[Acceptability of continuous combined versus cyclical HRT: a French multicentric randomized clinical study].
OBJECTIVE
To describe and compare acceptability of treatment and quality of life over 12 cycles in 2 groups of women randomised to continuous combined Climodiène (estradiol valerate 2 mg/dienogest 2 mg) or cyclic Climène (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.


METHODS
One hundred forty three postmenopausal women aged 54.39-years were recruited and randomised to Climène (N=68) or Climodiène (N=75). Acceptability 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 Climène group). Total WHQ score significantly improved after 12 months of treatment with Climène and Climodiène, 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 Climodiène, particularly in the hot flushes subscale. In Climodiène 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 Climodiène. 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 Climodiène.


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 Climodiène on quality of life in post-menopausal 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 Climodiène impact on postmenopausal symptoms.
Drapier-Faure
E
E
Service de gynécologie, pavillon L, hôpital Edouard-Herriot, 5, place d'Arsonval, 69437 Lyon cedex 03, France.
Azoulay
C
C
Abramovici
Y
Y
D017373:Cyproterone Acetate / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004958:Estradiol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008593:Menopause / Q000187:drug effects* / Q000523:psychology*; D008875:Middle Aged; D009277:Nandrolone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017698:Postmenopause; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D004338:Drug Combinations; C103294:estradiol valerate, cyproterone acetate drug combination; C454300:estradiol valerate-dienogest; D017373:Cyproterone Acetate; D004958:Estradiol; D009277:Nandrolone