MET2378 Estrovera Formula Focus Sheet
Formula Focus
Estrovera® Featuring ERr 731®
83% decrease in daily hot flashes*†1
Menopausal Relief Nearly 80% of women in Western countries suffer from hot flashes
Ho t
during menopause.2 Estrovera, featuring ERr 731®, provides safe,
Fl a s h
nonhormonal relief from hot flashes and other menopausal symptoms.*
Sleep disturbances
Irritability
Key Ingredient • ERr 731® is a patented plant-based extract of Siberian rhubarb that has been recommended by healthcare practitioners in Europe for over 24 years
Negativ e Mo od
ems
P ro b l
ual
Physical and mental exhaustion
Joi nt Disc& Muscula omfo r rt
S ex
Vaginal dryness
in Menopausal Symptoms*††
ty
Urinary tract discomfort
A n xi e
Sexual problems
ty
Reduction
• ERr 731® reduced a wide range of other menopausal symptoms by 83% in another 12-week RCT, including:*††3,4 Negative mood
83%
abili
• In a 12-week randomized controlled trial (RCT), ERr 731® reduced the number of daily hot flashes from 12 to 2—an 83% reduction*†1
Anxiety
up to
Irrit
Why Estrovera®?
S Distur leep ban ces
es
l Dr y Vagina
nes
s
– ERr 731®, the main ingredient in Estrovera, demonstrates selective affinity for ERb in endometrial tissue.*12,13
Estrogen (17b-estradiol)
ERα
ERr 731®
ERα
ERb
ERb R2
CH3 H
OH R1 R3 R1 R 2
H HO
Compared with perimenopausal women receiving placebo, those receiving Estrovera’s extract experienced a median 83% decrease in daily hot flashes.1 †† Compared with perimenopuasal women receiving placebo, those receiving Estrovera’s extract experienced decreases in symptoms as indicated by the mean reduction in individual Menopause Rating Scale scores.3 †
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
R3
Rhaponticin OH OCH3 O-glycoside Desoxyrhaponticin H OCH3 O-glycoside
H OH
Rhapontigenin OH OCH3 OH Desoxyrhapontigenin H OCH3 OH
Formula Focus
Clinical research Figure 1
• In a six-month study, ERr 731® demonstrated significant relief of 11 symptoms measured by the Menopause Rating Scale (Figure 1)*5 • Published postmarketing surveillance data confirms the safety of ERr 731® from approximately 153 million doses sold since 1993*6 • ERr 731® demonstrated a sustained alleviation of menopausal symptoms, and no changes in safety parameters were observed over two years*3 • The mean MRS II total score was reduced from 34.0 at baseline to 5.7 at end of observational Study II (after two years)—an 83% reduction (Figure 2)*†††3
MENOPAUSE RATING SCALE POINTS
• Two multicenter, randomized, placebo-controlled, clinical trials1,3,4 4
3
2
1
0 Negative Mood
Irritability
Baseline
Anxiety
Physical & Emotional Exhaustion
Hot Flashes/ Sweating
Heart Discomfort
Sleep Disturbances
Follow-up visit after 3 months
Joint & Muscular Discomfort
Sexual Problems
Urinary Tract Discomfort
Vaginal Dryness
Final assessment after 6 months
–Open observational study of 252 peri- and postmenopausal women4 –MRS scores at baseline, 3 months, and 6 months
Form: 30 Tablets, 90 Tablets Serving Size: 1 Tablet Rhapontic Rhubarb† .......................... 4 mg (Rheum rhaponticum L.) Root Extract (ERr 731®) [Providing 2.2 mg rhaponticin and 1 mg desoxyrhaponticin]
Directions: Take one tablet with food and a glass of water once daily at the same time of day or as directed by your healthcare practitioner. This product is non-GMO, gluten-free, and vegetarian. Caution: Do not use if pregnant or nursing. This product is contraindicated for individuals with any known or suspected estrogen-dependent cancer. If taking medication, consult your healthcare practitioner before use. Also known as Siberian rhubarb root.
