Prasad 2013.
Methods | Single‐centre placebo RCT | |
Participants | Participants randomised to 1 of 2 groups (n = 62) ‐ Mifepristone 10 mg ‐ Placebo Inclusion criteria ‐ Symptomatic fibroids No additional details available Setting: Delhi, India |
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Interventions | Mifepristone 10 mg orally daily vs placebo Duration: 3 months |
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Outcomes | Outcomes assessed at baseline and at 3 months Primary outcome ‐ Fibroid volume Secondary outcomes ‐ Endometrial biopsy. Reported on 'cystic glandular hyperplasia' but pathology criteria not available ‐ Hormone profile ‐ Fibroid symptoms ‣ Bleeding/amenorrhoea ‣ Dysmenorrhoea |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomized" ‐ no details. Attempts to contact study authors unsuccessful |
Allocation concealment (selection bias) | Unclear risk | Not stated. Attempts to contact study authors unsuccessful |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "Single blind" ‐ no further details. Attempts to contact study authors unsuccessful |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | "Single blind" ‐ no further details. Attempts to contact study authors unsuccessful |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details. Attempts to contact study authors unsuccessful |
Selective reporting (reporting bias) | Unclear risk | No details. Attempts to contact study authors unsuccessful |
Other bias | Unclear risk | Data in form of conference proceedings. No published follow‐up data. Protocol not found on clinicaltrials.gov |