Efficacy and safety of a phytoestrogen preparation derived from Glycine max (L.) Merr in climacteric symptomatology: a multicentric, open, prospective and non-randomized trial.
A multicentric, open, prospective, observational and no-randomized clinical trial was carried out in Spain with 190 postmenopausal women receiving a soy preparation rich in isoflavones (PHYTO SOYA, capsules containing 17.5 mg isoflavones). The main object of the present study was to investigate its efficacy in alleviating the symptomatology derived from the lack of estrogen, mainly hot flushes, but also other symptoms such as sleep disorder, anxiety, depression, vaginal dryness, loss of libido and bone pain. Each patient received 35 mg isoflavones per day in two doses. During the four months' treatment, a statistically significant decrease in the number of hot flushes with PHYTO SOYA was experienced by 80.82% women; only 5,48% patients did not improve with the treatment. The average reduction was 47.8%, which is equivalent to 4 hot flushes. All the other studied parameters also showed a statistically significant decrease. No severe side-effects were reported and tolerance was excellent. Treatment with PHYTO SOYA resulted in a significant improvement of the symptomatology that accompanies the lack of estrogen during menopause.
Albert
A
A
Virgen de la Macarena Hospital, Sevilla, Spain.
Altabre
C
C
Baró
F
F
Buendía
E
E
Cabero
A
A
Cancelo
M J
MJ
Castelo-Branco
C
C
Chantre
P
P
Duran
M
M
Haya
J
J
Imbert
P
P
Julía
D
D
Lanchares
J L
JL
Llaneza
P
P
Manubens
M
M
Miñano
A
A
Quereda
F
F
Ribes
C
C
Vázquez
F
F
D001007:Anxiety / Q000188:drug therapy; D001794:Blood Pressure / Q000187:drug effects; D002851:Chromatography, High Pressure Liquid; D002979:Climacteric / Q000187:drug effects*; D003863:Depression / Q000188:drug therapy; D004968:Estrogens, Non-Steroidal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy*; D006801:Humans; D007529:Isoflavones / Q000737:chemistry / Q000627:therapeutic use; D008593:Menopause / Q000187:drug effects; D008796:Metrorrhagia / Q000139:chemically induced; D008875:Middle Aged; D015394:Molecular Structure; D010146:Pain / Q000139:chemically induced; D048789:Phytoestrogens; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D028321:Plant Preparations; D011446:Prospective Studies; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013025:Glycine max; D013057:Spectrum Analysis; D013223:Statistics as Topic; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D004968:Estrogens, Non-Steroidal; D007529:Isoflavones; D048789:Phytoestrogens; D010936:Plant Extracts; D028321:Plant Preparations; C040641:genistin; C013908:daidzin; C433283:glycitin