The effect of a Cimicifuga racemosa extracts Ze 450 (simidona) in the treatment of climacteric complaints – an observational study

Juergen Drewe, Christian Zimmermann, Catherine Zahner

Abstract


Background: Root extracts of Cimicifuga racemosa (L.) Nutt. have been successfully used in the treatment of climacteric complaints.

Method: In this observational study, Cimicifuga racemosa (CR) extract Ze 450 was studied in 442 unselected ambulatory female outpatients with menopausal complaints under daily practice conditions. Physicians were suggested to treat patients for the first 3 months with 13 mg/d CR (high dose) and to continue over additional 6 months either with this treatment or to switch to 6.5 mg/d CR (low dose). The choice of treatment and its dose, however, was fully at the discretion of the physician.

Results: After 3-months treatment with high dose, symptom severity (Kupperman Menopause Index, KMI) decreased significantly (p < 0.001) from baseline values. Continuation of treatment with high dose or low dose decreased total KMI and its sub-item scores further (high dose, low dose: p < 0.001). However, more patients (84.9%) responded to high dose than to low dose (78.4%) and showed an improvement of symptoms (p = 0.011).

Conclusion: This observational study demonstrated that treatment with CR in unselected patients with climacteric complaints under the conditions of daily practice resulted in a significant improvement of menopausal symptoms assessed by the total KMI score and its sub-item scores with an effect size similar to that in a previous randomized, controlled clinical trial. Treatment with both doses Ze 450 (low and high dose) is well tolerated by patients and has an additional positive effect in extending the treatment for more than 3 months, with a further decrease in the total KMI. However, prolonged treatment with a high dose is more efficient, since it, in contrast to the low dose therapy, can significantly reduce each of menopausal symptoms.


Keywords


menopausal symptoms; Cimicifuga racemosa; observational study; Kupperman Menopause Index; phytotherapy; Ze 450

References


Bai, W., Henneicke-von Zepelin, H.-H., Wang, S., et al. “Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone.” Maturitas 58.1 (2007): 31–41.

Benson, K., Hartz, A.J. “A comparison of observational studies and randomized, controlled trials.” New England Journal of Medicine 342.25 (2000): 1878–86.

Carlson, M.D., Morrison, R.S. “Study design, precision, and validity in observational studies.” Journal of Palliative Medicine 12.1 (2009): 77–82.

Cochran, W.G. “The planning of observational studies of human populations (with discussion).” Journal of the Royal Statistical Society Series A 128 (1965): 134–55.

Concato, J., Shah, N., Horwitz, R.I. “Randomized, controlled trials, observational studies, and the hierarchy of research designs.” New England Journal of Medicine 342.25 (2000): 1887–92.

Committee on Herbal Medicinal Products, European Medicines Agency. Community Herbal Monograph on Cimicifuga racemosa (L.) Nutt., Rhizoma (2010). EMA/HMPC/600717/2007.

European Scientific Cooperative on Phytotherapy. Cimicifugae rhizoma. Black cohosh, ESCOP Monographs, Scientific Foundation for Herbal Medicinal Products, 2nd edn. Georg Thieme-Verlag, Stuttgart, New York (2003): 79–91.

Halmesmaki, K., Hurskainen, R., Tiitinen, A., et al. “A randomized controlled trial of hysterectomy or levonorgestrel-releasing intrauterine system in the treatment of menorrhagia-effect on FSH levels and menopausal symptoms.” Human Reproduction 19.2 (2004): 378–82.

Ioannidis, J.P., Haidich, A.B., Pappa, M., et al. “Comparison of evidence of treatment effects in randomized and nonrandomized studies.” JAMA 286.7 (2001): 821–30.

Kupperman, S., Wetchler, B.B., Blatt, M.H. “Contemporary therapy of the menopausal syndrome.” JAMA 171.12 (1959): 1627–37.

Liske, E., Hanggi, W., Henneicke-von Zepelin, H.-H., et al. “Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect.” Journal of Women’s Health and Gender-Based Medicine 11.2 (2002): 163–74.

MacLehose, R.R., Reeves, B.C., Harvey, I.M., et al. “A systematic review of comparisons of effect sizes derived from randomised and non-randomised studies.” Health technology assessment (Winchester, England) 4.34 (2000): 1–154.

Mitchell, M.L., Jolley, J.M. Research design explained. Wadsworth, Belmont, CA, USA (2010).

Osmers, R., Friede, M., Liske, E., et al. “Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.” Obstetrics and Gynecology 105.5 Pt 1 (2005): 1074–83.

Palacio, C., Masri, G., Mooradian, A.D. “Black cohosh for the management of menopausal symptoms: a systematic review of clinical trials.” Drugs and Aging 26.1 (2009): 23–36.

Schellenberg, R., Saller, R., Hess, L., et al. “Dose-dependent effects of the Cimicifuga racemosa extract Ze 450 in the treatment of climacteric complaints – a randomized, placebo-controlled study.” Evidence-Based Complementary and Alternative Medicine 10 (2012).

Schneider, H.P., Heinemann, L.A., Rosemeier, H.P., et al. “The Menopause Rating Scale (MRS): comparison with Kupperman index and quality-of-life scale SF-36.” Climacteric 3.1 (2000a): 50–8.

