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 |
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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. |
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Outcomes | LH, testosterone, LH/FSH, estradiol, insulin, BMI, cervical mucus Pregnancy rate (per woman) Ovulation rate (per cycle) |
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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 |
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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 |