Abstract
Background. The most common complaints during climacteric are vasomotor symptoms. A circadian rhythm has been observed when hot flashes start; however, not much information is available in this field.
Aims. To analyze whether the time (morning/evening) of administration of a compound containing 60 mg of dry soy seed extract (glycine max) with 40% of total isoflavones, primrose oil and α-tocopherol modifies the effect on the climacteric syndrome.
Trial design. Multicentric, observational, open, prospective, longitudinal and cross-sectional study.
Subjects and methods. One thousand six hundred eighty-two postmenopausal women with climacteric symptoms were allocated in two groups in order to receive the treatment in the morning (Group 1) or in the evening (Group 2), switching administration time after 3 months. Clinical evaluation was carried out at 0, 3 and 6 months of follow-up using Blatt–Kupperman and Greene scales
Results. 233 (13.9%) women dropped out from the study. Both administration times improved the climacteric symptoms after 3 and 6 months of treatment, showing a reduction in the scores of Blatt–Kupperman and Greene scales (p < 0.001). No differences between both groups during the follow-up were identified.
Conclusions. The time of administration of isoflavones does not modify its effect on climacteric symptoms.
Acknowledgements
Statistics have been carried out by Pedro Cortiñas Vázquez, professor of statistics in the Universidad Nacional de Educación a Distancia (UNED). This study was done with an unrestricted grant from Rovi Pharmaceutical labs, S.A. (Madrid, Spain).