Schneider, H.P., Heinemann, L.A., Rosemeier, H.P., et al. “The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints.” Climacteric 3.1 (2000b): 59–64.

Stoll, W. “Phytotherapeuticon influences atrophic vaginal epithelium.” Therapeutikon 1.23 (1987): 23–31.

Swissmedic. Notifications of Clinical Trials. 2.2 Definitions (2012).

Wong, V.C., Lim, C.E., Luo, X., Wong, W.S. “Current alternative and complementary therapies used in menopause.” Gynecological Endocrinology 25.3 (2009): 166–74.

Wuttke, W., Seidlova-Wuttke, D., Gorkow, C. “The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptoms and bone markers.” Maturitas 44.1 (2003): 67–77.


GOST Style Citations


1. Bai, W., Henneicke-von Zepelin, H.-H., Wang, S., et al. “Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone.” Maturitas 58.1 (2007): 31–41.

2. Benson, K., Hartz, A.J. “A comparison of observational studies and randomized, controlled trials.” New England Journal of Medicine 342.25 (2000): 1878–86.

3. Carlson, M.D., Morrison, R.S. “Study design, precision, and validity in observational studies.” Journal of Palliative Medicine 12.1 (2009): 77–82.

4. Cochran, W.G. “The planning of observational studies of human populations (with discussion).” Journal of the Royal Statistical Society Series A 128 (1965): 134–55.

5. Concato, J., Shah, N., Horwitz, R.I. “Randomized, controlled trials, observational studies, and the hierarchy of research designs.” New England Journal of Medicine 342.25 (2000): 1887–92.

6. Committee on Herbal Medicinal Products, European Medicines Agency. Community Herbal Monograph on Cimicifuga racemosa (L.) Nutt., Rhizoma (2010). EMA/HMPC/600717/2007.

7. European Scientific Cooperative on Phytotherapy. Cimicifugae rhizoma. Black cohosh, ESCOP Monographs, Scientific Foundation for Herbal Medicinal Products, 2nd edn. Georg Thieme-Verlag, Stuttgart, New York (2003): 79–91.

8. Halmesmaki, K., Hurskainen, R., Tiitinen, A., et al. “A randomized controlled trial of hysterectomy or levonorgestrel-releasing intrauterine system in the treatment of menorrhagia-effect on FSH levels and menopausal symptoms.” Human Reproduction 19.2 (2004): 378–82.

9. Ioannidis, J.P., Haidich, A.B., Pappa, M., et al. “Comparison of evidence of treatment effects in randomized and nonrandomized studies.” JAMA 286.7 (2001): 821–30.

10. Kupperman, S., Wetchler, B.B., Blatt, M.H. “Contemporary therapy of the menopausal syndrome.” JAMA 171.12 (1959): 1627–37.

11. Liske, E., Hanggi, W., Henneicke-von Zepelin, H.-H., et al. “Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect.” Journal of Women’s Health and Gender-Based Medicine 11.2 (2002): 163–74.

12. MacLehose, R.R., Reeves, B.C., Harvey, I.M., et al. “A systematic review of comparisons of effect sizes derived from randomised and non-randomised studies.” Health technology assessment (Winchester, England) 4.34 (2000): 1–154.

13. Mitchell, M.L., Jolley, J.M. Research design explained. Wadsworth, Belmont, CA, USA (2010).

14. Osmers, R., Friede, M., Liske, E., et al. “Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.” Obstetrics and Gynecology 105.5 Pt 1 (2005): 1074–83.

15. Palacio, C., Masri, G., Mooradian, A.D. “Black cohosh for the management of menopausal symptoms: a systematic review of clinical trials.” Drugs and Aging 26.1 (2009): 23–36.

16. Schellenberg, R., Saller, R., Hess, L., et al. “Dose-dependent effects of the Cimicifuga racemosa extract Ze 450 in the treatment of climacteric complaints – a randomized, placebo-controlled study.” Evidence-Based Complementary and Alternative Medicine 10 (2012).

17. Schneider, H.P., Heinemann, L.A., Rosemeier, H.P., et al. “The Menopause Rating Scale (MRS): comparison with Kupperman index and quality-of-life scale SF-36.” Climacteric 3.1 (2000a): 50–8.

18. Schneider, H.P., Heinemann, L.A., Rosemeier, H.P., et al. “The Menopause Rating Scale (MRS): reliability of scores of menopausal complaints.” Climacteric 3.1 (2000b): 59–64.

19. Stoll, W. “Phytotherapeuticon influences atrophic vaginal epithelium.” Therapeutikon 1.23 (1987): 23–31.

20. Swissmedic. Notifications of Clinical Trials. 2.2 Definitions (2012).

21. Wong, V.C., Lim, C.E., Luo, X., Wong, W.S. “Current alternative and complementary therapies used in menopause.” Gynecological Endocrinology 25.3 (2009): 166–74.

22. Wuttke, W., Seidlova-Wuttke, D., Gorkow, C. “The Cimicifuga preparation BNO 1055 vs. conjugated estrogens in a double-blind placebo-controlled study: effects on menopause symptoms and bone markers.” Maturitas 44.1 (2003): 67–77. 





DOI: http://dx.doi.org/10.18370/2309-4117.2016.32.77-86

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