Bai 2007.

Methods	Design: randomised, double‐blind, active‐controlled, double‐dummy, multicentre, parallel group trial Randomisation ratio: 1:1 Study duration: 9 months (from September 2004 to May 2005)
Participants	Participant characteristics: 244 women enrolled, 244 were randomised (black cohosh = 122, tibolone = 122) and 26 (10.7%) dropped out. Mean age (black cohosh = 51.8 ± 3.7 years, tibolone = 51.5 ± 3.5 years). Duration of amenorrhoea (black cohosh = 32.2 ± 24.6 months, tibolone = 35.4 ± 25.3 months) Inclusion criteria: female, aged between 40 and 60 years, history of menopausal complaints for at least 4 weeks, spontaneous amenorrhoeic interval ≥ 5 months since last regular menstruation, baseline E2 ≤ 30 pg/mL if amenorrhoeic < 12 months, KI ≥ 15 Exclusion criteria: HT within the last 4 weeks, psychoactive drugs, BMI > 28 kg/m2, endometrial thickness ≥ 5 mm if amenorrhoea ≥ 12 months or ≥ 15 mm if < 12 months, irregular gynaecological bleeding within the last 4 weeks, hysterectomy, amenorrhoea > 8 years, abnormal cervical smear examination, contraindication of tibolone, cancer, severe or current disease that could interfere with climacteric manifestations or treatment, drug abuse, alcohol addiction, participation in a Phase I or II trial in the last 180 days or a Phase III or IV trial within the last 90 days, and any drug, food, traditional Chinese medicine or nutritional supplement used for climacteric symptoms Diagnostic criteria: not stated Co‐morbidities: not stated Co‐medications: not stated
Interventions	Number of study centres: 5 Country/location: China Setting: hospital research centres Intervention (route, total, dose/day, frequency): oral isopropanolic extract of Cimicifuga racemosa (Remifemin, equivalent to 2.5 mg dry extract or 20 mg C. racemosa root) 2 tablet twice a day, and 2 tibolone‐matching placebo tablet daily Control (route, total, dose/day, frequency): oral tibolone 2.5 mg tablet daily, and 2 C. racemosa‐matching placebo tablets daily Duration of intervention: 12 weeks Duration of follow‐up: not applicable Run‐in period: not applicable Treatment before study: not stated Titration period: not applicable
Outcomes	Primary outcomes: benefit (i.e. change in KI) to risk (i.e. number of adverse events) balance Secondary outcomes: total KI score, KI subscale scores, KI responder rate, Clinical Global Impression items, subject's global efficacy of effectiveness Additional outcomes: vital signs, body weight, concomitant disease, adverse events, endometrial thickness, liver function test, complete blood picture
Notes	This study reported final value scores
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "All eligible subjects were randomly allocated to the two treatment groups" (method not described) Comment: probably not 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"; "double dummy"; "patients received two Remifemin® tablets (1‐0‐1) and one tibolone‐matching placebo...the tibolone‐group applied two Remifemin®‐ matching placebos and one tibolone tablet" Comment: probably done.
Incomplete outcome data (attrition bias) All outcomes	High risk	ITT was not mentioned, but the term 'full analysis set' was used; however, "six subjects were excluded from the full analysis set...for discontinuing the trial for any reason" A similar proportion of women withdrew from each group, though the reasons differed
Selective reporting (reporting bias)	Unclear risk	All primary and secondary outcomes listed were reported, although no study protocol was published or lodged
Other bias	Low risk	There were no significant differences in participant characteristics between groups at baseline