Wirkung des isopropanolischen Cimicifuga-racemosa-­Extrakts iCR auf Uterusmyome bei Frauen mit ­klimakterischen Beschwerden

Zusammenfassung

Der Einfluss des isopropanolischen Cimici­fuga-racemosa-Extrakts iCR auf Uterusmyome wurde an menopausalen Frauen mit klimakterischen Beschwerden untersucht. Die Studienpopulation entstammte einer randomisierten, kontrollierten (vs. Tibolon) Doppelblindstudie. Mit transvaginalen ­Ultraschallmessungen wurden die Tumordurchmesser (dreidimensional) gemessen und die Volumenänderungen im Vorher-­Nachher-Vergleich bestimmt. Nach 12-wöchiger Therapie mit iCR (n=34) war das ­Volumen der Myome deutlich reduziert (-30,3 %) und signifikant unterschiedlich (p=0,016) zu der Zunahme von 4,7 % unter Tibolon (n=28). Die Responderrate (Volumenabnahme) lag für iCR bei 70 % (Tibolon: 36 %). Die Confounder-adjustierte logistische Regression ergab eine 4,7-fach höhere Wahrscheinlichkeit, dass Myome unter iCR kleiner werden als unter Tibolon (p=0,008). Die Ergebnisse dieser Untersuchung weisen auf einen zusätzlichen Nutzen von iCR bei der Therapie klimakterischer Beschwerden von Patientinnen mit Myomen hin.

Summary

Effect of the isopropanolic Cimicifuga racemosa extract iCR on uterus myoma in women with climacteric complaints

The effect of the isopropanolic Cimicifuga racemosa extract iCR on uterus myoma has been studied in menopausal women with climacteric symptoms. The study population derived from a recent randomized, controlled (vs. tibolone) double-blind study. Transvaginal ultrasound was performed for measuring the (three-dimensional) diameters of the myoma, determining changes in volume for the pre-post comparison. After 12 weeks treatment with iCR (n=34), myoma volume was reduced by 30.3%, significantly different to the increase by 4.7% under tibolone (p=0.016). The responder rate (reduction in volume) for iCR was 70% (tibolone: 36%). The confounder-adjusted logistic regression revealed a 4.7 times higher probability of myoma reduction under iCR compared to tibolone (p=0.008). The results demonstrate an additional benefit for iCR during treatment of climacteric symptoms in women with myoma.