†
50 45 MRS II TOTAL SCORE
Other Ingredients: Microcrystalline cellulose, stearic acid (vegetable), croscarmellose sodium, silica, and enteric coating (ethyl cellulose, ammonium hydroxide, hydroxypropylmethylcellulose, hydroxypropylcellulose, medium chain triglycerides, sodium alginate, oleic acid, and stearic acid).
Figure 2
55
End of 3-month RCT and beginning of Observational Studies I & II (all subjects now taking equal doses of ERr 731®)
40 35 30 25 20 15 10 5 0 12
3-month RCT
24
36
48
60
Phase I–Week 12-60 Observational Study
Placebo for first 12 weeks
72
84
96
Phase II–Week 60-108 Observational Study
ERr 731® after 12 weeks
ERr 731® for entire 108 weeks
–12-week randomized, controlled trial followed by 96-week observational study of 109 perimenopausal women with hot flashes3 –ERr 731® showed a dramatic and statistically significant improvement in MRS II (Menopause Rating Scale II) scores*
Complementary Products: References: 1. Kaszkin-Behag M, et al. Altern Ther Health Med. 2009;15(1):24-34. 2. Umland EM. Et al, J Manag Care Pharm. 2008;14(3):S14-19. 3. Hasper I, et al., Menopause. 2009;16:117-131. 4. Heger M, et al., Menopause. 2006;13(5):744-759. 5. Kaszkin-Behag M, et al., Altern Ther Health Med. 2008;14(6):32-38. 6. Chang JL, et al., Integra2ve Med (Encinitas). 2016;15:34-39.
Compared with perimenopausal women receiving placebo, those receiving Estrovera’s extract experienced a 83.3% reduction in MRS II total score over 2 years.
†††
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
• PhytoMulti®—multivitamin and mineral support with phytonutrients* • Ostera®—nutritional support for healthy bone remodeling* • Cal Apatite® Bone Builder® Forte—bone health support with microcrystalline hydroxyapatite*
Talk to your healthcare practitioner today about Estrovera, or visit Metagenics.com
MET2378 092717 © 2017 Metagenics, Inc. All Rights Reserved.
Estrovera® Featuring ERr 731®
83% decrease in daily hot flashes*†1
Menopausal Relief Nearly 80% of women in Western countries suffer from hot flashes
Ho t
during menopause.2 Estrovera, featuring ERr 731®, provides safe,
Fl a s h
nonhormonal relief from hot flashes and other menopausal symptoms.*
Sleep disturbances
Irritability
Key Ingredient • ERr 731® is a patented plant-based extract of Siberian rhubarb that has been recommended by healthcare practitioners in Europe for over 24 years
Negativ e Mo od
ems
P ro b l
ual
Physical and mental exhaustion
Joi nt Disc& Muscula omfo r rt
S ex
Vaginal dryness
in Menopausal Symptoms*††
ty
Urinary tract discomfort
A n xi e
Sexual problems
ty
Reduction
• ERr 731® reduced a wide range of other menopausal symptoms by 83% in another 12-week RCT, including:*††3,4 Negative mood
83%
abili
• In a 12-week randomized controlled trial (RCT), ERr 731® reduced the number of daily hot flashes from 12 to 2—an 83% reduction*†1
Anxiety
up to
Irrit
Why Estrovera®?
