Carlisle 2008.
| Methods | Design: randomised, double‐blind, placebo‐controlled, parallel group trial Randomisation ratio: not stated Study duration: not stated |
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| Participants | Participant characteristics: 48 women were randomised (black cohosh = 24, placebo = 24), and 2 (4.2%) dropped out. Mean age (black cohosh = 54.1 ± 5.0 years, placebo = 52.8 ± 4.4 years). Time postmenopausal (black cohosh = 3.7 ± 1.5 months, placebo = 2.8 ± 1.7 months) Inclusion criteria: female, Caucasian, aged between 35 and 60 years, had natural or surgical menopausal for at least 1 year but not more than 6 years, able to give voluntary consent, not taking any hormone replacement therapy or SERMs for the past 3 months, had not been diagnosed with osteoporosis or an osteoporosis‐related bone fracture, were sedentary and not involved in a regular exercise programme, and had not taken black cohosh for the past 3 months Exclusion criteria: smoker, lactose intolerant, history of taking bisphosphonates at any time in their life, history of kidney or liver disease, diabetes, parathyroid disease or documented osteoporosis with DEXA scan, failed to take study medication as directed, became ill or were diagnosed with osteoporosis or fracture during the study, changed their mind about being included in the study Diagnostic criteria: not stated Co‐morbidities: not stated Co‐medications: not stated |
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| Interventions | Number of study centres: not stated Country/location: North Central Florida, US Setting: not stated Intervention (route, total, dose/day, frequency): oral Cimicifuga racemosa (40 mg, standardised to 2.5% triterpene glycosides) 1 capsule daily; plus calcium carbonate and vitamin D supplement, 1 caplet twice daily (dosage not described) Control (route, total, dose/day, frequency): oral placebo (lactose), 1 capsule daily; plus calcium carbonate and vitamin D supplement, 1 caplet twice daily (dosage not described) Duration of intervention: 12 weeks Duration of follow‐up: not applicable Run‐in period: not applicable Treatment before study: not stated Titration period: not stated |
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| Outcomes | Primary outcomes: serum C‐terminal telopeptide, serum osteocalcin Secondary outcomes: weight, height, BMI, blood pressure Additional outcomes: not stated |
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| Notes | The type of data reported was not clear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "the participant was...randomized into either the experimental or the control group using a computer generated randomization table" Comment: probably done |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not described Comment: probably not done |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind"; "the placebo group took an identical appearing placebo capsule" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | High risk | ITT was not mentioned 2 women withdrew from the study (1 in each arm) ‐ the reasons for withdrawal differed between groups. Both women were excluded from the analysis by researchers |
| Selective reporting (reporting bias) | Unclear risk | All primary and secondary outcomes listed were reported, although no study protocol was published or lodged |
| Other bias | Unclear risk | Baseline differences in years postmenopausal was observed |