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EstroG-100© clinical studies

The plant extract EstroG-100© has been investigated in numerous international studies. Three prospective, randomised, double-blind, placebo-controlled clinical studies focussing on efficacy and tolerability were conducted in Korean university hospitals and one Californian hospital on women in the age range of 40–70 years with climacteric symptoms.

In the first study, a significant improvement in climacteric symptoms was observed after three months compared to the placebo (Lee et al., 2005). In two subsequent studies, the effect was evaluated with the Kupperman menopausal index (KMI), an established test method for assessing the quality of life of menopausal women by means of a score.

In the US study, the plant extract led to a statistically significant improvement of 62% in the KMI compared to the placebo (Chang et al., 2012). The Korea II study delivered comparable results with 58% (Lee et al., 2014). Specifically, an improvement was observed in 12 typical menopausal symptoms (Chang et al., 2012).

No side effects occurred in any clinical study and there was no statistically significant difference in body weight, BMI, serum oestradiol or follicle stimulating hormone (FSH) compared to the baseline in all clinical studies.

In addition, several studies have shown that the EstroG© extract has no binding affinity to oestrogen receptors (Bo-Yeon Kwak et al., 2008) and no stimulatory effects on the growth of oestrogen-sensitive tissues such as female breast cells and endometrium. Furthermore, there were several toxicological studies in which the EstroG© extract showed no toxicological abnormality.

Korea I study

Lee KH, Lee DJ, Kim SM, Je SH, Kim EK, Han HS, Han IK. Evaluation of Effectiveness and Safety of Natural Plants Extract (Estromon®) on Perimenopausal Women for 1 Year. J. of Korea Society of Menopause. Vol. 11 No.1 March 2005, p1–11.

Study design

Randomised, double-blind, placebo-controlled study.
Primary endpoint: Improvement in menopausal symptoms.
Secondary endpoint: Evaluation of efficacy (bone density, serum osteocalcin, serum ALP, etc.)

Study site

School of Medicine, Sungkyunkwan Univ., Samsung Cheil Hospital (Seoul, Korea)

Study duration

Primary endpoint (climacteric syndrome): 12 weeks
Secondary endpoint and safety: 52 weeks (May 2003 – April 2004)

Dosage

514 mg daily as EstroG-100©

Study participants

24 in placebo group & 19 in treatment group (48 were enrolled, including six drop-outs)

Inclusion criteria

Diagnosed menopausal syndrome. Age between 46–66 years (mean age = 54)

Introduction/background

Due to the reports from the WHI study on the increased risk of hormone therapy for the occurrence of breast cancer, heart disease, stroke and thrombosis and the FDA warning against the long-term use of oestrogen replacement therapy and the lack of approval for phytoestrogens in Korea, the aim of this study at that time in 2003 was to investigate an extract from three natural plants in a clinical study for its efficacy and safety in women with menopausal symptoms.

Design

Prospective randomised, double-blind, placebo-controlled clinical study in women over 45 years of age with menopausal symptoms who received two capsules twice daily of verum (Estromon®=EstroG100©) or placebo (corn starch) for 48 weeks.

  • Primary endpoint: Change in menopausal symptoms after three months of capsule use.
  • Secondary endpoint: Change in individual variables after 12 months of capsule use.

The women’s age, pregnancy and menopause data as well as height, weight, waist circumference, body mass index, blood pressure, pulse, compliance with study material and additional comedications were documented at defined points after one, three, six, nine and twelve months, nine and twelve months at a hospital visit, with oestrogen, FSH, hGH, cholesterol, LDL, HDL, AP, osteocalcin, triglycerides, bone density and general haematological parameters determined, and interviews were conducted on improvement in menopausal symptoms within three months.

Results

48 women over 45 years of age with menopausal symptoms were enrolled in the study between 2003 and 2004. Of these, 24 women received Estromon® and 24 women received corn starch as a placebo for 48 weeks. 42 patients could be included in the complete final evaluation. Of the drop-outs, five left the study for their own reasons and one because she had skin symptoms. 19 patients were evaluated from the study group and 23 women from the placebo group. The mean age was 54 years with a range of 46–66. At the baseline examination at the start of the study, there were no significant differences in biophysical profiles except for a higher mean bone density in the verum group.

Primary endpoint:

Three months after the start of the study, 14 of 24 women in the verum group but only five of 23 women in the placebo group showed improvements in their climacteric symptoms (significant with an odds ratio of 5.04). Among the women who already had symptoms at the baseline assessment, the difference was not significant (4/7 vs. 5/6).

Secondary endpoint:

Femoral neck bone density at 12 months was significantly higher in the verum group (p0.05), while it decreased significantly in the placebo group (p0.05). Serum osteocalcin at 12 months was significantly lower in the verum group (p-values not clear in the table) and significantly higher in the placebo group (p0.05). Serum alkaline phosphatase was significantly lower in the verum group (p0.05). Serum hGH increased significantly in both the verum and placebo groups after 12 months, increasing by 268% in the former and 42% in the latter (p0.05). Serum triglycerides decreased in both groups, not significantly in the placebo group and significantly in the verum group after 12 months (p0.05).