S Distur leep ban ces
es
l Dr y Vagina
nes
s
– ERr 731®, the main ingredient in Estrovera, demonstrates selective affinity for ERb in endometrial tissue.*12,13
Estrogen (17b-estradiol)
ERα
ERr 731®
ERα
ERb
ERb R2
CH3 H
OH R1 R3 R1 R 2
H HO
Compared with perimenopausal women receiving placebo, those receiving Estrovera’s extract experienced a median 83% decrease in daily hot flashes.1 †† Compared with perimenopuasal women receiving placebo, those receiving Estrovera’s extract experienced decreases in symptoms as indicated by the mean reduction in individual Menopause Rating Scale scores.3 †
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
R3
Rhaponticin OH OCH3 O-glycoside Desoxyrhaponticin H OCH3 O-glycoside
H OH
Rhapontigenin OH OCH3 OH Desoxyrhapontigenin H OCH3 OH
Formula Focus
Clinical research Figure 1
• In a six-month study, ERr 731® demonstrated significant relief of 11 symptoms measured by the Menopause Rating Scale (Figure 1)*5 • Published postmarketing surveillance data confirms the safety of ERr 731® from approximately 153 million doses sold since 1993*6 • ERr 731® demonstrated a sustained alleviation of menopausal symptoms, and no changes in safety parameters were observed over two years*3 • The mean MRS II total score was reduced from 34.0 at baseline to 5.7 at end of observational Study II (after two years)—an 83% reduction (Figure 2)*†††3
MENOPAUSE RATING SCALE POINTS
• Two multicenter, randomized, placebo-controlled, clinical trials1,3,4 4
3
2
1
0 Negative Mood
Irritability
Baseline
Anxiety
Physical & Emotional Exhaustion
Hot Flashes/ Sweating
Heart Discomfort
Sleep Disturbances
Follow-up visit after 3 months
Joint & Muscular Discomfort
Sexual Problems
Urinary Tract Discomfort
Vaginal Dryness
Final assessment after 6 months
–Open observational study of 252 peri- and postmenopausal women4 –MRS scores at baseline, 3 months, and 6 months
Form: 30 Tablets, 90 Tablets Serving Size: 1 Tablet Rhapontic Rhubarb† .......................... 4 mg (Rheum rhaponticum L.) Root Extract (ERr 731®) [Providing 2.2 mg rhaponticin and 1 mg desoxyrhaponticin]
Directions: Take one tablet with food and a glass of water once daily at the same time of day or as directed by your healthcare practitioner. This product is non-GMO, gluten-free, and vegetarian. Caution: Do not use if pregnant or nursing. This product is contraindicated for individuals with any known or suspected estrogen-dependent cancer. If taking medication, consult your healthcare practitioner before use. Also known as Siberian rhubarb root.
†
50 45 MRS II TOTAL SCORE
Other Ingredients: Microcrystalline cellulose, stearic acid (vegetable), croscarmellose sodium, silica, and enteric coating (ethyl cellulose, ammonium hydroxide, hydroxypropylmethylcellulose, hydroxypropylcellulose, medium chain triglycerides, sodium alginate, oleic acid, and stearic acid).
Figure 2
55
End of 3-month RCT and beginning of Observational Studies I & II (all subjects now taking equal doses of ERr 731®)
40 35 30 25 20 15 10 5 0 12
3-month RCT
24
36
48
60
Phase I–Week 12-60 Observational Study
Placebo for first 12 weeks
72
84
96
Phase II–Week 60-108 Observational Study
ERr 731® after 12 weeks
ERr 731® for entire 108 weeks
–12-week randomized, controlled trial followed by 96-week observational study of 109 perimenopausal women with hot flashes3 –ERr 731® showed a dramatic and statistically significant improvement in MRS II (Menopause Rating Scale II) scores*
Complementary Products: References: 1. Kaszkin-Behag M, et al. Altern Ther Health Med. 2009;15(1):24-34. 2. Umland EM. Et al, J Manag Care Pharm. 2008;14(3):S14-19. 3. Hasper I, et al., Menopause. 2009;16:117-131. 4. Heger M, et al., Menopause. 2006;13(5):744-759. 5. Kaszkin-Behag M, et al., Altern Ther Health Med. 2008;14(6):32-38. 6. Chang JL, et al., Integra2ve Med (Encinitas). 2016;15:34-39.
Compared with perimenopausal women receiving placebo, those receiving Estrovera’s extract experienced a 83.3% reduction in MRS II total score over 2 years.
†††
*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
• PhytoMulti®—multivitamin and mineral support with phytonutrients* • Ostera®—nutritional support for healthy bone remodeling* • Cal Apatite® Bone Builder® Forte—bone health support with microcrystalline hydroxyapatite*
Talk to your healthcare practitioner today about Estrovera, or visit Metagenics.com
MET2378 092717 © 2017 Metagenics, Inc. All Rights Reserved.
