end of the 12 cycles study. Assessment of quality of life was obtained from the responses to the women’s health questionnaire (WHQ) and to an ad hoc questionnaireire at baseline, and at the 12th cycle of treatment. Results. -No significant difference in baseline characteristics of volunteers were found in the 2 treatment groups except for the socioeconomic status (more town-dwellers in Climè ne group). Total WHQ score significantly improved after 12 months of treatment with Clim ne ne and Clim ne respectively decreasing from 68.9 to 64.37 (-4.53) and from 69.95 to 62.06 ( -7.89), with a trend towards higher improvement with Climodiè ne, particularly in the hot flushes subscale. In Climodiè ne group, a significant decrease in sleep problems and cognitive function subscales was found, which is consistent with previous polysomnography and psycho physiological measures data with Climodiè ne. The evolution of Satisfaction Index is positive and of the same magnitude in the 2 groups, showing an improvement at 12 months: respectively -2.79 (P = 0.002) et -2.26 (P = 0.02) for Climène and Climodiè ne. Discussion and conclusions. -Even though the benefit / risk ratio of the hormonal substitutive treatment is recognized effective against climateric symptoms which affect the quality of life, this wo rk is the first randomized prospective study on the effects of Climodiè ne on quality of life in postmenopausal women assessed by the French validated version of the world-wide used WHQ. Decreases in “sleep problems” and “cognitive function” subscales scores in this study are of a magnitude clinically relevant and consistent with previous data on Climodi ne impact on postmenopausal symptoms.