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. 2021 Jun 4;2021(6):CD007535. doi: 10.1002/14651858.CD007535.pub4

Li 2007.

Study characteristics
Methods RCT, single centre, 90 participants, 3 years' duration
Participants 90 enrolled: CHM1 = 30, CHM2 = 30, control = 30, 21 to 38 years, baseline was comparable
87 analysed/evaluated: CHM1 = 29 (1 converted to IVF‐ET after CHM treatment for 1 month), CHM2 = 30, control = 28 (1 moved to another place, 1 discontinued therapy because of pelvic inflammation)
Obesity: CHM1 = 7, CHM2 = 6, control = 6
Hirsutism: CHM1 = 19, CHM2 = 18, control = 21
LH/FSH > 2.5: CHM1 = 20, CHM2 = 19, control = 21
High testosterone: CHM1 = 16, CHM2 = 17, control = 15
Follicle number > 10: CHM1 = 25, CHM2 = 24, control = 22
Enlarged ovary: CHM1 = 5, CHM2 = 6, control = 7
PCOS DC: consistent with Rotterdam criteria (evaluated by review authors)
In: PCOS and infertility
Ex: using other drugs for ovulation induction, participants unable to follow‐up, tumour patients, adrenal diseases, other hyperandrogenic diseases
Interventions CHM1: clomiphene simulacrum (5th to 9th day of menstrual cycle, 1 pill, once a day, 5 days), Lingzhu infusion (5th to 14th day of menstrual cycle, 1 bag, tid, 10 days), Shenqi capsule (from 14th day of menstrual cycle or after ovulation, 4 grains, tid, until menstrual onset or pregnancy or the 45th day of menstrual cycle), if amenorrhoea for 45 days then MPA would be prescribed (10 mg, once a day, 5 days)
CHM2: clomiphene (5th to 9th day of menstrual cycle, 50 mg, once a day, 5 days), Lingzhu infusion, Shenqi capsule, and MPA
Control: clomiphene, Lingzhu simulacrum, Shenqi simulacrum, and MPA
Duration: treated no more than 6 menstrual cycles, follow‐up time was unclear.
Outcomes LH, testosterone, LH/FSH, estradiol, insulin, BMI, cervical mucus
Pregnancy rate (per woman)
Ovulation rate (per cycle)
Notes Clomiphene: Codal Synto Ltd. batch number: H20020325
Lingzhu infusion: hospital preparation, batch number Z03020211, 6 g/bag
Shenqi capsule: hospital preparation, batch number Z03020212, 0.5 g/pill
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The study reported random method without the details. We were unable to contact the study authors for more information.
Allocation concealment (selection bias) Unclear risk We were unable to contact the study authors for more information.
Blinding of participants and personnel (performance bias)
All outcomes Low risk The study used mimic drugs. Participants and the outcome assessor were blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk The study used mimic drugs. Participants and the outcome assessor were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk No intention‐to‐treat (ITT) analysis. The analysis rate was 96.7% (87/90).
Selective reporting (reporting bias) Unclear risk The study protocol was unavailable.
Other bias Low risk No other potential risk of bias identified