Serum cholesterol showed no differences in either group after 12 months, nor did blood pressure, oestrogen, weight, BMI, FSH, LDL, HDL or spinal bone density.

Conclusion of the authors

Estromon® is composed of Phlomis umbrosa, which contains saponin including triterpene glycosides, and Cynanchum wilfordii contains saponin including wilforside and cyanuricuoside, which leads the authors to believe that the saponin activates the steroidal oestrogen receptor and thereby improves menopausal symptoms. Furthermore, Estromon® contains Angelica gigas, and its decursin acts as a coumarin derivative and thus as a phytoestrogen.

The authors conclude that Estromon® can be used to relieve climacteric symptoms such as hot flushes, joint pain and sweating without the usual side effects such as weight gain or increase in BMI or serum triglycerides.

Evaluation/conclusion

The prospective randomised, double-blind, placebo-controlled clinical study shows the effect of the plant extract on climacteric symptoms in a small number of cases, though relatively clearly. Unfortunately, these are not quantified further (but only improvement yes/no) and the symptoms are not listed and analysed individually. On the other hand, detailed potential effects on the bone, liver and hormone metabolism are excluded by determining numerous serum parameters and thus typical side effects of hormone therapy. Interestingly, the study group even showed an improvement in the bone density of the femoral neck.

USA study

Chang A, Kwak BY, Yi K, Kim JS. The effect of herbal extract (EstroG-100©) on pre-, peri- and post-menopausal women: a randomized double-blind, placebo-controlled study. Phytother Res. 2012 Apr;26(4):510–6.

Study design

Randomised, double-blind, placebo-controlled study.
Primary endpoint: Mean change in Kupperman menopausal index (by questionnaire.
Secondary endpoint: Mean change in score of 11 individual menopausal symptoms (KMI) and vaginal dryness.

Study site

Friends Medical Group (California, USA)

Study duration

12 weeks (May 2009 ~ January 2010).

Dosage

514 mg daily as EstroG-100©

Study participants

32 in placebo group & 29 in treatment group (64 were enrolled, including three drop-outs)

Introduction/background

Since the WHI study data showed a 26% increase in risk of breast cancer, 29% increase in risk of heart disease and 41% increase in risk of stroke with hormone replacement therapy, and there is a lack of scientific evidence on the efficacy of herbal supplements, EstroG-100© should be investigated for its efficacy on menopausal symptoms in a clinical study in non-Asian American women.

Design

Prospective, randomised, double-blind, placebo-controlled clinical study of the safety and efficacy of EstroG-100© in women with moderate to severe menopausal symptoms (Kupperman index score > 20). All study participants received either the verum preparation or a placebo, given as a tablet twice a day for 12 weeks.

The primary endpoint was an improvement in quality of life on the Kupperman index (menopausal index) as well as individual symptoms (vasomotor symptoms, numbness and tingling, sleep disturbances, nervousness, depressed mood, dizziness, fatigue, joint pain, headache, palpitations and tingling) and vaginal dryness.

Height, weight, BMI, smoking and alcohol consumption, blood pressure, pulse, body temperature, serum markers AP, osteocalcin, triglycerides, LDL, HDL, cholesterol, blood count, AST; ALT, creatinine, total protein, albumin, fasting glucose, oestradiol (E2) and FSH were also assessed.

Results

61 women were enrolled in the study between May 2009 and January 2010. The verum group showed a highly significant decrease in the Kupperman index because of treatment and also a highly significant greater decrease than the placebo group (from a mean of 29.5 to 13.6 at six and 11.3 at twelve weeks versus from 29.2 to 23.3 and 23.7 respectively, p<0.01). With regard to the individual symptoms, the verum group also showed a highly significant improvement in vasomotor complaints, as well as insomnia, nervousness, depressive mood, dizziness and fatigue, palpitations, tingling sensations after six and after twelve weeks, the symptoms of paraesthesia and joint pain after twelve weeks compared to the baseline (p<0.01) and versus the placebo group also at twelve weeks (p<0.05), and also on vaginal dryness versus the baseline at six and twelve weeks (p<0.01) and versus the placebo group (p<0.05), with the latter also showing a highly significant improvement in vaginal dryness at twelve weeks.

Safety: E2 and FSH levels did not change significantly during treatment, nor did weight and BMI in either group.

No side effects of the medication occurred in the verum group during the study.

EstroG-100: Ergebnisse individuelle menopausale Syndrome

Conclusion of the authors

Twelve weeks of treatment with EstroG-100© showed a statistically significant improvement in various menopausal symptoms such as hot flushes, night sweats, numbness, sleep disturbances, nervousness, depressed mood, dizziness, fatigue, joint pain and vaginal dryness compared to the placebo group. No side effects were reported after taking EstroG-100©, nor were changes in weight, BMI, serum E2 or FSH levels, or liver enzymes.

Short version: EstroG-100© was shown to be an effective and safe dietary supplement in pre-, peri- and postmenopausal women with menopausal symptoms.

