BLACK COHOSH: Benefits, Side Effects, Uses, Dosage, Warnings?
With entry into the menopause, reduce production and distribution of female sex hormones estrogen and progesterone. From these hormonal changes result in women usually between 45 and 55 years old menopausal symptoms, the subject in duration, type and intensity of a large variability and may also be culturally influenced. 1 Physically vasomotor symptoms are predominant, mentally come mainly insomnia and depressive moods added. Depending on the range and strength of the individual complaints women want to preserve their quality of life is often a drug treatment.
Hormone replacement therapy has traditionally been the treatment of choice and was up in the 90s even widely used prophylactically. This is not always tolerated and is contraindicated hormone-dependent, in the case of malignant diseases. In addition, the Women's Health Initiative (WHI) study found in the United States with over 16,000 patients at increased breast cancer and cardiovascular risk. 2 The use of anxiolytics, antidepressants or antiepileptics was indeed trying, but hard to justify medically because of significant side effects. However, the application of traditional herbal products is increasingly an alternative.
The healing effect of root extracts of black cohosh (Cimicifuga racemosa) has been known for over 200 years and has been intensively studied in recent decades. Studies with nearly 3,000 women showed good efficacy and tolerability. 3-8 Recently, the efficacy of Cimicifuga in the treatment of menopausal complaints but provided by the placebo and hormone-controlled STOP trial, however, unclear dose, and doubtful placebo response in question. 9 The declining after the media coverage of the WHI study results dissemination of hormone replacement therapy appears to be associated, however, with a declining incidence of breast cancer in the United States. 10 In this respect a treatment option remains desirable.
The dose-dependent efficacy and tolerability of Cimifemin® uno in the treatment of menopausal symptoms has been shown in a randomized, double-blind, placebo-controlled clinical trial. 3 Now its effectiveness and compatibility should be checked in a practical therapy observation. One tablet of the commercial preparation Cimifemin® uno contains 6,5mg native black cohosh extract Ze 450 or an average of 40mg dried Cimicifuga racemosa root drug (drug-extract ratio virgin 4.5-8.5: 1).
Patients and methods
The therapy observation was conducted as multicenter, open, prospective study in 128 general and specialist practices of Switzerland between 4 November 2005 and 4 September, 2006. This provided for an observation period of four months and a daily dose of a Cimifemin® uno tablet, although one could be customized by the treating physician.
Methodologically, the study leaned closely to a similar synthetic steroid with tibolone, 11 to evaluate the efficacy and tolerability of both drugs then be able to compare. Accordingly, and evaluation of menopausal symptoms using the described therein and established Menopause Rating Scale, MRS II. This is calculated from the sum of the individual ratings of 11 symptoms (hot flushes and sweating, heart complaints, sleep disturbances, depressive moods, irritability, anxiety, fatigue, sexual problems, urinary problems, vaginal dryness, and joint and muscle pain) on a 5-point ordinal scale from 0 ("no") to 4 ("very much"). The efficacy and tolerability total was also classified on an ordinal scale from 0 ("very bad") to 4 ("very good"). Scores between two stages were, although not provided in data collection, with values of 0.5; 1.5; 2.5 or 3.5 in the evaluation.
The evaluation is based on questionnaires that were completed before the start of treatment and after the first and fourth month of treatment by patient and physician. In addition, body weight and BMI and the occurrence of adverse events in all three visits were recorded.
Statistical analysis was performed (pairwise or multiple) using standard procedures such as those provided by the statistical program SPSS, version 15.0 is available (dependent or independent) or the respective comparison taking into account the data distribution, the nature of the sample. Bonferroni corrections for multiple comparisons had no effect on the original test results. Therapy data were received only in the evaluation if they could be considered by taking Cimifemin® uno.
total of 584 women were included with menopausal symptoms in the therapy monitoring, the planned finished 541.
The included patients had a mean age of 53.2 ± 6.6 years and a mean BMI of 25.0 ± 4.1 kg / m2. 127 women (21.8%) were perimenopausal, with the remaining post-menopausal women and the last menstrual period was back an average of 4.4 ± 5.6 years. Menopausal complaints at inclusion were on average 2.4 ± 3.8 years since; 366 women (62.7%) were in this investigation were first evaluated against such.
Most of the remaining 215 women, of whom information was available, had been previously treated with hormones (76.3%; 11.6% Cimicifuga, 7.4% other vegetable; 6.5% other or unknown; 5.6% homeopathic products), 73.5% of them more than a year. In 33 patients (5.7%) were probably the menopausal symptoms by chemotherapy triggered or surgery; 1.4% of patients had a history of liver problems, 3.6% pre-existing malignancy.
About a third of the patients received concomitant treatment against other diseases, mainly antihypertensives. A total of 43 patients completed (7.3%) the therapy prematurely, 9 (1.5%) in the first and 34 (5.8%) before the end of the fourth month of treatment (Table 1); 21 patients remained one of the two visits remotely without interrupting the medication.