Schlüsselwörter

Cimicifuga racemosa - Tibolon - Uterusmyome

Keywords

Black cohosh - tibolone - uterus myoma

• Literatur

• 1 Ang WC, Farrell E, Vollenhoven B. Effect of hormone replacement therapies and selective estrogen receptor modulators in postmenopausal women with uterine leiomyomas. Climacteric 2001; 4: 284-292
• 2 Bai W, Henneicke-von Zepelin HH, 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 2007; 58: 31-41
• 3 Beer AM. Update Cimicifuga racemosa − neue Erkenntnisse aus Wissenschaft und Forschung: Differenzierte Evidenz für Wirksamkeit und Sicherheit von Traubensilberkerzen-Arzneimitteln zur Behandlung klimakterischer Beschwerden. Journal für Gynäkologische Endokrinologie 2014; 24(4): 6-10 http://www.kup.at/kup/pdf/12573.pdf
• 4 Beer AM, Neff A. Differentiated evaluation of extract-specific evidence on Cimicifuga racemosa’s efficacy and safety for climacteric complaints. Evid Based Complement Alternat Med 2013 2013 860602
• 5 Bulun SE. Uterine Fibroids. N Engl J Med 2013; 469: 1344-1355
• 6 De Leo V, Morgante G, La Marca A et al. A benefit-risk assessment of medical treatment for uterine leiomyomas. Drug Saf 2002; 25: 759-779
• 7 Donnez J, Tatarchuk T, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012; 366: 409-420
• 8 Gregoriou O, Konidaris S, Botsis D et al. Long term effects of tibolone on postmenopausal women with uterine myomas. Maturitas 2001; 40: 95-99
• 9 Henneicke-von Zepelin HH, Meden H, Kostev K et al. Isopropanolic black cohosh extract and recurrence-free survival after breast cancer. Int J Clin Pharmacol Ther 2007; 45: 143-154
• 10 Kenemans P, Speroff L. Tibolon − Klinische Empfehlungen und praktische Richtlinien. Ein Bericht der internationalen Tibolon Konsensus-Gruppe. Frauenarzt 2005; 46: 575-580
• 11 Kenemans P, Bundred NJ, Foidart JM et al. Safety and efficacy of tibolone in breast cancer patients with vasomotor symptoms: a double-blind, randomised, non-inferiority trial. Lancet Oncol 2009; 10: 135-146
• 12 Kloosterboer HJ. Historische Meilensteine bei der Entwicklung von Tibolon. Journal für Gynäkologische Endokrinologie 2008; 11(1): 38-46 [Ausgabe für Schweiz]. http://www.kup.at/kup/pdf/7055.pdf
• 13 Li W, Sun NX, Chen X et al. Cimicifuga racemosa for treatment of menopausal symptoms in patients with early endometrial cancer after operation. Acad J Sec Mil Med Univ 2012; 33: 562-564
• 14 Linden-Hirschberg AL, Edlund M, Svane G et al. An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women. Menopause 2007; 14: 89-96
• 15 Liske E, Hänggi W, Henneicke-von Zepelin HH et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med 2002; 11: 163-174
• 16 Lundström E, Linden-Hirschberg AL, Södderqvist G. Digitized assessment of mammographic breast density − effects of continuous combined hormone therapy, tibolone and black cohosh compared to placebo. Maturitas 2011; 70: 361-364
• 17 Mavrelos D, Ben-Nagi J, Holland T et al. The natural history of fibroids. Ultrasound Obstet Gynecol 2010; 35: 238-242
• 18 Nappi RE, Malavasi B, Brundu B et al. Efficacy of Cimicifuga racemosa on climacteric complaints: A randomized study versus low-dose transdermal estradiol. Gynecol Endocrinol 2005; 20: 30-35
• 19 Nesselhut T, Liske E. Pharmacological measures in postmenopausal women with an isopropanolic aqueous extract of Cimicifugae racemosae rhizoma. Menopause 1999; 6: 331-
• 20 Obi N, Chang-Claude J, Berger J et al. The use of herbal preparations to alleviate climacteric disorders and risk of postmenopausal breast cancer in a German case-control study. Cancer Epidemiol Biomarkers Prev 2009; 18: 2207-2213
• 21 Parker WH. Etiology, symptomatology, and diagnosis of uterine myomas. Fertil Steril 2007; 87: 725-736
• 22 Peddada SD, Laughlin SK, Miner K et al. Growth of uterine leiomyomata among premenopausal black and white women. PNAS 2008; 105: 1987-1992
• 23 Rebbeck TR, Troxel AB, Norman S et al. A retrospective case-control study of the use of hormone-related supplements and association with breast cancer. Int J Cancer 2007; 120: 1523-1528
• 24 Stute P, Nisslein T, Götte M et al. Effects of black cohosh on estrogen biosynthesis in normal breast tissue in vitro. Maturitas 2007; 57: 382-391
• 25 von Wahlde MK, Kiesel L. Behandlung von klimakterischen Beschwerden nach Brustkrebs. Gynäkologische Endokrinologie 2014; 12: 156-161
• 26 Xi S, Liske E, Wang S et al. Effect of isopropanolic Cimicifuga racemosa extract on uterine fibroids in comparison with tibolone among patients of a recent randomized, double blind, parallel-controlled study in Chinese women with menopausal symptoms. Evid Based Complement Alternat Med 2014 2014 717686