Study designs of evaluations included in the review
Uncontrolled and controlled preclinical and clinical trials were eligible for inclusion. The review included randomised controlled trials (RCTs) and uncontrolled studies, including post-marketing surveillance reports, preclinical studies, and historical and anecdotal reports.
Specific interventions included in the review
The inclusion criteria were not explicitly stated in terms of the interventions, although it was clear that studies of Cimicifuga racemosa were eligible for inclusion. The review included studies of black cohosh, but the focus was on commercially available extracts of Cimicifuga. The included clinical trials used Cimicifuga in doses ranging from 20 to 40 drops of ethanolic extract twice daily (48 to 140 mg crude drug), to two to four tablets of isopropanolic extract per day (39 to 140 mg crude drug). Where reported, the duration of the studies ranged from 8 to 52 weeks.
Participants included in the review
The inclusion criteria were not explicitly stated in terms of the participants, although it was clear that studies of women with menopausal symptoms were to be included. The included clinical studies were of women with menopausal symptoms, premenstrual tension, pregnancy problems, dysmenorrhoea, amenorrhoea, oligomenorrhoea, hormone-related conditions, breast cancer (including women taking tamoxifen), or hysterectomy; perimenopausal women; and girls with juvenile menstrual disorders.
Outcomes assessed in the review
The inclusion criteria were not explicitly stated in terms of the outcomes, although it was clear that studies that reported adverse effects were eligible for inclusion. Some of the included studies assessed the oestrogenic effect, i.e. cell proliferation, luteinising hormone (LH), follicle stimulating hormone (FSH), prolactin and sex hormone-binding globulin levels.
How were decisions on the relevance of primary studies made?
The authors did not state how the papers were selected for the review, or how many reviewers performed the selection.