Evaluation/conclusion

The study, which is very significant due to its design, shows the impressive effect of EstroG-100© with only three months of treatment on the menopausal complaints of American women already after six weeks, but in any case after twelve weeks, without any relevant side effects or metabolic changes. At the same time, the significantly positive effect of the placebo preparation on menopausal symptoms is also very interesting. The cause of this effect can only be speculated, which might have to be deducted from the overall effect of EstroG-100©.

Korea II study

Lee DJ, Kim T, Seo SK. The Evaluation of the Efficacy and Safety of Herbal Extract (PAC EX01: EstroG 100©) on Menopausal Symptoms: 12 weeks, Multi Centre, A randomized, Double Blind Placebo-Controlled Clinical Study.

Study design

Randomised, double-blind, placebo-controlled study.
Primary endpoint: Mean change in Kupperman menopausal index (by questionnaire.
Secondary endpoint: Mean change in score of 11 individual menopausal symptoms (KMI) and vaginal dryness.

Study site

Ajou University Medical Centre

Korea University Anam Hospital

Yonsei University College of Medicine Severance Hospital (Seoul & Suwon, Korea)

Study duration

12 weeks (March – August 2014)

Dosage

514 mg daily as EstroG-100©

Study participants

96 women aged 40–70 years with menopausal symptoms (105 were enrolled, including 9 drop-outs).

Inclusion criteria

Menopausal syndrome, age between 40–70 years (mean age = 54).

Introduction/background

After numerous promising in vitro and in vivo studies on the plant root extract EstroG-100© (Cynanchum wilfordii, Phlomis umbrosa, and Angelica gigas) and initial clinical studies on the effect of EstroG-100© on menopausal symptoms, the aim of this study was to investigate the effect of EstroG-100© taken orally on menopausal symptoms in a larger number of women with such symptoms in a multi-centre setting.

Design

Prospective, randomised, double-blind, multi-centre clinical study of the safety and efficacy of EstroG-100© in women with moderate to severe menopausal symptoms (Kupperman menopausal index > 20). The primary endpoint was an improvement in quality of life on the Kupperman index (menopausal index), and the secondary endpoint was an improvement in the individual symptoms of the Kupperman index (vasomotor complaints, numbness, sleep disturbances, nervousness, depressive mood, dizziness, fatigue, joint pain, headaches, palpitations, tingling) and vaginal dryness.

Furthermore, height, weight, BMI, smoking and alcohol consumption, blood pressure, pulse, body temperature, serum markers AP, osteocalcin, triglycerides, LDL, HDL, cholesterol, blood count, AST; ALT, creatinine, total protein, albumin, fasting glucose, oestradiol (E2) and FSH were examined.

Study participants received either the verum drug or a placebo, each as two tablets per day for 12 weeks.

Results

122 women with menopausal symptoms were screened between November 2013 and August 2014 and of these, 105 were included in the study. Nine women were excluded from the final analysis before reaching the endpoint. In total, 96 women with a mean age of 54 years were included in the analysis. The groups did not differ in their general baseline data. The women in the verum group had a slightly higher Kupperman index at the start of the study. After four weeks, there was a significantly greater decrease in the Kupperman index in the verum group than in the placebo group (from a mean of 35.1 to 23.2 vs. 33.1 to 24.7, p<0.05) and a highly significant stronger decrease after 12 weeks (14.8 vs. 20.1, p<0.01). With regard to the individual symptoms, the verum group showed a significantly greater improvement in vasomotor complaints, tingling and numbness and nervousness, depressive mood, dizziness, fatigue and joint pain, palpitations (heart palpitations), tingling sensations and also vaginal dryness after 12 weeks of treatment, as well as a barely non-significant improvement in sleep disorders (p=0.052).

Regarding safety: AP and triglyceride levels were significantly higher in both groups after treatment than at the baseline (p<0.01 and p<0.05, respectively), while creatinine levels were highly significantly lower (for the total and verum groups p<0.01, for the control group p<0.05), with all mean values remaining within the normal range. White blood cell counts were significantly increased in the verum group compared to the baseline and also compared to the placebo group (p<0.01), while also remaining within the normal range. Although there was no significant increase in fasting glucose in the verum group, it was significantly higher in the verum group than in the placebo group after treatment (p<0.05). Weight, BMI and blood pressures were not significantly changed after treatment, nor were they between the groups. E2 and FSH levels were also not significantly different.

No side effects of the medication occurred in the verum group during the study.

Conclusion of the authors

EstroG-100©, administered over 12 weeks, significantly improved the quality of life and also the nine different individual symptoms of the Kupperman index in women with menopausal symptoms, without any side effects being reported or the laboratory values examined changing to pathological.

Short version: EstroG-100© proved to be a safe and effective herbal preparation in the treatment of quality of life and individual symptoms in women with menopausal symptoms.

Evaluation/conclusion

This data from the prospective, randomised, double-blind clinical studies impressively confirms the promising in vitro and in vivo results of EstroG-100© and give hope for an herbal oestrogen alternative for the treatment of women with menopausal symptoms without the typical oestrogen side effects, with changes in serum parameters indicating that EstroG-100© exerts effects on the metabolism.

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