madman
Super Moderator
ABSTRACT
A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John’s wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCRþHP combination was superior to iCR monotherapy. The efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCRþHP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCRþHP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.
Introduction
Up to 80% of climacteric women, especially those suffering from hot flushes, use complementary and alternative medicine, mainly without informing their health-care providers1–5. This highlights not only patients’ wishes but also the need for evidence-based information on the efficacy and safety of these treatments. One of the most popular herbal remedies is Cimicifuga racemosa (CR) syn. Actaea racemosa (black cohosh). CR has been used by Native Americans and Eclectic physicians as a gynecological remedy and for rheumatism and other conditions. The earliest literature references date back to the seventeenth century6. The first allopathic herbal medicinal product (HMP) containing CR rootstock extract was introduced in Germany in 1956 and has been extensively studied since7. In Germany, where HMPs are authorized medicines under strict regulatory control requiring state-of-the-art proof of efficacy, safety, and pharmaceutical quality, gynecologists rate CR treatment as well-known and effective for climacteric symptoms8. In many other countries, CR products are marketed as food supplements (FS). FS is not as rigorously controlled as HMPs and runs the risk of adulteration and contamination. Frequently, FS claiming to consist of authentic North American CR has contained completely different Asian Cimicifuga species9. While FS often have little or no scientific evidence behind them, they are regarded as complementary and alternative medicine. On the other hand, (CR) HMPs are evidence-based rational phytopharmaceuticals and should be treated as such10.
Conclusion and practical consequences
In summary, the clinical data and our meta-analysis consistently demonstrate that iCR/iCRþHP is an effective and safe, evidence-based treatment option for natural neurovegetative and psychological climacteric symptoms, meeting increasing patients’ demands for non-hormonal, herbal therapies. As benefits clearly outweigh risks, iCR/iCRþHP should be recommended to these women. With its good safety profile in general and at estrogen-sensitive organs, iCR can also be used in patients with hormone-dependent tumors suffering from iatrogenic menopausal symptoms. However, this should not take place in self-medication but under medical supervision. Breast-cancer patients are not appropriate candidates for non-supervised self-medication, and it seems reasonable that HD iCR or alternatively iCRþHP are more effective in patients with medication-induced symptoms. Breast cancer patients taking iCR may possibly benefit from prolonged recurrence-free survival, which should be confirmed by further clinical trials.
A systematic literature search revealed 35 clinical studies and one meta-analysis comprising 43,759 women, of which 13,096 were treated with isopropanolic Cimicifuga racemosa extract (iCR). Compared to placebo, iCR was significantly superior for treating neurovegetative and psychological menopausal symptoms, with a standardized mean difference of -0.694 in favor of iCR (p < 0.0001). Effect sizes were larger when higher dosages of iCR as monotherapy or in combination with St. John’s wort (Hypericum perforatum [HP]) were given (-1.020 and -0.999, respectively), suggesting a dose-dependency. For psychological symptoms, the iCRþHP combination was superior to iCR monotherapy. The efficacy of iCR was comparable to low-dose transdermal estradiol or tibolone. Yet, due to its better tolerability, iCR had a significantly better benefit-risk profile than tibolone. Treatment with iCR/iCRþHP was well tolerated with few minor adverse events, with a frequency comparable to placebo. The clinical data did not reveal any evidence of hepatotoxicity. Hormone levels remained unchanged and estrogen-sensitive tissues (e.g. breast, endometrium) were unaffected by iCR treatment. As benefits clearly outweigh risks, iCR/iCRþHP should be recommended as an evidence-based treatment option for natural climacteric symptoms. With its good safety profile in general and at estrogen-sensitive organs, iCR as a non-hormonal herbal therapy can also be used in patients with hormone-dependent diseases who suffer from iatrogenic climacteric symptoms.
Introduction
Up to 80% of climacteric women, especially those suffering from hot flushes, use complementary and alternative medicine, mainly without informing their health-care providers1–5. This highlights not only patients’ wishes but also the need for evidence-based information on the efficacy and safety of these treatments. One of the most popular herbal remedies is Cimicifuga racemosa (CR) syn. Actaea racemosa (black cohosh). CR has been used by Native Americans and Eclectic physicians as a gynecological remedy and for rheumatism and other conditions. The earliest literature references date back to the seventeenth century6. The first allopathic herbal medicinal product (HMP) containing CR rootstock extract was introduced in Germany in 1956 and has been extensively studied since7. In Germany, where HMPs are authorized medicines under strict regulatory control requiring state-of-the-art proof of efficacy, safety, and pharmaceutical quality, gynecologists rate CR treatment as well-known and effective for climacteric symptoms8. In many other countries, CR products are marketed as food supplements (FS). FS is not as rigorously controlled as HMPs and runs the risk of adulteration and contamination. Frequently, FS claiming to consist of authentic North American CR has contained completely different Asian Cimicifuga species9. While FS often have little or no scientific evidence behind them, they are regarded as complementary and alternative medicine. On the other hand, (CR) HMPs are evidence-based rational phytopharmaceuticals and should be treated as such10.
Conclusion and practical consequences
In summary, the clinical data and our meta-analysis consistently demonstrate that iCR/iCRþHP is an effective and safe, evidence-based treatment option for natural neurovegetative and psychological climacteric symptoms, meeting increasing patients’ demands for non-hormonal, herbal therapies. As benefits clearly outweigh risks, iCR/iCRþHP should be recommended to these women. With its good safety profile in general and at estrogen-sensitive organs, iCR can also be used in patients with hormone-dependent tumors suffering from iatrogenic menopausal symptoms. However, this should not take place in self-medication but under medical supervision. Breast-cancer patients are not appropriate candidates for non-supervised self-medication, and it seems reasonable that HD iCR or alternatively iCRþHP are more effective in patients with medication-induced symptoms. Breast cancer patients taking iCR may possibly benefit from prolonged recurrence-free survival, which should be confirmed by further clinical trials.
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