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					                               Controlled clinical study on Magnolia extract+isoflavones+L. sporogenes
                                                         activity in menopause.
                                                                     Marco Atlante1, Claudio Benvenuti2, Estronet study Group
                        1Menopause              Outpatient’s Dept, Osp. Regina Apostolorum, Albano Laziale (Rome) Italy; 2Medical Dept, Rottapharm, Monza, Italy

         Aim                                                                                           Results
         To verify the Magnolia extract activity in                                                    In 91 gynaecological centres, 634 women were treated (300 with E and 334
         menopausal women with typical menopausal                                                      with ES) mean age 53.1 years and BMI 25.2 kg/m2; 28% past HRT users
         symptoms and concomitant borderline psycho-                                                   and 3.3% with previous mammary cancer. Both treatments significantly
         affective and/or sleep alterations, of severity not                                           reduced versus baseline the symptoms checked at 0, 4, 8 and 12 weeks. E
         requiring a psychopharmacological therapy.                                                    and ES showed similar effectiveness on hot flushing, nocturnal sweating with
                                                                                                       awakenings, palpitations and vaginal dryness. ES was more active on
         Patients and methods                                                                          insomnia, irritability, anxiety, depressed mood, asthenia and libido loss.
         The experimental design of the study was                                                      Woman’s wellbeing and physician’s final judgement were positive in >70% in
         multicentre controlled, longitudinal, parallel                                                both groups. The rate of unwanted events possibly, probably or certainly
         groups randomised within centres.                                                             related with the treatment was 1% on E (metrorrhagia, cramps and
         Women with typical menopausal symptoms and                                                    constipation) and 1.2% on ES (gastralgia, haematic loss, constipation and
         concomitant anxious–depressive borderline                                                     mammary tension).
         symptoms and/or sleep alterations, not so                                                                   Vital characteristics of the population studied
         severe to require a pharmacological therapy,                                                                                                                      E                    ES
         were enrolled and randomised to E (isoflavones                                                                No. cases                                          301                   335
         60mg + Lactobacillus sporogenes + calcium and                                                                 BMI (kg/m2)                                      25.4±3.7            25.0±3.5
         vitamin D3 = Estromineral, Rottapharm)                                                                        Age (years)                                      53.3±4.7            53.0±5.2
         compared to ES (Magnolia extract + E =
                                                                                                                       Spontaneous menopause                             86.4%                80.9%
         Estromineral serena) 1 tablet/night for 12
         weeks. Other specific treatments were                                                                         HRT Use in the past                               71.6%                72.4%
         excluded.                                                                                                     Previous mammary Ca                               3.3%                  3.3%

                                                    insomnia                                                             anxiety                                                           irritability
                                        0-4               0-8               0-12                       0-4                  0-8              0-12                             0-4                   0-8          0-12 week
                                                                                           0.0
Severity: % reduction




                         0.0                                                                                                                                      0.0
                        -10.0                                                             -10.0                                                               -10.0
                        -20.0     -17.2                                                   -20.0                                                               -20.0
                                                                                                   -18.8                                                                  -18.2
                        -30.0              -25.3                                          -30.0             -26.0                                             -30.0
                                                                                                                                                                                  -27.4
                        -40.0            ***           -34.6                              -40.0            **            -36.1                                -40.0
                                                                                                                                  -43.7                                       ***            -37.9
                        -50.0                                                             -50.0                                                               -50.0
                                                               -48.1                                                             ***       -51.0                                                     -46.1
                                                                         -52.4            -60.0   E                                                                      E                                   -49.2
                        -60.0    E                          ***                                                                                     -59.0     -60.0                                 ***
                                 ES                                                               ES                                          ***                        ES
                        -70.0              p< 0.01 vs baseline              ***
                                                                              -65.4       -70.0             p< 0.01 vs baseline                               -70.0           p< 0.01 vs baseline
                                                                                                                                                                                                                ***-62.6

                                                    asthenia                                                     depressed mood                                                           libido loss
                                        0-4               0-8               0-12                       0-4                  0-8              0-12                             0-4                   0-8          0-12 week
                         0.0                                                               0.0                                                                 0.0
Severity: % reduction




                        -10.0                                                             -10.0                                                               -10.0
                        -20.0                                                                                                                                 -20.0       -12.9
                                  -16.9                                                   -20.0    -15.4
                                                                                                            -22.3                                                                 -20.5
                        -30.0            -24.3                                            -30.0                                                               -30.0                         -26.1
                                        NS                                                                 NS                                                                 *
                        -40.0                          -37.6                              -40.0                         -34.3                                 -40.0                                  -36.0   -37.9
                                                            -41.6                                                                 -38.4
                        -50.0                                                                                                                                                                                        -43.5
                                                           NS             -50.6 -48.7
                                                                                          -50.0                                  NS       -47.9
                                                                                                                                                              -50.0                                 ***
                        -60.0    E                                                                                                                 -52.3      -60.0      E                                           *
                                         p< 0.01 vs baseline                 NS           -60.0   E         p< 0.01 vs baseline                                               p< 0.01 vs baseline
                        -70.0
                                 ES
                                                                                                  ES                                               *          -70.0
                                                                                                                                                                         ES
                                                                                          -70.0


                                                     flushing                                                       palpitations
                                        0-4               0-8               0-12                    0-4                  0-8              0-12             week
                         0.0                                                               0.0
                                                                                                                                                                        Conclusions
Severity: % reduction




                        -10.0                                                             -10.0
                        -20.0
                                                                                                                                                                        Isoflavones are effective in
                                                                                          -20.0
                        -30.0
                                      -22.3 -22.2
                                                                                          -30.0
                                                                                                   -20.9 -21.1                                                          improving classical menopause
                                          NS                                                           NS
                        -40.0                                                             -40.0                                                                         symptoms. The clinical activity of
                                                       -41.1 -42.4
                        -50.0
                                                           NS                             -50.0                          -42.9
                                                                                                                             -46.4                                      the Magnolia extract on the
                        -60.0    E                                                                                          NS
                                 ES p< 0.01 vs baseline
                                                                         -57.6 -58.1      -60.0   E                                       -56.8                         relevant psycho-affective
                        -70.0                                               NS                    ES p< 0.01 vs baseline                        -60.0
                                                                                          -70.0                                              NS                         symptoms, particularly anxiety,
                                          nocturnal sweating                                                    vaginal dryness                                         irritability and insomnia, was
                                          0-4                  0-8            0-12                     0-4                  0-8              0-12       week
                          0.0                                                              0.0                                                                          evidenced. ES, in mild psychical
Severity: % reduction




                         -10.0                                                            -10.0                                                                         alterations that can occur in
                         -20.0                                                            -20.0    -18.3
                                                                                                            -23.4
                                                                                                                                                                        climacterium, avoids to run the
                         -30.0        -24.3 -25.8                                         -30.0
                                                                                                       NS               -32.1                                           known dependence risks linked to
                         -40.0            NS                                              -40.0                                  -37.1
                         -50.0                           -44.8 -45.9                      -50.0                                           -43.9                         psychopharmacological agents
                                                                                                                                 NS
                         -60.0    E                      NS               -55.4           -60.0   E
                                                                                                                                                   -50.7                withdrawal.
                                  ES p< 0.01 vs baseline                          -63.0                     p< 0.01 vs baseline                    *
                         -70.0                                               *            -70.0   ES

                            *** p< 0.01; ** p< 0.02; p< 0.05 between treatments

                                                                                 Oral communication presented at the
                                              13° World Congress of Gynaecological Endocrinology. Florence, Italy – February 28 - March 2, 2008

				
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