Comment: The quality of evidence is downgraded by imprecise results (one trial only) and upgraded by large magnitude of effect.
A Cochrane review included 10 studies with a total of 960 subjects. 2 RCTs compared mifepristone versus placebo or versus a different dose of mifepristone, one RCT compared asoprisnil versus placebo, one ulipristal versus leuprolide acetate, and 4 compared gestrinone versus danazol, gonadotropin-releasing hormone (GnRH) analogues, or a different dose of gestrinone. The quality of evidence ranged from high to very low. At three months, the mifepristone group had lower rates of dysmenorrhoea suggesting that if 40% of women taking placebo experience dysmenorrhoea, then between 3% and 10% of women taking mifepristone will do so. The mifepristone group also had lower rates of dyspareunia but higher rates of side effects . There was insufficient evidence to show differences between different doses of mifepristone. However, subgroup analysis suggested that the 2.5 mg dose may be less effective than 5 mg or 10 mg for treating dysmenorrhoea or dyspareunia. Evidence was insufficient to show differences, if present, between gestrinone and danazol in rate of pain relief, dysmenorrhoea, or dyspareunia. Only one small trial (n=38)assessed ulipristal.
| Outcome - Follow-up 3 months | Relative effect (95% CI) | Assumed risk- Control - Placebo | Corresponding risk - Intervention - Mifepristone (95% CI) | No. of participants (studies) Quality of evidence |
|---|---|---|---|---|
| Prevalence of dysmenorrhoea | OR 0.08 (0.04 to 0.17) | 402 per 1000 | 51 per 1000 (26 to 103) | 352 (1) Moderate |
| Prevalence of dyspareunia | OR 0.23 (0.10 to 0.51) | 288 per 1000 | 85 per 1000 (43 to 171) | 223 (1) Low |
| Side effects: amenorrhoea | OR 686.16 (92.29 to 5101.33) | 11 per 1000 | 884 per 1000 (507 to 983) | 360 (1) High |
| Side effects: hot flushes | OR 28.79 (3.93 to 210.73) | 11 per 1000 | 243 per 1000 (42 to 701) | 360 (1) High |
Date of latest search: 18 December 2018