Efficacy of black cohosh (Cimicifuga racemosa) medicines for treatment of menopausal symptoms - comments on major statements of the Cochrane Collaboration report 2012 "black cohosh (Cimicifuga spp.) for menopausal symptoms (review)".

Menopausal symptoms management with high-quality plant extracts from Actaea (Cimicifuga. racemosa rootstock is well-established. Efficacy and safety are supported by research and clinical trials since several decades and backed up by official monographs. However, the recent published Cochrane review on black cohosh neglects major evidence for beneficial effects. The authors' negative conclusions are questionable and call for reply and clarification. Our careful reconsideration of all appropriate placebo-controlled clinical studies reveals a standardized mean difference of 0.385 in favor of black cohosh (p < 0.0001).

Suspected black cohosh hepatotoxicity: no evidence by meta-analysis of randomized controlled clinical trials for isopropanolic black cohosh extract.

OBJECTIVE: Black cohosh, a popular herbal treatment for menopausal symptoms, has been implicated in a number of hepatotoxicity case reports. The purpose of this investigation was to analyze data gained from clinical trials on the effect of black cohosh on liver function. METHODS: A meta-analysis of randomized, double-blind, and controlled clinical trials was conducted. These studies primarily evaluated the efficacy and safety of the isopropanolic black cohosh extract (iCR) in perimenopausal and postmenopausal women. Raw data on liver function values of aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltranspeptidase were considered in this analysis, if these data at baseline and after 3 to 6 months of treatment were available. Standard methods of descriptive statistics were used in this analysis. RESULTS: Five studies involving a total of 1,117 women were included in the meta-analyses. A total of 1,020 women (test population=517 and reference population=503) completed the studies. Perimenopausal and postmenopausal women (40-60 y) were treated daily with iCR (corresponding to 40-128 mg drug) for 3 to 6 months. The meta-analyses of the standardized mean differences in the "test" versus "reference" showed no significant effects and no differences between double-blind, placebo-controlled and other trials. The overall fixed effect ± SEM was 0.055 ± 0.062 (P=0.37) for aspartate aminotransferase and 0.063 ± 0.062 (P=0.31) for alanine aminotransferase. The nonsignificant effects concerned the overall analyses of all included studies as well as the proportion of placebo-controlled studies. CONCLUSIONS: The results of this meta-analysis of five randomized, double-blind, and controlled clinical trials showed no evidence that iCR has any adverse effect on liver function.

Incidence of fetal malformations in pregnancies complicated by oligo- and polyhydramnios.

Oligo- and polyhydramnios could be observed in 1%-7% of all pregnancies and are associated with an increased risk of fetal anomalies. We evaluated the fetal outcomes of 840 pregnancies with oligo- and polyhydramnios on the basis of ultrasonographic findings (oligohydramnios: single deepest pocket <2 cm, polyhydramnios: single deepest pocket >8 cm) between 12 and 42 weeks of gestation. We observed 734 pregnancies (752 fetuses) with oligohydramnios and 106 pregnancies (108 fetuses) with polyhydramnios. Of the 752 fetuses with oligohydramnios, 81% survived and 19% died in utero. Among the 108 fetuses of pregnancies with polyhydramnios, 72% of the babies survived and 28% died in utero. In polyhydramnios, 48% (52 of 108) of the fetuses had severe malformations, which is significant compared to the rate of 11.8% (89 of 752) of fetal malformations in oligohydramnios ( P-value<0.001). Oligohydramnios is predominantly associated with malformations of the urinary tract, whereas polyhydramnios is associated with anomalies of the gastrointestinal tract. In conclusion, measurement of single deepest pocket is a valuable screening method to evaluate pregnancies showing the complications of oligo- and polyhydramnios. Pregnancies with severe polyhydramnios have a poorer outcome and fetuses have a significantly higher risk of congenital malformations compared to pregnancies with oligohydramnios.

Prediction of fetal Rh D and Rh CcEe phenotype from maternal plasma with real-time polymerase chain reaction.

Real-time PCR methods for the detection of RHD and the C, c, and E allele of RHCE were applied for the prediction of fetal Rh phenotype using maternal plasma. In one of 36 samples investigated the DNA extraction failed. When we tested the remaining 35 samples for Rh antigens which were absent on the mother's red cells, the fetal D-status was correctly determined in 26 of 27 cases (1 false negative). Fetal C was tested correctly in 23 samples, c was true positive in the only c-negative woman and the fetal E-status was correctly determined in 35 cases. In conclusion real-time PCR of maternal plasma is a non-invasive method to determine fetal RH genotype. However, more studies are required for routine applications because the method is not 100% sensitive.