Palomba 2004.
| Methods | Randomised double‐blind study conducted in Italy Timing: October 2001 to December 2002 |
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| Participants | 120 women; mean age of metformin group was 26.8 ± 2.2 and in LOD group 27.5 ± 2.4 years Inclusion: Overweight (BMI 25 ‐ 30 kg/m2) women with PCOS, clomiphene‐resistant Exclusion: Age < 22 or > 34 years; hypothyroidism, hyperprolactinaemia, Cushings syndrome, nonclassical congenital adrenal hyperplasia, and current or previous (within 6 months) use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or anti‐obesity drugs, or other hormonal drugs; neoplasms, metabolic, hepatic, or cardiovascular disorder or other concurrent medical illness; women who were intending to start a diet or a specific programme of physical activity; having organic pelvic disease, previous pelvic surgery, suspected peritoneal factor infertility , and tubal or male infertility |
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| Interventions | Diagnostic laparoscopy followed by metformin cloridrate 850 mg twice daily. If anovulatory at 6 months clomiphene citrate 150 mg daily from Day 3 ‐ 7 (n = 60), versus LOD (3 to 6 punctures in each ovary depending on size of ovary) followed by multivitamins twice daily. If anovulatory at 6 months clomiphene citrate 150 mg daily from day 3 ‐7 (n = 60) Follow‐up for 6 months |
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| Outcomes | Live birth, adverse events, menstrual cycle characteristics, ovulation rate, pregnancy, miscarriage, costs | |
| Notes | Conflict of interest: not stated | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The randomisation was carried out using online software to generate a random allocation sequence in double block as method of restriction" |
| Allocation concealment (selection bias) | Unclear risk | Quote: 'The random allocation sequence was concealed until the interventions were assigned" Comment: there were no further details in the paper |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 women in metformin group and 5 in the LOD group. Reasons given were evidence of minimal endometriosis by laparoscopy (4 in Group A and 2 from Group B) and non‐compliance (1 from each group). 1 woman from Group A and 2 from group B were excluded for weight loss observed in the first 3 months of the study |
| Selective reporting (reporting bias) | Unclear risk | The original protocol could not be retrieved. All outcomes cited in the Methods section were reported |
| Other bias | Low risk | No evidence of other risk of bias |