Ainehchi 2019.
Study characteristics | ||
Methods | RCT, single‐blind, single centre, 60 participants, 9 months duration | |
Participants | 75 enrolled: CHM1 = 25, CHM2 = 25, control = 25, 18 to 35 years, baseline was comparable 60 analysed/evaluated: CHM1 = 20 (3 converted to IVF/ IUI ; 2 did not feel comfortable enough to participate) CHM2 = 20 (2 did not take an initial blood test; 2 converted to IVF/ IUI; 1 did not feel comfortable enough to participate) Control = 20 (2 participants lost to follow‐up for consuming other medication along with treatment; 3 did not feel comfortable enough to participate) PCOS diagnosis criteria (DC): consistent with 2003 Rotterdam criteria (evaluated by review authors) Inclusion criteria (In): PCOS, infertility and willing to be pregnant; 18‐35 years old; BMI < 30 kg/m2. Exclusion criteria (Ex): diabetes mellitus, the use of medications such as those helping ovulation or insulin sensitisers, thyroid disorders, cholesterol‐lowering drugs, smoking, current treatment for infertility, hypertension, cardiovascular diseases, Cushing syndrome, and allergy to spearmint, ginger, cinnamon, and C sinensis. Abbreviations: IUI: intrauterine insemination; IVF: in vitro fertilisation. |
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Interventions | CHM1: 700 mg herbal mixture capsule daily for three months CHM2: 700 mg herbal mixture capsule daily + CC (50‐150 mg) for three menstrual cycles from the fifth day of menstruation for five days clomiphene, for the duration of three months Control: CC (50–150 mg) from the fifth day of menstruation for five days clomiphene, for the duration of three months Duration: treat for 3 months, follow‐up 6 months. Abbreviation: CC: Clomiphene citrate. |
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Outcomes | Pregnancy rate (per woman) Ovulation rate (per cycle) FBS: Fast blood sugar, HOMA‐IR: Homeostatic model assessment for insulin resistance, insulin, CAT: Catalase, GPx: Glutathione peroxidase, SOD: Superoxide dismutase, MDA: Malondialdehyde Side effects |
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Notes | Herbal mixture = 250 mg Mentha spicata + 200 mg Zingiber ocinale + 150 mg Cinnamomum zeylanicum + 100 mg Citrus sinensis; hospital preparation, 700 mg/capsule Clomiphene: Manufacturer not mentioned Iranian Registry of Clinical Trials (IRCT201509295563N7) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The participants were divided into three groups by random allocation software (RAS/ version 1.0.0, M Saghaei, Isfahan, Iran) randomised blocks of three and six with an allocation ratio of 1:1:1 by a person who was not involved in the study. This randomisation method is very unlikely to produce a perfect 25 vs 25 vs 25, so we assessed it as unclear risk. |
Allocation concealment (selection bias) | Low risk | For allocation concealment, according to sequence generation, opaque and sealed envelopes numbered from 1 to 75; each contained a letter designating the allocation. The first envelope was dedicated to the first participant and this process was followed to the end of the study. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | single‐blind; only the statistician was blind to the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | single‐blind; only the statistician was blind to the study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No intention‐to‐treat (ITT) analysis. The analysis rate was 80% (60/75) |
Selective reporting (reporting bias) | Low risk | This published study was consistent with the protocol |
Other bias | Low risk | No other potential risk of bias identified |