The most pronounced symptoms at the beginning of the investigation were hot flushes and sweating, followed by insomnia, irritability, general fatigue, and depressive symptoms; however, vaginal dryness, anxiety, sexual problems, joint and muscle pain, heart problems, and urinary problems were average? classified as mild or absent. The individual symptoms as well as the sum of all complaints (MRS II) showed a significant improvement (Table 2, Figure 1) continuously over the course of therapy with Cimifemin® uno.
Each of the detected symptoms pointed to four months an average rating of less than 1 (= "light") on. The change from baseline correlated weakly but significantly with the duration and severity of symptoms at baseline and with the age of the patient and the duration since the last menstrual period (Table 3). Even though this is for a greater efficacy in perimenopausal women spoke tended, but none of the differences compared to post-menopausal women and significant (all p> 0.05).
The overall effectiveness of therapy for menopausal complaints by patients and doctors took over the investigation, primarily due to a doubling up between the two treatment visits proportion of patients (from 19.3% to 35.1%) and physicians (16.3% to 33.2%), the 'excellent' rated the effectiveness with. After four months of estimated 77.1% of physicians and 75.5% of patients the efficacy as good or very good (Figure 2). The main symptom hot flash and sweating was reduced to the scale by 59% from 2.5 to 1.0 (Figure 3).
About 78% of all physicians and patients the therapy on the observation end also wanted to continue. Only 2.4% of patients discontinued therapy due to lack of efficacy prematurely (Table 1). The response to therapy can be used with great accuracy after one month predict, since all reviews for effectiveness after 4 months closely with those of the first month correlated (MRS II-difference, R = 0.765, assessing the overall effectiveness of R = 0.602 (doctor) R = 0.643 (patient), all p <0.01).
A total of 35 adverse events in 25 patients (4.3%) were registered, none was classified as serious. Most were non-specific and related to the digestive system (Table 4). In 7 cases (1.2%) led to discontinuation lack of compatibility. Body weight and BMI remained constant during the Cimicifuga treatment. Of 8 patients with anamnestic liver problems reported a patient tachycardias, but continued treatment without further adverse events; another patient completed the therapy prematurely because of lack of efficacy. Of 21 patients with pre-malignant disease had no adverse event, two patients completed the therapy prematurely because of a lack of efficacy, the other unknown reason. None of the patients with pre-malignant or hepatobiliary disorders showed a change in the findings. The compatibility of Cimifemin® uno was rated by physicians as very good (Figure 2).
This therapy observation confirmed the efficacy and safety of black cohosh in the treatment of menopausal symptoms such as they had previously been occupied in randomized, placebo-controlled trials. 3-8
In comparison with tibolone, a synthetic steroid, its efficacy and tolerability with the same design tested wurde11 showed Cimifemin® uno approximately equal effectiveness. Thus, the MRS II improved after 4 months of treatment with tibolone to an average of 8.1 compared to 7.0 points with Cimicifuga; 17% of patients treated with tibolone showed a worsening of symptoms compared to only 3% among black cohosh (Table 5). As well or very well judged 69.5% of patients and 73.5% of the physicians the effectiveness of tibolone, for Cimifemin® uno there were 75.5% and 77.1%. The compatibility of Cimifemin® uno was rated by 87% of physicians as good or very good, compared to just 80% for tibolone. With tibolone reported 39% of women have at least one adverse event, including black cohosh, there were only 4.3%. It was a weight increase with tibolone with a frequency of 5.2%, the second most common event whereas Cimifemin® uno no effect on body weight or BMI had. Thus Cimicifuga showed a significantly better tolerability. The predictive importance of the strength and duration of the symptoms of menopause or for the treatment response was also observed in the tibolone trial and thus does not appear to be specific for the response to Cimicifuga.
Compared to a previous treatment observation 14 with a slightly different technically prepared Cimicifuga extract is an increase in the willingness with therapy over the period of observation also revealed proceed from 70% to 78% of patients. In 2003, the proportion of beginning with a Cimicifuga product pretreated patients was 1% compared to 11.6% for inclusion in this therapy observation.
In controlled clinical trials, which cohosh extracts tested against hormone replacement therapy to treat menopausal symptoms, Cimicifuga showed a comparative effectiveness. 8.12 Newton and employees expressed based on the HALT study recently doubts about the clinical relevance and long-term effects of Cimicifuga. 9 The relevance an isolated negative study must be viewed critically, especially since the HALT study has major flaws in the methodology used Cimicifuga preparation and dose is unclear and the placebo effect was very high. 13 The results of the present investigation that the under usual practice everyday was performed, is further evidence that the efficacy and safety of Cimicifuga - and here specifically in the indirect comparison with tibolone - for menopausal symptoms of clinical relevance.
Due to the here again occupied favorable ratio of efficacy and tolerability, the "non-hormonal" therapy with Cimifemin® uno could thus become a new standard treatment of menopausal complaints. 3