International Journal of Phytomedicine and Phytotherapy
Table 2 Short description of clinical studies with Cimiciduga racemosa preparations preparations
From: Black cohosh (Cimicifuga racemosa) is a non-estrogenic alternative to hormone replacement therapy
Ref. (placebo or comparator controlled) | Design | Patient characteristics and age | Treatment, dose, and duration | Outcome measures | Finding and comments | Effects in short |
|---|---|---|---|---|---|---|
No = Ø | ||||||
Signif. pos = + | ||||||
Signif. neg = − | ||||||
Newton et al. 2006 [44] | Randomized, double-blind, comparator and placebo-controlled | 351 early postmenopausal women with 2 or more hot flushes daily | 160 mg of a CR extract daily (probably equivalent to 1600 mg dried rhizome powder) vs a multibotanical preparation vs placebo vs 0.625 mg conjugated estrogens with or without 2 mg medroxyprogesterone- acetate, duration 1 year | Frequency and intensity of vasomotor symptoms (Wiklund Vasomotor Symptom Subscale) | Significant reduction under hormone treatment. No significant differences between CR and placebo, worsening of symptoms in multibotanical group. | - |
Note: the CR dose was approximately 40 fold higher than in the studies which yielded positive effects | ||||||
Bai et al. 2007 [45] | Randomized, double-blind, comparator controlled | 244 early post-menopausal women with Kupperman Index > or = 15 | Isopropanolic CR extract (40 mg dried rhizome powder daily (equivalent to 5 mg dried extract)) vs 2.5 mg tibolone, duration 3 months. | Kupperman Menopause Index | CR preparation was as effective as tibolone in reducing KMI score | + |
Oktem et al. 2007 [46] | Randomized, comparator controlled trial | 120 women with climacteric symptoms | Aquous-ethanolic CR extract BNO 1055 (40 mg dried rhizome powder daily (equivalent to approximately 6.5 mg dried extract)) vs serotonin reuptake inhibitor fluoxetine, duration 6 months | Kupperman Menopause Index, Beck’s Depression Scale | Hot flush score improved by 85 % vs 62 under fluoxetine, whereas fluoxetine was more effective than CR to reduce depressive symptoms | + |
Geller et al. 2009 [47] | Randomized, double-blind, comparator and placebo-controlled | 89 postmenopausal women with 35 or more hot flushes per week | 128 mg of an ethanolic CR extract, vs 398 mg of a red clover extract (containing 120 mg isoflavones) vs 0.625 mg conjugated estrogens in combination with 2.5 mg medroxyprogesterone -acetate vs placebo, duration 12 months | Number of vasomotor symptoms and night sweats | No significant effects by both plant preparation Significant superiority of the hormone preparation. | − |
Note: the CR dose was approximately 25 fold higher than in the studies which yielded positive effects | ||||||
Van der Sluijs et al. 2009 [52] | Randomized, double-blind placebo controlled trial | 93 women women with 6 or more vasomotor symptoms per day | 3150 mg dried rhizome powder (equivalent to approximately 300 mg CR extract) per day, duration 16 weeks | Greene Climacte5ric Sclae | No significantly more improvement in comparison to placebo | − |
Note: The CR dose was approximately 50 fold higher than in the studies which positive results |